issue-1996-06-26•Federal Register proposed rules — 1996-06-26
Federal Register proposed rules — 1996-06-26
issue-1996-06-26Federal Register proposed rules — 1996-06-26Proposed 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. 96-16430 Winter Pears Grown in Oregon, Washington, and California; Hearings on Proposed Amendment of Marketing Order No. 927
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33047-33048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16430]
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DEPARTMENT OF AGRICULTURE
7 CFR Part 927
[Docket No. AO-99-A7; FV96-927-1]
Winter Pears Grown in Oregon, Washington, and California;
Hearings on Proposed Amendment of Marketing Order No. 927
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Notice of public hearings on proposed rulemaking.
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SUMMARY: Notice is hereby given of public hearings to consider amending
Marketing Agreement and Order No. 927 (order). The order regulates the
handling of winter pears grown in Oregon, Washington, and California.
The purpose of the hearings is to receive evidence on proposed
amendments to provisions of the order. With the exception of a proposal
submitted by the Fruit and Vegetable Division, Agricultural Marketing
Service (AMS), to make conforming changes and necessary revisions, the
proposed amendments were submitted by the Winter Pear Control Committee
(Committee), the agency responsible for the local administration of the
order. The proposals would remove the State of California from the
order and make related changes to the key provisions concerning the
production area, districts and establishment and membership of the
Committee. Another proposal would allow use of ``Telecopiers'' in the
mail voting procedures. The Committee believes that the proposed
changes would improve the administration, operation, and functioning of
the order.
DATES: The hearings will begin July 9, 1996, at the Red Lion Inn, 1401
Arden Way, Sacramento, California, and July 10, 1996, at the Holiday
Inn Airport, 8439 N. East Columbia Blvd., Portland, Oregon. Both
hearing sessions will begin at 9:00 am.
FOR FURTHER INFORMATION CONTACT: Britthany E. Beadle, Marketing
Specialist, Marketing Order Administration Branch, Fruit and Vegetable
Division, AMS, USDA, Room 2523-S., P.O. Box 96456, Washington, DC
20090-6456; telephone: (202) 720-5127 or FAX (202) 720-5698; or Teresa
Hutchinson, Marketing Specialist, Northwest Marketing Field Office,
Fruit and Vegetable Division, AMS, USDA, 1220 S.W. Third Avenue, room
369, Portland, OR 97204-2807; telephone: (509) 326-2724 or FAX (509)
326-7440.
SUPPLEMENTARY INFORMATION: This action is governed by the provisions of
sections 556 and 557 of title 5 of the United States Code and is
therefore excluded from the requirements of Executive Order 12866. The
hearings are called pursuant to the provisions of the Agricultural
Marketing Agreement Act of 1937 (Act), as amended (7 U.S.C. 601-674),
and the applicable rules of practice and procedure governing the
formulation of marketing agreements and orders (7 CFR part 900).
The Regulatory Flexibility Act (95 U.S.C. 601 et seq.) seeks to
ensure that within the statutory authority of a program, the regulatory
and informational requirements are tailored to the size and nature of
small businesses. Interested persons are invited to present evidence at
the
[[Page 33048]]
hearings on the regulatory and informational impact of the proposed
amendments on small businesses.
The notice of hearing herein has been reviewed under Executive
Order 12778, Civil Justice Reform. It is not intended to have
retroactive effect. The notice of hearing would not preempt any State
or local laws, regulations, or policies, unless they present an
irreconcilable conflict with this notice to consider an amendment.
The Act provides that administrative proceedings must be exhausted
before parties may file suit in court. Under section 608c(15)(A) of the
Act, any handler subject to an order may file with the Secretary a
petition stating that the order, any provision of the order, or any
obligation imposed in connection with the order is not in accordance
with law and requesting a modification of the order or to be exempted
therefrom. A handler is afforded the opportunity for a hearing on the
petition. After the hearing, the Secretary would rule on the petition.
The Act provides that the district court of the United States in any
district in which the handler is an inhabitant, or has his or her
principal place of business, has jurisdiction in equity to review the
Secretary's ruling on the petition, provided an action is filed not
later than 20 days after the date of the entry of the ruling.
The Committee submitted the proposed amendment to remove California
from the winter pear order. The suggested changes are as follows: (1)
Revise the definition of ``production area'' to mean only the States of
Oregon and Washington; (2) revise ``district'' by removing California
and have only those districts designated in the States of Oregon and
Washington; (3) revise ``establishment and membership'' of the
Committee to be consistent with the reduction in size of the regulated
production area; (4) revise ``procedure of Control Committee'', ``(a)
quorum and voting'', so that the number of members present for a quorum
and voting is consistent with Committee representation and amend ``(b)
mail voting'', to allow for the use of ``telecopiers''; and (5) revise
the definition of ``pears'' to exclude pears produced in California.
These proposals were submitted by the Committee, which works with the
Department in administering the order. These proposals have not
received the approval of the Secretary of Agriculture.
The Committee believes that the proposed changes would improve the
administration, operation, and function of the winter pear marketing
order.
In addition, proposals submitted by the Fruit and Vegetable
Division, AMS, are included to make such changes as may be necessary to
the order to conform with any amendment thereto that may result from
the hearing.
Public hearings are being held for the purpose of: (i) receiving
evidence about the economic and marketing conditions which relate to
the proposed amendments of the order; (ii) determining whether there is
a need for the proposed amendments to the order; and (iii) determining
whether the proposed amendments or appropriate modifications thereof
will tend to effectuate the declared policy of the Act.
All persons wishing to submit written material as evidence at the
hearing should submit at least four copies of such material and should
be present at the hearing to present oral testimony concerning the
material.
From the time the notice of hearing is issued and until the
issuance of a final decision in this proceeding, Department employees
involved in the decisional process are prohibited from discussing the
merits of the hearing issues on an ex parte basis with any persons
having an interest in the proceeding. The prohibition applies to
employees in the following organizational units: Office of the
Secretary of Agriculture; Office of the Administrator, Agricultural
Marketing Service; Office of the General Counsel, and the Fruit and
Vegetable Division, Agricultural Marketing Service.
Procedural matters are not subject to the above prohibition and may
be discussed at any time.
List of Subjects in 7 CFR Part 927
Marketing agreements, Pears, Reporting and recordkeeping
requirements.
PART 927--WINTER PEARS GROWN IN OREGON AND WASHINGTON
1. The authority citation for 7 CFR part 927 is revised to read as
follows:
Authority: 7 U.S.C. 601-674.
2. Testimony is invited on the following proposed amendments or
appropriate alternatives or modifications to such amendments. Proposed
amendments submitted by the Winter Pear Control Committee are as
follows:
Amend Secs. 927.4, 927.10, 927.11, 927.20, and 927.33 as follows:
Proposal No. 1
Sec. 927.4 Pears.
Pears means and includes any and all of the Beurre D'Anjou, Beurre
Bosc, Winter Nelis, Doyenne du Comice, Forelle, and Seckel varieties of
pears, and any other winter pear varieties or subvarieties that are
recognized by the Control Committee and approved by the Secretary.
Proposal No. 2
Sec. 927.10 Production area.
Amend Sec. 927.10 by deleting the comma after the word ``Oregon'',
placing the word ``and'' after the word ``Oregon'', deleting the comma
after the word ``Washington'', and removing the words ``and
California'' at the end of the sentence.
Proposal No. 3
Sec. 927.11 District.
Amending Sec. 927.11 by removing paragraph (e).
Proposal No. 4
Sec. 927.20 Establishment and membership.
Amend Sec. 927.20 by removing the number ``14'' in the first
sentence and adding in its place the number ``12''; and by removing the
word ``seven'' and adding in its place the word ``six'' at the
beginning of the sentence and before the word ``members'' in the third
sentence.
Proposal No. 5
Sec. 927.33 Procedure of Control Committee.
Amend Sec. 927.33 paragraph (a) by removing the word ``ten'' in the
first sentence and adding in its place the word ``nine''; and amending
paragraph (b) by adding the word ``telecopier'' and a comma after the
word ``mail'' in the first sentence.
The Fruit and Vegetable Division, AMS, submitted the following
proposal:
Proposal No. 6
Make such changes as may be necessary to the order to conform with
any amendment thereto that may result from the hearing.
Dated: June 24, 1996.
Michael V. Dunn,
Assistant Secretary, Marketing and Regulatory Programs.
[FR Doc. 96-16430 Filed 6-24-96; 12:40 pm]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 96-16396 Pay Telephone Reclassification and Compensation Provisions of the Telecommunications Act of 1996
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33074-33075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16396]
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FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 64
[CC Docket No. 96-128; DA 96-983]
Pay Telephone Reclassification and Compensation Provisions of the
Telecommunications Act of 1996
AGENCY: Federal Communications Commission.
ACTION: Proposed rule; extension of time.
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SUMMARY: In this Order, we are extending the comments and reply
comments deadlines in order to grant to the parties more time to
address all issues raised in the Notice of Proposed Rulemaking. This
Order is issued on the Commission's own motion because of the
relatively short time that was accorded to the parties to comment on
the important issues.
DATES: Comments due: July 1, 1996; Reply Comments due: July 15, 1996.
ADDRESSES: 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: Michael Carowitz, Enforcement
Division, Common Carrier Bureau, (202) 418-0960. For additional
information concerning the information collections contained in this
Further Notice of Proposed Rule Making contact Dorothy Conway at 202-
418-0217, or via the Internet at [email protected].
[[Page 33075]]
SUPPLEMENTARY INFORMATION:
Order
Adopted: June 20, 1996; Released: June 20, 1996.
1. On June 14, 1996, the American Public Communications Council
(``APCC'') filed a motion asking that we extend the deadline for filing
comments in the above-captioned proceeding 1 from June 27, 1996,
to July 1, 1996, a period of four days. APCC also requests a
corresponding extension of the due date for reply comments from July 8,
1996, to July 12, 1996. In support of its motion, APCC states that
virtually every issue in the proceeding vitally affects its members and
that, as a result, additional days are required to effectively prepare
comments.2 Also on June 14, 1996, Southwestern Bell Telephone
Company (``SWBT'') filed a motion for an extension of the deadline for
reply comments to July 12, 1996, although it does not request a change
in the deadline for the initial comment cycle. SWBT argues that due to
the forthcoming federal holiday, there will not be a sufficient number
of business days for parties to respond adequately to the initial
comments.
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\1\ Notice of Proposed Rulemaking, FCC 96-254 (rel. Jun. 6,
1996); 61 FR 31481, June 20, 1996.
\2\ As a national trade association of independent pay telephone
companies, APCC claims that the comment process will require
coordination with member companies and allied state associations.
APCC claims that this process cannot be completed effectively in the
time allotted.
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2. It is the policy of the Commission that extensions of time are
not routinely granted.3 However, in light of the important issues
presented in this proceeding and the relatively short period of time
accorded to the parties to comment on those issues, we believe that the
public interest would be served by granting all parties a brief
extension of the deadlines for the comments and reply comments. While
we take this action on our motion, we nevertheless believe that this
Order will grant relief that is substantially similar to that requested
by APCC and SWBT.
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\3\ See 47 CFR Sec. 1.46(a).
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3. Accordingly, it is ordered, pursuant to Sections 4(i), 4(j), and
5(c) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i),
154(j), and 155(c), and the authority delegated thereunder pursuant to
Sections 0.91 and 0.291 of the Commission's rules, 47 CFR Secs. 0.91
and 0.291, that the deadline for filing comments in the above-captioned
proceeding is extended to July 1, 1996, and the deadline for filing
reply comments is extended to July 15, 1996. Because they concern
issues that are now moot, the motions of APCC and SWBT for an extension
of time are dismissed.
Federal Communications Commission.
Robert W. Spangler
Deputy Chief (Policy), Enforcement Division, Common Carrier Bureau.
[FR Doc. 96-16396 Filed 6-25-96; 8:45 am]
BILLING CODE 6712-01-P
Complete official Federal Register PDF
FR Doc. 96-16334 Copper 8-quinolinolate; Proposed Tolerance Exemption
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33057-33059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16334]
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[[Page 33058]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP-5E4472/P667; FRL-5378-2]
RIN 2070-AC18
Copper 8-quinolinolate; Proposed Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that residues of copper 8-quinolinolate
(CAS Reg. No. 10380-28-6) be exempted from the requirement of a
tolerance when used as an inert ingredient (preservative) in
pesticidally treated paper products used on growing crops. This
proposed regulation was requested by American Agricultural Services
Inc., pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: Comments, identified by the docket number [PP 5E4472/P667], must
be received on or before July 26, 1996.
ADDRESSES: By mail, submit written comments 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 deliver comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Highway, Arlington, VA.
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 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 Virginia address given above, 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: [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 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket number, [PP 5E4472/P667]. No 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: Amelia M. Acierto,
Registration Support Branch, Registration Division (7505W), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: 2800 Crystal Drive, North Tower, Arlington, VA, (703)308-8375,
e-mail: [email protected].
SUPPLEMENTARY INFORMATION: American Agricultural Services, Inc., 404 E.
Chatham St., Cary, NC 27511, has submitted pesticide petition (PP)
5E4472 to EPA requesting that the Administrator, pursuant to section
408(e) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(e),
propose to amend 40 CFR 180.1001(d) by establishing an exemption from
the requirement of a tolerance for copper 8-quinolinolate (CAS Reg. No.
10380-28-6) when used as an inert ingredient (preservative) in
pesticidally treated paper products used on growing crops under 40 CFR
180.1001(d).
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
The data submitted in the petition and other relevant material have
been evaluated. As part of the EPA policy statement on inert
ingredients published in the Federal Register of April 22, 1987 (52 FR
13305), the Agency set forth a list of studies which would generally be
used to evaluate the risks posed by the presence of an inert ingredient
in a pesticide formulation. However, where it can be determined without
that data that the inert ingredient will present minimal or no risk,
the Agency generally does not require some or all of the listed studies
to rule on the proposed tolerance or exemption from the requirement of
a tolerance for an inert ingredient. The Agency has decided that no
data, in addition to that described below, for copper 8-quinolinolate
will need to be submitted. The rationale for this decision is described
below:
1. Copper 8-quinolinolate is cleared by the U.S. Food and Drug
Administration (FDA) as an indirect food additive for use as a
component in food packaging adhesives [21 CFR 175.105(c)]; in paper and
paperboard in contact with aqueous and fatty foods (21 CFR 176.170);
and in paper and paperboard in contact with dry foods (21 CFR 176.180).
2. Copper 8-quinolinolate is currently registered under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) as a fungicide/
preservative for (a) wood treatment including food contact surfaces,
for fruit and vegetable, food and feed containers, and bushel baskets
to protect the wood against mold, mildew, wood rot/decay fungi and wood
stain fungi; (b) agricultural paper mulch to protect against mildew,
fungal rot/decay (c) potato storage, handling, cutting and planting
equipment to protect against bacterial ring rot; and (d) for fabric,
cardboard and paper to protect against mold/mildew.
3. The toxicity data available from the open literature indicates
that copper 8-quinolinolate has a moderate acute toxicity in mice when
administered by intraperitoneal injection; it gave negative results in
a limited mice oral carcinogenicity studies; and has weak mutagenicity
in a bacterial Ames test.
Based on the expected low exposure and the similarity of the
proposed use pattern to the existing use, as an indirect food additive,
already approved by the FDA, and as an active ingredient registered
under FIFRA as preservative for wood, cardboard and paper intended for
storage and handling potatoes, fruits and vegetables, and the available
toxicology data, the EPA has found that, when used in accordance with
good agricultural practice, this ingredient is useful and a tolerance
is not necessary to protect the public health. Therefore, EPA proposes
that the exemption from the requirement of a tolerance be established
as set forth below.
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 any of the
ingredients listed herein, may request within 30 days after publication
of this document in the Federal Register that this proposal be referred
to an Advisory Committee in
[[Page 33059]]
accordance with section 408(e) of FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
docket number, [PP 5E4472/P667].
A record has been established for this rulemaking under docket
number [PP 5E4472/P667] (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:
[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 Virginia address in ``ADDRESSES'' at the
beginning of this document.
The Office of Management and Budget has exempted this proposed rule
from the requirements of section 3 of Executive Order 12866.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1955 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994). Pursuant to the requirements of the Regulatory
Flexibility Act (5 U.S.C. 601-612), the Administrator has determined
that regulations establishing new tolerances or raising tolerance
levels or establishing exemptions from tolerance requirements do not
have a significant economic impact on a substantial number of small
entities. A certification statement explaining the factual basis for
this determination was published in the Federal Register of May 4, 1981
(46 FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 12, 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.
2. In Sec. 180.1001 the table in paragraph (d) is amended by adding
alphabetically the inert ingredient Copper 8-quinolinolate (CAS Reg.
No. 10380-28-6), to read as follows:
Sec. 180.1001 Exemptions from the requirements of a tolerance.
* * * * *
(d) * * *
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Copper 8-quinolinolate (CAS Not to exceed 4% Preservative in
Reg. No. 10380-28-6). by weight of pesticidally treated
pesticide paper.
formulation.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 96-16334 Filed 6-25-96; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 96-16331 National Emission Standards for Hazardous Air Pollutants; National Emission Standard for Radon Emissions From Phosphogypsum Stacks
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Page 33053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16331]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 61
[FRL-5527-3]
National Emission Standards for Hazardous Air Pollutants;
National Emission Standard for Radon Emissions From Phosphogypsum
Stacks
AGENCY: Environmental Protection Agency.
ACTION: Notice of public hearing.
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SUMMARY: The Office of Radiation and Indoor Air, Radiation Protection
Division will hold a public hearing on the proposed rule for 40 CFR
Part 61, Subpart R, (Subpart R) the National Emission Standard for
Radon Emissions from Phosphogypsum Stacks--Notice of Reconsideration.
This proposed rule was in response to The Fertilizer Institute's
Petition for Reconsideration of the National Emission Standards for
Hazardous Air Pollutants regulating radon emissions from phosphogypsum
stacks. EPA partially granted and partially denied the TFI petition for
reconsideration. Pursuant to that decision, EPA is convening this
rulemaking to reconsider 40 CFR 61.205, the provision of the final rule
which governs distribution and use of phosphogypsum for research and
development, and the methodology utilized under 40 CFR Section 61.207
to establish the average radium-226 concentration for phosphogypsum
removed from a phosphogypsum stack.
In the May 8, 1996 Federal Register notice, EPA stated that the
hearing, if requested, would be in Washington, D.C.; however, in order
to provide the public with a more convenient location setting, the
hearing will be held in Orlando, Florida.
DATES: The hearing will be held on Thursday, August 1, 1996, beginning
at 9:00 am and will continue until concluded. In addition, pursuant to
Section 307(d)(5), the public may submit rebuttal and supplemental
information to the docket for thirty (30) days after the public
hearing. This comment period will end on August 31, 1996.
ADDRESSES: The hearing will take place at the Holiday Inn International
Drive Resort, 6515 International Drive, Orlando, Florida 32819.
Comments should be submitted (in duplicate) to: Central Docket Section
(6101), Environmental Protection Agency, ATTN: Air Docket No. 94-57,
Washington, D.C. 20460. The docket is available for public inspection
between the hours of 8:00 am and 5:30 pm, Monday through Friday, in
Room M1500 of Waterside Mall, 401 M Street, SW, Washington, DC 20460. A
reasonable fee may be charged for copying. The FAX number is (202) 260-
4400.
FOR FURTHER INFORMATION CONTACT: Rita Cestaric, Project Officer, Center
for Federal Guidance and Air Standards, Radiation Protection Division,
Office of Radiation and Indoor Air (6602J), Environmental Protection
Agency, Washington, DC 20460, (202) 233-9762.
SUPPLEMENTARY INFORMATION: This meeting is open to all members of the
public. Requests to attend and participate in the public hearing on the
proposed rule for 40 CFR Part 61, Subpart R, the National Emission
Standard for Radon Emissions from Phosphogypsum Stacks--Notice of
Reconsideration (61 FR 20775, No. 90, May 8, 1996), should be made by
July 16, 1996 and submitted in writing to Eleanor Thornton, Program
Analyst, Center for Office of Radiation and Indoor Air (6602J),
Environmental Protection Agency, 401 M Street, SW, Washington, DC
20460. Requests may also be faxed to EPA at (202) 233-9629 or 233-9626.
Requests to participate in the public hearing should also include an
outline of the topics to be addressed, the amount of time requested,
and the names of the participants. EPA may also allow testimony to be
given at the hearing without prior notice, subject to time restraints
and at the discretion of the hearing officer. Three (3) copies of
testimony should be submitted at the time of appearance at the
hearings. An agenda will be available at the hearing.
Dated: June 20, 1996.
Mary D. Nichols,
Assistant Administrator for Air and Radiation.
[FR Doc. 96-16331 Filed 6-25-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-16259 Identifying and Eliminating Market Entry Barriers for Small Businesses
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33066-33074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16259]
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FEDERAL COMMUNICATIONS COMMISSION
47 CFR Chapter I
[General Docket No 96-113; FCC 96-216]
Identifying and Eliminating Market Entry Barriers for Small
Businesses
AGENCY: Federal Communications Commission.
ACTION: Proposed rule; notice of inquiry.
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SUMMARY: The attached Notice of Inquiry (NOI) commences a proceeding to
examine barriers to small business entry into the telecommunications
marketplace. Section 101 of the Telecommunications Act of 1996 (1996
Telecommunications Act) adds new Section 257 to the Communications Act,
which requires the Commission, within 15 months after enactment, to
complete a proceeding to identify and eliminate market entry barriers
for entrepreneurs and other small businesses in the provision and
ownership of telecommunications services and information services, or
in the provision of parts or services to providers of
telecommunications services and information services. Through this NOI,
the Commission initiates an omnibus Section 257 proceeding and will
undertake specific initiatives that further the objective of reducing
market entry barriers for small businesses. The record developed in
connection with these intiatives also will, assist us in achieving our
mandate under Section 309(j) of the Communications Act of 1934 to
disseminate licenses for auctionable spectrum-based services to small
businesses, rural telephone companies, and businesses owned by women
and minorities, as well as in fulfilling our general obligation to
serve the public interest.
DATES: Comments must be submitted on or before July 24, 1996 and reply
comments are due on or before August 23, 1996.
ADDRESSES: Comments and reply comments may be mailed to the Office of
the Secretary, Federal Communications Commission, Washington, D.C.
20554.
FOR FURTHER INFORMATION CONTACT: Linda L. Haller, Office of General
Counsel, at (202) 418-1720 or S. Jenell Trigg, Office of Communications
Business Opportunities, at (202) 418-0990.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Notice of Inquiry which was adopted on May 10, 1996, and released on
May 21, 1996. The complete text of this NOI is available for inspection
and copying during normal business hours in the FCC Reference Center
(room 239), 1919 M Street, N.W., Washington, D.C., on-line at the
Office of Communications Business Opportunities' web site via the FCC's
Internet Home Page at www.fcc.gov., and may also be purchased from the
Commission's copy contractor, International Transcription Service (202)
857-3800, 2100 M Street, N.W., Suite 140, Washington, D.C. 20037.
I. Introduction
1. Section 101 of the Telecommunications Act of 1996 (1996
Telecommunications Act),\1\ adds new Section 257 to the Communications
Act of 1934.\2\ Section 257 requires the Commission, within 15 months
after enactment, to complete a proceeding ``for the purpose of
identifying and eliminating, by regulations pursuant to its authority
under this Act * * * market entry barriers for entrepreneurs and other
small businesses in the provision and ownership of telecommunications
services and information services, or in the provision of parts or
services to providers of telecommunications services and information
services.'' \3\ In implementing Section 257, the Commission must
``promote the policies and purposes of this Act favoring diversity of
media voices, vigorous economic competition, technological advancement,
and promotion of the public interest, convenience and necessity.'' \4\
Every three years following the completion of the market entry barriers
proceeding, the Commission must report to Congress on regulations that
have been issued to eliminate barriers and any statutory barriers that
the Commission recommends be eliminated.\5\
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\1\ Telecommunications Act of 1996, Public Law No. 104-104, 110
Stat. 56 (1996).
\2\ 47 U.S.C. 151 et seq.
\3\ 47 U.S.C. 257(a).
\4\ 47 U.S.C. 257(b).
\5\ 47 U.S.C. 257(c).
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2. This Notice of Inquiry (NOI) commences the Commission's omnibus
Section 257 proceeding. We also will undertake specific initiatives
that further the objective of Section 257 to reduce market entry
barriers for small businesses. The record developed in connection with
these initiatives also will assist us in achieving our mandate under
Section 309(j) of the Act \6\ to disseminate licenses for auctionable
spectrum-based services to small businesses, rural telephone companies,
and businesses owned by women and minorities, as well as in fulfilling
our general obligation to serve the public interest.\7\
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\6\ 47 U.S.C. 309(j).
\7\ See, e.g., 47 U.S.C. Sec. 214 (Commission must certify that
public convenience or necessity requires construction or extension
of lines); 47 CFR Sec. 303 (Commission must regulate radio as public
interest, convenience or necessity requires); 47 U.S.C. 307(a)
(Commission must grant radio licenses that serve the public
convenience, interest, or necessity).
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3. We also inquire whether small businesses owned by minorities or
women face unique entry barriers. We explore this area because the
legislative history of Section 257 suggests that Congress was concerned
about the underrepresentation of minority or women-owned small
businesses in the telecommunications market and sought to increase
competition by diversifying ownership.\8\ In addition, Section 309(j)
specifically requires that we further opportunities for businesses
owned by women and minorities in the provision of spectrum-based
services, because a portion of small telecommunications businesses
under Section 257 are owned by women and minorities, and because
[[Page 33067]]
evidence suggests that these entities encounter unique market barriers.
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\8\ The Congressional Record provides:
[W]hile we should all look forward to the opportunities
presented by new, emerging technologies, we cannot disregard the
lessons of the past and the hurdles we still face in making certain
that everyone in America benefits equally from our country's maiden
voyage into cyberspace. I refer to the well-documented fact that
minority and women-owned small businesses continue to be extremely
under represented in the telecommunications field. * * * Underlying
this amendment [Section 257] is the obvious fact that diversity of
ownership remains a key to the competitiveness of the U.S.
telecommunications marketplace.
142 Cong. Rec. H1141 at H1176-77 (daily ed. Feb. 1, 1996)
(statement of Rep. Collins).
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II. Background
4. The primary purpose of this inquiry is to fulfill our mandate
under Section 257 to identify and eliminate market barriers for small
businesses in the provision and ownership of telecommunications and
information services, and in the provision of parts or services to
providers of telecommunications services and information services. We
interpret ``market entry barriers'' to include obstacles that deter
entrepreneurs from forming small businesses, barriers that impede entry
into the telecommunications market by existing small businesses, and
obstacles that small telecommunications businesses face in providing
service or expanding within the telecommunications industry, e.g.,
those that inhibit a paging company from expanding into a new
geographic area or new service such as cellular.
5. The legislative history of Section 257 essentially parallels the
language of the enacted provision. The Conference Report states: ``The
conference agreement adopts the House provisions with minor
modifications as a new Section 257 of the Communications Act.'' \9\
There was no provision in the Senate bill and the House amendment
stated: ``Section 250 [now Section 257] requires the Commission to
adopt rules that identify and eliminate market entry barriers for
entrepreneurs and small businesses in the provision and ownership of
telecommunications and information services. The Commission must review
these rules and report to Congress every three years on how it might
prescribe or eliminate rules to promote the purposes of this section.''
\10\
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\9\ 142 Cong. Rec. H1078-03, H1113-14, Joint Explanatory
Statement of the Committee of Conference at 23.
\10\ 142 Cong. Rec. H1078-03 at H1113. In debates preceding
passage of the 1996 Telecommunications Act, two members of Congress
expressed the view that Section 257 would cover conduct including
that precluded by new Section 222(e), 47 U.S.C. Sec. 222(e), which
prohibits local telephone service providers from charging
discriminatory or unreasonable rates, or setting discriminatory or
unreasonable terms or conditions, in selling subscriber lists to
independent directory publishers. 142 Cong. Rec. H1145-06 at H1160
(daily ed. Feb. 1, 1996) (statement of Rep. Barton); 142 Cong. Rec.
E184-03 (daily ed. Feb. 6, 1996) (extension of remarks by Rep.
Paxon).
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6. Small businesses play a significant role in the U.S. economy.
According to the U.S. Small Business Administration (SBA), in 1992 (the
last year for which information is available), small businesses
constituted the vast majority of all employers, employed 53% of the
private work force, and provided 50% of all receipts. Research also has
shown that small firms innovate at a per person rate twice that of
large firms, spend more money on research and development (R&D), and
more efficiently convert R&D efforts to new products than large
firms.\11\ Furthermore, small businesses are able to serve narrower
niche markets that may not be easily or profitably served by large
corporations, especially as large telecommunications expand globally.
Despite the role of small businesses in the economy, and the growth of
the telecommunications market,\12\ small businesses currently
constitute only a small portion of telecommunications companies.\13\
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\11\ ``Report of the FCC Small Business Advisory Committee to
the Federal Communications Commission Regarding Gen Docket 90-314,''
reprinted at 8 FCC Rcd 7820, 7828 (1993) (SBAC PCS Report) (citing
Joint Petition for Further Rulemaking of Advanced Mobilecomm
Technologies, Inc. and Digital Spread Spectrum Technologies, Inc.,
in Gen Docket 90-314, Exhibit # 3, at 12-13).
\12\ For example, according to Edge Media, worldwide revenues
for Personal Communications Services (PCS) could grow to $31 billion
for equipment and services by the year 2000, The Telecommunications
Industry A Market Opportunity Analysis, Federal Communications
Commission, Office of Communications Business Opportunities (June
1995) (1995 OCBO Analysis) at 17 & n.30 (citing 1995
Telecommunications Market Review and Forecast, North American
Telecommunications Association), and PCS is expected to have 13.5
million subscribers by the year 2000, id. at 1. The cellular market
itself is growing rapidly: subscribership increased from
approximately 5 million in 1990 to over 24 million in 1994. Id. The
cable industry generated nearly $23 billion in 1994 and revenues
will likely continue to climb, given that over 65% of all households
with television sets subscribe to cable for video programming and
over 95% of the country is wired for cable. Id. at 3.
\13\ For example, the SBAC noted that SBA sales and employment
data for the period 1989-1991 indicated that while the total number
of small telecommunications enterprises had increased, cumulative
market share possessed by those businesses decreased significantly.
``Report of the FCC Small Business Advisory Committee to the Federal
Communications Commission Regarding Gen Docket 90-314,'' reprinted
at 8 FCC Rcd 7820, 7826 (1993) (SBAC PCS Report). Stated
differently, bigger businesses were commanding larger portions of
telecommunications revenues. Of a total of 990 firms in Standard
Industrial Code 4812 (radiotelephone industries) in 1989, 971 firms
with 249 employees or less possessed a 35.1% cumulative market share
in 1991, compared to 927 firms in the same employment size range
with a cumulative market share of 52.5% in 1989. Id. In contrast,
there were a total of 19 firms with over 249 employees commanding a
64.9% cumulative market share in 1991, compared to 21 firms of the
same size range with a cumulative market share of 47.5% in 1989.
Id.; see also FCC, ``Telecommunications Industry Revenue: TRS Fund
Worksheet Data'' (February 1996) at Table 21 (of all 1,347 local
exchange carriers (LEC) filing FCC Form 431 Telecommunications Relay
Service (TRS) Fund Worksheets, the top fifth represent 98% of all
LEC revenues; of all 97 interexchange carriers (IXC) filing TRS Fund
Worksheets, the top fifth represent 99% of all IXC revenues);
Implementation of Section 309(j) of the Communications Act--
Competitive Bidding, Fifth Report and Order, 9 FCC Rcd 5532, 5578,
59 Fed. Reg. 37,566 (1994) (Competitive Bidding Fifth Report and
Order) (comments of DCR Communications asserting that ten large
companies--the six RBOCs, AirTouch (formerly owned by Pacific
Telesis), McCaw (now owned by AT&T), GTE and Sprint--control nearly
86 percent of the cellular industry, and that nine of these ten
companies control 95% of the cellular population and licenses in the
50 BTAs that have one million or more people).
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III. Identifying Market Barriers
A. General Market Barriers
7. In this section, we first request commenters to provide profile
data about small telecommunications businesses, including financing
sources and terms, services provided, markets served, geographic areas
of operation, and employee workforce. This information will assist us
in identifying market barriers and designing appropriate measures to
eliminate barriers. Commenters may submit individualized or aggregated
data. We request commenters to provide the following information in as
much detail as possible regarding particular services, including but
not limited to PCS, cellular, paging, SMR, satellite, radio,
television, wired cable, wireless cable, local exchange, long-distance,
access, on-line, messaging, and international services, and resale of
any such service, as well as information regarding businesses that
provide parts or services to providers of telecommunications services
and information services:
(1) Ownership structure, including identity of owner(s) by gender
and racial group,14 as well as percentage of minority or female
control;
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\14\ Consistent with the definition of ``minority'' in our
rules, minority identification should be Black, Hispanic, American
Indian, Alaskan Native, Asian, or Pacific Islander, as appropriate.
See, e.g., 47 CFR Secs. 1.1621(b) and 24.720(i); see also Race and
Ethnic Standards for Federal Statistics and Administration
Reporting, OMB Statistical Policy Directive, No. 15 (1977).
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(2) Communications service(s) provided;
(3) Geographic region(s) served;
(4) Primary markets (e.g., businesses, residences, government);
(5) Number of employees, job categories (i.e., officials and
managers, professionals, technicians, clerical), and employee
composition in job categories by race and gender.
(6) Capital requirements for entry or expansion;
(7) Funding sources and methods of raising capital;
(8) Revenue, income and profit levels.
8. To help fulfill our responsibilities under Sections 257 and
309(j), we request comment on the following questions regarding market
barriers.
[[Page 33068]]
Comments should be as specific as possible and identify with
particularity the types of services and geographic regions covered.
(1) What obstacles do small businesses face in accessing capital
and credit?
(2) Do small businesses obtain capital and credit under terms and
conditions less favorable than those provided large businesses? If so,
why?
(3) What difficulties do small businesses face in their dealings
with suppliers, vendors, contractors, or FCC licensees?
(4) What obstacles do small businesses face in their abilities to
resell, interconnect, or benefit from economies of scale?
(5) Do high deposit requirements deter small business entry into
resale?
(6) Do small businesses have difficulty attracting or retaining
clients?
(7) Do small businesses have difficulty dealing with trade
associations and other private entities?
(8) Do small businesses have particular difficulties in obtaining
government contracts, licenses, franchises, or other government
benefits? Have small businesses faced any such problems regarding FCC
policies or rules?
(9) Do contracts for a single bidder to serve a large volume and
diversity of companies through one contract disadvantage small
businesses?
(10) Do small businesses encounter difficulties attracting
strategic partners?
(11) In forming alliances with other entities, are small businesses
required to do so under unfavorable terms and conditions for the small
business?
(12) Are there unique obstacles that small businesses face in
entering or operating in the telecommunications field that are not
faced by small businesses operating in other sectors (for example, in
the retail or service sectors)?
(13) Do small businesses experience difficulties identifying and
obtaining access to spectrum?
9. We request comment on how these impediments vary depending on
the particular service provided. What particular types of businesses
have difficulty getting started, operating, and expanding? Does the
cost of capital differ for small broadcast stations versus small
wireless providers? Does the cost of capital vary depending on the
particular type of wireless (paging, SMR, PCS, etc.) or broadcast
(television or radio) service offered? Do any other market entry
barriers exist? For what services? Parties should comment on the
geographic scope of any identified barrier, i.e., does the barrier
exist nationwide, or in particular regions or locales? For any barrier,
commenters also should identify whether it is a statutory
requirement,15 government regulation, or external factor, e.g.,
difficulty obtaining loans.
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\15\ Section 257 requires that we report to Congress any
statutory barriers that the Commission recommends be eliminated. 47
U.S.C. 257(c).
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10. We also request comment on how these difficulties are
influenced by size. Are impediments to entry and expansion greater for
very small businesses? For example, does the cost of capital increase
as the size of a small business decreases? Do very small businesses
encounter greater difficulties in dealings with suppliers, vendors, or
contractors than larger small businesses?
B. Unique Market Entry Barriers
11. In this section, we seek information to help us identify any
unique obstacles that small telecommunications businesses owned by
women or minorities encounter in forming firms, providing service, or
expanding in the telecommunications market. We explore this area
because first, the legislative history of Section 257 suggests Congress
was concerned about the underrepresentation of minority and women-owned
small businesses in the telecommunications market and sought to
increase competition by diversifying ownership. Second, Section 309(j)
specifically requires that we further opportunities for businesses
owned by women and minorities in the provision of spectrum-based
services. Third, based on our licensing information and other
statistical data, we know that a portion of small communications
businesses are owned by women and minorities and there is evidence that
these entities encounter unique market barriers.
12. Evidence demonstrates that a principal barrier is minority or
female status, rather than race or gender-neutral factors, and that
this barrier contributes directly to low participation rates. For
example, in the 1992 Small Business Act, Congress found that businesses
owned by minorities or women have particular difficulties in obtaining
capital.16 In the Women's Business Ownership Act of 1988,17
Congress found that women as a group are subject to discrimination that
adversely affects their ability to raise or secure capital. In 1993,
the National Foundation for Women Business Owners found that women-
owned firms are 22% more likely to report difficulties with banks than
are businesses at large, and that removal of financial barriers would
encourage stronger growth among women-owned businesses, resulting in
much greater growth throughout the economy.18 Further, in a 1992
Report to the President and Congress, the National Women's Business
Council cited lack of access to capital as the most pervasive barrier
to success for women business owners.19
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\16\ 1992 Small Business Act, sections 112(4) and 33(a)(4).
\17\ Public Law No. 100-533 (1988).
\18\ ``Financing the Business, A Report on Financial Issues from
the 1992 Biennial Membership Survey of Women Business Owners,'' The
National Foundation for Women Business Owners (October 1993).
\19\ ``Annual Report to the President and Congress,'' National
Women's Business Council (1992) at 11.
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13. As to communications businesses specifically, the American
Women in Radio and Television, Inc. asserts that ``[b]ased on their
gender, women today confront significant barriers in raising the amount
of capital necessary to seize the ownership opportunity. This lack of
access to capital has contributed directly to the low level of female
ownership of mass media facilities.'' The Commission has recognized
that ``considerable evidence has been presented showing that the
primary impediment to minorities seeking to enter the communications
industry or to increase their mass media holdings has been lack of
access to capital.'' In April 1995, the National Telecommunications and
Information Administration (NTIA) found that ``there are real barriers
to minority participation in telecommunications, and that minorities
often lack access to the types and amount of capital required to form
and expand telecommunications businesses.'' Congressional testimony
regarding minority discrimination in telecommunications shows that
controlling for education, work experience, age, gender, and other
factors, bank loan dollars, per dollar of owner equity investment, are
160% higher for white firms ($1.85) than black firms ($1.16).20
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\20\ Policies and Rules Regarding Minority and Female Mass Media
Ownership of Mass Media Facilities, Notice of Proposed Rulemaking,
10 FCC Rcd 2788, 2791, 60 Fed. Reg. 6,068 (1995) (Minority/Female
Mass Media Ownership NPRM).
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14. The relatively low representation of women or minority-owned
communications businesses also suggests that these types of businesses
encounter unique obstacles in entering the telecommunications industry.
According to the U.S. Census Bureau, in 1987 women owned and controlled
1.9% (27) of 1,342 commercial television stations and 3.8% (394) of
10,244 commercial radio stations in the
[[Page 33069]]
United States.21 In 1994, minorities owned and controlled 2.7% of
the commercial television stations and 2.9% of the commercial radio
stations in the United States.22 According to the Census Bureau,
in 1992, Blacks owned 3.5% of the entities characterized generally as
communications firms 23 and women owned 31%; and most of these
businesses were solely-owned.24
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\21\ See Comments of American Women in Radio and Television,
Inc. in MM Docket No. 94-149 and MM Docket No. 91-140, at 4 n.4
(filed May 17, 1995), citing 1987 Economic Censuses, ``Women-Owned
Business,'' WB87-1, U.S. Department of Commerce, Bureau of the
Census, August 1990 (based on 1987 Census).
After the 1987 Census report, the Census Bureau did not provide
data by particular communications services (four-digit Standard
Industrial Classification (SIC) Code), but rather by the general
two-digit SIC Code for communications (#48). Consequently, since
1987, the U.S. Census Bureau has not updated data on ownership of
broadcast facilities by women, nor does the FCC collect such data.
However, we sought comment on whether the Annual Ownership Report
Form 323 should be amended to include information on the gender and
race of broadcast license owners. Minority/Female Mass Media
Ownership NPRM, 10 FCC Rcd at 2797.
\22\ ``Analysis and Compilation of Minority-Owned Commercial
Broadcast Stations in the United States,'' U.S. Department of
Commerce, National Telecommunications and Information
Administration, The Minority Telecommunications Development Program
(MTDP) (September 1994). These percentages are based on reported
ownership of 1,155 commercial television stations and 9,973
commercial radio stations. MTDP considers ``minority ownership'' as
ownership of more than 50% of a broadcast corporation's stock, or
have voting control in a broadcast partnership.'' Id. Of the 11,128
combined radio and television stations nationwide, minorities owned
2.9% (323). Id.
\23\ ``Communications'' firms are a subcategory in a larger
grouping called ``transportation and public utilities.''
\24\ ``1992 Survey of Black-Owned Businesses,'' U.S. Department
of Commerce, Economics and Statistics Administration, Bureau of the
Census (``1992 Black-Owned Businesses''); ``1992 Survey of Women-
Owned Businesses,'' U. S. Department of Commerce, Economics and
Statistics Administration, Bureau of the Census (1992 Women-Owned
Businesses''). These figures represent firms classified by the
Census Bureau as Standard Industrial Classification Code (SIC) #48
and 1,517 Black-owned firms out of 43,666 total communications firms
and 13,592 women-owned firms out of 43,665 total communications
firms.
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15. Finally, the participation level of minority or women-owned
businesses in the Commission's spectrum auctions so far suggests that
these entities may face unique obstacles. Because auctions will
continue and various factors influence participation,25 we are not
able to fully assess participation by women and minorities. Figures
preliminarily indicate, however, that participation in auctions without
bidding incentives for minorities and women is lower than participation
in auctions with incentives. For example, in the broadband PCS auction
for A and B blocks, which concluded in March 1995, no minority-owned
businesses won a broadband PCS license and only one license (for one of
the lower-priced markets) was won by a woman-owned business. In the MDS
auction, which concluded on March 28, 1996, 7.7% of the eligible
bidders claimed woman-owned status; 8.4% of the eligible bidders
claimed minority-owned status. Of the 67 winners, 5.9% indicated they
were women-owned; 7.5% indicated they were minority-owned.26 In
the 900 MHz SMR auction, which concluded on April 15, 1996, 7.8% of the
eligible bidders claimed woman-owned status and 3.9% claimed minority-
owned status. Of the 80 successful bidders, 6.3% indicated they were
women-owned; 5% indicated they were minority-owned. Statistics for the
PCS C block auction, which ended May 6, 1996, were higher, even though
no competitive bidding incentives were available for businesses owned
by minorities or women: 27 13.3% of the eligible bidders claimed
woman-owned status, 18.0% claimed minority-owned status; 28 and of
the 89 successful bidders, 16.9% indicated they were woman-owned; 28.1%
indicated they were minority-owned.29
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\25\ Factors that may influence participation, include for
example, the type of service, presence of incumbents, projected cost
of a successful bid, capital requirements for offering service,
access to capital, license coverage area, availability of Commission
bidding incentives, and the extent of Commission outreach to small
minority or women-owned businesses and new entrants.
\26\ ``Multipoint Distribution Service Questions and Answers,''
FCC Auctions, Press Information (released March 29, 1996) at 3.
\27\ In the Competitive Bidding Sixth Report and Order, the
Commission noted that many minority-owned and women-owned applicants
prepared to bid in the C Block auction in reliance on race and
gender-based incentives. Thus, their rate of participation is likely
higher than it would have been in the absence of any pre-auction
incentives. See Amendment of Part 20 and 24 of the Commission's
Rules--Broadband PCS Competitive Bidding and the Commercial Radio
Service Spectrum Cap, Notice of Proposed Rulemaking, WT Docket No.
96-59, GN Docket No. 90-314, 61 Fed. Reg. 13,133 (released March 20,
1996) (D, E & F Block NPRM) at para. 27 (citing Implementation of
Section 309(j) of the Communications Act--Competitive Bidding, Sixth
Report and Order, 11 FCC Rcd 136, 60 Fed. Reg. 37,786 (1996).
\28\ Id.
\29\ ``Distribution of Licenses in PCS C-Block Auction,'' FCC
Auctions, Press Information (released May 6, 1996).
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16. By comparison, auctions that offered incentives for women and
minority-owned businesses yielded higher participation by those
entities (both as bidders and winners).
For example, in the July 1994 IVDS auction, 22.5% of the registered
bidders claimed status as minority-owned, and 33.2% as women-owned; of
the auctioned licenses, 23.6% were awarded to bidders claiming
minority-owned status, and 38.2% to bidders claiming women-owned
status.30 In the nationwide narrowband PCS auction, also held in
July 1994, of the 29 qualified bidders, 20.1% claimed minority-owned
status and 10.3% claimed women-owned status.31 None of the winners
were minority or women-owned businesses. In the Fall 1994 regional
narrowband PCS auction, which offered a larger bidding credit than was
available in the nationwide narrowband PCS auction, of the 28 qualified
bidders, 35.7% claimed minority-owned status, and 28.6 % claimed women-
owned status.32 Of the nine winners, 22.2% claimed minority-owned
status, and 33.3% claimed women-owned status.33
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\30\ ``Visitor's Auction Guide, FCC Auction, Broadband Personal
Communications Services'' (December 5, 1994) (1994 FCC Visitor's
Auction Guide) at Section IX.
\31\ Id. at Section VIII.
\32\ Id. at Section VII.
\33\ Id.
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17. We seek a broad and comprehensive record from which to
determine whether the experiences of women and particular minority
groups in entering and participating in the telecommunications market
warrant adopting more significant gender or race-based incentives for
minority or women-owned small businesses. Parties may submit personal
accounts of individual experiences, studies, reports, statistical data,
or any other relevant information.
18. Commenters should address whether there are particular barriers
to entry and expansion based on a small business owner's race or
gender. If so, for which services? Do barriers differ by service, e.g.,
radio, television, advanced television, DBS, PCS, equipment
manufacturing? What specific obstacles do women and minorities
encounter in trying to start small communications businesses? Are there
problems endemic to small women and minority-owned telecommunications
businesses but not to small businesses owned by women and minorities in
other industries (e.g., retail, real estate), and if so, why? Are any
such difficulties the result of race/gender neutral factors such as
economic status, geographic location, level of experience? Are
differences in capital requirements determinative? What other factors
play a role? Commenters should address to what extent any impediments
are unique to small businesses owned by women or minorities, rather
than small businesses generally.
19. Discrimination can be a market entry barrier. Parties may
submit evidence of past or current discrimination based on race or
gender. Judicial findings of discrimination are
[[Page 33070]]
not required.34 Evidence of discrimination can be derived from a
variety of sources, including academic research studies, adjudications,
legislative findings, statistical data, and personal accounts. To the
extent possible, evidence should relate to a particular racial, ethnic,
or gender group.
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\34\ Parties should be mindful, however, that to the extent it
is applicable to federal action, Croson requires that the government
have a `` `strong basis in evidence for its conclusion that remedial
action was necessary,' '' City of Richmond v. J.A.Croson, 488 U.S.
469, 500 (1989) (quoting Wygant, 476 U.S. at 277); see also
Memorandum Regarding Adarand to General Counsels from Walter
Dellinger, Assistant Attorney General, Office of Legal Counsel, U.S.
Department of Justice (dated June 28, 1995) (DOJ Memorandum) at 11.
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20. Women and minority owned businesses may have experienced
discrimination or difficulty in obtaining government licenses. These
experiences may have impeded the ability of such entities to enter the
communications market, and consequently, impeded subsequent
opportunities. We seek evidence of discrimination or unfavorable
treatment by any governmental or public entity with respect to
communications-related licenses, contracts or other benefits. It has
been argued to the Commission that as a result of our system of
awarding broadcast licenses in the 1940s and 1950s, no minority held a
broadcast license until 1956 or won a comparative hearing until 1975
35 and that special incentives for minority businesses ``are
needed in order to compensate for a very long history of official
actions which deprived minorities of meaningful access to the
radiofrequency spectrum.'' 36 We solicit comment on this
particular argument.
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\35\ See ``Statement of David Honig, Executive Director,
Minority Media and Telecommunications Council,'' En Banc Advanced
Television Hearing, MM Docket No. 87-268 (December 12, 1995) at 2-3
& n.2.
\36\ Id. at n.2 citing Southland Television Co., 10 RR 699, 750,
recon. denied, 20 FCC 159 (1955) (awarding a Shreveport VHF license
to the owner of a segregated movie theaters because such segregation
`would be legal under the laws of [Louisiana]').''
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21. Race or gender discrimination in employment may impede
participation and advancement in the communications industry.
Employment provides business knowledge, judgment, technical expertise,
and entrepreneurial acumen, and other experience that is valuable in
attaining ownership positions. For example, the Commission has found
that employment in the broadcast industry is a valuable stepping stone
to broadcast ownership.37
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\37\ See Streamlining Broadcast EEO Rule and Policies, Vacating
the EEO Forfeiture Policy Statement and Amending Section 1.80 of the
Commission's Rules to Include Forfeiture Guidelines, MM Docket No.
96-16, FCC 96-49, 61 Fed. Reg. 9,964 (released February 16, 1996)
(1996 EEO Order & NPRM) at para. 4 (``employment discrimination in
the broadcast industry . . . imped[es] opportunities for minorities
and women to learn the operating and management skills necessary to
become media owners and entrepreneurs''); see also Policy Statement,
Standards for Assessing Forfeitures for Violations of the Broadcast
EEO Rules, 9 FCC Rcd 929, 930, 59 Fed. Reg. 12,606 (1994) (EEO
Forfeiture Policy Statement), vacated on other grounds, 1996 EEO
Order and NPRM (``increased employment opportunities are the
foundation for increasing opportunities for minorities and women in
all facets of the communications industry, including participation
in ownership'').
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22. We seek any evidence that employment discrimination in the
communications industry has been a barrier to entry in the
telecommunications market by small businesses owned by minorities or
women. Submissions should be detailed and should explain why the
commenter believes the conduct at issue (e.g., failure to hire or
promote) was based on race or gender discrimination, rather than the
result of a race or gender-neutral factor (e.g., no job vacancy, job
applicant not qualified for the position).
IV. Eliminating Market Barriers
A. Small Businesses Generally
23. Section 257 requires that after identifying market barriers, we
prescribe regulations to eliminate those barriers. In implementing this
mandate, first, how should we define small businesses under Section
257? By number of employees, gross revenue, net revenue, assets, or any
other factor? Should we adopt a general size standard or specific
standards for particular services (e.g., broadcast, PCS)? For example,
the Commission's current Section 309(j) definitions are based on gross
revenues and assets. Are there other factors the Commission should
consider in defining what constitutes a small business? Should the
Commission explore minimum capital requirements, debt/equity ratios,
cash flow, net worth or other indicia of a business' ability to enter
and compete in the marketplace? To formulate a policy using such
indicia, the Commission would need specific financial information for
small businesses generally, and requests that commenters recommending
new approaches indicate the type of information needed by the
Commission.
24. Second, we seek comments and proposals regarding ways to
eliminate market entry barriers and enhance opportunities for small
businesses in communications services, including, e.g., wireline,
wireless, mass media, cable, satellite. What types of incentives or
requirements would be most effective in eliminating market entry
barriers? Commenters may propose new initiatives or suggest changes to
existing rules or make any other recommendation. Proposals may address,
for example, sale of subscriber lists to independent directory
publishers as recognized by Congress in enacting Section 257,38 or
any other area. Commenters should provide data to support their
proposals. Because Section 257 states that in prescribing rules to
eliminate barriers we must rely on our rulemaking authority under
provisions of the Act other than Section 257, we also request that
commenters identify specific rulemaking provisions in the Act, e.g.,
Section 4(i) 39 that would support any such proposals.
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\38\ See supra note 10 (citing legislative history of Section
257).
\39\ 47 U.S.C. 154(i).
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25. Our Section 309(j) competitive bidding incentives for small
businesses are examples of the types of mechanisms we could adopt in
furtherance of our Section 257 mandate. Have bidding credits,
installment payments, and reduced upfront payments enhanced
opportunities for small business participation? Did the Commission's
outreach efforts in providing information to prospective bidders
enhance small business participation in each auction? If commenters
believe the Commission's existing mechanisms could be modified to
enhance opportunities for small businesses, please explain how, or
suggest new approaches. In addition, we seek preliminary views on how
the Section 309(j) incentives have operated in the five completed
auctions employing small business incentives.40 For example, we
are aware of concerns that due to the high level of bidding in the PCS
C Block auction successful bidders may find it difficult later on to
secure the necessary financial resources to build out their systems,
and may ultimately encounter problems in the market against established
competitors like incumbent cellular providers and the generally large,
well-financed winners of PCS A and B block licenses.41 How do we
balance the
[[Page 33071]]
desire to do more with the need to ensure that larger businesses do not
usurp measures designed to aid small businesses? Do we need to do more
to make sure that small businesses have meaningful opportunities to
participate in the provision of spectrum-based services?
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\40\ Bidding ended in the IVDS MSA auction on July 29, 1994,
regional narrowband PCS auction on November 8, 1994, MDS auction on
March 28, 1996, 900 MHz SMR auction on April 15, 1996, and the C
Block auction on May 6, 1996.
\41\ ''$6 Billion Bid so Far in Latest F.C.C. Auction For
Airwaves,'' N.Y. Times, February 14, 1996, at D1 Column 6 (noting
concerns of one industry consultant that the C Block auction was
overvaluing the wireless market by 20%); ``Billions Pledged at
Wireless License Auction,'' Washington Post, February 17, 1996 at B1
Column 1 (noting that even with the Commission's liberal payment
terms for small businesses, which some analysts figure amounts to a
40-60% discount, small businesses may find difficulty surviving if
the market proves soft or glutted with competitors).
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B. Minority or Women-Owned Small Businesses
26. In Part III.B. above, we request data to identify whether small
businesses owned by minorities or women experience unique market
barriers. In this section, we explore whether there is sufficient
evidence of market barriers to justify special incentives to eliminate
those barriers. We do so because governmental action that takes race or
gender into account is subject to particular constitutional standards:
strict scrutiny for race-based incentives; intermediate scrutiny for
gender-based incentives. We discuss these standards below and then seek
comment on possible incentives that would satisfy the standards while
at the same time furthering the mandate of Section 257.
1. Constitutional Standards
27. The Constitution limits the power of government to classify
individuals based on race or gender. Thus, federal incentive programs
that take race or gender into account must satisfy constitutional
standards. Courts reviewing government programs have applied different
standards of review and reached various results depending on whether
the classification covers race or gender and whether the classification
burdens or benefits its subjects. Race-based programs must be narrowly
tailored to further a compelling governmental interest. Gender-based
programs must be substantially related to serve an important
governmental interest.
28. In Adarand Constructors, Inc. v. Pena, 42 the Supreme
Court held that the federal government's use of race-based criteria for
decisionmaking must satisfy the requirements of strict scrutiny.43
The Court wrote:
\42\ 115 S. Ct. 2097 (1995).
\43\ Prior to Adarand, the standard differed for federal and
state programs. Compare Fullilove v. Klutznick, 448 U.S. 448 (1980)
(federal program evaluated under intermediate scrutiny) with City of
Richmond v. J.A. Croson Co., 488 U.S. 469 (1989) (state program
evaluated under strict scrutiny).
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[W]e hold today that all racial classifications, imposed by
whatever federal, state, or local governmental actor, must be
analyzed by a reviewing court under strict scrutiny. In other words,
such classifications are constitutional only if they are narrowly
tailored measures that further compelling governmental
interests.44
\44\ Id. at 2113.
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By this decision, the Court rejected its earlier legal analysis in
Metro Broadcasting, Inc. v. FCC,45 which had applied the
intermediate scrutiny standard of judicial review to the Commission's
broadcasting distress sale and comparative preference policies for
minorities.46
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\45\ 497 U.S. 547 (1990).
\46\ In Metro Broadcasting, the Court held:
[B]enign race-conscious measures mandated by Congress--even if
those measures are not ``remedial'' in the sense of being designed
to compensate victims of past governmental or societal
discrimination--are constitutionally permissible to the extent that
they serve important governmental objectives within the power of
Congress and are substantially related to achievement of those
objectives.
Id. at 564-65.
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29. Overruling this aspect of Metro Broadcasting, the Court in
Adarand clarified the permissible scope of affirmative action. First,
the Court rejected the notion that the characterization of a racial
classification as ``benign'' should entitle it a lower level of
judicial review. Second, the Court applied to federal minority
preference programs the strict scrutiny standard it had applied to a
local contracting set-aside program in City of Richmond v. J.A. Croson
Co.47 Yet in doing so, the Court emphasized its intention not to
impinge upon the federal government's ability to actively combat both
the practice and the continuing effects of discrimination. A majority
of the Court rejected any notion that strict scrutiny review is
``strict in theory, but fatal in fact.'' As Justice O'Connor stated in
Adarand, ``[t]he unhappy persistence of both the practice and the
lingering effects of racial discrimination against minority groups in
this country is an unfortunate reality, and government is not
disqualified from acting in response to it.'' 48 In rejecting the
Metro Broadcasting standard, the Court nonetheless reasoned that
because the Constitution protects individuals rather than groups, any
governmental action based upon a racial group classification should be
subject to ``detailed judicial inquiry.'' 49
---------------------------------------------------------------------------
\47\ 488 U.S. 469 (1989).
\48\ Adarand, 115 S. Ct. at 2117.
\49\ Id. at 2113.
---------------------------------------------------------------------------
30. Thus, Adarand established a new strict scrutiny standard for
federal minority programs, based upon the two prong analysis of Croson:
(1) the governmental interest underlying the affirmative action measure
be ``compelling;'' and (2) the measure adopted must be ``narrowly
tailored'' to serve that interest. Because a federal minority program
has not yet been subjected to strict scrutiny pursuant to Adarand,
judicial guidance regarding the strict scrutiny standard thus far is
limited to Croson and lower court decisions applying strict scrutiny to
state and local programs.50
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\50\ See Hopwood v. Texas, 78 F.3d 932 (5th Cir. 1996) petition
for cert. filed (holding that the University of Texas School of Law
may not use race as a factor in law school admissions).
---------------------------------------------------------------------------
31. Under these cases, the most clearly permissible compelling
governmental interest is remedying the effects of present or past
discrimination. Thus, federal minority incentive programs that serve a
remedial interest are likely to satisfy the compelling governmental
interest prong. Discrimination can be that committed by the government
itself, or by private actors within the government's jurisdiction (such
that the government was a ``passive participant'' or facilitated the
perpetuation of a system of exclusion). The government must identify
with some precision the discrimination to be redressed,51
including evidence of discrimination against particular minority
groups.52 General, historical discrimination is an insufficient
predicate. ``[A]n amorphous claim that there has been past
discrimination in a particular industry cannot justify the use of an
unyielding racial quota.'' 53 In addition, the government should
have a ``strong basis,'' approaching a ``prima facie case of
constitutional or statutory violation'' 54 of the rights of
minorities. Croson permits remedial relief on the basis of ``evidence
of a pattern of individual discriminatory acts * * * supported by
appropriate statistical proof.'' 55 Post-Croson cases have held
that statistical evidence can be probative of discrimination in the
remedial setting,56 and that anecdotal evidence can buttress
statistical evidence.57
---------------------------------------------------------------------------
\51\ Croson requires that a government ``identif[y]
discrimination with the particularity required by the Fourteenth
Amendment.'' Croson, 488 U.S at 492, 499, 509; see also DOJ
Memorandum at 22.
\52\ Croson 488 U.S. at 506 (``The random inclusion of racial
groups that, as a practical matter, may never have suffered from
discrimination in the construction industry in Richmond suggests
that perhaps the city's purpose was not in fact to remedy past
discrimination.'')
\53\ Id. at 499.
\54\ Id. at 500.
\55\ Id. at 509.
\56\ See, e.g., Peightal v. Metropolitan Dade County, 26 F.3d
1548, 1556 (11th Cir. 1994) (statistical evidence constitutes
``requisite `strong basis in evidence' mandated by Croson'').
\57\ See, e.g., Coral Construction Co., 941 F.2d at 919
(convincing anecdotal and statistical evidence can be ``potent'');
see also DOJ Memorandum at 12-13.
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[[Page 33072]]
32. Courts generally give more deference to Congressional race-
based remedial action than to state action because of Congress' special
remedial powers under the Fourteenth Amendment. Thus, it is possible
that the Croson standards for remedial action, e.g., the degree of
discrimination required to justify remedial action,58 might be
lower where Congressional findings are involved.59
---------------------------------------------------------------------------
\58\ Croson, however, involved a race preference program adopted
at the local, rather than federal, level. See Croson, 488 U.S. at
469.
\59\ In the DOJ Memorandum, Justice states that Adarand
``hinted'' that where a federal preference program is
congressionally mandated, the Croson standards may apply more
loosely. DOJ Memorandum at 30. The Adarand majority confronted the
issue of congressional versus state remedial power, noting that
various Members of the Court have taken different views of the
authority that Section 5 of the Fourteenth Amendment confers upon
Congress--power not delegated to the states--and the extent to which
courts should defer to congressional exercise of that authority.
Adarand, 115 S. Ct. at 2114. The Court concluded it did not need to
resolve those differences in Adarand, and rejecting Justice Stevens'
assertion to the contrary, stated that none of the Justices in
Adarand repudiated previously expressed views on this subject.
Croson suggested that Congress has broader authority than the
states--a positive grant of legislative power--and rejected the City
of Richmond's finding that it was remedying the present effects of
past discrimination. Croson, 488 U.S. at 498.
---------------------------------------------------------------------------
33. A government may adopt race or gender based programs for
reasons other than to remedy discrimination. Such objectives are
nonremedial. For example, in Regents of the University of California v.
Bakke,60 the purpose of the state of California's college
admissions program was to diversify the student body. No majority
opinion of the Court has addressed the sufficiency of nonremedial
objectives. Because Croson addressed the authority of a local
government to engage in remedial action, it did not decide the
sufficiency of nonremedial objectives as a compelling interest. In
Croson, Justice O'Connor stated that affirmative action must be
``strictly reserved for the remedial setting.'' 61 In Justice
Stevens' dissent in Adarand, however, he stated that Adarand does not
expressly adopt the view that past discrimination is the only valid
compelling governmental interest; nor does it prohibit nonremedial
objectives.62 In Bakke, Justice Powell found that a university has
a compelling interest in taking the race of applicants into account in
its admission process in order to foster greater diversity among the
student body to enhance the exchange of ideas on campus,63 and in
Wygant v. Jackson Board of Education,64 Justice O'Connor expressed
approval of that view.65
---------------------------------------------------------------------------
\60\ 438 U.S. 265 (1978) (plurality).
\61\ Croson, 488 U.S. at 493.
\62\ Adarand, 115 S. Ct. at 2127-28 (Stevens, J., dissenting).
\63\ 438 U.S. at 311-14.
\64\ 476 U.S. 267 (1986).
\65\ Id. at 286. In Hopwood, a panel of the Fifth Circuit held
that the University of Texas ``law school has presented no
compelling justification, under the Fourteenth Amendment or Supreme
Court precedent, that allows it to continue to elevate some races
over others, even for the wholesome purpose of correcting perceived
racial imbalance in the student body.'' Hopwood, 78 F.3d at 934. A
majority of the Hopwood panel specifically rejected Justice Powell's
opinion in Bakke that diversity can be a compelling interest as
``not binding precedent'' and concluded that ``any consideration of
race or ethnicity by the law school for the purpose of achieving a
diverse student body is not a compelling interest under the
Fourteenth Amendment.'' Id. at 944. In a concurring opinion, Judge
Wiener disagreed with the panel's opinion that diversity can never
be a compelling governmental interest, but concluded that the
program in question was not narrowly tailored because it singled out
only two minority groups--Blacks and Mexican Americans. Id. at 962-
68.
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34. The second prong of strict scrutiny analysis requires that the
use of any racial classification be ``narrowly tailored,'' to ensure
that ``the means chosen `fit' [the] compelling goal so closely that
there is little or no possibility that the motive for the
classification was illegitimate racial prejudice or stereotype.''
66 In Adarand, the Court identified two factors in determining
whether the use of a racial classification is narrowly-tailored: (1)
Whether race-neutral alternatives were considered, and (2) whether the
measure is appropriately limited in duration so that it will not
continue longer than purposes for which it was adopted. Additional
factors, identified in post-Croson cases, are: (3) the flexibility of
the program, e.g., whether it contains a waiver provision that may
narrow its scope; (4) the manner in which race is used, whether as a
determinant, or as one of several factors; (5) whether any numerical
target is compared to the relevant number of qualified minorities or to
the population of minorities as a whole; (6) the extent of the burden
on nonminorities.
---------------------------------------------------------------------------
\66\ Croson, 488 U.S. at 493.
---------------------------------------------------------------------------
35. Since Adarand, the Supreme Court has not ruled on the standard
of review for federal gender-based programs, although the issue is
before it in a pending case.67 Prior to Adarand, the Court applied
intermediate scrutiny; that standard currently applies.68 Under
the intermediate scrutiny standard, ``[t]o withstand constitutional
challenge * * * classifications by gender must serve important
governmental objectives and must be substantially related to those
objectives.'' 69
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\67\ United States v. Commonwealth of Virginia, 44 F.3d 1229
(1995), cert. granted 116 S. Ct. 281 (1995) (No. 94-1941) (argued
Jan. 17, 1996). The case presents the question whether the Equal
Protection Clause permits a state to maintain single-sex military-
style educational programs.
\68\ Craig v. Boren, 429 U.S. 190, 197 (1976). Thus far, the
Court has not decided whether gender is a suspect category. See,
e.g., J.E.B. v. Alabama ex rel. T.B., 114 S. Ct. at 1419, 1425 n.6
(1992) (concluding that gender-based peremptory challenges are not
substantially related to an important governmental objective and
finding ``once again'' that the Court need not decide whether gender
classifications are inherently suspect''); Mississippi University
for Women v. Hogan, 458 U.S. 718, 724 n.9 (1982) (finding it
``unnecessary'' to decide whether classifications based upon gender
are inherently suspect).
\69\ Boren, 429 U.S. at 197; see also J.E.B. v. Alabama ex rel.
T.B., 114 S. Ct. 1419, 1425 (1994) (``our Nation has had a long and
unfortunate history of sex discrimination, a history which warrants
the heightened scrutiny we afford all gender-based classifications
today''); City of Cleburne v. Cleburne Living Center, 473 U.S. 432,
440 (1985) (``[l]egislative classifications based on gender * * *
call for a heightened standard of review'').
---------------------------------------------------------------------------
36. In applying intermediate scrutiny to invidious gender-based
classifications, the Court has expressed concern that such
classifications are, in fact ``reflective of `archaic and overbroad'
generalizations about gender'' or are ``based on `outdated
misconceptions concerning the role of females in the home rather than
in the marketplace and world of ideas.' '' 70
---------------------------------------------------------------------------
\70\ J.E.B., 114 S. Ct. at 1424-25 (citations omitted). The
Court has rejected attempts to exclude or protect one gender based
on presumptions. See Hogan, 458 U.S. at 725.
---------------------------------------------------------------------------
37. It is unclear what standard would apply to benign gender
classifications. In Adarand, the Court refused to apply a less strict
standard to benign race-based classifications than the standard applied
to ``invidious'' race-based classifications. Although Adarand did not
address gender, its rejection of a lower standard for benign action in
the race context suggests that the same standard applied to invidious
gender classifications should apply to benign gender classifications.
This conclusion is supported by the Court's analysis in Mississippi
University for Woman v. Hogan,71 which held that a state
university's exclusion of men from its nursing program violated the
Equal Protection Clause under a test of intermediate scrutiny.
---------------------------------------------------------------------------
\71\ 458 U.S. 718 (1982).
---------------------------------------------------------------------------
38. In evaluating the second prong of the intermediate scrutiny
test--whether a gender classification is substantially related to the
government's objective--courts consider several factors, including the
correlation between gender and the actual activity the government seeks
to regulate and the practical effect of the program.72
---------------------------------------------------------------------------
\72\ See, e.g., Boren, 429 U.S. at 200-04 (finding that the low
disparity between drunk driving statistics for men and women
``exemplifies the ultimate unpersuasiveness of this evidentiary
record''); Hogan, 458 U.S. at 730-32 (finding that presence of men
in nursing school would not have negative effect on women students,
and that the record is ``flatly inconsistent'' with the claim that
excluding men is necessary to reach the state's educational goals
and falls ``far short'' of the ``'exceedingly persuasive
justification''' needed to sustain a gender-based classification).
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[[Page 33073]]
2. Possible Incentives
39. As described above, a record of discrimination against a
particular group is necessary to support remedial measures to remedy
such discrimination. We seek comment on whether under the compelling
governmental interest prong, there is sufficient evidence of
discrimination in the communications industry against any particular
minority group to support race-based incentives to eliminate market
entry barriers for such group. As discussed above, minority groups
include African Americans, Hispanics, American Indians, Alaskan
Natives, Asians, and Pacific Islanders.73 We also ask whether
there is sufficient evidence of discrimination against women in
telecommunications to justify remedial-based mechanisms to eliminate
market entry barriers for women, under either the compelling
governmental interest prong (strict scrutiny) or important governmental
interest (intermediate scrutiny). Parties may use any data submitted in
response to Part III above to support their comments.
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\73\ See supra n.14 (definition of minority). When considering
incentives for Native Americans, the Commission looks for guidance
to the Indian Commerce clause, which recognizes the status of tribes
as sovereign nations. See Competitive Bidding Sixth Report and
Order, 11 FCC Rcd at 155-56. See also DOJ Memorandum at 8 (``Adarand
does not require strict scrutiny review for programs benefiting
Native Americans as members of federally recognized Indian
tribes'').
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40. We also seek comment on any nonremedial objectives that would
justify the use of race and gender-based incentives and also serve the
Section 257 mandate of decreasing market entry barriers for small
telecommunications firms owned by minorities and women. Nonremedial
objectives could be in addition to the objective of remedying past
discrimination; thus, they may provide a separate basis for
governmental action that takes race and gender into account. For
example, the Commission has sought to fulfill the nonremedial objective
of increasing diversity of voices and viewpoints over the airwaves
through various minority and women-based programs.74 Those
programs also decrease market entry barriers by providing new
opportunities for women and minorities and by increasing incentives for
other firms to do business with those entities. Other nonremedial
objectives that could justify taking race or gender into account in
Commission programs and also help eliminate market entry barriers might
include favoring diversity of media voices as required by Section
257(b),75 promoting economic opportunity and competition as
encouraged in the legislative history of Section 257 76 and
Section 257(b),77 and as required by Section 309(j),78 or
promoting the public interest.79 We seek comment on these
nonremedial objectives 80 and request commenters to suggest other
nonremedial objectives that would satisfy the governmental interest
prong under strict (race) or intermediate (gender) scrutiny.
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\74\ See, e.g., the broadcast licensing policy which was adopted
following the D.C. Circuit decision in TV 9, Inc. v. FCC, 495 F.2d
929 (D.C. Cir. 1973), cert. denied, 419 U.S. 986 (1974). The
Commission considered a minority applicant's proposed participation
in station operation as one of several factors in comparing
applicants for mutually exclusive broadcast licenses. In Metro
Broadcasting, Inc. v. FCC, 497 U.S. 547, 567 (1990), the Supreme
Court upheld our licensing policy, however, in Lamprecht v. FCC, 958
F.2d 395, 398 (D.C. Cir. 1992), the D.C. Circuit found the policy
for women to be unconstitutional. Thereafter, in Bechtel v. FCC, 10
F.3d 875, 877, 887 (D.C. Cir. 1993), the D.C. Circuit held that the
integration credit, upon which the minority/female licensing policy
is based, was arbitrary and capricious. Following Bechtel, the
Commission suspended comparative hearings altogether.
\75\ 47 U.S.C. 257(b).
\76\ See supra para. 3 and n.8.
\77\ Section 257(b) provides: ``In carrying out subsection (a),
the Commission shall seek to promote the policies and purposes of
this Act favoring * * * vigorous economic competition.'' 47 U.S.C.
Sec. 257(b).
\78\ 47 U.S.C. 309(j).
\79\ See, e.g., 47 U.S.C. 201 (public interest regulation of
common carriers); 47 U.S.C. 257(b) (promotion of public interest,
convenience and necessity in carrying out Section 257(a)); 47 U.S.C.
303 (public interest regulation of radio services).
\80\ Depending on the record of discrimination developed, any
such nonremedial objectives could be remedial in nature. For
example, if there were a strong record of discrimination against
women-owned small businesses in the telecommunications market (which
itself would be an entry barrier), we could adopt a mechanism
intended to increase ownership opportunities for those businesses.
The immediate objective--increasing ownership--would be a means of
achieving the ultimate objective--remedying discrimination.
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41. We also request that parties propose incentives to meet these
remedial or nonremedial objectives. Commenters may address incentives
that the Commission has adopted in the past that eliminated or reduced
barriers to market entry, e.g., designated entity rules for Section
309(j) services, as well as propose new incentives. We also seek
comment on whether incentives that foster ownership or employment of
women or minorities in telecommunications would further these
objectives.81 Parties should explain what objective an incentive
would be intended to achieve and whether it is properly designed to
achieve that objective, i.e., narrowly tailored (strict scrutiny);
substantially related (intermediate scrutiny). Parties may support
their proposals with data and should identify specific provisions of
the Act that would authorize us to implement those proposals.
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\81\ The legislative history of Section 257 indicates that
Congress recognized a nexus between ownership and competition:
``[M]inority and women-owned small businesses continue to be
extremely under represented in the telecommunications field * * *.
Underlying this amendment [Section 257] is the obvious fact that
diversity of ownership remains a key to the competitiveness of the
U.S. telecommunications marketplace.'' 142 Cong. Rec. H1141 at
H1177-78 (daily ed. Feb. 1, 1996) (statement of Rep. Collins).
We note that communications is among a handful of industries
with the highest expected growth between the year 1990 and 2005, and
is predicted to provide women opportunities for advancement into
management and decisionmaking positions. A Solid Investment: Making
Full Use of the Nation's Human Capital, Recommendations of the
Federal Glass Ceiling Commission (November 1995) (Glass Ceiling
Report), Special Supplement at S-9. In addition, facilitating
employment could serve the public interest by enhancing
productivity: the Glass Ceiling Commission found that
``[o]rganizations that excel at leveraging diversity (including
hiring and promoting minorities and women into senior positions) can
experience better financial performance in the long run than those
which are not effective in managing diversity.'' Glass Ceiling
Report, Special Supplement at S-8.
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C. Furthering Section 257(b) Objectives
42. As described in the Introduction to this NOI, in Section
257(b), Congress required that in implementing our market barriers
initiatives, the Commission must ``promote the policies and purposes of
this Act favoring diversity of media voices, vigorous economic
competition, technological advancement, and promotion of the public
interest, convenience, and necessity.'' 82 We ask for comment on
how the Commission should foster these objectives in its efforts to
eliminate market barriers for entrepreneurs and small businesses.
---------------------------------------------------------------------------
\82\ 47 U.S.C. 257(b).
---------------------------------------------------------------------------
V. Administrative Matters
43. Reason for Action: Section 101 of the Telecommunications Act of
1996 (1996 Telecommunications Act),83 adds new Section 257 to the
Communications Act of 1934.84 Section 257 requires the Commission,
within 15 months after enactment, to complete a proceeding ``for the
purpose of identifying and eliminating, by regulations pursuant to its
authority under this Act * * * market entry barriers for entrepreneurs
and other small businesses in the provision and ownership of
telecommunications services and
[[Page 33074]]
information services, or in the provision of parts or services to
providers of telecommunications services and information services.'' In
implementing Section 257, the Commission must ``promote the policies
and purposes of this Act favoring diversity of media voices, vigorous
economic competition, technological advancement, and promotion of the
public interest, convenience and necessity.'' Every three years
following the completion of the market barriers proceeding, the
Commission must report to Congress on regulations that have been issued
to eliminate barriers and any statutory barriers that the Commission
recommends be eliminated. This Notice of Inquiry commences our omnibus
Section 257 proceeding.
---------------------------------------------------------------------------
\83\ Telecommunications Act of 1996, Public Law No. 104-104, 110
Stat. 56 (1996).
\84\ 47 U.S.C. 151 et seq.
---------------------------------------------------------------------------
44. Objectives: The Commission seeks to develop a full record of
profile data on the type and scope of market entry barriers in the
telecommunications industry faced by small businesses. To this end, the
Commission solicits specific information regarding financing sources
and terms, services provided, markets served, geographic areas of
operation, and employee workforce. The Commission also seeks
information concerning obstacles small telecommunications businesses
encounter, as well as any unique obstacles that such businesses owned
by women and minorities encounter. We also will undertake specific
initiatives that further the objective of Section 257 to eliminate
market entry barriers for small businesses. The record developed in
connection with these initiatives also will assist us in achieving our
mandate under Section 309(j) of the Communications Act to disseminate
licenses for auctionable spectrum-based services to small businesses,
rural telephone companies, and businesses owned by women and
minorities, as well as in fulfilling our general obligation to serve
the public interest.
45. Legal Basis: The proposed action is authorized under the
Communications Act of 1934, 47 U.S.C. 257.
46. Reporting, Recordkeeping, and Other Compliance Requirements:
None
47. Description, Potential Impact and Number of Small Entities
Effected: None
48. Federal Rules Which Overlap, Duplicate or Conflict With These
Rules: None
49. Significant Alternatives Minimizing Impact on Small Entities
and Consistent with Stated Objectives: This NOI solicits comment on a
variety of issues and recommendations that impact small businesses. Any
additional significant issues or recommendations related to small
businesses in the telecommunications industry presented in the comments
also will be considered.
50. Paperwork Reduction Act: The requirements proposed herein have
been analyzed with respect to the Paperwork Reduction Act of 1995 and
found to impose no new or modified information collection requirements.
VI. Procedural Matters
51. This proceeding is exempt from ex parte restraints or
disclosure requirements, as provided in Section 1.1204(a)(4) of our
rules.
52. Parties must file initial comments on or before July 24, 1996
and reply comments on or before August 23, 1996. To file formally in
this proceeding, interested parties must file an original and six
copies of all comments. If parties want each Commissioner to receive a
personal copy of their comments, they must file an original plus ten
copies.
53. Parties should send comments to: Office of the Secretary,
Federal Communications Commission, Washington, D.C. 20554. Parties also
should send one copy of any documents filed in this docket with the
Commission's copy contractor, International Transcription Services,
Room 246, 1919 M Street, N.W., Washington, D.C. 20554. Comments will be
available for public inspection during regular business hours in the
FCC Reference Center (Room 239) of the Federal Communications
Commission, 1919 M Street, N.W., Washington, D.C. 20554. For further
information, contact Linda L. Haller in the Office of General Counsel
at (202) 418-1720 or S. Jenell Trigg in the Office of Communications
Business Opportunities at (202) 418-0990.
54. We also ask parties to submit comments and reply comments on
diskette in addition to and not as a substitute for the formal filing
requirements stated above. Parties submitting diskettes should submit
them to S. Jenell Trigg, Office of Communications Business
Opportunities, Federal Communications Commission, Suite 644, 1919 M
Street, N.W., Washington D.C. 20554. Submissions should be on a 3.5
inch diskette formatted in an IBM compatible form using WordPerfect 5.1
for Windows software. The diskette should be submitted in ``read only''
mode. The diskette should be accompanied by a cover letter and clearly
labelled with the party's name, proceeding, type of pleading (comment
or reply comment), and the date of submission.
VII. Ordering Clause
55. Accordingly, IT IS ORDERED that, pursuant to our authority
under the Communications Act of 1934, 47 U.S.C. 4(i) and 403, an
inquiry IS COMMENCED to identify and eliminate market entry barriers
for small businesses in the provision and ownership of
telecommunications and information services in the telecommunications
market.
Federal Communications Commission.
William F. Caton,
Acting Secretary.
[FR Doc. 96-16259 Filed 6-25-96; 8:45 am]
BILLING CODE 6712-01-P
Complete official Federal Register PDF
FR Doc. 96-16248 Public Availability of Information
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33075-33082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16248]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Office of the Secretary
49 CFR Part 7
[Docket No. OST-96-1430; Notice 96-17]
RIN 2105-AC58
Public Availability of Information
AGENCY: Office of the Secretary, DOT.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: Department of Transportation proposes to revise regulations
implementing the Freedom of Information Act (FOIA), 5 U.S.C. 552. This
revision updates organizational changes since the last revision and
streamlines the regulations in order to make the regulations more
useful.
DATES: Comments are due August 26, 1996.
ADDRESSES: Comments should be addressed to Documentary Services
Division, Attention: Docket Section, Room PL401, Docket No. OST-96-
1430, Department of Transportation, C-55, Washington, DC 20590. Any
person wishing acknowledgment that his/her comments have been received
should include a self-addressed stamped postcard. Comments received
will be available for public inspection and copying in the Documentary
Services Division, Room PL401, Department of Transportation Building,
400 Seventh Street, SW, Washington, DC, from 10:00 AM to 5:00 PM ET
Monday through Friday except Federal holidays.
FOR FURTHER INFORMATION CONTACT: Dorothy A. Chambers, Chief, FOIA
Division, Office of the General Counsel, C-12, Department of
Transportation, Washington, DC 20590, telephone (202) 366-4542, FAX
(202) 366-7152.
SUPPLEMENTARY INFORMATION: The President instituted a Regulatory Review
initiative, for the reinvention of regulations by eliminating
duplicate, redundant, or unnecessary language and revising regulations
to meet the needs of users. In response to this initiative, we have
reviewed part 7 and are proposing to revise this section to update and
streamline information on public availability of information. We
propose to reorganize this part by combining in subpart B sections that
relate to information that is publicly available without a specific
request. Similarly, we have combined sections in subpart C that address
information that must be requested under FOIA. We have shortened the
descriptions of FOIA exemptions and propose to delete the Appendices
that set forth redundant information concerning document inspection
facilities. We propose to replace these appendices with provisions in
Secs. 7.10 and 7.15, which set forth necessary information regarding
public records available at Department Docket locations and FOIA
contacts for records requested under the FOIA.
Analysis of Regulatory Impacts
This amendment is not a ``significant regulatory action'' within
the meaning of Executive Order 12866. It is also not significant within
the definition in DOT's Regulatory Policies and Procedures, 49 FR 11034
(1979), in part because it does not involve any change in important
Departmental policies. Because the economic impact should be minimal,
further regulatory evaluation is not necessary. Moreover, I certify
that this proposal will not have a significant economic impact on a
substantial number of small entities.
This proposal does not significantly affect the environment, and
therefore an environmental impact statement is not required under the
National Environmental Policy Act of 1969. It has also been reviewed
under Executive Order 12612, Federalism, and it has been determined
that it does not have sufficient implications for federalism to warrant
preparation of a Federalism Assessment.
Finally, the proposal does not contain any collection of
information requirements, requiring review under the Paperwork
Reduction Act, as amended.
List of Subjects in 49 CFR Part 7
Freedom of information.
In accordance with the above, DOT proposes to revise 49 CFR part 7
to read as follows:
PART 7--PUBLIC AVAILABILITY OF INFORMATION
Subpart A--General Provisions
Sec.
7.1 General.
7.2 Definitions.
Subpart B--Information Required to be Made Public by the Department
7.3 Publication in the Federal Register.
7.4 Publication Required.
[[Page 33076]]
7.5 Availability of Opinions, Orders, Staff Manuals, Statements of
Policy and Interpretations and Indices.
7.6 Deletion of Identifying Detail.
7.7 Access to Materials and Indices.
7.8 Copies.
7.9 Protection of Records.
7.10 Public Records Available at Department Docket Locations.
Subpart C--Availability of Reasonably Described Records Under the
Freedom of Information Act
7.11 Applicability.
7.12 Administration of Part.
7.13 Records Available.
7.14 Requests for Records.
7.15 Contacts for Records Requested Under the FOIA.
7.16 Requests for Records of Concern to More than One Government
Organization.
7.17 Consultation with Submitters of Commercial and Financial
Information.
Subpart D--Procedures for Appealing Decisions Not To Disclose Records
and/or Waive Fees
7.21 General.
Subpart E--Time Limits
7.31 Initial Determinations.
7.32 Final Determinations.
7.33 Extension.
Subpart F--Fees
7.41 General.
7.42 Payment of Fees.
7.43 Fee Schedule.
7.44 Services Performed Without Charge or at a Reduced Charge.
7.45 Transcripts.
7.46 Alternative Sources of Information.
Authority: 5 U.S.C. 552; 31 U.S.C. 9701; 49 U.S.C. 322; E.O.
12600
Subpart A--General Provisions
Sec. 7.1 General.
(a) This part implements 5 U.S.C. 552, and prescribes rules
governing the availability to the public of records of the Department
of Transportation. Many documents are made available to the public for
inspection and copying through the Department Docket locations that are
listed in subpart B, which contains the regulations of the Department
of Transportation concerning the availability to the public of opinions
issued in the adjudication of cases, policy issuances, administrative
manuals, and other information made available to the public.
(b) Subpart C of this part describes the records that are not
required to be disclosed on the Department's own action under this
part, but that may be available upon request under the Freedom of
Information Act.
(c) Indices are maintained to reflect all records subject to
subpart B of this part, and are available for public inspection and
copying as provided in subpart B.
Sec. 7.2 Definitions.
As used in this part--
Act and FOIA mean the Freedom of Information Act, 5 U.S.C. 552.
Administrator means the head of each operating element of the
Department and includes the Commandant of the Coast Guard and the
Director of the Bureau of Transportation Statistics.
Department or DOT means the Department of Transportation, including
the Office of the Secretary of Transportation, the Office of the
Inspector General, and the following operating elements:
(1) United States Coast Guard.
(2) Federal Aviation Administration.
(3) Federal Highway Administration.
(4) Federal Railroad Administration.
(5) National Highway Traffic Safety Administration.
(6) Federal Transit Administration.
(7) Saint Lawrence Seaway Development Corporation.
(8) Maritime Administration.
(9) Research and Special Programs Administration.
(10) Bureau of Transportation Statistics.
Record includes any writing, drawing, map, recording, tape, film,
photograph, or other documentary material by which information is
preserved. The term also includes any such documentary material stored
by computer.
Secretary means the Secretary of Transportation or any person to
whom the Secretary has delegated authority in the matter concerned.
Subpart B--Information Required To Be Made Public by the Department
Sec. 7.3 Publication in the Federal Register.
This section implements 5 U.S.C. 552(a)(1), and prescribes rules
governing the publication in the Federal Register of the following:
(a) Descriptions of the organization of the Department, including
its operating elements and the established places at which, the
officers from whom, and the methods by which, the public may secure
information and make submittals or obtain decisions;
(b) Statements of the general course and methods by which the
Department's functions are channeled and determined, including the
nature and requirements of all formal and informal procedures
available;
(c) Rules of procedure, descriptions of forms available or the
places at which forms may be obtained, and instructions as to the scope
and contents of all papers, reports, or examinations;
(d) Substantive rules of general applicability adopted as
authorized by law and statements of general policy or interpretations
of general applicability formulated and adopted by the Department; and
(e) Each amendment, revision, or repeal of any material listed in
paragraphs (a) through (d) of this section.
Sec. 7.4 Publication Required.
(a) General. The material described in Sec. 7.3 shall be published
in the Federal Register. For the purposes of this paragraph, material
that will reasonably be available to the class of persons affected by
it will be considered to be published in the Federal Register if it has
been incorporated by reference therein with the approval of the
Director of the Federal Register.
(b) Effect of nonpublication. Except to the extent that a person
has actual and timely notice of the terms thereof, a person may not in
any manner be required to resort to, or be adversely affected by, any
procedure or matter required to be published in the Federal Register,
but not so published.
Sec. 7.5 Availability of Opinions, Orders, Staff Manuals, Statements
of Policy, and Interpretations and Indices.
(a) This section implements 5 U.S.C. 552(a)(2). It prescribes the
rules governing the availability for public inspection and copying of
the following:
(1) Any final opinion (including a concurring or dissenting
opinion) or order made in the adjudication of a case.
(2) Any policy or interpretation that has been adopted under the
authority of the Department, including any policy or interpretation
concerning a particular factual situation, if that policy or
interpretation can reasonably be expected to have precedential value in
any case involving a member of the public in a similar situation.
(3) Any administrative staff manual or instruction to staff that
affects any member of the public, including the prescribing of any
standard, procedure, or policy that, when implemented, requires or
limits any action of any member of the public or prescribes the manner
of performance of any activity by any member of the public. However,
this does not include staff manuals or instructions to staff concerning
internal operating rules, practices, guidelines, and procedures for
Departmental inspectors, investigators, law enforcement officers,
examiners, auditors, and negotiators and other information developed
predominantly for internal use, the release of which
[[Page 33077]]
could significantly risk circumvention of agency regulations or
statutes.
(b) Any material listed in paragraph (a) of this section that is
not made available for public inspection and copying, or that is not
indexed as required by Sec. 7.7, may not be cited, relied on, or used
as precedent by the Department to affect any member of the public
adversely unless the person to whose detriment it is relied on, used,
or cited has had actual timely notice of the material.
(c) This section does not apply to material that is published in
the Federal Register or covered by subpart C of this part.
Sec. 7.6 Deletion of Identifying Detail.
Whenever it is determined to be necessary to prevent a clearly
unwarranted invasion of personal privacy, identifying details will be
deleted from any record covered by this subpart that is published or
made available for inspection. A full explanation of the justification
for the deletion will accompany the record published or made available
for inspection.
Sec. 7.7 Access to Materials and Indices.
(a) Except as provided in paragraph (b) of this section, material
listed in Sec. 7.5 will be made available for inspection and copying to
any member of the public at document inspection facilities of the
Department. It has been determined that it is unnecessary and
impracticable to publish the index of materials in the Federal
Register. Information as to the kinds of materials available at each
facility may be obtained from the facility or the headquarters of the
operating element of which it is a part.
(b) The material listed in Sec. 7.5 that is published and offered
for sale will be indexed, but is not required to be kept available for
public inspection. Whenever practicable, however, it will be made
available for public inspection at any document inspection facility
maintained by the Office of the Secretary or an operating element, as
appropriate.
Sec. 7.8 Copies.
Copies of any material covered by this subpart that is not
published and offered for sale may be ordered, upon payment of the
appropriate fee, from the Docket Offices listed in Sec. 7.10. Copies
will be certified upon request and payment of the fee prescribed in
Sec. 7.43.
Sec. 7.9 Protection of Records.
(a) Records made available for inspection and copying may not be
removed, altered, destroyed, or mutilated.
(b) 18 U.S.C. 641 provides, in pertinent part, for criminal
penalties for embezzlement or theft of government records.
(c) 18 U.S.C. 2071 provides, in pertinent part, for criminal
penalties for the willful and unlawful concealment, mutilation or
destruction of, or the attempt to conceal, mutilate, or destroy,
government records.
Sec. 7.10 Public Records Available at Department Docket Locations.
Publicly available records are located in DOT Docket Units as
follows (all times are eastern time zone, and are Monday--Friday except
Federal holidays):
(a) Docket Units located at 400 7th Street, S.W., Washington, D.C.
20590 include:
(1) Office of the Secretary and former Civil Aeronautics Board
material, Plaza 401, Hours 10:00-5:00.
(2) Federal Highway Administration, Room 4232, Hours 8:30-5:00.
(3) Federal Railroad Administration, Room 8209, Hours 9:30-4:00
(4) National Highway Traffic Safety Administration, Room 5111,
Hours 9:30-4:00.
(5) Federal Transit Administration, Room 9316A, Hours 8:30-5:00.
(6) Maritime Administration, Room 7210, Hours 8:30-5:00.
(7) Research and Special Programs Administration, Room 8421, Hours
8:30-5:00.
(b) Federal Aviation Administration, 800 Independence Avenue, S.W.,
Washington, D. C. 20591:
(1) Rules Dockets Room 915-G, Hours 8:30-5:00.
(2) Enforcement Dockets, Room 924-C, Hours 8:30-5:00.
(c) United States Coast Guard, Room 3406, Hours 8:30-5:00, 2100 2nd
Street, S.W., Washington, D. C. 20593-0001.
(d) Operating elements also maintain public record units at
regional offices and at the offices of the Commandant and District
Commanders of the United States Coast Guard. These facilities are open
to the public Monday through Friday except Federal holidays, during
regular working hours.
(e) Additional information on the location and hours of operations
for Department Docket Offices can be obtained through the Office of the
Secretary Docket Unit, mentioned above, at (202) 366-9322.
Subpart C--Availability of Reasonably Described Records Under the
Freedom of Information Act
Sec. 7.11 Applicability.
(a) This subpart implements 5 U.S.C 552(a)(3), and prescribes the
regulations governing public inspection and copying of reasonably
described records under the Freedom of Information Act.
(b) This subpart does not apply to:
(1) Records published in the Federal Register, opinions in the
adjudication of cases, statements of policy and interpretations, and
administrative staff manuals that have been published or made available
under subpart B of this part.
(2) Records or information compiled for law enforcement purposes
and covered by the disclosure exemption described in Sec. 7.13(c)(7)
if--
(i) The investigation or proceeding involves a possible violation
of criminal law; and
(ii) There is reason to believe that--
(A) The subject of the investigation or proceeding is not aware of
its pendency, and
(B) Disclosure of the existence of the records could reasonably be
expected to interfere with enforcement proceedings.
(3) Informant records maintained by a criminal law enforcement
component of the Department under an informant's name or personal
identifier, if requested by a third party according to the informant's
name or personal identifier, unless the informant's status as an
informant has been officially confirmed.
Sec. 7.12 Administration of Part.
Authority to administer this part and to issue determinations with
respect to initial requests is delegated as follows:
(a) to the General Counsel for the records of the Office of the
Secretary other than the Office of the Inspector General.
(b) to the Inspector General for records of the Office of the
Inspector General.
(c) to the Administrator of each operating element, who may
redelegate to officers of that element the authority to administer this
part in connection with defined groups of records. However, each
Administrator may redelegate the duties under subpart D of this part to
consider appeals of initial denials of requests for records only to his
or her deputy or to not more than one other officer who reports
directly to the Administrator and who is located at the headquarters of
that operating element.
Sec. 7.13 Records Available.
(a) Policy. It is the policy of the Department of Transportation to
make
[[Page 33078]]
the records of the Department available to the public to the greatest
extent possible, in keeping with the spirit of the Freedom of
Information Act. This includes providing reasonably segregable
information from documents that contain information that may be
withheld.
(b) Statutory disclosure requirement. The Act requires that the
Department, on a request from a member of the public submitted in
accordance with the procedures in this subpart, make requested records
available for inspection and copying.
(c) Statutory exemptions. Exempted from the Act's statutory
disclosure requirement are matters that are:
(1)(i) Specifically authorized under criteria established by
Executive Order to be kept secret in the interest of national defense
or foreign policy, and
(ii) In fact properly classified pursuant to such Executive order;
(2) Related solely to the internal personnel rules and practices of
an agency;
(3) Specifically exempted from mandatory disclosure by statute
(other than the Privacy Act), provided that such statute--
(i) Requires that the matters be withheld from the public in such a
manner as to leave not any discretion on the issue, or
(ii) Establishes particular criteria for withholding or refers to
particular criteria for withholding or refers to particular types of
matters to be withheld;
(4) Trade secrets and commercial or financial information obtained
from a person and privileged or confidential;
(5) Inter-agency or intra-agency memorandums or letters that would
not be available by law to a party other than an agency in litigation
with the agency;
(6) Personnel and medical files and similar files the disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy;
(7) Records or information compiled for law enforcement purposes,
but only to the extent that the production of such law enforcement
records or information--
(i) Could reasonably be expected to interfere with enforcement
proceedings,
(ii) Would deprive a person of a right to a fair or an impartial
adjudication,
(iii) Could reasonably be expected to constitute an unwarranted
invasion of personal privacy,
(vi) Could reasonably be expected to disclose the identity of a
confidential source, including a State, local, or foreign agency or
authority or any private institution that furnished information on a
confidential basis, and, in the case of a record or information
compiled by a criminal law enforcement authority in the course of a
criminal investigation, or by an agency conducting a lawful national
security intelligence investigation, information furnished by a
confidential source,
(v) Would disclose techniques and procedures for law enforcement
investigations or prosecutions or would disclose guidelines for law
enforcement investigations or prosecutions if such disclosure could
reasonably be expected to risk circumvention of the law, or
(vi) Could reasonably be expected to endanger the life or physical
safety of any individual;
(8) Contained in or related to examination, operating, or condition
reports prepared by, on behalf of, or for the use of an agency
responsible for the regulation or supervision of financial
institutions; or
(9) Geological and geophysical information and data, including
maps, concerning wells.
Sec. 7.14 Requests for Records.
(a) Each person desiring access to or a copy of a record covered by
this subpart shall comply with the following provisions:
(1) A written request must be made for the record.
(2) Such request should indicate that it is being made under the
Freedom of Information Act.
(3) The envelope in which the request is sent should be prominently
marked: ``FOIA.''
(4) The request should be addressed to the appropriate office as
set forth in Sec. 7.15.
(b) If the requirements of paragraph (a) of this section are not
met, treatment of the request will be at the discretion of the agency.
The ten-day limit for responding to requests, described in Sec. 7.31,
will not start to run until the request has been identified, or would
have been identified with the exercise of due diligence, by an employee
of the Department as a request pursuant to the Freedom of Information
Act and has been received by the office to which it should have been
originally sent.
(c) Form of Requests. (1) Each request should describe the
particular record to the fullest extent possible. The request should
describe the subject matter of the record, and, if known, indicate the
date when it was made, the place where it was made, and the person or
office that made it. If the description does not enable the office
handling the request to identify or locate the record sought, that
office will notify the person making the request and, to the extent
possible, indicate the additional data required.
(2) Each request shall--
(i) Specify the fee category (commercial use, news media,
educational institution, noncommercial scientific institution, or
other) in which the requester claims the request to fall and the basis
of this claim (see subpart F for fees and fee waiver requirements), and
(ii) State the maximum amount of fees that the requester is willing
to pay or include a request for a fee waiver.
(iii) Requesters are advised that the time for responding to
requests set forth in subpart E may be delayed--
(A) If a requester has not sufficiently identified the fee category
applicable to the request,
(B) If a requester has not stated a willingness to pay fees as high
as anticipated by the Department, or
(C) If a fee waiver request is denied and the requester has not
included an alternative statement of willingness to pay fees as high as
anticipated by the Department.
(iv) A request seeking a fee waiver shall, to the extent possible,
address why the requester believes that the criteria for fee waivers
set out in Sec. 7.44(f) are met.
(d) Creation of records. A request may seek only records that are
in existence at the time the request is received. A request may not
seek records that come into existence after the date on which it is
received and may not require that new records be created in response to
the request by, for example, combining or compiling selected items from
manual files, preparing a new computer program, or calculating
proportions, percentages, frequency distributions, trends, or
comparisons. In those instances where the Department determines that
creating a new record will be less burdensome than disclosing large
volumes of unassembled material, the Department may, in its discretion,
agree to creation of a new record as an alternative to disclosing
existing records.
(e) Each record made available under this subpart will be made
available for inspection and copying during regular business hours at
the place where it is located, or photocopying may be arranged with the
copied materials being mailed to the requester upon payment of the
appropriate fee. Original records ordinarily will be copied except in
this instances where, in the Department's judgment, copying would
endanger the quality of the original or raise the reasonable
possibility of irreparable harm to the record. In these instances,
copying of the original would not be in the public interest. In any
[[Page 33079]]
event, original records will not be released from Department custody.
(f) If a requested record is known not to exist in the files of the
agency, or to have been destroyed or otherwise disposed of, the
requester will be so notified.
(g) Fees will be determined in accordance with subpart F of this
part.
(h) Notwithstanding paragraphs (a) through (g) of this section,
informational material, such as news releases, pamphlets, and other
materials of that nature that are ordinarily made available to the
public as a part of any information program of the Government will be
available upon oral or written request. A fee will not be charged for
individual copies of that material so long as the material is in
supply. In addition the Department will continue to respond, without
charge, to routine oral or written inquiries that do not involve the
furnishing of records.
Sec. 7.15 Contacts for Records Requested Under the FOIA.
Each person desiring a record under this subpart should submit a
request in writing to the Departmental element where the records are
located:
(a) FOIA Offices at 400 7th Street, S.W., Washington, D.C. 20590:
(1) Office of the Secretary of Transportation, Room 5432
(2) Federal Highway Administration, Room 4428
(3) Federal Railroad Administration, Room 8201
(4) National Highway Traffic Safety Administration, Room 5219
(5) Federal Transit Administration, Room 9400
(6) Maritime Administration, Room 7221
(7) Research and Special Programs Administration, Room 8419
(8) St. Lawrence Seaway Development Corporation, Room 5424
(9) Bureau of Transportation Statistics, Room 2104
(10) Office of the Inspector General, Room 9210
(b) Federal Aviation Administration, 800 Independence Avenue, S.W.,
Room 906A, Washington, D. C. 20591.
(c) United States Coast Guard, 2100 2nd Street, S.W., Room 6418,
Washington, D. C. 20593-0001.
(d) Operating elements also maintain FOIA contacts at regional
offices and at the offices of the Commandant and District Commanders of
the United States Coast Guard. Additional information on the location
of these offices can be obtained through the FOIA contact offices
listed above.
(e) If the person making the request does not know where in the
Department the record is located, he or she may make inquiry to the
Chief, FOIA Division, Office of the General Counsel.
Sec. 7.16 Requests for Records of Concern to More Than One Government
Organization.
(a) If the release of a record covered by this subpart would be of
concern to both this Department and another Federal agency, the
determination as to release will be made only after consultation with
the other interested agency.
(b) If the release of the record covered by this subpart would be
of concern to both this Department and a State or local government, a
territory or possession of the United States, or a foreign government,
the determination as to release will be made by the Department only
after consultation with the other interested State or local government
or foreign government.
(c) As an alternative to consultation, the Department may refer the
request (or relevant portion thereof) to a Federal agency that
originated or is substantially concerned with the records. Such
referrals shall be made expeditiously and the requester shall be
notified in writing that a referral has been made.
Sec. 7.17 Consultation With Submitters of Commercial and Financial
Information.
(a) If a request is received for information that has been
designated by the submitter as confidential commercial information, or
which the Department has some other reason to believe may contain trade
secrets or other commercial or financial information of the type
described in Sec. 7.13(c)(4), the submitter of such information will,
except as is provided in paragraphs (c) and (d) of this section, be
notified expeditiously and asked to submit any written objections to
release. At the same time, the requester will be notified that notice
and an opportunity to comment are being provided to the submitter. The
submitter will, to the extent permitted by law, be afforded a
reasonable period of time within which to provide a detailed statement
of any such objections. The submitter's statement shall specify all
grounds for withholding any of the information. The burden shall be on
the submitter to identify all information for which exempt treatment is
sought and to persuade the agency that the information should not be
disclosed.
(b) The Office of the Secretary or the responsible operating
element, as appropriate, will, to the extent permitted by law, consider
carefully a submitter's objections and specific grounds for
nondisclosure prior to determining whether to disclose business
information. Whenever a decision is made to disclose such information
over the objection of a submitter, the office responsible for the
decision will forward to the submitter a written notice that will
include:
(1) A statement of the reasons for which the submitter's disclosure
objections were not accepted;
(2) A description of the business information to be disclosed; and
(3) A specific disclosure date. Such notice of intent to disclose
will, to the extent permitted by law, be forwarded to the submitter a
reasonable number of days prior to the specified date upon which
disclosure is intended. At the same time the submitter is notified, the
requester will be notified of the decision to disclose information.
(c) The notice requirements of this section will not apply if:
(1) The office responsible for the decision determines that the
information should not be disclosed;
(2) The information lawfully has been published or otherwise made
available to the public; or
(3) Disclosure of the information is required by law (other than 5
U.S.C. 552).
(d) The procedures established in this section shall not apply in
the case of:
(1) Business information submitted to the National Highway Traffic
Safety Administration and addressed in 49 CFR part 512.
(2) Information contained in a document to be filed or in oral
testimony that is sought to be withheld pursuant to Rule 39 of the
Rules of Practice (14 CFR 302.39) in Aviation Economic Proceedings.
(e) Whenever a requester brings suit seeking to compel disclosure
of confidential commercial information, the Office of the Secretary or
the responsible operating element, whichever the case may be, will
promptly notify the submitter.
Subpart D--Procedures for Appealing Decisions Not To Disclose
Records and/or Waive Fees
Sec. 7.21 General.
(a) Each officer or employee of the Department who, upon a request
by a member of the public for a record under this part, makes a
determination that the record is not to be disclosed, either because it
is subject to an exemption or not in the Department's custody and
control, will give a written statement of the reasons for that
determination to the person making the request; and indicate the names
and titles or positions of each person responsible for the initial
determination not to comply with such
[[Page 33080]]
request, and the availability of an appeal within the Department.
(b) When a request for a waiver of fees, pursuant to Sec. 7.44, has
been denied in whole or in part, the requester may appeal the denial.
(c) Any person to whom a record has not been made available within
the time limits established by Sec. 7.31 and any person who has been
given a determination pursuant to paragraph (a) of this section that a
record will not be disclosed may appeal to the head of the operating
element concerned or, in the case of the Office of the Secretary, to
the General Counsel of the Department, and in the case of the Office of
Inspector General, to the Inspector General. Any person who has not
received an initial determination on his or her request within the time
limits established by Sec. 7.31 can seek immediate judicial review,
which may be sought without the need first to submit an administrative
appeal. Judicial review may be sought in the United States District
Court for the judicial district in which the requester resides or has
his or her principal place of business, the judicial district in which
the records are located, or in the District of Columbia. A
determination that a record will not be disclosed and/or that a request
for a fee waiver or reduction will not be granted does not constitute
final agency action for the purposes of judicial review unless:
(1) It was made by the head of the operating element concerned (or
his or her designee), or the General Counsel or the Inspector General,
as the case may be; or
(2) The applicable time limit has passed without a determination on
the initial request or the appeal, as the case may be, having been
made.
(d) Each appeal must be made in writing within thirty days from the
date of receipt of the original denial and should include all
information and arguments relied upon by the person making the request.
Such letter should indicate that it is an appeal from a denial of a
request made under the Freedom of Information Act. The envelope in
which the appeal is sent should be prominently marked: ``FOIA Appeal.''
If these requirements are not met, the twenty-day limit described in
Sec. 7.32 will not begin to run until the appeal has been identified,
or would have been identified with the exercise of due diligence, by an
employee of the Department as an appeal under the Freedom of
Information Act, and has been received by the appropriate office.
(e) Whenever the head of the operating element concerned, or the
General Counsel or the Inspector General, as the case may be,
determines it to be necessary, he/she may require the person making the
request to furnish additional information, or proof of factual
allegations, and may order other proceedings appropriate in the
circumstances. The decision of the head of the operating element
concerned, or the General Counsel or the Inspector General, as the case
may be, as to the availability of the record or the appropriateness of
a fee waiver or reduction constitutes final agency action for the
purpose of judicial review.
(f) The decision of the head of the operating element concerned, or
the General Counsel or Inspector General, as the case may be, not to
disclose a record under this part or not to grant a request for a fee
waiver or reduction is considered to be a denial by the Secretary for
the purpose of 5 U.S.C. 552(a)(4)(B).
(g) Any final determination by the head of an operating element or
his or her delegate, not to disclose a record under this part, or not
to grant a request for a fee waiver or reduction, is subject to
concurrence by the General Counsel or his/her designee.
(h) Upon a determination that an appeal will be denied, the
requester will be informed in writing of the reasons for the denial of
the request and the names and titles or positions of each person
responsible for the determination, and that judicial review of the
determination is available in the United States District Court for the
judicial district in which the requester resides or has his or her
principal place of business, the judicial district in which the
requested records are located, or the District of Columbia.
Subpart E--Time Limits
Sec. 7.31 Initial Determinations.
An initial determination whether to release a record requested
pursuant to subpart C will be made within ten Federal working days
after the request is received by the appropriate office in accordance
with Sec. 7.14, except that this time limit may be extended by up to
ten Federal working days in accordance with Sec. 7.33. The person
making the request will be notified immediately of such determination.
If the determination is to grant this request, the desired record will
be made available as promptly as possible. If the determination is to
deny the request, the person making the request will be notified in
writing, at the same time he or she is notified of such determination,
of the reason for the determination, the right of such person to appeal
the determination, and the name and title of each person responsible
for the initial determination to deny the request.
Sec. 7.32 Final Determination.
A determination with respect to any appeal made pursuant to
Sec. 7.21 will be made within twenty Federal working days after receipt
of such appeal except that this time limit may be extended by up to ten
Federal working days in accordance with Sec. 7.33. The person making
the request will be notified immediately of such determination pursuant
to Sec. 7.21.
Sec. 7.33 Extension.
In unusual circumstances as specified in this section, the time
limits prescribed in Sec. 7.31 and Sec. 7.32 may be extended by written
notice to the person making the request setting forth the reasons for
such extension and the date on which a determination is expected to be
dispatched. Such notice may not specify a date that would result in a
cumulative extension of more than ten Federal working days. As used in
this subparagraph, ``unusual circumstances'' means, but only to the
extent reasonably necessary to the proper processing of the particular
request:
(a) The need to search for and collect the requested records from
field facilities or other establishments that are separate from the
office processing the request.
(b) The need to search for, collect, and appropriately examine a
voluminous amount of separate and distinct records that are demanded in
a single request; or
(c) The need for consultation, which will be conducted with all
practicable speed, with any other agency or DOT element having a
substantial interest in the determination of the request or among two
or more components of the agency having substantial subject-matter
interest therein.
Subpart F--Fees
Sec. 7.41 General.
(a) This subpart prescribes fees for services performed for the
public under subparts B and C of this part by the Department.
(b) All terms defined by the Freedom of Information Act apply to
this subpart, and the term ``hourly rate'' means the actual hourly base
pay for a civilian employee or, for members of the Coast Guard, the
equivalent hourly pay rate computed using a 40-hour week and the
member's normal basic pay and allowances.
(c) This subpart applies to all employees of the Department,
including those of non-appropriated fund
[[Page 33081]]
activities of the Coast Guard and the Maritime Administration.
(d) This subpart does not apply to any special study, special
statistical compilation, table, or other record requested under 49
U.S.C. 329(c). The fee for the performance of such a service is the
actual cost of the work involved in compiling the record. All such fees
received by the Department in payment of the cost of such work are
deposited in a separate account administered under the direction of the
Secretary, and may be used for the ordinary expenses incidental to
providing the information.
(e) This subpart does not apply to requests from record subjects
for records about themselves in Departmental systems of records. Fees
for such requests are to be determined in accordance with the Privacy
Act of 1974, as implemented by Department of Transportation regulations
(49 CFR part 10).
Sec. 7.42 Payment of Fees.
(a) The fees prescribed in this subpart may be paid by check,
draft, or money order, payable to the Treasury of the United States;
except that, in the case of the Saint Lawrence Seaway Development
Corporation, all fees resulting from a request to that operating
element shall be made payable to the Saint Lawrence Seaway Development
Corporation.
(b) Charges may be assessed by the Department for time spent
searching for requested records even if the search fails to locate
records or the records located are determined to be exempt from
disclosure. In addition, if records are requested for commercial use,
the Department may assess a fee for time spent reviewing any responsive
records located to determine whether they are exempt from disclosure.
(c) When it is estimated that the search charges, review charges,
duplication fees or any combination of fees that could be charged to
the requester will likely exceed $25, the requester will be notified of
the estimated amount of the fees, unless the requester has indicated in
advance his or her willingness to pay fees as high as those
anticipated. The notice will also inform the requester how to consult
with the appropriate Departmental officials with the object of
reformulating the request to meet his or her needs at a lower cost.
(d) Payment of fees may be required by the Department prior to
actual duplication or delivery of any releasable records to a
requester. However, advance payment of fees, i.e., payment before work
is commenced or continued on a request, may not be required unless:
(1) Allowable charges that a requester may be required to pay are
likely to exceed $250; or
(2) The requester has failed to pay within 30 days of the billing
date fees charged for a previous request to any part of the Department.
(e) When paragraph (d)(1) of this section applies, the requester
will be notified of the likely cost and, where he/she has a history of
prompt payment of FOIA fees, requested to furnish satisfactory
assurance of full payment of FOIA fees. Where the requestor does not
have any history of payment, he or she may be required to make advance
payment of any amount up to the full estimated charges.
(f) When paragraph (d)(2) of this section applies, the requester
will be required to demonstrate that the fee has, in fact, been paid or
to pay the full amount owed, including any applicable interest, late
handling charges, and penalty charges as discussed below. The requester
will also be required to make an advance payment of the full amount of
the estimated fee before processing of a new request or continuation of
a pending request is begun.
(g) The Department will assess interest on an unpaid bill starting
on the 31st day following the day on which the notice of the amount due
is first mailed to the requester. Interest will accrue from the date of
the notice of amount due and will be at the rate prescribed in 31
U.S.C. 3717. Receipt by the Department of a payment for the full amount
of the fees owed within 30 calendar days after the date of the initial
billing will stay the accrual of interest, even if the payment has not
been processed.
(h) If payment of fees charged is not received within 30 calendar
days after the date the initial notice of the amount due is first
mailed to the requester, an administrative charge will be assessed by
the Department to cover the cost of processing and handling the
delinquent claim. In addition, a penalty charge will be applied with
respect to any principal amount of a debt that is more than 90 days
past due. Where appropriate, other steps permitted by Federal debt
collection statutes, including disclosure to consumer reporting
agencies and use of collection agencies, will be used by the Department
to encourage payment of amounts overdue.
(i) In any instance where the Department reasonably believes that a
requester or a group of requesters acting in concert is attempting to
break down a single FOIA request into a series of requests for the sole
purpose of evading the payment of otherwise applicable fees, the
Department will aggregate the requests and determine the applicable
fees on the basis of the aggregation.
(j) Notwithstanding any other provision of this subpart, when the
total amount of fees that could be charged for a particular request (or
aggregation of requests) under subpart C, after taking into account all
services that must be provided free of, or at a reduced, charge, is
less than $10.00 the Department will not make any charge for fees.
Sec. 7.43 Fee Schedule.
(a) The standard fee for a manual search to locate a record
requested under subpart C of this part, including making it available
for inspection, will be determined by multiplying each searcher's
hourly rate plus 16 percent by the time spent conducting the search.
(b) The standard fee for a computer search for a record requested
under subpart C of this part is the actual cost. This includes the cost
of operating the central processing unit for the time directly
attributable to searching for records responsive to a FOIA request and
the operator/programmer salary (hourly plus 16 percent) costs
apportionable to the search.
(c) The standard fee for review of records requested under subpart
C of this part is the reviewer's hourly rate plus 16 percent multiplied
by the time he or she spent determining whether the requested records
are exempt from mandatory disclosure.
(d) The standard fee for duplication of a record requested under
subpart C of this part is determined as follows:
(1) Per copy of each page (not larger than 8 1/2 x 14 inches)
reproduced by photocopy or similar methods (includes costs of personnel
and equipment)--$0.10.
(2) Per copy prepared by computer such as tapes or printout--actual
costs, including operator time.
(3) Per copy prepared by any other method of duplication--actual
direct cost of production.
(e) Depending upon the category of requester, and the use for which
the records are requested, in some cases the fees computed in
accordance with the above standard fee schedule will either be reduced
or not charged, as prescribed by other provisions of this subpart.
(f) The following special services not required by the FOIA may be
made available upon request, at the stated fees: Certified copies of
documents, with Department of Transportation or operating element seal
(where authorized)--$4.00; or true copy, without seal--$2.00
[[Page 33082]]
Sec. 7.44 Services Performed Without Charge or at a Reduced Charge.
(a) A fee is not to be charged to any requester making a request
under subpart C for the first two hours of search time unless the
records are requested for commercial use. For purposes of this subpart,
when a computer search is required two hours of search time will be
considered spent when the hourly costs of operating the central
processing unit used to perform the search added to the computer
operator's salary cost (hourly rate plus 16 percent) equals two hours
of the computer operator's salary costs (hourly rate plus 16 percent).
(b) A fee is not to be charged for any time spent searching for a
record requested under subpart C if the records are not for commercial
use and the requester is a representative of the news media, an
educational institution whose purpose is scholarly research, or a non-
commercial scientific institution whose purpose is scientific research.
(c) A fee is not to be charged for duplication of the first 100
pages (standard paper, not larger than 8.5 x 14 inches) of records
provided to any requester in response to a request under subpart C
unless the records are requested for commercial use.
(d) A fee is not to be charged to any requester under subpart C to
determine whether a record is exempt from mandatory disclosure unless
the record is requested for commercial use. A review charge may not be
charged except with respect to an initial review to determine the
applicability of a particular exemption to a particular record or
portion of a record. A review charge may not be assessed for review at
the administrative appeal level. When records or portions of records
withheld in full under an exemption that is subsequently determined not
to apply are reviewed again to determine the applicability of other
exemptions not previously considered, this is considered an initial
review for purposes of assessing a review charge.
(e) Documents will be furnished without charge or at a reduced
charge if the official having initial denial authority determines that
disclosure of the information is in the public interest because it is
likely to contribute significantly to public understanding of the
operations or activities of the government and is not primarily in the
commercial interest of the requester.
(f) Factors to be considered by officials of the Department
authorized to determine whether a waiver or reduction of fees will be
granted include:
(1) Whether the subject matter of the requested records concerns
the operations or activities of the Federal government;
(2) Whether the disclosure is likely to contribute to an
understanding of Federal government operations or activities;
(3) Whether disclosure of the requested information will contribute
to the understanding of the public at large, as opposed to the
individual understanding of the requester or a narrow segment of
interested persons;
(4) Whether the contribution to public understanding of Federal
government operations or activities will be significant;
(5) Whether the requester has a commercial interest that would be
furthered by the requested disclosure; and
(6) Whether the magnitude of any identified commercial interest to
the requester is sufficiently large in comparison with the public
interest in disclosure that disclosure is primarily in the commercial
interest of the requester.
Sec. 7.45 Transcripts.
Transcripts of hearings or oral arguments are available for
inspection. Where transcripts are prepared by a nongovernmental
contractor, and the contract permits the Department to handle the
reproduction of further copies, Sec. 7.43 applies. Where the contract
for transcription services reserves the sales privilege to the
reporting service, any duplicate copies must be purchased directly from
the reporting service.
Sec. 7.46 Alternative Sources of Information.
In the interest of making documents of general interest publicly
available at as low a cost as possible, alternative sources shall be
arranged whenever possible. In appropriate instances, material that is
published and offered for sale may be obtained from the Superintendent
of Documents, U.S. Government Printing Office, Washington, DC 20402;
U.S. Department of Commerce's National Technical Information Service
(NTIS), Springfield, Virginia 22151; or National Audio-Visual Center,
National Archives and Records Administration, Capital Heights, MD
20743-3701.
Issued in Washington, DC, on May 31, 1996.
Federico Pena,
Secretary of Transportation.
[FR Doc. 96-16248 Filed 6-25-96; 8:45 am]
BILLING CODE 4910-62-P
Complete official Federal Register PDF
FR Doc. 96-16244 Airworthiness Directives; Boeing Model 737-300, -400, and -500 Series Airplanes
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33048-33050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16244]
=======================================================================
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[[Page 33049]]
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 96-NM-23-AD]
RIN 2120-AA64
Airworthiness Directives; Boeing Model 737-300, -400, and -500
Series Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: This document proposes the adoption of a new airworthiness
directive (AD) that is applicable to certain Boeing Model 737-300, -
400, and -500 series airplanes. This proposal would require inspections
to detect bent or damaged tie links and washers of the elevator feel
and centering unit, and replacement of the centering unit with a new or
serviceable unit, if necessary. This action also would provide an
optional replacement of the centering unit, which, if accomplished with
the installation of supports and a stop bolt, would constitute
terminating action for the repetitive inspections. This proposal is
prompted by a report of high control column forces that occurred during
takeoff and landing. The actions specified by the proposed AD are
intended to prevent such high forces, which could result in restriction
of elevator control during takeoff, climbout, and landing.
DATES: Comments must be received by August 5, 1996.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), Transport Airplane Directorate, ANM-103,
Attention: Rules Docket No. 96-NM-23-AD, 1601 Lind Avenue, SW., Renton,
Washington 98055-4056. Comments may be inspected at this location
between 9:00 a.m. and 3:00 p.m., Monday through Friday, except Federal
holidays.
The service information referenced in the proposed rule may be
obtained from Boeing Commercial Airplane Group, P.O. Box 3707, Seattle,
Washington 98124-2207. This information may be examined at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington.
FOR FURTHER INFORMATION CONTACT: Kristin Larson, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue, SW., Renton, Washington;
telephone (206) 227-1760; fax (206) 227-1181.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interested persons are invited to participate in the making of the
proposed rule by submitting such written data, views, or arguments as
they may desire. Communications shall identify the Rules Docket number
and be submitted in triplicate to the address specified above. All
communications received on or before the closing date for comments,
specified above, will be considered before taking action on the
proposed rule. The proposals contained in this notice may be changed in
light of the comments received.
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the proposed rule. All
comments submitted will be available, both before and after the closing
date for comments, in the Rules Docket for examination by interested
persons. A report summarizing each FAA-public contact concerned with
the substance of this proposal will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments
submitted in response to this notice must submit a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket Number 96-NM-23-AD.'' The postcard will be date stamped and
returned to the commenter.
Availability of NPRMs
Any person may obtain a copy of this NPRM by submitting a request
to the FAA, Transport Airplane Directorate, ANM-103, Attention: Rules
Docket No. 96-NM-23-AD, 1601 Lind Avenue, SW., Renton, Washington
98055-4056.
Discussion
The FAA has received a report of high control column forces during
takeoff and landing of a Model 737 series airplane. Investigation
revealed that the high forces were caused by bent tie links in the
elevator centering unit. Further investigation indicated that, when
hydraulic pressure is removed from the elevator feel actuator, the
actuator extends to its full length. If the control column is then
pulled back to the aft stop and then pushed forward with sufficient
force, the tie links in the centering unit can become bent. Bent tie
links can cause the elevator control forces to be higher than normal.
This will be noticeable when larger elevator inputs are necessary, such
as during takeoff and landing. This condition, if not corrected, could
result in restriction of elevator control during takeoff, climbout, and
landing.
Explanation of Relevant Service Information
The FAA has reviewed and approved Boeing Alert Service Bulletin
737-27A1194, dated February 1, 1996, which describes procedures for
repetitive visual inspections for bent or damaged tie links of the
elevator feel and centering unit, and replacement of the centering unit
with a new or serviceable unit, if necessary. The alert service
bulletin also describes procedures for installation of supports and a
stop-bolt on the elevator centering unit. Such installation eliminates
the need for repetitive inspections for airplanes on which no damaged
tie links or washers are found. The alert service bulletin also
indicates that replacement of the elevator centering unit with a new
unit, or one on which serviceable tie links, supports, and a stop-bolt
are installed, would eliminate the need for the repetitive inspections.
Explanation of Requirements of Proposed Rule
Since an unsafe condition has been identified that is likely to
exist or develop on other products of this same type design, the
proposed AD would require repetitive visual inspections to detect bent
or damaged tie links of the elevator centering unit, and replacement of
the elevator centering unit with a new or serviceable unit, if
necessary. Replacement of the elevator centering unit with a new or
serviceable unit on which serviceable tie links, supports, and a stop-
bolt are installed constitutes terminating action for the repetitive
inspections. The actions would be required to be accomplished in
accordance with the alert service bulletin described previously.
Cost Impact
There are approximately 1,618 Boeing Model 737-300, -400, and -500
series airplanes of the affected design in the worldwide fleet. The FAA
estimates that 684 airplanes of U.S. registry would be affected by this
proposed AD, that it would take approximately 3 work hours per airplane
to accomplish the proposed actions, and that the average labor rate is
$60 per work hour. Required parts would cost approximately $140 per
airplane. Based on these figures, the cost impact of the proposed AD on
U.S. operators is estimated to be $218,880, or $320 per airplane.
The cost impact figure discussed above is based on assumptions that
no operator has yet accomplished any of
[[Page 33050]]
the proposed requirements of this AD action, and that no operator would
accomplish those actions in the future if this AD were not adopted.
Should an operator elect to replace the elevator centering unit
rather than continue the repetitive inspections, it would take
approximately 10 work hours per airplane to accomplish the replacement,
at an average labor rate of $60 per work hour. Required parts would
cost approximately $640 per airplane. Based on these figures, the cost
impact of the replacement is estimated to be $1,240 per airplane.
Regulatory Impact
The regulations proposed herein would not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this
proposal would not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this proposed
regulation (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under the DOT
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
and (3) if promulgated, will not have a significant economic impact,
positive or negative, on a substantial number of small entities under
the criteria of the Regulatory Flexibility Act. A copy of the draft
regulatory evaluation prepared for this action is contained in the
Rules Docket. A copy of it may be obtained by contacting the Rules
Docket at the location provided under the caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Safety.
The Proposed Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration proposes to amend
part 39 of the Federal Aviation Regulations (14 CFR part 39) as
follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by adding the following new
airworthiness directive:
Boeing: Docket 96-NM-23-AD.
Applicability: Model 737-300, -400 and -500 series airplanes
through line position 2764 inclusive; certificated in any category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (f) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
Compliance: Required as indicated, unless accomplished
previously.
To prevent restriction of elevator control during takeoff,
climbout, and landing, due to higher than normal elevator control
forces caused by damaged tie links in the elevator centering unit,
accomplish the following:
(a) Within 6 months after the effective date of this AD: Perform
a visual inspection to detect any bent or damaged tie links of the
elevator feel and centering unit, in accordance with Boeing Alert
Service Bulletin 737-27A1194, dated February 1, 1996.
(b) If no tie link is found to be broken, bent, or damaged
during the inspection required by paragraph (a) of this AD:
Accomplish either paragraph (b)(1) or (b)(2) of this AD, in
accordance with Boeing Alert Service Bulletin 737-27A1194, dated
February 1, 1996:
(1) Prior to further flight, install supports and a stop-bolt on
the elevator centering unit. Once this installation is accomplished,
no further action is required by this AD. Or
(2) Repeat the inspection required by paragraph (a) of this AD
thereafter at intervals not to exceed 1,000 flight cycles.
Installation of supports and a stop-bolt in accordance with the
alert service bulletin, constitutes terminating action for the
repetitive inspections required by this AD, provided that no damage
is detected during any inspection required by paragraph (a) of this
AD.
(c) If any tie link is found to be bent or damaged during the
inspection required by paragraph (a) of this AD, and damage is
within the limits specified in Figure 1 of Boeing Alert Service
Bulletin 737-27A1194, dated February 1, 1996: Accomplish paragraphs
(c)(1) and (c)(2) of this AD in accordance with the alert service
bulletin:
(1) Repeat the inspection required by paragraph (a) of this AD
thereafter at intervals not to exceed those specified in Figure 1 of
the alert service bulletin. And
(2) Within 6 months after the effective date of this AD, install
supports and a stop-bolt on the elevator centering unit. This
installation does not terminate the repetitive inspection
requirements of this paragraph.
(d) If any tie link is found to be bent or damaged during any
inspection required by this AD, and the damage is beyond the limits
specified in Figure 1 of Boeing Alert Service Bulletin 737-27A1194,
dated February 1, 1996: Prior to further flight, replace the
elevator centering unit with a new or serviceable unit and
accomplish either paragraph (d)(1) or (d)(2) of this AD in
accordance with the alert service bulletin:
(1) Install supports and a stop-bolt on the elevator centering
unit; or
(2) Repeat the inspection required by paragraph (a) of this AD
thereafter at intervals not to exceed 1,000 flight cycles until the
installation specified in paragraph (d)(1) of this AD is
accomplished.
(e) Replacement of the elevator centering unit with a unit in
which the tie links have been inspected and determined to be
acceptable and in which supports and a stop-bolt have been
installed, in accordance with Boeing Service Bulletin 737-27A1194,
dated February 1, 1996, constitutes terminating action for the
requirements of this AD.
(f) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Seattle Aircraft Certification
Office (ACO), FAA, Transport Airplane Directorate. Operators shall
submit their requests through an appropriate FAA Principal
Maintenance Inspector, who may add comments and then send it to the
Manager, Seattle ACO.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Seattle ACO.
(g) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
Issued in Renton, Washington, on June 19, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-16244 Filed 6-25-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-16243 Airworthiness Directives; Boeing Model 747 Series Airplanes
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33050-33052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16243]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 39
[Docket No. 95-NM-226-AD]
RIN 2120-AA64
Airworthiness Directives; Boeing Model 747 Series Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: This document proposes the supersedure of an existing
airworthiness directive (AD), applicable to certain Boeing Model 747
and 767 series
[[Page 33051]]
airplanes, that currently requires inspection of the door opening
thrusters and door opening/snubbing actuators for proper oil quantity,
and modification of the off-wing compartment latching assemblies. This
action would add a requirement for replacement of the currently
installed door opening thrusters with new, improved thrusters for Model
747 series airplanes. This action also would remove Model 767 series
airplanes from the applicability of the existing AD. This proposal is
prompted by reports indicating that the requirements of the existing AD
do not adequately preclude leakage of fluid from the actuators. The
actions specified by the proposed AD are intended to prevent such
leakage, which could result in failure of the escape slide to deploy;
such failure could delay and possibly jeopardize the successful
emergency evacuation of an airplane.
DATES: Comments must be received by August 5, 1996.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), Transport Airplane Directorate, ANM-103,
Attention: Rules Docket No. 95-NM-226-AD, 1601 Lind Avenue, SW.,
Renton, Washington 98055-4056. Comments may be inspected at this
location between 9 a.m. and 3 p.m., Monday through Friday, except
Federal holidays.
The service information referenced in the proposed rule may be
obtained from Boeing Commercial Airplane Group, P.O. Box 3707, Seattle,
Washington 98124-2207. This information may be examined at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington.
FOR FURTHER INFORMATION CONTACT: Gregory L. Schneider, Aerospace
Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue, SW., Renton, Washington;
telephone (206) 227-2028; fax (206) 227-1181.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interested persons are invited to participate in the making of the
proposed rule by submitting such written data, views, or arguments as
they may desire. Communications shall identify the Rules Docket number
and be submitted in triplicate to the address specified above. All
communications received on or before the closing date for comments,
specified above, will be considered before taking action on the
proposed rule. The proposals contained in this notice may be changed in
light of the comments received.
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the proposed rule. All
comments submitted will be available, both before and after the closing
date for comments, in the Rules Docket for examination by interested
persons. A report summarizing each FAA-public contact concerned with
the substance of this proposal will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments
submitted in response to this notice must submit a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket Number 95-NM-226-AD.'' The postcard will be date stamped and
returned to the commenter.
Availability of NPRMs
Any person may obtain a copy of this NPRM by submitting a request
to the FAA, Transport Airplane Directorate, ANM-103, Attention: Rules
Docket No. 95-NM-226-AD, 1601 Lind Avenue, SW., Renton, Washington
98055-4056.
Discussion
On July 15, 1992, the FAA issued AD 92-16-17, amendment 39-8327 (57
FR 47987, October 21, 1992), which is applicable to certain Model 747
and 767 series airplanes. That AD requires repetitive inspections
(weighing program) of the door opening thrusters and door opening/
snubbing actuators for proper oil quantity, and modification of the
off-wing compartment latching assemblies. That action was prompted by
reports of failure of the off-wing escape slide system to deploy when
commanded. The requirements of that AD are intended to prevent such
failure, which could delay and possibly jeopardize the successful
emergency evacuation of an airplane.
Actions Since Issuance of Previous Rule
Since the issuance of that AD, the FAA received a report from an
operator of Model 767 series airplanes indicating that several
actuators leaked following accomplishment of the modification required
by AD 92-16-17. Consequently, the FAA determined that the modification
requirements of that AD do not adequately preclude leakage from the
actuators. Additionally, the operator reported that, during inspections
(weighing program) of the actuators, the weight of several actuators
increased from the original weight measured during the initial
inspection required by AD 92-16-17. Therefore, the FAA determined that
the inspection requirements of AD 92-16-17 cannot reliably determine
the fluid level of these actuators.
Subsequently, the manufacturer developed a new, improved actuator
for Model 767 series airplanes. On April 10, 1995, the FAA issued AD
95-08-11, amendment 39-9200 (60 FR 20013, April 24, 1995), to require
replacement of the currently installed door opening actuators of the
off-wing emergency escape system on Model 767 series airplanes with
new, improved actuators. Accomplishment of that replacement constitutes
terminating action for the repetitive inspections (weighing program) of
the door opening/snubbing actuators for those airplanes. The FAA
indicated in AD 95-08-11 that it was considering a separate rulemaking
action to remove the requirements for Model 767 series airplanes from
AD 92-16-17.
The door opening thrusters installed on Model 747 series airplanes
are similar in design to the door opening/snubbing actuators installed
on Model 767 series airplanes in that both require a small quantity of
oil to operate, and both have a tendency to leak oil from the chamber.
Such leakage can result in failure of an actuator or thruster.
Explanation of Relevant Service Information
Boeing has issued Service Bulletin 747-25-3073, dated September 21,
1995, which describes procedures for replacement of existing door
opening thrusters on Model 747 series airplanes with new, improved
thrusters. Since the new, improved thruster is not fluid filled,
accomplishment of the replacement eliminates the need for inspections
of the door opening thrusters and door opening/snubbing actuators for
proper oil quantity.
Explanation of Requirements of Proposed Rule
Since an unsafe condition has been identified that is likely to
exist or develop on other products of this same type design, the
proposed AD would supersede AD 92-16-17 to continue to require
repetitive inspections of the door opening thrusters and door opening/
snubbing actuators for proper oil quantity, and modification of the
off-wing compartment latching assemblies for Model 747 series
airplanes. For those airplanes, this proposed AD would add a
requirement for replacement of existing door opening thrusters with
new, improved thrusters. Accomplishment of the replacement constitutes
terminating action for the repetitive inspections. The actions would be
required to be accomplished
[[Page 33052]]
in accordance with the service bulletin described previously.
Additionally, the proposed AD would remove Model 767 series
airplanes from the applicability of the existing AD, since the subject
unsafe condition on those airplanes is addressed in AD 95-08-11.
Cost Impact
There are approximately 400 Model 747 series airplanes of the
affected design in the worldwide fleet. The FAA estimates that 125
airplanes of U.S. registry would be affected by this proposed AD.
The actions that are currently required by AD 92-16-17 take
approximately 12 work hours per airplane to accomplish, at an average
labor rate of $60 per work hour. Required parts cost approximately $510
per airplane. Based on these figures, the cost impact on U.S. operators
of the actions currently required is estimated to be $153,750, or
$1,230 per airplane.
The new actions that are proposed in this AD action would take
approximately 2 work hours per airplane to accomplish, at an average
labor rate of $60 per work hour. Required parts would cost
approximately $6,400 per airplane. Based on these figures, the cost
impact on U.S. operators of the proposed requirements of this AD is
estimated to be $815,000, or $6,520 per airplane.
The cost impact figures discussed above are based on assumptions
that no operator has yet accomplished any of the current or proposed
requirements of this AD action, and that no operator would accomplish
those actions in the future if this AD were not adopted.
Regulatory Impact
The regulations proposed herein would not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this
proposal would not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this proposed
regulation (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under the DOT
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
and (3) if promulgated, will not have a significant economic impact,
positive or negative, on a substantial number of small entities under
the criteria of the Regulatory Flexibility Act. A copy of the draft
regulatory evaluation prepared for this action is contained in the
Rules Docket. A copy of it may be obtained by contacting the Rules
Docket at the location provided under the caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Safety.
The Proposed Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration proposes to amend
part 39 of the Federal Aviation Regulations (14 CFR part 39) as
follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by removing amendment 39-8327 (57 FR
47987, October 21, 1992), and by adding a new airworthiness directive
(AD), to read as follows:
Boeing: Docket 95-NM-226-AD. Supersedes AD 92-16-17, Amendment 39-
8327.
Applicability: Model 747-100, -200, and -300 series airplanes
equipped with an off-wing, two-piece escape slide on Door 3;
certificated in any category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
otherwise modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (e) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
Compliance: Required as indicated, unless accomplished
previously.
To prevent failure of the escape slide to deploy, which could
delay and possibly jeopardize the successful emergency evacuation of
an airplane, accomplish the following:
(a) Within 18 months after November 25, 1992 (the effective date
of AD 92-16-17, amendment 39-8327), perform an inspection of the
door opening thrusters of the escape system in accordance with OEA
Service Bulletin 2174200-25-013, dated July 29, 1991. Repeat this
inspection thereafter at intervals not to exceed 20 months until the
replacement required by paragraph (c) of this AD is accomplished.
(b) Within 18 months after November 25, 1992, inspect and modify
the door latching mechanism of the escape slide compartment in
accordance with Boeing Service Bulletin 747-25-2951, dated August
15, 1991.
(c) Within 2 years after the effective date of this AD, replace
the door opening thrusters having part number (P/N) 60B50077-14 or -
17 with new thrusters having P/N 60B50077-19 in accordance with
Boeing Service Bulletin 747-25-3073, dated September 21, 1995.
Accomplishment of this replacement terminates the repetitive
inspections required by this AD.
(d) As of the effective date of this AD, no person shall install
a door opening thruster having P/N 60B50077-14 or -17 on any
airplane.
(e) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Seattle Aircraft Certification
Office (ACO), FAA, Transport Airplane Directorate. Operators shall
submit their requests through an appropriate FAA Principal
Maintenance Inspector, who may add comments and then send it to the
Manager, Seattle ACO.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Seattle ACO.
(f) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
Issued in Renton, Washington, on June 19, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-16243 Filed 6-25-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-16240 Endangered and Threatened Wildlife and Plants; Notice of Public Hearing and Reopening of Comment Period on Proposed Threatened and Endangered Status for Five Plants and a Lizard From Monterey County, California
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33082-33083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16240]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
50 CFR Part 17
Endangered and Threatened Wildlife and Plants; Notice of Public
Hearing and Reopening of Comment Period on Proposed Threatened and
Endangered Status for Five Plants and a Lizard From Monterey County,
California
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Proposed Rule; notice of public hearing and reopening of
comment period.
-----------------------------------------------------------------------
SUMMARY: The Fish and Wildlife Service (Service), pursuant to the
Endangered Species Act of 1973, as amended (Act), provides notice of a
public hearing on the proposed endangered status for coastal dunes
milkvetch (Astragalus tener var. titi), Yadon's piperia (Piperia
yadonii), Hickman's potentilla (Potentilla hickmanii), Monterey clover
(Trifolium trichocalyx) and the black legless lizard (Anniella pulchra
nigra); and threatened status for Gowen cypress (Cupressus goveniana
ssp. goveniana). In addition, the Service has reopened the comment
period. All parties are invited to submit comments on this proposal.
DATES: The public hearing will be held from 6 p.m. to 8 p.m. on
Wednesday, July 17, 1996, in Monterey, California. The public comment
period now closes August 30, 1996. Any comments received by the closing
date will be considered in the final decision on this proposal.
ADDRESSES: The public hearing will be held at the Hyatt Regency Hotel,
One Golf Course Road, Monterey, California. Written comments and
materials concerning this proposal may be submitted at the hearing or
sent directly to the Field Supervisor, Ventura Field Office, 2493
Portola Road, Suite B, Ventura, California 93003. Comments and
materials will be available for public inspection, by appointment,
during normal business hours at the above address.
FOR FURTHER INFORMATION CONTACT:
Connie Rutherford (see ADDRESSES section) or at 805/644-1766.
SUPPLEMENTARY INFORMATION:
Background
Most of the habitat for the plants and lizard is found in coastal
habitats in northern Monterey County. Coastal dunes milk-vetch and
Monterey clover are restricted to private lands on the Monterey
Peninsula. Hickman's potentilla is restricted to two populations: one
on the Monterey
[[Page 33083]]
Peninsula, and one recently discovered near Devil's Slide in San Mateo
County. Gowen cypress stands occur on the Monterey Peninsula, and at
Point Lobos State Reserve five miles to the south. Yadon's piperia
occurs primarily on private lands on the Monterey Peninsula, with other
populations extending as far south as Palo Colorado Canyon, and as far
north as Blohm Ranch north of Prunedale. The black legless lizard
occurs on private and State Park lands between the Salinas and Carmel
Rivers, on the Monterey Peninsula, and along Monterey Bay. A few
populations of Yadon's piperia and the black legless lizard occur on
Federal lands at Fort Ord.
The five plant taxa and the lizard are threatened by one or more of
the following: alteration, destruction, and fragmentation of habitat
resulting from urban and golf course development; recreational
activities; highway widening; military activities; competition with
non-native species; and alteration of natural fire cycles. All taxa are
also threatened with stochastic extinction due to the small numbers of
populations or individuals.
On August 2, 1995, the Service published a proposed rule on
proposed endangered status for Astragalus tener var. titi, Piperia
yadonii, Potentilla hickmanii, Trifolium trichocalyx, and the black
legless lizard (Anniella pulchra nigra); and threatened status for
Gowen cypress (Cupressus goveniana ssp. goveniana (60 FR 39326).
Section 4(b)(5)(E) of the Act requires that a public hearing be held if
one is requested within 45 days of the publication of the proposed rule
in the Federal Register. Public hearing requests were received within
the allotted time period from Robert D. Thornton of Nossaman, Guthner,
Knox, and Elliot in Irvine, California. Because a Congressional
moratorium on the Service's activities associated with final listing
actions was in effect from April 1995 to April 1996, scheduling of the
hearing had been delayed. The Service has scheduled a public hearing on
July 17, 1996, at the Hyatt Regency Hotel, One Golf Course Road,
Monterey, California.
Anyone wishing to make statements for the record should bring a
written copy of their statements to the hearing. Oral statements may be
limited in length if the number of parties present at the hearing
necessitates such a limitation. Oral and written comments receive equal
consideration. The Service places no limits to the length of written
comments or materials presented at the hearing or mailed to the
Service. Legal notices announcing the date, time, and location of the
hearing are being published in newspapers concurrently with this
Federal Register notice.
The comment period on the proposal was initially closed on October
17, 1995. To accommodate the hearing, the public comment period is
reopened upon publication of this notice. Written comments may now be
submitted until August 30, 1996, to the Service office in the ADDRESSES
section.
Authority
The authority for this action is the Endangered Species Act of 1973
(16 U.S.C. 1531 et seq.).
Dated: June 19, 1996.
Thomas J. Dwyer,
Acting Regional Director, Region 1, U.S. Fish and Wildlife Service.
[FR Doc. 96-16240 Filed 6-25-96; 8:45 am]
BILLING CODE 4310-55-M
Complete official Federal Register PDF
FR Doc. 96-16210 Financial Responsibility Requirements for Nonperformance of Transportation
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33059-33066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16210]
=======================================================================
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FEDERAL MARITIME COMMISSION
46 CFR Part 540
[Docket No. 94-06]
Financial Responsibility Requirements for Nonperformance of
Transportation
AGENCY: Federal Maritime Commission.
ACTION: Further notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Federal Maritime Commission proposes to remove its current
$15 million coverage ceiling for nonperformance of transportation by
passenger vessel operators. The Commission would replace the ceiling
with sliding-scale coverage requirements keyed to passenger vessel
operators' financial rating, length of operation in United States
trades and satisfactory explanation of claims for nonperformance of
transportation. For self-insuring passenger vessel operators, the
Commission proposes to reestablish a working capital requirement and to
require third-party coverage for 25 percent of unearned passenger
revenue. In order to clarify that the escrow agreement is for the
exclusive benefit of passengers' deposits and prepaid fares, the
Commission proposes revising the form escrow agreement it publishes as
a guideline for the industry. The Commission also proposes to require
applications for Certificates (Performance) to be filed at least 90
days in advance of the arranging, offering, advertising or providing of
water transportation or tickets in connection therewith, unless good
cause is shown. Finally, the Commission again solicits suggestions for
other alternatives to consider under its Public Law 89-777 program, as
well as suggestions for scheduling the phasing-in of the proposed
rule's revised coverage requirements. These changes are deemed
necessary to enhance the travelling public's protection against
nonperformance of transportation.
DATES: Comments due on or before August 26, 1996.
ADDRESSES: Send comments (original and 15 copies) to: 1 Joseph C.
Polking,
[[Page 33060]]
Secretary, Federal Maritime Commission, 800 North Capitol St., NW.,
Washington, DC 20573, (202) 523-5725.
\1\ The Commission also requests, but does not require, that
commenters submit an electronic copy of their comments in ASCII,
WordPerfect or Microsoft Word format.
---------------------------------------------------------------------------
FOR FURTHER INFORMATION CONTACT:
Bryant L. VanBrakle, Director, Bureau of Tariffs, Certification and
Licensing, Federal Maritime Commission, 800 North Capitol St., NW.,
Washington, DC 20573, (202) 523-5796.
SUPPLEMENTARY INFORMATION:
I. Introduction
The Federal Maritime Commission (``Commission'' or ``FMC'')
administers section 3, Public Law 89-777, 46 U.S.C. app. 817e
(``section 3''). Section 3 requires certain passenger vessel operators
(``PVOs'') 2 to establish financial responsibility for
nonperformance of transportation.3 The Commission's regulations
implementing section 3 (46 CFR 540, Subpart A) generally provide that a
PVO may evidence financial responsibility by one or more of the
following methods: A guaranty, escrow arrangement, surety bond,
insurance or self-insurance. The Commission requires coverage of at
least 110 percent of a PVO's highest unearned passenger revenue
(``UPR'') 4 over a two-year period. However, the maximum coverage
amount currently required is $15 million. Also, non-self-insuring PVOs
that can evidence a minimum of five years operation in U.S. trades with
a satisfactory explanation of any claims for nonperformance of
transportation are entitled to reduced coverage requirements under the
following sliding scale: 5
---------------------------------------------------------------------------
\2\ For the purposes of section 3, a PVO is any person in the
United States that arranges, offers, advertises or provides passage
on a vessel having berth or stateroom accommodations for fifty or
more passengers and which is to embark passengers at United States
ports.
\3\ Section 3 provides, in pertinent part:
(a) No person in the United States shall arrange, offer,
advertise, or provide passage on a vessel having berth or stateroom
accommodations for fifty or more passengers and which is to embark
passengers at United States ports without there first having been
filed with the Federal Maritime Commission such information as the
Commission may deem necessary to establish the financial
responsibility of the person arranging, offering, advertising, or
providing such transportation, or, in lieu thereof, a copy of a bond
or other security, in such form as the Commission, by rule or
regulation, may require and accept, for indemnification of
passengers for nonperformance of the transportation.
\4\ UPR is defined under 46 CFR 540.2(i) as:
* * * passenger revenue received for water transportation and
all other accommodations, services, and facilities relating thereto
not yet performed.
\5\ The Commission, in Docket No. 92-19, Revision of Financial
Responsibility Requirements for Non-Performance of Transportation,
amended 46 CFR Part 540, Subpart A, to (1) institute this sliding
scale formula for determining the amount of financial responsibility
coverage required for operators meeting certain requirements; (2)
exclude, under certain conditions, revenue from ``whole-ship''
arrangements from being considered UPR; and (3) publish a suggested
form escrow arrangement as a guideline for the industry (57 FR 51887
(September 14, 1992)).
------------------------------------------------------------------------
Unearned passenger revenue (``UPR'') Required coverage
------------------------------------------------------------------------
$0-$5,000,000.......................... 100% of UPR up to $5,000,000.
$5,000,001 to $15,000,000.............. $5,000,000 plus 50% of excess
UPR over $5,000,000 subject to
an overall maximum of
$5,000,000 per vessel.
$15,000,001 to $35,000,000............. $10,000,000 plus 25% of excess
of UPR over $15,000,000
subject to an overall maximum
of $5,000,000 per vessel and a
$15,000,000 overall maximum.
Over $35,000,000....................... $15,000,000 overall maximum.
------------------------------------------------------------------------
Under the Commission's present rules, self-insuring PVOs are
required to demonstrate, among other things, net worth equal to at
least 110 percent of their UPR. At an earlier stage of this proceeding,
as discussed below, the Commission had proposed to phase out self-
insurance except for PVOs which are state and Federal entities.
The Commission monitors activity of PVOs who are subject to Public
Law 89-777 and by rule requires semiannual UPR reports.6
Additionally, the Commission periodically surveys PVOs' future U.S.
cruise schedules and fare structures.
---------------------------------------------------------------------------
\6\ 46 CFR 540.9(h) provides, in pertinent part:
Every person who has been issued a Certificate (Performance)
must submit to the Commission a semiannual statement of any changes
that have taken place with respect to the information contained in
the application or documents submitted in support thereof. Negative
statements are required to indicate no change. Such statements must
cover every 6-month period of the fiscal year immediately subsequent
to the date of the issuance of the Certificate (Performance), and
include a statement of the highest unearned passenger revenue
accrued for each month in the 6-month reporting period. In addition,
the statement will be due within 30 days after the close of every
such 6-month period.
---------------------------------------------------------------------------
II. Background
A. Docket No. 94-6
These proceedings were instituted with a March 1994 Notice of
Proposed Rulemaking (``1994 NPR'' or ``1994 Proposed Rule'').7 The
1994 NPR addressed the Commission's concerns about the adequacy of its
coverage requirements in the light of several recent developments,
including $700 million in uncovered UPR, the voluntary bankruptcy of
one PVO and the dislocation of a self-insured carrier's operations as a
result of the 1993 floods in the Mississippi River system. The 1994 NPR
therefore proposed:
---------------------------------------------------------------------------
\7\ 59 FR 15149 (March 31, 1994).
---------------------------------------------------------------------------
(1) removing the current $15 million UPR coverage ceiling;
(2) revising the current UPR sliding scale to require coverage of
110 percent of UPR up to $25 million per operator, with coverage of 90
percent of UPR for amounts exceeding $25 million (the NPR also put
forth an alternative proposal which would require coverage of 110
percent of UPR up to $25 million per operator; 75 percent of UPR
between $25 million and $50 million per operator; and 50 percent
coverage for UPR over $50 million per operator); and
(3) removing self-insurance as an option for section 3 coverage
(except for state or federal entities). Existing self-insured
commercial operators would be provided one year following the effective
date of any final rule in this matter to obtain other evidence of
financial responsibility.
The 1994 NPR drew twelve comments. There was virtually unanimous
support for the Commission's existing coverage requirements, and
widespread questioning of the need for the 1994 Proposed Rule. Many
commenters drew attention to the Commission's earlier series of
proceedings in this area,8 and
[[Page 33061]]
asserted that there have been no industry changes warranting this
proposal. Positions ranged from strong Congressional and U.S.-flag PVO
opposition to any further changes to current coverage requirements, to
conditional support of a modified version of the 1994 Proposed Rule by
foreign-flag interests. There was no support for the 1994 Proposed Rule
outright; however, a foreign-flag PVO supported the 1994 Proposed
Rule's coverage requirements for those PVOs unable to meet that PVO's
self-insurance proposal.
---------------------------------------------------------------------------
\8\ Docket No. 90-1, Security for the Protection of the Public,
Maximum Required Performance Amount; Proposed Rule, 55 FR 1850
(January 19, 1990); Final Rule, 55 FR 34564 (August 23, 1990);
Correction, 55 FR 35983 (September 4, 1990).
Fact Finding Investigation No. 19, Passenger Vessel Financial
Responsibility Requirements, Order of Investigation, 55 FR 34610
(August 23, 1990).
Docket No. 91-32, Passenger Vessel Financial Responsibility
Requirements for Indemnification of Passengers for Nonperformance of
Transportation--Advance Notice of Proposed Rulemaking and Notice of
Inquiry, 56 FR 40586 (August 15, 1991).
Docket No. 92-19, Revision of Financial Responsibility
Requirements for Nonperformance of Transportation; Proposed Rule, 57
FR 19097 (May 4, 1992); Final Rule, 57 FR 41887 (September 14,
1992).
Docket No. 92-50, Financial Responsibility Requirements for
Nonperformance of Transportation--Revision of Self-Insurance
Qualification Standards; Proposed Rule, 57 FR 47830 (October 20,
1992); Final Rule, 57 FR 62479 (December 31, 1992).
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B. Docket No. 94-21
Given the concerns expressed in the industry comments to the 1994
NPR, the Commission determined to hold it in abeyance pending a formal
Inquiry under Docket No. 94-21, Inquiry into Alternative Forms of
Financial Responsibility for Nonperformance of Transportation (``1994
Inquiry'').9 The 1994 Inquiry's purpose was to determine whether
an acceptable alternative could be fashioned to both address the
industry's concerns with the 1994 NPR and ensure appropriate protection
for passengers. The 1994 Inquiry therefore solicited comment on
covering UPR liability through:
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\9\ 59 FR 52133 (October 26, 1994).
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(1) voluntary association(s) (such association(s) would be in
addition to the current individual methods of evidencing financial
responsibility for non-performance); 10 and
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\10\ In this connection, the Commission noted its approach in
Docket No. 92-37, Financial Responsibility for Non-Vessel-Operating
Common Carriers, Final Rule, 58 FR 5618 (January 22, 1993), which
permits groups or associations of non-vessel-operating common
carriers (``NVOCCs'') to collectively issue bonds to meet financial
responsibility coverage requirements imposed upon NVOCCs by the
Shipping Act of 1984. Because this approach had proven successful
with respect to NVOCCs, a purpose of the 1994 Inquiry was to
consider its applicability and adaptability to PVO requirements
under Pub. L. 89-777.
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(2) retained but strengthened self-insurance requirements.
In general terms, the association(s) envisioned by the 1994 Inquiry
would accept liability for all or a part of a PVO's section 3
liability, using a Commission-approved surety bond or guaranty in an
amount equal to the combined UPR of the two members having the highest
amount of UPR during the past two years. Because these associations
would necessarily involve concerted carrier activity, comments were
also invited on whether this approach could present issues under the
antitrust laws, to the extent such activity is not immunized under
Shipping Act agreements.\11\
\11\ The Shipping Act of 1984, 46 U.S.C. app. 1701, (``1984
Act'') governs concerted ocean common carrier activity in the U. S.
foreign waterborne trades. The Shipping Act, 1916, 46 U.S.C. app.
801, (``1916 Act'') governs concerted activity of common carriers by
water in interstate commerce in the transportation by water of
passengers on the high seas or the Great Lakes on regular routes
from port to port between one U.S. State, Territory, District or
possession and any other U.S. State, Territory, District or
possession or between places in the same Territory, District or
possession. Effective September 30, 1996, the ICC Termination Act of
1995, Pub. L. No. 104-88, 109 Stat. 803, repeals among other things
the 1916 Act provisions applicable to agreements.
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The reinforced self-insurance approach envisioned by the 1994
Inquiry would have worked in a manner whereby the Commission would
restore its former standard,\12\ but require prospective self-insurers
to provide alternative coverage for a percentage (e.g., 50% or 25%) of
their uncovered UPR, through either a traditional guaranty, surety,
escrow agreement or lien or other security instrument, or through
participation in a coverage association along the above-described
lines. This approach would, however, still require qualifying assets to
be located in the United States.
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\12\ The Commission previously required the maintenance of
working capital and net worth, each equal to 110 percent of the
operator's UPR. This standard provided that the Commission could,
for good cause shown, waive the requirement as to the amount of
working capital.
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The 1994 Inquiry was subsequently revised to clarify that the
Commission was also seeking comment on accepting liens, mortgages or
other security instruments as evidence of financial
responsibility.13
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\13\ 59 FR 54878 (November 2, 1994).
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Five comments on the 1994 Inquiry were submitted by three trade
associations (one representing surety interests,14 one
representing foreign-flag vessel operators 15 and one representing
U.S.-flag vessel operators)16, a foreign-flag vessel operator
17 and a U.S.-flag vessel operator.18
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\14\ The Surety Association of America (``Surety Association'')
is a trade association that represents 650 surety companies that
provide 95% of the surety bonds written in the United States.
\15\ The International Council of Cruise Lines (``ICCL'') states
that its members have the vast majority of the cruise industry berth
capacity. Its letterhead lists Carnival Cruise Lines; Celebrity
Cruise Lines; Commodore Cruise Line; Costa Cruise Lines NV; Crown
Cruise Line; Crystal Cruises; Cunard Line Ltd.; Dolphin Cruise Line;
Epirotiki Lines; Fantasy Cruise Lines; Holland America Line; Majesty
Cruise Line; Norwegian Cruise Line; Premier Cruise Lines, Ltd.;
Princess Cruises; Regency Cruises, Inc. (``Regency''); Royal
Caribbean Cruises, Ltd.; Royal Cruise Line; Royal Viking Line;
Seabourn Cruise Line; Sun Line Cruises, Inc.; and Windstar Cruises.
\16\ The Transportation Institute stated in its NPR comments
that it represents 140 U.S.-flag shipping companies engaged in
foreign and domestic trades, including American Classic Voyages Co.
The U.S.-flag PVOs under the Commission's section 3 program
presently consist of American Classic Voyages, Alaska Sightseeing/
Cruise West, Clipper Cruise Line, Special Expeditions, Alaska Marine
Highway, and American Canadian Caribbean Line.
\17\ Carnival Corporation (``Carnival''). Carnival's comments
are filed on behalf of Carnival Cruise Lines, Holland America Lines
and Windstar Cruises. Carnival is an ICCL member.
\18\ American Classic Voyages Co. (``AMCV''). AMCV is the
corporate parent of The Delta Queen Steamboat Co. (``Delta Queen'')
and Great Hawaiian Cruise Line, Inc. (``American Hawaii''). AMCV is
a section 3 self-insurer.
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All of the 1994 Inquiry's commenters had also commented on the NPR,
and indicate that their comments on the 1994 Inquiry supplement or
incorporate by reference those earlier comments, which generally
opposed the 1994 Proposed Rule and urged retaining current regulations.
Many commenters express appreciation for the Commission's efforts to
arrive at creative solutions to the financial responsibility issue. At
the same time, they reiterate their NPR comments that current
requirements are working well, and that no passengers have lost any
money.
The commenters' general opposition to the NPR carried over to the
alternatives proffered under the 1994 Inquiry: virtually all foresee
problems of one sort or another with the voluntary association
approach, ranging from skepticism about the availability of the large
bonds necessary, to a number of difficult risk management and
competitive factors. No commenter offers outright support for the
vessel lien concept, for a number of reasons generally based on
opposition to a requirement that qualifying assets be located in the
U.S. Commenters urge the Commission not to change its current self-
insurance standards, or to discontinue the requirement that qualifying
assets be based in the U.S.
1. Voluntary Associations
The comments opposing the 1994 Inquiry's voluntary association
proposal suggest that, although this general approach seems to be
viable for NVOCCs, it may not be feasible for PVOs. In particular,
these comments address the operational and fiscal
[[Page 33062]]
distinctions between the NVOCC and the PVO industries and make a
credible argument as to why in this particular case a mechanism which
works for one industry might not for another.19
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\19\ In this regard, the comments point out that P&I Clubs,
which are mutual insurance associations, were developed initially to
provide mutual insurance for casualty and other losses. Thus, they
are structured on the assumption that a member will survive a
casualty, and the P&I mechanism is designed to eventually recover
casualty losses from the member suffering that loss. (P&I Clubs
issue performance guaranties only as an accommodation to the
membership, and then only on a fully-collateralized basis.) The
NVOCC industry uses commercial instruments and does not have mutual
associations similar to P&I Clubs.
---------------------------------------------------------------------------
In short, the comments contend that an association approach would
not work at the coverage levels contemplated under the NPR (either the
original proposal or the alternative), due to the concentrated capital
structures, operational diversity and competitive considerations
inherent in the contemporary cruise industry.20 Also, ICCL
comments that the nature of the cruise business does not lend itself to
the mutuality inherent in the association approach, which seems to be
borne out by AMCV's explanation of the drawbacks it sees in the
association approach.21 It therefore appears unlikely that the
market could support the magnitude of risk exposure inherent in the
sort of voluntary association envisioned by the 1994 Inquiry.
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\20\ The Surety Association advises that, depending on the
actual make-up and financial strength of the passenger vessel
associations, some associations may find it extremely difficult to
qualify for a group surety bond and some may not be able to qualify
at all.
\21\ AMCV described the undesirability of PVOs becoming exposed
to liability for other PVOs' nonperformance; fiduciary risks to PVO
management for assuming liability for events within the sole control
of its competitors; the difficulties of allocating the levels of
risk involved and the narrowness of the base upon which that risk
would be shared; and the inherent susceptibility of weaker members
to termination--either for competitive reasons or because of normal
operational risks inherent in a seasonal industry that is ultimately
dependent upon discretionary income for all of its revenues.
---------------------------------------------------------------------------
Another material difference between these two industries is
prepayment: NVOCCs do not require their customers to fully prepay for
their services anywhere from two to six weeks (or, in some cases, eight
or more weeks) before they are performed, as is the practice with PVOs.
It is this practice which accounts for the approximately $700 million
shortfall in uncovered UPR that prompted these proceedings. The
shortfall's size more than anything else would appear ultimately to
render the voluntary association approach unworkable.
With regard to possible antitrust issues under this approach, AMCV
notes that an association attempting to limit membership to financially
sound PVOs could be subject to antitrust claims by excluded PVOs, and
that there is an inherent potential for detrimental disclosure of
confidential information.22
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\22\ Those PVOs subject to the 1984 Act could avail themselves
of agreement immunity to protect themselves from whatever exposure
such concerted activity would cause under antitrust laws. Thus, the
Shipping Act's antitrust exemption could result in uneven antitrust
exposure as between those PVOs entitled to the wide scope of 1984
Act agreement antitrust exemption (transportation between U.S. and
foreign locations), which would obtain either with the filing or
regulatory exemption of the Association agreement(s); and those
purely domestic PVOs (transportation solely within the U.S.), which
may not be entitled to any Shipping Act antitrust exemption at all.
(The immunity afforded by the 1916 Act is repealed September 30,
1996, by virtue of the ICC Termination Act of 1995, Pub. L. 104-88,
109 Stat. 803.)
---------------------------------------------------------------------------
In view of the foregoing considerations, the Commission has
determined not to pursue a voluntary association approach for the
purposes of its Pub. L. 89-777 program.
2. Self-Insurance
The self-insurance requirements currently in place were established
by the Commission's Final Rule in Docket No. 92-50, which became
effective February 1, 1993. Previously, self-insurers needed to
demonstrate net worth and working capital each equal to 110% of the
PVO's UPR--the standard the 1994 Inquiry suggested that the Commission
might restore.
Current self-insurance standards provide that PVOs demonstrating a
minimum of five years' operation in U.S. trades, with a satisfactory
explanation of any claims for nonperformance of transportation, need
only demonstrate net worth equal to 110% of their UPR to qualify for
self-insurance. Self-insurers are not, however, entitled to the sliding
scale UPR coverage requirements that had been adopted in the Final Rule
in Docket No. 92-19,23 and qualifying assets still must be located
in the U.S.
---------------------------------------------------------------------------
\23\ Please refer to footnote 5, infra.
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The comments on the 1994 Inquiry urge the Commission not to repeal
self-insurance for private operators. AMCV has offered a rationale why
the Commission should neither terminate self-insurance for commercial
PVOs, as proposed in the NPR, nor implement the 1994 Inquiry's
suggested restoration of the Commission's former and more rigorous
standard.
Foreign-flag operators take a different tack, urging repeal of the
U.S.-based asset requirement. Carnival proposes a standard that would
not only repeal the U.S.-based asset requirement but also provide for
self-insurance qualification for PVOs which either (1) have earned
investment grade ratings by the bonding rating agencies; or (2) meet
both (a) a three times tangible net worth test and (b) a liquidity test
(cash, short term investments and undrawn lines of credit equal to at
least 100% UPR).
The foreign-flag operators, and Carnival in particular, seek a
system that appears to be well suited for assessing a company's
investment risk. However, Carnival's ``investment risk'' test may not
be appropriate for a statute that contemplates indemnification of
passengers in the event a carrier does not fulfill its obligations.
In this regard, we note that Carnival's proposed test is
conditioned upon the Commission removing the U.S.-based asset
requirement. We believe this requirement is critical to the self
insurance standard. Unless passengers have the ability to attach a
defaulting carrier's assets, self insurance under any standard is
problematic.24 As the Commission remarked in its Final Rule in
Docket 92-50:
\24\ Although Carnival has proposed that self-insuring PVOs
assent to U.S. jurisdiction in disputes with passengers over UPR and
that PVOs designate agents for service of process, we do not believe
that these measures would be sufficient for a passenger to attach a
carrier's foreign-based assets. Moreover, this would not add
anything new because section 3 UPR is already protected by U.S. Law
(Pub. L. 89-777) and all section 3 applicants are required to
appoint agents for service of process before they are certificated.
Also, the Commission's concern is not limited to disputes between
viable PVOs and passengers over UPR; rather, the Commission is
concerned with a failing PVO's ability to indemnify passengers for
nonperformance, which goes well beyond U.S. jurisdiction over simple
disputes.
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Although AHC and ICCL have requested the Commission to relax the
requirement that the assets used to qualify as a self-insurer be
physically located in the United States, the final rule herein
continues existing requirements for the location of those assets.
The Commission remains concerned that passengers may not have the
ability or resources to pursue foreign-domiciled assets, and that
such efforts would not be cost-effective in the majority of
instances.* Moreover, as noted in the NPR, ``self-insurance presents
a greater risk of loss to the travelling public than do other forms
of coverage that are backed by independent interests holding sums of
money for the protection of the public.''
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* Docket No. 92-19, Notice of Proposed Rulemaking, p. 9.
Docket No. 92-50, Financial Responsibility Requirements for
Nonperformance of Transportation--Revision of Self-Insurance
Qualification Standards, 57 FR 47830 (October 20, 1992), Final Rule,
57 FR 62480 (December 31, 1992).
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On the other hand, AMCV's comments appear to provide a basis to
ameliorate some of the concerns that originally prompted the Commission
to propose withdrawing self-insurance as
[[Page 33063]]
an available option for commercial PVOs.25 AMCV explains that
traditional maritime liens and preferred mortgages, which have priority
over passenger claims, are first deducted prior to calculating net
worth under the existing rule; therefore, the resultant net worth used
to qualify for section 3 self-insurance has already accounted for those
liabilities.26
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\25\ AMCV also suggested that the widespread use of credit cards
and the protection offered by the Truth-in-Lending Laws and private
travel insurance programs, act to buttress any shortfalls in the
Commission's self-insurance options. While this may or may not be
true, the Commission nevertheless has an independent obligation to
make certain that PVOs have established their financial
responsibility to indemnify passengers for nonperformance of
transportation. Accordingly, we do not believe that the statutes or
programs referred to by AMCV obviate the need for the Commission to
fulfill its statutory responsibilities.
\26\ Although AMCV may have addressed some of the Commission's
concerns with respect to self-insurance, it did not address other
potential payables that may have priority over passengers claims,
e.g., employee salaries, benefits, legal fees. However, the proposed
restoration of the former working capital standard, together with
the additional requirement suggested below, should suffice to
establish the requisite level of financial responsibility.
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After further consideration, the Commission has determined to
withdraw its proposal to discontinue self-insurance for commercial
operators. Instead, the Commission proposes to continue self-insurance,
but with revised criteria. To this end, the proposed rule herein would
revise Part 540 to permit PVOs other than state or Federal
instrumentalities to qualify for a Performance Certificate using U.S.-
based net worth and working capital each equal to or greater than their
outstanding UPR, plus an additional cushion of 25% of UPR backed by a
traditional guaranty, surety bond, insurance or escrow account. Such an
approach would permit commercial operators, like AMCV, to continue to
use the self-insurance option currently set forth in the Commission's
rules, provided they also can evidence working capital equal to their
outstanding UPR and can acquire a guaranty, surety bond, insurance or
escrow account for 25% of their outstanding UPR.
3. Liens, Mortgages and Other Security Instruments
This aspect of the 1994 Inquiry drew no support in the comments. In
fact, commenters provided sound reasons why it should not be pursued
further. Accordingly, the Commission intends to take no further action
with respect to this option.
III. Discussion
Notwithstanding the industry's general position that changes are
not necessary, the Commission's concern about the adequacy of its
financial responsibility standards has, if anything, increased.
Subsequent to the close of the comment period in the 1994 Inquiry,
three additional passenger vessel operators have sought protection
under the Bankruptcy Code:
--In late December 1994, Gold Star Cruises ceased operations and filed
for Chapter 7 bankruptcy.
--As of October 29, 1995, Regency Cruises ceased operations. It
subsequently filed for Chapter 11 protection on November 7, 1995.
--On October 30, 1995, Palm Beach Cruises filed for Chapter 11
protection to reorganize.
In each of these cases, there appear to be sufficient funds set aside
to indemnify passengers scheduled to embark at U.S. ports. At the same
time, it should be noted that there was some concern regarding Regency
because its unearned passenger revenue had from time to time exceeded
the current ceiling; however, Regency ceased operations at a time when
its unearned passenger revenue was below the ceiling.
Accordingly, in light of the foregoing the Commission believes that
it must now proceed to revise its coverage requirements to narrow the
gap between coverage and UPR as a means of enhancing protection for the
public.
A. Revised Coverage Requirements
1. Coverage Levels
As aforementioned, the Commission remains concerned about the
increased exposure to risk of the travelling public's deposits and
prepaid fares in the event that a PVO holding UPR levels above the
current ceiling defaults, possibly leaving passengers unprotected and
subject to financial losses. The Commission therefore proposes to
remove the $15 million ceiling in 46 CFR 540.9(j). Adjustments will
also be proposed to the sliding scale and eligibility requirements
currently set forth in 540.5(e). The Commission also proposes to
introduce a new sliding scale coverage table that would apply to all
operators.
a. Reduced Coverage Scale. The revised sliding scale in 46 CFR
540.5(e) would continue to be available to passenger vessel operators
that can provide evidence of at least five years' operation in United
States trades, with a satisfactory explanation of any claims for
nonperformance of transportation. Operators opting to use this reduced
coverage sliding scale would, in addition, have to demonstrate that
their debt is rated ``Aa'' or better by Moody's Investors Service. For
those who qualify, this reduced coverage sliding scale would require
100 percent coverage for UPR up to $15 million and, when fully phased
in, 60 percent coverage for UPR between $15 and $50 million; 20 percent
coverage for amounts between $50 and $100 million; and 10 percent for
amounts over $100 million. The reduced coverage sliding scale would be
phased in over a 3-year period to minimize the impact of the new
coverage requirements.27
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\27\ The proposed reduced coverage sliding scale would require
100 percent coverage for a PVO's first $15 million in UPR and phase
in this revised coverage requirement in three increments:
First, effective March 1, 1997, it would require 60 percent
coverage for UPR between $15 and $25 million; 20 percent coverage
for amounts between $25 and $50 million and 10 percent coverage for
amounts over $50 million.
Second, effective March 1, 1998, it would require 60 percent
coverage for UPR between $15 and $35 million; 20 percent coverage
for amounts between $35 and $75 million and 10 percent coverage for
amounts over $75 million.
Finally, effective March 1, 1999, it would require 60 percent
coverage for UPR between $15 and $50 million; 20 percent coverage
for amounts between $50 and $100 million; and 10 percent coverage
for amounts over $100 million.
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The Commission believes that this approach would give more weight
to third-party, marketplace assessments of a PVO's financial strength
in determining its section 3 risk. Moreover, this approach relies,
albeit indirectly, upon foreign-based assets as urged by foreign-flag
PVOs in connection with the self-insurance standards.
b. Standard Coverage Scale. The new standard coverage sliding scale
would be available to all PVOs, regardless of the extent of their
operational experience, their financial standing or their explanations
for instances of nonperformance. When fully phased in, the standard
coverage sliding scale would ultimately require 100 percent coverage
for UPR up to $50 million; 75 percent coverage for amounts between $50
and $100 million; and 25 percent coverage for amounts over $100
million. The standard coverage sliding scale would be phased in over a
3-year period to minimize the impact of the new coverage
requirements.28
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\28\ The proposed rule would phase in this revised coverage
requirement in three increments:
First, effective March 1, 1997, it would require 100 percent
coverage for UPR up to $25 million; 75 percent coverage for amounts
between $25 and $35 million; and 25 percent coverage for amounts
over $35 million.
Second, effective March 1, 1998, it would require 100 percent
coverage for UPR up to $35 million; 75 percent coverage for amounts
between $35 and $50 million; and 25 percent coverage for amounts
over $50 million.
Finally, effective March 1, 1999, it would require 100 percent
coverage for UPR up to $50 million; 75 percent coverage for amounts
between $50 and $100 million; and 25 percent coverage for amounts
over $100 million.
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[[Page 33064]]
2. Self-Insurance
The Commission has determined to propose the restoration of self-
insurance for private PVOs that can demonstrate both U.S.-based net
worth and working capital each equal to their outstanding UPR,29
with an additional cushion of 25% of UPR backed by a traditional
guaranty, surety bond, insurance or escrow account.
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\29\ The Commission also proposes restoring the procedure to
waive, for good cause shown, the requirement as to the amount of
working capital appearing in the former Sec. 540.5(d).
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3. Effective Date
While the Commission wishes to revise section 3, Public Law 89-777,
requirements at the earliest practicable date, it does not wish to do
so in a manner that unnecessarily disrupts the passenger vessel
industry. In this connection, the Commission acknowledges the
widespread practice of P&I Clubs to require members to fully
countersecure their section 3, Public Law 89-777, guaranties as well as
the P&I Club practice of renewing coverages during February of each
year. Therefore, the proposed rule herein would phase in the revised
coverage requirements over a 3-year period beginning March 1, 1997, and
ending March 1, 1999.
B. Revision of Part 540's Escrow Agreement Guideline
In a recent bankruptcy involving a PVO that had used an escrow
agreement to meet its section 3, Public Law 89-777 financial
responsibility requirements, the question arose as to whether the
escrow's assets should be considered debtor's property. The escrow
agreement at issue contained language that the Commission has changed
in other escrow agreements it has since approved so as to address this
issue. Therefore, we are proposing a change to paragraph 12 to require
language that makes clear that escrow funds are not debtor's property
and should be made available to passengers.
C. Filing Deadline
Section 540.4(b) requires that an application for a Certificate
(Performance) shall be filed at least 60 days in advance of the
arranging, offering, advertising, or providing of any water
transportation or tickets in connection therewith. Late filing of the
application is permitted only for good cause shown. With the growth of
the passenger vessel industry over the years since this requirement was
first promulgated, together with the industry's increasing reliance on
complex financial responsibility proposals requiring case-by-case
assessment by the Commission, a 60-day period can be insufficient.
Accordingly, this is being changed to a 90-day period, absent good
cause shown.
The Federal Maritime Commission certifies, pursuant to section
605(b) of the Regulatory Flexibility Act, 5 U.S.C. 605(b), that this
proposed rule, if adopted, will not have a significant economic impact
on a substantial number of small entities, including small businesses,
small organizational units, and small governmental organizations. The
passenger vessel operators impacted by the rule are generally not small
businesses.
The collection of information requirements contained in this rule
have been submitted to the Office of Management and Budget for review
under section 3507 of the Paperwork Reduction Act of 1995. The annual
public reporting and recordkeeping burden for this collection of
information is estimated to average 14.91 hours per response. Burden
means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or provide
information to or for a Federal agency. This includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimates of
the burden (including hours and cost) of the proposed collection of
information; (c) ways to enhance the quality, utility, and clarity of
the information to be collected; and (d) ways to minimize the burden of
the collection of information on respondents, including through the use
of automated collection techniques or other forms of information
technology. Send comments concerning the information collection
requirements of this rule within 60 days of this notice to Bruce A.
Dombrowski, Deputy Managing Director, Federal Maritime Commission,
Washington, D.C. 20573 and to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Attention: Desk Officer for
the Federal Maritime Commission, Washington, D.C. 20503.
List of Subjects in 46 CFR Part 540
Insurance, Maritime carriers, Penalties, Reporting and
recordkeeping requirements, Surety bonds, Transportation.
Therefore, pursuant to 5 U.S.C. 553; section 3, Pub. L. 89-777, 80
Stat. 1356-1358 (46 U.S.C. app. 817e); section 43 of the Shipping Act,
1916 (46 U.S.C. app. 841a); and section 17 of the Shipping Act of 1984
(46 U.S.C. app. 1716), the Federal Maritime Commission proposes to
amend Part 540 of Title 46 of the Code of Federal Regulations as
follows:
PART 540--[AMENDED]
1. The authority citation to Part 540 continues to read:
Authority: 5 U.S.C. 552, 553; secs. 2 and 3, Pub. L. 89-777, 80
Stat. 1356-1358 (46 U.S.C. app. 817e, 817d); sec. 43 of the Shipping
Act, 1916 (46 U.S.C. app. 841a); sec 17 of the Shipping Act of 1984
(46 U.S.C. app. 1716).
Sec. 540.4 [Amended]
2. In section 540.4(b), the reference to ``60 days'' in the first
sentence is amended to read ``90 days.''
3. Section 540.5 is amended by revising the introductory text, the
introductory text of paragraph (d), paragraph (d)(6), and (e) to read
as follows:
Sec. 540.5 Insurance, guaranties, escrow accounts, and self-
insurance.
Except with regard to escrow accounts and self-insurers, the amount
of coverage required under this section and Sec. 540.6(b) shall be in
an amount determined by the Commission to be no less than 100 percent
of the unearned passenger revenue of the applicant on the date within
the 2 fiscal years immediately prior to the filing of the application
which reflects the greatest amount of unearned passenger revenue,
subject to the following schedule:
[[Page 33065]]
------------------------------------------------------------------------
Unearned passenger revenue (``UPR'') Required coverage
------------------------------------------------------------------------
Effective March 1, 1997:
$0-$25,000,000..................... 100% of UPR.
$25,000,001-$35,000,000............ $25,000,000 plus 75% of excess
UPR over $25,000,000.
Over $35,000,000................... $32,500,000 plus 25% of excess
UPR over $35,000,000.
Effective March 1, 1998:
$0-$35,000,000..................... 100% of UPR.
$35,000,001-$50,000,000............ $35,000,000 plus 75% of excess
UPR over $35,000,000.
Over $50,000,000................... $46,250,000 plus 25% of excess
UPR over $50,000,000.
Effective March 1, 1999:
$0-$50,000,000..................... 100% of UPR.
$50,000,001-$100,000,000........... $50,000,000 plus 75% of excess
UPR over $50,000,000.
Over $100,000,000.................. $87,500,000 plus 25% of excess
UPR over $100,000,000.
------------------------------------------------------------------------
The Commission, for good cause shown, may consider a time period other
than the previous 2-fiscal-year period requirement in this section or
other methods acceptable to the Commission to determine the amount of
coverage required. Evidence of adequate financial responsibility for
the purposes of this subpart may be established by one or a combination
(including Sec. 540.6 Surety Bonds) of the following methods:
* * * * *
(d) Filing with the Commission for qualification as a self-insurer
such evidence acceptable to the Commission as will demonstrate
continued and stable passenger operations over an extended period of
time in the foreign or domestic trade of the United States. In
addition, applicants other than state or Federal entities must
demonstrate financial responsibility by maintenance of working capital
and net worth, each in an amount no less than 100 percent of the
unearned passenger revenue of the applicant on the date within the 2
fiscal years immediately prior to the filing of the application which
reflects the greatest amount of unearned passenger revenue. The
Commission will take into consideration all current contractual
requirements with respect to the maintenance of such working capital
and/or net worth to which the applicant is bound. Evidence must be
submitted that the working capital and net worth required above are
physically located in the United States. This evidence of financial
responsibility shall be supplemented by evidence demonstrating that
twenty-five percent of applicant's unearned passenger revenue is
covered by one or a combination of the following: evidence of insurance
pursuant to Sec. 540.5(a); evidence of an escrow account pursuant to
Sec. 540.5(b); a guaranty pursuant to Sec. 540.5(c); or a surety bond
pursuant to Sec. 540.6. This evidence of financial responsibility shall
be supported by and be subject to the following which are to be
submitted on a continuing basis for each year or portion thereof while
the Certificate (Performance) is in effect;
* * * * *
(6) A list filed semiannually of all contractual requirements or
other encumbrances (and to whom the applicant is bound in this regard)
relating to the maintenance of working capital and net worth;
* * * * *
(e) (1) The following schedule may be applied to determine the
minimum coverage required for indemnification of passengers in the
event of nonperformance of water transportation for those operators who
have not elected to qualify by an escrow account or self-insurance; and
can provide evidence (in the form of an affidavit by the operator's
Chief Executive Officer or other responsible corporate officer) that
applicant's debt is rated by Moody's Investors Service at Aa or higher;
and of a minimum of five years of operation in United States trades
with a satisfactory explanation of any claims for nonperformance of
transportation.
------------------------------------------------------------------------
Unearned passenger revenue (``UPR'') Required coverage
------------------------------------------------------------------------
$0-$15,000,000......................... 100% of UPR.
Effective March 1, 1997:
$15,000,001-$25,000,000............ $15,000,000 plus 60% of excess
UPR over $15,000,000.
$25,000,001-$50,000,000............ $21,000,000 plus 20% of excess
UPR over $25,000,000.
Over $50,000,000................... $26,000,000 plus 10% of excess
UPR over $50,000,000.
Effective March 1, 1998:
$15,000,001-$35,000,000............ $15,000,000 plus 60% of excess
UPR over $15,000,000.
$35,000,001-$75,000,000............ $27,000,000 plus 20% of excess
UPR over $35,000,000.
Over $75,000,000................... $35,000,000 plus 10% of excess
UPR over $75,000,000.
Effective March 1, 1999:
$15,000,001-$50,000,000............ $15,000,000 plus 60% of excess
UPR over $15,000,000.
$50,000,001-$100,000,000........... $36,000,000 plus 20% of excess
UPR over $50,000,000.
Over $100,000,000.................. $46,000,000 plus 10% of excess
UPR over $100,000,000.
------------------------------------------------------------------------
(2) The qualifications of applicants seeking consideration under
the coverage requirements of this paragraph shall be supported by and
subject to the following which are to be submitted on a continuing
basis for each year or portion thereof while the Certificate
(Performance) is in effect:
(i) A report filed semiannually evidencing that Moody's Investors
Service rates applicant's debt at Aa or higher; and
(ii) Such additional evidence of financial responsibility as the
Commission may deem necessary in appropriate cases.
[[Page 33066]]
Sec. 540.9 [Amended]
5. In section 540.9, paragraph (j) is removed, and paragraph (k) is
redesignated as paragraph (j).
Appendix A to Subpart A--[Amended]
6. The following sentence is added at the end of Paragraph 12 of
Appendix A to subpart A--Example of Escrow Agreement for Use Under 46
CFR 540.5(b):
The Operator and/or Ticket Issuer are not entitled to, nor have any
interest in, any funds payable from this account to the extent such
funds represent unearned passenger revenue, as that term is defined
in subpart A of part 540 of title 46, Code of Federal Regulations.
* * * * *
By the Commission.
Joseph C. Polking,
Secretary.
[FR Doc. 96-16210 Filed 6-25-96; 8:45 am]
BILLING CODE 6730-01-P
Complete official Federal Register PDF
FR Doc. 96-16207 Limes Grown in Florida and Imported Limes; Reopening of Comment Period To File Written Comments to the Change in Regulatory Period
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Page 33047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16207]
========================================================================
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. 124 / Wednesday, June 26, 1996 /
Proposed Rules
[[Page 33047]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Parts 911 and 944
[Docket No. FV96-911-2PR]
Limes Grown in Florida and Imported Limes; Reopening of Comment
Period To File Written Comments to the Change in Regulatory Period
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Reopening of the comment period to file written comments to the
proposed rule.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that the time period for filing written
comments on the proposed changes to the regulatory period currently
prescribed under the lime marketing order and the lime import
regulations is reopened until July 8, 1996.
DATES: Comments must be received by July 8, 1996.
ADDRESSES: Interested persons are invited to submit written comments
concerning this proposal. Comments must be sent in triplicate to the
Docket Clerk, Fruit and Vegetable Division, AMS, USDA, room 2525-S,
P.O. Box 96456, Washington, DC 20090-6456, FAX Number (202) 720-5698.
All comments should reference the docket number and the date and page
number of this issue of the Federal Register and will be available for
public inspection in the Office of the Docket Clerk during regular
business hours.
FOR FURTHER INFORMATION CONTACT: Britthany Beadle, Marketing Order
Administration Branch, F&V, AMS, USDA, room 2522-S, P.O. Box 96456,
Washington, DC 20090-6456: telephone: (202) 720-5127; or Aleck Jonas,
Southeast Marketing Field Office, Marketing Order Administration
Branch, F&V, AMS, USDA, P.O. Box 2276, Winter Haven, Florida 33883;
telephone: (941) 299-4770.
SUPPLEMENTARY INFORMATION: A proposed rule was issued on May 2, 1996,
and published in the Federal Register (61 FR 20754). The proposed rule
would modify language in both the domestic and import regulations to
change the regulatory period to January 1 through May 31, from its
current continuous, year round, implementation. A 30-day comment period
was provided for interested persons to respond to the proposed rule.
The comment period ended June 7, 1996. One comment was received.
The Department of Agriculture (Department) has received a request
from Gail A. Knodel, Manager of the Florida Lime Administrative
Committee, asking that additional time be provided for interested
persons to analyze the proposed rule. Manager Knodel stated that the
proposal is a major change in the industry. Reopening the comment
period to July 8, 1996, would allow interested person more time to
review the proposed rule and address their concerns.
This delay should not substantially add to the time required to
complete this action. Accordingly, the period in which to file written
comments is reopened until July 8, 1996. This notice is issued pursuant
to the Agricultural Marketing Agreement Act of 1937.
Authority: 7 U.S.C. 601-674.
Dated: June 19, 1996.
Sharon Bomer Lauritsen,
Acting Director, Fruit and Vegetable Division.
[FR Doc. 96-16207 Filed 6-25-96; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 96-16204 Regulation of Fuels and Fuel Additives: Controls Applicable to Gasoline Retailers and Wholesale Purchaser-Consumers; 10 Gallon Per Minute Fuel Dispensing Limit Requirement Implementation
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33053-33054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16204]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 80
[FRL-5522-2]
RIN 2060-AG43
Regulation of Fuels and Fuel Additives: Controls Applicable to
Gasoline Retailers and Wholesale Purchaser-Consumers; 10 Gallon Per
Minute Fuel Dispensing Limit Requirement Implementation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: On January 20, 1993 EPA finalized a requirement limiting
vehicle service station fuel dispensing rates to 10 gallons per minute
(gpm) maximum, beginning January 1, 1996 for retailers and wholesale
purchaser-consumers handling over 10,000 gallons of fuel per month (55
FR 16002, March 24, 1993). In 1995, various groups in the petroleum
industry requested that EPA delay the January 1, 1996 deadline, due
mainly to the lack of available retrofit parts needed for compliance
with the 10gpm requirement. EPA is proposing to delay the
implementation date of the 10gpm requirement from January 1, 1996 until
July 1, 1996. In addition, EPA is proposing regulation changes to
clarify that the hardware/software for controlling the fuel dispensing
rate may be located anywhere in the pump/dispenser system and that
refueling facilities are exempt from the 10gpm requirement if used
exclusively to refuel heavy-duty vehicles, boats or airplanes.
Because the rule revision is not expected to receive any adverse
comments, the revision is also being issued as a direct final rule in
the Final Rules section of this Federal Register.
DATES: Comments on the regulations proposed by this action must be
received on or before July 26, 1996.
ADDRESSES: Materials relevant to the initial final rule, and today's
action are available for inspection in Public Dockets A-89-18 and A-95-
53 at Air Docket Section, U.S. Environmental Protection Agency, EPA Air
Docket Section (6102), First Floor, Waterside Mall, Room M-1500, 401 M
Street S.W., Washington, D.C. 20460 (telephone 202-260-7549, fax 202-
260-4400) between the hours of 8 a.m. and 5:30 p.m. A reasonable fee
may be charged by EPA for copying docket material.
All written comments must be identified with the appropriate docket
number (Docket No. A-95-53) and must be submitted in duplicate to the
address listed above, with a complimentary
[[Page 33054]]
copy to Karl Simon or Dave Good at the address listed below.
FOR FURTHER INFORMATION CONTACT: Karl Simon at the U.S. EPA, 401 M
Street S.W. (mail code 6405J), Washington D.C., 20460, telephone (202)
233-9299; or Dave Good at the U.S. EPA, 2565 Plymouth Rd, Ann Arbor,
Michigan, 48105, telephone (313) 668-4450.
SUPPLEMENTARY INFORMATION:
Regulated Entities
Entities potentially regulated by this action are retailers and
wholesale purchaser-consumers of gasoline and methanol which handle
over 10,000 gallons of fuel per month, for the purpose of refueling
passenger cars and light-duty trucks. Regulated entities would include
the following:
------------------------------------------------------------------------
Category Examples of regulated entities
------------------------------------------------------------------------
Industry..................... Service station owners, service station
managers, fleet managers who operate a
refueling facility to refuel motor
vehicles.
Federal Government........... Federal facilities, including military
bases, who operate a refueling facility
to refuel motor vehicles.
State, Local and Tribal State, local and tribal governments who
Governments. operate a refueling facilities to refuel
motor vehicles.
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could potentially be regulated by this action. Other types of entities
not listed in the table could also be regulated. To determine whether
your facility is regulated by this action, you should carefully examine
the criteria contained in Sec. 80.22(j) of title 40 of the Code of
Federal Regulations, as modified by today's action. If you have
questions regarding the applicability of this action to a particular
entity, consult one of the persons listed in the preceding FOR FURTHER
INFORMATION CONTACT section.
If no adverse comments are timely received, no further activity is
contemplated in relation to this proposed rule and the direct final
rule in the Final Rules section of this Federal Register will
automatically go into effect on the date specified in that rule. If
adverse comments are timely received on the direct final rule, the rule
will be withdrawn and all public comment received on it will be
addressed in a subsequent final rule based on this proposed rule.
Because the Agency will not institute a second comment period on this
proposed rule, any parties interested in commenting should do so during
this comment period.
For further supplemental information, the detailed rationale, and
the rule revisions, see the information provided in the direct final
rule in the Final Rules section of this Federal Register.
List of Subjects in 40 CFR Part 80
Environmental protection, Administrative practice and procedures,
Air pollution control, Gasoline, Motor vehicle pollution.
Dated: June 12, 1996.
Carol M. Browner,
Administrator.
[FR Doc. 96-16204 Filed 6-25-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-16203 Proposed Test Rule for Hazardous Air Pollutants
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33178-33200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16203]
[[Page 33177]]
_______________________________________________________________________
Part II
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 799
Proposed Test Rule for Hazardous Air Pollutants; Proposed Rule
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 /
Proposed Rules
[[Page 33178]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42187; FRL-4869-1]
RIN 2070-AC76
Proposed Test Rule for Hazardous Air Pollutants
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing a test rule under section 4(a) of the Toxic
Substances Control Act (TSCA) to require manufacturers and processors
of 21 hazardous air pollutants (HAPs) (biphenyl, carbonyl sulfide,
chlorine, chlorobenzene, chloroprene, cresols [3 isomers],
diethanolamine, ethylbenzene, ethylene dichloride, ethylene glycol,
hydrochloric acid, hydrogen fluoride, maleic anhydride, methyl isobutyl
ketone, methyl methacrylate, naphthalene, phenol, phthalic anhydride,
1,2,4-trichlorobenzene, 1,1,2-trichloroethane, and vinylidene chloride)
to test these substances for certain health effects. EPA is also
soliciting proposals for enforceable consent agreements (ECAs)
regarding the performance of pharmacokinetics studies which would
permit extrapolation from oral data to predict risk from inhalation
exposure. EPA is also withdrawing the oncogenicity testing proposed for
vinylidene chloride on August 12, 1986 (51 FR 28840).
DATES: Written comments on this proposed HAPs test rule must be
received by EPA on or before December 23, 1996. Proposals for
pharmacokinetics studies must be received by EPA on or before October
24, 1996. EPA will hold a public meeting in Washington, DC prior to the
close of the comment period. If any person requests an additional
public meeting by November 25, 1996, EPA will hold a second public
meeting in Washington, DC.
ADDRESSES: Submit three copies of written comments on this proposed
HAPs test rule, identified by document control number (OPPTS-42187A;
FRL-4869-1) and three copies of proposals for pharmacokinetics studies,
identified by document control number (OPPTS-42187B; FRL-4869-1) to:
U.S. Environmental Protection Agency, Office of Pollution Prevention
and Toxics (OPPT), Document Control Office (7407), Rm. G-099, 401 M
St., SW., Washington, DC, 20460.
A public version of the rulemaking record supporting this action,
excluding confidential business information (CBI), is available for
inspection at the TSCA Nonconfidential Information Center, Rm. NE-B607,
401 M St., SW., Washington, DC 20460, from 12 noon to 4 p.m., Monday
through Friday, except on legal holidays.
All comments which contain information claimed as CBI must be
clearly marked as such. Three additional sanitized copies of any
comments containing information claimed as CBI must also be submitted.
Nonconfidential versions of comments on this proposed rule will be
placed in the rulemaking record and will be available for public
inspection at the TSCA Nonconfidential Information Center. Unit IX of
this preamble contains additional information on submitting comments
containing information claimed as CBI.
Comments and data may also be submitted in electronic form by
sending electronic mail (e-mail) to: [email protected]. Such
comments and data must be submitted in 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 (OPPTS-42187A) (FRL-4869-1). No information claimed as
CBI should be submitted through e-mail. Comments in electronic form may
be filed online at many federal depository libraries. Additional
information on electronic submissions can be found under Unit X of this
preamble.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, U.S. Environmental Protection Agency, Room E-
543B, 401 M St., SW., Washington, DC 20460; telephone: (202) 554-1404;
TDD: (202) 554-0551; e-mail: TSCA-H[email protected]. For specific
information regarding this action or related activities, contact Gary
E. Timm, Chemical Control Division, OPPT; telephone: (202) 260-1859; e-
mail: [email protected].
SUPPLEMENTARY INFORMATION:
Regulated persons. Potentially regulated persons are manufacturers
(including importers) and processors of the chemical substances
included in this proposed test rule. Processors, small-quantity
manufacturers, and manufacturers of small quantities of these
substances solely for research and development purposes, while legally
subject to the rule, would be required to comply with the rule only if
directed to do so in a subsequent notice.
------------------------------------------------------------------------
Examples of regulated
Category persons
------------------------------------------------------------------------
Manufacturers Persons who manufacture or
import 500 kg (1,100 lbs)
or more of a subject
chemical per year.
Persons who produce a
subject chemical as a
byproduct.
Processors Persons who process one or
more subject chemicals.
Small-quantity manufacturers Persons who manufacture or
import less than 500
kg(1,100 lbs) per year of a
subject chemical.
Manufacturers of small quantities of these Persons who manufacture
substances solely for research and quantities of these
development purposes substances no greater than
those necessary for
purposes of scientific
experimentation or analysis
for research and
development purposes.
------------------------------------------------------------------------
This table is not intended to be exhaustive, but, rather, provides
a guide for readers regarding entities likely to be regulated by this
action. This table lists the types of persons of which EPA is now aware
that potentially could be regulated by this action. To determine
whether you would be subject to this rule, you should examine Unit
IV.F. of the preamble entitled ``Persons Required to Test'' and consult
40 CFR 790.42.
I. Statutory Authority
This notice proposes a test rule under section 4 of the Toxic
Substances Control Act (TSCA), 15 U.S.C. 2603 et seq., that would
require certain health effects testing for 21 chemical substances
listed as hazardous air pollutants (HAPs) in section 112 of the Clean
Air Act (CAA), 42 U.S.C. 7412.
Section 2(b)(1) of TSCA, 15 U.S.C. 2601(b)(1), states that it is
the policy of the United States that ``adequate data should be
developed with respect to the effect of chemical substances and
mixtures on health and the environment and that the development of such
data should be the responsibility of those who manufacture and those
who process such chemical substances and mixtures[.]'' To implement
this policy, section 4(a) of TSCA authorizes EPA to require by rule
that manufacturers and processors of chemical substances conduct
testing if the Administrator finds that:
[[Page 33179]]
(1)(A)(i) the manufacture, distribution in commerce, processing,
use, or disposal of a chemical substance or mixture, or that any
combination of such activities, may present an unreasonable risk of
injury to health or the environment, [or]
(1)(B)(i) a chemical substance or mixture is or will be produced
in substantial quantities, and (I) it enters or may reasonably be
anticipated to enter the environment in substantial quantities or
(II) there is or may be significant or substantial human exposure to
such substance or mixture, [and]
(1)(A)(ii) and (1)(B)(ii) there are insufficient data and
experience upon which the effects of the manufacture, distribution
in commerce, processing, use, or disposal of such substance or
mixture or of any combination of such activities on health or the
environment can reasonably be determined or predicted, and
(1)(A)(iii) and (1)(B)(iii) testing of such substance or mixture
with respect to such effects is necessary to develop such data[.]
Thus once the Administrator has made a finding under TSCA section
4(a)(1)(A)(i) that a chemical substance may present an unreasonable
risk of injury to health or the environment or a finding under section
4(a)(1)(B)(i) that a chemical substance is or will be produced in
substantial quantities and either it may enter the environment in
substantial quantities or there may be significant substantial human
exposure to the chemical substance, EPA may require any type of health
effects or environmental testing necessary to address unanswered
questions about the effects of the chemical substance. EPA need not
limit the scope of testing required to the factual basis for the
section 4(a)(1)(A)(i) or (B)(i) findings as long as EPA finds that data
relevant to a determination of whether a substance does or does not
present an unreasonable risk of injury to health or the environment are
insufficient and that testing is necessary to develop such data. This
concept is explained in more detail in EPA's statement of policy for
making findings under TSCA section 4(a)(1)(B) (frequently described as
the ``B policy'') in the Federal Register of May 14, 1993 (58 FR
28736). Unit V of this preamble also describes the B policy. Moreover,
EPA need not limit the scope of the requirement only to testing needed
to support regulatory action under TSCA. For further discussion of
findings under TSCA section 4, see Unit V of this preamble and the
document entitled ``TSCA Section 4 Findings for 21 Hazardous Air
Pollutants'' in the record for this rulemaking.
In this proposed rule, EPA intends to use its TSCA section 4
authority to obtain data necessary to implement section 112 of the CAA,
which provides a detailed strategy for the assessment and management of
HAPs. EPA has used this broad TSCA section 4 authority in the past to
support regulatory programs requiring health and environmental effects
testing data. See, e.g., final test rule for the Office of Solid Waste
chemicals (53 FR 22300, June 15, 1988); final test rule for the Office
of Water Chemicals (58 FR 59667, November 10, 1993). Additional users
of information collected under this test rule would include other
federal agencies (e.g. the Agency for Toxic Substances and Disease
Registry (ATSDR), the National Institute for Occupational Safety and
Health (NIOSH), the Occupational Safety and Health Administration
(OSHA), the Consumer Product Safety Commission (CPSC), other program
areas within EPA (such as the hazardous waste program under the
Resource Conservation and Recovery Act (RCRA), the Toxics Release
Inventory (TRI), the Integrated Risk Information System database
(IRIS), and the Office of Pesticide Programs (OPP)), and state and
local environmental authorities.
Supporting statutory authority for this proposed rule is provided
by section 112(b)(4) of the CAA, 42 U.S.C. 7412(b)(4), which
specifically authorizes EPA to use any authority available to EPA to
obtain the information needed to make determinations regarding the
addition or deletion of substances to the statutory list of HAPs in CAA
section 112(b)(1), 42 U.S.C. 7412(b)(1). If the data collected under
this proposed test rule show that a chemical substance is not a concern
to human health, this information would be helpful in making decisions
concerning delisting the substance from the Clean Air Act HAPs list.
This toxicity testing program is also intended to fulfill in part
EPA's statutory obligation under section 103(d) of the CAA, 42 U.S.C.
7403(d), to conduct a research program on the health effects of HAPs.
This preamble, along with the supporting material in the record,
provides information that would be used in the research program under
CAA section 103(d) for the HAPs proposed for testing in this rule.
II. Uses for Data
EPA will primarily use the data proposed to be collected under this
rule to implement several provisions of section 112 of the CAA,
including the determination of residual risk (see below), the
estimation of the risks associated with accidental releases of
chemicals, and determinations whether or not substances should be
removed from the CAA section 112(b)(1) list of hazardous air pollutants
(delisting). The acute toxicity test data and developmental toxicity
test data will be useful in judging risks from accidental release. The
term ``accidential release'' is used broadly in this proposal to
include any short-term, relatively high-level chemical exposure lasting
from several minutes to several hours. Such a release may result from
various causes, including spills, transportation accidents, process-
upset conditions, or short bursts during charging of reaction vessels.
All data are relevant to delisting decisions and all non-acute data
will be used by EPA in meeting its statutory obligation under CAA
section 112(f), 42 U.S.C. 7412(f), to assess the risk remaining (i.e.
residual risk) after the imposition of technology-based emission
standards (maximum achievable control technology or MACT standards)
required by CAA section 112(d), 42 U.S.C. 7412(d). Section 112(e) of
the CAA, 42 U.S.C. 7412(e), directs EPA to promulgate these standards
between 1992 and 2000.
Section 112(f)(1) of the CAA requires EPA to submit, by November
1996, a report to Congress that will describe the methods for assessing
the risk remaining after the application of technology-based standards
under section 112(d) of the CAA. These methods will be used to assess
any residual risk for persons exposed to MACT-regulated emissions. The
assessment will include an analysis of both cancer and noncancer
endpoints. Data generated by the proposed test rule would be used in
the analysis to determine the nature and magnitude of any residual
risk.
Within eight years after the promulgation of technology-based
standards, EPA may need to set additional standards (``post-MACT
standards'') to protect public health with an ample margin of safety.
Section 112(f)(2) of the CAA specifies that if MACT standards have not
reduced lifetime cancer risk to the individual most exposed to known or
suspected carcinogenic emissions from a source to a level of less than
1 in a million (1 x 10-6), health-based emission standards must be
promulgated in order to protect public health with an ample margin of
safety. EPA, therefore, would use data obtained under this proposed
rule to determine whether health-based post-MACT standards are needed
and, if they are needed, to assist in establishing the appropriate
level of these standards.
For noncancer health effects, EPA applies an appropriate
mathematical model to toxicity data in order to determine the benchmark
dose level. The benchmark dose or concentration (BMD/C) is defined as
the statistical
[[Page 33180]]
lower confidence limit on the dose estimated to produce a predetermined
level of change in response (the benchmark response--BMR) relative to
controls. If the data are not amenable to modeling, a no-observed-
adverse-effect level (NOAEL) or a lowest-observed-adverse-effect level
(LOAEL) may be obtained from an evaluation of the toxicity database.
``Uncertainty factors'' are then applied to these levels to account for
uncertainties in deriving a dose-response estimate for human exposure
(reference concentration (RfC)) from experimental data. An RfC is
defined as ``an estimate (with uncertainty perhaps spanning an order of
magnitude) of a continuous inhalation exposure to the human population
(including sensitive subgroups) that is likely to be without
appreciable risk of deleterious noncancer health effects during the
lifetime'' (Ref. 1).
Uncertainties due to the extrapolation of effects data between
species and for individual susceptibility within a species are
accounted for by uncertainty factors. Because RfCs are intended to
characterize risk for lifetime exposures, an uncertainty factor may be
applied if the effects data are extrapolated from a subchronic study.
An additional uncertainty factor is applied if a LOAEL is used to
derive the RfC rather than a NOAEL. To provide an accurate
characterization of lifetime risk, the database for a chemical should
be comprehensive and, in principle, should address all potential
endpoints at critical life stages. Therefore, an uncertainty factor
also may be applied if data for appropriate endpoints are not
available. Thus while each uncertainty factor may range up to 10, the
composite factor used to derive an RfC for a chemical with a limited
database may be on the order of up to 3,000 for inhalation studies and
up to 10,000 for oral studies. Five uncertainty factors are never
applied at the same time (i.e. no composite uncertainty factor can be
greater than 10,000) because such derivations are considered too
inaccurate to be used.
Large composite uncertainty factors result in lower RfCs (higher
risk estimates) than do smaller composite uncertainty factors. If the
RfC is low, EPA may be required to promulgate more stringent emission
standards. Industrial plants subject to these standards would, in turn,
be required to meet such standards, perhaps necessitating the
installation of more costly emission controls. Better and more complete
health effects data, on the other hand, may permit EPA to use smaller
composite uncertainty factors, resulting in higher RfCs and, as a
consequence, less stringent emission standards. Thus the economic cost
of using poor-quality health effects data to make residual risk
determinations under CAA section 112(f) could be considerable.
In addition, secondary--though as important--uses of the data to be
collected under this proposed rule would be:
(1) Helping to better inform communities and citizens of toxic
chemical hazards in their own localities. Understanding health effects
associated with these chemicals is integral to furthering the public's
involvement in environmental decisionmaking, especially at the state
and local level. To be an effective participant in this process, the
public needs information on both the inherent toxicity (i.e., hazard)
of a chemical and the potential sources of exposure to the chemical.
This rule will provide valuable information on health effects related
to the affected chemicals, and under TSCA, such health and safety data
are available to the public. Taken together with such publicly
available information sources such as the Toxics Release Inventory
(TRI), which provides site-specific information on chemical releases
into the environment, the health effects data generated under this rule
will allow all segments of the public to better assess the risks
associated with the releases of these chemicals. Taken as part of a
comprehensive right-to-know program, these data will provide the basis
for individuals, communities, governments, producers, and users to
assess the nature and relative severity of toxicity among different
chemicals, as well as to assess site-specific, individual chemical
risk.
(2) Assisting other agencies (e.g., ATSDR, NIOSH, OSHA, CPSC) in
assessing chemical risks and in taking appropriate action within their
programs. For example, OSHA has expressed a need for the data that will
be acquired under the proposed rule. Fifteen of the 21 HAPS are
candidates for OSHA's Permissible Exposure Limit (PEL) update and an
additional 3 have no corresponding PEL. OSHA does not have authority to
require testing, and must rely on toxicology data collected by other
agencies for their risk assessments (Ref. 2). Establishing an ongoing
mechanism for updating its PELs continues to be a high priority for
OSHA. Five of the HAPs are on ATSDR's list of hazardous substances
found at National Priorities List sites and are the subject of
toxicological profiles. CPSC noted that 11 of the 21 substances are
found in or are emitted by consumer products (Ref. 3).
(3) Assisting EPA in evaluating delisting petitions received under
the CAA and the Emergency Planning and Community Right-to-Know Act
(EPCRA), 42 U.S.C. 1101 et seq., in making better clean-up decisions
under the Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA), 42 U.S.C. 9601 et seq., in assessing inert
ingredients in pesticide products, in setting more appropriate
standards for hazardous wastes under RCRA, and by providing support for
chemical risk assessment activities under TSCA.
(4) Assisting state and local permitting authorities in setting
standards within their programs.
(5) Supporting assessments of ``burst'' exposures (high-level
releases of short duration), such as in the accidental release
prevention program under section 112(r) of the CAA, 42 U.S.C. 7412(r),
due to the inclusion of an acute testing protocol.
Many HAPs are of broad programmatic interest, and are included in
the Agency's Integrated Risk Assessment System (IRIS) database. Thus, a
secondary benefit of this rule is that the health effects data
generated by the rule may result in improvement to the data and
increased confidence in the RfCs contained in IRIS. Improvements to the
IRIS data can result in considerable benefits to the public since IRIS
is publicly available and is used by a wide variety of governmental and
non-governmental entities to assess the safety of chemicals.
In some cases where EPA has had access to better data, the Agency
has been able to revise standards to make them less stringent, thus
mandating less economically costly levels of control. For example, EPA
has revised the maximum contaminant levels (MCL) of barium (from 1 mg/L
to 2 mg/L) and selenium (from 0.01 mg/L to 0.05 mg/L) in drinking water
and withdrew the MCL for silver (0.05 mg/L) based on new data (Ref. 4).
Data have also been used to remove chemical substances from lists
of regulatory significance. Acrylic acid was removed from a list of
``high-risk'' pollutants developed under section 112(i)(5) of the CAA,
42 U.S.C. 7412(i)(5), for the early reductions program. The high-risk
listing for this chemical was based on its predicted environmental
exposure being at least 10 times larger than its RfC. Designation of
acrylic acid as ``high risk'' had the effect of limiting the use of
offsetting reduction of other pollutants in meeting early reduction
goals. Recent data,
[[Page 33181]]
including those related to reproductive effects, developmental
toxicity, and bioavailability, resulted in a decrease in the
uncertainty factor for database deficiency by a factor of three and an
increase in the RfC by the same amount (i.e. from 0.0003 mg/m3 to
0.001 mg/m3). Consequently, acrylic acid no longer met the
criteria for the high-risk list.
Serious deficiencies exist in the current toxicity database for the
189 HAPs listed in the CAA, in that no toxicity data exist for many
HAPs regarding various endpoints of concern. This problem is expected
to be especially serious because post-MACT residual risks will arise
primarily from exposures to emissions that contain different
combinations of HAPs in varying concentrations. In view of the large
number of HAPs of concern and the much larger number of combinations of
those HAPs found in the mixtures of emissions subject to residual risk
evaluation, the toxicity database should provide consistent
characterization of individual HAPs. Therefore, EPA is proposing to
obtain an even, across-the-board database for the HAPs listed in this
proposed rule.
In its report regarding the risk assessment of HAPs, the National
Academy of Sciences (NAS) states that ``[a]vailability of requisite
data varies widely among the 189 [HAPs] chemicals'' (Ref. 5). According
to this report, ``the toxicity data are incomplete on almost all 189
chemicals'' (Ref. 5). For example, the level of carcinogenic risk for
approximately 40% of the 189 HAPs cannot be classified under EPA's
current cancer risk classification system (Ref. 6). Moreover, while
quantitative estimates exist for 70% of the HAPs that have been
classified for cancer risk, about 70% of these estimates are based only
on oral data and thus may not reliably characterize the potential risk
encountered through inhalation exposure.
In evaluating 124 of the 189 HAPs for noncancer risk, EPA found
that the databases for about 62% of the 124 HAPs were not adequate for
deriving an RfC (Ref. 7). Even for those HAPs that have an RfC, the
level of uncertainty associated with such figures is often high. EPA
would use data from the testing proposed in this rule to identify the
critical health risks posed by many individual HAPs and to characterize
the adverse impact posed by exposure to mixtures of HAPs. EPA
anticipates that the test data produced in response to this rule would
provide the consistent database that the National Academy says is
lacking at this time.
III. Testing Approach and Selection of Chemical Substances for This
Proposed Rule
A. Testing Approach Chosen by EPA
With respect to EPA's responsibilities for meeting the requirements
under section 112 of the CAA, the central question is: How broad and
deep a data set should EPA require on each HAP?
Regarding specific endpoints and routes of exposure, CAA section
112(b)(2), 42 U.S.C. 7412(b)(2), indicates that Congress intended that
adverse effects from any endpoint by any route of exposure be taken
into account in listing substances as HAPs. According to this
subsection, substances added to the Clean Air Act HAPs list shall
include:
* * * pollutants which present, or may present, through
inhalation or other routes of exposure, a threat of adverse human
health effects (including, but not limited to, substances which are
known to be, or may reasonably be anticipated to be, carcinogenic,
mutagenic, teratogenic, neurotoxic, which cause reproductive
dysfunction, or which are acutely or chronically toxic) * * * .
Thus the CAA indicates that Congress was very concerned about the
wide variety of health risks attributable to HAPs and intended that
data necessary for characterizing both cancer and noncancer health
risks from exposure to HAPs be developed.
Faced with a broad range of options and little specific guidance
from Congress, EPA decided that some provision should be made for
evaluating the health effects endpoints listed in the CAA, including
respiratory tract toxicity, systemic effects, reproductive toxicity,
developmental toxicity, genotoxicity, neurotoxicity, and
carcinogenicity. EPA's objective was to select endpoints representing
serious health effects that could occur as a result of exposure to
HAPs. Each endpoint represents a health effect of concern arising from
one or more of the following exposures--local concentrations (e.g.,
hotspots and plumes), area-wide sources, or accidental releases of
HAPs.
EPA believes that it is critical to evaluate the respiratory tract
thoroughly in addition to examining extra-respiratory effects (i.e.,
systemic toxicity) because inhalation is an important exposure route of
concern. Carcinogenicity testing is significant because cancer is a
serious health effect that may be caused by long-term, low-level
exposure to toxic substances. Developmental toxicity addresses the
potential of chemical substances to interfere adversely with human
development (i.e., to cause death, structural abnormalities, growth
alterations, and/or functional deficits in the immature organism that
may be more sensitive than the adult to many chemical substances).
Reproductive testing is designed to assess the effects of an
environmental agent on male and female fertility and general
reproductive function to humans exposed prenatally as well as
postnatally. There is general consensus among toxicologists regarding
the assessment of cancer and reproductive and developmental effects,
and further explanation can be found in EPA's risk assessment
guidelines (Guidelines for Carcinogen Risk Assessment (51 FR 33992,
September 24, 1986); Guidelines for Developmental Toxicity Risk
Assessment (56 FR 63798, December 5, 1991); Guidelines for Reproductive
Toxicity Risk Assessment (Pub. No. EPA/600/AP-94/001, February 1994).
Finally, certain aspects of the neurotoxicity and immunotoxicity
testing required in this proposed rule warrant more explanation, which
is provided below. EPA recently published a proposed revision of the
1986 Guidelines for Carcinogen Risk Assessment (see ``Proposed
Guidelines for Carcinogen Risk Assessment'' at 61 FR 17960, April 23,
1996 (FRL-5460-3)).
Neurotoxicity resulting from chemical exposure can affect an
organism in many ways, causing, for example, functional and structural
deficits as well as behavioral effects. To assess neurotoxicity, EPA is
proposing a screening-level battery, consisting of the functional
observational battery and motoractivity and neuropathology tests. At
this time, EPA is not proposing to require additional, more specialized
testing for cognitive functions such as learning, memory, and
performance.
The interest in the potential toxic effects of chemicals on the
immune system arises from the critical role that the immune system
plays in maintaining health. EPA considers the field of immunotoxicity
a promising, scientifically sound, and important area in public health
protection. From time to time, the Agency has considered information on
the effects of chemicals on the immune system in risk assessments. For
example, in its draft report reassessing the effects of dioxin
compounds on human health (Ref. 8), EPA considered the effects of
dioxin on the immune system to serve as an important health endpoint
that provides useful information in developing a hypothesis about
toxicity. In the draft reassessment report, however, EPA arrived at the
preliminary conclusion that ``the impact of dioxin and related
compounds on the immune system and
[[Page 33182]]
implications for characterizing risks are largely unknown at this
time.''
This rule calls for an immunotoxicity screening test which can be
performed as a satellite test to either a 90-day subchronic test or a
reproductive effects test. This immunotoxicity screen will help
identify chemicals as potential immunotoxicants. EPA is not proposing
more comprehensive immunotoxicity testing at present because the
application of immunotoxicity data in risk assessment has not yet
sufficiently matured. As EPA's science policy develops and the Agency's
use of immunotoxicity data in risk assessment increases, EPA will
reconsider this position. Meanwhile, EPA seeks comments on its proposed
approach of using a minimal screen and its preliminary conclusion that
it is premature at this time to include more comprehensive
immunotoxicity testing in this proposed HAPs test rule.
In developing this proposed rule, EPA considered the following
range of options to select the information needed to characterize
health effects of concern to implement section 112 of the CAA.
Option 1. One-species 90-day inhalation subchronic plus follow-up
for known or suspect toxicities. Under this option, a 90-day inhalation
subchronic test would be required, as well as testing for endpoints
that have already been identified as existing or potential concerns,
including cancer, by previous test results of the HAP at issue or
structurally similar agents. A one-species 90-day inhalation test is
considered the minimum information for the development of an RfC. The
inhalation RfC takes into account toxic effects both for the
respiratory tract (portal-of-entry effects) and peripheral to the
respiratory system (extra-respiratory effects). Well-defined and well-
conducted inhalation subchronic toxicity studies--that provide for
histopathologic evaluation of organ toxicities, including the
respiratory tract--are considered to be reliable predictors of certain
kinds of chronic toxicity. But such studies do not, or do not
adequately, account for neurological, developmental and reproductive
toxicities. An RfC based solely on a 90-day subchronic test is, thus,
usually given a low confidence rating because some potentially
important toxic endpoints are not characterized.
In addition, EPA believes that for 90-day inhalation subchronic
testing to constitute a minimally credible option, such a test should
at least be augmented by testing for adverse health effects that are
suggested or indicated, but not adequately characterized, by existing
information such as short-term test data, mechanistic information or
structure-activity relationships (SAR). Even with this modification,
however, Option 1 still provides no test data on those health endpoints
of concern for which no current information exists. If such testing
were included, these effects might become critical in evaluating dose-
response relationships or in demonstrating that a standard uncertainty
factor is inadequate or inappropriate.
EPA thus believes that Option 1 is insufficient to meet EPA's
mandate under section 112 of the CAA because the endpoints listed in
section 112(b)(2) of the CAA, in particular, reproductive,
developmental, and neurological toxicities, would be considered for
testing only if data already exist that indicate or suggest the
potential for these adverse effects. Moreover, this option also does
not adequately address health risks associated with acute or accidental
releases.
EPA did not select Option 1 for the reasons stated above. EPA
believes that the TSCA section 4 program adopted for testing HAPs must
go further toward ensuring that no serious health threat exists from
both long- and short-term exposure for endpoints of potential concern
for which there are no existing data.
Option 2. Option 1 plus inhalation screening for untested toxicity
endpoints. The second option considered by EPA would require the
incorporation of screening level testing for certain untested
toxicities into Option 1. Like Option 1, Option 2 would include testing
for endpoints (including cancer) that have already been identified as
existing or potential concerns. At a minimum Option 2 would consist
of--a 90-day subchronic inhalation study, a screening test for
reproductive effects (i.e., a one-generation reproductive effects
study), a subchronic inhalation neurotoxicity screening battery
(consisting of the functional observation battery and motor activity
and neuropathology tests), an E. coli reverse mutation assay, gene
mutation in somatic cells in culture detection, an in vivo cytogenetics
test (chromosomal analysis or micronucleus assay), and an
immunotoxicity screening test. Any toxicity suggested but not
characterized by existing studies in the toxicological literature would
still be followed up on through more rigorous protocols.
Although Option 2 would conserve resources while allowing for the
testing of a broader range of endpoints, including cancer, it has
serious shortcomings. First, a one-generation reproductive test does
not adequately address reproductive and developmental risk. Two-
generation tests (in which animals have been exposed prenatally as well
as postnatally, including the prepubertal period) are generally needed
to evaluate the effects on reproduction from most exposures to chemical
substances (Ref. 9). Two-generation tests permit the evaluation of
delayed or latent manifestations of some toxicities, detection of
effects absent in the first generation, and the expression and
detection of some effects that may have a heritable basis. Because the
standard two-generation reproductive test would not detect internal
malformations, however, developmental toxicity testing is also needed
for an adequate assessment of developmental risk. The Agency's policy
is to require developmental testing in two species to adequately
characterize the risk because of species-specific differences.
EPA did not select Option 2 because this level of testing would not
provide an adequate evaluation of developmental or reproductive
toxicity. Additional follow-up testing would be required to confirm
suggestive results obtained in screening studies and provide data
adequate for risk assessment under this option. Such testing would
require an additional rulemaking cycle, costing further resources and
incurring so much delay that data would not be available to meet the
deadlines for setting risk-based standards. Moreover, this option does
not adequately address health risks, such as respiratory tract effects
and neurotoxicity, associated with acute or accidental releases.
Option 3. Option 1 plus less than chronic testing for noncancer
endpoints of concern. In addition to the 90-day inhalation subchronic
testing specified in Option 1, this option would add inhalation testing
to assess reproductive effects (i.e., two-generation reproductive test)
and developmental effects (developmental toxicity tests in two
mammalian species). Option 3 includes an acute toxicity testing
guideline for histopathology of the respiratory tract, kidney, and
liver and a bronchoalveolar lavage after four hours of exposure. EPA
believes that it is necessary to characterize the acute effects
associated with accidental releases of HAPs. In addition, a respiratory
sensory irritation assay is included. Acute and subchronic inhalation
neurotoxicity screening batteries consisting of the functional
observation battery, and motor activity and neuropathology tests would
also be conducted. As in Option 2, first-tier tests would be required
for mutagenicity
[[Page 33183]]
(i.e., an E. coli reverse mutation assay, gene mutation in somatic
cells in culture detection, an in vivo cytogenetics test (chromosomal
analysis or micronucleus assay)), as well as immunotoxicity.
Option 3 would follow Options 1 and 2 in requiring a cancer
bioassay where concern for cancer is indicated by short-term data,
general toxicity data, mechanistic information or structure-activity
relationships (SAR). Where no cancer bioassay data exist, testing two
species in both sexes would be required. If cancer bioassay data exist
but are found to be too uncertain for inhalation dose-response
assessment, a modified test, such as testing of the opposite sex in two
species, may be required (Ref. 10).
The Option 3 level of testing would enable EPA to better
characterize risk associated with both acute and longer-term exposures
by providing data to identify and evaluate all the health effects
listed under section 112 of the CAA and by providing data for dose-
response evaluation within the general time frame for risk-based
standards under CAA section 112(f). Accordingly, EPA has selected the
Option 3 level as its preferred option for testing under this proposed
rule.
Option 4. Option 3 plus chronic testing. Under this option, in the
absence of existing adequate data, EPA would require chronic inhalation
bioassays (for both cancer and noncancer effects) in two different
mammalian species for each chemical substance. The balance of the test
program would be the same as under Option 3 (developmental studies in
two mammalian species, a two-generation reproductive study, acute and
subchronic neurotoxicity screening batteries, first-tier mutagenicity
tests, an immunotoxicity screening test, and acute testing). In
general, cancer bioassay data in two species, a two-generation
reproductive test, and a developmental study in two species are
required to establish a high-confidence RfC. Because the RfC is
intended to serve as a lifetime estimate, lifetime exposure studies to
evaluate potential health endpoints at various critical life stages
should be considered.
To a greater degree than under other options, the broad and deep
database that would be produced by this comprehensive testing scheme
could help defuse complaints that EPA frequently regulates industrial
activities without sufficient data regarding either the need for an
appropriate level of regulation or what such a level should be. EPA has
decided, however, that the disadvantages of choosing this option
outweigh its considerable benefits. The extensive chronic testing
required under Option 4 would impose a significant cost on industry. In
addition, as compared to Option 3, the strain that choosing this option
would place on certain resources--such as inhalation testing facilities
and supplies of laboratory animals--would significantly diminish the
cost-effectiveness of compiling the data. For these reasons, EPA did
not select this option. EPA is soliciting comments on the testing
approach to the HAPs that it has selected in this proposal.
It should be noted that, regardless of the test option chosen, if
adequate toxicity data on a HAP is produced by testing using a route of
exposure other than inhalation, route-to-route extrapolation may be
possible (see Unit IV.D. of this preamble).
B. National Academy of Sciences Approach
In section 112(o) of the CAA, 42 U.S.C. 7412(o), Congress directed
EPA to arrange for the NAS to review EPA's risk assessment methodology
relevant to HAPs subject to section 112. EPA has considered the
recommendations of the NAS regarding the assessment of risks associated
with HAPs. The NAS recommended that EPA ``* * * compile for each of the
189 chemicals an inventory of the existing and relevant chemical,
toxicologic, clinical, and epidemiologic literature'' (Ref. 5). It also
recommended that EPA ``screen the 189 chemicals for priorities for the
assessment of health risks, identify the data gaps, and develop
incentives to expedite generation of the needed data by other public
agencies (such as the National Toxicology Program, the Agency for Toxic
Substances and Disease Registry, and state agencies) and by other
organizations (industry, academia, etc.)'' (Ref. 5). As discussed in
Unit III.C. of this preamble, EPA agrees and has taken this approach.
To identify testing needs and help prioritize HAPs testing, Syracuse
Research Corporation, an EPA contractor, has identified and summarized
the existing health and exposure literature on the HAPs, and has
identified testing programs currently in progress (Refs. 11, 12).
The NAS report also discussed how a gradual, highly iterative
testing approach to the generation of health effects data on HAPs might
work. The report recommended that HAPs could be prioritized on the
basis of their acute toxicity and chemical structure, and testing might
proceed stepwise, on a case-by-case basis, from acute toxicity to
studies of the uptake, distribution, retention, and excretion of the
substance, to subchronic toxicity, and ultimately, if needed, to
endpoint testing in animals. Depending on the animal toxicity data
produced by this iterative testing scheme, according to the NAS, EPA
might decide that further studies of human toxicity or mechanisms of
toxicity are warranted.
Although EPA agrees with the need to prioritize testing, it has
taken a different approach to prioritization that is based on
consideration of exposure potential and the rulemaking schedule of
section 112 of the CAA. The amount and type of existing data vary
greatly among the chemical substances that Congress designated as HAPs.
In practice, therefore, no single uniform iterative approach based on
toxicity factors alone would apply to all chemical substances. For
example, one HAP might have only acute and short-term test data, while
longer-term studies might exist for another HAP. Nevertheless, both the
NAS and EPA approaches recognize that existing data must be considered
if EPA is to avoid requiring duplicative testing that previously
produced adequate data.
An iterative testing approach based on toxicity factors alone would
be time consuming and require multiple rulemakings. This process would
take too long to collect useful data for making decisions needed to
meet upcoming statutory deadlines established in the CAA. Furthermore,
multiple iterative rulemakings to develop needed test data would be
prohibitively costly to EPA and would not recognize limitations on EPA
resources. For Option 3, EPA's preferred testing level, follow-up
testing would rarely be required beyond that level proposed in this
rule. Such testing, if necessary, would be required in a separate
rulemaking.
To make the multichemical decisions required under section 112 of
the CAA regarding, for example, residual risk and delisting HAPs, EPA
believes that it needs a consistent, even database covering HAPs across
the same broad set of endpoints. EPA believes that Option 3 will permit
timely gathering of a consistent database on HAPs more efficiently and
at less cost to industry and EPA than is possible with other
approaches.
C. Review of Data and Selection of HAPs
In choosing candidates for this proposed test rule, EPA considered,
consistent with TSCA section 4 requirements, the potential for a
chemical substance to present an unreasonable risk of injury to health
or the environment, the production
[[Page 33184]]
volume of the substance, the amount of emissions produced by the
chemical substance entering or reasonably anticipated to enter the
environment or become a source of exposure for humans, the sufficiency
of the existing database, and the need for further testing to develop
needed data. Consequently, as indicated in Unit IV of this preamble,
and explained in a separate document in the record entitled ``TSCA
Section 4 Findings for 21 Hazardous Air Pollutants'', each candidate
listed for testing in this proposed rule is:
(1) Considered to have the potential of presenting an unreasonable
risk of injury to health or the environment (except in the case of
ethylene glycol, for which no A finding was made--see the table in Unit
V of this preamble);
(2) Produced in quantities exceeding 1,000,000 pounds per year;
(3) Emitted (i.e., released into the atmosphere) in the amount of
50 tons (100,000 pounds) per year or more according to the 1993 Toxics
Release Inventory (TRI);
(4) Considered to have health effects data needs not addressed in
other testing and research programs;
(5) Considered to have health effects data that are insufficient
under TSCA section 4 for determining effects of the HAP on health; and
(6) Considered to need further testing to develop the needed data.
The determination that data are insufficient to ascertain the
effects of the HAPs on human health is based on several factors. First,
EPA determined the effects of concern (toxicological endpoints) and the
depth and quality of data which the Agency needs in order to make
residual risk determinations. This decision and the range of options
EPA considered are discussed in Unit III.A. of this preamble. Having
made the decision that standard endpoint tests are appropriate, EPA
reviewed existing studies and, for the purposes of this rule, compared
such studies against the testing methodology used in the 1985 version
of the EPA test guidelines for these endpoints. The 1985 test
guidelines were the first test guidelines issued by EPA for its TSCA
chemical testing program and represent widely accepted, peer-reviewed
methods for characterizing chemical toxicity.
The reasons why existing studies were judged to be inadequate are
explained in a separate document in the record entitled ``TSCA Section
4 Findings for 21 Hazardous Air Pollutants'', and summarized in the
table in Unit V of this preamble. The reasons are varied but include
the following examples--not studying the appropriate endpoint; too few
dose levels; inappropriately high- or low-dose levels; and too few
animals to have statistical confidence in the results. Nevertheless, in
some cases, EPA toxicologists determined that data were adequate when
the weight of evidence from several flawed studies, which, when
considered individually were determined to be inadequate, gave an
adequate characterization of the toxicity of the substance. Thus expert
judgment must always play a role in determinations of data adequacy.
Indeed, the determination of adequacy is so intimately connected to the
unique characteristics of study design for each toxicological endpoint
that EPA is unable to articulate a universal test of data adequacy that
might be applied consistently in all situations. EPA is soliciting
comments on its approach to determining data adequacy for the HAPs.
To select HAPs for testing, EPA initially reviewed the production
data and TRI data for all 189 HAPs. EPA realizes that TRI data
represent estimates of environmental emissions of the TRI-listed
chemicals and do not account for all chemical substances in the United
States. Nevertheless, TRI figures offer the most complete, readily
available emissions data, and EPA has determined that this database is
sufficient for the purpose of helping EPA select high-emission HAPs for
consideration as potential test candidates. While publicly available
sources of production data are cited in the analysis supporting this
rule, data from these sources were checked against the TSCA chemical
inventory update production data, most of which are claimed as CBI.
After reviewing TRI data for all HAPs, EPA decided to select a
number of HAPs for initial consideration by focusing its attention on
HAPs with TRI emissions of 50 tons or more per year. The 66 HAPs in
this group constituted a reasonably sized group for further review. The
selection of 50 tons per year or more as a cutoff is appropriate
because this number captures high-emission HAPs and because section 112
(a)(1) of the CAA, 42 U.S.C. 7412(a)(1), defines ``major source'' as
emitting ``* * * 10 tons per year or more of any hazardous air
pollutant or 25 tons per year or more of any combination of hazardous
air pollutants * * *.''
A survey of testing conducted by EPA under TSCA section 4, the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and other
testing programs supplemented a preliminary review of health findings
from secondary source documents and the IRIS database. This initial
survey revealed that certain HAPs having high emissions (50 tons or
more) already have a large inhalation toxicology database or are
subject to testing or research in existing programs. Therefore, EPA
decided not to pursue additional testing under this rule for benzene,
butadiene, carbon disulfide, chromium, cyanide, ethylene oxide,
formaldehyde, lead, methanol, methyl tertiary butyl ether, methylene
chloride, tetrachloroethylene, toluene, trichloroethylene, vinyl
chloride, and vinyl acetate. Additional testing under TSCA for these
chemicals may be considered at some time in the future.
EPA decided that the remaining group of 50 HAPs could be handled
most efficiently by promulgating more than one rule. Consequently, 21
high-emission HAPs were scrutinized further and were selected as
candidates for this proposed rule, and the remaining 29 HAPs were
deferred for consideration in subsequent HAPs test rulemaking efforts.
In the second HAPs test rule, EPA plans to focus on persistent HAPs
that may bioaccumulate. EPA may, therefore, require ecological and
environmental testing for these HAPs. EPA also may require testing in
the second rule to collect data needed to implement the ``Great
Waters'' program of section 112(m) of the CAA, 42 U.S.C. 7412(m).
During the selection process for this proposed rule, EPA's
contractor undertook a comprehensive search of the toxicological,
health, and exposure literature for the 21 HAPs proposed for testing in
the current rule (Refs. 11, 12). EPA's contractor performed the
literature search in a stepwise manner to save both time and expense.
The first step was to review secondary source health effects documents.
EPA's contractor identified documents published by EPA, the
International Agency for Research on Cancer (IARC), and ATSDR and
extracted relevant data. EPA performed online Environmental Mutagen
Information Center (EMIC) searches for genetic toxicity information
(Ref. 13). In addition, an article entitled ``Genetic Activity Profiles
of 110 Hazardous Air Pollutants Listed Under Title III of the Clean Air
Act'' (Ref. 14) and the International Commission for Protection against
Environmental Mutagens and Carcinogens (ICPEMC) have provided useful
summary information.
EPA realizes that using secondary sources of information is not
ideal. For example, it is possible that a secondary source document
could miss an important study or that the document could fail to
properly interpret a study. Consequently, whenever essential
[[Page 33185]]
information appeared to be missing from the review documents or was not
explained clearly, EPA's contractor consulted original articles.
Through its contractor, EPA next checked several sources for
relevant published and unpublished studies. It obtained unpublished but
publicly available studies submitted to EPA under TSCA, searched the
Toxic Substances Control Act Test Submissions (TSCATS) database by CAS
Registry number, and reviewed the National Toxicology Program (NTP)
Results Report (generated from NTP's CHEMTRACK database) to locate
completed but unpublished NTP studies. With the contractor's
assistance, EPA next undertook an update search of the open literature
to locate any as yet unidentified studies published either shortly
before or after the review documents appeared. For this purpose, EPA's
contractor searched the National Library of Medicine (NLM) TOXLINE
database for studies published during a period of time beginning three
years prior to the date of the review document initially used to obtain
toxicity information and ending on the date of the search.
In addition, EPA's contractor consulted with representatives of
NIOSH, OSHA, the Food and Drug Administration (FDA), the National
Institute of Environmental Health Sciences (NIEHS), and various
chemical companies. The purpose of these inquiries was to determine if
these organizations had any information on completed or ongoing studies
that might not be found in any readily available database. Through its
contractor, EPA also contacted the Chemical Industry Institute of
Toxicology (CIIT), as well as trade associations and allied
organizations to determine whether these organizations were sponsoring
or knew of any relevant studies currently in progress. Finally, EPA's
contractor closely reviewed data sheets compiled by EPA's IRIS RfD/RfC
Working Group to ascertain if the group had identified any additional,
otherwise unlocated information.
Varied levels of scrutiny were applied to different types of
toxicity testing information throughout the literature search. Because
the primary focus of the review of acute, subchronic, and chronic
systemic toxicity literature was inhalation exposure, only inhalation
studies were reviewed for these endpoints. Although oral studies can
provide important information on target organ toxicity and should be
considered in the design of any testing protocol, these studies usually
provide limited information on the effects of a compound on the
respiratory tract. In addition, the systemic dose remote to the
respiratory tract for many compounds is affected by modulation of
uptake at the portal of entry into the body. This modulation is not
only from first-pass effects but from other influences of anatomy and
physiology (Ref. 15). Because EPA's literature search did not encompass
oral acute and subchronic toxicity studies, the preliminary findings of
risk that EPA is making below, under TSCA section 4(a)(1)(A), are not
based on such studies. Thus, oral acute and subchronic studies may
provide additional evidence of potential toxicity.
The contractor reviewed studies of carcinogenicity, neurotoxicity,
and reproductive and developmental toxicity, regardless of the route of
administration.
EPA took a different approach to identify HAP candidates for
immunotoxicity testing. EPA relied on an EPA document ``Hazardous Air
Pollutants: Profiles of Non-Cancer Toxicity from Inhalation Exposures''
(Ref. 16), containing a database that was developed from EPA and ATSDR
documents and data files, and from the Hazardous Substances Data Bank
(HSDB) of NLM. The contractor searched recent literature (i.e., 1989 to
present) for immunotoxicity data on the 21 HAPs in both MEDLINE and
TOXLINE. For chemicals with ATSDR Toxicological Profiles, the profile
was used to identify immunotoxicity data. Much of the identified
immunotoxicity literature used rather insensitive indicators of impact
(e.g., organ weight changes, histopathology, leukocyte counts, and
total serum protein determinations), that were judged to constitute an
inadequate evaluation of suppression of immune system responsiveness
(Ref. 17). Thus, an immunotoxicity screening test is being proposed in
this rule for many of these HAPs.
Although EPA has made intense and thorough attempts to identify all
relevant studies, EPA recognizes the limitations inherent in relying on
secondary sources and realizes that its literature search may have
failed to locate studies recently undertaken or completed. Therefore,
EPA solicits comments bringing to its attention any valid studies not
identified in its search efforts.
D. Previous TSCA Testing Actions Affecting These Chemical Substances
Eight of the substances included in this proposed rule have been
the subject of previous testing under TSCA section 4. Testing by the
inhalation route was not generally required, however, and acute
effects--including respiratory tract effects--were not generally a
target endpoint. This subunit will briefly summarize previous testing
decisions and explain the relationship between those activities and
this proposed rule.
1,1'-Biphenyl was recommended by the Interagency Testing Committee
(ITC) in its 10th report for environmental effects and chemical fate
testing (47 FR 22585, May 25, 1982). Focusing only on environmental
testing, EPA found that 1,1'-biphenyl may present an unreasonable risk
to the environment and issued a test rule requiring environmental
effects and chemical fate testing of the chemical on September 12, 1985
(50 FR 37182). This proposed rule complements the earlier action by
requiring health effects testing of 1,1'-biphenyl, namely, acute
toxicity, respiratory sensory irritation, subchronic toxicity,
developmental toxicity, reproductive toxicity, neurotoxicity and
immunotoxicity.
Chlorobenzene was recommended to EPA for health and environmental
effects testing in the first report of the ITC (42 FR 55026, October
12, 1977). Subsequently, EPA found that the chemical may present an
unreasonable risk to human health (an A finding) and issued a rule
requiring reproductive effects testing (51 FR 24657, July 8, 1986).
Although the preamble of the proposed rule described specific
neurotoxicity concerns, EPA stated that neurotoxicity testing
requirements were not being proposed because it had not issued
neurotoxicity test guidelines at that time. Instead EPA explained its
then-current views on neurotoxicity testing in the preamble and
solicited public comment on those views (45 FR 48524, July 18, 1980).
Because a neurotoxicity screening battery guideline (OPPTS 870.6200)
has since been proposed, this rule proposes the testing of
chlorobenzene for neurotoxicity, acute toxicity, respiratory sensory
irritation, subchronic toxicity, and immunotoxicity.
Cresols are members of a chemical category consisting of three
isomers: ortho-, para-, and meta-cresol. Based on both A and B
findings, a test rule proposed on July 11, 1983 (48 FR 31812) would
have required testing of cresols for subchronic toxicity, mutagenicity,
carcinogenicity, developmental toxicity, reproductive effects,
neurotoxicity, and skin sensitization. The final rule, published on
April 28, 1986 (51 FR 15771), which specified testing for all three
isomers and provided a rationale for this decision, required testing
for mutagenicity, developmental toxicity, and reproductive effects.
Data received
[[Page 33186]]
under this test rule satisfy the HAPs data needs for these endpoints.
Based on the results from this first tier of tests, a conditionally
required cancer bioassay was not triggered. In addition, oral
subchronic toxicity studies and subchronic neurotoxicity studies were
conducted by EPA's Office of Solid Waste. In accordance with the need
for data on respiratory tract effects, today's rule proposes acute and
subchronic inhalation toxicity, respiratory sensory irritation, acute
neurotoxicity, and immunotoxicity tests for all three cresol isomers
(see Unit IV.B. of this preamble). For the purposes of this proposal,
the three cresol isomers are counted as a single chemical.
Methyl isobutyl ketone was the subject of a negotiated testing
agreement between EPA and industry for mutagenicity, developmental
toxicity, and subchronic testing (47 FR 58025, December 29, 1982, and
48 FR 44905, September 30, 1983). Data received under the negotiated
testing agreement satisfy the HAPs data needs for these endpoints.
Methyl isobutyl ketone is also being tested for neurotoxicity under a
TSCA enforceable consent agreement (ECA) with industry (announced at 60
FR 4514, January 23, 1995 (FRL-4924-8)). This rule proposes testing for
reproductive toxicity, acute toxicity, respiratory sensory irritation,
and immunotoxicity to complement ongoing testing and existing data.
Phenol is the subject of a test rule proposed on the basis of A and
B findings on November 22, 1993 (58 FR 61654). That rule proposed
subchronic toxicity, neurotoxicity, and reproductive and developmental
toxicity testing and a study of phenol's pharmacokinetics. EPA has
received a proposal for an ECA for this chemical substance that would
cover the testing proposed in the 1993 rule. The rule proposed herein
would add acute inhalation toxicity, respiratory sensory irritation,
and immunotoxicity to the testing program for phenol. Under the
procedures set forth at 40 CFR 790.22, members of the CMA Phenol Panel
and EPA have negotiated an ECA which provides for the testing proposed
in November 1993 as well as additional testing, including
immunotoxicity. Such testing would meet the HAPs-related data needs for
phenol. If the ECA is successfully concluded, EPA will drop the testing
requirement for phenol from the final HAPs rule.
1,2,4-Trichlorobenzene has been tested for carcinogenicity under a
test rule (51 FR 24657, July 8, 1986) based on an A finding. Data
received under this test rule satisfy the HAPs data needs for this
endpoint. Although the preamble of the proposed rule described specific
neurotoxicity concerns, EPA stated that neurotoxicity testing
requirements were not being proposed because it had not issued
neurotoxicity test guidelines at that time (45 FR 48545, July 18,
1980). Because a neurotoxity screening battery guideline (OPPTS
870.6200) has since been proposed, this rule proposes the testing of
1,2,4-trichlorobenzene for acute toxicity, respiratory sensory
irritation, neurotoxicity, immunotoxicity, and developmental toxicity.
Oncogenicity testing for vinylidene chloride was called for in a
proposed test rule based on an A finding on August 12, 1986 (51 FR
28840). The rule proposed that distribution, metabolism, and excretion
studies and an inhalation oncogenicity study be conducted in mice on
behalf of EPA's Office of Air Quality Planning and Standards (OAQPS).
EPA has not finalized the vinylidene chloride proposal and is hereby
withdrawing it. EPA is not pursuing these studies because the Agency
has concluded that, at this time, an oncogenicity bioassay would do
little to add to EPA's understanding of the oncogenic potential of the
substance. Today's rule proposes testing for acute toxicity,
respiratory sensory irritation, and neurotoxicity.
IV. Proposed Testing
A. Testing and Reporting Requirements
EPA is proposing specific testing and reporting requirements for
each of the 21 HAPs as specified in table 1 in Sec. 799.5053(a)(5) of
this proposed rule. EPA is proposing for the first time in a TSCA
section 4 rule to require an immunotoxicity screen and an acute
inhalation toxicity test that focuses on respiratory damage and
sublethal systemic toxicity. These and other test guidelines are
discussed below in Unit IV.C. of this preamble.
EPA is proposing to require a modified inhalation carcinogenicity
bioassay using only the male rat and female mouse when existing oral
carcinogenicity data and supporting information for a chemical
substance are deemed too uncertain to determine its carcinogenicity via
inhalation (Ref. 10). The reduced protocol is less expensive than a
traditional bioassay. However, test sponsors would also have the
alternative of performing pharmacokinetics studies and using route-to-
route extrapolation from existing adequate oral toxicity data under
enforceable consent agreements (EDAs) in lieu of this and other test
requirements if the Agency decides to use this approach (see Units
IV.D. and IV.E. of this preamble).
A total of 21 months would be given for the submission of final
reports for acute toxicity testing because the acute inhalation
toxicity with histopathology guideline proposes to make certain
histopathology studies contingent upon the results of the 90-day
subchronic studies. The time for the submission of immunotoxicity
studies would vary as a function of the test with which they can be
combined (e.g., subchronic and reproductive effects).
B. Test Substance
EPA is proposing that a substance of at least 97% purity be used as
the test substance. EPA recognizes that exposure to HAPs will occur as
exposure to complex mixtures and that ideally one would like data on
the mixtures themselves. However, it is not practical to test mixtures
due to the huge number of possible combinations. EPA will thus evaluate
the toxicity of HAP mixtures using data on the relatively pure
components in order to avoid the possible confounding effects of
impurities that might be found in technical grade substances. These
impurities, if substantial contributors to air pollution, should also
be captured as separate entries on the CAA list of HAPs. EPA believes
that a purity of 97% is available or readily achievable for all
substances covered by this rule.
For cresols, the subject of the test rule is a mixture (CAS No.
1319-77-3) of three isomers: ortho- (CAS No. 95-48-7), para- (CAS No.
106-44-5) and meta- (CAS No. 108-39-4). The mixture and individual
isomers are contained in the CAA section 112(b)(1) list of hazardous
air pollutants. Most human exposure is to the mixture. However, because
the mixture is of variable composition, EPA believes that it would be
very burdensome to test every possible variation of the mixture, which
would have different proportions of isomers. Therefore EPA is proposing
to follow the approach taken in the final test rule for cresols (51 FR
15771, 15776, April 28, 1986) and test each isomer (see Unit III.D. of
this preamble).
Another critical factor in study design for HAP testing is the low
vapor pressure of several of these substances (diethanolamine, 1,1'-
biphenyl, phthalic anhydride). This raises two questions. To which
forms of the chemical are humans exposed--vapor, aerosol or particle?
How does one design a valid toxicity study that can be used to assess
human risk to such exposures? Given the reported TRI releases to the
atmosphere for these substances, EPA has assumed that exposures are to
[[Page 33187]]
aerosols or particulates from the condensation of high temperature
stack gases. EPA is proposing that diethanolamine, 1,1'-biphenyl and
phthalic anhydride be tested via aerosol exposure. EPA invites
manufacturers and processors to submit information about the forms of
these substances that are encountered in ambient exposures and the
forms that should be tested, and encourages the development of
pharmacokinetics data that would permit testing by the less expensive
oral route for HAPs with low vapor pressure.
C. Test Guidelines
The 11 guidelines being proposed for use in testing HAPs under this
rule are included in the recently harmonized health effects test
guidelines proposed by EPA's Office of Prevention, Pesticides, and
Toxic Substances (OPPTS). When final, these harmonized guidelines will
incorporate an updated version of the test guidelines previously
developed for use under TSCA and FIFRA into a single set. A notice of
availability and request for comments on the proposed guidelines was
published in the Federal Register of June 20, 1996 (61 FR 31522).
The 11 guidelines proposed for use in testing HAPs are included in
the public version of the record for this rulemaking at the address
specified in the ``ADDRESSES'' section of this document. The complete
set of proposed guidelines is available electronically from the EPA
Public Access Gopher (gopher.epa.gov) under the heading:
``Environmental Test Methods and Guidelines''; by internet e-mail:
[email protected]; by mail: Public Docket and Freedom of
Information Section, Field Operations Division (7506C), Office of
Pesticide Programs, U.S. Environmental Protection Agency, Washington,
DC 20460; or in person or for courier pick-up: Room 1132, CM #2, 1921
Jefferson Davis Highway, Arlington, VA; telephone: (703) 305-5805.
The 11 guidelines proposed to be used for testing HAPs are as
follows:
(1) Acute Inhalation Toxicity with Histopathology, OPPTS 870.1350,
EPA Pub. No. 712-C-96-291, June 1996;
(2) Subchronic Inhalation Toxicity, OPPTS 870.3465, EPA Pub. No.
712-C-96-204, June 1996;
(3) Inhalation Developmental Toxicity Study, OPPTS 870-3600, EPA
Pub. No. 712-C-96-206, June 1996;
(4) Reproduction and Fertility Effects, OPPTS 870.3800, EPA Pub.
No. 712-C-96-208, February 1996;
(5) Carcinogenicity, OPPTS 870.4200, EPA Pub. No. 712-C-96-211,
June 1996;
(6) Escherichia coli WP2 and WP2 uvrA Reverse Mutation Assays,
OPPTS 870.5100, EPA Pub. No. 712-C-96-247, June 1996;
(7) Detection of Gene Mutations in Somatic Cells in Culture, OPPTS
870.5300, EPA Pub. No. 712-C-96-221, June 1996;
(8) In Vivo Mammalian Cytogenetics Tests: Bone Marrow Chromosomal
Analysis, OPPTS 870.5385, EPA Pub. No. 712-C-96-225, June 1996;
(9) In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus
Assay, OPPTS 870.5395, EPA Pub. No. 712-C-96-226, June 1996;
(10) Neurotoxicity Screening Battery, OPPTS 870.6200, EPA Pub. No.
712-C-96-238, June 1996; and
(11) Immunotoxicity, OPPTS 870.7800, EPA Pub. No. 712-C-96-351,
June 1996.
To be considered in this rulemaking, comments on the 11 proposed
test guidelines that are specific to HAPs testing must be submitted to
the OPPT Document Control Office. The comments must be submitted in the
manner specified in the ``DATES'' and ``ADDRESSES'' sections at the
beginning of this document. Comments on the 11 proposed guidelines,
which are not specific to the HAPs test rule must be submitted to the
Office of Pesticide Programs by August 19, 1996, at the address
identified in the Federal Register of June 20, 1996 (61 FR 31522).
The process of developing OPPTS harmonized guidelines described
above is proceeding at the same time as the development of the HAPs
test rule. The OPPTS harmonization process may result in the revision
of the guidelines prior to the end of the ocmment period for this
proposed rule. If so, EPA will announce the availability of those of
the 11 guidelines used in the HAPs rule that have been revised in order
to allow for public comment on the applicability of the revised
guidelines to the HAPs rule. If any of these 11 guidelines has not been
revised by the end of the comment period for this proposed rule, EPA
may issue the corresponding HAPs-specific guideline independent of the
OPPTS harmonization process.
EPA is proposing to modify the subchronic inhalation toxicity test
guideline (OPPTS 870.3465) for the purposes of this rulemaking to
include enhanced histopathology of the respiratory tract and an assay
for cell damage via lung lavage. EPA is requesting comment on adding
these parameters to the subchronic test guideline for testing HAPs.
As part of this rulemaking, EPA proposes to use the acute
inhalation toxicity with histopathology test guideline (OPPTS
870.1350). As indicated in Unit III.A. of this preamble, the study of
sublethal effects, especially effects on the respiratory system,
associated with accidental release and acute exposures is neces
FR Doc. 96-16203 Proposed Test Rule for Hazardous Air Pollutants
sary for
the HAPs. The standard acute inhalation toxicity test guideline (OPPTS
870.1300) focuses on gross lesions, body weight changes, and effects on
mortality. The acute inhalation toxicity with histopathology test
guideline assesses two endpoints: (1) histopathology of the respiratory
tract, kidney, liver, and other target organs; and (2) cell damage via
lung lavage. The guideline takes a stepwise approach to the evaluation
of acute toxicity and initially requires a 4-hour exposure at three
concentration levels. If the 4-hour study shows positive results in
histopathology or the bronchoalveolar lavage, a 1-hour study and an 8-
hour study would be required to define better the time and
concentration dependence of acute exposures. Histopathology is being
proposed for the respiratory tract, liver, and kidney. Other target
organs identified by either gross pathology in the 4-hour acute study
or by histopathology in the 90-day study would also have to be examined
by histopathology in the 4-hour acute study. If these results are
positive in the 4-hour study, histopathology in the 1-hour and 8-hour
studies would be required. The 4-hour acute testing may be combined
with acute neurotoxicity testing.
A respiratory sensory irritation test using American Standard Test
Method (ASTM) E 981-84 is also being proposed to provide a quantitative
estimate of the sensory irritant potential of an inhaled chemical.
Irritation is detected by a characteristic change in the breathing
pattern of mice, which results in a reduction in the breathing rate
during exposure to a test atmosphere.
For all testing proposed in this rule, test sponsors would have to
conduct testing and generate data in accordance with the specified test
guideline. Data developed under the final rule must be reported in
accordance with TSCA Good Laboratory Practice (GLP) Standards, 40 CFR
part 792.
EPA is considering three alternative procedures for handling these
test guidelines in the context of the final HAPs test rule. The first
alternative is for the final HAPs rule to incorporate the guidelines by
reference. Under this alternative, the text of the guideline would not
appear in the Code of Federal Regulations. Instead the rule would
include a reference to the guideline which would be available on the
internet and elsewhere, as noted above.
[[Page 33188]]
A copy of the applicable guideline would also be maintained in the
public version of the rulemaking record.
The second alternative would be for the final HAPs rule to refer to
the guideline, the text of which would be available on the internet and
elsewhere, as the pre-approved protocol. However, test sponsors may use
other protocols after such protocols have been approved by EPA
(``previously approved equivalents''). If EPA decides on this course of
action, the Agency may issue a supplemental notice proposing specific
implementation procedures if they are significantly different from the
following procedures. A test sponsor would be required to submit to EPA
for review and approval each test protocol that such sponsor believes
is equivalent to the corresponding OPPTS test guideline. A submission
would have to demonstrate equivalency, include a description of the
differences between the sponsor's protocol and the corresponding OPPTS
guideline, and indicate the rationale for changing the guideline. The
deadline for these submissions would be 90 days after the effective
date of the final HAPs rule. In the case of a study where the design
depends upon the results of an earlier test (such as carcinogenicity
where the dose level is contingent upon the results of a subchronic
study), the deadline is 90 days following the date of submission of the
final report for that study.
The third alternative is for the final HAPs rule to reference the
guidelines currently in part 798 of title 40 of the Code of Federal
Regulations and modify these guidelines to make them as nearly
identical as possible to the harmonized OPPTS guidelines. The
modifications that the Agency currently believes would be appropriate
are set forth in a separate document in the record entitled
``Modifications to Health Effects Test Guidelines Currently in 40 CFR
Part 798 for Use in the HAPs Test Rule''. EPA is soliciting comment on
these three alternative procedures.
D. Route-to-Route Extrapolation
EPA would consider route-to-route extrapolation of toxicity data
from routes other than inhalation when it is scientifically defensible
to empirically derive the inhalation risk. Derivation of the inhalation
risk is generally only reasonable when portal-of-entry effects (toxic
effects on the respiratory tract from inhalation exposure) and/or
first-pass effects can be ruled out or adequately characterized.
``First-pass'' effects refer to the metabolism that can take place
in portal-of-entry tissue, prior to a chemical's entry into the
systemic circulation. For example, after oral administration, many
chemicals are delivered to the liver via the portal vein from the
gastrointestinal (GI) tract before they enter into the systemic
circulation. The respiratory tract can also exhibit a first-pass effect
after inhalation due to its various cell types and metabolic enzyme
systems. The first-pass action can alter the disposition of the parent
and metabolites, thereby modulating the dose to remote or systemic
target tissues in a route-dependent fashion. Therefore, unless this
first-pass effect and dosimetry are adequately understood and taken
into account, substantial error can be introduced in route-to-route
extrapolation.
In the absence of data to determine dosimetry via inhalation,
quantitative route-to-route extrapolation is subject to substantial
error when a chemical is thought to be susceptible to first-pass
effects (e.g., metabolized) or when a potential for portal-of-entry
effects is indicated (e.g., skin irritation after dermal
administration). There are situations where oral data should not be
used for route extrapolation to inhalation. For example, chemicals with
a short active half-life that were administered by gavage may result in
high short-term blood concentrations and consequently much greater
effects than the much lower constant blood levels that occur with
inhalation exposure. Conversely, if a chemical requires metabolic
activation via a rate-limited reaction, bolus dosing via gavage may
underestimate the dose. Consideration of factors such as these is
important in judging whether the oral study of interest qualifies for
route extrapolation.
Regardless of the toxic endpoint considered, EPA's ability to
perform quantitative route-to-route extrapolation is critically
dependent on the amount and type of data available. The minimum
information generally needed includes both the nature of the toxic
effect and a description of the relationship between exposure and the
toxic effect. The actual impact of exposure by different routes can
best be estimated by taking account of factors that influence
absorption at the portal of entry, such as:
(1) Physicochemical characteristics of the chemical (e.g.,
disassociation state, molecular weight, partition coefficient,
reactivity, solubility);
(2) Exposure factors (e.g., concentration, duration, regimen); and
(3) Physiologic parameters (e.g., barrier capacity as related to
variability in species, blood flow, cell types and morphology,
metabolism, pH, specialized absorption sites, storage in cells) and
those parameters that influence dose that are remote to the portal of
entry including metabolism, clearance, tissue binding, tissue blood
flows, tissue:blood partition coefficients, and tissue volumes.
Oral toxicity data are the most commonly available data as
alternatives to inhalation data. Oral data are problematic for route-
to-route extrapolation in the following instances:
(1) When groups of chemicals are expected to have different
toxicities by the two routes, for example, metals, irritants, and
sensitizers.
(2) When a first-pass effect by the liver is expected.
(3) When a respiratory tract effect is established but nodosimetry
comparison can be clearly established between the two routes.
(4) When the respiratory tract was not adequately studied in the
oral studies.
(5) When short-term inhalation studies, dermal irritation, or in
vitro studies indicate potential portal-of-entry effects at the
respiratory tract, but the studies themselves are not adequate for risk
assessment.
Dose-response data from other routes of exposure, such as
intravenous, intraperitoneal, subcutaneous, dermal, and intramuscular
routes also may be available. Intravenous data can provide reliable
information on blood levels, but such information should be
supplemented by knowledge of the quantitative relationship between
exposure concentration and blood levels in order to be useful. The
other routes usually are less useful in route-to-route extrapolation
because the pharmacokinetics are, in general, poorly characterized.
Methods for route-to-route extrapolation vary in accuracy and,
therefore, in inherent uncertainty. The simplest approach is to use
default absorption values for each exposure route dependent on the
chemical class in question. Such values have only been developed for a
few classes of organic chemicals. Because this approach entails
increased uncertainty compared with those that use pharmacokinetics
(PK) data and physiologically based pharmacokinetics (PBPK) modeling,
use of default absorption values is generally considered highly
uncertain for quantitative dose-response assessment.
EPA's optimal but most complex and data intensive method for
performing route-to-route extrapolation involves the development of a
PBPK model that describes the disposition (deposition, absorption,
distribution, metabolism, and elimination) of the chemical for the
routes of interest (Ref. 15). Such models
[[Page 33189]]
account for fundamental physiological and biochemical parameters and
processes such as blood flows, ventilatory parameters, metabolic
capacities, and renal clearance tailored by the physicochemical (e.g.,
blood:air and tissue:blood partitions) and biochemical properties
(e.g., binding, depletion of cofactors) of the chemical in question.
PBPK models should be used in conjunction with toxicity and mechanistic
studies in order to relate the effective dose associated with an
adverse effect for the test species and conditions to other scenarios.
Although the development of a full PBPK model can involve greater
effort than other methods using pharmacokinetics data, the application
of pharmacokinetics modeling to determine health risk provides a
considerable improvement in the reliability of an extrapolation across
routes. The use of an existing model structure, essentially a template,
can greatly reduce the effort required for model development of
analogous chemicals.
More limited pharmacokinetics data such as measurement of
bioavailability and disposition of an internal dose marker (e.g., blood
cholinesterase activity, enzyme elevation, and amount of chemical bound
to protein) may be used for route-to-route extrapolation in conjunction
with a consideration of the uncertainties involved in each case. As
above, if the portal of entry is affected by the agent, then more
elaborate data may be required.
EPA realizes that the use of pharmacokinetics data for route-to-
route extrapolation, as well as for the broader purpose of generally
identifying the mechanisms by which exposure to a specific agent causes
particular health effects, is a fast-developing and often controversial
area of science at this time. However, under certain circumstances, as
explained above, route-to-route extrapolation based on valid
pharmacokinetics data can offer a useful and less expensive alternative
to testing or retesting by another route of exposure.
E. Opportunity To Submit Proposals for Enforceable Consent Agreements
for Pharmacokinetics Studies
Basic pharmacokinetics parameters provide information on a
substance's absorption, distribution, biotransformation, and excretion
which can aid in understanding the potential for accumulation of the
substance in various tissues or organs and the mechanism of toxicity.
Basic PK parameters can be determined through use of the OPPTS
harmonized test guideline for pharmacokinetics studies (870.7485). EPA
considered but rejected the option of requiring the use of this
guideline in this proposed rule because the Agency is interested in a
more sophisticated level of study that could potentially support PBPK
modeling.
EPA believes that enforceable consent agreements (ECAs) and testing
consent orders offer an opportunity to obtain this more in-depth
understanding of the pharmacokinetics of HAPs. The Agency, therefore,
is inviting manufacturers to submit proposals for pharmokinetics
studies for HAPs to be used in the ECA process. Each study proposal
should include the name of the chemical(s), a detailed description of
the proposed pharmacokinetics study, and discussion of the application
of the pharmacokinetics data in performing route-to-route
extrapolations. Study proposals should reflect an understanding of the
scientific reasoning presented in Unit IV.D. of this preamble, the
existing database on the chemical and testing required under this
proposed test rule. EPA expects to use a previously published decision
tree (Ref. 15) as an element in the evaluation of these proposals. As
noted in Unit IV.D., these data may be used for route-to-route
extrapolation with a level of uncertainty in inverse proportion to
their level of complexity and sophistication.
Each study proposal should be labeled: ``Proposal for
Pharmacokinetics Study of (name of chemical),'' identified by document
control number (OPPTS-42187B, FRL-4869-1), and sent to: U.S.
Environmental Protection Agency, Office of Pollution Prevention and
Toxics, Document Control Office (7407), Room G-099, 401 M St., SW.,
Washington, DC 20460. Proposals for pharmacokinetics studies must be
received by EPA no later than October 24, 1996. Enforceable consent
agreements must be negotiated and signed no later than 12 months after
the date of proposal of this rule in order to permit timely development
of the final HAPs rule.
EPA will review the submissions and will select promising
candidates for negotiation under the procedures in 40 CFR 790.22. If
the Agency decides to proceed with the ECA process, it will publish a
notice in the Federal Register soliciting persons interested in
participating in or monitoring negotiations for the development of ECAs
for PK studies to notify the Agency in writing.
EPA noted in Unit IV.D. that the development and use of a PBPK
model represents the optimal approach to route-to-route extrapolation.
The development of such models is often a complex and uncertain task
that in most cases lies beyond the expectations of performance that
could be embodied in an ECA. However, EPA would like to encourage
extension of the data generated under the ECAs described above to the
development of PBPK models. EPA envisions that PBPK models could be
developed through voluntary cooperative arrangements and is interested
in a dialogue with industry and others on ways to encourage and support
PBPK model development.
F. Persons Required To Test
Based on the findings in Unit V of this preamble, EPA is proposing
that persons who manufacture (including import) or process, or who
intend to manufacture or process 1,1'-biphenyl, carbonyl sulfide,
chlorine, chlorobenzene, chloroprene, cresols (all three isomers),
diethanolamine, ethylbenzene, ethylene dichloride, ethylene glycol,
hydrochloric acid, hydrogen fluoride, maleic anhydride, methyl isobutyl
ketone, methyl methacrylate, naphthalene, phenol, phthalic anhydride,
1,2,4-trichlorobenzene, 1,1,2-trichloroethane, and vinylidene chloride,
other than as an impurity, at any time from the effective date of the
final test rule to the end of the reimbursement period, be subject to
the testing requirements in this rule. Manufacturers would be required
to submit letters of intent to conduct testing or exemption
applications (40 CFR 790.45). However, under 40 CFR 790.42, processors,
small-quantity manufacturers, and manufacturers of small quantities of
these substances solely for research and development purposes would not
be required to submit letters of intent or exemption applications
unless directed to do so in a subsequent notice as described in 40 CFR
790.48(b).
EPA is proposing to exempt those manufacturers and processors that
produce the chemical substances listed above only as an impurity, as
defined in 40 CFR 790.3, because it would be difficult and
prohibitively expensive for EPA, manufacturers, and processors to
identify with complete assurance all chemical substances that contain
the 21 substances solely as an impurity. In addition, EPA would find it
difficult to apply both the exemption and reimbursement processes to
those who manufacture and/or process these chemical substances solely
as an impurity. EPA's reimbursement regulations, issued pursuant to
TSCA section 4(c), 15 U.S.C. 2603(c), state that those persons who
manufacture or process chemical substances as impurities are not
subject to test
[[Page 33190]]
requirements unless a particular test rule specifically states
otherwise (40 CFR 791.48(b)). EPA finds no basis to propose such a
requirement in this rule.
Persons who manufacture these substances as byproducts, as defined
in 40 CFR 791.3(c), would be subject to the testing requirements set
forth in this proposed rule. The total amount of imports and domestic
production of these chemical substances, including the amount produced
as a byproduct, would be used in determining reimbursement shares under
the TSCA section 4 data reimbursement regulations in 40 CFR part 791.
In a previous multichemical test rule (undertaken for EPA's Office of
Solid Waste) for which EPA had likewise proposed that byproducts be
subject to the rule, an industry commenter objected to this inclusion
based on historical grounds. The commenter said, ``The historical roots
of section 4 in the Eckart Subcommittee work on TSCA were the sharing
of the costs of test generation in direct proportion to the economic
benefits which producers derived from the chemicals.'' In response to
this comment, EPA explained that,
EPA does not agree that the intention of Congress to have
producers share the cost of testing should be interpreted to exclude
producers of byproducts from TSCA section 4 testing requirements.
While economic benefit is not derived directly from the production
of the subject chemical, the production and disposal of the
byproduct are a result of a production process by which the company
does derive economic benefit (an indirect benefit). (53 FR 22300,
22305, June 15, 1988)
Carbonyl sulfide would be the first chemical substance subject to a
TSCA section 4 test rule that is produced almost exclusively as a
byproduct. Although some carbonyl sulfide is reported to be used in
chemical synthesis, its large production and release, as reported in
the TRI, is due to its creation as a byproduct which is unwanted.
Consistent with EPA's position on byproducts testing, as explained
above, all persons reporting the release of carbonyl sulfide in the TRI
would be considered to be manufacturers of carbonyl sulfide and would
be subject to the provisions of this proposed rule.
V. Findings
As explained in Unit I of this preamble, EPA is proposing findings
under TSCA sections 4(a)(1)(A) and 4(a)(1)(B) for the 21 HAPs subject
to this rule. The findings are summarized in the table below. The
detailed discussion of the findings for each chemical substance
included in this rule is contained in a separate document entitled
``TSCA Section 4 Findings for 21 Hazardous Air Pollutants'' that is
available in the rulemaking record. Requirements for sections
4(a)(1)(A) and 4(a)(1)(B) findings appear in Unit I of this preamble.
In articulating its policy for making findings under TSCA section
4(a)(1)(B) (frequently described as the ``B policy'', see Unit I of
this preamble), EPA has defined ``substantial production'' as aggregate
annual production of 1 million pounds or more and ``substantial
release'' as an annual release, from all sources, into the environment
of 1 million pounds or 10% of production, whichever is lower (58 FR
28736, 28746, May 14, 1993). These definitions apply to the terms
``substantial production'' and ``substantial release'' as used in this
preamble. (As explained in Unit III.C. of this preamble, all the
chemical substances proposed for testing in this proposed rule are
emitted into the atmosphere in the amount of 50 tons per year or more
according to the TRI.) EPA also defined ``substantial human exposure''
as an annual exposure of 100,000 members of the general population,
10,000 consumers, or 1,000 workers. Id.
TSCA Section 4(a) Statutory Findings
----------------------------------------------------------------------------------------------------------------
4(a)(1)(A)(ii)/(iii)
Chemical substance 4(a)(1)(A)(i) Finding 4(a)(1)(B)(i) Findinga and 4(a)(1)(B)(ii)/
is based on: is based on: (iii) Finding are for:
----------------------------------------------------------------------------------------------------------------
1,1'-Biphenyl--------------------------Reproductive toxicity----Substantial production:--Acute toxicity\6\,\9\--
(CAS No. 92-52-4) Respiratory toxicity 53.5 million lbs Subchronic
Substantial human toxicity\5\,\9\
exposure: 20,351 Developmental
workers toxicity\2\
Consumer exposure Reproductive
toxicity\1\
Neurotoxicity\7\
Immunotoxicity\7\
Respiratory sensory
irritation\7\
----------------------------------------------------------------------------------------------------------------
Carbonyl Sulfide Oncogenicity Substantial production: Acute toxicity\6\
(CAS No. 463-58-1) Neurotoxicity production is at least Subchronic toxicity\7\
as much as Developmental
environmental release toxicity\7\
(produced as a Reproductive
byproduct) toxicity\5\,\6\
Substantial Neurotoxicity\6\,\7\
environmental release: Oncogenicity\7\
16.7 million lbs Immunotoxicity\7\
Genetic toxicity\7\
Respiratory sensory
irritation\7\
----------------------------------------------------------------------------------------------------------------
Chlorine Respiratory toxicity Substantial production: Acute toxicity\5\,\8\
(CAS No. 7782-50-5) 22.3 billion lbs
Substantial human
exposure: 170,000
workers
Consumer exposure
Substantial
environmental release:
78,498 million lbs
----------------------------------------------------------------------------------------------------------------
[[Page 33191]]
Chlorobenzene Respiratory toxicity Substantial production: Acute toxicity\6\
(CAS No. 108-90-7) Developmental toxicity 210 million lbs Subchronic
Reproductive toxicity Substantial human toxicity\3\,\4\,\6\,\8
Liver toxicity exposure: 17,056 \
Kidney toxicity workers Neurotoxicity\7\
Neurotoxicity General population Immunotoxicity\6\,\7\
Substantial
environmental release:
2.58 million lbs
----------------------------------------------------------------------------------------------------------------
Chloroprene Respiratory toxicity Substantial production: Acute toxicity\3\,\6\
(CAS No. 126-99-8) Reproductive toxicity 321 million lbs Reproductive
Liver toxicity Substantial human toxicity\7\,\8\
Neurotoxicity exposure: 17,749 Neurotoxicity\6\,\8\
Hematotoxicity workers Immunotoxicity\7\
Developmental toxicity General population Respiratory sensory
Substantial irritation\7\
environmental release:
1.7 million lbs
----------------------------------------------------------------------------------------------------------------
Cresols
(CAS No. 1319-77-3)
mixture of 3 isomers:
ortho-isomer
(CAS No. 95-48-7)
para-isomer
(CAS No. 106-445)
Respiratory toxicity Substantial production: Acute toxicity\8\
meta-isomer Developmental toxicity 84.3 million lbs Subchronic
(CAS No. 108-39-4) Neurotoxicity Substantial human toxicity\5\,\8\
exposure: 132,742 Acute
workers neurotoxicity\5\,\6\
Consumer exposure Immunotoxicity\6\,\7\
General population Respiratory sensory
Substantial irritation\7\
environmental release:
1.5 million lbs
----------------------------------------------------------------------------------------------------------------
Diethanolamine Reproductive toxicity Substantial production: Acute toxicity\8\
(CAS No. 111-42-2) Neurotoxicity 198 million lbs Subchronic toxicity\5\
Substantial human Developmental
exposure: 573,025 toxicity\6\
workers Reproductive
Consumer exposure toxicity\7\
Neurotoxicity\5\,\6\,\7
\
Immunotoxicity\7\
Respiratory sensory
irritation\7\
----------------------------------------------------------------------------------------------------------------
Ethylbenzene Developmental toxicity Substantial production: Acute toxicity\6\
(CAS No. 100-41-4) Kidney toxicity 11.4 billion lbs Developmental
Neurotoxicity Substantial human toxicity\2\
exposure: 80,726 Reproductive
workers toxicity\7\
Consumer exposure Neurotoxicity\6\,\7\
General population Immunotoxicity\6\,\7\
Substantial Respiratory sensory
environmental release: irritation\7\
8.8 million lbs
----------------------------------------------------------------------------------------------------------------
Ethylene dichloride Oncogenicity Substantial production: Acute
(CAS No. 107-06-2) General systemic 14.3 billion lbs toxicity\1\,\4\,\5\,\6
toxicity General population \
Substantial human Subchronic
exposure: 77,111 toxicity\4\,\5\,\8\
workers Developmental
Consumer exposure toxicity\2\
Substantial Reproductive
environmental release: toxicity\9\
4 million lbs Neurotoxicity\6\,\7\
Respiratory sensory
irritation\7\
----------------------------------------------------------------------------------------------------------------
Ethylene glycol Substantial production: Acute toxicity\7\
(CAS No. 107-21-1) 7.2 billion lbs Subchronic
Substantial human toxicity\4\,\6\
exposure: 1,133,792 Neurotoxicity\7\
workers Immunotoxicity\5\
Consumer exposure Respiratory sensory
Substantial irritation\7\
environmental release:
17.5 million lbs
----------------------------------------------------------------------------------------------------------------
Hydrochloric acid Respiratory toxicity Substantial production: Acute toxicity\5\,\6\
(CAS No. 7647-01-0) 5.75 billion lbs
Substantial human
exposure: 1,131,879
workers
Consumer exposure
Substantial
environmental release:
287.7 million lbs
----------------------------------------------------------------------------------------------------------------
[[Page 33192]]
Hydrogen fluoride Respiratory toxicity Substantial production: Acute
(CAS No. 7664-39-3) Liver toxicity 322 million lbs toxicity\3\,\5\,\6\,\8
Eye irritation Substantial human \
exposure: 182,589 Subchronic
workers toxicity\8\,\10\
Substantial Developmental
environmental release: toxicity\7\
9.2 million lbs Reproductive
toxicity\7\
Neurotoxicity\7\
Immunotoxicity\7\
Respiratory sensory
irritation\7\
----------------------------------------------------------------------------------------------------------------
Maleic anhydride Respiratory toxicity Substantial production: Acute toxicity\7\
(CAS No. 108-31-6) Eye irritation 382 million lbs Developmental
Substantial human toxicity\2\
exposure: 37,897 Neurotoxicity\7\
workers Oncogenicity\5\,\6\
Immunotoxicity\7\
Respiratory sensory
irritation\7\
----------------------------------------------------------------------------------------------------------------
Methyl isobutyl ketone Developmental toxicity Substantial production: Acute toxicity\5\,\6\
(CAS No. 108-10-1) Neurotoxicity 175 million lbs Reproductive
Substantial human toxicity\7\
exposure: 467,763 Immunotoxicity\7\
workers Respiratory sensory
Consumer exposure irritation
General population
Substantial
environmental release:
27.7 million lbs
----------------------------------------------------------------------------------------------------------------
Methyl methacrylate Respiratory toxicity Substantial production: Acute
(CAS No. 80-62-6) Liver toxicity 1,200 million lbs toxicity\1\,\3\,\4\,\6
Kidney toxicity Substantial human \
Neurotoxicity exposure: 120,788 Developmental
workers toxicity\2\
Consumer exposure Reproductive
Substantial toxicity\7\
environmental release: Neurotoxicity\3\,\4\,\6
2.8 million lbs \,\8\
Immunotoxicity\6\,\7\
Respiratory sensory
irritation\7\
----------------------------------------------------------------------------------------------------------------
Naphthalene Respiratory toxicity Substantial production: Acute toxicity\5\,\6\
(CAS No. 91-20-3) Neurotoxicity 235 million lbs Reproductive
Substantial human toxicity\5\,\6\,\7\
exposure: 23,092 Immunotoxicity\6\,\7\
workers Respiratory sensory
Consumer exposure irritation\7\
General population
Substantial
environmental release:
2.8 million lbs
----------------------------------------------------------------------------------------------------------------
Phenolb Respiratory toxicity Substantial production: Acute
(CAS No. 108-95-2) 3.9 billion lbs toxicity\4\,\5\,\8\
Substantial human Immunotoxicity\4\,\5\,\
exposure: 192,739 6\
workers Respiratory sensory
Consumer exposure irritation
General population
Substantial
environmental release:
10 million lbs
----------------------------------------------------------------------------------------------------------------
Phthalic anhydride Respiratory Substantial production: Acute toxicity\6\,\7\
(CAS No. 85-44-9) sensitization 874 million lbs Subchronic toxicity\7\
Substantial human Developmental
exposure: 62,644 toxicity\5\,\8\
workers Reproductive
toxicity\7\
Neurotoxicity\7\
Oncogenicity\5\
Immunotoxicity\7\
Respiratory sensory
irritation\7\
----------------------------------------------------------------------------------------------------------------
1,2,4-Trichlorobenzene Oncogenicity Substantial production: Acute
(CAS No. 120-82-1) Developmental toxicity CBI toxicity\1\,\3\,\6\
Substantial human Developmental
exposure: 4,032 toxicity\1\,\5\,\6\
workers Neurotoxicity\6\
General population Immunotoxicity\7\
Respiratory sensory
irritation\7\
----------------------------------------------------------------------------------------------------------------
[[Page 33193]]
1,1,2-Trichloroethane Oncogenicity Substantial production: Acute toxicity\7\
(CAS No. 79-00-5) Liver toxicity estimated - 210 Subchronic toxicity\7\
Kidney toxicity million lbs Developmental
Neurotoxicity Substantial human toxicity\5\,\6\
exposure: 1,036 Reproductive
workers toxicity\7\
General population Neurotoxicity\6\,\7\
Oncogenicity\5\
In vivo cytogenicity\7\
Immunotoxicity\6\
Respiratory sensory
irritation\7\
----------------------------------------------------------------------------------------------------------------
Vinylidene chloride Oncogenicity Substantial production: Acute toxicity\5\,\6\
(CAS No. 75-35-4) Respiratory toxicity 230 million lbs Neurotoxicity\7\
Developmental toxicity Substantial human Respiratory sensory
Liver toxicity exposure: 2,675 irritation\7\
Kidney toxicity workers
Consumer exposure
----------------------------------------------------------------------------------------------------------------
\1\ Too few animals were tested.
\2\ Only one species was adequately tested.
\3\ Only one sex was tested.
\4\ Too few exposure levels were tested.
\5\ Inadequate exposure duration, schedule, or route.
\6\ Only limited endpoints were assessed.
\7\ No study addressing the specific endpoint was found.
\8\ Insufficient reporting of data to make the study useful.
\9\ No no-observed-adverse-effect level (NOAEL) was identified.
\10\ No lowest-observed-adverse-effect level (LOAEL) was identified.
Notes to table:
a ``B'' findings are based on Ref. (10). It should be noted that
all HAPs meet the 50 tons of emissions per year selection criteria
discussed in Unit III.C. of this preamble.
b Findings made in 58 FR 61654, 61659-60, November 22, 1993.
VI. Economic Analysis of the Proposed Rule
EPA has prepared and placed in the record for this proposed rule an
economic analysis that evaluates the potential for significant economic
impacts as a result of the testing proposed in this notice. The total
cost of this proposed rule is estimated to range up to $41.4 million.
The total cost of testing for each chemical substance has been
annualized and compared with annual revenues (defined as the product of
sales price and total supply) as an indication of potential economic
impact. Annualized test costs, calculated over 15 years using a 7%
discount rate, represent the equivalent constant costs that would have
to be recouped each year of the payback period to finance the testing
expenditure in the first year. Annualized test costs are then divided
by the total supply of the chemical substance to derive the annualized
unit test costs. The percent price impact is calculated by dividing the
annualized unit test costs by the sales price and multiplying by 100.
The upper-bound estimated total costs of testing (including both
laboratory costs and administrative costs), annualized tests costs, and
price impact for the chemicals in this proposed rule are as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chemical Substances Total test cost ($) Annualized test cost ($) Price impact (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1,1'-Biphenyl 2,213,900 243,074 0.64
Carbonyl sulfide 5,509,163 609,876 NA
Chlorine 85,400 9,376 0.0003
Chlorobenzene 972,900 106,819 0.098
Chloroprene 1,603,488 176,054 0.076
Cresols (all 3 isomers) 2,139,600 234,917 0.39
Diethanolamine 2,327,838 255,584 0.23
Ethylbenzene 1,732,050 190,170 0.013
Ethylene dichloride 2,007,325 220,393 0.0071
Ethylene glycol 986,638 108,327 0.0097
Hydrochloric acid 85,400 9,376 0.0040
Hydrogen fluoride 2,135,888 234,509 0.094
Maleic anhydride 4,148,588 454,834 0.25
Methyl isobutyl ketone 1,228,913 134,928 0.16
Methyl methacrylate 1,732,050 190,170 0.023
Naphthalene 1,242,650 136,436 0.16
Phenol 85,400 9,376 0.0010
[[Page 33194]]
Phthalic anhydride 5,650,338 620,377 0.21
1,2,4-Trichlorobenzene 963,163 105,750 CBI
1,1,2-Trichloroethane 3,837,900 421,381 0.41
Vinylidene chloride 708,700 77,811 0.12
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: The table shows the maximum costs and impacts estimated by
EPA. The full range of estimates is given in the economic analysis
document placed in the record for this proposed rule.
EPA believes, on the basis of these calculations, that the proposed
testing of the HAPs presents a low potential for adverse economic
impact. Because these chemical substances have relatively large
production volumes, with the exception of carbonyl sulfide (to which
this methodology does not apply) the annualized costs of testing,
expressed as a percentage of annual revenue, are very small--ranging
from 0.0003% to 0.64%. Costs of testing are therefore found to be
insignificant relative to revenues for these chemical substances.
VII. Availability of Test Facilities and Personnel
Although earlier studies indicated that test facilities and
personnel were available to perform the testing specified in this
proposed rule (Ref. 18), the impact of this rule combined with other
testing requirements may exceed capacity for inhalation testing
facilities in the short term. While EPA believes that over the longer
term, additional inhalation facilities will become available, any
short-term effects can be dealt with by adjusting study due dates in
response to comments on this rule or in response to a request for
modification of reporting deadlines.
VIII. Public Meeting
EPA will hold a public meeting in Washington, DC prior to the close
of the comment period. Announcemment of this meeting will be published
in the Federal Register. If requested, EPA will hold an additional
public meeting in Washington, DC.
IX. Comments Containing Confidential Business Information
All comments will be placed in the public version of the rulemaking
record unless they are clearly labeled as containing information
claimed as CBI when they are submitted. CBI claims will be deemed to
have been waived if they are not made at the time of submission of the
document containing the information claimed as CBI, and such document
may be made public with no further notice to the submitter. While a
part of the rulemaking record, comments claimed as CBI will be treated
in accordance with 40 CFR part 2. A sanitized version of all comments
containing information claimed as CBI must be submitted to EPA for
inclusion in the public version of the rulemaking record.
It is the responsibility of the submitter to comply with 40 CFR
part 2 so that all materials claimed as CBI may be properly protected.
This includes, but is not limited to, clearly indicating on the face of
the revelant section of the comment (as well as on any revelant
associated correspondence) that information claimed as CBI is included
and marking ``CONFIDENTIAL,'' ``TSCA CBI,'' or similar designation on
the face of each section of any document or attachment in the comment
that contains information claimed as CBI. Should putatively private
information be put into the public file because of the submitter's
failure to clearly claim and designate its confidential claim on the
face of the comment, EPA will presume any such information that has
been in the public file for more than 30 days to be in the public
domain.
X. Rulemaking Record
EPA has established a record for this rulemaking (docket number
OPPTS-42187) (including comments and data submitted electronically).
This record contains the basic information considered by EPA in
developing this proposal and appropriate Federal Register notices. EPA
will supplement this record as necessary.
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 12 noon to 4 p.m., Monday
through Friday, except legal holidays. The public record is located in
the TSCA Nonconfidential Information Center, Rm. NE-B607, 401 M St.,
SW., Washington, DC 20460.
Comments in electronic form may be submitted directly to EPA at:
[email protected]
Comments in electronic form must be submitted in 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, 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 record includes the following information.
A. Supporting Documentation
(1) Federal Register notices/EPA documents pertaining to this
proposed rule consisting of:
(a) ``TSCA Interagency Testing Committee; Initial Report to the
Administrator, Environmental Protection Agency'' (42 FR 55026, October
12, 1977).
(b) ``Chloromethane and Chlorinated Benzenes Proposed Test Rule;
Amendment to Proposed Health Effects Standards'' (45 FR 48524, July 18,
1980).
(c) ``Dichloromethane, Nitrobenzene and 1,1,1-Trichloroethane;
Proposed Test Rule'' (46 FR 30300, June 5, 1981).
(d) ``Tenth Report of the Interagency Testing Committee to the
Administrator; Receipt of Report and Request for Comments Regarding
Priority List of Chemicals'' (47 FR 22585, May 12, 1982).
(e) ``Methyl Isobutyl Ketone and Methyl Ethyl Ketone; Response to
the Interagency Testing Committee'' (47 FR 58025, December 29, 1982).
(f) ``Toxic Substances Control Act; Data Reimbursement'' (48 FR
31786, July 11, 1983).
(g) ``Cresols; Proposed Test Rule'' (48 FR 31813, July 11, 1983).
(h) ``Methyl Isobutyl Ketone and Methyl Ethyl Ketone Decision to
Adopt Negotiated Testing Program'' (48 FR 44905, September 30, 1983).
(i) ``Toxic Substances; Biphenyl; Test Rule'' (50 FR 37182,
September 12, 1985).
(j) ``Cresols; Testing Requirements'' (51 FR 15771, April 28,
1986).
(k) ``Chlorinated Benzenes; Final Test Rule'' (51 FR 24657, July 8,
1986).
(l) ``Toxic Substances, 1,1,-Dichloroethylene; Proposed Test Rule''
(51 FR 28840, August 12, 1986).
(m) ``Guidelines for Carcinogen Risk Assessment'' (51 FR 33992
(September 24, 1986).
[[Page 33195]]
(n) ``Office of Solid Waste Chemicals; Final Test Rule'' (53 FR
22300, June 15, 1988).
(o) ``Toxic Substances Control Act (TSCA); Good Laboratory Practice
Standards'' (54 FR 34034, August 17, 1989).
(p) ``Metabolism and Pharmacokinetics Test Guideline'' (56 FR
32537, July 17, 1991).
(q) ``Guidelines for Developmental Toxicity Risk Assessment'' (56
FR 63798, December 5, 1991).
(r) ``TSCA section 4(a)(1)(B) Final Statement of Policy; Criteria
for Evaluating Substantial Production, Substantial Release, and
Substantial or Significant Human Exposure'' (58 FR 28736, May 14,
1993).
(s) ``Office of Water Chemicals; Final Test Rule'' (58 FR 59667,
November 10, 1993).
(t) ``Acetophenone, Phenol, N,N-Dimethylaniline, Ethyl Acetate, and
2,6-Dimethylphenol; Proposes Test Rule, Notice of Opportunity to
Initiate Negotiations for TSCA Section 4 Testing Consent Agreements''
(58 FR 61654, November 22, 1993).
(u) ``Testing Consent Orders for Acetone, n-Amyl Acetate, n-Butyl
Acetate, Ethyl Acetate, Isobutyl Alcohol, Methyl Isobutyl Ketone, and
Tetrahyrofuran'' (60 FR 4514, January 23, 1995).
(v) ``Executive Order 12866 of September 30, 1993; Regulatory
Planning and Review'' (58 FR 51735, October 4, 1993).
(w) ``Executive Order 12898 of February 11, 1994; Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
(x) ``Guidelines for Reproductive Toxicity Risk Assessment'' (Pub.
No. EPA/600/AP-94/001, February 1994).
(2) OPPTS test guidelines used in this proposed rule:
(a) Acute Inhalation Toxicity with Histopathology, OPPTS 870.1350,
EPA Pub. No. 712-C-96-291, June 1996;
(b) Subchronic Inhalation Toxicity, OPPTS 870.3465, EPA Pub. No.
712-C-96-204, June 1996;
(c) Inhalation Developmental Toxicity Study, OPPTS 870-3600, EPA
Pub. No. 712-C-96-206, June 1996;
(d) Reproduction and Fertility Effects, OPPTS 870.3800, EPA Pub.
No. 712-C-96-208, February 1996;
(e) Carcinogenicity, OPPTS 870.4200, EPA Pub. No. 712-C-96-211,
June 1996;
(f) Escherichia coli WP2 and WP2 uvrA Reverse Mutation Assays,
OPPTS 870.5100, EPA Pub. No. 712-C-96-247, June 1996;
(g) Detection of Gene Mutations in Somatic Cells in Culture, OPPTS
870.5300, EPA Pub. No. 712-C-96-221, June 1996;
(h) In Vivo Mammalian Cytogenetics Tests: Bone Marrow Chromosomal
Analysis, OPPTS 870.5385, EPA Pub. No. 712-C-96-225, June 1996;
(i) In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus
Assay, OPPTS 870.5395, EPA Pub. No. 712-C-96-226, June 1996;
(j) Neurotoxicity Screening Battery, OPPTS 870.6200, EPA Pub. No.
712-C-96-238, June 1996; and
(k) Immunotoxicity, OPPTS 870.7800, EPA Pub. No. 712-C-96-351, June
1996.
(3) Technical Support Documents consisting of:
(a) TSCA Section 4 Findings for 21 Hazardous Air Pollutants.
(b) Exposure Profiles for HAPs--Group 1.
(c) Summary Tables on the Health Effects Data for Hazardous Air
Pollutants (HAPs)--Group 1.
(d) Economic Analysis of the Impact of the Test Rule.
(4) Communications consisting of:
(a) Written letters and memoranda.
(b) Contact reports of telephone conversations.
(c) Meeting summaries.
B. References
(1) U.S. Environmental Protection Agency. ``Methods for derivation
of inhalation reference concentrations and application of inhalation
dosimetry.'' p. xxviii. Prepared by the Office of Health and
Environmental Assessment, Washington, DC. EPA/600/8-90/066F (1994).
(2) Letter from John F. Martonik, OSHA, to Susan B. Hazen, EPA, May
31, 1995.
(3) Letter from Val Schaeffer, CPSC, to Joe Carra, EPA, June 2,
1995.
(4) Orme-Zavaleta, J. ``OMB Question-Reply.'' Memorandum to Vicki
Dellarco. May 9, 1996.
(5) NAS. National Academy of Sciences, Washington DC, ``Science and
Judgment in Risk Assessment'' pp. 154, 157, 265 (1994).
(6) Siegel-Scott, C. ``Slope factors for hazardous air
pollutants.'' Memorandum to Vicki Dellarco. September 7, 1994.
(7) Shoaf, C.R. ``Clean Air Act chemicals with adequate databases
for development of RfC's.'' Memorandum to Vicki Dellarco. September 20,
1994.
(8) U.S. Environmental Protection Agency. Health assessment
document for 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) and related
compounds, Vol. III of III, pp. 9-48 to 9-50. Prepared by the Office of
Health and Environmental Assessment, Washington, DC. EPA/600/PB-92/001C
(1994).
(9) Francis, E.Z., and Kimmel, G.A. ``Proceedings of the workshop
on one versus two-generation reproductive effects studies.'' Journal of
the American College of Toxicology. 7:911-925 (1988).
(10) Lai, D.Y., Baetcke, K.P., Vu, V.T., Cotruvo, J.A., and Eustis,
S.L. ``Evaluation of reduced protocols for carcinogenicity testing of
chemicals: Report of a joint EPA/NIEHS workshop.'' Regulatory
Toxicology and Pharmacology. 19:183-201 (1994).
(11) Syracuse Research Corporation. ``Summary tables on the health
effects data for hazardous air pollutants (HARs)-Group 1.'' Syracuse,
New York. (1995a).
(12) Syracuse Research Corporation. ``Exposure profiles for HAPs-
Group 1.'' Syracuse, New York. (1995b).
(13) Valcovic, L.R. Memorandum: ``Genetic toxicity evaluation of
HAPs'' to Vicki Dellarco, July 14, 1994.
(14) Waters, M.D., Stack, H.F., and Jackson, M.A. 1990. ``Genetic
Activity Profiles of 110 Hazardous Air Pollutants Listed Under Title
III of the Clean Air Act, as amended.'' U. S. Environmental Protection
Agency. Internal Report. October 30, (1990).
(15) Gerrity, T.R., and Henry, C.J. ed. Principles of Route-to-
Route Extrapolation for Risk Assessment. pp 1-12. Elsevier Science
Publishing Co., Inc. New York, N.Y. (1990).
(16) U.S. Environmental Protection Agency. ``Hazardous Air
Pollutants: Profiles of Non-Cancer Toxicity from Inhalation
Exposures.'' Washington, DC. EPA/600/R-93/142. September 1993.
(17) Luster, M.I., Portier, C., Pait, D.G., White, K.L., Genings,
C., Munson, A.E., and Rosenthal, G.J. ``Risk assessment in
immunotoxicology. I. Sensitivity and predictability of immune tests.''
Fundamental and Applied Toxicology. 18:200-210 (1992).
(18) U.S. Environmental Protection Agency. ``EPA census of the
toxicological testing industry final report.'' (1990).
XI. Regulatory Assessment Requirements
A. Executive Order 12866
Pursuant to Executive Order 12866 (58 FR 51735, October 4, 1993),
it has been determined by OMB that this is a ``significant regulatory
action.'' OMB was concerned that the amount of inhalation testing
required by this rule may exceed the capacity of the testing industry,
at least in the short run. This action was submitted to OMB for review,
and any comments or changes made during that review have been
documented in the public record.
In addition, EPA has prepared an economic analysis of the impact of
this
[[Page 33196]]
action, which is contained in a document entitled ``Test Rule Support
for 21 Hazardous Air Pollutants.'' This document is available as a part
of the public record at the address listed in Unit X of this preamble
and is briefly summarized in Unit VI of this preamble.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), EPA
has determined that this test rule, if promulgated, would not have a
significant impact on small businesses. EPA has identified the entities
that currently manufacture or import the chemical substances required
to be tested under this proposed rule and examined the practices that
industry uses in carrying out chemical testing in response to EPA test
rules. EPA believes that: (1) small businesses would not be expected to
perform testing themselves, or to participate in the organization of
the testing effort, because health effects testing of chemical
substances is generally carried out by consortia of the large
manufacturers or importers of the chemical substances; (2) small
businesses would experience only very minor costs, if any, in securing
exemption from testing requirements because exemption request
requirements, described at 40 CFR 790.82, are minimal--particularly
when, as in this proposed rule, EPA is not requiring exemption
applicants to submit equivalence data (see Unit IV.F of this
preamble)--and EPA does not charge a fee for filing such requests; and
(3) small businesses are unlikely to be affected by reimbursement
requirements because under the reimbursement rules (at 40 CFR 791.40
through 791.52), manufacturers or importers with a significant share of
production or importation are the entities that must share testing
costs under the reimbursement rules, and small businesses generally do
not manufacture or import a significant portion of high-volume chemical
substances.
C. Paperwork Reduction Act
OMB has approved the information collection requirements contained
in this proposed rule under the provisions of the Paperwork Reduction
Act, 44 U.S.C. 3501 et seq., and has assigned OMB control number 2070-
0033.
The public reporting burden for this collection of information is
estimated to average approximately the following number of hours per
response for the chemicals listed below, including time for reviewing
instructions, searching e
FR Doc. 96-16203 Proposed Test Rule for Hazardous Air Pollutants
xisting data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
------------------------------------------------------------------------
Total
Chemical substance burden
------------------------------------------------------------------------
1,1'-Biphenyl 20,620
Carbonyl sulfide 47,644
Chlorine 693
Chlorobenzene 7,707
Chloroprene 13,039
Cresols (all 3 isomers) 6,048
Diethanolamine 21,826
Ethylbenzene 14,400
Ethylene dichloride 16,707
Ethylene glycol 7,816
Hydrochloric acid 693
Hydrogen fluoride 18,068
Maleic anhydride 35,849
Methyl isobutyl ketone 10,471
Methyl methacrylate 14,400
Naphthalene 10,580
Phenol 693
Phthalic anhydride 51,032
1,2,4-Trichlorobenzene 8,091
1,1,2-Trichloroethane 33,133
Vinylidene chloride 5,439
------------------------------------------------------------------------
The total public reporting burden is estimated to be 357,045 hours
for all responses. The overall average per chemical is 15,524 hours.
Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
An Agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
Comments are requested on the Agency's need for this information,
the accuracy of the provided burden estimates, and any suggested
methods for minimizing respondent burden, including through the use of
automated collection techniques. Send comments on the ICR to Sandy
Farmer, OPPE Regulatory Information Division; U.S. Environmental
Protection Agency (2136), 401 M St., SW., Washington, DC 20460, (202)
260-2740, or electronically by sending an e-mail message to:
[email protected]. Send a copy of these comments to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 17th St., NW., Washington, DC 20503, marked ``Attention:
Desk Officer for EPA.'' Please remember to include the ICR number in
any correspondence. The final rule will respond to any comments on the
information collection requirements contained in this proposal.
D. Unfunded Mandates Reform Act and Executive Order 12875
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4), EPA has determined that this action does not
contain a Federal mandate that may result in expenditures of $100
million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any one year. (The analysis of the
costs associated with this action is referenced in Unit XI.A. of this
preamble.) Therefore, this action is not subject to the requirements of
sections 202 and 205 of the UMRA.
E. Executive Order 12898
Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994),
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations,'' the Agency has considered
environmental justice-related issues with regard to the potential
impacts of this action on the environmental and health conditions in
low-income and minority communities. Because many sources of HAP
emissions are located near populations of lower socioeconomic status
and with a higher proportion of minorities, the improved health
database that will be generated by this action will help to protect
these individuals and communities.
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances, and
Reporting and recordkeeping requirements.
Dated: June 20, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, it is proposed that 40 CFR, chapter I, subchapter R, be
amended as follows:
[[Page 33197]]
PART 799--[AMENDED]
3. The authority citation for part 799 would continue to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
4. By adding Sec. 799.5053 to Subpart D of part 799 to read as
follows:
Sec. 799.5053 Chemical testing requirements for hazardous air
pollutants.
(a) General testing provisions--(1) Identification of test
substances. Table 1 in paragraph (a)(5) of this section identifies
those chemical substances that shall be tested in accordance with this
section. The purity of each test substance shall be 97 percent or
greater unless otherwise specified.
(2) Persons required to submit study plans, conduct tests, and
submit data. All persons who manufacture (including those who import
the substance or manufacture it as a byproduct) or intend to
manufacture one or more of the substances listed in table 1 after the
effective date listed in table 1 until the end of the reimbursement
period shall submit letters of intent to conduct testing, submit study
plans, conduct tests and submit data, or submit exemption applications,
as specified in this section, subpart A of this part and parts 790 and
792 of this chapter. Persons who manufacture or process these
substances only as an impurity are not subject to these requirements.
As explained in part 790 of this chapter, processors, small-quantity
manufacturers, and manufacturers of small quantities of these
substances solely for research and development purposes would become
subject to these requirements only after notification in the Federal
Register that no manufacturer had notified EPA of its intent to conduct
testing.
(3) Applicability of test guidelines. The guidelines and other test
methods cited in table 1 in paragraph (a)(5) of this section are
referenced here as they exist on the effective date listed in table 1
for that specific test. Testing shall be conducted in accordance with
the designated Series 870--Health Effects Test Guidelines and other
test methods. This incorporation by reference was approved by the
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Copies may be obtained from the Public Docket and
Freedom of Information Section, Field Operations Division (7506C),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20360. Copies may be inspected at the above
address or at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
(4) Interim reporting requirements. All testing requirements in
this section are subject to the submission of interim progress reports
every 6 months beginning 6 months after the effective date for any
specific test listed in table 1 in paragraph (a)(5) of this section.
The date for the submission of final reports is specified as the number
of months after the effective date for the specific test listed in
table 1.
(5) Testing and reporting requirements. The substances identified
by CAS Registry number and chemical name in the following table 1 shall
be tested in accordance with the designated OPPTS Harmonized Guideline
testing requirements and any additional requirements and limitations
specified in the ``Specific requirements under this section'' column of
table 1. The numbers and letters in this column refer to the specific
requirements set forth in paragraph (b) of this section. Final reports
shall be submitted by the deadlines indicated as the number of months
after the effective date shown in table 1.
Table 1
----------------------------------------------------------------------------------------------------------------
Specific
Chemical substance/ OPPTS harmonized requirements Final Effective
CAS No. required testing guidelines under this report date
section
----------------------------------------------------------------------------------------------------------------
75-35-4-------------------------Vinylidene---------- ----------------- ----------------- ---------- --------
chloride:
Acute 870.1350 (b)(2) 21 mo
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
----------------------------------------------------------------------------------------------------------------
79-00-5 1,1,2-
Trichloroethane:
Acute 870.1350 (b)(2) 21 mo
Subchronic 870.3465 (b)(3) 18 mo
Developmental 870.3600 12 mo
Reproductive 870.3800 (b)(1)(ii)(A), 29 mo
(b)(5)
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Carcinogenicity 870.4200 (b)(1)(i)(D), 60 mo
(b)(1)(ii)(A)
In vivo 870.5385 or (b)(1)(ii)(A) 14 mo
cytogenetics 870.5395
Immunotoxicity 870.7800 (b)(1)(ii)(A) 18 mo
----------------------------------------------------------------------------------------------------------------
80-62-6 Methyl
methacrylate:
Acute 870.1350 (b)(2) 21 mo
Developmental 870.3600 (b)(1)(i)(A) 12 mo
Reproductive 870.3800 (b)(1)(ii)(A), 29 mo
(b)(5)
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Immunotoxicity 870.7800 (b)(1)(ii)(A) 21 mo
----------------------------------------------------------------------------------------------------------------
85-44-9 Phthalic
anhydride:
Acute 870.1350 (b)(2) 21 mo
Subchronic 870.3465 (b)(1)(ii)(B), 18 mo
(b)(3)
Developmental 870.3600 (b)(1)(ii)(B) 12 mo
Reproductive 870.3800 (b)(1)(ii)(B), 29 mo
(b)(5)
Neurotoxicity 870.6200 (b)(1)(ii)(B), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Carcinogenicity 870.4200 (b)(1)(ii)(B) 60 mo
[[Page 33198]]
Immunotoxicity 870.7800 (b)(1)(ii)(B) 18 mo
----------------------------------------------------------------------------------------------------------------
91-20-3 Naphthalene:
Acute 870.1350 (b)(2) 21 mo
Reproductive 870.3800 (b)(1)(ii)(A), 29 mo
(b)(5)
Immunotoxicity 870.7800 (b)(1)(ii)(A) 21 mo
----------------------------------------------------------------------------------------------------------------
92-52-4 1,1'-Biphenyl:
Acute 870.1350 (b)(2) 21 mo
Subchronic 870.3465 (b)(1)(ii)(B), 18 mo
(b)(3)
Developmental 870.3600 (b)(1)(i)(A), 12 mo
(b)(1)(ii)(B)
Reproductive 870.3800 (b)(1)(ii)(B), 29 mo
(b)(5)
Neurotoxicity 870.6200 (b)(1)(ii)(B), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Immunotoxicity 870.7800 (b)(1)(ii)(B) 18 mo
----------------------------------------------------------------------------------------------------------------
95-48-7, Cresols:
106-44-5, and
108-39-4
Acute 870.1350 (b)(2) 21 mo
Subchronic 870.3465 (b)(3) 18 mo
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A)
Immunotoxicity 870.7800 (b)(1)(ii)(A) 18 mo
----------------------------------------------------------------------------------------------------------------
100-41-4 Ethylbenzene:
Acute 870.1350 (b)(2) 21 mo
Developmental 870.3600 (b)(1)(i)(A) 12 mo
Reproductive 870.3800 (b)(1)(ii)(A), 29 mo
(b)(5)
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Immunotoxicity 870.7800 (b)(1)(ii)(A) 21 mo
----------------------------------------------------------------------------------------------------------------
107-06-2 Ethylene
dichloride:
Acute 870.1350 (b)(2) 21 mo
Subchronic 870.3465 (b)(3) 18 mo
Developmental 870.3600 (b)(1)(i)(C) 12 mo
Reproductive 870.3800 (b)(1)(ii)(A), 29 mo
(b)(5)
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
----------------------------------------------------------------------------------------------------------------
107-21-1 Ethylene glycol:
Acute 870.1350 (b)(2) 21 mo
Subchronic 870.3465 (b)(3) 18 mo
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Immunotoxicity 870.7800 (b)(1)(ii)(A) 18 mo
----------------------------------------------------------------------------------------------------------------
108-10-1 Methyl isobutyl
ketone:
Acute 870.1350 (b)(2) 21 mo
Reproductive 870.3800 (b)(1)(ii)(A), 29 mo
(b)(5)
Immunotoxicity 870.7800 (b)(1)(ii)(A) 29 mo
----------------------------------------------------------------------------------------------------------------
108-31-6 Maleic anhydride:
Acute 870.1350 (b)(2) 21 mo
Developmental 870.3600 (b)(1)(i)(A) 12 mo
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Carcinogenicity 870.4200 (b)(1)(ii)(A) 60 mo
Immunotoxicity 870.7800 (b)(1)(ii)(A) 21 mo
----------------------------------------------------------------------------------------------------------------
108-90-7 Chlorobenzene:
Acute 870.1350 21 mo
Subchronic 870.3465 (b)(3) 18 mo
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Immunotoxicity 870.7800 (b)(1)(ii)(A) 18 mo
----------------------------------------------------------------------------------------------------------------
[[Page 33199]]
108-95-2 Phenol:
Acute 870.1350 (b)(2) 21 mo
Immunotoxicity 870.7800 (b)(1)(ii)(A) 12 mo
----------------------------------------------------------------------------------------------------------------
111-42-2 Diethanolamine:
Acute 870.1350 (b)(2) 21 mo
Subchronic 870.3465 (b)(1)(ii)(B), 18 mo
(b)(3)
Developmental 870.3600 (b)(1)(ii)(B) 12 mo
Reproductive 870.3800 (b)(1)(ii)(B), 29 mo
(b)(5)
Neurotoxicity 870.6200 (b)(1)(ii)(B), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Immunotoxicity 870.7800 (b)(1)(ii)(B) 18 mo
----------------------------------------------------------------------------------------------------------------
120-82-1 1,2,4-
Trichlorobenzene:
Acute 870.1350 (b)(2) 21 mo
Developmental 870.3600 12 mo
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Immunotoxicity 870.7800 (b)(1)(ii)(A) 21 mo
----------------------------------------------------------------------------------------------------------------
126-99-8 Chloroprene:
Acute 870.1350 (b)(2) 21 mo
Reproductive 870.3800 (b)(1)(ii)(A), 29 mo
(b)(5)
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Immunotoxicity 870.7800 (b)(1)(ii)(A) 21 mo
----------------------------------------------------------------------------------------------------------------
463-58-1 Carbonyl sulfide:
Acute 870.1350 (b)(2) 21 mo
Subchronic 870.3465 (b)(3) 18 mo
Developmental 870.3600 12 mo
Reproductive 870.3800 (b)(1)(ii)(A), 29 mo
(b)(5)
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Carcinogenicity 870.4200 (b)(1)(ii)(A) 60 mo
E.coli reverse 870.5100 6 mo
mutation
Gene mutation 870.5300 6 mo
In vivo 870.5385 or (b)(1)(ii)(A) 14 mo
cytogenetics 870.5395
Immunotoxicity 870.7800 (b)(1)(ii)(A) 18 mo
----------------------------------------------------------------------------------------------------------------
7647-01-0 Hydrochloric acid:
Acute 870.1350 (b)(2) 21 mo
----------------------------------------------------------------------------------------------------------------
7664-39-3 Hydrogen fluoride:
Acute 870.1350 (b)(2) 21 mo
Subchronic 870.3465 (b)(3) 18 mo
Developmental 870.3600 12 mo
Reproductive 870.3800 (b)(1)(ii)(A), 29 mo
(b)(5)
Neurotoxicity 870.6200 (b)(1)(ii)(A), 21 mo
(b)(1)(iii)(A),
(b)(1)(iii)(B)
Immunotoxicity 870.7800 (b)(1)(ii)(A) 18 mo
----------------------------------------------------------------------------------------------------------------
7782-50-5 Chlorine:
Acute 870.1350 (b)(2) 21 mo
----------------------------------------------------------------------------------------------------------------
(b) Test-specific requirements--(1) General. In addition to the
testing requirements specified in table 1 in paragraph (a)(5) of this
section and applicable test guideline-specific modifications listed
therein, the following additional requirements and limitations also
apply when specified for a particular chemical substance in table 1
under ``Specific requirements under this section''.
(i) Test species. The test animal shall be:
(A) A mammalian species other than the rat.
(B) A mammalian species other than the mouse.
(C) A mammalian species other than the rabbit.
(D) The male rat and the female mouse.
(ii) Route of exposure. Animals shall be exposed:
(A) Via vapor-phase inhalation.
(B) Via inhalation of aerosol.
(C) Orally in the diet.
(iii) Duration and frequency of exposure. (A) Animals shall be
exposed for a 4-hour period in an acute study.
[[Page 33200]]
(B) Animals shall be exposed for 6 hours per day, 5 days per week
for a 90-day period in a subchronic study.
(2) Acute test modifications. In addition to the acute testing
requirements specified in table 1 in paragraph (a)(5) of this section,
the following additional requirements and limitations also apply when
specified for a particular chemical substance in table 1 under
``Specific requirements under this section''.
(i) The appraisal of pulmonary irritation shall be evaluated during
exposure to the substance by the use of the mouse respiratory sensory
irritation assay method as outlined in ASTM E 981-84 (see paragraph
(b)(2)(iii)(C) of this section). This method assesses the breathing
patterns of test animals. This incorporation by reference was approved
by the Director of the Federal Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. This material is incorporated as it exists on
the date of approval and notice of any change in this material will be
published in the Federal Register. Copies of the incorporated materials
may be obtained from the TSCA Nonconfidential Information Center, Rm.
NE-B607, 401 M St., SW., Washington, DC, 20460 or from the American
Society for Testing and Materials (ASTM), 1916 Race Street,
Philadelphia, PA 10103. Copies may be inspected at the above address or
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC. For information on this test guideline, the
references in paragraph (b)(2)(iii) should be consulted.
(ii) Results of respiratory sensory irritation assay. (A) Data
shall be included in the final report and tabulated to show:
(1) The magnitude of change in respiratory rate with exposure
concentration and with time for each animal.
(2) A response concentration, which indicates the concentration at
which the respiration rate is decreased by 50% (RD50), will be
calculated, along with the 95% confidence limits.
(B) Time-effect curves shall be included in the final report to
evaluate the onset and shape of the response.
(iii) References.
(A) Alarie, Y., and Luo, J.E. ``Sensory Irritation by Airborne
Chemicals: A basis to establish acceptable levels of exposure.''
Toxicology of the Nasal Passages. Hemisphere Publishing Corporation:
New York pp. 91-100 (1986).
(B) Alarie, Y., and Stokinger, H.E. ``Sensory Irritation by
Airborne Chemicals.'' CRC Critical Reviews in Toxicology. pp. 299-363
(1973).
(C) ASTM. ``Standard Test Method for Estimating Sensory Irritancy
of Airborne Chemicals.'' In: 1984 Annual Book of ASTM Standards. Water
and Environmental Technology. Section 11. Volume 11.04 Designation E
981-84 pp. 572-584 (1984).
(3) Subchronic test modifications. In addition to the subchronic
testing requirements specified in table 1 in paragraph (a)(5) of this
section, the following additional requirements and limitations also
apply when specified for a particular chemical substance in table 1
under ``Specific requirements under this section''.
(i) Respiratory tract pathology. (A) Care shall be taken that the
method used to kill the animal does not result in damage to the tissues
of the upper or lower respiratory tract. The heart-lung, including the
trachea, shall be removed in bloc.
(B) Representative sections of the lungs shall be examined
histologically. This shall include trachea, major conducting airways,
alveolar region, terminal and respiratory bronchioles, alveolar ducts
and sacs, and interstitial tissues.
(C) The nasopharyngeal tissue shall be examined for histopathologic
lesions. This shall include sections through the nasal cavity, and
examination of the squamous, transitional, respiratory, and olfactory
epithelia.
(D) The larynx mucosa shall be examined for histopathologic
changes. Sections of the larynx to be examined include the epithelium
covering the base of the epiglottis, the ventral pouch, and the medial
surfaces of the vocal processes of the arytenoid cartilages.
(ii) Bronchoalveolar lavage. (A) The lungs shall be lavaged in situ
or after sacrifice. If the study will not be compromised, one lobe of
the lungs may be used for lung lavage while the other is fixed for
histologic evaluation. The lungs shall be lavaged using physiological
saline after cannulation of the trachea. The lavages shall consist of
two washes each of which consists of approximately 80 percent (e.g., 5
ml in rats and 1 ml in mice) of total lung volume. Additional washes
merely tend to reduce the concentrations of the material collected. The
lung lavage fluid shall be stored on ice at approximately 5 deg.C
until assayed.
(B) The following parameters shall be determined in the lavage
fluid as indicators of cellular damage in the lungs: total protein,
cell count and percent leukocytes. In addition, a phagocytosis assay
using the procedure of Burleson (Burleson et al., 1987; Gilmour and
Selgrade, 1993) shall be performed to determine macrophage activity.
The following references may be consulted:
(1) Burleson, G.R. et al. ``Poly (I): poly (C)-enhanced alveolar
peritoneal macrophage phagocytosis: Quantification by a new method
utilizing fluorescent beads.'' Proceedings of the Society for
Experimental Biology and Medicine. 184:468-476 (1987).
(2) Gilmour, G.I., and Selgrade, M.K. ``A Comparison of the
Pulmonary Defenses against Streptococcal Infection in Rats and Mice
Following O3 Exposure: Differences in Disease Susceptibility and
Neutrophil Recruitment.'' Toxicology and Applied Pharmacology. 123:211-
218 (1993).
(4) [Reserved]
(5) Reproductive toxicity and fertility study test modifications.
In addition to the reproductive toxicity and fertility testing
requirements specified in table 1 in paragraph (a)(5) of this section,
the following additional requirements and limitations also apply when
specified for a particular chemical substance in table 1 under
``Specific requirements under this section''.
(i) Administration of the test substance. The test substance shall
be administered by inhalation. The requirements of OPPTS
870.3800(e)(2)(iii) do not apply.
(ii) [Reserved]
[FR Doc. 96-16203 Filed 6-25-96; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 96-16194 Registration of Claims to Copyright, Group Registration of Photographs
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33052-33053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16194]
=======================================================================
-----------------------------------------------------------------------
LIBRARY OF CONGRESS
Copyright Office
37 CFR Part 202
[Docket No. RM 95-7A]
Registration of Claims to Copyright, Group Registration of
Photographs
AGENCY: Copyright Office, Library of Congress.
ACTION: Notice of public hearing; correction.
-----------------------------------------------------------------------
SUMMARY: This document corrects the July 15, 1996, deadline for
submission of written comments concerning the rulemaking on claims to
copyright group registration of photographs that was published in the
Federal Register of June 6, 1996 (61 FR 28829).
DATES: Submission of all written comments is on or before Thursday,
August 15, 1996.
[[Page 33053]]
FOR FURTHER INFORMATION CONTACT: Marilyn J. Kretsinger, Acting General
Counsel, Copyright GC/I&R, P.O. Box 70400, Southwest Station,
Washington, D.C. 20024. Telephone: (202) 707-8380. Facsimile: (202)
707-8366.
Dated: June 20, 1996.
Marilyn J. Kretsinger,
Acting General Counsel.
[FR Doc. 96-16194 Filed 6-25-96; 8:45 am]
BILLING CODE 1410-30-P
Complete official Federal Register PDF
FR Doc. 96-16173 Pesticides and Ground Water State Management Plan Regulation
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33260-33301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16173]
[[Page 33259]]
_______________________________________________________________________
Part VII
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 152 and 156
Pesticides and Ground Water State Management Plan Regulation; Proposed
Rule
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 /
Proposed Rules
[[Page 33260]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 152 and 156
[OPP-36190; FRL-4981-9]
RIN 2070-AC46
Pesticides and Ground Water State Management Plan Regulation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of proposed rulemaking.
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SUMMARY: This proposed rule implements a key component of the Agency's
1991 Pesticides and Ground Water Strategy, and reflects many years of
discussions and input from States and other stakeholders. Through the
development and use of State Management Plans (SMPs), EPA is proposing
to restrict the use of certain pesticides by providing States with the
flexibility to protect the ground water in the most appropriate way for
local conditions. This approach capitalizes on the most effective and
efficient roles for State and Federal governments to collaborate in the
protection of the nation's ground water resources. In this proposed
rule, using the proposed SMP approach, EPA is proposing to restrict the
legal sale and use of five pesticides that have been identified as
either ``probable'' or ``possible'' human carcinogens--alachlor,
atrazine, cyanazine, metolachlor, and simazine. Because of their
potential to contaminate ground water, EPA has determined that these
pesticides may cause unreasonable adverse effects on the environment in
the absence of effective management measures provided by an SMP. The
labels of these pesticides would be changed to require use in
accordance with an EPA-approved SMP, after a period allowed for
development and approval of these State plans. Incidentally, this
proposed rule will also revise existing pesticide labeling regulations,
in order to clarify general labeling requirements.
DATES: Written comments must be received on or before October 24, 1996.
ADDRESSES: Submit written comments, bearing the docket control number
``OPP-36190'' 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.
Comments may be submitted by facsimile to (703) 305-5558. In person,
bring comments to: Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis
Highway, Arlington, VA 22202.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: [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-36190.'' No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments on this
document may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found in Unit
V. of this document.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures 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 may be disclosed publicly
by EPA without prior notice. All written comments will be available for
public inspection in Rm. 1132 at the Virginia address given above from
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Arden Calvert, Policy and Special
Projects Staff (7501C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 1113, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, Telephone: (703) 305-7099, Fax:
(703) 305-6244, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: This document is organized into eight units.
Unit I. describes the background and statutory basis for this proposed
regulatory action. Unit II. describes the general considerations by
which the Agency will decide to classify specific pesticides to be
subject to State Management Plans (SMPs). Unit III. describes the
content of SMPs as an ``other regulatory restriction'' pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section
3(d). Unit IV. provides the risk and benefit determinations that are
the basis for today's proposed rule, summarizing data on human health
and environmental risks, ground-water contamination potential and
benefits of the five pesticides subject to today's proposal. Unit V.
provides further information on the public docket established for this
proposed rule. Unit VI. describes referral to the U.S. Department of
Agriculture and the Pesticides Scientific Advisory Panel. Unit VII.
provides a list of references cited in today's proposal. Unit VIII.
provides information on the Regulatory Impact Analysis provided for
this proposed rule and other requirements.
Regulated Entities
------------------------------------------------------------------------
Examples of Regulated
Category Entities
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State Governments States Developing Pesticide
SMPs
Industry Pesticide registrants;
farmers and other commercial
pesticide users
------------------------------------------------------------------------
This table is not exhaustive, but is a guide to the entities EPA
believes would be regulated by this action. Read carefully the contents
of the rule to determine whether this rule applies to you.
I. Basis for Regulatory Action
A. Background
Ground-water resources are of vital importance to the United
States. The quality of these resources affects the health of its
citizens, the integrity of many of its ecosystems, and the vigor of its
economy. Ironically, the variety of human activities made possible by
healthy ecosystems and abundant clean water also threatens the
continued viability of these resources.
Consequently, ground-water protection is a significant
responsibility for EPA. In July 1991, the Agency set forth its ground-
water protection goals and guiding principles in ``Protecting
[[Page 33261]]
the Nation's Ground Water: EPA's Strategy for the 1990's'' (Ref. 11).
The centerpiece of Agency ground-water protection efforts is
development of Comprehensive State Ground Water Protection Programs
(CSGWPPs). These programs are designed to integrate all State and
Federal efforts to protect ground water, increasing the efficiency and
effectiveness of State and Federal resources. The CSGWPPs also mark a
new direction in Federal/State cooperation: EPA supports voluntary
State initiatives to harmonize diverse ground-water protection
activities. Since the use of pesticides contributes significantly to
the problem of ground-water contamination, one of the Agency's first
efforts in developing CSGWPPs is the establishment of State Management
Plans (SMPs) for certain pesticides.
A State Management Plan consists of 12 components that together:
(a) Describe the State's ground-water protection philosophy and
goals, its authority and its organizational and resource basis for
fulfilling its commitment to manage the pesticide's use.
(b) Detail the manner in which the State intends to carry out this
commitment, using such measures as ground-water vulnerability
assessments, ground-water monitoring, and direct management of
pesticide use.
(c) Establish the State's commitments to develop and implement
these provisions through a process of public participation, to make
pesticide users aware of State management measures and to monitor the
effectiveness of the Plan through the development of meaningful
measurements of environmental results.
A pesticide State Management Plan is envisioned to be developed and
implemented in the context of a State's CSGWPP, which outlines the
State's overall ground-water protection approach. The additional
benefits of coordinated implementation of a State's CSGWPP and its SMPs
include: (1) More effective and consistent protection of the resource;
(2) increased State control to target efforts towards highest priority
protection; (3) more efficient use of limited program resources; and
(4) reduced potential for ground-water protection activities to be at
cross-purposes.
While EPA regards the creation of SMPs as a significant step in
protecting ground water from pesticides, EPA will continue to act to
reduce the risk of ground-water contamination in its ongoing national
pesticide registration and reregistration efforts. EPA will continue to
consider specific label provisions for individual pesticide products as
it screens both new and existing uses of pesticides. These may include
general advisory language (warning users of a pesticide's potential to
contaminate ground water and advising caution in the circumstances of
its use) or more specific constraints on the conditions of use, as the
evidence of contamination potential warrants. It may also include
classifying pesticides for use only by or under the supervision of a
certified applicator, under ``conventional'' restricted-use
classification authority (see section D. of this Unit). These
alternative risk-mitigation measures are also part of EPA's
consideration in proposing pesticides for SMPs (see Unit II. of this
preamble).
The concept and development of pesticide SMPs is the direct
outgrowth of extensive, collaborative work to produce a strategy for
achieving ground-water protection by using and integrating all Federal
and State pesticide regulatory authorities and resources. Beginning in
1986, with major public workshops EPA created an interactive process
with other Federal agencies, State agricultural, environment and health
agencies, the private sector, environmentalists, farmers and other
pesticide users, and ground-water experts. The States in particular
have taken an active and constructive role in addressing pesticide and
ground-water issues and have moved ahead with many of the management
approaches ultimately endorsed by the final Agency strategy for
pesticides and ground water.
The Pesticides and Ground-Water Strategy (hereafter referred to as
``the Strategy'') was issued October 31, 1991 (Ref. 12). The Strategy
describes the Agency's goals, policies, management programs, and
regulatory approaches for protecting the nation's ground-water
resources from risks of contamination by pesticides. The Strategy, and
the 1988 proposed Strategy, characterize the breadth and seriousness of
the potential problem of pesticides in ground water and the need for
coordinated regulatory and nonregulatory initiatives to protect the
resource (Ref. 7). Those interested in a more detailed discussion of
the history, purpose, objectives, and policy are referred to the
Strategy itself.
B. Goal
The Strategy articulated the Agency's goal for pesticides and
ground water. In summary, the goal:
is to prevent contamination of ground water resources resulting
from the normal, registered use of pesticides that would cause
unreasonable risks to human health and the environment by taking
appropriate actions where such risks may occur. (Ref. 12, p 9, see
also pp ES 6-7; emphasis added)
This goal highlights two important elements of EPA's pesticide and
ground-water policy: pollution prevention and local action.
Delaying action until ground-water contamination occurs at
significant levels and with a frequency sufficient to cause immediate
concern is costly, and ultimately counterproductive. ``[G]round-water
cleanup is extremely costly, and usually difficult and in some cases
impossible to achieve and demonstrate'' (Ref. 12, p. 10; also, Ref. 11,
p 5). In some cases, actual ground-water contamination may be virtually
irreversible. Allowing contamination to reach a level that presents an
immediate threat to human health or the environment forecloses
prevention and necessitates remediation. Remediation is more costly, as
well as more dangerous, than prudent action to anticipate and prevent
harm.
The second element of the Agency goal is local action. Taking
action locally, ``where such risks may occur,'' takes into account the
highly variable factors affecting the potential for ground-water
contamination. ``Ground water is a uniquely local resource due to the
ease with which small sources can affect it, and the impact that use
and hydrologic characteristics can have on its quality'' (Ref. 11).
There are several factors which generally influence whether
pesticides will contaminate ground water: (1) The properties of the
chemical itself (e.g., solubility in water, persistence, and mobility
in the subsurface environment); (2) the characteristics of the site of
use (e.g., soil type, depth to ground water, temperature, rainfall, and
site-specific hydrological factors collectively denoted by the term,
``sensitivity''); (3) application practices, (e.g., the amount of
pesticide per application, the frequency and method of applications);
and (4) other agronomic practices associated with the pesticide use
(e.g., irrigation or tillage practices).
The Agency believes that, as a general matter, the best method for
addressing differences in sensitivity throughout the country is to
tailor prevention measures in a given area to reflect the vulnerability
of local ground water to contamination. This approach minimizes the
complementary risks of over-regulating where ground water is not
particularly vulnerable to contamination and of underprotecting highly
vulnerable areas which might result from a solely ``national''
regulatory approach. It is expected to
[[Page 33262]]
result in an efficient regulation of pesticide use that will satisfy
the pre-eminent objective of reducing or eliminating unreasonable risk
with respect to ground water.
The Agency has further concluded that for pesticides which may pose
an unreasonable risk, the States can appropriately take the lead in
preventing unreasonable risk and protecting ground water through the
management of pesticide use. State management of use can be based on
local relative vulnerability of the ground-water resource, and where
necessary, its use and value. A lead role for the States, consistent
with overall Agency ground-water protection principles, acknowledges
the traditional primacy of States in the management and protection of
ground water as a natural resource; makes best use of expertise at the
State level in local hydrogeology, soils, agronomic practices, climate,
and pesticide use; and takes advantage of State and local understanding
of population and land use trends that help to define the future use of
ground-water resources.
C. SMP Start-up
State participation in pesticide-use management is a significant
new step for many States, requiring substantial preparation. EPA has
assisted this start-up in several ways, described more fully in the
Strategy.
1. Since 1990, EPA has provided funds to States to help develop
``generic'' SMPs. In these ``generic'' SMPs, States prepare for
development of pesticide-specific requirements by providing basic,
generalized information for each of the required components of a
pesticide-specific SMP. Generic SMPs give States an early opportunity
to consider how they will design Plan components and build the capacity
to implement them. Since Generic Plans have no legal force, EPA does
not ``approve'' them, in the sense of conferring legal authority upon
them; rather, States will submit Generic SMPs for review, comment and
concurrence. Fifty-seven States and territories with primary
enforcement authority for FIFRA use violations, as well as two Indian
tribal authorities, have received funds and are proceeding with
development of the generic SMPs. EPA has provided $35 million in grants
for this purpose in the Fiscal Years 1990 to 1996. By June 1995, all 50
States had developed and submitted draft Generic Plans to EPA regions
for early review and comment.
2. EPA published a Guidance for Pesticides and Ground Water State
Management Plans with two appendices in December 1993 (Ref. 18,
hereafter referred to as the Guidance). It provides practical
instruction on how to develop both Generic and pesticide-specific SMPs.
Much of the contents of the Guidance and the first Appendix anticipates
the contents of today's proposed rule (see Unit II.C. of this
preamble). These documents should be referred to for a more complete
description of how EPA envisions SMPs will be developed, and what EPA
envisions the level of protection will be.
3. As mentioned at the outset of this Unit, pesticide-specific SMPs
are intended to operate as an integral part of CSGWPPs. Likewise,
pesticide and ground-water protection measures tie into other EPA
programs and grants dedicated to ground-water protection. Among the
many related activities are: (a) The non-point source program under
section 319 of the Clean Water Act; (b) Coastal Zone non-point source
measures mandated by the Coastal Zone Management Act as amended in
1990; (c) the emerging ``watershed protection approach'' for
implementing the Agency's Clean Water Act activities; (d) Wellhead
Protection Programs and other drinking-water source-protection
initiatives under the Safe Drinking Water Act (SDWA); and (e) Public
Water System regulatory programs under SDWA, in particular, the
establishment of Maximum Contaminant Levels (MCLs) and monitoring
requirements for a variety of contaminants (including the five
pesticides subject to today's proposed rule). For example, an SMP
designed to deal with pesticide contamination risks could be integrated
with a Well Head Protection Program in a rural community where
pesticide use in nearby agricultural areas posed a threat to well field
re-charge areas. The SMP would provide Federal and State authorities
for pesticide regulation to complement and interact with the State's
other water quality protection authorities to help achieve the goal of
the Well Head Protection Program. A more detailed description of the
variety of interlocking programs is provided in an October 1992
document prepared by EPA's Office of Pesticide Programs (OPP),
``Integrating EPA's Agriculture and Water Grant Programs.''
In addition, the Strategy detailed a variety of related Federal
non-regulatory activities, including U.S. Department of Agriculture
(USDA) research and the ongoing activities of the U.S. Geological
Survey (USGS), as well as the connection between ground-water
protection and the Agency's ongoing pesticide regulatory initiatives,
such as encouraging the development of reduced-risk pesticides.
D. Statutory Authority
As a general matter, pesticides may not be sold, distributed, or
used in the United States unless they are registered by EPA [FIFRA
section 3(a)]. The standard for granting and maintaining a registration
is found in FIFRA section 3(c)(5). Among other things, this section
requires that the pesticide will perform its intended function without
causing unreasonable adverse effects on the environment and that, when
used in accordance with widespread and commonly recognized practice,
will not cause unreasonable effects on the environment.
Further, FIFRA section 3(d) gives EPA authority to classify a
pesticide for restricted use if EPA finds its use may cause
unreasonable adverse effects on the environment. Specifically, FIFRA
section 3 (d)(1)(C) [7 U.S.C. 136a(d)(1)(C)], provides:
If the Administrator determines that the pesticide, when applied
in accordance with its directions for use, warnings and cautions and
for the uses for which it is registered, or for one or more such
uses, or in accordance with widespread and commonly accepted
practice, may generally cause, without additional regulatory
restrictions, unreasonable adverse effects on the environment,
including injury to the applicator, he shall classify the pesticide,
or particular use or uses to which the determination applies, for
restricted use.
In the event the Administrator makes such a determination, ``the
pesticide shall be applied ... only by or under the direct supervision
of a certified applicator, or subject to such other restrictions as the
Administrator may provide by regulation'' (FIFRA section
3(d)(1)(C)(ii); emphasis added). An EPA-approved SMP would be such an
``other restriction.''
The basis for determining whether a pesticide warrants the
``additional regulatory restrictions'' referred to in section
3(d)(1)(C), is finding that the pesticide ``may generally cause ...
unreasonable adverse effects ...'' without such additional
restrictions. FIFRA section 2(bb) defines unreasonable adverse effects
as ``any unreasonable risk to man or the environment, taking into
account the economic, social and environmental costs and benefits of
the use of any pesticide.'' Thus, one of the critical aspects of
determining whether additional regulatory restrictions are necessary is
an evaluation of the risks and benefits of the pesticide use. However,
in finding a pesticide may cause unreasonable adverse effects, EPA will
consider these risks and benefits in a manner that takes into account
the considerable uncertainty surrounding both. Unit IV. of this
preamble, as well
[[Page 33263]]
as the Regulatory Impact Analysis prepared for this proposed rule,
describes the relative risks and benefits associated with the five
pesticides proposed to be subject to SMPs, as well as the costs and
benefits of State Management Plans as a regulatory measure.
Any restrictions imposed under FIFRA section 3(d) authority are
fully enforceable under FIFRA. Section 12 (a)(2) of FIFRA specifically
provides that it shall be unlawful (in subparagraph (F)):
to distribute or sell, or make available for use, or to use, any
registered pesticide classified for restricted use for some or all
purposes other than in accordance with section 3(d) and any
regulations thereunder.
Thus, once this rulemaking is final and EPA has approved the
requirements and specifications that constitute a SMP, that SMP will be
fully enforceable by Federal authorities. EPA will also require
registrants to incorporate the restriction to use a pesticide according
to the provisions of an EPA-approved State Plan as part of that
pesticide's labeling. Thus SMP requirements would also be federally
enforceable pursuant to section 12 (a)(2)(G), which makes it illegal
``to use any registered pesticide in a manner inconsistent with its
labeling.''
II. Process for Selecting Pesticides for Restriction under SMPs
A. Determining Potential to Contaminate Ground Water
As described in Unit I. of this preamble, the Agency's goal for
ground-water protection is to prevent contamination that would cause
unreasonable risks. Prevention entails the need to act in anticipation
of future environmental harm to ensure that this harm does not occur.
There are many uncertainties that limit the ability to quantify
risks and benefits to any reasonable degree of accuracy. These stem in
part from the circumstances pertaining to ground-water risks, and are
discussed further in Unit IV. of this preamble. These and other
impediments to national-level risk-benefit analysis were addressed in
the development of the Strategy, and in fact were instrumental in the
decision to favor the SMP approach in addressing serious pesticide
ground-water risks. Prescribing SMPs for individual pesticides fits
under EPA's regulatory authority to regulate beneficial but potentially
risky substances well before the onset of unreasonable adverse effects.
It also accommodates the uncertainties and variations which
characterize groundwater risk assessment.
This judgement will be made consistent with the Agency's current
regulatory procedures for classifying pesticides for restricted use.
These procedures are contained in 40 CFR part 152, subpart I. They
provide for EPA to impose restrictions other than limiting use to
certified applicators if the Agency determines that:
(a) Without such restrictions, the product when used in
accordance with warnings, cautions and directions for use or in
accordance with widespread and commonly recognized practices of use
may cause unreasonable adverse effects on the environment; and
(b) The decrease in risks as a result of restricted use would
exceed the decrease in benefits as a result of restricted use. (40
CFR 152.171)
Subpart I also provides for restricting use to certified applicators
and for other types of future restrictions, as authorized by FIFRA
section 3(d)(1)(C). Unit III. of this preamble explains in further
detail the distinction between such new ``other regulatory
restrictions'' as this SMP requirement and the conventional restricted
use of application only by or under the supervision of a certified
applicator.
EPA will make such a determination to subject a pesticide to the
requirements of an SMP through a weight of evidence analysis, taking
into account the economic, social and environmental costs and benefits
of the pesticide's use.
The first step in this weight-of-evidence approach is to
characterize a pesticide's potential to contaminate ground water.
Direct evidence of a pesticide's contamination potential includes its
physical-chemical properties (e.g., leaching potential) and the
circumstances, frequency and concentrations of known occurrence in
ground water. In addition to the direct evidence of contamination
potential, EPA will take into account information about use patterns
and practices which may supplement the more direct evidence of
contamination potential. Specifically, EPA will also consider: (a) The
crops and sites on which a pesticide is registered for use; (b) the
volume of pesticide used (on specific sites or crops, or in total) and
the extent of the pesticide's use (in terms of rates and/or number of
acres treated); and (c) the methods, timing, and rates of application
of a pesticide.
EPA will also take into account the potential of any of a
pesticide's by-products, metabolites or degradates, or any other
component of a product associated with the pesticide, to reach ground
water or to cause an adverse effect thereby, to the extent such
substances have been identified and information about their potentials
are known.
B. Determining Potential Risk
The second step is to compare the pesticide's potential to
contaminate ground water to an indicator of unreasonable risk. In
theory, a pesticide may have a ``potential to contaminate ground
water'' but not an associated significant ``potential to cause adverse
effects.'' The Ground-Water Reference Point is an important tool in
determining whether this association exists. Ground-Water Reference
Points are numerical indicators of the toxicity of a substance
established by EPA, based on test data and other reliable health
effects information. The concept of Ground-Water Reference Points was
explicated in the July 1991 Protecting the Nation's Ground Water: EPA's
Strategy for the 1990's (Ref. 11; in Part D, ``Agency Policy on EPA's
Use of Quality Standards in Ground-Water Prevention and Remediation
Activities'') and echoed in the Strategy (Ref. 12). Pursuant to these
policies, EPA will use as reference points for specific substances any
of the following: (1) Maximum Contaminant Levels (MCLs) established
under the Safe Drinking Water Act, or (2) Health Advisories (where MCLs
are not available for a substance), or (3) Water Quality Standards
(where the concern is adverse effects to ecosystems affected by closely
hydrologically linked surface waters) under the Clean Water Act. If
such numbers are not available, reference points may be derived from
the health effects literature where appropriate. In certain cases, the
Agency policy (cited above) provides that Maximum Contaminant Level
Goals (MCLGs) under the Safe Drinking Water Act may be used in order to
comply with Federal statutory requirements; however, MCLGs are unlikely
to be used in the context of any regulatory action the Agency might
take under FIFRA.
In protecting ground water, the Agency takes the reference point as
a benchmark that defines the failure of currently-implemented
preventive measures (c.f., Ref. 11, p. 31: ``Reaching the ...
appropriate reference point would be considered a failure of
prevention.''). In the context of pesticides and ground water, a
detection at or above the level established as the appropriate Ground-
Water Reference Point for a pesticide ingredient would be considered a
failure of measures to prevent unreasonable risk to human health or the
environment associated with that ingredient. Known
[[Page 33264]]
or predicted levels of contamination can be compared to these reference
points in order to gauge the relative risk of adverse effects.
Reference points provide a means by which the Agency may assess and
take into account the toxicity of ground-water contaminants, and
thereby the implicit level of hazard and risk posed by particular
contamination levels. Given the uncertainties regarding: (1) The actual
level and extent of pesticide contamination in ground water; (2) the
nature and degree of human exposure associated with such contamination;
(3) either the levels or the mechanisms of pesticide occurrence that
may affect ecosystems, habitats, or non-target biological organisms;
and (4) the anticipated future levels of occurrence, exposure and
associated hazard, it is problematic to make direct estimates of
exposure, and hence estimates of risk, with satisfactory accuracy.
Therefore, use of reference points to gauge the relative seriousness of
detected pesticide contamination serves as a useful surrogate to direct
estimates of exposure and risk.
It is theoretically possible to determine that a pesticide has the
potential to contaminate ground water, but that it is unlikely to cause
adverse effects. In practice, however, this distinction can often be
difficult to sustain with reasonable certainty. First, there is often
significant uncertainty about the levels and extent of current
contamination. Ground water is not systematically monitored across the
country. Ground waters susceptible to contamination by pesticides vary
significantly in character, limiting the ability to generalize beyond
ground-water monitoring sites. For ground water, models are not
sufficiently reliable to predict future contamination. Second, any
contamination of ground-water resources represents some tangible damage
to its value as a resource to present, and especially future,
generations. The Agency's pollution prevention philosophy clearly
states the Agency's interest in protecting the resource from
impairment. Hence, the Agency included in its Reference Point policy
that, as a matter of policy (Ref. 11):
Detection of a percentage of the reference point at an
appropriate monitoring location would then be used to trigger
consideration of additional action (e.g., additional monitoring,
restricting, limiting use or banning the use of a pesticide).
As a matter of prudence, therefore, the Agency considers the ability to
reach ground water, as indicated by physical and chemical properties,
and detections at any level to be evidence of some potential to reach
ground water at an unacceptable level.
C. Determining Appropriate Regulatory Action
After characterizing the pesticide's ground-water contamination
potential and its associated health and environmental risk, EPA next
considers the adequacy of current labeling safeguards. The Strategy
describes this step (Ref. 12):
If EPA has reasonable assurance from the evidence of a
particular chemical's contamination potential that it would not
cause `unreasonable adverse effects on the environment' if used in
accordance with the requirements of the label or under the
conditions of restricted use [to certified applicators], then
...those national-level management measures [would be] the only
measures necessary.
However, if EPA cannot conclude from the available evidence that
these measures would sufficiently reduce the risk of ground-water
contamination, it could pursue either an approved SMP, ... or
national cancellation if State Management Plans would not be
adequate to prevent risks.
A judgement on the need for State management measures depends on the
Agency's confidence in the effectiveness and efficacy of these uniform
national labeling instructions relative to the protection anticipated
from SMPs, present use practices and patterns, existing State risk-
mitigation measures and other prospective Federal regulatory actions,
including label changes and restricting use to certified applicators.
When EPA has adequate confidence in the efficacy of such measures, it
will conclude SMPs are unnecessary. The decision to prescribe SMPs is a
judgement that national labeling limitations likely will not prevent
the realization of a pesticide's ground-water contamination potential.
In considering whether to prescribe an SMP for a pesticide, EPA
evaluates the benefits of continued pesticide use under the provisions
of an SMP. The assessment of whether the reduced risk of ground-water
contamination might justify the social and economic costs of the SMP is
documented in a Regulatory Impact Assessment. The costs considered
include both the expense of developing and implementing SMPs (e.g.,
direct costs) as well as the costs of foregone benefits (e.g., indirect
costs). Indirect costs may include more expensive pest-control
substitutes and the economic loss associated with less pest control.
The Agency decides to establish the SMP restriction upon a reasoned
determination that the benefits of regulatory action justify its costs,
recognizing that some costs and benefits are difficult to quantify.
Finally, EPA also considers whether it is likely to take other,
more stringent regulatory action such as cancellation of major products
and/or uses of a particular pesticide. For instance, the Agency might
conclude that a pesticide in Special Review poses an unreasonable risk
for reasons different from and in addition to ground-water concerns, so
that only cancellation of major products and/or uses would be
appropriate. In that case, EPA would be inclined not to require the
States to develop SMPs to manage uses that will soon be prohibited. On
the other hand, EPA may both start a Special Review of a pesticide and
propose the same pesticide for SMPs via rule making. There may be a
need to provide the increased level of ground-water protection afforded
by State Plans while the Special Review is conducted. As the Strategy
explained, EPA may also use its cancellation authorities under FIFRA
section 6 to establish SMPs. There are many possible outcomes of a
Special Review besides the more stringent measure of cancellation. For
example, the Agency is addressing the ground-water contamination
potential of the pesticide aldicarb through a Special Review instituted
in 1984, and thus is not including it in this proposed rule. EPA sees
no inconsistency in pursuing both this proposed rule and the new
Special Review for the triazines, initiated in November 1994.
D. Selection of Pesticides for Today's Rule
The Agency has selected five pesticides for regulation under SMPs:
atrazine, simazine, cyanazine, alachlor and metolachlor. In selecting
these five, the Agency evaluated the ground-water contamination
potentials, hazards and uses of 20 currently registered pesticides that
have been reported to occur most frequently in ground water, according
to the available data compiled by EPA's Office of Pesticide Programs
(Ref. 15) (see Table 1). This included the pesticide aldicarb, which
was not considered for this proposed rule in light of its ongoing
Special Review.
Table 1.--Currently-Registered Pesticides Considered for SMPs Because of
Their Detection in Ground Water
------------------------------------------------------------------------
Selected Not selected at this time
------------------------------------------------------------------------
Alachlor Aldicarb
Atrazine Bentazon
Cyanazine Bromacil
[[Page 33265]]
Metolachlor Carbofuran
Simazine DCPA (Dacthal)
Dicamba
Diazinon
Lindane
Picloram
Methomyl
Metribuzin
Oxamyl
Promoton
1,3-D (Telone II)
2,4-D
------------------------------------------------------------------------
The five pesticides selected for this proposed rule, stand apart in
the breadth, frequency, and magnitude of ground-water contamination.
While Unit IV. of this preamble goes into the evidence in greater
detail, each has been detected hundreds of times in many States. Each
has been detected at levels exceeding their corresponding reference
points in multiple locations or times, clearly exhibiting a capacity to
contaminate ground water at concentrations exceeding health-based
standards. All five are also associated with serious and irreversible
toxicological effects, including carcinogenicity. One (alachlor) was
classified as a B2 (probable human) carcinogen by EPA, but is now
considered to be not classified pending further review of scientific
issues; the remaining four have been classified as C (possible human)
carcinogens. These classifications are under review, as discussed later
in this document.
All five are broad-spectrum herbicides with extensive agricultural
uses. These similarities of use suggest that these five can be
regulated together as a cluster. Since all raise significant ground-
water concerns, dealing with them together also helps prevent creating
unintended incentives to substitute ones under State-management
constraints for those less stringently regulated. Analytic methods for
ground-water monitoring of these compounds are available and in
widespread use around the country. This fact, combined with the
commonalities of use practices, will make it easier for States to
develop coordinated monitoring programs for these five as a group.
Among the other candidates, several are known to have occurred in
concentrations exceeding an MCL or Health Advisory Levels, but not as
frequently as the pesticides selected. Furthermore, previous regulatory
restrictions on use can be considered to have significantly reduced the
risks of ground-water contamination for some of these candidates. One
example is carbofuran, which has been detected over 4,100 times from
1980-1990 in 11 States, with 73 of those detections at levels over the
current MCL of 40 micrograms per liter (g/l) (Ref. 15).
However, the vast preponderance of those detections (and all but one of
those above the MCL) occurred in Suffolk County, New York, where all
carbofuran use was banned in 1987. In addition, granular carbofuran
products (which represent most of the chemical's prior use) have been
phased out except for a few specialty uses. Other candidates on the
list have had frequent occurrence in ground water, but neither as
widely nor as frequently at high concentrations, as the five selected
for this proposed rule.
EPA is proposing in today's rule to regulate those pesticides which
in its judgement pose the greatest threat to ground water. The number
of chemicals involved - five is a manageable number to ask States to
manage; EPA hopes to facilitate State participation by designating only
a manageable number of pesticides for SMPs at the outset.
III. State Management Plan Specifications, Development and Approval
Procedure
A. Introduction
This document proposes adding a new subpart J to 40 CFR part 152,
specifying SMPs as an ``other regulatory restriction'' authorized by
FIFRA section 3(d).
Much of what SMPs will be and how they will work has been discussed
in previous documents (e.g., the Strategy). In particular, this Unit of
today's proposal follows closely the contents of EPA's Guidance (Ref.
18). The Guidance (with two Appendices) describes in detail EPA's
expectations about the contents of an acceptable SMP, as well as the
criteria and procedures EPA Regional Offices will use in deciding
whether to accept or reject State Plans. Readers seeking more details
on these subjects should refer to the Guidance. EPA intends generally
to use the Guidance in reviewing State submissions, and to follow the
provisions of the Guidance's Appendix A in review, approval,
evaluation, amendment and (where necessary) revocation of State
Management Plans. However, the Guidance is subject to revision; for
example, the Agency fully expects to supplement the existing guidance
in light of comments on today's proposed rule.
As explained in Unit I. of this preamble, State Management Plans
are intended to complement CSGWPPs; as such, SMPs can be regarded as a
program-specific subset of a CSGWPP. However, the requirements proposed
here are specific to pesticide regulation under FIFRA, and so are
somewhat more detailed than what is required under a completed CSGWPP
as described in the 1992 Guidance. For example, under the Prevention
component of SMPs (c.f., section 2(g) of this Unit, below), specific
best management practices need to be listed and described for each
pesticide. To meet SMP requirements efficiently, a State can
extensively refer to portions of its CSGWPP, but the State also will
need to build on the basic policies and approaches of the Comprehensive
Program. Similarly, in the development of its CSGWPP, a State should
ensure that aspects relevant to pesticides management are consistent
with the requirements of an SMP. Because development of SMPs and
CSGWPPs will occur at the same time in most States, the development of
SMPs should not wait until a CSGWPP is completed. The Guidance on
Pesticides and Ground Water State Management Plans describes the
interrelationships of SMPs and CSGWPPs in greater detail (Ref. 18).
Several definitions of terms, applicable to this new subpart J, are
proposed, in the new 40 CFR 152.183. The term ``ground water reference
point'' (as discussed in Unit II.B. of this preamble) is defined for
purposes of specifying the contents of an approveable SMP, and is
consistent with the Agency's reference point policy. Two other terms
are defined simply to facilitate reference to frequently referred
concepts. The term ``Plan'' is defined as a shorthand term to refer to
the SMP which is the subject of subpart J. In addition, ``State''
itself is defined to mean not only the 50 States, but also Puerto Rico,
the District of Columbia, Guam and other territories and jurisdictions,
plus Indian lands. This last category will be discussed in more detail
below.
The proposed restriction itself is relatively simple and
straightforward: a pesticide or pesticide product that is classified in
this or a subsequent rulemaking may only be used in accordance with the
provisions and requirements of an Agency-approved SMP, as of a specific
date to be established by the rule. At that time, that pesticide or
pesticide product may not be sold or used within a State without an
Agency-approved Plan. These restrictions are the meaning of references
to a pesticide being ``under,''
[[Page 33266]]
``subject to,'' ``classified for,'' ``designated for,'' or ``listed
for'' SMPs.
The proposed ``restriction'' section (40 CFR 152.185) also contains
some requirements on the registrants to amend the labeling of the
products subject to SMPs, in order to notify users that use is now
subject to the conditions of an approved SMP. Labeling provisions will
be discussed in more detail in Unit III.G. of this preamble. Since the
direct effect of this rule would be to limit the sale and use of the
pesticide to States with approved SMPs, it would affect distribution
and sale of these pesticides. Thus, distribution and sale of the
pesticides subject to this rule with improper or obsolete labeling will
be prohibited after the effective date of the rule.
The ``restriction'' will entail a specific label statement, as
follows:
For use only in accordance with an EPA-approved State Management
Plan (SMP) for ground-water protection. Sale and use are prohibited
in States that do not have an EPA-approved State Management Plan.
This restriction would be effective 33 months after promulgation of
this proposed rule as final. This period is designed to allow States to
develop the Plans, EPA to review them, and registrants to change
labels. Comments on the proper time frame for the effective date of
SMPs are welcome; the Agency would especially value specific
explanations of any procedural or legal constraints that States face in
developing SMPs.
This restriction is a classification for restricted use pursuant to
FIFRA section 3(d), but the classification does not automatically
entail the restriction of use ``only by or under the supervision of a
certified applicator.'' Conventionally, ``restricted use'' has come to
mean exclusively this restriction to use by certified applicators, as
specified in the Act. This disregards the possibility of more flexible
meanings for ``other regulatory restrictions.'' Nonetheless, three of
the five pesticides being proposed for SMPs today are already
classified for restricted use in the conventional sense (one of which,
atrazine, is explicitly classified for ground-water contamination
concerns). Moreover, all five meet EPA's proposed criteria for
considering a pesticide for restricted use classification because of
ground-water concerns, as proposed May 13, 1991 (56 FR 22076).
Therefore, EPA is interested in receiving comment on whether the Agency
should simultaneously classify all of these pesticides for
``conventional'' restricted use due to ground-water concerns when it
determines that they require an SMP. Such a procedure would oblige EPA
to make a finding that the pesticide in question meets the criteria of
40 CFR 152.170, but such a finding could be made in this rulemaking for
SMPs, since the Agency has laid out in this proposed rule an analysis
of risks and benefits for these pesticides that could justify such a
determination. EPA believes that such findings would be facilitated by
the establishment of final ground-water restricted-use criteria.
The provisions, specifications, and requirements of these EPA-
required State Plans do not replace, but add to existing or future
national-level conditions of use, such as label directions for use,
restrictions or precautions. Unless specifically provided, either in a
final rule or in some action to amend a product's label, nothing in an
SMP will supersede a national-level condition of registration. States
may not supplant, override, or nullify a Federal label provision in
developing an SMP proposal, or in implementing an EPA-approved SMP.
B. Overview of Application Approval Process
Section 152.187 of the proposed new subpart J sets out the
procedures by which a State may submit, and EPA would approve, an SMP
for each of the five pesticides covered in today's proposed rule.
1. State submissions. While Sec. 152.187 provides that a State may
submit a proposed Plan at any time, Sec. 152.187 prohibits use of a
pesticide or pesticides in question in States without an EPA-approved
Plan after the effective date for the regulation. For practical
purposes, then, a State would need an approved SMP in place by the date
33 months after the promulgation of the final rule, the proposed
effective date of this regulation, in order that sale and use of the
pesticide(s) in question continue within the State's borders.
States that intend to develop SMPs for any or all of the five
pesticides in today's proposed rule will be required to submit proposed
Plans for official EPA review within 2 years of the promulgation date.
This would allow 9 months for EPA to review, consult and decide on
approval of the State's submittal, and for States to prepare the
implementation of the approved SMP on the effective date of the Federal
restriction. States submitting Plans later than 2 years after
promulgation of the rule would run a substantial risk that EPA will be
unable to perform its review, and approve the Plan before the effective
date of the regulation to enable the States to implement it at that
time. As noted above, EPA welcomes comments on the feasibility of this
proposed schedule.
In the interest of encouraging use of electronic information
technology, EPA is proposing to require States submit their SMPs
electronically (e.g., by disk) in an appropriate word processing
format.
EPA would encourage States to submit SMPs for these five pesticides
together, as a single package. While the SMP requirement imposed by
this proposed regulation would be a condition of registration for each
pesticide individually, EPA believes it is proper for States to combine
their SMP submittals, at least for the five pesticides subject to this
proposed rule. Combined submittals should be a resource savings for
both EPA and the States, since these five pesticides are similar in use
patterns and analytic methodologies. For practical purposes, large
portions of Plans for individual pesticides can be expected to be
substantially identical to each other (e.g., vulnerability assessments,
monitoring sites), beyond the shared ``generic'' elements like
philosophy and goals, legal authority, and resources. EPA would
evaluate the adequacy of such joint SMPs together, as a cohesive multi-
chemical Plan. However, EPA would retain the ability to selectively
approve or disapprove Plans for individual pesticides covered by such a
multi-chemical Plan, based on a judgement that the combined Plan is
inadequate in some respect.
2. EPA review, approval, or disapproval. EPA intends to be flexible
in its review of SMPs, recognizing that different approaches and
philosophies can obtain the same environmental results. States will
need to tailor prevention measures to local ground-water vulnerability,
current and future use and value of ground water, pesticide use and
agronomic characteristics and institutional characteristics. Appendix A
of the Guidance describes in greater detail the internal process,
including the general roles and responsibilities of EPA Headquarters
and Regional Offices.
While the regulation specifies that ``the Administrator'' will make
the determination whether a State submission is acceptable, it is the
Agency's intention to delegate this authority to the Regional
Administrator when the regulation is promulgated. The proposal as
drafted requires States to submit their Plans to the appropriate EPA
regional office. As the Guidance (Appendix A, p. 2-1) makes clear, EPA
believes the Regional Administrator is the proper official to make this
determination, given the proximity to the States and their particular
[[Page 33267]]
circumstances. In delegating approval authority to the Regional
Administrator, EPA anticipates that only a limited Agency Headquarters
role will be necessary. Headquarters will help assure overall national
consistency among Regions by providing a forum to, for example, air
issues which Regions believe may need additional clarification. It is
EPA's assumption that such consultation will be particularly helpful in
the beginning of SMP development and implementation; therefore, the
Agency has established a regular schedule of regional/HQ consultation
to facilitate regional review of initial Generic and pesticide-specific
SMPs. After promulgation of the rule, Headquarters will continue to
provide specific national policy guidance and technical assistance as
the regions require.
The Guidance, in Appendix A (Chapters 2-4), envisions a two-step
process for EPA review and approval or disapproval of proposed State
Plans. The first step, a completeness review, is to ensure that the
State has addressed all 12 components of an SMP, pursuant to the
requirements set forth in Sec. 152.190 of the proposed new subpart J.
The second step, content review, is a more thorough examination of the
SMP to determine whether it adequately addresses each of the 12
components of an SMP and therefore is likely to protect the ground-
water resource from pesticide contamination.
As expressed in Appendix A of the Guidance, EPA expects that during
the review and approval process there will be close and frequent
interaction between the regions and the States to reach a mutually
acceptable final Plan.
However, Sec. 152.187(d) of the proposed rule does provide for the
possibility of EPA disapproval of a State-submitted Plan. In content
this section parallels the procedure EPA is proposing to revoke
previously-approved SMPs (see Sec. 152.195, discussed in F., below and
Appendix A).
If the Regional review concludes that the State Plan is inadequate,
either in completeness or in content, the Regional Lead Office would
work with the State to address concerns before the effective date of
the SMP restriction to prevent interruption of sale and use of the
subject pesticide in the State. If the State fails to satisfy the
Agency's concerns, the sale and use of the pesticide would be
prohibited in the absence of EPA approval.
In the event the Region and State fail to reach agreement on an
SMP, the Regional Administrator will notify the State Liaison and the
officials directing the key State agencies in writing, indicating that
EPA will not approve the State's Plan in its present form. This letter
of notification will provide the State a last opportunity to satisfy
the Regional Administrator's concerns and/or persuade the Regional
Administrator that the State's proposal is adequate.
Even formal disapproval would not represent the end of a State's
opportunity to develop a Plan. Since proposed Sec. 152.187 provides
that States may submit an SMP for regional consideration ``at any
time,'' a State whose Plan or Plans have been disapproved would be free
to revise and re-submit the Plan at its discretion.
Whether the Regional Administrator approves or disapproves a
State's Plan, he or she will publish a formal notice of the decision in
the Federal Register. As proposed, notice of the final decision to
approve or disapprove is the only formal notice provided for by this
regulation. In proposing this rule, EPA considered, but decided
against, providing for formal public notice and opportunity for comment
on the Regional Administrator's review of each State Plan. In making
this decision, EPA in part relies on the requirement that the States
must provide for public participation in SMP development to obtain EPA
approval of such a Plan (see proposed Sec. 152.190(j) of the regulatory
text).
With this proposal, therefore, EPA states its belief that there is
sufficient evidence of unreasonable adverse effects on the environment,
within the meaning of FIFRA section 3(d)(1)(C)(ii), to warrant adoption
of SMP's as an additional regulatory restriction. The Agency's basis
for this proposed determination is set out in Unit IV. of this
preamble.
Today's proposal, if finalized, would establish that there may be
unreasonable adverse effects without the additional regulatory
restriction of an SMP. The question then remains as to whether the
particular Plan is adequate to prevent unreasonable adverse effects on
the environment, or whether it is overly restrictive, i.e. whether a
particular SMP adequately takes into account the social and
environmental costs and benefits of the use of the pesticide. The State
would consequently be able to develop and justify its SMP pursuant to
the unreasonable adverse effects standard, as well as against the
specific programmatic elements set out in this proposed rule.
EPA is also proposing procedures to assure adequate notice and
opportunity to comment on whether a particular SMP satisfies the
unreasonable adverse effects standard and the specific programmatic
elements. Thus, States would be required to provide notice and
opportunity to comment on these issues as part of its SMP
implementation procedures. The State would have to respond to any
comments and to justify its chosen approach in the administrative
record developed to support the SMP. In deciding whether to approve or
disapprove the SMP, EPA makes its final determination that unreasonable
adverse effects may be present without additional State measures,
relying on the record developed by the State during the SMP process, as
well as on the record of this initial rulemaking establishing the SMP
restriction.
3. Indian lands. It is EPA's intent in proposing this rule that no
geographic area be excluded from coverage by an EPA-approved SMP upon
the effective date of the regulation. To this end, Indian Tribal
authorities will have the opportunity to develop Tribal SMPs in the
event they wish to allow sale and use of these five pesticides on
Indian lands under their jurisdiction. A few Indian lands have already
received Federal financial assistance through FIFRA program grants to
develop Generic SMPs. Indian tribes preparing SMPs would be subject to
the same procedures and requirements that are described here for
States.
However, Indian tribal authorities will not be required to develop
Plans if they have no interest in allowing sale and use of the five
pesticides within their jurisdiction. Furthermore, Indian tribal
authorities that are interested in preserving sale and use of any of
these five pesticides within their jurisdictions, but believe they are
not able to commit the resources required to develop or implement a
Plan, might be able to reach an agreement with an adjoining State
authority to extend coverage of the State Plan to the Tribal lands.
Such an agreement would have to be submitted to the pertinent EPA
Regional Office for review.
C. Plan Requirements
An EPA-approved SMP will consist of 12 specific components, each
developed in sufficient detail and scope to demonstrate the adequacy of
the Plan. ``Adequacy,'' as generally used here and in the regulatory
text, means that the content of, or commitment contained in, each
component demonstrates that the general objective in establishing an
SMP is met: preventing ground-water contamination by the pesticide or
pesticides subject to this proposed rule, that may present adverse
effects to human health and the environment. This entails an evaluation
of the
[[Page 33268]]
adequacy of the State's proposal. A State's submission will not be
satisfactory if it only provides a ``description'' of a provision,
without regard to whether the provision represents adequate groundwater
protection. Provisions cannot be merely ``adequately'' described; they
must provide for successful implementation of ground-water protection.
A Regional Administrator could disapprove a Plan on the basis of
finding one or more of the components submitted will not fulfill the
general objective for which EPA decided to make the pesticide subject
to SMPs in the first place: the provision of State management measures
that will prevent unreasonable adverse effects and protect the
environmental integrity of the State's ground water.
Each State Plan, for each pesticide proposed for SMPs, must address
each of the 12 components. These components are being proposed under
the new 40 CFR 152.190. The proposed requirement that an acceptable SMP
contain 12 components still gives a State a large degree of flexibility
in managing the use of the pesticides subject to SMPs. While all 12 of
these components will need to be discussed in an SMP, States will be
allowed a substantial range of flexibility in the form and manner by
which they propose to perform the functions contained in each
component. This variability will reflect differences in State ground-
water protection philosophies and regulatory approaches. Further, the
Agency anticipates that the contents of State Plans will vary in
extensiveness and detail according to the potential magnitude of the
ground-water contamination threat. The Agency expects that in low-risk
circumstances (e.g., a State in which a subject pesticide is not
currently used, or in which use is limited to areas with a minimal risk
of contamination), an acceptable SMP may need to be little more than an
augmentation to a ``Generic'' SMP, showing how the State would move to
a greater level of effort in the event the original low-risk
circumstances change, or new evidence warrants. The Agency does not
intend that a State will necessarily impose regulatory restrictions on
every area of use or specific crop use pattern within a State involving
a subject pesticide; if there is an appropriate basis for determining
that an area or use site does not pose a significant risk of ground
water contamination, the State's SMP might not require any change in
user practices from the current Federal label. However, a State
proposing such a position in its SMP would have to provide a reasoned
basis for its conclusion that the risk of ground-water contamination
for a particular geographic area or use site is such that further
restriction is not required. EPA is prepared to accept this manner of
variation among State plans; indeed, the need for this flexibility is
the foundation of the entire SMP approach.
As a general matter, EPA Regional Administrators will evaluate each
component individually and as each complements the other components. In
many cases, the adequacy of a particular component's contents will
depend in a material way on the contents of another component. Again,
this approach is expected to give States a great deal of flexibility. A
good example of this is the interrelationship between the
``monitoring,'' ``assessment,'' ``prevention'' and ``response''
components. States may differ in judging the relative efficacy of
assessment methods for estimating the sensitivity of aquifers to
contamination, versus ground-water monitoring. As a result, one State
could put little emphasis on the assessment efforts, but compensate by
placing a more substantial emphasis on monitoring. Another State could
choose the opposite. Either approach could very well prove to be
adequate. Still another State might view relying on either or both as
deficient, and choose to emphasize prevention by imposing more
stringent use-management measures more routinely. However, a State Plan
that committed to a minimal effort in all three spheres could well be
found to be inadequate. These interrelationships are discussed in more
detail under the specific component headings in the Guidance. Thus,
each Regional Administrator will be evaluating each component on its
own merits, but also how all of the individual components work together
to fulfill the ultimate objective of protecting ground water.
Furthermore, the Agency recognizes that certain elements of SMPs,
particularly the vulnerability assessment and monitoring components
(described below), entail extensive technical activities and
substantial long-term resource commitments. One purpose in promoting
the development of ``Generic'' SMPs is to provide for a head start in
developing such technical capacity. However, the Agency does not expect
that an acceptable SMP must in every instance have such components
fully developed and in place at the time the State Plan is approved.
Rather, an acceptable SMP may be at times one that provides an
adequate, credible commitment and action plan to phase in such
components in order to meet the State's ground-water protection goal
specified in their SMP. Failure by the State to meet the commitments
made in the SMP would result in EPA reconsidering the original decision
to approve the SMP.
The Guidance, in chapter 3, describes EPA's expectations as to what
an adequate State submission will entail. As a general rule, EPA will
apply the criteria set forth in the Guidance in determining the
adequacy of individual State plans. Obviously, guidance criteria are
not intended to be as rigid as requirements established in regulations.
However, a Plan is more likely to be acceptable if it conforms as much
as possible to the provisions of chapter 3 of the Guidance. A State
submission that fails to meet these criteria risks disapproval.
The Agency notes that, since State Management Plans are a new and
evolving regulatory mechanism, the guidance for implementing Plans will
also evolve. Thus, the Agency is likely to issue further clarifications
to the Guidance as issues are raised by Regional Offices and States.
For example, the comments that EPA receives in response to this
proposed rule may be an important source for identifying such issues.
The following sections briefly describe each of the 12 mandatory
components of an adequate State Management Plan being proposed in
Sec. 152.190.
1. State's philosophy and goals toward protecting ground water.
Proposed Sec. 152.190(a) would require that a Plan describe the State's
philosophy and goals for protecting ground water. An acceptable plan
must demonstrate that the State's goals and objectives are no less
protective than EPA's goal of preventing unreasonable adverse effects
to human health and the environment and to protect the environmental
integrity of the nation's ground-water resources.
EPA's strategic approach emphasizes the prevention of contamination
over remedial treatment. Further, it focuses priorities on sources of
drinking water currently used, or reasonably expected to be, and ground
water that is closely hydrologically connected to surface waters. While
a State's goal must be no less protective than the Agency's, States
will be free under the regulation as proposed to articulate its ground-
water protection philosophy and goals in alternative form and language.
In any case, a State submission, to be judged adequate, must include a
statement that addresses both the ground waters to be
[[Page 33269]]
protected and the degree of protection to be achieved under the SMP.
2. Roles and responsibilities of State Agencies. State efforts to
implement the Strategy will, out of necessity, require extensive
coordination among State health, environment, agriculture, and water
agencies. The SMP must include a description of the roles and
responsibilities and coordination mechanisms of involved State
agencies. For an SMP to be found adequate by EPA, it must satisfy six
general provisions set forth in proposed Sec. 152.190(b). For a further
description of what these provisions entail, refer to pages 3-4 and 3-5
of the Guidance.
3. Legal authority. A State's ability to carry out prevention and
response actions for pesticides in ground water is dependent on its
legal authority to regulate pesticide use and protect ground water, to
be provided pursuant to the provisions of proposed Sec. 152.190(c).
Regulatory authorities must be sufficient to accomplish the desired
outcomes of the SMP. EPA will consider this component in parallel with
the provisions of proposed Sec. 152.190(i) on enforcement mechanisms.
Descriptions of enforcement authorities provided in this component
should be cross-referenced to that component as well. One suggestion is
that the State provide a graphic ``crosswalk'' of legal, regulatory and
enforcement authorities (e.g., a side-by-side comparison of SMP
requirements as described in proposed Sec. 152.190, and corresponding
State authorities for implementing each requirement, modelled after
what is currently provided for in the Public Water System program [40
CFR part 142.12(c)].
Under Sec. 152.190(c), a State's plan must identify the specific
legal authorities to be used in implementing the plan, to ensure that
the State's submission is legally enforceable. Presently there is no
provision that the State's chief legal officer be required to examine
the submission, and be satisfied that the appropriate provisions of the
plan are legally enforceable under State law. Several other EPA
programs require a certification from the State Attorney General (or a
designee) to ensure that there is sufficient legal authority to enforce
provisions of the program. This approach provides further assurance
that all of a State's rulemaking procedures have been followed, and
that, as a result, the SMP is enforceable under State law. Such a step
should reduce the likelihood that a legal challenge to the rule will
not be sustained, and should entail a small resource requirement on the
State. EPA is soliciting comment on whether the Agency should also
require in the final rule that the State's submittal include such a
certification.
4. Resources. A State's ability to carry out the commitments
delineated in its SMP depends on the resources available to implement
the program. Resources include technical expertise and personnel,
physical and operational capabilities, and funding. Proposed
Sec. 152.190(d) requires that the SMP demonstrate that the necessary
expertise is available and that there is an adequate match between
revenues and proposed expenditures. This demonstration must:
i. Indicate what categories of personnel or technical expertise are
necessary and available for implementation of the Plan.
ii. Include an estimate of the costs, both physical and
operational, to develop and implement each element of the Plan.
iii. Disclose the current funding available for implementation of
the program, existing and potential funding sources for the future, and
a commitment to pursue additional funding if needed.
EPA will only be evaluating the adequacy of the resources specified
in determining the adequacy of the overall Plan, and will not be
judging the manner in which the State provides for those resources.
However, EPA strongly encourages States to develop innovative means to
finance and implement SMPs, such as user and/or sales fees, in order to
reduce the burden on a State's general revenues. EPA will also explore
ways of helping to shift some of the financial burden of implementing
SMPs from the States to registrants, for example, in providing for
concurrent National ground-water monitoring requirements.
5. Basis for assessment and planning. One of the fundamental
principles in the Strategy is the tailoring of protection activities to
the unique hydrogeologic settings, pesticide usage patterns, and
agronomic practices of each State. The effectiveness of protection
activities depends to a large extent on the degree to which vulnerable
areas in need of protection can be accurately identified. Therefore,
States must have an ongoing program that provides basic information on
the occurrence, movement, and quality of ground water in relation to
patterns of pesticide use. State Agencies of environment, water,
agriculture, and health must all have the opportunity for input into
this program. Pages 3-7 and 3-8 of the Guidance (supplemented by
chapter 3 of the Guidance's Appendix B) describe in further detail the
function and activities embodied by the term, ``assessment and
planning.''
The component prescribed by the proposed Sec. 152.190(e) is, for
practical purposes, a description of the process by which a State will
set priorities for prevention and response actions. In this component,
the State will describe how it will assess ground-water vulnerability,
use and value and how that assessment will be used: (a) To set
priorities for protection activities; (b) to design and implement
prevention and response measures; and (c) to determine the
effectiveness of these measures and of the implementation of the
overall Plan. An adequate SMP for these five pesticides must include a
description of how the State will address vulnerability assessment on a
sub-county level for the geographic area in which the State intends to
allow continued use of the pesticides. EPA considers this level of
geographic detail necessary in ground-water vulnerability assessment
because it is generally held that current methods of vulnerability
assessment are generally not capable of
FR Doc. 96-16173 Pesticides and Ground Water State Management Plan Regulation
predicting the vulnerability of
broader geographic areas, such as counties. It is widely held that the
hydrogeologic factors which influence the sensitivity of particular
ground waters vary within areas smaller than typical American counties.
Distinguishing areas of different ground-water sensitivity must involve
``sub-county'' geographic units (see the Guidance and its Appendix B
for further discussion of the basis for these opinions). It is also
generally accepted that such assessments will entail a substantial
level of effort. There is no standard definition of what the size or
dimensions of a ``sub-county'' unit might be, other than the general
observation that it is an area that is relatively homogenous with
respect to the hydrogeologic characteristics that influence ground-
water sensitivity.
While an adequate SMP must discuss what the State's approach to
vulnerability assessment at the sub-county level will be, it must also
discuss the limitations of its assessment techniques and how these
limitations are taken into account in the design of prevention and
response programs (see g. and h., below). For example, a State could
describe in its submission for this component that it does not or
cannot currently perform adequate vulnerability assessments to the
desired level of detail, but then explain how the State will impose
more restrictive pesticide use practices across a wider geographic area
(e.g., an entire county where a pesticide might be used) so as to
protect the most vulnerable ground waters within that area. In other
words, if a State applies prevention measures
[[Page 33270]]
on broad regional or county-level designations, then sub-county level
assessments may not be needed. However, the State should explain why
the measures chosen are likely to be adequate to meet program goals.
Conversely, if a State plan allows sub-county or farm-level
distinctions in applying prevention measures, it should explain the
basis for making such distinctions, and how protection goals will be
met. EPA's expectations as to the adequacy of this component are
further discussed in pages 3-8 through 3-10 of the Guidance.
6. Monitoring. Broadly defined, ``ground-water monitoring'' is the
set of activities that provides chemical, physical, geological,
biological, and other environmental data needed by environmental
managers/decision-makers to assist in developing and implementing
ground-water protection policies and programs. Ground-water monitoring
is viewed as a continuum of activities ranging from defining background
conditions, to defining the existence and extent of contamination, to
defining the success of prevention and response measures and programs
to protect the ground-water resource. The Guidance (in pages 3-10 to 3-
11 and in Chapter 5 of Appendix B) discusses in further detail the
dimensions of ground-water monitoring activities and their various
functions in programs aimed at preventing pesticidal contamination of
ground water.
An adequate SMP must describe the State's monitoring program for
pesticides, the uses to which monitoring will be applied, and the
parties responsible for various functions associated with monitoring. A
current, approved State Quality Assurance Project Plan (QAPP), as
described in chapter 5.4.2 of the Guidance's Appendix B, is a
prerequisite for approval of an SMP. The provisions of such a plan will
apply to data collected by the State as well as to any data collected
by some other party on behalf of the State, for the purposes of
performing the State's monitoring component. Such a quality assurance
plan will provide sufficient assurance of the integrity of the data so
as to preclude the applicability of the Agency's Good Laboratory
Practices (GLP) regulations (40 CFR part 160). However, certain
conceivable data collection activities (e.g., monitoring studies
required by EPA as an adjunct to State monitoring, described in the
next paragraph) could be subject to GLP Standards. The distinction
would lie in: (1) Whether the monitoring activity is described in,
referred to, or otherwise pursuant to, the monitoring component of the
approved SMP; and (2) whether the monitoring activity directly relates
to the maintenance of the Federal registration of the pesticide. For
example, monitoring activities performed by a third party (e.g., a
university) under the authority of the State's monitoring plan would be
subject to QAPP provisions. Registrant monitoring directed by the State
would similarly be subject to the State's QAPP. However, registrant
monitoring performed either at EPA's behest or performed on the
registrant's own initiative (but without State mandate or not at the
State's behest) would be subject to EPA's GLP standards.
The essential criteria to determine the adequacy of the monitoring
component of a State Plan are whether the State's monitoring effort is
appropriate to achieve the purposes of the Plan, and whether the level,
quality and extent of specific monitoring efforts provide a reasonable
likelihood that contamination representing an unreasonable risk to the
environment will not go undetected. As discussed earlier, the judgement
of the adequacy of a monitoring component must be made in consideration
of the stated goal of the Plan, and the contents and design of its
constituent assessment and protection components. Further discussion of
EPA's expectation of what constitutes an adequate monitoring component
can be found in the Guidance (pages 3-11 through 3-13).
EPA assumes that monitoring activities will represent a significant
portion of a State's resource investment in implementing its SMPs.
Based on past State experience, EPA estimates in its Regulatory Impact
Analysis for this proposed rule (see Unit V. of this preamble) that
ground-water monitoring activities by themselves may constitute between
10 to 14 percent of the annualized State program costs. Furthermore,
the costs of performing ground-water monitoring can be expected to vary
widely across the country, inasmuch as the States are starting from
different points in the degree of current monitoring. To help alleviate
this resource requirement on the States, EPA is considering development
of national-level requirements (pursuant to its data-call-in
authorities under FIFRA section 3(c)(2)(B)) for additional ground-water
monitoring from the registrants of these five pesticides. Such
concurrent data-gathering requirements would be developed with
reference to submitted State Plans, so that the ultimate requirement on
the registrants would not be unduly burdensome and would be tailored to
the strengths and weaknesses of actual SMPs. Such a requirement would
also be designed to provide States the opportunity to review and
comment on Federal specifications to the registrants, to ensure harmony
with State intentions.
7. Prevention actions. The emphasis of EPA's Pesticides and Ground-
Water Strategy is on prevention, and the core of an acceptable SMP will
be its program of managing particular pesticide use in order to prevent
contamination. Preventive management approaches may vary based on
ground-water vulnerability and ground-water use and value, as well as
social and economic factors. The actual measures employed may range
from education of users, voluntary or mandatory best management
practices, such as changes in application rates, methods and timing,
all the way to use prohibitions in specific areas. As noted above, the
Agency does not necessarily expect that SMPs will impose new
restrictions on every use site or geographic area in which a pesticide
is used in a State; if there is a reasonable basis for determining that
risks for particular use sites or areas are not unreasonable, then
little or no change from current label requirements may be needed.
Prevention measures may overlap with response measures at the point
that pesticide contamination of ground water is detected. For example,
when pesticides are detected, preventive actions can still be pursued
to prevent further contamination. States may choose to combine their
prevention and response discussions because of this overlap.
Appendix B: Assessment, Prevention, Monitoring, and Response
Components of Pesticides State Management Plans of the Guidance
identifies ground-water protection practices and methods for
implementing prevention efforts that States may consider in the
development of their prevention component. The methods described there
are not considered an exclusive list of available options. The Agency
fully expects some States to develop innovative measures to achieve
their ground-water protection goals.
Because of the wide variety of possible approaches a State might
adopt to fit a wide variety of local circumstances, proposed
Sec. 152.190(g) is worded very generally in order not to restrict the
States' flexibility. While EPA is proposing that the rule provide for
maximum flexibility in State program design, it acknowledges that other
approaches are feasible. In recognition of this fact, EPA elsewhere in
this preamble (see section D of this Unit) is requesting public comment
on
[[Page 33271]]
alternative approaches to prevention program requirements.
The relation of these prevention programs to other risk-management
measures will be an important consideration for the States in the
development of SMPs. These SMPs are required to address the ground-
water contamination potential of the five pesticides subject to today's
rule. It happens, however, that these pesticides also represent a well-
documented risk of surface water contamination, at least in some of
their use-areas (see, for example, ``Triazines Water Resources Impact
Analysis'' (Ref. 19)). Thus, an acceptable Plan for these pesticides
must include consideration of whether specific measures employed by a
State to protect ground water might elevate risks to surface water. For
example, a Plan which would change a tillage practice to reduce
pesticide infiltration of ground water may in some instances increase
runoff to surface water. EPA therefore strongly encourages States to
implement measures to protect surface water from pesticide
contamination that is likely to impair water quality. Specifically,
States should coordinate the development of preventive measures with
measures under existing EPA programs, such as the Nonpoint Source,
Coastal Zone Management, Wellhead Protection, and Comprehensive State
Ground Water Protection Programs. Measures must also be coordinated
with the USDA Soil Conservation Service's Compliance Conservation
Plans.
As discussed in Unit IV.B. of this preamble, adverse ecological
effects associated with these compounds are a concern, and a reason for
proposing the compounds for SMPs. Because the ability to identify
ground-water discharge to surface water is limited by resources and the
current state of scientific knowledge, EPA will not disapprove out of
hand any proposed State Plan that fails to specifically address ground
water supporting surface water ecosystems in either the ``basis for
assessment and planning,'' ``monitoring,'' ``prevention,'' or
``response'' components. However, States that are aware of specific
bodies of water that receive a large percentage of their recharge from
ground water are strongly encouraged to attempt to take this fact into
account in designing the above components of their Plans. As in
evaluating the adequacy of any and all the elements of State proposals,
reviewing EPA regional offices will evaluate the adequacy of State
measures to address such ``closely hydrologically connected'' ground
waters on the basis of its own and the State's assessment of the
State's vulnerability in this respect.
Similarly, if a State expects that a risk reduction measure will
lead users to use alternative chemicals, then EPA encourages the State
to consider whether the alternative chemicals will cause adverse
effects to ground water, surface water, other areas of the environment,
or other types of risk, such as risks to pesticide applicators. In
other words, the State, in its Plan, should provide a reasonable
assurance that the preventive measures it proposes to protect ground
water are not likely to result in unreasonable adverse effects
elsewhere in the environment as a consequence.
8. Response to detections of pesticides. This component will
describe how the State plans to respond to contamination to ensure that
reference points (MCLs, HAs, or State quality standards) will not be
reached in ground water, and what actions the State will take in the
event that the reference points are reached or exceeded. Response
measures should be based on the State's ground-water philosophy and the
assessment and monitoring components. Further, this component is
closely tied to the requirements concerning prevention, which specify
that an SMP must describe actions that the State will take initially in
the absence of actual detection and those it will implement if the plan
appears to be failing to protect ground water. SMPs should describe how
the appropriate State agencies will be brought into remedial actions.
Response actions, such as increasing implementation of best
management practices, and use restrictions or prohibitions, are the
focus of this component, rather than remediation activities. Since
FIFRA provides limited means for responding to contamination, however,
States should increase efforts to coordinate enforcement and other
response activities under a number of other Federal/State authorities.
In addition, as in proposed Sec. 152.190(g), States should coordinate
response measures with measures under existing EPA programs, such as
Nonpoint Source, Coastal Zone Management, Wellhead Protection, and
Comprehensive State Ground Water Protection Programs. Appendix B of the
Guidance presents a framework for assessing and responding to ground-
water contamination by pesticides as well as suggested response
alternatives. Again, EPA does not regard the Guidance as providing an
exclusive list of options, since new information becomes available on a
routine basis. For example, EPA is developing new guidance accompanying
its new Hazardous Waste Identification Rule, defining ``best management
practices'' (BMPs) for the treatment of contaminated media at
remediation sites, in order to reduce the potential for cross-media
contamination. Such ``BMP Guidance'' will help States reduce the
possibility of incidental contamination of ground water at remediation
sites. A review draft guidance document has been available since April
1996.
9. Enforcement mechanisms. To meet this requirement, the Plan must
describe the State's enforcement capabilities, authorities, and
compliance activities (e.g., inspections, technical support, penalty
provision, etc.), if not already described pursuant to proposed
Sec. 152.190(c). The SMP also needs to identify the State agency with
each enforcement authority and how coordination of enforcement
capabilities will work to prevent and respond to contamination.
In addition, a Pesticide Plan must discuss the State's enforcement
authorities and capabilities to monitor compliance with the specific
measures included in the SMP, both those intended to protect ground
water from contamination and response actions where contamination has
already occurred. Further discussion of enforcement requirements can be
found on pages 3-18 to 3-19 of the Guidance.
10. Public awareness and participation. Most government activities
are subject to citizen involvement and review. An acceptable Plan must
demonstrate that the public has opportunity to be involved in the
process of Plan development and will be informed of significant Plan
implementation activities. The Plan must address three different
aspects of necessary public awareness and participation. The Plan must:
i. Describe the opportunities for public input regarding
development of the Plan and decision-making in implementing it.
ii. Indicate how, when, and by whom the public will be informed of
detections in ground water that are considered significant.
iii. Include a description of the process and means of
communication by which the public will be made aware of important
regulatory actions taken under the SMP. More discussion of public
participation issues can be found on pages 3-19 to 3-20 of the
Guidance. However, as discussed earlier in this unit, EPA expects that
in fulfilling the first requirement, a State will at a minimum provide
notice and opportunity to comment on whether the SMP under development
satisfies the criteria for SMPs proposed in this rule,
[[Page 33272]]
including an opportunity to assess costs and benefits under the
proposed SMP.
11. Information dissemination. The user is responsible for directly
controlling the use of pesticides in the field. Therefore, an important
part of any SMP must be the means by which ground-water protection
measures and other Plan requirements are communicated to pesticide
users as well as to appropriate industry groups and regulatory
officials (proposed Sec. 152.190(k)). Further discussion of this
requirement is provided in the Guidance (pages 3-20 to 3-21).
12. Records and reporting. Documentation of a State's program not
only serves as a source of data to share with EPA and other involved
Federal and State agencies, but also provides a basis on which to
assess the effectiveness of a State's prevention and response measures.
An adequate SMP discussion of records and reporting will identify both
management measures relating to the State's progress in implementing
the Plan and environmental indicators of the effectiveness of the
program. The Guidance provides a fuller description of the reporting
requirements established by the new Subsection (l), particularly the
key ``Biennial Report'' (pages 3-21 to 3-24). In addition, Chapter 5 of
the Guidance's Appendix A provides a fuller discussion of the Biennial
Report requirements pursuant to the provisions of this proposed rule
for evaluation of EPA-approved Plans.
D. Evaluation of State Management Plan Implementation
Once in place, SMPs are a permanent condition of registration for
the pesticide, for as long as the pesticide remains registered.
Proposed Sec. 152.191 of the new subpart J provides for EPA evaluation
of State implementation of their Plans. Periodic evaluations of the
implementation of SMPs will measure the State's progress towards its
goals and commitments, determine the environmental effectiveness and
the level of ground-water protection provided by the Plan, and ensure a
minimum level of national consistency.
EPA will use the SMP Biennial Report required in proposed
Sec. 152.190(l)(2) to evaluate a State's effectiveness in protecting
its ground-water resources from pesticide contamination. Both the
general provisions for EPA's evaluation of approved SMPs and the
Agency's expectations about the form and content of the Biennial
Reports are described in greater detail in Chapter 5 of Appendix A of
the Guidance. In specifying an evaluation requirement, EPA recognizes
that States have a variety of evaluation methodologies and measures at
their disposal.
E. Amendment of State Management Plans
Once in place, State Management Plans will have considerable built-
in flexibility, in order to respond to a variety of circumstances. For
instance, the response component entails a range of options for
responding to contingencies triggered by pesticide detections in ground
water; new information about pesticide usage patterns; and new
information on ground-water vulnerability, use and value. Consequently,
Plans will probably not need frequent revision and update. If the range
of options in a given Plan turns out not to meet the State's needs,
however, States may need to modify and update plans. States should
consider revising SMPs:
If EPA's periodic evaluation of the SMP determines that
the provisions in a State's SMP are not adequately protecting the
ground-water resource from pesticide contamination.
If the statutory or regulatory framework for SMP
development and implementation changes.
If more comprehensive ground-water vulnerability
assessments, additional monitoring methods, improved prevention
technologies or new information concerning the risks posed by a
pesticide become available and need to be accommodated in order to make
the Plan more effective.
If a State, through experience, finds substantially
different, more effective ways to assess ground-water contamination,
prevent or respond to contamination, or disseminate information.
If changes in crops or crop production systems within the
State are significant enough to require different pesticide management
measures in order to manage risks to ground water.
If roles and responsibilities of State agencies materially
change.
Section 152.193 provides for the modification and update of SMPs
under these circumstances.
Ordinarily, a State will submit needed amendments as part of the
SMP Biennial Report. In an urgent case, a State may appeal for revision
outside the biennial review process to the Regional Administrator. In
addition, if the Regional Lead Office determines through the evaluation
process that the SMP needs to be amended, then the Regional
Administrator can initiate the amendment process by requesting that the
State submit an SMP Update Report. Chapter 6 of the Guidance's Appendix
A describes the process EPA envisions for the modification and update
of approved SMPs.
F. Withdrawal of Approval of a State Management Plan
Section 152.195 of the proposed regulatory text provides for EPA
withdrawal of its approval of existing State Plans under certain
circumstances. Withdrawal of approval can begin when:
The State fails to demonstrate that it is satisfactorily
implementing the SMP as approved.
The State's SMP is not protecting ground water from
contamination above the ground-water reference point.
The State fails to address deficiencies identified in the
SMP Evaluation (per proposed Sec. 152.191), by updating the SMP (per
proposed Sec. 152.193) and/or improving implementation of the SMP.
EPA envisions such revocation of a State's Plan to be generally a
last resort. Before the withdrawal process commences, the State will
have the opportunity to respond to EPA-identified deficiencies in its
Pesticide SMPs through the SMP amendment process or by demonstrating to
the Agency that the SMP is being satisfactorily implemented. Regions
will work closely with individual State agencies or the State Liaison
to assist the State in updating the plan or in addressing deficiencies
or gaps in protection.
Withdrawal of approval of an SMP (as discussed in greater detail in
the Guidance's Appendix A, Chapter 7) is a multi-step process. EPA
would commence the withdrawal process by issuing a formal letter from
the Regional Administrator (acting for the Administrator) to State
officials responsible for implementing the Plan. The notice will
include:
A statement concerning the potential withdrawal of the
SMP.
A listing of the deficiencies of the SMP or a description
of the failure of the Pesticide SMP to protect ground water.
A brief summary of the events that led to the withdrawal
notice, e.g., failure to respond to SMP's deficiencies in the Biennial
Report and failure to update the SMP adequately.
A time frame in which the State can respond to the
deficiencies to stop the withdrawal process e.g., time frames for
submitting an SMP Update Report, for improving implementation of the
plan.
In the event this letter fails to elicit a satisfactory State
response, EPA's next step is a second notice, announcing imminent
publication of a Federal Register notice withdrawing EPA's
[[Page 33273]]
approval of the SMP. In the event this second letter does not elicit a
satisfactory resolution, the final step is publication of a Notice of
Withdrawal in the Federal Register. This withdrawal of EPA's approval
will have the effect of prohibiting the sale and use of the pesticide
in the State. Chapter 7 of the Guidance's Appendix A has a further
description of the Agency and State roles and responsibilities in this
process.
Proposed Sec. 152.195 provides the State the opportunity to respond
to EPA's initial decision to withdraw approval in at least two
different ways. The State may respond in writing to the notice with a
commitment to address the deficiencies in the SMP itself or in SMP
implementation. In this case, the State must respond to the initial
notice within 30 days of receiving it. However, the State may choose to
appeal the EPA decision to initiate withdrawal. In that event, the
State may request a meeting with the Regional Administrator (who will
be the deciding official in these instances); that request must be made
within 60 calendar days of the date of the initial notice. If the State
does not respond to the initial notice within either of these time
frames, or consultations pursuant to the initial notice fail to resolve
EPA's concerns, the Region will take the next step of sending a second
letter, and ultimately, of publishing a Federal Register notice.
In some instances EPA may find an SMP (or its implementation) is so
deficient that further sale and use under its provisions would
constitute an unreasonable risk to the environment. If so, the Regional
Administrator may also prohibit sale and use of the pesticide during
the withdrawal process if, in his or her judgement, continued use of
the pesticide in the State under the conditions of the deficient SMP
presents an unreasonable risk to human health or the environment. In
this event, EPA would propose a temporary prohibition in a Federal
Register notice, in addition to the letters to the States described
above. This notice would explain the Regional Administrator's judgement
that unreasonable risks to the environment may be present during the
time required for correcting the deficiencies in the State's Plan, and
solicit public comment on the impending prohibition. This Federal
Register notice could be published simultaneously with the initial
letter to the State, or at any time after that initial letter, in the
event the Regional Administrator found an unreasonable risk to the
environment was impending. After addressing any public comment, the
Regional Administrator would implement the temporary prohibition. The
prohibition of sale and use would remain in effect until the State and
EPA reach agreement on how to address the SMP's deficiencies.
G. Label Changes
This regulation requires a change to the label of any pesticide
subject to an SMP, so that users will be aware of their responsibility
to use a product in accordance with the provisions and restrictions of
an EPA-approved SMP. All products subject to an SMP must bear the
following statement describing the SMP restriction itself:
For use only in accordance with an EPA-approved State Management
Plan (SMP) for ground-water protection. Sale and use are prohibited
in States that do not have an EPA-approved State Management Plan.
Each State Plan will provide for other means, separate from the product
label, to disseminate to pesticide users specific additional
provisions, management measures and geographic restrictions. These
State-specific information dissemination measures are intrinsic to the
SMP in accordance with Sec. 152.190(k) described above. However,
additional information may be placed elsewhere on the label in order to
direct users to appropriate State sources for more information, or to
describe in more detail SMP requirements. Such information will not
appear in the Restricted Use area of the front label, but preferably
within the Directions for Use portion of the label.
In Sec. 152.185(b) of the new subpart J, EPA proposes that
registrants adhere to the same provisions for label changes,
distribution and sale and advertising as apply to pesticides classified
for conventional restricted use. In addition, registrants of pesticides
classified for SMPs need to submit proposed labels specifying the SMP
classification within 3 months of the effective date of the SMP
provision.
An amended label containing the narrative restriction specified in
this proposed rule must be submitted by each registrant of a product
classified by this proposed rule to be subject to SMPs within 12 months
of the publication of the final rule; and the amended label must be
affixed to all products subject to this classification on the effective
date for the rule.
EPA is proposing in this document to reorganize part 156, the
regulation specifying labeling requirements for pesticides and devices.
Part 156 is now organized so that paragraphs (a) through (j) of
Sec. 156.10 each describe one of nine specific components of a
pesticide product label. EPA proposes that the last two paragraphs of
Sec. 156.10 become a separate subpart. EPA regards these as
particularly important components. Specifically, the Agency is
proposing to amend part 156: (1) By creating a new subpart G to
encompass the existing paragraphs (i) and (j) of Sec. 156.10; (2)
redesignating paragraph (i) as two new sections, Sec. Sec. 156.120 and
156.121, within this new subpart G; and (3) creating new Sec. Sec.
156.135, 156.136 and 156.137 within this subpart G (from the previous
paragraph (j)) to describe labeling pertaining to use classification,
including both conventional restricted use to certified applicators and
restriction to use under approved SMPs. The new label statement to
accompany a product classified for SMPs is specified in the new
proposed Sec. 156.137(c)(2). As proposed, the SMP statement would
appear under the ``Classification'' heading, because legally, an SMP is
a form of classification pursuant to the ``other regulatory
restrictions'' authority in FIFRA section 3(d).
H. Request for Comments
EPA is interested in receiving comments on all aspects of its
proposed 40 CFR part 152 subpart J. For instance, is the effective date
of 33 months after promulgation of the rule appropriate? Does it permit
sufficient time for registrants to make the necessary label changes?
Does it permit States sufficient time to develop Plans and EPA to
review them before the restriction is effective? Does the proposed
development, review and approval process provide sufficient public
opportunity to comment on the contents of the Plan before its approval
and implementation as a regulatory restriction? Has EPA properly
specified the criteria which State Plans must meet? Has EPA provided
sufficient mechanisms for appealing decisions to approve or disapprove
Plans, and for evaluating, amending, and revoking Plans? Is two years a
sufficient interval for EPA to require States to report on their
implementation of SMPs? What further measures could be employed to
encourage States to prepare Plans for pesticides with minor uses within
their boundaries, so as to provide for their appropriate continued use?
Should EPA concurrently develop National datagathering requirements to
be applied to the registrants of the pesticides subject to SMPs, with
the intent of easing States' ground-water monitoring burdens? If so,
how should the Agency design such a requirement, i.e., balancing
between helping the States with their monitoring efforts and not
infringing on States' flexibility and
[[Page 33274]]
power to prescribe its own monitoring regimen? What further national-
level resources (e.g., technical assistance from the USDA's Natural
Resources Conservation Service) should be anticipated for supporting
development of State Plans? Should EPA classify a pesticide for
``conventional'' restricted use classification at the same time it
determines the pesticide must be subject to SMPs, in this or a
subsequent rule? Should EPA propose a new form of labeling for
pesticides classified for SMPs, to distinguish those pesticides from
pesticides classified as ``conventional'' restricted use?
In addition to comments on issues like those described above, the
Agency is interested in receiving comments on alternative approaches to
the specification of State prevention-program components. Within the
general framework of the SMP approach, there are many ways to specify
how States will perform the duties of protecting ground water from
contamination by pesticides. The approach being proposed today is in
conformance with the previously published Guidance, which remains the
Agency's preferred approach. EPA believes the approach developed in the
Guidance provides for maximum flexibility in developing the means of
ground-water protection, within the broad determination by the Agency
that these pesticides warrant additional regulatory restriction. This
flexibility, in turn, maximizes the opportunities for State initiative
and effectiveness in tailoring its ground-water protection efforts.
At the same time, the balance between national consistency and
State flexibility may be struck in numerous other ways, while still
maintaining a fundamental partnership between EPA and the States. The
Agency is pecifically soliciting comment on how to strike this balance,
within the general consensus it believes exists on the existence of
Federal and State roles. For instance, should EPA require an SMP to
include regulatory action to prohibit use of the pesticide under SMPs
in areas where contamination from current, legal use exceeds the
reference point in current or reasonably expected sources of drinking
water? If so, should EPA also require States to complete their
identification of current and reasonably expected sources of drinking
water (if States choose to make such a delineation) prior to Plan
approval?
In addition, EPA is soliciting comment on whether it would be
helpful for the Agency to provide more specific guidance to States (in
the form of technical assistance, new guidance documents or amendments
to the existing Guidance) on particular risk-reduction measures that
may be appropriate to particular indications of present groundwater
contamination. Such guidance would not be prescriptive (that is,
codified in rulemaking), but rather reflect the best experience of EPA
and the States in managing ground-water protection, as the States
develop and implement SMPs. A State and EPA Region could benefit from
the experience of others, with the cumulative effect of all States and
Regions reaching a mutual understanding of what works best in general
situations.
The Agency could be more specific in advance about certain
prerequisites of an adequate SMP. For example, EPA might specify by
regulation different ground-water contamination levels which would
require State response. These levels would be based on the reference
points specified in proposed Sec. 152.198. A State would be free to
specify in its Plan an array of risk-management measures it found
appropriate to respond to such levels of contamination. In contrast,
this regulation as presently fashioned only requires a State to
describe its goals and response program elements in a manner that
allows the Agency to evaluate their adequacy in relation to the
adequacy of the other supporting Plan elements.
Under this alternative, proposed Sec. 152.190(a) would require a
Plan to establish, within its statement of philosophy and goals toward
protecting ground water, its ground-water protection objectives in
terms of EPA's reference point policy. This alternative would also
change proposed Sec. 152.190(h) to require SMP response-program
elements to specify prospective risk-management measures in the event
contamination is detected at or above EPA-specified contamination
levels. For purposes of eliciting comment, EPA offers the following as
appropriate levels: (a) 10 percent of a subject pesticide's ground-
water reference point; (b) 50 percent of the ground-water reference
point; and (c) 100 percent of the ground-water reference point. EPA
would not pre-specify particular risk-management measures for these
levels. However, whatever measures that a State does propose would be
subject to the Agency's evaluation of its adequacy with respect to the
fulfillment of the general objective of ``preventing unreasonable
adverse effects ... and protecting the integrity of the ground-water
resource.''
Such a specification of program performance objectives would be
consistent with the EPA's role under the Federal-State partnership,
that of establishing uniform national policy goals and determining the
overall regulatory approach. At the same time, States would be free to
specify the means of meeting those performance objectives, subject to
Agency review. One benefit of a more concrete specification would be
the avoidance of misunderstandings between EPA and States: EPA would
have stated more clearly what it will find acceptable (or unacceptable)
in defining its requirements in this fashion. Another benefit would be
greater assurance in the adequacy of a State's plan, since an approved
Plan would clearly embrace a risk-management scheme tied to a uniform
set of criteria for action. Regulation would be more protective insofar
as all States would meet a minimum threshold of risk-management
measures. This approach might also facilitate EPA review of Plans, by
eliminating an additional interpretive step, that of determining
whether the State proposal, in its unique form, conforms with EPA's
expectations.
Finally, the Agency recognizes that some potentially affected
parties have expressed concern that the proposed rule does not offer an
opportunity to maintain use of a pesticide in the event a state does
not have an approved SMP, for whatever reason. Therefore the Agency
requests comment on whether there should be a default provision for
stringent federal label requirements and/or conditions on the terms of
registration for these pesticides that would allow continued use in
lieu of an approved SMP.
Under this option, the Agency would specify in the final rule the
national-level requirements that would apply to use of these pesticides
in States without approved SMPs by the effective date. The Agency has
established a model for such requirements. In 1994, the Agency granted
a conditional registration for a new herbicide, acetochlor, for which
the potential for ground water contamination is a concern. In that
case, the Agency imposed a variety of restrictions on the use of
acetochlor, including limiting application to certain soil types,
prohibiting aerial application, and restricting use to certified
applicators. In addition, the Agency required the registrant to conduct
ground-water monitoring at a specified level of effort, and set
triggers that would result in localized use prohibitions, and
ultimately national cancellation of the registration if certain
detection criteria are met. A copy of the specification of the terms
and conditions of registration for pesticides containing acetochlor,
which would
[[Page 33275]]
serve as the model for such specifications in the final rule, is
available in the public docket for this rule. EPA notes that nothing in
this proposal would preclude registrants themselves from proposing
additional restrictions on the use of their product to the Agency,
pursuant to FIFRA section 3(c)(5), in the event a State chose not to
adopt an SMP. Consequently, this proposal leaves open to registrants
the option of themselves devising suitable restrictions to prevent
unreasonable adverse effects on the environment from use of these
pesticides in the unlikely event that a State chooses not to develop an
SMP, or that no SMP is approved.
The Agency would like comments on the following. Would a similar
approach be appropriate for the SMP chemicals in the event a State
elected not to develop an SMP for one or more of the chemicals? Should
the default be available if a State did submit an SMP, but EPA did not
approve it? What specific precautions and limitations on the label
would provide adequate protection of ground water in the absence of an
SMP? Is the Agency correct in proposing to use the specifications of
the acetochlor registration as the basis of such national-level
defaults, or are there specific provisions to be added or deleted?
Should registrants be required to conduct monitoring, and if so, to
what extent? If there is a registrant monitoring program, should States
have a role in determining where and how monitoring is carried out?
Should there be triggers for use prohibition in a State, or only in a
local use area; if so, what should they be? What would the impact of
this Federal alternative be on registrants and users? What would the
effect of this alternative be on State development of SMPs and other
ground water protection activities or programs?
IV. Risk and Benefit Determination
A. Chemical Background and Characteristics
1. Uses. The five candidates for SMPs proposed today are similar in
many important respects. All five are broad-spectrum herbicides
registered for use on a total of 100 different crops, including most of
the major field crops grown in the United States (e.g., corn, sorghum,
and wheat). Together, the five compounds are registered for another 31
non-crop and non-food uses including ornamental tree, plant, and grass
sites. Atrazine, simazine and cyanazine are members of the s-triazine
family of compounds, and are each used to control a variety of
broadleaf weeds and grasses. Each is used for preplant, preemergence
and postemergence weed control in crops. Alachlor and metolachlor are
acetanilide compounds registered for pre-emergent control of broadleaf
weeds and grasses.
EPA estimates that between 200 and 250 million pounds of the five
herbicides, together, are used annually in the United States, which
represents as much as one-half of total annual agricultural use of
herbicides. Atrazine, alachlor, and metolachlor are currently ranked as
the three highest-volume pesticides in use in the United States today,
with cyanazine ranked fifth. Approximately 150 to 160 million pounds of
active ingredient (a.i.) of these four pesticides are applied to just
two field crops: corn and sorghum. Alachlor and metolachlor are also
commonly applied to soybeans, with 20 to 30 percent of their annual use
attributable to this crop. Remaining uses of these four herbicides,
while representing a small fraction of their combined use, still
represent several million pounds of active ingredient. For example, 1
to 2 million pounds of cyanazine are used annually on cotton; also,
another substantial use of atrazine is on sugar cane.
Historically, use of atrazine was marked by a rapid rise in use on
row crops through the 1960's, joined by a similar sharp rise in
alachlor use from 1969 to 1974. At that time, use volumes of each
leveled off at comparatively high levels (e.g., about 80 million pounds
annually) as use of cyanazine, and then metolachlor, climbed. Through
the 1980's, use volumes began to fluctuate, with use of the two older
chemicals drifting down from combined uses of 170 to 190 million pounds
per year to levels of 120 to 150 million pounds per year. These general
declines were matched by corresponding increases in the other two.
During the first half of this decade, this general trend continues,
with the exception of a relatively sharp decline in alachlor, and a
slightly earlier, but more-than-offsetting increase in metolachlor use.
Simazine stands as the exception to the rest of the candidates with
respect to use. Only 3 to 5 million pounds of active ingredient are
used in the United States annually. However, 1 to 2 million pounds (31
to 42 percent) of simazine is applied to corn, making it the principal
use of simazine as well. Simazine's remaining uses include crops such
as alfalfa, seed crops, fruits (apples, citrus, grapes, berries and
stone fruits, among others) nuts and vegetables. Simazine is also
registered for several terrestrial non-agricultural uses, as well as
for aquatic uses (i.e., ornamental ponds).
2. Other regulatory actions. All five pesticides are subject to the
reregistration requirements of the 1988 FIFRA Amendments.
Reregistration of existing pesticide products entails the determination
that they are eligible for reregistration because: (a) The data
necessary to determine the pesticide's risk are substantially complete;
and (b) these data indicate that the pesticide does not cause
unreasonable adverse effects when the products are used according to
label directions and restrictions. EPA publishes Reregistration
Eligibility Documents (REDs), which summarize the studies reviewed and
the findings reached. A RED for metolachlor has already been published
(EPA 738-R-95-006, April 1995); a RED for alachlor is scheduled to be
published in 1996. REDs for the three triazines are not expected before
the conclusion of the triazines special review.
In addition to the scheduled reregistrations, four of these
pesticides are in Special Review. One, alachlor, has been under Special
Review since 1985. While EPA resolved substantial risk concerns about
the use of alachlor in 1987, the Agency deferred action on whether the
risks posed from alachlor in drinking water from contamination of
ground water required regulatory action. EPA proposes to conclude
review on these issues with the promulgation of this rule.
In November 1994, the Agency initiated Special Review (59 FR 60412,
November 23, 1994) of the three triazine compounds - atrazine, simazine
and cyanazine - subject to this rule. The Review will address the
potential overall risks to human health and the environment posed by
use of these three pesticides, particularly the carcinogenic risks from
human exposure in drinking water, food, and through handling and
application of products. Ground-water contamination is part of the
concern in conducting the Special Review, but only part of the broader
concerns addressed by it. Therefore, the Agency believes it is
appropriate to carry out both regulatory proceedings for the triazines
at this time.
B. Risk Assessment
1. Adverse health effects-- a. Toxicological endpoints of concern.
Toxicological endpoints of concern for these five compounds (and their
metabolites) include carcinogenicity (all five compounds),
developmental toxicity (atrazine and cyanazine), chronic blood and
organ toxicity (cyanazine, simazine, alachlor, and metolachlor), and
cardiotoxicity (atrazine). In the following discussion,
[[Page 33276]]
atrazine, simazine, and cyanazine are frequently referred to together
as triazines, when the three compounds exhibit similar characteristics
and effects.
EPA's Integrated Risk Information System (IRIS) summarizes the
available information on the toxicological endpoints of concern for the
five pesticides in today's proposed rule. IRIS data are available to
the public in both printed and on-line form, and can be accessed by
telephoning IRIS User Support at EPA's Center for Environmental
Research Information in Cincinnati, Ohio; (513) 569-7254. The
discussion below does not include a detailed review of studies showing
relatively minor adverse effects, such as changes in average body
weight or the rate of weight gain in developing animals. More extensive
discussion of the evidence of adverse health effects for each of these
pesticides has been presented in other documents, e.g., for
metolachlor, in the recent Reregistration Eligibility Decision document
and for the triazines, in the Federal Register notice announcing the
initiation of the triazines Special Review. A more complete description
of the toxicological evidence to support this rulemaking, drawn from
these existing sources, is provided in the docket for this regulation.
All five compounds exhibit adverse effects in animals after long-
term exposure, raising concern about chronic toxicity. For example,
long-term (usually 2-years) feeding studies with the triazines
typically show reduced rates of weight gain, and in some cases,
hematological effects, such as reduced red-cell count. Treatment of
pregnant animals with all of these compounds shows some developmental
effects, such as reduced weight gain, or reduced litter size. In
addition, a 1-year dog study with atrazine showed cardiac effects such
as increased heart rate and irregular heartbeat. Although these are all
adverse effects, they do not present the same level of concern as the
evidence of cancer risk.
EPA had classified atrazine, simazine, cyanazine and metolachlor as
Group C (possible human) carcinogens. EPA's Office of Pesticide
Programs has assigned a numerical cancer potency coefficient, known as
a Q1*, to each of these chemicals as well (see Table 2 below).
The triazine compounds have an extremely close structural
similarity and produce similar tumor profiles in animal bioassays,
primarily malignant mammary tumors in female rats. In addition to
animal study data, EPA has reviewed a number of epidemiology studies
which suggest possible associations between triazine exposure and
various human health effects, including ovarian cancer, non-Hodgkins
lymphoma, and birth defects. All of the studies, however, had
significant limitations, and the Agency does not consider any of the
suggested health-effect associations to be established by currently
available information.
Alachlor was classified as a B2 (probable human) carcinogen by
virtue of positive results in studies of both rats and mice. At this
time, however, alachlor is considered to be not classified under the
current agency system pending further review of scientific issues
raised by the registrant. Metolachlor has limited evidence of liver
carcinogenicity in animals.
The cancer classifications cited here are likely to change in the
future for several reasons. First, EPA has recently proposed to revise
its guidelines for the assessment of cancer risks. The new proposed
guidelines were made available on April 16, 1996, for a 120-day public
comment period. The issues raised during the comment period will then
be presented to the Agency's Science Advisory Board. New guidelines are
likely to become final in 1997. Among other things, the new guidelines
may change the way the Agency weighs the various kinds of laboratory
evidence used to identify carcinogenic potential.
In addition to changing guidelines, the registrants of the triazine
and acetanilide herbicides have recently submitted new data which they
believe should reduce concerns about human cancer risks for these
compounds. It is not clear at this time how this new evidence will
affect the Agency's risk assessment for these compounds, or how the
evidence will be evaluated under the new guidelines. In any case, human
cancer risk is not the only basis for the Agency's concern about these
chemicals.
b. Ground Water Reference Points. Table 2 of this Unit displays the
relevant summary toxicological data for these five compounds. The
derivation of the Ground Water Reference Points shown in Table 2 is
discussed below.
The Ground Water Reference Point for a compound is a representation
of the compound's toxicity, expressed in units corresponding to
environmental exposure. The Reference Point provides a means to assess
the significance of known or anticipated concentrations that occur in
ground water. As described in Unit II. of this preamble, the Agency
normally will use MCLs established under the Safe Drinking Water Act
(SDWA) as reference points. MCLs are derived from Maximum Contaminant
Level Goals (MCLGs), which is that concentration, ``... at which no
known or anticipated adverse effects on the health of persons occur and
which allows an adequate margin of safety'' (SDWA section 1412(b)(4)).
In most cases an MCLG is based on the Reference Dose (RfD) for the
compound, to which standard conversion and uncertainty factors have
been applied to account for anticipated drinking water exposure. For
compounds classified as Group C carcinogens, EPA also applies a 10-fold
uncertainty factor to provide for an additional margin of safety. The
enforceable MCL, set simultaneously with the MCLG, is set ``as close to
the [MCLG] as is feasible'' (Ibid). In the case of B2 carcinogens,
Agency policy has been to set the MCLG at zero. The corresponding MCL
is then set at a finite level by evaluating the performance of feasible
water treatment and analytic technology. More information on EPA's
methodology for setting MCLs and MCLGs is available in the final rule
which established MCLs for atrazine and alachlor (56 FR 3526, January
30, 1991).
The following Table 2 is a summary of the human health risk posed
by these five chemicals:
Table 2.--Summary of Human Health Risk
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ground Water
Reference Reference Dose
Point Source (MCL, HAL, (RfD) (g/ Study/Endpoint\1\ Cancer Category Q1* (1/mg/kg/d)
(g/ or other) kg/d)
l)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Atrazine......................... 3 Final MCL 35\2\ Chronic Animal C 0.22
Study decreased
body wt. gain;
cardio-
developmental
toxicity
Simazine......................... 4 Final MCL 5 Chronic Rodent C 0.12
Study (decreased
body wt. gain
hematological
changes)
[[Page 33277]]
Cyanazine........................ 1 HA 2 Chronic Animal C 1.00
Study (decreased
body wt. gain)
Alachlor......................... 2 Final MCL 10 Sub-Chronic Dog * 0.08
Study (hematology)
Metolachlor...................... 70 HA 100 Chronic Rodent C 0.009
Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This column refers to the study or toxicological endpoint which serves as the basis for the RFD listed in the column immediately to the left.
\2\ The RfD for atrazine was revised in December 1992; the previous RfD (of 5 micrograms per kilogram per day) served as the basis for the current MCL
displayed at left.
In the absence of MCLs, EPA will use a Health Advisory (HA) to
establish Ground Water Reference Points. HA levels are established
using the same methodology used for non-zero MCLGs. MCLs have been
established for atrazine, simazine, and alachlor, and these are Ground
Water Reference Points for these compounds. The Reference Points for
cyanazine and metolachlor are based on HA levels.
In summary, the Agency feels that there is sufficient evidence to
concluded that each of the five compounds addressed in today's rule may
cause serious, irreversible adverse effects to the health of persons,
if any of the compounds were present in drinking water at or above
particular concentrations or at other concentrations for a prolonged
period of time. In fact EPA has set drinking water standards for three
of the compounds in this proposed rule, in order to prevent the onset
of such effects as a result of drinking water in Public Water Systems
(PWSs). The Agency has set Health Advisories for the other two
compounds, in order to allow PWSs to evaluate and avert potential
adverse effects to human health should these compounds be encountered.
MCLs for these two compounds may also be developed at a later date.
2. Environmental effects. In addition to their potential for
adverse human health effects, EPA is also concerned about the potential
adverse effects of these compounds: (1) On specific non-target plants
and animals, including the potential economic impact associated with
adverse effects on both commercial crops and animals; and (2) on
ecosystems as a whole.
EPA has far less specific data on the potential adverse ecological
effects of these five compounds than for adverse health effects.
However, both the chloro-triazines and the acetanilides inhibit
photosynthesis in plants and may have phytotoxic effects to terrestrial
and aquatic plants.
Of these chemicals, atrazine has been the most fully studied and
characterized for environmental effects. In comparative laboratory
acute toxicity testing, atrazine exhibits moderate toxicity to birds,
mammals, fish, or aquatic invertebrates. Studies representing simulated
field conditions have also been conducted. For aquatic plants,
available information indicates that short-term exposure to relatively
low levels of atrazine (for example, concentrations of approximately 20
g/l) can produce phytotoxic effects from which plant
populations will not recover. Information on simazine and cyanzine
indicate that longer-term exposure at even lower levels, in the range
of about 5 g/l, can also inhibit plant reproduction.
Substantial risks can be anticipated from continuing off-target
movement of these five compounds and consequent exposure of aquatic
organisms and ecosystems. Contamination of ground water can be a
mechanism of transport for these compounds to surface water, since
ground water provides a significant source of recharge for many bodies
of surface water. While it is difficult to segregate potential risks
from the presence of these compounds in ground water from those that
might result from other means of environmental transport such as
runoff, the risks are real enough to be of concern.
In addition, there is a considerable body of monitoring data
available on these five pesticides, primarily in the mid-western
``corn-belt'' States where they are most heavily used. These data
demonstrate that residues of these five pesticides can be detected in
both ground and surface waters in areas of heavy use, at levels which
frequently approach, and sometimes exceed, the MCLs or HAs. (Data for
ground-water occurrence are discussed in more detail below).
Thus, the Agency feels that there is sufficient evidence to infer
that present environmental levels of these herbicides from various
environmental transport mechanisms, including leaching to ground water,
pose substantial risks to aquatic plant life, both in the form of
outright phytotoxicity and in the longer-term and more subtle effect of
inhibiting plant reproduction. If such effects occur in an aquatic
environment, the effects on the ecosystem could be profound. Complete
loss of habitats may occur. Even partial loss of food supply or
protective cover can result in significant impacts on other aquatic
organisms. Herbicides in the aquatic environment could destroy the food
source for higher organisms, which may then starve. Herbicides may also
reduce the amount of vegetation available for protective cover and the
laying of eggs by aquatic species. Submerged aquatic vegetation is the
nursery for commercial and recreational species. As such, drastic loss
of submerged aquatic vegetation in rivers or estuaries is a serious
environmental concern. Some experts believe that herbicide related
ecosystem damage may already be occurring in locations such as the
Chesapeake Bay and parts of the Mississippi delta.
EPA has drafted a Water Quality Criteria document for atrazine that
proposes to establish a fish-protection level of 22.7 g/l
(measured as a 4-day average concentration over a 3-year period), below
which ``freshwater aquatic animals and their uses should not be
affected unacceptably ...,'' adding a peak 1-hour concentration limit
of 571.9 g/l (not to be exceeded more than an average of once
in a 3-year period). For the protection of freshwater aquatic plants,
atrazine concentrations should not exceed 2.0 g/l for any 4-
day period within a 3-year period.
The total risks of these five pesticides to aquatic ecosystems are
beyond the scope of the regulatory action being proposed today. These
ecological risks involve, in addition to contamination of ground water,
contamination of surface water through many alternative routes, such as
runoff through the unsaturated zone to a nearby water body.
Ground water SMPs cannot be expected to address all of these
potential routes to surface water contamination that may occur as a
result of the legal use of these five pesticides. However, certain use
management measures implemented by States as part
[[Page 33278]]
of their ground-water Plans may provide some ancillary protection
against such surface-water contamination. At a minimum, no SMP will be
approved that contains a preventive measure that will clearly increase
the likelihood that surface water will be adversely affected as a
consequence (see Unit III.C.7. of this preamble, and Guidance, pp 3-15-
6, Ref. 18).
3. Ground water contamination potential-- a. Persistence and
mobility. EPA requires that all pesticide registrants submit data on
the physical and chemical characteristics of a pesticide in order to
characterize its environmental fate. These data are generated through a
battery of basic laboratory tests and limited field studies as
specified in 40 CFR 158.290, otherwise known as the ``Subpart N''
Guidelines. Two important factors, known as persistence and mobility,
are particularly relevant in predicting whether a substance has the
potential to reach ground water.
Persistence refers to a substance's relative resistance to
environmental processes which tend to break that substance down, and
thus to the length of time that substance can exist in the environment.
Persistence is generally measured as a half-life (t1/2 or
t50), or the length of time in which 50 percent of an
environmental concentration disappears as a result of transport or
degradation. Mobility refers to the potential for an ingredient to move
away from the point of application, and is typically represented by a
substance's resistance to binding to soil or soil constituents.
Measures such as the soil-water partition coefficient (kd) or the
carbon-referenced sorption coefficient (Koc) are used to indicate a
substance's binding potential.
A pesticide that is relatively persistent and mobile would tend to
remain in the subsurface environment, be present at substantial
fractions of the original environmental residue, and reach underlying
aquifers relatively quickly. Together, persistence and mobility are
referred to as a pesticide's leaching potential.
(i) Parent compounds. Table 3 of this Unit contains a summary of
the persistence and mobility characteristics for the five pesticides
subject to today's proposed rule. The Table shows chemical-specific
values for the seven parameters that EPA uses to evaluate a pesticide's
propensity to reach ground water. These values, generated from the
combination of laboratory and field studies EPA requires for
registration, are compared against the values (displayed in the Table)
that EPA regards as indicative of leaching potential.
EPA proposed these values in a previous proposed rulemaking (see 56
FR 22076, May 13, 1991) as criteria indicating a reasonable potential
for reaching ground water on a widespread basis, for purposes of
considering a pesticide for restricted use classification. While EPA is
not proposing to apply these criteria to determine whether a pesticide
needs to be subject to an SMP, the Agency provides the information as
evidence of the pesticides' leaching potential. As indicated in Table
3, all five pesticides display persistence and mobility characteristics
exceeding the values EPA considers evidence of a propensity to leach.
In the event EPA were to classify the pesticides for conventional
restricted use independently of the regulatory action referred to
above, the Agency believes that this evidence, combined with the
detections of the parent compounds in ground water to date, would not
only meet the EPA's final criteria for restricted use for ground-water
concerns, it would establish that these pesticides could pose a serious
hazard to the environment in the absence of the mitigation provided by
restricted use classifications. Such evidence would be sufficient for
EPA to propose restricted use classification for simazine and
metolachlor, the two pesticides subject to today's proposed rule not
now classified as such, under the existing regulations for restricted
use classification (c.f., 40 CFR 152.170(d)).
As shown in Table 3 below, all five pesticides are resistant to
chemical hydrolysis, indicating their likely environmental persistence.
The term ``stable'' as used in Table 3 means the compound was observed
to degrade more slowly than the rate of degradation specified as the
critical value in the criteria column, i.e., a decrease of 10 percent
or more in the tested concentration of a substance over 30 days
duration of a hydrolysis test.
Table 3.-- Persistence and Mobility
(A value exceeding a criterion shown in Italic)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Parameter Criteria Atrazine Simazine Cyanazine Alachlor Metolachlor
--------------------------------------------------------------------------------------------------------------------------------------------------------
Persistence.................. Field > 21 days (3 60-120 days 44-231 days 6-181 days 11 days 7-292 days
........................... Lab-derived > 21 days (3 146 days 110 days 17 days 2-3 weeks 67 days
aerobic soil wks), or
metabolism half-
life
........................... Hydrolysis half- < 10% in 30 stable (pH stable (pH 148 days (pH stable (pH stable (pH
life days, or 5,7,9) 5,7,9) 5), stable (pH 3,6,9) 5,7,9)
7,9)
........................... Photolysis half- < 10% in 30 days > 30 days > 30 days 6 days NA 8 days
life (soil)
Mobility..................... Soil adsorption: 5 ml/ 0.20 (sand) 4.31 (clay) 0.28-2.3 1.87 (clay)
Kd g, or
......................... 0.73 (loam) 0.65 (sand) 2.16 (sandy
loam)
......................... 0.79 (sandy 1.27 (sandy 0.62-8.13 0.108 (sand)
loam) loam)
......................... 2.45 (clay) 0.48 (loam) 0.77 (loam)
........................... Soil adsorption 500 38 - 152 103 - 152 40 - 84 190 (est)\1\ 22 - 110
Koc ml/g, or
[[Page 33279]]
........................... Depth of 75 cm NA\2\ NA\2\ 45 cm 122 cm 122
leaching in cm
field
dissipation
study
-----------------------------------------------------------------
FR Doc. 96-16173 Pesticides and Ground Water State Management Plan Regulation
---------------------------------------------------------------------------------------
\1\ est = estimate.
\2\ NA = Not Available (either not reported by the registrant or not required - waived - by EPA).
(ii) Degradates. In the case of all five of these pesticides, the
leaching potential of metabolites and/or degradates are an additional
concern. For example, since the 1980s investigators have reported
detections of triazine degradates as well as the parent compounds in
both ground and surface water. Alachlor and metolachlor also have
various degradation products which may be mobile and persistent enough
to leach.
b. Occurrence of ground water contamination. Registrants, States,
the United States Geological Survey (USGS), and EPA's National
Pesticide Survey are all sources of ground-water monitoring data (Refs.
10 and 14). In reviewing monitoring data, EPA's Office of Pesticide
Programs (OPP) records occurrence in ground water as the number of
discrete locations where a pesticide ingredient was detected at least
once. Multiple detections at the same well over an interval of time
from repeat sampling are not counted as separate detections in the main
data collections cited below. EPA recognizes that this procedure could
function to put wells with only a single detection from repeated
sampling on an equal footing with wells in which occurrence is
regularly found. Specified detection limits are a measure of the
sensitivity of the analyses. Such sites are typically water-supply
wells or, to a lesser extent, ground-water monitoring wells. OPP uses
the term ``wells'' to refer to occurrence sites.
EPA's sources of ground-water data include: (1) The Pesticides in
Ground Water Data Base (PGWDB), a data base containing the information
described above, and periodically up-dated by OPP (Ref. 15); (2) EPA's
National Pesticide Survey (NPS; Refs. 10 and 14), a statistically
designed one-time survey of existing wells, including both community
wells and rural domestic wells nationwide, (data not included in the
PGWDB); (3) Monsanto's National Alachlor Well Water Survey (NAWWS)
(Ref. 3)-this survey was limited to alachlor use areas, and sampling
was limited to private rural domestic wells; (4) Ciba-Geigy (now Ciba
Plant Protection) performed a Large-Scale Retrospective Ground-Water
Study for Metolachlor in Four Areas of the U.S. (Ref. 2) with high
metolachlor use and/or high vulnerability to contamination of ground
water by pesticides; and (5) a number of State-initiated ground water
monitoring programs. All of these information sources are described in
greater detail in the ``Water Resources Impact Analysis for the
Triazine Herbicides'' (Ref. 20). Tables 4 through 8 of this Unit
summarize information developed from those sources.
(i) Atrazine and triazine metabolites-- (a) Atrazine parent. The
evidence of atrazine occurrence is summarized in Table 4 of this
preamble. Atrazine was the third most often detected of all currently
registered pesticides in OPP's Pesticides in Ground Water Data Base,
after aldicarb (and its metabolites) and carbofuran (and also after two
banned pesticides, EDB and DBCP).
Atrazine was found in the National Pesticide Survey, as shown in
Table 4, and in the Monsanto NAWWS Survey. In particular, in the
latter, atrazine was the most frequently found pesticide, estimated to
be present in 12 percent of wells in the alachlor use area. The study
estimated that concentrations will exceed the MCL of 3 g/l in
0.1 percent of the wells in the alachlor use area.
(b) Chloro-triazine degradates and other triazine occurrence. There
are fewer data on degradates in ground water than for the parent
triazines; cyanazine and simazine degradates in particular are rarely
looked for. The Pesticides in Ground Water Data Base contains
detections of two chloro degradates of atrazine at concentrations of
0.05 to 2.86 g/l. The NPS analyzed for only one degradation
product of atrazine (desethyl atrazine) and the detection limit for
that product was relatively high (2.2 g/l); the NAWWS did not
analyze samples for degradation products of atrazine or the other
triazines at all. Two of the three major chloro-triazine degradates of
atrazine were analytes in Iowa's SWRL study, the results of which are
shown in Table 4. The Wisconsin Rural Well Study provided significant
information on the occurrence of atrazine degradates. Almost 92 percent
of wells that were resampled in phase 2 of the study contained a
combination of parent and degradate residues. Overall, degradates found
in the Wisconsin Rural Well Survey accounted for 67 percent of total
triazine residues.
Results of a recent USGS study of herbicides and nitrates in near-
surface aquifers in the mid-continent United States (Kolpin, et. al.,
1994) reported that desethyl atrazine was the most frequently reported
compound (18.1 percent of wells), followed by atrazine (17.4 percent),
and desisopropyl atrazine (5.7 percent). The detection of total
residues was 25 percent more than the detection of atrazine alone. This
study differs from the NPS and NAWWS studies in that it sampled ambient
ground water, not just ground water used as a source of drinking water.
Finally, the advent of new analytic techniques such as the rapid,
highly sensitive and relatively cheap detection methods based on
enzyme-linked immunosorbant assay (ELISA), has allowed monitoring
studies of ``total triazine'' levels. While typically employed as a
``screen,'' with detections subsequently analyzed by conventional
methods to identify and quantitate specific compounds, the PGWDB
contains reports of one State's findings of undifferentiated ``total
triazine'' occurrence. In 1990, Ohio reported monitoring at 863 sites,
with 48 detections at concentrations ranging from 0.1 to 5 g/l
(Baker, et. al., ``Nitrate and Pesticides in Private Wells of Ohio: A
State Atlas,'' Heidelberg College, (Ongoing)).
(ii) Simazine. The evidence of simazine occurrence in ground water
is summarized in Table 5 of this preamble. Simazine was the eighth most
often detected pesticide in OPP's Pesticides in Ground Water Data Base
and the sixth most frequently detected of the currently registered
analytes. In Kolpin, et. al. (1994) simazine residues were detected in
1.0 percent of the wells sampled in the mid-continental U.S.
(iii) Cyanazine. Less monitoring data exist for cyanazine in ground
water than for atrazine and simazine. Table 6
[[Page 33280]]
summarizes data on monitoring results for cyanazine. Cyanazine was the
15th most often detected pesticide in OPP's Pesticides in Ground Water
Data Base, with detections in 15 out of 27 States in which samples were
collected. Additionally, cyanazine has been reported to be found at
concentrations greater than 0.1 g/l (or 10 percent of its reference
point of 1 g/l) in more than 80 additional wells in 12 States.
No detections were reported in the NPS; however, the minimum
detection limit in that study was 2.4 g/l whereas the likely
MCL for cyanazine is 1 g/l. NAWWS estimates that detectable
levels of cyanazine are expected to occur in 0.3 percent of rural
domestic wells in counties where alachlor is used. As is the case for
simazine, this may not be a good national estimate of cyanazine
occurrence because the use areas of cyanazine and alachlor may not
closely coincide. The detection limit for cyanazine in this study was
0.1 g/l; whereas the detection limit for the other 4 analytes
was 0.03 g/l. This higher detection limit undoubtedly reduced
the number of observed positives. No estimate was given for cyanazine
concentrations that exceed 1 g/l. NAWWS did not analyze water
samples for degradation products of cyanazine. Cyanazine was not an
analyte in the Ciba-Geigy Large-Scale Retrospective Ground-Water Study.
As regards State surveys, cyanazine was the 5th most frequently
detected pesticide in Iowa's SWRL study (of the 27 pesticide analytes).
Cyanazine was not an analyte in the Wisconsin study and no confirmed
detections of cyanazine are reported in the California database.
Cyanazine was detected in 0.7 percent of the wells sampled in the USGS
study by Kolpin et. al. (1994).
(iv) Alachlor (and metabolites). Table 7 of this preamble
summarizes the information available to the Agency regarding alachlor
occurrence in ground water. Alachlor is the seventh most often found
pesticide in the Pesticides in Ground Water Database, with only
aldicarb (and its metabolites), carbofuran, atrazine and oxamyl among
the currently registered pesticides detected more often. In addition,
alachlor has been reported to be found at concentrations greater than
0.2 g/l (or 10 percent of its reference point) in more than
350 wells in 21 States.
The NPS estimated that 3,140 (or <0.1 percent) rural domestic wells
contained alachlor at levels above the Reference Point of 2 g/
l. There were no detections of alachlor in community water system
wells. The NAWWS estimated that alachlor occurs in approximately 1
percent of rural wells throughout its use area. Less than half of these
detections are at levels exceeding 0.2 g/l (or 10 percent of
the MCL). Alachlor is estimated to occur at levels exceeding its 2
g/l MCL in 0.02 percent (or approximately 1200 wells) of the 6
million rural wells in the alachlor use area. There were no degradation
products analyzed in either the NPS or the NAWWS. Alachlor residues
were detected in 1.7 percent of the wells sampled by USGS (c.f.,
Kolpin, 1994). The State survey results are summarized in Table 7. In
addition, several investigators (including USGS) have reported finding
a major metabolite of alachlor, t-sulfonic acid in ground-water samples
(c.f., Ref. 3).
(v) Metolachlor. Metolachlor was the 12th most often found
pesticide in the OPP Pesticides in Ground Water Database (see Table 8).
Metolachlor was also reportedly found at concentrations exceeding 7
g/l (or 10 percent of its reference point) in 19 wells across
6 States. NAWWS estimates that metolachlor has a detection frequency
near 1 percent in the surveyed ``alachlor use area.'' Less than half of
the metolachlor detections are at levels exceeding 0.2 g/L.
The average detection limit was 0.03 g/L.
Results from the Ciba large-scale retrospective study of
metolachlor indicate that metolachlor was detected in 89 of 920 samples
(or 10 percent), and 39 of 240 wells (or 16 percent). The screening
level was 0.1 g/l. Detections ranged from 0.1 to 88
g/l with half of these detections at concentrations of 0.1 to
0.5 g/l. None of the detections in this study exceeded the
Health Advisory (HA) of 70 g/l. USGS (Kolpin, 1994) reported
that 2.7 percent of the wells sampled in the mid-continental United
States contained metolachlor residues. The following five tables
(Tables 4 through 8) summarize the data on occurrence for each of the
five pesticides.
Table 4.--Atrazine Occurrence in Ground Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Source
-----------------------------------------------------------------------------------------------------------------------
Atrazine (Rf. Pt. = 3 g/ State Surveys
l) PGWDB NPS NAWWS -----------------------------------------------------------
IA: SWRL WI: RWS CA: WID
--------------------------------------------------------------------------------------------------------------------------------------------------------
# of Wells Sampled............. 26,909 (in 40 1,349 (566 PWS, 1,430 (in 89 686 2,200/236 6286 (in 53
Frequency & Distribution of 1,512 (in 32 NA 166 NA 603/200 (143- 111 (in 21
Detections (# of wells). states)\2\ 208)\1\,\2\ counties)
Frequency & Distribution of 172 (in 22 states) NA 2 NA NA/15 (56)\1\,\2\ 0
Wells > Rf. Pt..
Range of Detected Concentrations trace-1500 trace - 7.0 0.1 - 0.13 - 6.61 0.10 - 16.0 0.1 - 0.19
(in g/l). 6.72
Estimated Occurrence Rate NA Among CSWs: 1.7% 12% 4.4%(2.8-5.9) NA NA
(Statistical Surveys only; (0.5-2.9%); 3.5% \3\..........
Confidence interval ranges in Private wells: 3.5%\4\...........
parens). 0.7% (0.1-2.0%)
Estimated Number of Wells with NA Among CSWs: 1570 720,000 NA NA NA
measurable residues (420-2710);
(Statistical Surveys only; Private wells:
Confidence interval ranges in 70,800 (13,300-
parens). 214,000)
[[Page 33281]]
Estimated Occurrence Rates & # NA < 0.1% Private 0.1%; 8,400 NA NA 0
of wells with concentrations > wells < 9,450 private wells
Rf. Pt. (Statistical Surveys Private wells
only).
Detection Limit (g/l).. Various 0.12 0.025 0.13 0.1 Various
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Results of both Phase I and II Studies shown; Phase I (immunoassay) results shown first, separatefrom Phase II with a slash (/).
\2\ There are additional chloro-metabolite detections reported in PGWDB, but the majority of samples and detections occur within the IA:SWRL study. Des-
ethyl atrazine reported in 27 sites in Indiana and Iowa; des-isopropyl atrazine reported in 24 sites in Indiana and Iowa.
\3\ Desethyl atrazine (a chloro-metabolite).
\4\ Desisopropyl atrazine (a chlorinated metabolite).
Table 5.--Simazine Occurrence in Ground Water
----------------------------------------------------------------------------------------------------------------
DATA SOURCE
-------------------------------------------------------------------------------
Simazine(Rf. Pt. = 4 g/ State Surveys
l) PGWDB NPS NAWWS -------------------
CA: WID
----------------------------------------------------------------------------------------------------------------
# of Wells Sampled.............. 22,374 (30 states) * * 6,752 (55
Frequency & Distribution of 486 in 19 states NA 23 308 (9 counties)
Detections ( of wells).
Frequency & Distribution of 36 in 12 states NA 1 0
wells > Rf. Pt..
Range of Detected Concentrations trace - 67 trace - 1 < 0.15 - 8.36 0.1-2.4
(g/l).
Estimated Occurrence Rate NA For CSWs: 1.1% Private wells:
(Statistical Surveys only). (0.4-2.7%) 1.6%
private wells:
0.2% (< 0.1 -
1.3%)
Estimated Number of Wells with NA For PWSs: 1,080 96,000 private
measurable residues (350 - 2540) wells
(Statistical Surveys only). private wells:
25,100 (590 -
141,000)
Estimated Occurrence Rates & # NA < 0.1 % NA
of Wells with concentrations < 9,450 private
Rf. Pt. wells.
(Statistical Surveys only).
Detection Limit (g/l).. Various 0.38 0.025 Various
----------------------------------------------------------------------------------------------------------------
[[Page 33282]]
Table 6.--Cyanazine Occurrence in Ground Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
DATA SOURCE
--------------------------------------------------------------------------------------------------------------------
Cyanazine (Rf. Pt. = 1 g/ State Surveys
l) PGWDB NPS NAWWS ---------------------------------------------
IA: SWRL CA: WID
--------------------------------------------------------------------------------------------------------------------------------------------------------
# of Wells Sampled................. 7,468 (in 27 states) * * 686 871 (in 24 counties)
#Frequency & Distribution of 155 in 15 states NA NA NA 0
Detections ( of Wells).
Frequency & Distribution of Wells 22 in 9 states NA 0 0 0
Rf. Pt..
Range of Detected Concentrations trace -29.0 0 < 0.45 0.14 - 0.84 0
(g/l).
Estimated Occurrence Rate NA < 0.1% 0.3% (private wells) 1.2% (private wells) NA
(Statistical Surveys only).
Estimated Number of Wells with NA < 9,450 private wells 18,000 private wells NA NA
measurable residues (Statistical
Surveys only).
Estimated Occurrence Rates & # of NA < 0.1% 0 NA NA
Wells with concentrations > Rf.
Pt. (Statistical Surveys only).
Detection Limit (g/l)..... Various 2.4 0.1 0.12 Various
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 7.--Alachlor Occurrence in Ground Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
DATA SOURCE
--------------------------------------------------------------------------------------------------------------------
Alachlor (Rf. Pt. = 2 g/l) State Surveys
PGWDB NPS NAWWS ---------------------------------------------
IA: SWRL CA: WID
--------------------------------------------------------------------------------------------------------------------------------------------------------
# of Wells Sampled................. 26,856 (in 35 states) * * 686 2,009 (34 counties)
Frequency & Distribution of 543 (in 25 states) * 28 NA 1
Detections ( of Wells).
Frequency & Distribution of Wells > 101 (in 16 states) * NA 1
Rf. Pt..
Range of Detection Concentrations trace - 3,000 4.2 < 0.15 - 6.19 0.02 - 4.76 9.0
(g/l).
Estimated Occurrence Rate NA < 0.1% (< 0.1 - 1.0%) - 0.8% - private wells 1.2% (0.4 - 2.0%) NA
(Statistical Surveys only). private wells
Estimated Number of Wells with NA 3,140 (1 - 101,000) 48,000 private wells NA
measurable residues (Statistical private wells
Surveys only).
Estimated Occurrence Rates & # of NA < 0.1% (<0.1 - 1.0%); 0.02%; 1200 private Various
Wells with concentrations Rf. Pt. (Statistical Surveys private wells
only).
Detection Limit (g/l)..... Various 0.50 0.025 0.02
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 33283]]
Table 8.--Metolachlor Occurrence in Ground Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
DATA SOURCE
--------------------------------------------------------------------------------------------------------------------
Metolachlor (Rf. Pt. = 70 g/l) PGWDB NPS NAWWS ---------------------------------------------
IA: SWRL CA: WID
--------------------------------------------------------------------------------------------------------------------------------------------------------
# of Wells Sampled................. 22,255 (in 29 states) * 240 (in 4 states) 686 107 (10 counties)
Frequency & Distribution of 213 (in 20 states) * 39 (in 4 states) NA 0
Detections (# of Wells).
Frequency & Distribution of Wells > 3 (in 3 states) 0 0 NA 0
Rf. Pt..
Range of Detection Concentrations 0 - 157 0.20 - 3.81 0.1 - 88.0 0.04 -9.00 0
(g/l).
Estimated Occurrence Rate NA 1.0% (private wells) 16% (private wells) 1.5% (0.6- 2.4%)- NA
(Statistical Surveys only). private wells
Estimated Number of Wells with NA 60,000 private wells NA NA NA
measurable residues (Statistical
Surveys only).
Detection Limit (g/l)..... Various 0.025 0.1 0.04 Various
--------------------------------------------------------------------------------------------------------------------------------------------------------
Legend (for Tables 4-8) Data in Tables include data on
identifiable metabolites, shown in italics. Specific degradate
compounds identified by footnote. Numbers in parentheses in rows
displaying estimates for statistical surveys are 95% confidence
intervals for a given estimate. Studies, surveys, and reports
containing the information summarized in Table, denoted by
abbreviations as explained below:
PGWDB = Pesticides in Ground Water Data Base (as summarized in
Ref. 15), which also includes the data reported in the ``state
surveys'' in this Table - thus, ``detections'' as reported in each
column are not additive (although the PGWDB does not include the
detections from the NPS, NAWWS or Ciba statistical studies).
NPS = National Pesticide Survey, Phase I Report (Ref. 10); also
Phase II Report (Ref. 14). Data may be displayed reporting separate
results for community-supply wells (CSWs), serving public community
water systems and rural, private wells. The two categories were
selected for sampling according to different stratification schemes.
NAWWS = National Alachlor Well Water Survey (as summarized in
Refs. 3 and 4); note that estimates of occurrence rates listed in
the Table under the ``NAWWS'' column apply only to rural private
water wells in the ``alachlor use area'' as defined in the NAWWS
design; ascribing Study's occurrence rates nationally would
overstate prospective occurrence. However, the projected number of
wells and/or population exposed take that limitation into account.
Ciba = Large-scale Retrospective G.W. Monitoring Study (for
metolachlor only; Ref. 2).
IA: SWRL= Iowa State-Wide Rural Water Survey (1990); note that
specified occurrence rates in the Table apply to estimated
occurrence in the State of Iowa only.
WI: RWS = Wisconsin Rural Well Survey (1990).
CA: WID = California Well Inventory Database (annual reports;
data contained in Ref. 15).
NA = Not applicable or unavailable.
Trace = Detection below a specified detection limit.
* = See Table 4.
c. Conclusions--Ground water contamination potential. The five
pesticides selected in today's proposed rule exhibit persistence and
mobility characteristics that suggest the capacity to reach ground
water on a widespread basis. This potential is confirmed by the record
of occurrence produced from ground-water monitoring efforts. Each of
the five has been detected hundreds of times in many States, indicating
the breadth and magnitude of ground-water contamination potential.
Moreover, each has been detected at concentrations exceeding its
respective reference point in multiple locations, in different States,
and across a variety of hydrologic and geologic conditions. This, and
the fact that many more detected concentrations of each are within one
order of magnitude (i.e., 10 percent or more) of each reference point,
confirms that each pesticide exhibits the capacity to reach ground
water at concentrations exceeding health-based standards. To EPA's
knowledge, point sources do not explain the range and number of these
occurrences. All five can be reasonably expected to contaminate ground
water at or above their respective reference points. EPA has reached
the tentative conclusion from this data that continued use of these
pesticides without further controls and protective measures constitutes
a clear risk of continued ground-water contamination.
4. Risk conclusions. In summary, EPA concludes that exposure from
these pesticides may present the potential for adverse human health and
environmental effects associated with exposure from these five
pesticides.
These five, while they may differ among themselves in the frequency
and severity of prior detections in ground water, entail a significant
number of detections in multiple States. Among currently registered
pesticides, only these five and aldicarb, which is being addressed by
other regulatory means, have been detected above their respective
reference points in three States or more. Second, these five share a
substantial overlap in use sites and crops, such that each pesticide
could represent a significant alternative to the use of one or more of
the others. This latter circumstance plays a significant role in EPA's
decision to subject all five to SMPs. Leaving one or more of these free
from State management measures might constitute an incentive for users
to substitute that pesticide for one of those subject to SMPs. EPA's
analysis of the contamination potential of these pesticides suggests
that such a course might only increase the occurrence of the excluded
pesticide(s) to a frequency and severity that would rival that observed
for atrazine and alachlor. The practical effect of such an exclusion
might be to worsen the overall quality of the ground-water resource.
EPA has also considered the potential impact associated with the
increased use of substitute pesticides that may result from reduced use
of the five under consideration here. This issue includes two separate
considerations. The first is the possibility that increased ground-
water contamination will result from increased use of substitute
[[Page 33284]]
pesticides not subject to SMPs. EPA acknowledges that there is a
likelihood that other pesticides will be used in substitution for these
five in cases where State measures constrain triazine and acetanilide
use. EPA has analyzed the likelihood for such substitutions in its
Regulatory Impact Analysis (see Unit VIII. of this preamble); in this
analysis the Agency has identified the likely substitute pesticides for
a substantial variety of crops and other uses. Only a few of the
prospective substitutes exhibit similar persistence and mobility
characteristics; upon closer examination, moreover, it is unlikely that
any of the prospective substitutes exhibit as severe a potential for
ground-water contamination as these five candidates. None of the
prospective substitutes have been detected in ground water to the
extent and frequency as these five. Given the substantial evidence
summarized in here that these five are the largest ground-water
contamination risks of any pesticides in current use, EPA concludes
that it is has no reason to anticipate that increased use of
substitutes will result in a greater risk to ground water for the
foreseeable future.
The other consideration is that the increased use of substitutes
might indirectly increase net risks, because of greater risks through
other routes of exposure, such as dietary and worker exposures. This is
a considerably more complex question. EPA believes that these risks
will not measurably rise because of the use of anticipated substitutes.
EPA reaches this conclusion, considering: (1) There will be
comparatively little substitution of use of these pesticides with
potentially more dangerous alternatives (at least compared to an
outright cancellation), since EPA's analysis of impacts concludes that
State measures will permit substantial continuing use of the five
pesticides in question; and (2) none of the anticipated substitutes
pose particularly elevated risks for these other exposure routes at
reasonably expected increased levels of use. EPA has confidence that
none of the substitutes are particularly more toxic, overall and in
relation to particular endpoints, than the five pesticides in question.
For example, none of the prospective substitutes are in Special Review,
for health concerns as the triazines are.
a. Metabolites. At this time EPA does not intend to require that
State Plans provide for monitoring degradates of these five pesticides.
However, EPA would like comments on: (1) Whether it should require
State submissions to address selected metabolites of toxicological
concern; (2) what specific metabolites should be addressed by SMPs; and
(3) what specific SMP provisions should apply to the metabolites.
The Agency notes that relatively inexpensive screening methods are
available for all five of the parent compounds, and for many of their
metabolites. Thus, a State may choose to include degradates in their
monitoring plan, as some already do. Moreover, if additional
information about some or all of these degradates raises concerns in
the future, EPA may revisit this issue. The availability of practical
analytical methods would be an important consideration in asking States
to include degradates in their monitoring plan.
C. Costs and Benefits
The following section completes EPA's proposed determination that
the five pesticides may present an unreasonable risk to the environment
without additional management measures to reduce the chances of their
contamination of ground-water resources, by evaluating the risks
represented by that contamination potential in light of the social and
economic costs that SMPs represent. Costs and benefits under
consideration are conceived on the broadest, most inclusive fashion
(i.e., beyond the direct costs of the SMPs envisioned by this proposed
rule and the benefits of averting human health risks represented by
ground-water contamination). The remainder of this section summarizes
the data, analysis and conclusions contained in the Agency's draft
Regulatory Impact Analysis (RIA) prepared for this rule pursuant to
Executive Order 12866 (see Unit VIII. of this preamble). Those
interested in a more detailed analysis of costs and benefits should
refer to that document.
The assessment of risks and benefits associated with the decision
to make these five pesticides subject to SMPs as a regulatory
requirement takes into account the Agency's policy objective of
prevention, i.e., to act in order to avert reasonably expected adverse
effects to human health or the environment before they may occur. EPA
must exercise its judgement on the basis of an analysis of the
respective costs and benefits of regulatory action in a manner that
takes into account the considerable uncertainty surrounding both. This
entails acting on the basis of less tangible evidence of risk and
considerable degree of uncertainty about both existing and future
ground water contamination and its consequences, and taking
considerable allowance of these uncertainties. It also entails weighing
a detailed and quantified analysis of costs against an array of
prospective benefits, many of which are difficult to describe in
quantitative terms. Such a comparison, between what appear to be
tangible costs and more intangible benefits, presents well-recognized
analytic difficulties. Care must be taken not to let the quantified
factors override consideration of important qualitative factors. In
other words, SMPs will be justified based on a reasoned determination
that the benefits (generally conceived and including elements difficult
to quantify) justify the cost impacts associated with SMPs.
In developing the Strategy (Ref. 12) EPA evaluated a range of
available regulatory options in addition to the State Management Plan
approach. Specifically, EPA compared three general approaches in a
companion document to the Strategy, the ``Pesticides and Ground-Water
Strategy: A Survey of Potential Benefits'' (February 1991; Ref. 13).
This analysis is discussed in Unit IV.D., of this preamble.
In the interests of presenting as full and honest a
characterization of risk and benefit as possible, the Agency will also
point out: (1) The relative magnitude of uncertainty regarding the true
value of a quantity or attribute that EPA is estimating in its
analysis; and (2) the reasons for believing that any specific estimate
or characterization may overstate or understate the true value of such
a quantity or attribute.
1. Costs. EPA identifies four general areas where some level of
adverse economic impact (i.e., both direct and indirect costs) could
result from regulatory action in response to ground water concerns.
Federal program costs are the attributable costs of developing and
justifying regulatory action regarding ground-water protection,
including the assembly and evaluation of ground-water risk data, as
well as expenditures relating to implementation of protection measures.
Current expenditures include the cost of ongoing regulatory and risk
assessment activities pertaining to ground-water protection in the
pesticides program and grants to State pesticide programs to help
sustain the cost of ground-water protection activities and, in
particular, the development of ``generic'' SMPs.
EPA program costs are subdivided into headquarters (HQ) program
costs and regional costs. As should be evident from the description in
Unit II. of this preamble, the larger portion of EPA's effort will
reside with the Regions. EPA estimated its regional-program costs by
estimating a per-SMP average level of
[[Page 33285]]
effort and multiplying by the expected number of State Plans that are
currently anticipated for these five pesticides. EPA's analysis is
calculated on the expectation that 236 Plans will be submitted. This
translates into an annualized cost of $1.1 million for regional
activities. EPA estimates its annual HQ program costs will range
approximately from $413,300 to $437,000 (in current dollars) for the
first 3 years after promulgating this rule, with costs decreasing to an
average of $160,600 annually thereafter.
The margin of uncertainty for EPA's estimate is relatively small
(mostly reflecting the relatively small dollar estimate) and relatively
insignificant with regard to its potential impact on EPA's decision. It
is difficult to determine whether EPA's estimate tends to understate or
overstate the likely actual value of Federal costs, in part since a
substantial proportion of the costs are part of ongoing regulatory
activities. However, any error in EPA's estimate (because of these
uncertainties) is probably more likely to understate the estimate
slightly.
State program costs are the estimated State expenditures for
implementing Federal ground-water protection actions. These include the
costs of developing five pesticide-specific SMPs and of implementing
and enforcing elements of approved Plans and represent a substantial
level of expenditure.
Because the scale of State Management Plans is contingent upon
pesticide usage and aquifer sensitivity-- which will vary not only
between States but also within a given State--the costs of developing,
implementing, and enforcing SMPs are particularly difficult to
generalize. In calculating the costs of SMPs, it is reasonable to
assume that costs will vary directly with the scale of a State's plan.
Finally, several additional factors will influence the eventual costs
of a State's plan. These include: the risk mitigation options available
to State planners; the role of coordination between State agencies and
other governmental bodies; the shifting of costs to registrants; and
technological innovations that may lead to decreasing costs over time.
States have reported (in the process of developing ``generic'' SMPs) a
broad range of anticipated costs (from as little as $17,000, to write a
generic plan to over $1 million, counting in full the conduct of
vulnerability assessments, ground-water monitoring and data base
management), corroborating the assumption of variable State costs.
EPA made some critical simplifying assumptions in developing its
cost estimates: (1) That ``States'' (including territories and some
Indian tribal authorities) would develop and submit State Plans for all
or most of the five pesticides in question before the effective date of
the rule; (2) that the Plans would represent an adequate level of
protection, i.e., would be approved by EPA; (3) that some States would
be obliged to develop SMPs that entailed extensive protection programs
for one or more of the five pesticides, that others would have to
develop Plans with some additional protection and that still others
would have to do little more than minor amendments to their ``generic''
SMPs to provide for future use of any of the five chemicals (based on
an analysis of the current use patterns of the five pesticides); (4)
that virtually all States would submit Plans that would consolidate the
activities related to any and all pesticides as much as possible, so
that substantial costs in ground-water vulnerability assessment and
monitoring, for example, would be shared and not duplicated among
individual-pesticide proposals - a reasonable assumption in this case,
considering in particular the common use areas among these five
candidates and their concentration in areas of high-intensity field-
crop agriculture that would otherwise be of high State concern in any
case; and (5) that the mix of ``extensive'' and less-extensive State
Plans would entail a level of effort that could be estimated on the
basis of a ``model'' SMP activity, that could in turn be extrapolated
from analysis of existing State programs, ``generic'' SMP submissions
and the requirements of pesticide-specific SMPs embodied here in
today's proposed rule and in the Agency's Guidance. The Agency regards
this last assumption as particularly conservative, since the Agency
expects that a significant number of actual Plans will turn out to be
of the less-extensive variety. Pricing every Plan on the basis of a
``model'' Plan will significantly overstate the true costs, since the
Agency constructed the ``model'' to represent a relatively extensive
level of effort.
EPA developed its aggregate State-cost estimate by means of using
an existing State plan (Wisconsin's) as a model or surrogate for
individual State plans. Wisconsin's program was chosen as
representative for several reasons; its ability and readiness to share
its data on program development and costs; and its exemplary nature (in
terms of level and extent of commitment and exercise of risk-management
measures). Furthermore, Wisconsin falls into the range of moderate
vulnerability as measured by several macro-level ground-water
vulnerability indices. However, this latter circumstance is in itself
not the consummate proof of Wisconsin's representativeness (or even
adequate characterization of Wisconsin's relative ground-water
sensitivity), since State situations in terms of vulnerability are so
diverse as to preclude the classification of any State as ``average.''
Finally, EPA did not view the Wisconsin program as the maximum effort a
State might have to exert: not only has the program dealt primarily
with a few, particular pesticides, but it terms of general ground-water
contamination risk, Wisconsin may not represent the greatest degree of
vulnerability.
EPA, in its analysis, took into account both the one-time costs of
a Wisconsin-type program (annualized over either a 5- or 10-year
period) and estimated annual incremental costs to arrive at a range of
estimated annual State expenditures. One reason for using Wisconsin's
experience as a model is the fact that it has performed some of the
initial activities necessary to implement an SMP, enabling the Agency
to model such activities as the establishment of pesticide usage
surveys, vulnerability assessment, soil susceptibility mapping, other
data base creation, monitoring (establishing and sampling sites),
maintenance of records, personnel, public awareness and education, and
other miscellaneous costs of plan development.
EPA estimates State programs on the average may annually cost in
the range of $250,000 to $750,000 during the first several years of
implementation, with $500,000 as the average annual cost. Successive
SMPs required by the Agency will undoubtedly require less new effort by
the States, so that incremental costs would be expected to decline over
the long run. EPA took this expectation into account in its estimate of
State program costs, projecting that each State, in developing multiple
SMPs for these five pesticides, would incur some economies by
developing Plans with common elements. Therefore, national costs were
calculated by positing one per-SMP cost estimate ($500,000) for a
single Plan, and fractional estimates for accompanying Plans.
Calculated on this basis, if States and territories were to implement a
total of 236 SMPs (EPA's current estimate of States' intentions), their
total annual cost of implementing this regulation would be $ 59.9
million.
The Agency wishes to emphasize that the use of a ``model'' level of
effort, based largely on one State's experience, is for purposes of
estimating the costs
[[Page 33286]]
and benefits of this proposed rule. The analysis is not meant to
represent pre-conceptions about the contents of State submissions.
State Plans could depart substantially from the details presented in
the ``model.'' Such differences could be caused by the State's
particular situation (varying in size, ground-water vulnerability, and
pesticide use patterns from the model) or by an innovative approach
that EPA has not anticipated. These Plans would be found adequate to
the extent States could demonstrate to the satisfaction of the
reviewing Region that they assure adequate protection. At the same
time, the Agency believes that it has projected the particulars of the
``model'' Plan in a manner that depicts the kind of effort necessary to
meet the objectives of this proposed rule. To that extent, EPA offers
the State-cost analysis as a reasonable basis for evaluating the cost
and benefit of this rule.
Moreover, the Agency wishes to emphasize that the estimate of $59.9
million is the annual average of aggregate State costs over a 10-year
period. As such, it represents: (1) The amortization of high one-time
costs, such as drilling monitoring wells or performing baseline
vulnerability assessments; and (2) several years of operation of fully-
developed, mature State programs. Under no circumstances should the
figure be construed to be the immediate, first- (or even second-) year
costs the States will incur. As stated in Unit III. of this proposed
rule, EPA anticipates that States can be expected to have to phase in
``capital'' elements of an SMP (e.g., the development of monitoring and
vulnerability assessment activities).
EPA's assumption of broad State participation (that all States will
develop Plans for most of the five pesticides, and that many will
develop Plans for all five) may appear to be particularly tenuous,
since there is no compulsion on the States to develop such Plans,
beyond the loss of the legal use of a pesticide within the State. The
consequences of error in this assumption are two-fold with respect to
estimating costs: (1) EPA's estimate of State costs may overestimate
actual State costs, because the Agency has over-estimated State
participation; but (2) in that event, EPA's estimate of user impacts
might be low. Since the absence of an acceptable SMP would result in
prohibition of a pesticide's use in a State, more user impacts may
result than EPA has estimated. The fact that the effects of error in
this assumption are at least potentially offsetting reduces the
Agency's concern.
EPA has confidence in the validity of assuming maximum State
participation, however. First, the Agency believes the States have
strong incentive to avoid these increased impacts to its own users by
developing Plans. This belief is bolstered by the strong evidence of
the States' interest in assuming the responsibility for managing
pesticide use to protect ground water (for example, the near-universal
acceptance of grants and development of ``generic'' SMPs). At the same
time, EPA has little alternative to such an assumption. EPA does not
have any basis for estimating which or how many States might fail to
implement plans, beyond current informal communications between EPA
regions and the States. Finally, it seems reasonable to assume the
States least likely to participate are those with the least incentive
to do so (i.e., those with little or no current or projected use of the
pesticides), so that their non-participation would have comparatively
little effect on current use (and consequently little user impact).
Among the other sources of EPA's uncertainty of its estimate are
the inherent variation in the size and level of agricultural activity
across States, and the anticipated variation in State approaches,
ground-water protection objectives and the like. EPA does not believe
the margin of uncertainty in its estimate exceeds the magnitude of the
estimates. Among the reasons for believing EPA's estimate
underestimates the true impact of regulatory action are unanticipated
difficulties or obstacles in State implementation of its requirements
(such as unanticipated non-compliance, necessitating substantially more
enforcement activities), as well as those considerations described
above. In addition, EPA has not taken into account potential increased
costs of Federal-State enforcement of sale/use prohibitions for those
States that fail to develop Plans. For the reasons explained above in
describing the assumptions, EPA does not anticipate many States will
not develop approveable Plans for all five pesticides. For those few
cases that may arise it is EPA's expectation that enforcement and
compliance costs will be minimal, since part of the reason for State
disinterest in developing SMPs for these pesticides will be their
insignificant use in the State. Among the reasons for anticipating that
EPA's estimate overstates the true level of State expenditures would be
the deliberate conservatism in pricing aggregate State costs on the
basis of a ``model'' Plan that represents substantial effort, limiting
the estimate of economies-of-scale achieved by developing multiple SMPs
and the possibilities for innovations in ground-water assessment and
monitoring techniques (particularly the latter).
Registrant (or pesticide-industry) impacts are those that would be
the direct result of regulatory action, apart from any anticipated loss
of income from reduced use of the products attributable to regulatory
restriction. Attributable costs would include: (1) The lost revenue
associated with decreased use of the products, caused by State risk-
management measures; (2) the costs of increased technical assistance
(such as ground-water monitoring) and outreach to users that the
registrants might provide, to help them ascertain and follow the new,
applicable State management measures or other safeguards on the
chemicals' continued use; and (3) the direct costs of relabeling and
compliance with the administrative provisions of this proposed rule.
The first category, lost revenue, was calculated as a function of
likely State actions, which in turn are represented as three scenarios
of differing regulatory stringency. Projected annual lost revenues for
a ``medium impact'' scenario was calculated to be $33.6 million. Using
current sales figures from the major registrants of these five
pesticides, this figure represents an estimated 0.06 percent decrease
in total sales, and a 0.48 percent decrease in pesticide-product sales
for these registrants. The estimated costs in the second category are
those that are incremental to ongoing ground-water monitoring,
technical assistance or outreach efforts the registrants now perform
with regards to ground-water protection. They are estimated to be in
the range of $3.1 to 12.7 million annually, conceived as substantial
new ground-water monitoring activities performed in addition to State
efforts. These costs can also be attributed to the possible new ground-
water monitoring requirements that EPA may prescribe on registrants
concurrently with State development of SMPs (see Unit III. of this
preamble). While EPA has not committed to the development of such
requirements at this time, the Agency nevertheless includes a cost
estimate for the activity in the interests of not underestimating
costs. Uncertainties include EPA's actual specification of those
requirements, the level of effort represented by that specification,
the identification of further technical-assistance activities and their
delineation from ongoing regulatory efforts.
By far the most substantial impact (in terms of relative magnitude)
is anticipated to be impacts on agricultural
[[Page 33287]]
and non-agricultural users, and associated indirect impacts of reduced
consumer benefits. These impacts pertain to the changes caused by
regulatory restrictions in use of pesticides and the consequent changes
in agricultural (and other economic) productivity and expenditures. In
addition to being the largest component of cost, its magnitude is the
most uncertain and difficult to estimate. Estimating these impacts
entails an econometric analysis with consideration of a multitude of
cascading secondary effects across geographic regions and economic
sectors and with estimated impacts expressed through a variety of
economic measures. These difficulties are compounded by the necessary
consideration of the combined behavior changes of perhaps a million
affected farmers and other users, the normal uncertainties in the
agricultural sector (the effect of weather, etc.) and the like.
EPA attempted to anticipate as many of these interactions and
uncertainties as possible by using a widely used multi-sector, multi-
regional econometric computer simulation model called AGSIM. The
analysis was performed to take into account not only regional
variations in commodity supply and production (i.e., varying responses
to changes in per-acre yields, variable costs, and prices) but also the
present and projected influences of farm policy elements (e.g., Federal
price-support and conservation programs, Federal monetary policy, etc).
These measures aggregate into separate (and additive) dollar estimates
of the combined impact to the agricultural-production sectors
(expressed as the change in net agricultural production and income) and
the consequent decrease in domestic-consumer benefits (sometimes
referred to as ``surplus value,'' or the amount of additional consumer
expenditures to maintain the same standard of living as reflected in
the ``baseline'' conditions, prior to a regulatory action).
In order to estimate impacts it is necessary to estimate certain
effects of the SMPs and use these as inputs to the econometric model.
Specifically, a critical task was to estimate how State risk-management
measures would influence: (1) The acreage where these five pesticides
are used; (2) yield impacts; and (3) input (i.e., pesticide-chemical)
cost impacts. Thus, SMP impacts on users are estimated by a matrix of
combinations of these three factors (taking the availability of non-SMP
pesticide substitutes into account) and the consequent change in crop
yield and price. The critical measure of impact is the reduced treated
acreage associated with State risk-management measures. These values
must be regarded as a proxy for the variety of potential effects that
SMPs may have on agricultural practices. They are not intended to
represent a forecast of actual State practices, but rather a surrogate
measure of their potential effect on agricultural practices.
These estimates were made by consultation with a variety of
sources. Affected acreage was identified by the use of a Ground-water
Vulnerability Index for Pesticides designed by Robert Kellogg of USDA's
Soil Conservation Service. A percentage of these affected acres was
assumed to be subject to either restricted or prohibited use under
State Management Plans; this percentage varied according to impact
scenario and was based upon the 1992 Wisconsin Atrazine Rule. EPA tried
to account for the considerable uncertainty about the impact of State
management measures by positing a variety of reduced-use scenarios
across the principal use areas of these five pesticides. EPA believes
the most-likely estimate of user impacts rests with its medium-impact
scenario, but has provided companion low- and high-impact scenarios for
comparison. The Regulatory Impact Analysis accompanying this proposal
provides a fuller explanation of EPA's estimates and the methodology
used to derive them. The SMP-use restrictions have the anticipated
effect of lowering expected yields and pesticide input costs.
Restrictions on application rates lower pesticide input costs since
total usage declines; use prohibitions also lower costs since the cost
of alternative pesticides are less than that of the SMP pesticides.
Crop producers are actually expected to be better off in terms of net
crop revenues as a result of such restrictions, due to the combination
of increased prices obtained for affected commodities and reduced input
costs. Increased commodity prices are predicted due to reduced acreage
planted, which in turn, decreases the total supply of a particular
commodity. However, increased prices resulting from reduced supply are
a net negative impact to the economy overall, in the form of reduced
consumer surplus value.
At the same time, increased feed crop (corn, soybean, sorghum)
prices raise input costs for livestock producers. Coupled with stagnant
or declining demand for livestock products, increased input costs
negatively impact livestock returns in this analysis by reducing
livestock revenues. Because the reduction in livestock returns is
estimated to be greater than the increase in crop returns, net impacts
to the U.S. agricultural sector are negative, but relatively minor (-$1
million to -$11 million, across the three scenarios).
Correspondingly, indirect impacts, in the form of reduced consumer
benefits, are estimated to be in the range of $242 to $254 million.
While the absolute magnitude of such impacts appear to be
substantial, in relative terms such impacts are moderate. Relative to
the economic value of U.S. field corn production ($16 to $23 billion),
such impacts are small. For example, the SMP-use restrictions are
anticipated to lower U.S. field corn production by about 1 percent,
leading to a potential 1.1 percent increase in market prices. Such
impacts would have a de minimis effect on the Gross Domestic Product.
Average annual consumer expenditures and food prices would change less
than $1.00 per person (from $0.94 to $0.98) as a result of these
impacts. Individual farmer income in the aggregate would also change
little, but regional effects of greater magnitudes (both positive and
negative) could occur.
This range of projected impacts compares to impacts of $ 3.6
billion or more in combined user costs and reduced consumer benefits,
associated with either outright cancellation of the five pesticides
(plus aldicarb, which had minimal costs associated with its management)
or more stringent, nationwide use restrictions, as estimated by Taylor,
et al. in 1991, using a similar econometric approach.
EPA's method for estimating user impacts, like its projection of
State-program costs, relies on some key simplifying assumptions: (1) A
degree of regulatory restriction will translate into a discrete (and
predictable) level of decreased (or alternative) pesticide use,
resulting in predictable adverse effects to agricultural production and
the other relevant economic effects summarized above; and (2) the
scenarios vary (predictably) in the degree of regulatory restriction
they represent, and this difference can be expressed in terms of the
cropped acreage subject to reduced, substituted or eliminated pesticide
use. Among the reasons for anticipating that EPA's estimate understates
the true potential impact of ground-water protection measures are: (1)
That the analysis pertains only to uses on field crops (which, however,
represent over 90 percent of the combined current use of these five),
overlooking the potential impact on fruit and vegetable crops; and (2)
that EPA assumes all States will participate, so that no greater
restrictions on use will ensue from the fact that State inaction causes
a
[[Page 33288]]
complete curb on use. However, EPA has equal or greater reason to
believe its estimate overstates the actual potential impact; chief
among these is faith in the States' ability to develop a variety of
innovative management measures that will minimize the disruption in
crop production caused by ground-water safeguards. State
resourcefulness in developing new approaches will undoubtedly outrun
the Agency's present expectations. It is already clear, for instance,
that States will emphasize measures that will enhance the
sustainability of agricultural production simultaneously with ground-
water protection, preserving much of the necessary use of the
pesticides in question. Also, inevitable improvements in ground-water
monitoring and vulnerability-assessment techniques will enable states
to ``fine-tune'' necessary restrictions to a degree EPA cannot yet
anticipate in its estimate. In addition, in developing its estimates of
crop yield losses, EPA did not take into account the considerable
promise that is subsequently emerging in the areas of integrated pest
management and other reduced-use strategies.
In summary, it needs to be stated that in distinguishing the
various costs that may be attributable to Federal regulatory action for
purposes of weighing the costs and benefits of any action, EPA did not
attempt to assess the reasonable likelihood that a particular category
of parties would actually incur the costs. For example, the boundaries
between ``State'' and ``registrant'' costs may be considerably more
blurred than our analysis would suggest. A variety of activities
attributed to the States in managing the use of a pesticide subject to
an SMP rule (including those involving substantial levels of effort,
such as ground-water monitoring or user education and outreach), for
example, could in practice be either performed (in part or in whole) or
paid for (either directly or through State imposition of fees) by the
registrants. Likewise, some of the activities identified by EPA as
``registrant costs,'' e.g., the provision of increased user training
and technical assistance, could be expected to be performed often at
the behest of State agencies pursuant to their Plans. Accrual of
expenditures accurately to the various parties was of less importance
to EPA in making this analysis than was concern for the projection of
overall level of effort and expenditure attributable to this rule.
2. Benefits. Chapter 7 of the RIA contains the Agency's appraisal
of the potential benefits associated with establishing SMPs for these
five pesticides. This appraisal begins by cataloging the different
kinds of values associated with protecting ground water as a natural
resource. These values are categorized in terms of their various
services as a resource. This categorization follows a recent Agency
conceptual framework for assessing the economic value of ground-water
protection in evaluating regulatory impacts (Ref. 19). Each of these
service values, (associated with two general functions of ground water:
both as a source of water stock and as a discharge to surface water
supplies) may be subject to a variety of economic valuation techniques.
FR Doc. 96-16173 Pesticides and Ground Water State Management Plan Regulation
Since these categories generally involve the value of the resource in
terms of its economic use, other categories of value recognized by
natural-resources economists must also be acknowledged: the so-called
altruistic, bequest, and existence values (sometimes referred
collectively as ``non-use value'') associated with protecting a natural
resource per se.
In general, however, the benefits of SMPs will accrue from the
reduced levels of ground-water contamination, by substances associated
with adverse human and/or environmental effects, that result from the
regulatory safeguards required by the individual Plans. It is the
presence of this contamination that jeopardizes any and all of the use
and non-use values under consideration.
In order to perform a reasonable quantitative analysis of benefits,
accurate and reliable estimation of exposure levels (both existing and
projected, and in the case of the latter, projected for a number of
different regulatory options) are critical. Unfortunately, reliable
estimation of ground-water contamination occurrence is among the most
difficult and uncertain issues with regards to ground-water concerns.
Past and current efforts at ground-water monitoring have not been of a
sufficient level and frequency to give adequate assurance that the
Agency knows the levels of occurrence of pesticide contamination of
ground water, either of the specific pesticides addressed in this
proposed rule or of pesticides in general.
The United States Department of Interior, in comments submitted to
EPA regarding the proposed Ground Water Restricted Use Rule (in 56 FR
22076, referred to in Unit I. of this preamble), characterized the
state of knowledge associated with the nation's ground-water monitoring
efforts as follows: ``Given shortcomings in national ground-water
monitoring efforts, it is highly unlikely that all locations of all
contaminants in ground water have been determined.'' [July 5, 1991
letter from Jonathan P. Deason, Director, Office of Environmental
Affairs; exhibit 7 in OPP comment file no. 36172]. While not
necessarily reflecting the views of EPA, these comments are testimony
to the limitations associated with the evidence of contamination from
current ground-water monitoring results, particularly the substantial
likelihood of under-estimating the present and future level of
exposure. Other methods of estimating prospective occurrence, such as
projections from data on the leaching potential, volume and location of
use of a pesticide or projections using environmental-fate-and-
transport models, have even greater limitations (see, for example,
National Resource Council, ``Ground Water Vulnerability Assessment,''
NAS Press, 1993, for a fuller description of the strengths and
weaknesses of various ground-water analytic techniques).
The consequences of this potential under-measurement of present
ground-water contamination has another dimension. Since known ground-
water contamination is particularly localized, it is characterized by
the incidence of limited ``hot spots'' of high concentrations.
Occurrence of ground-water contamination is unevenly distributed, due
to the variety of hydrologic and topographic factors. Locations of high
concentrations of pesticides (and a corresponding high risk of
potential adverse effects) in ground water are dispersed unevenly
across the country. The overall profile of the risks associated with
pesticides in ground water, then is one of large numbers of people at
relatively low risk, punctuated with ``hot spots'' of higher risk. The
risk concentrated in these ``hot spots'' are likely to exceed national
average risks, but are difficult to characterize using aggregate
occurrence estimates. This unevenness in the distribution of risk
levels raises concerns regarding ``environmental equity,'' to the
extent that effects are disproportionately high and adverse, which the
Agency is committed to take into account as a matter of policy.
Finally, it should be noted that taking the next step of
quantifying human health risk by combining population exposure figures
with some benchmark of toxicity associated with a unit quantity of
exposure, is hampered by limited methodologies for quantifying hazard.
At present, the Agency customarily confines hazard quantification to
carcinogenicity (e.g., projecting ``number of cancer cases avoided''),
while the possible consequences of other toxicological endpoints cannot
usually be presented with the same appearance of precision.
[[Page 33289]]
Despite the limitations on available evidence and methodologies
discussed above, as a matter of illustration the Agency has presented
in the RIA a number of different estimates of nationwide human exposure
to these five pesticides in drinking water using ground-water sources.
These alternatives represent different data sources and estimation
methods. Three of these data sources have been referenced earlier in
Unit IV. of this preamble: the Pesticides in Ground Water Data Base,
the National Pesticide Survey and the National Alachlor Water Well
Survey. Another estimate is based on the application of a modeling
procedure, i.e., the application of an environmental-fate model using
assumed values for prevailing hydrogeological conditions across all
local areas where corn pesticides are used. This estimate is provided
in a yet-unpublished Agency analysis of the cumulative risks and
benefits of a host of pesticides frequently used on corn, a so-called
``corn cluster'' analysis. A copy of this analysis is available in the
public docket for this rule-making.
The Agency presents these alternative estimates without making a
judgement that one estimate is superior to another, or that any (or
all, considered collectively) can be considered a reliable estimate of
nationwide exposure and hence, national risk. Three of the four
analyses provide estimates of both: (1) the number of individuals
exposed to any measurable concentration of these five pesticides (or,
in the case of the NPS, a surrogate estimate of ``total pesticide''
exposure); and (2) the number of individuals exposed to concentrations
at or above health-based ground water reference points. The model-based
estimate also estimates total population with any exposure, but offers
a calculation of baseline cancer and non-cancer risk in place of the
number of individuals exposed above reference points.
It is notable that when viewed together, there is a wide variation
in central-tendency estimates of population exposed among the studies,
as well as considerable uncertainty surrounding each estimate, taken
individually and together. For example, best estimates derived from the
available statistically-based studies of total population exposed to
any concentration of the five pesticides, from domestic wells alone,
range from a few hundred thousand to as many as 5 million. Estimates
from the non-statistically based Pesticides in Ground Water Data Base,
which does not differentiate private and public well occurrence, range
to more than 20 million. More importantly, the estimated numbers
exposed to high concentrations range from nearly none to one-half
million people or more; taking estimates of random error into account,
the number exposed above health-based standards could theoretically
also be as high as 20 million. Estimates from the Data Base for this
subset run as high as 2.84 million people.
In addition, each of the four estimations discussed has specific
shortcomings which need to be recognized before relying on any
estimate, considered either individually or together, as a credible
basis for estimating the benefits of the rule. Some of the problems to
be aware of with these studies are: (1) Most fail to account for the
entire nationwide exposure potential, leaving out parts of the total
exposed population (e.g., those drinking from community water systems);
(2) not every data source addresses precisely the five pesticides in
question; (3) most are based on limited and imperfect monitoring data
(i.e., data from surveys with design flaws, or data that are not
statistically based), and the modeling exercise is not based on
monitoring results at all; (4) all of them measure or estimate the
frequency and concentration of well contamination and not human
exposure per se, which means that certain unverified assumptions were
made regarding the numbers of people drinking well water to produce
population-exposure estimates; and (5) they all produce estimates that
are highly uncertain, for example, with the potential for random error
(among the statistically designed studies) represented by 95 percent
confidence intervals ranging from zero to the hundreds of thousands.
One method (based on the PGWDB) is based on a larger amount of well
water sampling, but such sampling is not statistically based, so no
estimate of the degree of expected random error in the estimate is
possible.
Given the wide range of divergent estimates, and the significant
limitations on their reliability, the Agency cannot reasonably identify
a single ``best estimate'' of prevailing exposure to the SMP pesticides
in ground water. The Agency believes that the evidence of substantial
contamination of ground-water-based drinking water supplies, indicated
by the data summarized in Unit IV. of this preamble, provides reason to
believe: (1) That many individuals (running up to the thousands, or
even hundreds of thousands) are or will be consuming ground water
contaminated by one or more of these pesticides at levels above health-
based standards, in the absence of effective, localized risk-reduction
measures as envisioned in SMPs; and (2) that many more individuals
(running into the millions) are or will be consuming ground water with
at least detectable levels of contamination. While concern tends to
focus on the former subset, SMPs can be expected to substantially
reduce the exposure to the larger population as well. The Agency
further believes that the potential health risk represented by this
magnitude of occurrence/exposure bears a reasonable relation to the
magnitude of the economic impacts discussed in the section above.
The uncertainty surrounding the actual levels of individual
exposure makes it very difficult to take the next step, that is,
combining indications of toxicological potency with the estimates of
exposure to obtain an estimate of human health risk. Where the
particular study cited presents no estimates of population risk
associated with the estimated exposure, the Agency has not developed
any subsequent estimates. However, one of the studies (the modeling-
based analysis associated with the Corn Cluster) offers both estimates
of cancer and non-cancer population risks. The analysis suggests that
these five pesticides together represent about 0.4 excess cancer cases
per year, given a 3-meter depth of ground water as a drinking water
source. The preponderance of this risk comes from one chemical alone,
atrazine. The analysis arrives at an estimate of maximum individual
cancer risk at this depth of 2 x 10-4. To put the magnitude of
this risk into perspective, as a measure of risk in hotspots, is to
note that it is roughly twice as great as the incremental lifetime risk
that this analysis estimates for the dietary pathway, about 8 x
10-5 for an individual of average exposure. A less conservative
assumption that a 1 meter depth is representative of ground water
recharge leads to an estimate of about 5 statistical cancers a year,
with a corresponding estimate of maximum individual cancer risk of 3
x 10-3, or nearly 40 times the average dietary estimate stated
earlier. However, given that neither estimate can be regarded as a
direct representation of ground-water exposure (since the model only
simulates the loading to ground water via percolation through crop root
zones), the Agency regards neither estimate as authoritative. In
particular, the Agency has reason to believe the 3 meter estimate
understates ground-water occurrence, based on the Agency's
[[Page 33290]]
experience with controlled field-scale studies, and describes this
experience in Chapter 7 of the RIA. In addition, it is very likely that
the cluster analysis underestimates the risk posed by pesticides other
than atrazine. Specifically, risks presented by alachlor and simazine
should be only slightly less than that of atrazine, based on the
monitoring record.
The Agency is not attempting to authoritatively quantify the risks
of ground-water contamination by these five pesticides, nor to monetize
the value of avoiding these risks. The Agency believes such estimates
are difficult to support scientifically, under these circumstances. The
Agency solicits comment on the reliability of risk estimates that may
be developed from these exposure estimates cited above, or from other
sources.
Beyond the difficulties of characterizing the magnitude of
potential human exposure to these pesticides in drinking water, absent
the risk reduction afforded by SMPs, there remains the question of how
effective SMPs will be in reducing that risk. The main impediment to
the evaluation of SMPs' prospective effectiveness is the fact that
individual SMP provisions remain to be set. However, even making some
assumptions as to the general features of future SMPs, there remains
the problem of estimating ground-water contamination occurrences. As
mentioned earlier, present levels of ground-water monitoring are
inadequate to gauge the levels of overall ground-water contamination
with confidence. Alternatives to monitoring, e.g., environmental fate
models, are not yet developed to provide an adequate substitute to
monitoring results.
However, what little evidence is available to the Agency appears to
support the conclusion that the risk-management measures contained in
SMPs are likely to be effective in reducing the occurrence of ground-
water contamination. The most reasonable approach to assessing the
prospective effectiveness of SMPs is to consider the closest existing
analogue to SMPs, i.e., the performance of existing State-imposed
localized risk-reduction measures. Very few such analogues presently
exist, but there is recent information that the Wisconsin atrazine use
restrictions referred to earlier have resulted in an overall reduction
in atrazine concentrations in contaminated wells.
In 1995, the Wisconsin Department of Agriculture, Trade and
Consumer Protection (DATCP) conducted an extensive analysis of atrazine
and its metabolites in drinking water wells located within risk-
management areas imposed by the Department beginning in 1992, which had
been previously monitored (Ref. 22). Seventy-six (84 percent) of 90
wells sampled in 1995 declined in total atrazine concentration, and 16
percent increased. For the 76 wells that decreased in concentration,
levels decreased an average of 2.5 parts per billion (ppb). While the
re-sampling of these wells generally occurred in one time period, from
June to September 1995, the study compares these results to a baseline
sampling frame that varies for each well. Each well was sampled with
varying frequency across a period that spans from March 1990 to
September 1994. Relative to the State standard, 57 percent of a
slightly larger universe of 111 wells (encompassing the 90 cited above)
are now below 3 ppb (with an average concentration of 1.4 ppb). The 43
percent of wells still above the 3 ppb standard had an average
concentration of 5.9 ppb. The overall average concentration for the 111
wells is 3.3 ppb. While the report attributes the reductions in
contamination to the use reductions, it was less able to explain the
reasons for the occasional increases. However, the report mentions
several plausible reasons, including the possibility that these wells
are deeper (and so experienced higher levels of contamination from pre-
controlled atrazine use later than the norm), or are located in more
recently designated areas, or were affected by continued illegal use or
spills near the wells. These are in addition to the common-sense
explanations, i.e., the natural variability in sample results over time
and/or metabolite contributions from non-prohibited triazine use in the
areas (because atrazine, simazine, and cyanazine have some common
degradation by-products that will be detected by first-round analytic
methods). These data provide some evidence that state risk-reduction
measures seem to have a beneficial effect, reducing both the number of
occurrences of pesticide contamination in affected areas and the level
of that contamination.
In addition to health effects, the Agency believes that the
possibility of resource effects need to be acknowledged and considered
in the decision whether to exact further regulatory protection for
these pesticides. There are two major considerations. First is the
adverse effect to ecosystems linked to ground-water sources. The
scientific basis for estimating such things as the location, frequency,
and duration of sensitive-ecosystem exposure to such ground-water
contamination is less developed than even the limited information
discussed above for human exposure. At the same time, the risk of
ecological adverse effects is certainly a real possibility, and should
not be discounted merely out of lack of currently available scientific
means of ascertaining it. Second, there is an even more inestimable,
but nonetheless relevant, concern over the intrinsic or future value of
ground water as a resource, as free of man-made pollution as may be
practicable. Studies that estimate ``willingness to pay'' based on
survey methodologies have suggested proxy values of substantial
magnitude, which if extrapolated to national scale, amount to billions
of dollars, but the estimates from this controversial approach have
uncertain applicability. One can hypothesize a threshold willingness to
pay commensurate to the estimated costs of this proposed rule, which
would compare favorably to the results of previous studies.
Specifically, if an estimated 5 to 8 million potentially-affected
households (an estimated 15 to 20 million potentially exposed
individuals divided by the national-average per household population of
2.64) were willing to spend between $47 to $63 annually, these sums
would be commensurate with the $356 million projected cost of the SMP
rule. EPA believes that these estimates are well within the range of
expectations, but only a carefully conducted survey, expressly
clarifying the expected risk-reductions specifically associated with
SMPs, could confirm these expectations. Likewise, prevention is a value
that EPA subscribes to because the costs of prevention can be expected
to be much lower than the costs of remediating contaminated ground
water when and if it occurs.
The fact that the dimensions of risk and the effect of risk-
reduction efforts are both highly uncertain dictates a policy to
proceed cautiously and with maximum flexibility. The Agency believes
the prudent course in the face of the uncertainties presented by
pesticidal ground-water contamination is to take positive action that
avoids irrevocable national policy courses at the outset that might
lead to programmatic dead-ends. The Agency believes this is the essence
of the SMP approach, and that this is the most practical policy course
from among the regulatory alternatives.
EPA therefore recognizes the lack of information necessary to
calculate quantifiable benefits that may be associated with the SMP
approach. However, the States, in electing to participate, will have
made a practical
[[Page 33291]]
evaluation of both the real and intangible benefits of ground-water
protection measures, and their participation will represent the choice
for prevention over remediation. These States will have evaluated the
benefits of participating relative to their respective environmental
policy philosophy and goals and on the State economies depending upon
pesticide use.
D. Risk-Benefit Conclusions
Based on the information currently available, it is EPA's reasoned
determination that the benefits of preventing ground-water
contamination by these five pesticides justify the expected costs of
implementing preventive measures through the SMP approach, and further,
that the SMP approach appears to be the most cost-effective of the
means available for protecting ground water.
EPA believes that the level and nature of protection to be afforded
by SMPs is appropriate to the magnitude and character of contamination
potential indicated by the evidence. In developing the SMP approach in
cooperation with a broad spectrum of interested parties from the public
and private sectors, there was much discussion of the alternative
approach of having EPA impose national-level risk-reduction measures,
such as labeling or use restricted to certified applicators. That
alternative is discussed in Unit III. of this preamble and is being
offered for comment in this proposal. The Agency wishes to point out,
however, several factors which led EPA to propose the SMP approach
rather than the national-level restrictions approach.
The main issue is whether label changes alone, or in combination
with restricted use classification, and perhaps additional requirements
placed on the registrants would be sufficient to address the risks of
ground-water contamination. The evidence of each of the five
pesticides' ground-water contamination risks suggests no particular,
specific circumstances causing such contamination. The evidence of
present ground-water contamination is so broad and general that it is
unlikely that a pesticide user could readily identify a specific
condition that would, to a high degree of certainty, cause the
pesticide to contaminate ground water. Consequently, it seems
questionable whether clear and simple label instructions could be
developed that would adequately identify conditions for a user to avoid
such that ground water risks would be significantly reduced or
eliminated. Many ground water experts, including EPA staff, believe
that reliable neutralization of the risks requires a knowledge of
technical, site-specific factors that most pesticide users cannot
reasonably be expected to possess. Furthermore, as a matter of policy,
EPA believes that the users of pesticide products should not be given
the burden of interpreting label instructions that are either
unreasonably complex or technical, or are uncertain to achieve their
purpose. The training associated with classification for restricted use
may alleviate some of this concern, but would not address the issue of
whether label restrictions would actually work.
If this alternative approach were to include monitoring
requirements to demonstrate effectiveness, and use prohibitions if
specific detection triggers were met, then this approach might well end
up being substantially more onerous to both users and registrants than
SMPs. The Agency is requesting detailed comments on this alternative
from all potentially affected parties.
In considering the issue of national-level labeling measures, EPA
has taken into consideration the fact that new risk-reduction measures
have recently been in effect for atrazine (since 1992) which are
intended to reduce the pesticide's contamination potential for both
surface and ground water. These measures include label changes
providing for the deletion of certain non-crop uses including highway
and railroad rights-of-way, reduction of the rates of application for
remaining crop uses and the imposition of set-backs (non-application
zones) for wells and bodies of water, prohibiting use and mixing/
loading within specified distances from surface waters and drinking
water wells. These measures have not been in place long enough for EPA
to discern any positive effect on the ground-water contamination
potential of this pesticide. However, when EPA agreed to these risk-
reduction proposals (which were voluntary measures proposed by the
registrant), it made clear that additional measures would have to be
considered. Furthermore, the Agency is taking into account the
voluntary phase-out and eventual cancellation of cyanazine, announced
in August 1995 (see 1., below). Finally, EPA is anticipating that all
the pesticides ultimately subject to SMPs will also be classified for
``conventional'' restricted use, that is, restricted to use by or under
the direct supervision of a certified applicator.
In the Strategy EPA committed to considering existing State and
local measures in making its regulatory decisions about pesticides with
ground-water concerns. To EPA's knowledge, a total of 10 States have or
are working on some kind of independent restriction for one or more
pesticides with ground-water concerns. However, not all of these apply
to the five pesticides discussed here. Another 12 States have some
authority to impose such restrictions, but have heretofore not employed
it. From a national perspective, this level of effort appears to be
inadequate to address the extent and character of ground-water
contamination potential associated with these five pesticides. It
appears that, in the main, States are anticipating that this proposed
rule requiring pesticide-specific SMPs will serve as the framework for
their own efforts in this regard.
Finally, it is EPA's belief and expectation that SMPs should
sufficiently reduce the risks associated with the ground-water
contamination potential of these five pesticides, so that full
cancellation of use based on ground-water concerns alone is not likely
to be necessary. While the potential risks represented by these five
are substantial and warrant the imposition of effective preventive
measures, the measures to be taken by the States should be adequate to
mitigate the risks.
A remaining issue is whether the risks associated with ground water
may combine with other routes of exposure for any of these five
pesticides to constitute an unreasonable risk and thus warrant
cancellation. EPA customarily uses the Special Review procedure to
determine whether the combination of different routes of exposures
represents unreasonable risks. Alachlor and cyanazine have been subject
to Special Reviews in the past, and the three triazine active
ingredients (atrazine, simazine, and cyanazine) have just recently
begun Special Review. Any or all of these five may be subject to this
further consideration in the future. In such Special Reviews, EPA will
take into account the level of risk-reduction expected to be afforded
by SMPs in making an evaluation of the pesticides' overall risk to
human health and the environment.
1. Cyanazine special review. The recent agreement between the
Agency and DuPont Agricultural Products, the principal registrant of
cyanazine in the United States, to phase out and eventually terminate
sale and use of cyanazine, affects this proposed rule. On August 4,
1995, DuPont signed an agreement with EPA whereby DuPont will amend its
registration to: (1) Reduce the maximum use rates on cyanazine labels
in four increments,
[[Page 33292]]
from 1997 to 1999; (2) cease production and sale at the end of 1999;
and (3) prohibit all uses of cyanazine by the end of the year 2002.
This arrangement will resolve the Agency's concerns with respect to
cyanazine in its Special Review of the three triazines. EPA will soon
publish its termination of the cyanazine Special Review. However, EPA
will proceed with proposing cyanazine to be subject to SMPs in this
rule, for several reasons. First, until the Special Review is
officially terminated and the registrant's voluntary actions go into
effect, the ground-water risks enumerated in this notice will remain,
warranting at least proposed regulatory action. Second, even when the
agreement is implemented, the phase-out schedule provides for a brief
interval during which cyanazine may be used in States that would need
SMPs. Third, the Agency is concerned with the possibility that
cyanazine could be registered at some future date as a completely new
pesticide. In that event, it is the Agency's judgement at this time
that the present evidence of the pesticide's severe contamination
potential requires that any such future use needs to be subject to
SMPs.
It may be EPA's judgement in considering a final SMP rule that
cyanazine's eventual cancellation will be sufficient to address the
Agency's ground-water concerns; if so, it may choose to issue a final
rule for only four of the pesticides proposed today. In any event, the
Agency wishes to emphasize that the fact that cyanazine use will
terminate soon after the effective date of the SMP restriction will be
taken into account when EPA evaluates State submissions. EPA does not
anticipate that State Plans for cyanazine will have to be as extensive
or detailed as for pesticides whose uses are expected to continue
indefinitely.
2. Alachlor Special Review. In 1985, EPA initiated a Special Review
of Alachlor (50 FR 1115, January 9, 1985). As noted above, alachlor was
classified as a B2 (probable human) carcinogen, and the
carcinogenicity potential has been quantified, although the
classification is now under review. EPA concluded the Special Review of
alachlor (52 FR 49480, December 31, 1987), after taking the following
actions to reduce risk for workers: EPA classified alachlor for
restricted use by certified applicators; prohibited aerial application
using human flaggers; and required persons applying alachlor to 300 or
more acres per year to use mechanical transfer systems for mixing and
loading alachlor. In addition to these regulatory actions, however, EPA
deferred action on whether the risks posed from alachlor in drinking
water from contamination of ground water required regulatory action.
EPA concluded that the further evaluation of the ground-water risks
would offer an appropriate occasion to revisit the overall risks and
benefits of alachlor (including dietary risks) on a crop-by-crop basis
to determine whether the risk benefit balance had changed to a degree
requiring regulatory action.
Since 1987, Monsanto has submitted the National Alachlor Well Water
Survey (NAWWS) and review has been completed. EPA's concerns with
respect to continuing ground-water risks are evident in its proposal to
classify alachlor for SMPs in this proposed rule. In addition, EPA has
reviewed recent trends in usage and percent of crop treated with
alachlor and determined it is not necessary to revisit the risk/benefit
determination of alachlor on a crop-by-crop basis. The dietary risks
posed by alachlor were in the 10-6 range at the time the Special
Review was concluded and have declined further since then.
EPA has determined that the remaining Special Review concern about
alachlor in ground-water is adequately addressed by the actions
proposed in today's document. Thus, EPA concludes that the concerns
deferred by the Special Review will have been addressed with
promulgation of this proposed rule and no further action related to the
Special Review of alachlor will be necessary upon this proposed rule's
promulgation. In a separate notice, EPA will announce the cessation of
the alachlor special review.
E . Analysis of Regulatory Options
In developing the Strategy EPA evaluated a range of available
regulatory options in addition to the SMP approach. Specifically, EPA
compared three general approaches in a companion document to the
Strategy, the ``Pesticides and Ground-Water Strategy: A Survey of
Potential Benefits'' (Ref. 13). In supporting the comparative
advantages of the SMP approach, this document compared it to the option
of a projected extension of current national-level risk-reduction
measures, and another of full cancellation of a problem pesticide. Both
options were regarded as establishing the extremes of potentially
effective and reasonably feasible alternatives to the SMP approach.
The first alternative to SMPs was construed to permit significant
levels of ground-water contamination before milder forms of regulatory
action (e.g., label changes or restricted use) would be considered. In
other words, the option constituted a non-prevention-oriented approach
that, although contrary to Agency policy, constituted a conceivable
approach to the problem of pesticide contamination of ground water. The
option relied to a considerable degree upon remediation of projected
contamination sites to address the problem; as such, it was tantamount
to addressing the problem of pesticides in ground water through other
environmental statutes, especially the Safe Drinking Water and
Superfund (CERCLA) Acts. Consequently, the costs of remediation, and,
by extension, the costs associated with degradation of ground water as
a natural resource, were construed to be a larger component of this
option's cost impacts than any other. While these impacts were not
directly monetized in EPA's 1991 analysis (for the same considerations
discussed in Unit IV.C. of this preamble), by indirect analysis EPA
concluded that the ``status quo'' option would bear considerably higher
societal-cost impacts than the SMP approach. Moreover, such an approach
would be unacceptable on policy grounds, representing insufficient
commitment to a preventive approach. This policy preference, of course,
in part reflects EPA's discomfort about the ability to correct (much
less correctly estimate the price of) ground-water contamination once
it occurs. EPA's view is that such ground-water contamination may be in
many circumstances practically irreversible, based in part on the
economics of remedial action (where millions of dollars can be spent
for uncertain results at a single site).
Likewise, outright cancellation of one or more pesticides that
might represent a substantial risk via ground water stands to entail
far higher societal costs than other regulatory alternatives, such as
SMPs. As the Taylor analysis (Ref. 5) indicates, the magnitude of user
and consumer impacts associated with cancellation of these five
pesticides dwarf those that might be associated with SMPs. Taking into
account the additional administrative and technical program costs
associated with the SMP approach (that would not be necessary if the
pesticides were canceled instead), the SMP approach still appears to
represent the most cost-effective approach. While absolute cancellation
may provide a degree of greater surety that ground-water contamination
will be averted (and in that way affords greater benefits), it is
unlikely that the incremental gain in surety justifies the enormous
difference in economic impact between the two options.
[[Page 33293]]
F. Request for Comments
EPA is interested in receiving comments on its determination of the
risks and benefits associated with its proposal to classify these five
pesticides as subject to SMPs. EPA in particular invites all interested
persons to submit further information concerning the risks and benefits
(with respect to ground-water contamination, its prevention and any
ancillary issues) associated with the use of atrazine, simazine,
cyanazine, alachlor, and metolachlor, as discussed in this proposed
rule. EPA would like comments on its estimate of the economic impacts
of the proposed rule. For instance, has the Agency sufficiently
addressed the indirect costs, such as those associated with minor use
sites (e.g., fruits, nuts, and turf)? Of particular interest would be
suggestions for how to improve both: (1) The estimate of present/future
risks posed by these five pesticides in ground water absent further
risk-reduction measures like SMPs; and (2) the estimate of
environmental results likely to be achieved by SMPs.
V. Public Docket
A record has been established for this rulemaking under docket
number OPP-36190 (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:
[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.
VI. Notification to Secretary of Agriculture and the Scientific
Advisory Panel
As provided in 40 CFR 153.31(b), EPA has transmitted copies of this
Notice and the Regulatory Impact Analysis, to the Secretary of
Agriculture and the Scientific Advisory Panel for comment, prior to
today's publication. In the process of reviewing the proposed
regulation USDA has raised a number of concerns that the Agency has
addressed in the text of the proposal. Among those concerns are the
effects on minor uses, the potential for de facto cancellations with
the States' failure to have an approved Plan, possible costs incurred
by USDA programs, the need for an appropriate balancing of risks and
benefits in the development and approval of SMPs, and the most
appropriate statutory authority for taking regulatory action. USDA
looks forward to a full public consideration of these and other
critical issues in the promulgation of the final regulation. In
particular, USDA urges the Agency to adopt a streamlined process which
examines a broad range of possible alternatives for efficiently
mitigating the environmental impacts while preserving sound
agricultural production. The Panel had no written comments.
VII. References
1. Baker, David B., et.al., ``Immunoassay Screens for Alachlor
in Rural Wells: False Positives and an Alachlor Soil Metabolite,''
Environmental Science Technology., 1993, 27, 562-4.
2. Roux, Paul R., Large-Scale Retrospective Ground-Water Study
for Metolachlor in Four Areas of the U.S., [Ciba-Geigy, Corp.],
1989.
3. Holden, L.R., and Graham, J.A., ``Project Summary of the
National Alachlor Well Water Survey,'' (Project Summary and 6
Volumes), Monsanto Agricultural Co., St. Louis, MO, February 1990.
4. ``Review of the Monsanto Company National Alachlor Well Water
Survey,'' Phase II Report prepared for EPA by ICF, Inc., March 29,
1991.
5. Taylor, C. Robert, et. al., ``Economic Impacts of Chemical
Use Reduction in the South,'' Southern Journal of Agricultural
Economics, July 1991.
6. USEPA-OPTS, 1987a: ``Agricultural Chemicals in Ground Water:
Summary Minutes from the 1987 Pesticide Strategy Workshop,'' October
1987.
7. USEPA-OPTS, 1987b: ``Agricultural Chemicals in Ground Water:
Proposed Pesticide Strategy,'' December 1987.
8. USEPA-OPTS, 1988a: ``Summary of State Commissioners Meeting
on EPA Proposed Strategy on Agricultural Chemicals in Ground
Water,'' August 1988.
9. USEPA-OPTS, 1988b: ``Pesticides in Ground Water Data-Base
1988 Interim Report,'' December 1988.
10. USEPA, 1990: National Survey of Pesticides in Drinking Water
Wells: Phase I Report, EPA 570/9-90-015, November 1990.
11. USEPA 1991a, Protecting the Nation's Ground Water: EPA's
Strategy for the 1990s (The Final Report of the EPA Ground-Water
Task Force), 21Z-1020, July 1991.
12. USEPA 1991b, Pesticides and Ground-Water Strategy, 21T-1022,
October 1991.
13. USEPA, 1991c; USEPA, Office of Pesticide Programs,
Biological and Economic Analysis Division (Economic Analysis
Branch), ``Pesticides and Ground-Water Strategy: A Survey of
Potential Benefits,'' February 1991.
14. USEPA, 1992a, National Survey of Pesticides in Drinking
Water Wells: Phase II Report, EPA 570/9-91-021, Winter 1992.
15. USEPA, 1992b, Pesticides in Ground Water Database: A
Compilation of Monitoring Studies: 1971 - 1991 (11 volumes: a
National Summary and 10 Regional Summaries), EPA 734-123-92-001,
September 1992.
16. USEPA, 1992c, ``EPA Definition of `Pollution Prevention',''
Memorandum to all EPA personnel from F. Henry Habicht, Deputy
Administrator, May 28, 1992.
17. USEPA, 1992d, Final Comprehensive State Ground Water
Protection Program Guidance, EPA 100-R-93-001, December 1992.
18. USEPA, 1993; USEPA-OPPTS, Guidance for Pesticides and Ground
Water State Management Plans: Implementation Document for the
Pesticides and Ground Water Strategy, EPA 735-B-93-005a, December,
1993; and two Appendices (EPA 735-B-93-005b, and EPA 735-B-93-005c).
19. USEPA, 1995, ``A Framework for Measuring the Economic
Benefits of Ground Water,'' EPA 230-B-95-003, October 1995.
20 USEPA, 1996, ``Water Resources Impact Analysis for the
Triazine Herbicides,'' [unpublished]
21. Nowak, Peter, Wolfe, Steven, et. al., ``Assessment of 1992
Wisconsin Atrazine Rule (Ag 30),'' Final Report - University of
Wisconsin College of Agricultural and Life Sciences, May 1993).
22. WDATCP, 1996: Wisconsin Department of Agriculture, Trade and
Consumer Protectiion (Postle, Jeff), ``Resampling Wells that
Previously Exceeded a Pesticide Enforcement Standard,'' Final Report
- February 1996.
VIII. Regulatory Assessment Requirements
A. Executive Order 12866
Pursuant to Executive Order 12866 (58 FR 51735, October 4, 1993),
it has been determined that this is a ``significant regulatory action''
because it may result in an annual effect of $100 million or more. This
action was therefore submitted to the Office of Management and Budget
(OMB) for review, and any comments or changes made during that review
have been documented in the public record.
[[Page 33294]]
In addition, the Agency has conducted an economic analysis of the
potential impacts associated with this proposed action, which is
included in a Regulatory Impact Analysis' document prepared for this
regulation. A copy of this analysis, which is discussed in Unit IV. of
this preamble, is also included in the public record.
B. Regulatory Flexibility Act
Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.),
EPA has determined that this regulatory action does not impose any
adverse economic impacts on small entities.
An analysis of the prospective impacts of this proposed rule on
small States, pesticide distributors, and agricultural producers was
prepared as part of the Agency's economic analysis for this proposed
action, which is summarized in Unit IV. of this preamble. This analysis
is included in a Regulatory Impact Analysis' document, a copy of which
is included in the public record for this action. This information is
also being forwarded to the Chief Counsel for Advocacy of the Small
Business Administration. Any comments regarding the economic impacts
that this proposed regulatory action may impose on small entities
should be submitted to the Agency at the address listed above.
C. Paperwork Reduction Act
The information collection requirements in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.
An Information Collection Request (ICR) document has been prepared by
EPA (EPA ICR No. 1771.01) and a copy may be obtained from Sandy Farmer,
OPPE Regulatory Information Division; U.S. Environmental Protection
Agency (2136); 401 M St., SW.; Washington, DC 20460, by calling (202)
260-2740, or by sending an e-mail request to:
[email protected].
For PRA purposes, ``burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
Development and implementation of pesticide SMPs entails the
collection of various sorts of information. In particular, States will
need to create and/or gather information to conduct ground water
vulnerability assessments, including data on agronomic practices (e.g.,
pesticide use, cropping patterns) and aquifer sensitivity; the States
will either gather the data themselves or require third parties (users
and/or pesticide registrants) to report the data. States will then use
this data to assess the vulnerability of ground water to the pesticides
requiring Pesticide SMPs. In addition, States may need to develop and/
or maintain ground-water monitoring efforts, or expand their existing
efforts to gather chemical, physical, geological, biological, and other
environmental data. This data will be necessary to support Pesticide
SMP activities such as determining ground water levels, analyzing the
existence and extent of contamination, and evaluating the effectiveness
of management measures. Furthermore, once Pesticide SMPs are approved
by EPA, States will need to submit an SMP Biennial Report every 2 years
beginning 2 years from the EPA approval date and continuing every 2
years thereafter. The SMP Biennial Report will provide a basis for
measuring States' progress toward protection of ground water resources
from pesticide contamination. The commitment to develop and report such
information is a mandatory component of SMPs.
The total annual burden for the information collection related
activities associated with this proposed action is estimated to average
412,560 hours per year for all respondents, including State (and
territorial) government, and private parties. The per respondent burden
(i.e., burden for each State, territory, or private party divided by
the number of States, territories and tribal authorities expected to
submit SMPs) is expected to average 7,367 hours per year. First year
burden is estimated to be a total of 673,083 hours, with 12,1019 hours
per respondent. The total annual costs for the information collection
related activities associated with this proposed action is estimated to
average $18,043,080 per year for all respondents, with an annual
estimated cost of $322,198 per year for each respondent. First year
start-up costs are expected to be $22,395,865, with an estimated
$399,926 cost per respondent.
An Agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
Comments are requested on the Agency's need for this information,
the accuracy of the provided burden estimates, and any suggested
methods for minimizing respondent burden, including through the use of
automated collection techniques. Send comments on the ICR to the
Director, OPPE Regulatory Information Division, U.S. Environmental
Protection Agency (2136), 401 M St., SW., Washington, DC 20460, and to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 17th St., NW., Washington, DC 20503, marked
``Attention: Desk Officer for EPA.'' Include the ICR number in any
correspondence. Comments related to these estimates may be submitted to
the address listed in the ADDRESSES unit anytime during the comment
period for the proposed action. However, since OMB is required to make
a decision concerning the proposed collection between 30 and 60 days
after June 26, 1996, a comment to OMB is best assured of having its
full effect if OMB receives it by July 26, 1996. The final rule will
respond to any OMB or public comments on the information collection
requirements contained in this proposal.
D. Unfunded Mandates Reform Act and Executive Order 12875
Pursuant to Title II of the Unfunded Mandates Reform Act (UMRA) of
1995 (Pub. L. 104-4), EPA has determined that this regulatory action
contains a Federal mandate that may result in expenditures of $100
million or more for State, local and tribal governments, in the
aggregate, or to the private sector in any 1-year. Accordingly, EPA has
prepared the following description of the intergovernmental
consultation under UMRA, and Executive Order 12875 (58 FR 58093,
October 28, 1993), entitled ``Enhancing the Intergovernmental
Partnership.'' The basis for EPA's determination is contained in the
economic analysis accompanying this rule, which is included in the
public record for this action and summarized in Unit IV. of this
preamble.
UMRA requires that such a rule be accompanied by a statement that,
among other things, documents that the rule is the least costly, most
cost-effective or least burdensome alternative that achieves the
regulatory objective. In the absence of such documentation, UMRA
[[Page 33295]]
provides that the head of the promulgating Agency may otherwise provide
in the statement an explanation of why the least burdensome approach
was not adopted or is inconsistent with law. The discussion in part E
of Unit IV of this preamble describes the Agency's analysis of
regulatory options. As this discussion, and the earlier analysis cited
therein (c.f., Ref. 13) indicates, the Agency believes that this
proposed action is the most cost-effective and least burdensome
alternative to the alternatives considered in the development of the
Pesticides and Ground-Water Strategy (Ref. 12), developed as the
groundwork for today's proposed rule. A particularly advantageous
feature of the chosen option is that it allows States to determine the
most appropriate approach for preventing unreasonable adverse effects
within their individual States. The practical alternatives are a choice
between different kinds of Federally mandated restrictions, either
national standards and/or risk-reduction measures (principally in the
form of label changes) or outright cancellations of use. The principal
disadvantage of both is that they can not take State specific issues
into consideration, and so can be anticipated to increase the loss of
economic benefits associated with the pesticides' use, relative to the
impacts of SMPs. National-level measures are potentially less certain
of meeting the regulatory objective, that is, of achieving the goal of
preventing unreasonable levels of ground-water contamination. This
greater uncertainty is caused by the relative inability to tailor risk-
management measures, proceeding instead on a ``lowest common
denominator'' approach. Still another conceivable (but unanalyzed)
option is doing nothing at the Federal level, leaving the potential for
ground-water contamination to be addressed, if at all, by voluntary
action and/or independent State action. This alternative was not
analyzed because it clearly failed to meet the regulatory objective.
Such an option that freely permits contamination would entail no direct
regulatory costs, but the far larger reduction in the value of the
resource must be compared to the more conventional economic impacts.
The statement required by UMRA also requires a summary description
of State/local/Tribal governmental input in the rule's development.
Prior consultation with State and Tribal authorities has been
extensive. The Pesticides and Ground Water Strategy development process
began with a major public workshop held in 1986 in Coolfont, West
Virginia. State Agriculture, Environment and Health agencies were among
the participants. A second public workshop was held at Coolfont during
the summer of 1987, also with similar participation. Beyond the
Strategy, State regulatory officials were involved in the development
of the subsequent Guidance beginning in 1989, when EPA sponsored
working sessions to determine how best to guide the process of managing
pesticide use to protect the ground water resource. Two week long
sessions were held in Fredericksburg, Virginia during October and
November of 1989. These sessions were actual working sessions to
develop the document that today is the SMP guidance document. Between
five and seven States participated in each session. Drafts of the
guidance document were shared with all 50 State Lead Agencies for
Pesticides, EPA Regional Offices, and other Federal agencies.
During development of the proposed rule, many issues were discussed
with the Water Quality Working Committee Group of the State FIFRA
Issues Research and Evaluation Group (SFIREG) on which eight State Lead
Agencies sit. This group meets three times per year with OPP to discuss
water quality issues and this forum was used extensively in the early
stages of development of the proposed rule.
The proposed regulation itself has been provided as an initial
draft twice to EPA's 10 regional offices and all 50 states for review
and comment, in addition to the SFIREG Water Quality Committee and to
SFIREG's parent body, the American Association of Pesticide Control
Officials (AAPCO). The first round of review in fall 1994 elicited 38
written comments from State and Tribal agencies; the second round in
spring 1995 elicited 18 further comments. As a result of each round of
review, the draft proposed rule was modified. These written comments
are in the public record and were considered in the development of the
proposed rule. Virtually all of the principal State comments and
concerns are reflected in the discussion in Unit III of this preamble,
and in the request for comments accompanying that Unit.
All other UMRA requirements for the accompanying statement to a
``significant regulatory action,'' e.g., descriptions of statutory
authority, anticipated costs and benefits, compliance costs, are
contained throughout this preamble, in the appropriate headings.
E. Executive Order 12898
Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994),
the Agency has considered environmental justice related issues with
regard to the potential impacts of this action on the environmental and
health conditions in low-income and minority communities. As related
throughout this document, the approach the Agency is proposing to
address the problem of pesticides in ground water is based on a full
appreciation of the localized nature of the problem, and this approach
strives to be the most effective strategy for localized protection of
the ground-water resource. As the Strategy highlights, alternatives to
effective local-level risk reduction measures (e.g., national-level
regulation or no regulatory protection) are considered likely to either
over-regulate pesticide use (causing undue economic hardship to
affected parties) or under-protect (increasing the risk of various
adverse health and environmental effects to specific parties).
List of Subjects
40 CFR Part 152
Environmental protection, Administrative practice and procedure,
Pesticides and pest, Reporting and recordkeeping requirements.
40 CFR Part 156
Environmental protection, Labeling, Occupational safety and health,
Pesticides and pest, Reporting and recordkeeping requirements.
Dated: June 19, 1996.
Carol M. Browner,
Administrator.
Therefore, 40 CFR chapter I, is proposed to be amended as follows:
1. In Part 152:
PART 152 --[AMENDED]
a. The authority citation for part 152 would continue to read as
follows:
Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31
U.S.C. 9701.
b. By adding a new subpart J to part 152, to read as follows:
Subpart J--Ground-Water State Management Plans
Sec.
152.180 Applicability.
152.183 Definitions.
152.185 Restriction.
152.187 Submission and approval of ground-water State Management
Plans.
152.190 Specifications and requirements of a ground-water State
Management Plan.
152.191 Evaluation of State Management Plan Implementation.
152.193 Amendment of State Management Plans.
[[Page 33296]]
152.195 Withdrawal of approval of a State Management Plan.
152.198 Pesticides classified for restricted use subject to a
ground water State Management Plan.
Subpart J--Ground-Water State Management Plans
Sec. 152.180 Applicability.
This subpart applies to any pesticide or pesticide product
designated to be subject to the requirements and provisions of ground-
water State Management Plans by means of a Restricted Use
Classification.
Sec. 152.183 Definitions.
In addition to the definitions in Sec. 152.3, the following terms
also apply to this subpart:
Ground Water Reference Point means an environmental concentration
of a pesticide ingredient based on any of the following:
(1) Maximum Contaminant Levels (MCLs) established under the Safe
Drinking Water Act; or
(2) Health Advisories (where MCLs are not available for a
substance); or
(3) Water Quality Standards (where the ingredient poses adverse
effects to ecosystems affected by closely hydrologically linked surface
waters) under the Clean Water Act.
Plan means a State Management Plan developed for the purpose of
managing the use of a pesticide in order to prevent unreasonable risks
of ground water contamination.
State means each of the 50 States, Puerto Rico, the U.S. Virgin
Islands, the District of Columbia, Guam, American Samoa and other
Pacific Island Territories of the United States, as well as Indian
Lands under Tribal jurisdiction.
Sec. 152.185 Restriction.
(a) Restriction. A pesticide or pesticide product classified for
restricted use subject to a State Management Plan may be used only in
accordance with the provisions and requirements of an Agency-approved
State Management Plan, after a date 33 months from the date the
pesticide or product is so classified. Such a pesticide or pesticide
product may not be sold or used after that date within the boundaries
of a State without an Agency-approved State Management Plan.
(b) Labeling. (1) Upon classification of a pesticide for restricted
use, subject to ground-water State Management Plans, each registrant of
a product subject to that classification shall, within 12 months after
the date of that classification by final Agency rule, submit for such
product:
(i) A copy of the labeling amended to include the statement
specified in Sec. 156.137(a)(2)(ii) of this chapter.
(ii) A statement that the registrant will comply with the labeling
requirements prescribed by the Agency by the effective date of this
rule. The Agency will regard such statement to be a report under the
Act. The Agency may deny registration or initiate cancellation
proceedings if a registrant fails to comply with the timetables
established in this section.
(2) A product whose labeling bears directions for end use and that
has been classified as subject to ground-water State Management Plans
must be labeled in accordance with the requirements of Sec. 156.10 of
this chapter after the effective date of the restriction.
(c) Distribution and sale of classified products. No product with a
use classified for restricted use, subject to ground-water State
Management Plans, may be distributed or sold by a retailer or other
person after the effective date of the restriction, unless the product
bears a label or labeling which contains the terms of the
classification and otherwise complies with paragraph (b)(2) of this
section.
Sec. 152.187 Submission and approval of ground-water State Management
Plans.
If any State, at any time after the classification of a pesticide
or pesticide product to be subject to State Management Plans by final
rule, wishes to establish a ground-water State Management Plan for such
a pesticide or pesticide product, that State shall submit a proposed
Plan for that purpose to the Administrator. The Administrator will
approve the Plan submitted by any State if, in the Administrator's
judgement, the Plan meets the requirements of Sec. 152.190.
(a) Schedule. A State that wishes to implement a Plan on the
effective date of the State Management Plan restriction shall submit a
proposed Plan, along with the administrative record accompanying
development of the proposed Plan to the appropriate EPA region under 40
CFR 1.7, before a date 24 months from the date a pesticide or product
is classified. The submission shall include an electronic file in
Wordperfect 5.1 or higher or ASCII for all material. The Administrator
will review such submittals and approve or disapprove Plans within 9
months of receipt of a complete submittal.
(b) Review. Upon receipt of a proposed State Plan submitted for EPA
approval, the Administrator or a designee will first review the
proposed Plan to determine that all requirements as provided in
Sec. 152.190 have been addressed. Upon completion of this review, the
Administrator will notify the State in writing of the initial
determination of the completeness of the submission. In the event that
the Administrator determines that the submission fails to address all
requirements, the Administrator will request the State revise its
submission to provide the missing components. Once the Administrator is
satisfied that the submission is complete, full evaluation of the
submission will proceed.
(c) Approval. Upon completion of the review of the submission, if
the Administrator finds that the Plan meets the requirements of
Sec. 152.190, then the Administrator will publish a Notice of Approval
in the Federal Register and a letter of notification to the State
official designated as State Liaison, pursuant to Sec. 152.190(b),
informing of the approval.
(d) Disapproval. If, after completion of the review of the
submission, the Administrator finds that the submission fails to meet
the requirements of Sec. 152.190, the Administrator shall notify the
State Liaison by letter that EPA will not approve the Plan as
submitted, and specifying the deficiencies in the Plan that prevent its
approval. If, after further consultation, the Administrator still finds
that the submission fails to meet the requirements, the Administrator
will publish a notice in the Federal Register announcing the
disapproval of the Plan and including the reasons for finding the Plan
inadequate pursuant to Sec. 152.190. In this event, sale or use in the
State of the pesticide that is the subject of the Plan shall be
prohibited 33 months after the promulgation of a rule classifying the
pesticide as subject to a ground-water State Management Plan.
Sec. 152.190 Specifications and requirements of a ground-water State
Management Plan.
The Administrator shall approve the State Management Plan submitted
by any State, or any modification thereof, if in the Administrator's
judgement, the Plan fulfills the following requirements.
(a) State's philosophy and goals toward protecting ground water. An
acceptable Plan must, to the satisfaction of the Administrator, contain
a description of the State's ground-water protection philosophy and
goals regarding pesticide management, including an explanation how its
philosophy and goals will be no less protective than EPA's goal of
preventing adverse effects to human health and the environment and
protecting the environmental integrity of the nation's ground water.
[[Page 33297]]
(b) Roles and responsibilities of State agencies. An acceptable
Plan must, to the satisfaction of the Administrator:
(1) Identify and describe both the general responsibility of, and
the specific technical and administrative tasks to be performed by,
each participating agency responsible for the development and
implementation (including enforcement) of the Plan, including a
description of how the State agencies intend to use the programs and
expertise of Federal agencies in carrying out the Plan.
(2) Identify a Liaison who will serve as a single contact point for
all formal communications concerning the Plan process between EPA and
the State, including responsibility for the transmittal and receipt of
official correspondence and information.
(3) Describe the coordination mechanisms between all participating
State agencies, local entities, and appropriate Federal agencies.
(4) Describe how local governments are included in activities under
the Plan. When local governments have authority to address State
ground-water-related objectives and priorities, the State must
demonstrate that program coordination, guidance, or oversight is
provided.
(5) Contain official concurrences from the directors of all State
agencies with responsibilities under the Plan stating their agreement
with the Plan, and their commitment to carry out their responsibilities
under the Plan.
(6) Discuss any relevant inter-State multi-jurisdictional
coordination, including how any multi-jurisdictional issues will be
resolved for purposes of implementing the Plan.
(c) Legal authority. An acceptable Plan must, to the satisfaction
of the Administrator:
(1) Contain regulatory authorities that are sufficient to
accomplish the objectives of the Plan, established in paragraph (a) of
this section.
(2) Specify the legal authorities of the State to implement the
Plan successfully and specify the State's authority to impose
preventive measures, its remedial action authority and its compliance
and enforcement authorities, citing all relevant State laws and
regulations and including Federal legislation, regulations and program
delegation, available to the State.
(3) Identify the specific authorities that will be used to carry
out the specific commitments made in the Plan. The State must
specifically identify the authority to conduct or require others to
conduct monitoring, prohibit use in specific areas, close public wells,
or supply or require others to supply alternative sources of water,
where such actions are elements of the Plan, must be identified.
(d) Resources. An acceptable Plan must, to the satisfaction of the
Administrator, demonstrate there are adequate resources available to
implement and enforce the program. Resources include technical
expertise and personnel, physical and operational capabilities, and
funding. The Plan must demonstrate there is an adequate match between
revenues and proposed expenditures and that the necessary expertise is
available.
(e) Basis for assessment and planning. An acceptable Plan must, to
the satisfaction of the Administrator, specify the State's approach and
activities to assess vulnerability for the geographic area in which the
State intends to allow pesticide use, identifying the sources of all
such data. The State shall specifically describe the State's available
pesticide use data (e.g., geographic use and application rates) and how
it will be factored into assessing vulnerability.
(f) Monitoring. An acceptable Plan must, to the satisfaction of the
Administrator, demonstrate that monitoring activities (including
ground-water monitoring) performed pursuant to the Plan are appropriate
for the purposes of the Plan, with assurances that the activities will
be carried out adequately. Specifically, an acceptable Plan must
identify and describe key elements of the monitoring program, including
the scope and objective (in relation to the purposes of the Plan) of
such monitoring, design and justification (including the number of
sites to be sampled, the number of samples to be taken and the
frequency of sampling) of such monitoring, monitoring protocols,
quality assurance/quality control, sampling methodology, analytical
methods, and analytes. Such description must make clear how the
placement of monitoring sites relates to the State's priorities for
protecting ground water, and will allow evaluation of the effectiveness
of prevention and response measures specified in paragraphs (g) and (h)
of this section. Monitoring performed for the purpose of fulfilling
this requirement must be performed in accordance with an EPA-approved
Quality Assurance Project Plan (as described in Chapter 5.4.2 of
Appendix B, ``Assessment, Prevention, Monitoring and Response
Components of State Management Plans,'' to the Guidance for Pesticides
and State Management Plans (EPA 735-B-93-005c, February 1994). This
incorporation by reference was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the Public Response and Program Resources Branch,
Field Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Copies may be inspected at the above address or at the Office of the
Federal Register, 800 North Capitol St., NW., suite 700, Washington,
DC. Good Laboratory Practice Standards (40 CFR part 160) do not apply
to monitoring performed for the purpose of fulfilling this requirement.
(g) Prevention actions. An acceptable Plan must, to the
satisfaction of the Administrator, specify the actions a State will
take to manage the use of the pesticide classified for use subject to
the Plan, to fulfill the State's goals and principles enunciated
pursuant to paragraph (a) of this section and will otherwise prevent
unreasonable adverse effects to human health and protect the
environmental integrity of the nation's ground-water resources.
(h) Response to detections of pesticides. An acceptable Plan must,
in the judgement of the Administrator, adequately specify the measures
that the State will take (and the circumstances under which the State
will take them) to respond to contamination so that Ground Water
Reference Points are not reached, and specify the actions the State
will take in the event Reference Points are met or exceeded. This
description must be presented in the form of a general corrective
response scheme, illustrating the State's capacity for timely,
coordinated response to contamination.
(i) Enforcement mechanisms. An acceptable Plan must, to the
satisfaction of the Administrator, demonstrate that the State's
enforcement authorities and capabilities are adequate to implement and
to monitor compliance with the specific measures included in the Plan,
describing authorities and capabilities that are intended to protect
ground water from contamination and response actions where
contamination has already occurred. Enforcement authority must be
identified by the State, and the roles and responsibilities of each
State agency must be defined, including how coordination of enforcement
capabilities within agencies will work to prevent and respond to
contamination.
(j) Public awareness and participation. An acceptable Plan must, to
the satisfaction of the Administrator, demonstrate that there is notice
and opportunity for public comment within the process of Plan
development, and will be informed of significant Plan
[[Page 33298]]
implementation activities. This demonstration must:
(1) Describe the public role regarding development of the Plan and
decision-making in implementing the Plan, and identify or describe
existing legal requirements within the State that would ensure public
participation in the process (i.e., an Administrative Procedure Act
requiring notice and comment, etc.). If no such legal requirements
exist within the State, the Plan must describe any other public
participation process that the State uses in the development of the
Plan.
(2) The Plan must also specify the level of detection in ground
water that is considered by the State to be of such significance that
the State will inform the public. Indicate how, when, and by whom the
public will be informed of detections in ground water that are
considered significant, providing for, at a minimum:
(i) The notification of any well owner of any detections in ground
water; and
(ii) The notification of all users of any detections above the
reference point.
(3) Include a description of the process and means of communication
by which the public will be made aware of important regulatory actions
taken under the Plan.
(k) Information dissemination. An adequate Plan must, to the
satisfaction of the Administrator, describe the means by which measures
prescribed pursuant to the Plan will be communicated to pesticide users
and all other interested parties. A plan must:
(1) Describe how information regarding prevention measures (e.g.,
use limitations and precautions) will be relayed to the appropriate
audiences.
(2) Describe how pesticide users will be trained or educated in how
to comply with requirements of applying a pesticide where use is
governed by the Plan.
(3) Identify the targeted parties and discuss how information will
be relayed.
(4) Explain why the information dissemination approach is
appropriate for the type of contamination prevention actions being
employed, and the education and/or awareness of the targeted audience
is required.
(5) Describe how information will be updated as requirements
change. Such discussion should include the form these updates will take
and the distribution methods. The Plan should also discuss any existing
mechanisms (i.e., Memoranda of Understanding, cooperative agreements,
etc.) between the State and other entities that will be involved in
this effort.
(l) Records and reporting. An adequate Plan must, to the
FR Doc. 96-16173 Pesticides and Ground Water State Management Plan Regulation
satisfaction of the Administrator:
(1) Include a commitment by the State to maintain essential records
relating to Plan implementation for a period of at least 6 years. The
information maintained must include, but is not limited to, records on
any monitoring or sampling conducted, results of analyses, issuance of
permits, types and numbers of enforcement actions taken, records of any
site-specific regulatory actions, and administrative actions. The State
must commit to promptly make available to the Agency, upon request,
records related to the development or implementation of the Plan.
(2) Commit to developing and submitting to the appropriate Regional
Office a Plan Biennial Report, as described in Sec. 152.191(a), and to
report any significant findings to the appropriate Agency Regional
Office.
(3) Commit to submitting with each report to EPA a signed
certification, worded as follows:
I certify under penalty of law that I have personally examined
and am familiar with the information submitted herein and based on
my inquiry of those individuals immediately responsible for
obtaining the information, I believe the submitted information is
true, accurate and complete. I am aware that there are significant
penalties for submitting false information, including the
possibility of fine and imprisonment. See 18 U.S.C. section 1001 and
7 U.S.C. section 136).
Sec. 152.191 Evaluation of State Management Plan Implementation.
Any State Management Plan approved under Sec. 152.190 shall be
subject to periodic evaluations of its implementation by the Agency, in
order to assure implementation of the Plan consistent with its goals
and commitments, to determine the environmental effectiveness and the
level of ground-water protection provided by the Plan, and to ensure a
minimum level of national consistency.
(a) Biennial Report. A Biennial Report, as described in
Sec. 152.190 (l)(2), must be developed and submitted by the State in
order to maintain Agency approval, and will be used by the Agency and
by State officials to evaluate a State's effectiveness in protecting
its ground-water resources from pesticide contamination. The State
shall prepare the Biennial Report according to the provisions of
Chapter 5 of Appendix A, ``Review, Approval and Evaluation of State
Plans,'' to the Guidance for Pesticides and State Management Plans (EPA
735-B-93-005b, February 1994).
(b) Evaluation reporting requirements. The Biennial Report must be
approved by State officials directing the key State agencies that play
a role in implementing the Plan. The Biennial Report must be submitted
in October of alternate years, starting in October [of the year 4 years
after date of publication of the final rule] to the appropriate Agency
Regional Office. The State may submit a single Biennial Report in the
event it implements Plans for more than one classified pesticide. In
that event, the report must include programmatic and environmental
evaluations addressing each approved Plan. States will also submit a
programmatic and an environmental evaluation that addresses any
progress made in implementing the Plan.
Sec. 152.193 Amendment of State Management Plans.
(a) The State will amend an approved Plan as part of the Biennial
Report required under Sec. 152.191(a) when:
(1) The evaluation performed pursuant to Sec. 152.191 demonstrates
that the provisions in the Plan do not adequately protect the ground-
water resource from pesticide contamination.
(2) A change in the legal (statutory or regulatory) and enforcement
framework for Plan development and implementation necessitates a change
in the Plan.
(3) A State, through experience, finds more effective ways to
assess ground-water contamination, to prevent and respond to
contamination, and to educate affected parties or disseminate
information.
(4) Changes in pesticide management measures or approaches become
necessary as a result of significant changes in crops or crop
production systems and technologies within the State.
(5) Roles and responsibilities of State agencies involved in the
implementation of the Plan change so as to necessitate a change in the
Plan.
(b) If a State is aware that an amendment is needed, then that
amendment should be submitted as part of the Plan Biennial Report. In
addition, if the Regional Office that is the recipient of that Report
determines through the evaluation process that the Plan needs to be
updated, then the Regional Administrator of that region, or a designee,
can initiate the updating process by requesting that the State submit a
Plan Update Report. In every case, the Update Report must include:
(1) A description of the proposed changes in the Plan.
(2) An explanation of why the changes are necessary.
(3) An analysis of the impact the changes will have on the other
[[Page 33299]]
components of the Plan, the implementation of the Plan and the
protection of the resource.
(4) If changes will affect pesticide users, a description of how
users will be alerted to the changes in the Plan.
(5) Concurrences by all officials directing the key State agencies.
(6) If changes are significant, a description of how the State
received public input on changes to the Plan, and the administrative
record developed in the course of changing the Plan. Amendments to
Plans must be concurred or approved by the Regional Administrator.
Sec. 152.195 Withdrawal of approval of a State Management Plan.
(a) If, in the judgement of the Administrator or a designee,
either:
(1) A State fails to demonstrate that it is satisfactorily
implementing the Plan; or
(2) A State's Plan is not protecting ground water from
contamination at or above ground water reference points (as specified
in Sec. 152.198); or
(3) A State fails to address deficiencies identified by the Plan
evaluation through updating the Plan and/or improving implementation of
the Plan; or
(4) A State fails to submit a biennial report;
he or she shall notify the designated State Liaison, named pursuant to
Sec. 152.190(b), and relevant State administrators of the Agency's
concerns. In that event, the State will have 90 days to respond to
these deficiencies in its Pesticide Plans, either through the Plan
updating process or by demonstrating to the Region that the Plan is
being satisfactorily implemented.
(b)(1) If the Administrator determines that the State has failed to
address the deficiencies identified by the Agency or has failed to
correct the deficiencies, the Administrator shall notify the officials
directing the key State agencies involved in implementing the Plan and
the designated State Liaison by letter that withdrawal of Agency
approval is being considered. The notice will include:
(i) A statement concerning the potential withdrawal of Agency
approval of the Plan.
(ii) A listing of the deficiencies of the Plan or a description of
the failure of the Plan or its implementation to protect ground water.
(iii) A brief summary of the events that led to the withdrawal
notice.
(iv) Dates by which the State can respond to the deficiencies to
stop the withdrawal process.
(2) The State must respond to the notice within 30 days of receipt
of the notice in writing with a commitment to address the deficiencies
in the Plan itself or in its implementation. If the State disagrees
with the judgement or the findings of the Administrator in the initial
notice described in paragraph (b) of this section, the State may
request to meet with the Administrator within 60 calendar days from the
time the EPA Administrator sends the letter of potential withdrawal to
the Administrators of the key State agencies.
(3) If, in the Administrator's judgement, continued use of the
pesticide within the State presents unreasonable adverse effects on the
environment because of the deficiencies cited pursuant to paragraph
(b)(1) of this section, the Administrator may prohibit further sale and
use of the pesticide in the State until the Agency and the State reach
an agreement on how to address the Plan's deficiencies. Such a
prohibition shall be published in a Federal Register notice describing
the basis for the Administrator's findings, and soliciting comment
thereon. After addressing any public comment, the Administrator may
take final action temporarily prohibiting use of the pesticide in the
State.
(c) If the State does not respond to the notice that withdrawal of
approval is being considered or fails to address the deficiencies
identified in the notice to the satisfaction of the Administrator, the
Administrator will send a formal letter to the officials directing the
key State agencies and the State Liaison indicating that EPA is
publishing a Federal Register Notice proposing to withdraw the
Pesticide Plan. In the event the State does not respond to this notice,
the Administrator will publish a Federal Register Notice to provide an
opportunity for public comment on withdrawal of the Plan. After
addressing any public comments, the Region will publish a Notice of
Withdrawal in the Federal Register and prohibit the sale and use of the
pesticide in the State.
(d) Upon publication of the final Notice of Withdrawal in the
Federal Register, sale and use of the pesticide within the boundaries
of the State will be prohibited.
Sec. 152.198 Pesticides classified for restricted use subject to a
ground water State Management Plan.
Pesticide products containing the active ingredients listed in the
table to this section, with the corresponding Ground Water Reference
Points specified are classified for restricted use, to be subject to
the provisions and requirements of an EPA-approved State Management
Plan.
------------------------------------------------------------------------
Ground Water
Active Ingredient CAS Number Reference Point
------------------------------------------------------------------------
Alachlor 15972-60-8 2 g/l
Atrazine 1912-24-9 3 g/l
Cyanazine 21725-46-2 1 g/l
Metolachlor 51218-45-2 70 g/l
Simazine 122-34-9 4 g/l
------------------------------------------------------------------------
2. In Part 156:
PART 156--[AMENDED]
a. The authority citation for part 156 continues to read as
follows:
Authority: 7 U.S.C. 136-136y.
b. In Sec. 156.10, by revising paragraphs (a)(1)(viii) and
(a)(1)(ix) and removing paragraph (i) to read as follows:
Sec. 156.10 Labeling Requirements
(a) * * *
(1) * * *
(viii) The directions for use as prescribed in subpart G of this
part; and
(ix) The use classification(s) as prescribed in subpart G of this
part.
* * * * *
c. By adding a new subpart G to part 156 to read as follows:
Subpart G--Directions for Use
Sec.
156.120 General requirements.
156.121 Contents of directions for use.
156.135 Statements of use classification.
156.136 General use statements. [Reserved]
156.137 Restricted use statements.
[[Page 33300]]
Subpart G--Directions for Use
156.120 General requirements.
(a) Adequacy and clarity of directions. Directions for use must be
stated in terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide. When
followed, directions must be adequate to protect the public from fraud
and from personal injury and to prevent unreasonable adverse effects on
the environment.
(b) Placement of directions for use. Directions may appear on any
portion of the label provided that they are conspicuous enough to be
easily read by the user of the pesticide product. Directions for use
may appear on printed or graphic matter which accompanies the pesticide
provided that:
(1) If required by the Agency, such printed or graphic matter is
securely attached to each package of the pesticide, or placed within
the outside wrapper or bag.
(2) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as ``See directions in the
enclosed circular.''
(3) The Administrator determines that it is not necessary for such
directions to appear on the label.
(c) Exceptions to requirement for direction for use--(1) Detailed
directions for use may be omitted from labeling of pesticides which are
intended for use only by manufacturers of products other than pesticide
products in their regular manufacturing processes, provided that:
(i) The label clearly shows that the product is intended for use
only in manufacturing processes and specifies the type(s) of products
involved.
(ii) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of product
involved and its proper use in manufacturing processes.
(iii) The product will not come into the hands of the general
public except after incorporation into finished products.
(iv) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Detailed directions for use may be omitted from the labeling of
pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(i) The label clearly states that the product is for use only by
physicians or veterinarians.
(ii) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(iii) The product is also a drug and regulated under the provisions
of the Federal Food, Drug and Cosmetic Act.
(3) Detailed directions for use may be omitted from the labeling of
pesticide products which are intended for use only by formulators in
preparing pesticides for sale to the public, provided that:
(i) There is information readily available to the formulators on
the composition, toxicity, methods of use, applicable restrictions or
limitations, and effectiveness of the product for pesticide purposes.
(ii) The label clearly states that the product is intended for use
only in manufacturing, formulating, mixing, or repacking for use as a
pesticide and specifies the type(s) of pesticide products involved.
(iii) The product as finally manufactured, formulated, mixed, or
repackaged is registered.
(iv) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
156.121 Contents of directions of general use.
The directions for use shall include the following, under the
headings ``Directions for Use'':
(a) The statement of use classification as prescribed in paragraph
(j) of this section immediately under the heading ``Directions for
Use.''
(b) Immediately below the statement of use classification, the
statement ``It is a violation of Federal law to use this product in a
manner inconsistent with its labeling.''
(c) The site(s) of application, as for example the crops, animals,
areas, or objects to be treated.
(d) The target pest(s) associated with each site.
(e) The dosage rate associated with each site and pest.
(f) The method of application, including instructions for dilution,
if required, and type(s) of application apparatus or equipment
required.
(g) The frequency and timing of applications necessary to obtain
effective results without causing unreasonable adverse effects on the
environment.
(h) Worker protection statements meeting the requirements of
subpart K of this part.
(i) Specific directions concerning the storage and disposal of the
pesticide and its container, meeting the requirements of 40 CFR part
165. These instructions shall be grouped and appear under the heading
``Storage and Disposal.'' This heading must be set in type of the same
minimum sizes as required for the child hazard warning. (See Table in
Sec. 162.10(h)(1)(iv))
(j) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(1) Required intervals between application and harvest of food or
feed crops.
(2) Rotational crop restrictions.
(3) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(4) [Reserved]
(5) For restricted use pesticides, a statement that the pesticide
may be applied under the direct supervision of a certified applicator
who is not physically present at the site of application but
nonetheless available to the person applying the pesticide, unless the
Agency has determined that the pesticide may only be applied under the
direct supervision of a certified applicator who is physically present.
(6) Other pertinent information which the Administrator determines
to be necessary for the protection of man and the environment.
Sec. 156.135 Statements of use classification.
(a) Requirement. Each product bearing one or more uses that has
been classified for restricted use must bear a classification statement
on the label of the product, and also in any supplemental labeling that
accompanies the product in sale or distribution. A product that bears
only unclassified uses as described in Sec. 152.160 or uses classified
for general use is not required to bear any classification statement.
Restricted use statements are set out in Sec. 156.137.
(b) Products bearing mixed classified uses. A product for which
some uses are not classified, and other uses are classified for general
use or for restricted use must have a separate registration for uses
that are restricted, except that a product bearing restricted uses may
also bear unclassified or general uses in addition to the restricted
uses. A product bearing mixed restricted uses and other uses is
considered a restricted use product.
(c) Placement of classification statements. (1) Statements of
restricted use classification must be located at the top of the front
panel of the label (the ``Restricted Use'' area), and in a similarly
prominent location in supplemental labeling. No other label statements
shall appear above the restricted use statements, and no other
statements than those prescribed by the
[[Page 33301]]
Agency shall appear in the restricted use area of the label.
(2) The restricted use statements shall be distinguished from
surrounding label text by suitable means, such as white space or a box
around the statements. The words ``Restricted Use Pesticide'' shall
appear in a type size at least that of the signal word prescribed by
Sec. 156.10(h)(1)(iv).
Sec. 156.136 General use statements. [Reserved]
Sec. 156.137 Restricted use statements.
(a) A product that is classified for restricted use must bear, on
the front panel in accordance with Sec. 156.135(c), the statements in
paragraphs (a)(1) and (a)(2) of this section.
(1) The phrase, ``Restricted Use Pesticide.''
(2) Immediately below the phrase ``Restricted Use Pesticide,'' a
statement of the reason for the restricted use classification. This
statement will describe the characteristic of the pesticide, its
formulation, or its use pattern, that is the basis for the
classification. These characteristics include acute or chronic
toxicity, environmental fate (biodegradability, leaching potential,
etc.), or non-target organism toxicity. The Agency will prescribe the
nature and wording of the statement.
(i) A product that is restricted to use by certified applicators
(for example, pesticides and uses listed in Sec. 152.170) must bear the
statement, ``For retail sale to and use only by Certified Applicators
or persons under their direct supervision and only for those uses
covered by the Certified Applicator's certification.''
(ii) A product that is classified for restricted use subject to a
ground-water State Management Plan (SMP) under subpart J of part 152 of
this chapter must bear the statement, ``For use only in accordance with
an EPA-approved State Management Plan for ground-water protection. Sale
and use are prohibited in States that do not have an EPA-approved State
Management Plan.''
(b) The Agency may develop and require a label statement different
from, or in addition to, those described in paragraphs (b)(1) and
(b)(2) of this section, for any product classified for ``restricted
use.''
[FR Doc. 96-16173 Filed 6-25-96; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 96-15597 Linuron; Proposed Revision of Tolerances
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33054-33057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15597]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300424; FRL-5368-7]
RIN 2070-AC18
Linuron; Proposed Revision of Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA has completed the reregistration process and issued a
Reregistration Eligibility Decision document (RED) for the herbicide
linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea). In the
reregistration process, all information to support a pesticide's
continued registration is reviewed for adequacy and, when needed,
supplemented with new scientific studies. This proposed action updates
and corrects the tolerance actions indicated in the RED. Based on the
RED, tolerance assessment for linuron, and subsequent comments and
analyses, EPA is proposing to revise food tolerance levels, revoke some
linuron tolerances, and to revise the tolerance expression for residues
of linuron (40 CFR 180.184).
DATES: Written comments, identified by the docket number [OPP-300424],
must be received on or before August 26, 1996.
ADDRESSES: By mail, submit written comments 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: Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA. Information submitted and any
comment(s) concerning this notice 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 set forth in 40 CFR part 2. A copy of the
comment(s) that does not contain CBI must be submitted for inclusion in
the public record. Information not marked confidential may be disclosed
publicly by EPA without prior notice to the submitter. Information on
the proposed test and any written comments will be available for public
inspection in Rm. 1132 at the Virginia address given above, 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: [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-300424]. No 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: Paul Parsons, Special Review
and Reregistration Division (7508W), Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. By telephone: (703) 308-8037.
Office location: Special Review Branch, Crystal Station #1, 3rd floor,
2800 Crystal Drive, Arlington, VA 22202, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
[[Page 33055]]
I. Legal Authorization
The Federal Food, Drug, and Cosmetic Act (FFDCA) [21 U.S.C. 301 et
seq.] authorizes the establishment of tolerances (maximum legal residue
levels) and exemptions from the requirement of a tolerance for residues
of pesticide chemicals in or on raw agricultural commodities pursuant
to section 408 [21 U.S.C. 346(a)]. Without such tolerances or
exemptions, a food containing pesticide residues is considered to be
``adulterated'' under section 402 of the FFDCA, and hence may not
legally be moved in interstate commerce [21 U.S.C. 342]. To establish a
tolerance or an exemption under section 408 of the FFDCA, EPA must make
a finding that the promulgation of the rule would ``protect the public
health'' [21 U.S.C. 346a(b)]. To establish food additive regulations
(FARs) to cover pesticide residues in processed foods under section 409
of FFDCA, EPA must determine that the proposed use of the food additive
will be safe (21 U.S.C. 348). For a pesticide to be sold, distributed,
and used in the production of food crops, animals, or processed food,
the pesticide must not only have appropriate tolerances or FARs under
the FFDCA, but also must be registered under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.). In 1988,
Congress amended FIFRA and required EPA to review and reassess the
potential hazards arising from currently registered uses of pesticides
registered prior to November 1, 1984. As part of this process, the
Agency must determine whether a pesticide is eligible for
reregistration and if any subsequent actions are required to fully
attain reregistration status. EPA has chosen to include in the
reregistration process a reassessment of existing tolerances or
exemptions from the need for a tolerance. Through this reassessment
process, EPA can determine whether a tolerance must be amended,
revoked, or established, or whether an exemption from the requirement
of one or more tolerances must be amended or is necessary.
The procedure for establishing, amending, or repealing tolerances
or exemptions from the requirement of tolerances is set forth in the
Code of Federal Regulations at 40 CFR parts 177 through 180. The
Administrator of EPA or any person may initiate an action proposing to
establish, amend, revoke, or exempt a tolerance for a pesticide
registered for food uses. Each petition or request for a new tolerance,
an amendment to an existing tolerance, or a new exemption from the
requirement of a tolerance must be accompanied by a fee or a request
for a waiver of such fee. Current Agency policy on tolerance actions
arising from the reregistration process is to administratively process
some actions without requiring payment of a fee; this waiver of fees
applies to revisions or revocations of established tolerances, and to
proposed exemptions from the requirement of a tolerance if the proposed
exemption requires the concurrent revocation of an established
tolerance. Comments submitted in response to the Agency's published
proposals are reviewed; the Agency then publishes its final
determination regarding the specific tolerance actions.
II. Regulatory Background and Proposed Actions
A. Regulatory Background
The proposals described in this action follow the Agency's
tolerance reassessment that was completed and included in the RED for
linuron dated March 1995. While the reassessment determined that many
tolerances established for linuron are adequate and supported by
sufficient data, changes are needed to other linuron tolerances for
various reasons, including: increasing or decreasing tolerances based
on new data and revising commodity terminology, crop group
designations, and definitions that are not in accordance with the
revised crop group regulation (40 CFR part 180, 60 FR 26625, May 17,
1995) or with Table II of Subdivision O of the Pesticide Assessment
Guidelines.
The section of the CFR to be amended by this document is
Sec. 180.184.
B. Proposed Actions
1. Tolerance expression. The tolerance expression under 40 CFR
Sec. 180.184 would be revised to: ``Tolerances are established for the
combined residues of the herbicide linuron (3-(3,4-dichlorophenyl)-1-
methoxy-1- methylurea) and its metabolites convertible to 3,4-
dichloraniline, calculated as linuron....''.
The food tolerances currently listed in 40 CFR 180.184(a) and (b)
are for residues of linuron per se. Plant and animal metabolism studies
indicate the presence of unidentified metabolites of linuron that are
hydrolyzed to 3,4-dichloroaniline (3,4-DCA) under the enforcement
analytical method. Since the Agency believes in this case that the
metabolites converted to 3,4-DCA are unlikely to be more toxic than the
parent compound, and since the enforcement analytical method detects
compounds convertible to 3,4-DCA, it is reasonable to express the
tolerance as the combined residues of linuron and its metabolites
convertible to 3,4-DCA. Because of the very low levels of 3,4-DCA
found, the Agency has determined that 3,4-DCA poses no greater than a
negligible risk in connection with the registered use of linuron and it
is not necessary to regulate 3,4-DCA separately.
Adequate enforcement methods are available for the determination of
linuron residues of concern in/on plant and animal tissues. The current
enforcement methods determine linuron and all metabolites hydrolyzable
to 3,4-DCA.
2. Tolerance revocations. The Agency proposes to revoke the
tolerances for: barley, forage; barley, grain; barley, hay; barley,
straw; corn, pop, fodder; corn, pop, forage; oats, forage; oats, grain;
oats, hay; oats, straw; rye, forage; rye, grain; rye, hay; and rye,
straw. There are no registered products for these uses, and it is the
Agency's policy to revoke tolerances in such cases.
In addition, the Agency proposes to revoke the linuron tolerance
for parsnips, tops. This commodity is no longer listed as a raw
agricultural commodity of parsnips, since it has been determined to be
an insignificant feed item (see Table II of Subdivision O of the
Pesticide Assessment Guidelines).
3. Revisions to tolerances and food and feed additive regulations.
The proposed increases and decreases in linuron tolerances are based on
new data which indicate that a change is needed in the tolerances. To
determine whether the proposed tolerance changes are protective of the
public health, EPA considered all available health effects data.
Dietary exposure resulting from the changes in this proposed action are
protective of the public health and do not result in an unreasonable
chronic or acute risk.
The reference dose (RfD) is established at 0.0077 mg/kg body
weight/day based on a no-observed-effect-level (NOEL) of 0.77 mg/kg
body weight/day for hematological changes and is derived from a 1-year
chronic toxicity study in dogs. An uncertainty factor of 100 was used
to account for interspecies extrapolation and intraspecies variability.
Chronic dietary exposure to the general population with existing and
proposed tolerances utilize only 2 percent of the RfD. For the two
subgroups with the highest exposures, non-nursing infants less than 1
year old and children 1 through 6 years, residues are expected to
utilize 6 percent and 4 percent of the RfD, respectively.
The acute dietary toxicological endpoint is based on a NOEL of 25
mg/
[[Page 33056]]
kg body weight/day, derived from a developmental toxicity study in
rabbits. Acute, high-end, exposure to women of childbearing age
(females 13 years of age or older) results in a Margin of Exposure
(MOE) of 1,667 for developmental toxicity. The Agency generally
considers an MOE of 100 adequate to protect the public health. Thus,
dietary exposure to linuron is not expected to result in an
unreasonable acute effect.
The Agency considers that linuron ``induces cancer'' within the
meaning of section 409 of the FFDCA, based on a dose-related increase
in interstitial cell hyperplasia and adenomas in a two-year rat feeding
study, and hepatocellular tumors in a two-year mouse feeding study.
However, the Agency believes that the weight of evidence for the
carcinogenic potential of linuron in humans is weak and it should not
be regulated using a linearized multi-stage risk assessment model.
Therefore, no quantitative assessment of the dietary cancer risk has
been conducted for linuron; however, such risk is considered to be
negligible.
The following section describes the proposed substantive changes in
the linuron tolerances for food or feed additive regulations.
a. Field corn grain. EPA has reviewed new data analyzed by a method
with a lower level of quantitation (0.05 ppm). These data support a
lower linuron tolerance on field corn grain. The Agency therefore
proposes to lower the linuron tolerance on field corn grain from 0.25
ppm to 0.1 ppm.
b. Field corn fodder (stover). The Agency proposes to increase the
tolerance on corn, field, fodder from 1 ppm to 6 ppm. A review of data
based on residue trials indicated the presence of residues ranging from
0.1 to 5.5 ppm.
c. Livestock commodities. For meat, fat, and meat byproducts of
cattle, goats, hogs, horses, and sheep, the established tolerances are
set at 1.0 ppm. Based on its review of data on residues of linuron in
these commodities, which show that residues in meat, fat, and meat
byproducts (except kidney and liver) are at least an order of magnitude
lower than previously believed, the Agency proposes to lower the
current tolerances for the meat, fat, and meat byproducts (excluding
liver and kidney) of cattle, goats, hogs, horses, and sheep to 0.1 ppm,
and to establish tolerances for the liver and kidney of cattle, goats,
hogs, horses, and sheep at 1.0 ppm.
d. Potatoes. The Agency proposes to reduce the tolerance on
potatoes from 1 ppm to 0.2 ppm. Residue data submitted to support
reregistration of the potato use support this reduction.
e. Wheat. EPA has reviewed new data using an analytical method with
a lower level of quantitation (0.05 ppm). These data support a lower
linuron tolerance, and therefore the Agency proposes to lower the
linuron tolerance on wheat grain from 0.25 ppm to 0.1 ppm. The Agency
also proposes to raise the linuron tolerance on wheat straw from 0.5
ppm to 2.0 ppm based on a reassessment of residue data which showed
residues of up to 2 ppm on wheat straw.
4. Changes from the RED--a. Food additive regulations related to
potatoes. The RED stated that food and feed additive regulation
petitions (409 tolerances) would be required for potatoes, granules;
potatoes, chips; and potatoes, waste from processing. As a result of
the revised Agency policy (60 FR 31300, June 14, 1995) or with Table II
of Subdivision O concerning when a food or feed additive regulation is
needed, the Agency has re-examined its decision in the Linuron RED on
food or feed additive regulations for potato-related commodities. EPA
has also considered new data on residue levels of linuron in potatoes
submitted to support reregistration. These data show that residues of
linuron in potato processed commodities are unlikely to exceed the
section 408 tolerance. Therefore, food or feed additive regulations are
not needed for these commodities.
b. Sorghum. The tolerance for linuron residues on sorghum grain
should remain at 0.25 ppm rather than be lowered to 0.2 ppm as proposed
in the RED. Field studies show that residues are close to the current
tolerance level of 0.25 ppm.
c. Wheat, hay, and corn, sweet, fodder. In the RED, the Agency
stated that the linuron tolerances for wheat, hay, and corn, sweet,
fodder, should be revoked, since these commodities were no longer raw
agricultural commodities. However, these commodities are listed as RACs
in updated versions of Table II of Subdivision O of the Pesticide
Assessment Guidelines. Consequently, the Agency will not propose to
revoke the associated tolerances since these tolerances are needed.
5. Reassessment of tolerances for uses with outstanding data
requirements. In the RED, the Agency has required additional studies to
support reassessment of tolerances for: corn, field, grain; corn,
field, fodder; corn, field, forage; corn, sweet (K + CWHR); corn,
sweet, forage; sorghum, fodder; sorghum, forage; soybeans, forage;
soybeans, hay; and wheat, forage. EPA will reassess these tolerances
once the required data have been submitted and reviewed. Two
registrants for the cotton use have requested voluntary cancellation of
this use, but other registrants may support the use. If the use is
supported, the Agency will require a processing study to support
reassessment of the tolerance for cottonseed; if the use is not
supported, the Agency will propose to revoke the cottonseed tolerance.
In addition, data to support establishing a tolerance for aspirated
grain fractions for field corn are outstanding; and data are needed to
support tolerances for corn, sweet, stover and wheat, hay.
6. Revising commodity definitions. Current linuron tolerances
include commodity terminology, Crop Group designations, or definitions
that are not in accordance with the revised Crop Group Regulation (40
CFR part 180, 60 FR 26625, May 17, 1995) or with Table II of
Subdivision O of the Pesticide Assessment Guidelines. Most of these
changes are slight, and not likely to result in any confusion; the
exception is corn fodder, which has been changed to corn stover for
both field and sweet corn. The amendments at the end of this notice
show all changes in commodity terminology.
III. Public Comment Procedures
EPA invites interested persons to submit written comments,
information, or data in response to this proposed rule. Comments must
be submitted by August 26. 1996. Comments must bear a notation
indicating the document control number. Three copies of the comments
should be submitted to either location listed under ADDRESSES.
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 any of the
ingredients listed herein, may request within 30 days after publication
of this proposed rule in the Federal Register that this rulemaking
proposal be referred to an Advisory Committee in accordance with
section 408(e) of the FFDCA.
A record has been established for this rulemaking under docket
number [OPP-300424] (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,
[[Page 33057]]
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.
IV. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 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; or (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.
B. Regulatory Flexibility Act
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 a substantial number of small businesses, small
governments, or small organizations.
Accordingly, I certify that this proposed rule does not require a
separate regulatory flexibility analysis under the Regulatory
Flexibility Act.
C. Paperwork Reduction 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.
D. Unfunded Mandates Reform Act
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
List of Subjects in 40 CFR Part 180
Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Reporting and recordkeeping requirements.
Dated: June 11, 1996.
Lois Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
Therefore, 40 CFR, chapter I, part 180 is proposed to 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.
2. Section 180.184 is revised to read as follows:
Sec. 180.184 Linuron, tolerances for residues.
(a) Tolerances are established for the residues of the combined
residues of the herbicide linuron (3-(3,4-dichlorophenyl)- 1-methoxy-1-
methylurea) and its metabolites convertible to 3,4- dichloroaniline,
calculated as linuron, in or on the following raw agricultural
commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Asparagus.................................................. 7
Carrot..................................................... 1
Cattle, fat................................................ 0.1
Cattle, kidney............................................. 1
Cattle, liver.............................................. 1
Cattle, meat............................................... 0.1
Cattle, mbyp (except liver and kidney)..................... 0.1
Celery..................................................... 0.5
Corn, field, forage........................................ 0.1
Corn, field, grain......................................... 0.1
Corn, field, stover........................................ 6
Corn, sweet (K+CWHR)....................................... 0.25
Corn, sweet, forage........................................ 1
Corn, sweet, stover........................................ 1
Cottonseed................................................. 0.75
Goats, fat................................................. 0.1
Goats, kidney.............................................. 1
Goats, liver............................................... 1
Goats, meat................................................ 0.1
Goats, mbyp (except liver and kidney)...................... 0.1
Hogs, fat.................................................. 0.1
Hogs, kidney............................................... 1
Hogs, liver................................................ 1
Hogs, meat................................................. 0.1
Hogs, mbyp (except liver and kidney)....................... 0.1
Horses, fat................................................ 0.1
Horses, kidney............................................. 1
Horses, liver.............................................. 1
Horses, meat............................................... 0.1
Horses, mbyp (except liver and kidney)..................... 0.1
Parsnips, roots............................................ 0.5
Potatoes................................................... 0.2
Sheep, fat................................................. 0.1
Sheep, kidney.............................................. 1
Sheep, liver............................................... 1
Sheep, meat................................................ 0.1
Sheep, mbyp (except liver and kidney)...................... 0.1
Sorghum, fodder............................................ 1
Sorghum, forage............................................ 1
Sorghum, grain............................................. 0.25
Soybeans................................................... 1
Soybeans, forage........................................... 1
Soybeans, hay.............................................. 1
Wheat, forage.............................................. 0.5
Wheat, grain............................................... 0.1
Wheat, hay................................................. 0.5
Wheat, straw............................................... 2.0
------------------------------------------------------------------------
(b) Tolerances with regional registration, as defined in
Sec. 180.1(n) are established for the residues of the combined residues
of the herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-
methylurea) and its metabolites convertible to 3,4-dichloroaniline,
calculated as linuron, in or on the following raw agricultural
commodities:
------------------------------------------------------------------------
Parts per
Commodity million
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Parsley.................................................... 0.25
------------------------------------------------------------------------
[FR Doc. 96-15597 Filed 6-25-96; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 96-15272 Performance-Oriented Packaging Standards; Final Transitional Provisions
[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33216-33230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15272]
[[Page 33215]]
_______________________________________________________________________
Part IV
Department of Transportation
_______________________________________________________________________
Research and Special Programs Administration
_______________________________________________________________________
49 CFR Part 171, et al.
Performance-Oriented Packaging Standards: Final Transitional
Provisions; Proposed Rule
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 /
Proposed Rules
[[Page 33216]]
DEPARTMENT OF TRANSPORTATION
Research and Special Programs Administration
49 CFR Parts 171, 172, 173, 178
[Docket No. HM-181H; Notice No. 96-11]
RIN 2137-AC80
Performance-Oriented Packaging Standards; Final Transitional
Provisions
AGENCY: Research and Special Programs Administration (RSPA), DOT.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: RSPA is proposing to incorporate into the Department's
Hazardous Materials Regulations (HMR) a number of changes, based on
agency initiative, petitions for rulemaking and comments received at
public meetings, to the classification of certain hazardous materials
which are poisonous by inhalation and to provisions for the
manufacture, use and reuse of hazardous materials packagings. The
intended effect of these regulatory changes is to improve safety,
reduce costs to offerors and transporters of hazardous materials, make
the regulations easier to use and correct errors.
DATES: Comments must be received on or before August 2, 1996.
ADDRESSES: Address comments to Dockets Unit (DHM-30), Hazardous
Materials Safety, RSPA, U.S. Department of Transportation, Washington,
DC 20590-0001. Comments should identify the docket and notice number
and be submitted, when possible, in five copies. Persons wishing to
receive confirmation of receipt of their comments should include a
self-addressed, stamped postcard. The Dockets Unit is located in Room
8421 of the Nassif Building, 400 Seventh Street SW., Washington, DC
20590-0001. Office hours are 8:30 am to 5:00 pm Monday through Friday,
except on public holidays when the office is closed.
FOR FURTHER INFORMATION CONTACT: Beth Romo, telephone (202) 366-8553,
Office of Hazardous Materials Standards, or Bill Gramer, telephone
(202) 366-4545, Office of Hazardous Materials Technology, Research and
Special Programs Administration, Washington DC, 20590-0001.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 1990, RSPA published a final rule [Docket HM-181;
55 FR 52402], which comprehensively revised the HMR with respect to
hazard communication, classification, and packaging requirements based
on the United Nations (UN) Recommendations on the Transport of
Dangerous Goods. A document responding to petitions for reconsideration
and containing editorial and substantive revisions to the final rule
was published on December 20, 1991 [56 FR 66124]. On October 1, 1992,
under Dockets HM-181 and HM-189, RSPA issued editorial and technical
corrections to the regulations published in 1991. On September 24,
1993, RSPA issued a final rule under Docket HM-181F [58 FR 50224] which
made changes to the HMR based on agency initiative and petitions for
rulemaking received since the December 20, 1991 response to petitions
for reconsideration. That final rule primarily revised requirements
with a mandatory compliance date of October 1, 1993, as provided in the
transitional provisions in Sec. 171.14(b)(4).
This rule, as proposed, addresses most remaining issues associated
with the implementation of Docket HM-181 provisions and certain other
issues arising from a final rule issued December 29, 1994, under Docket
HM-215A [59 FR 67390]. Many of these proposed changes are to
requirements with a compliance date of October 1, 1996. These issues
have been raised through petitions for rulemaking and agency
initiative. Although these proposed changes focus primarily on
provisions concerning hazard classification and the maintenance and use
of performance packaging, RSPA also is proposing changes to
intermediate bulk container (IBC) requirements, portable tank
requirements, and regulated medical waste provisions adopted under
Dockets HM-181E and HM-181G, respectively. Several current exemptions
would be converted into regulations of general applicability, and an
approval concerning design qualification and periodic testing would be
incorporated into the HMR.
This proposed rule does not address the manufacture, maintenance
and use of fiber drums. A final rule was published February 29, 1996
[61 FR 7958] which extends the authority to ship certain liquid
hazardous materials in open-head fiber drums that do not meet
performance-oriented packaging standards for hazardous materials in
Packing Group III.
This proposed rule is consistent with the goals of President
Clinton's Regulatory Reinvention Initiative. The President directed
Federal agencies to review all agency regulations and eliminate or
revise those that are outdated or in need of reform. A notice issued
April 4, 1995 by RSPA requested comments on regulatory reform (Docket
HM-222; 60 FR 17049) and announced a comprehensive review of the HMR to
identify provisions that are candidates for elimination, revision,
clarification, or relaxation. Certain proposed changes in this document
reflect the results of this review.
II. Summary of Proposed Regulatory Changes by Section
Listed below is a section-by-section summary of the proposed
changes and, where applicable, the assigned petition number.
Part 171
Section 171.7. The table of material incorporated by reference
would be amended by adding a new entry referencing a publication issued
by the Department of Health and Human Services for defining biosafety
levels.
Section 171.14. All transitional provisions reflecting a compliance
date of October 1, 1996, or earlier would be removed. Three remaining
transition provisions apply to packages filled prior to October 1,
1991, new placard specifications, and authorization for use of fiber
drums.
Part 172
Section 172.101. The text preceding the Sec. 172.101 Hazardous
Materials Table (HMT) sets forth procedures for using the HMT. RSPA
received a petition for rulemaking [P-1169] from the Hazardous
Materials Advisory Council (HMAC) requesting clarification of the
procedures contained in paragraph (c)(12)(iii) for selecting a proper
shipping name for a material that meets the definition of more than one
hazard class. RSPA agrees and is proposing to replace the phrase
``identify . . . by a specific description'' with ``identify . . .
specifically by name'' and include an example.
Section 172.101; the Hazardous Materials Table (HMT). A new entry
to provide for the domestic transportation of black powder for small
arms reclassed as a Division 4.1 would be added. This proposed revision
is in response to a petition [P-1295] asking RSPA to incorporate the
provisions of an exemption (DOT-E-8958) into regulations of general
applicability. As part of the justification for the request, the
petitioner noted an incident-free shipping history of more than 12
years and cited comparable provisions for smokeless powder, small arms
cartridges and power device cartridges. In conjunction with this
proposed
[[Page 33217]]
change, a new Special Provision 70 and new non-bulk packaging section
Sec. 173.170 would be added.
In the HMT, the entries ``Chlorosilanes, n.o.s.'', with
identification numbers UN 2986, UN 2987, and UN 2988, are not
authorized to be shipped in IM portable tanks. A petitioner [P-1257]
requested that RSPA authorize IM portable tanks for all chlorosilanes
because individual chlorosilanes, such as Ethyldichlorosilane,
Methyldichlorosilane and Trichlorosilane, pose similar hazards and are
authorized under the HMR to be shipped in IM portable tanks. RSPA
agrees with the petitioner that authorizing certain IM portable tanks
for all chlorosilanes would not compromise safety and would be
consistent with packaging authorizations for other materials posing
similar hazards. RSPA proposes to add special provisions in Column (7)
for ``Chlorosilanes, n.o.s.'', with identification numbers UN 2986, UN
2987, and UN 2988, to permit the transport of these materials in IM
portable tanks.
Bulk packaging references for three Type F organic peroxides (UN
3110, UN 3119, and UN 3120) would be revised by changing ``None'' to
``225'' in Column (8C) to indicate that these materials are authorized
in bulk packagings. In addition, for the entries ``Organic Peroxide,
type F, liquid (or solid), temperature controlled'' (UN 3119 and UN
3120), in Column (8A), the packaging exception reference ``152'' would
be removed for each entry to indicate that these temperature controlled
organic peroxides are not eligible for packaging exceptions.
Twenty-nine entries classed as Division 4.3 (dangerous when wet)
solids in Packing Groups II and III would be amended by revising Column
(8A) to authorize Sec. 173.151 as a packaging exception section.
Revisions to Classification and Hazard Zone Identification for
Certain Materials Poisonous by Inhalation. Based on acute inhalation
toxicity data and related information obtained by RSPA, the HMT would
be amended to change the hazard zone for some materials poisonous by
inhalation, and to add other materials to the list of materials
poisonous by inhalation. For certain materials this revision would
impose more stringent hazard communication and packaging requirements.
The materials and a description of the data on which these proposals
are based are listed as follows:
a. Bromine trifluoride (UN1746). This material is a liquid at
20 deg.C and is identified as a Hazard Zone B inhalation hazard. Based
on harmonization of the HMR with the UN Recommendations (Eighth revised
edition), bromine trifluoride is assigned to Division 5.1. However,
according to Sec. 173.2a(a), ``Division 6.1 (poisonous liquids),
Packing Group I, poisonous-by-inhalation only'' takes precedence over
``Division 5.1 (oxidizers).'' Therefore, RSPA is proposing to add the
plus (+) symbol to Column 1 of the entry for bromine trifluoride.
b. Hydrogen cyanide, solution in alcohol (with not more than 45
percent hydrogen cyanide) (UN3294). This material is a liquid at
20 deg.C and is classified as a Division 6.1 material. Packing Group I
only is assigned. Hydrogen cyanide, stabilized (UN1051), is identified
as a Hazard Zone A inhalation hazard. Therefore, based on the toxicity
and volatility of hydrogen cyanide, the packing group assigned and the
dilution factor for this solution of hydrogen cyanide, RSPA is
proposing to identify hydrogen cyanide, solution in alcohol with not
more than 45 percent hydrogen cyanide as a Hazard Zone B inhalation
hazard.
c. Metal carbonyls, n.o.s. (UN3281). This generic entry covers
Division 6.1, Packing Group I, II and III toxic metal carbonyls that
are not specifically listed by name but which exhibit acute oral,
dermal and/or inhalation toxicity. The acute toxicity of these metal
carbonyls may differ from one compound to another. Those toxic by
inhalation may fall into Hazard Zone A or Hazard Zone B. Others may not
be toxic by inhalation, but may exhibit oral and/or dermal toxicity,
which places them in Division 6.1, Packing Group I. Therefore, RSPA is
proposing to add special provision ``5'' to Column 7 of the entry for
metal carbonyls, n.o.s. at the Packing Group I level.
d. Methanesulfonyl chloride (UN3246). This material is a liquid at
20 deg.C and is classified as a Division 6.1 material. Acute inhalation
toxicity data for this material was obtained from a Special Approval
application before the material was listed by name in the UN
Recommendations (Seventh revised edition) and, subsequently, in the
HMR. Following publication of the final rule under Docket HM-215A (59
FR 67390; December 29, 1994), a manufacturer submitted data identifying
the material as a Hazard Zone B inhalation hazard (rat; LC50:205 ppm/1H
(hour); V (saturated vapor concentration):2760 ppm). RSPA agrees with
the data and is proposing to identify methanesulfonyl chloride as a
Hazard Zone B inhalation hazard.
e. Methyl vinyl ketone (UN1251). This material is a liquid at
20 deg.C and is classified as a Class 3 material. Acute inhalation
toxicity data for methyl vinyl ketone was listed in the Registry of
Toxic Effects of Chemical Substances (RTECS) (RTECS: EM9800000), as
follows: Rat; LC50:7 mg/m\3\/4H. The value, converted to ppm/one hour,
was: Rat; LC50:5 ppm/1H. The saturated vapor concentration was
calculated to be: V:93400 ppm at 20 deg.C, indicating that methyl vinyl
ketone is a material poisonous by inhalation and falls within Hazard
Zone A. RSPA agrees with this data and is proposing to identify methyl
vinyl ketone as a Hazard Zone A inhalation hazard. Also, to maintain
harmony with the UN Recommendations (Eighth revised edition), RSPA is
proposing to add the plus (+) symbol to Column 1 of the entry for
methyl vinyl ketone.
f. Nitriles, toxic, flammable, n.o.s. (UN3275). This generic entry
covers Division 6.1, Packing Group I and II toxic, flammable nitriles
that are not specifically listed by name but exhibit acute oral, dermal
and/or inhalation toxicity. The acute toxicity of these nitriles may
differ from one compound to another. Those toxic by inhalation may fall
into Hazard Zone A or Hazard Zone B. Other nitriles may not be toxic by
inhalation, but may exhibit oral and/or dermal toxicity which places
them in Division 6.1, Packing Group I. Therefore, RSPA is proposing to
add special provision ``5'' to Column 7 of the entry for nitriles,
toxic, flammable, n.o.s. at the Packing Group I level.
g. Nitriles, toxic, n.o.s. (UN3276). This generic entry covers
Division 6.1, Packing Group I, II and III toxic nitriles that are not
specifically listed by name but exhibit acute oral, dermal and/or
inhalation toxicity. The acute toxicity of these nitriles may differ
from one compound to another. Those toxic by inhalation may fall into
Hazard Zone A or Hazard Zone B. Other nitriles may not be toxic by
inhalation, but may exhibit oral and/or dermal toxicity which places
them in Division 6.1, Packing Group I. Therefore, RSPA is proposing to
add special provision ``5'' to Column 7 of the entry for nitriles,
toxic, n.o.s. at the Packing Group I level.
h. Organoarsenic compound, n.o.s. (UN3280). This generic entry
covers Division 6.1, Packing Group I, II and III toxic organoarsenic
compounds that are not specifically listed by name but exhibit acute
oral, dermal and/or inhalation toxicity. The acute toxicity of these
organoarsenic compounds may differ from one compound to another. Those
toxic by inhalation may fall into Hazard Zone A or Hazard Zone B.
Others may not be toxic by inhalation, but may exhibit oral and/or
dermal
[[Page 33218]]
toxicity which places them in Division 6.1, Packing Group I. Therefore,
RSPA is proposing to add special provision ``5'' to Column 7 of the
entry for organoarsenic compound, n.o.s. at the Packing Group I level.
i. Organophosphorus compound, toxic, flammable, n.o.s. (UN3279).
This generic entry covers Division 6.1, Packing Group I and II toxic,
flammable organophosphorus compounds that are not specifically listed
by name but may exhibit acute oral, dermal and/or inhalation toxicity.
The acute toxicity of these organophosphorus compounds may differ from
one compound to another. Those toxic by inhalation may fall into Hazard
Zone A or Hazard Zone B. Others may not be toxic by inhalation, but may
exhibit oral and/or dermal toxicity which places them in Division 6.1,
Packing Group I. Therefore, RSPA is proposing to add special provision
``5'' to Column 7 of the entry for organophosphorus compound, toxic,
flammable, n.o.s. at the Packing Group I level.
j. Organophosphorus compound, toxic, n.o.s. (UN3278). This generic
entry covers Division 6.1, Packing Group I, II and III toxic
organophosphorus compounds that are not listed by name but exhibit
acute oral, dermal and/or inhalation toxicity. The acute toxicity of
these organophosphorus compounds may differ from one compound to
another. Those toxic by inhalation may fall into Hazard Zone A or
Hazard Zone B. Others may not be toxic by inhalation, but may exhibit
oral and/or dermal toxicity which places them in Packing Group I.
Therefore, RSPA is proposing to add special provision ``5'' to Column 7
of this entry for organophosphorus compound, toxic, n.o.s. at the
Packing Group I level.
k. Phosphorus pentafluoride (UN2198). This material is a gas at
20 deg.C and is currently identified as a Hazard Zone A inhalation
hazard - a tentative classification since no acute inhalation toxicity
data was available. The Compressed Gas Association, Inc. (CGA) has
reviewed the acute inhalation toxicity of phosphorous pentafluoride,
among others. In their Standard for Classification of Toxic Gas
Mixtures (CGA P-20--1995), the CGA estimates the toxicity to be: Rat;
LC50:260 ppm/1H. RSPA agrees with the CGA estimate and is proposing to
identify phosphorus pentafluoride as a Hazard Zone B inhalation hazard.
l. Tungsten hexafluoride (UN2196). This material is a gas at
20 deg.C and is currently identified as a Hazard Zone C inhalation
hazard. This was an RSPA estimate since no acute inhalation toxicity
data was available. The CGA has reviewed the acute inhalation toxicity
of tungsten hexafluoride. In their Standard for Classification of Toxic
Gas Mixtures, the CGA estimates the toxicity to be: Rat; LC50:217 ppm/
1H. RSPA agrees with the CGA estimate and is proposing to identify
phosphorus pentafluoride as a Hazard Zone B inhalation hazard.
Section 172.102. Special Provision B59, which authorizes AAR 207A
rail cars for phosphorus pentasulfide, would be revised based on a
petition [P-1286] submitted by the Association of American Railroads
(AAR). In its petition, the AAR maintained that the current
authorization in B59 for AAR Specification ``207A tank cars'' is not
correct. The AAR acknowledged that it has contributed to the problem by
referring to these cars in its Tank Car Manual as tank cars, when they
are, in fact, hopper cars used to transport solid materials. RSPA
agrees that these cars are more appropriately described as hopper cars
and proposes to amend Special Provision B59 accordingly.
A new special provision (N42) would be added to authorize a UN 1A1
steel drum for stabilized benzyl chloride. Prior to the adoption of
performance packaging standards under Docket HM-181, the use of DOT
Specification 5A and 17C steel drums was authorized for stabilized
benzyl chloride. Under Docket HM-181, Special Provision N43 was
assigned to both stabilized and unstabilized benzyl chloride, which
prohibited use of metal drums other than those constructed of monel or
nickel. Based on a petition for rulemaking [P-1296], RSPA agrees with
the petitioner that certain 1A1 steel drums having a phenolic lining
are appropriate for stabilized benzyl chloride. Therefore, RSPA is
proposing to remove N43 from the entry for benzyl chloride and replace
it with a new special provision N42, which will allow use of phenolic-
lined steel drums with a minimum thickness of 0.050 inches which have
been tested and certified to a Packing Group I level at a specific
gravity of 1.8.
Section 172.302. In the general marking requirements for bulk
packagings, markings on portable tanks with capacities of less than
3,785 L (1,000 gallons) must be at least 6.0 mm (0.24 inch) wide and at
least 25 mm (one inch) high. RSPA received a petition for rulemaking
[P-1191] requesting that paragraph (b)(2) of this section be amended to
decrease to 3 mm the minimum width of markings required on portable
tanks having a capacity less than 3,785 L (1,000 gallons). The
petitioner stated that the required minimum width (6 mm) is
disproportionate to the required minimum height (25 mm). The petitioner
stated that this marking is difficult to read, which reduces the
effectiveness of the marking. RSPA agrees that the width of the
markings should be proportionate to the height, but believes that 3 mm
may be too narrow for the size of the packaging. In this notice, RSPA
proposes to revise the minimum width of markings for portable tanks
with capacities less than 3,785 L (1,000 gallons) to 4 mm (0.16
inches). In addition, minimum height of markings required on IBCs would
be specified in paragraph (b)(2) as 25 mm (one inch). Currently,
minimum height markings for IBCs would fall under paragraph (b)(3) with
IBCs described as ``other bulk packagings'' which are required to have
a minimum height of 50 mm (2.0 inches). RSPA has received comments
requesting the minimum height requirement be lowered for IBCs. After
reviewing this issue, RSPA agrees that the minimum marking height for
IBCs should be consistent with markings for smaller portable tanks and
is proposing a reduction in both height and width for IBCs.
Section 172.504. In response to a petition for rulemaking from HMAC
[P-1169], RSPA is proposing to remove paragraph (f)(8), which allows a
CLASS 9 placard to be substituted for a COMBUSTIBLE LIQUID placard for
a material meeting both Combustible liquid and Class 9 hazard classes.
HMAC noted the potential for confusion and delay of a shipment because
of inconsistencies between the documentation and marking requirements
describing a Combustible liquid and the application of CLASS 9
placards. In addition, this alternative placarding conflicts with
paragraph (f)(9), which provides an exception from placarding for Class
9 materials in domestic transportation.
Part 173
Section 173.24a. It has come to RSPA's attention that certain
cushioning materials deteriorate if there is even minimal leakage from
an inner packaging. A degradation of cushioning materials could
seriously reduce the effectiveness of a packaging and render it as not
conforming to its marked performance standard or not meeting general
packaging requirements. Paragraph (a)(3) would be revised to clarify
that cushioning material used to protect inner packagings must not be
adversely affected (e.g., disintegrate) if there is leakage of a
hazardous material from the inner packagings. This clarification is
consistent with
[[Page 33219]]
international air transport provisions contained in the International
Civil Aviation Organization's Technical Instructions.
Currently, paragraphs (b)(1) and (b)(2) provide filling limits for
single and composite packagings, but no such limits are provided for
combination packagings. RSPA proposes to revise paragraph (b)(2) of
this section to prescribe filling limits for all non-bulk packagings,
including combination packagings. This provision would prohibit
combination packagings from being filled with a hazardous material to a
gross mass greater than the maximum gross mass marked on the packaging.
In addition, a new paragraph (e) would be added to incorporate a
definition for stainless steel as it pertains to non-bulk packaging.
This is consistent with paragraph (b) in Sec. 173.24b for calculating
equivalent steel for bulk packagings.
Section 173.28. RSPA received a petition [P-1303] requesting that
paragraph (b)(4) be revised to incorporate a calculation which may be
used to determine an equivalent drum thickness for stainless steel
drums. The petitioner maintained that drums fabricated of stainless
steel are less susceptible to damage or a reduction in structural
integrity resulting from mechanical stresses associated with handling
and reuse. The petitioner further claimed that an equivalent level of
safety can be achieved through reuse of a thinner stainless steel drum
and noted the same method is authorized already in the HMR for
calculating equivalent minimum thicknesses of portable tanks and metal
IBCs. RSPA agrees, and is proposing to add a formula in paragraph
(b)(4) for calculating an equivalent minimum thickness for stainless
steel drums. This proposed formula is consistent with the formula
contained in Sec. 178.705 for calculating minimum wall thicknesses for
metal IBCs.
The Association of Container Reconditioners (ACR) submitted a
petition for rulemaking [P-1292] dated August 10, 1995, asking RSPA to
revise the footnote in paragraph (b)(4) once again to reflect a 1.1 mm
(0.043 inch) head. This footnote has been revised three times since the
issuance of the 1990 Docket HM-181 final rule. In 1988, ACR (formerly
National Barrel and Drum Association) was among commenters to the HM-
181 NPRM asking RSPA to allow the ``20/18 gauge'' drum. RSPA responded
to this comment in the 1990 final rule by adopting a footnote to the
Sec. 173.28(b)(4) minimum thickness table, to allow the ``20/18 gauge''
drum, (i.e. drums of 220 liters with a body thickness of 0.82 mm and
head thickness of 1.09 mm) to be reused. The 1991 revised final rule
under Docket HM-181 amended the footnote to allow a minimum body
thickness of 0.8 mm, with minimum head thickness of 1.1 mm. This change
was not based on comments or RSPA's intent to change minimum thickness
requirements, but from revised methods of rounding metric units. In
1993, the eighth revised edition of the UN Recommendations adopted a
requirement to mark nominal thickness, which is tied to minimum
thickness by ISO 3574. RSPA, in response to an ACR request for
clarification, stated that drums marked in accordance with the UN
Recommendations would be satisfactory, but they must be marked with the
minimum thickness to the nearest 0.1 mm. In the 1994 edition of the
HMR, Footnote 1 continued to authorize a minimum thickness of 0.8 mm
(0.03 inch) body and 1.1 mm (0.043 inch) head. No changes to the
footnote were proposed in the Docket HM-215A NPRM published July 18,
1994, but in its September 6, 1994 comment to this proposed rule, ACR
``strongly'' urged RSPA to restore Footnote 1 to the original provision
implemented in the 1990 HM-181 final rule ( 0.82 mm body and 1.09 mm
head). ACR stated: ``In reprinting this table in 1991, however, the
thicknesses identified in this footnote were changed, from 0.82 mm
(0.0324 inch) to `0.8 mm (0.03 inch' in the body and from 1.09 mm
(0.0428 inch) to `1.1 mm (0.043 inch)' in the heads.'' ACR claimed
these criteria do not correspond to the 20/18 gauge DOT specification
drums in current use at the time HM-181 was adopted, ``nor were they
explained in any fashion in the preamble to the second printing of the
final rule.'' ACR suggested that the footnote ``could be recast'' to
prescribe ``0.9 mm nominal (0.82 mm minimum) body and 1.2 mm nominal
(1.1 mm minimum) body''. In the December 29, 1994 final rule issued
under HM-215A, RSPA adopted a requirement to mark drums with nominal,
rather than minimum thickness, based on revised UN Recommendations, but
retained minimum thickness standards for reuse. In Footnote 1, RSPA
revised the 0.8 mm thickness to read ``0.80 mm'' for clarity. On
January 27, 1995, ACR submitted a petition for reconsideration of HM-
215A final rule within the prescribed 30-day period following the
December 29, 1994 final rule. ACR requested an immediate ``spot''
amendment to Footnote 1. In its petition, ACR stated ``. . . we ask you
to issue an immediate correction to the footnote to Sec. 173.28(b)(4)
to make it read properly as it did in the December 21, 1990 Federal
Register: `Metal drums or jerricans constructed with a minimum
thickness of 0.82 mm (0.032 inch) body and 1.09 mm (0.043 inch) heads
are authorized.' '' However, on February 24, 1995, after the petition
for reconsideration period for HM-215A had ended, ACR submitted another
letter ``intended to provide clarifying detail'' regarding Footnote 1.
This letter indicated the footnote should be corrected to express
minimum thicknesses for nominal markings in accordance with the ISO
standard and should reference a minimum thickness of 0.82 mm body and
1.11 mm heads, which would bear a nominal marking ``1.2/0.9/1.2.'' Less
than a month after receipt of the petition requesting an immediate
correction to authorize 1.09 mm minimum thickness for heads, ACR again
requested a minimum thickness of 1.11 mm heads. A revised final rule
under Docket HM-215A issued on May 18, 1995, addressed the ACR petition
of January 27, 1995, by restoring the minimum thicknesses of 0.82 mm
body and 1.09 heads, as adopted in the HM-181 final rule issued
December 21, 1990. ACR responded by submitting a petition for
rulemaking on August 10, 1995, claiming that RSPA had not adjusted
Footnote 1 to correlate with ISO Standard 3574:1986, and petitioning
RSPA to revise Footnote 1 to prescribe a metal drum minimum thickness
of 0.82 mm body and 1.11 mm heads. ACR indicated that this would result
in a ``modest increase in the minimum head thickness of 0.02 mm, . . .
most of the metal thicknesses now set forth in the table . . . also
involved modest increases.'' In a subsequent action, ACR sent a letter
to the RSPA Administrator, claiming that ``DOT has been unable to
successfully marry the international standards used and cited by the UN
with DOT's minimum thickness requirements, with respect to `20/18'
style drums.'' ACR also cited ``changes made by RSPA in HM-215A'' (one
based on the ACR petition for a spot amendment to restore the footnote
to 0.82 body and 1.09 heads) and noted the agency's failure to adjust
the Sec. 173.28 footnote to correspond with ISO. Based on this
discussion, RSPA is proposing one final adjustment to Footnote 1 to
specify a minimum thickness of 0.82 mm body and 1.11 mm head to
correspond with ISO and respond to ACR's latest petition.
Paragraph (b)(7)(iv)(C) would be revised to clarify that there are
established conditions which must be met before an approval is granted
by the
[[Page 33220]]
Associate Administrator for Hazardous Materials Safety to allow relief
from leakproofness testing for a packaging constructed of a material or
thickness not otherwise authorized in the exception.
Paragraph (c)(2) prescribes reconditioning requirements for non-
bulk packagings other than metal drums. Based on the merits of a
request for clarification from the National Association of Chemical
Distributors, RSPA is proposing that paragraph (c)(2) be revised to
clarify that repair or replacement of a bung or a removable gasket in a
plastic closed head (UN 1H1) drum is not considered reconditioning and
does not subject the drum to reconditioning marking requirements or to
leakproofness testing requirements if the drum was otherwise excepted
from leakproofness testing.
Section 173.32. A final rule issued July 26, 1994, under Docket HM-
181E adopted provisions for intermediate bulk containers and imposed a
termination date of September 30, 1996 for new construction of DOT
Specification 56 and 57 portable tanks. As part of that final rule,
requirements in Part 178 for design, construction and testing of these
tanks were removed. Although new construction of these tanks will no
longer be authorized after September 30, 1996, existing DOT 57 tanks
are authorized for use as long as they are successfully retested in
accordance with retest provisions of Sec. 173.32(e). Because the
pressure testing requirements for DOT 57 tanks refer to a section in
Part 178 which has been removed, RSPA is proposing to reinstate this
requirement in paragraph (e)(2)(i). In addition, based on the merits of
a petition [P-1092], RSPA is proposing to amend paragraph (d) to allow
plastic discharge valves for certain stainless steel DOT 57 tanks
constructed before October 1, 1996. Allowing a plastic discharge valve
on these tanks will eliminate the need for an existing exemption, DOT-
E-10916, and will permit continued use of thousands of portable tanks
with a proven safety record.
Section 173.115. The Association of American Railroads (AAR), in a
petition for rulemaking [P-1152], requested a revision to paragraph
(b)(1) to correct the conversion of 280 kPa to read ``280 kPa (40.6
psia).'' RSPA agrees and paragraph (b)(1) is revised to reflect the
correct conversion in parentheses for informational purposes.
Section 173.120 and Appendix H to Part 173. Based on the merit of
requests from industry, RSPA is proposing to add provisions to test
combustible liquids with a flash point above 60.5 deg.C (141 deg.F) and
below 93 deg.C (200 deg.F) for the ability to sustain combustion.
Appendix H was added in the Docket HM-215A final rule to incorporate
additional testing procedures for a material meeting the definition of
Class 3 (flammable liquid). If this material was unable to sustain
combustion when heated under test conditions and exposed to an external
source of flame, it was excepted from the regulations as a Class 3
material. This notice proposes to expand the exception to apply to
materials which meet the definition in paragraph (b) for combustible
liquids. Appendix H to Part 173 would be revised to provide additional
test temperatures in paragraph 5.(h) for combustible liquids that would
closely parallel the approach for flammable liquids.
Sections 173.121, 173.125, and 173.127. Currently, procedures for
assigning a packing group to a hazardous material in these sections
convey to the reader that the Sec. 172.101 Table indicates that the
packing group is to be determined on the basis of the grouping criteria
for a given hazard class. The AAR and HMAC, in petitions for rulemaking
[P-1152 and P-1169, respectively], requested that RSPA amend the
regulatory language in Secs. 173.121(a), 173.125(a), and 173.127(b) to
mirror the language in Secs. 173.133 and 173.137 for consistency and
clarity. In this notice, RSPA proposes to clarify the methods for
determining packing groups described in Secs. 173.121(a), 173.125(a),
and 173.127(b) for Class 3, Class 4, and Class 5 materials,
respectively.
Section 173.133. The introductory text of paragraph (a) sets forth
procedures for selecting packing group or hazard zone when the
Sec. 172.101 Table provides more than one packing group and hazard zone
for a hazardous material. The AAR requested, in a petition for
rulemaking [P-1152], that RSPA revise the wording ``provides more than
one packing group and hazard zone'' to read ``provides more than one
packing and/or hazard zone'' because hazard zones do not apply to
Packing Group II and III Division 6.1 materials. RSPA agrees and
proposes to revise the wording ``more than one packing group and hazard
zone'' to read ``more than one packing group or hazard zone''.
Section 173.134. Paragraph (a)(4) limits the definition of
regulated medical waste to exclude discarded cultures and stocks of
infectious substances. In this proposed rule, paragraph (b) would be
revised by adding a new paragraph (b)(4) authorizing discarded cultures
and stocks in Biosafety Levels 1, 2 and 3, as defined in HHS
Publication No. (CDC) 93-8395, Biosafety in Microbiological and
Biomedical Laboratories, 3rd Edition, May 1993, Section II to be
described and packaged as regulated medical waste rather than
infectious substances. Packagings would be required to conform to
Packing Group II performance requirements. Transport of these materials
would be limited to private or contract motor freight carriers in
dedicated service to the transportation of medical waste.
Section 173.151. A new paragraph (d) would be added to incorporate
limited quantity provisions for Division 4.3 (dangerous when wet) solid
materials in Packing Groups II and III. This proposal would align the
HMR with limited quantity exceptions contained in the UN
Recommendations.
Section 173.156. In the December 21, 1990 final rule under Docket
HM-181, RSPA imposed a gross weight limit of 30 kg (66 pounds) per
package on materials shipped under limited quantity and consumer
commodity provisions to minimize their aggregate risk. RSPA also
provided an exception in Sec. 173.156 from this 30 kg weight limitation
for packages of consumer commodities unitized in cages, carts, boxes,
or similar overpacks when shipped by private or contract carrier or
common carrier in exclusive use between a manufacturer, a distribution
center, and a retail outlet. RSPA received a petition for rulemaking
[P-1213] from the Conference on the Safe Transportation of Hazardous
Articles (COSTHA) requesting removal of the 30 kg weight restriction
for ORM-D materials packaged in ``display packs.'' COSTHA described
these display packs as containing inner receptacles of ORM-D materials
which are secured in corrugated fiberboard trays and then stacked and
placed within a strong outer container. Each outer container is
strapped to a wooden pallet with steel or polyester strapping to form
an integral part of the packaging. COSTHA claimed the completed package
meets the general packaging requirements of Subpart B of Part 173 and
is marked in accordance with Sec. 172.316. As part of its petition,
COSTHA cited an exemplary safety record in transporting these display
packs under pre-HM-181 limited quantity provisions, which do not impose
any weight limitations, but will no longer be authorized after October
1, 1996.
RSPA believes that ORM-D materials shipped in the above-described
display packs achieve an adequate level of safety in transportation.
Therefore, RSPA proposes to amend Sec. 173.156 by revising paragraph
(b) to authorize
[[Page 33221]]
ORM-D materials in palletized display packs exceeding the 30 kg (66
pound) gross weight limitation to be offered for transportation, or
transported, by highway or rail between a manufacturer, a distribution
center, and a retail outlet.
In addition, RSPA is proposing to provide an exception for
transportation of ORM-D materials to disposal facilities. A petitioner
[P-1308] requested that RSPA amend paragraph (b) to allow discarded
consumer commodities to be transported from manufacturing, distribution
or retail facilities to a disposal facility when packaged in large
boxes or overpacks exceeding 30 kg (66 pounds). The petitioner claimed
that the cost of meeting the 30 kg weight limit or packaging these
consumer commodities in UN-certified performance packagings far exceeds
any safety benefit achieved. The petitioner also noted that allowing
distribution centers and retail outlets to ship discarded consumer
commodities to local disposal facilities rather than back to the
manufacturer could enhance transportation safety by shortening the
shipping distance. RSPA agrees and is proposing to amend paragraph (b)
to authorize discarded consumer commodities to be shipped to disposal
facilities when packaged in large boxes or similar overpacks exceeding
30 kg (66 pounds).
Section 173.158. This section would be revised to authorize
additional packagings for nitric acid. RSPA received one petition [P-
1280] which pointed out that packaging authorizations for nitric acid
in 90 percent or greater concentrations, when offered for
transportation or transported by rail, highway or water, are more
stringent than packaging authorizations for transportation by cargo
aircraft only or packaging authorizations for red fuming nitric acid, a
toxic by inhalation hazard material. RSPA agrees with this petitioner,
and paragraph (d) would be revised to authorize additional packagings
for nitric acid in concentrations of 90 percent or greater when offered
for transportation or transported by rail, highway or water. A
combination packaging consisting of a 1A2, 1B2, 1D, 1G, 1H2, 3H2 or 4G
outer packaging with inner glass packagings of 2.5 L (0.66 gallons) or
less capacity cushioned with a non-reactive, absorbent material and
packed within a leak-tight packaging of metal or plastic would be
authorized.
In addition, RSPA is proposing to revise paragraph (f)(1) based on
the merits of a petition [P-1289] requesting that 6HH1 and 6HA1
composite packagings with PFA Teflon inner receptacles be authorized
for nitric acid concentrations of 70 percent or less. These composite
packagings are authorized under the provisions of three exemptions and
have demonstrated an equivalent level of safety
Section 173.183. Currently under the HMR, Sec. 173.183 authorizes
nitrocellulose base film to be packaged in combination packagings
consisting of inner packagings made of metal, strong cardboard, or
fiberboard, that are packed in certain UN standard packagings. Plastic
inner packagings are not authorized except under the terms of an
exemption. A petitioner [P-1130] requested that RSPA amend Sec. 173.183
to authorize the use of polypropylene inner packagings because
polypropylene is flame-retardant, produces minimum toxic gases when
burned, and will not deteriorate film. Because the petitioner has been
using the packaging under the terms of an exemption and has encountered
no adverse experience in transportation, RSPA proposes to amend
Sec. 173.183 by adding a packaging authorization to allow the use of
polypropylene inner packagings for nitrocellulose base film.
Section 173.225. Paragraph (a) would be revised to specify that
inner plastic packagings of a combination packaging used for
transporting organic peroxides must be constructed of new resin. This
proposed change is based on a petition for rulemaking [P-1281]
submitted by the Society of the Plastics Industry for the Organic
Peroxide Producers Safety Division, which represents major U.S. organic
peroxide manufacturers. RSPA agrees with the petitioner's claim that
most regulated organic peroxides are too sensitive to contamination to
be stored in packages manufactured from ``resin of unknown history.''
Section 173.306. This section specifies limited quantity provisions
for compressed gases. In its petition [P-1169], HMAC requested that
RSPA amend Sec. 173.306 by removing paragraph (i)(1) because it is
ineffective and does not provide accurate results. In addition, RSPA is
proposing to revise the introductory text of paragraph (i) to clarify
that flammability of aerosols is based on obtaining a positive test
result from any of the three methods contained in this paragraph. This
approach is consistent with the ICAO Technical Instructions.
Section 173.314. Prior to issuance of a final rule under Docket HM-
181, the HMR contained summer and winter fill tables that authorized an
increase in filling densities for liquids and liquefied gases during
the winter months. In a supplemental notice of proposed rulemaking
under Docket HM-181C (55 FR 21342), RSPA noted that this filling limit
provision was ambiguous and did not take into account lading
temperatures that might be encountered in transit, such as temperature
extremes in the Northern and Southern regions of the United States.
Without regard for these broad ranges of temperature, the HMR
authorized a higher filling limit for certain Class 2 (compressed gas)
materials in the same tank car during the months of November through
March (winter) than during the months of April through October
(summer). Also, for certain products RSPA discovered that the filling
limit was higher for noninsulated tanks than for insulated tanks during
the winter season. Based on these inconsistencies and comments received
to the Docket HM-181C NPRM, RSPA removed the winter filling limit
criteria for tank cars in the Docket HM-181 final rule published
December 21, 1990. When transitional provisions for the maintenance and
use of current packagings end on October 1, 1996, the regulations will
require for hazardous materials (other than those meeting the criteria
for materials poisonous by inhalation) a 1.0% outage (or 99.0% filling
limit) at 41 deg. C (105 deg. F) for insulated tanks and 46 deg. C
(115 deg. F) for noninsulated tanks, throughout the year. Unless
otherwise specified in the HMR, materials poisonous by inhalation
require a 5.0% outage (or 95% filling limit) at 41 deg. C (105 deg. F)
for insulated tanks and 46 deg. C (115 deg. F) for noninsulated tanks.
In a letter dated May 24,1996, the American Petroleum Institute
(API) petitioned RSPA to amend the filling limit regulations to account
for lower air temperatures during the winter months. The basis for
API's letter was its further review of safety and economic impacts of
the final rule on its member companies. As stated in API's letter,
``the industry calculates that the amount of product loaded will be
reduced by 3.9 percent from the amount of product now loaded using the
Winter Fill tables. In the case of uninsulated tank cars, there is a
4.8 percent reduction. * * *'' As part of its petition, API referenced
a Phillips Petroleum report, Maximum Calculated Liquid Temperatures for
Tank Cars in Anhydrous Ammonia and LP Gas Service for 14 Summer and 23
Winter Locations in the United States for the Years 1933 through 1957,
that empirically calculated the maximum liquid temperature in a tank
under extreme temperature conditions. This report concludes that for
liquefied petroleum gas, the maximum temperature of the liquid in
transit would reach 83 deg. F in an insulated tank car and 100.6 deg. F
for a noninsulated tank
[[Page 33222]]
car in the winter months. The temperatures indicated in the Phillips
Petroleum report are for the years 1933 through 1957.
The Phillips Petroleum report confirms RSPA's earlier findings that
the filling limit requirement did not take into account the maximum
lading temperatures that might be encountered in transit; i.e, the
temperature maximum for a noninsulated tank car loaded in the winter
season was recorded at 100.6 deg. F, but the pre-HM-181 regulations
assumed a temperature maximum of 32 deg. C (90 deg. F). The Phillips
Petroleum report also indicates a number of data points within the
range of 90 deg. F to 100 deg. F during the winter season. This data
confirms that the pre-HM-181 filling limit for noninsulated tanks
loaded in the winter months did not allow sufficient outage for gas
expansion.
In its letter, API petitioned for a reference temperature of
80 deg. F for insulated tanks, 87 deg. F for certain thermally
protected and jacketed tanks, and 90 deg. F for noninsulated tanks. If
adopted, API stated that its proposed reference temperatures for the
winter months would align the filling limit requirement for tank cars
with the regulations in effect prior to Docket HM-181. The filling
limit reference temperature used by API for thermally protected and
jacketed tanks is based on RSPA's provisions adopted recently under
Docket HM-216. In the Docket HM-216 final rule, RSPA authorized a new
reference temperature for certain tank cars having a thermal protection
material (see Secs. 173.24b and 173.314(c) Note 2) that reduces heat
transfer into the tank. (See 61 FR 28665)
The following Table I compares API's proposal and the post-HM-181
fill limit requirement. The filling limit reference temperatures of
46 deg. C (115 deg. F) and 41 deg. C (105 deg. F) in Sec. 173.24b are
adjusted to 15.5 deg. C (60 deg. F) for liquefied petroleum gas to
correspond to pre-HM-181 regulations and to aid in the comparison
between the old and the new requirements.
Table I.--API and Pre- and Post-HM-181 Requirements
[Filling Limits for LPG]
------------------------------------------------------------------------
Winter (adjusted to 60 deg.
F)
Type of tank -----------------------------
Pre HM- Post HM- API
181 181 Proposal
------------------------------------------------------------------------
Insulated................................. 0.9495 0.9108 0.9489
Thermally- protected, jacketed (See HM-
216)..................................... ........ ........ 0.9440
Noninsulated.............................. 0.9386 0.8915 0.9380
------------------------------------------------------------------------
Note: The American Society for Testing Materials' Table-24
provides an easy correction factor for the conversion of a liquid
volume to 15.5 deg. C (60 deg. F). For liquefied petroleum gas at
46 deg. C (115 deg. F), the correction factor is 0.904. Multiplying
the post-HM-181 filling limit of 99.0% (0.990) by the ASTM
correction factor of 0.904 yields an authorized filling limit of
89.5% at 15.5 deg. C (60 deg. F), a close approximation to the pre-
HM-181 requirement.
Although the Phillips Petroleum data supports RSPA's earlier
findings, the data does suggest that a lower reference temperature than
the post-HM-181 regulatory minimum may be acceptable during the winter
months. Based on a review of API's application and the Phillips
Petroleum report, RSPA is proposing an amendment to the HMR to
recognize a winter filling reference temperature. However, to account
for the maximum liquid temperature extremes expected in transit, RSPA
is proposing winter reference temperatures of 29 deg. C (85 deg. F),
32 deg. C (90 deg. F), and 38 deg. C (100 deg. F), compared to API's
request of 84 deg. F, 87 deg. F, and 90 deg. F, for insulated,
thermally-protected and jacketed, and noninsulated tanks respectively.
RSPA is soliciting comments on whether the temperature extremes
shown in the Phillips Petroleum report have changed since 1957 and, if
so, whether the proposed changes in this NPRM would have an adverse
impact on transportation safety. Commenters also are encouraged to
supply transportation data to support or argue against the proposed
reference temperatures in this NPRM. Such data may be used to increase
or decrease the proposed reference temperatures.
Table II shows RSPA's proposed filling limits, adjusted to
15.5 deg. C (60 deg. F). RSPA's proposal would authorize a filling
limit less than API's suggestion, but greater than the HM-181 final
rule for noninsulated tanks loaded in the winter. For insulated and
thermally-protected and jacketed tanks, the proposed filling limits
would authorize a filling limit greater than the HM-181 final rule.
RSPA believes that the proposed filling limits will ensure safety in
transit while providing economic relief from the requirements adopted
in the HM-181 final rule.
Table II.--Proposed Amendments
[Filling Limits for LPG]
------------------------------------------------------------------------
Winter adjusted to 60 deg.F
-----------------------------
Type of tank Pre-HM- Post-HM- RSPA
181 181 proposal
------------------------------------------------------------------------
Insulated................................. 0.9495 0.9108 0.9484
Thermally-protected, jacketed (See HM-216) ........ ........ 0.9306
Noninsulated.............................. 0.9386 0.8915 0.9010
------------------------------------------------------------------------
In this NPRM, RSPA is proposing to amend the reference temperatures
used to calculate the required outage for tank car tanks that are
loaded during the winter (November through March). No changes are
proposed to the reference temperatures used for other bulk packagings;
i.e., cargo tanks and portable tanks. This decision is based on the
Phillips Petroleum report, which considered only tank car tanks. No
similar information has been submitted on temperature extremes for
insulated and noninsulated cargo tanks or portable tanks. Commenters
seeking corresponding changes for other bulk packagings and materials
should provide RSPA with information and an analysis similar to the
Phillips Petroleum report.
Part 178
Section 178.245. RSPA is proposing to make several editorial
changes for clarity and one significant change to allow DOT
Specification 51 portable tanks to have openings at locations other
than the top or one end of the tank under certain circumstances.
Section 178.245-1. This section would be reorganized for clarity
and revised to allow DOT Specification 51 portable tanks to have
openings at locations other than the top or one end of the tank under
certain circumstances. When originally developed, the DOT Specification
51 portable tank was principally a skid mounted liquefied petroleum gas
container. With the advent and acceptance of containerization as a
means of shipping bulk quantities of compressed gases, RSPA has issued
numerous exemptions which authorize the transportation in commerce of
portable tanks which fully conform to the requirements of DOT
Specification 51 except for the location of filling and discharge
openings. These tanks generally must be enclosed in an ISO frame and
fitted with bottom or side filling and discharge openings. Based upon
the successful operating experience of these tanks under exemption,
RSPA believes that the HMR
[[Page 33223]]
should be revised to authorize portable tanks with this type of loading
and discharge configuration. Additionally, one petitioner [P-1108]
requested that paragraph (b) be amended to permit openings on the sides
or bottom of these portable tanks. The petitioner stated that
authorizing side or bottom mounted valves and openings on DOT
Specification 51 portable tanks is consistent with the IMDG Code and
would improve the competitiveness of U.S. manufacturers of these tanks
in the European market. The petitioner asserted that the side or bottom
mounted valves would be protected to a degree equal or greater than top
mounted valves. By adopting this proposed change, numerous exemptions
will no longer be required.
Section 178.245-4. RSPA is proposing to add a new paragraph (e) to
require that a DOT 51 portable tank in an ISO framework for
containerized transportation must meet the requirements specified in 49
CFR Parts 450-453.
Section 178.245-6. The first sentence of paragraph (a) would be
revised to require the nameplate to be in close proximity to the ASME
plate.
Section 178.270-12. RSPA is proposing to amend paragraph (a) to
assure that manufacturers, owners and approval agencies are aware of
the requirements for the number and type of closures required for
filling and discharge connections located below the normal liquid level
of DOT Specification Intermodal (IM) portable tanks. In a review of the
regulations concerning IM portable tanks, RSPA discovered a discrepancy
in the regulations. While Sec. 173.32c(g) clearly informs shippers of
the requirements for the number and type of closures required for
filling and discharge connections located below the normal liquid level
of the tank, there is no corresponding requirement in the design
requirements for the manufacture of IM portable tanks.
Section 178.601. Paragraph (g)(8) would be added, based on an
approval issued to the Steel Shipping Container Institute, to list
changes in one or more design elements which would constitute a
different drum design type. If one or more of these changes is made to
a carbon steel drum having a capacity greater than 50 liters, the drum
manufacturer must perform design qualification testing and periodic
retesting in accordance with Subpart M of Part 178.
Section 178.705. Paragraph (c)(2) of this section specifies
pressure relief devices for metal IBCs. RSPA received a petition [P-
1271] from a manufacturer of fusible vents stating that since fusible
vents do not open at room temperature, start-to-discharge pressure
requirements in Sec. 178.702(c)(2) appear to prohibit fusible venting.
In response to this petition, RSPA is proposing to add a new sentence
in paragraph (c)(2)(ii) to clarify that the specified start-to-
discharge pressure does not apply to fusible links unless these links
are the sole source of pressure relief for the IBC. In addition, a
correction would be made to the constant in the equivalence thickness
formula for U.S. Standard Units in paragraph (c)(1)(iv)(B) to ensure
that the resulting thickness is in inches.
III. Rulemaking Analyses and Notices
A. Executive Order 12866 and DOT Regulatory Policies and Procedures
This proposed rule is not considered a significant regulatory
action under section 3(f) of Executive Order 12866 and therefore, was
not reviewed by the Office of Management and Budget. The rule is not
considered a significant rule under the Regulatory Policies and
Procedures of the Department of Transportation [44 FR 11034].
The economic impact of this proposed rule is expected to result in
only minimal costs to certain persons subject to the HMR and may result
in modest cost savings to a small number of persons subject to the HMR
and to the agency. Because of the minimal economic impact of this rule,
preparation of a regulatory impact analysis or a regulatory evaluation
is not warranted. This certification may be revised as a result of
public comment.
B. Executive Order 12612
This proposed rule has been analyzed in accordance with the
principles and criteria contained in Executive Order 12612
(``Federalism''). Federal law expressly preempts State, local, and
Indian tribe requirements applicable to the transportation of hazardous
material that cover certain subjects and are not substantively the same
as Federal requirements. 49 U.S.C. 5125(b)(1). These subjects are:
(1) The designation, description, and classification of hazardous
material;
(2) The packing, repacking, handling, labeling, marking, and
placarding of hazardous material;
(3) The preparation, execution, and use of shipping documents
pertaining to hazardous material, and requirements respecting the
number, content, and placement of such documents;
(4) The written notification, recording, and reporting of the
unintentional release in transportation of hazardous material; or
(5) The design, manufacturing, fabrication, marking, maintenance,
reconditioning, repairing, or testing of a package or container which
is represented, marked, certified, or sold as qualified for use in the
transportation of hazardous material.
If adopted as final, this rule would preempt State, local, or
Indian tribe requirements concerning these subjects unless the non-
Federal requirements are ``substantively the same'' (see 49 CFR
107.202(d) as the Federal requirements.
Federal law (49 U.S.C. 5125(b)(2)) provides that if DOT issues a
regulation concerning any of the covered subjects, after November 16,
1990, DOT must determine and publish in the Federal Register the
effective date of Federal preemption. The effective date may not be
earlier than the 90th day following the date of issuance of the final
rule and not later than two years after the date of issuance. RSPA
requests comments on what the effective date of Federal preemption
should be for the requirements in this proposed rule that concern
covered subjects.
C. Regulatory Flexibility Act
This proposed rule would respond to petitions for rulemaking. It is
intended to provide clarification of the regulations and relax certain
requirements. Therefore, I certify that this proposal will not, if
promulgated, have a significant economic impact on a substantial number
of small entities. This certification is subject to modification as a
result of a review of comments received in response to this proposal.
D. Paperwork Reduction Act
There are no new information collection requirements in this
proposed rule.
E. Regulation Identifier Number (RIN)
A regulation identifier 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 number contained in the heading
of this document can be used to cross-reference this action with the
Unified Agenda.
List of Subjects
49 CFR Part 171
Exports, Hazardous materials transportation, Hazardous waste,
Imports, Incorporation by reference, Reporting and recordkeeping
requirements.
[[Page 33224]]
49 CFR Part 172
Hazardous materials transportation, Hazardous waste, Labels,
Markings, Packaging and containers, Reporting and recordkeeping
requirements.
49 CFR Part 173
Hazardous materials transportation, Packaging and containers,
Radioactive materials, Reporting and recordkeeping requirements,
Uranium.
49 CFR Part 178
Hazardous materials transportation, Motor vehicle safety, Packaging
and containers, Reporting and recordkeeping requirements.
In consideration of the foregoing, 49 CFR Chapter I is proposed to
be amended as follows:
PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS
1. The authority citation for Part 171 would continue to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.
2. In the Sec. 171.7(a)(3) Table, a new entry would be added in
alphabetical order to read as follows:
Sec. 171.7 Reference material.
(a) Matter incorporated by reference * * *
(3) Table of material incorporated by reference. * * *
------------------------------------------------------------------------
49 CFR
Source and name of material reference
------------------------------------------------------------------------
* * * *
* * *
Health and Human Services:
Centers for Disease Control and Prevention, 1600
Clifton Road N.E., Atlanta GA 30333, HHS Publication
No. (CDC) 93-8395, Biosafety in Microbiological and
Biomedical Laboratories, 3rd Edition, May 1993,
Section II............................................ 173.134
* * * *
* * *
------------------------------------------------------------------------
* * * * *
Sec. 171.14 [Amended]
3. In Sec. 171.14, as amended at 61 FR 7959, effective October 1,
1996, the following changes would be made:
a. Paragraph (a) introductory text, paragraph (a)(1), and paragraph
(b) would be removed.
b. Paragraph (a)(2) heading would be removed, paragraph (a)(2)(i)
heading and introductory text would be redesignated as paragraph (a)
heading and introductory text, and paragraphs (a)(2)(i)(A) through
(a)(2)(i)(D) would be redesignated as (a)(1) through (a)(4).
c. Paragraphs (a)(2)(ii) and (a)(2)(iii) would be redesignated as
paragraphs (b) and (c).
PART 172--HAZARDOUS MATERIALS TABLE, SPECIAL PROVISIONS, HAZARDOUS
MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, AND
TRAINING REQUIREMENTS
4. The authority citation for Part 172 would continue to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.
5. In Sec. 172.101, a new paragraph (c)(10)(iii) would be added to
read as follows:
Sec. 172.101 Purpose and use of hazardous materials table.
* * * * *
(c) * * *
(10) * * *
(iii) A mixture or solution not identified in the Table by a
specific description, comprised of two or more hazardous materials in
the same hazard class, shall be described using an appropriate shipping
description (e.g., ``Flammable liquid, n.o.s.''). Some mixtures may be
more appropriately described according to their application, such as
``Coating solution'' or ``Extracts, flavoring liquid'' rather than by
an n.o.s. entry. Under the provisions of subparts C and D of this part,
the technical names of at least two components most predominately
contributing to the hazards of the mixture or solution may be required
in association with the proper shipping name.
* * * * *
Sec. 172.101 [Amended]
6. In addition, in Sec. 172.101, in paragraph (c)(12), the
following changes would be made:
a. In paragraph (c)(12)(ii), in the last sentence, the wording
``technical name of the constituent'' would be revised to read
``technical name of one or more constituents''.
b. In paragraph (c)(12)(iii), in the first sentence, the wording
``by a specific description,'' would be revised to read ``specifically
by name (e.g., acetyl chloride),''.
7. In Sec. 172.101, the Hazardous Materials Table, as amended at 61
FR 18932, effective October 1, 1996, would be amended by adding in
alphabetical order or revising the following entries to read as
follows:
Sec. 172.101 Purpose and use of hazardous materials table.
* * * * *
Sec. 172.101--Hazardous Materials Table
(8) Packaging authorizations (Sec. (9) Quantity limitations (10) Vessel stowage
Hazardous 173.* * *) ------------------------------ requirements
materials Hazard Identification Label Special -------------------------------------- ------------------------
Symbols descriptions and class or numbers PG codes provisions Passenger Cargo aircraft Other
proper shipping division Exceptions Nonbulk Bulk aircraft or only Vessel stowage
names packaging packaging railcar stowage provisions
(1) (2)............... (3) (4).............. (5) (6)....... (7)......... (8A)........ (8B) (8C)....... (9A)........ (9B).......... (10A) (10B)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
[add:]
D Black powder for 4.1 NA0027........... I 4.1....... 70.......... None........ 170 None....... Forbidden... Forbidden..... E ............
small arms.
* * * * * * *
[Revise:]
[[Page 33225]]
* * * * * * *
Hydrogen cyanide, 6.1 UN3294........... I 6.1, 3.... 2, B9, B14, None........ 227 244........ Forbidden... Forbidden..... D 40
solution in B32, B74,
alcohol with not T38, T43,
more than 45 T45.
percent hydrogen
cyanide.
* * * * * * *
Methanesulfonyl 6.1 UN3246........... I 6.1, 8.... 2, B9, B14, None........ 227 244........ Forbidden... Forbidden..... D 40
chloride. B32, B74,
T38, T43,
T45.
* * * * * * *
+ Methyl vinyl 3 UN1251........... II 3, 6.1.... 1, B9, B14, None........ 226 244........ Forbidden... Forbidden..... D 20, 40, 95
ketone. B30, B72,
T38, T43,
T44.
* * * * * * *
Sec. 172.101 [Amended]
8. In addition, in Sec. 172.101, in the Hazardous Materials Table,
the following changes would be made:
a. For the entry ``Benzyl chloride'', in column (7), Special
Provision ``N43'' would be revised to read ``N42''.
b-c. For the entry ``Chlorosilanes, corrosive, flammable, n.o.s.'',
in Column (7), Special Provisions ``,T18,'' ``T26'' would be added
following ``B100''.
d. For the entry ``Chlorosilanes, corrosive, n.o.s.'', in Column
(7), Special Provisions ``,T8,'' ``T26'' would be added following
``B2''.
e. For the entry, ``Chlorosilanes, water-reactive, flammable,
corrosive, n.o.s.'', in Column (7), Special Provisions ``,T24,''
``T26'' would be added following ``A2''.
f. For the entries ``Organic peroxide type F, liquid, temperature
controlled'' and ``Organic peroxide type F, solid, temperature
controlled'', in Column (8A), the reference ``225'' would be removed
each place it appears and ``None'' added in each place,
FR Doc. 96-15272 Performance-Oriented Packaging Standards; Final Transitional Provisions
and in Column
(8C), the reference ``None'' would be removed each place it appears and
``225'' added in each place.
g. For the entry ``Organic peroxide type F, solid'', in Column
(8C), the reference ``None'' would be removed and ``225'' would be
added in its place.
h. For the entry ``Phosphorus pentafluoride'', in Column (7), the
wording ``1'' would be removed and ``2, B9, B14'' would be added in its
place; in Column (8B) ``302'' would be revised to read ``302, 304'';
and in Column (8C), ``None'' would be revised to read ``314, 315''.
i. For the entry ``Tungsten hexafluoride'', in Column (7), special
provision ``3'' would be revised to read ``2''.
j. For the entries ``Metal carbonyls, n.o.s., UN3281, PG I'';
``Nitriles, toxic, flammable, n.o.s., UN3275, PG I''; ``Nitriles,
toxic, n.o.s., UN3276, PG I''; ``Organoarsenic compound, n.o.s.,
UN3280, PG I''; ``Organophosphorus compound, toxic, flammable, n.o.s.,
UN3279, PG I''; and ``Organophosphorus compound, toxic, n.o.s., UN3278,
PG I'', in Column (7), Special Provision ``5'' would be added.
k. For each of the following entries, in Column (8A), the word
``None'' would be removed and ``151'' added in its place:
Alkali metal amides
Alkaline earth metal alloys, n.o.s.
Aluminum carbide
Aluminum ferrosilicon powder (both entries)
Aluminum powder, uncoated (both entries)
Aluminum processing by-products (both entries)
Aluminum silicon powder, uncoated
Barium
Calcium
Calcium carbide, in Packing Group II
Calcium cyanamide with more than 0.1 percent of calcium carbide
Calcium manganese silicon
Calcium silicide (both entries)
Cerium, turnings or gritty powder
Ferrosilicon with 30 percent or more but less than 90 percent silicon
Lithium ferrosilicon
Lithium hydride, fused solid
Lithium silicon
Magnesium granules, coated particle size not less than 149 microns
Magnesium, powder or Magnesium alloys, powder, in Packing Groups II and
III
Magnesium silicide
Maneb stabilized or Maneb preparations, stabilized against self-heating
Metal hydrides, water-reactive, n.o.s., in Packing Group II
Metallic substance, water-reactive, n.o.s., in Packing Groups II and
III
Phosphorous pentasulfide, free from yellow or white phosphorous
Sodium aluminum hydride
Water-reactive solid, n.o.s., in Packing Groups II and III
Zinc ashes
[[Page 33226]]
9. In Sec. 172.102, in paragraph (c)(1) Special Provision 70 would
be added, in paragraph (c)(3) Special Provision B59 would be revised,
and in paragraph (c)(5), Special Provision N42 would be added, to read
as follows:
Sec. 172.102 Special provisions.
* * * * *
(c) * * *
(1) * * *
* * * * *
70 Black powder that has been classed in accordance with the
requirements of Sec. 173.56 of this subchapter may be reclassed and
offered for domestic transportation as a Division 4.1 material if it
is offered for transportation and transported in accordance with the
limitations and packaging requirements of Sec. 173.170 of this
subchapter.
* * * * *
(3) * * *
* * * * *
B59 Water-tight, sift-proof, closed-top, metal-covered hopper
cars are also authorized provided that the lading is covered with a
nitrogen blanket.
* * * * *
(5) * * *
* * * * *
N42 1A1 drums made of carbon steel with thickness of body and
heads of not less than 0.050 inches and with a corrosion-resistant
phenolic lining are authorized for stabilized benzyl chloride if
tested and certified to the Packing Group I performance level at a
specific gravity of not less than 1.8.
* * * * *
10. In Sec. 172.302, paragraph (b) would be revised to read as
follows:
Sec. 172.302 General marking requirements for bulk packagings.
* * * * *
(b) Size of markings. Except as otherwise provided, markings
required by this subpart on bulk packagings must--
(1) Have a width of at least 6.0 mm (0.24 inch) and a height of at
least 100 mm (3.9 inches) for rail cars;
(2) Have a width of at least 4.0 mm (0.16 inch) and a height of at
least 25 mm (one inch) for portable tanks with capacities of less than
3,785 L (1,000 gallons) and intermediate bulk containers; and
(3) Have a width of at least 6.0 mm (0.24 inch) and a height of at
least 50 mm (2.0 inches) for cargo tanks and other bulk packagings.
* * * * *
Sec. 172.504 [Amended]
11. In Sec. 172.504, paragraph (f)(8) would be removed and
reserved.
PART 173--SHIPPERS--GENERAL REQUIREMENTS FOR SHIPMENTS AND
PACKAGINGS
12. The authority citation for Part 173 would continue to read as
follows:
Authority: 49 U.S.C. 5102-5127; 49 CFR 1.53.
13. In Sec. 173.24a, the last sentence of paragraph (a)(3) and
paragraph (b)(2) would be revised, to read as follows:
Sec. 173.24a Additional general requirements for non-bulk packagings
and packages.
(a) * * *
(3) * * * Cushioning material must not be capable of reacting
dangerously with the contents of the inner packagings or having its
protective properties significantly impaired in the event of leakage.
* * * * *
(b) * * *
(2) Except as otherwise provided in this section, a non-bulk
packaging may not be filled with a hazardous material to a gross mass
greater than the maximum gross mass marked on the packaging.
* * * * *
Sec. 173.24b [Amended]
14. In Sec. 173.24b, in the first sentence of paragraph (b), the
wording ``stainless steel is steel'' would be revised to read ``the
reference stainless steel is stainless steel''.
15-16. In Sec. 173.28, paragraphs (b)(4) and (b)(7)(iv)(C) would be
revised and a new sentence would be added in paragraph (c)(2) following
the first sentence, to read as follows:
Sec. 173.28 Reuse, reconditioning and remanufacture of packagings.
* * * * *
(b) * * *
(4) Metal and plastic drums and jerricans used as single packagings
or the outer packagings of composite packagings are authorized for
reuse only when they are marked in a permanent manner (e.g., embossed)
in millimeters with the nominal (for metal packagings) or minimum (for
plastic packagings) thickness of the packaging material, as required by
Sec. 178.503(a)(9) of this subchapter, and--
(i) Except as provided in paragraph (b)(4)(ii) of this section,
conform to the following minimum thickness criteria:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Minimum thickness of packaging material
Maximum capacity not over --------------------------------------------------------------------------------------------------------------
Metal drum or jerrican Plastic drum or jerrican
--------------------------------------------------------------------------------------------------------------------------------------------------------
20 L..................................... 0.63 mm (0.025 inch).......................................... 1.1 mm (0.043 inch)
30 L..................................... 0.73 mm (0.029 inch).......................................... 1.1 mm (0.043 inch)
40 L..................................... 0.73 mm (0.029 inch).......................................... 1.8 mm (0.071 inch)
60 L..................................... 0.92 mm (0.036 inch).......................................... 1.8 mm (0.071 inch)
120 L.................................... 0.92 mm (0.036 inch).......................................... 2.2 mm (0.087 inch)
220 L.................................... 0.92 mm (0.036 inch) \1\...................................... 2.2 mm (0.087 inch)
450 L.................................... 1.77 mm (0.070 inch).......................................... 5.0 mm (0.197 inch)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Metal drums or jerricans constructed with a minimum thickness of 0.82 mm body and 1.11 mm heads are authorized.
(ii) For stainless steel drums and jerricans, conform to a minimum
wall thickness as determined by the following equivalence formula:
[GRAPHIC] [TIFF OMITTED] TP26JN96.000
[GRAPHIC] [TIFF OMITTED] TP26JN96.001
Where:
e1 = required equivalent wall thickness of the metal to be used
(in mm or, for U.S. Standard units, use inches).
eo = required minimum wall thickness for the reference steel (in
mm or, for U.S. Standard units, use inches).
Rm1 = guaranteed minimum tensile strength of the metal to be used
(in N/mm2 or for U.S. Standard units, use pounds per square inch).
A1 = guaranteed minimum elongation (as a percentage) of the metal
to be used on fracture under tensile stress (see paragraph (c)(1) of
this section).
* * * * *
(7) * * *
(iv) * * *
(C) another material or thickness when approved under the
conditions established by the Associate
[[Page 33227]]
Administrator for Hazardous Materials Safety for reuse without
retesting.
(c) * * *
(2) * * * For a UN 1H1 plastic drum, replacing a removable gasket
or closure device with a replacement which provides equivalent
performance does not constitute reconditioning. * * *
* * * * *
Sec. 173.28 [Amended]
17. In addition, in Sec. 173.28, in the first sentence of paragraph
(c)(2), the wording ``or a UN 1H1 plastic drum'' would be added
immediately following the wording ``other than a metal drum''.
18. In Sec. 173.32, in paragraph (d) a new sentence would be added
at the end of the paragraph and in paragraph (e)(2)(i), the second
sentence would be revised, to read as follows:
Sec. 173.32 Qualification, maintenance and use of portable tanks other
than Specification IM portable tanks.
* * * * *
(d) * * * A stainless steel portable tank internally lined with
polyethylene, which was constructed on or before October 1, 1996, and
complies with all requirements of Specification 57 except that it is
equipped with a polypropylene discharge ball valve and polypropylene
secondary discharge opening closure, may be marked as a Specification
57 portable tank and used in accordance with the provisions of this
section.
(e) * * *
(2) * * *
(i) * * * Each Specification 57 tank must be leak tested by a
minimum sustained air pressure of at least three pounds per square inch
gage applied to the entire tank. * * *
* * * * *
Sec. 173.115 [Amended]
19. In Sec. 173.115, in paragraph (b)(1), the wording ``(41 psia)''
would be revised to read ``(40.6 psia)''.
20. In Sec. 173.120, paragraph (b)(1) would be amended by adding
two sentences at the end of the paragraph to read as follows:
Sec. 173.120 Class 3--Definitions.
* * * * *
(b) * * *
(1) * * * A combustible liquid which does not sustain combustion is
not subject to the requirements of this subchapter as a combustible
liquid. A procedure for determining if a material sustains combustion
when heated under test conditions and exposed to an external source of
flame is provided in Appendix H of this part.
* * * * *
Sec. 173.121 [Amended]
21. In Sec. 173.121, in the second sentence of paragraph (a), the
wording ``or indicates that the packing group is to be determined on
the basis of the grouping criteria for Class 3,'' would be removed.
22. In Sec. 173.125, paragraph (a) would be revised to read as
follows:
Sec. 173.125 Class 4--Assignment of packing group.
(a) The packing group of a Class 4 material is assigned in Column
(5) of the Sec. 172.101 Table. When the Sec. 172.101 Table provides
more than one packing group for a hazardous material, the packing group
shall be determined on the basis of test results following test methods
given in appendix E of this part and by applying the appropriate
criteria given in this section.
* * * * *
23. In Sec. 173.127, the section heading would be revised,
paragraph (b)(1) would be removed, paragraphs (b)(2) and (b)(3) would
be redesignated as paragraphs (b)(1) and (b)(2), and the paragraph (b)
heading and newly designated paragraph (b)(1) introductory text would
be revised to read as follows:
Sec. 173.127 Class 5, Division 5.1--Definition and assignment of
packing group.
* * * * *
(b) Assignment of packing group. (1) The packing group of a
Division 5.1 material shall be as assigned in Column (5) of the
Sec. 172.101 Table. When the Sec. 172.101 Table provides more than one
packing group for a hazardous material, the packing group shall be
determined on the basis of test results following test methods given in
appendix F of this part and by applying the following criteria:
* * * * *
Sec. 173.133 [Amended]
24. In Sec. 173.133, in paragraph (a) introductory text, in the
second sentence, the wording ``more than one packing group and hazard
zone'' would be revised to read ``more than one packing group or hazard
zone''.
25. In Sec. 173.134, the introductory text of paragraph (b)(3)(ii)
would be revised and a new paragraph (b)(4) would be added to read as
follows:
Sec. 173.134 Class 6, Division 6.2--Definitions, exceptions and
packing group assignments.
* * * * *
(b) * * *
(3) * * *
(ii) For other than a waste culture or stock of an infectious
substance, the specific packaging requirements of Sec. 173.197, if
packaged in a rigid non-bulk packaging conforming to--
* * * * *
(4) A waste culture or stock of infectious substances may be
offered for transportation and transported as a regulated medical waste
when the culture or stock--
(i) Conforms to Biosafety Levels 1, 2 or 3, as defined in HHS
Publication No. (CDC) 93-8395, Biosafety in Microbiological and
Biomedical Laboratories. 3rd Edition, May 1993, Section II;
(ii) Is packaged in accordance with requirements specified in
Sec. 173.197; and
(iii) Is transported by a private or contract carrier using a
vehicle dedicated to the transportation of medical waste.
* * * * *
26. In Sec. 173.151, the section heading would be revised and a new
paragraph (d) would be added to read as follows:
Sec. 173.151 Exceptions for Class 4.
* * * * *
(d) Limited quantities of Division 4.3 (dangerous when wet)
material. Limited quantities of Division 4.3 (dangerous when wet)
solids in Packing Groups II and III are excepted from labeling, unless
offered for transportation or transported by aircraft, and the
specification packaging requirements of this subchapter when packaged
in combination packagings according to this paragraph. In addition,
shipments of limited quantities are not subject to subpart F
(Placarding) of part 172 of this subchapter. Each package must conform
to the packaging requirements of subpart B of this part and may not
exceed 30 kg (66 pounds) gross weight. The following combination
packagings are authorized:
(1) For Division 4.3 solids in Packing Group II, inner packagings
not over 0.5 kg (1.1 pound) net capacity each, packed in strong outer
packagings; and
(2) For Division 4.3 solids in Packing Group III, inner packagings
not over 1 kg (2.2 pounds) net capacity each, packed in strong outer
packagings.
27. In Sec. 173.156, paragraph (b) would be revised to read as
follows.
Sec. 173.156 Exceptions for ORM materials.
* * * * *
(b) ORM-D. Packagings for ORM-D materials are specified according
to hazard class in Secs. 173.150 through 173.155 and in Sec. 173.306.
In addition to other exceptions specified for ORM-D materials in this
part:
(1) Strong outer packagings as specified in this part, the marking
requirements specified in Sec. 172.316 of this subchapter, and the 30
kg (66
[[Page 33228]]
pound) gross weight limitation are not required for materials classed
as ORM-D when unitized in cages, carts, boxes or similar overpacks and
when offered for transportation, or transported, by rail or by a
private or contract motor carrier or a common carrier vehicle under
exclusive use for such service, to or from a manufacturer, a
distribution center, or a retail outlet, or to a disposal facility.
(2) The 30 kg (66 pound) gross weight limitation does not apply to
materials classed as ORM-D when offered for transportation, or
transported, by highway or rail between a manufacturer, a distribution
center, and a retail outlet provided--
(i) The combination packaging consists of inner containers
conforming to the quantity limits for inner packagings specified in
Secs. 173.150(b), 173.152(b), 173.154(b), 173.155(b) and 173.306(a) and
(b), as appropriate;
(ii) The inner containers are packed into corrugated fiberboard
trays to prevent individual containers from moving freely inside the
completed combination packaging;
(iii) The trays are placed in a fiberboard box which is banded and
secured to a wooden pallet by metal, fabric, or plastic straps, to form
a single palletized unit;
(iv) The package conforms to the general packaging requirements of
subpart B of this part;
(v) The maximum net quantity of hazardous material permitted on one
palletized unit is 250 kg (550 pounds); and
(vi) The package is properly marked in accordance with Sec. 172.316
of this subchapter.
28. In Sec. 173.158, paragraph (d) would be revised, and paragraph
(f)(1) would be amended by adding a sentence at the end of the
paragraph, to read as follows:
Sec. 173.158 Nitric acid.
* * * * *
(d) Nitric acid of 90 percent or greater concentration, when
offered for transportation or transported by rail, highway, or water
may be packaged as follows:
(1) In 4C1, 4C2, 4D or 4F wooden boxes with inner packagings
consisting of glass bottles further individually overpacked in tightly
closed metal packagings. Glass bottles must be of 2.5 L (0.66 gallon)
or less capacity and cushioned with a non-reactive, absorbent material
within the metal packagings.
(2) In combination packagings with 1A2, 1B2, 1D, 1G, 1H2, 3H2 or 4G
outer packagings with inner glass packagings of 2.5 L (0.66 gallons) or
less capacity cushioned with a non-reactive, absorbent material and
packed within a tightly closed intermediate packaging of metal or
plastic.
* * * * *
(f) * * *
(1) * * * 6HH1 and 6HA1 composite packaging with plastic inner
receptacles meeting the compatibility requirements Sec. 173.24(e)
(e.g., PFA Teflon) are authorized.
* * * * *
29. Section 173.170 would be added to read as follows:
Sec. 173.170 Black powder for small arms.
Black powder for small arms that has been classed in Division 1.1
may be reclassed as a Division 4.1 material, for domestic
transportation by motor vehicle, rail freight, and cargo vessel only,
subject to the following conditions:
(a) The powder must be examined and approved for Division 1.1
classification in accordance with Sec. 173.56 and 173.58;
(b) The total quantity of black powder in one motor vehicle, rail
car, or freight container may not exceed 45.4 kg (100 pounds) net mass,
and no more than four freight containers may be on board one cargo
vessel;
(c) The black powder must be packed in inner metal or heavy wall
conductive plastic receptacles not over 450 g (15.9 ounces) net
capacity each, with no more than 25 cans in one outer UN 4G fiberboard
box. The inner packagings must be arranged and protected so as to
prevent simultaneous ignition of the contents;
(d) Each completed package must be marked ``BLACK POWDER FOR SMALL
ARMS'' and ``UN 1325''; and
(e) Each package must bear the FLAMMABLE SOLID label.
Sec. 173.183 [Amended]
30. In Sec. 173.183, in paragraphs (a) and (b), the wording ``,
polypropylene canister,'' would be added immediately following the
wording ``closed metal can'' each place it appears.
31. In Sec. 173.225, in paragraph (a), a new sentence would be
added as the penultimate sentence to read as follows:
Sec. 173.225 Packaging requirements and other provisions for organic
peroxides.
(a) * * * No used material, other than production residues or
regrind from the same production process, may be used in plastic
packagings. * * *
* * * * *
32. In Sec. 173.306, paragraph (i)(1) would be removed, paragraphs
(i)(2) through (i)(4) would be redesignated as paragraphs (i)(1)
through (i)(3), respectively, and the introductory text in paragraph
(i) would be revised to read as follows:
Sec. 173.306 Limited quantities of compressed gases.
* * * * *
(i) An aerosol is flammable if a positive test result is obtained
using any of the following test methods:
* * * * *
33. In Sec. 173.314, as amended at 60 FR 49074, effective July 1,
1996, and further amended at 61 FR 28676, effective October 1, 1996, in
the paragraph (c) table, Note 2 would be revised and Notes 9 and 10
would be added, to read as follows:
Sec. 173.314 Compressed gases in tank cars and multi-unit tank cars.
* * * * *
(c) * * *
Notes:
* * * * *
2. The liquefied gas must be loaded so that the outage is at
least two percent of the total capacity of the tank at the reference
temperature of 46 deg.C (115 deg.F) for a noninsulated tank;
43 deg.C (110 deg.F) for a tank having a thermal protection system
incorporating a metal jacket that provides an overall thermal
conductance at 15.5 deg.C (60 deg.F) of no more than 10.22
kilojoules per hour per square meter per degree Celsius (0.5 Btu per
hour/per square foot/per degree F) temperature differential; and
41 deg.C (105 deg.F) for an insulated tank having an insulation
system incorporating a metal jacket that provides an overall thermal
conductance at 15.5 deg.C (60 deg.F) of no more than 1.5333
kilojoules per hour per square meter per degree Celsius (0.075 Btu
per hour/per square foot/per degree F) temperature differential.
* * * * *
9. For a liquefied petroleum gas, the liquefied gas must be
loaded so that the outage is at least one percent of the total
capacity of the tank at the reference temperature of 46 deg.C
(115 deg.F) for a noninsulated tank; 43 deg.C (110 deg.F) for a tank
having a thermal protection system incorporating a metal jacket that
provides an overall thermal conductance at 15.5 deg.C (60 deg.F) of
no more than 10.22 kilojoules per hour per square meter per degree
Celsius (0.5 Btu per hour/per square foot/per degree F) temperature
differential; and 41 deg.C (105 deg.F) for an insulated tank having
an insulation system incorporating a metal jacket that provides an
overall thermal conductance at 15.5 deg.C (60 deg.F) of no more than
1.5333 kilojoules per hour per square meter per degree Celsius
(0.075 Btu per hour/per square foot/per degree F) temperature
differential.
10. For liquefied petroleum gas and anhydrous ammonia, during
the months of November through March (winter), the following
reference temperatures may be used: 38 deg.C (100 deg.F) for a
noninsulated tank; 32 deg.C (90 deg.F) for a tank having a thermal
protection system incorporating a metal jacket that provides an
overall thermal conductance at 15.5 deg.C (60 deg.F) of no more than
10.22 kilojoules per hour per square meter
[[Page 33229]]
per degree Celsius (0.5 Btu per hour/per square foot/per degree F)
temperature differential; and 29 deg.C (85 deg.F) for an insulated
tank having an insulation system incorporating a metal jacket and
insulation that provides an overall thermal conductance at
15.5 deg.C (60 deg.F) of no more than 1.5333 kilojoules per hour per
square meter per degree Celsius (0.075 Btu per hour/per square foot/
per degree F) temperature differential. The winter reference
temperatures may only be used for a tank car shipped directly to a
consumer for unloading and not stored in transit. The offeror of the
tank must inform each customer that the tank car was filled based on
winter reference temperatures and must be unloaded as soon as
possible after March in order to retain the specified outage and to
prevent a release of hazardous material which might occur due to the
tank car becoming liquid full at higher temperatures.
* * * * *
Sec. 173.314 [Amended]
34. In addition, in Sec. 173.314, in the paragraph (c) table, as
amended at 60 FR 49074, effective July 1, 1996, and further amended at
61 FR 28676, effective October 1, 1996, the following changes would be
made:
a. For the entry ``Ammonia, anhydrous, or ammonia solutions > 50
percent ammonia'', in Column 2, the wording ``Note 2'' would be removed
and ``Notes 2, 10'' added in its place.
b. For the entry ``Division 2.1 materials not specifically provided
in this table'' in Column 2, the wording ``Note 3'' would be removed
and the wording ``Notes 3, 9, 10'' added in its place.
Appendix H to Part 173 [Amended]
35. In Appendix H to Part 173, the second sentence of paragraph
5.(b) would be revised and in paragraph 5.(h), a sentence would be
added at the end of the paragraph to read as follows:
Appendix H to Part 173--Method of Testing for Sustained
Combustibility
* * * * *
5. * * *
(b) * * * For the appropriate test temperature, see paragraph
5.(h) of this appendix. * * *
* * * * *
(h) * * * In the case of a material which has a flash point
above 60.5 deg.C (141 deg.F) and below 93 deg.C (200 deg.F), if
sustained combustion interpreted in accordance with paragraph 6. of
this appendix is not found at a test temperature of 5 deg.C
(9 deg.F) above its flash point, repeat the complete procedure with
new test portions, but at a test temperature of 20 deg.C (36 deg.F)
above its flash point.
* * * * *
PART 178--SPECIFICATIONS FOR PACKAGINGS
36. The authority citation for part 178 would continue to read as
follows:
Authority: 49 U.S.C. 5101-5127; 49 CFR 1.53.
37. Section 178.245-1 would be revised to read as follows:
Sec. 178.245-1 Requirements for design and construction.
(a) Tanks must be seamless or welded steel construction or
combination of both and have a water capacity in excess of 1,000
pounds. Tanks must be designed, constructed, certified and stamped in
accordance with the ASME Code.
(b) Tanks must be postweld heat treated and radiographed as
prescribed in the ASME Code except that each tank constructed in
accordance with part UHT of the ASME Code must be postweld heat
treated. Where postweld heat treatment is required, the tank must be
treated as a unit after completion of all the welds in and/or to the
shell and heads. The method must be as prescribed in the ASME Code.
Welded attachments to pads may be made after postweld heat treatment is
made. A tank used for anhydrous ammonia must be postweld heat treated.
The postweld heat treatment must be as prescribed in the ASME Code, but
in no event at less than 1050 deg.F tank metal temperature.
Additionally, tanks constructed in accordance with part UHT of the ASME
Code must conform to the following requirements:
(1) Welding procedure and welder performance tests must be made
annually in accordance with section IX of the ASME Code. In addition to
the essential variables named therein the following must be considered
to be essential variables: Number of passes, thickness of plate, heat
input per pass, and manufacturer's identification of rod and flux. The
number of passes, thickness of plate and heat input per pass may not
vary more than 25 percent from the procedure qualification. Records of
the qualification must be retained for at least 5 years by the tank
manufacturer and made available to duly identified representatives of
the Department of Transportation or the owner of the tank.
(2) Impact tests must be made on a lot basis. A lot is defined as
100 tons or less of the same heat and having a thickness variation no
greater than plus or minus 25 percent. The minimum impact required for
full-sized specimens shall be 20 foot-pounds (or 10 foot-pounds for
half-sized specimens) at 0 deg.F Charpy V-Notch in both the
longitudinal and transverse direction. If the lot test does not pass
this requirement, individual plates may be accepted if they
individually meet this impact requirement.
(c) Except as provided in paragraph (d) of this section, all
openings in the tank shall be grouped in one location, either at the
top of the tank or at one end of the tank.
(d) The following openings may be installed at locations other than
on the top or end of the tank:
(1) The openings for liquid level gauging devices, or for safety
devices, may be installed separately at the other location or in the
side of the shell;
(2) One plugged opening of 2-inch National Pipe Thread or less
provided for maintenance purposes may be located elsewhere;
(3) An opening of 3-inch National Pipe Size or less may be provided
at another location, when necessary, to facilitate installation of
condensing coils; or
(4) Filling and discharge connections may be installed below the
normal liquid level of the tank if the tank design conforms to the
following requirements:
(i) The tank must be permanently mounted in a full framework for
containerized transport. For each tank design, a prototype tank, must
fulfill the requirements of parts 450 through 453 of this title for
compliance with the requirements of Annex II of the International
Convention for Safe Containers.
(ii) Each filling and discharge connection must be equipped with an
internal self-closing stop-valve capable of closing within 30 seconds
of actuation. Each internal self-closing stop-valve must be protected
by a shear section or sacrificial device located outboard of the valve.
The shear section or sacrificial device must break at no more than 70
percent of the load that would cause failure of the internal self-
closing stop-valve.
(iii) Each internal self-closing stop-valve must be provided with
remote means of automatic closure, both thermal and mechanical. The
thermal means of automatic closure must actuate at a temperature of not
over 250 deg.F.
(e) Each uninsulated tank used for the transportation of compressed
gas, as defined in Sec. 173.300 of this subchapter, must have an
exterior surface finish that is significantly reflective, such as a
light reflecting color if painted, or a bright reflective metal or
other material if unpainted.
38. In Sec. 178.245-4, a new paragraph (e) would be added to read
as follows:
[[Page 33230]]
Sec. 178.245-4 Tank mountings.
* * * * *
(e) A DOT 51 portable tank that meets the definition of
``container'' in Sec. 450.3(a)(3) must meet the requirements of parts
450 through 453 of this title, in addition to the requirements of this
subchapter.
Sec. 178.245-6 [Amended]
39. In Sec. 178.245-6, in the first sentence of paragraph (a), the
wording ``on one of the heads of the tank'' would be revised to read
``in close proximity to the ASME ``U'' stamp certification''.
40. In Sec. 178.270-12, in paragraph (a), the first two sentences
would be revised to read as follows:
Sec. 178.270-12 Valves, nozzles, piping, and gauging devices.
(a) All tank nozzles, except those provided for filling and
discharge connections below the normal liquid level of the tank, relief
devices, thermometer wells, and inspection openings, must be fitted
with manually operated stop valves located as near the shell as
practicable either internal or external to the shell. Each filling and
discharge connection located below the normal liquid level of the tank
must be equipped with an internal discharge valve. * * *
* * * * *
41. In Sec. 178.601, the word ``or'' would be removed at the end of
paragraph (c)(4)(iv), the period at the end of (c)(4)(v) would be
removed and ``; or'' added in its place and new paragraphs (c)(4)(vi)
and (g)(8) would be added to read as follows:
Sec. 178.601 General requirements.
* * * * *
(c) * * *
(4) * * *
(vi) For a steel drum, variations in design elements which do not
constitute a different design type under the provisions of paragraph
(g)(8) of this section.
* * * * *
(g) * * *
(8)(i) For a steel drum with a capacity greater than 50 liters
manufactured from low carbon, cold-rolled sheet steel meeting ASTM
designations A366/A366M or A568/A568M, a change in any one or more of
the following design elements constitutes a different drum design type:
(A) The packaging type and category of the original drum and the
remanufactured drum, i.e., 1A1 or 1A2;
(B) The style, (i.e., straight-sided or tapered);
(C) The rated (marked) capacity and outside dimensions;
(D) The physical state for which the packaging was originally
approved (e.g., tested for solids or liquids);
(E) The marked level of performance of the original drum (i.e., the
highest packing group, hydrostatic test pressure, or specific gravity
to which the packaging has been tested);
(F) Type of side seam welding;
(G) Steel thicknesses in the head, in the body and in the bottom,
and type of steel, i.e., stainless or low-carbon;
(H) End seam type, (e.g., triple or double seam);
(I) The number of rolling hoops which equal or exceed the diameter
over the chimes;
(J) The location, type or size, and material of closures (other
than the cover of UN 1A2 drums); and
(K) For UN 1A2 drums:
(1) Gasket material (e.g., plastic), or properties affecting the
performance of the gasket;
(2) Configuration or dimensions of the gasket;
(3) Closure ring style including bolt size, (e.g., square or round
back, 0.625'' bolt); and
(4) Closure ring thickness.
(ii) Variations in elements other than those listed in paragraph
(g)(8)(i) of this section are considered minor and do not constitute a
different drum design type, or ``different packaging'' as defined in
paragraph (c) of this section for which design qualification testing
and periodic retesting are required. Minor variations authorized
without further testing include changes in the identity of the supplier
of component material made to the same specifications, or the original
manufacturer of a DOT specification or UN standard drum to be
remanufactured.
* * * * *
42. In Sec. 178.705, in paragraph (c)(2)(ii), a new second sentence
would be added after the first sentence to read as follows.
Sec. 178.705 Standards for metal intermediate bulk containers.
* * * * *
(c) * * *
(2) * * *
(ii) * * * This does not apply to fusible links unless such devices
are the only source of pressure relief for the IBC. * * *
* * * * *
Sec. 178.705 [Amended]
43. In addition, in Sec. 178.705, in paragraph (c)(1)(iv)(B), in
the second formula, the Formula for U.S. Standard units, the number
``544'' would be revised to read ``21.4''.
Issued in Washington, DC on June 12, 1996 under authority
delegated in 49 CFR part 106.
Alan I. Roberts,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 96-15272 Filed 6-25-96; 8:45 am]
BILLING CODE 4910-60-P
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