issue-1996-04-03•Federal Register proposed rules — 1996-04-03
Federal Register proposed rules — 1996-04-03
issue-1996-04-03Federal Register proposed rules — 1996-04-03Proposed Regulation
Published Federal Register documents, not public-inspection drafts. The GPO XML/text rendition is a research aid; the linked complete official PDF retains the printed layout and all graphics. Graphics are retained in that PDF and are not independently reproduced in this text rendition. Publication does not establish that every provision remains legally in force.
FR Doc. 96-8181 Request for Comments Concerning Interpretations of Magnuson-Moss Warranty Act; Rule Governing Disclosure of Written Consumer Product Warranty Terms and Conditions; Rule Governing Pre-Sale Availability of Written Warranty Terms; and Guides for the Advertising of Warranties and Guarantees
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14687-14690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8181]
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[[Page 14688]]
FEDERAL TRADE COMMISSION
16 CFR Parts 700, 701, 702, and 239
Request for Comments Concerning Interpretations of Magnuson-Moss
Warranty Act; Rule Governing Disclosure of Written Consumer Product
Warranty Terms and Conditions; Rule Governing Pre-Sale Availability of
Written Warranty Terms; and Guides for the Advertising of Warranties
and Guarantees
AGENCY: Federal Trade Commission.
ACTION: Request for public comments.
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SUMMARY: The Federal Trade Commission (``the Commission'') is
requesting public comment on a set of warranty-related rules and
guides: (1) its Interpretations of the Magnuson-Moss Warranty Act
(``Interpretations''); (2) its Rule Governing Disclosure of Written
Consumer Product Warranty Terms and Conditions (``Rule 701''); (3) its
Rule Governing Pre-Sale Availability of Written Warranty Terms (``Rule
702''); and (4) its Guides for the Advertising of Warranties and
Guarantees (``Guides''). The Commission is also requesting comments
about the overall costs and benefits of these rules and guides and
their overall regulatory and economic impact as part of its systematic
review of all current Commission regulations and guides.
The Interpretations represent the Commission's views on various
aspects of the Magnuson-Moss Warranty Act (``the Act''), 15 U.S.C. et
seq., and are intended to clarify the Act's requirements. They are
similar to industry guides in that they are advisory in nature, but
failure to comply with them may result in corrective action by the
Commission under the applicable statutory provisions. Rule 701
specifies the information that must appear in a written warranty on a
consumer product. Rule 702 details the obligations of sellers and
warrantors to make warranty information available to consumers prior to
purchase. The Guides are intended to help advertisers avoid or
deceptive practices in the advertising of warranties or guarantees.
DATES: Written comments will be accepted until June 3, 1996.
ADDRESS: Comments should be directed to: Secretary, Federal Trade
Commission, Room H-159, Sixth and Pennsylvania Ave., N.W., Washington,
D.C. 20580. Comments about the Interpretations, Rules, and/or Guides
should be identified as ``Warranty Rules--Comment.''
FOR FURTHER INFORMATION CONTACT:
Carole I. Danielson, Investigator, Division of Marketing Practices,
Federal Trade Commission, Washington, D.C. 20580, (202) 326-3115.
SUPPLEMENTARY INFORMATION: The Commission has determined, as part of
its oversight responsibilities, to review rules and guides
periodically. Pursuant to these reviews, the Commission seeks
information about the costs and benefits of the rules and guides under
review, as well as their regulatory and economic impact. The
information obtained will assist the Commission in identifying rules
and guides that warrant modification or rescission. At this time, the
Commission in identifying rules and guides that warrant modification or
rescission. At this time, the Commission solicits written public
comments concerning its warranty rules and guides: (1) the Commission's
Interpretations of the Magnuson-Moss Warranty Act, 16 CFR Part 700; (2)
the Rule Governing Disclosure of Written Consumer Product Warranty
Terms and Conditions, 16 CFR Part 701; (3) the Rule Governing Pre-Sale
Availability of Written Warranty Terms, 16 CFR Part 702; and (4) the
Guides for the Advertising of Warranties and Guarantees, 16 CFR Part
239. These four rules and guides are being reviewed together because
all four pertain to warranties.
A. Background
1. 16 CFR Part 700: Interpretations of the Magnuson-Moss Warranty
Act (``Interpretations''). The Magnuson-Moss Warranty Act, 15 U.S.C.
2301 et seq., which governs written warranties on consumer products,
was signed into law on January 4, 1975. After the Act was passed, the
Commission received many questions concerning the Act's requirements.
In response to these inquiries, the Commission decided to provide
guidance in order to ease compliance with the requirements of the Act.
Initially, the Commission published, on June 18, 1975, a policy
statement in the Federal Register (40 FR 25721) to provide interim
guidance during the initial implementation of the Act. However, as the
Commission continued to receive questions and requests for advisory
opinions, it determined that guidance of a more permanent nature was
appropriate. Therefore, on July 13, 1977, the Commission published in
the Federal Register (42 FR 36112) its Interpretations of the Magnuson-
Moss Warranty Act to assist warrantors and suppliers of consumer
products in complying with the Act.
These Interpretations apply to consumer products distributed in
commerce and sold with a written warranty. They represent the
Commission's views on various terms and provisions of the Act that are
not entirely clear on the face of the statute. Thus, they are intended
to clarify the Act's requirements for consumers, manufacturers,
importers, distributors, and retailers attempting to comply with them.
They are not substantive rules, and do not have the force or effect of
statutory provisions; like industry guides, they are advisory in
nature. Nonetheless, failure to comply with the Interpretations could
result in enforcement action by the Commission under the applicable
statutory provisions.
The Interpretations cover a wide range of subjects, including which
types of products are considered ``consumer products'' under the Act;
whether warrantors have a duty to install under a full warranty; how to
distinguish between ``written warranty,'' ``service contract,'' and
``insurance''; what constitutes an ``expression of general policy'' and
the requirements for expressions of general policy; the use of warranty
registration cards under full and limited warranties; and what may be
an illegal tying arrangement under Section 102(c) of the Act.
2. 16 CFR Part 701: Disclosure of Written Consumer Product Warranty
Terms and Conditions (``Rule 701''). The language of the Act and its
legislative history indicate that Congress intended that the Commission
promulgate rules regarding the disclosure of written warranty terms and
conditions. Accordingly, on December 31, 1975, the Commission published
in the Federal Register (40 FR 60188) its Rules Governing Disclosure of
Written Consumer Product Warranty Terms and Conditions. Rule 701
establishes requirements for warrantors for disclosing the terms and
conditions of written warranties on consumer products actually costing
the consumer more than $15.00. It tracks the disclosure requirements
suggested in Section 102(a) of the Act. It also specifies the
information that must appear in the written warranty, as well as the
exact language that must be used for certain disclosures. Under Rule
701, the information must be disclosed in simple, easily understood,
and concise language in a single document. In promulgating Rule 701,
the Commission determined that the items required to be disclosed are
material facts about product warranties, the nondisclosure of which
would be deceptive or misleading.
In addition to specifying the information that must appear in a
written warranty, Rule 701 also requires
[[Page 14689]]
that, if the warrantor uses a warranty registration or owner
registration card, the warranty must disclose whether return of the
registration card is a condition precedent to warranty coverage.
Finally, it clarifies that, in connection with some ``seal of
approval'' programs, the disclosures required by the Rule do not have
to be given in the actual seal itself, but rather must be made in a
publication.
3. Pre-Sale Availability of Written Warranty Terms, 16 CFR Part 702
(``Rule 702''). Section 102(b)(1)(A) of the Act directs the Commission
to prescribe rules requiring that the terms of any written warranty on
a consumer product be made available to the prospective purchaser prior
to the sale of the product. Accordingly, on December 31, 1975, the
Commission published in the Federal Register (40 FR 60189) its Rules
Governing the Pre-Sale Availability of Written Warranty Terms (``Rule
702''). In promulgating Rule 702, the Commission determined that the
availability of warranty information prior to sale is an important tool
for consumers in making a purchasing decision either about the product
itself or about buying a service contract for the product. The Rule was
amended on March 12, 1987 (52 FR 7569).
Rule 702 establishes requirements for sellers and warrantors for
making the terms of any written warranty on a consumer product
available to the consumer prior to sale. Among other things, the Rule
require sellers to make warranty information readily available either
by (1) displaying it in close proximity to the product or (2)
furnishing it on request and posting signs in prominent locations
advising consumers that warranty information is available. The Rule
requires warrantors to provide materials to enable sellers to comply
with the Rule's requirements, and also sets out the methods by which
warranty information can be made available prior to the sale if the
product is sold through catalogs, mail order or door-to-door sales.
4. Guides for the Advertising of Warranties and Guarantees, 16 CFR
Part 239 (``Guides''). In May, 1985, the Commission published in the
Federal Register its Guides for the Advertising of Warranties and
Guarantees, 16 CFR Part 239 (50 FR 18470, May 1, 1985 and 50 FR 20899,
May 21, 1985). The Guides were intended to help advertisers avoid
unfair or deceptive practices when advertising warranties or
guarantees. They took the place of the Commission's ``Guides Against
Deceptive Advertising of Guarantees,'' 16 CFR Part 239, adopted April
26, 1960, which had become outdated due to developments in Commission
case law and, more importantly, changes in circumstances brought about
by the Magnuson-Moss Warranty Act and by Rules 701 and 702 under that
Act. The 1985 Guides advise that advertisements mentioning warranties
or guarantees should contain a disclosure that the actual warranty
document is available for consumers to read before they buy the
advertised product. In addition, the Guides set forth advice for using
the terms ``satisfaction guarantees,'' ``lifetime,'' and similar
representations. Finally, the Guides advise that sellers or
manufacturers should not advertise that a product is warranted or
guaranteed unless they promptly and fully perform their warranty
obligations.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act provides for analysis of the
potential impact on small businesses of Rules proposed by federal
agencies. (5 U.S.C. 603, 604). Rules 701 and 702 are the only warranty-
related matters currently under review that require such an analysis.
In 1987, the Commission conducted a Regulatory Flexibility Act analysis
of Rule 702 in connection with its amendment of that Rule. See 52 FR
7569. This is the first review of Rule 701 since it was promulgated in
1975 and thus presents the first opportunity to conduct such an
analysis for that Rule. Therefore, this notice includes questions to
elicit information for that analysis.
The Commission believes that a very high percentage of businesses
subject to Rule 701 are ``small'' based on Small Business
Administration size standards. Unfortunately, the available data do not
provide a precise measurement of the impact Rule 701 has had on small
businesses nor the economic impact that would result from leaving the
Rule unchanged.
For example, in the regulatory analysis conducted for Rule 702, the
Commission's investigation found that nearly all the manufacturers
(11,365 companies or 97 percent) and nearly all retailers (952,916
companies or 99.3 percent) affected by Rule 702 were considered
``small'' using the size standards promulgated by the Small Business
Administration. That investigation indicated that, if the companies
were compared according to annual receipts, small retailers would
represent about 47 percent and small manufacturers about 23 percent of
the gross annual receipts in their respective industries.
In 1984, the FTC's Office of Impact Evaluation issued a study
evaluating the Impact of the Warranty Rules [Market Facts, Warranty
Rules Consumer Follow-Up: Evaluation Study, Final Report, Washington,
D.C., July 1984 (``the Study'')]. The Study found that some type of
warranty was offered for 87 percent of the consumer products surveyed.
Of those warranted products, almost 63 percent carried only a
manufacturer's warranty, about 12 percent were warranted only by the
retailer, and about 13 percent were covered by both a manufacturer's
and a retailer's warranty. Thus, the costs of Rule 701 would appear to
fall principally on manufacturers, since those entities are more likely
to provide a written warranty. However, we do not know how many of
those manufacturers or retailers who give written warranties are also
small entities.
Section 102 of the Magnuson-Moss Warranty Act, 15 U.S.C. 2301 et
seq., requires warrantors who use written warranties to disclose fully
and conspicuously the terms and conditions of the warranty. The Act
lists a number of items that may be included in any rules requiring
disclosure that the Commission might prescribe, and, in Rule 701, the
Commission tracked those items. In promulgating the Rule, the
Commission attempted to comply with the congressional mandate in
Section 102 of the Act while minimizing the economic impact on affected
business. For example, the Commission limited the disclosure
requirements to warranties on consumer products actually costing the
consumer more than $15.00. Furthermore, the Commission exempted ``seal
of approval'' programs from providing the disclosures on the actual
seal.
The Commission nonetheless wishes to ensure that no substantial
economic impact is being overlooked. Therefore, public comment is
requested on the effect of Rule 701 on the costs to, profitability and
competitiveness of, and employment in small entities.
C. Issues for Comment
At this time, the Commission solicits written public comments on
the following questions with regard to the Interpretations, Rule 701,
Rule 702, and the Guides:
1. Is there a continuing need for these Interpretations, Rules, and
Guides?
2. Have the Interpretations, Rules, and Guides had a significant
economic impact (costs or burdens) on consumers? What significant
benefits or costs (including costs of compliance) have they had on
firms who are subject to their requirements?
3. What benefits have the Interpretations, Rules, and Guides
provide to consumers who purchase the
[[Page 14690]]
warranted products or services affected by the Act?
(a) What changes, if any, should be made to the Interpretations,
Rules, and Guides to increase the benefits to consumers?
(b) How would these changes affect the costs the Interpretations,
Rules, and Guides impose on firms subject to their requirements?
4. What changes, if any, should be made to the Interpretations,
Rules and Guides to minimize any burden or cost imposed on firms
subject to their requirements?
5. Do the Interpretations, Rules, and Guides overlap or conflict
with other federal, state, or local government laws or regulations?
6. Since the Interpretations, Rules, and Guides were issued, have
changed in technology or economic conditions affected the need or
purpose for them?
7. What has been the effect of Rule 701 on the costs,
profitability, competitiveness, and employment of small business
entities?
(a) What would be the economic impact on small businesses from
leaving Rule 701 unchanged?
(b) Are there regulatory alternatives that would reduce any adverse
economic impact of Rule 701, yet comply with the mandate of the
Magnuson-Moss Warranty Act?
(c) What are the aggregate costs and benefits of Rule 701? Are
there provisions in the Rule that are not necessary to implement the
Magnuson-Moss Warranty Act or that have imposed costs not outweighed by
benefits? Who has benefited and who has borne the cost? Have the costs
or benefits of the Rule dissipated over time?
List of Subjects in 16 CFR Part 700
Warranties, trade practices.
Authority: 15 U.S.C. 41-58.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 96-8181 Filed 4-2-96; 8:45 am]
BILLING CODE 6750-01-M
Complete official Federal Register PDF
FR Doc. 96-8180 Deceptive Advertising and Labeling of Previously Used Lubricating Oil
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14686-14687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8180]
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FEDERAL TRADE COMMISSION
16 CFR Part 406
Deceptive Advertising and Labeling of Previously Used Lubricating
Oil
AGENCY: Federal Trade Commission.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Federal Trade Commission (the ``Commission'') proposes to
commence a rulemaking proceeding to repeal its Trade Regulation Rule on
Deceptive Advertising and Labeling of Previously Used Lubricating Oil
(``the Used Oil Rule'' or ``the Rule''), 16 CFR Part 406. The
Commission is soliciting written comments, data, and arguments
concerning this proposal. The Commission also is requesting comments
about the overall costs and benefits of the Rule and its overall
regulatory and economic impact as a part of its systematic review of
all current Commission regulations and guides.
DATES: Written comments must be submitted on or before May 3, 1996.
ADDRESSES: Written comments should be identified as ``16 CFR Part 406
Comment'' and sent to Secretary, Federal Trade Commission, room 159,
Sixth Street and Pennsylvania Ave., NW., Washington, DC 20580.
FOR FURTHER INFORMATION CONTACT:
Neil Blickman, Attorney, Federal Trade Commission, Bureau of Consumer
Protection, Division of Enforcement, Washington, DC 20580, (202) 326-
3038.
SUPPLEMENTARY INFORMATION:
Part A--Background Information
This notice is being published pursuant to Section 18 of the
Federal Trade Commission (``FTC'') Act, 15 U.S.C. 57a et seq., the
provisions of Part 1, Subpart B of the Commission's Rules of Practice,
16 CFR 1.7 et seq., and 5 U.S.C. 551 et seq. This authority permits the
Commission to promulgate, modify, and repeal trade regulation rules
that define with specificity acts or practices that are unfair or
deceptive in or affecting commerce within the meaning of Section
5(a)(1) of the FTC Act, 15 U.S.C. 45(a)(1).
Based on the Commission's finding that the new or used status of a
lubricant was material to consumers, the Used Oil Rule was promulgated
by the Commission on August 14, 1964 to prevent deception of those who
prefer new and unused lubricating oil. The Rule requires that
advertising, promotional material, and labels for lubricant made from
used oil disclose such previous use. The Rule prohibits any
representation that used lubricating oil is new or unused. In addition,
it prohibits use of the term ``re-refined,'' or any similar term, to
describe previously used lubricating oil unless the physical and
chemical contaminants have been removed by a refining process.
On October 15, 1980, the Used Oil Recycling Act suspended the
provision of the Used Oil Rule requiring labels to disclose the origin
of lubricants made from used oil,\1\ until the Commission issued rules
under the Energy Policy and Conservation Act of 1975 (``EPCA''). The
legislative history indicates congressional concern that the Used Oil
Rule's labeling requirement had an adverse impact on consumer
acceptance of recycled oil, provided no useful information to consumers
concerning the performance of the oil, and inhibited recycling.
Moreover, the origin labeling requirements in the Used Oil Rule may be
inconsistent with the intent of section 383 of EPCA, which is that
``oil should be labeled on the basis of performance characteristics and
fitness for intended use, and not on the basis of the origin of the
oil.'' \2\
\1\ 42 U.S.C. 6363 note.
\2\ See Legislative History Pub. L. 96-463, U.S. Code Cong. and
Adm. News, pp. 4354-4356 (1980).
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Accordingly, on April 8, 1981, the Commission published a notice
announcing the statutory suspension of the origin labeling requirements
of the Used Oil Rule. In the same notice, the Commission suspended
enforcement of those portions of the Used Oil Rule requiring that
advertising and promotional material disclose the origin of lubricants
made from used oil.\3\
\3\ 46 FR 20979.
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The purposes of the recycled oil section of EPCA are to encourage
the recycling of used oil, to promote the use of recycled oil, to
reduce consumption of new oil by promoting increased utilization of
recycled oil, and to reduce environmental hazards and wasteful
practices associated with the disposal of used oil.\4\ To achieve these
goals, section 383 of EPCA directs the National Institute of Standards
and Technology
[[Page 14687]]
(``NIST'') to develop test procedures for the determination of the
substantial equivalency of re-refined or otherwise processed used oil
or blend of oil (consisting of such re-refined or otherwise processed
used oil and new oil or additives) with new oil distributed for a
particular end use and to report such test procedures to the
Commission.\5\ Within 90 days after receiving such report from NIST,
the Commission is required to prescribe, by rule, the substantial
equivalency test procedures, as well as labeling standards applicable
to containers of recycled oil.\6\ EPCA further requires that the
Commission's rule permit any container of processed used oil to bear a
label indicating any particular end use, such as for use as engine
lubricating oil, so long as a determination of ``substantial
equivalency'' with new oil has been made in accordance with the test
procedures prescribed by the Commission.\7\
\4\ 42 U.S.C. 6363(a).
\5\ 42 U.S.C. 6363(c).
\6\ 42 U.S.C. 6363(d)
\7\ 42 U.S.C. 6363(d) (1) (B).
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On July 27, 1995, NIST reported to the Commission test procedures
for determining the substantial equivalency of re-refined or otherwise
processed used engine oils with new engine oils. To implement EPCA's
statutory directive, therefore, the Commission issued, and thereafter
published on October 31, 1995, a rule (covering recycled engine oil)
entitled Test Procedures and Labeling Standards for Recycled Oil
(``Recycled Oil Rule''), 16 CFR Part 311.\8\ The Recycled Oil Rule
adopts the test procedures developed by NIST, and allows (although it
does not require) a manufacturer to represent on a recycled engine-oil
container label that the oil is substantially equivalent to new engine
oil, as long as the determination of equivalency is based on the NIST
test procedures.
\8\ 60 FR 55414 (Oct. 31, 1995).
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The EPCA further provides that once the Recycled Oil Rule becomes
final, no Commission order or rule, and no law, regulation, or order of
any State (or political subdivision thereof), may remain in effect if
it has labeling requirements with respect to the comparative
characteristics of recycled oil with new oil that are not identical to
the labels permitted by this rule.\9\ Also, no rule or order of the
Commission may require any container of recycled oil to also bear a
label containing any term, phrase, or description connoting less than
substantial equivalency of such recycled oil with new oil.\10\
\9\ 42 U.S.C. 6363(e)(1).
\10\ 42 U.S.C. 6363(e)(2).
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Under EPCA, the Recycled Oil Rule preempts the Used Oil Rule's
labeling and advertising requirements for engine oils. For non-engine
oils, the Used Oil Rule's labeling disclosure provisions continue to be
subject to the Congressional stay, and the advertising disclosure
provisions continue to be subject to the Commission's stay. The only
part of the Used Oil Rule not affected by the stays is that section
which prohibits the deceptive use of the term ``re-refined.'' When the
Commission published the Recycled Oil Rule in October 1995, it also
stated that as part of its regulatory review process, it would consider
the continuing need for the Used Oil Rule.\11\
\11\ 60 FR 55414, 55417.
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Part B--Objectives
Based on the foregoing, the Commission has tentatively determined
that to eliminate unnecessary duplication, and any inconsistency with
EPCA's goals, a separate Used Oil Rule is no longer necessary.\12\ The
objective of this notice is to solicit comment on whether the
Commission should initiate a rulemaking proceeding to repeal the Used
Oil Rule.
\12\ Repealing the used Oil Rule would eliminate the
Commission's ability to obtain civil penalties for any future
misrepresentations of the re-refined quality of oil. However, the
Commission has tentatively determined that repealing the Rule would
not seriously jeopardize the Commission's ability to act
effectively. The Recycled Oil Rule defines re-refined oil to mean
used oil from which physical and chemical contaminants acquired
through use have been removed. Any significant problems that might
arise could be addressed on a case-by-case basis, administratively
under Section 5 of the FTC Act, 15 U.S.C. 45, or through Section
13(b) actions, 15 U.S.C. 53(b), filed in federal district court.
Prosecuting serious misrepresentations in district court allows the
Commission to obtain injunctive relief as well as equitable
remedies, such as redress or disgorgement.
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Part C--Alternative Actions
The Commission is not considering any alternative other than the
possibility of repealing the Used Oil Rule.
Part D--Request for Comments
Members of the public are invited to comment on any issues or
concerns they believe are relevant or appropriate to the Commission's
review of the Used Oil Rule. The Commission requests that factual data
upon which the comments are based be submitted with the comments. In
this section, the Commission identifies the issues on which it solicits
public comments. The identification of issues is designed to assist the
public and should not be construed as a limitation on the issues on
which public comment may be submitted.
Questions
(1) Is there a continuing need for the Rule?
(a) What benefits has the Rule provided to purchasers of the
products affected by the Rule?
(b) Has the Rule imposed costs on purchasers?
(2) What changes, if any, should be made to the Rule to increase
the benefits of the Rule to purchasers?
(a) How would these changes affect the costs the Rule imposes on
firms subject to its requirements?
(3) What significant burdens or costs, including costs of
compliance, has the Rule imposed on firms subject to its requirements?
(a) Has the Rule provided benefits to such firms?
(4) What changes, if any, should be made to the Rule to reduce the
burdens or costs imposed on firms subject to its requirements?
(a) How would these changes affect the benefits provided by the
Rule?
(5) Does the Rule overlap or conflict with other federal, state, or
local laws or regulations?
(6) Since the Rule was issued, what effects, if any, have changes
in relevant technology or economic conditions had on the Rule?
(7) Is misrepresentation of the re-refined quality of used
lubricating oil by manufacturers and distributors of such oil a
significant problem in the marketplace?
(8) Should the Rule, or any portion of it, be kept in effect, or
should it be repealed?
(9) How would repealing the Rule affect the benefits experienced by
consumers?
(10) How would repealing the Rule affect the benefits and burdens
experienced by firms subject to the Rule's requirements?
(11) Is the Recycled Oil Rule likely to provide all or most of the
benefits now provided by the Used Oil Rule?
Authority: Section 18(d)(2)(B) of the Federal Trade Commission
Act, 15 U.S.C. 57a(d)(2)(B).
List of Subjects in 16 CFR Part 406
Advertising, Labeling, Trade practices, Used lubricating oil.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 96-8180 Filed 4-2-96; 8:45 am]
BILLING CODE 6750-01-M
Complete official Federal Register PDF
FR Doc. 96-8179 Parts and Accessories Necessary for Safe Operation: Television Receivers and Data Display Units
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14733-14735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8179]
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DEPARTMENT OF TRANSPORTATION
Federal Highway Administration
49 CFR PART 393
[FHWA Docket No. MC-96-5]
RIN 2125-AD76
Parts and Accessories Necessary for Safe Operation: Television
Receivers and Data Display Units
AGENCY: Federal Highway Administration (FHWA), DOT.
ACTION: Notice of proposed rulemaking (NPRM); request for comments.
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SUMMARY: The FHWA is proposing to rescind restrictions on the locations
at which television viewers or screens may be positioned within
commercial motor vehicles (CMVs). Under the President's Regulatory
Reinvention Initiative, the FHWA has reviewed the Federal Motor Carrier
Safety Regulations (FMCSRs) and believes the restrictions to be
obsolete and redundant. The unsafe behavior that the regulation is
intended to discourage is more effectively deterred through State
traffic laws concerning driver inattentiveness. Further, the current
regulation may have the unintended effect of discouraging the use of
certain Intelligent Transportation Systems (ITS)-related
[[Page 14734]]
technologies such as collision- avoidance and traveler information
systems which could be used to improve safety and efficiency of CMV
operations.
DATES: Written comments must be received on or before June 3, 1996.
ADDRESSES: Submit written, signed comments to FHWA Docket No. MC-96-5,
Room 4232, HCC-10, Office of the Chief Counsel, Federal Highway
Administration, 400 Seventh Street, SW., Washington, D.C. 20590. All
comments received will be available for examination at the above
address from 8:30 a.m. to 3:30 p.m., e.t., Monday through Friday,
except Federal holidays. Those desiring notification of receipt of
comments must include a self-addressed, stamped postcard.
FOR FURTHER INFORMATION CONTACT: Mr. Larry W. Minor, Office of Motor
Carrier Research and Standards, HCS-10, (202) 366-4009; or Mr. Charles
E. Medalen, Office of the Chief Counsel, HCC-20, (202) 366-1354,
Federal Highway Administration, 400 Seventh Street, SW., Washington,
D.C. 20590. Office hours are from 7:45 a.m. to 4:15 p.m., e.t., Monday
through Friday, except Federal holidays.
SUPPLEMENTARY INFORMATION:
Background
On January 3, 1951, after conferences with representatives of the
motor carrier industry to discuss the need for revisions to the Federal
Motor Carrier Safety Regulations (FMCSRs) and consultations with
Federal and State agencies, technical societies and other experts, the
Interstate Commerce Commission (ICC) published a comprehensive notice
of proposed rulemaking (NPRM) (16 FR 23).
The NPRM included a section on television receivers. The ICC
proposed that any commercial motor vehicle equipped with a television
viewer, screen or other means of visually receiving a television
broadcast be required to have the viewer or screen located at a point
to the rear of the driver's seat if the device is in the driver's
compartment. Further, the viewer or screen could not be visible to the
driver while the vehicle is being operated. The television controls
would have to be located so they could not be operated from the
driver's seat. The NPRM did not discuss this section, but the proposal
was apparently intended to prevent a potential problem from becoming a
reality. It is unlikely that any significant number of television
receivers had been installed in trucks by the early 1950's.
On May 15, 1952, the ICC published a final rule adopting the
proposed restrictions on television receivers, along with many other
new or revised regulations (17 FR 4422). The ICC report on the final
rule amounted to a preamble, but, like the NPRM, it failed to explain
why the television provision was necessary (54 M.C.C. 337, April 14,
1952). The regulation has not been amended since 1952.
Regulatory Reinvention
As part of the President's Regulatory Reinvention Initiative, the
FHWA has reviewed the FMCSRs and believes that Sec. 393.88 is obsolete
and redundant. At the time is was adopted, the ICC apparently believed
that the absence of a Federal requirement would tempt drivers or motor
carriers to install receivers that operators could watch while driving.
This concern has not been borne out, and was probably unrealistic even
in 1952. Television broadcasts are designed to be visually attractive
and therefore have an enormous potential to distract the driver. For
that very reason, however, motor carriers recognize the inherent safety
risks of allowing drivers to watch television while driving, which
would make them far more susceptible to accidents that could be avoided
by watching the road and other vehicles. There is no reason to believe
that Sec. 393.88 has any beneficial effect on the behavior of drivers
or motor carriers.
The behavior that Sec. 393.88 is intended to address, driver
inattentiveness, is effectively covered by State laws. Accidents
attributed to driver inattentiveness are generally cited by State
officials as a failure to maintain control of the vehicle, with a brief
description of the activity with which the driver was preoccupied.
Therefore, State's have a legal means to cite commercial motor vehicle
drivers for failing to pay attention to their driving tasks.
In addition to being obsolete, the regulation may have the
unintended effect of discouraging the use of certain ITS-related
technologies such as collision-avoidance and traveler information
systems which could be used to improve the safety and efficiency of CMV
operations. These systems may include the use of in-vehicle display
screens which provide real-time displays of areas of traffic
congestion, construction, and accidents on maps which may be viewed by
the driver while the vehicle is being operated. Some satellite
communications systems enable motor carriers to track CMVs en route to
a destination and to transmit written messages to drivers that appear
on video terminals in the cab. Also, some collision avoidance/warning
systems display video images of traffic around the CMV.
On November 17, 1993 (58 FR 60734, 60757), the FHWA published
regulatory guidance on the applicability of Sec. 393.88 to closed
circuit monitoring devices used as safety viewing systems to prevent
certain types of accidents between passenger cars and CMVs. The
regulatory guidance indicated that Sec. 393.88 is not applicable if the
system cannot receive television broadcasts or be used for the viewing
of video tapes.
More recently the FHWA has received a number of requests for
regulatory guidance on the applicability of Sec. 393.88 to other
configurations of display units that may be viewed by the driver while
the vehicle is being operated. Some of these systems have functions
which could be considered inconsistent with the intent of Sec. 393.88
in that the systems may be capable of displaying information or video
images that are not associated with collision avoidance or other ITS
concepts.
The FHWA believes that case-by-case regulatory guidance on the many
different configurations of in-cab video display systems would be
burdensome, confusing, and ineffective at ensuring safety. It would not
be in the best interest of the manufacturers of these systems, the
motor carrier industry, or the agency. Further, the regulatory guidance
process, if applied to each make and model of in-cab displays, would
become a de facto design approval program. Equipment manufacturers,
motor carriers, and CMV drivers are capable of working together to
design and develop in-cab information systems using the most cost-
effective technology and resources to facilitate improvements in the
safety and efficiency of CMV operations. The effectiveness of this
approach would be greatly enhanced by the removal of Sec. 393.88.
This rulemaking is not intended to encourage motor carriers to
install display screens for entertainment purposes or otherwise reduce
the safety of operation of commercial motor vehicles. Rather, it is the
intent of this rulemaking to eliminate a Federal regulation that does
not ensure a level of safety greater than that provided by State laws,
and to remove regulatory obstacles to the use of ITS-related
technologies.
Rulemaking Analyses and Notices
All comments received before the close of business on the comment
closing date indicated above will be
[[Page 14735]]
considered and will be available for examination in the docket at the
above address. Comments received after the comment closing date will be
filed in the docket and will be considered to the extent practicable,
but the FHWA may issue a final rule at any time after the close of the
comment period. In addition to late comments, the FHWA will also
continue to file in the docket relevant information that becomes
available after the comment closing date, and interested persons should
continue to examine the docket for new material.
Executive Order 12866 (Regulatory Planning and Review) and DOT
Regulatory Policies and Procedures
The FHWA has considered the impacts of this document and has
determined that it is neither a significant rulemaking action within
the meaning of Executive Order 12866 nor a significant rulemaking under
the regulatory policies and procedures of the Department of
Transportation. The rulemaking would amend part 393 of the FMCSRs by
removing an obsolete regulation. It is anticipated that the economic
impact of this rulemaking will be minimal. Therefore, a full regulatory
evaluation is not required.
Regulatory Flexibility Act
In compliance with the Regulatory Flexibility Act (5 U.S.C. 601-
612), the FHWA has evaluated the effects of this rule on small
entities. Based upon this evaluation, and for the reasons set forth in
the preceding paragraph, the FHWA certifies that this rule would not
have a significant economic impact on a substantial number of small
entities.
Executive Order 12612 (Federalism Assessment)
This action has been analyzed in accordance with the principles and
criteria contained in Executive Order 12612, and it has been determined
that this rule does not have sufficient federalism implications to
warrant the preparation of a Federalism Assessment.
Executive Order 12372 (Intergovernmental Review)
Catalog of Domestic Assistance Program Number 20.217, Motor Carrier
Safety. The regulations implementing Executive Order 12372 regarding
intergovernmental consultation on Federal programs and activities apply
to this program.
Paperwork Reduction Act
This document does not contain information collection requirements
for the purposes of the Paperwork Reduction Act of 1980 (44 U.S.C. 3501
et seq).
National Environmental Policy Act
The agency has analyzed this rulemaking for the purpose of the
National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and
has determined that this action would not have any effect on the
quality of the environment.
Regulation Identification Number
A regulation identification number (RIN) is assigned to each
regulatory action listed in the Unified Agenda of Federal Regulations.
The Regulatory Information Service Center publishes the Unified Agenda
in April and October of each year. The RIN contained in the heading of
this document can be used to cross reference this action with the
Unified Agenda.
List of Subjects in 49 CFR Part 393
Highway safety, Highways and roads, Motor carriers, Motor vehicle
safety.
Issued on: March 26, 1996.
Rodney E. Slater,
Federal Highway Administrator.
In consideration of the foregoing, the FHWA proposes to amend title
49, Code of Federal Regulations, subchapter B, chapter III, as follows:
PART 393--[AMENDED]
1. The authority citation for part 393 continues to read as
follows:
Authority: Section 1041(b) of Pub. L. 102-240, 105 Stat. 1914,
1993 (1991); 49 U.S.C. 31136 and 31502; 49 CFR 1.48.
Sec. 393.88 [Removed and Reserved]
2. Section 393.88 is removed and reserved.
[FR Doc. 96-8179 Filed 4-2-96; 8:45 am]
BILLING CODE 4910-22-P
Complete official Federal Register PDF
FR Doc. 96-8178 Snapper Grouper Fishery of the South Atlantic; Public Scoping Meeting
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14735-14736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8178]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 646
[I.D. 032596D]
Snapper Grouper Fishery of the South Atlantic; Public Scoping
Meeting
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Public scoping meeting.
-----------------------------------------------------------------------
SUMMARY: The South Atlantic Fishery Management Council (Council) is
holding a public scoping meeting to solicit comments on the sale of
fish (all species) caught under the recreational bag limits established
by the Council's fishery management plans (FMPs). The public scoping
meeting will be held in conjunction with the Council's public meetings
to be held April 8-12, 1996.
DATES: The public scoping meeting is scheduled to begin at 6:30 p.m. on
Tuesday, April 9, 1996, and will end when all business is completed.
ADDRESSES: The public scoping meetings will be held at the Comfort Inn
Island Suites, 711 Beachview Drive, Jekyll Island, GA; telephone: (912)
635-2211.
[[Page 14736]]
Requests for copies of the public scoping document should be sent
to the Council at the following address: South Atlantic Fishery
Management Council; One Southpark Circle, Suite 306; Charleston, SC
29407-4699.
FOR FURTHER INFORMATION CONTACT: Susan Buchanan, Public Information
Officer; telephone: (803) 571-4366; fax (803) 769-4520.
SUPPLEMENTARY INFORMATION: At the scoping meeting, comments will be
solicited on the sale of fish caught under the recreational bag limits
for all species as established by the Council's FMPs. The Council has
considered this issue on numerous occasions over the past several
years, and both commercial and recreational fishermen have expressed
concern about this matter. Currently, all of the Council's FMPs allow
for the sale of fish taken in a legal bag limit. The issue regarding
the sale of fish caught under bag limits involves several
considerations including: (1) The definitions of recreational and
commercial fisherman; (2) the ethical question of a ``recreational''
fisherman selling his catch; and (3) the impacts of selling fish caught
under a recreational bag limit on an established commercial quota for
the same species. The Council will consider prohibiting the sale of
fish caught by recreational fishermen. The Council is inviting, and
will consider, the views of recreational and commercial fishermen and
other interested persons on this matter prior to taking any formal and
final action. The Council is particularly interested in hearing about
the possible impacts of prohibiting the sale of recreationally caught
fish.
Written public comments on the subject of the scoping meeting, as
well as on any Council scoping documents made available to the public,
may be submitted to the Council from the time of the scoping meeting
until such time as the Council has prepared appropriate public hearing
documents that are available for public comment. For copies of the
public scoping documents, see ADDRESSES.
These meetings are physically accessible to people with
disabilities. Requests for sign language interpretation or other
auxiliary aids should be directed to the Council office by April 3,
1996, (see ADDRESSES).
Authority: 16 U.S.C. 1801 et. seq.
Dated: March 28, 1996.
Richard W. Surdi,
Acting Director, Office of Fisheries Conservation and Management,
National Marine Fisheries Service.
[FR Doc. 96-8178 Filed 4-2-96; 8:45 am]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-8166 Substances Approved for Use in the Preparation of Meat and Poultry Products; Reopening of Comment Period
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Page 14690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8166]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 71, 170, and 171
[Docket No. 95N-0220]
RIN 0910-AA66
Substances Approved for Use in the Preparation of Meat and
Poultry Products; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is reopening for 60
days the comment period for a proposed rule that appeared in the
Federal Register of December 29, 1995 (60 FR 67490). The document
proposed to amend FDA's regulations governing the review of petitions
for the approval of food and color additives and substances generally
recognized as safe (GRAS) to provide for joint review of such petitions
by the Food Safety and Inspection Service (FSIS), U.S. Department of
Agriculture (USDA), when meat or poultry product uses are proposed. The
closing date for submission of comments was March 14, 1996. This action
is being taken in response to a request for additional time to answer
comments.
DATES: Written comments by June 3, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: George H. Pauli, Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3090.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 29, 1995
(60 FR 67490), FDA published a proposal to amend the regulations
governing the review of petitions for the approval of food and color
additives and GRAS substances to provide for joint review of such
petitions by FSIS when meat or poultry product uses are proposed. By
agreement between USDA and FDA, such listings would eliminate the need
for a separate FSIS rulemaking to allow the use in meat and poultry
products of FDA-approved substances. Interested persons were given
until March 14, 1996, to submit comments on the proposal. FSIS
published a companion document in the same issue of the Federal
Register (60 FR 67459) and is extending its comment period for 60 days.
In response to a request for additional time to answer comments, as
well as for consistency with FSIS, FDA is reopening the comment period
on FDA's proposal for 60 days.
Interested persons may, on or before June 3, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
Dated: March 28, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-8166 Filed 4-2-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-8146 Pesticide Chemicals; Various Tolerance Actions
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14694-14696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8146]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300396; FRL 4971-1]
RIN 2070-AC18
Pesticide Chemicals; Various Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA proposes to revoke tolerances for residues of 10 pesticide
chemicals in or on certain raw agricultural commmodities (RACs). EPA is
taking this action because there are no current registrations for these
uses. The applicable registrations for these pesticide uses have been
canceled because of nonpayment of maintenance fees and/or voluntary
registrant company request.
DATES: Comments identified by the docket number, [OPP-300396], must be
received on or before June 3, 1996.
ADDRESSES: Submit written comments by mail to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring comments to: Public Docket, Rm.
1132, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with procedures as set forth in
40 CFR part 2. A copy of the comment that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential will be included in the public docket by EPA without prior
notice. The public docket is available for public inspection in Rm.
1132 at the above address, from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: opp [email protected]. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number, [OPP-300396]. No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments on this
proposed rule may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found below in
this document.
FOR FURTHER INFORMATION CONTACT By mail: Owen F. Beeder, Registration
Division (7505W), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Sixth Floor, Crystal Station #1, 2800
Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-8351; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: This document proposes the revocation of
tolerances established under section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) (21 U.S.C. 346a) for residues of the herbicides 2-
chloro-N,N-diallylacetamide (allidochlor), chloramben, 2,3,6-
trichlorophenylacetic acid (chlorfenac), chloroxuron, and diethatyl-
ethyl; the fungicides biphenyl, sec-butylamine, and chlorosulfamic
acid; and the insecticides calcium cyanide and chlorthiophos in or on
certain raw agricultural commodities (RACs). EPA is initiating this
action because all registered uses of these pesticide chemicals in or
on RACs have
[[Page 14695]]
been canceled. The registrations for these pesticide chemicals were
canceled because the registrant failed to pay the required maintenance
fee and/or the registrant voluntarily canceled all registered uses of
the pesticide.
Because there are no current food use registrations for any of
these 10 pesticide chemicals EPA proposes to immediately revoke the
tolerances for all of the pesticides listed above with the exception of
chloramben, chloroxuron and diethatyl ethyl. Although no usages in 1992
have been found for the herbicides chloramben, chloroxuron and
diethatyl ethyl, and their registered products were canceled over 3
years ago (except for diethatyl ethyl, for which the last product was
canceled in April 1993), each of the herbicides still had usages on
certain crops as late as 1994 and 1995. EPA has therefore decided to
delay the revocation of chloramben, chloroxuron and diethatyl ethyl
until March 1, 1999, instead of immediately, to allow domestic growers
who may still have stocks on hand to use up their supplies and permit
any treated raw commodities and products processed from such
commodities to move through marketing channels, and, therefore, result
in little or no domestic impacts. EPA is effecting this delayed
revocation by including an expiration date in the tolerance. An import
tolerance for tomatoes is established on chlorthiophos although there
is no active registration. The Agency has been advised by the
registrant (E.M. Industries) that the registrant no longer has an
interest in maintaining the import tolerance. Therefore, the Agency is
proposing to revoke the inactive import tolerance on chlorthiophos. The
Agency is not recommending the establishment of action levels in place
of these regulations. Since there are no food use registrations
associated with these tolerances; hence, no legal use in the United
States, and since these pesticides are either not persistent, or
sufficient time has elapsed since their prior use for residues to
dissipate, residues should not appear in any domestically produced
commodities.
The tolerances listed in 40 CFR part 180 being proposed for
revocation are as follows: Sec. 180.125 (calcium cyanide), Sec. 180.141
(biphenyl), Sec. 180.201 (chlorosulfamic acid), Sec. 180.216
(chloroxuron), Sec. 180.266 (chloramben), Sec. 180.282 (2-chloro-N,N-
diallylacetamide (allidochlor)), Sec. 180.283 (2,3,6-
trichlorophenylacetic acid) (chlorfenac)), Sec. 180.321 (sec-
butylamine), Sec. 180.398 (chlorthiophos), and Sec. 180.402 (diethatyl-
ethyl).
Any person who has registered or submitted an application for
registration of a pesticide under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains the ingredient
listed herein, may request within 30 days after the publication of this
document in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the Federal Food, Drug, and Cosmetic Act (FFDCA).
Interested persons are invited to submit written comments on the
proposed regulation. Further, EPA is soliciting comments from anyone
adversely affected by revocation of these tolerances, exemptions from
tolerance, and food additive and feed additive regulations. EPA
requests that anyone adversely affected by these revocations submit
information pertaining to why and provide specific information as
follows:
1. Are there any existing stocks of the chemicals?
2. If so, how much?
3. When will the stocks be depleted?
4. How long would the commodities treated with these chemicals be
in the channels of trade?
5. Are any of these pesticide chemicals used in foreign countries?
6. Would residues of these pesticide chemicals be present in or on
commodities grown in foreign countries and imported into the United
States?
Comments must bear a notation indicating the document control
number, [OPP-300396]. All written comments filed in response to this
petition will be available in the Public Response and Program Resources
Branch at the above address from 8 a.m. to 4:30 p.m., Monday through
Friday, except legal holidays.
A record has been established for this rulemaking under docket
number [PP OPP-300396] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
opp D[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ``ADDRESSES'' at the
beginning of this document.
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in a rule: (1) having an annual effect on the
economy of $100 million or more, or adversely and materially affecting
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local or tribal
governments or communities (also referred to as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; (4) raising novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
this Executive Order. Pursuant to the terms of this Executive Order, it
has been determined that this rule is not a ``significant regulatory
action,'' because it does not meet any of the regulatory-significance
criteria listed above.
This proposed rule has been reviewed under the Regulatory
Flexibility Act of 1980 (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601 et
seq.), and EPA has determined that it will not have a significant
economic impact on any small businesses, governments, or organizations.
Accordingly, I certify that this proposed rule does not require a
separate regulatory flexibility analysis under the Regulatory
Flexibility Act.
This proposed regulatory action does not contain any information
collection requirements subject to review by OMB under the Paperwork
Reduction Act of 1980, 44 U.S.C. 3501 et seq.
[[Page 14696]]
This proposed rule contains no Federal mandates under Title II of
the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4, for State,
local, or tribal governments or the private sector because it would not
impose enforceable duties on them.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 26, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
Sec. 180.125 [Removed]
2. By removing Sec. 180.125 Calcium cyanide; tolerances for
residues.
Sec. 180.141 [Removed]
3. By removing Sec. 180.141 Biphenyl; tolerances for residues.
Sec. 180.201 [Removed]
4. By removing Sec. 180.201 Chlorosulfamic acid; tolerances for
residues.
5. By revising Sec. 180.216 Chloroxuron; tolerances for residues,
to read as follows:
Sec. 180.216 Chloroxuron; tolerances for residues.
A time-limited tolerance, with an expiration date of March 1, 1999,
is established for negligible residues of the herbicide chloroxuron (3-
[p-(p-chlorophenoxy)phenyl]-1,1-di-methylurea) and its metabolites
containing the p-(p-chlorophenoxy)aniline moiety calculated as
chlorxuron in or on the raw agricultural commodities: soybeans and
soybean forage, carrots, celery, onions, (dry bulb), and strawberries.
6. By revising Sec. 180.266 Chloramben; tolerances for residues, to
read as follows:
Sec. 180.266 Chloramben; tolerances for residues.
A time-limited tolerance, with an expiration date of March 1, 1999,
is established for negligible residues of the herbicide chloramben (3-
amino-2,5-dichlorobenzoic acid) in or on the raw agricultural
commodities: dried beans; lima beans; snap beans; bean vines;
cantaloupes; corn, field, forage, corn, fodder; corn, field, grain;
cucumbers; peanuts; peanut forage; pigeon peas, pidgeon pea forage,
peppers, pumpkins, soybeans, soybean forage, summer squash; winter
squash; sunflower seed, sweet potatoes and tomatoes.
Sec. 180.282 [Removed]
7. By removing Sec. 180.282 2-Chloro-N,N-diallylacetamide;
tolerances for residues.
Sec. 180.283 [Removed]
8. By removing Sec. 180.283 2,3,6-Trichlorophenylacetic acid;
tolerances for residues.
Sec. 180.321 [Removed]
9. By removing Sec. 180.321 sec-Butylamine; tolerances for
residues.
Sec. 180.398 [Removed]
10. By removing Sec. 180.398 Chlorthiophos; tolerances for
residues.
11. By revising Sec. 180.402 Diethatyl-ethyl, to read as follows:
Sec. 180.402 Diethatyl-ethyl; tolerances for residues.
A time-limited tolerance, with an expiration date of March 1, 1999,
is established for negligible residues of the herbicide diethatyl-ethyl
and its metabolites determinable as the N-acetyl N-(2,6-diethylphenyl)
glycine derivative in or on the raw agricultural commodities: red beet
roots, red beet tops, spinach, sugar beet roots and sugar beet tops.
[FR Doc. 96-8146 Filed 4-2-96; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 96-8140 Hazardous Waste Management System; Identification and Listing of Hazardous Waste; Proposed Exclusion
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14696-14709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8140]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 261
[FRL-5448-4]
Hazardous Waste Management System; Identification and Listing of
Hazardous Waste; Proposed Exclusion
AGENCY: Environmental Protection Agency.
ACTION: Proposed rule and request for comment.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or Agency) today is
proposing to grant a petition submitted by United Technologies
Automotive (UTA), Detroit, Michigan, to exclude (or ``delist''),
conditionally, on a one-time, upfront basis, a certain solid waste
generated by UTA's chemical stabilization treatment of lagoon sludge at
the Highway 61 Industrial Site in Memphis, Tennessee, from the lists of
hazardous wastes in Secs. 261.31 and 261.32. Based on careful analyses
of the waste-specific information provided by the petitioner, the
Agency has concluded that UTA's petitioned waste will not adversely
affect human health and the environment. This action responds to UTA's
petition to delist this waste on a ``generator-specific'' basis from
the hazardous waste lists. If the proposed decision is finalized, the
petitioned waste will not be subject to regulation under Subtitle C of
the Resource Conservation and Recovery Act (RCRA).
The Agency is also proposing to use two methods to evaluate the
potential impact of the petitioned waste on human health and the
environment: (1) A fate and transport model (the EPA Composite Model
for Landfills, ``EPACML'' model) , based on the waste-specific
information provided by the petitioner; and (2) the generic delisting
levels in Sec. 261.3(c)(2)(ii)(C)(1) for nonwastewater residues
generated from treatment of the listed hazardous waste F006, by high
temperature metal recovery (HTMR). Specifically, EPA proposes to use
the EPACML model to calculate the concentration of each hazardous
constituent that may be present in an extract of the petitioned waste
obtained by means of the Toxicity Characteristic Leaching Procedure
(TCLP), which will not have an adverse impact on groundwater if the
petitioned waste is delisted and then disposed in a Subtitle D
landfill. EPA will compare the concentration for each hazardous
constituent calculated by the EPACML model to the generic delisting
level for that constituent in Sec. 261.3(c)(2)(ii)(C)(1). EPA proposes
to use the lower of these two concentrations as the delisting level for
each hazardous constituent in the waste.
DATES: EPA is requesting public comments on this proposed decision and
on the applicability of the fate and transport model and the generic
delisting levels used to evaluate the petition. Comments will be
accepted until May 20, 1996. Comments postmarked after the close of the
comment period will be stamped ``late.''
Any person may request a hearing on this proposed decision by
filing a request with Richard D. Green, Acting Director of the Waste
Management Division, EPA, Region 4, whose address appears below, by
April 18, 1996. The request must contain the information prescribed in
Sec. 260.20(d).
ADDRESSES: Send three copies of your comments to Jeaneanne M. Gettle,
Acting Chief, RCRA Compliance Section, U.S. Environmental Protection
[[Page 14697]]
Agency, Region 4, 345 Courtland Street, NE., Atlanta, Georgia 30365.
Identify your comments at the top with this regulatory docket number:
R4-96-UTEP
Requests for a hearing should be addressed to Richard D. Green,
Acting Director, Waste Management Division, U.S. Environmental
Protection Agency, Region 4, 345 Courtland Street, NE., Atlanta,
Georgia 30365.
The RCRA regulatory docket for this proposed rule is located at the
EPA Library, U.S. Environmental Protection Agency, Region 4, 345
Courtland Street, N.E., Atlanta, Georgia 30365, and is available for
viewing from 9:00 a.m. to 4:00 p.m., Monday through Friday, excluding
Federal holidays.
The public may copy material from any regulatory docket at no cost
for the first 100 pages, and at a cost of $0.15 per page for additional
copies.
Copies of the petition are available during normal business hours
at the following addresses for inspection and copying: Tennessee
Department of Environment and Conservation, 5th Floor, L & C Tower, 401
Church Street, Nashville, Tennessee 37243-1535; and U.S. EPA Region 4,
Library, 345 Courtland Street, NE., Atlanta, Georgia 30365; (404) 347-
4216.
FOR FURTHER INFORMATION CONTACT: For general information, contact the
RCRA Hotline, toll free at (800) 424-9346, or at (703) 412-9810. For
technical information concerning this notice, contact Judy
Sophianopoulos, RCRA Compliance Section, (Mail Code 4WD-RCRA), U.S.
Environmental Protection Agency, Region 4, 345 Courtland Street, NE.,
Atlanta, Georgia 30365, (404) 347-3555, x6408, or call, toll free,
(800) 241-1754, and leave a message, with your name and phone number,
for Ms. Sophianopoulos to return your call. You may also contact Jerry
Ingram, Tennessee Department of Environment and Conservation, 5th
Floor, L & C Tower, 401 Church Street, Nashville, Tennessee 37243-1535,
(615) 532-0850.
SUPPLEMENTARY INFORMATION:
I. Background
A. Authority
On January 16, 1981, as part of its final and interim final
regulations implementing Section 3001 of RCRA, EPA published an amended
list of hazardous wastes from non-specific and specific sources. This
list has been amended several times, and is published in Secs. 261.31
and 261.32. These wastes are listed as hazardous because they exhibit
one or more of the characteristics of hazardous wastes identified in
Subpart C of part 261 (i.e., ignitability, corrosivity, reactivity, and
toxicity) or meet the criteria for listing contained in Sec. 261.11
(a)(2) or (a)(3).
Individual waste streams may vary, however, depending on raw
materials, industrial processes, and other factors. Thus, while a waste
that is described in these regulations generally is hazardous, a
specific waste from an individual facility meeting the listing
description may not be. For this reason, Secs. 260.20 and 260.22
provide an exclusion procedure, allowing persons to demonstrate that a
specific waste from a particular generating facility should not be
regulated as a hazardous waste.
To have their wastes excluded, petitioners must show, first, that
wastes generated at their facilities do not meet any of the criteria
for which the wastes were listed. See Sec. 260.22(a) and the background
documents for the listed wastes. Second, the Administrator must
determine, where he/she has a reasonable basis to believe that factors
(including additional constituents) other than those for which the
waste was listed could cause the waste to be a hazardous waste, that
such factors do not warrant retaining the waste as a hazardous waste.
Accordingly, a petitioner also must demonstrate that the waste does not
exhibit any of the hazardous waste characteristics (i.e., ignitability,
reactivity, corrosivity, and toxicity), and must present sufficient
information for the Agency to determine whether the waste contains any
other toxicants at hazardous levels. See Sec. 260.22(a), 42 U.S.C.
Sec. 6921(f), and the background documents for the listed wastes.
Although wastes which are ``delisted'' (i.e., excluded) have been
evaluated to determine whether or not they exhibit any of the
characteristics of hazardous waste, generators remain obligated under
RCRA to determine whether or not their wastes continue to be
nonhazardous based on the hazardous waste characteristics (i.e.,
characteristics which may be promulgated subsequent to a delisting
decision.)
In addition, residues from the treatment, storage, or disposal of
listed hazardous wastes and mixtures containing listed hazardous wastes
are also considered hazardous wastes. See Secs. 261.3(a)(2)(iv) and
(c)(2)(i), referred to as the ``mixture'' and ``derived-from'' rules,
respectively. Such wastes are also eligible for exclusion and remain
hazardous wastes until excluded. On December 6, 1991, the U.S. Court of
Appeals for the District of Columbia vacated the ``mixture/derived-
from'' rules and remanded them to the Agency on procedural grounds.
Shell Oil Co. v. EPA, 950 F.2d 741 (D.C. Cir. 1991). On March 3, 1992,
EPA reinstated the mixture and derived-from rules, and solicited
comments on other ways to regulate waste mixtures and residues (57 FR
7628, Mar. 3, 1992). The Agency plans to address issues related to
waste mixtures and residues in a future rulemaking.
On October 10, 1995, the Administrator delegated to the Regional
Administrators the authority to evaluate and approve or deny petitions
submitted in accordance with Secs. 260.20 and 260.22, by generators
within their Regions [National Delegation of Authority 8-19], in States
not yet authorized to administer a delisting program in lieu of the
Federal program. On March 11, 1996, the Regional Administrator of EPA,
Region 4, redelegated delisting authority to the Director of the Waste
Management Division [Regional Delegation of Authority 8-19].
B. Approach Used To Evaluate This Petition
This petition requests a delisting for a hazardous waste listed as
F006. In making the initial delisting determination, the Agency
evaluated the petitioned waste against the listing criteria and factors
cited in Secs. 261.11 (a)(2) and (a)(3). Based on this review, the
Agency agrees with the petitioner that the waste is nonhazardous with
respect to the original listing criteria. (If the Agency had found,
based on this review, that the waste remained hazardous based on the
factors for which the waste was originally listed, EPA would have
proposed to deny the petition.) EPA then evaluated the waste with
respect to other factors or criteria to assess whether there is a
reasonable basis to believe that such additional factors could cause
the waste to be hazardous. See Secs. 260.22 (a) and (d). The Agency
considered whether the waste is acutely toxic, and considered the
toxicity of the constituents, the concentration of the constituents in
the waste, their tendency to migrate and to bioaccumulate, their
persistence in the environment once released from the waste, plausible
and specific types of management of the petitioned waste, the
quantities of waste generated, and waste variability.
For this delisting determination, the Agency used such information
to identify plausible exposure routes (i.e., groundwater, surface
water, air) for hazardous constituents present in the petitioned waste.
The Agency determined that disposal in a Subtitle D landfill is the
most reasonable, worst-case disposal scenario for UTA's petitioned
waste, and that the major exposure route of concern would be
[[Page 14698]]
ingestion of contaminated groundwater. Therefore, the Agency is
proposing to use a particular fate and transport model (the ``EPACML''
model) to predict the maximum allowable concentrations of hazardous
constituents that may be released from the petitioned waste after
disposal and to determine the potential impact of the disposal of UTA's
petitioned waste on human health and the environment.
Specifically, the Agency used the maximum estimated waste volume
and the maximum reported leachate concentrations as inputs to estimate
the constituent concentrations in the groundwater at a hypothetical
receptor well downgradient from the disposal site. The calculated
receptor well concentrations (referred to as compliance-point
concentrations) were then compared directly to the health-based levels
used in delisting decision-making for the hazardous constituents of
concern.
EPA believes that this fate and transport model represents a
reasonable worst-case scenario for disposal of the petitioned waste in
a landfill, and that a reasonable worst-case scenario is appropriate
when evaluating whether a waste should be relieved of the protective
management constraints of RCRA Subtitle C. The use of a reasonable
worst-case scenario results in conservative values for the compliance-
point concentrations and ensures that the waste, once removed from
hazardous waste regulation, will not pose a threat to human health or
the environment. Because a delisted waste is no longer subject to
hazardous waste control, the Agency is generally unable to predict and
does not control how a waste will be managed after delisting.
Therefore, EPA currently believes that it is inappropriate to consider
extensive site-specific factors when applying the fate and transport
model.
For example, a generator may petition the Agency for delisting of a
metal hydroxide sludge which is currently being managed in an on-site
landfill and provide site-specific data, such as the nearest drinking
water well, permeability of the aquifer, and dispersivities. If the
Agency were to base its evaluation solely on these site-specific
factors, the Agency might conclude that the waste, at that specific
location, cannot affect the closest well, and the Agency might grant
the petition. Upon promulgation of the exclusion, however, the
generator is under no obligation to continue to manage the waste at the
on-site landfill. In fact, the generator may well choose to either send
the delisted waste off site immediately, or eventually reach the
capacity of the on-site facility and subsequently send the waste off
site to a facility which may have very different hydrogeological and
exposure conditions.
The Agency also considers the applicability of groundwater
monitoring data during the evaluation of delisting petitions. In this
case, the Agency determined that, because UTA is seeking a delisting
for treated lagoon wastes which will be generated during a removal
action under the Comprehensive Environmental Response, Compensation,
and Liability Act (CERCLA), and may be managed ultimately either on
site or off site, groundwater monitoring data collected from the areas
where the petitioned waste is contained prior to treatment, are
necessary to determine whether hazardous constituents have already
migrated to the underlying groundwater. Groundwater monitoring data
collected from UTA's monitoring wells will help characterize the
potential impact (if any) of the disposal of UTA's waste on human
health and the environment.
UTA petitioned the Agency for an upfront, conditional, one-time
exclusion based on analytical data on samples from a treatability study
and on samples of untreated waste. Similar to other facilities seeking
upfront exclusions, this upfront exclusion would be contingent upon UTA
conducting analytical testing of representative samples of the
petitioned waste as soon as the treatment system is brought on-line.
This testing would be necessary to demonstrate that the treated waste
is a nonhazardous waste (i.e., meets the Agency's verification testing
conditions).
From the evaluation of UTA's delisting petition, a list of
constituents was developed for the verification testing conditions.
Proposed maximum allowable leachable concentrations for these
constituents, and a total concentration for one, were derived as
described in Section II.D. and Section II.E. of this preamble.
The Agency encourages the use of upfront delisting petitions
because they have the advantage of allowing the applicant to know what
treatment levels for constituents will be sufficient to render specific
wastes nonhazardous, before investing in new or modified waste
treatment systems. Therefore, upfront delistngs will allow new
facilities to receive exclusions prior to generating wastes, which,
without upfront exclusions would unnecessarily have been considered
hazardous. Upfront delistings for existing facilities can be processed
concurrently during construction or permitting activities; therefore,
new or modified treatment systems should be capable of producing wastes
that are considered nonhazardous sooner than would otherwise be
possible. At the same time, conditional testing requirements to verify
that the delisting levels are achieved by the fully operational
treatment systems will ensure that only nonhazardous wastes are removed
from Subtitle C control.
In the past, the Agency has granted numerous conditional
delistings, including conditional delistings for waste treatment
facilities located at multiple sites (see 51 FR 41323, November 14,
1986, and 51 FR 41494, November 17, 1986), as well as an upfront
delisting that allows an additional treatment unit to be added at the
same site (see 56 FR 32993, July 18, 1991), and an upfront delisting
that allows new treatment units at different sites to be added,
provided the verification testing conditions are satisfied (see 60 FR
31107, June 13, 1995).
The Agency provides notice and an opportunity for comment before
granting or denying a final exclusion. Thus, a final decision will not
be made until all timely public comments (including those at public
hearings, if any) on today's proposal are addressed. Late comments will
be considered to the extent possible.
II. Disposition of Delisting Petition United Technologies Automotive,
Detroit, Michigan
A. Petition for Exclusion
United Technologies Automotive (UTA), located in Detroit, Michigan,
is seeking a delisting for treated lagoon waste which will be generated
during a removal action under the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA). The removal action is
required by the Unilateral Administrative Order (``the UAO'') issued to
UTA by EPA, on January 26, 1995. The waste to be treated was generated
prior to 1980 in seven lagoons formerly used to manage electroplating
wastewater at the Highway 61 Industrial Site in Memphis, Tennessee
(``the Site''). Notwithstanding the fact that the waste was generated
prior to 1980, the waste so generated meets the listing definition of
EPA Hazardous Waste No. F006--``Wastewater treatment sludges from
electroplating operations except from the following processes: (1)
Sulfuric acid anodizing of aluminum; (2) tin plating on carbon steel;
(3) zinc plating (segregated basis) on carbon steel; (4) aluminum or
zinc-aluminum
[[Page 14699]]
plating on carbon steel; (5) cleaning/stripping associated with tin,
zinc, and aluminum plating on carbon steel; and (6) chemical etching
and milling of aluminum''--when it is actively managed by excavation
and treatment after the effective date of the listing of F006.
(Original listing of F006 by Interim Final Rule in 45 FR 33112-33133,
May 19, 1980; Modified in 45 FR 74384-74892, Nov. 12, 1980; and
clarified by Interpretative Rule in 51 FR 43350-43351, Dec. 2, 1986).
See 51 FR 40577, Nov. 7, 1986; 53 FR 31147-31148, Aug. 17, 1988; 53 FR
51444 and 51445, Dec. 21, 1988; 55 FR 22678, June 1, 1990; and Chemical
Waste Management v. EPA, 869 F.2d at 1535-37 (D.C. Cir. 1989), for
Agency position on active management. UTA proposes to treat the sludge
by chemical stabilization, and to delist the treatment residue, which
is also classified as F006 by application of Sec. 261.3(c)(2)(i), the
derived-from rule. By application of the ``contained-in policy,'' any
lagoon soil excavated and treated with the sludge must also be managed
as F006. See memorandum, dated February 17, 1995, from Devereaux Barnes
to Norm Niedergang, and Region 4 Guidance Number TSC-92-02, dated
August 1992.
UTA petitioned the Administrator, in October 1995, to exclude, on a
one-time, upfront basis, the treatment residue generated from chemical
stabilization of sludges removed from six of the seven lagoons located
at the Site. Sludges from Lagoon 7 will not be removed and treated,
because constituent concentrations were found, by total analysis of
these samples, to be below the cleanup levels required by the UAO. On
November 21, 1995, in accordance with the delegation of delisting
authority by the Administrator to the Regional Administrators, UTA
submitted to EPA, Region 4, the petition to delist F006 generated by
chemical stabilization of sludges from the six lagoons at the Site.
The hazardous constituents of concern for which F006 was listed are
cadmium, hexavalent chromium, nickel, and cyanide (complexed).
Chemically stabilized sludge and soil from the six lagoons at the Site
is the waste which is the subject of this petition. UTA petitioned the
Agency to exclude its waste because it does not believe that the waste
meets the criteria of the listing.
UTA claims that its chemically stabilized sludge/soil is not
hazardous because the constituents of concern, although present in the
waste, are present in either insignificant concentrations or, if
present at significant levels, are essentially in immobile forms. UTA
also believes that this waste is not hazardous for any other reason
(i.e., there are no additional constituents or factors that could cause
the waste to be hazardous). Review of this petition included
consideration of the original listing criteria, as well as the
additional factors required by the Hazardous and Solid Waste Amendments
(HSWA) of 1984. See Section 222 of HSWA, 42 USC 6921(f), and 40 CFR
260.22(d)(2)-(4). Today's proposal to grant this petition for delisting
is the result of the Agency's evaluation of UTA's petition.
B. Background
On November 21, 1995, UTA petitioned EPA, Region 4, to exclude the
chemically stabilized sludge and soil from Lagoons 1-6 at the Highway
61 Industrial Site in Memphis, Tennessee (``the Site''), and
subsequently provided additional information, in response to a request
by EPA. After evaluating the petition and the additional information,
the Agency proposes to approve UTA's petition to exclude the subject
waste, because the Agency believes that the petitioned waste is
eligible for an exclusion based on the current evaluation criteria.
Therefore, the Agency hereby proposes to grant UTA's petition. The
Agency's evaluation of UTA's petitioned waste, which consists of the
chemically stabilized sludge and soil from Lagoons 1-6 at the Site, is
the subject of today's proposal.
In support of its petition, UTA submitted: (1) detailed
descriptions of the waste and history of its management; (2) detailed
descriptions of all previously known and current activities at the
Site; (3) results from total constituent analyses for arsenic, barium,
cadmium, chromium, lead, mercury, selenium, and silver, (the eight
Toxicity Characteristic (TC) metals listed in Sec. 261.24); the
priority pollutant metals, including nickel, (a hazardous constituent
for which F006 is listed), antimony,and thallium; and cyanide; (4)
results for the eight Toxicity Characteristic (TC) metals from the
Toxicity Characteristic Leaching Procedure (TCLP; Method 1311 in ``Test
Methods for Evaluating Solid Waste, Physical/Chemical Methods,'' EPA
Publication SW-846 [Third Edition (November 1986), as amended by
Updates I (July 1992), II (September 1994), IIA (August 1993), and IIB
(January 1995)]; methods in this publication are referred to in today's
proposed rule as ``SW-846,'' followed by the appropriate method
number); (5) results from the Multiple Extraction Procedure (MEP; SW-
846 Method 1320) for cadmium and chromium; (6) results from the
analysis for total petroleum hydrocarbons (TPH, Method 418.1 in
``Methods for Chemical Analysis of Water and Wastes,'' EPA Publication
EPA-600/4-79-020; (7) results from characteristics testing for
ignitability, corrosivity, and reactivity; (8) results from total
constituent analyses for 33 volatile organic compounds and 64
semivolatile organic constituents, including the TC organic
constituents; and (9) groundwater monitoring data collected from wells
monitoring the on-site lagoons.
UTA's petition states that electroplating operations at the Site
were conducted between the early 1960s and 1973, and no electroplating
wastewater sludge was generated after 1973. Lagoons 1-7 contained
electroplating wastewaters and were allegedly used for oxidation
purposes. UTA reported that the sludge generated in the lagoons has a
moisture content of approximately 56%.
A CERCLA Unilateral Administrative Order issued on January 26, 1995
(``the UAO''), required that sludge from lagoons at the Site be
excavated, stabilized, and disposed of, as part of an emergency removal
action. UTA estimates that the total volume of the chemically
stabilized sludge and soil from Lagoons 1-6 at the Site will be 11,500
cubic yards. (Site Lagoon 7 met the cleanup standards of the UAO, and
did not require removal.)
The UAO required UTA to develop a Removal Action Work Plan Sampling
Protocol. EPA approved the Removal Action Work Plan, including the
Sampling Protocol, on March 30, 1995. UTA's sampling and analysis
methods were conducted in accordance with the approved Removal Action
Work Plan.
UTA's sampling demonstration included data on 225 samples of
untreated waste from Lagoons 1-7, collected in April 1995, and 4
samples of treated waste from Lagoons 1-6, collected in September 1995.
UTA conducted sampling and analysis of the seven Site lagoons,
ranging in size from approximately \1/4\-1 acre, in accordance with the
Sampling Protocol of the Removal Action Work Plan required by the UAO.
Each lagoon was divided into a minimum of 4 quadrants; grab samples of
sludge or soil in each quadrant to be analyzed for all constituents
except volatile organic compounds (VOCs), were composited. VOC analysis
was performed on a minimum of two grab samples per lagoon. A total of
225 samples were collected and analyzed. The sampling and analysis were
performed in order to obtain representative samples of each
[[Page 14700]]
lagoon and determine whether the following Site soil removal cleanup
levels required by the UAO were met; areas not meeting these levels
were subject to the removal action:
Table 1.--Site Cleanup Levels
------------------------------------------------------------------------
Cleanup
level,
parts
Parameter per
million
(ppm)
------------------------------------------------------------------------
Total Petroleum Hydrocarbons (TPH)............................. 100
Cadmium (total)................................................ 60
Chromium (total)............................................... 400
Chromium VI.................................................... 205
Lead........................................................... 500
------------------------------------------------------------------------
With the exception of total petroleum hydrocarbons (TPH), all
contaminants in treated and untreated waste were analyzed using SW-846
methods. All composite samples of untreated wastes were analyzed for
TPH, using Method 418.1, in ``Methods for Chemical Analysis of Water
and Wastes,'' EPA Publication EPA-600/4-79-020).
All composite samples of untreated wastes were analyzed for 64
semivolatile organic compounds (SVOCs), otherwise known as base-neutral
or acid extractables (BNAs, SW-846 extraction Method 3550, SW-846
analysis Method 8270); and the eight RCRA TC metals, arsenic, barium,
cadmium, chromium, lead, mercury, selenium, and silver (SW-846 Method
6010 for all except mercury; SW-846 Method 7471 for mercury). One
composite sample of untreated waste from each lagoon, except Lagoon 1
and Lagoon 3, was analyzed for metals on the Target Analyte List (TAL)
(SW-846 Method 6010), which includes aluminum, antimony, beryllium,
calcium, cobalt, copper, iron, magnesium, manganese, nickel, potassium,
sodium, thallium, vanadium, and zinc, in addition to the RCRA TC
metals. These metals are also referred to as ``priority pollutant
metals,'' regulated under the Clean Water Act and the Safe Drinking
Water Act. Toxic TAL metals antimony, beryllium, and thallium, and RCRA
TC metals mercury, selenium, and silver were not detected in the
untreated waste samples above the quantitation limits of 10.0, 1.0,
1.0, 0.09, 1.0 and 1.0 mg/kg, respectively. The concentrations of all
metals which were detected in the untreated waste, except for cadmium
and chromium, were low enough that the UAO did not set cleanup levels
for them. Concentrations of metals which were detected in untreated
wastes are presented in Table 2. SVOCs were undetected in most of the
untreated waste samples at quantitation limits ranging from 0.33-0.83
mg/kg. Table 2 shows the SVOCs that were detected in untreated waste
samples; their concentrations were low enough that the UAO did not
require cleanup levels for them. At least two grab samples of untreated
waste from each lagoon were analyzed for 33 VOCs by SW-846 Method 8240;
these VOCs were not detected in most of the samples of untreated waste
at quantitation limits ranging from 0.005-0.010 mg/kg. The VOCs
detected in untreated waste are shown in Table 2. The concentrations
detected in the untreated waste were low enough that the UAO did not
establish cleanup levels for VOCs.
All of the analyses summarized in the preceding paragraph are
methods for total analysis of the samples; that is, the samples were
subjected to the appropriate SW-846 method without prior extraction by
means of the Toxicity Characteristic Leaching Procedure (TCLP). The
analytical result obtained in a total analysis is the concentration of
contaminant on a weight/weight basis, in units of milligrams of
contaminant per kilogram of sample (mg/kg). The result of a TCLP
analysis is the concentration of contaminant on a weight/volume basis
in an extract of the sample obtained by means of the TCLP, in units of
milligrams of contaminant per liter of TCLP extract.
The RCRA TC metals cadmium and total chromium were analyzed in all
composite samples of untreated waste using SW-846 Method 6010, with a
reported quantitation limit (total analysis on unextracted sample) of
1.0 mg/kg for each. Results are presented in Table 2. A total analysis
for hexavalent chromium was conducted on all samples (both composite
and grab) of untreated waste (SW-846 Method 7197), and was not detected
in any of the samples, at a quantitation limit of 10.0 mg/kg.
Therefore, UTA concluded that the total chromium concentrations in the
untreated lagoon samples were due to trivalent chromium. Based on the
analytical results for the untreated waste samples, UTA identified
cadmium, trivalent chromium, and TPH as the only constituents of
concern in the Site lagoons, because these were the only constituents
found with concentrations above the cleanup levels required by the UAO.
TCLP extracts of two samples of untreated waste from Lagoon 6 were
prepared and analyzed, because constituent concentrations by total
analysis (analysis of the unextracted samples) exceeded the cleanup
levels required by the UAO, to a greater extent than any of the other
samples. TCLP results for untreated waste samples from Lagoon 6, as
well as total analysis results for untreated waste samples from all
lagoons, are presented in Table 2.
Table 2.--Concentrations in Untreated Samples From Site Lagoons 1 Through 7
Maximum concentration \1\ in lagoons 1-7: (total analysis in mg/kg; TCLP in mg/l)
Constituent -------------------------------------------------------------------------------------------------
Lagoon Lagoon Lagoon Lagoon Lagoon Lagoon Lagoon
1 2 3 4 5 6 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arsenic (total)....................................... 3.1 4.5 4.5 4.1 4.7 3.0 4.6
Barium (total)........................................ 144 79.3 91.6 89.5 71.2 370 71.5
Cadmium (total)....................................... 1010 345 383 239 141 1590 11.2
Cadmium (TCLP)........................................ NA NA NA NA NA 26.0 ............
Chromium (total)...................................... 1320 219 578 345 292 943 13.1
Chromium (TCLP)....................................... NA NA NA NA NA <0.50 ............
Lead (total).......................................... 19.5 10.10 25.9 9.0 9.5 26.2 17.9
Nickel (total)........................................ ............ 12 ............ 10.2 8.7 7.0 13.1
TPH (total)........................................... 440 217 278 100 58.7 272 52.7
Acetone (total)....................................... 0.492 -- 0.482 0.219 3.07 4.54 0.556
Bis(2-ethylhexyl) phthalate (total)................... 0.47 -- 1.37 1.40 -- 0.77 --
Chlorobenzene (total)................................. 0.015 -- 0.078 -- -- -- --
Di-n-butylphthalate (total)........................... -- -- -- 0.63 -- -- --
[[Page 14701]]
1,2-dichloroethene (total)............................ 0.020 0.060 0.020 -- 0.007 -- --
Vinyl chloride (total)................................ 0.015 0.055 -- -- -- -- --
\1\ The concentration level for each constituent in each lagoon in Table 2 is the maximum found for that lagoon; the values for each lagoon are not
necessarily from the same sample. Frequently, a sample with a maximum concentration level for one constituent did not contain maximum levels for all
constituents.
< denotes undetected at the practical quantitation limit, the number to the right of the symbol <. NA means not analyzed.
--Denotes analyzed but not detected.
UTA reported that one sample of untreated waste from each lagoon
was tested for the hazardous characteristics of corrosivity,
ignitability, and reactivity for cyanide and sulfide, and that none of
the samples exhibited these hazardous characteristics.
UTA conducted a treatability study on samples of lagoon sludge in
order to determine the optimum conditions for chemical stabilization.
UTA found that the most effective chemical stabilization recipe to
achieve maximum immobilization of cadmium and chromium and maxium
compressive strength in the petitioned waste was 20% lime kiln dust
(LKD) and 5% portland cement (PC). Treatability study samples #32 and
#36 were composite sludge samples from Lagoons 1 through 6, and were
chemically stabilized with two different recipes. Sample #32 was
stabilized with 20% LKD only, and sample #36 was stabilized with 20%
LKD and 5% PC. Samples #6-32 and #6-36 were composite samples from
Lagoon 6, the most contaminated lagoon. Sample #6-32 was chemically
stabilized with 20% LKD only, and sample #6-36 was chemically
stabilized with 20% LKD and 5% PC. UTA reported that, prior to
treatment, samples #32, #36, #6-32, #6-36 were subjected to total
analysis for cadmium and chromium (SW-846 Method 6010). After
treatment, SW-846 Method 6010 was performed on TCLP extracts of treated
samples to determine concentrations of cadmium and chromium in the
extracts. Total analysis for 33 VOCs was performed on treated samples
(not on TCLP extracts), using SW-846 Method 8240. VOCs were not
detected in any of the samples of treated waste at quantitation limits
ranging from 0.005-0.010 mg/kg. Analytical results for treatability
study samples are shown in Table 3. UTA informed EPA during a meeting
on December 13, 1995, that these analytical results are for chemically
stabilized, but not fully cured, waste samples. Samples from Lagoon 7
were not included in the treatability study, because constituent
concentrations were found, by total analysis of these samples, to be
below the cleanup levels required by the UAO. Therefore, the UAO does
not require removal of Lagoon 7 sludge and soil.
UTA believes that the treatability study of chemical stabilization
of the lagoon waste indicated that cadmium and chromium concentrations
in the TCLP extracts were reduced to levels which would meet delisting
criteria, and that TPH constituents were removed in the offgas from the
chemical stabilization process.
If UTA's delisting petition is approved, UTA proposes to dispose of
the delisted waste either (a) onsite in accordance with a Closure/Post-
Closure Plan approved by the State of Tennessee or (b) in an off-site
Subtitle D landfill. Therefore, UTA subjected treatability study
samples #32 and #36, after treatment, to the Multiple Extraction
Procedure (MEP). The MEP (SW-846 Method 1320) is a test developed by
the Agency to assist in predicting the long-term leachability of
stabilized wastes. The MEP consists of a TCLP extraction of a sample
followed by nine sequential extractions of the same sample, using a
synthetic acid rain extraction fluid (prepared by adding a 60/40 weight
mixture of sulfuric acid and nitric acid to distilled deionized water
until the pH is 3.0 0.2). The sample which is subjected to
the nine sequential extractions consists of the solid phase remaining
after, and separated from, the initial TCLP extract. The Agency
designed the MEP to simulate multiple washings of percolating rainfall
in the field, and estimates that these extractions simulate
approximately 1,000 years of rainfall. (See 47 FR 52687, Nov. 22,
1982.) MEP results for samples #32 and #36 are presented in Table 3. In
response to a request by EPA for additional information, UTA reported a
quantitation limit of 0.01 mg/l for cadmium and chromium in the MEP
test on samples #32 and #36. Samples #32, #36, #6-32, and #6-36 were
also tested by the synthetic precipitation leaching procedure (SPLP,
SW-846 Method 1312), which consists of a single extraction by the same
synthetic acid rain solution used in the MEP. Total analysis, TCLP,
SPLP, and MEP results for stabilized, but not fully cured, treatability
study samples are presented in Table 3.
Table 3.--Analytical Results (ppm) for Treated Samples of Site Lagoon Sludge
[Chemically Stabilized, But Not Fully Cured]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals (untreated) TCLP (treated) SPLP (treated) Multiple extraction procedure (treated)
-------------------------------------------------------------------------------------------------------------
Maximum conc./ Concentration in
Sample \1\ Cadmium Chromium extract number final extract
(Cd) (Cr) Cd Cr Cr Cr -------------------------------------------
Cd Cr Cd Cr
--------------------------------------------------------------------------------------------------------------------------------------------------------
36........................................ 543 449 <0.10 <0.50 <0.01 0.07 0.56/6 0.07/1 0.03 0.02
6-36...................................... 777 289 <0.10 <0.50 ......... ......... ......... ......... ......... .........
32........................................ 543 449 <0.10 <0.50 <0.01 0.04 0.80/6 0.06/7 0.05 0.03
[[Page 14702]]
6-32...................................... 777 289 <0.10 <0.50 ......... ......... ......... ......... ......... .........
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Sample 36 (composite of Lagoons 1-6) was stabilized with 20% lime kiln dust (LKD) and 5% portland cement (PC); Sample 6-36 (composite from Lagoon 6)
was stabilized with 20% LKD and 5% PC; Sample 32 (composite of Lagoons 1-6) was stabilized with 20% LKD only; Sample 6-32 (composite from Lagoon 6)
was stabilized with 20% LKD only.
< Denotes that the constituent was not detected above the practical quantitation limit, the number to the right of the symbol <.
UTA included Site groundwater monitoring data in its delisting
petition, because disposal option (a) above involves onsite disposal of
the treated waste. These data are shown in Table 4, and were obtained
by sampling 5 groundwater monitoring wells which had been installed to
assess the impact of untreated lagoon waste on Site groundwater. The
wells were installed upgradient, cross-gradient, and downgradient to
the Site lagoons in accordance with the Removal Action Work Plan
required by the UAO. The wells were sampled and analyzed for cadmium
and chromium in July 1995.
Table 4.--Groundwater Result Summary (ppm) Untreated Lagoon Waste
--------------------------------------------------------------------------------------------------------------------------------------------------------
State of
Constituent MW-1 MW-2 MW-3 MW-4 MW-5 Tennessee Federal MCL
MCL
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cadmium..................................................... <0.005 <0.005 <0.005 <0.005 <0.005 0.01 0.005
Chromium.................................................... 0.010 <0.010 0.011 <0.010 <0.010 0.05 0.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
< Denotes that the constituent was not detected above the practical quantitation limit, the number to the right of the symbol <.
Monitoring wells are numbered consecutively MW-1--MW-5.
MCL is the maximum contaminant level allowable in drinking water, as established by the Safe Drinking Water Act; MCLs for the State of Tennessee are the
levels adopted by State law.
UTA believes that the groundwater results summarized in Table 4
indicate that land disposal of chemically stabilized waste from Site
Lagoons 1-6 will not have an adverse impact on groundwater quality,
because UTA believes that the data in Table 4 demonstrate that the
untreated lagoon waste has not adversely affected groundwater quality.
In addition to the data in Table 4, the groundwater monitoring
information submitted by UTA also included: (1) Well location
information; and (2) water level contour maps.
EPA does not generally verify submitted test data before proposing
delisting decisions. The sworn affidavit submitted with this petition
binds the petitioner to present truthful and accurate results. The
Agency, however, has maintained a spot-check sampling and analysis
program to verify the representative nature of data for some percentage
of the submitted petitions. A spot-check visit to a selected facility
may be initiated before finalizing a delisting petition or after
granting an exclusion.
The Agency reviews a petitioner's estimates and, on occasion, has
requested a petitioner to re-evaluate estimated waste volume. EPA
accepts UTA's estimate of 11,500 cubic yards.
D. Agency Evaluation
The Agency considered the appropriateness of alternative waste
management scenarios for UTA's chemically stabilized sludge and soil
and decided, based on the information provided in the petition, that
disposal in a Subtitle D landfill is the most reasonable, worst-case
scenario for this waste. Under a landfill disposal scenario, the major
exposure route of concern for any hazardous constituents would be
ingestion of contaminated groundwater. The Agency, therefore, evaluated
UTA's petitioned waste using the EPA's Composite Model for Landfills
(EPACML), as modified for delisting evaluations, which predicts the
potential for groundwater contamination from wastes that are
landfilled. For metal constituents in 40 CFR 261.3(c)(2)(ii)(C)(1), EPA
also evaluated UTA's petitioned waste by comparing generic delisting
levels in Sec. 261.3(c)(2)(ii)(C)(1) with EPACML levels. See 60 FR
31108-31115, June 13, 1995, a Final Rule in which EPA evaluated a
petition and approved an exclusion based on comparing these generic
delisting levels with EPACML levels, and selecting the generic
delisting levels if they were lower than the levels generated from the
EPACML model. The EPACML model is more sophisticated than the Vertical
Horizontal Spread (VHS) model used previously by the Agency for
evaluating delisting petitions. See 56 FR 32993, July 18, 1991; and 56
FR 67197, Dec. 30, 1991 for a detailed description of the EPACML model,
the disposal assumptions, the modifications made for delisting, and the
benefits of replacing the VHS model with the EPACML model for
delisting. This model, which includes both unsaturated and saturated
zone transport modules, was used to predict reasonable worst-case
contaminant levels in groundwater at a compliance point (i.e., a
receptor well serving as a drinking-water supply). Specifically, the
model estimated the dilution/attenuation factor (DAF) resulting from
subsurface processes such as three-dimensional dispersion and dilution
from groundwater recharge for a specific volume of waste.
The Agency requests public comments on its use of the EPACML model
and generic delisting levels in Sec. 261.3(c)(2)(ii)(C)(1) as applied
to the evaluation of UTA's waste. EPA will
[[Page 14703]]
consider all comments on the validity of the EPACML model and generic
delisting levels in Sec. 261.3(c)(2)(ii)(C)(1) and the appropriateness
for their use here to evaluate the potential for groundwater
contamination if UTA's petitioned waste is disposed of in any Subtitle
D landfill.
For the evaluation of UTA's petitioned waste, the Agency used the
EPACML model to evaluate the mobility of hazardous inorganic
constituents detected in the extract of samples of UTA's petitioned
waste. The Agency's evaluation, using UTA's estimated one-time waste
volume of 11,500 cubic yards and the EPACML modified for delisting
yielded a dilution/attenuation factor (DAF) of 100. See Table 5, which
is a list of DAFs calculated by the EPACML model, modified for
delisting, for landfills receiving different annual volumes of waste.
The DAFs in Table 5 include a scaling factor of 20, because the average
life of a subtitle D landfill is 20 years and the typical delisting
petition is for continuously generated waste which is sent to a
landfill at a certain annual rate. That annual rate, the volume of
waste in cubic yards per year, can be converted to a landfill size for
input into the EPACML model to generate a DAF, with the assumption that
the annual rate supplied by the delisting petitioner is multiplied by
20 prior to the conversion. The Agency has completed these calculations
for a range of annual waste volumes and they are summarized in Table 5.
The Agency need not use the scaling factor of 20 for a petitioned one-
time exclusion. Therefore, instead of a DAF of 34 obtained from Table 5
for 11,500 cubic yards, the Agency could eliminate the scaling factor
of 20 by dividing 11,500 cubic yards by 20, thereby obtaining a waste
volume of 575 and the maximum possible DAF of 100 in Table 5. See 55 FR
11826, March 29, 1990; 56 FR 32993, July 18, 1991; and 56 FR 67197,
Dec. 30, 1991 for a detailed description of the EPACML model, the
disposal assumptions, and the modifications made for delisting. See
also 60 FR 62801, Dec. 7, 1995, for a previous delisting proposal in
which the Agency obtained a DAF of 48, instead of 14.8, from a table
containing the same landfill DAFs and waste volumes as Table 5, for a
one-time exclusion of a volume of waste equal to 110,000 cubic yards.
(See docket for this rule for further details on the use of the EPACML
model in evaluating UTA's waste.)
Table 5.--Dilution/Attenuation Factors (DAFs) for Landfills Calculated
by the EPACML Model, Modified for Delisting
------------------------------------------------------------------------
DAF (95th
Waste volume in cubic yards per year \1\ percentile)
----------------------------------------------------------------\2\-----
1,000................................................... \3\ 100
1,250................................................... 96
1,500................................................... 90
1,750................................................... 84
2,000................................................... 79
2,500................................................... 74
3,000................................................... 68
4,000................................................... 57
5,000................................................... 54
6,000................................................... 48
7,000................................................... 45
8,000................................................... 43
9,000................................................... 40
10,000.................................................. 36
12,500.................................................. 33
15,000.................................................. 29
20,000.................................................. 27
25,000.................................................. 24
30,000.................................................. 23
40,000.................................................. 20
50,000.................................................. 19
60,000.................................................. 17
80,000.................................................. 17
90,000.................................................. 16
100,000................................................. 15
150,000................................................. 14
200,000................................................. 13
250,000................................................. 12
300,000................................................. 12
------------------------------------------------------------------------
\1\ The waste volume includes a scaling factor of 20; see 56 FR 32993,
July 18, 1991; and 56 FR 67197, Dec. 30, 1991, and text of today's
proposed rule, for a discussion of the use of the scaling factor.
\2\ The DAFs calculated by the EPACML are a probability distribution
based on a range of values for each model input parameter; the input
parameters include such variables as landfill size, climatic data, and
hydrogeologic data. The 95th percentile DAF represents a value in
which one can have 95% confidence that a contaminant's concentration
will be reduced by a factor equal to the DAF, as the contaminant moves
from the bottom of the landfill through the subsurface environment to
a receptor well. For example, if the 95th percentile DAF is 10, and
the leachate concentration of cadmium at the bottom of the landfill is
0.05 mg/l, one can be 95% confident that the receptor well
concentration of cadmium will not exceed 0.005 mg/l. See 55 FR 11826,
March 29, 1990; 56 FR 32993, July 18, 1991; and 56 FR 67197, December
30, 1991.
\3\ DAF cutoff is 100, corresponding to the Toxicity Characteristic Rule
(55 FR 11826, March 29, 1990).
The Agency calculated delisting levels for UTA's chemically
stabilized F006, based on the EPACML Model, as shown in Table 6.
[[Page 14704]]
Table 6.--EPACML-Based Delisting Levels for Cadmium and Chromium in Landfill Waste (TCLP, mg/l)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Waste volume (cubic yards, Allowable
one-time exclusion) Allowable TCLP \1\
----------------------------- TCLP \1\ leachate
leachate concentration
concentration (mg/l) for
Constituent Volume; DAF MCL (mg/l) (mg/l) for waste,
Volume; DAF without waste, with without
with scaling scaling scaling scaling
factor=20 factor=20 factor of 20 factor and
and DAF of DAF of
34=34 x MCL 100=100 x MCL
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cadmium........................................................................ 11,500; 34 575; 100 0.005 0.17 0.5
Chromium....................................................................... 11,500; 34 575; 100 0.10 3.4 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ As of September 25, 1990 the Agency adopted the TCLP as a replacement for and improvement upon the Extraction Procedure (EP) leachate test in its
hazardous waste regulatory program. Thus, the Agency now requires that petitioners provide TCLP data rather than EP data in support of their
petitions. The Agency believes that the maximum leachable concentrations of samples analyzed using the TCLP will be more representative of the
potential mobility of constituents from UTA's petitioned waste than if EP extracts of samples were analyzed.
These calculated delisting levels are the concentrations in the
TCLP extracts of the waste that the EPACML model predicts will not
result in contaminant levels above MCLs in groundwater at receptor
wells. The confidence level of this prediction is 95%, which is also
the level required for evaluating groundwater monitoring data subject
to 40 CFR part 264. See 56 FR 32998, July 18, 1981. The Agency uses
maximum contaminant levels, when they are available, as the health-
based levels for groundwater. See the ``Docket Report on Health-based
Levels and Solubilities Used in the Evaluation of Delisting Petitions,
Submitted Under 40 CFR Sec. 260.20 and Sec. 260.22,'' December 1994,
located in the RCRA public docket, for the Agency's methods of
calculating health-based levels for evaluating delisting petitions from
MCLs, and when MCLs are not available.
The Agency did not evaluate the mobility of constituents that were
undetected in UTA's petitioned waste because the non-detectable values
were obtained using the appropriate SW-846 analytical test methods and
adequate detection limits (see Tables 2 and 3). The Agency believes
that it is inappropriate to evaluate non-detectable concentrations of a
constituent of concern in its modeling efforts for RCRA delistings if
the non-detectable value was obtained using the appropriate analytical
method. If a constituent cannot be detected (when using the appropriate
analytical method with an adequate detection limit), the Agency
believes it is reasonable to assume that the constituent is not present
and therefore does not present a threat to either human health or the
environment.
The Agency did not calculate EPACML-based delisting levels in the
petitioned waste for arsenic, barium, VOCs, and SVOCs because levels of
these constituents in the untreated waste were below the health-based
levels used in delisting decision-making, and VOCs were undetected in
the petitioned (treated) waste. See Tables 2, 3, and 7.
Table 7.--Maximum Concentrations in Untreated Samples From Site Lagoons
----------------------------------------------------------------------------------------------------------------
Maximum \2\
concentration
Maximum in TCLP TCLP leachate
concentration leachate, (mg/ concentration Health-based
Constituent \1\ in site l), divided by level \4\
lagoons (total calculated DAF of 100 (mg/l)
analysis, mg/kg) from total \3\ (mg/l)
concentration
----------------------------------------------------------------------------------------------------------------
Arsenic........................................... 4.7 0.8 0.008 0.05
Barium............................................ 370 60 0.6 2
Lead.............................................. 26.2 4 0.04 0.015
Nickel............................................ 13.1 2 0.02 0.1
Bis(2-ethylhexyl)phthalate........................ 1.40 0.2 0.002 0.006
Di-n-butylphthalate............................... 0.63 0.1 0.001 4
----------------------------------------------------------------------------------------------------------------
\1\ The concentration level for each constituent in Table 7 is the maximum concentration found for that
constituent in Site lagoons.
\2\ The maximum possible concentration in a TCLP leachate of untreated waste, assuming all the constituent is
leachable, and assuming the dilution factor of 20 for the TCLP on 100% solids has been reduced to 6 by a
moisture content of 70% in the untreated waste.
\3\ The DAF of 100 was obtained from Table 5 for a one-time waste volume of 11,500 cubic yards of stabilized
waste, by eliminating the scaling factor of 20. See 55 FR 11826, March 29, 1990; 56 FR 32993, July 18, 1991;
and 56 FR 67197, Dec. 30, 1991 for a detailed description of the EPACML model, the disposal assumptions, and
the modifications made for delisting. See also 60 FR 62801, Dec. 7, 1995, for delisting proposal for a one-
time exclusion and a DAF obtained by eliminating the scaling factor of 20.
\4\ See the ``Docket Report on Health-based Levels and Solubilities Used in the Evaluation of Delisting
Petitions, Submitted Under 40 CFR Sec. 260.20 and Sec. 260.22,'' December 1994, located in the RCRA public
docket, for the Agency's methods of calculating health-based levels for evaluating delisting petitions from
MCLs, and when MCLs are not available.
Lead is the only constituent which exceeds the health-based level,
based on the assumptions made in the calculations for Table 7. Since
this was found for the maximum lead level in untreated waste, the
Agency believes that lead in the petitioned waste, which will be
treated and cured, will not adversely affect either human health or the
environment.
UTA submitted analytical results for tests of reactive cyanide and
reactive sulfide in the untreated lagoon waste; the concentrations of
reactive cyanide and reactive sulfide were well below the
[[Page 14705]]
Agency's interim standards of 250 mg/kg and 500 mg/kg, respectively.
See ``Interim Agency Thresholds for Toxic Gas Generation,'' July 12,
1985, internal Agency Memorandum in the RCRA public docket, and SW-846
Chapter 7, Section 7.3.3.2. Therefore, reactive cyanide and sulfide
levels in UTA's petitioned waste would not cause this waste to be
considered a hazardous waste for Subtitle C purposes and are not of
concern.
Although lead, nickel, and cyanide concentrations in untreated
waste indicate they may not pose a significant threat, the Agency
proposes to select as delisting levels for the petitioned waste the
generic delisting levels for cadmium, chromium, lead, nickel, and
cyanide in 40 CFR 261.3(c)(2)(ii)(C)(1). These levels are lower than
the EPACML-based levels; both generic and EPACML-based levels are
presented in Table 8.
Table 8.--Generic Delisting Levels and EPACML-Based Delisting Levels
------------------------------------------------------------------------
EPACML-
Generic based
delisting delisting
level from level DAF
Sec. = 100
Constituent 261.3 (TCLP, mg/
(TCLP, mg/ l) (level
l, except = DAF x
for MCL = 100
cyanide) x MCL)
------------------------------------------------------------------------
Cadmium.......................................... 0.050 0.50
Chromium......................................... 0.33 10
Lead............................................. 0.15 1.5
Nickel........................................... 1.0 10
Cyanide (total) (mg/kg) \1\...................... 1.8 20
------------------------------------------------------------------------
\1\ The cyanide (total, not amenable) concentration must not exceed 1.8
mg/kg, by total analysis, not analysis of leachate. Cyanide
concentrations must be measured by the method specified in 40 CFR
268.40, Note 7.
UTA reported that tests on the untreated lagoon waste demonstrated
that it did not exhibit the characteristics of ignitability or
corrosivity. Therefore, the petitioned waste would not be considered a
hazardous waste for Subtitle C purposes because of these
characteristics.
The Agency concluded after reviewing UTA's data on the Multiple
Extraction Procedure (MEP, Tables 3 and 10) that the long-term
leachability of the petitioned waste is unlikely to have an adverse
impact on either human health or the environment. The data for treated,
but not fully cured waste, in Table 3, indicate that a relatively small
percent of the available cadmium and chromium would leach from this
waste, after disposal in a subtitle D landfill, over a period of 1000
years. Furthermore, the data in Table 3 indicate that a period of more
than 100 years would be required for the leachate to contain a
concentration of cadmium greater than the EPACML-based delisting level
for a DAF of 100, in Table 6. EPACML-based-delisting levels, with a DAF
of 100 or 34, for chromium are not exceeded in any of the MEP extracts.
The MEP pH data in Table 10 indicate that the pH of the treated, but
not fully cured waste would remain alkaline for a period of more than
100 years.
Sample calculations which the Agency used to evaluate the MEP data
are presented in Table 9.
Table 9.--Long-Term Leachability Calculations From MEP Data for Stabilized, But Not Fully Cured Waste
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total chromium (Cr) in MEP extracts (mg) Total cadmium (Cd) Total Cr available (mg) \2\; % Total Cd available (mg); % leached EPACML-based
\1\ in MEP extracts (mg) leached after final extract (1000- after final extract (1000-year delisting level,
--------------------------------------------------------------- year estimate) \3\ estimate) DAF 100; Sec.
------------------------------------------------------------------------ 261.3 generic
delisting level
Sample #32 Sample Sample Sample (mg/1, in TCLP
#36 #32 #36 Sample #32 Sample #36 Sample #32 Sample #36 leachate)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.64......................... 0.74 3.01 2.49 28.9; 2.2%...... 44.9; 1.6%...... 77.7; 3.9%...... 54.3; 4.6%...... Cr: 10; 0.33.
Cd: 0.5; 0.05.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Concentrations of Cd in 6th and 7th extracts of treated Sample #32 (0.80, 0.52) and 6th extract of Sample #36 (0.56) are greater than generic delisting
level and EPACML-based DAF of 100 x MCL.
Concentrations of Cd in 8th extract of treated Sample #32 (0.11) and 7th extract of treated Sample #36 (0.46) are greater than generic delisting level,
but less than EPACML-based DAF of 100 x MCL.
\1\ Milligrams of Cr in all MEP extracts of treated Sample #32, assuming a 100-gram sample is sequentially extracted with 2 liters of extraction fluid/
extract = 2 l (.04 + .04 + .04 + .03 + .02 + .03 + .06 + .03 + .03) = 2 (.32) = .64 mg. See Table 3; the SPLP result is used for the concentration in
the first of 9 MEP extractions. The same assumptions were used to calculate the values for Cd in Sample #32 and Sample #36 and Cr in Sample #36.
\2\ Total concentration Cr in untreated Sample #32 = 289 mg/kg = 28.9 mg/100 g. See Table 3, and with the assumption of a 100-gram sample.
\3\ % leached after the last extract, estimated to simulate 1000 years of acid rain (See 47 FR 52687, November 22, 1982): (.64 x 100)/28.9 = 2.2%
Similar calculations were made for Cd in treated Sample #32 and for Cr and Cd in treated Sample #36:
Milligrams Cd MEP extracts of treated Sample #32 = 2 l (.005 + .005 + .005 + .005 + .005 + .80 + .52 + .11 + .05) = 2 x 1.505 = 3.01 mg; Total Cd in
untreated Sample #32 = 777 mg/kg = 77.7 mg/100 g; % leached in 1000 years = (3.01 x 100)/77.7 = 3.9%.
Milligrams of Cr treated Sample #36 = 2 l x (.07 + .07 + .03 + .03 + .02 + .04 + .05 + .04 + .02) = 2 (.37) = .74 mg; Total Cr in Sample #36 = 449 mg/kg
= 44.9 mg/100 g; % leached in 1000 years = (100 x .74)/44.9 = 1.6%.
Milligrams of Cd in treated Sample #36 = 2 l x (.005 + .01 + .005 + .005 + .03 + .56 + .46 + .14 + .03) = 2 x 1.245 = 2.49 mg; Total Cd in Sample #36 =
543 mg/kg = 54.3 mg/100 g; % leached in 1000 years = (100 x 2.49)/54.3 = 4.6%.
Table 10.--pH Data From MEP Extractions
--------------------------------------------------------------------------------------------------------------------------------------------------------
pH of each MEP extract at beginning and end of extraction (top value is beginning; bottom value is
end)
Sample No. ----------------------------------------------------------------------------------------
FR Doc. 96-8140 Hazardous Waste Management System; Identification and Listing of Hazardous Waste; Proposed Exclusion
---------------
Ext. # 1 Ext. # 2 Ext. # 3 Ext. # 4 Ext. # 5 Ext. # 6 Ext. # 7 Ext. # 8 Ext. # 9
--------------------------------------------------------------------------------------------------------------------------------------------------------
32.............................................. 12.0 11.6 11.3 10.7 10.0 7.90 6.40 4.50 3.00
[[Page 14706]]
11.6 11.3 10.7 10.0 7.90 6.40 4.50 3.00 3.00
36.............................................. 11.8 11.6 11.4 10.8 10.6 7.2 6.4 4.0 3.4
11.6 11.4 10.8 10.6 7.2 6.4 4.0 3.4 3.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
----------
The Agency concluded after reviewing UTA's waste management and
waste history information that no other hazardous constituents, other
than those tested for, are likely to be present in UTA's petitioned
waste. In addition, on the basis of test results and information
provided by UTA, pursuant to Sec. 260.22, the Agency concludes that the
petitioned waste does not exhibit any of the characteristics of
ignitability, corrosivity, or reactivity. See Secs. 261.21, 261.22, and
261.23, respectively.
During its evaluation of UTA's petition, the Agency also considered
the potential impact of the petitioned waste via nongroundwater routes.
With regard to airborne dispersal of waste, the Agency evaluated the
potential hazards resulting from airborne exposure to waste
contaminants from the petitioned waste using an air dispersion model
for releases from a landfill. The results of this evaluation indicated
that there is no substantial present or potential hazard to human
health from airborne exposure to constituents from UTA's petitioned
waste. (A description of the Agency's assessment of the potential
impact of airborne dispersal of UTA's waste is presented in the RCRA
public docket for today's proposed rule.)
The Agency also considered the potential impact of the petitioned
waste via a surface water route. The Agency believes that containment
structures at municipal solid waste landfills can effectively control
surface water runoff, as the recently promulgated Subtitle D
regulations (see 56 FR 50978, October 9, 1991) prohibit pollutant
discharges into surface waters.
Furthermore, if the waste were to remain on-site, the disposal
landfill containing the petitioned waste would be closed in accordance
with a closure/post-closure plan approved by the State of Tennessee.
Therefore, any significant future releases of contaminants from the
petitioned waste at its current location via a surface water route are
highly unlikely.
While some contamination of surface water is possible through
runoff from a waste disposal area (i.e., storm water), the Agency
believes that the dissolved concentrations of any hazardous
constituents in the runoff will tend to be lower than the extraction
procedure test results reported in today's notice because of the
aggressive acidic medium used for extraction in the TCLP.
The Agency also believes that, in general, leachate derived from
the waste will not directly enter a surface water body without first
traveling through the saturated subsurface where dilution of hazardous
constituents may occur.
In addition, any transported contaminants would be further diluted
in the receiving water body. Significant releases to surface water due
to erosion of undissolved particulates in runoff are also unlikely, due
to the controls noted above. Nevertheless, the Agency evaluated the
potential hazards resulting from possible releases from Site Lagoon 6,
which may become an onsite landfill. The results of these evaluations
indicate that UTA's waste would not present a threat to human health or
the environment. (See the docket to today's rule for a description of
this analysis).
E. Conclusion
The Agency believes that UTA has demonstrated that the petitioned
waste is not hazardous for Subtitle C purposes. The Agency believes
that the sampling procedures used by UTA were adequate, and that the
samples collected from the lagoons are representative of the waste
contained in the lagoons, and that the treatability study samples are
representative of the petitioned waste, to be generated later.
The Agency, therefore, is proposing that UTA's petitioned waste be
delisted as non-hazardous and thus not subject to regulation under RCRA
Subtitle C. The Agency proposes to grant a conditional, upfront, one-
time exclusion to United Technology Automotive's Detroit, Michigan,
facility for the chemically stabilized sludge and soil described in its
petition as EPA Hazardous Waste No. F006 and to be generated while
conducting a CERCLA removal of untreated sludge and soil from Lagoons
1-6 at the Highway 61 Industrial Site in Memphis, Tennessee (``the
Site'').
The Agency's decision to exclude this waste is based on
descriptions of waste management and waste history, results from the
analysis of samples of a treatability study on the chemical
stabilization process which will generate the petitioned waste, results
from the analysis of samples of the untreated waste from which the
petitioned waste will be generated, and groundwater monitoring data
available for untreated waste contained in Site lagoons. The Agency's
decision is also contingent upon verification testing conditions. If
the proposed rule becomes effective, the exclusion will be valid only
if the petitioner demonstrates that the petitioned waste meets the
verification testing conditions and delisting levels in the amended
Table 1 of Appendix IX of 40 CFR Part 261. If the Agency approves that
demonstration, the petitioned waste would not be subject to regulation
under 40 CFR Parts 262 through 268 and the permitting standards of 40
CFR Part 270. Although management of the waste covered by this petition
would, upon final promulgation, be relieved from Subtitle C
jurisdiction, the waste would remain a solid waste under RCRA. As such,
the waste must be handled in accordance with all applicable Federal and
State solid waste management regulations.
III. Limited Effect of Federal Exclusion
This proposed rule, if promulgated, would be issued under the
Federal (RCRA) delisting program. States, however, are allowed to
impose their own, non-RCRA regulatory requirements that are more
stringent than EPA's, pursuant to section 3009 of RCRA. These more
stringent requirements may include a provision which prohibits a
Federally issued exclusion from taking effect in the States. Because a
petitioner's waste may be regulated under a dual system (i.e., both
Federal and State programs), petitioners are urged to contact State
regulatory authorities to determine the current status of their wastes
under the State laws. Furthermore, some States are authorized to
administer a delisting program in lieu of the Federal program, i.e., to
make their own delisting decisions. Therefore, this proposed
[[Page 14707]]
exclusion, if promulgated, would not apply in those authorized States.
If the petitioned waste will be transported to any State with delisting
authorization, UTA must obtain delisting authorization from that State
before the waste may be managed as nonhazardous in that State.
IV. Effective Date
This rule, if made final, will become effective immediately upon
final publication. The Hazardous and Solid Waste Amendments of 1984
amended Section 3010 of RCRA to allow rules to become effective in less
than six months when the regulated community does not need the six-
month period to come into compliance. That is the case here, because
this rule, if finalized, would reduce the existing requirements for
persons generating hazardous wastes. In light of the unnecessary
hardship and expense that would be imposed on this petitioner by an
effective date six months after publication and the fact that a six-
month deadline is not necessary to achieve the purpose of Section 3010,
EPA believes that this exclusion should be effective immediately upon
final publication. These reasons also provide a basis for making this
rule effective immediately, upon final publication, under the
Administrative Procedure Act, pursuant to 5 USC 553(d).
V. Regulatory Impact
Under Executive Order 12866, EPA must conduct an ``assessment of
the potential costs and benefits'' for all ``significant'' regulatory
actions. The effect of this proposed rule would be to reduce the
overall costs and economic impact of EPA's hazardous waste management
regulations. This reduction would be achieved by excluding waste from
EPA's lists of hazardous wastes, thereby enabling this facility to
treat its waste as nonhazardous. Therefore, this proposed rule would
not be a significant regulatory action under the Executive Order, and
no assessment of costs and benefits is necessary. The Office of
Management and Budget (OMB) has also exempted this proposed rule from
the requirement for OMB review under Section (6) of Executive Order
12866.
VI. Regulatory Flexibility Act
Pursuant to the Regulatory Flexibility Act, 5 U.S.C. 601-612,
whenever an agency is required to publish a general notice of
rulemaking for any proposed or final rule, it must prepare and make
available for public comment a regulatory flexibility analysis that
describes the impact of the rule on small entities (i.e., small
businesses, small organizations, and small governmental jurisdictions).
No regulatory flexibility analysis is required, however, if the
Administrator or delegated representative certifies that the rule will
not have a significant economic impact on a substantial number of small
entities.
This rule, if promulgated, will not have an adverse economic impact
on any small entities since its effect would be to reduce the overall
costs of EPA's hazardous waste regulations and would be limited to one
facility. Accordingly, I hereby certify that this proposed regulation,
if promulgated, will not have a significant economic impact on a
substantial number of small entities. This regulation, therefore, does
not require a regulatory flexibility analysis.
VII. Paperwork Reduction Act
Information collection and record-keeping requirements associated
with this proposed rule have been approved by the Office of Management
and Budget (OMB) under the provisions of the Paperwork Reduction Act of
1980 (Pub.L. 96-511, 44 U.S.C 3501 et seq.) and have been assigned OMB
Control Number 2050-0053.
VIII. Unfunded Mandates Reform Act
Under section 202 of the Unfunded Mandates Reform Act of 1995
(``UMRA''), Public Law 104-4, which was signed into law on March 22,
1995, EPA generally must prepare a written statement for rules with
Federal mandates that may result in estimated costs to State, local,
and tribal governments in the aggregate, or to the private sector, of
$100 million or more in any one year. When such a statement is required
for EPA rules, under section 205 of the UMRA EPA must identify and
consider alternatives, including the least costly, most cost-effective
or least burdensome alternative that achieves the objectives of the
rule. EPA must select that alternative, unless the Administrator
explains in the final rule why it was not selected or it is
inconsistent with law. Before EPA establishes regulatory requirements
that may significantly or uniquely affect small governments, including
tribal governments, it must develop under section 203 of the UMRA a
small government agency plan. The plan must provide for notifying
potentially affected small governments, giving them meaningful and
timely input in the development of EPA regulatory proposals with
significant Federal intergovernmental mandates, and informing,
educating, and advising them on compliance with the regulatory
requirements.
The UMRA generally defines a Federal mandate for regulatory
purposes as one that imposes an enforceable duty upon State, local, or
tribal governments or the private sector. EPA finds that today's
proposed delisting decision is deregulatory in nature and does not
impose any enforceable duty on any State, local, or tribal governments
or the private sector. In addition, the proposed delisting does not
establish any regulatory requirements for small governments and so does
not require a small government agency plan under UMRA section 203.
List of Subjects in 40 CFR Part 261
Environmental Protection, Hazardous waste, Recycling, Reporting and
recordkeeping requirements.
Authority: Sec. 3001(f) RCRA, 42 U.S.C. 6921(f).
Dated: March 20, 1996
James S. Kutzman,
Acting Director, Waste Management Division.
For the reasons set out in the preamble, 40 CFR part 261 is
proposed to be amended as follows:
PART 261-IDENTIFICATION AND LISTING OF HAZARDOUS WASTE
1. The authority citation for part 261 continues to read as
follows:
Authority: 42 U.S.C 6905, 6912(a), 6921, 6922, and 6938.
2. In Table 1 of Appendix IX, part 261 add the following
wastestream in alphabetical order by facility to read as follows:
Appendix IX--Wastes Excluded Under Secs. 260.20 and 260.22
[[Page 14708]]
Table 1.--Wastes Excluded From Non-Specific Sources
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facility Address Waste description
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
United Technologies Automotive.......................... Detroit, Michigan...................... Chemically stabilized wastewater treatment sludge and
soil (CSWWTSS) (EPA Hazardous Waste No. F006) that
United Technologies Automotive (UTA) will generate
during CERCLA removal of untreated sludge and soil
(EPA Hazardous Waste No. F006) from six lagoons at
the Highway 61 Industrial Site in Memphis,
Tennessee. This is an upfront, one-time exclusion
for approximately 11,500 cubic yards of waste that
will be disposed of in a Subtitle D landfill or an
on-site landfill approved by the State of Tennessee
after [insert date of final rule.] UTA must
demonstrate that the following conditions are met
for the exclusion to be valid:
(1) Verification Testing Requirements: Sample
collection and analyses, including quality control
procedures must be performed according to SW-846
methodologies.
(A) Initial Verification Testing: UTA must collect
and analyze a representative sample of every batch,
for eight sequential batches of CSWWTSS generated
during full-scale operation. A batch is the CSWWTSS
generated during one run of the stabilization
process. UTA must analyze for the constituents
listed in Condition (3). A minimum of four composite
samples must be collected as representative of each
batch. UTA must report operational and analytical
test data, including quality control information, no
later than 60 days after the generation of the first
batch of CSWWTSS.
(B) Subsequent Verification Testing: If the initial
verification testing in Condition (1)(A) is
successful, i.e., delisting levels of condition (3)
are met for all of the eight initial batches, UTA
must test a minimum of 5% of the remaining batches
of CSWWTSS. UTA must collect and analyze at least
one composite sample representative of that 5%. The
composite must be made up of representative samples
collected from each batch included in the 5%. UTA
may, at its discretion, analyze composite samples
gathered more frequently to demonstrate that smaller
batches of waste are non-hazardous.
(2) Waste Holding and Handling: UTA must store as
hazardous all CSWWTSS generated until verification
testing as specified in Condition (1)(A) and (1)(B),
as appropriate, is completed and valid analyses
demonstrate that Condition (3) is satisfied. If the
levels of constituents measured in the samples of
CSWWTSS do not exceed the levels set forth in
Condition (3), then the CSWWTSS is non-hazardous and
may be managed in accordance with all applicable
solid waste regulations. If constituent levels in a
sample exceed any of the delisting levels set forth
in Condition (3), the batch of CSWWTSS generated
during the time period corresponding to this sample
must be retreated until it meets the delisting
levels set forth in Condition (3), or managed and
disposed of in accordance with Subtitle C of RCRA.
(3) Delisting Levels: All leachable concentrations
for these metals must not exceed the following
levels (ppm): Cadmium--0.05; chromium--0.33; lead--
0.15; and nickel--1.0. Metal concentrations must be
measured in the waste leachate by the method
specified in 40 CFR 261.24. The cyanide (total, not
amenable) concentration must not exceed 1.8 mg/kg,
by total analysis, not analysis of leachate. Cyanide
concentrations must be measured by the method
specified in 40 CFR 268.40, Note 7.
(4) Changes in Operating Conditions: UTA must notify
the Agency in writing when significant changes in
the stabilization process are necessary (e.g., use
of new stabilization reagents). Condition (1)(A)
must be repeated for significant changes in
operating conditions.
(5) Data Submittals: UTA must notify EPA when the
full-scale chemical stabilization process is
scheduled to start operating. Data obtained in
accordance with Conditions (1)(A) must be submitted
to Jeaneanne M. Gettle, Acting Chief, RCRA
Compliance Section, Mail Code: 4WD-RCRA, U.S. EPA,
Region 4, 345 Courtland Street, N.E., Atlanta,
Georgia. 30365. This notification is due no later
than 60 days after the first batch of CSWWTSS is
generated. Records of operating conditions and
analytical data from Condition (1) must be compiled,
summarized, and maintained by UTA for a minimum of
five years, and must be furnished upon request by
EPA or the State of Tennessee, and made available
for inspection. Failure to submit the required data
within the specified time period or maintain the
required records for the specified time will be
considered by EPA, at its discretion, sufficient
basis to revoke the exclusion to the extent directed
by EPA. All data must be accompanied by a signed
copy of the following certification statement to
attest to the truth and accuracy of the data
submitted:
Under civil and criminal penalty of law for the
making or submission of false or fraudulent
statements or representations (pursuant to the
applicable provisions of the Federal Code, which
include, but may not be limited to, 18 U.S.C. 1001
and 42 U.S.C. 6928), I certify that the information
contained or accompanying this document is true,
accurate and complete.
[[Page 14709]]
As to the (those) identified section(s) of this
document for which I cannot personally verify its
(their) truth and accuracy, I certify as the company
official having supervisory responsibility for the
persons who, acting under my direct instructions,
made the verification that this information is true,
accurate and complete.
In the event that any of this information is
determined by EPA in its sole discretion to be
false, inaccurate or incomplete, and upon conveyance
of this fact to the company, I recognize and agree
that this exclusion of waste will be void as if it
never had effect or to the extent directed by EPA
and that the company will be liable for any actions
taken in contravention of the company's RCRA and
CERCLA obligations premised upon the company's void
exclusion.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
[FR Doc. 96-8140 Filed 4-2-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-8134 Request for Comments Concerning Guides for Private Vocational Schools
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14685-14686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8134]
=======================================================================
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
16 CFR Part 254
Request for Comments Concerning Guides for Private Vocational
Schools
AGENCY: Federal Trade Commission.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Federal Trade Commission (the ``Commission'') is
requesting public comments on its Guide for Private Vocational Schools.
The Commission is also requesting comments about the overall costs and
benefits of the guides and their overall regulatory and economic impact
as part of its systematic review of all current Commission regulations
and guides.
DATES: Written comments will be accepted until May 3, 1996.
ADDRESSES: Comments should be directed to: Secretary, Federal Trade
Commission, Room H-159, Sixth and Pennsylvania Ave., N.W., Washington,
D.C. 20580. Comments about the Guides for Private Vocational Schools
should be identified as ``16 CFR Part 254--Comment.''
FOR FURTHER INFORMATION CONTACT:
Joseph J. Koman, Jr., Federal Trade Commission, Bureau of Consumer
Protection, Division of Enforcement, Room S-4302, 601 Pennsylvania
Ave., N.W., Washington, D.C. 20580, (202) 326-3014, or Walter Gross
III, Federal Trade Commission, Bureau of Consumer Protection, Division
of Service Industry Practices, Room H-200, Sixth Street and
Pennsylvania Ave., N.W., Washington, D.C. 20580, (202) 326-3319.
SUPPLEMENTARY INFORMATION: The Commission has determined, as part of
its oversight responsibilities, to review rules and guides
periodically. These reviews seek information about the costs and
benefits of the Commission's rules and guides and their regulatory and
economic impact. The information obtained assists the Commission in
identifying rules and guides that warrant modification or recision.
At this time, the Commission solicits written public comments
concerning the Commission's Guides for Private Vocational Schools, 16
CFR Part 254. These guides, like the other industry guides issued by
the Commission, ``are
[[Page 14686]]
administrative interpretations of laws administered by the Commission
for the guidance of the public in conducting its affairs in conformity
with legal requirements.'' 16 CFR 1.5. Conduct inconsistent with the
guides may result in corrective action by the Commission under
applicable statutory provisions.
The Private Vocational Schools Guides provide guidance about
acceptable and unacceptable claims made in advertising, or other
promotional materials, however disseminated, for resident or
correspondence courses or training or instruction programs by private
career or vocational schools. Specifically, the guides pertain to
claims about the nature of the school, its accreditation, programs of
instruction or methods of teaching and available employment
opportunities. The guides also include provisions on representations
concerning financial assistance, appropriate disclosures as to the
nature of courses or training programs offered, pictorial or other
misrepresentations, deceptive prices, and sales, collection and credit
practices.
Accordingly, the Commission solicits public comments on the
following questions:
1. Is there a continuing need for the Guides?
a. What benefits have the Guides provided to purchasers of the
products or services affected by the Guides?
b. Have the Guides imposed costs on purchasers?
2. What changes, if any, should be made to the Guides to increase
the benefits of the Guides to purchasers?
a. How would these changes affect the costs the Guides impose on
firms subject to their requirements?
3. What significant burdens or costs, including costs of adherence,
have the Guides imposed on firms subject to their requirements?
a. Have the Guides provided benefits to such firms?
4. What changes, if any, should be made to the Guides to reduce the
burdens or costs imposed on firms subject to their requirements?
a. How would these changes affect the benefits provided by the
Guides?
5. Do the Guides overlap or conflict with other federal, state, or
local laws or regulations?
6. Since the Guides were issued, what effects, if any, have changes
in relevant technology or economic conditions had on the Guides?
7. Are there problems today in the marketing of vocational school
programs or correspondence courses? If yes, what is the nature of these
problems? Do the Guides adequately address any problems that may
exists?
Authority: 15 U.S.C. 41-58.
List of Subjects in 16 CFR Part 254
Advertising, Trade practices.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 96-8134 Filed 4-2-96; 8:45 am]
BILLING CODE 6750-01-M
Complete official Federal Register PDF
FR Doc. 96-8128 Proposed Flood Elevation Determinations
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14715-14717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8128]
-----------------------------------------------------------------------
FEDERAL EMERGENCY MANAGEMENT AGENCY
44 CFR Part 67
[Docket No. FEMA-7177]
Proposed Flood Elevation Determinations
AGENCY: Federal Emergency Management Agency (FEMA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: Technical information or comments are requested on the
proposed base (1% annual chance) flood elevations and proposed base
flood elevation modifications for the communities listed below. The
base flood elevations and modified base flood elevations are the basis
for the floodplain management measures that the community is required
either to adopt or to show evidence of being already in effect in order
to qualify or remain qualified for participation in the National Flood
Insurance Program (NFIP).
DATES: The comment period is ninety (90) days following the second
publication of this proposed rule in a newspaper of local circulation
in each community.
ADDRESSES: The proposed base flood elevations for each community are
available for inspection at the office of the Chief Executive Officer
of each community. The respective addresses are listed in the following
table.
FOR FURTHER INFORMATION CONTACT: Michael K. Buckley, P.E., Chief,
Hazard Identification Branch, Mitigation Directorate, 500 C Street, SW,
Washington, DC 20472, (202) 646-2756.
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
proposes to make determinations of base flood elevations and modified
base flood elevations for each community listed below, in accordance
with Section 110 of the Flood Disaster Protection Act of 1973, 42
U.S.C. 4104, and 44 CFR 67.4(a).
These proposed base flood and modified base flood elevations,
together with the floodplain management criteria required by 44 CFR
60.3, are the minimum that are required. They should not be construed
to mean that the community must change any existing ordinances that are
more stringent in their floodplain management requirements. The
community may at any time enact stricter requirements of its own, or
pursuant to policies established by other Federal, State, or regional
entities. These proposed elevations are used to meet the floodplain
management requirements of the NFIP and are also used to calculate the
appropriate flood insurance premium rates for new buildings built after
these elevations are made final, and for the contents in these
buildings.
National Environmental Policy Act. This proposed rule is
categorically excluded from the requirements of 44 CFR Part 10,
Environmental Consideration. No environmental impact assessment has
been prepared.
Regulatory Flexibility Act. The Acting Associate Director,
Mitigation Directorate, certifies that this proposed rule is exempt
from the requirements of the Regulatory Flexibility Act because
proposed or modified base flood elevations are required by the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4104, and are required to
[[Page 14716]]
establish and maintain community eligibility in the NFIP. No regulatory
flexibility analysis has been prepared.
Regulatory Classification. This proposed rule is not a significant
regulatory action under the criteria of Section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
Executive Order 12612, Federalism. This proposed rule involves no
policies that have federalism implications under Executive Order 12612,
Federalism, dated October 26, 1987.
Executive Order 12778, Civil Justice Reform. This proposed rule
meets the applicable standards of Section 2(b)(2) of Executive Order
12778.
List of Subjects in 44 CFR Part 67
Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.
Accordingly, 44 CFR Part 67 is proposed to be amended as follows:
PART 67--[AMENDED]
1. The authority citation for Part 67 continues to read as follows:
Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.
Sec. 67.4 [Amended]
2. The tables published under the authority of Sec. 67.4 are
proposed to be amended as follows:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
#Depth in feet above
ground. Elevation in
State City/town/county Source of flooding Location feet. (NGVD)
-------------------------
Existing Modified
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
California........................... Orange (County) Arroyo Salada............................ At confluence with Salt Creek............................. *122 None
Unincorporated Areas.
Just upstream of East Nine Drive.......................... *186 *206
Approximately 400 feet upstream of East Nine Drive........ *200 *208
Approximately 800 feet upstream of East Nine Drive........ *210 *212
Approximately 1,200 feet upstream of East Nine Drive...... *219 224
Approximately 1,600 feet upstream of East Nine Drive...... *229 *232
Approximately 2,000 feet upstream of East Nine Drive...... *236 *238
Approximately 2,400 feet upstream of East Nine Drive...... *244 *244
Approximately 2,800 feet upstream of East Nine Drive...... *250 *251
Approximately 3,200 feet upstream of East Nine Drive...... *258 *261
Approximately 3,600 feet upstream of East Nine Drive...... *269 271
Approximately 3,900 feet upstream of East Nine Drive...... *274 *276
Maps are available for inspection at Orange County Flood Programs, EMA, 400 Civic Center, Santa Ana, California.
Send comments to The Honorable Gaddi Vasquez, Chairman, Orange County Board of Supervisors, P.O. Box 687, Santa Ana, California 92702-0687.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
California........................... Williams (City) Colusa Salt Creek............................... At Freshwater Road........................................ None *72
County.
At Interstate 5........................................... None *73
At Business Route 5....................................... None *77
Approximately 350 feet upstream of Business Route 5....... None *77
Salt Creek--Overflow Area 1.............. At Freshwater Road........................................ None *69
Approximately 3,250 feet upstream of Freshwater Road...... None *72
Salt Creek--Overflow Area 2.............. Southwest of intersection of Interstate 5 and State Route None *77
20.
At Business Route 5....................................... None *78
Approximately 950 feet upstream of Worth Street........... None *83
West of intersection of State Route 20 and E Street....... None *86
South of intersection of State Route 20 and E Street...... None *90
Salt Creek--Overflow Area 3.............. At Husted Road............................................ None *68
Approximately 5,100 feet upstream of Husted Road.......... None *73
[[Page 14717]]
Maps are available for inspection at the City Building Department, City Hall, 810 E Street, Williams, California.
Send comments to The Honorable Donald Burnett, Mayor, City of Williams, P.O. Box 310, Williams, California 95987.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Missouri............................. Lawson (City) Clay and Brushy Creek............................. Approximately 3,950 feet downstream of the Atchison, None *996
Ray Counties. Topeka, and Santa Fe Railroad bridge.
Approximately 2,600 feet downstream of the Atchison, None *1,000
Topeka, and Sante Fe Railroad bridge.
Approximately 1,000 feet downstream of the Atchison, None *1,005
Topeka, and Santa Fe Railroad bridge.
Approximately 900 feet upstream of confluence with Brushy None *1,010
Creek Tributary II.
Brush Creek Tributary II................. At confluence with Brushy Creek........................... None *1,008
At County Highway D....................................... None *1,013
Approximately 2,500 feet upstream of County Highway D..... None *1,020
Approximately 1,500 feet downstream of Salem Road......... None *1,030
Just downstream of Salem Road............................. None *1,043
Maps are available for inspection at the City of Lawson, City Hall, City Administrator's Office, 3rd and Pennsylvania, Lawson, Missouri.
Send comments to The Honorable Robert Gill, Mayor, City of Lawson, P.O. Box 185, Lawson, Missouri 64062.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Texas................................ Montgomery County Sam Bell Gully........................... Approximately 300 feet downstream of Maplewood Drive...... *121 *121
(Unincorporated Areas).
Approximately 1,100 feet just upstream of Maplewood Drive. *122 *123
Just upstream of Maplewood Drive.......................... *124 *124
Maps are available for inspection at the County Administration Building, 301 North Thompson, Suite 208, Conroe, Texas.
Send comments to The Honorable Alan Sadler, Montgomery County Judge, County Administration Building, 301 North Thompson, Suite 208, Conroe, Texas 77301.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(Catalog of Federal Domestic Assistance No. 83.100, ``Flood
Insurance.'')
Dated: March 25, 1996.
Richard W. Krimm,
Acting Associate Director for Mitigation.
[FR Doc. 96-8128 Filed 4-2-96; 8:45 am]
BILLING CODE 6718-04-P
Complete official Federal Register PDF
FR Doc. 96-8127 National Flood Insurance Program; Assistance to Private Sector Property Insurers
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14709-14715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8127]
=======================================================================
-----------------------------------------------------------------------
FEDERAL EMERGENCY MANAGEMENT AGENCY
44 CFR Part 62
RIN 3067-AC26
National Flood Insurance Program; Assistance to Private Sector
Property Insurers
AGENCY: Federal Insurance Administration (FEMA).
ACTION: Proposed Rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would amend the National Flood Insurance
Program (NFIP) regulations establishing the Financial Assistance/
Subsidy Arrangement that may be entered into by and between the
Administrator and private sector insurers under the Write Your Own
(WYO) program. The proposed amendments would: (1) Simplify the
Arrangement by streamlining the format; (2) reflect recent policy
changes regarding loss adjustment and financial operation of the
private insurers in the WYO program; and (3) delete references to
obsolete operating manuals and handbooks. The proposed amendments would
also improve the flexibility of the Arrangement and would provide
information to permit WYO participants to discharge their
responsibilities for underwriting, claims adjustment, and financial
control procedures established by the Federal Insurance Administration
(FIA).
DATES: All comments received on or before May 20, 1996 will be
considered before final action is taken on the proposed rule.
ADDRESSES: Please submit any written comments to the Rules Docket
Clerk, Office of the General Counsel, Federal Emergency Management
Agency, 500 C Street SW., room 840, Washington, DC 20472, (facsimile)
202-646-4536.
FOR FURTHER INFORMATION CONTACT: Edward T. Pasterick, Federal Emergency
Management Agency, Federal Insurance Administration, 500 C Street SW.,
Washington, DC 20472, (202) 646-3443.
SUPPLEMENTARY INFORMATION: The WYO program has operated for thirteen
years. The program's operating documents reflect program experience as
well as the FIA's ongoing dialogue with private insurers that have
participated in the WYO program, insurance company executives, FEMA's
Office of Financial Management, and FEMA's Office of Inspector General.
Under the WYO Program, insurers signatory to the Financial Assistance/
Subsidy Arrangement may issue in their own names the Standard Flood
Insurance Policy, the form and substance of which is approved by the
Administrator. Insurers are responsible for all aspects of service,
including policy issuance to new policyholders and to their
policyholders insured under other lines of property insurance;
endorsement and renewals of policies; and the adjustment of claims
brought under the policies. The insurers pay losses and loss adjustment
expenses, as well as the commissions of agents, out of written
premiums. In return for discharging these responsibilities under the
Arrangement, insurers retain a set portion of the written premium. The
amount of retained written premium by an insurer is based in part on
the insurer's performance in achieving marketing goals during the
Arrangement year.
The proposed changes to the regulations are intended therefore to
simplify the terms and conditions of the WYO Arrangement itself in
order to make it easier for private insurers to participate in the WYO
program and thereby serve an underlying Congressional intent to carry
out the NFIP ``to the maximum extent practicable by the private
insurance industry,'' as called for in the Declaration of Purpose for
the National Flood Insurance Act of 1968, Pub. L. 90-448, 42 U.S.C.
4001.
The proposed changes would offer a more flexible framework than now
for private insurers participating in the WYO program to operate while
maintaining the operational and financial controls and standards
necessary to preserve program integrity and accountability--both for
the Government and for the participating private insurers. For example,
the adjuster's fee schedule needs to be revised to reflect program
changes prompted by the National Flood Insurance Reform Act (NFIRA) of
1994. Those revisions could be made, more appropriately, in a parallel
effort and published in operating manuals rather than encumbering the
Arrangement. Operating processes relating to the single adjuster
program may be better handled differently from the Arrangement. Also,
references to many documents should be deleted so that the Arrangement
is not encumbered with details about publications that may be scheduled
for revision during the course of the Arrangement year. Consistent with
the proposed changes to the WYO Financial Control Plan, Appendix B to
44 CFR Part 62 published in the Federal Register on February 1, 1996,
61 FR 3635-3644, this proposed rule would discontinue the self-audit
requirement for private insurers participating in the WYO program.
In sum, the proposed changes to the regulations would produce a WYO
Arrangement that would clearly specify the responsibilities and duties
of the Government and the private insurers participating in the WYO
program without burdening the Arrangement with unnecessary detail or
references that may become obsolete before the Arrangement year
expires.
National Environmental Policy Act. This proposed rule would be
[[Page 14710]]
categorically excluded from the requirements of 44 CFR Part 10,
Environmental Consideration. No environmental impact assessment has
been prepared.
Executive Order 12866, Regulatory Planning and Review. This
proposed rule would not be a significant regulatory action as defined
under Executive Order 12866 of September 30, 1993, Regulatory Planning
and Review, 58 FR 51735, October 4, 1993. To the extent possible, this
rule adheres to the principles of regulation set forth in Executive
Order 12866. This rule has not been reviewed by the Office of
Management and Budget under the provisions of Executive Order 12866.
Paperwork Reduction Act. This proposed rule would not contain a
collection of information and is therefore not subject to the
provisions of the Paperwork Reduction Act of 1995.
Executive Order 12612, Federalism. This proposed rule would involve
no policies that have federalism implications under Executive Order
12612, Federalism, dated October 26, 1987.
Executive Order 12778, Civil Justice Reform. This proposed rule
would meet the applicable standards of section 2(b)(2) of Executive
Order 12778.
List of Subjects in 44 CFR Part 62
Claims, Flood Insurance.
We use certain conventions in this proposed rule to highlight the
proposed revisions. New language is shown inside boldfaced arrows >><<,
while language that would be deleted is set off with boldfaced brackets
[].
Accordingly, 44 CFR part 62 is proposed to be amended as follows:
PART 62--SALE OF INSURANCE AND ADJUSTMENT OF CLAIMS
1. The authority citation for Part 62 continues to read as follows:
Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 43 FR 41943, 3 CFR, 1978 Comp., p. 329; E.O. 12127 of Mar. 31,
1979, 44 FR 19367, 3 CFR, 1979 Comp., p. 376.
2. Appendix A of part 62 would be revised to read as follows:
Appendix A to Part 62--Federal Emergency Management Agency, Federal
Insurance Administration, Financial Assistance/Subsidy Arrangement
Purpose: To assist the company in underwriting flood insurance
using the Standard Flood Insurance Policy.
Accounting Data: Pursuant to Section 1310 of the Act, a Letter of
Credit shall be issued for payment as provided for herein from the
National Flood Insurance Fund.
Effective Date: [October 1, 1995.] >> October 1, 1996.<<
Issued By: Federal Emergency Management Agency, Federal Insurance
Administration, Washington, DC 20472.
Article I--Findings, Purpose, and Authority
Whereas, the Congress in its ``Finding and Declaration of Purpose''
in the National Flood Insurance Act of 1968, as amended, (``the Act'')
recognized the benefit of having the National Flood Insurance Program
(the Program) ``carried out to the maximum extent practicable by the
private insurance industry''; and
Whereas, the Federal Insurance Administration (FIA) recognizes this
Arrangement as coming under the provisions of Section 1345 of the Act;
and
Whereas, the goal of the FIA is to develop a program with the
insurance industry where, over time, some risk-bearing role for the
industry will evolve as intended by the Congress (Section 1304 of the
Act); and
Whereas, [the Program, as presently constituted and implemented, is
subsidized, and] the insurer (hereinafter the ``Company'') under this
Arrangement shall charge rates established by the FIA; and
Whereas, this Arrangement will subsidize all flood policy losses by
the Company; and
Whereas, this Financial Assistance/Subsidy Arrangement has been
developed to [involve individual Companies in the Program, the initial
step of which is to explore ways in which any interested insurer may be
able] >> enable any interested qualified insurer<< to write flood
insurance under its own name; and
Whereas, one of the primary objectives of the Program is to provide
coverage to the maximum number of structures at risk and because the
insurance industry has marketing access through its existing facilities
not directly available to the FIA, it has been concluded that coverage
will be extended to those who would not otherwise be insured under the
Program; and
Whereas, flood insurance policies issued subject to this
Arrangement shall be only that insurance written by the Company in its
own name pursuant to the Act; and
Whereas, over time, the Program is designed to increase industry
participation, and, accordingly, reduce or eliminate Government as the
principal vehicle for delivering flood insurance to the public; and
Whereas, the direct beneficiaries of this Arrangement will be those
Company policyholders and applicants for flood insurance who otherwise
would not be covered against the peril of flood.
Now, therefore, the parties hereto mutually undertake the
following:
Article II--Undertakings of the Company
A. In order to be eligible for assistance under this Arrangement
the Company shall be responsible for:
1.0 Policy Administration, including
1.1 Community Eligibility/Rating Criteria
1.2 Policyholder Eligibility Determination
1.3 Policy Issuance
1.4 Policy Endorsements
1.5 Policy Cancellations
1.6 Policy Correspondence
1.7 Payment of Agents' Commissions
The receipt, recording, control, timely deposit and disbursement of
funds in connection with all the foregoing, and correspondence relating
to the above in accordance with the Financial Control Plan
requirements.
2.0 Claims processing in accordance with general Company standards
and the Financial Control Plan. [The Write Your Own Claims Manual, the
Federal Emergency Management Agency Adjuster Manual, the FIA National
Flood Insurance Program Policy Issuance Handbook, the Write Your Own
Operational Overview, and other instructional material also provide
guidance to the Company.] >> Other technical and policy material
published by FEMA and FIA will also provide guidance to the Company. <<
3.0 Reports
3.1 Monthly Financial Reporting and Statistical Transaction
Reporting shall be in accordance with the requirements of National
Flood Insurance Program Transaction Record Reporting and Processing
Plan for the Write Your Own (WYO) Program and the Financial Control
Plan for business written under the WYO Program. These data shall be
validated/edited/audited in detail and shall be compared and balanced
against Company financial reports.
3.2 Monthly financial reporting shall be prepared in accordance
with the WYO Accounting Procedures.
[3.3 The Company shall establish a program of self audit
acceptable to the FIA or comply with the self audit program contained
in the Financial Control Plan for business written under
[[Page 14711]]
the WYO Program. The Company shall report the results of this self-
audit to the FIA annually.]
B. The Company shall use the following time standards of
performance as a guide:
1.0 Application Processing--15 days (Note: If the policy cannot be
mailed due to insufficient or erroneous information or insufficient
funds, a request for correction or added monies shall be mailed within
10 days);
1.1 Renewal Processing--7 days;
1.2 Endorsement Processing--[7 days;] >> 15 days; <<
1.3 Cancellation Processing--15 days;
[1.4 Correspondence, Simple and/or Status Inquiries--7 days;]
[1.5 Correspondence, Complex Inquiries--20 days;]
[1.6 Supply, Materials, and Manual Requests--7 days;]
[1.7] >> 1.4 << Claims Draft Processing--7 days from completion of
file examination;
[1.8] >> 1.5 << Claims Adjustment--45 days average from receipt of
Notice of Loss (or equivalent) through completion of examination.
[1.9] >> 1.6 << For the elements of work enumerated above, the
elapsed time shown is from the date of receipt through the date of mail
out. Days means working, not calendar days.
In addition to the standards for timely performance set forth
above, all functions performed by the Company shall be in accordance
with the highest reasonably attainable quality standards generally
utilized in the insurance and data processing industries.
These standards are for guidance. Although no immediate remedy for
failure to meet them is provided under this Arrangement, nevertheless,
performance under these standards and the marketing guidelines provided
for in Section G. below can be a factor considered by the Federal
Insurance Administrator (the Administrator) in requiring corrective
action by the Company, in determining the continuing participation of
the Company in the Program, or in taking other action, e.g., limiting
the Company's authority to write new business.
C. To ensure maximum responsiveness to the National Flood Insurance
Program's (NFIP) policyholders following a catastrophic event, e.g., a
hurricane, involving insured wind and flood damage to policyholders,
the Company shall agree to the adjustment of the combined flood and
wind losses utilizing one adjuster under an NFIP-approved Single
Adjuster Program in the following cases and under procedures issued by
the Administrator:
1.0 Where the flood and wind coverage is provided by the Company;
2.0 Where the flood coverage is provided by the Company and the
wind coverage is provided by a participating State Property Insurance
Plan, Windpool Association, Beach Plan, Joint Underwriting Association,
FAIR Plan, or similar property insurance mechanism;
3.0 Where the flood coverage is provided by the Company and the
wind coverage is provided by another WYO Company and the necessary
information on the dual coverage is part of the Claims Coordinating
Office (CCO) system; and
4.0 Where the flood coverage is provided by the Company and the
wind coverage is provided by another property insurer and the State
Insurance Regulator has determined that such property insurer shall, in
the interest of consumers, facilitate the adjustment of its wind loss
by the adjuster engaged to adjust the flood loss of the Company.
[The Government shall provide for the direct business flood losses
to be adjusted by a single adjuster where the wind damage coverage is
insured by a state market mechanism described in 2.0, above, or by a
WYO Company as described in 3.0 above, or by a property insurer, as
described in 4.0 above.]
[Except for 1.0, above, the Company shall submit its flood losses
that are reasonably believed to involve wind damage to the Single
Adjuster Program's Stationary CCO in Lanham, Maryland at the following
address:]
[National Flood Insurance Program Stationary Claims Coordinating
Office 10115 Senate Drive Lanham, Maryland 20706]
[Such flood losses shall be reported on the ACORD Notice of Loss
form, ``ACORD 1 (1/93),'' or a like form calling for the reporting of
losses involving both flood and wind damage arising out of a single
hurricane event under the following procedures:]
[ Where flood losses reasonably believed to involve wind
damage are reported by property insurance agents of brokers, the
Company shall instruct its agents or brokers to mail or preferably send
by facsimile the ACORD Notice of Loss form, with complete details
regarding flood and, if available, wind insurance policies covering the
property, to the Single Adjuster Program Stationary CCO for assignment
to a single adjuster. The Stationary CCO will also accept loss
information directly from the agent by modem in CCO format where the
Company has arranged for its agents to provide the information in this
fashion.]
[ Where flood losses reasonably believed to involve wind
damage are reported directly to the Company by its policyholders or
agents, by telephone, the Company shall report the flood loss, with the
wind property insurer information, if available, to the Single Adjuster
Program Stationary CCO, by modem transfer in CCO format as such flood
losses are reported to the Company. Transfer by facsimile from the
Company can also be arranged where circumstances warrant it.]
[Upon receipt of the Notice of Loss, the Stationary CCO shall
effect immediate entry of all relevant data into the stand-alone CCO
System (i.e., not part of the NFIP mainframe computer system) for
instantaneous relay to the Catastrophe CCO established in the field. At
the Catastrophe CCO, which will be sited and fully operational within
24 hours of landfall, in coordination with the State Insurance
Regulator, a qualified loss adjustment organization shall be promptly
selected for each loss, and participating insurers shall be promptly
advised of the selection for their assignment of the loss to that
organization.]
[In respect to the foregoing, the Administrator will continue to
implement existing and future CCO Arrangements with State Insurance
Regulators and their State Property Insurance Plans, Windpool
Associations, Beach Plans, Joint Underwriting Associations, FAIR Plans,
or similar property insurance mechanisms, for example, as has been done
with the Insurance Department of the State of South Carolina.]
D. Policy Issuance
1.0 The flood insurance subject to this Arrangement shall be only
that insurance written by the Company in its own name pursuant to the
Act.
2.0 The Company shall issue policies under the regulations
prescribed by the Administrator in accordance with the Act;
3.0 All such policies of insurance shall conform to the
regulations prescribed by the Administrator pursuant to the Act, and be
issued on a form approved by the Administrator;
4.0 All policies shall be issued in consideration of such premiums
and upon such terms and conditions and in such States or areas or
subdivisions thereof as may be designated by the Administrator and only
where the Company is licensed by State law to engage in the property
insurance business;
5.0 The Administrator may require the Company to immediately
discontinue issuing policies subject to
[[Page 14712]]
this Arrangement in the event Congressional authorization or
appropriation for the National Flood Insurance Program is withdrawn.
E. The Company shall [establish a bank account,] separate >>
Federal flood insurance funds >> [and apart] from all other Company
accounts, at a bank >> or banks << of its choosing for the collection,
retention and disbursement of >> Federal << funds relating to its
obligation under this Arrangement, less the Company's expenses as set
forth in Article III, and the operation of the Letter of Credit
established pursuant to Article IV. All funds not required to meet
current expenditures shall be remitted to the United States Treasury,
in accordance with the provisions of the WYO Accounting Procedures
Manual.
F. The Company shall investigate, adjust, settle and defend all
claims or losses arising from policies issued under this Arrangement.
Payment of flood insurance claims by the Company shall be binding upon
the FIA.
G. The Company shall market flood insurance policies in a manner
consistent with the marketing guidelines established by the Federal
Insurance Administration.
Article III--Loss Costs, Expenses, Expense Reimbursement, and Premium
Refunds
A. The Company shall be liable for operating, administrative and
production expenses, including any >> State premium << taxes,
dividends, agent's commissions [or any board, exchange or bureau
assessments,] or any other expense of whatever nature incurred by the
Company in the performance of its obligations under this Arrangement.
B. The Company shall be entitled to withhold, on a provisional
basis, as operating and administrative expenses, including agents' or
brokers' commissions, an amount from the Company's written premium on
the policies covered by this Arrangement in reimbursement of all of the
Company's marketing, operating and administrative expenses, except for
allocated and unallocated loss adjustment expenses described in Section
C. of this Article, which amount shall be 32.6% of the Company's
written premium on the policies covered by this Arrangement. The final
amount retained by the Company shall be determined by an increase or
decrease depending on the extent to which the Company meets the
marketing goals for the [combined 1994-1995 and 1995-1996] 1996-1997
Arrangement year[s] contained in marketing guidelines established
pursuant to Article II.G.
The [decrease or increase] >> adjustment << in the amount retained
by the Company shall be made after the end of the [1995-1996] >> 1996-
1997 << Arrangement year. Any decrease from 32.6% made as a result of a
Company not meeting its marketing goals shall be directly related to
the extent to which the Company's goal was not achieved, but shall not
exceed two (2) percentage points (providing for a minimum of 30.6%).
[The amount of any decrease shall be calculated for each month, and
each month's decrease shall be subject to interest compounded at rates
provided for by 31 U.S.C. 3717(a)(1). Upon notice of the cumulative
monthly decreases and interest, the Company agrees to promptly remit to
the Government the total amount due.]
The increase, which shall be distributed among the Companies
exceeding their marketing goals, shall be drawn from a pool composed of
the difference between 32.6% of all WYO Companies' written premium in
Arrangement year[s 1994-1995 and 1995-1996,] >> 1996-1997 << and the
total amount, prior to the increase, provided to the Companies on the
basis of the extent to which they have met their marketing goals. A
distribution formula will be developed and distributed to WYO Companies
which will consider the extent to which the Company has exceeded its
goal and the size of the Company's book of business in relation to the
total number of WYO policies. The amount of any increase shall be paid
promptly to the Company after the end of the [1995-1996] >> 1996-1997
<< Arrangement year.
[If the Company does not enter into the Arrangement for 1995-1996,
the extent to which the Company met its goals shall be based upon its
Arrangement year 1994-1995 performance, and the final amount retained
shall be determined after the end of the 1994-1995 Arrangement year,
but the Company shall not be entitled to any increase above the
provisional amount.]
[Premium income net of provisional reimbursement (net premium
income) and Federal Policy Fee shall be deposited in a special account
for the payment of losses and loss adjustment expenses (see Article II,
Section E).]
The Company, with the consent of the Administrator as to terms and
costs, shall be entitled to utilize the services of a national rating
organization, licensed under state law, to assist the FIA in
undertaking and carrying out such studies and investigations on a
community or individual risk basis, and in determining more equitable
and accurate estimates of flood insurance risk premium rates as
authorized under the National Flood Insurance Act of 1968, as amended.
The Company shall be reimbursed in accordance with the provisions of
the WYO Accounting Procedures Manual for the charges or fees for such
services.
C. Loss Adjustment Expenses shall be reimbursed as follows:
1. Unallocated loss adjustment shall be an expense reimbursement of
3.3% of the incurred loss (except that it does not include ``incurred
but not reported'').
2. Allocated loss adjustment expense shall be reimbursed to the
Company pursuant to [Exhibit A, entitled ``Fee Schedule.''] >> a fee
schedule established by FIA. <<
3. Special allocated loss expenses shall be reimbursed to the
Company [for only those expenses the Company has obtained prior
approval of the Administrator to incur.] >> in accordance with
guidelines issued by the Administrator. <<
D.1. Loss payments under policies of flood insurance shall be made
by the Company from funds retained in the bank account(s) established
under Article II, Section E. and, if such funds are depleted, from
funds derived by drawing against the Letter of Credit established
pursuant to Article IV.
2. Loss payments will include payments as a result of awards or
judgments for damages arising under the scope of this Arrangement,
policies of flood insurance issued pursuant to this Arrangement, and
the claims processing standards and guides set forth at Article II,
Section A.,2.0 of this Arrangement. Prompt notice of any claim for
damages as to claims processing or other matters arising outside the
scope of this Section D.2. shall be sent to the [Assistant
Administrator of the FIA's Office of Insurance Policy Analysis and
Technical Services (OIPATS),] >> Administrator << along with a copy of
any material pertinent to the claim for damages arising outside of the
scope of the matters set forth in this Section D.2.
Following receipt of notice of such claim, the General Counsel
(OGC), FEMA, shall review the cause and make a recommendation to FIA as
to whether the claim is grounded in actions by the Company which are
significantly outside the provisions of this Section D.2. After
reviewing the General Counsel's recommendation, the Administrator will
make her decision and the Company will be notified, in writing, within
thirty (30) days of the General Counsel's recommendation, if the
decision is that any award or
[[Page 14713]]
judgment for damages arising out of such actions will not be recognized
under Article III of this Arrangement as a reimbursable loss cost,
expense or expense reimbursement. In the event that the Company wishes
to petition for reconsideration of the notification that it will not be
reimbursed for the award or judgment made under the above
circumstances, it may do so by mailing, within thirty days of the
notice declining to recognize any such award or judgment as
reimbursable under Article III, a written petition to the Chairman of
the WYO Standards Committee established under the Financial Control
Plan. The WYO Standards Committee will, then, consider the petition at
its next regularly scheduled meeting or at a special meeting called for
that purpose by the Chairman and issue a written recommendation to the
Administrator, within thirty days of the meeting. The Administrator's
final determination will be made, in writing, to the Company within
thirty days of the recommendation made by the WYO Standards Committee.
E. Premium refunds to applicants and policyholders required
pursuant to rules contained in the National Flood Insurance Program
(NFIP) ``Flood Insurance Manual'' shall be made by the Company from
Federal flood insurance funds referred to in Article II, Section E.
and, if such funds are depleted, from funds derived by drawing against
the Letter of Credit established pursuant to Article IV.
Article IV--Undertakings of the Government
A. Letter(s) of Credit shall be established by the Federal
Emergency Management Agency (FEMA) against which the Company may
withdraw funds daily, if needed, pursuant to prescribed procedures
implemented by FEMA. The amounts of the authorizations will be
increased as necessary to meet the obligations of the Company under
Article III, Sections C., D., and E. Request for funds shall be made
only when net premium income has been depleted. The timing and amount
of cash advances shall be as close as is administratively feasible to
the actual disbursements by the recipient organization for allowable
Letter of Credit expenses.
Request for payment on Letters of Credit shall not ordinarily be
drawn more frequently than daily nor in amounts less than $5,000, and
in no case more than $5,000,000 unless so stated on the Letter of
Credit. This Letter of Credit may be drawn by the Company for any of
the following reasons:
1. Payment of claim as described in Article III, Section D.;
2. Refunds to applicants and policyholders for insurance premium
overpayment, or if the application for insurance is rejected or when
cancellation or endorsement of a policy results in a premium refund as
described in Article III, Section E.; and
3. Allocated and unallocated Loss Adjustment Expenses as described
in Article III, Section C.
B. The FIA shall provide technical assistance to the Company as
follows:
1. The FIA's policy and history concerning underwriting and claims
handling.
2. A mechanism to assist in clarification of coverage and claims
questions.
3. Other assistance as needed.
Article V--Commencement and Termination
A. Upon signature of authorized officials for both the Company and
the FIA, this Arrangement shall be effective for the period October 1
through September 30. The FIA shall provide financial assistance only
for policy applications and endorsements accepted by the Company during
this period pursuant to the Program's effective date, underwriting and
eligibility rules.
B. By June 1, of each year, the FIA shall publish in the Federal
Register and make available to the Company the terms for the re-
subscription of this Financial Assistance/Subsidy Arrangement. In the
event the Company chooses not to re-subscribe, it shall notify the FIA
to that effect by the following July 1.
C. In the event the Company elects not to participate in the
Program in any subsequent fiscal year, or the FIA chooses not to renew
the Company's participation, the FIA, at its option, may require (1)
the continued performance of this entire Arrangement for >> a period
not to exceed << one (1) year following the [effective expiration date
only for those policies issued during the] original term of this
Arrangement, or any renewal thereof, or (2) the transfer to the FIA of:
a. All data received, produced, and maintained through the life of
the Company's participation in the Program, including certain data, as
determined by FIA, in a standard format and medium; and
b. A plan for the orderly transfer to the FIA of any continuing
responsibilities in administering the policies issued by the Company
under the Program including provisions for coordination assistance; and
c. All claims and policy files, including those pertaining to
receipts and disbursements which have occurred during the life of each
policy. In the event of a transfer of the services provided, the
Company shall provide the FIA with a report showing, on a policy basis,
any amounts due from or payable to insureds, agents, brokers, and
others as of the transition date.
D. Financial assistance under this Arrangement may be cancelled by
the FIA in its entirety upon 30 days written notice to the Company by
certified mail stating one of the following reasons for such
cancellation: (1) Fraud or misrepresentation by the Company subsequent
to the inception of the contract, or (2) nonpayment to the FIA of any
amount due the FIA. Under these very specific conditions, the FIA may
require the transfer of data as shown in Section C., above. If transfer
is required, the unearned expenses retained by the Company shall be
remitted to the FIA. >> In such event the Government will assume all
obligations and liabilities owed to policyholders under such policies
arising before and after the date of transfer. <<
E. In the event the Act is amended, or repealed, or expires, or if
the FIA is otherwise without authority to continue the Program,
financial assistance under this Arrangement may be cancelled for any
new or renewal business, but the Arrangement shall continue for
policies in force which shall be allowed to run their term under the
Arrangement.
F. In the event that the Company is unable to, or otherwise fails
to, carry out its obligations under this Arrangement by reason of any
order or directive duly issued by the Department of Insurance of any
Jurisdiction to which the Company is subject, the Company agrees to
transfer, and the Government will accept, any and all WYO policies
issued by the Company and in force as of the date of such inability or
failure to perform. In such event the Government will assume all
obligations and liabilities owed to policyholders under such policies
arising before and after the date of transfer and the Company will
immediately transfer to the Government all funds in its possession with
respect to all such policies transferred and the unearned portion of
the Company expenses for operating, administrative and loss adjustment
on all such policies.
Article VI--Information and Annual Statements
The Company shall furnish to [the FIA] >> FEMA << such summaries
and analyses of information >> including claim file information << in
its records as may be necessary to carry out the
[[Page 14714]]
purposes of the National Flood Insurance Act of 1968, as amended, in
such form as the FIA, in cooperation with the Company, shall prescribe.
The Company shall be a property/casualty insurer domiciled in a State
or territory of the United States. Upon request, the Company shall file
with the FIA a true and correct copy of the Company's Fire and Casualty
Annual Statement, and Insurance Expense Exhibit or amendments thereof,
as filed with the State Insurance Authority of the Company's
domiciliary State.
Article VII--Cash Management and Accounting
A. FEMA shall make available to the Company during the entire term
of this Arrangement and any continuation period required by FIA
pursuant to Article V, Section C., the Letter of Credit provided for in
Article IV drawn on a repository bank within the Federal Reserve System
upon which the Company may draw for reimbursement of its expenses as
set forth in Article IV which exceed net written premiums collected by
the Company from the effective date of this Arrangement or continuation
period to the date of the draw.
B. The Company shall remit all funds >> including interest, << not
required to meet current expenditures to the United States Treasury, in
accordance with the provisions of the WYO Accounting Procedures Manual.
C. In the event the Company elects not to participate in the
Program in any subsequent fiscal year, the Company and FIA shall make a
provisional settlement of all amounts due or owing within three months
of the termination of this Arrangement. This settlement shall include
net premiums collected, funds drawn on the Letter of Credit, and
reserves for outstanding claims. The Company and FIA agree to make a
final settlement of accounts for all obligations arising from this
Arrangement within 18 months of its expiration or termination, except
for contingent liabilities which shall be listed by the Company. At the
time of final settlement, the balance, if any, due the FIA or the
Company shall be remitted by the other immediately and the operating
year under this Arrangement shall be closed.
Article VIII--Arbitration
A. If any misunderstanding or dispute arises between the Company
and the FIA with reference to any factual issue under any provisions of
this Arrangement or with respect to the FIA's non-renewal of the
Company's participation, other than as to legal liability under or
interpretation of the standard flood insurance policy, such
misunderstanding or dispute may be submitted to arbitration for a
determination which shall be binding upon approval by the FIA. The
Company and the FIA may agree on and appoint an arbitrator who shall
investigate the subject of the misunderstanding or dispute and make a
determination. If the Company and the FIA cannot agree on the
appointment of an arbitrator, then two arbitrators shall be appointed,
one to be chosen by the Company and one by the FIA.
The two arbitrators so chosen, if they are unable to reach an
agreement, shall select a third arbitrator who shall act as umpire, and
such umpire's determination shall become final only upon approval by
the FIA.
The Company and the FIA shall bear in equal shares all expenses of
the arbitration. Findings, proposed awards, and determinations
resulting from arbitration proceedings carried out under this section,
upon objection by FIA or the Company, shall be inadmissible as evidence
in any subsequent proceedings in any court of competent jurisdiction.
This Article shall indefinitely succeed the term of this
Arrangement.
Article IX--Errors and Omissions
The parties shall not be liable to each other for damages caused by
ordinary negligence arising out of any transaction or other performance
under this Arrangement, nor for any inadvertent delay, error, or
omission made in connection with any transaction under this
Arrangement, provided that such delay, error, or omission is rectified
by the responsible party as soon as possible after discovery.
However, in the event that the Company has made a claim payment to
an insured without including a mortgagee (or trustee) of which the
Company had actual notice prior to making payment, and subsequently
determines that the mortgagee (or trustee) is also entitled to any part
of said claim payment, any additional payment shall not be paid by the
Company from any portion of the premium and any funds derived from any
Federal Letter of Credit deposited in the bank account described in
Article II, section E. In addition, the Company agrees to hold the
Federal Government harmless against any claim asserted against the
Federal Government by any such mortgagee (or trustee), as described in
the preceding sentence, by reason of any claim payment made to any
insured under the circumstances described above.
Article X--Officials Not to Benefit
No Member or Delegate to Congress, or Resident Commissioner, shall
be admitted to any share or part of this Arrangement, or to any benefit
that may arise therefrom; but this provision shall not be construed to
extend to this Arrangement if made with a corporation for its general
benefit.
Article XI--Offset
At the settlement of accounts the Company and the FIA shall have,
and may exercise, the right to offset any balance or balances, whether
on account of premiums, commissions, losses, loss adjustment expenses,
salvage, or otherwise due one party to the other, it successors or
assigns, hereunder or under any other Arrangements heretofore or
hereafter entered into between the Company and the FIA. This right of
offset shall not be affected or diminished because of insolvency of the
Company.
All debts or credits of the same class, whether liquidated or
unliquidated, in favor of or against either party to this Arrangement
on the date of entry, or any order of conservation, receivership, or
liquidation, shall be deemed to be mutual debts and credits and shall
be offset with the balance only to be allowed or paid. No offset shall
be allowed where a conservator, receiver, or liquidator has been
appointed and where an obligation was purchased by or transferred to a
party hereunder to be used as an offset.
Although a claim on the part of either party against the other may
be unliquidated or undetermined in amount on the date of the entry of
the order, such claim will be regarded as being in existence as of the
date of such order and any credits or claims of the same class then in
existence and held by the other party may be offset against it.
Article XII--Equal Opportunity
The Company shall not discriminate against any applicant for
insurance because of race, color, religion, sex, age, handicap, marital
status, or national origin.
Article XIII--Restriction on Other Flood Insurance
As a condition of entering into this Arrangement, the Company
agrees that in any area in which the Administrator authorizes the
purchase of flood insurance pursuant to the Program, all flood
insurance offered and sold by the Company to persons eligible to buy
pursuant to the Program for coverages available under the Program shall
be written pursuant to this Arrangement.
[[Page 14715]]
However, this restriction applies solely to policies providing only
flood insurance. It does not apply to policies provided by the Company
of which flood is one of the several perils covered, or where the flood
insurance coverage amount is over and above the limits of liability
available to the insured under the Program.
Article XIV--Access to Books and Records
The FIA and the Comptroller General of The United States, or their
duly authorized representatives, for the purpose of investigation,
audit, and examination shall have access to any books, documents,
papers and records of the Company that are pertinent to this
Arrangement. The Company shall keep records which fully disclose all
matters pertinent to this Arrangement, including premiums and claims
paid or payable under policies issued pursuant to this Arrangement.
Records of accounts and records relating to financial assistance shall
be retained and available for three (3) years after final settlement of
accounts, and to financial assistance, three (3) years after final
adjustment of such claims. The FIA shall have access to policyholder
and claim records at all times for purposes of the review, defense,
examination, adjustment, or investigation of any claim under a flood
insurance policy subject to this Arrangement.
Article XV--Compliance With Act and Regulations
This Arrangement and all policies of insurance issued pursuant
thereto shall be subject to the provisions of the National Flood
Insurance Act of 1968, as amended, the Flood Disaster Protection Act of
1973, as amended, >> the National Flood Insurance Reform Act of 1994,
<< and Regulations issued pursuant thereto and all Regulations
affecting the work that are issued pursuant thereto, during the term
hereof.
Article XVI--Relationship Between the Parties (Federal Government and
Company) and the Insured
Inasmuch as the Federal Government is a guarantor hereunder, the
primary relationship between the Company and the Federal Government is
one of a fiduciary nature, i.e., to assure that any taxpayer funds are
accounted for and appropriately expended.
The Company is not the agent of the Federal Government. The Company
is solely responsible for its obligations to its insured under any
flood policy issued pursuant hereto.
[In witness whereof, the parties hereto have accepted this
Arrangement on this ________ day of ________, 1993.]
________________________
[Company]
[by ________________________]
[(Title) ________________________]
[The United States of America]
[Federal Emergency Management Agency]
[by ________________________]
[(Title) ________________________]
[Exhibit A]
[FEE SCHEDULE]
------------------------------------------------------------------------
[Range (by covered loss) Fee]
------------------------------------------------------------------------
[Erroneous Assignment...................................... $40.00]
[Closed Without Payment.................................... 125.00]
[Minimum for Upton-Jones Claims............................ 800.00]
[$0.01 to $600.00.......................................... 150.00]
[$600.01 to $1,000.00...................................... 175.00]
[$1,000.01 to $2,000.00.................................... 225.00]
[$2,000.01 to $3,500.00.................................... 275.00]
[$3,500.01 to $5,000.00.................................... 350.00]
[$5,000.01 to $7,000.00.................................... 425.00]
[$7,000.01 to $10,000.00................................... 500.00]
[$10,000.01 to $15,000.00.................................. 550.00]
[$15,000.01 to $25,000.00.................................. 600.00]
[$25,000.01 to $35,000.00.................................. 675.00]
[$35,000.01 to $50,000.00.................................. 750.00]
[$50,000.01 to $100,000.00................................. 1,000.00]
[$100,000.01 to $150,000.00................................ 1,300.00]
[$150,000.01 to $200,000.00................................ 1,600.00]
[$200,000.01 to limits..................................... 2,000.00]
------------------------------------------------------------------------
[Allocated fee schedule entry value is the covered loss under the
policy based on the standard deductibles ($500 and $500) and limited to
the amount of insurance purchased.]
(Catalog of Federal Domestic Assistance No. 83.100, ``Flood
Insurance'')
Dated: March 26, 1996.
Harvey G. Ryland,
Deputy Director.
[FR Doc. 96-8127 Filed 4-2-96; 8:45 am]
BILLING CODE 6718-03-P
Complete official Federal Register PDF
FR Doc. 96-8122 Radio Broadcasting Services; Kiowa, KS
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Page 14733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8122]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 96-65; RM-8773]
Radio Broadcasting Services; Kiowa, KS
AGENCY: Federal Communications Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Commission requests comments on a petition by Kiowa
Broadcasters requesting the allotment of Channel 252C1 to Kiowa,
Kansas. Channel 252C1 can be allotted to Kiowa in compliance with the
Commission's minimum distance separation requirements without the
imposition of a site restriction. The coordinates for Channel 252C1 at
Kiowa are 37-01-00 and 98-29-12.
DATES: Comments must be filed on or before May 21, 1996, and reply
comments on or before June 5, 1996.
ADDRESSES: Federal Communications Commission, Washington, DC 20554. In
addition to filing comments with the FCC, interested parties should
serve the petitioner, or its counsel or consultant, as follows: Leonard
Johnson, III, Kiowa Broadcasters, 218 Carriage Place Court, Decatur,
Georgia 30033 (Petitioner).
FOR FURTHER INFORMATION CONTACT: Pam Blumenthal, Mass Media Bureau,
(202) 418-2180.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Notice of Proposed Rule Making, MM Docket No. 96-65, adopted March 14,
1996, and released March 29, 1996. The full text of this Commission
decision is available for inspection and copying during normal business
hours in the FCC's Reference Center (Room 239), 1919 M Street, NW.,
Washington, DC. The complete text of this decision may also be
purchased from the Commission's copy contractor, ITS, Inc., (202) 857-
3800, 2100 M Street, NW., Suite 140, Washington, DC 20037.
Provisions of the Regulatory Flexibility Act of 1980 do not apply
to this proceeding.
Members of the public should note that from the time a Notice of
Proposed Rule Making is issued until the matter is no longer subject to
Commission consideration or court review, all ex parte contacts are
prohibited in Commission proceedings, such as this one, which involve
channel allotments. See 47 CFR 1.1204(b) for rules governing
permissible ex parte contacts.
For information regarding proper filing procedures for comments,
see 47 CFR 1.415 and 1.420.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Federal Communications Commission.
John A. Karousos,
Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-8122 Filed 4-2-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-8116 Interstate, Interexchange Marketplace; and Implementation of Section 254(g) of the Communications Act of 1934, as Amended
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14717-14733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8116]
=======================================================================
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Chapter I
[CC Docket No. 96-61, FCC 96-123]
Interstate, Interexchange Marketplace; and Implementation of
Section 254(g) of the Communications Act of 1934, as Amended
AGENCY: Federal Communications Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: In the light of the passage of the 1996 Act, changes in the
interexchange market over the past decade, and the recent
reclassification of AT&T as a non-dominant carrier, the Commission is
issuing this Notice of Proposed Rulemaking (``Notice'' or ``NPRM'')
seeking comment on possible changes in the regulatory treatment of
interstate, interexchange telecommunications service providers.
Specifically, the Notice tentatively concludes that, as required by the
forbearance provision in Section 10 of the Communications Act, as
amended, the Commission must forbear from applying Section 203 tariff
filing requirements to non-dominant interexchange carriers for domestic
services. The Notice tentatively concludes that the Commission's
proposed detariffing policy should be implemented on a mandatory basis.
The Notice seeks comment on whether the Commission should forbear, with
respect to non-dominant carriers that file bundled domestic and
international tariffs, from requiring such carriers to file tariffs for
the international portions of their service offerings as well.
DATES: Comments on Section IV of the NPRM (related to market
definition), Section V (related to separation requirements) and Section
VI (related to the implementation of Section 254(g) of the
Communications Act of 1934, as amended) must be submitted on or before
April 19, 1996. Reply comments for these sections must be filed on or
before May 3, 1996. Comments on all other sections of the NPRM must be
submitted on or before April 25, 1996. Reply comments for these
sections must be submitted on or before May 24, 1996. Written comments
on the Initial Regulatory Flexibility Analysis must be filed in
accordance with the same filing deadlines set for comments on the other
issues (other than Sections IV, V, and VI) in the NPRM, but they must
have a separate and distinct heading designating them as responses to
the Regulatory Flexibility Analysis. Written comments by the public on
the proposed and/or modified information collections are due on or
before April 19, 1996. Written comments must be submitted by the Office
of Management and Budget (OMB) on the proposed and/or modified
information collections on or before June 3, 1996.
ADDRESSES: Comments and reply comments should be sent to Office of
[[Page 14718]]
the Secretary, Federal Communications Commission, 1919 M Street, N.W.,
Room 222, Washington, D.C. 20554, with a copy to Janice Myles of the
Common Carrier Bureau, 1919 M Street, N.W., Room 544, Washington, D.C.
20554. Parties should also file one copy of any documents filed in this
docket with the Commission's copy contractor, International
Transcription Services, Inc., 2100 M Street, N.W., Suite 140,
Washington, D.C. 20037. Comments and reply comments will be available
for public inspection during regular business hours in the FCC
Reference Center, 1919 M Street, N.W., Room 239, Washington, D.C.
20554. In order to facilitate review of comments and reply comments,
both by parties and by Commission staff, we require that comments on
Section IV of the NPRM (related to market definition), Section V
(related to separation requirements), and Section VI (related to
Implementation of Section 254(g) of the Communications Act, as amended)
be no longer than forty-five (45) pages and reply comments be no longer
than twenty-five (25) pages. We require that comments on the remaining
sections of the NPRM be no longer than forty-five (45) pages and reply
comments on the remaining sections be no longer than twenty-five (25)
pages. Comments and reply comments must include a short and concise
summary of the substantive arguments raised in the pleading. Parties
are also asked to submit comments and reply comments on diskette. Such
diskette submissions would be in addition to and not a substitute for
the formal filing requirements addressed above. Parties submitting
diskettes should submit them to Janice Myles of the Common Carrier
Bureau, 1919 M Street, N.W., Room 544, Washington, D.C. 20554. Such a
submission should be on a 3.5 inch diskette formatted in an IBM
compatible form using MS DOS 5.0 and WordPerfect 5.1 software. The
diskette should be submitted in ``read only'' mode. The diskette should
be clearly labelled with the party's name, proceeding, type of pleading
(comment or reply comments) and date of submission. The diskette should
be accompanied by a cover letter. In addition to filing comments with
the Secretary, a copy of any comments on the information collections
contained herein should be submitted to Dorothy Conway, Federal
Communications Commission, Room 234, 1919 M Street, N.W., Washington,
DC 20554 or via the Internet to [email protected], and to Timothy Fain,
OMB Desk Officer, 10236 NEOB, 725 - 17th Street, N.W., Washington, DC
20503 or via the Internet to [email protected].
FOR FURTHER INFORMATION CONTACT: Melissa Waksman or Donald Stockdale at
(202) 418-1580, Common Carrier Bureau, Policy and Program Planning
Division. For additional information concerning the information
collections contained in this NPRM, contact Dorothy Conway at 202-418-
0217, or via the Internet at [email protected].
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Notice of Proposed Rulemaking (FCC 96-123) adopted on March 21, 1996
and released on March 25, 1996. The full text of this Notice of
Proposed Rulemaking is available for inspection and copying during
normal business hours in the FCC Reference Center (Room 239), 1919 M
St., N.W., Washington, DC. The complete text also may be purchased from
the Commission's copy contractor, International Transcription Service,
Inc., (202) 857-3800, 2100 M St., NW., Suite 140, Washington, DC 20037.
Background
The Notice reserves for another day, in a separate proceeding, the
broader question of whether the Commission should consider generally
forbearing from requiring tariffs for international service provided by
a non-dominant carrier, given the current market conditions in the
international market. The Notice also invites parties to comment on
whether, with respect to existing regulations examined in this Notice,
the Commission should forbear from applying such regulations to some or
all interexchange carriers or services, in particular areas or regions.
The Notice also considers whether the Commission should reexamine the
geographic and product market definitions that the Commission adopted
in the Competitive Carrier proceeding. The Notice tentatively concludes
that the Commission should follow the approach taken in the U.S.
Department of Justice/Federal Trade Commission 1992 Merger Guidelines
for defining relevant markets. The Notice interprets the Guidelines'
approach as suggesting that the Commission should define as a relevant
product market an interstate, interexchange service for which there are
no close substitutes or group of services that are close substitutes
for each other but for which there are no other close substitutes. The
Notice tentatively concludes, however, that the Commission need not
address the issue of delineating the boundaries of specific product
markets, except where there is credible evidence suggesting that there
is or could be a lack of competitive performance with respect to a
particular service or group of services. The Notice also tentatively
concludes that the Commission should define a relevant geographic
market for interstate, interexchange services as all calls between two
particular points. The Notice states, however, that geographic rate
averaging and other factors imply that a carrier or group of carriers
cannot change interexchange rates for calls between two particular
points without changing rates nationwide for calls of that distance.
The Notice, therefore, tentatively concludes that the Commission should
treat interstate, interexchange calling as generally one national
market. Where, however, there is credible evidence suggesting that
there is or could be a lack of competition in a particular point-to-
point market or group of markets, and that geographic rate averaging
will not sufficiently mitigate the exercise of market power, the Notice
proposes that the Commission will examine individually that market (or
group of markets) for the presence of market power. In the BOC Out-of-
Region NPRM, 60 FR 6607 (February 21, 1996) the Commission stated its
intent to consider whether it may be appropriate to modify or eliminate
separation requirements that are currently imposed upon independent
LECs, and that we tentatively concluded in the BOC Out-of-Region NPRM
should be imposed on BOCs, in order to qualify for non-dominant
treatment in the provision of out-of-region interstate, interexchange
services. The Notice thus seeks comment on whether the Commission
should modify or eliminate the separation requirements independent LECs
must satisfy if they are to be treated as non-dominant carriers in the
provision of interstate, interexchange services outside their local
exchange areas. The Notice seeks comment on whether, if the Commission
modifies or eliminates these requirements for independent LECs, it
should apply the same requirements to BOCs that provide out-of-region
interstate, interexchange services. Section 254(g) of the
Communications Act of 1934, as amended by the 1996 Act, requires the
Commission to adopt rules to implement the requirements that rates for
interexchange services be geographically averaged and be integrated.
The Notice proposes to adopt a rule requiring that the rates charged by
all providers of interexchange telecommunications services to
subscribers in rural and high cost areas shall be no higher than the
rates charged by each such provider to subscribers in
[[Page 14719]]
urban areas. The Notice states that Section 254(g) requires the
Commission to adopt rules to require geographic averaging for
intrastate and interstate telecommunications services. The Notice
states the Commission believes that Section 254(g) preempts state laws
or regulations requiring geographic rate averaging only to the extent
such laws or regulations are inconsistent with the Commission's rules
and policies. The Notice also proposes to adopt a rule to require rate
integration for services between the contiguous forty-eight states and
Alaska, Hawaii, U.S. territories and possessions. The Notice
tentatively concludes that providers of interexchange services must
file certifications stating they are in compliance with their statutory
geographic rate averaging obligations and that providers of interstate,
interexchange services must file certifications stating that they are
in compliance with their statutory rate integration obligations. The
Notice also seeks comment on: (1) the extent to which interexchange
carriers do not offer discount plans throughout their service areas,
and whether such carriers' failure to do so constitutes geographic
deaveraging; (2) the appropriate mechanism for implementing rate
integration for U.S. territories and possessions that are not currently
subject to the Commission's domestic rate integration policy; and (3)
whether there may be competitive conditions or other circumstances that
could justify Commission forbearance from enforcing the proposed
geographic rate averaging requirement with respect to particular
interexchange telecommunications carries or services. Changes in the
structure of the interexchange marketplace over the past decade have
raised certain issues relating to the pricing of interexchange
telecommunications services. The Notice seeks comment on certain of
these issues. Based on the Commission's prior findings regarding
competition in both the customer premises equipment (CPE) and
interstate, interexchange markets, the Notice tentatively concludes
that the Commission should amend Section 64.702(e) of the Commission's
rules to allow non-dominant interexchange carriers to bundle CPE with
interstate, interexchange services. The Notice notes that the
Commission intends to initiate a comprehensive proceeding to address
payphone issues, and therefore any amendment to Section 64.702(e) of
the Commission's rules adopted in this proceeding will not apply to
payphone bundling. Concerns about the application of the substantial
cause test and other issues related to contract tariffs raised in the
AT&T Reclassification proceeding by resellers and large business
subscribers remain relevant if the Commission decides not to adopt a
mandatory detariffing policy or implements permissive detariffing.
Accordingly, the Notice seeks comment on such tariff-related issues.
This NPRM contains proposed or modified information collections subject
to the Paperwork Reduction Act of 1995 (PRA). It has been submitted to
the Office of Management and Budget (OMB) for review under the PRA.
OMB, the general public, and other Federal agencies are invited to
comment on the proposed or modified information collections contained
in this proceeding.
Paperwork Reduction Act: This NPRM contains either a proposed or
modified information collection. The Commission, as part of its
continuing effort to reduce paperwork burdens, invites the general
public and the Office of Management and Budget (OMB) to comment on the
information collections contained in this NPRM, as required by the
Paperwork Reduction Act of 1995, Pub. L. No. 104-13. Public and agency
comments are due at the same time as comments on Section IV of the NPRM
(related to market definition), Section V (related to separation
requirements), and Section VI (related to Implementation of Section
254(g) of the Communications Act, as amended); OMB notification of
action is due June 3, 1996. Comments should address: (a) whether the
proposed collection of information is necessary for the proper
performance of the functions of the Commission, including whether the
information shall have practical utility; (b) the accuracy of the
Commission's burden estimates; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burden of the collection of information on the
respondents, including the use of automated collection techniques or
other forms of information technology.
OMB Approval Number: None.
Title: Policy and Rules Concerning the Interstate, Interexchange
Marketplace; and Implementation of Section 254(g) of the Communications
Act of 1934, as amended, CC Docket No. 96-61.
Form No.: N/A.
Type of Review: New Collection.
Respondents: Businesses or other for-profit, including small
businesses.
------------------------------------------------------------------------
Estimated
Proposed requirement No. of time per
respondents response
------------------------------------------------------------------------
Detariffing*.................................... 0 0
Recordkeeping................................... 519 1
Certification................................... 519 2
Advertising..................................... 519 2
------------------------------------------------------------------------
* The Commission proposes to eliminate the tariffing requirement now
imposed on non-dominant interexchange carriers for domestic services.
Total Annual Burden: 2595.
Estimated Costs Per Respondent: $0.
Needs and Uses: The information collected under the proposed
recordkeeping and certification requirements would be used by the
Common Carrier Bureau of the Commission to ensure that affected
interexchange carriers fulfill their obligations under the
Communications Act, as amended. The information collected under the
advertising requirement, if adopted, would be used to ensure that
consumers have information regarding carriers' rate plans.
Synopsis of Notice of Proposed Rulemaking
I. Introduction
1. On February 8, 1996, the Telecommunications Act of 1996 (1996
Act) became law. The 1996 Act seeks ``to provide for a pro-competitive,
de-regulatory national policy framework'' designed to make available to
all Americans advanced telecommunications and information technologies
and services ``by opening all telecommunications markets to
competition.'' Integral to achieving this goal, the 1996 Act requires
the Commission to forbear from applying any provision of the
Communications Act of 1934, as amended (Communications Act), or our
regulations, to a telecommunications carrier or telecommunications
service, or class thereof, if the Commission makes certain specified
findings with respect to such provisions or regulations. In addition,
the 1996 Act provides for the entry of the Bell Operating Companies
(BOCs) and their affiliates into the interstate, interexchange market,
after certain preconditions are satisfied. 1996 Act at Sec. 151 (adding
Sec. 271). This entry can be expected to intensify competition in the
interstate, domestic, interexchange market. For purposes of this
proceeding, we generally use the term ``BOCs'' as that term is defined
in Section 3(a)(35) of the Communications Act of 1934, as amended. In a
few instances, however,
[[Page 14720]]
we use the term ``BOCs'' also to encompass BOC affiliates, such as are
contemplated by Section 272 of the Communications Act of 1934, as
amended. The preconditions specified in the 1996 Act apply to a BOC's
provision of interLATA services originating in any of its in-region
states. 1996 Act at Sec. 151 (adding Sec. 271).
2. Consistent with the thrust of the 1996 Act, the Commission has
long pursued policies designed to facilitate the growth of competition
in the domestic long-distance market. In 1979, the Commission commenced
the Competitive Carrier proceeding in which it considered how its
regulations should be modified to reflect and promote competition in
this market. In succeeding years, in part as a result of reforms
adopted in the Competitive Carrier proceeding, the interstate,
domestic, interexchange market has evolved from a market of fledgling
competitors overshadowed by a single, dominant service provider to a
market characterized by substantial competition. The Commission
explicitly acknowledged these dramatic changes when, in October 1995,
we concluded that AT&T Corporation (AT&T) no longer possessed
individual market power in the domestic long-distance market taken as a
whole and, accordingly, reclassified AT&T as a non-dominant carrier for
interstate, domestic, interexchange services.
3. The 1996 Act builds upon the progress made to date in
facilitating competition in the domestic long-distance market, and
provides a framework for raising competition to a higher plane. In
light of the passage of the 1996 Act, changes in the interexchange
market over the past decade, and our recent reclassification of AT&T as
a non-dominant carrier, we believe it is timely to review our
regulatory regime for interstate, domestic, interexchange
telecommunications services. In this proceeding, we therefore examine
whether and how our policies and rules should be changed, consistent
with the intent of the 1996 Act.
4. Specifically, we propose, pursuant to the forbearance authority
provided in the 1996 Act, to adopt a mandatory detariffing policy for
domestic services of non-dominant, interexchange carriers. We also
propose to eliminate the prohibition against bundling customer premises
equipment with the provision of interstate, interexchange services by
non-dominant interexchange carriers. In addition, we consider whether
to reduce or eliminate the separation requirements for non-dominant
treatment of local exchange carriers in their provision of certain
interstate, interexchange services. By these proposals, we seek to
promote competition by reducing or eliminating existing regulations
that may no longer be in the public interest in the increasingly
competitive interexchange marketplace.
5. We also reexamine other aspects of our oversight of the
interstate, interexchange market. In this respect, we consider whether
we should more narrowly focus our definitions of relevant product and
geographic markets for interexchange services to reflect current and
future market conditions. We also address issues related to residential
services pricing, including allegations of tacit price coordination in
the interexchange market, and inquire how additional facilities-based
competition pursuant to the 1996 Act affects this issue. We also
consider other issues, including tariff-related issues that would
remain relevant if we determine not to forbear from requiring non-
dominant interexchange carriers to file tariffs, or if we decide to
adopt a permissive detariffing policy. Finally, as required by the 1996
Act, we propose rules to implement the 1996 Act's provisions relating
to geographic rate averaging and rate integration.
II. Background
A. The Telecommunications Act of 1996
6. The 1996 Act significantly alters the legal framework governing
the interstate, interexchange market. The new statutory provisions
should generally promote facilities-based competition in the
interexchange market and open the door for new entrants to compete with
existing service providers. For example, the 1996 Act, inter alia,
permits the BOCs immediately to provide interLATA telecommunications
services originating outside their in-region states, as well as
``incidental'' interLATA services. More significantly, after fulfilling
specified preconditions, BOCs may provide interLATA telecommunications
services originating inside their in-region states. In addition, the
1996 Act provides regulatory flexibility by requiring the Commission to
forbear from applying any regulation or any provision of the
Communications Act to telecommunications carriers or telecommunications
services, or classes thereof, if the Commission determines that certain
specified conditions are satisfied. The forbearance authority applies
to all provisions of the Communications Act, except the provisions
added by the 1996 Act relating to interconnection and BOC entry into
long-distance services.
B. The Competitive Carrier Proceeding
7. The Commission, since 1979, has pursued, in the Competitive
Carrier proceeding, pro-competitive and deregulatory goals similar to
those now underlying the 1996 Act. The Commission there examined how
its regulations should be adapted to reflect and promote increasing
competition in interexchange telecommunications markets, and sought to
reduce or eliminate the application of economic regulation to new
competitive entrants. In these efforts, the Commission pursued a
forbearance policy, encompassing both permissive and mandatory
detariffing. Upon judicial review, however, the Court found that the
Communications Act, at that time, did not provide the Commission with
the requisite authority to do so.
8. In its Competitive Carrier orders, the Commission distinguished
two kinds of carriers--those with market power (dominant carriers) and
those without market power (non-dominant carriers). In determining
whether a firm possessed market power, the Commission focused on
certain ``clearly identifiable market features,'' including the number
and size distribution of competing firms, the nature of barriers to
entry, the availability of reasonably substitutable services, and
whether the firm controlled bottleneck facilities. The Commission
relaxed its tariff filing and facilities authorization requirements for
non-dominant carriers, and focused its regulatory efforts on
constraining the ability of dominant firms to act contrary to consumer
welfare.
C. The Interexchange Competition Proceeding
9. In 1990, the Commission commenced the Interexchange Competition
proceeding to examine the state of competition in the interstate, long-
distance marketplace, and to assess the efficacy of existing regulation
in light of this competition. In the First Interexchange Competition
Order, 56 FR 66602 (December 24, 1991), the Commission found that
business services (except analog private line services) had become
``substantially competitive.'' The Commission accordingly streamlined
its regulation of those AT&T services. For services subject to
``streamlined'' regulation, AT&T was allowed to file tariffs on 14
days' notice, without cost support, and such tariffs were presumed
lawful. In addition, price cap ceilings, bands and rate floors did not
apply to streamlined services. Later, the Commission, after
[[Page 14721]]
ordering 800 number portability, found that 800 services (except 800
directory assistance services) were also subject to substantial
competition, and streamlined regulation of those AT&T services as well.
10. In the First Interexchange Competition Order, 56 FR 55235
(October 25, 1991) the Commission also authorized all interexchange
carriers to offer services pursuant to individually negotiated,
contract-based tariffs, provided they make such rates generally
available to similarly situated customers. The Commission found such
arrangements would allow customers to negotiate service arrangements
that best addressed their particular needs and would unleash
competition by allowing AT&T to offer the same type of contract
arrangements its competitors were already offering.
D. The AT&T Reclassification Order
11. On October 23, 1995, we issued an order granting AT&T's motion
to be reclassified as a non-dominant carrier, based upon our finding
that AT&T no longer possessed individual market power in the
interstate, domestic, interexchange market taken as a whole. As a
result, AT&T is now generally subject to the same regulations as its
long-distance competitors. Like other non-dominant carriers, AT&T is
still subject to regulation under Title II of the Communications Act.
Thus, it is required to do the following: offer interstate services
under rates, terms and conditions that are just, reasonable and not
unduly discriminatory; file tariffs; and give notice prior to any
discontinuance, reduction or impairment of service. Moreover, like
other non-dominant carriers, AT&T continues to be subject to the
Commission's complaint process.
12. In the AT&T Reclassification proceeding, AT&T made certain
voluntary commitments, which AT&T stated were intended to serve as
transitional arrangements to address concerns expressed by parties
about possible adverse effects of reclassifying AT&T. These commitments
concerned: service to low-income and other customers; analog private
line and 800 directory assistance services; service to and from the
State of Alaska and other regions subject to our rate integration
policy; geographic rate averaging; changes to contract tariffs that
adversely affect existing customers; and dispute resolution procedures
for reseller customers. In the AT&T Reclassification Order, we accepted
AT&T's commitments and ordered AT&T to comply with those commitments.
13. In the AT&T Reclassification Order, we stated that we would
consider the following issues relevant to the interstate, domestic,
interexchange market as a whole in this proceeding: (1) whether there
is tacit price coordination in the interexchange market; (2) how
changes in the interexchange market affect our rate integration and
geographic averaging policies; (3) reseller and large user concerns
regarding contract tariffs; and (4) the application of the filed rate
doctrine to contract tariff arrangements.
E. Need for Review of Commission Regulation of the Interexchange Market
14. The Commission's obligation to be responsive to the dynamic
nature of the communications industry has long been recognized. The
passage of the 1996 Act, the dramatic changes in the interstate,
domestic, interexchange telecommunications services market since the
Interexchange Competition proceeding, and our reclassification of AT&T
as a non-dominant carrier in the overall interstate, domestic,
interexchange market, make it timely for us to reexamine our policies
and rules in light of the goals of the 1996 Act. In pursuing the pro-
competitive policy established by the 1996 Act, we intend to examine
existing regulations to see whether they can be reduced or eliminated
consistent with our public interest responsibilities.
III. Regulatory Forbearance
A. Introduction
15. The 1996 Act amends the Communications Act to require the
Commission to:
[F]orbear from applying any regulation or any provision of this Act
to a telecommunications carrier or telecommunications service, or class
of telecommunications carriers or telecommunications services, in any
or some of its or their geographic markets, if the Commission
determines that--
(1) enforcement of such regulation or provision is not necessary to
ensure that the charges, practices, classifications or regulations by,
for, or in connection with that telecommunications carrier or
telecommunications service are just and reasonable, and are not
unjustly or unreasonably discriminatory;
(2) enforcement of such regulation or provision is not necessary
for the protection of consumers; and
(3) forbearance from applying such provision or regulation is
consistent with the public interest.
In addition, in determining whether forbearance from enforcing a
particular provision or regulation is in the public interest, the
Commission is specifically required to consider whether forbearance
will promote competitive market conditions, including the extent to
which forbearance will enhance competition among providers of
telecommunications services. New Section 10(b) also provides that,
``[i]f the Commission determines that such forbearance will promote
competition among providers of telecommunications services, that
determination may be the basis for a Commission finding that
forbearance is in the public interest.'' Section 401 of 1996 Act also
provides that the Commission may not forbear from applying the
requirements of the provisions of new Section 251 related to
interconnection (except as provided in Section 251(f)) and of new
Section 271 related to BOC provision of interLATA services until the
Commission determines that those requirements have been fully
implemented.
16. Accordingly, with respect to each of the existing regulations
examined in this proceeding, we invite parties to comment on whether we
should forbear from applying such regulations to some or all
interexchange carriers or services, in particular geographic areas or
regions. With respect to each issue, parties should specify the bases
on which they believe we can make the findings required to meet the
statutory criteria for forbearance.
17. We address below whether, given the current domestic,
interstate, interexchange market, the 1996 Act requires the Commission
to forbear from requiring non-dominant interexchange carriers to file
tariffs for domestic services. Based on the Commission's analyses and
findings in prior proceedings, we tentatively conclude that we are
required by the 1996 Act to forbear from applying the Section 203
tariff filing requirements to non-dominant interexchange carriers for
domestic interexchange services.
18. We note that we do not address here the issue of forbearance
from applying Section 226 of the Act, which requires operator service
providers to file informational tariffs. That issue will be addressed
in a separate upcoming proceeding.
B. Forbearance From Tariff Filing Requirements for Non-Dominant
Interexchange Carriers
1. Background
19. In the Competitive Carrier proceeding, the Commission explored
the cost of imposing Title II regulation on entities lacking market
power. In the Competitive Carrier Further NPRM, 46 FR 10924 (February
5, 1981), the
[[Page 14722]]
Commission suggested that tariff filing requirements for non-dominant
carriers could harm consumers by slowing ``the introduction of new
services, dampening competitive responses and ultimately encouraging
price collusion through the forced publication of charges.'' The
Commission accordingly, in a series of orders, established a permissive
tariff forbearance policy for non-dominant carriers. In the Sixth
Report and Order, 50 FR 1215 (January 10, 1985), the Commission
established a mandatory detariffing policy for non-dominant carriers.
The Commission concluded that tariff filings were not essential to its
ability to ensure that non-dominant carriers do not unjustly
discriminate in their rates, and that other means were available to
ensure that the Commission fulfilled its mandate under the
Communications Act.
20. The Sixth Report and Order subsequently was vacated and
remanded by the U.S. Court of Appeals for the D.C. Circuit. The court
held that the Commission lacked statutory authority to prohibit
carriers from filing tariffs. The court, however, did not reach the
issue of whether the Commission's earlier permissive detariffing orders
were valid. The Commission, accordingly, continued to apply permissive
detariffing for non-dominant carriers. The Commission's permissive
detariffing regime subsequently was invalidated by the U.S. Court of
Appeals for the D.C. Circuit in 1992. The court, in reviewing and
disposing of a complaint filed by AT&T against MCI, vacated the
Commission's Fourth Report and Order, 48 FR 52452 (November 18, 1983),
thereby invalidating the Commission's tariff filing forbearance policy
for non-dominant carriers. While stating that it had no ``quarrel with
the Commission's policy objectives,'' the court found that the
Communications Act did not give the Commission authority to adopt such
a policy.
21. Prior to the U.S. Court of Appeals' vacation of the Fourth
Report and Order, the Commission adopted a Report and Order in a
rulemaking proceeding commenced in response to AT&T's complaint. The
Commission again determined that permissive detariffing was within its
authority under the Communications Act. The U.S. Court of Appeals for
the D.C. Circuit granted summary reversal of the Commission's order
based on the court's earlier ruling. In affirming the U.S. Court of
Appeal's ruling, the Supreme Court found that Section 203(b)(2) of the
Communications Act gave the Commission authority to modify the Act's
tariff filing requirement, but not to eliminate it entirely. The
Commission thereafter established a one-day tariff notice period for
all non-dominant carriers after again concluding that traditional
tariff regulation of non-dominant carriers is not necessary to ensure
just and reasonable rates.
22. Against this background, Congress enacted Section 401 of the
1996 Act, adding Section 10(a) to the Communications Act, to grant the
Commission authority to forbear from applying the provisions of Title
II, subject to certain, limited exceptions.
2. Discussion
23. As noted above, the 1996 Act requires the Commission to forbear
from applying to a telecommunications carrier or telecommunications
service any regulation or any provision of the Communications Act, if
the Commission makes the three specified determinations.
24. We believe, based on the Commission's prior analyses and
findings, that we can make the determinations necessary in order to
forbear from enforcing Section 203's tariffing requirements with
respect to the domestic services offered by non-dominant, interexchange
carriers. Specifically, we tentatively find that enforcement of the
Section 203 tariffing requirements with respect to non-dominant
interexchange carriers: (1) is not necessary to ensure that non-
dominant interexchange carriers' charges, practices, or classifications
are just and reasonable, and are not unjustly or unreasonably
discriminatory; and (2) is not necessary for the protection of
consumers. We also tentatively find that forbearing from enforcing
Section 203 tariffing requirements with respect to non-dominant
interexchange carriers is consistent with the public interest.
Accordingly, we tentatively conclude that we must forbear from applying
Section 203 tariff filing requirements to non-dominant interexchange
carriers for domestic services. Each of these tentative determinations
is discussed below.
25. We tentatively conclude that tariff filings for non-dominant
interexchange carriers are not necessary to ensure that the charges,
and practices of a telecommunications carrier or telecommunications
service are just and reasonable and are not unjustly or unreasonably
discriminatory. As the Commission stated in the First Report and Order,
45 FR 76148 (November 18, 1980):
The economic underpinning of our proposal to streamline the
regulatory procedures for non-dominant carriers flows from the fact
that firms lacking market power simply cannot rationally price their
services in ways which, or impose terms and conditions which,
contravene Sections 201(b) and 202(a) of the Act.
Two years ago, in adopting a mandatory detariffing policy for providers
of domestic commercial mobile radio service (CMRS), the Commission
reiterated its conclusion that ``non-dominant carriers are unlikely to
behave anticompetitively, in violation of Sections 201(b) and 202(a) of
the Act, because they recognize that such behavior would result in a
loss of customers.'' Based on the Commission's experience under its
prior tariff forbearance policy for non-dominant interexchange
carriers, as well as the Commission's findings in the Regulatory
Treatment of Mobile Services proceeding, we continue to believe that
non-dominant carriers are unlikely to price their services in ways
which, or to impose terms and conditions which, violate Section 201(b)
and Section 202(a) of the Act. Similarly, we continue to believe that
the Communications Act's objectives of just, reasonable, and not
unjustly or unreasonably discriminatory rates can be achieved
effectively through market forces and the administration of the
complaint process.
26. We also tentatively conclude that requiring non-dominant
interexchange carriers to file tariffs for domestic offerings is not
necessary for the protection of consumers of interexchange services. To
the contrary, we believe a tariff filing requirement harms consumers by
undermining the development of vigorous competition. The Commission
previously has found, in the Second Report and Order, 47 FR 37899
(August 27, 1982), that applying tariff requirements to competitive
entities is superfluous as a consumer protection device, since
competition circumscribes the prices and practices of these companies.
Moreover, beginning with the Second Report and Order, and as recently
as the 1994 Regulatory Treatment of Mobile Services Order, 59 FR 18493
(April 19, 1994), the Commission has consistently found that the
imposition of tariff obligations in these circumstances stifles price
competition and service and marketing innovations. We tentatively find
that these conclusions remain valid in today's more competitive
domestic, interexchange market.
27. Finally, we tentatively conclude that forbearing from imposing
tariff filing requirements on non-dominant interexchange carriers is
consistent with the public interest. As part of the determination of
whether forbearance is
[[Page 14723]]
consistent with public interest, the 1996 Act requires the Commission
to consider ``whether forbearance from enforcing the provision or
regulation will promote competitive market conditions, including the
extent to which forbearance will enhance competition among providers of
telecommunications services.'' We believe that forbearance from
requiring tariff filings for non-dominant carriers will promote
competition and deter price coordination. In the Sixth Report and
Order, the Commission found that requiring non-dominant carriers to
file tariffs can: (1) take away carriers' ability to make rapid,
efficient responses to changes in demand and cost; (2) impede and
remove incentives for competitive price discounting; and (3) impose
costs on carriers that attempt to make new offerings. The Commission
also concluded that continuing to require non-dominant carriers to file
tariffs presents an opportunity for collusive pricing by competing
carriers because carriers can ascertain their competitors' existing
rates and keep track of any changes by reviewing filed tariffs. The
Commission indicated that this may encourage carriers to maintain rates
at artificially high levels.
28. The Commission recently reiterated, in the Regulatory Treatment
of Mobile Services Order, its findings in the Sixth Report and Order.
We believe that forbearance from tariff filing requirements will
promote competition by enabling non-dominant carriers to respond
quickly to changes in the market, and reducing administrative costs on
carriers making new offerings. We also believe that, without pricing
and other material information available from the public tariffs of
their rivals, non-dominant interexchange carriers are more likely to
initiate price reductions and other competitive programs. Accordingly,
we tentatively conclude that forbearing from requiring non-dominant
carriers to file tariffs for interexchange services promotes
competitive market conditions, and therefore is in the public interest.
29. Based on the foregoing tentative determinations, we tentatively
conclude that we are required by Section 10 of the Communications Act,
as amended, to forbear from requiring non-dominant interexchange
carriers to file tariffs for domestic services. We invite comment on
all of these tentative conclusions.
30. We note that many carriers currently file bundled tariffs that
include both domestic and international services. We therefore seek
comment as to whether the Commission should forbear from requiring
these non-dominant firms to file tariffs for the international portions
of their offerings as well. We reserve for another day, in a separate
proceeding, the broader question of whether the Commission should
consider generally forbearing from requiring tariffs for international
service provided by a non-dominant carrier, given current market
conditions in the international market. As stated in an order adopted
earlier this month, we ``anticipate review of our international Section
214 authorization and tariffing procedures to identify new areas where
additional streamlining may be appropriate. . . . [S]uch steps should
be taken in the context of a new proceeding where we can make
additional determinations about the state of competition in the
international market and receive more public input.'' Streamlining the
International Section 214 Authorization Process and Tariff
Requirements, IB Docket No. 95-118, Report and Order, at para. 86 (rel.
Mar. 13, 1996).
31. We also tentatively conclude that forbearance from tariff
filing requirements for domestic services of non-dominant interexchange
carriers should be implemented on a mandatory basis. Permitting non-
dominant interexchange carriers to file tariffs in this context does
not appear to be in the public interest. We believe that a regime
without non-dominant interexchange carrier tariffs is the most pro-
competitive, deregulatory regime. The risk of anticompetitive conduct
inherent in, and the costs associated with, tariff filings by non-
dominant interexchange carriers, discussed above, would persist if
carriers were permitted to file tariffs voluntarily. In addition, the
absence of tariffs would eliminate possible invocation by carriers of
the filed rate doctrine, which allows carriers certain rights
unilaterally to change rates, terms, and conditions of contract tariffs
and other long-term service arrangements, and to limit their liability
for damages. Absent filed tariffs, the legal relationship between
carriers and customers will much more closely resemble the legal
relationship between service providers and customers in an unregulated
environment. Therefore, to establish a more market-based environment
that will help prevent these possible anti-competitive practices and
better protect consumers, we tentatively conclude that it would be in
the public interest to prohibit non-dominant interexchange carriers
from filing tariffs with respect to domestic interstate, interexchange
services.
32. Our proposal to adopt a mandatory tariff forbearance policy for
non-dominant interexchange carriers is supported by the Commission's
adoption of a mandatory tariff forbearance policy for domestic CMRS, in
response to a similar grant of forbearance authority with respect to
CMRS providers and services in Section 6002(b) of the Omnibus Budget
Reconciliation Act of 1993 (OBRA). In Regulatory Treatment of Mobile
Services, the Commission concluded that, in a competitive environment,
voluntary tariff filings would create a risk that competitors would use
tariff filings ``merely to send price signals and thereby manipulate
prices.'' It also found that forbearance would promote competition by
enabling providers of CMRS to respond quickly to competitors' price
packages and reducing administrative costs. To prevent collusive
pricing practices, and to protect consumers and the public interest,
the Commission determined that it would ``forbear from requiring or
permitting tariffs for interstate service offered directly by CMRS
providers to their customers.''
33. We seek comment on our tentative conclusion that we should
adopt a mandatory detariffing policy for the domestic services offered
by non-dominant interexchange carriers. We also seek comment on whether
the Commission has the authority pursuant to the Communications Act, as
amended, to prohibit carriers from filing tariffs. We tentatively
conclude that, if we adopt a mandatory or a permissive detariffing
policy, non-dominant carriers should be required to maintain at their
premises price and service information regarding all of their
interstate, interexchange offerings, that they can submit to the
Commission upon request. We seek comment on this tentative conclusion.
34. We recognize that the Commission gradually relaxed its
regulation of non-dominant carriers in the Competitive Carrier
proceeding in part because it concluded that the availability of
service from a nationwide dominant carrier subject to close regulation
would effectively constrain the rates that could be charged by non-
dominant carriers. Given the recent reclassification of AT&T, there
currently are no nationwide dominant interstate, domestic,
interexchange carriers. While we still believe that non-dominant
carriers lacking market power cannot rationally price services
anticompetitively, we seek comment on whether the absence of a
nationwide dominant carrier should affect our tentative conclusion to
forbear from requiring non-dominant interexchange carriers to file
tariffs, and if so, how.
35. We note that market conditions or other circumstances may
change in the
[[Page 14724]]
future. In the event of changed circumstances, such that the statutory
prerequisites for forbearance are no longer present, the Commission can
revisit tariff forbearance to consider whether it continues to meet the
statutory criteria.
36. Finally, in the AT&T Reclassification proceeding, AT&T made
certain voluntary commitments regarding its provision of interstate
analog private line and 800 directory assistance services.
Specifically, AT&T committed, for a period of three years, to limit any
price increases for these services to a maximum increase in any year of
no more than the increase in the consumer price index. AT&T also
committed, for a period of three years, to file tariff changes
increasing the prices of these services on not less than five business
days' notice, and to identify clearly such tariff transmittals as
affecting the provisions of this commitment. We believe that it would
be consistent with AT&T's intent that its commitments act as a
transitional mechanism for AT&T to continue to tariff these services in
accordance with its commitments. Accordingly, we tentatively conclude
that, even if we decide to forbear from requiring non-dominant
interexchange carriers to file tariffs, AT&T should remain subject to
its prior commitments, and our corresponding order, that AT&T file
tariffs with respect to these services for the specified term of the
commitments. We seek comment on these tentative conclusions.
IV. Definition of Relevant Product and Geographic Markets
37. In the Competitive Carrier proceeding, the Commission found,
for purposes of assessing the market power of interexchange carriers
covered by that proceeding, that: ``(1) interstate, domestic,
interexchange telecommunications services comprise the relevant product
market, and (2) the United States (including Alaska, Hawaii, Puerto
Rico, U.S. Virgin Islands, and other U.S. offshore points) comprises
the relevant geographic market for this product, with no relevant
submarkets.'' In this section, we consider whether we should reexamine
the geographic and product market definitions that the Commission
adopted in the Competitive Carrier proceeding. We believe more sharply
focused market definitions will aid us in evaluating whether the BOCs
possess market power with respect to the provision of interLATA
services in areas where they provide local access service. Moreover,
evidence in the recent AT&T Reclassification proceeding suggests that
the market definitions adopted in the Competitive Carrier proceeding
might be more narrowly drawn to provide us with a more refined
analytical tool for evaluating whether a carrier or group of carriers
has market power. For example, there was evidence that suggested that
AT&T might possess the ability to raise and sustain prices for 800
directory assistance and analog private line services above competitive
levels without making the price increase unprofitable, which may imply
that these services might constitute separate relevant product markets.
38. We invite comment on whether we should retain the relevant
product and geographic market definitions adopted in the Competitive
Carrier proceeding. We tentatively conclude that we should follow the
approach taken in the U.S. Department of Justice/Federal Trade
Commission 1992 Merger Guidelines (the ``Guidelines'') for defining
relevant markets. 1992 U.S. Department of Justice/Federal Trade
Commission Merger Guidelines, 4 Trade Reg. Rep. (CCH) para. 13,104, at
p. 20,569. ``In many respects the . . . Guidelines and the scholarship
on which they are based offer important insights and substantially
improved formulations of relevant market issues.'' Moreover, courts
have increasingly relied on the Guidelines' approach in defining
relevant markets. We believe the Guidelines' approach suggests that we
should define as a relevant product market an interstate, interexchange
service for which there are no close substitutes or a group of services
that are close substitutes for each other but for which there are no
other close substitutes. We tentatively conclude, however, that we need
not address the issue of delineating the boundaries of specific product
markets, except where there is credible evidence suggesting that there
is or could be a lack of competitive performance with respect to a
particular service or group of services.
39. With respect to the relevant geographic market, we tentatively
conclude that we should define a relevant geographic market for
interstate, interexchange services as all calls (in the relevant
product market) between two particular points. However, geographic rate
averaging and other factors imply that a carrier or group of carriers
cannot change interexchange rates for calls between two particular
points without changing rates nationwide for calls of that distance.
For purposes of market power analysis, we tentatively conclude to treat
interstate, interexchange calling generally as one national market, as
the Commission did in the Competitive Carrier proceeding. If there is
credible evidence suggesting that there is or could be a lack of
competition in a particular point-to-point market (or group of
markets), and there is a showing that geographic rate averaging will
not sufficiently mitigate the exercise of market power (if it exists);
however, we propose to examine individually that market (or group of
markets) for the presence of market power.
40. We note that comments and reply comments on this section are
due April 19, 1996; reply comments are due May 3, 1996.
A. Relevant Product Market
41. For the reasons discussed above, we tentatively conclude that
we should follow the Guidelines' approach for defining the relevant
product market. In the Competitive Carrier proceeding, the Commission
defined the relevant product market as ``all interstate, domestic,
interexchange telecommunications services'' and concluded that there
were no relevant submarkets. Although we recently used this product
market definition to reclassify AT&T as non-dominant, we question
whether a narrower product market definition might provide us with a
more refined analytical tool for evaluating whether a carrier or group
of carriers together are exerting market power. For example, our
finding that the prices of 800 directory assistance and analog private
line services could profitably be raised above competitive levels may
imply these services constitute distinct relevant product markets.
42. The Guidelines define the relevant product market as ``the
product or group of products such that a hypothetical profit maximizing
firm that was the only present and future seller of those products
(`monopolist') would impose at least a `small but significant and
nontransitory' increase in price.'' Accordingly, in defining the
relevant product market, one must examine whether a ``small but
significant and nontransitory'' increase in the price of the relevant
product would cause enough buyers to shift their purchases to a second
product, so as to make the price increase unprofitable. If so, the two
products should be considered to be in the same product market.
43. Under the Guidelines, ``[m]arket definition focuses solely on
demand substitution factors--i.e., possible consumer responses.''
Consideration of substitutability of demand supports the use of
narrower relevant product markets than the ``all services'' product
market defined in the Competitive
[[Page 14725]]
Carrier proceeding. It appears unlikely, for example, that a
substantial number of residential customers would switch from
residential service to 800 service in response to a small but
significant nontransitory increase in the price of residential service.
Thus, these two services may fall in different product markets. On the
other hand, it appears that defining each interexchange service as a
separate relevant product market would result in relevant markets that
are too narrow. Business customers, in particular, may view certain
interexchange services as sufficiently close substitutes that, if an
interexchange carrier raised the price of one of the services,
customers would switch to one of the substitute services. Based on this
analysis, we believe that we should define as a relevant product market
an interstate, interexchange service for which there are no close
substitutes or a group of services that are close substitutes for each
other, but for which there are no other close substitutes.
44. We believe that it would be administratively burdensome to
delineate all relevant product markets for interstate, interexchange
services. The fact that we have previously found that there is
substantial competition with respect to most interstate, domestic,
interexchange service offerings suggests that we do not need to do so
at this time. Accordingly, we tentatively conclude that we should
address the question whether a specific interstate, interexchange
service (or group of services) constitutes a separate product market
only if there is credible evidence suggesting that there is or could be
a lack of competitive performance with respect to that service (or
group of services). We seek comment on this approach and invite parties
to suggest other approaches. Interested parties should provide support
for the position they advocate. Parties recommending that services be
grouped in relevant product markets should identify the services that
should be grouped together, as well as providing evidence that there is
or could be a lack of competitive performance with respect to those
services. We also seek comment on what factors we should consider in
defining relevant product markets, as well as what obstacles, problems,
or administrative burdens we are likely to face in adopting narrower
market definitions.
B. Relevant Geographic Market
45. The Merger Guidelines define the relevant geographic market as
the ``region such that a hypothetical monopolist that was the only
present or future producer of the relevant product at locations in that
region would profitably impose at least a `small but significant and
nontransitory' increase in price, holding constant the terms of sale
for all products produced elsewhere.'' This definition focuses on
whether products in one region are good substitutes for products in
other regions. Accordingly, in defining the relevant geographic market,
one must examine whether a ``small but significant and nontransitory''
increase in the price of the relevant product at a particular location
would cause a buyer to shift his purchase to a second location, so as
to make the price increase unprofitable. If so, the two locations
should be considered to be in the same geographic market.
46. In applying the principles in the Guidelines, we note that, at
its most fundamental level, interexchange calling involves a customer
making a connection from a specific location to another specific
location. We believe that most telephone customers do not view
interexchange calls originating in different locations to be close
substitutes for each other. For example, it is unlikely that a person
living in Chicago who wishes to make a telephone call to San Francisco
will be willing to travel to another location to make the call for a
lower price. Similarly, a customer will not view a call that terminates
in a place other than the location of the person to whom he or she is
calling to be a good substitute for a call to that person. Thus,
applying the Merger Guidelines principles, we tentatively conclude that
the relevant geographic market for interstate, interexchange services
should be defined as all calls from one particular location to another
particular location. We note that defining a relevant geographic market
as transport between two specific points is well established in other
contexts. For example, the Department of Justice has used city pairs as
the relevant geographic market for evaluating mergers in the airline
industry. Similarly, in the International Competitive Carrier
proceeding, the Commission found that each country pair constitutes a
separate geographic market. See International Competitive Carrier
Policies, 50 FR 48191 (November 22, 1985). Thus, one geographic market
consists of calls between the U.S. and France, and another consists of
calls between the U.S. and Great Britain.
47. We recognize that it would be impracticable to conduct a market
power analysis in each individual market implied by a point-to-point
market definition for interstate, interexchange services. We believe
that, in the majority of cases, economic factors and the realities of
the marketplace will cause these markets to behave in a sufficiently
similar manner to allow us to aggregate them into broader, more
manageable groups of markets for purposes of market power analysis. For
example, residential interexchange service can be thought of as a
bundle of all possible interexchange calls originating from a single
point and terminating anywhere, and 800 service as a bundle of
interstate, interexchange calls originating from a certain geographic
region and terminating at a specific point. Similarly, the ``single
nationwide geographic market'' the Commission adopted in the
Competitive Carrier proceeding can be viewed as an aggregate of the
point-to-point markets encompassing all points in the United States.
48. We tentatively conclude for the following reasons that, in most
cases, we should continue to treat interstate, interexchange services
as a single national market when examining whether a carrier or group
of carriers acting together has market power. First, geographic rate
averaging reduces the likelihood that a carrier could exercise market
power in a single point-to-point market. Because the prices a carrier
can charge in a particular market are linked to the prices it charges
in all other markets, it generally would not be profitable for a
carrier to raise its prices throughout the nation (with a resulting
loss of market share in some areas) to take advantage of market power
between two particular cities. Second, customers typically purchase
ubiquitous calling that enables them to make calls to all domestic
locations. Thus, because of geographic rate averaging, a price change
in one point-to-point market would require such price changes to be
extended to all residential customers.
49. Another reason we can treat the relevant geographic market as a
national market is that price regulation of access services and excess
capacity in interstate transport further reduce the likelihood that an
interexchange carrier could exercise market power in most point-to-
point markets. In making this determination, we recognize that an
interstate, interexchange call from point A to point B requires three
separate inputs, each of which is sold in a separate input market: (1)
originating access from point A; (2) interstate transport from point A
to point B; and (3) terminating access to point B. The ability to raise
the price for any of the inputs above the competitive level or to
prevent competitors from assembling inputs to provide retail service
would enable a firm unilaterally to raise the
[[Page 14726]]
retail price of and thereby exercise market power with respect to
interexchange calls between points A and B. We note, however, that all
originating and terminating access services are currently subject to
some form of price regulation, which constrains a LEC's ability to
raise access prices to monopoly levels. We also note that there are
ways in which a LEC could exercise market power without raising the
price of interstate, interexchange services. For example, a LEC could
raise its interexchange rivals' costs by providing poorer
interconnection to the LEC's network facilities than the LEC provides
to itself or its affiliate, or by delaying fulfillment of its rivals'
requests to connect to the LEC's network. We will be addressing these
issues in upcoming proceedings that address implementation of new
Sections 251 and 272 of the Communications Act, as amended. While
interstate transport service is not subject to price regulation, we
concluded in the AT&T Reclassification Order that, between most points,
excess transport capacity undermines the ability of any carrier to
raise and maintain the price of interstate transport above the
competitive level. Thus, because the prices of access and transport
services are similarly constrained in all point-to-point markets, we
believe we can generally examine simply whether a carrier has market
power in the group of point-to-point markets that comprise the
``nationwide geographic market.''
50. Nevertheless, we believe there may be special circumstances in
which treating interexchange services as a national market will not be
sufficient for purposes of market power analysis. For example, the
BOCs' control of access facilities in their local service regions may
require us to examine those regions individually in determining whether
the BOCs have market power with respect to in-region interexchange
services. If market power were found to exist in such a large region,
there is no guarantee that geographic rate averaging would provide a
credible check on the exercise of such power. For instance, if a BOC's
interexchange customers and traffic are concentrated in one region, the
BOC might find it profitable to raise prices above competitive levels,
even if geographic rate averaging might cause it to lose market share
outside that region. We therefore propose to examine a particular
point-to-point market (or group of markets) for the presence of market
power if there is credible evidence suggesting that there is or could
be a lack of competition in that market (or group of markets) and there
is a showing that geographic rate averaging will not sufficiently
mitigate the exercise of market power (if it exists) in that market (or
group of markets). We are not addressing in this proceeding the
circumstances, if any, in which a BOC or independent LEC should be
classified as a dominant carrier with respect to the provision of
interstate, interexchange services in areas where it provides local
access services. We intend to address these questions in an upcoming
proceeding.
51. We seek comment on the proposed approach. We also seek comment
on how narrowly we would need to define points of origination and
termination if we adopt this approach. Because it would be
administratively infeasible to conduct a market power analysis that
defines separate geographic markets between each pair of individual
locations (such as homes), we need to adopt somewhat broader
definitions for this situation. One possibility is to define geographic
markets between two local exchange areas. An alternative approach might
be to use geographic areas currently used by the Commission, such as
Major Trading Areas (MTAs), Basic Trading Areas (BTAs), or Metropolitan
Statistical Areas (MSAs). Commenters should explain why the geographic
market definition they recommend is appropriate and should address the
administrative benefits or burdens of their proposed definition. We
note that Rand McNally & Company is the copyright owner of the Basic
Trading Area and Major Trading Area Listings, which list the counties
contained in each BTA, as embodied in Rand McNally's Trading Area
System Diskette and Atlas & Marketing Guide. Rand McNally has licensed
the use of its copyrighted MTA/BTA listings and maps for certain
wireless telecommunications services.
52. We also invite parties to suggest alternative approaches they
believe better characterize the relevant geographic market for
interstate, interexchange services, than the point-to-point market
definition we have proposed. Parties should explain how the market
definition they recommend reflects the market for interexchange
services and should describe the likely administrative benefits or
burdens of their proposal. Finally, parties should discuss the factors
that we should consider in defining the relevant geographic market for
interstate, domestic, interexchange services.
V. Separation Requirements for Independent Local Exchange Carrier and
Bell Operating Company Provision of ``Out-of-Region'' Interstate,
Interexchange Services
53. The 1996 Act authorizes the BOCs, upon enactment, to provide
interLATA services originating outside their in-region states. In a
recent Notice of Proposed Rulemaking, we considered what regulatory
regime we should apply to BOC provision of such ``out-of-region''
interstate, interexchange services. Specifically, we considered whether
such services should be subject to dominant carrier or non-dominant
carrier regulation. The BOC Out-of-Region NPRM, 60 FR 6607 (February
21, 1996) addresses only BOC provision of out-of-region interstate,
interexchange services; BOC provision of in-region interstate,
interexchange services will be considered in a separate proceeding. In
that Notice, we tentatively concluded that the separation requirements
imposed for non-dominant treatment of independent LEC provision of
interexchange services, presented a useful model upon which to base, on
an interim basis, oversight of BOC provision of out-of-region
interstate, interexchange services.
54. The separation requirements imposed on independent LECs were
established by the Commission in the Competitive Carrier proceeding.
The Commission there determined that interexchange carriers affiliated
with independent LECs would be regulated as non-dominant carriers. In
the Fifth Report and Order, 49 FR 34824 (September 4, 1984), the
Commission specified that an ``affiliate'' of an independent LEC was
``a carrier that is owned (in whole or in part) or controlled by, or
under common ownership (in whole or in part) or control with, an
exchange telephone company.'' The Commission further clarified that, to
qualify for non-dominant treatment, the affiliate providing interstate,
interexchange services must: (1) maintain separate books of account;
(2) not jointly own transmission or switching facilities with its
affiliated exchange telephone company; and (3) acquire any services
from its affiliated exchange telephone company at tariffed rates, terms
and conditions. The Commission also stated that any interstate service
offered directly by an independent LEC, rather than through a separate
affiliate, would be regulated as dominant.
55. The Commission observed that the separation requirements would
provide some ``protection against cost-shifting and anticompetitive
conduct'' by an
[[Page 14727]]
independent LEC that could result from using its control of local
bottleneck facilities. Noting that the requirements it had specified
were less stringent than those established in the Second Computer
Inquiry, the Commission concluded that the separation requirements
would not impose excessive burdens on independent LECs.
56. The Commission stated in the Fifth Report and Order that the
non-dominant treatment accorded to interexchange carriers affiliated
with independent LECs did not apply to the BOCs, which, the Commission
noted, were then prohibited from offering interLATA services. The
Commission added that, ``if this bar is lifted in the future, we would
regulate the BOCs' interstate, interLATA services as dominant until we
determined what degree of separation, if any, would be necessary for
the BOCs or their affiliates to qualify for nondominant regulation.''
57. As noted, in the BOC Out-of-Region NPRM we tentatively
concluded that the separation requirements imposed upon independent
LECs providing interexchange services, presented a useful model upon
which to base, on an interim basis, oversight of BOC provision of out-
of-region interstate, interexchange services. Accordingly, we
tentatively concluded that, if a BOC provides out-of-region interstate,
interexchange services through an affiliate that satisfies the
separation requirements established in the Competitive Carrier Fifth
Report and Order, the BOC affiliate should be regulated as a non-
dominant carrier. We also tentatively concluded that, if a BOC provides
out-of-region interstate, interexchange services directly, or through
an affiliate that does not meet the separation requirements, those
services should be regulated as dominant carrier offerings.
58. We stated in that Notice, however, our intent to consider in
this proceeding whether it may be appropriate at some future date to
modify or eliminate the separation requirements that are currently
imposed upon independent LECs, and that we tentatively concluded should
be imposed on BOCs, in order to qualify for non-dominant treatment in
the provision of out-of-region interstate, interexchange services.
Accordingly, we now seek comment on whether we should modify or
eliminate these separation requirements as a condition for non-dominant
treatment of independent LEC provision of interstate, interexchange
services outside their local exchange areas. We also seek comment on
whether, if we modify or eliminate these separation requirements for
non-dominant treatment of independent LEC provision of interstate,
interexchange services outside their local exchange areas, we should
apply the same requirements to BOC provision of out-of-region
interstate, interexchange services. We defer to another proceeding
consideration of the appropriate regulatory treatment of BOCs that
provide in-region interstate, interexchange services and independent
LECs that provide interstate, interexchange services within the area in
which they also provide local exchange service.
59. Parties should identify the requirement or requirements that
they believe should be modified or eliminated, and offer support for
their positions. Parties should comment on whether complying with the
separation requirements would create an unnecessary burden for LECs
subject to those requirements. Parties should also comment on whether
there is a possibility of cost-shifting or other anti-competitive
conduct that could result if the separation requirements are modified
or eliminated, and if so, how we can or should address such conduct.
60. We note that comments and reply comments on this section are
due April 19, 1996; reply comments are due May 3, 1996. See also
Section X.D. infra regarding requirements for all pleadings
FR Doc. 96-8116 Interstate, Interexchange Marketplace; and Implementation of Section 254(g) of the Communications Act of 1934, as Amended
.
VI. Rate Averaging and Integration Requirements of 1996 Act
61. Section 254(g) of the Communications Act, as amended by the
1996 Act, provides that the Commission, within six months after the
date of enactment, must:
[A]dopt rules to require that the rates charged by providers of
interexchange telecommunications services to subscribers in rural
and high cost areas shall be no higher than the rates charged by
each such provider to its subscribers in urban areas. Such rules
shall also require that a provider of interstate interexchange
telecommunications services shall provide such services to its
subscribers in each State at rates no higher than the rates charged
to subscribers in any other State.
Accordingly, we propose and address here the rules necessary to
implement these requirements.
62. We note that comments and reply comments on this section
implementing Section 254(g) of the Communications Act, as amended, are
due April 19, 1996; reply comments are due May 3, 1996. See also
Section X.C. infra regarding requirements for all pleadings.
A. Geographic Rate Averaging
63. We first address the statutory requirement that the rates
charged by providers of interexchange telecommunications services to
subscribers in rural and high cost areas not be higher than the rates
charged to subscribers in the interexchange carrier's urban areas
(i.e., that rates be geographically averaged). The Commission has long
supported a policy of geographic rate averaging for interstate,
domestic, interexchange services. As the Commission stated in 1989:
This Commission has repeatedly voiced our support for rate
averaging. . . . Geographic rate averaging redounds to the benefit
of rural ratepayers, and customers of high cost local exchange
carriers. First, geographic rate averaging ensures that
interexchange rates for rural areas, or areas served by high cost
companies, will not reflect the disproportionate burdens that may be
associated with common line cost recovery in these areas. Thus,
geographic rate averaging furthers our goal of providing a universal
nationwide telecommunications network. Second, geographic rate
averaging ensures that ratepayers share in the benefits of
nationwide interexchange competition. If prices are falling due to
competition in the corridors carrying the most traffic, prices will
also fall for rural Americans. An additional benefit of rate
averaging has been its contribution to the simplicity of [message
toll service] rates. Customers seeking to compare rates charged by
various interexchange carriers have been substantially benefited by
the relative simplicity of the existing rate structure.
As recently as the AT&T Reclassification Order, we reaffirmed our
commitment to maintain our geographic rate averaging policy.
64. While the Commission has consistently endorsed a policy of
geographic rate averaging, the Commission has not formally promulgated
a requirement that rates be geographically averaged. As required by the
1996 Act, we propose to adopt a rule requiring that the rates charged
by all providers of interexchange telecommunications services to
subscribers in rural and high cost areas shall be no higher than the
rates charged by each such provider to its subscribers in urban areas.
As established by the 1996 Act, this requirement would apply to all
providers of interexchange telecommunications services. We seek comment
generally on this proposed rule.
65. Section 254(g) of the Communications Act, as amended by the
1996 Act, states in part:
the Commission shall adopt rules to require that the rates charged
by providers of interexchange telecommunications services to
subscribers in rural and high cost areas shall be no higher than the
rates charged by each such provider to its subscribers in urban
areas.
[[Page 14728]]
Thus, the statute requires the Commission to adopt rules to require
geographic rate averaging for intrastate and interstate, interexchange
telecommunications services. We note that the legislative history
states:
[n]ew section 254(g) is intended to incorporate the policies of
geographic rate averaging . . . of interexchange services in order
to ensure that subscribers in rural and high cost areas throughout
the Nation are able to continue to receive both intrastate and
interstate interexchange services at rates no higher than those paid
by urban subscribers.
We also believe, however, that Section 254(g) preempts state laws or
regulations requiring intrastate geographic rate averaging only to the
extent such laws or regulations are inconsistent with the rules we
adopt with respect to geographic rate averaging. Preemption may occur
even when Congress has not fully foreclosed state regulation in a
specific area if state law conflicts with federal law. See Florida Lime
& Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 (1963) (conflict
when ``compliance with both federal and state regulations is a physical
impossibility''); Hines v. Davidowitz, 312 U.S. 52, 67 (1941) (conflict
when state law ``stands as an obstacle to the accomplishment and
execution of the full purposes and objectives of Congress''). Although
the statute makes clear that the Commission is to establish the rules
requiring geographic averaging, it does not appear to foreclose
consistent state action in this area. Indeed, the Senate Report
statement included in the Joint Explanatory Statement provides:
States shall continue to be responsible for enforcing this
[geographic averaging provision] with respect to intrastate
interexchange services, so long as the State rules are not
inconsistent with Commission rules and policies on rate averaging.
The Joint Explanatory Statement indicates that the House receded to the
Senate with modifications with respect to new Communications Act
Section 254. We note that the geographic rate averaging provision of
Section 254(g) contains only minor modifications from the Senate Bill
geographic rate averaging provision, Section 253(h). See S. 652 104th
Cong., 1st Sess. Sec. 253(h) (1995). Thus, we invite comment on these
views.
66. In addition to seeking comment on preemption, we seek comment
on whether there may be competitive conditions or other circumstances
that could justify Commission forbearance from enforcing the proposed
geographic rate averaging requirement with respect to particular
interexchange telecommunications carriers or services.
67. In light of our proposal in this Notice to forbear from
requiring non-dominant interexchange carriers to file tariffs, we
tentatively conclude that it would not be in the public interest to
attempt to enforce geographic rate averaging through the tariff
process. Rather, we believe that we can ensure compliance with the
proposed rate averaging requirements by requiring providers of
interexchange telecommunications services to file certifications
stating that they are in compliance with their statutory geographic
rate averaging obligations. Such a requirement would not impose a
significant burden on such providers. Accordingly, we tentatively
conclude that we should require providers of interexchange
telecommunications services to file such certifications. We also
tentatively conclude that we should rely on the complaint process under
Section 208 to bring violations to our attention. We seek comment on
these tentative conclusions. Parties challenging these tentative
conclusions should suggest possible alternative enforcement mechanisms.
68. Enforcement issues similarly arise in the absence of tariff
forbearance. Because non-dominant carriers currently are permitted to
file tariffs on one day's notice, we seek comment on whether, in the
absence of tariff forbearance, we should adopt any requirements in
order to facilitate enforcement of the proposed rule that requires,
inter alia, that the rates of non-dominant providers of interexchange
telecommunications services be geographically averaged. Parties
supporting such requirements should propose specific examples of
regulatory mechanisms that could be adopted.
69. Parties in the AT&T Reclassification proceeding asserted that
carriers often do not offer discount rate plans ubiquitously, and that,
as a result, interexchange customers in some rural and high cost areas
are forced to pay the carriers' higher basic rates, while customers in
other geographic areas can take advantage of the carriers' discount
plans. These parties further asserted that this disparity amounts to
geographic rate deaveraging. We seek comment on the extent to which
providers of interexchange telecommunications services do not offer
optional discount plans to subscribers in rural and high cost areas
and, if so, the reasons for this practice. We also seek comment on
whether an interexchange carrier's failure to make a promotional plan
available in the entirety of its service area constitutes geographic
deaveraging, and if so, whether we should require that discount rate
plans be made available and advertised in the entirety of an
interexchange telecommunications service provider's service area.
70. Finally, as noted above, in the AT&T Reclassification
proceeding, AT&T made voluntary commitments related to geographic rate
averaging. Specifically, AT&T committed to file any new geographically
specific tariffs that depart from its traditional approach to
geographic averaging for interstate residential direct dial services on
five business days' notice. AT&T committed that such tariff
transmittals will be clearly identified as affecting the provisions of
the commitment. AT&T committed that ``[t]his will continue for three
years unless the Commission adopts rules addressing this issue for all
carriers or there is a change in federal law addressing this issue.''
We tentatively conclude that, given the specific limitation of AT&T's
commitment on this issue, upon adoption of the foregoing proposed rules
relating to geographic rate averaging, AT&T would be subject to those
adopted rules, and would not be bound to the specific commitments it
made with respect to geographic rate averaging. We seek comment on this
tentative conclusion.
B. Rate Integration
71. As noted above, the 1996 Act also requires that the Commission
adopt rules to require that providers of interstate, interexchange
telecommunications services provide such services to their subscribers
in each State at rates no higher than the rates charged to their
subscribers in any other State (i.e., that rates be integrated). As
with geographic rate averaging, the Commission has long maintained a
rate integration policy for interexchange rates between the forty-eight
contiguous states and various non-contiguous United States regions,
including Alaska, Hawaii, Puerto Rico and the U.S. Virgin Islands.
72. As required by the 1996 Act, and guided by the Conference
Committee's statement to incorporate the policies contained in our 1976
Integration of Rates and Services Order, we propose to adopt a rule
requiring that ``a provider of interstate interexchange
telecommunications services shall provide such services to its
subscribers in each State at rates no higher than the rates charged to
its subscribers in any other State.'' The Joint Explanatory Statement
provides: ``[t]he conferees intend the Commission's rules to require
geographic rate averaging and rate integration, and to incorporate the
policies contained in the Commission's
[[Page 14729]]
proceeding entitled `Integration of Rates and Services for the
Provision of Communications by Authorized Common Carriers between the
United States Mainland and the Offshore Points of Hawaii, Alaska and
Puerto Rico/Virgin Islands' (61 FCC 2d 380 (1976)).'' We seek comment
on this proposed rule.
73. We note that the Communications Act, as amended, defines the
term ``State'' as including ``the District of Columbia and the
Territories and possessions.'' Accordingly, the 1996 Act extends rate
integration to U.S. Territories and possessions, such as Guam and the
Northern Mariana Islands, that currently are not subject to the
Commission's domestic rate integration policy. The U.S. Virgin Islands
and Puerto Rico are the only territories or possessions subject to the
Commission's domestic rate integration policy at the present time. We
seek comment on appropriate mechanisms to implement rate integration
for U.S. territories and possessions that currently are not subject to
the Commission's domestic rate integration policies. We note that
currently pending before the Commission are three petitions to
establish rulemakings to implement domestic rate integration policies
for the Territory of Guam and the Commonwealth of the Northern Mariana
Islands. See Governor's Office of the Territory of Guam Petition for
Rulemaking to Integrate Rates, filed May 12, 1995, Public Notice, AAD
95-84 (rel. June 16, 1995); JAMA Corporation Petition for Rulemaking to
Implement Domestic Rate Integration Policies for Guam, filed May 1,
1995, Public Notice, AAD 95-85 (rel. June 16, 1995); Commonwealth of
the Northern Mariana Islands Petition for Rulemaking to Implement
Domestic Rate Integration for the Commonwealth of the Northern Mariana
Islands, filed June 7, 1995, Public Notice, AAD 95-86 (rel. June 16,
1995). We believe these petitions would become moot when we adopt the
rules implementing new Section 254(g).
74. We tentatively conclude, in light of our proposal in this
Notice to forbear from requiring non-dominant interexchange carriers to
file tariffs, that it would not be in the public interest to attempt to
enforce rate integration through the tariff process. Rather, we believe
that we can ensure compliance with the proposed rate integration
requirements by requiring providers of interstate, interexchange
telecommunications services to file certifications stating that they
are in compliance with their statutory rate integration obligations.
Such a requirement would not impose a significant burden on such
providers. Accordingly, we tentatively conclude that we should require
providers of interstate, interexchange telecommunications services to
file such certifications. We also tentatively conclude that we should
rely on the complaint process under Section 208 to bring violations to
our attention. We seek comment on these tentative conclusions. Parties
challenging these tentative conclusions should suggest possible
alternative enforcement mechanisms.
75. Finally, in the AT&T Reclassification proceeding, AT&T made
voluntary commitments relating to service to and from the State of
Alaska and other regions subject to our rate integration policy.
Specifically, AT&T committed that it ``will continue to comply with all
conditions and obligations contained in the various Commission orders
regarding rate integration between the contiguous forty-eight states
and the states of Alaska, Hawaii, Puerto Rico and the Virgin Islands,
until or unless those orders are superseded by Congressional or
Commission action.'' We tentatively conclude that, given the specific
limitation of AT&T's commitment on this issue, upon adoption of the
foregoing proposed rule relating to rate integration, AT&T would be
subject to that rule, and would not be bound to the specific commitment
it made with respect to rate integration. We seek comment on this
tentative conclusion. We note that this tentative conclusion does not
apply to AT&T's separate commitment to ``comply with all the conditions
and obligations contained in the Commission orders associated with
AT&T's purchase of Alascom, Inc.'' as that commitment is not limited in
duration.
VII. Pricing Issues
76. Changes in the structure of the interexchange marketplace over
the past decade have raised certain issues relating to the pricing of
interexchange telecommunications services. In the AT&T Reclassification
proceeding, a number of parties alleged that the interexchange market
is characterized by oligopolistic price coordination, and that the
reclassification of AT&T would lead to an increase in basic rates for
domestic residential service. We address these issues in this section.
A. Allegations of Tacit Price Coordination
77. In the AT&T Reclassification Order, we found inconclusive and
conflicting evidence in the record regarding the existence of alleged
tacit price coordination among interexchange carriers for basic
residential services, or residential services generally. We concluded
that, if there were tacit price coordination in the interexchange
market, the problem was generic to the industry and would be better
addressed by removing regulatory requirements that may have facilitated
such conduct. Our reclassification of AT&T as non-dominant removed one
such regulatory requirement--the longer advance notice period
applicable only to AT&T tariff filings. In addition, we believe that
the 1996 Act provides the best solution to any problem of tacit price
coordination, to the extent that it exists currently, by allowing for
competitive entry in the interstate interexchange market by the
facilities-based BOCs and others. Increasing the number of facilities-
based carriers should make tacit price coordination more difficult.
Moreover, we believe that the mandatory detariffing regime we propose
in this Notice similarly will discourage price coordination by
eliminating carriers' ability to ascertain their competitors'
interstate rates and service offerings from publicly available tariffs
filed with the Commission. We seek comment on these issues.
B. Residential Services Rate Plans
78. In order to alleviate concerns expressed in the AT&T
Reclassification proceeding that rates for residential services would
increase if AT&T were reclassified as non-dominant, AT&T voluntarily
committed, for a period of three years, to offer two optional calling
plans designed to mitigate the impact of future increases in basic
schedule or residential rates. The first plan is targeted to low-income
customers, and the second is targeted to low-volume consumers, but is
generally available to all residential customers.
79. With respect to low-income customers, in our recent Notice of
Proposed Rulemaking regarding implementation of the 1996 Act's
universal service directives, we solicited comment ``on whether and how
we should encourage domestic interstate interexchange carriers to
provide optional calling plans for low-income consumers to promote the
statutory [universal service] principles enumerated [in the 1996
Act].'' We anticipate resolving this issue in the Universal Service
proceeding, but because the service is interstate in nature, we retain
concurrent jurisdiction.
[[Page 14730]]
VIII. Bundling of Customer Premises Equipment
80. In 1980, the Commission adopted a rule prohibiting common
carriers from bundling the provision of customer premises equipment
(CPE) with the provision of common carrier telecommunications services.
Carriers previously offered CPE as part of a package of services to
subscribers. Changes in the industry, in particular the advent of
competitive CPE vendors, led the Commission to conclude that carriers'
continued bundling of telecommunications services with CPE could force
customers to purchase unwanted CPE in order to obtain necessary
transmission services, thus restricting customer choice and retarding
the development of a competitive CPE market. It therefore required
carriers to separate the provision of CPE from the provision of
transmission services. Section 64.702(e) of our rules provides:
``Except as otherwise ordered by the Commission, after March 1, 1982,
the carrier provision of customer-premises equipment used in
conjunction with the interstate telecommunications network shall be
separate and distinct from provision of common carrier communications
services and not offered on a tariffed basis.''
81. The Commission recognized, however, that ``[i]f the markets for
components of [a] commodity bundle are workably competitive, bundling
may present no major societal problems so long as the consumer is not
deceived concerning the content and quality of the bundle.'' It further
acknowledged that some consumers may believe that bundled offerings can
reduce transaction costs to customers. Bundling can also enable market
participants to compete more effectively by offering attractive sales
packages.
82. Since the adoption of the rule prohibiting CPE bundling in
1980, significant changes have occurred in the markets for CPE and
interstate long-distance services. The CPE market is now widely
recognized to be fully competitive. In the AT&T Reclassification Order,
we found that AT&T no longer possesses market power in the overall
interstate, domestic, interexchange market. Moreover, in the
Interexchange Competition Proceeding, we concluded that the business
services market was ``substantially competitive.''
83. The Supreme Court has stated that the essential characteristic
of an illegal tying or bundling arrangement ``lies in the seller's
exploitation of its control over [one] product to force the buyer into
the purchase of a [second] product that the buyer either did not want
at all or might have preferred to purchase elsewhere on different
terms.'' Under the ``leverage theory'' of tying, ``tying provides a
mechanism whereby a firm with monopoly power in one market can use the
leverage provided by this power to foreclose sales in, and thereby
monopolize, a second market.''
84. Based on our earlier findings regarding competition in both the
CPE and interstate, interexchange services markets, we tentatively
conclude that it is unlikely that non-dominant interexchange carriers
can engage in the type of anticompetitive conduct that led the
Commission to prohibit the bundling of CPE with the provision, inter
alia, of interstate, interexchange services. We also tentatively
conclude that allowing non-dominant interexchange carriers to bundle
CPE with interstate, interexchange services would promote competition
by allowing such carriers to create attractive service/equipment
packages for customers. Accordingly, we tentatively conclude that we
should amend Section 64.702(e) of the Commission's rules to allow non-
dominant interexchange carriers to bundle CPE with interstate,
interexchange services. We seek comment on these tentative conclusions.
85. Parties that believe we should amend Section 64.702(e) should
also comment on whether we should require interexchange carriers
offering bundled packages of CPE and interstate, interexchange services
to continue to offer separately, unbundled interstate, interexchange
services on a nondiscriminatory basis. We note that the U.S. Government
has committed in the Uruguay Round Agreements of the General Agreement
on Tariffs and Trade, to ensure, among other things, that ``service
suppliers'' are permitted ``to purchase or lease and attach terminal or
other equipment which interfaces with the [public telecommun-ications
transport] network and which is necessary to supply a supplier's
service. . . .'' See Uruguay Round Agreements Act of 1994, Pub. L. No.
103-465, Section 801, 108 Stat. 4809 (1994) (to be codified at 47
U.S.C. Sec. 309(j)(13)). ``Service supplier'' is defined to mean a
supplier of any service in any sector except services supplied in the
exercise of governmental authority. We seek comment on whether this
commitment implies that interexchange carriers should be required to
offer separately, unbundled interstate, interexchange services on a
nondiscriminatory basis if they are permitted to bundle CPE with the
provision of interstate, interexchange services.
86. Parties that believe that we should not amend Section 64.702(e)
as proposed should set forth specific reasons in support of their
position. We also seek comment on the effect that the proposed
amendment of Section 64.702(e) would have on our other policies or
rules. We believe that our tentative conclusions regarding CPE bundling
are consistent with our nation's foreign trade policy that seeks to
promote, in trade negotiations with other countries, the unbundling of
telecommunications services and CPE in certain international markets
where monopoly providers may exist in either the services or CPE
market. As described above, our domestic CPE and interstate, domestic,
interexchange markets are both subject to competition, thus we believe
that the potential for anticompetitive bundling behavior is highly
unlikely in the U.S. market. Finally, we seek comment on whether and
how the anticipated entry of local exchange carriers, in particular the
BOCs, into the market for interstate, interexchange services should
affect our analysis.
87. We note that we intend to initiate a comprehensive proceeding
to address payphone issues, and to implement the sections of the 1996
Act relating to the provision of payphone service. In that proceeding,
we intend to consider the issue of bundling of pay telephone equipment
with underlying transmission capacity. Accordingly, any amendment to
Section 64.702(e) of our rules adopted in this proceeding will not
apply to payphone bundling.
IX. Other Issues
88. For reasons set forth above, we have tentatively concluded that
we are required to forbear from requiring non-dominant interexchange
carriers to file tariffs, and that such detariffing should be
mandatory. In the AT&T Reclassification proceeding, commenters raised
certain issues regarding contract tariffs. We deferred consideration of
those issues to this proceeding because we found those issues were
unrelated to the determination of whether AT&T possessed market power.
We note that these issues will largely be mooted if, as proposed above,
we adopt a mandatory detariffing policy. We examine those and other
tariff-related issues here, however, because such issues will remain
relevant if we determine not to forbear from requiring non-dominant
interexchange carriers to file tariffs. In addition, if we determine to
adopt a policy of permissive detariffing, it is possible that some
carriers will choose
[[Page 14731]]
to continue to file tariffs, including contract tariffs.
89. In the First Interexchange Competition Order, the Commission
established its contract carriage regime under which interexchange
carriers are permitted to offer services pursuant to individually
negotiated contracts. The Commission further found that, as long as all
contracts were made generally available to similarly situated customers
under substantially similar circumstances, the offering of
individually-negotiated contracts for interexchange services under the
contract carriage regime would comply with the nondiscrimination
provisions of the Communications Act. The Commission later found that
the ``contract carriage policy serves the public interest by enabling
users to purchase services that match their needs in particular ways
and by facilitating user and interexchange carrier planning by
increasing the availability of long-term commitments and price
protection.''
90. The Title II statutory scheme permits carriers to make changes
to their tariffs. Moreover, it is well established that, pursuant to
the ``filed rate doctrine,'' in a situation where a filed tariff rate
differs from a rate set in a non-tariffed carrier-customer contract,
the carrier is required to assess the tariff rate. Consequently, if a
carrier unilaterally changes a rate by filing a tariff revision, the
newly filed rate becomes the applicable rate unless the revised rate is
found to be unjust, unreasonable, or unlawful under the Communications
Act.
91. In the RCA Americom Decisions, the Commission recognized that a
dominant carrier's proposal ``to modify extensively a long term service
tariff may present significant issues of reasonableness under Section
201(b) that are not ordinarily raised in other tariff filings.''
Accordingly, the Commission held that a dominant carrier's unilateral
tariff revisions that alter material terms and conditions of a long-
term service tariff will be considered reasonable only if the carrier
can make a showing of ``substantial cause'' for the revision. The
Commission has stated that the substantial cause test would apply to
unilateral changes by dominant carriers to long-term contract tariffs.
In the February 1995 Interexchange Reconsideration Order, 60 FR 13637
(March 14, 1995), the Commission indicated that the substantial cause
test would also apply to unilateral tariff modifications made by non-
dominant carriers.
92. In the February 1995 Interexchange Reconsideration Order, we
indicated that commercial contract law was highly relevant in assessing
the reasonableness of a unilateral tariff revision, but we declined to
declare that contract law principles constituted the sole and
dispositive basis for a substantial cause showing. We seek comment on
whether commercial contract law principles should be the sole criterion
in applying the substantial cause test. If not, parties should suggest
other factors that the Commission should consider in evaluating whether
a carrier has shown substantial cause for unilaterally changing a
contract tariff. We also seek comment on whether the substantial cause
test should apply only to the carrier and the customer with whom it
negotiated the original contract, or whether it also should apply to
subsequent customers who take service under the contract tariff. We
note that, in the February 1995 Interexchange Reconsideration Order, we
stated that in applying the substantial cause test, we would consider
whether the original tariff terms were the product of negotiation and
mutual agreement. Commenters arguing that the substantial cause test
should apply only to the initial customer, should explain how this
position is consistent with the nondiscrimination requirements of
Section 202 of the Communications Act. In addition, in cases in which
the Commission determines that a carrier has established substantial
cause for a unilateral change to a contract tariff, we seek comment on
whether the modified contract tariff should be treated as a new
contract tariff and should be made available to other similarly
situated customers.
93. The Mobile-Sierra doctrine established a strict ``public
interest'' standard that a carrier must meet before a regulatory agency
can accept a superseding tariff that modifies the terms of a negotiated
carrier-to-carrier contract. See United Gas Pipe Line Co. v. Mobile Gas
Service Corp., 350 U.S. 332 (1956) (Mobile); FPC v. Sierra Pacific
Power Co., 350 U.S. 348 (1956) (Sierra). In Bell Telephone Company of
Pennsylvania v. FCC, 503 F.2d 1250 (3rd Cir. 1974), cert. denied, 422
U.S. 1026 (1975), rehearing denied, 423 U.S. 886 (1975), the U.S. Court
of Appeals for the Third Circuit, applying the Mobile-Sierra doctrine,
held that a common carrier could not abrogate a contract with another
carrier simply by filing superseding tariffs. We seek comment on the
relationship between the substantial cause test and the Mobile-Sierra
doctrine in cases where a carrier attempts through a tariff revision to
abrogate an underlying carrier-to-carrier contract.
94. In the AT&T Reclassification proceeding, resellers raised
various issues concerning contract tariffs. Several commenters argued
that resellers and other large customers need protection from the
ability of carriers to revise unilaterally contract-based service
arrangements. AT&T made certain transitional voluntary commitments, for
a period of twelve months, in order to alleviate those concerns on an
interim basis. Commenters proposed, among other things, that the
Commission require carriers to: give customers advance notice of any
tariff filing that materially alters negotiated agreements; obtain the
consent of all affected customers before making such a filing; treat
the lack of consent to a proposed tariff change as prima facie evidence
of its unlawfulness; allow any non-consenting customer either to
terminate its service arrangement without liability or to enforce the
unchanged term; and provide a reasonable period of rate stability to
permit service migration if the customer chooses to terminate its
service agreement. We seek comment on the above proposals. In addition,
we tentatively conclude that AT&T should remain subject to its
voluntary commitments concerning unilateral changes to contract
tariffs, regardless of what action we take in this proceeding with
respect to the foregoing proposals. We seek comment on this tentative
conclusion.
95. Parties in the AT&T Reclassification proceeding also argued
that the ability of non-dominant carriers to file unilateral tariff
modifications on one day's notice effectively precludes customers from
challenging such revisions before they become effective. We seek
comment on whether we should require a longer notice period for tariff
filings that materially revise long-term service or contract tariffs,
and if so, what notice period should be established. We also seek
comment on whether a carrier should be required to identify clearly
tariff filings that unilaterally alter existing long-term service or
contract tariffs.
96. Resellers have also complained that ordering procedures are
used to prevent them from subscribing to contract tariffs. Accordingly,
we seek comment on whether specific ordering procedures should be
allowed to be incorporated in contract tariffs (i.e., when is an order
placed, what documents must a customer file, when must a customer
identify locations that
[[Page 14732]]
it will include in the plan). Resellers also complain that carriers use
narrowly circumscribed customer descriptions in order to prevent
resellers from taking service under contract-based tariffs. We seek
comment on what is an appropriate level of specificity for customer
descriptions that are used by carriers to determine eligibility under a
contract tariff. We also seek comment on whether there are certain
terms that should be prohibited as unreasonable (e.g., extremely large
upfront deposits from the customer).
97. Finally, in the AT&T Reclassification proceeding, we indicated
that we would in the future ``initiate a new proceeding to identify
specific areas of the interstate, domestic, interexchange market that
may raise policy concerns, and if there are any, to seek comment on
possible remedies.'' Further, we noted that we would monitor closely
the areas in which AT&T had made voluntary commitments in order to
protect consumers. Should parties wish to raise issues in this
proceeding with regard to these issues, we encourage parties to
comment.
X. Procedural Issues
A. Ex Parte Presentations
98. This is a non-restricted notice-and-comment rulemaking
proceeding. Ex parte presentations are permitted, except during the
Sunshine Agenda period, provided that they are disclosed as provided in
the Commission's rules. See generally 47 CFR Secs. 1.1202, 1.1203,
1.1206.
B. Initial Regulatory Flexibility Analysis
99. Pursuant to the Regulatory Flexibility Act of 1980, 5 U.S.C.
Secs. 601-612, the Commission's Initial Regulatory Flexibility Analysis
with respect to the Notice of Proposed Rulemaking is as follows:
100. Reason for Action: The Commission is issuing this Notice of
Proposed Rulemaking to review our regulatory regime for interstate,
domestic, interexchange telecommunications services, and to implement
certain provisions of the 1996 Act.
101. Objectives: The objective of the Notice of Proposed Rulemaking
is to provide an opportunity for public comment and to provide a record
for a Commission decision on the issues stated above.
102. Legal basis: The Notice of Proposed Rulemaking is adopted
pursuant to Sections 1, 2, 4, 201-205, 215, 218 and 220 of the
Communications Act of 1934, as amended, 47 U.S.C. Secs. 151, 152, 154,
201-205, 215, 218 and 220.
103. Description, potential impact, and number of small entities
affected: Any rule changes that might occur as a result of this
proceeding could impact entities which are small business entities, as
defined in Section 601(3) of the Regulatory Flexibility Act. After
evaluating the comments in this proceeding, the Commission will further
examine the impact of any rule changes on small entities and set forth
findings in the Final Regulatory Flexibility Analysis. The Secretary
shall send a copy of this Notice of Proposed Rulemaking to the Chief
Counsel for Advocacy of the Small Business Administration in accordance
with Section 603(a) of the Regulatory Flexibility Act, Pub. L. No. 96-
354, 94 Stat. 1164, 5 U.S.C. Sec. 601, et seq. (1981).
014. Reporting, recordkeeping and other compliance requirement: The
proposed rules would require non-dominant interexchange carriers to
retain business records containing price and service information
regarding their interstate, domestic, interexchange offerings. The
proposed rules also would require providers of interexchange services
to certify their compliance with their statutory geographic rate
averaging obligations, and providers of interstate, interexchange
services to certify their compliance with their statutory rate
integration obligations.
105. Federal rules which overlap, duplicate or conflict with the
Commission's proposal: None.
106. Any significant alternatives minimizing impact on small
entities and consistent with stated objectives: The Notice of Proposed
Rulemaking solicits comments on alternatives.
107. Comments are solicited: Written comments are requested on this
Initial Regulatory Flexibility Analysis. These comments must be filed
in accordance with the same filing deadlines set for comments on the
other issues (other than those in Sections IV, V, and VI) in this
Notice of Proposed Rulemaking but they must have a separate and
distinct heading designating them as responses to the Regulatory
Flexibility Analysis. The Secretary shall send a copy of the Notice to
the Chief Counsel for Advocacy of the Small Business Administration in
accordance with Section 603(a) of the Regulatory Flexibility Act, 5
U.S.C. Sec. 601, et seq.
C. Initial Paperwork Reduction Act of 1995 Analysis
108. This Notice contains either a proposed or modified information
collection. As part of its continuing effort to reduce paperwork
burdens, we invite the general public and the Office of Management and
Budget (OMB) to take this opportunity to comment on the information
collections contained in this Notice, as required by the Paperwork
Reduction Act of 1995, Pub. L. No. 104-13. Public and agency comments
are due April 19, 1996; OMB comments are due June 3, 1996. Comments
should address: (a) whether the proposed collection of information is
necessary for the proper performance of the functions of the
Commission, including whether the information shall have practical
utility; (b) the accuracy of the Commission's burden estimates; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on the respondents, including the use of automated
collection techniques or other forms of information technology.
D. Comment Filing Procedures
109. Pursuant to applicable procedures set forth in Sections 1.415
and 1.419 of the Commission's rules, 47 CFR Secs. 1.415, 1.419,
interested parties may file comments on Sections IV, V, and VI, on or
before April 19, 1996, and reply comments on Sections IV, V, and VI on
or before May 3, 1996. Interested parties may file comments on all
other sections of this Notice on or before April 25, 1996, and reply
comments on or before May 24, 1996.
110. To file formally in this proceeding, parties must file an
original and six copies of all comments, reply comments, and supporting
comments. Parties wanting each Commissioner to receive a personal copy
of their comments, must file an original and eleven copies. Comments
and reply comments should be sent to Office of the Secretary, Federal
Communications Commission, 1919 M Street, N.W., Room 222, Washington,
D.C. 20554, with a copy to Janice Myles of the Common Carrier Bureau,
1919 M Street, N.W., Room 544, Washington, D.C. 20554. Parties should
also file one copy of any documents filed in this docket with the
Commission's copy contractor, International Transcription Services,
Inc., 2100 M Street, N.W., Suite 140, Washington, D.C. 20037. Comments
and reply comments will be available for public inspection during
regular business hours in the FCC Reference Center, 1919 M Street,
N.W., Room 239, Washington, D.C. 20554.
111. In order to facilitate review of comments and reply comments,
both by parties and by Commission staff, we require that comments
submitted on Sections IV, V, and VI, be no longer than
[[Page 14733]]
45 pages and reply comments on those sections be no longer than 25
pages. We require that comments on the remaining sections of this
Notice be no longer than 45 pages and reply comments on the remaining
sections be no longer than 25 pages.
112. Comments and reply comments on all sections of this Notice
must include a short and concise summary of the substantive arguments
raised in the pleading. Comments and reply comments must also comply
with Section 1.49 and all other applicable sections of the Commissions
Rules. See 47 CFR Sec. 1.49. However, we require here that a summary be
included with all comments and reply comments, regardless of length.
The summary may be paginated separately from the rest of the pleading
(e.g., as ``i, ii''). See 47 CFR Sec. 1.49.
113. Parties are also asked to submit comments and reply comments
on diskette. Such diskette submissions would be in addition to and not
a substitute for the formal filing requirements addressed above.
Parties submitting diskettes should submit them to Janice Myles of the
Common Carrier Bureau, 1919 M Street, N.W., Room 544, Washington, D.C.
20554. Such a submission should be on a 3.5 inch diskette formatted in
an IBM compatible form using MS DOS 5.0 and WordPerfect 5.1 software.
The diskette should be submitted in ``read only'' mode. The diskette
should be clearly labelled with the party's name, proceeding, type of
pleading (comment or reply comments) and date of submission. The
diskette should be accompanied by a cover letter.
114. Written comments by the public on the proposed and/or modified
information collections are due April 19, 1996. Written comments must
be submitted by the Office of Management and Budget (OMB) on the
proposed and/or modified information collections on or before 60 days
after date of publication in the Federal Register. In addition to
filing comments with the Secretary, a copy of any comments on the
information collections contained herein should be submitted to Dorothy
Conway, Federal Communications Commission, Room 234, 1919 M Street,
N.W., Washington, DC 20554, or via the Internet to [email protected] and
to Timothy Fain, OMB Desk Officer, 10236 NEOB, 725--17th Street, N.W.,
Washington, DC 20503 or via the Internet to [email protected].
E. Ordering Clauses
115. Accordingly, it is ordered that pursuant to Sections 1, 4, 10,
201-205, 214(e), 215, 218, 220 and 254 of the Communications Act of
1934, as amended, 47 U.S.C. Secs. 151, 154, 201-205, 214(e), 215, 218
and 220 a notice of proposed rulemaking is hereby adopted.
116. It is further ordered that, the Secretary shall send a copy of
this notice of proposed rulemaking, including the regulatory
flexibility certification, to the Chief Counsel for Advocacy of the
Small Business Administration, in accordance with paragraph 603(a) of
the Regulatory Flexibility Act, 5 U.S.C. Secs. 601 et seq. (1981).
Federal Communications Commission.
William F. Caton,
Acting Secretary.
[FR Doc. 96-8116 Filed 4-2-96; 8:45 am]
BILLING CODE 6712-01-P
Complete official Federal Register PDF
FR Doc. 96-8090 National Environmental Policy Act; Proposed Revision of Policies and Procedures
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14922-14942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8090]
[[Page 14921]]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 25
National Environmental Policy Act: Proposed Revision of Policies and
Procedures; Proposed Rule
Federal Register / Vol. 61, No. 65 / Wednesday, April 3, 1996 /
Proposed Rules
[[Page 14922]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 25
[Docket No. 96N-0057]
National Environmental Policy Act; Proposed Revision of Policies
and Procedures
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations governing compliance with the National Environmental
Policy Act of 1969 (NEPA) as implemented by the regulations of the
Council on Environmental Quality (CEQ). The primary purpose of this
proposed rule is to increase the efficiency of FDA's implementation of
NEPA and reduce the number of NEPA evaluations by providing for
categorical exclusions for additional classes of actions that do not
individually or cumulatively have a significant effect on the human
environment and for which, therefore, neither an environmental impact
statement (EIS) nor an environmental assessment (EA) is required. FDA
is also proposing to amend its regulations to make its NEPA procedures
more concise and understandable to the public and to reflect current
FDA policy with respect to environmental considerations. This proposed
rule is in response to initiatives announced in the President's
National Performance Reports, ``Reinventing Drug and Medical Device
Regulations,'' April 1995, and ``Reinventing Food Regulations,''
January 1996.
DATES: Submit written comments on the proposed rule by July 2, 1996.
Submit written comments on the information collection requirements by
May 3, 1996.
ADDRESSES: Submit written comments on the proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857. Submit written comments on the
information collection requirements to the Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), New
Executive Office Building, 725 17th St. NW., rm. 10235, Washington, DC
20503, Attn.: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: For information regarding human drugs:
Nancy Sager, Center for Drug Evaluation and Research (HFD-357),-Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
594-6740.
For information regarding biologics: Nancy Roscioli, Center for
Biologics Evaluation and Research (HFM-205), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-3031.
For information regarding veterinary medicines: Charles E. Eirkson,
Center for Veterinary Medicine (HFV-150), Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855, 301-594-1683.
For information regarding foods: Buzz L. Hoffmann, Center for Food
Safety and Applied Nutrition (HFS-246), Food and Drug Administration,
200 C St. SW.,Washington, DC 20204, 202-418-3005.
For information regarding medical devices and radiological health:
Mervin Parker,-Center for Devices and Radiological Health (HFZ-402),
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 301-594-2186.
SUPPLEMENTARY INFORMATION:
I. Background
NEPA requires all Federal agencies to assess the environmental
impact of their actions and to ensure that the interested and affected
public is informed of environmental analyses. CEQ is responsible for
overseeing Federal efforts to comply with NEPA. Both CEQ and FDA have
issued regulations governing agency obligations and responsibilities
under NEPA. In the Federal Register of March 15, 1973 (38 FR 7001), FDA
issued its first regulations to implement NEPA. FDA amended these
regulations in the Federal Register of April 15, 1977 (42 FR 19986),
based on consideration of revised guidelines for preparing EIS's issued
by CEQ. In 1978, CEQ replaced its guidelines with regulations
implementing the procedural requirements of NEPA (40 CFR parts 1500 to
1508). To comply with CEQ regulations, in the Federal Register of April
26, 1985 (50 FR 16636), FDA revised its NEPA policies and procedures in
part 25 (21 CFR part 25).
The CEQ regulations, which are binding on all Federal executive
agencies, establish formal guidance on the requirements of NEPA.
Agencies must adopt procedures to supplement them. In adopting NEPA-
implementing procedures, Federal agencies are directed by CEQ to reduce
paperwork (40 CFR 1500.4 and 1500.2(b)) and to reduce delay (40 CFR
1500.5) by using several means including the use of categorical
exclusions. CEQ defines categorical exclusions as categories of actions
which do not individually or cumulatively have a significant effect on
the human environment and for which neither an EA nor an EIS is
required (40 CFR 1508.4). The CEQ regulations also state that agencies
shall continue to review their policies and procedures and, in
consultation with CEQ, revise them as necessary to ensure full
compliance with the purpose and provisions of NEPA (40 CFR 1507.3).
II. Overview of the Proposed Rule
Since FDA's NEPA policies and supplemental procedures were
published in 1985, the agency has prepared EA's for many agency-
initiated actions and has reviewed hundreds of EA's for a variety of
industry requests for agency action. Based on FDA's experience
reviewing EA's and on its evaluation and knowledge of other relevant
environmental science, FDA has determined that certain classes of
actions normally do not cause significant environmental effects, and
therefore, should be added to the list of actions that are excluded
from the requirement to prepare an EA or an EIS. Some of these actions
had already been identified by FDA as unlikely to cause significant
environmental effects, as evidenced by the fact that the agency has
been requiring less information to support these actions, i.e., an
abbreviated EA rather than a full EA (see Sec. 25.31a(b)).
Thus, in response to the President's reinventing Government
initiatives announced in the President's National Performance Reports,
``Reinventing Drug and Medical Device Regulations,'' April 1995, and
``Reinventing Food Regulations,'' January 1996, FDA, in consultation
with CEQ, is now proposing to increase the efficiency of FDA's
implementation of NEPA and to substantially reduce the number of NEPA
evaluations by providing for categorical exclusions for additional
classes of actions that do not individually or cumulatively have a
significant impact on the human environment and for which, therefore,
neither an EA nor an EIS is required. This proposal would substantially
reduce the number of EA's required to be submitted by industry and
reviewed by FDA and, consequently, reduce the number of findings of no
significant impact (FONSI's) the agency would be required to prepare.
Furthermore, the proposal will not compromise the environment because
the excluded actions have been found not to have a significant effect
on the environment, and the proposed rule would continue
[[Page 14923]]
to provide for the preparation of an EA under extraordinary
circumstances in which a categorically excluded action may have a
significant environmental impact. This proposal would enable FDA to
focus its resources in the environmental area on situations likely to
have an effect on the environment.
The agency is also proposing to revise its environmental
regulations to make them more concise and useful to the public and
regulated industry by reorganizing, simplifying, and eliminating
unnecessary and duplicative language. The proposed rule would
reorganize and renumber various sections so that information on certain
topics is grouped together. The agency solicits comments on and
suggestions for further improvement in these regulations.
III. Specific Proposed Changes
A. General Provisions
The proposed rule would eliminate unnecessary language in current
subpart A of part 25 by deleting the reference to the environmental
statutes listed in current Sec. 25.5 Policies, amending Sec. 25.15
Terminology (proposed Sec. 25.5), and making other minor revisions,
including combining Sec. 25.5 Policies and Sec. 25.10 NEPA planning
into proposed Sec. 25.10 Policies and NEPA planning.
In proposed Sec. 25.5 Terminology, FDA is proposing to remove
definitions listed in current Sec. 25.15 that are not used in part 25,
and add new definitions for ``active moiety'' and ``increased use'' of
a drug. ``Increased use'' of a drug will occur if the drug will be
administered at higher dosage levels, for longer duration, or for
different indications than were previously in effect, or if the drug is
a new molecular entity. ``Increased use'' encompasses consideration of
FDA-regulated articles that are disposed of by consumers.Eric Flamm
suggests wording: ``Increased use'' encompasses consideration of
disposal of FDA regulated articles by consumers. ``Active moiety'' has
been previously defined in FDA regulations (21 CFR 314.108(a)).
B. Agency Actions Requiring Environmental Consideration-
Proposed Sec. 25.15 would contain the general procedural
information now found in current Secs. 25.20 and 25.22.
The proposed rule would create new Sec. 25.l6 Public health and
safety emergencies using revised language now contained in current
Sec. 25.40(b).
Actions requiring preparation of an EA (proposed Sec. 25.20) would
remain essentially the same as current Sec. 25.22, except that: (1)
Current Sec. 25.22(a)(13), promulgation and enforcement of FDA
regulations relating to the control of communicable disease and to
interstate conveyance sanitation, has been deleted and is covered by
proposed Sec. 25.20(g); and (2) actions relating to approval of new
drug applications (NDA's) and abbreviated applications, actions on
investigational new drug applications (IND's) (current
Sec. 25.22(a)(14)), issuance of licenses for biologic products (current
Sec. 25.22(a)(16)), and approval of supplements to existing approvals
of FDA-regulated articles (Sec. 25.22(a)(8)) have been combined into
one provision (proposed Sec. 25.20(l)) and revised to reflect current
terminology.
The proposed regulations include new Sec. 25.21 Extraordinary
circumstances, which addresses circumstances under which categories of
actions that would ordinarily be categorically excluded would require
preparation of environmental documents. Proposed Sec. 25.21
incorporates current Sec. 25.23(b) and includes two examples of
circumstances under which an action would require the preparation of
environmental documents because it might have the potential to
significantly affect the environment. The examples of circumstances
that will cause an action not to qualify for categorical exclusion are:
(1) Actions for which data available establish that, at the expected
level of exposure, there is the potential for serious harm to the
environment (proposed Sec. 25.21(a)); and (2) actions that adversely
affect a species or the critical habitat of a species determined under
the Endangered Species Act or the Convention on International Trade in
Endangered Species of Wild Flora and Fauna to be endangered or
threatened, or wild flora or fauna that are entitled to special
protection under some other Federal law (proposed Sec. 25.21(b)). In
addition, the proposed rule references the CEQ regulations at 40 CFR
1508.27, which provide examples of circumstances in which significant
effects may occur. Extraordinary circumstances may be shown by either
data available to the agency or data available to the applicant or
petitioner and may be based on production, use, or disposal from use.
The two examples of extraordinary circumstances in proposed
Sec. 25.21 reflect Are they really disqualification criteria? If the
criteria are met, the exclusion is warranted. See 25.24(c)(1). Gail
concurs with this.criteria that appear in some of the categorical
exclusions listed in current Sec. 25.24. The language in the first
example, proposed Sec. 25.21(a), is derived from but differs slightly
from current Sec. 25.24 language relating to toxicity (see, e.g.,
Sec. 25.24(a)(10), (b)(2), and (c)(6)). The extraordinary circumstance
example in proposed Sec. 25.21(a) would revise the language in current
Sec. 25.24, ``the substance may be toxic to organisms in the
environment'' to read ``there may be harm to the environment.'' FDA is
revising this language to reflect that possible adverse environmental
effects other than toxicity should be considered. For example, some
biological agents that may be released may not be toxic to indigenous
organisms, but could have lasting effects on ecological community
dynamics.
FDA considers a substance to be toxic if it is harmful to some
biological mechanism or system. Although FDA recognizes that any
substance may produce damage to biological mechanisms or systems under
specific conditions, for the purposes of these regulations, FDA
considers a substance to be toxic if it is harmful to appropriate test
organisms at the expected level of exposure even though it may be
without effect in humans or other organisms at these concentrations,
and may even be used by humans because of its toxic properties.
As a result of the new language in proposed Sec. 25.21(a), the
words ``toxic'' and ``toxic substance'' are no longer used in the
proposed regulation. Therefore, FDA is proposing to remove the
definition of ``toxic substance'' at current Sec. 25.15(b)(6).
Furthermore, FDA no longer believes that the second part of the current
definition relating to toxicity of a substance is appropriate for the
following reasons: (1) Evaluation of the toxicity of a substance based
only on the concentration at the point of entry or point of highest
concentration ignores factors such as instantaneous dispersion that
typically takes place as a result of processes such as river flow and
wind, and that not all substances bioaccumulate. Consideration of such
dilution processes may be reasonable and scientifically sound in
estimating environmental concentrations for certain purposes; and (2)
the use of a factor of 1/100 of the concentration that causes 50-
percent mortality in a test organism to assess the toxicity of a
substance is not appropriate in all cases. The factors used to assess
toxicity should be directly related to the amount of valid ecotoxicity
data available. Although a factor of 1/100 may be appropriate in some
instances, it may be too much or too little in others. In evaluating
whether extraordinary circumstances exist, FDA will take into account
any ecotoxicity data relevant to the issue.
[[Page 14924]]
The second example of extraordinary circumstances relates to
instances in which the proposed action could adversely affect an
endangered or threatened species, or a species entitled to protection
under some other Federal law. FDA intends to closely examine proposed
actions that involve FDA-regulated articles obtained from wild flora
and fauna and will use the extraordinary circumstances provision to
require at least an EA in any instance in which it appears from an
examination of the proposed action that the action may cause a species
to become endangered or threatened.
In addition, the agency notes that the language in proposed
Sec. 25.21(a) includes the indirect effects as well as direct effects
of agency actions. For example, when the agency takes action to
prohibit or restrict the use of an FDA-regulated product, the agency
may consider whether the increased use of substitutes for the
prohibited or restricted product might, at the expected level of
exposure, result in harm to the environment.
FDA is proposing to remove current Sec. 25.25 (Retroactive
environmental consideration), because any request by FDA to an
applicant to submit additional information to an existing FDA approval
will be made under authority granted to FDA by the Federal Food, Drug,
and Cosmetic Act (the act) or the Public Health Service Act (the PHS
Act).
C. Categorical Exclusions
1. General
The proposed rule would increase the number of categorical
exclusions and reorganize the categorical exclusions into the following
five sections in proposed subpart C of part 25: Section 25.30 General;
Sec. 25.31 Human drugs and biologics; Sec. 25.32 Foods, food additives,
and color additives; Sec. 25.33 Animal drugs, and Sec. 25.34 Devices
and electronic products. The agency is also proposing to delete the
general introductory language from current Sec. 25.24 because it is
unnecessary to include this information in the regulation.-
The agency is proposing to retain most of the general categorical
exclusions listed in current Sec. 25.24(a) (proposed Sec. 25.30) and to
make certain revisions described below:
Current Sec. 25.24(a)(4) categorically excludes destruction or
disposition of any FDA-regulated article condemned after seizure,
following detention or recall at agency request, or the distribution or
use of which has been enjoined. In proposed Sec. 25.30(d), FDA is
proposing to revise the criteria for the categorical exclusion from
``if the method of destruction or disposition of the article, including
packaging material, will not result in the release of a toxic substance
into the environment'' to ``if the waste is disposed of in compliance
with all Federal, State, and local requirements.'' The agency is
proposing this revision to reflect current agency practice and because
the previous criterion is covered under paragraph (a) of proposed
Sec. 25.21 Extraordinary circumstances.
The agency is proposing to revise the categorical exclusion for
current good manufacturing practice (CGMP) regulations
(Sec. 25.24(a)(10), proposed Sec. 25.30(j)) to include regulations
based on the hazard analysis critical control points (HACCP)
principles. The HACCP concept is a systematic approach to the
identification, assessment of risk, and control of the biological,
chemical, and physical food safety hazards associated with a particular
food production process. The HACCP system is based upon the
implementation of a control plan developed by a food producer that
analyzes significant food safety hazards, identifies the points in the
production process where a hazard can be prevented, and determines the
preventive measures that are necessary for proper control.
The agency has recently issued regulations (60 FR 65096, December
18, 1995) that use HACCP principles to ensure the safe processing and
importing of seafood. The agency is also considering developing HACCP
regulations for other regulated food industries (59 FR 39888, August 4,
1994). FDA has found that the environmental considerations based on
HACCP principles are essentially identical to the environmental
considerations of regulations based on CGMP's. Neither type of
regulation is likely to have significant environmental impacts.
Therefore, the agency believes that it is appropriate to incorporate
into the categorical exclusion for CGMP regulations an exclusion of the
HACCP regulations.
FDA also is proposing to add a categorical exclusion (proposed
Sec. 25.30(m)) for actions relating to the disposal of the hazardous
laboratory waste materials generated in FDA laboratories (low-level
radioactive waste and chemical waste). Today, all of this hazardous
waste is disposed of under contract with a hazardous waste management
firm.We don't mention what the waste is--even though it is in the
codified part. The contractor is responsible for the collection,
handling, storage, packing, and ultimate disposal of the waste
materials at facilities permitted by the U.S. Environmental Protection
Agency (EPA) and/or facilities licensed by the Nuclear Regulatory
Commission (NRC). In awarding contracts, FDA takes into consideration
whether a prospective contractor has all applicable licenses, permits,
and insurance necessary to perform the work and transport the waste as
required under the contract. The contractor and all disposal facilities
must certify that they are in full compliance with all applicable
Federal, State, and local requirements, before FDA will award the
contract. Further, FDA requires the contractor to present a
comprehensive operational plan. FDA reviews this plan to determine if
the contractor's approach is complete, safe, appropriate, and
responsive to, among other things, FDA's requirements for waste
disposal. Further, the contractor must operate in full compliance with
appropriate regulations issued by EPA (Title 40), the Department of
Transportation (Title 49), the Department of Labor (Title 29), NRC
(Title 10), and with relevant State and local regulations governing the
disposal of hazardous and nonhazardous waste. Therefore, FDA is
proposing in Sec. 25.30(m) to categorically exclude disposal of low-
level radioactive waste materials and chemical waste materials
generated in laboratories serviced by FDA-administered contracts.
2. Human Drugs and Biologics
In the National Performance Report, ``Reinventing Drug and Medical
Device Regulations,'' April 1995, the President announced FDA's
proposal to reduce the number of EA's submitted by industry under NEPA
by increasing the number of categorical exclusions for those actions
relating to drugs and biologics that, as a class, have no individual or
cumulative significant effect on the environment. As described below,
in fulfillment of this commitment, FDA is proposing additional
categorical exclusions for classes of actions on drugs and biologic
products that, based on experience in reviewing these types of actions,
the Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER) have concluded do not have
significant effects on the human environment. All of the environmental
reviews of these categories of actions performed under the current
regulations have resulted in FONSI's.
The proposed new categorical exclusions in Sec. 25.31(a) and (b)
apply to actions on an NDA, abbreviated application or a supplement to
such
[[Page 14925]]
applications, or action on an over-the-counter (OTC) monograph. They
are divided into two sections: (1) Proposed Sec. 25.31(a), which
applies if FDA's action does not increase the use and disposal of the
drug; and (2) proposed Sec. 25.31(b), which applies if FDA's action
does increase the use and disposal of the drug. This is similar to the
distinction drawn in the existing regulations between actions that
increase use and actions that do not. Proposed Sec. 25.31(a) and (b)
use the term ``active moiety'' rather than substance, drug product, or
other terminology to clarify the exact focus of the environmental
review.
The categorical exclusion in proposed Sec. 25.31(a) is based on the
categorical exclusions in current Sec. 25.24(c)(1) and (c)(2) and the
fact that, if the action does not increase the use of a drug, there is
no change in the level of the substance in the environment. FDA has
defined ``increased use'' of a drug to include those circumstances
currently listed in Sec. 25.24(c)(1) and (c)(2). Because the
environmental effects, if any, associated with the use and disposal of
the drug were incurred when it was first approved, actions to approve
additional products may be categorically excluded if they do not
increase the use of the drug. Among the actions covered under this
categorical exclusion may be approvals of new dosage forms, prodrugs,
generic drug products, and manufacturing supplements that may change
the method or site of manufacture of a drug but not its use.
Actions under proposed Sec. 25.31(b) that may increase the use or
disposal of a drug product may be categorically excluded if the
concentration of the substance in the environment will be below 1 part
per billion (ppb), the level that FDA has found, based on past
experience, will not significantly affect the aquatic environment. This
reflects a change from current regulations that require an
environmental assessment in any case in which an action may increase
the use of a drug. The basis for this change is described below.
CDER performed a retrospective review of available toxicity
information from EA's that were previously submitted in support of
NDA's and NDA supplements. This information, which includes data from
each review division that are representative of pharmacological drug
classifications, has routinely demonstrated that there are no
significant observed effects on relevant standard test organisms in the
aquatic environment at concentrations below 1 ppb.
Based on the method of entry into the environment from use and
their physical and chemical characteristics (e.g., water solubility),
human drugs would be expected predominantly to enter the aquatic
environment, and the data submitted in EA's reviewed by CDER have
routinely supported this hypothesis. Human drugs and their metabolites
enter the environment from use by excretion from patients. The majority
of hospitals, clinics, and homes in the United States are serviced by a
wastewater treatment facility where compounds are subjected to some
form of aerobic and anaerobic decomposition. Drug and/or metabolites
that are not degraded in the wastewater treatment facility may be
discharged into surface water or removed from the wastewater treatment
plant in sludge.
The data also have routinely shown that in those cases in which an
applicant has provided toxicity results for terrestrial organisms in
addition to acute toxicity results for aquatic organisms, the drugs are
toxic to aquatic organisms at lower levels than they are to terrestrial
organisms, suggesting that the use of aquatic organisms is a
conservative approach.
CDER evaluates the potential for significant environmental effects
by relating the concentrations determined to have toxic effects on
relevant standard test organisms to the level of the substance expected
in the environment. CDER's retrospective review shows that drugs at
concentrations less than 1 ppb in the aquatic environment have no
significant effect on relevant standard test organisms and, therefore,
are unlikely to have a significant effect on the environment. The vast
majority of actions taken by CDER result in the substance being in the
aquatic environment at concentrations less than 1 ppb because the
majority of drugs are produced and used at low levels, and the use of
drugs is not typically localized but rather is spread throughout the
United States.
One of the criteria for determining that a drug is safe for human
use is consideration of its potential to bioaccumulate. The vast
majority of drugs do not have the physical or chemical characteristics
that would allow them to bioaccumulate in tissue because this would
raise safety concerns for use in humans. If a drug does have the
physical or chemical characteristics that would allow it to
bioaccumulate, there has to be a mechanism for the human body to
metabolize the compound to a substance that has lower bioaccumulation
potential so that it is cleared from the body. In the environmental
assessments that CDER reviewed, bioaccumulation has not been an issue.
Thus, FDA has determined that actions that may increase the use or
disposal of a drug should be categorically excluded if the
concentration of the substance in the environment from use will be less
than 1 ppb and no extraordinary circumstances exist. For example, even
under conditions in which an action would increase the use of a drug,
such as an efficacy supplement adding a new indication, the proposed
action may be categorically excluded under this proposal if the
substance in the environment will be below 1 ppb. CDER has provided
guidance on appropriate calculations for estimating environmental
concentrations (Guidance for Industry for the Submission of an
Environmental Assessment in Human Drug Applications and Supplements,
November 1995).
CDER will continue to critically review the environmental toxicity
information submitted for those actions requiring an EA. As additional
data become available to CDER, the agency may propose to modify the 1
ppb environmental concentration cut-off through notice and comment
rulemaking.
Proposed Sec. 25.31(a) and (b) include actions on NDA's. Under the
current regulations (Sec. 25.24(c)(1) and (c)(2)), abbreviated new drug
applications (ANDA's) and supplements may be categorically excluded,
but NDA's for the same type of action may not. Sometimes an applicant
has a choice whether to submit a proposed action as an NDA or ANDA
(e.g., a new dosage form may be submitted as an ANDA with a suitability
petition or as an NDA). Thus, the applicant's choice of submission
would determine whether an EA would need to be submitted. Proposed
Sec. 25.31(a) and (b) would permit FDA to treat NDA's, abbreviated
applications, and supplements alike based on the type of action being
affected by the application.
Current Sec. 25.24(c)(6) categorically excludes actions on OTC
monographs if the product is already marketed for the proposed use. FDA
is proposing to add OTC monographs to proposed Sec. 25.31(a) and (b)
because, by action on an OTC monograph, FDA permits the manufacture and
marketing of OTC drugs that meet the monograph. It should be noted that
actions to switch drugs from prescription to OTC use that are submitted
in an NDA or supplement would also be covered under these provisions.
Proposed Sec. 25.31(a) and (b) would also delete any reference to
``actions on amendments'' to clarify that the agency
[[Page 14926]]
does not take actions on amendments. Amendments are merely changes to a
pending application that are incorporated into the application. The
action the agency takes is on the application as a whole, not on the
amendment.
Proposed Sec. 25.31(a) and (b) applies to drugs regulated by CDER.
FDA is proposing a new categorical exclusion in Sec. 25.31(c) for
substances that occur naturally in the environment, that would apply to
both drugs and biologics. Proposed Sec. 25.31(b) would apply to actions
on an NDA, abbreviated application, application for marketing approval
of a biologic product, a supplement to such applications, or action on
an OTC monograph when the action is not expected to alter significantly
the concentration or distribution of the substance, its metabolites, or
degradation products in the environment. Under the current regulations,
FDA requires an abbreviated EA for a drug that occurs naturally in the
environment. These abbreviated EA's require information about the
production site and about whether the use of the product will
significantly alter the concentration, distribution, and effect of the
natural substance in the environment.
Since the publication of the NEPA regulations in 1985, FDA has
reviewed abbreviated EA's for substances that are naturally occurring.
FDA has found that actions on submissions for these substances will not
affect the environment if the action will not significantly alter the
concentration or distribution of the natural substance in the
environment. Under these circumstances, the agency has prepared
FONSI's. Both CDER and CBER routinely include in safety evaluations
evidence that a product and/or living system used to produce the
product are inactivated following production and prior to release into
the environment, if there is a reasonable possibility that the product
or living system may be harmful to the environment. Therefore, there
are not likely to be any environmental effects. The proposed
regulations would categorically exclude an action for a substance that
occurs naturally in the environment when the action will not alter
significantly the concentration or distribution of the substance in the
environment. FDA has access to information regarding metabolites and
degradation products to aid in determining if the categorical exclusion
request is appropriate.
When an action does alter significantly the concentration or
distribution of a naturally occurring substance, its metabolites, or
degradation products in the environment, e.g., when the use and
disposal will occur in a geographic area where the substance is not
naturally occurring, an EA may be required.
FDA is proposing in Sec. 25.31(d) to expand the categorical
exclusion provision for the withdrawal of approval of an NDA or
abbreviated application. The agency is proposing that all types of
withdrawals of approval, whether requested by industry or initiated by
the agency, be categorically excluded because, based on CDER's
experience, these types of actions will not result in the production or
distribution of any substances and, therefore, will not result in the
introduction of any substance into the environment.There would be no
increase in use of substitutes? See line 21 on page 38 (of 1/26 draft).
EIS considered increase of hydrocarbon propellants in anti-perspirant
aerosols.
Proposed Sec. 25.31(e) would revise the categorical exclusions for
actions on an IND. Current Sec. 25.24(c)(4) categorically excludes
actions on IND's if the drug shipped under such notice is intended to
be used for clinical studies or research in which waste will be
controlled or the amount of waste expected to enter the environment may
reasonably be expected to be nontoxic. Under proposed Sec. 25.31(e),
FDA would categorically exclude all IND's. In many cases, FDA's actions
on IND's do not significantly increase the use of the drug or the
amount of drug introduced into the environment because the drug is
being tested in few patients or is already being marketed for another
use. Therefore, no changes in environmental effects will occur. In
those cases in which an increase in the use of the drug may occur as a
result of an investigation under an IND, CDER's experience in reviewing
actions on IND's indicates that significant environmental effects will
not occur because the use of such drugs is limited and controlled.
The agency is proposing to delete the language ``if the drug
shipped * * * may reasonably be expected to be nontoxic'' because an
action that results in waste that is expected to be toxic would require
an EA under proposed Sec. 25.21 Extraordinary circumstances.Is that
what 25.21(a) means--that if waste is toxic, there may be harm and an
EA will be required?
Proposed Sec. 25.31(g) would add a categorical exclusion for the
testing and release by CBER of lots or batches of a licensed biologic
product. The effects on the environment of licensed biologic products
are evaluated during the safety evaluation and approval of the license
application. Therefore, conducting a separate NEPA review for the
testing and release by CBER of individual lots or batches is
unnecessary.
Proposed Sec. 25.31(i) would permit a categorical exclusion for the
establishment of a comparability determination for a biologic product
subject to licensing. Establishment of a comparability determination
does not result in introduction of a substance into the environment. A
substance will be introduced into the environment only when CBER has
made a comparability determination and subsequently approves a license
application for a specific biologic product. The environmental
considerations will be made in connection with the review of individual
license applications that meet the comparability criteria.
Proposed Sec. 25.31(j) incorporates current Sec. 25.24(c)(10), the
categorical exclusion for promulgation, amendment, or revocation of a
standard for a licensed biologic product, and would eliminate the
current requirement that there be no increased use of the product. The
standards normally explain how the product is to be manufactured and
any additional requirements for approval and marketing. Therefore, the
increased use criterion is unnecessary.
Proposed Sec. 25.31(k), regarding revocation of a biologic product,
would eliminate the current criteria in Sec. 25.24(c)(9) that the
biological product ``is no longer being marketed'' or that the action
is ``at the request of the license holder. The agency is proposing to
delete these criteria as unnecessary because revocation of a license
for a biologic product means that the product can no longer be
marketed. Marketing of the product after license revocation must cease
regardless of whether the revocation was at the request of the license
holder or initiated by the agency. Revocation of a license for a
biologic product under any circumstances will not result in the
introduction of any substance into the environment and, therefore, will
not significantly affect the environment.
The agency is also proposing other minor, nonsubstantive amendments
to delete unnecessary language, improve the accuracy and clarity of the
categorical exclusions, and reflect current terminology.
3. Foods, Food Additives, and Color Additives
In the President's National Performance Report, ``Reinventing Food
Regulations,'' January 1996, the President announced that FDA proposed
to reduce the number of EA's
[[Page 14927]]
submitted by industry under NEPA by increasing the number of
categorical exclusions for food and color additives and generally
recognized as safe (GRAS) substances based on little or no impact on
the environment from the use and disposal of these products. As
described below, in fulfillment of this commitment, FDA is proposing
additional categorical exclusions for actions on foods, food additives,
color additives, and GRAS substances which, based on experience in
reviewing these types of actions, the Center for Food Safety and
Applied Nutrition (CFSAN) has concluded will not significantly affect
the human environment.
As was explained previously, FDA is proposing to remove criteria
from certain exclusions in current Sec. 25.24. For actions involving
foods, food additives, color additives, and GRAS substances, the
criteria for the exclusions in current Sec. 25.24(a)(10), (b)(2),
(b)(3), (b)(7), (b)(8), and (b)(9) have been removed. These exclusions
can be located in proposed Secs. 25.30(j), and 25.32(b), (c), (f), (g),
and (h). This change is being made because the provisions in proposed
Sec. 25.21 Extraordinary circumstances could apply to any of the
agency's exclusions, making certain criteria for individual exclusions
unnecessary.
In addition, to reflect current FDA policy, the agency is removing
from part 25 the environmental review requirements for the
establishment of action levels for unavoidable poisonous or deleterious
substances in food or food packaging, and for natural or unavoidable
defects in food that present no health hazard. This change is discussed
below.
For the classes of actions proposed for categorical exclusion in
Sec. 25.32(i), (j), (k), (l), (o), (q), and (r), FDA has traditionally
required certain information to assess the potential environmental
impact of the production of the food additive, color additive, or GRAS
substance. In all cases, FDA has found in its reviews that the
production of these substances did not significantly affect the
environment. The agency has determined that FDA ordinarily will not
consider potential impacts at sites of production of FDA-regulated
products, as discussed in section III.D of this document.
a. Proposed Sec. 25.32(f). Currently, FDA's NEPA procedures in
Sec. 25.24(b)(7) provide for a categorical exclusion for actions
relating to the affirmation of a food substance as GRAS if the
substance is already marketed for the use for which affirmation is
sought. FDA is proposing to expand this categorical exclusion in
proposed Sec. 25.32(f) to include actions to establish and amend
regulations under part 181 (21 CFR part 181) for prior-sanctioned
ingredients that are already marketed in the United States. Actions
involving prior-sanctioned ingredients are similar to certain GRAS
affirmation actions in that the food substance is likely to be already
marketed in the United States for the proposed use at the time the
action is being considered and will continue to be marketed after the
regulation is published. As defined in Sec. 170.3(l) (21 CFR 170.3(l))
and Sec. 181.5(a), a prior sanction shall exist only for a specific use
of a substance for which there was explicit approval by FDA or the U.S.
Department of Agriculture (USDA) before September 6, 1958. Actions to
affirm substances as GRAS or prior-sanctioned for the specific uses for
which they were already marketed in the United States create little or
no change in the introduction of the substance into the environment.
Therefore, such actions have no significant effect on the environment.
b. Proposed Sec. 25.32(i). FDA is proposing to amend its NEPA
procedures to categorically exclude from the requirement to prepare an
EA actions to approve a food additive petition or grant a request for
exemption from regulation as a food additive under Sec. 170.39 (21 CFR
170.39) (threshold of regulation) when a food additive is a functional
component of finished food-packaging materials present at not greater
than 5 percent-by-weight. FDA based this proposed exclusion on its
review of 95 petitions for food additives in this class, all of which
resulted in FONSI's, and on the evaluation of the potential for future
petitions in this class to have significant environmental effects. FDA
has had limited experience in considering the environmental impact of
threshold of regulation submissions because the regulations
establishing a threshold of regulation policy were recently issued (60
FR 36582, July 17, 1995). However, because the information currently
required for such submissions is identical to the information required
for the food-packaging class of indirect food additives discussed in
this section, the agency believes that its experience with the 95 food
additive petitions is relevant to these threshold of regulation
submissions and that these submissions also warrant a categorical
exclusion.
The agency's evaluation of functional components of food-packaging
materials present at not greater than 5 percent-by-weight has
traditionally included consideration of potential impacts relating to
the disposal of food-packaging materials containing the additive and
the use of natural resources and energy.
To determine the potential for significant introductions of
substances into the environment at the site of disposal of food-
packaging materials, i.e., municipal solid waste landfill or combustion
sites, the agency currently requires an estimate of the maximum yearly
market volume for the proposed use of the food additive and the percent
of that amount that will become a component of the finished food-
packaging material. To determine the potential for significant
introductions at landfill sites, FDA estimated the concentration of the
additive that could be present in landfill leachate for each of the 95
petitions it reviewed for additives used as functional components of
food-packaging materials. FDA found that in virtually all cases, the
concentration of the additives in landfill leachate was less than 50
ppb. The concentration of the additives in surface or ground water
receiving landfill leachate was expected to be substantially less,
taking into consideration the mobility and degradation of the additives
in landfills and their dilution in receiving waters.
Consequently, FDA determined in all cases that these extremely low
levels would not have significant environmental impacts at landfill
sites. The agency believes that approvals of future petitions in this
class are even less likely to result in significant introductions of
substances at landfill sites because EPA published new landfill
regulations in the Federal Register of October 9, 1991 (56 FR 50978),
that require new and expanded landfills to have leachate collection
systems and liners to prevent leachate from entering surface or
groundwater. Although operators of existing landfills are not required
to retrofit liner systems, they are required to monitor groundwater
adjacent to existing landfills and to take corrective action as
appropriate.
The agency's evaluation of petitions for additives used as
functional components of food-packaging materials has also shown that
there is little potential for significant introductions from the
combustion of packaging materials containing the additives. These types
of additives are used at low levels in the packaging materials, <5
percent by weight, and, therefore, the additional amounts of combustion
products emitted were found to be insignificant compared to the levels
already being generated during municipal solid waste combustion.
Because FDA's experience shows that the use levels for additives used
as
[[Page 14928]]
functional components of food-packaging materials are low, the agency
believes that future approvals will also result in insignificant
introductions into the environment at municipal solid waste combustor
sites.
Under current part 25, FDA requires no documentation to assess
potential impact on energy and resource use if the proposed additive is
intended for the same use as another additive already in use and will
not materially change the potential uses of the packaging materials to
which it is added. The agency has required sponsors to provide
information in an abbreviated EA showing that these criteria are met.
Based on FDA's experience in reviewing petitions for functional
components of food-packaging materials, the agency has found that
petitioners generally were able to demonstrate that a proposed additive
would compete with and replace other, already regulated additives and
that approval would not change the uses of the packaging materials to
which they were added. In cases where a proposed additive did not
compete with and replace an already regulated additive, the agency was
still able to conclude that there would not be a significant impact on
energy and natural resource use largely because use of the additive in
food-contact articles represented a very small fraction of total usage.
Thus, based on the low levels of use of these functional components
of food-packaging materials and on FDA's experience reviewing
abbreviated EA's for these functional components, the agency believes
that approvals of future submissions for such additives are highly
unlikely to have significant effects on the environment. Therefore,
under proposed Sec. 25.32(i) a requestor need not ordinarily submit an
EA.
c. Proposed Sec. 25.32(j). FDA is proposing to categorically
exclude actions to approve a food additive and to grant a request for
exemption from regulation as a food additive under Sec. 170.39 when the
additive is a component of food-contact surfaces of permanent or
semipermanent equipment or of other food-contact articles intended for
repeated use (proposed Sec. 25.32(j)). This proposed exclusion is based
on FDA's experience with 43 petitions for additives used as components
of repeat-use food-contact articles, all of which resulted in a FONSI.
FDA has had limited experience in considering the environmental impact
of threshold of regulation submissions for components of repeat-use,
food-contact articles because the regulations establishing a threshold
of regulation policy were recently issued. However, because the
information currently required for such submissions is identical to the
information required for food additive petitions for these types of
indirect food additives used in repeat-use, food-contact articles, the
agency believes that its experience with the 43 food additive petitions
is relevant to these threshold of regulation submissions and that
approval of these submissions warrants a categorical exclusion.
In reviewing the petitions for components of repeat-use, food-
contact articles, the agency's evaluation of environmental impact has
traditionally included consideration of potential impacts relating to
the disposal of the food-contact articles containing the additive. To
determine the potential for significant introductions of substances
into the environment at the sites of disposal of food additives that
are used as components of the food-contact surfaces of permanent or
semipermanent equipment, or of other repeat-use articles, the agency
currently requires an estimate of the maximum yearly market volume for
the proposed use of the additive. In reviewing abbreviated EA's for
these additives, FDA found that these additives ordinarily have limited
potential for causing significant environmental effects as a result of
their use and disposal. The potential for significant introductions of
substances to the environment due to disposal is, in fact, very low
because of the long service life of the food-contact equipment or other
repeat-use articles, of which additives in this class are components,
and the limited market volumes of the additives as estimated by the
petitioners. Because its actions on these petitions and requests will
not significantly affect the environment, FDA will not ordinarily
require the preparation of an EA.
d. Proposed Sec. 25.32(k). FDA is proposing to categorically
exclude actions to approve food additive, color additive, and GRAS
affirmation petitions for substances added directly to food that are
intended to remain in food through ingestion by consumers and that are
not intended to replace macronutrients in food. This proposed exclusion
is based on FDA's experience reviewing 21 petitions in this class, all
of which resulted in a FONSI. Examples of the types of additives and
GRAS substances that belong to this class are the color additives added
to foods listed in 21 CFR parts 73 and 74, most of the direct food
additives listed in part 172 (21 CFR part 172), and certain GRAS
substances listed in part 184 (21 CFR part 184). Examples of substances
that are not included in the class for which this categorical exclusion
is being proposed are the substances intended to replace macronutrients
in food (such as sweetening agents intended to replace sugar, e.g., see
Secs. 172.800 and 172.804, and fat substitutes, e.g., Sec. 184.1498).
The agency's evaluation of the environmental effects of substances
added directly to food has included consideration of the potential for
impacts from the disposal of human waste products containing the
petitioned substance and/or its products of digestion and metabolism,
and from the use of natural resources and energy.
The substances added directly to food considered here will be
ingested by consumers as components of food containing these
substances. After ingestion, these substances are either digested and/
or metabolized to other substances or excreted largely intact. In all
cases, the agency's review of past actions on substances added directly
to food resulted in decisions to issue FONSI's. To address the
potential for environmental impacts from disposal of this class of
substances, the agency's FONSI's relied on one or more of the following
scenarios: (1) The agency's approval of the petition resulted in very
low levels (in the low ppb range or lower) of the substances in either
effluents and/or sewage sludge from publicly owned wastewater treatment
plants and these levels were determined not to be toxic to organisms in
the environment; (2) the petitioned substance was digested and/or
metabolized bypara.humans such that only products of digestion and
metabolism were expected to be excreted and these products were the
same as (or very similar to) the products of digestion and metabolism
resulting from human food; such products should have no potential for
significant environmental effects because wastewater treatment
facilities are already designed to handle them; or (3) the petitioned
substance was excreted largely intact but was rapidly degraded into
nontoxic products either in wastewater treatment plants or in the
environment.
FDA's experience shows that substances added directly to food and
intended to remain with food through ingestion that are the subject of
new petitions will have use and disposal patterns similar to those
described above and will not be toxic to organisms in the environment
at the expected levels of exposure. Thus, use and disposal of such
substances are not expected to result in significant environmental
effects.
The agency has also found, as a result of its review of petitions
for substances in the class being considered here, that
[[Page 14929]]
in no case was there potential for significant impacts on energy and
natural resources. These findings relied on one or more of the
following scenarios: (1) The substances were expected to compete with
and replace other already regulated substances with no significant
change in the overall use of natural resources or energy, (2) the
substances are also used in nonfood contact situations and the food-
contact usage represented a small increase in the overall production
and usage of the substance such that the small increase in the uses of
natural resources and energy was not significant, or (3) the predicted
market volumes for the petitioned substances were very small so that
the use of natural resources and energy for the petitioned substances
was very limited. In no case did the agency find that there would be
any effects on threatened or endangered species. Because the use and
disposal of substances added directly to foods and intended to remain
with foods through ingestion has no significant effect on the
environment and has very limited potential for significant effects on
energy and natural resources, EA's for these substances will not
ordinarily be required.
e. Proposed Sec. 25.32(l). FDA is proposing to categorically
exclude actions to approve color additives used in contact lenses,
sutures, polymethylmethacrylate filaments used in supporting haptics
for intraocular lenses, bone cement, and in other FDA-regulated
products that involve similar low levels of use. The agency reviewed
EA's for 20 color additive petitions for these types of uses and found
that all proposed uses involve small amounts of color additives.
Because of the nature of these uses, the highest annual market volume
encountered for any of these color additives was 12 kilograms (kg),
while most of the petitioned uses involved considerably less than 5 kg.
Consequently, the environmental introduction levels of the color
additives from manufacture, use, and disposal would be exceedingly
small. FDA's experience shows that petitions for color additives in
these types of applications will have very low market volumes such that
only extremely low levels of substances will be introduced into the
environment and will not cause significant environmental effects.
Therefore, FDA is proposing to categorically exclude actions on such
petitions from the requirement to prepare an EA.
f. Proposed Sec. 25.32(m). FDA is proposing to categorically
exclude actions to prohibit or otherwise restrict or reduce the use of
a substance in food, food packaging, or cosmetics, e.g., the withdrawal
of approval for the use of a food or color additive, removal of the use
of a substance from a GRAS list (21 CFR parts 182, 184, and 186), or
prohibition of the use of a prior-sanctioned substance (defined under
Secs. 170.3(l) and 181.5(a)). The agency has prepared EA's for 12
actions to withdraw approval for the use of a food or color additive or
to prohibit the use of a substance in food. The agency has prepared
only one EIS for the withdrawal of approval of a food additive. In
1978, the agency prepared an EIS for its action to prohibit the use of
certain chlorofluorocarbons in food, food additive, drug, animal food,
animal drug, cosmetic, and medical device products as propellants in
self-pressurized containers (43 FR 11301, March 17, 1978). The
specified chlorofluorocarbons were prohibited because their continued
use was predicted to result in the depletion of the stratospheric ozone
layer. FDA prepared the EIS as part of an interagency effort to address
this problem. CEQ determined that an EIS was necessary for this
particular action because of the controversy surrounding the scientific
issues associated with the potential effects of these chemicals on
stratospheric ozone. The agency considers its action on
chlorofluorocarbons to be an exception. It is the only action of this
type that involved potentially significant effects on the environment.
The effect of withdrawing approval or prohibiting the use of a
substance is to reduce or eliminate environmental exposure to that
substance. Thus, no potential exists for direct adverse environmental
effects from the agency's prohibition of the use of a substance. It may
sometimes be necessary, however, to consider the potential indirect
environmental effects that would result from increased use of
substitutes for the prohibited substance. Since the agency began
considering the environmental impact of its actions under NEPA, it has
not found that significant adverse environmental effects would result
from the increased use of a substitute for a food or color additive or
other food substance that was being restricted. In the agency's
evaluation of past actions in this class, the agency has found that
there are frequently a number of substitutes for the prohibited
substance. Thus, the increase in production, use, or disposal of
substitutes is spread among a number of substances. Further,
environmental exposure to any one substitute is minimal. In some cases,
the agency has found that substitutes have been previously subjected to
environmental review under NEPA by the agency, and that this review
encompassed the use of the substitute as a replacement for the
prohibited substance and resulted in an EA and FONSI being prepared.
Any new food or color additive that may be developed to replace a
prohibited one would undergo environmental review during the premarket
approval process.
g. Proposed Sec. 25.32(n). FDA is proposing to categorically
exclude actions to issue, amend, or revoke regulations pertaining to
infant formulas. FDA is proposing to exclude actions on infant formulas
because they have little or no potential for adverse environmental
effects. The preparation, distribution, and directions for use of
infant formulas are carefully controlled by regulations in 21 CFR parts
106 and 107 and, along with other foods, by the CGMP regulations in 21
CFR part 110. In addition, the nature of this product, a food designed
for infants, means that the product itself is very unlikely to cause
adverse environmental impacts. Infant formulas are expected to be used
and disposed of in a manner similar to other human food, but infant
formulas form only a small fraction of the total human food supply
since they are used only in the first year or 2 of human life.
Therefore, it is unlikely that future actions on infant formulas will
have potential for significant environmental effects, and thus, FDA is
proposing to exclude them from the requirement to prepare an EA.
h. Proposed Sec. 25.32(o). FDA is proposing to exclude actions to
approve a food additive petition when an additive is the intended
expression product(s) present in food derived from new plant varieties.
The proposed exclusion is based on our determination that the USDA
Animal and Plant Health Inspection Service (APHIS) has lead
responsibility, under the Federal Plant Pest Act (7 U.S.C. 150aa et
seq.), to prevent the movement and dissemination in the United States
of plant pests. Under that authority, USDA APHIS addresses the
potential of new plant varieties to pose a plant pest risk in
accordance with the requirements mandated under NEPA. USDA considers
the potential for risk in a very broad context, so that not only is
direct disease or damage to plants and plant materials considered as a
component of plant pest risk, but indirect effects on beneficial or
other organisms in the agronomic context are also addressed. Before
issuing a determination of nonregulated status for an organism that has
been subject to USDA oversight because it was considered to present a
[[Page 14930]]
potential risk of being a plant pest, USDA conducts an environmental
analysis in compliance with its NEPA requirements that addresses plant
pest risk characteristics, disease and pest susceptibilities,
expression of any introduced gene products and effects thereof, new
enzymes, or changes to plant metabolism, weediness of the plant, impact
on the weediness of any other plant with which it can interbreed,
agricultural or cultivation practices, effects of the plant on
nontarget organisms, indirect plant pest effects on other agricultural
products, transfer of genetic information to organisms with which it
cannot interbreed, and any other information believed to be relevant to
a determination. The issues considered by FDA are the same or a subset
of the issues that USDA addresses as part of its NEPA review.
Therefore, a NEPA review by FDA would be redundant.
i. Proposed Sec. 25.32(p). FDA is proposing to categorically
exclude actions under part 101 (21 CFR part 101) to issue, amend, or
revoke a regulation in response to a reference amount petition
(Sec. 101.12(h)), a nutrient content claim petition (Sec. 101.69), a
health claim petition (Sec. 101.70), or a petition pertaining to the
label declaration of ingredients (Sec. 101.103). The agency has
regulations pertaining to various aspects of food labeling in part 101.
These regulations include provisions that enable interested persons to
petition the agency to issue regulations on several subjects related to
labeling, listed above. These petitions must include, under current
regulations, either a claim for categorical exclusion under current
Sec. 25.24 or an EA under current Sec. 25.31.
Current Sec. 25.24(a)(11) contains an exclusion for the
establishment or repeal by regulation of labeling requirements for
marketing articles, ``if there will be no increase in the existing
levels of use or change in the intended uses of the product or its
substitutes.`` The criteria are intended to ensure that the excluded
labeling actions will not cause significant environmental effects. This
exclusion can be used with petitions of the type listed above, if
petitioners demonstrate that the criteria are met. For those actions
that would not qualify for exclusion under current Sec. 25.24(a)(11)
because there will be an increase in the use of the product, FDA now
believes that this increased use will not have significant
environmental effects. Thus, the agency has determined that a specific
unqualified categorical exclusion for petitions related to food
labeling is appropriate.
When changes in the labeling on food products are allowed, there is
a potential for changes in the levels of use, and in the intended uses,
of such products or their substitutes. In fact, nutrient content claims
and health claims are generally intended to increase the use of the
labeled product. However, the changes that will result from FDA's
actions on the types of petitions listed above will be modifications of
the purchasing and consumption habits of consumers. A food labeled in
the newly allowed manner will be purchased and consumed instead of
another food that, for a variety of reasons, will not be labeled in
this new manner. The net result will be the substitution of one food
for a similar food. Thus, no significant adverse effects on the
environment will result. Therefore, the agency is proposing that its
future actions on petitions for the issuance, amendment, or revocation
of regulations on reference amounts customarily consumed per eating
occasion (Sec. 101.12(h)), on nutrient content claims (Sec. 101.69), on
health claims (Sec. 101.70), and on the label declaration of
ingredients (Sec. 101.103) be categorically excluded from the
preparation of an environmental assessment.
j. Proposed Sec. 25.32(q). FDA is proposing in Sec. 25.32(q) to
categorically exclude from the requirement to submit an EA actions to
approve food additive petitions for substances registered by EPA under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7
U.S.C. 136 et seq.) for the same use requested in the petition. FDA has
had limited experience in considering the environmental impact of
threshold of regulation submissions for substances registered by EPA
under FIFRA because the regulations establishing threshold of
regulation policy were recently issued. However, because the
information currently required for such submissions is identical to the
information required for food additive petitions for these types of
substances, the agency believes that its experience with food additive
petitions is revelant. This proposed exclusion is based on FDA's
experience reviewing 12 petitions in this class, all of which resulted
in a FONSI. All of these petitions were for antimicrobial substances
used either in the processing of food or in food-packaging materials.
FDA's evaluation of the potential environmental effects of
antimicrobial substances has included consideration of potential
impacts at the site of use and disposal of the antimicrobial substance,
and from the use of natural resources and energy. Currently, for the
use sites of antimicrobial substances, petitioners are directed to rely
on information in studies submitted to EPA for registration of the
product under FIFRA, and to describe any potential adverse
environmental effects determined by EPA. Petitioners may submit a brief
description and summary of results of EPA studies in lieu of the
complete test reports. For use sites, FDA has based its environmental
decision on a prediction of exposure levels, using introduction and
fate information, that is compared with relevant toxicological data to
determine the potential for significant environmental effects.
The agency's experience with antimicrobial petitions has been that,
before an antimicrobial product can be used in food-contact situations,
EPA will have already examined the environmental risks and benefits of
registering the product under FIFRA. The parallel between EPA's review
and FDA's environmental review is illustrated by FDA's finding that it
has not had to require environmental testing for antimicrobial products
because such tests were already conducted as part of EPA's review. In
addition, antimicrobial substances that are used and discharged at
point sources within the United States are subject to the requirements
of National Pollution Discharge Elimination System (NPDES) permits
under the Clean Water Act (33 U.S.C. 1251 et seq.). In registering a
product under FIFRA, EPA requires the label to state that: (1) The
product is not to be discharged into lakes, streams, ponds, estuaries,
oceans, or other waters unless in accordance with the requirements of
an NPDES permit and unless the permitting authority has been notified
in writing prior to discharge; and (2) the product is not to be
discharged to sewer systems without previously notifying the local
sewage treatment plant authority. EPA also requires, if necessary, that
labels contain information such as a warning of toxicity to fish and/or
wildlife, as specified in 40 CFR 156.10(h)(2)(ii). Thus, FDA has found
that its assessment of the fate and effects of antimicrobial substances
essentially duplicates the review by EPA under FIFRA and, to some
extent, the review by NPDES permitting authorities under the Clean
Water Act.
Currently, petitioners must address the potential for impact on the
use of natural resources and energy as required in an EA by specifying
the natural resources and energy required to produce, transport, use,
and/or dispose of a given amount of the product that is the subject of
the action. FDA's experience with this area of potential impacts is
that these types of substances almost always compete with and replace
other similar substances so that there is
[[Page 14931]]
little or no change in the use of natural resources and energy. Thus,
FDA believes that future food additive petitions for the same use as
pesticides approved by EPA under FIFRA will have little or no potential
for significant environmental impacts and that FDA's actions on these
petitions warrant exclusion from the requirement to prepare an EA.
k. Removal of action levels. At the time the current environmental
regulations were issued, the agency believed that the establishment of
an action level required environmental review. Thus, the agency
included a paragraph for the establishment of action levels in current
Sec. 25.22(a)(11) and specified an EA format in current Sec. 25.31d.
FDA also provided a categorical exclusion in current Sec. 25.24(b)(6)
for action levels for natural or unavoidable defects in food for humans
or animals if these defects presented no health hazard.
In 1987, in a limited holding, the Court of Appeals for the D.C.
Circuit in Community Nutrition Institute v. Young, 818 F.2d 943 (D.C.
Cir. 1987), found that FDA was treating its action levels as
substantive, legislative rules and, thus, action levels were subject to
the notice-and-comment requirements of the Administrative Procedure Act
(5 U.S.C. 551 et seq.). The court recognized, however, that FDA could
proceed by action levels that are not binding rules. Since the court's
holding, FDA has followed this approach. Under its statutory authority
under 21 U.S.C. 342(a)(1), (a)(2)(A), and 346 to limit the amount of
poisonous or deleterious substances in food, FDA establishes ``action
levels'' to inform food producers of the level of contaminants in food
that may result in regulatory action. Action levels are not intended to
bind the public, or FDA, or to create or confer any rights, privileges,
immunities, or benefits on or for any private person, but are intended
merely for internal FDA guidance for deciding whether to bring an
enforcement action. The establishment of an action level is not agency
action and is not subject to NEPA.
Moreover, under CEQ regulations (40 CFR 1508.18(a)), bringing
judicial, administrative, civil, or criminal enforcement actions is not
major Federal action. Because establishment of action levels is
intended merely for internal guidance for deciding whether to bring an
enforcement action, establishment of an action level is not major
Federal action.
Therefore, FDA is proposing to remove all references to action
levels from part 25. The agency will continue to apply these
regulations to the establishment of tolerances for poisonous or
deleterious substances in food for human or animal consumption or in
packaging materials intended for use with human food and animal feeds.
l. Proposed Sec. 25.32(r). FDA is proposing to categorically
exclude actions to approve a food additive, a color additive, or a GRAS
affirmation petition for a substance that occurs naturally in the
environment, when the action is not expected to alter significantly the
concentration or distribution of the substance, its metabolites, or
degradation products. This proposed exclusion is based on FDA's review
of 19 petitions for substances in this class, all of which resulted in
a finding of no significant impact.
The agency currently requires limited information for substances
that occur naturally in the environment, as specified in the
abbreviated EA format in current Sec. 25.31a(b)(5). This format focuses
on whether the use of the substance can reasonably be expected, on the
basis of all available evidence, to alter significantly the
concentration and distribution of the substance, its metabolites, or
degradation products in the environment and on information about the
environmental effects of substances expected to be emitted into the
environment. From its review of 19 petitions, the agency has found that
the use of naturally occurring substances as food additives, color
additives, or GRAS substances did not alter significantly the
concentration and distribution of the substance, its metabolites or
degradation products in the environment, and therefore, substances
emitted into the environment did not have adverse environmental
effects.
Among the 19 petitions for naturally occurring substances reviewed
by the agency were several petitions for substances intended to replace
macronutrients in food. In Sec. 25.32(k), FDA is not proposing to
exclude from the requirement to prepare an EA petitions for substances
intended to replace macronutrients. However, when a macronutrient
replacement is also a substance that occurs naturally in the
environment, the categorical exclusion proposed here will apply, unless
the agency finds that extraordinary circumstances exist, as delineated
in proposed Sec. 25.21.
4. Veterinary Drugs and Feed Additives
The National Performance Report, ``Reinventing Food Regulations,''
January 1996, announced FDA's proposal to reduce the number of EA's
submitted by industry under NEPA by increasing the number of
categorical exclusions for actions relating to animal drugs, animal
feeds, and food and color additives, which as a class have no
individual or cumulative significant effects on the environment. As
described below, in fulfillment of this commitment, FDA is proposing
additional categorical exclusions for actions on animal drugs and feed
additives that, based upon its experience in reviewing these types of
actions, the Center for Veterinary Medicine (C
FR Doc. 96-8090 National Environmental Policy Act; Proposed Revision of Policies and Procedures
VM) has concluded will
not significantly affect the human environment.
Under proposed Sec. 25.33(a), actions relating to new animal drug
applications (NADA's), abbreviated applications, and supplements to
such applications that do not increase the use and disposal of the
substances are categorically excluded.
Proposed Sec. 25.33(a) includes the categorical exclusions listed
in current Sec. 25.24(d)(1) and (d)(2), and broadens the categorical
exclusion to allow FDA to categorically exclude other actions that do
not result in increased use of a drug and, consequently, do not result
in an increase in the expected level of environmental exposure. For
example, the approval of a supplement for a new manufacturing site is
not specifically listed but may be categorically excluded if it is not
expected to result in increased use of the substance for which the
supplement was submitted. Proposed Sec. 25.33(a)(7) for animal drugs
used in feeds is the same as current Sec. 25.24(d)(2) but has been
revised for clarity because FDA approves animal drugs for use in animal
feeds.What about 512(m) and proposed 25.24(e)?
The categorical exclusions in proposed Sec. 25.33(a) include
actions relating to abbreviated new animal drug applications (ANADA's)
in recognition of the creation of ANADA's under the 1988 Generic Animal
Drug and Patent Term Restoration Act (GADPTRA) (21 U.S.C. 301 note). An
ANADA is merely an abbreviated form of an NADA and seeks to effectuate
the same action, approval of an animal drug. Therefore, the nature of
environmental considerations is similar. For animal drugs not otherwise
excluded in Sec. 25.33(a), the agency is reserving Sec. 25.33(b) to
provide for a categorical exclusion analogous to that contained in
proposed Sec. 25.31(b) for human drugs. The categorical exclusion would
be for actions that increase the use of an animal drug in the instance
that the agency determines a level at or below which the concentration
of the substance in the environment does not significantly affect the
environment.
[[Page 14932]]
FDA recognizes that proposed Sec. 25.31(b) for human drugs allows
for a categorical exclusion for increased uses of human drugs if the
concentration of the substance in the aquatic environment will be at or
below 1 ppb. At this time, FDA is not adopting a specific environmental
concentration from use of animal drugs because the agency is still
conducting a retrospective review of environmental assessments for
these products and a review of revelant environmental science. The
Animal Health Institute and FDA/CVM held an Environmental Risk
Assessment Workshop on February 20 and 21, 1996, to establish a
comprehensive ecological risk assessment process for the evaluation of
animal health products. Following this opportunity for public debate,
and for drugs not otherwise excluded, FDA will adopt a risk assessment
paradigm for determining environmental introductions for animal drugs
and an environmental concentration at or below which no meaningful
environmental effects are expected to occur.
Proposed 25.33(c) would categorically exclude any action on an
NADA, abbreviated application, or a supplement to such actions for
substances that occur naturally in the environment, when the action is
not expected to alter significantly the concentration or distribution
of the substance, its metabolites, or degradation products in the
environment. Currently, FDA's regulations require an abbreviated EA for
an animal drug substance that occurs naturally in the environment.
These abbreviated EA's require information about the production site
and about whether the use of the product will significantly alter the
concentration, distribution, and effect of the natural substance in the
environment.
Since the publication of the NEPA regulations in 1985, FDA has
reviewed abbreviated EA's for substances that are naturally occurring.
FDA has found that actions on submissions for these substances will not
affect the environment if the action will not significantly alter the
concentration or distribution of the natural substance in the
environment. Under these circumstances, the agency has prepared
FONSI's.
Therefore, the proposed regulations would categorically exclude
actions on an NADA, abbreviated application, or a supplement to such
applications for substances that occur naturally in the environment
when the action is not expected to alter significantly the
concentration or distribution of the substance, its metabolites, or
degradation products in the environment. FDA has access to information
regarding metabolites and degradation products to aid in determining if
the categorical exclusion request is appropriate. Neither an EA nor an
EIS would be required for such actions. When an action does alter
significantly the concentration or distribution of the products, its
metabolites, or degradation products in the environment, e.g., when the
use and disposal will occur in a geographic area where the substance is
not naturally occurring, an environmental assessment may be required.
Proposed Sec. 25.33(d) includes categorical exclusions for actions
relating to approval of applications for animal drugs intended for use
in nonfood animals, for local or general anesthesia, for ophthalmic or
topical applications, for the treatment of a disease occurring in minor
species animals, as defined in Sec. 514.1(d)(1)(i) (21 CFR
514.1(d)(1)(i)), and for use under prescription or veterinarian's
order. Under current Sec. 25.31a(b)(4), FDA requires abbreviated EA's
to be submitted as part of any request for such approvals. These
abbreviated EA's require environmental information for production
sites. Since the publication of the NEPA regulation in 1985, CVM has
reviewed many abbreviated EA's for these types of products. In every
instance, the agency has prepared a FONSI because the manufacturing was
determined to be in compliance and would remain in compliance with the
Federal, State, and local environmental requirements that apply to the
site of manufacturing, and the market volume for such products was so
low that FDA found, based on its experience, the drugs would not
significantly affect the environment. Furthermore, as the agency
explains in section III.D. of this document, the agency has determined
that ordinarily FDA will not consider potential impacts at the site of
production.
The categorical exclusion for local and general anesthetic products
applies only to those products that are administered individually. Some
anesthetic products may be intended to be administered to many animals
or in significant quantities. In these instances, potential
environmental effects exist that require environmental analysis. The
exclusion for ophthalmic and topical products is limited to those
products intended for nonsystemic use. Products used systemically could
result in greater environmental introductions that could potentially
affect the environment and, therefore, require further environmental
analysis. Furthermore, FDA is clarifying that the categorical exclusion
for drugs for minor species applies only to those animal drugs that
have been previously approved for use in another or the same species
when similar animal management practices are used. When management
practices are different, environmental introductions and impacts may
also be different and require environmental analyses. Minor species
include wildlife and endangered species (Sec. 514.1(d)(1)(ii)).
The categorial exclusion for animal drugs used under prescription
or veterinarian's order applies only to animal drugs for therapeutic
uses as defined in section 201(g)(1)(B) of the act (21 U.S.C.
321(g)(1)(B)). Based on its experience in reviewing EA's for these
products, FDA has found that prescription products are generally
administered individually to a limited number of animals for a limited
amount of time. Therefore, there are no significant environmental
effects. However, FDA may require an EA if the agency determines that
there are extraordinary circumstances associated with the use of such a
product.
Current Sec. 25.24(d)(4) categorically excludes actions on an
investigational new animal drug application (INAD) if the drug to be
shipped under such notice is intended to be used for clinical studies
or research in which wastes will be controlled or the amount of wastes
expected to enter the environment may reasonably be expected to be
nontoxic. Under proposed Sec. 25.33(e), FDA would categorically exclude
all actions on INAD's. In many cases, FDA's actions on INAD's do not
significantly increase the use of the drug and, thus, the amount of
drug introduced into the environment. Therefore, no changes in
environmental effects will occur. In those cases where an increase in
use of a drug may occur as a result of an investigation under an INAD,
FDA's experience from reviewing many actions on INAD's shows that
significant environmental effects will not occur because the use of
such drugs is limited and controlled.
Proposed Sec. 25.33(f) would categorically exclude actions on
applications submitted under section 512(m) of the act (21 U.S.C.
360b(m)). FDA is proposing to exclude actions on such applications
because they permit feed manufacturers to manufacture animal feed
bearing or containing new animal drugs previously approved for use in
feeds. The potential for environmental effects to occur is considered
at the time the new animal drug is approved for use in feed. Therefore,
there is no need to require an
[[Page 14933]]
additional EA each time the agency considers approval of an application
submitted under section 512(m) of the act.
Current Sec. 25.24(d)(3) categorically excludes withdrawals of
approval of NADA's when the drug is no longer marketed or at the
request of the application holder. Under proposed Sec. 25.33(g), FDA
would categorically exclude withdrawals of approval of ANADA's, as well
as withdrawals of approval of NADA's, without conditions. FDA has
determined that withdrawal of an NADA or ANADA approval does not
significantly affect the environment because any change in introduction
of the drug will generally be a decrease.
Under proposed Sec. 25.33(h), FDA would categorically exclude
actions to withdraw the approval for uses of food additives in animal
feeds or to remove substances for use in animal feeds from the GRAS
list or to remove substances from the GRAS list (parts 182, 184, or
186). Withdrawal or removal of a food additive substance that reduces
or eliminates animal feed use will not significantly affect the
environment because any change in introduction of the substance to the
environment will generally be a decrease.
In those cases where the withdrawal of the NADA, ANADA, or FAP, or
GRAS substance has resulted in the use of a substitute product, the
agency has found in all instances that the increased use of the
substitutes will not significantly affect the environment.
FDA is proposing to eliminate the categorical exclusions under
current Sec. 25.24(d)(5) and (d)(6) because FDA does not do testing and
certification of batches of antibiotics for animal use, and FDA does
not use monographs for animal drugs. FDA is proposing to eliminate
current Sec. 25.24(d)(7). This action takes place under an INAD, and
its effect is to set the standard for approving ANADA's. FDA will
determine whether it needs to consider environmental effects when it
approves individual ANADA's.
5. Devices and Electronic Products
The agency is proposing to redesignate current Sec. 25.24(e) as
proposed Sec. 25.34 and to remove criteria in Sec. 25.24(e)(4) and
(e)(7), now incorporated in proposed Sec. 25.21 Extraordinary
circumstances.
D. Subpart D--Preparation of Environmental Documents
The proposed rule would reorganize current subpart C of part 25 to
improve the usefulness and readability of the current regulations.
Proposed Sec. 25.40(b) would eliminate the EA and abbreviated EA
formats and delete any reference to formats. After consultation with
CEQ, the agency has decided to remove the standard formats from part
25, and to provide appropriate formats in guidance documents. Guidance
documents, which do not bind the agency or the public, are more easily
revised. Use of such documents will give FDA greater flexibility to
tailor environmental documents to reflect state-of-the-art developments
in environmental analysis and to assist companies in focusing on
important environmental issues. Information/guidance concerning the
nature and scope of information that an applicant or petitioner should
submit in an EA may be obtained from the center responsible for the
action subject to environmental evaluation (proposed Sec. 25.40(c)).
In the Federal Register of January 11, 1996, FDA announced the
availability of a guidance document entitled, ``Guidance for Industry
for the Submission of an Environmental Assessment in Human Drug
Applications and Supplements'' (61 FR 1031). The guidance, prepared by
CDER, is intended to assist industry by providing guidance on how to
prepare EA's for submission to CDER as part of NDA's, antibiotic
applications, ANDA's, abbreviated antibiotic applications, and IND's.
This guidance will be amended to reflect the final regulations and
categorical exclusions and to include biologic products subject to
licensure under the PHS Act. The guidance document employs a tiered
approach to testing and accepts the use of test methods recognized and
recommended by competent authorities such as FDA (see e.g., FDA's EA
Technical Assistance Handbook), EPA (see 40 CFR parts 796 and 797) and
the Organization for Economic Co-operation and Development. Under the
proposed rule, this approach will continue to be acceptable.
The current formats in part 25 focus the environmental analysis on
the use and disposal from use of FDA-regulated articles but also
address production impacts. FDA proposes to maintain this focus in the
proposed revised regulations, but, for the following reasons, is
proposing to change the way it addresses production impacts. To address
the potential environmental impacts from production of FDA-regulated
articles, FDA currently requires a limited amount of information to
make sure that the article will be produced in compliance with
applicable emissions requirements. Specifically, the agency requires
that the following information be included in an EA: A list of the
substances expected to be emitted, the controls exercised, a citation
of applicable emissions requirements and statement of compliance with
these requirements, and a discussion of the effect the approval of the
petition will have on compliance with these requirements.
FDA recognizes, however, that Federal, State, and local
environmental protection agencies have the responsibility for issuing
regulations, permitting and licensing facilities, and enforcing
compliance with the requirements that these agencies have determined
are necessary to ensure adequate protection of the environment from
emissions from production operations. Regulating emissions from
production sites requires balancing between air, water, and solid waste
emissions for all production operations carried out at a production
site and in the region with consideration of the costs of compliance
and available technology that requires expertise found primarily in
Federal, State, and local environmental agencies. As required by
environmental regulations and/or as conditions of retaining licenses
and permits, manufacturers must obtain or modify permits and provide
information to these agencies when production operations are initiated
or changed. The information required to be provided to FDA regarding
production impacts and compliance with emission requirements is
information that is generally required to be provided to or is known by
other agencies whose responsibility is to monitor compliance.
FDA has reviewed hundreds of EA's in which information regarding
the manufacturing site, such as emitted substances and emission
controls, was provided. As a result of this review, FDA has found that
FDA-regulated articles produced in compliance with all applicable
emission requirements (e.g., Clean Air Act, Clean Water Act,
Occupational Safety and Health Act) will not significantly affect the
environment. Based on these findings, FDA has determined that it is no
longer necessary to review a company's compliance with Federal, State,
and local environmental laws and FDA is proposing to delete the
requirements for the submission of emission information for production
sites. Accordingly, under the proposed regulations, FDA will continue
to focus its environmental reviews on the use and disposal from use of
FDA-regulated articles, and FDA will no longer routinely require
submission of information regarding manufacturing sites or a
certification of compliance with Federal, State, and
[[Page 14934]]
local emission requirements. However, if information available to the
agency or the applicant establishes that the general or specific
emission requirements promulgated by Federal, State, or local
environmental protection agencies do not address unique emission
circumstances and the emissions may harm the environment, this would be
sufficient grounds for requesting manufacturing information in an EA.
FDA generally requires manufacturing information to be submitted as
part of applications or petitions for FDA-regulated articles. This
information will aid FDA in determining if a categorical exclusion
request is appropriate.
Proposed Sec. 25.40(a) includes additional information found in the
CEQ regulations to clarify that the EA shall include brief discussions
of the need for the proposal, alternatives, environmental impacts of
the proposed action, and a listing of agencies and persons consulted,
and include additional information to clarify the scope and focus of an
EA. Environmental documents shall concentrate on timely and significant
issues, not amass needless detail. To that end, the agency has included
some general information regarding the acceptability of using a tiered
testing scheme. A tiered testing scheme results in test termination
when sufficient data are available to assess the potential
environmental fate and effects of an FDA-regulated article in the
environment. Specific information regarding tiered testing will be
provided in guidance documents. Although the number of pages for any EA
may vary in relation to the complexity of the issues, generally they
should not exceed 30 pages, not including test reports and data.
The agency is proposing to add Sec. 25.40(b) to clarify that CEQ
regulations (40 CFR 1506.5(b)) place ultimate responsibility on FDA for
the scope and content of environmental analyses. Thus, FDA may require
additional information from applicants or may itself include additional
information in environmental documents (EA's, FONSI's, or EIS's) when
warranted. Proposed Sec. 25.40(c) would include information found in
current Sec. 25.30(a) and encourages applicants or petitioners who
submit EA's to FDA to consult with FDA regarding the appropriate scope
and content for EA's for the requested action. Proposed Sec. 25.40(d)
discusses incorporation of information in an EA by reference.
Proposed Sec. 25.41 would include information on FONSI's that is
found in current Sec. 25.32(a) and (c). The agency is proposing to
delete the language on notices of intent and draft, final, and
supplemental EIS's, found in current Secs. 25.33 and 25.34, because the
CEQ regulations describe the process for determining the scope of an
EIS and provide detailed requirements for the preparation of draft and
final EIS's. Thus, this information is duplicative and unnecessary in
FDA regulations (40 CFR 1501.7 and part 1502).
Proposed Sec. 25.42 would describe the subject matter that needs to
be discussed in an EIS and references the CEQ regulations governing the
requirements for preparation of an EIS. Proposed Sec. 25.42(c) fulfills
the CEQ requirement under 40 CFR 1502.9(c) that FDA adopt procedures
for introducing a supplement into its administrative record.
The agency is proposing to add new Sec. 25.43 to clarify the
agency's existing responsibility under the CEQ regulations to prepare a
concise public record of decision for cases requiring EIS's (40 CFR
1505.2).
Proposed Sec. 25.44 would include information found in current
Sec. 25.10(b), describing the responsibilities of lead and cooperating
agencies. The agency is proposing to delete duplicative and unnecessary
information on lead and cooperating agencies that is already found in
the CEQ regulations, and to delete the first sentence in current
Sec. 25.10(b) because it is self-evident that FDA will be the lead
agency for programs administered by FDA.
Proposed Sec. 25.45 would include information from current
Sec. 25.42, describing who the responsible agency official will be and
his or her responsibilities. The agency is proposing to remove
information in current Sec. 25.42 that is duplicative of requirements
already found in CEQ regulations.
E. Subpart E--Public Participation and Notification of Environmental
Documents-
The proposed rule would improve the usefulness and readability of
the regulations by reorganizing current subpart D of part 25, ``agency
decisionmaking'' (now proposed ``Public Participation and Notification
of Environmental Documents'') by deleting unnecessary information that
is duplicative of requirements found in the CEQ regulations, and, as
discussed above, moving information to other relevant sections.
Proposed subpart E would now address public participation in the NEPA
process and clarify circumstances under which environmental documents
will publicly be disclosed. These revisions are consistent with our
responsibilities under the CEQ regulations and under Executive Order
12898, Federal Actions to Address Environmental Justice in Minority
Populations and Low Income Populations, February 11, 1994.
CEQ regulations require that agency procedures ensure full
compliance with NEPA to the extent possible, unless existing law
applicable to the agency's operations expressly prohibits or makes
compliance impossible (40 CFR 1500.6). Proposed Sec. 25.50 clarifies
that laws governing public disclosure may limit FDA's ability to comply
with NEPA and CEQ regulations.
Proposed Sec. 25.51(a) and (b), public disclosure of FONSI's and
EA's, would include the public disclosure information found in current
Sec. 25.30(b) and 25.41(b). The proposed rule would move the
information relating to statutory time frames from current
Sec. 25.40(c) to proposed Sec. 25.51(b)(1).
Proposed Sec. 25.52 would add new information relating to the
public disclosure of EIS's.
F. Subpart F--Other Requirements
Current subpart E will be renumbered as subpart F. The agency is
not proposing to amend this subpart.
IV. Environmental Impact Considerations
The agency has determined under current 21 CFR 25.24(a)(8) that
this action is of a type that does not individually or cumulatively
have a significant effect on the human environment. Therefore, neither
an EA nor an EIS is required.
V. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, under the Regulatory Flexibility Act (Pub. L. 96-354), and
under the Unfunded Mandates Reform Act (Pub. L. 104-4). Executive Order
12866 directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts and equity). The Regulatory
Flexibility Act requires agencies to analyze regulatory options that
would minimize any significant impact of a rule on small entities. The
Unfunded Mandates Reform Act requires (in section 202) that agencies
prepare an assessment of anticipated costs and benefits before
proposing any rule that may result in an annual expenditure by State,
local, and tribal governments, in
[[Page 14935]]
the aggregate, or by the private sector, of $100,000,000 (adjusted
annually for inflation). That act also requires (in section 205) that
the agency identify and consider a reasonable number of regulatory
alternatives and from those alternatives select the least costly, most
cost effective, or least burdensome alternative that achieves the
objective of the rule. The following analysis demonstrates that this
proposed rule is consistent with the principles set forth in the
Executive Order and in these two statutes. The proposed rule is not an
economically significant regulatory action under Executive Order 12866.
Based on the approximate number of EA's that FDA currently receives
each year and the resources needed to prepare them, the agency
estimates that the proposed reduced requirements for submitting EA's
will result in an annual cost savings to industry of approximately
$15.7 million. The basis for this estimate is as follows:
Human pharmaceuticals: Approximately 125 EA's related to human
pharmaceuticals would be eliminated annually under the proposal. About
one-half of these are abbreviated EA's; the remainder are full
assessments. FDA assumes that the average cost of preparing an
abbreviated assessment was approximately $40,000, while the average
cost of a full assessment was approximately $200,000. These assumptions
yield a cost savings of about $2.5 million for abbreviated EA's and
$12.5 million for full EA's, for a total savings to industry from the
reduced requirements of EA's relating to human pharmaceuticals of
approximately $15 million per year.
Veterinary products: The proposed changes would eliminate
approximately 37 abbreviated EA's for veterinary products each year, at
an average cost of approximately $5,000 each. About 77 brief
submissions, which currently require categorical exclusion criteria
review, would also be eliminated; these cost an estimated $300 each to
prepare. Total cost savings to the veterinary products industry under
the proposal would thus be approximately $208,000 per year.
Food products: About 36 EA's per year received by CFSAN would be
eliminated under the proposal. Approximately 28 of these would have
been abbreviated EA's and 8 would have been full assessments under
current rules. FDA estimates that the cost of producing most
abbreviated EA's for CFSAN is approximately $2,500 and the average cost
of producing a full EA is approximately $50,000. These assumptions
imply an annual cost savings of approximately $70,000 for abbreviated
EA's and $400,000 for full EA's, for a total annual savings to the
foods industry of approximately $470,000.
In addition to these savings to industry, the proposed changes
would improve FDA efficiency by eliminating agency review costs of
approximately $1 million per year.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
of small entities. Because these regulations will not impose
significant new costs on any firms, the agency certifies that the
proposed rule will not have a significant economic impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
VI. Paperwork Reduction Act of 1995
This proposed rule contains reporting requirements that are subject
to public comment and review by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3506 and
3507). Therefore, in accordance with 5 CFR part 1320, a description of
reporting requirements with an estimate of the annual collection of
information burden is given below by cross reference to existing FDA
clearance submissions previously approved by OMB which this proposed
rule affects.
FDA is soliciting comments to: (1) Evaluate whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (2) evaluate the accuracy of the agency's
estimate of the proposed collection of information; (3) evaluate the
quality, utility, and clarity of the information to be collected; and
(4) minimize the burden of the collection of information on those who
are to respond.
Title: National Environmental Policy Act; Policies and Procedures.
Description: FDA has previously issued regulations that implement
NEPA (part 25). The proposed rule would reduce the number of NEPA
evaluations by providing for categorical exclusions for additional
classes of actions that do not individually or cumulatively have a
significant effect on the human environment and for which, therefore,
neither an EIS nor an EA is required. FDA is also proposing to amend
these regulations to ensure that the NEPA procedures are more concise
and understandable to the public and to reflect current FDA policy with
respect to environmental considerations. This proposed rule is in
response to initiatives announced in the President's National
Performance Reports, ``Reinventing Drug and Medical Device
Regulations,'' April 1995, and ``Reinventing Food Regulations,''
January 1996.
Description of Respondents: Persons and businesses, including small
businesses.
Estimated Annual Reporting and Recordkeeping Burden. The estimated
burden associated with the information collection requirements for this
proposed rule will be recognized in the individual FDA clearances where
NEPA considerations apply. Listed below are those clearances affected
by this regulation, including the section of title 21 CFR, the title,
and the OMB approval number:
Section 10.30, Citizen Petitions, 0910-0183; Sec. 71.1, Color
Additive Petitions, 0910-0185; Sec. 170.35, Affirmation of Generally
Recognized As Safe (GRAS) Status, 0910-0132; Sec. 101.12, Reference
amounts customarily consumed per eating occasion, 0910-0286;
Sec. 101.69, Petitions for nutrient content claims, 0910-0288;
Sec. 101.70, Petitions for health claims, 0910-0287; Sec. 170.39,
Threshold of regulation for substances used in food-contact articles,
0910-0298; Sec. 171.1, Food Additive Petitions, 0910-0016; Sec. 312.23,
Conditions for Exemption of New Drugs for Investigational Use, 0910-
0014; Sec. 511.1, New Animal Drugs for Investigational Use Exempt From
Section 512(a) of the Act, 0910-0117; Sec. 514.1, New Animal Drug
Applications, 0910-0032; Sec. 514.8, Supplemental New Animal Drug
Applications, 0910-0032; Sec. 571.1, Food Additive Petitions, 0910-
0016; Sec. 601.2 Product Licenses-Procedures for Filing, 0910-0124;
Sec. 812.20, Investigational Device Exemptions Application, 0910-0078.
The proposed rule would reduce these information collections that
have already been reviewed and approved by the OMB.-Reporting burdens
imposed by current part 25 are approved by OMB through December 31,
1997 (see OMB control number 0910-0190, ``National Environmental Policy
Act; Policy and Procedures--21 CFR Part 25'').
The agency has submitted copies of the proposed rule to OMB for its
review of these reporting requirements. Interested persons are
requested to send comments regarding information collection by May 3,
1996, to the Office of Information and Regulatory Affairs, OMB (address
above).
[[Page 14936]]
List of Subjects in 21 CFR Part 25
Environmental impact statements, Foreign relations, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and authority delegated to the Commissioner
of Food and Drugs, it is proposed that 21 CFR part 25 be revised to
read as follows:
PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS
Subpart A--General Provisions
Sec.
25.1 Purpose.
25.5 Terminology.
25.10 Policies and NEPA planning.
Subpart B--Agency Actions Requiring Environmental Consideration
25.15 General procedures.
25.16 Public health and safety emergencies.
25.20 Actions requiring preparation of an environmental
assessment.
25.21 Extraordinary circumstances.
25.22 Actions requiring preparation of an environmental impact
statement.
Subpart C--Categorical Exclusions
25.30 General.
25.31 Human drugs and biologics.
25.32 Foods, food additives, and color additives.
25.33 Animal drugs.
25.34 Devices and electronic products.--
Subpart D--Preparation of Environmental Documents
25.40 Environmental assessments.-
25.41 Findings of no significant impact.
25.42 Environmental impact statements.
25.43 Records of decision.-
25.44 Lead and cooperating agencies.
25.45 Responsible agency official
Subpart E--Public Participation and Notification of Environmental
Documents---
25.50 General information.
25.51 Environmental assessments and findings of no significant -
impact.
25.52 Environmental impact statements.-
Subpart F--Other Requirements
25.60 Environmental effects abroad of major agency actions.
Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321-393); secs. 351, 354-361 of the Public Health
Service Act (42 U.S.C. 262, 263b-264); 42 U.S.C. 4321, 4332; 40 CFR
parts 1500-1508; E.O. 11514, 3 CFR, 1966-1970 Comp., p. 902, as
amended by E.O. 11991, 3 CFR, 1977 Comp., p. 123; E.O. 12114, 3 CFR,
1979 Comp., p. 356.
Subpart A--General Provisions
Sec. 25.1 Purpose.
The National Environmental Policy Act of 1969 (NEPA), as amended,
directs that, to the fullest extent possible, the policies,
regulations, and public laws of the United States shall be interpreted
and administered in accordance with the policies set forth in NEPA. All
agencies of the Federal Government shall comply with the procedures in
section 102(2) of NEPA except where compliance would be inconsistent
with other statutory requirements. The regulations in this part
implement section 102(2) of NEPA in a manner that is consistent with
FDA's authority under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act. This part also supplements the regulations
for implementing the procedural provisions of NEPA that were published
by the Council on Environmental Quality (CEQ) in 40 CFR Parts 1500
through 1508 and the procedures included in the ``HHS General
Administration Manual, Part 30: Environmental Protection'' (45 FR 76519
to 76534, November 19, 1980).Sec. 25.5 Terminology.
(a) Definitions that apply to the terms used in this part are set
forth in the CEQ regulations under 40 CFR part 1508. The terms and the
sections of 40 CFR part 1508 in which they are defined follow:
(1) Categorical exclusion (40 CFR 1508.4).
(2) Cooperating agency (40 CFR 1508.5).
(3) Cumulative impact (40 CFR 1508.7).
(4) Effects (40 CFR 1508.8).
(5) Environmental assessment (EA) (40 CFR 1508.9).
(6) Environmental document (40 CFR 1508.10).
(7) Environmental impact statement (EIS) (40 CFR 1508.11).
(8) Federal agency (40 CFR 1508.12).
(9) Finding of no significant impact (40 CFR 1508.13).
(10) Human environment (40 CFR 1508.14).
(11) Lead agency (40 CFR 1508.16).
(12) Legislation (40 CFR 1508.17).
(13) Major Federal action (40 CFR 1508.18).
(14) Mitigation (40 CFR 1508.20).
(15) NEPA process (40 CFR 1508.21).
(16) Notice of intent (40 CFR 1508.22).
(17) Proposal (40 CFR 1508.23).
(18) Scope (40 CFR 1508.25).
(19) Significantly (40 CFR 1508.27).
(b) The following terms are defined solely for the purpose of
implementing the supplemental procedures provided by this part and are
not necessarily applicable to any other statutory or regulatory
requirements:-
(1) Abbreviated application applies to an abbreviated new drug
application, an abbreviated antibiotic application, and an abbreviated
new animal drug application.
(2) Active moiety means the molecule or ion, excluding those
appended portions of the molecule that cause the drug to be an ester,
salt (including a salt with hydrogen or coordination bonds), or other
noncovalent derivative (such as a complex chelate or clathrate) of the
molecule responsible for the physiological or pharmacological action of
the drug substance.
(3) Agency means the Food and Drug Administration (FDA).
(4) Increased use of a drug or biologic product may occur if the
drug will be administered at higher dosage levels, for longer duration
or for different indications than were previously in effect, or if the
drug is a new molecular entity. New molecular entity means a drug for
which the active moiety (present as the unmodified (parent) compound,
or an ester or a salt, clathrate, or other noncovalent derivative of
the base (parent) compound) has not been previously approved or
marketed in the United States for use in a drug product, either as a
single ingredient or as part of a combination product or as part of a
mixture of stereoisomers. The term ``use'' also encompasses disposal of
FDA-regulated articles by consumers.
(5) Responsible agency official means the agency decisionmaker
designated in part 5 of this chapter.
(c) The following acronyms are used in this part:
(1) CEQ--Council on Environmental Quality.
(2) CGMP--Current good manufacturing practice.
(3) EA--Environmental assessment.
(4) EIS--Environmental impact statement.
(5) The act--Federal Food, Drug, and Cosmetic Act.
(6) FIFRA--Federal Insecticide, Fungicide, and Rodenticide Act.
(7) FONSI--Finding of no significant impact.
(8) GLP--Good laboratory practice.
(9) GRAS--Generally recognized as safe.
(10) HACCP--Hazard analysis critical control point.
(11) IDE--Investigational device exemption.
(12) IND--Investigational new drug application.
(13) INAD--Investigational new animal drug application.
(14) NADA--New animal drug application.
(15) NDA--New drug application.
(16) NEPA--National Environmental Policy Act of 1969.-
(17) PDP--Product development protocol.
(18) PMA--Premarket approval application.-
[[Page 14937]]
Sec. 25.10 Policies and NEPA planning.
(a) All FDA's policies and programs will be planned, developed, and
implemented to achieve the policies declared by NEPA and required by
CEQ's regulations to ensure responsible stewardship of the environment
for present and future generations.
(b) Assessment of environmental factors continues throughout
planning and is integrated with other program planning at the earliest
possible time to ensure that planning and decisions reflect
environmental values, to avoid delays later in the process, and to
avoid potential conflicts.
(c) For actions initiated by the agency, the NEPA process will
begin when the agency action under consideration is first identified.
For actions initiated by applicants or petitioners, NEPA planning
begins when FDA receives a submission from an applicant or petitioner
seeking action by FDA. FDA may issue a public call for environmental
data or otherwise consult with affected individuals or groups when a
contemplated action in which it is or may be involved poses potential
significant environmental effects.
(d) Environmental documents shall concentrate on timely and
significant issues, not amass needless detail.
(e) If a proposed action for which an EIS will be prepared involves
possible environmental effects that are required to be considered under
statutes or Executive Orders other than those referred to under
``AUTHORITY'' in this part, these effects shall be considered in the
NEPA review, consistent with 40 CFR 1502.25 and the Department of
Health and Human Services' General Administration Manual, part 30.
Subpart B--Agency Actions Requiring Environmental Consideration
Sec. 25.15 General procedures.
(a) All applications or petitions requesting agency action require
the submission of an EA or a claim of categorical exclusion. A claim of
categorical exclusion shall include a certification of compliance with
the categorical exclusion criteria and shall certify that to the
applicant's knowledge, no extraordinary circumstances exist. Failure to
submit an adequate EA for an application or petition requesting action
by the agency of a type specified in Sec. 25.20, unless the agency can
determine that the action qualifies for exclusion under Secs. 25.30,
25.31, 25.32, 25.33, or 25.34, is sufficient grounds for FDA to refuse
to file or approve the application or petition.
(b) The responsible agency officials will evaluate the information
contained in the EA to determine whether it is accurate and objective,
whether the proposed action may significantly affect the quality of the
human environment, and whether an EIS will be prepared. If significant
effects requiring the preparation of an EIS are identified, FDA will
prepare an EIS for the action in accordance with the procedures in
subparts D and E of this part. If significant effects requiring the
preparation of an EIS are not identified, resulting in a decision not
to prepare an EIS, the responsible agency official will prepare a FONSI
in accordance with Sec. 25.41.
(c) Classes of actions that individually or cumulatively do not
significantly affect the quality of the human environment ordinarily
are excluded from the requirement to prepare an EA or an EIS. The
classes of actions that qualify as categorical exclusions are set forth
in Secs. 25.30, 25.31, 25.32, 25.33, or 25.34.
(d) A person submitting an application or petition of a type
subject to categorical exclusion under Secs. 25.30, 25.31, 25.32,
25.33, or 25.34, or proposing to dispose of an article as provided in
Secs. 25.30(d) or 25.32(h), is not required to submit an EA if the
person certifies that the action requested qualifies for a categorical
exclusion, citing the particular categorical exclusion that is claimed,
and certifies that to the applicant's knowledge, no extraordinary
circumstances exist.
Sec. 25.16 Public health and safety emergencies.
There are certain regulatory actions that, because of their
immediate importance to the public health or safety, may make adherence
to the procedural provisions of NEPA and CEQ's regulations impossible.
For such actions, the responsible agency official shall consult with
CEQ about alternative arrangements before the action is taken, or after
the action is taken, if time does not permit prior consultation with
CEQ.
Sec. 25.20 Actions requiring preparation of an environmental
assessment.
Any proposed action of a type specified in this section ordinarily
requires at least the preparation of an EA, unless it is an action in a
specific class that qualifies for exclusion under Secs. 25.30, 25.31,
25.32, 25.33, or 25.34:
(a) Major recommendations or reports made to Congress on proposals
for legislation in instances where the agency has primary
responsibility for the subject matter involved.
(b) Destruction or other disposition of articles condemned after
seizure or whose distribution or use has been enjoined, unless
categorically excluded in Secs. 25.30(d) or 25.32(h).
(c) Destruction or other disposition of articles following
detention or recall at agency request, unless categorically excluded in
Secs. 25.30(d) or 25.32(h).
(d) Disposition of FDA laboratory waste materials, unless
categorically excluded in Sec. 25.30(m).
(e) Intramural and extramural research supported in whole or in
part through contracts, other agreements, or grants, unless
categorically excluded in Sec. 25.30(e) or (f).
(f) Establishment by regulation of labeling requirements, a
standard, or a monograph, unless categorically excluded in
Secs. 25.30(k) or 25.31(a), (b), (c), (h), (i), or (j), or 25.32(a) or
(p).
(g) Issuance, amendment, and enforcement of FDA regulations, or an
exemption or variance from FDA regulations, unless categorically
excluded in Secs. 25.30(h), (i), or (j), or 25.32(e), (g), (n), or (p).
(h) Withdrawal of existing approvals of FDA-approved articles,
unless categorically excluded in Secs. 25.31(d) or (k), 25.32(m), or
25.33(g) or (h).
(i) Approval of food additive petitions and color additive
petitions, approval of requests for exemptions for investigational use
of food additives, and granting of requests for exemption from
regulation as a food additive, unless categorically excluded in
Sec. 25.32(b), (c), (i), (j), (k), (l), (o), (q), or (r).
(j) Establishment of a tolerance for unavoidable poisonous or
deleterious substances in food or in packaging materials to be used for
food.--
(k) Affirmation of a food substance as GRAS for humans or animals,
on FDA's initiative or in response to a petition, under part 182, 184,
186, or 582 of this chapter and establishment or amendment of a
regulation for a prior-sanctioned food ingredient, as defined in
Secs. 170.3(l) and 181.5(a) of this chapter, unless categorically
excluded in Sec. 25.32(f), (k), or (r).
(l) Approval of NDA's, abbreviated applications, applications for
marketing approval for marketing of a biologic product, supplements to
such applications, and actions on IND's, unless categorically excluded
in Sec. 25.31(a), (b), (c), (e), or (l).
(m) Approval of NADA's, abbreviated applications, supplements, and
actions on INAD's, unless categorically excluded under Sec. 25.33(a),
(c), (d), or (e).
(n) Approval of PMA's for medical devices, notices of completion of
PDP's for medical devices, authorizations to commence clinical
investigation under an approved PDP, or applications for an
[[Page 14938]]
IDE, unless categorically excluded in Sec. 25.34.
Sec. 25.21 Extraordinary circumstances.
As required under 40 CFR 1508.4, FDA will require at least an EA
for any specific action that ordinarily would be excluded if
extraordinary circumstances indicate that the specific proposed action
may significantly affect the quality of the human environment (see 40
CFR 1508.27 for examples of significant impacts). Examples of such
extraordinary circumstances include:
(a) Actions for which available data establish that, at the
expected level of exposure, there is the potential for serious harm to
the environment; and
(b) Actions that adversely affect a species or the critical habitat
of a species determined under the Endangered Species Act or the
Convention on International Trade in Endangered Species of Wild Flora
and Fauna to be endangered or threatened or wild flora or fauna that
are entitled to special protection under some other Federal law.
Sec. 25.22 Actions requiring the preparation of an environmental
impact statement.
(a) There are no categories of agency actions that routinely
significantly affect the quality of the human environment and that
therefore ordinarily require the preparation of an EIS.
(b) EIS's are prepared for agency actions when evaluation of data
or information in an EA or otherwise available to the agency leads to a
finding by the responsible agency official that a proposed action may
significantly affect the quality of the human environment.
Subpart C--Categorical Exclusions
Sec. 25.30 General.
The classes of actions listed in this section and Secs. 25.31
through 25.34 are categorically excluded and, therefore, ordinarily do
not require the preparation of an EA or an EIS:
(a) Routine administrative and management activities, including
inspections, and issuance of field compliance programs, program
circulars, or field investigative assignments.
(b) Recommendation for an enforcement action to be initiated in a
Federal court.
(c) Agency requests for initiation of recalls.
(d) Destruction or disposition of any FDA-regulated article
condemned after seizure or the distribution or use of which has been
enjoined or following detention or recall at agency request if the
method of destruction or disposition of the article, including
packaging material, is in compliance with all Federal, State, and local
requirements.
(e) Extramural contracts, other agreements, or grants for
statistical and epidemiological studies, surveys and inventories,
literature searches, and report and manual preparation, or any other
studies that will not result in the production or distribution of any
substance and, therefore, will not result in the introduction of any
substance into the environment.
(f) Extramural contracts, other agreements, and grants for research
for such purposes as to develop analytical methods or other test
methodologies.
(g) Activities of voluntary Federal-State cooperative programs,
including issuance of model regulations proposed for State adoption.
(h) Issuance, amendment, or revocation of procedural or
administrative regulations and guidelines, including procedures for
submission of applications for product development, testing and
investigational use, and approval.
(i) Corrections and technical changes in regulations.
(j) Issuance of CGMP regulations, HACCP regulations, establishment
standards, emergency permit control regulations, GLP regulations, and
issuance or denial of permits, exemptions, variances, or stays under
these regulations.
(k) Establishment or repeal by regulation of labeling requirements
for marketed articles if there will be no increase in the existing
levels of use or change in the intended uses of the product or its
substitutes.
(l) Routine maintenance and minor construction activities such as:
(1) Repair to or replacement of equipment or structural components
(e.g., door, roof, or window) of facilities controlled by FDA;
(2) Lease extensions, renewals, or succeeding leases;
(3) Construction or lease construction of 10,000 square feet or
less of occupiable space;
(4) Relocation of employees into existing owned or currently leased
space;
(5) Acquisition of 20,000 square feet or less of occupiable space
in a structure that was substantially completed before the issuance of
solicitation for offers; and
(6) Acquisition of between 20,000 square feet and 40,000 square
feet of occupiable space if it constitutes less than 40 percent of the
occupiable space in a structure that was substantially completed before
the solicitation for offers.
(m) Disposal of low-level radioactive waste materials (as defined
in the Nuclear Regulatory Commission regulations at 10 CFR 61.2) and
chemical waste materials generated in the laboratories serviced by the
contracts administered by FDA, if the waste is disposed of in
compliance with all applicable Federal, State, and local requirements.
Sec. 25.31 Human drugs and biologics.
The classes of actions listed in this section are categorically
excluded and, therefore, ordinarily do not require the preparation of
an EA or an EIS:
(a) Action on an NDA, abbreviated application, or a supplement to
such application, or action on an OTC monograph, if the action does not
increase the use of the active moiety.
(b) Action on an NDA, abbreviated application, or a supplement to
such application, or action on an OTC monograph, if the action
increases the use of the active moiety, but the concentration of the
substance in the environment will be below 1 part per billion.
(c) Action on an NDA, abbreviated application, application for
marketing approval of a biologic product, or a supplement to such
application, or action on an OTC monograph, for substances that occur
naturally in the environment when the action does not alter
significantly the concentration or distribution of the substance, its
metabolites, or degradation products in the environment.
(d) Withdrawal of approval of an NDA or an abbreviated application.
(e) Action on an IND.
(f) Testing and certification of batches of an antibiotic or
insulin.
(g) Testing and release by the Center for Biologics Evaluation and
Research of lots or batches of a licensed biologic product.
(h) Issuance, revocation, or amendment of a monograph for an
antibiotic drug.
(i) Establishment of bioequivalence requirements for a human drug
or a comparability determination for a biologic product subject to
licensing.
(j) Issuance, revocation, or amendment of a standard for a biologic
product.
(k) Revocation of a license for a biologic product.
(l) Action on an application for marketing approval for marketing
of a biologic product for transfusable human blood or blood components
and plasma.
Sec. 25.32 Foods, food additives, and color additives.
The classes of actions listed in this section are categorically
excluded and,
[[Page 14939]]
therefore, ordinarily do not require the preparation of an EA or an
EIS:
(a) Issuance, amendment, or repeal of a food standard.
(b) Action on a request for exemption for investigational use of a
food additive if the food additive to be shipped under the request is
intended to be used for clinical studies or research.
(c) Approval of a color additive petition to change a provisionally
listed color additive to permanent listing for use in food, drugs,
devices, or cosmetics.
(d) Testing and certification of batches of a color additive.
(e) Issuance of an interim food additive regulation.
(f) Affirmation of a food substance as GRAS for humans or animals
on FDA's initiative or in response to a petition, under parts 182, 184,
186, or 582 of this chapter, and establishment or amendment of a
regulation for a prior-sanctioned food ingredient, as defined in
Secs. 170.3(l) and 181.5(a) of this chapter, if the substance or food
ingredient is already marketed in the United States for the proposed
use.
(g) Issuance and enforcement of regulations relating to the control
of communicable diseases or to interstate conveyance sanitation under
parts 1240 and 1250 of this chapter.
(h) Approval of a request for diversion of adulterated or
misbranded food for humans or animals to use as animal feeds.
(i) Approval of a food additive petition or the granting of a
request for exemption from regulation as a food additive under
Sec. 170.39 of this chapter when the additive is present in finished
food-packaging material at not greater than 5 percent-by-weight and is
also a functional component of the finished packaging material.
(j) Approval of a food additive petition or the granting of a
request for exemption from regulation as a food additive under
Sec. 170.39 of this chapter when the additive is to be used as a
component of a food-contact surface of permanent or semipermanent
equipment or of another food-contact article intended for repeated use.
(k) Approval of a food additive, color additive, or GRAS petition
for substances added directly to food that are intended to remain in
food through ingestion by consumers and that are not intended to
replace macronutrients in food.
(l) Approval of a petition for color additives used in contact
lenses, sutures, filaments used as supporting haptics in intraocular
lenses, bone cement, and in other FDA-regulated products having
similarly low levels of use.
(m) Action to prohibit or otherwise restrict or reduce the use of a
substance in food, food packaging, or cosmetics.
(n) Issuance, amendment, or revocation of a regulation pertaining
to infant formulas.
(o) Approval of a food additive petition for the intended
expression product(s) present in food derived from new plant varieties.
(p) Issuance, amendment, or revocation of a regulation in response
to a reference amount petition as described in Sec. 101.12(h) of this
chapter, a nutrient content claim petition as described in Sec. 101.69
of this chapter, a health claim petition as described in Sec. 101.70 of
this chapter, or a petition pertaining to the label declaration of
ingredients as described in Sec. 101.103 of this chapter.
(q) Approval of a food additive petition or the granting of a
request for an exemption from regulation as a food additive under
Sec. 170.39 of this chapter for a substance registered by the
Environmental Protection Agency under FIFRA for the same use requested
in the petition.
(r) Approval of a food additive, color additive, or GRAS
affirmation petition for a substance that occurs naturally in the
environment, when the action does not alter significantly the
concentration or distribution of the substance, its metabolites, or
degradation products in the environment.
Sec. 25.33 Animal drugs.
The classes of actions listed in this section are categorically
excluded and, therefore, ordinarily do not require the preparation of
an EA or an EIS:
(a) Action on an NADA, abbreviated application, or supplement to
such applications, if the action does not increase the use of the drug.
Actions to which this categorical exclusion applies include:
(1) An animal drug to be marketed under the same conditions of
approval as a previously approved animal drug;
(2) A combination of previously approved animal drugs;
(3) A new premix or other formulation of a previously approved
animal drug;
(4) Changes specified in Sec. 514.8(a)(5), (a)(6), or (d) of this
chapter;
(5) A change of sponsor;
(6) A previously approved animal drug to be contained in medicated
feed blocks under Sec. 510.455 of this chapter or as a liquid feed
supplement under Sec. 558.5 of this chapter; or
(7) Approval of a drug for use in animal feeds if such drug has
been approved under Sec. 514.2 or 514.9 of this chapter for other uses.
(b) [Reserved]
(c) Action on an NADA, abbreviated application, or a supplement for
substances that occur naturally in the environment when the action does
not alter significantly the concentration or distribution of the
substance, its metabolites, or degradation products in the environment.
(d) Action on an NADA, abbreviated application, or a supplement to
such applications, for:
(1) Drugs intended for use in nonfood animals;
(2) Anesthetics, both local and general, that are individually
administered;
(3) Nonsystemic topical and ophthalmic animal drugs;
(4) Drugs for minor species, including wildlife and endangered
species, when the drug has been previously approved for use in another
or the same species where similar animal management practices are used;
and
(5) Drugs intended for use under prescription or veterinarian's
order for therapeutic use.
(e) Action on an INAD.
(f) Action on an application submitted under section 512(m) of the
act.
(g) Withdrawal of approval of an NADA or an abbreviated NADA.
(h) Withdrawal of approval of a food additive petition that reduces
or eliminates animal feed uses of a food additive.
Sec. 25.34 Devices and electronic products.
The classes of actions listed in this section are categorically
excluded and, therefore, ordinarily do not require the preparation of
an EA or an EIS:
(a) Action on a device premarket notification submission under
subpart E of part 807 of this chapter.
(b) Classification or reclassification of a device under part 860
of this chapter.
(c) Issuance, amendment, or repeal of a standard for a class II
medical device or an electronic product, and issuance of exemptions or
variances from such a standard.
(d) Approval of a PMA or a notice of completion of a PDP or amended
or supplemental applications or notices for a class III medical device
if the device is of the same type and for the same use as a previously
approved device.
(e) Changes in the PMA or a notice of completion of a PDP for a
class III medical device that do not require submission of an amended
or supplemental application or notice.
(f) Issuance of a restricted device regulation if it will not
result in increases in the existing levels of use or changes in the
intended uses of the product or its substitutes.
[[Page 14940]]
(g) Action on an application for an IDE or an authorization to
commence a clinical investigation under an approved PDP.
(h) Issuance of a regulation exempting from preemption a
requirement of a State or political subdivision concerning a device, or
a denial of an application for such exemption.
Subpart D--Preparation of Environmental Documents
Sec. 25.40 Environmental assessments.-
(a) As defined by CEQ in 40 CFR 1508.9, an EA is a concise public
document that serves to provide sufficient evidence and analysis for an
agency to determine whether to prepare an EIS or a FONSI. The EA shall
include brief discussions of the need for the proposal, of alternatives
as required by section 102(2)(E) of NEPA, of the environmental impacts
of the proposed action and alternatives, and a listing of agencies and
persons consulted. An EA shall be prepared for each action not
categorically excluded in Secs. 25.30, 25.31, 25.32, 25.33, or 25.34.
The EA shall focus on relevant environmental issues and shall be a
concise, objective, and well-balanced document that allows the public
to understand the agency's decision. If potentially adverse
environmental impacts are identified for an action or group of related
actions, the EA shall discuss any reasonable alternative course of
action that offers less environmental risk or that is environmentally
preferable to the proposed action. The use of a scientifically
justified tiered testing approach, in which testing may be stopped when
the results suggest that no significant impact will occur, is an
acceptable approach.
(b) Generally, FDA requires an applicant to prepare an EA and make
necessary corrections to it. Ultimately, FDA is responsible for the
scope and content of EA's and may include additional information in
environmental documents when warranted.
(c) Information concerning the nature and scope of information that
an applicant or petitioner shall submit in an EA may be obtained from
the center or other office of the agency having responsibility for the
action that is the subject of the environmental evaluation. Applicants
and petitioners are encouraged to submit proposed protocols for
environmental studies for technical review by agency staff. Applicants
and petitioners also are encouraged to consult applicable FDA EA
guidance documents, which provide additional advice on how to comply
with FDA regulations.
(d) Consistent with 40 CFR 1500.4(j) and 1502.21, EA's may
incorporate by reference information presented in other documents that
are available to FDA and to the public.
(e) The agency evaluates the information contained in an EA and any
public input to determine whether it is accurate and objective, whether
the proposed action may significantly affect the quality of the human
environment, and whether an EIS or FONSI will be prepared. The
responsible agency official designated in part 5 of this chapter as
responsible for the underlying action examines the environmental risks
of the proposed action and the alternative courses of action, selects a
course of action, and ensures that any necessary mitigating measures
are implemented as a condition for approving the selected course of
action.
Sec. 25.41 Findings of no significant impact.
(a) As defined by the CEQ regulations (40 CFR 1508.13), a FONSI is
a document prepared by a Federal agency stating briefly why an action,
not otherwise excluded, will not significantly affect the human
environment and for which, therefore, an EIS will not be prepared. A
FONSI includes the EA or a summary of it and a reference to any other
related environmental documents.
(b) The agency official(s) responsible for approving the FONSI will
sign the document, thereby establishing that the official(s) approve(s)
the conclusion not to prepare an EIS for the action under
consideration.
Sec. 25.42 Environmental impact statements.
(a) As defined by CEQ regulations (40 CFR 1508.11) and section
102(2)(C) of NEPA, an EIS should be a clear, concise, and detailed
written statement describing:
(1) The environmental impacts of a proposed action;
(2) Any adverse effects that cannot be avoided if the action is
implemented;
(3) Alternatives to the action;
(4) The relationship between local short-term uses of the
environment and the maintenance and enhancement of long-term
productivity; and
(5) Any irreversible and irretrievable commitments of resources
that would be involved in the proposed action should it be implemented.
(b) The CEQ regulations (40 CFR 1501.7 and part 1502) describe the
process for determining the scope of an EIS and provide detailed
requirements for the preparation of draft and final EIS's. CEQ format
and procedures for preparing EIS shall be followed.
(c) Under the conditions prescribed in 40 CFR 1502.9, the agency
will prepare a supplement for a draft or final EIS and introduce the
supplement into the administrative record.
Sec. 25.43 Records of decisions.
(a) In cases requiring environmental impact statements, at the time
of its decision, the agency shall prepare a concise public record of
decision.
(b) The record of decision shall:
(1) State what the decision was;
(2) Identify and discuss alternatives considered by the agency in
reaching its decision;
(3) State whether all practicable means to avoid or minimize
environmental harm have been adopted, and if not, why not; and
(4) Discuss and implement any monitoring and enforcement program
necessary to affect mitigation.
Sec. 25.44 Lead and cooperating agencies.--
For actions requiring the preparation of an EIS, FDA and other
affected Federal agencies will agree which will be the lead agency and
which will be the cooperating agencies. The responsibilities of lead
agencies and cooperating agencies are described in the CEQ regulations
(40 CFR 1501.5 and 1501.6, respectively). If an action affects more
than one center within FDA, the Commissioner of Food and Drugs will
designate one of these units to be responsible for coordinating the
preparation of any required environmental documentation.
Sec. 25.45 Responsible agency official.
(a) The person designated in part 5 of this chapter as the
responsible agency official for the underlying action is responsible
for preparing environmental documents or ensuring that they are
prepared.
(b) The responsible agency official will weigh any environmental
impacts of each alternative course of action, including possible
mitigation measures, and will balance environmental impacts with the
agency's objectives in choosing an appropriate course of action. The
weighing of any environmental impacts of alternatives in selecting a
final course of action will be reflected in the agency's record of
formal decisionmaking as required by 40 CFR 1505.2.
Subpart E--Public Participation and Notification of Environmental
Documents
Sec. 25.50 General information.
(a) To the extent actions are not protected from disclosure by
existing law applicable to the agency's operation, FDA will involve the
public
[[Page 14941]]
in preparing and implementing its NEPA procedures and will provide
public notice of NEPA-related hearings, public meetings, and the
availability of environmental documents.
(b) Many FDA actions involving investigations, review, and approval
of applications, and premarket notifications for human drugs, animal
drugs, biologic products, and devices are protected from disclosure
under the Trade Secret Act, 18 U.S.C. 1905, and 301(j) of the act.
These actions are also protected from disclosure under FDA's
regulations including part 20, Secs. 312.130(a), 314.430(b), 514.11(b),
514.12(a), 601.50(a), 601.51(a), 807.95(b), 812.38(a), and 814.9(b) of
this chapter. Even the existence of applications for human drugs,
animal drugs, biologic products, and devices is protected from
disclosure under these regulations. Therefore, unless the existence of
applications for human drugs, animal drugs, biologic products, or
premarket notification for devices has been made publicly available,
the release of the environmental document before approval of human
drugs, animal drugs, biologic products, and devices is inconsistent
with statutory requirements imposed on FDA. Appropriate environmental
documents, comments, and responses will be included in the
administrative record to the extent allowed by applicable laws.
Sec. 25.51 Environmental assessments and findings of no significant -
impact.
(a) Data and information that are protected from disclosure by 18
U.S.C. 1905 or 21 U.S.C. 331(j) or 360j(c) shall not be included in the
portion of environmental documents that is made public. When such data
and information are pertinent to the environmental review of a proposed
action, an applicant or petitioner shall submit such data and
information separately in a confidential section We have spend 20 years
trying to keep confidential information out of Eas. I suggest the
preceding revision. Gail said she prefers confidential appendix to the
EA.and shall summarize the confidential data and information in the EA
to the extent possible.
(b) FONSI's and EA's will be available to the public in accordance
with 40 CFR 1506.6 as follows:
(1) When the proposed action is the subject of a notice of proposed
rulemaking or a notice of filing published in the Federal Register, the
notice shall state that no EIS is necessary and that the FONSI and the
EA are available for public inspection at FDA's Dockets Management
Branch. If the responsible agency official is unable to complete
environmental consideration of the proposed action before a notice of
filing of a food or color additive petition is required to be published
under the act, and if the subsequent environmental analysis leads to
the conclusion that no EIS is necessary, the Federal Register document
publishing the final regulation rather than the notice of filing shall
state that no EIS is necessary and that the FONSI and the EA are
available upon request and filed in FDA's Dockets Management Branch.
(2) For actions for which notice is not published in the Federal
Register, the FONSI and the EA shall be made available to the public
upon request according to the procedures in 40 CFR 1506.6.
(3) For a limited number of actions, the agency may make the FONSI
and EA available for public review (including review by State and
areawide information clearinghouses) for 30 days before the agency
makes its final determination whether to prepare an EIS and before the
action may begin, as described in 40 CFR 1501.4(e). This procedure will
be followed when the proposed action is, or is closely similar to, one
that normally requires an EIS or when the proposed action is one
without precedent.
Sec. 25.52 Environmental impact statements.
(a) If FDA determines that an EIS is necessary for an action
involving investigations or approvals for drugs, animal drugs, biologic
products, or devices, an EIS will be prepared but will become available
only at the time of the approval of the product. Disclosure will be
made in accordance with 40 CFR 1506.6 and part 20 of this chapter. The
EIS will in all other respects conform to the requirements for EIS's as
specified in 40 CFR part 1502 and 1506.6(f).
(b) Comments on the EIS may be submitted after the approvalof the
drug, animal drug, biologic product, and device. Those comments can
form the basis for the agency to consider beginning an action to
withdraw the approval of applications for a drug, animal drug, biologic
product, or to withdraw premarket notifications or premarket approval
applications for devices.
(c) In those cases where the existence of applications and
premarket notifications for drugs, animal drugs, biologic products, or
devices has already been disclosed before the agency approves the
action, the agency will make diligent effort (40 CFR 1506.6) to involve
the public in preparing and implementing the NEPA procedures for EIS's
while following its own disclosure requirements including those listed
in part 20, Secs. 312.130(b), 314.430(d), 514.11(d), 514.12(b),
601.51(d), 807.95(e), 812.38(b), and 814.9(d) of this chapter.
(d) Draft and final EIS's, comments, and responses will be included
in the administrative record and will be available from the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
Subpart F--Other Requirements
Sec. 25.60 Environmental effects abroad of major agency actions.
(a) In accordance with Executive Order 12114, ``Environmental
Effects Abroad of Major Federal Actions'' of January 4, 1979 (44 FR
1957, January 9, 1977), the responsible agency official, in analyzing
actions under his or her program, shall consider the environmental
effects abroad, including whether the actions involve:
(1) Potential environmental effects on the global commons and areas
outside the jurisdiction of any nation, e.g., oceans and the upper
atmosphere.
(2) Potential environmental effects on a foreign nation not
participating with or otherwise involved in an FDA activity.
(3) The export of products (or emissions) that in the United States
are prohibited or strictly regulated because their effects on the
environment create a serious public health risk.
(4) Potential environmental effects on natural and ecological
resources of global importance designated under the Executive Order.
(b) Before deciding on any action falling into the categories
specified in paragraph (a) of this section, the responsible agency
official shall determine in accordance with section 2-3 of the
Executive Order whether such actions may have a significant
environmental effect abroad.
(c) If the responsible agency official determines that an action
may have a significant environmental effect abroad, the responsible
agency official shall determine in accordance with section 2-4(a) and
(b) of the Executive Order, whether the subject action calls for:
(1) An EIS;
(2) A bilateral or multilateral environmental study; or
(3) A concise environmental review.
(d) In preparing environmental documents under this subpart, the
responsible official shall:
(1) Determine, as provided in section 2-5 of the Executive Order,
whether proposed actions are subject to the exemptions, exclusions, and
[[Page 14942]]
modification in contents, timing, and availability of documents.
(2) Coordinate all communications with foreign governments
concerning environmental agreements and other arrangements in
implementing the Executive Order.
Dated: March 19, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-8090 Filed 4-2-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-8037 Special Conditions: Embraer (Brazil) Aircraft Corporation Model EMB-145 Airplane; High-Intensity Radiated Fields
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14684-14685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8037]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 61, No. 65 / Wednesday, April 3, 1996 /
Proposed Rules
[[Page 14684]]
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 25
[Docket No. NM-123; Notice No. SC-96-2-NM]
Special Conditions: Embraer (Brazil) Aircraft Corporation Model
EMB-145 Airplane; High-Intensity Radiated Fields
AGENCY: Federal Aviation Administration, DOT.
ACTION: Notice of proposed special conditions.
-----------------------------------------------------------------------
SUMMARY: This document proposes special conditions for the Embraer
Model EMB-145 airplane. This new airplane will utilize new avionics/
electronic systems that provide critical data to the flightcrew. The
applicable regulations do not contain adequate or appropriate safety
standards for the protection of these systems from the effects of high-
intensity radiated fields. These proposed special conditions contain
the additional safety standards that the Administrator considers
necessary to establish a level of safety equivalent to that established
by the existing airworthiness standards.
DATES: Comments must be received on or before May 20, 1996.
ADDRESSES: Comments on this proposal may be mailed in duplicate to:
Federal Aviation Administration, Office of the Assistant Chief Counsel,
Attn: Rules Docket (ANM-7), Docket No. NM-123, 1601 Lind Avenue SW.,
Renton, Washington, 98055-4056; or delivered in duplicate to the Office
of the Assistant Chief Counsel at the above address. Comments must be
marked: Docket No. NM-123. Comments may be inspected in the Rules
Docket weekdays, except Federal holidays, between 7:30 a.m. and 4:00
p.m.
FOR FURTHER INFORMATION CONTACT:
Gerry Lakin, FAA, Standardization Branch, ANM-113, Transport Airplane
Directorate, Aircraft Certification Service, 1601 Lind Avenue SW.,
Renton, Washington, 98055-4056; telephone (206) 227-1187; facsimile
(206) 227-1149.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interested persons are invited to participate in the making of
these proposed special conditions by submitting such written data,
views, or arguments as they may desire. Communications should identify
the regulatory docket or notice number and be submitted in duplicate to
the address specified above. All communications received on or before
the closing date for comments will be considered by the Administrator
before further rulemaking action is taken on these proposals. The
proposals contained in this notice may be changed in light of comments
received. All comments submitted will be available in the Rules Docket
for examination by interested persons, both before and after the
closing date for comments. A report summarizing each substantive public
contact with FAA personnel concerning this rulemaking will be filed in
the docket. Persons wishing the FAA to acknowledge receipt of their
comments submitted in response to this notice must submit with those
comments a self-addressed, stamped postcard on which the following
statement is made: ``Comments to Docket No. NM-123.'' The postcard will
be date stamped and returned to the commenter.
Background
On August 30, 1989, Embraer Aircraft Corporation, Caixa Postal 343,
12227-901 Sao Jose dos Campos, Sao Paulo SP Brasil, applied for a new
type certificate in the transport airplane category for the Model EMB-
145 airplane. The EMB-145 is a T-tail, low swept wing, small transport
airplane powered by two Allison GMA-3007A turbofan engines mounted on
pylons extending from the aft fuselage. Each engine will be capable of
delivering 7,040 pounds thrust. The flight controls will be powered and
capable of manual reversion. The airplane has a seating capacity of up
to 50 passengers, and a maximum takeoff weight of 42,328 pounds.
Type Certification Basis
Under the provisions of Sec. 21.17 of the FAR, Embraer must show,
except as provided in Sec. 25.2, that the Model EMB-145 meets the
applicable provisions of part 25, effective February 1, 1965, as
amended by Amendments 25-1 through 25-75. In addition, the proposed
certificate basis for the Model EMB-145 includes part 34, effective
September 10, 1990, plus any amendments in effect at the time of
certification; and part 36, effective December 1, 1969, as amended by
Amendment 36-1 through the amendment in effect at the time of
certification. No exemptions are anticipated. The special conditions
that may be developed as a result of this notice will form an
additional part of the type of certification basis. In addition, the
certification basis may include other special conditions that are not
relevant to these proposed special conditions.
If the Administrator finds that the applicable airworthiness
regulations (i.e., part 25, as amended) do not contain adequate or
appropriate safety standards for the Embraer Model EMB-145 because of a
novel or unusual design feature, special conditions are prescribed
under the provisions of Sec. 21.16 to establish a level of safety
equivalent to that established in the regulations.
Special conditions, as appropriate, are issued in accordance with
Sec. 11.49 of the FAR after public notice, as required by Secs. 11.28
and 11.29, and become part of the type certification basis in
accordance with Sec. 21.17(a)(2).
Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, the special conditions would also apply to the
other model under the provisions of Sec. 21.101(a)(1).
Novel or Unusual Design Features
The Model EMB-145 incorporates new avionic/electronic
installations, including a digital Electronic Flight Instrument System
(EFIS), Air Data System, Attitude and Heading Reference System (AHRS),
Navigation and Communication System, Autopilot System, and a Full
Authority Digital Engine Control (FADEC) system that controls critical
engine parameters. These systems may be vulnerable to high-intensity
radiated fields (HIRF) external to the airplane.
[[Page 14685]]
Discussion
There is no specific regulation that addresses protection
requirements for electrical and electronic systems from HIRF. Increased
power levels from ground-based radio transmitters and the growing use
of sensitive electrical and electronic systems to command and control
airplanes have made it necessary to provide adequate protection.
To ensure that a level of safety is achieved equivalent to that
intended by the regulations incorporated by reference, special
conditions are proposed for the Embraer Model EMB-145, which would
require that new technology electrical and electronic systems, such as
the EFIS, FADEC, AHRS, etc., be designed and installed to preclude
component damage and interruption of function due to both the direct
and indirect effects of HIRF.
With the trend toward increased power levels from ground-based
transmitters, plus the advent of space and satellite communications,
coupled with electronic command and control of the airplane, the
immunity of critical digital avionics systems to HIRF must be
established.
It is not possible to precisely define the HIRF to which the
airplane will be exposed in service. There is also uncertainty
concerning the effectiveness of airframe shielding for HIRF.
Furthermore, coupling of electromagnetic energy to cockpit-installed
equipment through the cockpit window apertures is undefined. Based on
surveys and analysis of existing HIRF emitters, an adequate level of
protection exists when compliance with the HIRF protection special
condition is shown with either paragraphs 1 or 2 below:
1. A minimum threat of 100 volts per meter peak electric field
strength from 10KHz to 18GHz.
a. The threat must be applied to the system elements and their
associated wiring harnesses without the benefit of airframe shielding.
b. Demonstration of this level of protection is established through
system tests and analysis.
2. A threat external to the airframe of the following field
strengths for the frequency ranges indicated.
------------------------------------------------------------------------
Peak (V/ Average
Frequency M) (V/M)
------------------------------------------------------------------------
10 KHz-100 KHz...................................... 50 50
100 KHz-500 KHz..................................... 60 60
500 KHz-2000 KHz.................................... 70 70
2 MHz-30 MHz........................................ 200 200
30 MHz-100 MHz...................................... 30 30
100 MHz-200 MHz..................................... 150 33
200 MHz-400 MHz..................................... 70 70
400 MHz-700 MHz..................................... 4,020 935
700 MHz-1000 MHz.................................... 1,700 170
1 GHz-2 GHz......................................... 5,000 990
2 GHz-4 GHz......................................... 6,680 840
4 GHz-6 GHz......................................... 6,850 310
6 GHz-8 GHz......................................... 3,600 670
8 GHz-12 GHz........................................ 3,500 1,270
12 GHz-18 GHz....................................... 3,500 360
18 GHz-40 GHz....................................... 2,100 750
------------------------------------------------------------------------
As discussed above, the proposed special conditions would be
applicable initially to the Embraer Model EMB-145. Should Embraer apply
at a later date for a change to the type certificate to include another
model incorporating the same novel or unusual design feature, the
special conditions would apply to that model as well under the
provisions of Sec. 21.101(a)(1).
Conclusion
This action affects only certain design features on the Embraer
Model EMB-145 airplane. It is not a rule of general applicability and
affects only the manufacturer who applied to the FAA for approval of
these features on the airplane.
List of Subjects in 14 CFR Part 25
Aircraft, Aviation safety, Reporting and recordkeeping
requirements.
The authority citation for these special conditions is as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
The Proposed Special Conditions
Accordingly, the Federal Aviation Administration (FAA) proposes the
following special conditions as part of the type certification basis
for the Embraer Model EMB-145 series airplanes.
1. Protection from Unwanted Effects of High-Intensity Radiated
Fields (HIRF). Each electrical and electronic system that performs
critical functions must be designed and installed to ensure that the
operation and operational capability of these systems to perform
critical functions are not adversely affected when the airplane is
exposed to high-intensity radiated fields.
2. For the purpose of these special conditions, the following
definition applies: Critical Functions. Functions whose failure would
contribute to or cause a failure condition that would prevent the
continued safe flight and landing of the airplane.
Issued in Renton, Washington, on March 25, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-8037 Filed 4-2-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-8016 Federal Acquisition Regulation; Withdrawal of Proposals
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Page 14944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8016]
[[Page 14943]]
_______________________________________________________________________
Part IV
Department of Defense
General Services Administration
National Aeronautics and Space Administration
_______________________________________________________________________
48 CFR Part 15, et al.
Federal Acquisition Regulations (FAR): Withdrawal of Proposals;
Proposed Rule
Federal Register / Vol. 61, No. 65 / Wednesday, April 3, 1996 /
Proposed Rules
=======================================================================
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[[Page 14944]]
DEPARTMENT OF DEFENSE
GENERAL SERVICES ADMINISTRATION
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
48 CFR Parts 15, 17, 31, and 52
[FAR Cases 90-52, 91-018, 95-008, and 92-024]
RINs 9000-AE21, 9000-AE65, 9000-AG67, and 9000-AG53
Federal Acquisition Regulation; Withdrawal of Proposals
AGENCIES: Department of Defense (DOD), General Services Administration
(GSA), and National Aeronautics and Space Administration (NASA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Civilian Agency Acquisition Council and the Defense
Acquisition Regulations Council have decided to withdraw four proposed
rules published in the Federal Register as follows:
FAR Case 90-52, Evaluation Factors (55 FR 46930, November 7, 1990).
This rule proposed an amendment to the Federal Acquisition Regulation
(FAR) to state, among other things, that quality must be considered in
planning every source selection and, if appropriate, included as an
evaluation factor. A final rule, 93-002, Past Performance Information,
was published in the Federal Register at 60 FR 16718, March 31, 1995.
The final rule revised the FAR in a manner which meets the intent of
the proposed rule concerning evaluation factors, by allowing
``quality'' to be addressed through inclusion in one or more of the
non-cost evaluation factors or subfactors (i.e., past performance).
Therefore, the proposed rule is withdrawn.
FAR Case 91-018, Special Contracting Methods (Multiyear
Contracting) (56 FR 20507, May 3, 1991). This rule proposed amendments
to the FAR concerning multiyear solicitations and contracts. The case
has been superseded by FAR Case 94-712, Multiyear Contracting, which
implements Sections 1022 and 1072 of the Federal Acquisition
Streamlining Act of 1994 (Pub. L. 103-355). Therefore, the proposed
rule is withdrawn.
FAR Case 95-008, Competitive Range (60 FR 56035, November 6, 1995).
This rule proposed an amendment to the FAR to delete the statement that
a proposal should be included in the competitive range. Section 4203 of
the 1996 DoD Authorization Act. (Public Law 104-106) contains authority
for establishing more flexibility in determining competitive ranges.
The Councils believe that the DOD Procurement Process Reform Process
Action Team's recommended FAR change would not be best addressed under
the more general revisions that will arise from implementation of the
acquisition reform provisions of the 1996 DOD Authorization Act.
Therefore, the proposed rule is withdrawn.
FAR Case 92-024, Employee Stock Ownership Plans (60 FR 56216,
November 7, 1995). This rule proposed revisions to the FAR to ensure
uniform treatment on the allowability of costs of all employee stock
ownership plans (ESOPs), irrespective of whether the ESOP is structured
as a pension plan or as deferred compensation,including making the
interest costs of leveraged ESOPs expressly unallowable.
The respondents expressed concerns that the rule, as currently
written, would (1) inhibit the establishment of new ESOPs and the
expansion of existing ESOPs by Government contractors, and (2)
adversely impact the financial condition of Government contractors with
existing ESOPs. Therefore, this rule has been withdrawn.
for further information contact: Ms. Beverly Fayson, FAR Secretariat,
Room 4037, GS Building, Washington, DC 20405 (202) 501-4755.
List of Subjects in 48 CFR Parts 15, 17, 31, and 52
Government procurement.
Dated: March 27, 1996.
Edward C. Loeb,
Director, Federal Acquisition Policy Division.
[FR Doc. 96-8016 Filed 4-2-96; 8:45 am]
BILLING CODE 6820-EP-P
Complete official Federal Register PDF
FR Doc. 96-8015 Federal Acquisition Regulation; OFPP Policy Letter 93-1, Management Oversight of Service Contracting
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14946-14947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8015]
[[Page 14945]]
_______________________________________________________________________
Part V
Department of Defense
General Services Administration
National Aeronautics and Space Administration
_______________________________________________________________________
48 CFR Parts 9, 35, and 37
Federal Acquisition Regulation; OFPP Policy Letter 93-1, Management
Oversight of Service Contracting; Proposed Rule
Federal Register / Vol. 61, No. 65 / Wednesday, April 3, 1996 /
Proposed Rules
[[Page 14946]]
DEPARTMENT OF DEFENSE
GENERAL SERVICES ADMINISTRATION
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
48 CFR Parts 9, 35, and 37
[FAR Case 94-008]
RIN 9000-AG86
Federal Acquisition Regulation; OFPP Policy Letter 93-1,
Management Oversight of Service Contracting
AGENCIES: Department of Defense (DOD), General Services Administration
(GSA), and National Aeronautics and Space Administration (NASA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Civilian Agency Acquisition Council and the Defense
Acquisition Regulations Council are proposing amendments to the Federal
Acquisition Regulation to provide agency guidance on the management of
service contracts. This regulatory action was not subject to Office of
Management and Budget review under Executive Order 12866, dated
September 30, 1993.
DATES: Comments should be submitted on or before June 3, 1996 to be
considered in the formulation of a final rule.
ADDRESSES: Interested parties should submit written comments to:
General Services Administration, FAR Secretariat (VRS), 18th & F
Streets, NW, Room 4037, Washington, DC 20405. Please cite FAR case 94-
008 in all correspondence related to this case.
FOR FURTHER INFORMATION CONTACT: Mr. Peter O'Such at (202) 501-1759 in
reference to this FAR case. For general information, contact the FAR
Secretariat, Room 4037, GS Building, Washington, DC 20405 (202) 501-
4755. Please cite FAR case 94-008.
SUPPLEMENTARY INFORMATION:
A. Background
On May 24, 1994, the Office of Federal Procurement Policy (OFPP)
reissued, as a final policy letter, and published in the Federal
Register (59 FR 26818), Policy Letter 93-1, entitled ``Management
Oversight of Service Contracting''. The policy letter provides
Governmentwide guiding principles which are intended to improve the
acquisition, management, and administration of service contracts.
The proposed FAR rule removes references to advisory and assistance
services at 9.505-3; removes the reference to OMB Circular No. A-120,
``Guidelines for the Use of Advisory and Assistance Services'' from
35.017-2(i); clarifies 37.000; adds paragraphs (d) through (g) to
37.102 to address additional agency responsibilities concerning service
contracts in general; and adds a new Subpart 37.5, Management Oversight
of Service Contracts, to address FAR implementation of OFPP Policy
Letter 93-1.
B. Regulatory Flexibility Act
The proposed changes may have a significant economic impact on a
substantial number of small entities within the meaning of the
Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because it
implements OFPP Policy Letter 93-1, Management Oversight of Service
Contracting, which establishes Governmentwide policies concerning
contracting for services. These changes will affect the manner in which
Federal agencies will develop requirements for, award, manage, and
administer contracts for services which, in turn, will affect each
small entity which is awarded a contract for services. An Initial
Regulatory Flexibility Analysis (IRFA) has been prepared and will be
provided to the Chief Counsel for Advocacy for the Small Business
Administration. A copy of the IRFA may be obtained from the FAR
Secretariat. Comments are invited. Comments from small entities
concerning the affected FAR subpart will be considered in accordance
with 5 U.S.C. 610. Such comments must be submitted separately and
should cite 5 U.S.C. 601, et seq. (FAR Case 94-008), in correspondence.
C. Paperwork Reduction Act
The Paperwork Reduction Act does not apply because the proposed
changes to the FAR do not impose recordkeeping or information
collection requirements, or collections of information from offerors,
contractors, or members of the public which require the approval of the
Office of Management and Budget under 44 U.S.C. 3501, et seq.
List of Subjects in 48 CFR Parts 9, 35, and 37
Government procurement.
Dated: March 26, 1996.
Edward C. Loeb,
Director, Federal Acquisition, Policy Division.
Therefore, it is proposed that 48 CFR Parts 9, 35, and 37 be
amended as set forth below:
1. The authority citation for 48 CFR Parts 9, 35, and 37 continues
to read as follows:
Authority: 40 U.S.C. 486(c); 10 U.S.C. chapter 137; and 42
U.S.C. 2473(c).
PART 9--CONTRACTOR QUALIFICATIONS
2. Section 9.505-3 is revised to read as follows:
9.505-3 Providing evaluation services.
Contracts for the evaluation of offers for products or services
shall not be awarded to a contractor that will evaluate its own offers
for products or services, or those of a competitor, without proper
safeguards to ensure objectivity to protect the Government's interests.
PART 35--RESEARCH AND DEVELOPMENT CONTRACTING
3. Section 35.017-2 is amended by revising paragraph (i) to read as
follows:
35.017-2 Establishing or changing an FFRDC.
* * * * *
(i) Quantity production or manufacturing is not performed unless
authorized by legislation.
* * * * *
PART 37--SERVICE CONTRACTING
4. Section 37.000 is revised to read as follows:
37.000 Scope of part.
This part prescribes policy and procedures which are specific to
the acquisition and management of services by contract. This part
applies to all contracts for services regardless of the type of
contract or kind of service being acquired. Additional guidance for
research and development services is in part 35; architect-engineering
services is in part 36; information resources is in part 39; and
transportation services is in part 47. Parts 35, 36, 39, and 47 take
precedence over this part in the event of inconsistencies. This part
includes, but is not limited to, contracts for services to which the
Service Contract Act of 1965, as amended, applies (see subpart 22.10).
5. Section 37.102 is amended by adding paragraphs (d) through (g)
to read as follows:
37.102 Policy.
* * * * *
(d) Agency program officials are responsible for accurately
describing the need to be filled, or problem to be resolved, through
service contracting in a manner that assures full understanding and
responsive performance by contractors and in so doing, should obtain
assistance from contracting officials, as needed;
[[Page 14947]]
(e) Agencies shall establish effective management practices in
accordance with the OFPP Policy Letter 93-1, Management Oversight of
Service Contracting, to prevent fraud, waste, and abuse in service
contracting.
(f) Services are to be obtained in the most cost-effective manner,
without barriers to full and open competition, and free of any
potential conflicts of interest.
(g) Agencies shall ensure that sufficiently trained and experienced
officials are available within the agency to manage and oversee the
contract administration function.
6. Subpart 37.5 is added to read as follows:
Subpart 37.5--Management Oversight of Service Contracts
Sec.
37.500 Scope of subpart.
37.501 Definition.
37.502 Exclusions.
37.503 Agency-head responsibilities.
37.504 Contracting officials responsibilities.
37.500 Scope of subpart.
This subpart establishes responsibilities for implementing Office
of Federal Procurement Policy (OFPP) Policy Letter 93-1, Management
Oversight of Service Contracting.
37.501 Definition.
Best practices, as used in this subpart, means techniques that
agencies may use to help detect problems in the acquisition, management
and administration of service contracts. Best practices are practical
techniques gained from experience that agencies may use to improve the
procurement process.
37.502 Exclusions.
(a) This subpart does not apply to services that are (1) obtained
through personnel appointments and advisory committees; (2) obtained
through personal service contracts authorized by statute; (3) for
construction as defined in FAR 36.102; or (4) obtained through
interagency agreements where the work is being performed by in-house
Federal employees.
(b) Services obtained under contracts below the simplified
acquisition threshold and services incidental to supply contracts are
excluded from coverage of this subpart. Good management practices and
contract administration techniques should be used regardless of the
contracting method.
37.503 Agency-head responsibilities.
The agency head or designee should ensure that--
(a) Requirements for services are clearly defined and appropriate
performance standards are developed so that the agency's requirements
can be understood by potential offerors and that performance in
accordance with contract terms and conditions will meet the agency's
requirements.
(b) Service contracts are awarded and administered in a manner that
will provide the customer its goods and services within budget and in a
timely manner.
(c) Specific procedures are in place before contracting for
services to assure compliance with OFPP Policy Letters 92-1, Inherently
Governmental Functions, 91-2, Service Contracting, and 89-1, Conflicts
of Interest Policies Applicable to Consultants.
(d) Strategies are developed and necessary staff training is
initiated to assure effective implementation of the policies in FAR
37.102.
37.504 Contracting officials responsibilities.
Contracting officials should ensure that ``best practices''
techniques are used when contracting for services and in contract
management and administration (see OFPP Policy Letter 93-1).
[FR Doc. 96-8015 Filed 4-2-96; 8:45 am]
BILLING CODE 6820-EP-P
Complete official Federal Register PDF
FR Doc. 96-8014 Expedited Procedures for Processing Rail Rate Reasonableness, Exemption and Revocation Proceedings; Correction
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Page 14735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8014]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Surface Transportation Board
49 CFR Parts 1100 through 1149
[STB Ex Parte No. 527]
Expedited Procedures for Processing Rail Rate Reasonableness,
Exemption and Revocation Proceedings; Correction
AGENCY: Surface Transportation Board.
ACTION: Advance notice of proposed rulemaking; correction.
-----------------------------------------------------------------------
SUMMARY: This document contains corrections to the advance notice of
proposed rulemaking that was published Friday, March 22, 1996, at 61 FR
11799. In that notice the Board solicited comments on how existing
regulations could be modified to expedite the handling of rail rate
reasonableness and exemption/revocation proceedings.
FOR FURTHER INFORMATION CONTACT: Thomas J. Stilling, (202) 927-7312.
[TDD for the hearing impaired: (202) 927-5721.]
Accordingly, the publication on March 22, 1996 of the advance
notice of proposed rulemaking [STB Ex Parte No. 527] which was the
subject of FR Doc. 96-6986, is corrected as follows:
1. On page 11799, 3rd column, in the heading of the document, the
CFR citation should read as set forth above.
2. On page 11799, 3rd column, in the SUMMARY, lines 14-15, the
reference to ``49 CFR Parts 1000 through 1149'' should read ``49 CFR
Parts 1100 through 1149''.
3. On page 11800, 2nd column, 5th paragraph of SUPPLEMENTARY
INFORMATION, lines 5-6, the reference to ``49 CFR 1000 through 1129''
should read ``49 CFR 1100 through 1129''.
Vernon A. Williams,
Secretary.
[FR Doc. 96-8014 Filed 4-2-96; 8:45 am]
BILLING CODE 4915-00-P
Complete official Federal Register PDF
FR Doc. 96-7918 Approval and Promulgation of Implementation Plans; Tennessee: Revisions to Chattanooga/Hamilton County Regulations for Definitions of Ambient Air Standards for Particulate Matter
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Page 14694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7918]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[TN-111-1-7094b; FRL-5442-8]
Approval and Promulgation of Implementation Plans; Tennessee:
Revisions to Chattanooga/Hamilton County Regulations for Definitions of
Ambient Air Standards for Particulate Matter
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The EPA proposes to approve the State implementation plan
(SIP) revision submitted by the State of Tennessee for the purpose of
incorporating changes to regulations for ambient air standards for
particulate matter and changes to several definitions in the
Chattanooga/Hamilton County portion of the Tennessee SIP. In the final
rules section of this Federal Register, the EPA is approving the
State's SIP revision as a direct final rule without prior proposal
because the Agency views this as a noncontroversial revision amendment
and anticipates no adverse comments. A detailed rationale for the
approval is set forth in the direct final rule. If no adverse comments
are received in response to this proposed rule, no further activity is
contemplated in relation to this proposed rule. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. The EPA will not institute a second comment period
on this document. Any parties interested in commenting on this document
should do so at this time.
DATES: To be considered, comments must be received by May 3, 1996.
ADDRESSES: Written comments on this action should be addressed to Karen
Borel, at the EPA Regional Office listed below. Copies of the documents
relative to this action are available for public inspection during
normal business hours at the following locations. The interested
persons wanting to examine these documents should make an appointment
with the appropriate office at least 24 hours before the visiting day.
Air and Radiation Docket and Information Center (Air Docket 6102), U.S.
Environmental Protection Agency, 401 M Street, SW., Washington, DC
20460.
Environmental Protection Agency, Region 4 Air Programs Branch, 345
Courtland Street, NE., Atlanta, Georgia 30365.
Chattanooga-Hamilton County Air Pollution Control Bureau, 3511
Rossville Boulevard, Chattanooga, Tennessee 37407.
FOR FURTHER INFORMATION CONTACT: Karen C. Borel, Regulatory Planning
and Development Section, Air Programs Branch, Air, Pesticides & Toxics
Management Division, Region 4 Environmental Protection Agency, 345
Courtland Street, NE., Atlanta, Georgia 30365. The telephone number is
404/347-3555 x4197. Reference file TN111-01-7094.
SUPPLEMENTARY INFORMATION: For additional information see the direct
final rule which is published in the rules section of this Federal
Register.
Dated: February 15, 1996.
Phyllis P. Harris,
Acting Regional Administrator.
[FR Doc. 96-7918 Filed 4-2-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-7878 Removal of Interpretive Bulletins and Regulations Relating to the Employee Retirement Income Security Act of 1974
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14690-14694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7878]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF LABOR
Pension and Welfare Benefits Administration
29 CFR Parts 2509, 2520 and 2550
RIN 1210-AA51
Removal of Interpretive Bulletins and Regulations Relating to the
Employee Retirement Income Security Act of 1974
AGENCY: Pension and Welfare Benefits Administration, Department of
Labor.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This document contains a notice of a proposal to remove from
the Code of Federal Regulations certain interpretive bulletins and
regulations (or portions thereof) under the Employee Retirement Income
Security Act of 1974 (ERISA, 29 U.S.C. 1001, et. seq.) that the
Department of Labor (the Department) believes are obsolete
(collectively, the obsolete regulations). The obsolete regulations
generally provided transitional relief for plan sponsors, plan
administrators, and others subject to the requirements of title I of
ERISA, in coming into compliance with ERISA's requirements in the first
several years following ERISA's enactment in 1974. Because the election
periods or dates of applicability under these rules have expired, the
Department believes that the regulations are no longer
[[Page 14691]]
needed. In other instances, the obsolete regulations are unnecessary
because they merely provide notice of a rescission or withdrawal of
prior guidance or regulations, or were rendered ineffective by a
subsequent Supreme Court decision.
DATES: Comments must be received by June 3, 1996.
ADDRESSES: All written comments and requests for a public hearing
(preferably three copies) should be sent to: Pension and Welfare
Benefits Administration, Office of Regulations and Interpretations,
Room N-5669, 200 Constitution Avenue, N.W., Washington, D.C. 20010.
This notice, as well as all comments received from interested persons,
will be available for public inspection in the Public Disclosure Room,
Pension and Welfare Benefits Administration, U.S. Department of Labor,
Room N-5638, 200 Constitution Ave., N.W., Washington, D.C. 20210.
FOR FURTHER INFORMATION CONTACT: Katherine D. Lewis, Office of
Regulations and Interpretations, Pension and Welfare Benefits
Administration, U.S. Department of Labor, Rm. N-5669, 200 Constitution
Avenue, N.W., Washington, D.C. 20210 (telephone (202) 219-7461), or
Vicki Shteir-Dunn, Plan Benefits Security Division, Office of the
Solicitor, U.S. Department of Labor, Rm. N-4611, 200 Constitution Ave.,
N.W., Washington, D.C. 20210 (telephone (202) 219-8610).
SUPPLEMENTARY INFORMATION: In accordance with the President's Executive
Order No. 12866 of September 1993, ``Regulatory Planning and Review,''
and the President's directive of April 24, 1995, ``Regulatory
Reinvention Initiative,'' the Department has undertaken to identify and
eliminate regulations which are no longer needed. Pursuant to a review
of regulations under the Employee Retirement Income Security Act of
1974 (ERISA), the Department identified 28 interpretative bulletins and
regulations (or portions thereof) which it believes to be obsolete.
Nearly all of these interpretive bulletins and regulations were issued
over fifteen years ago. This document proposes the removal of these
interpretive bulletins, regulations and paragraphs of regulations from
the Code of Federal Regulations. In order to ensure that members of the
public have the opportunity to comment on the proposed removal, the
Department is publishing this notice as a notice of proposed
rulemaking.
The proposal would remove the obsolete regulations prospectively,
as of the date of publication of a final rule, and would have no effect
on their legal effectiveness prior to that date. Following is a brief
description of each of the obsolete interpretive bulletins and
regulations (or portions thereof) proposed for removal by the
Department. All of these items are presently contained in title 29 of
the Code of Federal Regulations.
I. Part 2509--Interpretive Bulletins Relating to the Employee
Retirement Income Security Act of 1974
The Department is proposing to remove interpretive bulletins 75-1,
75-7, 76-2 and 76-3 from subchapter A, part 2509 of the Code of Federal
Regulations (29 CFR Secs. 2509.75-1, 2509.75-7, 2509.76-2 and 2509.76-
3). In addition, the Department is proposing to remove paragraph (b) of
interpretive bulletin 75-2 (29 CFR 2509.75-2).
Interpretive bulletin 75-1 outlines and clarifies section 414(c)(4)
of ERISA, which provides that sections 406 and 407(a) of ERISA
(relating to prohibited transactions) are not applicable to the
provision of certain services between a plan and a party in interest
before June 30, 1977, if certain conditions described in that section
are met. Interpretive bulletin 75-7 supplemental interpretive bulletin
75-1 and provided examples of its application. Interpretive bulletins
76-2 and 76-3 merely gave notice of the rescission or withdrawal of
earlier guidance relating to the definition of ``seasonal industries,''
a matter now under the jurisdiction of the Internal Revenue Service
pursuant to Reorganization Plan No. 4 of 1978. Paragraph (b) of
interpretive bulletin 75-2 took the position that consideration paid
for a contract or policy of insurance issued to a plan would not be
considered plan assets if placed in the general account of the issuing
insurance company, and therefore could not give rise to prohibited
transactions. This interpretation may no longer be relied on as a
result of the December 13, 1993 Supreme Court decision in John Hancock
Mutual Life Insurance Co. v. Harris Trust & Savings Bank, 114 S. Ct.
517 (1993), and therefore, has no force or effect.
II. Part 2520--Rules and Regulations for Reporting and Disclosure
The Department is proposing to remove ten regulations and
provisions of two other regulations from subchapter C, part 2520 of the
Code of Federal Regulations (29 CFR Part 2520), pertaining to reporting
and disclosure under ERISA.
From subpart C of Part 2520, the Department proposes to remove
Sec. 103-6(b)(1)(ii), which defined the current value of plan assets
for purposes of schedules of reportable transactions for plan years
beginning in 1975. The remainder of Sec. 103-6(b)(1) would be revised
to eliminate the reference to Sec. 103-6(b)(1)(ii), and to otherwise
conform to this change. The Department also proposes to remove
Sec. 103-7. This regulation, which provided special accounting rules
for plans filing the annual report for plan years beginning in 1975,
applied only with respect to plan years beginning in 1975 and not to
any subsequent plan years.
The Department proposes to remove the following seven regulations
from subpart D of part 2520. The Department's regulation at Sec. 104-2
postponed the effective date of annual reporting requirements for non-
calendar year plans and extended the reporting requirements under prior
legislation for such plans until the end of the first plan year
beginning after January 1, 1975. This regulation does not apply to
subsequent plan years. The Department's regulation at Sec. 104-3
deferred certain reporting and disclosure requirements for welfare
plans, and provided an alternative method of compliance for pension
plans, until May 30, 1976. The Department's regulation at Sec. 104-5
deferred, until no later than November 16, 1977, the application of
certain reporting and disclosure requirements relating to the summary
plan description for welfare plans. The Department's regulation at
Sec. 104-6 provided an alternative method of compliance for pension
plans which elected to defer the summary plan description reporting and
disclosure requirements. The availability of the deferral expired on
November 16, 1977. The Department's regulation at Sec. 104-28 provided
an extension of time for filing and disclosure of the initial summary
plan description for certain employee benefit plans that became subject
to part 1 of title I of ERISA on or before July 17, 1977. The
regulation does not apply to any subsequent summary plan descriptions.
The Department's regulation at Sec. 104-45 provided a temporary
exemption and alternative method of compliance with respect to the
requirement to report insurance fees and commissions for insured plans
with fewer than 100 participants. The regulation applies only to annual
reports required to be filed for the plan years beginning in 1975 and
1976, and does not apply to annual reports filed for subsequent plan
years.
[[Page 14692]]
From subpart F of part 2520, the Department proposes to remove and
reserve certain paragraphs of Sec. 104b-2 and Sec. 104b-4, and to
remove Secs. 104b-5 and 104b-12.
With respect to Sec. 104b-2, the Department proposes to revise
paragraphs (b)(1) and (b)(2), and to remove and reserve paragraphs (c),
(d), (e), (f) and (h). Paragraphs (b)(1) and (b)(2) establish the
periods within which updated summary plan descriptions must be
furnished to participants and beneficiaries receiving benefits under
the plan (which differ depending on whether there have been amendments
to the plan). In both cases, the periods for providing an updated
summary plan description are no later than 210 days after the end of
the plan year within which occurs the later of a date certain (November
16, 1983 or November 16, 1987) or a period of years after the last date
a change in the information required to be disclosed by section 102 of
ERISA or Sec. 102-3 would have been reflected in the most recently
distributed summary plan description. The proposed revisions to
paragraphs (b)(1) and (b)(2) would eliminate the references to the
dates certain.
Paragraph (c) of Sec. 104b-2 pertained to plans making elections
under Sec. 2520.104-5 and 2520.104-6, for which the election periods
expired in 1977. Paragraph (d) of the regulation provided an
alternative method of compliance for plans using a Form EBS-1 with a
print date of April 1975 as the summary plan description. The Form EBS-
1 was eliminated in 1976. Paragraph (e) of the regulation provided an
alternative method of compliance with ERISA's summary plan description
requirements for plans which filed and disclosed an initial summary
plan description on or before May 30, 1976, in reliance upon earlier
guidance of the Department. The availability of the alternative method
of compliance was conditioned on the disclosure by such plans, prior to
November 16, 1977, of a statement of ERISA rights which complied with
Sec. 2520.102-3(t). Paragraph (f) of the regulation provided an
alternative method of compliance for plans which were not described in
paragraphs (d) or (e) and which met certain requirements. The
alternative method of compliance under paragraph (f) expired on
November 16, 1977. Paragraph (h) of the regulation merely refers to
Secs. 2520.104-5 and 2520.104-6, both of which authorize alternative
methods of compliance which expired on November 16, 1977.
With respect to Sec. 104b-4, the Department proposes to remove
paragraph (d). This paragraph required certain plans to furnish
information to certain classes of participants or beneficiaries by
November 16, 1977.
The Department also proposes to remove Sec. 104b-5 and Sec. 104b-
12. The Department's regulation at Sec. 104b-5 created a new disclosure
document, the ``ERISA Notice'', for use as an interim disclosure
document by welfare and pension benefit plans electing to use the
deferral until November 16, 1977 provided under Secs. 2520.104-5 and
2520.104-6. The Department's regulation at Sec. 104b-12 provided
multiemployer plans lacking records of covered participants with
optional methods of distributing the first summary annual report to
participants covered under the plan. The regulation generally applied
to reports distributed before February 15, 1977.
III. Part 2550--Rules and Regulations for Fiduciary Responsibility
The Department is proposing to remove eight regulations from
subchapter F, part 2550 of title 29 of the Code of Federal Regulations,
pertaining to fiduciary responsibility under ERISA. These include
Secs. 407a-3, 407a-4, 407c-3, 414b-1, 414c-1, 414c-2, 414c-3 and 414c-
4, all of which provide transitional relief for the first several years
following ERISA's enactment.
The Department's regulation at Sec. 407a-3 provided plan
administrators with prospective guidance clarifying the meaning of
section 407(a)(3)(B) of ERISA. This guidance assisted plan
administrators in determining whether their plans held qualifying
employer securities and/or qualifying employer real property the fair
market value of which, on any date between January 1, 1975 and December
31, 1984, did not exceed ten percent of the fair market value of the
plan's assets, and thus would not be subject to the ten percent holding
limitation contained in section 407(a)(3)(A) of ERISA. The period for
which plan administrators needed such prospective guidance was from
January 1, 1975 until December 31, 1984. Accordingly, the need for such
guidance no longer exists.
The Department's regulation at Sec. 407a-4 clarifies the
requirements of section 407(a)(4) of ERISA, which required that plans
divest, by December 31, 1979, 50 percent of the qualifying employer
securities and qualifying real property which they would be required to
divest before January 1, 1985, under section 407(a)(3) or 407(c) of
ERISA. Accordingly, the transactions addressed by the regulation were
transactions that were required to occur on or before December 3,1
1979.
The Department's regulation at Sec. 407c-3 describes an election
plans could make, prior to January 1, 1976, to utilize an alternative
method of calculating the value of employer securities for purposes of
satisfying the limitations of section 407(a)(3) of ERISA on the holding
of such securities or real property. The regulation also provided that
after making such an election, and before January 1, 1985, the plan
could not acquire any real property. There are no provisions in the
regulation that remain applicable after January 1, 1985.
The Department's regulation at Sec. 414b-1 provided guidance to
plans applying to the Department of Labor, in accordance with section
414(b)(1) of ERISA, for postponement, until no later than January 1,
1976, of the effective date of certain provisions of ERISA.
Applications for such postponement generally had to be submitted to the
Department on or before December 31, 1974.
The Department's regulations at Secs. 414c-1, 414c-2, and 414c-3
provided guidance concerning transitional rules relating to certain
types of transactions prior to June 30, 1984, after which the rules
became inapplicable. Specifically, Sec. 414c-1 relates to certain loans
or other extensions of credit prior to June 30, 1984; Sec. 414c-2
relates to certain leases or joint uses of property prior to June 30,
1984; and Sec. 414c-3 relates to certain sales, exchanges, or other
dispositions of property prior to June 30, 1984. The Department's
regulation at Sec. 414c-4 provides guidance regarding a transitional
rule relating to the provision of certain services until June 30, 1977,
after which the rule is inapplicable.
Executive Order 12866
The Department has determined that this proposed regulatory action
is not a ``significant rule'' within the meaning of Executive Order
12866 concerning Federal regulations, because it is not likely to
result in: (1) an annual effect on the economy of $100 million or more,
or an adverse and material effect on sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local or tribal governments or communities; (2) the
creation of a serious inconsistency or interference with an action
taken or planned by another agency; (3) a material alteration in the
budgetary impacts of entitlement, grants, user fees, or loan programs
or the rights and obligations of recipients thereof; or (4) the raising
of novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in Executive Order
12866.
[[Page 14693]]
Regulatory Flexibility Act
This proposal will not have a significant economic impact on a
substantial number of small employers.
Paperwork Reduction Act
This proposal is not subject to the requirements of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.) because it contains no
``collection of information'' as defined in 44 U.S.C. 3502(3).
List of Subjects
29 CFR Part 2509
Employee benefit plans, Pensions.
29 CFR Part 2520
Employee benefit plans, Pensions, Reporting requirements.
29 CFR Part 2550
Employee benefit plans, Pensions, Prohibited transactions.
Authority
For the reasons described in the preamble, Parts 2509, 2520, and
2550 of Chapter XXV of Title 29 of the Code of Federal Regulations, are
proposed to be amended as set forth below:
PART 2509--INTERPRETIVE BULLETINS RELATING TO THE EMPLOYEE
RETIREMENT INCOME SECURITY ACT OF 1974
1. The authority citation for part 2509 is revised to read as
follows:
Authority: 29 U.S.C. 1135. Sections 2509.75-10 and 2509.75-2
also issued under 29 U.S.C. 1052, 1053, 1054. Secretary of Labor's
Order No. 1-87 (52 FR 13139).
Sec. 2509.75-1 [Removed]
2. Section 2509.75-1 is removed.
Sec. 2509.75-2 [Amended]
3. Section 2509.75-2 is amended by removing and reserving paragraph
(b).
Secs. 2509.75-7, 2509.76-2, 2509.76-3 [Removed]
4. Sections Secs. 2509.75-7, 2509.76-2, 2509.76-3 are removed.
PART 2520--RULES AND REGULATIONS FOR REPORTING AND DISCLOSURE
5. The authority citation for part 2520 continues to read as
follows:
Authority: Secs. 101, 102, 103, 204, 105, 109, 110, 111(b)(2), ,
111(c), and 505, Pub. L. 93-406, 88 Stat. 840-52 and 894 (29 U.S.C.
1021-25, 1029-31, 1135); Secretary of Labor's Order No. 27-74, 13-
76, 1-87, and Labor Management Services Administration Order No. 2-
6.
Subpart C of Part 2520--[Amended]
6. Section 2520.103-6 is amended by revising paragraph (b)(1) to
read as follows:
Sec. 2520.103-6 Definition of reportable transaction for Annual
Return/Report.
* * * * *
(b) Definitions. (1) Except as provided in paragraphs (c)(2) and
(d)(1)(vi) (relating to assets acquired or disposed of during the plan
year), ``current value'' shall mean the current value, as defined in
section 3(26) of the Act, of plan assets as of the beginning of the
plan year, or the end of the previous plan year.
* * * * *
7. Subpart C of part 2520 is amended by removing Sec. 2520.103-7.
Subpart D of Part 2520--[Amended]
8. Subpart D of part 2520 is amended by removing Secs. 2520.104-2,
2520.104-3, 2520.104-5, 2520.104-6, 2520.104-28, and 2520.104-45.
Subpart F of Part 2520--[Amended]
9. Section 2520.104b-2 is amended by revising paragraphs (b)(1) and
(b)(2) to read as follows:
Sec. 2520.104b-2 Summary plan description.
* * * * *
(b) Periods for furnishing updated summary plan description. (1)
For purposes of the requirement to furnish the updated summary plan
description to each participant and each beneficiary receiving benefits
under the plan (other than beneficiaries receiving benefits under a
welfare plan) required by section 104(b)(1) of the Act, the
administrator of an employee benefit plan shall furnish such updated
summary plan description no later than 210 days following the end of
the plan year which occurs five years after the last date a change in
the information required to be disclosed by section 102 or 29 CFR
2520.102-3 would have been reflected in the most recently distributed
summary plan description (or updated summary plan description) as
described in section 102 of the Act.
(2) In the case of a plan to which no amendments have been made
between the end of the time period covered by the last distributed
summary plan description (or updated summary plan description),
described in section 102 of the Act, and the next occurring applicable
date described in paragraph (b)(1) of this section, for purposes of the
requirement to furnish the updated summary plan description to each
participant, and to each beneficiary receiving benefits under the plan
(other than beneficiaries receiving benefits under a welfare plan),
reburied by section 204(b)(1) of the Act, the administrator of an
employee benefit plan shall furnish such updated summary plan
description no later than 210 days following the end of the plan year
which occurs ten years after the last date a change in the information
required to be disclosed by section 102 or 29 CFR 2520.102-3 would have
been reflected in the most recently distributed summary plan
description (or updated summary plan description), as described in
section 102 of the Act.
* * * * *
Sec. 2520.104b-2 [Amended]
10. Subpart F of part 2520 is amended by removing and reserving
paragraphs (c), (d), (e), (f) and (h) of Sec. 2520.104b-2.
Sec. 2520.104b-4 [Amended]
11. Subpart F of part 2520 is amended by removing paragraph (d) of
Sec. 2520.104b-4.
Secs. 2520.1046-5, 2520.104b-12 [Amended]
12. Subpart F of part 2520 is amended by removing Secs. 2520.104b-5
and 2520.104b-12.
PART 2550--RULES AND REGULATIONS FOR FIDUCIARY RESPONSIBILITY
13. The authority citation for part 2550 is revised to read as
follows:
Authority: 29 U.S.C. 1135. Section 2550.401b-1 also issued under
sec. 102, Reorganization Plan No. 4 of 1978 (43 FR 47713, Oct. 17,
1978), effective December 31, 1978 (44 FR 1065, Jan. 3, 1979), 3
CFR, 1978 Comp., 332. Section 2550.404c-1 also issued under 29
U.S.C. 1104. Section 2550.407c-3 also issued under 29 U.S.C. 1104.
Section 2550.407c-3 also issued under 29 U.S.C. 1107. Section
2550.408b-1 also issued under sec. 102 Reorganization Plan No. 4 of
1978 (43 FR 47713, Oct. 17, 1978), effective December 31, 1978 (44
FR 1065, Jan. 3, 1979), 3 CFR 1978 Comp., 332, reprinted in 5 U.S.C.
app. at 1163 (1982), and under 29 U.S.C. 1108(b)(1). Section
2550.412-1 also issued under 29 U.S.C. 1112. Secretary of Labor's
Order No. 1-87 (52 FR 13139).
Secs. 2550.407a-3, 2550.407a-4, 2550.407c-3, 2550.414b-1, 2550.414c-1,
2550.414c-2, 2550.414c-3, 2550.414c-4 [Removed]
15. Sections 2550.407a-3, 2550.407a-4, 2550.407c-3, 2550.414b-1,
2550.414c-1, 2550.414c-2, 2550.414c-3 and 2550.414c-4 are removed.
[[Page 14694]]
Signed at Washington, DC, this 27th day of March, 1996.
Olena Berg,
Assistant Secretary for Pension and Welfare Benefits, U.S. Department
of Labor.
[FR Doc. 96-7878 Filed 4-2-96; 8:45 am]
BILLING CODE 4510-29-M
Complete official Federal Register PDF
FR Doc. 96-7833 Proposed Quality Standards for Mammography Equipment and Quality Assurance
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14908-14920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7833]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. 95N-0195]
RIN 0910-AA24
Proposed Quality Standards for Mammography Equipment and Quality
Assurance
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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[[Page 14909]]
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the regulations for facility standards established in the interim
regulations implementing the Mammography Quality Standards Act of 1992
(the MQSA). This proposed rule will establish additional performance
standards for mammography equipment and equipment-related quality
assurance practices currently required of mammography facilities. FDA
is proposing these amendments based on advice from the National
Mammography Quality Assurance Advisory Committee (NMQAAC), mammography
equipment manufacturers, and public comments received in response to
the interim regulations. This proposed rule is intended to assure safe,
accurate, and reliable mammography on a nationwide basis. This document
is the fifth of five related proposed rules that FDA is publishing
concurrently in this issue of the Federal Register.
DATES: Written comments by July 2, 1996. The agency is proposing that
any final rule based on this proposed rule become effective 1 year
after its date of publication in the Federal Register, except where
otherwise indicated.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857. The Regulatory Impact Study (RIS) is available at
the Dockets Management Branch for review between 9 a.m. and 4 p.m.,
Monday through Friday. Requests for copies of the RIS should be
submitted to the Freedom of Information Staff (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for
Devices and Radiological Health (HFZ-240), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.
SUPPLEMENTARY INFORMATION:
I. Background
This proposal is the fifth of five related proposed rules published
in this issue of the Federal Register to amend interim regulations
published on December 21, 1993 (58 FR 67558 and 58 FR 67565),
implementing the MQSA (Pub. L. 102-539). The first proposed rule,
``Quality Mammography Standards; General Preamble and Proposed
Alternative Approaches'' contains background information and a summary
of the preliminary analysis of the costs and benefits of the proposed
rules, a description of the information collection requirements,
proposed revisions to Sec. 900.1 Scope and Sec. 900.2 Definitions (21
CFR 900.1 and 900.2), and proposed alternative approaches to
mammography quality standards and a request for comments on the
proposed alternatives.
II. Provisions of the Proposed Rule
A. Development of the Proposed Regulation
As with the interim regulations, FDA was guided in the development
of this proposed rule by the intent of the legislation to guarantee
access to safe and effective mammography services for all women in the
United States (Ref. 1). FDA also relied upon three major sources of
information, in addition to the expertise and research of FDA
personnel.
First, the agency considered public comments received on the
interim regulations. The agency received 103 comments from individuals
and organizations, including: Professional organizations, medical
facilities, State agencies, consumer groups, manufacturers, and
individual physicians, medical physicists, and radiologic
technologists. The proposed regulations were also discussed in a series
of quarterly meetings with the NMQAAC. Members of the NMQAAC include
interpreting physicians, medical physicists, radiologic technologists,
representatives of State agencies, and consumer representatives.
Consultants to the NMQAAC and guests invited to attend the committee
meetings in recognition of their expertise in mammography also
participated in these discussions of the proposed regulations. Finally,
the agency obtained input through discussions with various professional
and trade organizations and individuals with expertise related to
mammography equipment, quality assurance, and infection control.
Preliminary drafts of the proposed regulations were made generally
available at the NMQAAC meetings and through notices of availability
published in the Federal Register on December 30, 1994 (59 FR 67710)
and January 26, 1995 (60 FR 5152).
Organizations participating in discussions of the regulations
included the National Electrical Manufacturers Association (NEMA), the
Conference of Radiation Control Program Directors (CRCPD), and four
national medical physicist organizations: The American Association of
Physicists in Medicine, the American Academy of Health Physics, the
American College of Medical Physicists, and the Health Physics Society.
A discussion of the proposed amendments and a summary and analysis
of NMQAAC input and public comments regarding the regulations is
provided below.
B. Equipment Regulations
In Sec. 900.12(b) of the interim regulations, performance standards
were established for equipment used in the production of mammograms.
These standards were substantially harmonized with existing standards,
such as those established by the Health Care Financing Administration
(HCFA), the American College of Radiology (ACR), and some States. This
interim approach was consistent with the legislative intent of the MQSA
(Ref. 1) and enabled FDA to certify the thousands of facilities that
already met voluntary accreditation standards prior to publication of
the interim regulations. This approach also allowed the agency to
concentrate its initial resources on facilities with no such prior
accreditation. Now that additional input regarding the equipment
standards has been obtained from the NMQAAC, equipment manufacturers,
and the public, FDA is proposing additional requirements in
Sec. 900.12(b) for radiographic, processing, and ancillary equipment
used in mammography.
In developing the proposed equipment standards, FDA recognized the
need to balance the economic impact of new standards against the
associated gains to the public health. It was also necessary for FDA to
consider the availability (initially, and over time) of mammography
equipment meeting the new requirements. This was necessary because, for
some requirements, considerable time might be needed to allow for
redesign, production, purchase, and installation of new equipment, or
for retrofitting of the installed equipment base. The amount of time
needed would depend on the nature of the requirement, the capacity of
manufacturers, and the number of facilities already meeting the
requirement. In consideration of these factors, the agency is proposing
to phase in the equipment standards in proposed Sec. 900.12(b) over the
next 1 to 10 years.
In accordance with guidance from the NMQAAC, three effective dates
are being proposed for different phases of implementation. Requirements
to be implemented during the first phase would have an effective date
of 1 year after the date of publication of the final rule. Such
requirements would cover aspects of equipment performance that the
NMQAAC considered fundamental to the delivery of quality mammography.
Requirements to be
[[Page 14910]]
implemented during the second and third phases would have effective
dates of 5 and 10 years after the date of publication of the final
rule, which FDA estimates would correspond to approximately October 1,
2000, and October 1, 2005, respectively. Although these dates have been
used for the purpose of this proposal, the final effective dates will
be modified to correspond to the dates 5 and 10 years after the
publication date of the final rule. The agency believes that this
advance guidance to the industry regarding upcoming changes in
requirements and the phasing in of such requirements will minimize the
economic impact of implementing improvements in mammography.
Several comments received on the interim regulations indicated a
lack of awareness of agency plans for notice-and-comment rulemaking in
promulgating final regulations, or listed specific recommendations for
changes or additions. Most of the recommendations for specific
equipment requirements have been incorporated into the proposed
standards. A summary of these comments and the FDA responses follow:
1. General
One comment disagreed with the prohibition in the interim
regulations against performance of mammography using a conventional x-
ray system with device modifications or options specifically designed
to enable use of the system for mammography. The comment stated that
allowing use of such systems for mammography would represent an
economical source of equipment that should not be problematic as long
as the systems can produce quality images without compromising examinee
safety or dosage considerations.
In response to this comment, FDA notes that the MQSA expressly
states that equipment standards must ``require use of radiological
equipment specifically designed for mammography'' (42 U.S.C.
263b(f)(1)(B)). Therefore, FDA is continuing the prohibition against
use of nonmammography x-ray equipment for the production of mammograms.
One comment supported the interim requirements in Sec. 900.12
(b)(2)(i) to (b)(2)(iii) but requested the addition of two subsections
requiring: (1) Cassettes of appropriate size, to allow the technologist
to obtain a complete breast image on a single film, and (2) grids
specifically designed for mammography for each size of cassette.
FDA agrees with these comments and has included such requirements
in proposed Sec. 900.12(b)(4).
Three comments suggested that the provision in
Sec. 900.12(b)(2)(iii), requiring mammography equipment to have a
removable grid, be expanded to require a reciprocating removable grid.
A reciprocating (moving) grid would avoid grid lines often seen with a
stationary grid. One comment did not understand the requirement in
Sec. 900.12(b)(2)(iv), and in particular the phrase ``removable grid.''
The comment stated that, if the intent is not to reduce radiation dose,
the appropriate word would be ``moving,'' rather than ``removable,''
because moving the grid improves image quality. Also, the comment
questioned whether this standard refers to regular view or
magnification mode.
FDA believes that all equipment should be provided with
reciprocating (moving) grids and that these grids should be removable
for all systems providing magnification capability. These grid
requirements have been proposed in Sec. 900.12 (b)(4)(ii) and
(b)(4)(iii). The intent is that the grid be removable so that
magnification procedures can be completed properly without increasing
the radiation dose to the examinee.
Discussions with the NMQAAC indicated considerable concern that
radiographic equipment be equipped to enable a number of routine views
for all examinees. Of specific concern were the mediolateral oblique,
caudo-cranial, and cranio-caudal views, and the need to ensure that
each facility has equipment that allows for variation in individual
body habitus.
Under Sec. 900.12(b)(3) (ii) and (iii), FDA has proposed specific
requirements related to the motion capability of the gantry assembly
that the NMQAAC believes will achieve this goal.
The NMQAAC also strongly recommended that all mammography systems
be required to have a light field that approximates the x-ray field and
passes through the collimation system. This configuration would assist
in positioning and allow visual verification that the radiographic view
of the breast remains unobstructed. In response to this NMQAAC
recommendation, FDA received comments from a major trade association
representing manufacturers of mammography x-ray equipment indicating
that a significant portion of the installed equipment base would not
meet these requirements. This association further indicated that there
may be significant costs associated with retrofitting existing
equipment to comply with this recommendation.
FDA is proposing to require in Sec. 900.12(b)(5) that all
mammography systems have the light field recommended by the NMQAAC,
effective October 1, 2000. FDA is requesting public comment on this
proposed requirement and its likely impact on the cost and availability
of mammography services.
Proposed Sec. 900.12(b)(11)(i) references the requirements in
Sec. 1020.30(m)(l) (21 CFR 1020.30(m)(1)) for minimum beam quality
(half-value layer (HVL)) for mammography x-ray systems. FDA realizes
that this reference is redundant with proposed Sec. 900.12(b)(2), but
believes that it is necessary to clarify the requirements stated in
proposed Sec. 900.12(b)(11)(i).
One comment stated that, in addition to requiring the incorporation
of a breast compression device, the regulation should mandate use of
this device (at least for screening mammography), because compression
enables better visualization of the breast and permits lower radiation
dose to be used.
FDA recognizes that use of a breast compression device is
considered by professionals to be essential for proper imaging of the
breast. By requiring that each system be equipped with a breast
compression device, FDA has attempted to ensure that this feature is
always available to the technologist. However, because the requirement
that the compression device always be used would be extremely difficult
to enforce, such a requirement has not been proposed.
In Sec. 900.12(b)(12), FDA is proposing that all mammography
systems be equipped with both foot-controlled power driven and fine
adjustment controls (either manual or power driven). The intent of this
requirement is to allow the technologist to use both hands to position
the examinee under foot regulated power control, and to make final
adjustments to the compression under the increased control provided by
the fine adjustment mechanism. FDA is specifically requesting
additional comments on this proposed requirement. For example, would a
power-only system that provided a slower, more controlled, final
application of power driven compression be as useful as a combination
of power and manual compression?
One comment suggested requiring that all compression equipment
allow for automatic release of compression in case of power or
mechanical failure.
FDA recognizes that some facilities consider an automatic
compression release desirable, and the proposed regulations permit
this. However, under
[[Page 14911]]
some conditions, an automatic release may represent a physical hazard
to the examinee. Therefore, under Sec. 900.12(b)(12)(ii), FDA is
proposing certain restrictions on systems that provide an automatic
decompression feature.
Two comments noted that the interim regulations do not require that
the breast compression device be parallel to the imaging plane, thus
potentially allowing unequal compression to occur.
FDA agrees and the proposed regulations contain a requirement under
Sec. 900.12(b)(12)(iii)(B) to address this concern. FDA notes, however,
that there is one manufacturer that does not meet this proposed
requirement because it claims that the nonparallel design of its device
provides uniform compression. FDA requests comments (and supporting
data) regarding whether the agency should: (1) Modify the proposed
regulations to accommodate this alternative design, or (2) retain the
requirement as proposed and allow manufacturers to obtain variances to
market alternative devices, in accordance with the alternative
equipment provision in proposed Sec. 900.18 (published elsewhere in
this issue of the Federal Register).
Seven comments recommended that FDA require automatic exposure
control (AEC) capability on all systems. One comment suggested that the
equipment requirements should be more specific to address phototimers,
acceptable operating energies, radiation output, and milliampere (mA)
requirements.
FDA agrees and has included requirements for each of these areas in
proposed Sec. 900.12 (b)(13), (b)(14), and (b)(15). These requirements
were supported by the NMQAAC.
One comment suggested that all mammography systems installed or
transferred following implementation of the interim regulations should
provide for milliampere second (mAs) readout following each exposure.
FDA agrees that mAs readout is important and under proposed
Sec. 900.12(b)(13)(iv), all equipment that automatically selects the
mAs will be required to indicate the mAs value used following the
exposure.
Two comments suggested a number of technical requirements that all
mammography equipment should be required to meet.
The recommended requirements are supported by FDA and the NMQAAC
and have been included in proposed Sec. 900.12 (b)(4), (b)(5), (b)(8),
(b)(11), (b)(14), and (b)(15), or were already covered under the
diagnostic x-ray system performance standard in Secs. 1020.30 and
1020.31 (21 CFR 1020.31), with the exception of the following:
(1) One comment suggested that a tungsten target tube should never
be used for screen-film mammography.
FDA disagrees with this comment. The agency believes there is no
evidence to support prohibiting the use of tungsten target tubes and
has not included this limitation in the proposed regulations.
(2) One comment stated that the nominal focal spot size should be
regulated in conjunction with the system source-image receptor distance
(SID).
FDA is proposing to address the issue of focal spot size through
the proposed requirement for system resolution in Sec. 900.12(b)(8).
The intent of this requirement (which has been adopted by the ACR), is
to provide a test for system resolution that is easier to perform than
a focal spot size determination.
(3) One comment stated that the SID should not be less than 50
centimeters (cm).
FDA is proposing to adopt the ACR's minimum requirement for SID,
which is 55 cm.
2. Xeromammography
Three comments requested FDA to prohibit use of xeromammography,
which the comments believed produces lower quality mammograms at a
higher dose of radiation than screen-film modalities.
FDA is aware of the controversy regarding use of xeromammography,
but the agency believes that, with respect to certain diagnostic
applications, the modality may still be equal to screen-film systems.
At the same time, the virtual disappearance of xeromammography units
from the marketplace indicates that the mammography community itself is
discontinuing the general use of this modality. Both the interim and
proposed regulations place a maximum limit on the dose that can be
delivered to an examinee using xeromammography. In proposed
Sec. 900.12(c), published elsewhere in this issue of the Federal
Register, the dose that may be delivered by xeromammography has been
reduced from the interim requirement of 4.0 milliGray (mGy) to 3.0 mGy.
This decision was based on communication from the manufacturer of
xeromammography systems informing FDA that properly adjusted and
maintained xeromammography systems could meet such a requirement. Under
the proposed regulations, therefore, the dose limits for screen-film
and xeromammography would be the same.
One comment questioned whether xeromammography will continue to be
considered inadequate for screening purposes, in accordance with HCFA
regulations.
FDA regulations replace those issued by HCFA concerning mammography
facilities and FDA regulations do not prohibit the use of
xeromammography for screening.
3. Operator Protection
Two comments expressed concern that no regulations addressed the
protection of the operator by requiring radiation protective barriers
or anchored exposure switches.
FDA believes that specific operator safety requirements remain the
responsibility of State and local authorities regulating the use of
diagnostic x-ray equipment. Therefore, FDA has not proposed any
requirements relating to this aspect of the facility operation.
4. Examinees With Disabilities
In addition to meeting the specific requirements listed in this
regulation, it was the opinion of the NMQAAC that each facility has the
responsibility to accommodate examinees with physical disabilities and
to provide such examinees with access to the same quality mammography
provided to other examinees. The NMQAAC further believed that
facilities that could not provide such special services should be
required to screen prospective examinees during the appointment
scheduling process and refrain from scheduling disabled examinees who
cannot be accommodated.
FDA has included a requirement in proposed Sec. 900.12(b)(16)
reflecting this recommendation. The agency also encourages facilities
that cannot accommodate disabled individuals to refer these individuals
to a facility that is equipped to provide mammography services for
them. FDA encourages comments regarding the necessity and
appropriateness of this section in light of the requirements currently
imposed by the Americans with Disabilities Act of 1990.
5. Interventional Mammography
Five comments indicated that standards and test methods are needed
for stereotactic units and dedicated biopsy-type machines.
FDA agrees with these comments. However, the agency believes that
no consensus exists in the mammography community regarding appropriate
standards for such equipment and
[[Page 14912]]
procedures. Various public and private organizations are working to
develop such standards and FDA will propose requirements some time in
the future.
6. International Harmonization
In the Federal Register of November 28, 1994 (59 FR 60870), FDA
published an agency policy on international harmonization of regulatory
requirements. In accordance with that policy, the agency requests
comments regarding the implications of the proposed equipment standards
on any related international harmonization efforts for mammography
equipment.
C. Quality Assurance (QA)--Equipment
The primary purpose of the equipment aspects of the quality
assurance program is to prevent problems with equipment or detect and
correct problems before they can have a significant effect on clinical
image quality. To achieve this, the performance parameters of the
equipment must be tested at appropriate frequencies, the test results
must be promptly analyzed to determine if the performance of the
equipment is satisfactory, and any identified problems must be
corrected as soon as possible. In addition, followup tests must be
conducted to determine whether the corrective actions were effective.
Requirements for these types of tests are proposed in Sec. 900.12(e).
1. Testing of Screen-Film Systems
Proposed Sec. 900.12 (e)(1) through (e)(5) establish the minimum
performance tests to be conducted on screen-film systems. The agency
has decided not to propose extensive detailed requirements in order to
provide facilities with the flexibility to use alternative methods that
might be equally satisfactory or to add other tests. Under the interim
regulations, FDA adopted the ACR's relatively detailed QA requirements
(Ref. 2). However, the NMQAAC has advised FDA that these ACR
requirements were intended to be used as guidelines, not in a
prescriptive manner.
Therefore, the agency is proposing to limit the quality assurance
requirements for equipment to a more general listing of the required
tests, establishment of the required test frequencies, definition of
action limits, and, in some cases, specification of critical test
conditions.
At the July 1994 NMQAAC meeting, an additional daily total system
test was discussed, which read as follows:
Total System Test:
(A) The optical density (OD) of the film at the center of an image
of a uniform phantom when exposed in AEC mode shall not change by more
than 0.20 from the established operating level. The OD of
the established operating level shall be above 1.20. The mAs shall not
change by more than 10 percent from the established value corresponding
to the operating level OD.
(B) The film shall be examined for system artifacts.
The agency believes that this total system test, in conjunction
with the processor performance test set forth in proposed
Sec. 900.12(e)(1), should be performed daily before the first examinee
is examined. The performance of these two tests will assure the overall
quality of the x-ray machine, processor, and films. The records of the
tests will also enable a medical physicist to quickly detect the source
of a problem when it occurs. The above described system test takes only
a few minutes to perform and can be performed by a quality control
technologist.
The NMQAAC suggested that more data about the usefulness of the
total system test should be gathered before this test is introduced as
a required daily test. The NMQAAC also agreed that the image quality
evaluations described in proposed Sec. 900.12(e)(2) should be performed
weekly if the total system test is not required.
The agency is proposing system testing requirements in accordance
with the NMQAAC's advice. Although FDA is not proposing to require the
daily total system test at this time, the agency requests comments
regarding the utility of this test. If the total system test were
introduced, FDA would revise the regulations to require monthly, rather
than weekly, performance of the image quality evaluations in proposed
Sec. 900.12(e)(2).
Several comments on the interim regulations raised concern about
basing the quality control requirements on a single manual, such as the
ACR manual (Refs. 2 and 3).
In the proposed regulations, no manual has been referenced. A
facility may consult any appropriate manual or rely on agency guidance
to meet the requirements in proposed Sec. 900.12(e)(1) through (e)(5).
One comment requested that any standard that is developed be
achievable with current technology. As an example of a test that the
comment believed could not be achieved using current technology, the
comment cited ACR's criteria for passing the screen-film contact test,
as described in the 1992 ACR manual (Ref. 2).
The agency is convinced, based on the expertise of its staff and
experience with the interim regulations, that the requirements and
action limits proposed in this regulation can be met with current
technology.
One comment suggested that a minimum allowable dose should be
specified for a 4.5-cm compressed breast composed of 50 percent
glandular tissue and 50 percent adipose tissue. Also, one comment
suggested that the mean glandular dose should not exceed 1.0 mGy for
screen-film systems without grids.
FDA believes that placing a lower limit on dose may hamper further
technological advancement of systems that may reduce the dose without
compromising image quality. In addition, the agency has decided to use
only one upper dose limit for all systems.
Several comments stated that FDA's data indicate that an accepted
phantom simulates a 4.2-cm thick compressed breast, not 4.5 cm.
Therefore, the regulations should use a 4.2-cm thickness. One comment
stated that the dose should be determined using clinically employed
technique factors for a 4.5-cm thick compressed breast composed of 50
percent glandular tissue and 50 percent adipose tissue, instead of
using the phantom technique factors promulgated in the interim
regulations. Two comments noted that, in many cases, the technique
factors used by a facility to produce phantom images do not reflect the
technique factors actually used on examinees. This could result in
examinees receiving doses exceeding the limits specified in the
regulations, even though the facility technically passed the compliance
test by using their phantom image technique factors. One comment stated
that the dose should be determined under the facility's proposed
technique factors for a 4.2-cm thick compressed 50 percent glandular/50
percent adipose breast.
After review of these comments, FDA is proposing to require
clinical technique factors and a phantom simulating a 4.2-cm thick
compressed 50 per cent glandular/50 per cent adipose tissue breast to
be used during dose measurements. Although FDA has data to show that an
accepted phantom simulates the attenuation properties of 4.2 cm of 50/
50 compressed breast tissue, the agency recently has developed
additional data indicating that the phantom may be equivalent in
attenuation properties to approximately 4.0-cm of 50/50 compressed
breast tissue, as per the dose model used to convert skin exposure to
dose. The agency, therefore, is soliciting more information and
comments on the appropriate equivalent thickness of the phantom for
dose calculation.
[[Page 14913]]
One comment requested an explanation of the methods for obtaining
FDA certification of QA phantoms. Another comment suggested that the
regulations should specify one, and only one phantom, and should
specify the minimum acceptable performance, rather than leaving this to
the discretion of accreditation bodies.
The agency continues to believe that accreditation bodies should
establish phantom specifications and related performance criteria.
However, as part of it responsibilities for accreditation body approval
and oversight, FDA will examine each body's phantom specifications and
performance requirements, which will have to be substantially the same
among different accreditation bodies.
One comment recommended that FDA publish some type of voluntary
form(s) for maintaining appropriate records.
FDA believes it is inadvisable for the agency to generate sample
forms because such forms may be unnecessarily restrictive. Facilities
that do not want to generate their own forms may adopt forms that are
provided in various manuals, as appropriate.
2. Systems With Other Modalities
Proposed Sec. 900.12(e)(6) would require that the facility quality
assurance program for systems with image receptor modalities other than
screen-film (e.g., xeromammography) be substantially the same as that
recommended by the image receptor manufacturer. This section would also
require that such systems meet the same dose limits as screen-film
systems.
3. Mobile Units
Proposed Sec. 900.12(e)(7) would establish additional quality
assurance requirements for mobile mammography units. These mobile units
are operated in a variety of environments and undergo the stress of
frequent movements, often over rough surfaces. In view of this, a
number of comments on the interim regulations urged FDA to require that
a phantom image quality test be performed after every move, before any
additional examinations are conducted at the new site. These comments
stated that if a problem occurs after a move which could compromise the
quality of clinical images, this problem should be detected and
corrected before any further clinical use of the equipment. These
comments believe this additional testing is necessary for mobile units
in order to minimize the need for repeat examinations, which would
result in additional radiation exposure and expense and might result in
some cancers going undetected if it is not possible to get examinees to
return to the facility.
In contrast, other comments noted that a requirement for a post-
move, pre-examination image quality test would pose great difficulties
to mobile services that are some distance from their home base and do
not have access to adequate processing at the test site. These comments
expressed concern that such a requirement would cause some mobile
services to cease operation and would significantly reduce access to
mammography in rural and inner city areas. Several comments cited their
own experience in stating that image quality tests conducted after
moves rarely or never show that a problem has occurred because of the
move. The preliminary results of a survey of mobile facilities
conducted by the ACR found that nearly 90 percent of the facilities
rarely found problems after a move. However, the remaining facilities
found problems as often as daily or weekly.
The 1992 edition of the ACR QA manual (Ref. 2) recommended that an
image quality test be conducted after every move, but was somewhat
ambiguous regarding when the processing and analysis of the images
should occur. However, the agency has been informed by members of the
ACR committee who were responsible for the manual that they did not
intend to require processing before further examinations were
conducted. The 1994 edition of the ACR QA manual (Ref. 3) completely
dropped the requirement for conducting image quality testing after
every move. Under this revised ACR requirement, therefore, mobile units
are required to undergo image quality testing at the same frequency as
fixed units, which ordinarily is monthly.
At its September 1994 meeting, the NMQAAC discussed this issue and
recommended that post-move, pre-examination testing of mobile units be
required in the final regulations. FDA agreed with this recommendation
and has incorporated it in proposed Sec. 900.12(e)(7).
The NMQAAC further recommended allowing use of a method of testing
based on post-exposure mAs readout values in place of phantom image
testing. FDA has decided not to require a particular method of testing
at this time. Instead, the agency is proposing to require each facility
to adopt a test method that will verify the adequacy of image quality
following a move, but to leave the choice of test method to the
facility. The agency believes that this approach will give individual
facilities maximum flexibility. FDA will issue guidance documents that
reflect the agency's current thinking about test methods that are
appropriate. At this time, FDA expects those methods to include the
method recommended by the NMQAAC as well as the traditional phantom
image quality test.
Including these methods of testing in guidance rather than in
regulations has the advantage of increased speed and flexibility. As
the agency becomes aware of new test methods of proven value, the
agency's evaluation of such methods can be publicized through
modification of guidance materials much more rapidly than through
amendment of regulations. In addition, mobile units will have the
option of using post-move pre- examination image quality test methods
that are different from those described in guidance. Testing methods
described in these materials will guide inspectors as they evaluate the
adequacy of an individual facility's testing methods. Although the
methods described in guidance will represent the agency's most current
thinking about appropriate testing for this purpose, such guidance will
not bind the facility or the agency. If a facility chooses alternative
procedures, FDA encourages the facility to discuss the choice in
advance in order to prevent expenditure of efforts and resources on
testing that may later be determined to be unacceptable because it does
not establish the adequacy of image quality following a move.
4. Use of Test Results
Proposed Sec. 900.12(e)(8) describes how results from the tests
specified in paragraphs (e)(1) through (e)(7) would be used to ensure
that problems are detected and corrected before they adversely affect
the quality of examinations.
5. Survey
Proposed Sec. 900.12(e)(9) describes the activities that would have
to be carried out by the medical physicist as part of the annual
evaluation of facility equipment performance and quality assurance
programs. A concern raised at the February 1994 NMQAAC meeting and
elsewhere was that qualified medical physicists might delegate the
onsite survey work to less qualified personnel and merely review and
sign the survey report.
Because FDA is also concerned about such delegation occurring, the
agency is proposing in Sec. 900.12(e)(9)(i) that only qualified medical
physicists be authorized to conduct the surveys. The agency is further
proposing to require in Sec. 900.12(e)(9)(V) that the report be signed
and dated by the individual who
[[Page 14914]]
performs the survey. As is the case with the signature of the
interpreting physician on the mammography report (see discussion of
Sec. 900.12(c)(1) published elsewhere in this issue of the Federal
Register), the purpose of the signature requirement is to identify the
individual who performed or provided direct supervision of the work.
Therefore, in addition to handwritten signatures, FDA will accept
``signatures'' that are generated from computer systems, typewritten,
name stamped, and possibly provided in other ways. These requirements
would not prohibit physicists-in-training from performing surveys to
gain experience, but would require that such surveys be done under the
direct supervision of a fully qualified medical physicist, who would
have to sign the report as the responsible physicist. If another
individual performs any part or all of the survey under the direct
supervision of a medical physicist, that person and the part of the
survey that person performed must also be identified on the survey
report.
6. Mammography Equipment Evaluation
Proposed Sec. 900.12(e)(10) would require a mammography equipment
evaluation to be performed whenever a mammography unit or image
processor is installed or major components of that unit or processor
are changed. This requirement was added to ensure that the performance
of new or significantly changed equipment is evaluated, and problems
corrected, before such equipment is used during examinations. FDA
believes mammography equipment evaluation, rather than a complete
survey of the facility as described in Sec. 900.12(e)(9), is adequate
for this purpose because not all aspects of the facility operation
which are checked during a survey would be affected by the installation
of new equipment or the modification of old equipment.
The agency will describe its current thinking about appropriate
procedures for carrying out these evaluations in guidance documents and
will update that guidance, when warranted, to reflect scientific and
professional developments. Similarly, the agency will describe in
guidance its current thinking about appropriate qualifications for
persons doing this work. As discussed previously with respect to agency
guidance for testing mobile units, facilities will have the option of
using procedures other than those described in guidance or employing
individuals with qualifications different than those listed in
guidance, assuming such alternative procedures or qualifications are
adequate to examine equipment for such purposes. The guidance issued by
FDA will not be binding on either the facility or the agency. Once
again, however, FDA encourages facilities that choose alternative
personnel or procedures, to discuss the choice in advance in order to
prevent expenditure of efforts and resources on evaluations that may
later be determined to be inadequate.
FDA realizes that Sec. 900.12(e)(10), as presently proposed, raises
the question as to what constitutes a ``major component'' of the
equipment, i.e., what components would have a significant impact on the
performance of the equipment if their repair or replacement were done
improperly. The agency specifically requests comments on this issue.
7. Housekeeping and Maintenance Tasks
At its July 1994 meeting, the NMQAAC stressed the importance of
carrying out regular maintenance and housekeeping activities as well as
properly storing film and processing chemicals. However, the agency
decided, for two reasons, not to propose detailed and comprehensive
requirements for such activities.
First, failure to follow proper maintenance and housekeeping
activities at a facility will be revealed through failure of the tests
outlined in Sec. 900.12(e)(1) through (e)(6) and through adverse
findings in the physicist's survey. Additional detailed requirements
would be redundant.
Second, there are a wide variety of effective maintenance and
housekeeping activities. The agency believes that it would be overly
prescriptive to limit facilities to one set of activities in this area
by regulation.
At its January 1995 meeting, the NMQAAC agreed that the details of
these activities could be incorporated into guidance materials rather
than regulatory requirements. However, the members believed that
general requirements should be established for certain especially
important activities. Therefore, FDA is proposing to require in
Sec. 900.12(e)(11) that facilities establish and follow protocols for
the maintenance of darkroom, screen, and view box cleanliness.
8. Calibration of Exposure Measuring Instruments
In order to have reliable uniform dose measurements in facilities
all across the United States, it is important to have proper
traceability of the instruments used to measure x-ray exposure. The
agency is proposing to add in Sec. 900.12(e)(12) a requirement for
annual calibration of such instruments, which must be traceable to a
national standard.
9. Infection Control
Concern was expressed during the open public portion of several
NMQAAC meetings and by one comment on the interim regulations that,
because of the possibility of nipple discharge during mammography, FDA
should mandate the use of universal precautions during all mammography
examinations to protect examinees and health care workers from possible
transmission of bloodborne pathogens. The comment also expressed
concern that present procedures used to disinfect mammography equipment
between examinations are inadequate to prevent disease transmission.
FDA notes that the concept of ``universal precautions'' is an
approach to infection control stipulating that all human blood and
certain human body fluids should be treated as if known to be
infectious for human immunodeficiency virus (HIV), hepatitis B and C
viruses (HBV, HCV), and other bloodborne pathogens. The Occupational
Safety and Health Administration (OSHA) already mandates the use of
universal precautions for all situations where occupational exposure
can reasonably be anticipated (29 CFR 1910.1030). Although staff at the
Centers for Disease Control (CDC) have advised FDA that there have been
no reported cases of transmission of HIV, HBV, or HCV to examinees or
health care workers during mammography, such transmission is
theoretically possible (if no infection control precautions are taken).
Therefore, the OSHA regulations are applicable to the practice of
mammography, and it would be redundant for FDA to issue a universal
precautions requirement under the MQSA authority.
With respect to appropriate decontamination practices, members of
the NMQAAC noted during an advisory committee meeting that guidelines
and regulations addressing infection control practices relevant to
mammography are available from CDC (Ref. 4) and OSHA (29 CFR
1910.1030(d)(4)). These guidelines and regulations specifically address
the decontamination of medical equipment and working surfaces after
contact with blood or other potentially infectious materials. Local
infection control policies are also in effect in many locations.
In addition, the Association for the Advancement of Medical
Instrumentation (AAMI) recently published a technical information
report on reprocessing of reusable medical
[[Page 14915]]
devices (Ref. 5). Several other national and international standards
setting organizations are developing guidance in this area as well.
However, these guidelines, regulations, reports, and standards do not
completely cover all aspects of reprocessing mammography equipment,
because they may not address the special concerns of disinfecting
electrical equipment, and may not consider the effect of the
disinfecting agent upon the equipment. For these reasons, FDA is
developing a guidance document regarding labeling of reusable medical
devices for reprocessing in health care facilities (Ref. 6). A notice
of availability requesting comments on this guidance document was
published in the Federal Register on June 15, 1995 (60 FR 31484). FDA
and industry will utilize this document to ensure appropriate labeling
for new devices as well as for improving labeling for currently
marketed devices.
FDA believes that the concern raised by the comment transcends the
issue of reuse of mammography devices and addresses the broader general
issue of safe reuse of any reusable medical device. Therefore, it is an
issue to be resolved under the agency's general medical device
authority, rather than under the authority of the MQSA. In light of the
concerns raised, however, FDA is reviewing current guidance and
regulations, as well as additional guidance under development by the
agency, to determine whether new labeling information or accessories
are necessary with respect to reuse of mammography devices. FDA
encourages interested parties to communicate to the agency any concerns
and proposed solutions in this area.
To ensure that the practice of mammography benefits from infection
control guidance already available, FDA is proposing to require that
facilities establish, adhere to, and document their compliance with a
system of infection control. In addition to requiring compliance with
any applicable infection control regulations, each facility's system
would have to require adherence to infection control recommendations
provided by the manufacturer(s) of the mammography equipment used in
the facility, or, if adequate manufacturer's recommendations are not
available, adherence to generally accepted guidance on infection
control (e.g., Refs. 4 and 5), until such recommendations become
available.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(3) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Analysis of Impacts
FDA has examined together the impacts of this proposed rule and the
proposed rules on accreditation bodies, general facility requirements,
and personnel, published elsewhere in this issue of the Federal
Register, under Executive Order 12866, the Regulatory Flexibility Act
(Pub. L. 96-354), and under the Unfunded Mandates Reform Act. The
analysis has addressed the proposed requirements of these four rules as
one unit for purposes of determining their economic impact. The
preamble to the proposed rule ``Quality Mammography Standards; General
Preamble and Proposed Alternative Approaches,'' published elsewhere in
this issue of the Federal Register, contains a brief summary of the
cost and benefit determination and the Regulatory Impact Study that
details the agency's calculation of these economic impacts and is
available at the Dockets Management Branch (address above) for review.
FDA recognized that these proposed regulations may have a
disproportionate effect on small volume mammography facilities and is
currently collecting additional information on the potential impact on
this industry sector. The agency requests comments that will assist it
in accounting for this impact.
V. Paperwork Reduction Act of 1995
This proposed rule contains no information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995.
VI. Comments
Interested persons may, on or before July 2, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets at the heading of this
document. Information submitted in response to this notice may be seen
in the office above between 9 a.m. and 4 p.m., Monday through Friday.
VII. References
The following information has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday:
1. ``Report on the Mammography Quality Standards Act of 1992,''
U.S. Senate, Report 102-448, October 1, 1992.
2. American College of Radiology, ``Mammography Quality Control:
Radiologist's Manual, Radiologic Technologist's Manual, and Medical
Physicist's Manual,'' February, 1992.
3. American College of Radiology, ``Mammography Quality Control:
Radiologist's Manual, Radiologic Technologist's Manual, and Medical
Physicist's Manual,'' 1994.
4. Centers for Disease Control, ``Recommendations for Prevention
of HIV Transmission in Health-Care Settings,'' Morbidity and
Mortality Weekly Report, 36(2S):3S-18S, 1987.
5. AAMI TIR No. 12-1994, ``Designing, Testing, and Labeling
Reusable Medical Devices for Reprocessing in Health Care Facilities:
A Guide for Device Manufacturers,'' Association for the Advancement
of Medical Instrumentation, 3330 Washington Blvd., suite 400,
Arlington, VA 22201-4598, 1995.
6. Food and Drug Administration, ``Labeling Reusable Medical
Devices for Reprocessing in Health Care Facilities: FDA Reviewer
Guidance,'' Rockville, MD, March, 1995.
List of Subjects in 21 CFR Part 900
Electronic products, Health facilities, Mammography, Medical
devices, Radiation protection, Reporting and recordkeeping
requirements, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 900 be
amended to follows:
PART 900--MAMMOGRAPHY
1. The authority citation for 21 CFR part 900 continues to read as
follows:
Authority: Secs. 519, 537, and 704(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360i, 360nn, and 374(e)); sec. 354 of
the Public Health Service Act (42 U.S.C. 263b).
2. Section 900.12 is amended by revising paragraphs (b) and (e) to
read as follows:
Sec. 900.12 Quality standards.
* * * * *
(b) Equipment--(1) Prohibited equipment. Radiographic equipment
designed for general purpose or special nonmammography procedures shall
not be used for mammography. This includes systems that have been
modified or equipped with special attachments for mammography. This
requirement supersedes the implied acceptance of such systems in
Sec. 1020.31(f)(3) of this chapter.
(2) General. All radiographic equipment used for mammography shall
[[Page 14916]]
be specifically designed for mammography and shall be certified
pursuant to Sec. 1010.2 of this chapter as meeting the applicable
requirements of Secs. 1020.30 and 1020.31 of this chapter in effect at
the date of manufacture.
(3) Motion of Tube-Image receptor assembly. (i) Gantry assembly
motion.
(A) The gantry assembly shall be capable of being rigidly fixed in
any position where it is designed to operate. Once fixed in any such
position, the gantry shall not move without operator intervention.
(B) The mechanism assuring compliance with paragraph (b)(2)(A) of
this section shall not fail in the event of power interruption.
(ii) Effective October 1, 2000, the gantry assembly shall allow
continuous rotation of at least 180 deg. from vertical (cranio-caudal
position) in one direction and of at least 105 deg. from vertical in
the other direction.
(iii) Effective October 1, 2005, the gantry assembly shall allow
continuous rotation of at least 180 deg. from vertical (cranio-caudal
position) in one direction and of at least 135 deg. from vertical in
the other direction.
(iv) Effective October 1, 2005, the system shall provide visual
indication of the gantry angle to within 5 deg..
(4) Image receptor sizes. (i) Systems using screen-film image
receptors shall provide, at a minimum, for operation with image
receptors of 18 x 24 centimeters (cm) and 24 x 30 cm.
(ii) Systems using screen-film image receptors shall be equipped
with moving grids matched to all image receptor sizes provided.
(iii) Systems used for magnification procedures shall be capable of
operation with the grid removed.
(iv) Grid motion shall not be impeded when a breast is subjected to
compression during mammography. For each size of breast support device
provided with the system, compliance shall be determined by applying
compression to, and exposing, a 12-cm diameter acrylic disk, 1.5 cm-
thick, placed with its center located 4 cm in from the center of the
chest wall edge of the breast support surface. A 4-cm thick homogeneous
acrylic attenuator with rounded edges shall be located in the beam
between the source and the compression paddle during the exposure. A
film exposed at 28 kilovoltage peak (kVp) to obtain an optical density
as close to 1.3 as possible shall be examined for grid-related
artifacts. For equipment provided with automatic exposure control
(AEC), the test shall be performed in the AEC mode. The compression to
be applied during these tests shall be determined as follows:
(A) Before October 1, 2000, for systems meeting the requirements in
paragraph (b)(12)(i)(C) of this section, the maximum attainable power
driven compression shall be used; and for systems not meeting the
requirements in paragraph (b)(12)(i)(C) of this section, the
compression applied shall be as close to 200 newtons (45 pounds) as
possible, using manual compression or a combination of manual and power
driven compression.
(B) Effective October 1, 2000, the maximum attainable power-drive
compression shall be used to determine compliance.
(5) Beam limitation and light fields. (i) All systems shall have
beam limitation devices that provide means to restrict the useful beam
so that the x-ray field can be adjusted to extend beyond the chest wall
edge of the image receptor.
(ii) Any mammography system with a light field that passes through
the beam-limiting device shall meet the following requirements:
(A) The light field shall be aligned with the x-ray field so that
the total misalignment of the edges of the light field and the x-ray
field along either the length or the width of the visually defined
field at the plane of the breast support shall not exceed 2 percent of
the distance from the source to the midpoint of the chest wall edge of
the image receptor support device.
(B) The light field shall provide an average illumination of not
less than 160 lux (15 footcandles) at 100 cm or the maximum source-
image receptor distance (SID), whichever is less.
(iii) Effective October 1, 2000, all mammography systems shall be
equipped with light fields that pass through the beam-limiting device
and approximate the x-ray field.
(iv) Effective October 1, 2005, all systems shall be interlocked to
prevent exposure unless appropriate combinations of beam limitation and
image receptor size are selected.
(v) Effective October 1, 2005, all systems shall be interlocked to
prevent exposure with an x-ray field that extends beyond the nonchest
wall edges of the image receptor support device.
(6) Source-image receptor distance (SID). Effective October 1,
2000:
(i) Systems designed solely for contact mammography shall have a
minimum SID of at least 55 cm.
(ii) All systems shall provide visual indication of the selected
SID to within 2 percent of its actual value.
(7) Magnification. (i) Systems used for diagnostic procedures shall
have magnification capability available for use by the operator at any
time.
(ii) Systems designed for magnification procedures shall provide at
least one magnification setting within the range of 1.4 to 2.0.
(8) System resolution. (i) The focal spot shall be such that, with
the mammography screen-film combination used in the facility, the
system will provide a minimum resolution of 11 line-pairs/mm when the
high contrast resolution bar pattern is oriented with the bars
perpendicular to the anode-cathode axis, and 13 line-pairs/mm when the
bars are parallel to that axis.
(ii) Effective October 1, 2005, for those systems providing
magnification capability, a focal spot that meets the following
requirements shall be provided:
(A) The resolution provided by the magnification focal spot shall
meet, at a minimum, the requirements of paragraph (b)(8)(i) of this
section. Compliance shall be determined with the test pattern placed
4.5 cm above the magnification breast support, under the conditions of
system magnification providing a magnification factor as close to 1.5
as can be achieved with the system.
(B) When more than one target material is provided, the measurement
in paragraph (b)(8)(ii)(A) of this section shall be made using the
appropriate focal spot for each target material.
(C) The grid shall be removed from the imaging chain during these
measurements.
(9) Focal spot selection. (i) When more than one focal spot is
provided, the system shall indicate, prior to exposure, which focal
spot is selected.
(ii) When more than one target material is provided, the system
shall indicate, prior to exposure, the preselected target material.
(iii) When the target material is selected by the system algorithm,
based on the exposure or a test exposure, the system shall display the
target material selected after the exposure.
(iv) When the selected target is related to the kVp, the system
shall prevent exposure unless the correct combination of target and kVp
is selected.
(10) Focal spot location. (i) The focal spot shall be located so
that the ray falling on the mid-point of the chest wall edge of the
image receptor is within 5 deg. of perpendicular to the
image receptor.
(ii) Compliance shall be determined for each focal spot provided.
(11) Filtration. (i) General. Each system shall comply with the
beam quality requirements of Sec. 1020.30(m)(1)
[[Page 14917]]
of this chapter for the minimum half-value layer (HVL).
(ii) Variable filtration. (A) Effective October 1, 2000, systems
with variable filtration type or thickness shall be interlocked to
prevent exposure if the selected filtration material is inappropriate
for the target chosen or is outside the allowable range specified in
paragraph (b)(11)(i) of this section.
(B) If different types of filtration materials are available, the
system shall display the type of filtration in use prior to exposure.
(C) Effective October 1, 2000, if the filtration is automatically
selected based on a test exposure, the system shall visually indicate
the filtration that was actually used after the exposure is completed.
(12) Compression. All mammography systems shall incorporate a
compression device.
(i) Application of compression. Effective October 1, 2000:
(A) Power driven compression activated by foot controls operable
from both sides of the examinee shall be provided.
(B) Fine adjustment compression controls operable from both sides
of the examinee shall be provided.
(C) The compression device shall provide a maximum compression for
the power drive between 111 newtons (25 pounds) and 200 newtons (45
pounds).
(ii) Decompression. (A) If the system is equipped with a provision
for automatic decompression after completion of an exposure or
interruption of power to the system, the system shall also provide an
override capability to allow maintenance of compression and shall
continuously display the override status.
(B) Each system shall provide a manual emergency compression
release that can be activated in the event of power or automatic
release failure.
(C) If a system is equipped with a remote compression release
control for the operator, the release control shall be located in a
position that allows the operator to observe the examinee during
activation of the release control.
(iii) Compression paddle. (A) Systems shall be equipped with
different sized compression paddles that match the sizes of all full-
sized image receptors provided. Compression paddles for special
purposes, including those smaller than the full size of the image
receptor (for ``spot compression'') may be provided. Such compression
paddles for special purposes are not subject to the requirements of
paragraphs (b)(12)(iii)(B) and (b)(12)(iv)(A) of this section.
(B) When compression is applied, the compression paddle shall be
flat and parallel to the breast support table and shall not deflect
from parallel by more than 1.0 cm at any point on the surface of the
compression paddle. Compliance shall be determined by applying maximum
system power compression to a 12-cm diameter acrylic disk 1.5-cm thick
placed with its center located 4 cm in from the center of the chest
wall edge of the breast support surface for each full size compression
paddle provided. For systems without power driven compression, or for
systems which, before October 1, 2000, do not meet the requirements in
paragraph (b)(12)(i)(C), compliance shall be determined by applying
compression at as close to 200 newtons (45 pounds) as achievable using
manual or a combination of manual and power driven compression.
Vertical measurements shall be made between the breast support surface
and the compression paddle at each of the four corners of the image
receptor and shall be compared to each other and to the 1.5-cm
thickness of the test device. The maximum difference between any two
values shall not exceed 1.0 cm.
(C) The chest wall edge of the compression paddle shall be straight
and parallel to the edge of the image receptor.
(D) The chest wall edge should be bent upward, forming a lip to
allow for examinee comfort, but shall not interfere with the image at
the chest wall.
(iv) Compression paddle alignment. (A) Effective October 1, 2000,
when compression is applied, a line constructed perpendicular to the
flat surface of the compression paddle through the vertex of the angle
formed by the flat surface and the lip of the compression paddle and
extending to the plane of the image receptor, shall intercept that plan
within a distance no greater than 1 percent of the SID
from the useful edge of the image receptor at the chest wall side (see
Figure 1).
BILLING CODE 4160-01-P
[GRAPHIC] [TIFF OMITTED] TP03AP96.000
(B) Effective October 1, 2005, when compression is applied, a line
constructed perpendicular to the flat surface of the compression paddle
through the vertex of the angle formed by the flat surface and the lip
of the compression paddle and extending to the plane of the image
receptor, shall pass within 2 millimeters of the useful
[[Page 14918]]
edge of the image receptor at the chest wall side.
(C) When the system is configured without magnification capability,
compliance shall be determined with the bottom surface of the
compression paddle placed at a distance within the range of 2.0 to 6.0
cm above the breast support.
(D) When the system is configured for magnification procedures,
compliance shall be determined with the bottom surface of the
compression paddle placed at a distance within the range of 2.0 to 6.0
cm above the breast support of the magnification device.
(v) Display of compressed breast thickness. Effective October 1,
2005, the compressed breast thickness shall be displayed and visible to
the operator during positioning.
(A) The compressed breast thickness shall be displayed to within
0.5 cm.
(B) Compliance shall be determined at the maximum attainable power
compression using a flat sheet of rigid material with known thickness
placed between the examinee support and the compression device. This
sheet shall be placed in flat contact with the top surface of the
breast support. If the support is uneven or has projections around the
edges, the sheet shall be in contact with that part of the surface that
actually supports the breast. This test shall be performed using sheets
of the following thicknesses: 3 cm, 4.5 cm, and 6 cm.
(13) Technique factor selection and display. (i) Manual selection
of milliampere seconds (mAs) shall be available.
(ii) All technique factors shall be clearly displayed at the
control panel prior to exposure.
(iii) When operating in AEC mode, the system shall indicate initial
technique factors prior to exposure.
(iv) Following AEC mode use, the system shall indicate the actual
kVp and mAs used during the exposure.
(v) All indications of kVp shall be within 5 percent of
the actual kVp.
(vi) Effective October 1, 2005:
(A) Each system shall provide, at a minimum, for the selection of
tube potentials of between 22 and 34 kVp.
(B) Selection of kVp shall be available in increments no greater
than 1 kilovolt each over the entire range provided.
(C) Adjacent mAs settings shall differ by no more than 26 percent
of the lower of the adjacent settings.
(D) Combinations of exposure time and tube current (mAs) shall be
available over the range of at least 5 mAs to 300 mAs.
(14) Radiation output. (i) The system shall be capable of producing
a minimum output of 1.29 x 10-4 coulomb/kilogram (C/kg) per second
(500 milliroentgen (mR) per second) when operating at 28 kVp in the
standard mammography mode at any SID where the system is designed to
operate. Effective October 1, 2000, the system shall be capable of
producing a minimum output of 2.06 x 10-4 C/kg per second (800 mR
per second) when operating at 28 kVp in the standard mammography mode
at any SID where the system is designed to operate.
(ii) The system shall be capable of maintaining the required
minimum radiation output for at least 3.0 seconds.
(iii) Compliance shall be determined with the center of the
detector located 4.5 cm above the breast support device used for
contact mammography and centered on the breast support 4 cm in from the
chest wall edge of the support with the compression paddle in place
between the source and the detector.
(15) Automatic exposure control. (i) Each system shall provide an
AEC mode which is operable in all combinations of equipment
configuration provided, i.e. grid, nongrid; magnification,
nonmagnification; and various target-filter combinations.
(ii) The AEC shall be capable of providing automatic mAs selection.
(iii) The AEC shall provide reproducible radiation exposures with a
coefficient of variation not to exceed 0.05.
(iv) The positioning or selection of the active detector shall
permit flexibility in the placement of the detector under the target
tissue.
(A) The size and available positions of the detector shall be
clearly indicated at the input surface of the breast compression
paddle.
(B) The selected position of the detector shall be clearly
indicated and visible from both sides of the examinee.
(v) The system shall provide means for the operator to vary the
selected optical density from the normal (zero) setting.
(vi) Effective October 1, 2005, the system shall provide means for
the operator to vary the optical density a minimum of 4 steps above and
4 steps below the normal (zero) setting of optical density. These steps
shall vary in optical density increments of between 10 to 20 percent of
the difference between adjacent mAs settings;
(vii) The system shall meet, at a minimum, the following
requirements at all detector positions and for thicknesses of 2, 4, and
6 cm of homogeneous breast tissue-equivalent material. Compliance shall
be determined using the screen-film and processing combination used at
the facility when the mean optical density is at least 1.20.
(A) Effective October 1, 2000, equipment shall produce images with
optical densities that vary from the mean optical density by no more
than 0.30.
(B) Effective October 1, 2005, equipment shall produce images with
optical density that varies from the mean optical density by no more
than 0.15.
(16) Disabled examinees. Each facility scheduling disabled
individuals shall have equipment and established protocols to ensure
the facility's capability to perform mammography adequately on such
individuals.
(17) X-ray film. The facility shall use x-ray film for mammography
that has been designated by the film manufacturer as appropriate for
mammography.
(18) Intensifying screens. The facility shall use intensifying
screens for mammography that have been designated by the screen
manufacturer as appropriate for mammography and shall match them to the
spectral sensitivity specified by the manufacturer of the film used.
(19) Film processing solutions. For processing mammography films,
the facility shall use chemical solutions that are capable of
developing the films used in a manner equivalent to the minimum
requirements specified by the film manufacturer.
(20) Lighting. The facility shall provide a special light with
variable luminance capable of producing light levels greater than that
provided by the view box.
(21) Film Masking Devices. (i) All facilities shall have film
masking devices that can limit the illuminated area to a region equal
to or smaller than the exposed portion of the film.
(ii) Facilities using x-ray collimation that provides
nonrectangular exposed areas on the film shall provide masking devices
appropriate to these fields.
(iii) Facilities shall make devices meeting the requirements of
paragraphs (b)(21)(i) and (b)(21)(ii) of this section available to the
interpreting physician.
(22) Film processors. Film processors used to develop mammograms
shall meet the following requirements:
(i) The processor shall be adjusted and maintained to meet the
technical development specifications for the mammography film in use.
(ii) Effective October 1, 2000, the processor shall indicate the
selected time cycle reflecting the time from leading edge entry into
the developer to leading edge entry into the fixer.
[[Page 14919]]
(iii) Effective October 1, 2000, the processor shall be capable of
maintaining the developer temperature to within 0.3 deg.
Celsius (0.5 deg.F). Compliance measurements for immersion
tank type processors shall be taken at the center of the surface of the
developer solution and 7.5 cm (3 inches) below the surface when the
developer is at the proper operating level.
(iv) Effective October 1, 2005, the processor shall clearly display
the actual developer temperature to within 0.1 deg.C
(0.2 deg.F) of the actual temperature.
(v) Effective October 1, 2005, for processors with variable cycles,
the selectable parameters shall be interlocked to prevent any
initiation of changes in the parameters until any film in process is
completed, and to prevent any new film from entering the process cycle
until the variables are properly stabilized at the new cycle
parameters. If the unit is equipped with an override of this interlock
for maintenance procedures, the override status shall be clearly
indicated to the operator.
* * * * *
(e) Quality assurance--equipment--(1) Daily quality control tests.
Facilities with screen-film systems shall perform a processor
performance test on each day that examinations are performed before any
examinations are performed that day. The test shall include an
assessment of base plus fog density, mid-density, and density
difference, using the mammography film used clinically at the facility.
(i) The base plus fog density shall be within + 0.03 of the
established operating level.
(ii) The mid-density shall be within 0.15 of the
established operating level of no less than 1.20 optical density (OD).
(iii) The density difference shall be within 0.15 of
the established operating level.
(2) Weekly quality control tests. Facilities with screen-film
systems shall perform an image quality evaluation test at least weekly.
(i) The optical density of the film at the center of an image of a
standard FDA-accepted phantom shall be at least 1.20 when exposed under
a typical clinical condition.
(ii) The optical density of the film at the center of the phantom
image shall not change by more than 0.20 from the
established operating level.
(iii) The phantom image shall achieve at least the minimum score
acceptable to FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(9).
(iv) The image contrast between the background of the phantom and
an added test object, used to assess density difference, shall be
measured and shall not vary by more than 0.05 from the
established operating level.
(3) Quarterly quality control tests. Facilities with screen-film
systems shall perform the following quality control tests at least
quarterly:
(i) Fixer retention in film. The residual fixer shall be no more
than 5 micrograms per square cm.
(ii) Repeat analysis. If the total repeat or reject rate changes
from the previously determined rate by more than 2.0 percent of the
total films included in the analysis, the reason(s) for the change
shall be determined and any corrective actions and their results shall
be recorded.
(4) Semiannual quality control tests. Facilities with screen-film
systems shall perform the following quality control tests at least
semiannually:
(i) Darkroom fog. The optical density attributable to darkroom fog
shall not exceed 0.05 when a mammography film of the type used in the
facility, which has a mid-density of no less than 1.2 OD, is exposed to
typical darkroom conditions for 2 minutes while such film is placed on
the counter top. If the darkroom has a safelight, it shall be on during
this test.
(ii) Screen-film contact. Testing for screen-film contact shall be
conducted using 40 mesh screen.
(iii) Compression. The compression device shall meet the
specifications described in Sec. 900.12(b)(12).
(5) Annual quality control tests. Facilities with screen-film
systems shall perform the following quality control tests at least
annually:
(i) Automatic exposure control performance. (A) The AEC shall be
capable of maintaining film optical density within 0.30 of
the mean optical density when phantom thickness is varied over a range
of 2 to 6 cm and the kVp is varied over the kVp range used in the
facility for such thicknesses.
(B) The operating optical density of the film in the center of the
phantom image shall not be less than 1.20.
(C) If the requirement of paragraph (e)(5)(i)(A) of this section
cannot be met, a technique chart shall be developed showing appropriate
techniques (kVp and density control settings) for different breast
thicknesses and compositions that must be used so that optical
densities within 0.30 of the average under phototimed
conditions can be produced.
(ii) Kilovoltage peak (kVp) accuracy and reproducibility.
(A) At the lowest and highest clinical values and at any other
commonly used clinical settings of kVp, the kVp shall be accurate to
within 10 percent, and
(B) At the most commonly used clinical settings of kVp, the
coefficient of variation of reproducibility of the kVp shall be equal
to or less than 0.02.
(iii) System Resolution. The limiting spatial resolution shall not
be less than 13 line-pairs/mm parallel to the anode-cathode axis of the
x-ray tube and 11 line-pairs/mm perpendicular to the anode-cathode
axis.
(iv) Beam quality and half-value layer (HVL). The HVL shall meet
the specifications in paragraph (b)(11) of this section.
(v) Breast entrance exposure and AEC reproducibility. The
coefficient of variation for both exposure and mAs shall not exceed
0.05.
(vi) Dosimetry. The average glandular dose delivered during a
single cranio-caudal view of an FDA-accepted phantom simulating a 4.2-
cm thick, compressed breast consisting of 50 percent glandular and 50
percent adipose tissue, shall not exceed 3.0 milliGray (0.3 rad) per
exposure. The dose shall be determined with technique factors and
conditions used clinically for a 4.2-cm, 50 percent glandular/50
percent adipose tissue compressed breast.
(vii) X-ray field/light field/image receptor/compression paddle
alignment. The x-ray field/light field/image receptor alignment shall
meet the specifications of paragraph (b)(5) of this section and
Sec. 1020.31(f)(3) of this chapter. In addition, the chest wall edge of
the compression paddle shall not extend beyond the chest wall edge of
the image receptor by more than one per cent of the SID.
(viii) Screen speed uniformity. Screen speed uniformity of all the
cassettes in the facility shall be tested and the difference between
the maximum and minimum optical densities shall not exceed 0.30. Screen
artifacts shall also be evaluated during this test.
(ix) System artifacts. System artifacts shall be evaluated with a
high-grade, defect-free phantom large enough to cover the mammography
cassette.
(6) Quality control tests--other modalities. For systems with
image receptor modalities other than screen-film, the quality assurance
program shall be substantially the same as the quality assurance
program recommended by the image receptor manufacturer, except that the
maximum allowable dose shall not exceed the maximum allowable dose for
screen-film systems in paragraph (e)(5)(vi) of this section.
[[Page 14920]]
(7) Mobile Units. The facility shall verify that mammography units
used to produce mammograms at more than one location meet the
requirements in paragraphs (e)(1) through (e)(6) of this section. In
addition, at each examination location, before any additional
examinations are conducted, the facility shall verify satisfactory
performance of such units using a test method that establishes the
adequacy of the image quality produced by the unit.
(8) Use of test results. (i) After completion of the tests
specified in paragraphs (e)(1) through (e)(7) of this section, the
facility shall compare the test results to the corresponding specified
action limits; or, for non screen-film modalities, to the
manufacturer's recommended action limits; or, for post-move, pre-
examination testing of mobile units, to the limits established in the
test method used by the facility. The applicable tests shall be
repeated immediately for any parameters found to be beyond the
specified acceptable ranges.
(ii) If the repeated tests continue to produce unacceptable
results, the source of the problem shall be identified and corrective
actions shall be taken before any further examinations are performed.
(9) Surveys. (i) At a frequency of no less than once a year, each
facility shall undergo a survey by a medical physicist or by an
individual under the direct supervision of a medical physicist. At a
minimum, this survey shall include the performance of tests to ensure
that the facility meets the quality assurance requirements of the
annual tests in paragraphs (e)(5) and (e)(6) of this section and the
weekly phantom image quality test in paragraph (e)(2) of this section.
(ii) The results of all tests conducted by the facility in
accordance with paragraphs (e)(1) through (e)(7) of this section, as
well as written documentation of any corrective actions taken and their
results, shall be evaluated for adequacy by the medical physicist
performing the survey.
(iii) The medical physicist shall prepare a survey report that
includes a summary of this review and recommendations for necessary
improvements.
(iv) The survey report shall be sent to the facility within 30 days
of the date of the survey.
(v) The survey report shall be dated and signed by the medical
physicist performing or supervising the survey. If the survey was
performed entirely or in part by another individual under the direct
supervision of the medical physicist, that individual and the part of
the survey that individual performed shall also be identified in the
survey report.
(10) Mammography equipment evaluations. Additional evaluations of
mammography units or image processors shall be conducted whenever a new
unit or processor is installed, or major components of a mammography
unit or processor equipment are changed. These evaluations shall be
used to determine whether the new or changed equipment meets the
requirements of applicable standards in paragraphs (b) and (e) of this
section. All problems shall be corrected before the new or changed
equipment is put into service for examinations. The mammography
equipment evaluation shall be performed by an individual whose
qualifications are adequate to examine equipment for this purpose and
in accordance with procedures that are adequate to ensure that the
examination is complete and accurate.
(11) Facility cleanliness. (i) The facility shall establish and
implement adequate protocols for maintaining darkroom, screen, and view
box cleanliness.
(ii) The facility shall document that all cleaning procedures are
performed at the frequencies specified in the protocols.
(12) Calibration of exposure measuring instruments. (i) Instruments
used to measure the exposure or exposure rate from a mammography unit
shall be traceable to a national standard.
(ii) Effective October 1, 2005, the manufacturers calibrating
instruments to measure exposure or exposure rate from mammography units
shall meet the requirements of a recognized quality assurance program.
A calibration laboratory calibrating instruments to measure exposure or
exposure rate from mammography units must be accredited by a recognized
national program or an equivalent international program which requires
continuing participation with NIST in measurements and testing for
maintaining quality assurance appropriate for mammography.
(13) Infection control. Facilities shall establish and comply with
a system specifying procedures to be followed by the facility for
cleaning and disinfecting mammography equipment after contact with
blood or other potentially infectious materials. This system shall
specify the methods for documenting facility compliance with the
infection control procedures established and shall:
(i) Comply with all applicable Federal, State, and local
regulations pertaining to infection control; and
(ii) Comply with the manufacturer's recommended procedures for the
cleaning and disinfection of the mammography equipment used in the
facility; or
(iii) If adequate manufacturer's recommendations are not available,
comply with generally accepted guidance on infection control, until
such recommendations become available.
Dated: March 22, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-7833 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-P
Complete official Federal Register PDF
FR Doc. 96-7832 Quality Standards and Certification Requirements for Mammography Facilities; Personnel Requirements
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14898-14908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7832]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR PART 900
[Docket No. 95N-0215]
RIN 0910-AA24
Quality Standards and Certification Requirements for Mammography
Facilities; Personnel Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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[[Page 14899]]
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the mammography facility standards by modifying and adding to the
personnel requirements for interpreting physicians, radiologic
technologists, and medical physicists who perform mammography services.
In addition to the statutory framework and the expertise and research
of FDA personnel, the agency is proposing this rule based on advice
provided by the National Mammography Quality Assurance Advisory
Committee (NMQAAC) and public comments received in response to the
interim regulations. This action is being taken to ensure that all
personnel involved in mammography meet at least the minimum
requirements for providing safe, accurate, and reliable mammography.
This is the fourth of five proposed rules being published concurrently.
DATES: Written comments on this proposed rule by July 2, 1996.
Written comments on the information collection requirements should
be submitted by May 3, 1996. The agency is proposing that any final
rule based on this proposed rule become effective 1 year after its date
of publication in the Federal Register.
ADDRESSES: Submit written comments on this proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. The Regulatory Impact
Study (RIS) is available at the Dockets Management Branch for review
between 9 a.m. and 4 p.m., Monday through Friday. Requests for copies
of the RIS should be submitted to the Freedom of Information Staff
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16,
Rockville, MD 20857.
Submit written comments on the information collection requirements
to the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for
Devices and Radiological Health (HFZ-240), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.
SUPPLEMENTARY INFORMATION:
I. Background
This proposal is the fourth of five related proposed rules
published in this issue of the Federal Register to amend interim
regulations published on December 21, 1993 (58 FR 67558 and 58 FR
67565), implementing the Mammography Quality Standards Act of 1992 (the
MQSA). The first proposed rule entitled ``Quality Mammography
Standards; General Preamble and Proposed Alternative Approaches''
contains background information and a summary of the preliminary
analysis of the costs and benefits of all of these proposed rules, a
description of the information collection requirements, proposed
revisions to Sec. 900.1 Scope and Sec. 900.2 Definitions, and proposed
alternative approaches to mammography quality standards and a request
for comments on the proposed alternatives.
II. Provisions of the Proposed Rule
A. Development of the Proposed Regulation
This proposed rule establishes the personnel qualification
standards that the staff of each mammography facility must meet in
order to comply with requirements under the MQSA. As in the development
of the interim regulations, FDA has been guided by the requirements of
this statute and its stated legislative intent to guarantee access to
safe and effective mammography services for all women in the United
States (Ref. 1).
In addition to the statutory framework and the expertise and
research of FDA personnel, the agency relied upon three major sources
of information in developing this proposed rule. The first source was
the written comments received on the interim regulations. FDA received
103 comments from individuals and organizations on the interim
regulations. Included among the written comments were responses from
professional organizations, medical facilities, State agencies,
consumer groups, manufacturers, and individual physicians, medical
physicists, and radiologic technologists.
Drafts of this proposed rule were also discussed with the NMQAAC,
particularly at the February 1994 and January 1995 public meetings with
the agency. The members of the NMQAAC include interpreting physicians,
medical physicists, radiologic technologists, representatives of State
agencies, and consumer representatives. Consultants to the Committee
and guests invited to attend the meetings in recognition of their
expertise in mammography also participated in these discussions. In the
Federal Register of January 26, 1995 (60 FR 5152), the agency published
a notice of availability of the draft of the proposed rule that was
discussed with the NMQAAC.
Finally, the problems with the interim regulation were discussed
with many of the individuals who currently perform annual inspections
of mammography facilities under the MQSA to determine whether minimum
quality standards are being achieved. Most of these inspectors have
extensive prior experience in the inspection of radiology facilities.
After the MQSA inspections began in January 1995, the agency closely
monitored the process and gathered information that was valuable for
developing the proposed final regulations.
B. Interpreting Physicians
The proposed regulation for interpreting physicians generally
clarifies the requirements issued under the interim regulations and
adds some new requirements. Although neither a national standard nor a
continuing competency test for mammography interpretation currently
exists, the proposed training and experience requirements for
interpreting physicians will provide minimum standards to help ensure
the reliability and accuracy of interpretation of mammograms for women
throughout the country.
As discussed below, the quality standards proposed by FDA for
interpreting physicians are divided into four general sections: Initial
qualifications; continuing experience and education; exceptions; and
reestablishing qualifications.
1. General Comments
Two comments expressed concern that providers in rural areas would
have difficulty meeting the requirements of the interim regulations.
They suggested that allowance should be made for such facilities,
either through lowering the standards for rural facilities or
establishing a longer phase-in period. One of these comments also
stated that it would be helpful if the Department of Health and Human
Services monitored the effect of the rules on rural providers.
Both FDA and NMQAAC are concerned about the impact of the MQSA on
access to mammography in rural areas. However, both the agency and
NMQAAC believe that the standards should not be lower for certain
facilities. One of the primary goals of the MQSA is to ensure that all
women receive at least the same minimum standard of care, no matter
which facility they use. However, one of the specific duties that the
MQSA requires of NMQAAC is to determine whether there exists a shortage
of mammography facilities or health professionals in any areas and to
determine the effects of the quality standards on access to mammography
[[Page 14900]]
services in such areas. This study already has begun and the results
will be published upon completion.
2. Initial Qualifications
The first qualification for an interpreting physician under the
MQSA is a State license to practice medicine (proposed
Sec. 900.12(a)(1)(i)(A)).
One comment stated that Sec. 900.12(a)(1)(i)(A) in the interim
regulations was confusing and would appear to allow a facility to
license a physician. Similarly, another comment stated that the
licensing requirements of physicians practicing in Federal facilities
are unclear.
In response, FDA notes that a facility cannot license a physician
to practice medicine. Licensing of physicians is a State function.
Proposed Sec. 900.12(a)(1)(i) simply requires the interpreting
physician to have a State license to practice medicine. However, if the
State in which the mammography facility is located is different from
the State that issued the license, a physician may have to meet
additional State requirements in order to practice medicine lawfully at
that facility. With respect to physicians practicing in Federal
facilities, a valid State license from any State is sufficient.
However, the Federal employee would be unable to practice outside the
Federal facility unless the physician also fulfilled the requirements
of that State for the practice of medicine.
Proposed Sec. 900.12(a)(1)(i)(B) provides two pathways to establish
the second initial qualification: Board certification or documented
training in interpreting mammograms. The training shall include
radiation physics (including radiation physics specific to
mammography), radiation effects, and radiation protection.
One comment recommended that FDA accept both American and Canadian
boards as certifying bodies.
FDA does accept certification from both American and Canadian
boards. Currently, FDA recognizes certification in Diagnostic Radiology
and Radiology by the American Board of Radiology (ABR), the American
Osteopathic Board of Radiology (AOBR), and the Royal College of
Physicians and Surgeons of Canada.
Another comment asked that two British radiology boards be added to
the list of bodies designated by FDA as eligible to certify
interpreting physicians: Fellow of the Royal College of Radiologists
(FRCR) and, Diploma in Medical Radiodiagnosis (DMRD) from the Royal
College of Physicians and Surgeons of England.
NMQAAC discussed but did not recommend including other bodies to
certify interpreting physicians at this time because there was
insufficient information about the procedures and requirements for
obtaining board certification from other bodies. FDA has not added
additional bodies to its list of certifying bodies because FDA agrees
that it has insufficient information at this time.
One comment stated that certifying bodies for interpreting
physicians should be listed in the regulations. Another comment noted
that the interim regulations do not indicate the particular bodies that
have or will be designated by FDA as eligible to certify interpreting
physicians and noted that approval of inappropriate certifying bodies
could result in poorly qualified physicians reading and interpreting
mammograms. The comment suggested that guidelines are needed regarding
the certification of interpreting physicians.
FDA believes that it is best not to codify the list of eligible
certifying bodies in the regulation in order to be able to make changes
to the list of certifying bodies in a timely manner each time a body
must be added to or deleted from the list. FDA will add or delete names
based upon the agency's determination that the body has in place and
implements procedures and requirements that are adequate to ensure that
interpreting physicians certified by the body are capable of satisfying
the MQSA needs. Whenever possible, FDA intends to consult with the
NMQAAC before making a determination about adding or removing a body
from the list of those eligible to certify physicians. The list of
currently eligible certifying boards is based upon FDA evaluation and
consultation with NMQAAC, as described above. FDA will follow a similar
policy with respect to its determination of eligibility for boards or
organizations that certify radiologic technologists and medical
physicists.
One comment noted that his State's requirements for interpreting
physicians are more stringent than the interim requirements and
suggested that FDA may want to include the following language in the
regulation (sic): ``require A.B.R. or A.O.B.R. certification or has
successfully completed and graduated from an accredited radiology
residency within the past 24 months.'' Another comment stated that FDA
should give careful consideration before approving either the ABR or
the AOBR to certify interpreting physicians. The comment further
explained that if the ABR or AOBR certifies physicians based on ``board
certification,'' many physicians who are not adequately trained in
mammography automatically would be allowed to interpret mammograms.
FDA recognizes that some earlier board examinations may not have
included testing in mammography. FDA also recognizes that board
certification that includes mammography cannot by itself ensure the
accuracy of outcomes in clinical mammography practices. However, board
certification is evidence that the physician is knowledgeable in the
basics of diagnostic radiology and board certification serves as a
foundation for the additional requirements specific to mammography that
interpreting physicians must meet under FDA's interim and proposed
regulations.
Alternatively, proposed Sec. 900.12(a)(1)(i)(B) would permit 3
months of documented formal training in mammography, including the
interpretation of mammograms and other topics related to mammography,
in place of board certification in diagnostic radiology. The other
topics related to mammography include, but are not limited to:
Radiation physics, including radiation physics specific to mammography;
radiation effects; and radiation protection. The interim regulations
require 2 months of documented full-time training. The agency is
proposing an additional month of required training to reflect the
increased emphasis that has been placed on mammography in residency
programs.
During discussions at an NMQAAC meeting, it was recommended that
FDA require training in radiation physics specific to mammography
instead of training in general radiation physics as the training
required by the alternative pathway in proposed
Sec. 900.12(a)(1)(i)(B). FDA agrees that mammography specific training
is necessary, but also believes that general training in radiation
physics is important for basic principles and should be retained as
part of the requirements for the alternative pathway provided by
proposed Sec. 900.12(a)(1)(i)(B). NMQAAC also suggested that all
required training in physics be obtained from a physicist. However, the
agency believes that this suggestion is too restrictive and would limit
the availability of adequate training opportunities.
The agency is proposing that the training in interpretation
required for the alternative pathway be performed under the direct
supervision of an interpreting physician who meets the MQSA
requirements for an interpreting physician. It was recommended during
NMQAAC discussions that there be additional qualifications for the
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supervising physician beyond those required of an interpreting
physician. For example, FDA could require supervising physicians to be
qualified to offer continuing medical education (CME) credits. Again,
the agency believes that this suggestion would be too restrictive and
reduce the availability of effective training opportunities.
One comment suggested having an alternative method for allowing a
physician who is not a radiologist but who is experienced in
interpreting film mammography to be certified and allowed to continue
to interpret mammograms.
The agency agrees and has proposed Sec. 900.12(a)(1)(i)(B) in order
to provide an alternative to board certification for radiologists and
physicians who are not radiologists, but who otherwise qualify.
One comment stated that the alternate pathway to board
certification in the interim regulations, requiring 2 months of
training in the interpretation of mammograms, is not adequate. The
comment stated that some type of board certification is necessary to
ensure that women are receiving high quality interpretation of
mammograms. Another comment advocated the addition of a proficiency
examination, which would require a physician to demonstrate his or her
ability to interpret mammograms, both at the point of the physician's
initial certification and at periodic intervals to maintain that
certification. The latter comment noted that academic achievement,
although important, is not sufficient to ensure high quality
mammography.
The NMQAAC discussed the possibility of requiring that interpreting
physicians undergo proficiency testing in mammography, but did not
recommend such testing at this time. To date, sufficient data have not
been compiled on existing levels of interpretive skills for
interpreting physicians to determine whether there is a general need
for proficiency testing. With respect to the adequacy of the training
required under the alternate pathway, FDA is proposing to increase that
requirement from 2 to 3 months of documented training in the
interpretation of mammograms.
Proposed Sec. 900.12(a)(1)(i)(C) requires 60 hours of documented
continuing medical education credits in mammography for all
interpreting physicians, including instruction in the interpretation of
mammograms and training appropriate to each mammographic modality used
in the interpreting physician's practice. At least 40 of these hours
must be Category I CME credits and, to ensure that the physician has
recent mammography education, at least 15 of these 40 Category I CME
hours must have been acquired within the 3 years immediately preceding
qualifying as an interpreting physician. Hours spent in residency
specifically devoted to mammography will be considered as equivalent to
Category I CME and will be accepted if documented in writing by the
appropriate representative of the training institution.
One comment stated that the interim regulations, which require 40
hours of documented CME in mammography, are quite adequate to ensure
that interpreting physicians have the training, expertise, and
experience necessary to do mammographic interpretations.
The agency believes that an increase to 60 hours is in keeping with
current training trends and the emergence of new technologies.
Proposed Sec. 900.12(a)(1)(i)(C) requires training in each
mammographic modality employed in the interpreting physician's
practice. FDA added this requirement because of the differences among
imaging modalities (e.g., film screen and xeromammography) currently in
use and emerging technologies, such as digital mammography. The agency
believes that, before a physician begins to interpret images produced
by a particular modality, he or she should have specific training in
the interpretation of such images. FDA is proposing that at least 8
hours of Category I CME credit be related to each mammographic modality
used by the interpreting physician.
FDA has also proposed, with the concurrence of NMQAAC, that the
interpreting physician must have education in each of the following:
basic breast anatomy; breast pathology and physiology; technical
aspects of mammography (e.g., exposure factors, compression,
positioning); quality assurance and quality control in mammography.
One comment questioned whether ABR certified physicians are
required to document 40 hours of initial education under the interim
regulations.
The interim regulations require this documentation from physicians
using either of the two pathways and proposed Sec. 900.12(a)(1)(i)(C)
would continue this requirement for the 60 hours of required initial
training.
Two comments asked what FDA will consider to be adequate
documentation of the radiologist's training.
A variety of documentation has and will be accepted (e.g., copy(s)
of the license(s) to practice medicine, copy(s) of the certificate
issued by certifying board(s), CME credit certificates). The agency
previously issued guidance on adequate documentation under the interim
regulations that will be revised, as needed, and made available when
the final regulations are published. Such guidance does not bind the
agency or the facility and facilities may choose to accept
documentation that is not discussed in FDA guidance. However, FDA
encourages facilities that plan to accept alternate documentation to
discuss the matter in advance with FDA in order to avoid potential loss
of time and resources. Upon inspection of the facility, in any
situation in which documentation appears inadequate, the burden will be
upon the employee and the facility to provide additional evidence to
demonstrate the qualifications of personnel employed by the facility.
One comment suggested that time spent in a residency program
devoted to mammography should be documented by the residency program.
FDA agrees and is proposing that the resident's training be
documented in writing by the appropriate representative of the training
institution.
Proposed Sec. 900.12(a)(1)(i)(D) requires the qualifying physician
to interpret at least 240 mammographic examinations under the direct
supervision of a qualified interpreting physician within the 6 months
immediately prior to fulfilling the initial qualifications as an
interpreting physician. The intent of this requirement is to
demonstrate recent supervised experience before the physician begins to
interpret mammograms independently. Proposed Sec. 900.12(a)(1)(iii)(B)
provides an exception from this prior 6-month timeframe for diagnostic
radiology residents who become board certified at the first allowable
time, as defined by the eligible certifying body of their choice. Such
residents must still interpret at least 240 mammographic examinations
in the last 2 years of residency under the direct supervision of a
qualified interpreting physician.
One comment expressed concern that the volume of films that must be
read to achieve and maintain certification may have an unintended,
negative impact on a physician working on a locum tenens basis, that
is, a physician serving as a temporary replacement for another
physician.
In response, FDA notes that proposed Sec. 900.12(a)(1)(i)(D) is an
initial requirement that need only be met once if the interpreting
physician maintains his or her continuing experience requirements under
proposed Sec. 900.12(a)(1)(ii).
[[Page 14902]]
3. Continuing Qualifications
Proposed Sec. 900.12(a)(1)(ii)(A) is the first of the requirements
established to ensure that interpreting physicians maintain their
qualifications. Under this requirement, in order to continue to qualify
under the MQSA, interpreting physicians must have read an average of at
least 40 mammographic examinations a month during the previous 24
months. Although the wording has changed somewhat from the interim
rule, the proposed regulation is not substantially different from the
interim requirement.
There were numerous comments on this requirement in the interim
regulations. Comments expressed concern about the difficulty in meeting
this requirement in rural areas due to lack of volume at the facility.
One comment expressed concern that the requirement may have a negative
impact on physicians serving as temporary replacements for other
physicians (i.e., on a locum tenens basis). Two comments suggested
allowing the substitution of continuing education for this experience
requirement, and one of these comments suggested that the physician be
allowed to submit interpretations on a specified number of test
mammograms in lieu of the 40 per month average and that the
requirements could also be modified slightly to focus on the number of
mammograms read per year, instead of per month. Another comment
requested that rural x-ray departments be exempted from this
requirement.
As previously stated, FDA believes that all women, including those
in rural areas, are entitled to the same quality of care, and the
agency cannot support lower standards for particular facilities. The
agency also believes, as discussed below, that it will not be difficult
for most physicians to meet this continuing qualification, even for
those in rural areas.
The monthly average is to be maintained over a 24-month period. FDA
selected 24 months to allow interpreting physicians a reasonable chance
to maintain the required average. Physicians who are absent for a
period of time, due to sabbaticals or other reasons, or who only read
mammographic images during selected periods, because of their facility
rotation schedule or employment on a locum tenens basis, will have the
opportunity to read enough images during some portions of the 24-month
period to maintain the required average. The agency also wants to
clarify that this is a physician requirement, not a facility
requirement. Interpreting physicians who provide services to low
workload facilities can read films at more than one facility to attain
the required average. Double reading of images (2 or more physicians
interpreting the same mammogram) is also accepted as a way of meeting
this requirement. However, the agency excludes from its definition of
double reading the interpretation of the same mammogram more than once
by a same physician. For all of these reasons, the agency believes
there will not be widespread difficulty in meeting this requirement.
One comment suggested that the agency develop something besides an
artificial number to tell whether or not a radiologist is able to do a
good job.
FDA recognizes that numbers alone cannot guarantee competency, but
believes that the experience a radiologist accumulates through
interpreting a certain minimum number of films is a necessary aspect of
the qualification process. Elsewhere in this issue of the Federal
Register, FDA is proposing requirements for the establishment and
implementation of a medical outcomes' audit for individual physicians.
This type of monitoring can further improve the reliability, clarity,
and accuracy of interpretation of mammograms.
One comment suggested that FDA establish a maximum number of images
that the interpreting physician would be allowed to read in a given
period of time.
FDA does not believe there is any evidence to support a need to
establish such a limit.
Proposed Sec. 900.12(a)(1)(ii)(B) requires interpreting physicians
to further maintain their skills by teaching or completing at least 15
Category I CME credits in mammography in the previous 3 years. Category
I CME credits are generally those that offer more formal training and
provide a solid basis for the ongoing maintenance and growth of the
interpretive skills of the physician.
The interim regulations require interpreting physicians to
participate in education programs, either by teaching or completing an
average of at least five CME credits in mammography per year. There
were numerous comments on this requirement in the interim regulations,
most of which focused on the lack of a specified average period. Some
comments suggested that it should be 15 hours over a 3-year period.
Proposed Sec. 900.12(a)(1)(ii)(B) addresses these concerns by
establishing a 3-year period of time for determining the yearly
average. FDA has proposed that the credits be in category I CME in
order to ensure that continuing education is more formal and
contributes to the development of the physician. The section also
requires that at least 6 of the CME hours be in each mammographic
modality used in the interpreting physician's practice. Therefore, the
CME hours required for an interpreting physician who practices in a
facility that employs more than 2 modalities will be in excess of the
minimum requirement of 15 hours of category I CME.
Proposed Sec. 900.12(a)(1)(ii)(C) requires that, before using a
new mammographic modality in his or her practice, the interpreting
physician must have at least 8 hours of training with that modality.
This education requirement is a logical parallel to the requirement in
proposed Sec. 900.12(a)(1)(i)(C) that the physician must have at least
8 hours of training in each modality used in his or her practice when
the initial qualifications are first met.
4. Exceptions
Proposed Sec. 900.12(a)(1)(iii) would allow exceptions to some of
these requirements in certain specific cases. In order to ensure
continuing and uninterrupted availability of mammography services, FDA
is proposing to permit those interpreting physicians who have qualified
under the interim regulations to continue to interpret mammograms,
provided that they maintain the continuing experience and education
requirements in proposed Sec. 900.12(a)(1)(ii)(A) through
(a)(1)(ii)(C). Proposed Sec. 900.12(a)(1)(iii)(A) would exempt these
physicians from the new and additional initial requirements proposed in
Sec. 900.12(a)(1)(i). The additional month of training in proposed
Sec. 900.12(a)(1)(i)(B) for physicians using the alternative pathway,
the additional 20 hours of CME in proposed Sec. 900.12(a)(1)(i)(C), the
8 Category I CME credits in new modalities in proposed
Sec. 900.12(a)(1)(i)(C), and the requirement that 15 Category I CME
credits must have been acquired in the 3 years immediately before
qualifying as an interpreting physician in proposed
Sec. 900.12(a)(1)(i)(C).
Proposed Sec. 900.12(a)(1)(iii)(B) allows another exception in
response to NMQAAC's concern that the initial experience requirement in
proposed Sec. 900.12(a)(1)(i)(D) may pose a problem in some diagnostic
residency programs that schedule mammography rotations in the first 6
months of the last year. This exception permits a resident to satisfy
the requirement of proposed Sec. 900.12(a)(1)(i)(D) by having
interpreted at least 240 mammographic examinations under the direct
supervision of a qualified interpreting
[[Page 14903]]
physician during the last 2 years of the residency. FDA has included
this exception only for the diagnostic radiology resident who
successfully becomes board certified at the earliest opportunity
provided by an eligible certifying board (``first allowable time'').
For the physician who qualifies for the exception under proposed
Sec. 900.12(a)(1)(iii)(B), the continuing education and experience
requirements of proposed Sec. 900.12(a)(1)(ii)(A) through (a)(1)(ii)(C)
would begin from the date of that physician's board certification in
diagnostic radiology, provided the other initial requirements are
satisfied. If the physician does not become board certified at the
first allowable time by the certifying board, then this physician must
interpret 240 mammographic examinations under the direct supervision of
a qualified interpreting physician within a period of 6 months
immediately prior to initial qualification as an interpreting
physician. The ``first allowable time'' means the earliest time a
physician is eligible to take the diagnostic radiology boards of an
eligible certifying body. Because the ``first allowable time'' a
resident becomes eligible to take the boards may vary with the
certifying body, that term is not defined further in the regulations.
If the physician wishes to use this exemption, it is the physician's
responsibility to ascertain the requirements of the body by which he or
she wishes to become certified and to seek that certification as soon
as he or she becomes eligible to do so.
5. Reestablishment of Qualifications
Proposed Sec. 900.12(a)(1)(iv) provides a method for physicians to
reestablish their qualifications as interpreting physicians in the
event they do not maintain the continuing experience or education
requirements. Proposed Sec. 900.12(a)(1)(iv)(A) requires the physician
who fails to meet the continuing experience requirements to interpret
at least 240 mammographic examinations under the direct supervision of
a qualified interpreting physician within a period of 6 months
immediately before reestablishing qualifications and resuming
independent interpretation.
Proposed Sec. 900.12(a)(1)(iv)(B) requires physicians who do not
maintain the continuing education requirements to obtain a sufficient
number of Category I CME credits in mammography to bring their total up
to the required 15 credits in the previous 3 years. A physician who
fails to maintain continuing experience or education requirements may
not serve as an interpreting physician until he or she reestablishes
those qualifications.
C. Radiologic Technologists
FDA's interim regulations for radiologic technologists performing
mammography sought to ensure that: (1) The technologists possessed
adequate general qualifications for performing radiologic examinations;
(2) the technologists possessed adequate specific qualifications for
performing mammography examinations; and (3) the technologists
maintained these qualifications over time. The proposed regulations are
intended to achieve the same goals. They are primarily clarifications
of the interim regulations with some added requirements to address
concerns that developed as the interim regulations were implemented.
The first clarification is in response to a number of comments
received by FDA asking whether all of the radiologic technologists who
perform mammography at the facility had to meet the requirements or if
it would be sufficient if only some of them did. These questions may
have been generated from experience with a previous voluntary system
for accreditation.
All radiologic technologists who perform mammography must meet the
requirements. The plain language of the statute clearly states that
personnel who perform mammography must meet the minimum training and
experience requirements and either be licensed by a State or certified
to perform radiological procedures by an organization designated by the
Secretary of HHS (42 U.S.C. 263b(f)(1)(C)). The statute does not
provide, nor does the legislative history indicate, that Congress
intended any of the individuals who perform mammography to be exempt
from minimum quality standards. Exempting some radiologic technologists
from compliance with the personnel standards required under the act
would increase, not diminish, the possibility that an incipient cancer
might be misdiagnosed because of a poorly produced mammogram. FDA has
revised Sec. 900.12(a)(2) to read ``All mammographic examinations shall
be performed by radiologic technologists who meet the following general
requirements, mammography requirements, and continuing education and
experience requirements.'' Similar revisions were included in other
paragraphs of Sec. 900.12(a) to clarify the requirement that all
physicians and medical physicists must also meet the personnel
qualifications specific to their areas of practice.
Several comments expressed concern that the interim regulations
would allow technologists with ``partial'' or ``special'' licenses to
perform mammography. States that issue such licenses usually limit
their holders to the performance of certain narrow types of
examinations (e.g., extremities or dental x-rays) or particular medical
practices (e.g., podiatry).
The intent of the licensure requirement under the MQSA is to ensure
that the radiologic technologist has a broad background in radiologic
technology as a basis for his or her specific work in mammography. FDA
does not believe that partial or special licenses demonstrate this
necessary background. The provisions set forth in proposed
Sec. 900.12(a)(2)(i)(A) require the State license to be a general
license to perform radiologic procedures. As an alternative to
obtaining such a State license, proposed Sec. 900.12(a)(2)(i)(B) would
recognize a general certification by one of the bodies designated by
FDA to certify radiologic technologists as adequate evidence that a
technologist satisfies the general radiologic technology requirements.
The license required by proposed Sec. 900.12(a)(2)(i)(A) must be a
State license but need not be from the State in which the technologist
currently practices, as some States do not have a licensing
requirement. For States that do have their own licensing requirements,
the technologists practicing in these States are responsible for
meeting those licensing requirements as well as the requirements under
the MQSA.
One comment suggested that FDA amend the language of the interim
regulations at Sec. 900.12(a)(2)(i)(B) to indicate that certification
by an eligible body is an alternative that is available only when the
State in which the radiologic technologist is practicing has no
licensure procedures or requirements.
Proposed Sec. 900.12(a)(2)(i) requires the technologist to become
licensed or certified to perform general radiological procedures. The
license may be obtained from a State under Sec. 900.12(a)(2)(i)(A) or
the certificate can be obtained from an eligible certification body
under Sec. 900.12(a)(2)(i)(B). If the technologist is certified by an
eligible certifying body and practices in a State that has its own
licensing requirement, the technologist must still become licensed
under State law, unless otherwise exempted by the State.
Although such individuals would be in compliance with Federal
requirements under the MQSA, a technologist that is not licensed in
accordance with the requirements of the
[[Page 14904]]
State in which he or she practices will be in violation of the State
law.
Several comments on the interim regulations stated that FDA should
clarify the initial requirements that a radiological technologist must
satisfy to demonstrate specific mammography training.
After seeking and obtaining the advice of the NMQAAC, the agency
has proposed more specific requirements for this training in
Sec. 900.12(a)(2)(ii). Under the proposed regulation, training specific
to mammography includes the performance of a minimum of 50 examinations
under the direct instruction of a qualified individual. After the
effective date of these regulations, only individuals meeting the
requirements of Sec. 900.12(a)(2) for radiologic technologists will be
considered qualified to provide this supervision.
The NMQAAC has discussed the option of recognizing the American
Registry of Radiologic Technologists' (ARRT) special certification in
mammography as fulfilling, at least in part, the training requirement
under Sec. 900.12(a)(2)(ii). At its February 1994 meeting, the NMQAAC
advised against reducing the training required based on the ARRT
special certification. However, at its subsequent meeting in May 1994,
members reconsidered this possibility and discussed how much credit
might reasonably be allocated for an ARRT special certification and for
which aspects of the training requirements. Suggestions were made by
some NMQAAC committee members that this special certificate be accepted
in lieu of 20 of the required 40 contact hours, but that the
certificate not be a substitute for any part of the required
performance of 50 examinations under the direct supervision of a
qualified radiologic technologist.
After further consideration, FDA has decided not to propose
recognition of the special certificate as a partial fulfillment of the
training requirement. FDA does not want to incorporate into its
regulations a training requirement that specifically relies on a
particular certification program by a private group. If, in the
agency's view, subsequent changes in the certification program
diminished the certificate's value in assuring properly trained
radiologic technologists, the agency might, nevertheless, be bound to
continue to accept the certificate until the regulations could be
amended through notice and comment rulemaking to remove the recognition
of the certificate as a substitute for training. On the other hand, the
agency believes that the training that is required to earn the
certificate can fulfill part of the proposed training requirements,
even if the program is not mentioned explicitly in the regulations. In
fact, when evaluating technologists' training under the interim
regulations, the agency has recognized the value of training hours
required for AART special certification as well as training hours
required by other programs. The agency intends to continue to do so, as
long as it believes such recognition is warranted. Agency guidance on
this subject is available for review. As mentioned earlier, guidance
represents the agency's best thinking at the current time and does not
bind either the facility or FDA.
The NMQAAC did recommend that there be a requirement that all
technologists have the equivalent of at least five continuing education
units (CEU) of initial training in imaging examinees with breast
implants. NMQAAC recognized that many technologists rarely conduct
examinations of individuals with breast implants. However, the
committee recommended that this training be required of all
technologists so that all examinees with breast implants can use any
certified facility with assurance that there will be technologists
trained to perform these examinations.
FDA agrees and has included this requirement in proposed
Sec. 900.12(a)(2)(ii)(C).
The interim regulations permit a technologist to have all of his or
her training in mammography, both initial and continuing, related to
one modality (e.g., film screen, xerography), even if the radiologic
technologist uses other modalities to perform mammography. However, the
agency and the NMQAAC believe that education and training should be
required for each modality performed by the technologist. Proposed
Sec. 900.12(a)(2)(ii)(B) and (a)(2)(iii)(B) would correct this
shortcoming in the interim regulations by requiring both the initial
training and the continuing education requirements to include training
in each modality used by the technologist.
Several comments on the interim regulations objected to the use of
an undefined overall averaging period for the requirement that the
radiologic technologist earn at least five CEU's per year in
mammography.
Although the use of an undefined time period has provided a
flexibility that is advantageous under the interim regulations, FDA
agrees that more specific requirements are desirable. Therefore,
proposed Sec. 900.12(a)(2)(iii) requires that, on any given date, each
technologist must have earned at least 15 CEU's in mammography in the 3
years immediately preceding that date. To be fair to technologists who
have just completed their initial training in mammography, proposed
Sec. 900.12(a)(2)(iii) would not apply this requirement immediately.
Technologists will have up to 3 years after completing their initial
training to earn at least 15 CEU's related to mammography. After the
end of the initial 3-year period, all technologists would have to be
able to demonstrate, on any subsequent date, that they had earned at
least 15 CEU's in mammography in the 3 previous years.
Proposed Sec. 900.12(a)(2)(iii)(C) describes the actions that must
be taken by technologists who fail to meet the continuing education
requirement in order to reestablish their qualifications. Until these
actions are taken, such technologists cannot perform mammographic
examinations without supervision.
In recognition of the fact that unused skills may deteriorate,
proposed Sec. 900.12(a)(2)(iv) establishes a continuing experience
requirement corresponding to the continuing experience requirement for
interpreting physicians found in both the interim and proposed
regulations. This requirement is based upon the advice of NMQAAC that
performance of 100 or more mammography examinations a year represents a
reasonable level of experience. Proposed Sec. 900.12(a)(2)(iv)(B)
permits radiologic technologists who fail to meet this continuing
requirement to reestablish their qualification through performance of
50 examinations (a number suggested by NMQAAC) under the direct
supervision of a qualified radiologic technologist before resuming
independent performance of mammography examinations.
One comment on the interim regulations questioned the use of
October 1, 1996, for changing certain requirements for radiologic
technologists while a date of October 27, 1997, was used for similar
changes for medical physicists. The comment suggested that the dates
should be the same.
FDA notes that the MQSA established these dates and FDA cannot
modify them. It is likely that the differences in these provisions is
the result of congressional concern about the availability of medical
physicists.
Another comment suggested that a training and experience
alternative to the licensure or certification requirement be made
available to radiologic technologists similar to the alternative
available to medical physicists.
[[Page 14905]]
FDA disagrees, Congress specified the alternative route for medical
physicists in the statute. The MQSA did not provide a similar
alternative for technologists.
D. Medical Physicists
Proposed requirements for medical physicists are set forth in
Sec. 900.12(a)(3). FDA recognizes that the medical physicist plays a
pivotal role in assuring the overall quality of mammography and,
therefore, seeks to emphasize, in the proposed regulations, the need
for uniform national minimum requirements for medical physicists
working in mammography facilities.
In developing the proposed qualifications for medical physicists,
the agency has considered: (1) The requisite amount of prior knowledge
and experience to evaluate mammography equipment; (2) the level of
performance of individuals currently providing mammography physics
support; (3) the concern over the supply of qualified medical
physicists; and (4) the recommendations from members of the NMQAAC and
comments from the Conference of Radiation Control Program Director's
Task Force on Medical Physics Criteria. The issue of qualifications for
medical physicists was discussed extensively at several NMQAAC
meetings. Earlier draft regulations on this subject were shared with
the NMQAAC and made available to the public.
The MQSA provides two alternative pathways for medical physicists
to demonstrate minimum qualifications after October 27, 1997. These
alternative pathways, set forth in the statute and codified in proposed
Sec. 900.12(a)(3)(i)(A), are: (1) State licensure or approval or (2)
certification by a board approved by FDA. However, the NMQAAC expressed
concern during the February 1994 meeting that not all States have
adequate minimum qualification standards. Concern has also been
expressed that some board certified physicists do not have adequate
experience with mammography equipment. Therefore, FDA proposes to add
additional requirements for all physicists, regardless of which initial
route they follow to become qualified under the MQSA. After October 27,
1997, or the effective date of the regulation, whichever is later, only
those medical physicists who meet the initial additional education and
experience requirements proposed in Sec. 900.12(a)(3)(i)(B) or
(a)(3)(ii)(B) will be qualified to perform surveys under the MQSA.
FDA believes that ongoing developments in imaging technology,
including the development of new technologies, such as digital
mammography, will require medical physicists to have increased
understanding of science and technology in order to apply these
scientific advances to the practice of mammography. Proposed
Sec. 900.12(a)(3)(i)(B) addresses this need by requiring medical
physicists who enter the field after October 27, 1997, to hold at least
a master's degree in a physical science, including a minimum of 20
semester credit hours or equivalent of college level physics, to have
specialized training in conducting mammography surveys, and to have
actual experience conducting surveys of at least 5 mammography
facilities and a total of at least 10 mammography units. The experience
in conducting surveys must be acquired under the direct supervision of
a medical physicist who has fulfilled all of the requirements of
Sec. 900.12(a)(3)(i) and (a)(3)(iii). This requirement is intended to
ensure that medical physicists who serve as supervisors will have an
adequate educational background to train new physicists in new imaging
technologies.
The advisory committee recommended that FDA require the 20 semester
credit hours of physics be specific to imaging physics.
FDA agrees that courses in imaging physics would be desirable.
However, the agency does not have enough information about the number
of imaging physics courses offered in different curricula to be certain
that these courses would be available nationwide. Therefore, the agency
has not proposed limiting the physics credit hours to imaging physics
at this time. The agency is soliciting public comment on this issue.
Although FDA believes that future changes in technology will
require an enhancement of the educational qualifications of medical
physicists, the agency also recognizes that currently there are a
number of medical physicists with bachelor's degrees and substantial
experience who are performing medical physics surveys of mammography
facilities with care and competence. These physicists provide valuable
physics support to facilities. The agency believes that it would be
unjust to these physicists and potentially detrimental to the
facilities that they serve to bar them from continuing to provide this
physics support to mammography facilities in the absence of any
evidence to show that the services that they currently offer are
inadequate. Accordingly, proposed Sec. 900.12(a)(3)(ii) provides an
opportunity for those individuals who are lawfully practicing medical
physics under the interim regulations (21 CFR 900.12(a)(3)) to continue
their practice after October 27, 1997.
Proposed Sec. 900.12(a)(3)(ii) has been modified from the draft
proposal discussed at the January 1995 meeting with the NMQAAC. During
this meeting, the NMQAAC recommended that the opportunity to continue
services as a mammography physicist because of prior experience should
be open only to physicists with bachelor's degrees and 5 years of
experience in conducting surveys of mammography facilities by October
27, 1997.
However, upon further consideration, FDA believes that the
fundamental requirement of this alternative pathway is the quality and
depth of the survey experience itself, and not the number of years it
has taken the individual to acquire that experience. Therefore,
proposed Sec. 900.12(a)(3)(ii) requires those physicists who intend to
qualify because of prior experience to have performed surveys of at
least 10 facilities and a total of at least 20 units by October 27,
1997, or the effective date of these regulations, whichever date is
later. This change has been made in order to give all medical
physicists who are currently eligible to practice under the interim
rules a reasonable opportunity to acquire the requisite experience
before this alternative pathway closes.
Proposed Sec. 900.12(a)(3)(ii) further requires that the bachelor's
degree and specific training requirements be completed before any
physics survey or unit evaluations may be counted toward satisfying the
experience requirement under this provision. During a presentation at
the January 1995 NMQAAC meeting, a representative of the medical
physics community, speaking on behalf of the professional medical
physicists who are members of the American College of Radiology, the
American College of Medical Physics, and the North American Association
of Physicists in Medicine, expressed the view that any mammography
medical physics experience obtained prior to obtaining a basic
understanding of fundamental principles through education is of little
value. The NMQAAC also strongly recommended that the degree requirement
must be a prerequisite to the experience requirement. The agency's
proposal, therefore, establishes that the initial education and
training qualifications must be met before any experience can be
considered for purposes of satisfying the initial experience
qualifications. The
[[Page 14906]]
agency is soliciting public comment on this requirement.
Under proposed Sec. 900.12(a)(3)(iii), medical physicists will be
required to maintain their education and experience qualifications, as
are radiologic technologists and interpreting physicians.
Proposed Sec. 900.12(3)(iv) establishes the requirements that
medical physicists who fail to maintain their qualifications must meet
to reestablish their eligibility to perform mammography facility
surveys.
At its February 1994 meeting, the NMQAAC members raised the concern
that medical physicists who meet the qualifications requirement may
nevertheless delegate the onsite survey work to less qualified
personnel.
FDA shares this concern and, therefore, is proposing in
Sec. 900.12(e)(9), published elsewhere in this issue of the Federal
Register, that the medical physicist who signs the facility survey
report must be present at the facility during the survey and must meet
the requirements of proposed Sec. 900.12(a)(3).
Physicists in training may perform surveys in order to meet the
experience requirement described in these standards, but they must do
so under the direct supervision of a qualified medical physicist.
``Direct supervision'' is defined in proposed Sec. 900.2(k)(2), also
published elsewhere in this issue of the Federal Register, to mean:
``During the performance of a mammography examination or survey of the
facility's equipment and quality assurance program, the supervisor is
present to observe and correct, as needed, the performance of the
individual being supervised who is performing the examination or
conducting the survey.''
E. Retention of Personnel Records
Under the interim regulations, FDA is often asked how long records
demonstrating personnel qualifications must be kept after an individual
is no longer employed by the facility.
Proposed Sec. 900.12(a)(4) requires that records be retained for
all individuals employed in mammography by the facility from: (1) The
date of the last inspection or (2) the effective date of the final
regulations, whichever is later. Because inspections are required
annually under the MQSA, records of individuals no longer employed by
the facility typically would be retained less than a year after the
individual's employment ends. The agency believes that this requirement
will allow FDA adequately to assess whether personnel requirements are
being met without putting an undue paperwork burden on the facility.
Facilities should also become familiar with any State regulations that
are applicable to personnel records because these State laws may
require retaining the records for a longer period of time.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(3) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Analysis of Impacts
FDA has examined together the impacts of this proposed rule and the
proposed rules on accreditation bodies, general facility requirements,
and quality standards for mammography equipment and quality assurance,
published elsewhere in this issue of the Federal Register, under
Executive Order 12866, the Regulatory Flexibility Act (Pub. L. 96-354),
and under the Unfunded Mandates Reform Act. The analysis has addressed
the proposed requirements of these four rules as one unit for purposes
of determining their economic impact. The preamble to the proposed rule
``Quality Mammography Standards; General Preamble and Proposed
Alternative Approaches'', published elsewhere in this issue of the
Federal Register, contains a brief summary of the cost and benefit
determination and the Regulatory Impact Study that details the agency's
calculation of these economic impacts and is available at the Dockets
Management Branch (address above) for review. FDA recognized that these
proposed regulations may have a disproportionate effect on small volume
mammography facilities and is currently collecting additional
information on the potential impact on this industry sector. The agency
requests comments that will assist it in accounting for this impact.
V. Paperwork Reduction Act of 1995
This proposed rule contains information collections which are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title,
description, and respondent description of the information collection
and an estimate of the annual reporting and recordkeeping burden are
contained in the proposed rule entitled ``Quality Mammography
Standards; General Preamble and Proposed Alternative Approaches''
published elsewhere in this issue of the Federal Register.
The agency has submitted a copy of this proposed rule to OMB for
its review of these information collections. Other organizations and
individuals desiring to submit comments regarding this burden estimate
or any aspect of these information collection requirements, including
suggestions for reducing the burden, should direct them to the Office
of Information and Regulatory Affairs, OMB, New Executive Office Bldg.,
725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer
for FDA. Written comments on the information collection should be
submitted by May 3, 1996.
VI. Request for Comments
Interested persons may, on or before July 2, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposed rule. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
VII. Reference
The following reference has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. ``Report on the Mammography Quality Standards Act of 1992,'' S.
Rept. 102-448, October 1, 1992.
List of Subjects in 21 CFR Part 900
Electronic products, Health facilities, Medical devices, Radiation
protection, Reporting and recordkeeping requirements, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 900 be
amended as follows:
PART 900--MAMMOGRAPHY
1. The authority citation for 21 CFR part 900 continues to read as
follows:
Authority: Secs. 519, 537, and 704(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360i, 360nn, and 374(e)); sec. 354 of
the Public Health Service Act (42 U.S.C. 263b).
2. Section 900.12 is amended by revising paragraph (a) to read as
follows:
Sec. 900.12 Quality standards.
* * * * *
[[Page 14907]]
(a) Personnel. The following requirements apply to all personnel
involved in any aspect of mammography, including the production,
processing, and interpretation of mammograms and related quality
assurance activities.
(1) Interpreting physicians. All physicians interpreting mammograms
shall meet the following qualifications:
(i) Initial qualifications. Before beginning to interpret
mammograms independently, the interpreting physician shall:
(A) Be licensed to practice medicine in a State;
(B)(1) Be certified in an appropriate specialty area by a body
determined by FDA to have procedures and requirements adequate to
ensure that physicians certified by the body are competent to interpret
radiological procedures, including mammography; or
(2) Have had at least 3 months of documented formal training in the
interpretation of mammograms and in topics related to mammography. The
training shall include instruction in radiation physics, including
radiation physics specific to mammography, radiation effects, and
radiation protection. The mammographic interpretation component shall
be under the direct supervision of a physician who meets the
requirements of paragraph (a)(1) of this section;
(C) Have a minimum of 60 hours of documented medical education in
mammography, which must include: Instruction in the interpretation of
mammograms; at least 8 hours of Category I continuing medical education
credits in each mammographic modality used in the interpreting
physician's practice; and education in basic breast anatomy, pathology,
and physiology; technical aspects of mammography, and quality assurance
and quality control in mammography. At least 40 of these hours must be
Category I and at least 15 of the Category I hours must have been
acquired within the 3 years immediately prior to the date that the
physician qualifies as an interpreting physician. Hours spent in
residency specifically devoted to mammography will be considered as
equivalent to Category I continuing medical education credits and will
be accepted if documented in writing by the appropriate representative
of the training institution; and
(D) Have interpreted at least 240 mammographic examinations under
the direct supervision of a qualified interpreting physician within the
6-month period immediately prior to fulfilling the requirements of
paragraph(a)(1)(i) of this section.
(ii) Continuing experience and education. All interpreting
physicians shall maintain their qualifications by meeting the following
requirements:
(A) At all times following the second anniversary date of
completion of the requirements of paragraph (a)(1)(i) of this section,
the interpreting physician shall have interpreted an average of at
least 40 mammographic examinations a month during the previous 24
months;
(B) At all times following the third anniversary date of completion
of the requirements of paragraph (a)(1)(i) of this section, the
interpreting physician shall have taught or completed at least 15
Category I continuing medical education credits in mammography in the
previous 3 years. This training must include at least six Category I
continuing medical education credits in each mammographic modality used
by the interpreting physician in his or her practice; and
(C) Before an interpreting physician may begin independently
interpreting mammograms produced by a new mammographic modality, that
is, a modality in which the physician has not previously been trained,
the interpreting physician shall have at least 8 hours of training in
the new modality.
(iii) Exceptions. (A) Those physicians who previously qualified as
interpreting physicians under FDA's interim regulations at
Sec. 900.12(a)(1) are considered to have met the initial requirements
of paragraph (a)(1)(i) of this section. They may continue to interpret
mammograms provided they continue to meet the continuing experience and
education requirements of paragraph (a)(1)(ii) of this section.
(B) Physicians who have interpreted at least 240 mammographic
examinations under the direct supervision of a qualified interpreting
physician during the last 2 years of a diagnostic radiology residency
and who become appropriately board certified at the first allowable
time, as defined by an eligible certifying body, are otherwise exempt
from paragraph (a)(1)(i)(D) of this section.
(iv) Reestablishing qualifications. Interpreting physicians who
fail to maintain the required continuing experience or continuing
education requirements shall reestablish their qualifications before
resuming the independent interpretation of mammograms, as follows:
(A) Interpreting physicians who fail to meet the continuing
experience requirements of paragraph (a)(1)(ii)(A) of this section
shall interpret at least 240 mammographic examinations under the direct
supervision of a qualified interpreting physician, within a period of 6
months immediately prior to reestablishing their qualifications as an
interpreting physician.
(B) Interpreting physicians who fail to meet the continuing
education requirements of paragraph (a)(1)(ii)(B) of this section shall
obtain a sufficient number of additional Category I continuing medical
education credits in mammography to bring their total up to the
required 15 credits in the previous 3 years before resuming independent
reading.
(2) Radiologic technologists. All mammographic examinations shall
be performed by radiologic technologists who meet the following general
requirements, mammography requirements, and continuing education and
experience requirements:
(i) General requirements. (A) Be licensed to perform general
radiographic procedures in a State; or
(B) Have general certification from one of the bodies determined by
FDA to have procedures and requirements adequate to ensure that
radiologic technologists certified by the body are competent to perform
radiologic examinations; and
(ii) Mammography requirements. Have undergone 40 contact hours of
documented training specific to mammography under the supervision of a
qualified individual. A qualified individual is one that has met all
the requirements of paragraph (a)(2) of this section. The 40 hours of
documented training shall include:
(A) Training in breast anatomy and physiology, positioning and
compression, quality assurance/quality control techniques;
(B) The performance of a minimum of 50 examinations under the
direct supervision of a qualified individual; and
(C) At least 5 hours of training in imaging examinees with breast
implants and at least 8 hours of training in each imaging modality to
be used by the technologist in performing mammography exams.
(iii) Continuing education requirements. (A) At all times following
the third anniversary date of completion of the requirements of
paragraphs (a)(2)(i) and (a)(2)(ii) of this section or (insert
effective date of the final regulation), whichever date is later, the
radiologic technologist shall have taught or completed at least 15
continuing education units related to mammography in the previous 3
years.
(B) At least six of these continuing education units shall be
related to each
[[Page 14908]]
modality used by the technologist in mammography.
(C) Requalification. Following any 3-year period in which a
radiologic technologist fails to meet the continuing education
requirements under paragraphs (a)(2)(iii)(A) through (a)(2)(iii)(B) of
this section, that technologist shall obtain a sufficient number of
continuing education units in mammography to bring the total up to at
least 15 in the previous 3 years, at least 6 of which shall be related
to each modality used by the technologist in mammography. The
technologist may not resume performing unsupervised mammography
examinations until the continuing education requirements are completed.
(D) Before a radiologic technologist may begin independently
performing mammographic examinations using a modality other than one of
those for which the technologist received training under paragraph
(a)(2)(ii)(C) of this section, the technologist shall have at least 8
hours of continuing education units in the new modality.
(iv) Continuing experience requirements. (A) In each 12-month
period after completion of the requirements of paragraphs (a)(2)(i) and
(a)(2)(ii) of this section or (effective date of the final rule),
whichever date is later, the radiologic technologist shall perform a
minimum of 100 mammography examinations.
(B) Requalification. Following any 12-month period in which a
radiologic technologist fails to perform at least 100 mammography
examinations, that technologist shall perform a minimum of 50
mammography examinations under the direct supervision of a qualified
radiologic technologist, before resuming the performance of
unsupervised mammography examinations.
(3) Medical physicists. All medical physicists conducting surveys
of mammography facilities and providing oversight of the facility
quality assurance program under 42 U.S.C. 263b shall meet the
following:
(i) Initial qualifications. (A) Be State licensed or approved or
have certification in an appropriate specialty area by one of the
bodies determined by FDA to have procedures and requirements to ensure
that medical physicists certified by the body are competent to perform
physics surveys; and
(B)(1) Have a master's degree or higher in a physical science from
an accredited institution, including at least 20 semester hours or
equivalent (e.g., 30 quarter hours) of college (graduate or
undergraduate) level physics;
(2) Have 20 contact hours of documented specialized training in
conducting surveys of mammography facilities; and
(3) Have the experience of conducting surveys of at least 5
mammography facilities and a total of at least 10 mammography units.
After the later date of October 27, 1997, or the effective date of
these regulations, experience conducting surveys must be acquired under
the direct supervision of a medical physicist who meets all the
requirements of paragraphs (a)(3)(i) and (a)(3)(iii) of this section;
or
(ii) Alternative initial qualifications. (A) Have qualified as a
medical physicist under the interim regulations at Sec. 900.12(a)(3)
and maintained the active status of any qualifying licensure, approval,
or certification required under the interim regulations; and
(B) By October 27, 1997, or [Date 1 year after date of publication
of the final rule] regulations, whichever is later, have:
(1) A bachelor's degree or higher in a physical science from an
accredited institution with no less than 10 semester hours or
equivalent of college level physics,
(2) Forty contact hours of documented specialized training in
conducting surveys of mammography facilities and,
(3) The experience of conducting surveys of at least 10 mammography
facilities and a total of at least 20 mammography units. The training
and experience requirements must be met after fulfilling the degree
requirement.
(iii) Continuing qualifications. (A) Continuing education. At all
times after the third anniversary of completion of the initial
requirements of paragraph (a)(3)(i) or (a)(3)(ii) of this section, the
medical physicist shall have taught or completed at least 15 continuing
education units in mammography over the preceding 3 years. This
continuing education shall include training appropriate to each
mammographic modality evaluated by the medical physicist during his or
her surveys or oversight of quality assurance programs.
(B) Continuing experience. At all times after the first anniversary
of completion of the initial requirements of paragraph (a)(3)(i) or
(a)(3)(ii) of this section, the medical physicist shall have surveyed
at least three mammography facilities within the preceding 12 months.
(C) Before a medical physicist may begin independently performing
mammographic examinations using a new modality, that is, a modality
other than one for which the physicist received training to qualify
under paragraph (a)(3)(i) or (a)(3)(ii) of this section, the physicist
must receive at least 8 hours of training in surveying units with the
new modality.
(iv) Reestablishing qualifications. Medical physicists who fail to
maintain the required continuing qualifications of paragraph
(a)(3)(iii) of this section may not perform the MQSA surveys without
the supervision of a qualified medical physicist. Before independently
surveying another facility, medical physicists must reestablish their
qualifications, as follows:
(A) Medical physicists who fail to meet the continuing educational
requirements of paragraph (a)(3)(iii)(A) of this section shall obtain a
sufficient number of continuing education units to bring their total
units up to the required 15 in the previous 3 years.
(B) Medical physicists who fail to meet the continuing experience
requirement of paragraph (a)(3)(iii)(B) of this section shall complete
a satisfactory survey of three mammography facilities under the direct
supervision of a medical physicist who meets the qualifications of
paragraphs (a)(3)(i) and (a)(3)(iii) of this section.
(4) Retention of personnel records. Facilities shall maintain
records to document the qualifications of all personnel employed by the
facility in the production, processing, and interpretation of
mammographic images. These records must be available for review by the
MQSA inspectors and should not bediscarded until the next annual
inspection has been completed and FDA has determined that the facility
is in compliance with the MQSA personnel requirements.
* * * * *
Dated: March 22, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-7832 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-P
Complete official Federal Register PDF
FR Doc. 96-7831 Proposed Requirements for Accreditation Bodies of Mammography Facilities
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14884-14898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7831]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. 95N-0192]
RIN 0910-AA24
Proposed Requirements for Accreditation Bodies of Mammography
Facilities
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its interim regulations for application procedures for FDA approval as
an accreditation body under the Mammography Quality Standards Act of
1992 (the MQSA). FDA is proposing these amendments based on experience
gained in administering the interim regulations, advice from the
National Mammography Quality Assurance Advisory Committee (NMQAAC), and
public comments received in response to the interim regulations. This
proposal would also establish new requirements and responsibilities for
accreditation bodies. This proposal is the second of five proposed
rules published in this issue of the Federal Register regarding MQSA
requirements applicable to mammography facilities. These proposed rules
are being issued to ensure adequate and consistent evaluation of
mammography facilities on a nationwide basis.
DATES: Written comments on this proposed rule by July 2, 1996. Written
comments on the information collection requirements should be submitted
by May 3, 1996. The agency is proposing that any final rule based on
this proposed rule become effective 1 year after its date of
publication in the Federal Register.
ADDRESSES: Submit written comments on this proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. The Regulatory Impact
Study (RIS) is available at the Dockets Management Branch for review
between 9 a.m. and 4 p.m., Monday through Friday. Requests for copies
of the RIS should be submitted to the Freedom of Information Staff
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16,
Rockville, MD 20857.
Submit written comments on the information collection requirements
to the Office of Information and Regulatory Affairs, Office of
Management and Budget, New Executive Office Bldg., 725 17th St. NW.,
rm. 10235, Washington, DC 20503, Attn: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for
Devices and Radiological Health (HFZ-240), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.
SUPPLEMENTARY INFORMATION:
I. Background
This proposal is the second of five related proposed rules
published in this issue of the Federal Register to amend interim
regulations published on December 21, 1993 (58 FR 67558 and 58 FR
67565) implementing the MQSA (Pub. L. 102-539). The first proposed
rule, ``Quality Mammography Standards; General Preamble and Proposed
Alternative Approaches'' contains background information and a summary
of the preliminary analysis of the costs and benefits of the proposed
rules, a description of the information collection requirements,
proposed revisions to Secs. 900.1 Scope (21 CFR 900.1) and 900.2
Definitions (21 CFR 900.2), and proposed alternative approaches to
mammography quality standards and a request for comments on the
proposed alternatives.
II. Provisions of the Proposed Rule
A. Development of the Proposed Regulation
This proposed rule covers procedures for application to FDA for
approval as an accreditation body and the requirements and
responsibilities of such bodies. As with the interim regulations, FDA
was guided in the development of this proposed rule by the intent of
the legislation to guarantee access to safe and effective mammography
services for all women in the United States (Ref. 1). FDA also relied
upon three major sources of information, in addition to the expertise
and research of FDA personnel.
First, the agency considered public comments received on the
interim regulations. The agency received 103 comments from individuals
and organizations, including professional organizations, medical
facilities, State agencies, consumer groups, manufacturers, and
individual physicians, medical physicists, and radiologic
technologists. The proposed regulations were also discussed in a series
of quarterly meetings with the NMQAAC. Members of the NMQAAC include
interpreting physicians, medical physicists, radiologic technologists,
representatives of State agencies, and consumer representatives.
Consultants to the NMQAAC and guests invited to attend the committee
meetings in recognition of their expertise in mammography also
participated in these discussions of the proposed regulations. Finally,
the agency's experience over the last year with the four accreditation
bodies approved under the interim regulations also influenced the
development of the proposed regulations. A discussion of the proposed
amendments and a summary and analysis of both NMQAAC input and public
comments regarding the regulations are provided below.
B. Application for Approval as an Accreditation Body
In Sec. 900.3 (21 CFR 900.3) of the interim regulations, FDA
established standards for approving the applications of prospective
accreditation bodies. These standards are expanded in proposed
Sec. 900.3 to provide FDA with more thorough criteria for assessing a
[[Page 14885]]
prospective body's capabilities. FDA is also proposing regulations to
establish renewable terms of authority and the scope of authority of
accreditation bodies.
1. Accreditation Body Assessment Criteria
To identify more comprehensive criteria for evaluating prospective
accreditation bodies, FDA researched Federal oversight of other
accreditation organizations in the health care field. This included
review of HCFA regulations and of an assessment of those regulations by
GAO.
In the Federal Register of December 14, 1990 (55 FR 51434), HCFA
published a proposed regulation entitled ``Medicare Program: Granting
and Withdrawal of Deeming Authority to National Accreditation
Organizations.'' GAO reviewed that proposed regulation and stated in a
1991 report that, with only one exception, the proposed regulation met
all of the criteria that GAO considers important in the evaluation of
an accreditation organization (Ref. 2). This regulation was finalized
in the Federal Register of November 23, 1993 (58 FR 61816).
Based on GAO's review of the proposed HCFA regulation, and FDA's
experience with accreditation bodies under the interim regulations, FDA
considers it essential to require a complete description of a
prospective accreditation body's review and decisionmaking processes,
including policies and procedures used to notify facilities of
deficiencies and to monitor the correction of deficiencies. In
addition, FDA considers the following criteria to be important in
evaluating a prospective accreditation body's application: (1)
Qualifications of the body's professional staff; (2) adequacy of the
body's staffing level, finances, and other resources; (3) the body's
ability to provide data and reports in an electronic format compatible
with FDA data systems; and (4) adequacy of the body's consumer
complaint mechanism. These additional criteria, together with the
interim criteria, are reflected in proposed Sec. 900.3(b)(3).
Several comments on the interim regulations as well as members of
the NMQAAC noted the importance of timely processing of accreditation
applications. These comments requested that accreditation body
applications include satisfactory assurances that the applicant will be
able to complete the accreditation process for a given facility within
6 months if the facility submits the required information in a timely
manner.
FDA agrees that timely processing of accreditation materials is
necessary in order to: (1) Meet statutory requirements, that, in most
cases, allow new facilities to be provisionally certified for only 6
months, and (2) ensure that reaccreditation applications will be
processed before expiration of a facility's accreditation. Therefore,
FDA is proposing to add a requirement in Sec. 900.3(b)(3)(iii)(J) for
prospective accreditation bodies to submit such assurances with their
application for approval, along with a description of their policies
and procedures for ensuring timely processing of accreditation
materials.
To gain further insight regarding appropriate criteria for
evaluating prospective accreditation bodies, FDA reviewed a regulation
entitled ``Secretary's Procedures and Criteria for Recognition of
Accrediting Agencies,'' which was finalized by the U.S. Department of
Education in the Federal Register of April 29, 1994 (59 FR 22250).
Based on FDA's review of that regulation, along with the agency's
experience under the interim regulations and comments by NMQAAC
members, FDA is proposing to add new Sec. 900.3 (b)(3)(iii)(K),
(b)(3)(viii), and (b)(3)(ix). These sections would require each
prospective accreditation body to submit with its accreditation
application: (1) A description of the body's appeals process for
facilities contesting accreditation decisions; (2) a description of the
body's mechanism for ensuring against conflicts of interest; and (3)
information disclosing any commercial products used in mammography that
the body develops, sells, or distributes.
2. Term Limits and Scope of Authority
In Sec. 900.3(g), FDA is proposing to establish renewable 5-year
terms of approval for accreditation bodies. The agency believes that a
body should not be approved for an indefinite amount of time without
undergoing periodic comprehensive reviews. Although the interim
regulations addressed the possibility of withdrawing the approval of an
accreditation body for unsatisfactory performance, the interim
regulations did not establish a regular term limit for accreditation
body approval.
FDA is proposing in Sec. 900.3(c) a schedule and requirements for
application for renewal of an accreditation body's approval. These
schedule and renewal requirements would also apply to accreditation
bodies approved under the interim regulations that seek to continue
serving as accreditation bodies under the final regulations. FDA's
intention in establishing such a schedule is to ensure sufficient time
for the review and processing of applications in order to avoid
interruption in the availability of the services of the accreditation
body. The agency solicits comments on whether the 90-day timeframe for
application is appropriate.
Proposed Sec. 900.3(d) describes the process the agency would use
for reviewing accreditation body applications and renewals. The
proposed process includes a provision for extending an accreditation
body's previous approval if FDA has not reached a final decision on
renewal before the previous approval expires.
FDA is proposing new provisions in Sec. 900.3 (e) and (f) requiring
the accreditation body to notify facilities and FDA, and to transfer
records in instances where the body: (1) Voluntarily ceases its
accreditation functions before expiration of its 5-year term, (2)
decides not to reapply for an additional term of approval, or (3) fails
to become reapproved by FDA.
In addition to limiting the term of approval of accreditation
bodies, FDA believes that the agency should be permitted to limit the
scope of authority of an accreditation body (for example,
geographically, for State agencies). This is proposed in Sec. 900.3(g).
FDA plans to issue application guidance to prospective
accreditation bodies to assist them in preparing materials and
supporting documentation required by the revised accreditation
regulations, when finalized. It is expected that for accreditation
bodies applying for renewal, the supporting documentation will consist
primarily of updates of information previously provided to FDA.
C. Standards for Accreditation Bodies
In Sec. 900.4 (21 CFR 900.4), FDA is proposing expanded
requirements and responsibilities for accreditation bodies. These
standards are intended to ensure that accreditation bodies work
together with FDA and mammography facilities to achieve and maintain
high quality mammography at all facilities.
Proposed Sec. 900.4(a) establishes a code of conduct and general
responsibilities for accreditation bodies to assure the integrity and
impartiality of accreditation body actions and appropriate oversight of
the quality of mammography at all accredited facilities. Other proposed
paragraphs in Sec. 900.4 and the accreditation body requirements they
address include: Sec. 900.4(b)--standards that the accreditation body
must apply to
[[Page 14886]]
accredit facilities; Sec. 900.4 (c) and (d)--accreditation body review
of facility clinical and phantom images; paragraph (e)--accreditation
body review of reports of mammography equipment evaluation, physics
surveys, quality control records, and personnel updates at facilities;
Sec. 900.4(f)--accreditation body onsite visits to facilities and
performance of random clinical image reviews; Sec. 900.4(g)--consumer
complaint mechanisms; Sec. 900.4(h)--other reporting and recordkeeping
requirements; and Sec. 900.4(i)--fees that accreditation bodies may
charge facilities for accreditation. While most of these requirements
were addressed by the interim regulations, FDA is proposing additions
and modifications that are described in this preamble.
1. Code of Conduct and General Responsibilities
In Sec. 900.4(a)(1), FDA is proposing to require an accreditation
body to take certain actions if the agency believes that the clinical
image quality or other aspects of a facility's practice are seriously
compromised and would pose an unreasonable risk of substantial harm to
the public. The agency's intention is that this authority would only be
used in those situations, hopefully rare, where the mammography-
specific health hazard is serious enough to warrant actions beyond the
scope of those normally used to meet the facility quality standards. It
is not intended to replace the normal interaction between accreditation
bodies and facilities as they seek to meet the quality standards.
This section was added in response to discussions with the NMQAAC
and public comments requesting additional measures to ensure timely
compliance with regulatory requirements by facilities. For example, one
comment questioned whether the loss of a facility's certification would
assure termination of a facility's ability to provide mammography
services. Another comment stated that accreditation bodies should have
the authority to take action against miscreant facilities.
FDA advises that there are a number of mechanisms in place to
ensure that decertified facilities no longer provide mammography
services. When facilities lose their certification, they can no longer
provide mammography services lawfully and are required to return their
certificate to the agency. Consumers have been advised through various
publicity campaigns to check for the presence of an FDA certificate
when they go for a mammogram, so many consumers will be aware that they
should not have a mammogram performed at a facility that does not
display an FDA certificate. In addition, the statute provides for civil
money penalty and injunctive sanctions against facilities that practice
mammography without a certificate. Nonetheless, for circumstances where
FDA believes there is a risk of substantial harm to the public,
proposed Sec. 900.4(a)(1) would provide an additional means of
monitoring facility compliance with MQSA requirements and would allow
FDA to require accreditation bodies to assist the agency in taking
actions or requiring facilities to take actions that the agency deems
necessary to prevent harm to consumers. FDA solicits comments on the
nature and appropriateness of this proposed additional monitoring.
Similarly, Sec. 900.4(a)(2) and (a)(3) propose additional steps to
be taken by accreditation bodies in circumstances where a facility's
operations may compromise the quality of mammography or otherwise pose
a health or safety hazard that is within the scope of the MQSA but not
as severe as situations addressed by Sec. 900.4(a)(1). In accordance
with these proposed paragraphs, accreditation bodies would be required
to notify FDA any time the accreditation body becomes aware that there
has been actual loss of life or serious injury or illness associated
with facility noncompliance with MQSA requirements. Such notification
would have to be provided to FDA within 5 business days of the
accreditation body's learning of the event. The 5-business day interval
was chosen as a compromise between the agency's need to be informed as
soon as possible of serious mammography-specific health hazards and the
need for the accreditation body to have sufficient time to identify and
report the event. Comments are specifically invited upon the
appropriateness of the allowed length of time. Accreditation bodies
would also be required to obtain, review, and monitor plans of
correction from facilities not in compliance with the facility
standards. These provisions should further address the concerns of the
comments mentioned above.
One comment requested that all time period designations related to
requirements for action by accreditation bodies be specified in
``business'' days rather than ``calendar'' days.
FDA agrees that some time period designations should be specified
as business days and has proposed changes to the interim regulations
accordingly. Where proposed time periods are not explicitly specified
as business days, they should be interpreted as calendar days. In
addition, in order to afford accreditation bodies and facilities
increased flexibility, FDA is proposing to eliminate some of the
mandatory schedules specified under the interim regulations. For
example, FDA is eliminating the interim requirement that accreditation
bodies with minor deficiencies submit a plan of corrective action
within 90 days. Thus, under the proposed regulations, certain schedule
requirements would be left to the discretion of the accreditation body
or FDA or would be subject to FDA approval during the accreditation
body application process.
In Sec. 900.4(a)(4), FDA is proposing that accreditation bodies be
required to establish a quality assurance (QA) program that includes
clinical and phantom image review. This QA program would establish
policies and procedures to ensure consistent and accurate evaluation of
facility images with respect to both methods of review. The QA program
would also address training and evaluation of staff performing the
reviews.
In proposed Sec. 900.4(a)(5), FDA calls for new measures to reduce
the possibility of conflict of interest or bias on the part of an
accreditation body or anyone acting on an accreditation body's behalf
with regard to specific facilities. NMQAAC members and consultants
expressed concern about conflicts of interest or bias with regard to
clinical image reviewers evaluating images from their own States or
from geographically limited areas where the reviewers may know the
facilities and their interpreting physicians. Also, various comments
expressed concern that: (1) ``Innumerable `non-profit' health care
corporations'' could be approved as accreditation bodies and accredit
their own facilities as long as clinical image reviewers had no
financial interest in the facilities; (2) a professional organization
serving as an accreditation body has members with ``vested interests in
the outcome of the body's decisions;'' (3) individuals employed by a
professional organization that is an accreditation body have a conflict
of interest with regard to the establishment of standards by which
their facilities would be evaluated under the MQSA; and (4) members of
a professional organization that was an approved accreditation body
would be prevented from conducting clinical image reviews.
The proposed code of conduct in Sec. 900.4(a) is intended to
address the various concerns raised regarding conflict of interest
considerations for accreditation bodies. In addition, FDA notes that
all standards used by accreditation bodies to accredit facilities
[[Page 14887]]
are subject to review and approval by the agency. However, neither the
interim requirements nor the proposed code of conduct would preclude
members of a professional organization that is designated as an
accreditation body from conducting clinical image reviews for that
organization solely on the basis of membership in that organization. In
addition, the proposed standards include conflict of interest
provisions that would preclude other situations suggested by the
comments.
Several comments and presentations at the NMQAAC meetings, on
behalf of a trade association of software vendors, expressed concern
that a currently approved accreditation body that markets mammography
reporting software might have a sales advantage because of its MQSA
accreditation functions and a perceived ``imprimatur of government
approval'' for its products. In particular, this trade association
proposed that the following language be incorporated into FDA's
standards for approval of an accreditation body:
Satisfactory assurances that the body does not have any interest
in the development, sale, promotion, or distribution of any product
(including computer software) under circumstances where the product
will be the subject of inspection or review by the accreditation
body in facility quality assurance or quality control or other
aspects of the accreditation process. This restriction does not
apply to educational programs or educational material typically
prepared or disseminated by an accreditation body.
Although FDA has not proposed the standard suggested by this
comment, the agency specifically solicits public comment on this
alternative. This issue has been raised repeatedly during the open
public sessions of the NMQAAC meetings, and FDA wants to be certain
that there is full opportunity for the public to comment on the
underlying question: Is there an inherent conflict in an accreditation
body also being a product vendor for a mammography- related product? As
currently proposed, the requirements in Sec. 900.4(a)(6) minimize the
possibility of accreditation body conflict of interest with regard to
the marketing of commercial products by prohibiting an accreditation
body from representing in any way that the purchase of a particular
product is a condition of accreditation. However, proposed
Sec. 900.4(a)(6) would not require accreditation bodies to divest all
interests in commercial products. Moreover, the proposed regulation
would permit an accreditation body to require the use of a product by
facilities it accredits, even when there is the possibility of a
conflict of interest, if FDA determines that such use is in the best
interest of public health. As noted previously, FDA encourages further
public comment on the conflict of interest issue, including comment on
whether the outcome of any conflict of interest issue would be affected
by: (1) The cost of the product sold by an accreditation body, i.e., by
the magnitude of the financial interest; or (2) the number of
accreditation bodies available to choose from.
Proposed Sec. 900.4(a)(6) would require an accreditation body to
state the bases for denying accreditation in a written notification to
the affected facility. In accordance with proposed
Sec. 900.3(b)(3)(iii)(K), each accreditation body will establish
procedures for appeal of adverse accreditation decisions to the
accreditation body. The accreditation body's notification of denial of
accreditation also would be required to describe the appeals process
available from the body if the facility wishes to contest the adverse
decision.
Proposed Sec. 900.4(a)(8) would explicitly prohibit any State that
has been approved as an accreditation body from precluding any other
FDA-approved accreditation bodies from operating in that State. This
amendment is intended to codify what has been FDA policy and practice
under the interim regulations.
Several comments stated that FDA should allow only one
accreditation body to operate in a given State or should allow only
States to serve as accreditation bodies.
FDA disagrees with these comments. The statute itself does not
provide for such exclusivity. The MQSA allows FDA to approve either
State agencies or private nonprofit organizations to serve as
accreditation bodies, as long as they meet the standards established by
FDA. The agency believes that facilities, consumers, and the
professional community can benefit from the existence of more than one
accreditation body.
Consistent with the interim regulations, the proposed regulations
would require that accreditation bodies obtain FDA authorization before
changing accreditation body standards previously approved by FDA
(Sec. 900.4(a)(9)). Several comments expressed concern that this
requirement would preempt section 354(m) of the PHS Act, which permits
States to enact and enforce laws that are more stringent than those
mandated by the MQSA. There was also discussion during the January 1995
NMQAAC meeting as to whether accreditation bodies could have more
stringent requirements than those mandated under MQSA.
FDA requires State agencies and private nonprofit organizations
approved as accreditation bodies by FDA to establish and implement
facility standards that have been approved by FDA. FDA will approve
such standards only if FDA determines that they are substantially the
same as the standards required under MQSA. In addition, all
accreditation bodies, whether State agencies or private nonprofit
organizations, must determine the MQSA accreditation status of a
facility using only FDA-approved standards. However, accreditation
bodies may use more stringent standards under other (non-MQSA)
authorities for purposes other than that of determining the MQSA
accreditation status of facilities. For example, a State public health
agency approved as an MQSA accreditation body by FDA may require
facilities in the State to meet additional standards (beyond those
required by MQSA) under the body's authority as a State accreditation
agency. However, the body may not require facilities to meet these
additional standards in order to obtain MQSA accreditation. Similarly,
a private nonprofit organization approved as an accreditation body may
recommend compliance with more stringent standards than those mandated
under MQSA, but may not use such standards in determining the MQSA
accreditation status of a facility.
Proposed Sec. 900.4(a)(10) states the accreditation body's
obligation to protect the confidentiality of nonpublic information
acquired in connection with carrying out accreditation body
responsibilities. The accreditation body may not use or disclose
information it receives from facilities, other than to FDA or its
designated representatives, without the consent of the facility. The
accreditation body must also protect the confidentiality of nonpublic
information it receives from FDA or its duly designated
representatives.
2. Facility Standards
In proposed Sec. 900.4(b), FDA outlines the quality standards for
mammography that accreditation bodies would have to apply to facilities
they accredit (facility standards). The details of the facility
standards required under the MQSA are being proposed elsewhere in this
issue of the Federal Register. FDA is also proposing in Sec. 900.4(b)
actions to be required by the accreditation body with respect to
facilities not in compliance with the quality standards, such as
reviewing and monitoring the implementation of facility plans of
correction and revoking a facility's accreditation.
[[Page 14888]]
One comment recommended that a single quality standard be
implemented nationwide by all accreditation bodies.
FDA intends to ensure that each accreditation body's standards are
substantially the same as those promulgated by the agency, in
accordance with the requirements of section 354(e)(1) of the PHS Act
(42 U.S.C. 263b(e)). However, FDA notes that mammography standards are
unlikely to be identical across the country because the MQSA allows for
both private nonprofit organizations and State agencies to serve as
accreditation bodies, and also permits States to establish more
stringent mammography standards under their own authority. In addition,
FDA believes it is necessary to allow some flexibility in accreditation
body operations in order to provide for efficient accreditation
services for the more than 10,000 mammography facilities nationwide.
Nonetheless, the statute and proposed regulations are intended to
establish minimum nationwide facility standards, and proposed
Sec. 900.4(b) would require all accreditation bodies to adopt and apply
these standards.
3. Clinical Image Review
FDA believes that effective clinical image review is essential to
ensure high quality mammograms. A primary purpose of the MQSA is to
ensure that all mammography facilities have the benefit of such review
and that accreditation bodies be qualified to perform that function.
Accordingly, FDA is proposing to establish more specific requirements
with respect to clinical image review than were established under the
interim regulations. The requirements proposed are based on advice from
the NMQAAC and public comments.
The areas covered by the proposed standards in Sec. 900.4 for
clinical image review are as follows: Sec. 900.4(c)(1)--requirements
for the minimum frequency of review; Sec. 900.4(c)(2)--clinical image
attributes to be evaluated (with a provision for FDA approval of
alternatives, including ones that may be appropriate for new
technology); Sec. 900.4(c)(3)--scoring of clinical images;
Sec. 900.4(c)(4)--selection of clinical images for review;
Sec. 900.4(c)(5)--qualifications and procedures for clinical image
reviewers; Sec. 900.4(c)(6)--management of clinical images to ensure
their timely return to facilities and the reporting of unsuspected
abnormalities; and Sec. 900.4(c)(7)--corrective measures for
unsatisfactory image quality. With respect to this last paragraph, it
is FDA's intent that the accreditation process be a constructive one
that helps facilities improve mammography quality. Therefore, FDA is
proposing that clinical image reviewers be required to provide
information to facilities that can help them correct deficiencies
identified from their clinical images.
Several comments as well as NMQAAC discussions concerned the
interim requirements for clinical image review. Some NMQAAC members and
consultants expressed uncertainty about whether States would have the
expertise to perform clinical image reviews, because States had no
prior experience with such reviews. Some comments called for increased
standardization and the establishment of minimum requirements for
clinical image review. One comment believed that all clinical images
should be selected randomly in order to prevent facilities from merely
selecting their best images for accreditation body review. Two comments
questioned the need for clinical image review requirements at all.
These two comments believed that other requirements in the interim
regulations adequately addressed image quality. Another comment
believed that clinical images should be independently reviewed by more
than one radiologist.
In response to these comments, FDA notes first that the MQSA
mandates clinical image reviews and FDA fully supports the need for
such reviews. FDA does not intend to approve any entity as an
accreditation body, including a State agency, without first determining
that the prospective body will be capable of performing or providing
satisfactory clinical image reviews. The proposed regulations
concerning clinical image review add specific details and requirements
that are in addition to those set forth in the interim regulations. FDA
believes that these additions in the proposed regulations, as well as
anticipated agency guidance, will ensure that prospective accreditation
bodies understand what FDA expects of them regarding such reviews and
will be prepared to establish their ability to perform or provide these
reviews as part of their application to become accreditation bodies. In
addition, FDA will monitor accreditation bodies' compliance with the
agency's standards and expectations, including their clinical image
review functions. This will be done through annual performance
evaluations and other oversight mechanisms.
FDA agrees with the comment that clinical images should be
independently reviewed by more than one radiologist. Although such a
requirement was not explicitly established in the interim regulations,
it has been the practice established by FDA and the accreditation
bodies under those regulations. FDA is proposing to codify this policy
in Sec. 900.4(c)(3)(ii).
FDA disagrees with the comment that all clinical images submitted
by facilities should be selected completely at random. For example, it
is important in assessing the quality of a facility's mammography that
accreditation bodies evaluate, for each mammography unit in a facility,
mammograms for women with different types of breast composition (e.g.,
with predominantly glandular versus adipose tissue). FDA believes that
systems for clinical image review under the MQSA can be implemented
using random or nonrandom methods of image selection. FDA also notes
that nonrandom methods for clinical image review were used by the ACR
as part of its voluntary accreditation program before the passage of
the MQSA.
4. Phantom Image Review
FDA is proposing a new requirement in Sec. 900.4(d) for review of
phantom images by the accreditation body. This is being done on the
recommendation of the NMQAAC. To the extent that issues in the review
of phantom images parallel issues in the review of clinical images, the
requirements of this paragraph parallel those of Sec. 900.4(c).
However, a unique issue with respect to phantom images is determining
what constitutes acceptable phantom characteristics for
radiographically modeling aspects of breast disease and cancer.
FDA recognizes that a variety of phantoms may be useful for this
purpose, and that the desirable phantom characteristics may change over
time, particularly with the introduction of new technology.
Consequently, FDA is not proposing that any specific attributes, such
as specks, fibers, or masses, or their dimensions, be required by
regulation. However, to assure the adequacy of phantoms used, FDA is
proposing to require that accreditation bodies obtain FDA approval for
the phantoms and methods of use that the bodies specify for facilities
they accredit. This approach will provide needed flexibility for
accreditation bodies and facilities and will enable FDA to respond in a
timely manner to technological advances in this area.
5. Reports of Mammography Equipment Evaluation, Surveys, and Quality
Control
Consistent with the interim regulations and statutory requirements,
FDA is proposing to require in Sec. 900.4(e) that accreditation bodies
mandate submission of a survey by facilities in
[[Page 14889]]
order to obtain accreditation. ``Survey'' is defined in Sec. 900.2
(published elsewhere in this issue of the Federal Register) as an
onsite physics consultation and evaluation of a facility performed by a
medical physicist. This survey would have to demonstrate the facility's
compliance with the MQSA standards adopted by the accreditation body.
The statute does not require new facilities to submit a survey in
order to qualify for provisional certification from FDA. Therefore, new
facilities may perform mammography for up to 6 months without
undergoing a survey. Both the agency and the NMQAAC believe that
postponement of the survey required for full accreditation under MQSA
should not be interpreted as permitting the clinical use of equipment
that has not been evaluated for safety. Accordingly, FDA is proposing
that all facilities, whether seeking full or provisional certification,
be required to submit with their initial accreditation application a
mammography equipment evaluation demonstrating that the facility's
equipment is in compliance with the requirements in Sec. 900.12(e) (21
CFR 900.12)(e)) for equipment quality assurance (published elsewhere in
this issue of the Federal Register). This requirement would ensure that
provisionally certified facilities verify the proper functioning of
their mammography equipment prior to clinical use.
FDA will be developing a guidance document outlining the criteria
for an adequate equipment evaluation. The agency invites comments on
possible criteria for inclusion within this guidance document. A
complete survey, which includes reviews and information in addition to
equipment QA, would still have to be submitted in order for a
provisionally certified facility to obtain accreditation and full
certification.
There was some discussion with the NMQAAC regarding who should
perform the mammography equipment evaluation that is part of the
initial application for accreditation. In deference to comments from
rural health care providers, FDA has decided against requiring that
this evaluation be performed by a medical physicist. Rural health care
providers have indicated that, because of the limited availability of
medical physicists in rural areas, it might be difficult for a
physicist to visit a rural facility twice over a short time period in
order to perform the mammography equipment evaluation and, later, the
survey required for accreditation and full certification. In addition,
the agency's experience under the Radiation Control for Health and
Safety Act (Pub. L. 90-602) shows that the types of measurements being
requested for the mammography equipment evaluation can be performed
effectively by nonphysicists. Therefore, FDA believes it would not be
cost-effective or practical to require performance of the mammography
equipment evaluation by a medical physicist.
FDA is proposing specific time periods for facility submission and
accreditation body review of mammography equipment evaluations and
surveys. These requirements are being recommended as a result of FDA's
experience with MQSA over the last year and advice from the NMQAAC. In
particular, both the agency and the NMQAAC believe it is important that
facilities be required to submit survey and evaluation data that
reflects current practice in the facility at the time of application
for accreditation.
FDA is proposing to require in Sec. 900.4(e) that accreditation
bodies mandate annual submission of certain materials by the facility
to the accreditation body for review. These materials would include the
annual survey and quality control records, personnel updates, and other
information that the body may require. This requirement is intended to
assure continued compliance with the facility standards and to provide
continued accreditation body oversight of facilities' quality control
programs as they relate to such standards.
Several comments addressed issues related to accreditation and
certification of facilities with more than one mammography unit
(consisting of the x-ray generator and associated image receptor and
auxiliary equipment). In particular, clarification was requested
regarding the status of multiple-unit facilities that had not undergone
all tests to assure compliance with standards or that had failed to
meet all requirements. Some comments favored requiring the complete
evaluation of all units in a facility, with measures to ensure that
only equipment meeting the necessary requirements is used to perform
mammography.
FDA agrees that only equipment meeting necessary requirements
should be used to perform mammography. Under both the interim and
proposed regulations, all units that are used for mammography in a
facility must be reported to the accreditation body and meet applicable
standards. As discussed previously, FDA is proposing to require that
facilities submit the results of mammography equipment evaluations with
their initial application for accreditation. Those evaluations will
establish compliance with equipment QA standards under Sec. 900.12(e)
for every unit in the facility. In addition, surveys (Sec. 900.4(e)),
as well as clinical (Sec. 900.4(c)(4)(i)) and phantom images
(Sec. 900.4(d)(4)), would have to be submitted for each mammography
unit at a facility during specified time periods. FDA is also proposing
in Sec. 900.4(c)(2)(viii)(G) that facilities with multiple units have a
mechanism for identifying the unit used to produce each mammography
image. This would enable inspectors and accreditation body visitors to
check facility images against the compliance status of facility
equipment and would facilitate problem identification and corrective
measures, if necessary.
It is FDA's policy that similar requirements apply to new and
repaired equipment, i.e., such equipment may be used clinically after
the mammography equipment evaluation has demonstrated compliance of the
equipment with the requirements in Sec. 900.12(e). A survey and
clinical and phantom image reviews may be required after the initiation
of clinical use. Such image reviews and a survey are now, and would
continue to be, necessary for new equipment; however, the accreditation
body will specify, with FDA's approval, the circumstances under which
repaired equipment will require a survey or image reviews by the
accreditation body. Any facility that performs mammography with
equipment the facility has reason to believe does not meet MQSA
standards will be subject to sanctions under section 354(h)(2) of the
PHS Act, including civil money penalties.
One comment questioned the value of requiring annual submission of
all facility quality control records to both the accreditation body and
FDA. The comment also suggested that quality control records may be
useful for internal evaluations, but that documents that are to be
submitted to the accreditation body may be screened or amended by the
facility in order to avoid negative publicity or regulatory action.
FDA advises that no routine requirement exists to submit all
quality control records to FDA. In addition, the use of the phrase
``quality control records'' in Sec. 900.4(e)(2)(iii) of the interim
regulations is not intended to mandate submission of all quality
control records to the accreditation body every year. The records to be
submitted will depend on the specific requirements established by the
accreditation body, subject to FDA approval. FDA agrees that quality
control records can serve as an
[[Page 14890]]
important internal source of information for helping facilities
identify problems and appropriate solutions. However, FDA would regard
any purposeful alterations of records to be acts of fraud.
6. Accreditation Body Onsite Visits and Random Clinical Image Reviews
The MQSA requires that accreditation bodies make a ``sufficient
number'' of onsite visits to facilities they accredit ``to allow a
reasonable estimate of the performance'' of the body (42 U.S.C.
263b(e)(4)). The MQSA also requires the accreditation body to conduct
random reviews of clinical images from the facilities it accredits, in
addition to the clinical image reviews required for accreditation (42
U.S.C. 263b(e)(1)(B)). These requirements are listed in Sec. 900.4(f)
of the proposed regulations (corresponding to Sec. 900.4(e) in the
interim regulations). In the proposed regulations, the word ``visits''
is substituted for the previously used word ``inspections'' in order to
reduce any confusion between onsite visits by accreditation bodies and
annual inspections by State or FDA inspectors.
One comment disputed the need for onsite visits by accreditation
bodies and another comment questioned the need for the interim
requirement that the accreditation body submit a copy of the visit
report to FDA.
FDA disagrees with both of these comments. The need for onsite
visits is established by the statute. The purpose of the visits is to
provide a mechanism by which an accreditation body can both ensure
facility compliance with quality standards and monitor its own
performance of accreditation functions. The accreditation body would be
able to compare the results from visits for consistency with
information obtained through other accreditation body functions. Also,
because FDA is required to evaluate annually the performance of each
accreditation body, the reports of onsite visits would provide valuable
information on which to base such evaluations. Therefore, although the
agency is proposing to delete the requirement that a full copy of each
onsite visit report be provided to FDA at the conclusion of the
accreditation body's onsite visit, FDA would continue to require that a
summary of findings obtained as a result of accreditation body visits
to facilities be included in the accreditation body's annual report to
FDA. As discussed previously, notification about situations involving
health hazards and death or serious injury or illness cannot wait for
annual reports.
Several comments addressed the selection process, number, and need
for advance notification of facilities for accreditation body onsite
visits. Some comments stated that the percentage of visits performed by
accreditation bodies should be established by FDA (at perhaps 5 or 10
percent of accredited facilities). One comment suggested that a means
be established to ensure proportionate distribution of visits to
facilities with regard to facility size and geographic distribution.
Several comments believed that accreditation bodies should be required
to give facilities advance notice of a visit, although one comment
believed that FDA should specify certain circumstances for which
unannounced visits might be appropriate.
In response to these comments, FDA is proposing in Sec. 900.4(f)(1)
that accreditation bodies select some facilities for onsite visits on a
random basis and select other facilities based on specific reasons for
concern with those facilities, such as previous history of
noncompliance with quality standards. In general, each accreditation
body would have to visit annually at least 5 percent of facilities it
accredits, up to a maximum of 50 facilities, but no less than 5. The
number could exceed 50 if many facilities need to be visited because of
previously identified concerns.
Regarding advance notification of facilities by accreditation
bodies, FDA believes that accreditation bodies will need flexibility in
scheduling onsite visits. In some cases, particularly if an
accreditation body has serious concerns about a facility's ability to
meet quality standards, significant advance notice would not be
appropriate. In general, however, for facilities selected randomly for
onsite visits, FDA will encourage accreditation bodies to work with
facilities to schedule visits so as to minimize examinee inconvenience
and disruption to facility operations.
For random clinical image reviews, FDA is proposing that, on an
annual basis, 3 percent of facilities (but no less than five
facilities) accredited by an accreditation body would have to be chosen
randomly to submit clinical images for review. These clinical images
would be in addition to those submitted every 3 years as part of the
accreditation process. As the requirements have been proposed, the
accreditation body would be able to count toward this 3 percent
requirement all facilities that have undergone an additional clinical
image review because of random selection for the onsite visits in
Sec. 900.4(f)(1)(i)(A).
The requirement for selecting a 3 percent random sample of
facilities is changed from that in the interim regulations, which
required random clinical image review for each facility accredited by a
body. The change in the sampling requirement is based on FDA experience
with implementing the interim regulations. The agency believes that
annual random clinical image review for every facility in addition to
the clinical image reviews required for initial accreditation and
renewal is not an effective use of accreditation body resources. In
addition, accreditation bodies should not schedule random clinical
image reviews at facilities that have received their notification of
their need to begin the accreditation renewal process or at facilities
that have completed the accreditation renewal process within the
previous 6 months.
7. Consumer Complaint Mechanism
The interim regulations required accreditation bodies to establish
processes for receipt, investigation, and records maintenance of
consumer complaints about facilities they accredit. In accordance with
42 U.S.C. 263(n)(3)(E), FDA has worked with the NMQAAC to develop
mechanisms to investigate consumer complaints. The committee and FDA
agree that the investigation of ``serious complaints'' and the
correction of underlying problems that may have precipitated them can
help improve the practice of mammography. The proposed role of
accreditation bodies in this process is specified in Sec. 900.4(g).
A ``serious'' complaint is defined in proposed Sec. 900.2
(published elsewhere in this issue of the Federal Register) as a report
by a consumer of: (1) A ``serious adverse event'' that significantly
compromises, or has the potential to significantly compromise, clinical
outcomes, or (2) an ``adverse event'' for which the facility fails to
take appropriate corrective action. ``Consumer'' is defined in proposed
Sec. 900.2 as an individual who chooses to comment or complain in
reference to a mammography exam. Consumers, therefore, may include the
examinee or representatives of the examinee (e.g., family members or
referring physicians).
In the proposed regulations, the consumer complaint mechanism
focuses on serious complaints related to incidents over which FDA has
regulatory authority under MQSA. FDA acknowledges that there may be
additional kinds of serious complaints that are legitimate and worthy
of investigation, but that do not fall under the agency's regulatory
authority under MQSA (e.g., sexual harassment or discrimination). FDA
encourages the channeling and resolution of such complaints through
appropriate existing mechanisms, such as State oversight
[[Page 14891]]
organizations and professional licensing boards.
The proposed consumer complaint mechanism would set minimum
requirements for facilities and accreditation bodies. FDA has worked
extensively with NMQAAC in developing this mechanism and believes that
the proposed requirements meet the important needs of the consumer
without imposing undue burden on mammography facilities. The proposed
regulations would allow facilities flexibility in instituting their own
complaint resolution procedures. FDA encourages facilities to design
their complaint mechanisms to be responsive to language, ethnic, and
literacy differences among consumers served by the facility.
FDA believes that all comments and complaints should be directed
first to the facility, where there is the greatest opportunity for
resolution. FDA is proposing that facilities be required to establish
and administer a documented consumer complaint mechanism that complies
with standards in proposed Sec. 900.12(h), published elsewhere in this
issue of the Federal Register. However, FDA also recognizes that, under
certain circumstances, consumers may want to report serious complaints
that they have been unable to resolve with the facility to a more
impartial organization. FDA believes that a facility's accreditation
body should receive these complaints because the accreditation body has
the responsibility for assuring that facilities meet quality standards.
To fulfill this responsibility, accreditation bodies need data on
serious complaints related to mammography quality. Therefore, FDA is
proposing that the accreditation body be the second level in the
complaint process to receive, investigate, and resolve serious consumer
complaints.
The third level of the complaint process, should the complaint go
unresolved at the accreditation body level, would be FDA. The
accreditation body could recommend that FDA take regulatory action,
including inspections, sanctions, or revocation of the facility's
certificate. Some consumers might want to address complaints about
facilities directly to FDA, and this option is also open to them.
FDA is proposing to require accreditation bodies to review and
evaluate each facility's plan for handling consumer complaints. The
agency is also proposing that the accreditation body be required to
maintain a record of each serious complaint it receives regarding
facilities it accredits, whether or not the accreditation body is able
to resolve the complaint. All records of serious complaints would have
to be retained for at least 3 years after the date of receipt of the
complaint by the accreditation body. Accreditation bodies would also be
required to submit to FDA an annual report summarizing serious
complaints.
One comment on the interim regulations requested that complaint
information be shared with States and the public.
The MQSA does not include a provision requiring public disclosure
of individual consumer complaints or release of such information by
individual facilities to State authorities. However, the MQSA does
require in 42 U.S.C. 263b(l)(1) that information FDA determines to be
useful in evaluating the performance of mammography facilities be made
available to the general public no later than October 1, 1996, and
annually thereafter. This information must include a list of facilities
that have been convicted under Federal or State laws relating to fraud
and abuse, false billings, or kickbacks, have been subject to
sanctions, have had certificates revoked or suspended, or have had
accreditation revoked.
One comment on the interim regulations noted that the mechanism for
handling complaint information contains no provision for protecting
confidentiality and that unsubstantiated allegations should not be made
publicly available.
As discussed above, FDA does not believe the MQSA is intended to
authorize public disclosure of details concerning specific complaints
or allegations. FDA encourages all individuals involved in resolution
of complaints to protect the confidentiality of consumers and health
professionals to the full extent required by State law and professional
ethics. However, knowledge of the identity of individuals involved in
the complaint process may be necessary in order for the accreditation
body or FDA to investigate the complaint. The agency's own regulations
prohibit disclosure of information that would be an unwarranted
invasion of personal privacy and FDA will not release names or personal
identifiers without consent of the individuals involved (21 CFR 20.63
and 20.111).
8. Reporting and Recordkeeping
In Sec. 900.4(h), FDA is proposing to require that accreditation
body reports to FDA be submitted in the format and medium prescribed by
the agency. This requirement would facilitate the use of uniform
methods for efficient data management and analysis, including the use
of computer-based systems by FDA.
One comment stated that the timeframes specified in the interim
regulations (Sec. 900.4(g)) for accreditation body reporting were
unreasonable.
FDA agrees that changes in this area are needed and the proposed
regulations have been designed to allow greater flexibility in
specifying timeframes for reports to FDA, based on FDA and
accreditation body needs.
One comment expressed concern that the wording of the interim
requirement in Sec. 900.4(g)(6) might result in a request for
proprietary information not specifically required by or relevant to the
MQSA. Another comment indicated concern that the interim requirement in
Sec. 900.4(d)(1) for a facility to provide its accreditation body with,
``any other information the body may require, as a part of the annual
report about the facility'', was excessively broad.
FDA believes that the MQSA provides the agency with the authority
to determine the information that is necessary to meet the agency's
statutory responsibilities under MQSA (e.g., 42 U.S.C.
263b(d)(1)(B)(iii) and (e)(1)(C)(vi)). In addition, FDA has
considerable experience with receiving and protecting proprietary
information. However, in response to the comments, FDA has modified the
regulatory language to specify that any information collected by an
accreditation body from a facility should be relevant to the MQSA. In
addition, as part of FDA's approval and oversight responsibilities, the
agency will review the information required by accreditation bodies
with regard to its relevance to such bodies' responsibilities under
MQSA.
As discussed earlier, FDA has also addressed the issue of
confidentiality in the accreditation body code of conduct and general
responsibilities. Proposed Sec. 900.4(a)(9) states the obligation of
the accreditation body to keep confidential all nonpublic information
it acquires in connection with carrying out its accreditation body
responsibilities.
9. Fees
In proposed Sec. 900.4(i), FDA is continuing to require that
accreditation body fees charged to facilities be reasonable, as in
Sec. 900.4(c) of the interim regulations.
Several comments regarding accreditation fees mentioned the
relatively small amounts of various third party reimbursements for
screening mammography and hoped that FDA would consider this
information when establishing requirements for fees. Two comments
disagreed with the interim requirements for limiting fee increases to
adjustments in the consumer price index (CPI). A
[[Page 14892]]
few other comments raised additional issues related to determining the
reasonableness of fees, including expansion costs and accreditation
body activities specifically attributable to MQSA responsibilities. The
latter issue was raised with respect to State agencies with multiple
responsibilities in addition to those associated with MQSA.
FDA is proposing certain changes in the fee provisions in response
to comments. The proposed regulations would permit variation in
accreditation body fees, and adjustments would no longer be limited to
changes in the CPI. However, FDA is proposing that accreditation bodies
only be allowed to recover costs that are a result of MQSA-attributable
functions. Consequently, fee changes might be appropriate for changes
in accreditation body activities that have been approved by FDA.
However, accreditation body activities that are not FDA-approved
activities could not be considered in determining fees charged for MQSA
accreditation functions. Consequently, the relationship of fees to
costs incurred because of accreditation body responsibilities under
these regulations would be an important factor in determining the
reasonableness of fees.
One comment questioned whether providers would have an opportunity
to question the reasonableness of fees before they are approved by FDA.
Although there is no official provision for public comment on
accreditation fees, anyone who feels that fee increases are excessive
may raise these concerns with FDA at any time.
D. Evaluation of Accreditation Bodies
In proposed Sec. 900.5, FDA states that the agency will evaluate
all accreditation bodies at least annually and at other times if
specific circumstances warrant.
Two comments suggested the following additions to the factors
specified in the interim regulations for evaluating accreditation
bodies: (1) Responsiveness of the body to FDA and to complaints from
other sources, and (2) compliance of the body with requirements for
approval as an accreditation body. One of these comments also suggested
that more detail be added related to the sample size of facilities and
clinical images to be assessed by FDA as part of FDA's evaluation of
accreditation bodies.
In response to these comments, FDA advises that the proposed
regulations contain more extensive requirements (in Sec. 900.3) for
approval as an accreditation body than did the interim regulations. As
part of its annual evaluation of accreditation bodies, FDA will
consider compliance with these requirements, including the
responsiveness and timeliness with which accreditation bodies meet
their various responsibilities. In order to perform these evaluations,
FDA will have access to the results of annual inspections of facilities
by FDA or State inspectors, information from annual and other reports
from accreditation bodies, and visits to facilities or accreditation
bodies to evaluate their compliance with the standards specified under
subparts A and B of part 900 (21 CFR part 900). FDA also will be able
to request more data, such as additional clinical images, at any time
the agency determines that it needs further information to complete its
evaluation.
E. Withdrawal of Approval
In Sec. 900.6, FDA has proposed certain changes to the interim
criteria for withdrawal of approval of an accreditation body and the
addition of certain other actions the agency may take against
accreditation bodies, when warranted.
Under the interim regulations, FDA was precluded from reinstating
approval of an accreditation body if withdrawal of approval was based
on fraud or material false statements. FDA has reconsidered these
criteria in drafting these proposed rules and in light of the agency's
experience implementing the interim regulations.
FDA continues to believe that certain actions are so egregious that
they should automatically preclude an accreditation body from
continuing or ever resuming service as an accreditation body. The
agency believes that, in addition to the commission of fraud, willful
disregard of the public health constitutes an action by an
accreditation body that should permanently disqualify that body from
future approval. Accordingly, FDA has added willful disregard of the
public health as a bar to reinstatement as an accreditation body.
However, FDA is proposing to review on a case-by-case basis
applications from former accreditation bodies whose approval was
withdrawn due to the submission of material false statements. The
agency is persuaded that there may be instances where the submission of
material false statements was unintentional or had limited
consequences. FDA has drafted the proposed regulations to retain
discretion to reinstate accreditation bodies if the agency determines
there is evidence to demonstrate that such conduct will not recur.
The proposed regulations also clarify that FDA reserves the right
to withdraw approval or place an accreditation body on probationary
status, depending on the specific deficiencies involved. Unlike the
interim regulations, the proposal gives FDA discretion about how to
proceed, even with respect to accreditation bodies that have
demonstrated major deficiencies. FDA would make these determinations on
a case-by-case basis. In addition, FDA would have discretion to specify
particular corrective actions that the accreditation body must take or
to offer the accreditation body an opportunity to submit its own plan
of corrective action (including timetables) for FDA approval.
Two comments stated that the specification in the interim
regulations of a 90-day time period for submitting a corrective action
plan to FDA for minor deficiencies should be shortened from 30 to 60
days, and that FDA should respond to the proposed plan within the same
timeframe.
FDA has concluded that establishing fixed time periods for
submission or implementation of corrective action plans does not allow
the agency or accreditation bodies sufficient flexibility. Timeframes
for correction of minor deficiencies should be based on the specific
deficiencies that must be addressed. Therefore, the agency has not set
forth specific timeframes in proposed Sec. 900.6(b)(2). Instead, FDA
will determine the necessary implementation schedules on a case-by-case
basis.
F. Hearings
Under proposed Sec. 900.7 on hearings, a facility that has been
denied accreditation would be entitled to an appeals process from the
accreditation body (Sec. 900.7(b)). The facility could then appeal the
results of this process to FDA and the Department of Health and Human
Services in accordance with proposed Sec. 900.15, published elsewhere
in this issue of the Federal Register.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(3) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Analysis of Impacts
FDA has examined together the impacts of this proposed rule and the
proposed rules on general facility requirements, personnel
requirements, and quality standards for mammography equipment and
quality assurance, published elsewhere in this issue of the
[[Page 14893]]
Federal Register, under Executive Order 12866, the Regulatory
Flexibility Act (Pub. L. 96-354), and under the Unfunded Mandates
Reform Act. The analysis has addressed the proposed requirements of
these four rules as one unit for purposes of determining their economic
impact. The preamble to the proposed rule ``Quality Mammography
Standards; General Preamble and Proposed Alternative Approaches,''
published elsewhere in this issue of the Federal Register, contains a
brief summary of the cost and benefit determination and the Regulatory
Impact Study that details the agency's calculation of these economic
impacts and is available at the Dockets Management Branch (address
above) for review. FDA recognized that these proposed regulations may
have a disproportionate effect on small volume mammography facilities
and is currently collecting additional information on the potential
impact on this industry sector. The agency requests comments that will
assist it in accounting for this impact.
V. Paperwork Reduction Act of 1995
This proposed rule contains information collections which are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title,
description, and respondent description of the information collection
are contained in the proposed rule ``Quality Mammography Standards;
General Preamble and Proposed Alternative Approaches,'' published
elsewhere in this issue of the Federal Register, with an estimate of
the annual reporting and recordkeeping burden.
The agency has submitted a copy of this proposed rule to OMB for
its review and approval of these information collection requirements.
Other organizations and individuals desiring to submit comments
regarding this burden estimate or any aspect of these information
collection requirements, including suggestions for reducing the burden,
should direct them to the Office of Information and Regulatory Affairs,
OMB, rm. 10235, New Executive Office Bldg., Washington, DC 20503, Attn:
Desk Officer for FDA. Written comments on the information collection
requirements should be submitted by May 3, 1996.
VI. Comments
Interested persons may, on or before July 2, 1996, submit to the
Dockets Management Branch (address above) written commentsregarding
this proposed rule. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
VII. References
The following information has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. ``Report on the Mammography Quality Standards Act of 1992,''
U.S. Senate, Report 102-448, October 1, 1992.
2. ``Health Care: Hospitals with Quality-of-Care Problems Need
Closer Monitoring,'' U.S. GAO, GAO/HRD-91-40, May 1991.
List of Subjects in 21 CFR Part 900
Electronic products, Health facilities, Mammography, Medical
devices, Radiation protection, Reporting and recordkeeping
requirements, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 900 be
amended as follows:
PART 900--MAMMOGRAPHY
1. The authority citation for 21 CFR part 900 continues to read as
follows:
Authority: Secs. 519, 537, and 704(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360i, 360nn, and 374(e)); sec. 354 of
the Public Health Service Act (42 U.S.C. 263b).
2. Sections Sec. 900.3 through 900.7 are revised to read as
follows:
Sec. 900.3 Application for approval as an accreditation body.
(a) Eligibility. Private nonprofit organizations or State agencies
capable of meeting the requirements of this subpart may apply for
approval as accreditation bodies.
(b) Application for initial approval. (1) An applicant seeking
initial FDA approval as an accreditation body shall inform the Division
of Mammography Quality and Radiation Programs, Center for Devices and
Radiology Health (HFZ-240), Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850, marked Attn: Mammography Standards Branch, of
its requested scope of authority.
(2) Following receipt of the request, FDA will send application
guidance to the applicant.
(3) In accordance with the guidance provided, the applicant shall
furnish to FDA at the address in paragraph (b)(1) of this section three
copies of an application containing the following information,
materials, and supporting documentation:
(i) Name, address, and phone number of the applicant and evidence
of nonprofit status (i.e., of fulfilling Internal Revenue Service
requirements as a nonprofit organization) if the applicant is not a
State agency;
(ii) Detailed description of the accreditation standards the
applicant will require facilities to meet and a discussion
substantiating their equivalence to FDA standards required under 42
U.S.C. 263b(e)(3);
(iii) Detailed description of the applicant's accreditation review
and decisionmaking process, including:
(A) Procedures for performing clinical image review;
(B) Procedures for performing phantom image review;
(C) Procedures for assessing mammography equipment evaluations and
surveys;
(D) Procedures for performing onsite visits to facilities;
(E) Procedures for assessing facility personnel qualifications;
(F) Copies of the accreditation application forms, guidelines,
instructions, and other materials the applicant will send to facilities
during the accreditation process;
(G) Policies and procedures for notifying facilities of
deficiencies;
(H) Procedures for monitoring corrections of deficiencies by
facilities;
(I) Policies and procedures for revoking a facility's
accreditation;
(J) Policies and procedures that will assure processing of
accreditation applications and renewals within a timeframe approved by
FDA and assurances that the body will adhere to such policies and
procedures; and
(K) A description of the applicant's appeals process for facilities
contesting adverse accreditation status decisions.
(iv) Education, experience, and training requirements for the
applicant's professional staff, including reviewers of clinical or
phantom images;
(v) Description of the applicant's electronic data management and
analysis system with respect to accreditation review and decision
processes and the applicant's ability to provide electronic data in a
format compatible with FDA data systems;
(vi) Resource analysis that demonstrates that the applicant's
staffing, funding, and other resources are adequate to perform the
required accreditation activities;
(vii) Fee schedules with supporting cost data;
[[Page 14894]]
(viii) Statement of policies and procedures established to avoid
conflicts of interest or the appearance of conflicts of interest by the
applicant's board members, commissioners, professional personnel
(including reviewers of clinical and phantom images), consultants,
administrative personnel, and other representatives of the applicant;
(ix) Disclosure of any specific brand of imaging system or
component, measuring device, software package, or other commercial
product used in mammography that the applicant develops, sells, or
distributes;
(x) Description of the body's documented consumer complaint
mechanism;
(xi) Satisfactory assurances that the applicant shall comply with
the requirements of Sec. 900.4; and
(xii) Any other information as may be required by FDA.
(c) Application for renewal of approval. An approved accreditation
body that intends to continue to serve as an accreditation body beyond
its current term shall apply to FDA for renewal or notify FDA of its
plans not to apply for renewal in accordance with the following
procedures and schedule:
(1) At least 9 months before the date of expiration of a body's
approval, an applicant for renewal shall inform FDA at the address
given in paragraph (b)(1) of this section.
(2) FDA will notify the applicant of the applicable information,
materials, and supporting documentation from paragraph (b)(3) of this
section that the applicant shall submit as part of the renew
FR Doc. 96-7831 Proposed Requirements for Accreditation Bodies of Mammography Facilities
al
procedure.
(3) At least 6 months before the date of expiration of a body's
approval, the applicant shall furnish to FDA at the address in
paragraph (b)(1) of this section three copies of a renewal application
containing the information, materials, and supporting documentation
requested by FDA in accordance with paragraph (c)(2) of this section.
(4) No later than July 2, 1996, any accreditation body approved
under the interim regulations published in the Federal Register of
December 21, 1993 (58 FR 67558) that intends to continue to serve as an
accreditation body under the final regulations shall apply for renewal
of approval in accordance with the procedures set forth in paragraphs
(c)(1) through (c)(3) of this section.
(5) Any accreditation body that does not plan to renew its approval
shall so notify FDA at the address given in paragraph (b)(1) of this
section at least 90 days before the expiration of the body's term of
approval.
(d) Rulings on applications for initial and renewed approval. (1)
FDA will conduct a review and evaluation to determine whether the
applicant substantially meets the applicable requirements of this
subpart and whether the accreditation standards the applicant will
require facilities to meet are substantially the same as the quality
standards published under subpart B of this part.
(2) FDA will notify the applicant of any deficiencies in the
application and request that those deficiencies be rectified within a
specified time period. If the deficiencies are not rectified to FDA's
satisfaction within the specified time period, the application for
approval as an accreditation body will be rejected.
(3) The applicant will receive a formal notice from FDA stating
whether the application has been approved or denied and a statement of
the bases for any denial.
(4) The review of any application may include a meeting between FDA
and representatives of the applicant at a time and location mutually
acceptable to FDA and the applicant.
(5) FDA will advise the accreditation body of the circumstances
under which a denied application may be resubmitted.
(6) If FDA does not reach a final decision on a renewal application
in accordance with this paragraph before the expiration of an
accreditation body's approval, the approval will be deemed extended
until the agency reaches a final decision on the application, unless an
accreditation body does not rectify deficiencies in the application
within the specified time period, as required in paragraph (d)(2) of
this section.
(e) Relinquishment of authority. An accreditation body that decides
to relinquish its accreditation authority before expiration of the
body's term of approval shall submit a letter of such intent to FDA at
the address in paragraph (b)(1) of this section at least 90 days before
relinquishing such authority.
(f) Transfer of records. An accreditation body that does not apply
for renewal of accreditation body approval, is denied such approval by
FDA, or relinquishes its accreditation authority and duties before
expiration of its term of approval, shall:
(1) Transfer facility records and other related information as
required by FDA to a location and according to a schedule approved by
FDA.
(2) Notify, in a manner and time period approved by FDA in
accordance with Secs. 900.3(d) or 900.4(a)(9), all facilities
accredited or seeking accreditation by the body that the body will no
longer have accreditation authority.
(g) Scope of authority. The accreditation body's term of approval
is for a period of 5 years. FDA may limit the scope of accreditation
authority.
Sec. 900.4 Standards for accreditation bodies.
(a) Code of conduct and general responsibilities. The accreditation
body shall accept the following responsibilities in order to ensure
safe and accurate mammography at the facilities it accredits and shall
perform these responsibilities in a manner that ensures the integrity
and impartiality of accreditation body actions.
(1) Upon request by FDA, the accreditation body shall review a
facility's clinical images or other aspects of a facility's practice to
assist FDA in determining whether or not the facility's practice poses
an unreasonable risk of substantial harm to the public. Such reviews
would be in addition to the evaluation an accreditation body performs
as part of the initial accreditation or renewal process for facilities.
If FDA determines that a facility's practice poses an unreasonable risk
of substantial harm to the public:
(i) The accreditation body shall require the facility to take
appropriate corrective actions as determined by the accreditation body
or FDA, including, but not limited to, notifying examinees or referring
physicians; and
(ii) The accreditation body shall monitor the facility's
implementation of corrective actions in accordance with a schedule
specified by FDA.
(2) The accreditation body shall provide guidance to facilities
regarding reporting requirements for conditions within the scope of 42
U.S.C. 263b that arise at the facility and that pose a health hazard to
examinees, personnel, or others in the facility.
(i) The accreditation body shall require that such information and
a plan of correction addressing the conditions be submitted by the
facility in a manner and time period specified by the accreditation
body.
(ii) The accreditation body shall require the facility to cease use
of any equipment or to eliminate any practices that may contribute to
such potentially harmful conditions as soon as possible. In those
circumstances where the accreditation body has reason to believe a
hazard exists, the accreditation body shall notify the facility that
use of the equipment or continuation of the practice shall stop
immediately.
(iii) The accreditation body shall monitor the facility's
compliance with the plan of correction and progress
[[Page 14895]]
toward meeting applicable standards and minimizing health hazards.
(3) The accreditation body shall inform FDA within 5 business days
of becoming aware of equipment or practices that pose an unreasonable
risk of substantial harm to the public.
(4) The accreditation body shall establish and administer a quality
assurance (QA) program that has been approved by FDA in accordance with
Sec. 900.3(d) or paragraph (a)(8) of this section. Such quality
assurance program shall:
(i) Include requirements for clinical image review and phantom
image review;
(ii) Ensure that clinical and phantom images are evaluated
consistently and accurately; and
(iii) Specify the methods and frequency of training, evaluation,
and performance improvement for clinical and phantom image reviewers,
and the bases and procedures for removal of such reviewers.
(5) The accreditation body shall establish measures that FDA has
approved in accordance with Sec. 900.3(d) or paragraph (a)(8) of this
section to reduce the possibility of conflict of interest or facility
bias on the part of individuals acting on the body's behalf. Such
individuals who review clinical or phantom images under the provisions
of paragraphs (c) and (d) of this section or who visit facilities under
the provisions of paragraph (f) of this section shall not review
clinical or phantom images from or visit a facility with which such
individuals maintain a financial relationship, or when it would
otherwise be a conflict of interest for them to do so, or when they
have a bias in favor of or against the facility.
(6) The accreditation body may require specific equipment
performance or design characteristics that FDA has approved. However,
no accreditation body shall require, either explicitly or implicitly,
the use of any specific brand of imaging system or component, measuring
device, software package, or other commercial product as a condition
for accreditation by the body, unless FDA determines that it is in the
best interest of public health to do so.
(i) Any representation, actual or implied, either orally, in sales
literature, or in any other form of representation, that the purchase
or use of a particular product brand is required in order for any
facility to be accredited or certified under 42 U.S.C. 263b, is
prohibited, unless FDA approves such representation.
(ii) Unless FDA has approved the exclusive use and promotion of a
particular commercial product in accordance with this section, all
products produced, distributed, or sold by an accreditation body or an
organization that has a financial or other relationship with the
accreditation body that may be a conflict of interest or have the
appearance of a conflict of interest with the body's accreditation
functions, shall bear a disclaimer stating that the purchase or use of
such products is not required for accreditation or certification of any
facility under 42 U.S.C. 263b. Any representations about such products
shall include a similar disclaimer.
(7) When an accreditation body denies accreditation to a facility,
the accreditation body shall notify the facility in writing and explain
the bases for its decision. The notification shall also describe the
appeals process available from the accreditation body for the facility
to contest the decision.
(8) No State agency that is approved as an accreditation body may
require facilities in the State to be accredited under 42 U.S.C. 263b
only by the State agency and not by other FDA- approved accreditation
bodies.
(9) The accreditation body shall obtain FDA authorization for any
changes it proposes to make in any standards that FDA has previously
accepted under Sec. 900.3(d).
(10) An accreditation body shall protect confidential information
it collects or receives in its role as an accreditation body.
(i) Nonpublic information collected from facilities for the purpose
of carrying out accreditation body responsibilities shall not be used
for any other purpose or disclosed, other than to FDA or its duly
designated representatives, without the consent of the facility;
(ii) Nonpublic information that FDA or its duly designated
representatives share with the accreditation body concerning a facility
that is accredited or undergoing accreditation by that body shall not
be further disclosed except with the written permission of FDA.
(b) Facility standards. (1) The accreditation body shall require
that each facility it accredits meet standards for the performance of
quality mammography that are substantially the same as those in this
subpart and in subpart B of this part.
(2) The accreditation body shall notify a facility regarding
equipment, personnel, and other aspects of the facility's practice that
do not meet such standards and take reasonable steps to ensure that
such equipment, personnel, or other aspects of the practice are not
used by the facility for activities covered by 42 U.S.C. 263b.
(3) The accreditation body shall specify the actions that
facilities must take to correct deficiencies in equipment, personnel,
and other aspects of the practice to ensure facility compliance with
applicable standards.
(4) If deficiencies cannot be corrected to ensure compliance with
standards or if a facility is unwilling to take corrective actions, the
accreditation body shall revoke the facility's accreditation in
accordance with the policies and procedures in
Sec. 900.3((b)(3)(iii)(I).
(c) Clinical image review. (1) Frequency of review. The
accreditation body shall review clinical images from each facility
accredited by the body at least once every 3 years.
(2) Requirements for clinical image attributes. The accreditation
body shall use the following attributes for all clinical image reviews,
unless FDA has approved other attributes.
(i) Positioning. Sufficient breast tissue shall be imaged to ensure
that cancers are not likely to be missed because of inadequate
positioning.
(ii) Compression. Compression shall be applied in a manner that
minimizes the potential obscuring effect of overlying breast tissue and
motion artifact.
(iii) Tissue exposure. Tissue exposure shall be adequate to
visualize breast structures. Images shall be neither underexposed nor
overexposed.
(iv) Contrast. Image contrast shall permit differentiation of
subtle tissue density differences.
(v) Sharpness. Margins of normal breast structures shall be
distinct and not blurred.
(vi) Noise. Noise in the image shall not significantly obscure
breast structures or suggest the appearance of structures not actually
present.
(vii) Artifacts. Artifacts due to lint, scratches, and other
factors external to the breast shall not obscure breast structures or
suggest the appearance of structures not actually present.
(viii) Examination identification. Each image shall have the
following information indicated on it in a permanent and unambiguous
manner and placed so as not to obscure anatomic structures:
(A) Examinee identification.
(B) Date of examination.
(C) View and laterality. This information shall be placed on the
image in a position near the axilla. Standardized codes specified by
the accreditation body and approved by FDA in accordance with
Sec. 900.3(d) or
[[Page 14896]]
paragraph (a)(9) of this section shall be used to identify view and
laterality.
(D) Facility name and location. At a minimum, the location shall
include the city, state, and zip code number of the facility.
(E) Technologist identification.
(F) Cassette/screen identification.
(G) Mammography unit identification, if there is more than one unit
in the facility.
(3) Scoring of clinical images. Accreditation bodies shall
establish and administer a system for scoring clinical images using all
attributes specified in paragraphs(c)(2)(i) through (c)(2)(viii) of
this section or an alternative system that FDA has approved in
accordance with Sec. 900.3(d) or paragraph (a)(9) of this section. The
scoring system shall include an individual scoring scale for each
attribute. Each scoring scale shall cover the range from unacceptable
deficiencies that markedly reduce the clinical value of an image to no
significant deficiencies. Each clinical image submitted shall be scored
for each attribute.
(i) The accreditation body shall establish and employ criteria for
a pass-fail system for clinical image review that has been approved by
FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(9).
(ii) All clinical images submitted by a facility to the
accreditation body shall be reviewed independently by two or more
clinical image reviewers.
(4) Selection of clinical images for review. Unless otherwise
specified by FDA, the accreditation body shall require that for each
mammography unit in the facility:
(i) The facility shall submit craniocaudal (CC) and mediolateral
oblique (MLO) views from two mammographic examinations that the
facility produced during a time period specified by the accreditation
body;
(ii) Clinical images submitted from one such mammographic
examination for each unit shall be of dense breasts (predominance of
glandular tissue) and the other shall be of fat-replaced breasts
(predominance of adipose tissue);
(iii) All clinical images submitted shall be images that the
facility's interpreting physician(s) interpreted as normal.
(iv) If the facility has no clinical images meeting the
requirements in paragraphs (c)(4)(i) through (c)(4)(iii) of this
section, it shall so notify the accreditation body, which shall specify
alternative clinical image selection methods that do not compromise
care of the examinee.
(5) Clinical image reviewers. Accreditation bodies shall ensure
that all of their clinical image reviewers:
(i) Meet the interpreting physician requirements specified in
Sec. 900.12(a)(1);
(ii) Are trained and evaluated in the clinical image review
process, for the types of clinical images to be evaluated by a clinical
image reviewer, by the accreditation body before designation as
clinical image reviewers and periodically thereafter; and
(iii) Clearly document their findings and reasons for assigning a
particular score to any clinical image and provide information to the
facility for use in improving the attributes for which significant
deficiencies were identified.
(6) Image management. The accreditation body's QA program shall
include a tracking system to assure the security and return to the
facility of all clinical images received and to assure completion of
all clinical image reviews by the body in a timely manner. The
accreditation body shall return all clinical images to the facility
within 60 days of their receipt by the body, with the following
exceptions:
(i) If the clinical images are needed earlier by the facility for
clinical purposes, the accreditation body shall work with the facility
to accommodate such needs.
(ii) If a clinical image reviewer identifies an abnormality on a
clinical image that the facility interpreted as normal, and this
finding is not clearly specified on mammography reports submitted with
the clinical images, the accreditation body shall ensure that this
information is provided and the clinical images returned to the
facility no later than 10 business days after identification of the
suspected abnormality.
(7) Corrective measures for unsatisfactory image quality. If the
accreditation body determines that the clinical images from a facility
it accredits are of insufficient quality, the body shall notify the
facility of the nature of the problem and its possible causes. The
accreditation body shall monitor facility progress in correcting the
problem and take appropriate action if the necessary corrective
measures are not implemented in a manner and time period satisfactory
to the body.
(d) Phantom image review. (1) Frequency of review. The
accreditation body shall review phantom images from each facility
accredited by the body at least once every 3 years.
(2) Requirements for the phantom used. The accreditation body shall
require that each facility submit for review phantom images that the
facility produced using a phantom and methods of use specified by the
body and approved by FDA in accordance with Sec. 900.3(d) or paragraph
(a)(9) of this section.
(3) Scoring phantom images. The accreditation body shall use a
system for scoring phantom images that has been approved by FDA in
accordance with Sec. 900.3(d) or paragraph (a)(9) of this section.
(4) Phantom images selected for review. For each mammography unit
in the facility, the accreditation body shall require the facility to
submit phantom images that the facility produced during a time period
specified by the body.
(5) Phantom image reviewers. Accreditation bodies shall ensure that
all of their phantom image reviewers:
(i) Meet the requirements specified in Sec. 900.12(a)(3) or
alternative requirements established by the accreditation body and
approved by FDA in accordance with Sec. 900.3(d) or paragraph (a)(9) of
this section;
(ii) Are trained and evaluated in the phantom image review process,
for the types of phantom images to be evaluated by a phantom image
reviewer, by the accreditation body before designation as phantom image
reviewers and periodically thereafter; and
(iii) Clearly document their findings and reasons for assigning a
particular score to any phantom image and provide information to the
facility for use in improving its phantom image quality with regard to
the significant deficiencies identified.
(6) Image management. The accreditation body's QA program shall
include a tracking system to assure the security and return to the
facility of all phantom images received and to ensure completion of all
phantom image reviews by the body in a timely manner.
(7) Corrective measures for unsatisfactory image quality. If the
accreditation body determines that any phantom images are of
insufficient quality, the body shall notify the facility of the nature
of the problem and its possible causes. The accreditation body shall
monitor facility progress in correcting the problem and take
appropriate action if the necessary corrective measures are not
implemented in a manner and time period satisfactory to the body.
(e) Reports of mammography equipment evaluation, surveys, and
quality control. The following requirements apply to all facility
equipment covered by the provisions of subparts A and B:
(1) The accreditation body shall require every facility applying
for accreditation to submit:
[[Page 14897]]
(i) With its initial accreditation application, a mammography
equipment evaluation performed no earlier than 6 months before the date
of application for accreditation by the facility. Such evaluation shall
demonstrate compliance of the facility's equipment with the
requirements in Sec. 900.12(e).
(ii) A survey which was performed no earlier than 6 months before
the date of application for accreditation by the facility. Such survey
shall assess the facility's compliance with the facility standards
referenced in paragraph (b) of this section.
(2) The accreditation body shall require that all facilities
undergo an annual survey to assure continued compliance with the
standards referenced in paragraph (b) of this section and to provide
continued oversight of facilities' quality control programs as they
relate to such standards. The accreditation body shall require for all
facilities that:
(i) Such annual surveys be conducted no later than 14 months after
the most recent prior survey;
(ii) Facilities take reasonable steps to ensure that they receive
reports of such surveys within 30 days of survey completion; and
(iii) Facilities submit the results of such surveys, together with
quality control records, personnel updates, and other information that
the body may require, to the body at least annually.
(3) The accreditation body shall review and analyze the information
required in this section and use it to determine the accreditation
status of a facility and to identify necessary corrective measures for
facilities.
(f) Onsite visits to facilities and random clinical image reviews.
The accreditation body shall conduct onsite visits and random clinical
image reviews of a sample of facilities to monitor and assess their
compliance with the facility standards imposed under Sec. 900.3. The
accreditation body shall submit annually to FDA, at the address given
in Sec. 900.3(b)(1), 3 copies of a summary report describing all
facility assessments the body conducted under the provisions of this
section for the year being reported.
(1) Onsite visits. (i) Sample size. Annually, each accreditation
body shall visit at least 5 percent of the facilities it accredits.
However, a minimum of 5 facilities shall be visited, and visits to no
more than 50 facilities are required, unless problems identified in
paragraph (f)(1)(i)(B) of this section indicate a need to visit more
than 50 facilities.
(A) At least 50 percent of the facilities visited shall be selected
randomly.
(B) Other facilities visited shall be selected based on problems
identified through State or FDA inspections, complaints received from
consumers or others, a previous history of noncompliance, or any other
information in the possession of the accreditation body, inspectors, or
FDA.
(C) Before, during, or after any facility visit, the accreditation
body may require that the facility submit to the body for review
clinical images, phantom images, or any other information relevant to
applicable standards in this subpart and in subpart B of this part.
(ii) Visit plan. The accreditation body shall conduct visits
according to a visit plan that has been approved by FDA in accordance
with Sec. 900.3(d) or paragraph (a)(9) of this section. At a minimum,
such plan shall address review of the following elements during visits
to facilities selected randomly and facilities selected because of
previously identified concerns:
(A) Assessment of overall clinical image QA activities of the
facility;
(B) Review of facility documentation to determine if appropriate
mammography reports are sent to examinees and physicians as required;
(C) Selection of a sample of clinical images for clinical image
review by the accreditation body. Clinical images shall be selected in
a manner that does not compromise care of the examinee as a result of
the absence of the selected images from the facility;
(D) Review of the facility's medical audit system and assessment of
correlation between film and pathology reports for positive cases;
(E) Verification that personnel specified by the facility are the
ones actually performing designated personnel functions;
(F) Verification that equipment specified by the facility is the
equipment that is actually being used to perform designated equipment
functions;
(G) Verification of facility compliance with its consumer complaint
mechanism; and
(H) Review of all factors related to previously identified concerns
or concerns identified during that visit.
(2) Clinical image review for random sample of facilities. (i)
Sample size. In addition to conducting clinical image reviews for
initial and renewed accreditation for all facilities, the accreditation
body shall conduct clinical image reviews annually for a randomly
selected sample of 3 percent of the facilities the body accredits.
However, a minimum of five facilities shall be selected for such random
clinical image review. Accreditation bodies may count toward this 3
percent requirement all facilities selected randomly for the onsite
visits described in paragraph (f)(1)(i)(A) of this section.
Accreditation bodies shall not count toward the 3 percent random sample
requirement any facilities selected for a visit because of previously
identified concerns described in paragraph (f)(1)(i)(B) of this
section.
(ii) Clinical image review. In performing clinical image reviews of
the 3 percent random sample of facilities, accreditation bodies shall
apply the same standards as those in paragraph (c) of this section for
review of clinical images for initial and renewed accreditation.
(iii) Accreditation bodies should not schedule random clinical
image reviews at facilities that have received notification of need to
begin the accreditation renewal process or that have completed the
accreditation renewal process within the previous 6 months.
(g) Consumer complaint mechanism. The accreditation body shall
develop and administer a written and documented system, including
timeframes, for collecting and resolving serious consumer complaints
that could not be resolved at a facility. Such system shall have been
approved by FDA in accordance with Sec. 900.3(d) or paragraph (a)(9) of
this section. Accordingly, all accreditation bodies shall:
(1) Provide a mechanism for filing a serious complaint with the
accreditation body if the complaint has not been resolved at the
facility;
(2) Maintain a record of every serious complaint received by the
body on all facilities it accredits for a period of at least 3 years
from the date of receipt of each such complaint;
(3) Submit to FDA, at the address in paragraph (b)(1) of this
section, in a manner and time period specified by FDA, an annual report
summarizing all serious complaints received during the previous
calendar year, their resolution status, and any actions taken in
response to them.
(h) Reporting and recordkeeping. All reports to FDA specified in
paragraphs (h)(1) through (h)(4) of this section shall be prepared and
submitted in a format and medium prescribed by FDA and shall be
submitted to a location and according to a schedule specified by FDA.
The accreditation body shall:
(1) Collect and submit to FDA the information required by 42 U.S.C.
263b(d) for each facility when the facility is initially accredited and
at least annually when updated, in a manner and at a time specified by
FDA.
[[Page 14898]]
(2) Accept applications containing the information required in 42
U.S.C. 263b(c)(2) for provisional certificates and in Sec. 900.12(b)(2)
for extension of provisional certificates, on behalf of FDA, and notify
FDA of the receipt of such information;
(3) Submit to FDA the name, identifying information, and other
information relevant to 42 U.S.C. 263b and specified by FDA for any
facility for which the accreditation body denies or revokes
accreditation, or for which the accreditation body denies submission to
FDA of information required from facilities for provisional
certification or for extension of provisional certification, as
described in paragraph (h)(3) of this section, and the reason(s) for
such action;
(4) Provide to FDA other information relevant to 42 U.S.C. 263b and
required by FDA about any facility accredited or undergoing
accreditation by the body.
(i) Fees. Fees charged to facilities for accreditation shall be
reasonable. Costs of accreditation body activities that are not related
to accreditation functions under 42 U.S.C. 263b are not recoverable
through fees established for accreditation.
(1) The accreditation body shall make public its fee structure,
including those factors, if any, contributing to variations in fees for
different facilities.
(2) At FDA's request, accreditation bodies shall provide financial
records or other material to assist FDA in assessing the reasonableness
of accreditation body fees. Such material shall be provided to FDA in a
manner and time period specified by the agency.
Sec. 900.5 Evaluation.
FDA will evaluate annually the performance of each accreditation
body. Such evaluation shall include an assessment of the reports of FDA
or State inspections of facilities accredited by the body as well as
any additional information deemed relevant by FDA that has been
provided by the accreditation body or other sources or has been
required by FDA as part of its oversight initiatives.
Sec. 900.6 Withdrawal of approval.
If FDA determines, through the evaluation activities of Sec. 900.5,
or through other means, that an accreditation body is not in
substantial compliance with this subpart, FDA shall initiate
enforcement actions as follows:
(a) Major deficiencies. If FDA determines that an accreditation
body has failed to perform a major accreditation function
satisfactorily, has demonstrated willful disregard for public health,
has violated the code of conduct, has committed fraud, or has submitted
material false statements to the agency, FDA may withdraw its approval
of that accreditation body.
(1) FDA will notify the accreditation body of the agency's action
and the grounds on which the approval was withdrawn.
(2) An accreditation body that has lost its approval shall notify
facilities accredited or seeking accreditation by it that its approval
has been withdrawn. Such notification shall be made within a time
period and in a manner approved by FDA.
(b) Minor deficiencies. If FDA determines that an accreditation
body has demonstrated deficiencies in performing accreditation
functions and responsibilities that are less serious or more limited
than the deficiencies in paragraph (a) of this section, FDA shall
notify the body that it has a specified period of time to take
particular corrective measures directed by FDA or to submit to FDA for
approval the body's own plan of corrective action addressing the minor
deficiencies. FDA may place the body on probationary status for a
period of time determined by FDA, or may withdraw approval of the body
as an accreditation body if corrective action is not taken.
(1) If FDA places an accreditation body on probationary status, the
body shall notify all facilities accredited or seeking accreditation by
it of its probationary status within a time period and in a manner
approved by FDA.
(2) Probationary status will remain in effect until such time as
the body can demonstrate to the satisfaction of FDA that it has
successfully implemented or is implementing the corrective action plan
within the established schedule, and that the corrective actions have
substantially eliminated all identified problems.
(3) If FDA determines that an accreditation body that has been
placed on probationary status is not implementing corrective actions
satisfactorily or within the established schedule, FDA may withdraw
approval of the accreditation body. The accreditation body shall notify
all facilities accredited or seeking accreditation by it of its loss of
approval authority, within a time period and in a manner approved by
FDA.
(c) Reapplication by accreditation bodies that have had their
approval withdrawn. (1) A former accreditation body that has had its
approval withdrawn may submit a new application for approval if the
body can provide information to FDA to establish that the problems that
were grounds for withdrawal of approval have been resolved.
(2) If FDA determines that the new application demonstrates that
the body satisfactorily has addressed the causes of its previous
unacceptable performance, FDA may reinstate approval of the
accreditation body.
(3) FDA may request additional information or establish additional
conditions that must be met by a former accreditation body before FDA
approves the reapplication.
(4) FDA will not accept an application from a former accreditation
body whose approval was withdrawn because of fraud or willful disregard
of public health.
Sec. 900.7 Hearings.
(a) Opportunities to challenge final adverse actions taken by FDA
regarding approval or reapproval of accreditation bodies, withdrawal of
approval of accreditation bodies, or rejection of a proposed fee shall
be communicated through notices of opportunity for informal hearings in
accordance with part 16 of this chapter.
(b) A facility that has been denied accreditation is entitled to an
appeals process from the accreditation body. The appeals process shall
be specified in writing by the accreditation body and shall have been
approved by FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(9).
(c) A facility that cannot achieve satisfactory resolution of an
adverse accreditation decision through the accreditation body's appeals
process may appeal to FDA for reconsideration in accordance with
Sec. 900.15.
Dated: March 22, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-7831 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-P
Complete official Federal Register PDF
FR Doc. 96-7830 Quality Standards and Certification Requirements for Mammography Facilities; General Facility Requirements
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14870-14884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7830]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. 93N-0351]
RIN 0910-AA24
Quality Standards and Certification Requirements for Mammography
Facilities; General Facility Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the facility standards established in the interim regulations
implementing the Mammography Quality Standards Act of 1992 (the MQSA).
This proposed rule would modify and add to the general requirements for
mammography facilities, including requirements for a medical reporting
and recordkeeping program, a medical outcomes audit program, special
methods for examining individuals with breast implants, a consumer
complaint mechanism, and a variance procedure for requesting FDA
approval of alternative standards. In addition to the statutory
framework and the expertise and research of FDA personnel, the agency
is proposing this rule based on advice from the National Mammography
Quality Assurance Advisory Committee (NMQAAC) and public comments
received in response to the interim regulations. This action is being
taken to ensure safe, accurate, and reliable mammography on a
nationwide basis. This is the third of five related proposed rules
being published concurrently.
DATES: Written comments on this proposed rule by July 2, 1996.
Written comments on the information collection requirements should
be submitted by May 3, 1996. The agency is proposing that any final
rule based on this proposed rule become effective 1 year after its date
of publication in the Federal Register.
ADDRESSES: Submit written comments on this proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. The Regulatory Impact
Study (RIS) is available at the Dockets Management Branch for review
between 9 a.m. and 4 p.m., Monday through Friday. Requests for copies
of the RIS should be submitted to the Freedom of Information Staff
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16,
Rockville, MD 20857.
Submit written comments on the information collection requirements
to the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for
Devices and Radiological Health (HFZ-240), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.
SUPPLEMENTARY INFORMATION:
I. Background
This proposal is the third of five related proposed rules published
in this issue of the Federal Register to amend interim regulations
published on December 21, 1993 (58 FR 67558 and 58 FR 67565)
implementing the MQSA (Pub. L. 102-539). The first proposed rule,
``Quality Mammography Standards; General Preamble and Proposed
Alternative Approaches'' contains background information and a summary
of the preliminary analysis of the costs and benefits of all of these
proposed rules, a description of the information collection
requirements, proposed revisions to Sec. 900.1 Scope and Sec. 900.2
Definitions, and proposed alternative approaches to mammography
standards and a request for comments on the proposed alternatives.
II. Provisions of the Proposed Rule
A. Development of the Proposed Regulations
This proposed rule establishes mammography facility standards for
recordkeeping and reporting, medical outcomes audit, quality assurance,
imaging of examinees with breast implants, and addressing consumer
complaints. The proposal also establishes general certification
requirements, and a procedure for any entity regulated under this rule
to request FDA approval of alternative standards. As in the development
of the interim regulations, FDA has been guided by the requirements of
the MQSA and its stated legislative intent to guarantee access to safe
and effective mammography services for all women in the United States
(Ref. 1).
In addition to the statutory framework and the expertise and
research of FDA personnel, the agency relied upon two major sources of
information in developing this proposed rule. The first source was the
written comments received on the interim regulations. FDA received 103
comments from individuals and organizations on the interim regulations.
Included among the written comments were responses from professional
organizations, medical facilities, State agencies, consumer groups,
manufacturers, and individual physicians, medical physicists, and
radiologic technologists.
The second outside source of information used to develop the
proposed regulations was the advice and recommendations of the NMQAAC.
Sections of these proposed regulations were discussed at the NMQAAC
meetings in February, May, July, and September 1994. All of these
proposed regulations, as then drafted, were reviewed again at the
January 1995 meeting of the NMQAAC. The members of the NMQAAC include
interpreting physicians, medical physicists, radiologic technologists,
representatives of State agencies, and consumer representatives.
Consultants to the NMQAAC and guests invited to attend the meetings in
recognition of their expertise in mammography also participated in the
discussions.
B. Applicability
Proposed Sec. 900.10 states that the provisions of subpart B apply
to all facilities under the jurisdiction of the United States that
provide mammography services, with the exception of the facilities of
the Department of Veterans Affairs (DVA).
Several comments objected to the exemption of DVA facilities from
the interim regulations. In response to these comments, the agency
notes that the DVA facilities are excluded from the requirements of the
MQSA by the statute itself (42 U.S.C. 263b(a)(3)(A)). However, since
the publication of the interim regulations, DVA has voluntarily
committed its facilities to a program consistent with the standards
issued under the MQSA.
C. Certification Requirements
Proposed Sec. 900.11 defines the two types of certificates,
provisional and
[[Page 14871]]
full, that permit a mammography facility to operate lawfully after
October 1, 1994. This section states the length of time the
certificates will be valid and the circumstances under which the
certificates may be renewed or extended. In addition, proposed
Sec. 900.11(c) outlines reinstatement procedures for a facility that
has allowed its certificate to expire, has been refused a renewal of
its certificate, or has had its certificate revoked by FDA. It also
states that the owner or operator of a facility that has had its
certificate revoked by FDA may not apply for reinstatement until at
least 2 years have passed from the time of the revocation. This
additional restriction is required by the statute (42 U.S.C.
263b(i)(3)).
One comment on the interim regulations requested that FDA state
clearly that a provisional certificate can only be issued once.
FDA reviewed this issue in connection with implementation of the
interim regulations and concluded that the statute does not limit any
particular facility to receiving a provisional certificate only once.
Situations in which a subsequent provisional certificate might be
issued to a facility include cases where a facility was denied an
initial full certificate or renewal of its full certificate or has had
its certificate revoked by FDA but subsequently has made substantial
progress in correcting the problems that led to denial or revocation of
the certificate. In the case of a facility that failed to achieve
accreditation and certification during its initial 6-month provisional
time period, the regulations permit FDA to issue a second provisional
certificate if the facility applies for one after a corrective action
plan has been effectively implemented. At that point, a new 6-month
provisional certificate may be provided to the facility while the
accreditation process is underway. In the case of a revoked
certificate, as described previously, at least 2 years must pass before
the owner or operator of the facility can apply for a new provisional
certificate. A subsequent provisional certificate also might be issued
to a facility that allowed its previous certificate to expire but later
wishes to resume providing mammography services.
However, the comment is correct to the extent that FDA may not
issue two sequential, uninterrupted 6-month provisional certificates to
the same facility. The agency invites comments on whether its policy of
permitting a facility to obtain a subsequent 6-month provisional
certificate once the facility has effectively corrected its
deficiencies should be included in the final regulations and, if so,
what if any, conditions should be placed in the process.
The same comment expressed the opinion that provisional
certificates were only intended to aid facilities in meeting the
October 1, 1994, deadline.
Although it is true that the provisional certificates were valuable
in helping existing facilities meet the October 1, 1994, deadline, they
are also intended to provide a way for new facilities to commence
operation after the date became effective. To become accredited and
certified, a facility must pass clinical image review. However, without
provisional certification, a new facility would be unable to perform
the necessary mammographic examinations for presentation to the
accreditation body for review after October 1, 1994. The provisional
certificate allows such facilities lawfully to produce the images they
need to achieve full accreditation and certification.
Two comments suggested that other justifications, in addition to
avoiding an adverse impact on the availability of mammography, should
be considered in making a determination to grant a 90-day extension of
the provisional certificate.
Congress limited the possibility of a 90-day extension of a
provisional certificate under the MQSA to cases in which there would be
a significant reduction of access to mammography in the geographic area
served by the facility (42 U.S.C. 263b(c)(2)). Provisionally certified
facilities should make every effort to obtain full certification no
later than 6 months from the date the provisional certificate is
issued.
Other comments asked that the time periods for the provisional
certificates and the 90-day extensions be increased, primarily because
of the difficulty accreditation bodies experienced in meeting the
timeframes.
Again, the agency notes that the MQSA established these timeframes
and FDA cannot amend them. Although the number of applications for
accreditation submitted to meet the October 1, 1994, deadline did cause
some difficulties for accreditation bodies meeting the timeframes, the
accreditation bodies have increased their staffs to match the workload.
The agency believes that once the initial implementation period is
over, the accreditation bodies will be fully staffed to meet these
timeframes effectively and efficiently, provided that facilities
promptly submit the required information for evaluation. In addition,
accreditation bodies are taking steps to adjust the timeframes for
renewal of accreditation so that the workload is more evenly
distributed.
One comment suggested that some additional time be allowed for FDA
and facilities to gain experience with the interim standards before any
major changes are proposed. The comment stated that experience could
then serve as a guide in determining what revisions were needed.
When Congress gave FDA interim regulation authority, it intended
that FDA take prompt action to promulgate final regulations through
notice and comment rulemaking. Accordingly, FDA began work on the final
standards almost immediately after the interim regulations were
published. Because of the deliberative nature of the rulemaking
process, however, the agency will have had some experience with the
interim regulations before the final regulations are published. The
lessons learned during this interim period have been and will continue
to be applied in the development of the final regulations.
In addition, the passage of time has helped FDA identify concerns
that were not immediately apparent when the interim regulations were
drafted. For example, FDA has realized that there is a possibility
that, at some future time, particular facilities may not have access to
an accreditation body. If this event were to occur, FDA would have to
provide an alternative for accreditation or the facilities could not
lawfully operate. To be prepared for this possibility, the agency has
added the words ``or other entity as designated by FDA'' at every point
in Sec. 900.11, and elsewhere in the regulations, where facilities are
required to take some action with respect to their accreditation body.
D. Medical Records and Mammography Reports
Proposed Sec. 900.12(c) establishes certain requirements for the
content and terminology of the mammography examination report, the
manner of communicating results of the mammography examination to the
examinee and to health care providers, and the duties of the facility
for maintaining records of examinees.
1. Mammography Reporting
The information and assessment categories listed in proposed
Sec. 900.12(c)(1) are intended to establish a minimum national standard
that will permit the results of mammography examinations to be more
easily compared. This standardized format for presenting the results of
the
[[Page 14872]]
examination will assist in preparation of the medical outcomes audit
that each facility is required to perform. The standard will also
facilitate communication about the risk of breast cancer from the
interpreting physician to the referring health care providers. The
categories proposed in the regulation are recommended by the American
College of Radiology and also recommended by the Agency for Health Care
Policy and Research (AHCPR) mammography practice guidelines, ``Quality
Determinants of Mammography.''
During discussions with NMQAAC, certain advisory committee members
suggested that FDA establish standard operating procedures that
facilities should follow for the production of mammography reports. FDA
believes that regulating a facility's internal procedures for
generating mammography reports would be overly intrusive. Interested
parties can find suggested guidelines for optimal facility operating
procedures for production and dissemination of mammography results in
the AHCPR's ``Quality Determinants of Mammography.''
FDA and NMQAAC discussed the collection of racial and ethnic data
as part of the recordkeeping requirements. Opinions of individual
committee members varied with respect to collection of such data. FDA
recognizes the value of these data in addressing such important issues
as the utilization and efficacy of mammography, as well as other
pertinent public health research questions. However, after consultation
with other Public Health Service agencies that have experience in
attempting to collect racial and ethnic data from mammography
facilities, FDA determined that there is currently no effective
established method for collecting this information. Therefore, FDA is
not at this time proposing a requirement for facilities to collect
racial and ethnic data. FDA does encourage facilities to collect all
information, including racial and ethnic data, that will allow
facilities to better understand and serve their particular communities.
The items listed in proposed Sec. 900.12 (c)(1) and (c)(2)(i) are
minimum requirements and do not preclude the facility from including
additional information in mammography reports or in notifications to
examinees, including relevant public health messages to the health care
provider or to the examinee.
2. Signatures
Proposed Sec. 900.12(c)(1) would require the written mammography
report to be signed by the interpreting physician. FDA views the
signature on the report as an attestation of the signatory as the
individual who has read the mammogram and has rendered the
interpretation in the report. Therefore, in addition to handwritten
signatures on the mammography reports, FDA will accept other
``signatures,'' including those that are generated from computer
systems, typewritten, or name stamped, on the condition that these
signatures were personally authorized by the interpreting physician.
NMQAAC advised FDA to adopt regulations to mandate that all
facilities have a written policy that ensures the integrity of the
signature on the mammography report as coming from the interpreting
physician, or a designated interpreting physician, if the interpreting
physician is unavailable. NMQAAC also encouraged FDA to mandate that
facilities assure that all personnel signatures, and other legally
binding equivalents in the medical record, include professional titles.
FDA encourages these practices but believes that it is unnecessary to
require them through regulation.
3. Communication With the Examinee and Health Care Providers
Communication responsibilities have long been a frustrating area in
mammography practice. All women who have mammography need to know the
results. Examinees without any health care providers need to have the
actual reports to show to subsequent health care providers, especially
in the case of abnormal findings. Many examinees believe no news is
good news. This fallacy contributes to delays in treatment when,
through communication problems, the significance of a finding is not
properly communicated to the examinee.
Currently, interim regulations provide that only women who have no
health care provider receive the actual medical report and a summary of
the mammography results in lay language. Two comments on the interim
regulations recommended that the final regulations be amended to ensure
that every examinee receives a written report signed by the
interpreting physician and presented in lay language. One comment on
the interim regulations suggested requiring the report to include all
elements previously required by the Health Care Financing
Administration's (HCFA's) screening mammography program.
Proposed Sec. 900.12(c)(2) would require that all examinees receive
notification of results expressed in lay terms. Examinees without
health care providers would receive the actual mammography report along
with the lay notification. If there is a health care provider, the lay
notification would go to the examinee and the actual report would go to
the health care provider, who, in turn, could communicate with the
examinee again or in greater detail, if necessary.
This proposal is in response to consumer complaints of failure to
communicate abnormal and normal results to examinees. The proposed
standard intends to maintain the examinee-provider relationship while
ensuring that results get communicated to the examinee. The lay
notification of results and recommendations vary in length and detail,
but may be as simple as ``Your mammogram reveals you need further
tests. Please contact your physician.'' FDA also believes that
notifications to examinees should be written in a way that is not
overly alarming. In addition, FDA believes that in those cases in which
an examination reveals the need for followup, notification directly to
the examinee is essential.
FDA recognizes there are some referring health care providers who
feel that they may be placed in an uncomfortable position if an
examinee is notified of results before the health care provider is
notified. There is also a concern that the examinee may be unduly
alarmed by the facility's notification.
In response to these concerns, the agency notes that the main
purposes of the lay notification requirements are to provide another
safety mechanism to help to ensure that abnormal results are followed
up and to ensure that all examinees know their mammography results. If
facilities notify physicians and examinees simultaneously, the
referring doctor will have access to the results of the mammogram at
the time an examinee calls for clarification or followup. Those
physicians who prefer to handle all communication with their examinees
may continue that practice if procedures are properly coordinated with
the facility generating the reports. The proposed requirements would
not prohibit the mammography facility from providing standard lay
notifications, along with the mammography report, to a referring health
care provider who has agreed to issue these notices to his or her
examinees. This agreement should be documented by attestation
statements from the referring provider and should be on file at the
mammography facility for inspection purposes.
During discussions with NMQAAC, FDA heard diverse opinions
concerning the form and content of the notification that all examinees
will receive.
[[Page 14873]]
However, NMQAAC did favor some form of written notification to all
examinees, and that recommendation has been incorporated into the
proposal.
Section 900.12(e)(2)(ii)(A) of the interim regulations establishes
that the written report of any mammography examination shall be sent
directly to the patient if the patient's physician is not ``available''
or if the patient does not have a physician. Two comments stated that
the word ``available'' in this provision is ambiguous and could be
interpreted to mean that the physician will not be notified if he or
she is on vacation, at a meeting, or absent. One comment suggested
deleting this word. Another comment asked how one is to ascertain the
availability of the examinee's physician at the time a report is
generated.
FDA advises that, in the proposed regulation, communication of
mammography results to examinees and communication of results to health
care providers are addressed in separate sections. As with the interim
regulations, the proposed regulations require a facility to provide the
mammography report directly to the examinee if she does not have a
health care provider (Sec. 900.12(c)(2)(ii)). The issue of the
``availability'' of a physician is addressed in the section of the
proposed regulation that covers communications of results to health
care providers, Sec. 900.12(c)(3).
Proposed Sec. 900.12(c)(3)(ii) is intended to address the specific
concern that arises when a mammography report reveals possible
malignancy. The proposed regulations would require the mammography
facility immediately to make reasonable attempts to communicate a
finding of possible malignancy directly to the health care provider or
a responsible designee, if the health care provider is not available.
``Not available'' is intended to mean ``not on call,'' ``not able to be
reached at this time,'' or other similar situations. Health care
providers normally have means of handling unexpected important health
matters concerning their examinees through coverage systems and the
proposed regulation recognizes this practice. The regulations are
intended to require reasonable attempts to notify the health care
provider or the entity designated by the referring health care provider
as responsible for patient care while the referring health care
provider is not available.
Questions were raised by the NMQAAC about retention of lay
notifications. Although the regulations do not require a facility to
keep a copy of the notification in the medical record, each facility
should have a system to monitor and verify that such a notice was sent
out for each examinee. In addition, samples of the lay notifications
which go to all examinees must be available for inspectors during
annual the MQSA inspections.
The results given in the lay notification are purposely labeled as
``results'' and not as ``assessment'' to avoid facilities having to use
one of the six assessment categories in proposed Sec. 900.12(c)(1)(iii)
and (c)(1)(iv). FDA encourages facilities to tailor these lay
notification letters of results to their clientele's literacy level,
and ethnic, cultural, and social sensibilities in order to maximize the
likelihood that these examinees will understand and appropriately
followup results.
Proposed Sec. 900.12(c)(2) recognizes that assessments indicating a
high probability of cancer need to be communicated with special care to
examinees, especially to those examinees without health care providers.
Examinees without a health care provider should receive person-to-
person communication, such as a telephone call, if it is at all
possible, when immediate followup is needed. In addition, in these and
other circumstances, such as when there are physical findings in the
absence of mammographic findings, when there are symptoms of breast
disease, or when a mammography report recommends further testing, the
proposed regulation requires each facility to have a formal system that
can refer an examinee who is without a health care provider. FDA
believes this proposed regulation codifies the role many radiologists
now assume with self-referred examinees.
The interim regulations require each facility to prepare a written
report of the results of each mammographic examination as soon as
possible. Two comments on the interim regulations stated that it is not
clear how a time limit of ``as soon as reasonably possible'' for
completing a report can be enforced. The comments suggested inclusion
of an actual time limit or replacing the word ``shall'' with
``should.''
FDA agrees that a timeframe should be specified. Proposed
Sec. 900.12(c)(3)(i) requires every mammography report to be prepared
and communicated to the health care provider as soon as possible, but
no later than 30 days from the date of the examination. Proposed
Sec. 900.12(c)(2) establishes the same timeframe for communication of
results to examinees. If the facility is gathering comparison films, an
initial report or notification can be sent to the examinee or health
care provider indicating preliminary results with an addendum to
follow.
4. Recordkeeping
One comment stated that the mammograms should be kept indefinitely,
noting particularly the need for retention of baseline mammograms.
FDA believes that the 10-year time period, which is set forth in
the statute itself, 42 U.S.C. 263b(f)(1)(G)(i), allows for adequate
prior information to be stored and used. The proposed regulations thus
adopt, in Sec. 900.12(c)(4)(i), the same retention periods required by
the interim regulations, which establish a minimum of 10 years in
situations where no additional mammography examinations are done for an
examinee. The time period may be longer, if required by State law.
One comment stated that the retention requirement in Sec. 900.12(e)
of the interim regulations requires facilities to retain all mammograms
for 10 years, because costs of determining after 5 years whether an
examinee has had additional mammograms will exceed storage costs.
FDA does not agree with this comment. One way to determine if
mammograms can be discarded is during filing of each new mammogram. At
that time, prior mammograms over 5 years old can be discarded if
clinically appropriate and if permitted by State law. This policy
allows for a case by case determination of record retention for
individual examinees. A facility can keep images longer than the
minimum set forth in the proposed regulations.
The same comment further requested that FDA revise the interim
regulations to require that mammography records be retained for the
same time periods that are otherwise required by State law, or if any
State lacks such a requirement, for a period of 7 years, which is the
time period specified by California.
Because the MQSA specifies minimum retention periods, the proposed
change would be inconsistent with the statute. The MQSA permits States
to have more stringent regulations, including requirements relating to
record retention. However, the 7-year California requirement for
retention of a single mammography examination would not be a more
stringent requirement, because it is less than the 10 years required by
the MQSA.
One comment noted that two mammography studies taken on consecutive
days would allow a facility to circumvent the requirement for 10-year
record retention.
[[Page 14874]]
FDA does not believe this comment raises a valid concern. Although
the first mammograms would be exempt from the 10-year retention period,
the second study would not be. It is doubtful that a facility would
discard the first study while maintaining the second and highly
improbable that any facility would do double studies simply to avoid
retaining a set of images.
One comment suggested that examinees should only have a right to
copies of mammograms, not to the originals, because of the increased
risk of loss or misplacement associated with examinees permanently
taking possession of their original films and reports. Another comment
from an interpreting physician noted great difficulty in obtaining
original mammograms for comparison purposes. This comment stated that
copied films are of inadequate quality when assessing the need for
surgery.
The issue of whether to require copies or originals to be sent to
facilities for clinical use or for comparison studies was discussed
with NMQAAC. Although NMQAAC members did acknowledge problems with loss
or misplacement of original films, there was general concern that many
copies were of such poor quality that they did not provide adequate
information. Sometimes only original films can provide the information
that will prevent a woman from undergoing unnecessary invasive
procedures, or confirm the need for such procedures. Thus, the NMQAAC
agreed that FDA should require that originals be sent for comparison
studies, as proposed in Sec. 900.12(c)(4)(ii). Under the proposed
regulations, examinees would need to request any transfer of their
films. Facilities could ask examinees to sign releases as part of the
request for the transfer of originals. A copy of the film could be kept
at the original facility until the original films are returned.
FDA and NMQAAC discussed the issue of facility closure and
disposition of the films and mammography reports. Members of the NMQAAC
advised FDA to require that facilities give the public notice of their
impending closure to allow a reasonable opportunity for examinees to
obtain or transfer films and reports; that facilities be required to
make financial plans to fulfill this notification requirement and to
transfer medical records in the event of cessation of mammography
activities; that facilities be required to notify the accreditation
bodies and FDA of the disposition of films and records; and that
facilities establish contingency locations for the transfer of
examinees' films and records.
The issue of medical record and film disposition in the event of a
closure is generic to the health care system. Facilities are required
under the interim and proposed regulations to report all changes in
status to their accreditation bodies, including plans to close. FDA
would encourage facilities to plan for an orderly transfer of records
in case of closure and to comply with applicable State laws concerning
record retention. However, FDA believes that additional Federal
regulations on this issue would be problematic with respect to
compliance and enforcement.
E. Quality Assurance--General
The MQSA requires each facility to establish and maintain a quality
assurance and quality control program to ensure the reliability,
clarity, and accuracy of interpretation of mammograms.
Proposed Sec. 900.12(d) establishes general requirements for
quality assurance (QA) programs.
Proposed Sec. 900.12(d)(1) requires the facility to assign
responsibility for various components of its QA program to individuals
who are qualified for their assignments and who shall be given adequate
time to perform their duties. Proposed Sec. 900.12(d)(1) also
establishes QA responsibilities for the lead interpreting physician,
interpreting physician, medical physicist, and quality control
technologist.
The agency developed these regulations in response to several
comments that objected to the medical physicist having primary
responsibility for the QA program under the interim regulations. The
comments noted that, especially if the medical physicist is a contract
employee, he or she may not have the authority to ensure that all the
actions necessary for proper implementation of the QA program are
carried out. In addition, NMQAAC members advised FDA that some aspects
of the QA program fall outside the medical physicist's area of
expertise.
The agency believes that the division of responsibility under the
proposed regulations addresses these concerns and satisfies the
requirements under the MQSA that certain responsibilities be assigned
to the physicist.
Proposed Sec. 900.12(d)(1)(i) states that the lead interpreting
physician shall have general responsibility for assuring that all of
the QA requirements are met. The regulation is intended to recognize
that, in order to carry out this responsibility effectively, the lead
interpreting physician must have authority to ensure that the
individuals involved with the QA program are qualified for their duties
and that they perform them properly.
The proposed regulation requires each facility to designate a
qualified individual as lead interpreting physician for purposes of the
QA program. However, the actual administrative title of the individual
is left to the facility. Decisions to assign other supervisory duties,
unrelated to the QA program, to the lead interpreting physician are
left to the discretion of each facility.
NMQAAC felt strongly that the individual assigned overall
responsibility for the QA program should be an interpreting physician.
NMQAAC recognized that this may cause some difficulty for a facility
whose interpreting physician is not normally at the facility. However,
the committee believed, and FDA agrees, that the benefits to be gained
when the individual overseeing the QA program has the skills of an
interpreting physician outweighed the difficulties.
Proposed Sec. 900.12(d)(1)(ii) establishes that all interpreting
physicians have a responsibility to assist and participate in the QA
program.
Proposed Sec. 900.12(d)(1)(iii) establishes that the primary
responsibility of the medical physicist in the QA program is related to
mammography equipment.
Proposed Sec. 900.12(d)(1)(iv) is intended to recognize that many
aspects of the QA program should be assigned to quality control
technologists. NMQAAC believed that it was essential that quality
control technologists be qualified to perform diagnostic radiology
examinations in order to be able to carry out adequately the
responsibilities normally assigned to them, including, for example,
responsibility for darkroom cleanliness, darkroom fog tests, processor
quality control, analysis of fixer retention in film, and retake
analysis. After some discussion, NMQAAC also concluded that the quality
control technologists need not be qualified to perform mammography
examinations specifically.
NMQAAC's position is reflected in the definition of quality control
technologist in proposed Sec. 900.2, published elsewhere in this issue
of the Federal Register. The definition would bar biomedical engineers,
manufacturer's service personnel, darkroom personnel, or individuals in
other positions from serving as quality control technologists unless
they were also qualified to perform diagnostic radiology examinations.
NMQAAC discussed the advisability of limiting performance of
certain QA
[[Page 14875]]
tasks exclusively to quality control technologists. NMQAAC concluded
that there might be certain situations where the absence of the
technologist might require a medical physicist or interpreting
physician to step in and perform these tasks in order to avoid the
temporary closure of a facility. The proposed regulations, therefore,
do not assign specific QA duties to particular individuals, as do the
ACR manuals.
Proposed Sec. 900.12(d)(2) outlines the necessary QA records the
facility will be required to keep. These records include: A QA manual;
a list assigning responsibility for the various aspects of the QA
program; records to show the qualifications of the individuals involved
in the program; and records that monitor the facility's implementation
of its QA program and resolution of any problems that occur. FDA
believes that such records are necessary to ensure that all employees
are aware of their QA responsibilities and trained to perform them and
that appropriate actions are taken to meet the goal of providing high
quality mammography.
F. Medical Outcomes Audit
Proposed Sec. 900.12(f) requires a mammography medical outcomes
audit program to be part of each facility's QA program. A mammography
medical outcomes audit is a systematic collection and analysis of
mammography results and the comparison of those results with data from
biopsy results.
The intent of the mammography medical audit is to provide an
objective measure of the interpretive ability of the interpreting
physician. This information can be useful for determining how the
interpreting physician performs from year to year and in comparison
with other interpreting physicians in the same facility and serving the
same examinee population.
As the medical outcomes audit data are collected and analyzed, a
facility should acquire information that can improve the interpretive
skills of the physicians. Some examples of this type of information
include: positive predictive value (PPV), cancer detection rate, and
percent of minimal cancers found. The medical literature describes
these and other outcome data that may prove useful in assisting the
interpreting physician in assessing and continuing to develop and
improve his or her interpretive skills. If one interpreting physician
is not ``doing as well'' as his/her colleagues in the same practice,
he/she may obtain additional training.
Although audits can be as detailed as necessary, the proposed
requirements in Sec. 900.12(f) for the medical outcomes audit program
are general in nature. There are several reasons for this. In drafting
the MQSA, Congress recognized that there is not consensus on the most
desirable methodologies for such audit programs and provided
authorization in 42 U.S.C. 263b(p) for research grants to study the
most desirable methods for the collection and use of outcomes data.
These research grants are administered by the National Cancer Institute
(NCI). FDA believes it would be premature to require specific
methodologies in the regulations before these studies are complete. In
addition, some facilities may not be able to collect data that are
meaningful if specific methodologies are mandated. The agency also
believes that each facility should have flexibility to design an audit
program that best serves its needs.
There was also concern expressed during discussion with NMQAAC that
facilities may be reluctant to collect medical audit data because of
concerns relating to legal liability and malpractice litigation.
In response to these concerns, FDA advises that the MQSA requires
the agency to establish standards for a quality assurance and quality
control program at each facility (42 U.S.C. 263b(f)(1)(A)). The agency
believes that data generated and reviewed for mammography audits are to
be used internally by each facility to improve individual and group
performance and should not necessarily be viewed as information that is
accessible to third parties.
The MQSA inspectors are trained to verify that a facility has a
medical audits system that tracks positive mammograms, seeks followup
results of surgical procedures, correlates those results with the
mammogram, and interprets and evaluates the resulting data at least
yearly for both the facility as a whole and for individual interpreting
physicians. Inspectors ordinarily will not copy the data as part of the
inspection and FDA has no current plans to ask facilities to provide
the agency with the results of their medical audits. Accordingly, it is
unlikely that the agency will have records in its possession that would
be responsive to requests from the public for medical audit data.
If it does become necessary for an MQSA inspector to collect
specific medical audit data, or if FDA should wish to obtain such data
in the future, the agency would protect audit results from public
disclosure in accordance with the Freedom of Information Act, the Trade
Secrets Act, and the agency's implementing public information
regulations. Aggregate data that does not identify the medical audit
outcomes of any particular facility would be available to the public.
The agency recognizes that State laws with respect to medical audit
information vary considerably. The 1993 ACHPR guidelines on ``Quality
Determinants of Mammography'' noted that very few broadly drawn
statutes protecting audit information from discovery are in place at
this time. Accordingly, the agency's commitment to protect such data
may not prevent disclosure in state courts through discovery or other
procedures established by State law. The agency believes, however, that
the medical audit requirements that are proposed in this rule are
general requirements that will not increase third-party requests for
medical audit data.
Proposed Sec. 900.12(f) requires each facility to establish and
maintain a mammography medical outcomes audit program that correlates
the results of biopsy and cytology examinations with the interpreting
physician's recommendations. A facility must correlate the biopsy or
cytology results of its positive mammograms with the interpreting
physician's recommendations and mammographic report. A positive
mammogram includes one that has an overall assessment of findings that
are suspicious or highly suggestive of malignancy, as set forth in
proposed Sec. 900.12(c)(1)(iii). The pathologist examines the tissue
sample and its cellular structure to determine whether or not the
tissue is cancerous.
Proposed Sec. 900.12(f)(4) requires each facility to designate at
least one interpreting physician to review the audit data at least
annually. This individual shall record the dates of the audit period(s)
and be responsible for identifying issues and analyzing results based
on this audit. This physician will notify other interpreting physicians
of these issues and results, and ensure that necessary corrective
actions are taken and documented. The proposal requires evaluations to
be made individually and collectively for all interpreting physicians
at the facility.
One comment noted that the preamble to the interim regulations
discussed preventing false negative results, but the only quality
assurance issue actually addressed in the interim regulations was the
tracking of positive readings.
FDA believes that it would be too burdensome to require facilities
to identify all false negative exams because, at the current time,
adequate methods are not available to track all negative readings. The
research studies funded by NCI grants may prove helpful
[[Page 14876]]
in future development of adequate methods for tracking false negative
results.
A related comment expressed the belief that it was imperative that
FDA spell out specific audit standards in the regulations. Another
comment suggested that the final regulations should include a
requirement for keeping statistics on additional procedures ordered by
each radiologist.
Again, NCI's research program may aid in determining whether the
collection and analysis of specific statistics should be mandated.
However, FDA believes that currently there is inadequate data to
justify making these suggestions regulatory requirements. NMQAAC
supported the agency's position at its January 1995 meeting.
One comment suggested that, instead of correlating surgical biopsy
results with mammography reports, a similar result can be achieved by
requiring documentation of all erroneous or indistinguishable
mammography results through a complaint program.
FDA believes the complaint mechanism and audit are substantially
different in intent; therefore, one cannot replace the other.
One comment did not understand how the radiology department could
use outcomes data, such as pathology reports, to improve the quality of
mammography or the performance of technologists.
FDA believes that an audit program helps to provide quality
assurance for the interpretation component of mammography by reviewing
outcome data for each interpreting physician and monitoring how that
physician is performing over time with respect to other interpreting
physicians in the same facility and serving the same patient
population. This review and analysis provides physicians with an
opportunity to evaluate and improve performance. As mentioned
previously, a physician may learn from an audit that he or she needs
additional training in particular skills. Technologists' performance
may be better evaluated through the repeat analysis process.
One comment mistakenly perceived a deficiency in the interim audit
regulations because the comment believed that the interim regulations
did not require followup of positive screening examinations. In fact,
the interim regulations do require the facility's medical audit to
track all positive mammograms and this requirement has been maintained
in the proposed regulations at Sec. 900.12(f)(1).
One comment suggested that all mammograms should be read a second
time by a second qualified physician to avoid unnecessary surgery and
emotional distress that can be associated with a false positive
reading, and to avoid lack of appropriate followup and treatment in the
case of a false negative reading.
Although the proposed regulations do not preclude this practice,
FDA has not required it due to a lack of consensus within the medical
community as to whether the benefits of double reading outweigh the
costs. FDA solicits further comments on this issue.
G. Mammography of Examinees With Breast Implants
The MQSA specifically requires that standards be established
relating to special techniques for mammography of examinees with breast
implants (42 U.S.C. 263b(f)(1)(H)). FDA interprets this requirement to
mean mammography of the breast for the early detection of breast
cancer, and not for imaging of the implant for rupture, leakage, or
other problems. The agency recommends that women who have had breast
surgery for cancer, including reconstruction with breast implants,
consult with their physician as to the appropriateness of mammography
for their particular situation.
Proposed Sec. 900.12(g) requires facilities to establish
procedure(s) to identify examinees with breast implants. The regulation
also sets forth general techniques facilities should follow for
mammographic examinations of women with breast implants. The proposed
requirements are flexible enough to allow efficient adoption of newer
imaging techniques as they become available.
One comment suggested that facilities should simply establish an
intake procedure to identify examinees with implants and to indicate
that special techniques are necessary. Another comment expressed
concern that, if an examinee does not notify the technician that she
has an implant, the mammogram may have to be redone.
FDA agrees with these comments and has proposed in
Sec. 900.12(g)(1) that facilities have a procedure to inquire if an
examinee has a breast implant at the time of mammogram scheduling.
Another comment suggested that there be a requirement for
``Eklund'' views (four views per breast). A similar comment stated
that, in order to obtain an adequate image of a breast with an implant,
both the breast and implant should be carefully manipulated so that the
maximum amount of breast tissue is imaged. A third comment, however,
stated that FDA should not mandate medical procedures in regulations.
FDA and NMQAAC agree that currently the Eklund procedures,
including appropriate individualized views, provide the best
mammographic means to visualize breast tissue for most women with
implants. There was also recognition, however, that other methods may
exist that would be preferable in particular cases.
In addition, breast implant imaging is evolving, and the agency
believes that it would be premature to limit this imaging by regulation
to only one technique.
However, in response to the comment that stated FDA should not
require medical procedures in regulations, the agency notes that the
MQSA does require FDA to establish standards and that the codification
of certain procedures in regulations may be appropriate when there is
consensus that such procedures are necessary to protect women and
assure accurate and safe mammography.
Another comment suggested that mammography facilities provide an
excellent opportunity for further data collection and health assessment
of examinees with implants.
In response to this comment, FDA notes that proposed Sec. 900.12(f)
requires mammography facilities to perform mammography medical outcomes
audits, and that these audits would include examinees with breast
implants.
Two comments were concerned about possible harm from the
compression of the implant.
To minimize this possibility, FDA has proposed in
Sec. 900.12(a)(2)(ii)(C) (published elsewhere in this issue of the
Federal Register) that the technologist have at least 5 hours of
training in imaging examinees with breast implants and in
Sec. 900.12(g)(3) that the supervising interpreting physician be
required to have training in mammography of examinees with breast
implants, including specialized mammographic techniques.
H. Facility Complaint Mechanism
In accordance with section 354(n)(3)(E) of the Public Health
Service Act (the PHS Act) as amended by the MQSA (42 U.S.C.
263b(n)(3)(E)), FDA has worked with the NMQAAC to develop mechanisms to
investigate consumer complaints about mammography services provided by
facilities. The preamble for proposed Sec. 900.4(g), published
elsewhere in this issue of the Federal Register, provides a thorough
discussion of the complaint mechanism, including the role of the
accreditation body in the process. In addition, FDA received a number
of written comments on the complaint
[[Page 14877]]
mechanism following the publication of the interim rules (58 FR 67558
and 58 FR 67565). These comments are also addressed in the preamble to
proposed Sec. 900.4(g).
While proposed Sec. 900.4(g) focuses on the responsibility of
accreditation bodies for consumer complaint processes, proposed
Sec. 900.12(h) establishes corresponding requirements for facilities to
develop a system to evaluate and resolve consumer complaints about the
mammography services that they provide. FDA believes that consumer
complaints can be resolved most easily at the individual facilities
providing the mammography services. Therefore, FDA encourages the
facilities to work diligently to resolve these complaints. However, in
the event that a facility is unable to resolve a complaint to the
consumer's satisfaction, proposed Sec. 900.12(h) requires the facility
to provide the consumer with adequate directions to file the complaint
with the facility's accreditation body.
Some members of the NMQAAC suggested that FDA require facilities to
post a sign that explains how to file consumer complaints or provide a
toll free telephone number for making such reports to the accreditation
body.
At this time, FDA is proposing not to mandate such requirements.
Instead, FDA believes facilities should have the flexibility to promote
their own consumer complaint mechanism to their clientele in a manner
that is most appropriate. The agency notes that the name of the
accreditation body is listed on the facility certificate, which the
facility is required by statute to post prominently within view of the
examinees.
Proposed Sec. 900.12(h) is intended to ensure that ``serious''
complaints within the purview of the MQSA are adequately addressed.
``Serious'' complaints are defined in proposed Sec. 900.2. FDA has
worked extensively with the NMQAAC in developing the proposed consumer
complaint mechanism and believes the proposed requirements meet
important consumer needs without imposing an undue burden on
facilities. Proposed Sec. 900.12(h) establishes minimum requirements
for facilities and provides them with the flexibility to institute
their own complaint mechanism procedures. FDA encourages facilities to
design their complaint mechanism procedures to be responsive to the
language, ethnic, and literacy differences among consumers served by
the facility.
I. Additional Clinical Image Review and Examinee Notification
Proposed Sec. 900.12(i) requires a facility to cooperate with FDA
in the investigation of concerns about the quality of the images
produced by that facility and in notification of examinees or the
public, should the investigation justify such notification.
Proposed Sec. 900.12(i)(1) complements the requirements in proposed
Sec. 900.4(f) of the accreditation body regulations, which are
published elsewhere in this issue of the Federal Register. Proposed
Sec. 900.4(f), among other things, would require accreditation bodies,
or other entities as specified by FDA, to perform additional clinical
image reviews when there are concerns or complaints about the quality
of images produced at a facility. Proposed Sec. 900.12(i)(1) requires
the facility to provide the clinical images for this review.
If FDA determines that any activity related to the provision of
mammography at a facility presents a serious risk to human health,
proposed Sec. 900.12(i)(2) would require a facility to notify
examinees, their designees, or the public of actions that may be
necessary to minimize the risk. Such notification may be used in cases
where diagnoses of possible malignancy may have been missed due to the
grossly inadequate performance of the facility. Examinees, their
designees, health professionals, or the public may have to be notified
so that they may take appropriate remedial action. For example,
affected examinees may wish to repeat examinations at another facility
or a member of the public may be able to contact an otherwise
unreachable examinee.
J. Revocation of a Facility's Accreditation and Revocation of FDA
Approval of a Facility's Accreditation Body
Proposed Sec. 900.13 establishes procedures for revocation of
facility accreditation and accreditation body approval. No comments
were received on these requirements as promulgated under the interim
regulations. The agency is proposing to retain these procedures with
the exception of the following changes and additions:
Proposed Sec. 900.13(a) gives FDA the discretion to revoke or
suspend the certificate of a facility whose accreditation has been
revoked by its accreditation body while the agency investigates what
actions to take with respect to the facility as a result of the
revocation.
Proposed Sec. 900.13(b)(1) gives the agency greater flexibility
with respect to facilities when FDA has revoked approval of the
accreditation body that accredited the facilities. Under the proposed
regulation, the certificates of the facilities would normally remain in
effect for up to 1 year after the accreditation body approval was
revoked. The change from the interim regulations, however, would allow
the agency to shorten this period if FDA determined that a facility had
been accredited fraudulently or posed a serious threat to public health
or safety.
Proposed Sec. 900.13(b)(2) incorporates the additional language the
agency has proposed in Sec. 900.11 in order to provide alternative
means of accreditation if the accreditation body cannot or will not
perform this function at some future date.
K. Suspension and Revocation of Certificates
FDA has revised Sec. 900.14 to set forth the bases for agency
action to suspend or revoke certificates and the procedural rights
available to facilities in these circumstances.
Proposed Sec. 900.14 tracks 42 U.S.C. 263b(i), the section of the
PHS Act that establishes provisions for suspension and revocation of
certificates. Proposed Sec. 900.14(a) provides that the agency may
suspend or revoke a certificate, following notice and opportunity for a
hearing in accordance with part 16 (21 CFR part 16), if FDA finds that
the owner, operator, or any employee of the facility: (1) Has been
guilty of misrepresentation in obtaining the certificate; (2) has
failed to comply with standards under Sec. 900.12; (3) has failed to
comply with reasonable requests for records or information; (4) has
refused to permit duly authorized inspections; (5) has violated or
aided and abetted violations of the MQSA or implementing regulations;
or (6) has failed to comply with prior sanctions imposed under 42
U.S.C. 263b(h).
Proposed Sec. 900.14(b) sets forth the bases for FDA to suspend a
certificate prior to holding a hearing. Here, too, the regulation
tracks the statutory provision. FDA may dispense with a hearing if, in
addition to making one of the findings listed above, the agency also
determines that: (1) Failure to comply with the required standards
presents a serious risk to human health; (2) the refusal to permit
inspection makes immediate suspension necessary; or (3) there is reason
to believe that the violative acts were intentional or otherwise rise
to a level that presents a threat to the public. These three
aggravating factors create circumstances in which the need to protect
the public health outweighs the harm to the affected facility, which
will have to wait a period of time for an
[[Page 14878]]
opportunity to demonstrate that the agency's determinations are
erroneous.
As set forth in the statute and in the proposed regulation at
Sec. 900.14(b)(1), FDA may take action before a hearing if the agency
determines that a facility's failure to comply with promulgated
standards presents a serious risk to human health.
FDA may also take such action following a determination that a
facility has refused reasonable requests for inspection. The agency
believes this provision is intended to provide discretion for the
agency to suspend a certificate in circumstances where recalcitrant
actions by a facility make it impossible for the agency to inspect and
investigate violations in order to determine whether the public is at
risk if the facility continues operation. Proposed Sec. 900.14(b)(2)
sets forth this basis for suspension prior to hearing.
The agency may also take action prior to hearing upon a
determination that a facility has violated or aided and abetted in the
violation of any provision of the statute or an implementing
regulation. FDA has interpreted this statutory provision to mean that
the agency may suspend prior to hearing when the compliance record of
the facility or other evidence demonstrates that responsible persons at
that facility are not disposed to comply with established standards or
with representations that were made during the certifying process.
Proposed Sec. 900.14(b)(3) states that the agency may suspend a
certificate prior to hearing when the agency determines that there is
reason to believe that the violation, or aiding and abetting of the
violation, was intentional or associated with fraud. Such behavior
cannot be tolerated without undermining the entire regulatory system
and is sufficiently egregious to warrant immediate action by the
agency.
As required by the MQSA and proposed in Sec. 900.14(c)(1),
facilities whose certificates are suspended prior to hearing will have
an opportunity for a hearing within 60 days of the suspension.
As a matter of general policy, FDA will not suspend certificates
without a hearing unless the agency believes that violations at the
facility or misconduct by responsible persons present a serious risk to
human health. Furthermore, suspension of a certificate, with or without
a hearing, is not a regulatory action FDA intends to initiate as a
matter of course. The MQSA favors voluntary compliance over regulatory
sanctions, and FDA is committed to working with facilities to correct
deficiencies rather than eliminating services. Suspension will be
necessary only in those cases where voluntary action or lesser
sanctions have proven ineffective.
L. Appeals of Adverse Accreditation Decisions
The MQSA includes a provision that requires the Secretary of DHHS
(the Secretary) to provide particular appeal procedures to a facility
that has been denied certification. Section 263b(d)(2) of the PHS Act
requires the Secretary (FDA, by delegation) to provide the facility
with a statement of the grounds upon which the denial is based, and
``an opportunity for an appeal in accordance with procedures set forth
in regulations published at 42 CFR 498 and in effect on the date of the
enactment of [the MQSA].'' (42 U.S.C. 263b(d)(2).)
Because FDA may not certify a facility that has failed to become
accredited, appeal of an FDA decision not to certify a facility will
become, in actuality, a review of the accreditation body's
determination that the facility did not meet necessary standards. For
this reason, FDA believes that the procedural rights that are
referenced in the statute should be available to the facility at the
time it receives an adverse accreditation decision from the
accreditation body to which it has applied.
FDA also believes that accreditation bodies should establish and
implement impartial procedures for review and reconsideration of
adverse accreditation decisions. As discussed elsewhere in this issue
of the Federal Register, FDA is requiring each accreditation body to
establish such reconsideration procedures and to inform any facility
that receives an adverse accreditation decision of the opportunity to
seek reconsideration by the accreditation body. Because it is the
accreditation body that has the most detailed knowledge of the facts
and alleged deficiencies of the facility's mammography practice, it is
the accreditation body that is in the best position to make suggestions
or review additional information that may result in accreditation.
FDA is proposing to require mammography facilities to seek
reconsideration by the accreditation body before appealing the adverse
decision to FDA. The agency believes this practice is in the best
interest of the facility, the agency, and the public. As discussed
above, the accreditation body will be in the best position to evaluate
any additional information the facility presents for reconsideration.
In addition, in order to perform an adequate evaluation of the adverse
accreditation decision, FDA will request and review materials provided
by the accreditation body as well as the facility. The internal
reconsideration process at the accreditation body level will permit the
areas of dispute to be clarified for FDA review and conserve the
limited resources of agency personnel.
A facility that is not satisfied with the result of the
accreditation body's reconsideration may appeal that determination to
the government. The regulations set forth at 42 CFR part 498, which are
referenced in the MQSA, are Health Care Financing Administration (HCFA)
regulations that were promulgated for appeals of decisions that among
other things deny providers of medical services the opportunity to
participate in Medicare. In order to implement a certification appeals
process that is in accordance with those provisions and appropriate to
the review of mammography accreditation decisions, FDA has consulted
with other agencies of the Department of Health and Human Services
(DHHS) that utilize and apply those procedures on a regular basis. As a
result of those cooperative efforts, FDA and other agencies of DHHS
have agreed that FDA's Division of Mammography Quality and Radiation
Programs (DMQRP) will handle all appeals for reconsideration of an
accreditation body's decision to deny accreditation. Hearing officers
of the DHHS' Departmental Appeals Board (DAB) will conduct formal
hearings for facilities that wish to appeal the FDA's reconsideration
decision, and the DAB itself will hear appeals of the hearing officer's
decision.
The procedures to be followed for these various appeals are
detailed in 42 CFR part 498. However, as discussed above, because those
are HCFA regulations, references to HCFA should be read as FDA for
purposes of the MQSA program. In addition, references to the Social
Security Appeals Council in 42 CFR part 498 should be read as the DAB;
although 42 CFR part 498 has not been amended to reflect the delegation
of authority, administrative law judges of the DAB have been handling
adversarial HCFA hearings since 1992 and the DAB itself has been
handling appeals of those hearing decisions.
Although 42 CFR part 498 is referenced in the MQSA and in FDA's
implementing regulations, FDA is also proposing that its MQSA
regulations broadly summarize the way these HCFA regulations will be
applied by FDA. The agency believes that summary of the various appeal
levels will make the procedures more accessible to facilities that wish
to challenge adverse
[[Page 14879]]
decisions. Applicable details about the various appeal procedures that
are not codified in FDA's proposed regulations can be found at 42 CFR
part 498.
A facility that is appealing an adverse accreditation decision,
regardless of the level of appeal, may not perform mammography services
until the decision has been reversed and the facility has been
certified by FDA.
M. Alternative Requirements
In the interim rule published in the Federal Register of September
30, 1994 (59 FR 49808), FDA established procedures for approval of
alternatives to the quality standards of Sec. 900.12. Such alternatives
can be approved if, among other things, the alternatives provide at
least as great an assurance of quality mammography as the original
standards. These procedures were developed to permit flexibility in
appropriate individual circumstances and to encourage further
improvement in the practice of mammography. The alternative requirement
procedures will allow the agency to permit the practice of mammography
to benefit rapidly from improvements and advancements without the need
first to amend regulations, which is often a lengthy process. Approved
alternative requirements will be made available for review in the
public docket file in FDA's Dockets Management Branch (address above).
In addition, notices of approved alternative requirements with wide
applicability will be published in the Federal Register.
The comment period on the interim regulations ended on December 29,
1994. No comments were received on the alternative requirements or, for
that matter, on any of the amendments. The agency has interpreted this
lack of response to indicate that members of the public did not object
to the content of the amendments.
NMQAAC discussed the alternative requirement regulation
(Sec. 900.18) at its February 1994 meeting. The regulation was
discussed again at NMQAAC's January 1995 meeting. The only suggestion
for change at the latter meeting came from a Federal liaison to NMQAAC
who recommended that Federal agencies be given the same opportunity as
State Governments to apply for approval of alternative requirements.
NMQAAC endorsed this suggestion and FDA has revised Sec. 900.18(b)(2)
accordingly.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(3) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Analysis of Impacts
FDA has examined together the impacts of this proposed rule and the
proposed rules on accreditation bodies, personnel requirements, and
quality standards for mammography equipment and quality assurance,
published elsewhere in this issue of the Federal Register, under
Executive Order 12866, the Regulatory Flexibility Act (Pub. L. 96-354),
and under the Unfunded Mandates Reform Act. The analysis has addressed
the proposed requirements of these four rules as one unit for purposes
of determining their economic impact. The preamble to the proposed rule
``Quality Mammography Standards; General Preamble and Proposed
Alternative Approaches'' published elsewhere in this issue of the
Federal Register, contains a brief summary of the cost and benefit
determination and the Regulatory Impact Study that details the agency's
calculation of these economic impacts and is available at the Dockets
Management Branch (address above) for review. FDA recognized that these
proposed regulations may have a disproportionate effect on small volume
mammography facilities and is currently collecting additional
information on the potential impact on this industry sector. The agency
requests comments that will assist it in accounting for this impact.
V. Paperwork Reduction Act of 1995
This proposed rule contains information collections which are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title,
description, and respondent description of the information collection
are contained in the proposed rule ``Quality Mammography Standards;
General Preamble and Alternative Approaches'' published elsewhere in
this issue of the Federal Register with an estimate of the annual
reporting and recordkeeping burden.
The agency has submitted a copy of this proposed rule to OMB for
its review and approval of these information collections. Other
organizations and individuals desiring to submit comments regarding
this burden estimate or any aspect of these information collection
requirements, including suggestions for reducing the burden, should
direct them to the Office of Information and Regulatory Affairs, OMB
New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC
20503, Attn: Desk Officer for FDA. Written comments on the information
collection should be submitted by May 3, 1996.
VI. Request for Comments
Interested persons may, on or before July 2, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
VII. Reference
The following reference has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. ``Report on the Mammography Quality Standards Act of 1992,'' S.
Rept. 102-448, October 1, 1992.
List of Subjects in 21 CFR Part 900
Electronic products, Health facilities, Mammography, Medical
devices, Radiation protection, Reporting and recordkeeping
requirements, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 900 be
amended as follows:
PART 900--MAMMOGRAPHY
1. The authority citation for 21 CFR part 900 continues to read as
follows:
Authority: Secs. 519, 537, and 704(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360i, 360nn, and 374(e)); sec. 354 of
the Public Health Service Act (42 U.S.C. 263b).
2. Section 900.10 is revised to read as follows:
Sec. 900.10 Applicability.
The provisions of subpart B are applicable to all facilities under
the regulatory jurisdiction of the United States that provide screening
or diagnostic mammography services, with the exception of the
facilities of the Department of Veterans Affairs.
3. Section 900.11 is revised to read as follows:
Sec. 900.11 Requirements for certification.
(a) General. After October 1, 1994, a certificate issued by FDA is
required for
[[Page 14880]]
lawful operation of all mammography facilities subject to the
provisions of subpart B of this part. To obtain a certificate from FDA,
facilities are required to meet the quality standards in Sec. 900.12
and to be accredited by an approved accreditation body or other entity
as designated by FDA.
(b) Application--(1) Certificates. (i) In order to qualify for a
certificate, a facility must apply to an FDA-approved accreditation
body, or to another entity as designated by FDA. The facility shall
submit to such body or entity the information required in 42 U.S.C.
263b(d)(1).
(ii) Following the agency's receipt of the accreditation body's
decision to accredit a facility, or an equivalent decision by another
entity as designated by FDA, the agency will issue a certificate to the
facility, or renew an existing certificate, if the agency determines
that the facility has satisfied the requirements for certification or
recertification.
(2) Provisional certificates. (i) New facilities beginning
operation after October 1, 1994, are eligible to apply for provisional
certificates. The provisiona
FR Doc. 96-7830 Quality Standards and Certification Requirements for Mammography Facilities; General Facility Requirements
l certificate will enable the facility to
perform mammography and to obtain the clinical images needed to
complete the accreditation process. To apply for and receive a
provisional certificate, a facility must meet the requirements of 42
U.S.C. 263b(c)(2) and submit the necessary information to an approved
accreditation body or other entity designated by FDA.
(ii) FDA will issue a provisional certificate to a facility upon
determination that the facility has satisfied the requirements of
paragraph (b)(2)(i) of this section. A provisional certificate shall be
effective for up to 6 months from the date of issuance. A provisional
certificate cannot be renewed, but a facility may apply for a 90-day
extension of the provisional certificate.
(3) Extension of provisional certificate. (i) To apply for a 90-day
extension to a provisional certificate, a facility shall submit to its
accreditation body, or other entity as designated by FDA, a statement
of what the facility is doing to obtain certification and evidence that
there would be a significant adverse impact on access to mammography in
the geographic area served if such facility did not obtain an
extension.
(ii) FDA will issue a 90-day extension for a provisional
certificate upon determination that the extension meets the criteria
set forth in 42 U.S.C. 263b(c)(2).
(iii) There can be no renewal of a provisional certificate beyond
the 90-day extension.
(c) Reinstatement policy. A previously certified facility that has
allowed its certificate to expire, that has been refused a renewal of
its certificate by FDA, or that has had its certificate revoked by FDA,
may apply to have the certificate reinstated.
(1) Unless prohibited from reinstatement under paragraph (c)(4) of
this section, a facility applying for reinstatement shall:
(i) Contact an FDA-approved accreditation body or other entity as
designated by FDA to determine the requirements for reapplication for
accreditation;
(ii) Fully document its history as a previously provisionally or
fully certified mammography facility, including the following
information:
(A) Name and address of the facility under which it was previously
provisionally or fully certified;
(B) Name of previous owner/lessor;
(C) FDA facility identification number assigned the facility under
its previous certification; and
(D) Expiration date of the most recent FDA provisional or full
certificate; and
(iii) Justify application for reinstatement of accreditation by
submitting to the accreditation body or other entity as designated by
FDA, a corrective action plan that details how the facility has
corrected deficiencies that contributed to the lapse of, denial of
renewal, or revocation of its certificate.
(2) FDA will issue a provisional certificate to the facility if:
(i) The accreditation body or other entity as designated by FDA
notifies the agency that the facility has adequately corrected, or is
in the process of correcting, pertinent deficiencies; and
(ii) FDA determines that the facility has taken sufficient
corrective action since the lapse of, denial of renewal, or revocation
of its previous certificate.
(3) After receiving the provisional certificate, the facility may
lawfully resume performing mammography services while completing the
requirements for full certification.
(4) If a facility's certificate was revoked, that facility is not
eligible for reinstatement until at least 2 years from the date the
certificate was revoked if the facility is owned or operated by any
person who owned or operated the facility at the time of revocation.
4. Section 900.12 is amended by revising paragraphs (c) and (d) and
by adding new paragraphs (f), (g), (h), and (i) to read as follows:
Sec. 900.12 Quality standards.
* * * * *
(c) Medical records and mammography reports. (1) Contents and
terminology. Each facility shall prepare a written report signed by the
interpreting physician for each mammography examination performed under
its certificate. The mammography report shall include the following
information:
(i) The name of the examinee;
(ii) Date of examination;
(iii) Overall final assessment of findings, classified in one of
the following categories:
(A) ``Negative:'' Nothing to comment upon. (If the interpreting
physician is aware of clinical findings or symptoms, despite the
negative assessment, these shall be explained);
(B) ``Benign:'' Also a negative assessment, but benign finding(s)
can be described at the discretion of the interpreter;
(c) ``Probably benign:'' Finding(s) has a high probability of being
benign;
(D) ``Suspicious:'' Finding(s) without all the characteristic
morphology of breast cancer but indicating a definite probability of
being malignant;
(E) ``Highly suggestive of malignancy:'' Finding(s) has a high
probability of being malignant;
(iv) In cases where no final assessment category can be assigned
due to incomplete work-up, ``Needs additional imaging evaluation''
shall be assigned as an assessment and reasons why no assessment can be
made shall be stated by the interpreting physician; and
(v) Recommendations made to the health care provider about what
additional actions, if any, should be taken. All clinical questions
raised by the referring health care provider shall be addressed in the
report to the extent possible.
(2) Communication of mammography results to the examinee. Each
facility shall maintain a system for providing written notification of
results of each mammographic examination to the examinee. The written
notification issued by the facility or by its designee shall be
communicated to the examinee as soon as possible, but no later than 30
days from the date of the mammography examination. If assessments are
``Suspicious'' or ``Highly suggestive of malignancy'' and if the
examinee has not named a referring health care provider, the facility
shall make reasonable attempts to communicate results to the examinee
immediately.
(i) The written notification of results provided to the examinee
shall include:
(A) The date of the examination;
[[Page 14881]]
(B) The results of the examination in lay terms; and
(C) A recommendation to the examinee on followup actions.
(ii) Examinees who do not name a health care provider to receive
the mammography report shall be sent the report described in paragraph
(c)(1) of this section, in addition to the written notification
described in paragraph (c)(2)(i) of this section.
(iii) Each facility that accepts examinees who do not have a
primary care provider shall maintain a system for referring such
examinees to a health care provider when clinically indicated.
(3) Communication of mammography results to health care providers.
When the examinee has a referring health care provider or the examinee
has named a health care provider, the facility shall:
(i) Provide a written report of the mammography examination,
including the items listed in paragraph (c)(1) of this section, to that
health care provider as soon as possible, but no later than 30 days
from the date of the mammography examination; and
(ii) If the assessment is ``Suspicious'' or ``Highly suggestive of
malignancy,'' make reasonable attempts to communicate with the health
care provider immediately, or if the health care provider is
unavailable, to a responsible designee of the health care provider.
(4) Recordkeeping. Each facility shall maintain mammography films
and reports in a permanent medical record of the examinee as follows:
(i) For a period of not less than 5 years, or of not less than 10
years if no additional mammograms of the examinee are performed at the
facility, or a longer period if mandated by State or local law; or
(ii) Until requested by an examinee to transfer the original
mammograms and copies of the examinee's reports to a medical
institution, or to a physician or health care provider designated by
the examinee, or to the examinee directly, and the records are so
transferred.
(iii) Any fee charged to examinees for providing the services in
paragraphs (c)(4)(ii) of this section shall not exceed the actual
documented costs associated with this service.
(d) Quality assurance--general. Each facility shall establish and
maintain a quality assurance program to ensure the safety, reliability,
clarity, and accuracy of mammography services performed at the
facility.
(1) Responsible individuals. Responsibility for the quality
assurance program and for each of its elements shall be assigned to
individuals who are qualified for their assignments and who shall be
given adequate time to perform these duties.
(i) Lead interpreting physician. The facility shall identify a lead
interpreting physician who shall have the general responsibility of
ensuring that the quality assurance program meets all requirements of
paragraphs (d) through (f) of this section. No other individual shall
be assigned or shall retain responsibility for quality assurance tasks
unless the lead interpreting physician has determined that the
individual's qualifications for, and performance of, the assignment are
adequate.
(ii) Interpreting physicians. All interpreting physicians
interpreting mammograms for the facility shall provide feedback on the
quality of the mammograms they interpret to the radiologic
technologists producing those mammograms and shall participate in the
facility's medical outcomes audit program.
(iii) Medical physicist. Each facility shall have available the
services of an individual or individuals, who meet the qualifications
of paragraph (a)(3) of this section, to survey mammography equipment
and oversee the equipment-related quality assurance practices of the
facility.
(iv) Quality control technologist. Responsibility for all
individual tasks within the quality assurance program not assigned to
the lead interpreting physician or the medical physicist shall be
assigned to quality control technologists.
(2) Quality assurance records. The facility shall maintain the
following documents related to its quality assurance program:
(i) A quality assurance manual describing the procedures that are
to be followed in meeting the requirements of paragraphs (e) and (f) of
this section, including ``action levels'' for corrective actions, as
defined in Sec. 900.2. The manual shall be readily available to all
staff members. It shall contain a sign-off page documenting that it has
been read and approved by the lead interpreting physician and the
medical physicist.
(ii) A current list of the individuals to whom quality assurance
responsibilities have been assigned and the duties assigned to them.
This list shall be readily available to all staff members.
(iii) Records to show that all staff members assigned
responsibilities in the quality assurance program are qualified to
conduct their assigned duties.
(iv) Records to show the data obtained during monitoring of the
facility's performance, the analysis of the monitoring data, the
problems detected and corrective actions carried out, and the
effectiveness of the corrective actions in resolving the problems.
These records shall be kept for each test specified in paragraphs (e)
and (f) of this section for a minimum of 1 year or until the test has
been performed two additional times at the required frequency,
whichever is longer.
* * * * *
(f) Quality assurance--mammography medical outcomes audit. Each
facility shall establish and maintain a mammography medical outcomes
audit program for followup based on mammographic assessments and to
correlate biopsy or cytology results with interpreting physicians'
recommendations. This program shall be designed to ensure the
reliability, clarity, and accuracy of the interpretation of mammograms.
(1) General requirements. Each facility shall establish a system
for reviewing outcome data from all mammography performed, in order to
followup on the disposition of positive mammograms and to correlate
biopsy or cytology results with interpreting physician's mammography
report.
(2) Data collection. Data shall be collected on an ongoing basis
for all examinees with positive mammograms.
(3) Frequency of audit analysis. An initial audit analysis shall be
conducted no later than 12 months after the date the facility became
fully certified. Subsequent audit analyses shall be conducted at least
once every 12 months from the date of the initial analysis.
(4) Reviewing interpreting physician. The facility shall designate
at least one interpreting physician to review the audit data at least
once every 12 months. This individual shall record the dates of the
audit period(s) and shall be responsible for identifying issues and
analyzing results based on this audit, notifying the other interpreting
physicians of these issues and results, and ensuring that necessary
corrective actions are taken and documented. Evaluations shall be made
individually and collectively for all interpreting physicians at the
facility.
(g) Mammographic procedure and techniques for mammography of
examinees with breast implants. (1) Each facility shall have a
procedure to inquire whether an examinee has a breast implant at the
time of mammogram scheduling.
(2) Except where contraindicated, or unless modified by a
physician's directions, examinees with breast implants undergoing
mammography shall have mammographic views to maximize the visualization
of breast tissue and optimize breast cancer detection.
[[Page 14882]]
(3) These mammographic examinations shall be supervised by an
onsite interpreting physician who is trained in mammography of
examinees with breast implants, including training in specialized
mammographic techniques of these examinees and training in interpreting
the mammograms of these examinees.
(h) Consumer complaint mechanism. Each facility shall:
(1) Establish a written and documented system for collecting and
resolving consumer complaints;
(2) Maintain a record of each serious complaint received by the
facility for at least 3 years from the date the complaint was received;
(3) Provide the consumer with adequate directions for filing the
complaint with the facility's accreditation body, if the facility is
unable to resolve a serious complaint to the consumer's satisfaction;
(4) Report unresolved serious complaints to the accreditation body
in a manner and timeframe specified by the accreditation body.
(i) Additional clinical image review and examinee notification.
(1) If FDA believes that image quality at a facility has been
severely compromised and presents a serious risk to human health, the
facility shall provide clinical images, as specified by FDA, for review
by the accreditation body or other entity designated by FDA. This
additional clinical image review will help the agency to determine
whether there is a need to notify affected examinees and the public.
(2) If FDA determines that any activity related to the provision of
mammography at a facility presents a serious risk to human health such
that examinee notification is necessary, the facility shall notify
examinees, their designees, or the public of action that may be taken
to minimize the effects of the risk. Such notification shall occur
within a timeframe specified by FDA.
5. Section 900.13 is revised to read as follows:
Sec. 900.13 Revocation of accreditation, and revocation of
accreditation body approval.
(a) FDA action following revocation of accreditation. If a
facility's accreditation is revoked by an accreditation body, the
agency may conduct an investigation into the reasons for the
revocation. If FDA determines that the revocation was justified, FDA
may take action, revoke or suspend the facility's certificate, or
require the submission and implementation of a corrective action plan,
whichever action or combination of actions will best protect the public
health.
(b) Revocation of FDA approval of an accreditation body.
(1) If FDA revokes approval of an accreditation body under
Sec. 900.6, the certificates of facilities previously accredited by
such body shall remain in effect for up to 1 year from the date of
revocation, unless FDA determines, in order to protect human health or
because the accreditation body fraudulently accredited facilities, that
the certificates of some or all of the facilities should be revoked or
suspended or that a shorter time period should be established for the
certificates to remain in effect.
(2) After 1 year from the date of revocation of approval of an
accreditation body, or within any shorter period of time established by
the agency, the affected facilities must obtain accreditation from
another accreditation body, or from another entity designated by FDA.
6. Section 900.14 is revised to read as follows:
Sec. 900.14 Suspension or revocation of certificates.
(a) FDA may suspend or revoke a certificate if FDA finds, after
providing the owner or operator of the facility with notice and
opportunity for an informal hearing in accordance with part 16 of this
chapter, that the owner, operator, or any employee of the facility:
(1) Has been guilty of misrepresentation in obtaining the
certificate;
(2) Has failed to comply with the standards of Sec. 900.12;
(3) Has failed to comply with reasonable requests of the agency for
records, information, reports, or materials that FDA believes are
necessary to determine the continued eligibility of the facility for a
certificate or continued compliance with the standards of Sec. 900.12;
(4) Has refused a reasonable request of a duly designated FDA
inspector, State inspector, or accreditation body representative for
permission to inspect the facility or the operations and pertinent
records of the facility;
(5) Has violated or aided and abetted in the violation of any
provision of or regulation promulgated pursuant to 42 U.S.C. 263b; or
(6) Has failed to comply with prior sanctions imposed by the agency
under 42 U.S.C. 263b(h).
(b) FDA may suspend the certificate of a facility before holding a
hearing if FDA makes a finding described in paragraph (a) of this
section and also determines that:
(1) The failure to comply with required standards presents a
serious risk to human health;
(2) The refusal to permit inspection makes immediate suspension
necessary; or
(3) There is reason to believe that the violation or aiding and
abetting of the violation was intentional or associated with fraud.
(c) If FDA suspends a certificate in accordance with paragraph (b)
of this section:
(1) The agency shall provide the facility with an opportunity for
an informal hearing under part 16 of this chapter not later than 60
days from the effective date of the suspension;
(2) The suspension shall remain in effect until the agency
determines that:
(i) Allegations of violations or misconduct were not substantiated;
(ii) Violations of required standards have been corrected to the
agency's satisfaction; or
(iii) The facility's certificate is revoked in accordance with
Sec. 900.14(d).
(d) After providing a hearing in accordance with paragraph (c)(1)
of this section, the agency may revoke the facility's certificate if
the agency determines that the facility:
(1) Is unwilling or unable to correct violations that were the
basis for suspension; or
(2) Has engaged in fraudulent activity to obtain or continue
certification.
7. New Sec. 900.15 is added to subpart B to read as follows:
Sec. 900.15 Appeals of adverse accreditation and certification
decisions.
(a) The appeals procedures described in this section are available
only for adverse accreditation decisions that preclude certification or
recertification by FDA. Agency decisions to suspend or revoke
certificates that are already in effect will be handled in accordance
with Sec. 900.14.
(b) Upon learning that a facility has failed to become accredited,
FDA will notify the facility that the agency is unable to certify that
facility without proof of accreditation.
(c) A facility that has been denied accreditation is entitled to an
appeals process from the accreditation body, in accordance with
Sec. 900.7. A facility must avail itself of the accreditation body's
appeal process before requesting reconsideration from FDA.
(d) A facility that cannot achieve satisfactory resolution of an
adverse accreditation decision through the accreditation body's appeal
process is entitled to further appeal in accordance with procedures set
forth in this section and in regulations published at 42 CFR part 498.
(1) References to the Health Care Financing Administration (HCFA)
in 42
[[Page 14883]]
CFR part 498 should be read as the Division of Mammography Quality and
Radiation Programs, Center for Devices and Radiological Health, Food
and Drug Administration.
(2) References to the Appeals Council of the Social Security
Administration in 42 CFR part 498 should be read as references to the
Departmental Appeals Board.
(3) In accordance with the procedures set forth in subpart B of 42
CFR part 498, a facility that has been denied accreditation following
appeal to the accreditation body may request reconsideration of that
adverse decision from DMQRP.
(i) A facility must make its request for reconsideration to DMQRP,
within 60 days of the accreditation body's adverse appeals decision, at
the following address: Division of Mammography Quality and Radiation
Programs (HFZ-240), Center for Devices and Radiological Health, Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, Attn:
Facility Accreditation Review Committee.
(ii) The request for reconsideration shall include 3 copies of the
following records:
(A) The accreditation body's original denial of accreditation;
(B) All information the facility submitted to the accreditation
body as part of the appeals process;
(C) A copy of the accreditation body's adverse appeals decision;
and
(D) A statement of the bases for the facility's disagreement with
the accreditation body's decision.
(iii) DMQRP will conduct its reconsideration in accordance with the
procedures set forth in subpart B of 42 CFR part 498.
(4) A facility that is dissatisfied with DMQRP's decision following
reconsideration is entitled to a formal hearing in accordance with
procedures set forth in subpart D of 42 CFR part 498.
(5) Either the facility or FDA may request review of the hearing
officer's decision. Such review will be conducted by the Departmental
Appeals Board in accordance with subpart E of 42 CFR part 498.
(6) A facility cannot perform mammography services while an adverse
accreditation decision is being appealed.
8. Section 900.18 is revised to read as follows:
Sec. 900.18 Alternative requirements for 42 U.S.C. 263b quality
standards.
(a) Criteria for approval of alternative standards. Upon
application by a qualified party as defined under paragraph (b) of this
section, the Director, Division of Mammography Quality and Radiation
Programs (the Director), may approve an alternative to a quality
standard under Sec. 900.12, when the Director determines that:
(1) The proposed alternative standard will be at least as effective
in assuring quality mammography as the standard it proposes to replace,
and
(2) The proposed alternative:
(i) Is too limited in its applicability to justify an amendment to
the standard; or
(ii) Offers an expected benefit to human health that is so great
that the time required for amending the standard would present an
unjustifiable risk to the human health; and
(3) The granting of the alternative is in keeping with the purposes
of 42 U.S.C. 263b.
(b) Applicants for alternatives. (1) Mammography facilities and
accreditation bodies may apply for alternatives to the quality
standards of Sec. 900.12.
(2) Federal agencies and State governments that are not
accreditation bodies may apply for alternatives to the standards of
Sec. 900.12(a).
(3) Manufacturers and assemblers of equipment used for mammography
may apply for alternatives to the standards of Sec. 900.12 (b) and (e).
(c) Applications for approval of an alternative standard. An
application for approval of an alternative standard or for an amendment
or extension of the alternative standard shall be submitted in an
original and two copies to the Director, Division of Mammography
Quality and Radiation Programs, Center for Devices and Radiological
Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850. The application for approval of an alternative
standard shall include the following information:
(1) Identification of the original standard for which the
alternative standard is being proposed and an explanation of why the
applicant is proposing the alternative;
(2) A description of the manner in which the alternative is
proposed to deviate from the original standard;
(3) A description, supported by data, of the advantages to be
derived from such deviation.
(4) An explanation, supported by data, of how such a deviation
would assure equal or greater quality of production, processing, or
interpretation of mammograms than the original standard;
(5) The suggested period of time that the proposed alternative
standard would be in effect; and
(6) Such other information required by the Director to evaluate and
act on the application.
(d) Ruling on applications. (1) The Director may approve or deny,
in whole or in part, a request for approval of an alternative standard
or any amendment or extension thereof, and shall inform the applicant
in writing of this action. The written notice will state the manner in
which the requested alternative standard differs from the agency
standard and a summary of the reasons for approval or denial of the
request. If the request is approved, the written notice will also
include the effective date and the termination date of the approval and
a summary of the limitations and conditions attached to the approval
and any other information that may be relevant to the approved request.
Each approved alternative standard will be assigned an identifying
number.
(2) Notice of an approved request for an alternative standard or
any amendment or extension thereof will be placed in the public docket
file in the Dockets Management Branch and may also be in the form of a
notice published in the Federal Register. The notice will state the
name of the applicant, a description of the published agency standard,
and a description of the approved alternative standard, including
limitations and conditions attached to the approval of the alternative
standard.
(3) Summaries of the approval of alternative standards, including
information on their nature and number, will be provided to the
National Mammography Quality Assurance Advisory Committee.
(4) All applications for approval of alternative standards and for
amendments and extensions thereof and all correspondence (including
written notices of approval) on these applications will be available
for public disclosure in the Dockets Management Branch, excluding
examinee identifiers and confidential commercial information.
(e) Amendment or extension of an alternative standard. An
application for amending or extending approval of an alternative
standard shall include the following information:
(1) The approval number and the expiration date of the alternative
standard;
(2) The amendment or extension requested and the basis for the
amendment or extension; and
(3) An explanation, supported by data, of how such an amendment or
extension would assure equal or greater quality of production,
processing, or
[[Page 14884]]
interpretation of mammograms than the original standard.
(f) Applicability of the alternative standards. Any approval of an
alternative standard, amendment, or extension may be implemented only
by the entity to which it was granted and under the terms under which
it was granted, except that when an alternative standard is approved
for a manufacturer of equipment, any facility using that equipment will
also be covered by the alternative standard. Other entities interested
in similar or identical approvals must file their own application
following the procedures of paragraph (c) of this section.
(g) Withdrawal of approval of alternative requirements. The
Director shall amend or withdraw approval of an alternative standard
whenever the Director determines that this action is necessary to
protect the human health or otherwise is justified by Sec. 900.12. Such
action will become effective on the date specified in the written
notice of the action sent to the applicant, except that it will become
effective immediately upon notification of the applicant when the
Director determines that such action is necessary to prevent an
imminent health hazard.
Dated: March 22, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-7830 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-P
Complete official Federal Register PDF
FR Doc. 96-7829 Quality Mammography Standards; General Preamble and Proposed Alternative Approaches
[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14856-14870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7829]
[[Page 14855]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 900
Mammography Quality Standards; Proposed Rules
Federal Register / Vol. 61, No. 65 / Wednesday, April 3, 1996 /
Proposed Rules
[[Page 14856]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. 95N-0192]
RIN 0910-AA24
Quality Mammography Standards; General Preamble and Proposed
Alternative Approaches
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its interim regulations issued under the Mammography Quality Standards
Act of 1992 (the MQSA). In addition, FDA is also setting forth ideas
for the application of alternative performance and outcome-based
standards to ensure quality mammography. FDA is soliciting comments on
these alternatives as possible ways of meeting the objectives of
Executive Order 12866, which requires Federal agencies to, where
feasible, specify performance objectives, rather than specifying the
behavior and manner of compliance and to avoid duplicative regulations.
Elsewhere in this issue of the Federal Register, FDA is proposing
amendments to the requirements for accreditation bodies, procedures for
facility certification and quality standards for mammography personnel,
equipment and practices, including quality assurance. These actions are
being taken to ensure adequate and consistent evaluation of mammography
facilities on a nationwide basis.
DATES: Written comments on the proposed rule by July 2, 1996. Written
comments on the information collections should be submitted by May 3,
1996.
ADDRESSES: Submit written comments on the proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. The Regulatory Impact
Study (RIS) is available at the Dockets Management Branch for review
between 9 a.m. and 4 p.m., Monday through Friday. Requests for copies
of the RIS should be submitted to the Freedom of Information Staff
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16,
Rockville, MD 20857.
Submit written comments on the information collections to the
Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), New Executive Office Building, 725 17th St. NW., rm.
10235, Washington DC 20503, ATTN: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for
Devices and Radiological Health (HFZ-240), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.
SUPPLEMENTARY INFORMATION:
I. General Preamble
The MQSA (Pub. L. 102-539) was passed on October 27, 1992, to
establish national quality standards for mammography. The MQSA required
that, to provide mammography services legally after October 1, 1994,
all facilities, except facilities of the Department of Veterans
Affairs, be accredited by an approved accreditation body and certified
by the Secretary of Health and Human Services (the Secretary). The
authority to approve accreditation bodies and to certify facilities was
delegated by the Secretary to FDA.
The MQSA was enacted in response to the growing incidence of breast
cancer and its associated mortality rate. Breast cancer is now the most
common nonskin cancer and is the second leading cause of cancer deaths
among women, after lung cancer. The American Cancer Society projects
that in 1995 there will be 180,000 new cases of breast cancer among
women in the United States (Ref. 1). Of these new cases, it is
estimated that approximately 46,000 of these women will die from the
disease. The lifetime risk of developing breast cancer is increasing.
In 1993, breast cancer was projected to affect 1 in 8 women in their
lifetime, as compared to 1 in 11 in 1980, 1 in 14 in 1960, and 1 in 20
in 1940 (Ref. 2).
Early detection of breast cancer, typically involving breast
physical examination and mammography, is the best means of preventing
deaths that can result when the diagnosis is delayed until the onset of
more advanced symptoms. The value of undergoing screening mammography
is that it can detect cancers that are asymptomatic. Mammograms can
reveal breast cancer up to 2 years before a woman or her doctor can
feel a lump. In addition, over 90 percent of these early stage cancers
can be cured (Ref. 3).
However, according to the General Accounting Office, a mammogram is
among the most difficult radiographic images to read. It must be of
high quality for the image to be interpreted correctly. If the image
quality is poor, the interpreter may miss an incipient cancerous
lesion. This false negative diagnosis could delay early treatment and
result in an avoidable death or mastectomy. Further, it is equally true
that poor quality images or faulty interpretations can lead to a false
positive diagnosis when normal tissue is misread as abnormal. This can
lead to needless anxiety for the examinee, costly additional testing,
and painful biopsies.
The Senate Committee on Labor and Human Resources held hearings on
breast cancer in 1992 and found a wide range of problems with
mammography practice in the United States: (1) Poor quality equipment,
(2) a lack of quality assurance procedures, (3) poorly trained
radiologic technologists and interpreting physicians, and (4) a lack of
facility inspections or consistent governmental oversight.
A. Provisions of the MQSA
The MQSA legislation was enacted to address these deficiencies in
mammography practice. Under the MQSA, Congress established a
comprehensive statutory scheme for the certification and inspection of
mammography facilities to ensure that, after October 1, 1994, only
those facilities that comply with minimum Federal standards for safe,
high-quality mammography services may lawfully continue to operate.
Operation after that date is contingent on receipt of an FDA
certificate attesting that the facility meets the minimum mammography
quality standards issued under section 354(f) of the Public Health
Service Act (the PHS Act)(42 U.S.C. 263b(f)). These standards are
intended to apply equally to screening and diagnostic mammography.
Specifically, the MQSA required the following:
(1) Accreditation of mammography facilities by private, nonprofit
organizations or State agencies that have met the standards established
by FDA for accreditation bodies and have been approved by FDA. The MQSA
requires a direct Federal audit of the accreditation bodies through
facility inspections by Federal inspectors. It also requires that, as
part of the overall accreditation process, actual clinical mammograms
from each facility be evaluated for quality by the accreditation body.
(2) An annual mammography facility physics survey, consultation,
and evaluation performed by a qualified medical physicist.
(3) Annual inspection of mammography facilities, to be performed by
FDA-certified Federal or
[[Page 14857]]
State inspectors. If State inspectors are used, the MQSA requires a
Federal audit of the State inspection program by direct Federal
inspections of a sample of State-inspected facilities.
(4) Establishment of initial and continuing qualification standards
for interpreting physicians, radiologic technologists, medical
physicists, and mammography facility inspectors.
(5) Specification of boards or organizations eligible to certify
the adequacy of training and experience of mammography personnel.
(6) Establishment of quality standards for mammography equipment
and practices, including quality assurance and quality control
programs.
(7) Establishment by the Secretary of a National Mammography
Quality Assurance Advisory Committee (NMQAAC). Among other things, the
NMQAAC is required to advise FDA on appropriate quality standards for
mammography facilities and accreditation bodies.
(8) Standards governing recordkeeping for examinee files and
requirements for mammography reporting and examinee notification by
physicians.
The MQSA replaced a patchwork of Federal, State, and private
standards in order to guarantee sufficient oversight of mammography
facilities to ensure that all women nationwide will receive high
quality mammography services.
B. Interim Regulations
On December 14, 1993, the President signed legislation (H. Rept.
2202) granting interim rule authority to the Secretary (and by
delegation, to FDA) to issue interim quality standards under MQSA. This
authorization was provided in recognition of the fact that FDA
certification of the over 10,000 mammography facilities in the United
States could not be accomplished by the October 1, 1994, statutory
deadline without streamlining the rulemaking process for issuing the
initial standards. Because of the urgent public health need for
national mammography standards, Congress decided to grant this interim
rule authority rather than extend the deadline to develop standards.
Under the interim rule legislation, FDA was authorized to issue
temporary interim regulations setting forth standards for approving
accreditation bodies and quality standards for mammography facilities.
Under the abbreviated process, Congress expected FDA to adopt
existing standards to the maximum extent feasible, such as those
established by the Health Care Financing Administration (HCFA), private
voluntary accreditation bodies such as the American College of
Radiology (ACR), and some States. The Secretary was not required to
consult with the NMQAAC in developing the interim regulations. However,
following issuance of the interim standards, Congress intended that FDA
proceed with the more extensive rulemaking procedures envisioned under
the MQSA, including consultation with the NMQAAC.
In the Federal Register of December 21, 1993 (58 FR 67558 and 58 FR
67565), FDA issued interim rules establishing requirements for entities
applying to serve as accreditation bodies and for facilities applying
to obtain FDA certification in order to continue legally providing
mammography services after October 1, 1994. These interim rules became
effective on February 22, 1994. They were amended by another interim
rule published in the Federal Register on September 30, 1994 (59 FR
49808).
There are several reasons why it is important to replace the
existing interim regulations on quality mammography standards with more
comprehensive final regulations, apart from strong congressional
encouragement for such action when the agency was granted interim
regulation authority. In a 1995 report by the Physician Insurers
Association of America, misdiagnosis of breast cancer remains the most
common charge against radiologists in malpractice situations. In
addition, there was considerable variation in clinical performance of
mammography facilities in 1992 and 1993 despite compliance with
existing voluntary accreditation standards that were similar to the
interim regulations published by FDA (Ref. 4). FDA believes that more
comprehensive final regulations would optimize facility performance.
The interim regulations, for reasons stated above, were based
primarily upon the voluntary standards of the American College of
Radiology (ACR) Mammography Accreditation Program (MAP). Applying these
standards to all facilities has had a significant impact on mammography
nationwide but evaluations of the ACR program (Ref. 5) have shown that
further improvement is possible through more comprehensive standards
than those of MAP.
This is especially true in the equipment area where the MAP
standards were minimal and where the FDA's authority under the Medical
Device Amendments to the Food, Drug, and Cosmetic Act is limited
because presently used mammography systems are pre-amendment devices.
To provide greater assurances of quality equipment performance (and to
meet a priority identified in ``The National Strategic Plan for the
Early Detection of Breast and Cervical Cancers'' (Ref. 7), the ACR,
with the Centers for Disease Control and Prevention had convened expert
committees to develop specifications for mammography equipment. The
reports of these expert committees were an important basis for the
equipment provisions in the proposed regulations.
Other portions of the proposed regulations, such as those providing
standards for imaging patients with breast implants, are required by
the MQSA. In addition, some of the details contained in the proposed
regulations, such as requirements to ensure that personnel have
practical training on equipment they use, reflect areas of concern that
were inadvertently neglected in the interim regulations.
For all of these reasons, therefore, it is necessary to replace the
interim regulations with more comprehensive final regulations if the
highest quality mammography that is reasonably achievable is to be
obtained.
In issuing the interim regulations, FDA attempted to balance the
pressing need to put national mammography standards into effect with
the agency's concern that facilities be provided a reasonable amount of
time to comply with these standards. The interim regulations were
drafted and implemented to maximize lawful operation by facilities
under existing quality standards, and to ensure adequate examinee
access to quality mammography during the transition to more
comprehensive national standards.
For example, the ACR, a private, nonprofit association of
radiologists, began a voluntary Mammography Accreditation Program (MAP)
in 1987 to provide assurance of quality to examinees seeking services
at ACR-accredited facilities. Many of the requirements under the
interim rules were derived from the ACR's MAP program, as well as from
HCFA regulations and some State programs. The MAP included a number of
procedural and image quality requirements for facilities applying for
ACR accreditation, including an evaluation of actual clinical images
produced by each facility. In the absence of a national regulatory
requirement, only those facilities that voluntarily sought
accreditation pursued the ACR accreditation process. Nevertheless, many
mammography facilities applied for and obtained ACR accreditation.
Historically, approximately 30 percent of the facilities that applied
for ACR
[[Page 14858]]
accreditation failed to become accredited on their first attempt,
although many of these were subsequently able to improve their services
and gain accreditation on a second attempt.
C. Accreditation and Certification
Before the October 1, 1994, statutory deadline, FDA approved the
ACR and the State of Iowa as accreditation bodies and issued
certificates to the more than 6,000 facilities (out of an estimated
total of 10,666 facilities in the United States) accredited by these
bodies. The States of Arkansas and California were also approved by FDA
as accreditation bodies and began accrediting mammography facilities
within their States after the statutory deadline. These facilities were
subsequently certified by FDA.
In addition, the MQSA permitted FDA to issue 6-month provisional
certificates to facilities whose applications for accreditation had not
been approved by the statutory deadline but were sufficiently complete
to be accepted for review by an FDA-approved accreditation body. The
statute also allowed FDA to extend a facility's provisional certificate
once, for up to 90 days, if: (1) The owner, lessor, or agent of the
facility could demonstrate that, without such an extension, access to
mammography in the geographic area served by the facility would be
significantly reduced; and (2) the owner, lessor, or agent described in
a report the steps that would be taken to qualify for full
certification (42 U.S.C. 263b(c)(2)).
In recognition of the fact that a large number of facilities were
working to meet accreditation standards at the same time, and cognizant
of the increased demands placed on accreditation bodies during the
initial implementation of the MQSA, FDA issued 6-month provisional
certificates on October 1, 1994, to facilities whose applications for
accreditation were sufficiently complete for review and which, on
preliminary examination, appeared reasonably likely to receive
accreditation. These 6-month provisional certificates were extendable
for an additional 90 days for those facilities that satisfied the
extension criteria under the statute (42 U.S.C. 263b(c)(2)) and had
diligently pursued accreditation, but had not yet completed all aspects
of the accreditation process before expiration of their provisional
certificate.
Of the more than 10,000 facilities that provide mammography
services in the United States, the vast majority have received full
accreditation and certification. By October 1, 1994, FDA had issued
approximately 6,000 certificates and 4,800 provisional certificates.
Moreover, over 50 percent of those facilities issued provisional
certificates on October 1, 1994, subsequently became accredited and
FDA-certified by March 31, 1994, which was the closing date for the 6-
month provisional period. The remainder of the provisionally certified
facilities satisfied the extension criteria and were granted a 90-day
extension to obtain accreditation and certification.
The agency estimates that 427 mammography facilities closed between
October 1993 and October 1994. These closings were due to a number of
reasons, including failure to apply for certification, voluntary
closure, and failure to successfully complete the accreditation
process. By April 26, 1995, 4 weeks after the end of the 6-month
provisional period, 153 additional facilities had to close either
because they did not pursue accreditation (57 facilities) or they
failed accreditation (96 facilities). Sometime during the 6-month
provisional certification period, 187 facilities voluntarily withdrew
from the accreditation process.
D. Onsite Inspection of Facilities
In accordance with the MQSA, FDA established an annual onsite
inspection program to monitor facility compliance with MQSA standards.
FDA has trained and certified inspectors from most States, and
inspection of mammography facilities began in January 1995. As of
February 21, 1996, 7,265 inspections had been conducted and the results
have been reported to the agency.
E. Role of the States
The MQSA explicitly states that nothing in the statute is intended
to limit the authority of any State to enact State laws relating to
mammography that are at least as stringent as the MQSA or regulations
under the MQSA (42 U.S.C. 263b(m)). In addition to ensuring that States
retain their authority to pass laws that raise mammography standards
even higher, Congress provided a significant role for States to play in
implementing the regulatory scheme and nationwide standards required by
the MQSA.
A State may apply to FDA to become an accreditation body to
accredit mammography facilities operating within the State. As earlier
described, three States--Iowa, California, and Arkansas--have been
approved to accredit the facilities operating within their respective
jurisdictions. A State also may apply to the agency to become the
certifying authority for mammography facilities operating within its
borders (42 U.S.C 263b(q)). The agency currently is conducting research
into various alternatives that would allow States to fulfill this role.
The statute also permits States to perform annual onsite facility
inspections to ensure that facilities operating within the State are
performing quality mammography (42 U.S.C 263b(g)). To date, the
District of Columbia, Puerto Rico, New York City, and all of the
States, except New Mexico, have negotiated contracts with the agency to
perform these annual inspections.
Facilities located in States that elect to serve as accreditation
bodies may elect to be accredited either by the State or the ACR, a
private national approved accreditation body. Both types of
accreditation bodies are audited by FDA to ensure that MQSA standards
are being satisfied.
As mentioned above, most States contract with FDA to perform the
annual inspection required under MQSA. These inspections are subject to
audit by FDA. In those cases where States do not do the inspection,
Federal personnel conduct the required annual inspection.
States' participation and implementation of MQSA is funded in a
variety of ways. Because the MQSA provides for but does not mandate a
particular level of State involvement in the mammography program, a
State can choose to participate at a level that does not require the
appropriation or expenditure of State funds. States acting as
accreditation bodies may charge and collect a reasonable fee from the
facilities which seek the States' accreditation. States that currently
participate in the annual onsite inspection of facilities are paid by
FDA through contract. The agency charges the facilities a reasonable
inspection fee for this service in accordance with 42 U.S.C 263b(r).
Once the agency issues provisions to permit States to serve as
certifiers of mammography facilities, MQSA requires States that elect
voluntarily to serve in this capacity to devote adequate funds to the
administration and enforcement of MQSA requirements.
F. Development of Proposed Regulations
Coincident with the implementation of the interim rules, work was
proceeding on the development of proposed regulations to replace the
interim rules. As discussed previously, the MQSA established an
advisory committee (NMQAAC) to advise FDA in this effort. By statute,
the NMQAAC is to consist of 13 to 19 members, including health
professionals whose work focused significantly on
[[Page 14859]]
mammography, as well as representatives of consumer groups. The NMQAAC
was chartered on July 7, 1993. Nominations for members were accepted
until September 7, 1993. The first meeting of the NMQAAC was held
February 17 through 18, 1994. At that meeting, and in subsequent
meetings in April, July, and September 1994, the NMQAAC reviewed and
commented on drafts of portions of the proposed regulations developed
by FDA. At its January, 1995 meeting, the NMQAAC reviewed the entire
body of proposed regulations as then drafted. Many of the requirements
in the proposed regulations are based on advice obtained from the
NMQAAC during these meetings.
G. Framework of Proposed Regulations
FDA is issuing five separate proposed rules to amend the interim
regulations. All of these proposals are published in this issue of the
Federal Register. The first proposed rule as set forth below, contains
background information (given above), a summary of the preliminary
analysis of the costs and benefits of the proposed amendments to 21 CFR
part 900, a description of the information collection requirements,
proposed revisions to Secs. 900.1 Scope (21 CFR 900.1) and 900.2
Definitions (21 CFR 900.2), and proposed alternative approaches to
mammography quality standards and a request for comments on the
proposed alternatives. The other four proposals set forth requirements
related to: (1) Accreditation bodies; (2) general facility
requirements, including requirements for a medical reporting and
recordkeeping program, a medical outcomes audit program, special
methods for examining individuals with breast implants, a consumer
complaint mechanism, and a variance procedure for requesting FDA
approval of alternative standards; (3) personnel requirements for
interpreting physicians, radiologic technologists, and medical
physicists; and (4) definitions, mammography equipment standards, and
quality assurance requirements for mammography equipment.
The agency believes that the proposed amendments, when implemented,
will increase the quality of mammography nationwide and facilitate the
early diagnosis and treatment of breast cancer or other diseases of the
breast.
In drafting the proposed regulations, and in consultation with the
NMQAAC, FDA has established specific requirements for those areas that
the agency believes are essential to the practice of quality
mammography. Conversely, in those areas where the agency is aware of
multiple methods or procedures for effectively accomplishing the same
task, the proposed requirements have been drafted in more general
terms, to give facilities more flexibility to accomplish a particular
quality practice. In some cases, FDA will provide guidance documents
that explain methods and practices that the agency recommends, based on
its current thinking, but does not require by regulation.
The rules that are developed and finalized as a result of this
rulemaking will replace the interim rules issued on December 21, 1993.
The interim rules will continue to apply until final rules become
effective.
II. Alternative Approaches for Quality Mammography
Executive Order 12866 requires Federal agencies to identify and
assess alternative forms of regulation and, where feasible, specify
performance objectives, rather than specifying the behavior and manner
of compliance that regulated entities must adopt (E.O. 12866, Section
1(b)(8)). In addition, Executive Order 12866 (Section 1(b)(10))
requires each agency to avoid regulations that duplicate other
regulations. In proposing final standards, FDA is aware that there can
be alternative means for ensuring quality mammography other than
through those presented in these proposals. FDA notes that the MQSA
itself establishes many overlapping requirements relating to quality
mammography which are reflected in the proposed final regulations. FDA
also recognizes that many of the proposed final regulations contain
design specifications, training and educational requirements, and
process requirements, rather than performance or outcomes standards. In
order to meet objectives established by the Executive Order 12866, FDA
is soliciting comments on the following alternative approaches to
achieve quality mammography under the MQSA. FDA encourages comments on
these alternative approaches to be as detailed as possible. Comments
that address and describe the application of specific performance or
outcomes standards will be most useful in the event the agency is
persuaded that this alternative is the more desirable approach.
Overlapping functions for facilities, accreditation bodies, and FDA
have advantages and disadvantages. As an example, under section
354(e)(1)(B)(v) of the Public Health Service Act (PHS Act) (42 U.S.C.
263b(e)(1)(B)(v)), as amended by the MQSA, the accreditation body is
required to perform monitoring and evaluation of medical physicists'
annual surveys. At the same time, under section 354(g)(1)(B)(v) of the
PHS Act, the MQSA requires FDA to annually inspect facility compliance
with quality standards, including compliance with the section of the
MQSA that requires each facility to have a qualified medical physicist
annually survey mammography equipment (42 U.S.C. 263b(f)(1)(F)). In
this instance, therefore, annual physicist surveys are being reviewed
by both the accreditation body and the inspector. FDA's experience
under the interim final regulations is that of 7,431 MQSA inspections
in 1995, only 5 accredited facilities were without annual physicist
surveys. This suggests that duplicative review serves a compliance
purpose. However, it may be possible under a different approach for the
accreditation body to accept inspection reviews of surveys, or, for
inspectors to accept an accreditation body's review of a facility's
survey. While there are strengths in a program that has multiple checks
and overlapping areas of responsibility to ensure compliance, there are
also cost and resource considerations that may favor alternative
approaches to satisfy statutory mandates. Such alternative approaches
will need to adequately ensure integrity of the evaluation if oversight
mechanisms are decreased. FDA is soliciting comments on approaches that
would reduce the overlapping nature of many quality assurance
provisions proposed, while maintaining assurances for integrity of the
evaluation.
Advantages and disadvantages exist in adopting an approach that
utilizes detailed design and qualification-based standards versus an
approach based on performance standards and outcomes measures. For
example, detailed design and behavior-based standards may be clear and
precise; they can provide an objective evaluation of compliance during
an inspection and make clear to facilities what is expected of them.
However, these standards can limit flexibility and innovation and do
not ensure that everyone who meets the established criteria is indeed
competent. On the other hand, performance standards and outcome
measures may allow greater variability in behavior and methods of
compliance. However, while outcome measures may reflect the true nature
of performance in a population and be an incentive to good performance,
they may also be subject to adjustments to circumvent low performance.
FDA is soliciting comments on the possibility of pursuing
[[Page 14860]]
quality mammography through more performance and outcome-based
standards. FDA would also like comments on the anticipated economic
consequences of this approach compared to the approach of the proposed
regulations. FDA hopes the comments will provide more information
regarding the short and long-term viability of this alternative
approach for purposes of mammography regulation.
The following sections discuss ideas for the application of
performance and outcome-based standards to mammography facility
operations:
A. Mammography Equipment and Quality Control
Under current proposals, FDA has specified mammography equipment
performance and design requirements. While design specifications are
clear, they may inadvertently impede technical innovation. An
alternative proposal would be to use phantom image testing as a
complete equipment system test, thereby eliminating the need for other
specific quality control tests, or, permitting those other tests to be
conducted less frequently. The phantom image test is currently being
proposed to be done weekly as a part of the facility's ongoing quality
assurance program. The current phantom used, however, is not the
optimal design if phantom image testing were to serve as a single
system performance evaluation criterion. A recent article (Ref. 8)
suggested that the current phantom has limitations in simulating the
average breast. Research may be necessary to design a phantom whose
image will be significantly affected by enough characteristics of the
system so that other tests could be eliminated.
Another issue associated with the use of phantom image testing as a
single system evaluation test is that there is inadequate information
available on how phantom images correlate with actual clinical images.
There is concern that no phantom image evaluation will adequately
predict the clarity and characteristics of the entire biologic spectrum
of breast tissue.
FDA believes it is theoretically possible to substitute phantom
image testing for some equipment requirements and some quality control
tests if some other standards were made more stringent and the phantom
were suitable. For example, the frequency of phantom image testing
might be increased to daily if the backing material could be changed to
be more tissue equivalent, if different thicknesses could be developed
to represent the range of actual breast thicknesses encountered in
daily practice, and if research established appropriate performance
parameters based on these changes. A step wedge might be included in
the design of the phantom so that, after a trial period, daily
sensitometry could be eliminated. It may be necessary to record the mAs
value daily, so that when deviations occur, it would be possible to
determine if it was an x-ray machine variation or film processor
variation. Ideally, this image test would be combined with a dose
measurement, at least periodically, so that an even more complete
system test would be conducted.
Another possible performance measure for equipment and substitute
for equipment specifications and quality control tests is an ongoing
analysis of a facility's repeat rate. Under both the interim final
regulations and the proposed final regulations set forth elsewhere in
this issue of the Federal Register, the repeat rate is to be analyzed
every 3 months, and up to 250 exams are used. Ongoing repeat analysis
might substitute for some quality control tests, equipment
requirements, and technologist requirements. Using the repeat rate as a
performance outcome might be appropriate if repeat analysis were
conducted continuously, rather than periodically, if personnel were
trained to evaluate the films according to the criteria currently used
by accreditation bodies for clinical image review, and if trends or
problems were identified and corrected immediately. One potential
problem with this approach is that the repeat rate is easily altered by
a facility through the acceptance of all examinations of any quality
performed. Thus, a facility could conceivably have a zero repeat rate,
but many problems. Adopting use of repeat rates as a performance
measure would require the development of mechanisms to minimize this
type of manipulation.
B. Mammography Personnel: The Interpreting Physician and the Medical
Audit
Under the current proposal for final standards, interpreting
physicians would be required to meet initial qualifications through
board certification or training, mammography-specific training and
experience, and continuing education and experience requirements. While
these requirements for training and experience guarantee familiarity
with mammography and interpretation issues, it is possible that
interpretation performance can be less than optimal despite meeting
these requirements. An alternative means to ensuring the MQSA's mandate
of ``* * * quality assurance * * * at each facility that is adequate
and appropriate to ensure the reliability, clarity, and accuracy of
interpretation of mammograms * * *'' (42 U.S.C. 263b(A)(1)(A)) may be
to use performance-based standards.
The use of specific medical outcomes measures is discussed in the
proposal entitled ``Quality Standards and Certification Requirements
for Mammography Facilities; General Facility Requirements'', published
elsewhere in this issue of the Federal Register. FDA recognizes the
significant cost and effort associated with tracking examinations
interpreted as nonmalignant. While the absence of cancer registries in
many locales limits the feasibility of collecting many outcomes
measures, those locales with cancer registries may be able to collect
data on sensitivity and specificity. These locales might be able to
forego compliance with all or some of the proposed personnel
qualifications so long as sensitivity and specificity for screening
mammography, or other measures such as minimal cancer detection rates,
were within an acceptable range, e.g., the Agency for Health Care and
Policy Research guidelines. These ranges may have to be refined using
other data from recently published practice patterns, clinical trials,
and information from the National Cancer Institute's Breast Cancer
Consortium studies. In order to be valid, facilities would have to
track other variables of the screening clientele that could affect
sensitivity and specificity such as age and other parameters that are
currently being identified through research. This data collection,
while time-consuming, would enhance the validity of calculated
statistics.
In areas without cancer registries, positive predictive value may
be calculated to assist in ensuring appropriateness and accuracy of
physician recommendations. FDA notes that there is not yet a consensus
on what ranges of the positive predictive value are acceptable, and
that this value is subject to intentional adjustment by practices in
the facility. However, use of the positive predictive value coupled
with indices of early detection, such as sizes of cancers detected,
could reduce concerns about intentional manipulation of data and
provide a useful measure of an individual physician's comparative
performance from year to year.
FDA recognizes concerns raised by the NMQAAC about public
disclosure of statistics, including issues of legal liability and
public confusion over the meaning and limitations of statistics.
[[Page 14861]]
The agency believes that data generated and reviewed for mammography
audits should be used internally by each facility to improve individual
and group performance. The agency further recognizes that State laws
with respect to medical audit information vary and may not prevent
disclosure in State courts through discovery or other procedures
established by State law. However, concerns raised about public
disclosure of statistics and consumers not understanding their
limitations could be addressed through active consumer education to
assist consumers in analyzing information and making health care
decisions. A recent summary of the New York State experience with
public reporting of cardiovascular surgery mortality outcomes showed
improved risk-adjusted operative mortality beyond what was expected
using nationwide trends for adjustment. The summary states that the
collection data on mortality and reporting risk-adjusted mortality
rates to hospitals and physicians contributed to improved outcomes
(Ref. 9).
Finally, FDA is aware that substantial differences in statistics
can arise from differences in definitions of screening mammography.
Under an outcomes measurement approach, it might be necessary for the
agency to define the precise situations that would constitute
screening. For example, a woman with implants might have a diagnostic
mammogram, meaning the procedure was under the direct supervision of an
interpreting physician and consisted of more than standard mediolateral
oblique/craniocaudal views. However, this woman's mammogram
interpretation and her medical outcome might be classified by FDA as
screening for statistical calculations if she was asymptomatic at the
time of the examination. Thus, choosing to use outcomes measures could
require the agency to establish certain definitions of medical
practice.
Another alternative to proposed training and experience regulations
is to have interpreting physicians undergo proficiency testing on
mammogram interpretation. While the establishment of such tests and
their periodic administration would be challenging, this testing,
perhaps administered through the accreditation bodies, would allow for
direct assessment of mammography interpretive skills. Remedial programs
and reassessments would have to be established as well. FDA is aware of
the ACR's Committee on Mammography Interpretive Skills Assessment
(COMISA), created in 1992. COMISA is charged with development of an
educational examination tool. Experiences gained through this project
could be used for development of a proficiency test.
It is possible that regulations for interpreting physician
qualifications could include all three options: Training and experience
requirements, medical outcomes audit statistics and acceptable ranges,
and an option for periodic proficiency testing, or some combination
allowing for choice of compliance option. Again, FDA solicits comments
on the utility and advisability of this approach.
C. Mammography Personnel: The Radiologic Technologist
Under the current proposal for final standards, radiologic
technologists would be required to meet initial qualifications through
board certification or training, mammography-specific training and
experience, and continuing education and experience requirements. While
these requirements for training and experience guarantee familiarity
with the performance of mammograms and mammography issues, it is
possible that the technologist's own performance can be less than
optimal despite meeting these requirements. An alternative means to
ensure proper mammography performance is to consider using clinical
image review as a performance assessment tool. Clinical image review of
a sufficient number of mammograms performed by the radiologic
technologist would provide information on compression, positioning,
selection of adequate technique factors, and production of clear and
reliable mammograms. This assessment would have to control for
equipment performance and processing in order for it to be a true
measure of technologist performance. This could perhaps be accomplished
through appropriate daily phantom imaging as discussed above. In
addition, the method for selection of mammograms would have to be
carefully defined to allow for representative sampling of technologist
performance given differences in patients' habitus, breast morphology,
and cooperativeness with the procedure. The assessment would also have
to be correlated with repeat rate. It would be undesirable for the
technologist to achieve a high level of clinical image quality at the
cost of a high repeat rate.
As with interpreting physicians, the development of a technologist
proficiency test that would include a practical examination could also
be viewed as a performance-based measure. Currently, the ARRT's
certification in mammography only includes a written examination.
Expansion of this to include a practical examination along with
periodic recertification examinations would increase the viability of
ensuring competency in mammographic procedures.
D. Mammography Personnel: The Mammography Medical Physicist
Under the current proposal for final standards, medical physicists
must be either board certified in an appropriate specialty or State
approved, and, in addition, meet education and experience requirements.
While these requirements are meant to ensure knowledge and experience
in surveying and overseeing mammography machines and quality control,
they do not necessarily ensure good performance. Alternative
performance measures would include the development of a written
examination along with a practical survey test. The survey test, while
most reflective of actual practice, still could not test for all
possible situations a medical physicist is called upon to deal with at
facilities. It would be necessary to have this proficiency test
repeated periodically, requiring the development of new logistic and
administrative procedures. If this approach were adopted, the
practicing medical physicist's actual performance outside of the
testing environment still must be correlated to test performance.
Development of an accurate and predictive tool would require adequate
resources.
E. Request for Comments
FDA is interested in comments on the desirability of any of the
approaches described above, and on any other possible approaches that
would address the issue of performance-based standards. If performance-
based standards are considered desirable, there may be need for
additional research to provide information to make scientifically sound
and cost effective performance based standards. There are several
options as to how the agency could proceed while such research is being
performed. The agency could leave the interim final standards in place,
or, the agency could make minor amendments to the interim final
standards to clarify points but not add any new requirements, or, the
agency could proceed with final implementation of the set of standards
contained in this proposal as modified after consideration of the
comments. FDA invites comment on the pursuit of any of these or other
options.
[[Page 14862]]
III. Scope and Definitions
A. Scope
Proposed Sec. 900.1 summarizes the scope of part 900 (21 CFR part
900), which contains two subparts implementing different sections of 42
U.S.C. 263b. Subpart A of part 900 establishes application procedures
and requirements for accreditation bodies. Subpart B of part 900
establishes procedures for mammography facility certification and
quality standards for mammography facilities. The proposed requirements
for subpart B of part 900 are published elsewhere in this issue of the
Federal Register.
B. Definitions
FDA is proposing amendments and additions to the definitions
established in Sec. 900.2 of the interim regulations. These proposed
definitions apply to the regulations in this proposal and in the other
MQSA proposals published elsewhere in this issue of the Federal
Register.
1. Amendments
a. Mammography. The amendments to the interim regulations published
in the Federal Register of September 30, 1994 (59 FR 49808), added
definitions of ``screening mammography'' and ``diagnostic mammography''
to clarify the applicability of the interim regulations to various
types of facilities. However, differences of opinion within the
professional community regarding the distinction between these two
types of mammography became apparent in discussions between NMQAAC
members and consultants at the January 1995 NMQAAC meeting. In
addition, proposed changes to the interim regulations have made it
unnecessary to define screening and diagnostic mammography for the
purpose of these regulations. Therefore, FDA is proposing to delete
these two definitions. The reference to screening and diagnostic
mammography previously included in the interim definition of
``interpreting physician'' also would be deleted.
The definitions of screening and diagnostic mammography were
intended to clarify which breast cancer screening or diagnostic
mammography activities conducted by a facility were exempt from the
MQSA regulations. Such exempted activities included any breast imaging
conducted in a research setting as part of a scientific study to
evaluate experimental mammography devices, in accordance with FDA's
investigational device exemption regulations (21 CFR part 812). This
exclusion did not apply to mammography conducted using any conventional
mammography device as part of the scientific study to provide baseline
data for evaluating the safety and efficacy of the experimental device.
An exemption was also made for interventional mammography, which
involves the use of breast radiography devices to produce radiographic
images of the breast in association with localization or biopsy
procedures.
These exemptions were based on FDA's belief that science had not
advanced to the point where effective national quality standards could
be developed for these devices. Because FDA still believes this to be
the case, the agency is proposing to retain these exemptions, but to
incorporate them into the proposed definition of ``mammography.''
Eventually, FDA does expect to develop standards for interventional
mammography devices and for research devices that come into standard
use.
b. Interpreting physician. Throughout the MQSA regulations, FDA is
proposing to use only the term ``interpreting physician'' to refer to
persons who interpret mammograms or perform clinical image reviews.
Therefore, the agency is deleting the interim definition for
``qualified practicing physician.'' Also, as discussed previously, the
term ``interpreting physician'' would be modified to refer to
mammography, rather than screening and diagnostic mammography.
c. Patient. In the interim regulations, the term ``patient'' is
used to mean any individual who undergoes clinical evaluation in a
mammography facility, regardless of whether the person is referred by a
physician or self-referred. However, most individuals who undergo
mammography are not ill and do not have a condition requiring medical
care. Therefore, FDA is proposing to substitute the term ``examinee''
for the term ``patient.''
2. New Definitions
a. Personnel qualifications. During implementation of the interim
regulations, questions were raised concerning how physicians,
technologists, or physicists in training, who had not satisfied the
personnel requirements by October 1, 1994, or who failed to maintain
them after October 1, 1994, might establish or reestablish their
credentials. In response to these concerns, FDA is proposing amendments
(published elsewhere in this issue of the Federal Register) to the
personnel requirements in Sec. 900.12(a) (21 CFR 900.12(a)). For the
purpose of implementing these provisions, FDA is proposing to add
definitions of ``contact hour,'' ``direct instruction,'' and ``direct
supervision.'' The intent of these definitions is to clarify that: (1)
The individuals providing training to mammography personnel must be in
contact with the trainees, at least to the extent of evaluating their
work; and (2) those who are supervising the trainees must be available
to review, and, if necessary, correct the trainees' work.
The proposed revisions to Sec. 900.12(a) also would ensure that
individuals trained in the use, survey, or interpretation of images
produced using one modality do not begin work using another modality
without first receiving training related to that modality. The addition
of this requirement made it necessary to define the term ``modality.''
FDA is proposing to define this as a form of technology, within the
scope of the MQSA, for performing radiography of the breast. The
technologies considered to be modalities under this proposed definition
would include existing technologies, such as screen-film systems and
xeromammography, and any future technologies within the scope of the
MQSA. Technologies such as ultrasound that are used to image breast
tissue but do not fall within the scope of the MQSA would not be
considered modalities for the purpose of this proposed rule.
Under the interim regulations, interpreting physicians are allowed
to use double reading to meet the initial and continuing experience
requirements for physicians. The proposed requirements would permit
this practice to continue. However, because there was some confusion
over the meaning of the term, FDA is proposing to add a definition of
``double reading.''
A major concern of the NMQAAC was to make sure that the initial
experience requirement for interpreting physicians did not cause
problems for diagnostic residency programs that schedule the
mammography rotations in the first 6 months of the final year. At the
same time, it was considered important that interpreting physicians
meet this requirement in a relatively short time before beginning to
interpret mammograms independently. To meet both goals, FDA is
proposing (elsewhere in this issue of the Federal Register) to require
residents to become certified at the ``first allowable time'' if they
want to use residency training to meet the initial experience
requirement. Therefore, a definition of the term ``first allowable
time'' has been added to the proposed regulations.
The interim requirements in Sec. 900.12(a)(3) deal specifically
with the qualifications of the medical physicist.
[[Page 14863]]
The interim regulation refers to requirements for degree programs in
``physical science.'' This term can cover a broad spectrum of
scientific disciplines, some of which are unrelated to the knowledge
and skills needed for mammography. For this reason, a narrower
definition of physical science is needed (with respect to both
bachelor's and advanced degrees). FDA is proposing that only physics,
chemistry, radiation science (including medical physics and health
physics), and engineering be considered as physical sciences for the
purpose of this regulation.
b. Equipment. Standards for equipment used in mammography were
established in Sec. 900.12(b) of the interim regulations. Because of
additional proposed equipment requirements, FDA is adding a definition
for the term ``mean optical density,'' defined as the average of
optical densities measured for specified phantom thicknesses at
clinically appropriate peak kilovoltage (kVp) levels. A definition of
the term ``mammography unit'' is being added to clarify that when this
term is used, the reference is to the x-ray generator and associated
components.
c. Quality assurance. Proposed Sec. 900.12(d) would specify new
requirements for the individuals responsible for various aspects of the
facility quality assurance program. These proposed changes have made it
necessary to define the terms ``lead interpreting physician'' and
``quality control technologist.'' The lead interpreting physician would
be the interpreting physician with primary responsibility for ensuring
that the facility quality assurance program meets the requirements of
paragraphs (d) through (f) of Sec. 900.12. It would be left to the
discretion of the facility whether this individual would also have
other supervisory duties. The quality control technologist(s) would be
responsible for those aspects of the quality assurance program not
carried out by the lead interpreting physician or medical physicist.
Several definitions are being added to proposed Sec. 900.2 on
quality assurance requirements for equipment. These include a
definition for ``time cycle,'' which means the film development time,
and for ``traceability,'' which relates to calibration of radiation
measuring instruments.
d. Mammography medical outcomes audit. Discussions with the NMQAAC
regarding the medical auditing requirements in proposed Sec. 900.12(f)
indicated a need to define medical audit. Therefore, FDA is proposing
to define the ``mammography medical outcomes audit'' as a systematic
collection of mammography results and the comparison of these results
with outcome data (e.g., results of subsequent biopsy followup
procedures).
For use with the mammography medical outcomes audit, FDA is also
defining a ``positive mammogram'' as one with an overall assessment of
findings that are either ``suspicious'' or ``highly suggestive of
malignancy.'' This definition incorporates two of the assessment
categories described in Sec. 900.12(c)(1)(iii) (published elsewhere in
this issue of the Federal Register) for use in mammography records and
reports.
e. Breast implant. Proposed Sec. 900.12(g), published elsewhere in
this issue of the Federal Register, contains new standards for
mammography of examinees with breast implants. Establishment of such
standards is required by the MQSA. FDA is proposing to define a
``breast implant'' as a prosthetic device implanted in the breast.
f. Consumer complaint mechanism. FDA is proposing new requirements
in Secs. 900.4(g) and 900.12(h), published elsewhere in this issue of
this Federal Register, for consumer complaint mechanisms to be
established by facilities and accreditation bodies. The purpose of
these new requirements is to ensure that serious complaints about the
quality of the MQSA-related mammography services are adequately
addressed without unduly burdening facilities and accreditation bodies
with Federal regulations requiring extensive consideration of
relatively minor complaints (e.g., complaints about facility air
temperature). Therefore, FDA is proposing to add definitions of
``adverse event,'' ``serious adverse event,'' and ``serious complaint''
to clarify the kinds of situations that would require full
investigation and correction under the statute. These definitions also
would clarify that any substantive complaints that warrant attention,
but are not within the scope of the MQSA (e.g., discrimination or
harassment), must be handled through other mechanisms.
FDA is proposing to add a definition of ``consumer'' to clarify
that the consumer complaint process also can be used by interested
parties other than the examinee (e.g., family members or referring
physicians).
IV. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(3) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
V. Analysis of Impacts
This proposed rule sets forth preliminary ideas for the application
of alternative performance and outcome-based standards to ensure
quality mammography. FDA requests that comments submitted on this
proposal also address the estimated costs and benefits of such
alternatives.
FDA has examined together the impacts of the remaining four
proposed rules to implement the MQSA requirements, published
concurrently in this issue of the Federal Register, under Executive
Order 12866, under the Regulatory Flexibility Act (Pub. L. 96-354), and
under the Unfunded Mandates Reform Act (Pub. L. 104-4). Executive Order
12866 directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages, distributive impacts, and equity). The Regulatory
Flexibility Act requires agencies to analyze regulatory options that
would minimize any significant impact of a rule on small entities. The
Unfunded Mandates Reform Act requires (in section 202) that agencies
prepare an assessment of anticipated costs and benefits before
proposing any rule that may result in an annual expenditure by State,
local, and tribal governments, in the aggregate, or by the private
sector, of $100 million (adjusted annually for inflation). The agency
has conducted preliminary analyses of the proposed rules, and has
determined that the proposed rules are consistent with the principles
set forth in the Executive Order and in these two statutes. The
Regulatory Impact Study that details the agency's calculation of these
economic impacts is available at the Dockets Management Branch for
review. A brief summary of the cost and benefit determination follows.
Incremental annual costs were estimated for each section of the
proposed regulations. Actions expected to be taken by mammography
facilities to come into compliance with the proposal were identified
and current compliance levels were estimated in conjunction with agency
experts and industry consultants. Costs were determined for a 10-year
analysis period. Yearly costs of compliance for mammography facilities
were estimated to range from a high of $203.2 million during the first
year of implementation
[[Page 14864]]
to $25.2 million during the 10th year (2005). These yearly costs
differed due to the phased implementation dates for some of the
proposed requirements. Overall, average annualized costs of this
proposal (at a 7-percent discount rate) are preliminarily estimated to
equal $61.4 million.
Over the full 10-year analysis period, expenditures for the largest
cost element (replacement of mammography units and film processors with
units meeting standards required in proposed Sec. 900.12(b)) could
total more than $270 million and contribute approximately $35 million
in average annual costs (57 percent of total average annual costs).
Other major cost components include proposed Sec. 900.12(c)(2)(i)
(written notification of patient) which accounts for average annual
costs of $14 million (23 percent of total average annual costs),
proposed Sec. 900.12(c)(3)(ii) (telephone contact with referring
physicians) which accounts for over $4 million in annual costs (7
percent of total average annual costs), and proposed Sec. 900.12(e)(2)
(requiring weekly image quality tests) which accounts for average
annual costs of almost $2 million (3 percent of total average annual
costs).
The benefits of the proposed rule were estimated as illustrations
of the expected health outcomes for given levels of quality
improvement. FDA believes that the proposed rules are complementary,
and that quality improvements are limited by the ``weakest link'' in
the process of conducting or interpreting a mammographic examination.
Thus, benefits were estimated assuming compliance with all of the
proposed requirements at the same level of overall quality.
Benefit scenarios were based on an outcome prediction model that
forecast breast cancer survival based on stage-determination at the
time of identification. In addition, FDA estimated the reduction in
costs attributable to the avoidance of followup procedures for those
patients correctly diagnosed as not having cancer due to a range of
quality gains that may occur as a result of the proposed rule. The
calculated benefits are illustrative of the magnitude of health gains
that would be expected to follow heightened quality levels of
sensitivity and specificity. For example, a 5-percent gain in a
sensitivity measurement of 80 percent would indicate a revised
sensitivity level of 81 percent (a reduction of the rate of false
positives from 20 percent to 19 percent).
Overall, the agency could not predict precise quality improvement
gains. FDA estimates, however, those 5-year survival rates of all
patients identified with breast cancer would increase by 0.006 percent
if quality improves by 1 percent, 0.028 percent if the proposed rules
result in a 5-percent gain in quality, and 0.084 percent if the quality
improvements induce a 20-percent gain in sensitivity. (These are equal
to increased survival rates of 0.02, 0.1, and 0.3 percent for all
screened patients at the estimated levels of improvement.) Based on
current disease prevalence rates, these results project that a 1-
percent quality improvement would avert 10 breast cancer fatalities
annually (based on 5-year survival rates), whereas quality improvement
levels of 5 and 20 percent, respectively, would prevent 50 and 150
cancer fatalities.
Several analyses have estimated that society has indicated a
willingness to pay to avoid a statistical death of approximately $5
million. Therefore, a 1-percent improvement in sensitivity as a result
of this proposal would have monetized benefits of $50 million.
Likewise, 5 and 20 percent improvements would bring annual benefits of
$250 million and $750 million, respectively.
In addition, the proposed rules are anticipated to result in
corresponding percent improvements in specificity, which would reduce
the number of followup procedures in nondiseased patients. An
improvement of 1 percent would reduce current annual medical
expenditures by approximately $14 million. If the improvement in
specificity were as high as 5 percent, the annual reduction in medical
costs would equal $72 million. A 20-percent improvement in quality
would reduce current annual medical costs by $287 million.
FDA recognizes that the nature of these proposed regulations may
have a disproportionate effect on small volume mammography facilities
as fixed costs of compliance for equipment improvements are likely to
increase the cost per mammogram for low-volume facilities relatively
more than for high-volume facilities. FDA is currently collecting
additional information on the potential impact on this industry sector,
and requests comments that will assist it in accounting for this
impact.
The agency also notes that average annual compliance costs of $61.4
million could increase the cost per screening mammogram at certain
clinics by from 2 to 6 percent. FDA has estimated that if these costs
are passed on to consumers, the demand for mammograms could be reduced
by approximately 200,000 per year (or 0.9 percent of current demand).
However, the agency believes that quality improvement savings may more
than balance these expected price effects.
[[Page 14865]]
FDA also examined the effect of alternative implementation
schedules for this proposal. An alternative requiring even more
elaborate equipment upgrade immediately upon issuance of the
regulations was rejected as putting an unnecessary burden on the
industry, with estimated average annual costs of more than $120
million. By eliminating some specifications that were considered
marginal to ensuring mammography quality, and phasing in some
requirements to allow for normal replacement of current equipment, the
agency reduced the cost of compliance. FDA also found that delaying the
implementation of the proposed equipment requirements by an additional
year, while reducing the average annual compliance costs by $7.1
million, would mitigate the expected impact of the proposed rule on
quality improvements. Therefore, the proposed implementation schedule
was selected as a reasonable balance between compliance costs and
quality improvements.
MQSA includes a separate reimbursement mechanism to repay State,
local, or tribal governments for the costs of inspections required by
these proposed regulations. Consequently, no unfunded mandate is placed
on local governments as a result of these proposals.
In summary, FDA expects that the proposal would lead to mammography
quality increases. Average annual costs of compliance with this
proposal are estimated to be $61.4 million. The estimated benefits
accrue as a result of fewer breast cancer mortalities as well as the
avoidance of unnecessary surgery. While the magnitude of the expected
quality increases are currently under investigation, an improvement of
only 1 percent would result in monetized annual benefits of $64 million
including 10 fewer cancer mortalities, which slightly exceed the
estimated compliance costs. If the quality improvements range to 5 or
20 percent, the benefits would increase proportionately. A 5-percent
improvement projects average annual monetized benefits of $322 million.
At this level of quality improvement, the cost savings of avoiding
surgery are, by themselves, greater than compliance costs. This would
occur in addition to 50 fewer breast cancer mortalities per year. A 20-
percent quality improvement would result in average annual monetized
benefits of $1,037 million, with 150 fewer annual breast cancer deaths
due to earlier detection.
Because of the preliminary nature of these estimates, FDA requests
comments on all of the methodology and projections included in this
analysis. Comments may be submitted to the Dockets Management Branch
(address above).
IV. Paperwork Reduction Act of 1995
The information collections contained in the December 21, 1993,
interim regulations implementing the MQSA were approved by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of
1995 (Pub. L. 104-13) under control number 0910-0309, which includes
OMB approval for Form FD-3422. The approval will expire July 31, 1998.
Three of the five proposed rules to amend 21 CFR part 900, published
together in this issue of the Federal Register, contain amendments to
the approved information collections, and these revisions are subject
to review by OMB under the Paperwork Reduction Act of 1995 (Pub. L.
104-13). The title, description, and respondent description of the
revised information collections to 21 CFR part 900 are shown below with
an estimate for any annual reporting and recordkeeping burdens which
will be changed by these proposed rules. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the collection of information.
Title: Mammography Facilities.
Description: These information collection requirements apply to
accreditation bodies and to mammography facilities. In order to be an
approved accreditation body, private nonprofit organizations or State
agencies must submit an application to FDA and establish procedures and
a quality assurance program. Mammography facilities must obtain and
prominently display an FDA-issued certificate or provisional
certificate; have a medical reporting and recordkeeping program, a
medical outcomes audit program, a consumer complaint mechanism; and
maintain records documenting personnel qualifications. These actions
are being taken to ensure safe, accurate, and reliable mammography on a
nationwide basis.
Respondent Description: Businesses and other for-profit
organizations, nonprofit organizations, Federal, State, and local
governments.
Therefore, the agency solicits public comments on the revised
information collection requirements in order to: (1) Evaluate whether
the proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information will have practical utility; (2) evaluate the accuracy of
the agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) enhance the quality, utility, and clarity of the information
to be collected; and (4) minimize the burden of the collection of
information on those who are to respond, including through the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of responses.
[[Page 14866]]
Proposed Requirements for Accreditation Bodies of Mammography Facilities
[Table 1a.--Estimated Annual Reporting Burden]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Annual Total annual Hours per Total capital operating and
CFR Section respondents frequency per responses response Total hours costs maintenance
response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.3(b)(3)................................ 10.0 1.0 10.0 60 600 $50
900.4(a)(7) \1\............................
900.4(b)(2) \1\............................
900.4(c) \1\...............................
900.4(d) \1\...............................
900.4(e)(1) \1\............................
900.4(e)(2) \1\............................
900.4(h)(1) \1\............................
900.4(h)(3) \1\............................
900.4(i)(1)\1\.............................
900.4(i)(2)\1\.............................
------------------------------------------------------------------------------------------------------------
Total.................................. .............. .............. .............. .............. 600 $50 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There is no additional burden.
Proposed Requirements for Accreditation Bodies of Mammography Facilities
[Table 1b.--Estimated Annual Recordkeeping Burden]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Annual Total annual Hours per Total capital operating and
CFR section recordkeeepers frequency of records recordkeeper Total hours costs maintenance
recordkeeping costs
----------------------------------------------------------------------------------
FR Doc. 96-7829 Quality Mammography Standards; General Preamble and Proposed Alternative Approaches
----------------------------------------------------------------------
900.3(f)(1)................................ 10 130 1,300 200 2,000
900.4(c) \1\...............................
900.4(c)(2)(viii) \1\......................
900.4(c)(5)(iii) \1\.......................
900.4(d) \1\...............................
900.4(d)(5)(iii) \1\.......................
900.4(e)(1) \1\............................
900.4(e)(2) \1\............................
900.4(f)(2) \1\............................
900.4(g) \1\...............................
900.4(h)(1) \1\............................
------------------------------------------------------------------------------------------------------------
Total.................................. .............. .............. .............. .............. 2,000 0 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There is no additional burden.
[[Page 14867]]
Quality Standards and Certification Requirements for Mammography Facilities; General Facility Requirements
[Table 2a.--Estimated Annual Reporting Burden]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Annual Total annual Hours per Total capital operating and
CFR section respondents frequency per responses response Total hours costs maintenance
response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.11(b)(1) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.11(b)(2) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.11(b)(3) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.11(c).................................. 10,000 0.005 50 20 1,000 .............. $1,000
900.12(c)(1) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.12(c)(2)(i) \1\........................ .............. .............. .............. .............. ........... .............. ..............
900.12(c)(3)(i) \1\........................ .............. .............. .............. .............. ........... .............. ..............
900.15(d)(3)(ii)........................... 10,000 0.002 20 2 40 .............. 100
900.18(c).................................. 10,000 0.0005 6 2 12 .............. 60
900.18(e) \1\.............................. 10 0.1 1 1 1 .............. 10
------------------------------------------------------------------------------------------------------------
Total.................................. .............. .............. .............. .............. 1,053 0 $1,170
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There is no additional burden.
Quality Standards and Certification Requirements for Mammography Facilities; General Facility Requirements
[Table 2b.--Estimated Annual Recordkeeping Burden]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Annual Total annual Hours per Total capital operating and
CFR section recordkeeepers frequency of records recordkeeper Total hours costs maintenance
recordkeeping costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.12(c)(4) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.12(d)(2)(i) \1\........................ .............. .............. .............. .............. ........... .............. ..............
900.12(d)(2)(ii)........................... 10,000 1 10,000 0.25 2,500
900.12(d)(2)(iii).......................... 10,000 1 10,000 1 10,000
900.12(d)(2)(iv) \1\....................... .............. .............. .............. .............. ........... .............. ..............
900.12(f)(2) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.12(f)(4) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.12(h)(2)............................... 10,000 2 20,000 0.5 10,000 .............. $20,000
------------------------------------------------------------------------------------------------------------
Total.................................. .............. .............. .............. .............. 22,500 0 $20,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There is no additional burden.
[[Page 14868]]
Quality Standards and Certification Requirements for Mammography Facilities; Personnel Requirements
[Table 3.--Estimated Annual Recordkeeping Burden]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Annual Total annual Hours per Total capital operating and
CFR Section recordkeeepers frequency of records recordkeeper Total hours costs maintenance
recordkeeping costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.12(a)(4)\1\............................ .............. .............. .............. .............. ........... .............. ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There is no additional burden.
Under OMB information collection no. 0910-0309, 82,810 burden hours
were approved for information collection currently contained in 21 CFR
part 900. The additional requirements contained in these proposed rules
will add 26,153 burden hours to this estimate, resulting in a total
annual burden of 108,963.
As required by section 3507(d) of the Paperwork Reduction Act of
1995, FDA has submitted a copy of the five proposed rules amending 21
CFR part 900 to OMB for its review of the revised information
collection requirements; these five proposed rules are published
together in this issue of the Federal Register. Other organizations and
individuals interested in submitting comments regarding this burden
estimate or any aspect of these information collection requirements,
including suggestions for reducing the burden, should direct them to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, ATTN:
Desk Officer for FDA. Written comments on the information collections
should be submitted by May 3, 1996.
VII. Comments
The agency will consider any comments submitted in response to this
proposed rule in its evaluation of the proposed alternative approaches
for quality mammography and the four proposed amendments to the interim
regulations published elsewhere in this issue of the Federal Register.
FDA advises that, under 21 CFR 10.30(d), any comments submitted in
response to this notice will be included under the docket number found
in brackets in the heading of this document.
Interested persons may, on or before July 2, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this NPRM. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday.
VIII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Wingo, P. A., T. Tong, and S. Bolden, ``Cancer Statistics
1995,'' CA: A Cancer Journal for Clinicians, 45:8-30, 1995.
2. Feuer, E. J., L. M. Wun, and C. C. Boring, et al., ``The
Lifetime Risk of Developing Breast Cancer,'' Journal of the National
Cancer Institute, 85:892-897, 1993.
3. Ries, L. A. G., B. A. Miller, and B.F. Hankey, et al. (eds.),
``SEER Cancer Statistics Review, 1973-1991,'' National Cancer
Institute, NIH Pub. No. 94-2789, Bethesda, MD, 1994.
4. Brown, M. L., F. Houn, E. A. Sickles, L.G. Kessler,
``Screening Mammography in Community Practice: Positive Predictive
Value of Abnormal Findings and Yield of Follow-Up Diagnostic
Procedures,'' American Journal of Radiology, 165:1373-1377; 1995.
5. Kuester, G. F., S. M. Wolfe, ``HRG Report on Screening
Mammography, Public Citizen Health Research Group,'' July 1991.
6. Conway, B. J., O. H. Suleiman, F. G. Rueter, R. G. Antonsen,
R. J. Slayton, J. L. McCrohan, ``Does Credentialing Make a
Difference in Mammography?,'' U.S. Food and Drug Administration,
Center for Devices and Radiological Health, Rockville, MD, Presented
to the Radiological Society of North America, November 19, 1992.
7. ``The National Strategic Plan for the Early Detection and
Control of Breast and Cervical Cancers,'' U.S. Department of Health
and Human Services, Public Health Service.
8. Geise, R. A., A. Palchevsky. Composition of Mammographic
Phantom Materials. Radiology 198:347-350, 1996.
9. Chassin, M. R., E. L. Hannan, B. A. DeBuono. Benefits and
Hazards of Reporting Medical Outcomes Publicly. The New England
Journal of Medicine, pp. 394-398 February 8, 1996.
List of Subjects in 21 CFR Part 900
Electronic products, Health facilities, Mammography, Medical
devices, Radiation protection, Reporting and recordkeeping
requirements, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 900 be
amended as follows:
PART 900--MAMMOGRAPHY
1. The authority citation for 21 CFR part 900 continues to read as
follows:
Authority: Secs. 519, 537, and 704(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360i, 360nn, and 374(e)); sec. 354 of
the Public Health Service Act (42 U.S.C. 263b).
2. Sections 900.1 and 900.2 are revised to read as follows:
Sec. 900.1 Scope.
The regulations set forth in this part implement the Mammography
Quality Standards Act (42 U.S.C. 263b). The intent of subpart A of this
part is to establish procedures whereby an entity can apply to become
an FDA-approved accreditation body to accredit facilities to be
eligible to perform screening or diagnostic mammography services.
Subpart A further establishes requirements and standards for
accreditation bodies to ensure that all mammography facilities under
the jurisdiction of the United States are adequately and consistently
evaluated for compliance with national quality standards for
mammography. The intent of subpart B of this part is to establish
minimum national quality standards for mammography facilities to ensure
safe, reliable, and accurate mammography. The regulations set forth in
this part do not apply to facilities of the Department of Veterans
Affairs.
Sec. 900.2 Definitions.
The following definitions apply to subparts A and B of this part:
(a) Accreditation body or body means an entity that has been
approved by FDA under 42 U.S.C. 263b(e)(1)(A) to accredit mammography
facilities.
(b) Action limits or action levels means the minimum and maximum
values of a quality assurance measurement that can be interpreted as
representing acceptable performance of the equipment being tested.
Values less than the minimum or greater than the maximum action limit
or level indicate that corrective action must be taken by the facility.
Action limits or levels are also sometimes called control limits or
levels.
[[Page 14869]]
(c) Adverse event means an undesirable experience associated with
mammography activities within the scope of 42 U.S.C. 263b. Adverse
events include, but are not limited to:
(1) Poor image quality;
(2) Failure to send mammography reports within 30 days to the
referring physician or the self-referred examinee (as specified in
Sec. 900.12(c)(2) and (c)(3)(i)); and
(3) Use of personnel that do not meet the applicable requirements
of Sec. 900.12(a).
(d) Breast implant means a prosthetic device implanted in the
breast.
(e) Certificate means the certificate described in 42 U.S.C.
263b(b)(1).
(f) Certification means the process of approval of a facility by
FDA to provide mammography services.
(g) Clinical image means a mammogram.
(h) Consumer means an individual who chooses to comment or complain
in reference to a mammography examination, including the examinee or
representatives of the examinee (e.g., family members or referring
physicians).
(i) Contact hour means an hour of training received through direct
instruction.
(j) Direct instruction means:
(1) Face-to-face interaction between instructor(s) and student(s),
as when the instructor provides a lecture, conducts demonstrations, or
reviews student performance; or
(2) The administration and correction of student examinations by an
instructor(s) with subsequent feedback to the student(s).
(k) Direct supervision means that:
(1) During joint interpretation of mammograms, the supervising
physician reviews, discusses, and confirms the diagnosis of the
physician being supervised and signs the resulting report before it is
entered into the examinee's records; and
(2) During the performance of a mammography examination or survey
of the facility's equipment and quality assurance program, the
supervisor is present to observe and correct, as needed, the
performance of the individual being supervised who is performing the
examination or conducting the survey.
(l) Double reading means two or more interpreting physicians
interpreting the same clinical image.
(m) Examinee means any individual who undergoes a mammography
evaluation in a facility, regardless of whether the person is referred
by a physician or is self-referred.
(n) Facility means a hospital, outpatient department, clinic,
radiology practice, mobile unit, office of a physician, or other
facility that conducts mammography activities, including the following:
Operation of equipment to produce a mammogram, processing of the
mammogram, initial interpretation of the mammogram, and maintaining
viewing conditions for that interpretation. This term does not include
a facility of the Department of Veterans Affairs.
(o) First allowable time means the earliest time a resident is
eligible to take the diagnostic radiology boards from an FDA-approved
certifying body. The ``first allowable time'' may vary with the
certifying body.
(p) Interpreting physician means a physician who interprets
mammograms and who meets the requirements set forth in
Sec. 900.12(a)(1).
(q) Lead interpreting physician means the interpreting physician
assigned the general responsibility for ensuring that a facility's
quality assurance program meets all of the requirements of
Sec. 900.12(d) through (f). The administrative title and other
supervisory responsibilities of this individual, if any, are left to
the discretion of the facility.
(r) Mammogram means a radiographic image produced through
mammography.
(s) Mammography means radiography of the breast, but does not
include:
(1) Radiography of the breast performed during invasive
interventions for localization or biopsy procedures; or
(2) Radiography of the breast performed as part of a scientific
study to evaluate an investigational mammography device conducted in
accordance with FDA's investigational device exemption regulations in
part 812 of this chapter.
(t) Mammography equipment evaluation means an onsite assessment of
a mammography unit or image processor for the purpose of making a
preliminary determination as to whether the equipment meets all of the
applicable standards in Sec. 900.12(b) and (e).
(u) Mammography medical outcomes audit means a systematic
collection of mammography results and the comparison of those results
with outcomes data.
(v) Mammography unit or unit means an assemblage of components for
the production of x-rays for use during mammography, including, at a
minimum: An x-ray generator, an x-ray control, a tube housing assembly,
a beam limiting device, and the necessary supporting structures for
these components.
(w) Mean optical density means the average of the optical densities
measured for phantom thicknesses of 2 centimeters to 6 centimeters
using values of kilovolt peak (kVp) clinically appropriate for those
thicknesses.
(x) Medical physicist means a person trained in evaluating the
performance of mammography equipment and facility quality assurance
programs and who meets the qualifications for a medical physicist set
forth in Sec. 900.12(a)(3).
(y) Modality means a technology, within the scope of 42 U.S.C.
263b, for radiography of the breast. Examples are screen-film
mammography and xeromammography.
(z) Phantom means a test object used to simulate radiographic
characteristics of compressed breast tissue and containing components
that radiographically model aspects of breast disease and cancer.
(aa) Phantom image means a radiographic image of a phantom.
(bb) Physical science means physics, chemistry, radiation science
(including medical physics and health physics), and engineering.
(cc) Positive mammogram means a mammogram that has an overall
assessment of findings that are either ``suspicious'' or ``highly
suggestive of malignancy.''
(dd) Provisional certificate means the provisional certificate
described in 42 U.S.C. 263b(c)(2).
(ee) Quality control technologist means an individual meeting the
requirements of Sec. 900.12(a)(2)(i) who is responsible for those
quality assurance responsibilities not assigned to the lead
interpreting physician or to the medical physicist.
(ff) Radiographic equipment means x-ray equipment used for the
production of static x-ray images.
(gg) Radiologic technologist means an individual specifically
trained in the use of radiographic equipment and the positioning of
examinees for radiographic examinations and who meets the requirements
set forth in Sec. 900.12(a)(2).
(hh) Serious adverse event means an adverse event that may
significantly compromise clinical outcomes, or an adverse event for
which a facility fails to take appropriate corrective action in a
timely manner.
(ii) Serious complaint means a report of a serious adverse event.
(jj) Survey means an onsite physics consultation and evaluation of
a facility performed by a medical physicist.
(kk) Time cycle means the film development time.
(ll) Traceability means the ability to show that an instrument has
been
[[Page 14870]]
calibrated at least annually through an unbroken chain of comparisons
starting with either an appropriate national standard established by
the National Institute of Science and Technology (NIST), Gaithersburg,
MD, or with a transfer standard calibrated by NIST.
Dated: March 22, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-7829 Filed 3-29-96; 8:45 am]
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