issue-1994-01-03•Federal Register final rules — 1994-01-03
Federal Register final rules — 1994-01-03
issue-1994-01-03Federal Register final rules — 1994-01-03Regulation
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FR Doc. 93-32098 Transfer by Federal Agencies of Scientific, Technical and Engineering Information to the National Technical Information Service
[Federal Register Volume 59, Number 1 (Monday, January 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-32098]
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[Federal Register: January 3, 1994]
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DEPARTMENT OF COMMERCE
National Technical Information Service
15 CFR Part 1180
[Docket No. 921242-3202]
RIN 0692-AA12
Transfer by Federal Agencies of Scientific, Technical and
Engineering Information to the National Technical Information Service
AGENCY: National Technical Information Service, Technology
Administration, Commerce.
ACTION: Final rule.
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SUMMARY: This final rule establishes procedures for federal agencies to
transfer unclassified scientific, technical and engineering information
resulting from federally funded research and development activities to
the National Technical Information Service. This rule is issued
pursuant to the American Technology Preeminence Act of 1991. Its
purpose is to facilitate public access to the vast amount of
scientific, technical and engineering information that is produced by
and for federal agencies.
EFFECTIVE DATE: This regulation is effective February 1, 1994.
FOR FURTHER INFORMATION CONTACT:
Donald W. Corrigan (703) 487-4636.
SUPPLEMENTARY INFORMATION: On May 11, 1993, the National Technical
Information Service (NTIS) published a proposed rule (58 FR 27681) to
implement Section 108 of the American Technology Preeminence Act (ATPA)
of 1991 (Pub. L. 102-245). Section 108 of the ATPA requires all federal
agencies to submit to NTIS in a timely manner unclassified scientific,
technical and engineering information (STEI) resulting from federally
funded research and development activities. This final rule establishes
procedures for employees of agencies to follow and those contractors
and grantees who are authorized by agencies to transfer products
directly to NTIS.
These regulations should significantly expand NTIS' collection of
more than two million printed reports and documents, videotapes,
computer software and computerized data files on tape, diskette, and
CD-ROM. Such information can be purchased from NTIS by the research and
development community, business, and the general public. This expansion
should significantly improve public access to STEI and contribute to
NTIS's ability to operate on a self-sustaining basis without
appropriations.
The major features of these regulations include (a) a system of
``affiliates'' to serve as NTIS agents to receive information on behalf
of NTIS; (b) a system of federal agency ``liaisons'' to work with NTIS
to ensure cost-effective compliance; (c) an optional system by which
agencies may allow their contractors and grantees to transfer
information directly to NTIS; (d) an optional system by which agencies
may allow NTIS to ride their production orders; (e) a method for
granting waivers if transfer of STEI products would be inappropriate;
and (f) a requirement that certain copyright information be provided to
NTIS so that it does not inadvertently make available a product for
which the Government lacks appropriate dissemination rights.
A number of technical and clarifying changes have been made to the
proposed regulations, most of which are intended to make it clearer
that certain provisions are optional at the discretion of individual
agencies. The most important amendment alerts agencies that compliance
with these procedures in no way relieves them of their responsibilities
for distributing publications to the Depository Library Program
established by Chapter 19 of Title 44 of the United States Code and
establishes a procedure through which NTIS can assist agencies in
meeting that responsibility with respect to STEI submitted to NTIS
under this regulation.
Comments and Decisions
A number of comments involved inquiries relating to internal NTIS
processes or procedures of the commenting agency and did not propose
specific changes to the regulation. They are included in this section
to the extent they raise matters of general interest.
General Comments
Comment: Authors should clear publications printed by contractors
and grantees prior to public dissemination.
NTIS Response: These regulations apply only to products that are
available for public dissemination. How that determination is made is
up to individual agencies and is beyond the scope of the ATPA and these
regulations.
Comment: The regulations do not appear to take into account that
some government-funded research products may be published in
professional journals and other publications produced by the private
sector or that some STEI produced by non-federal employees may be
protected by copyright.
NTIS Response: Section 1180.7(a) of the final regulations now
explicitly states that agencies are not required to take any action to
transfer to NTIS agency generated articles published in privately
produced journals or federally funded STEI for which no license
permitting distribution by NTIS has been reserved to the Government.
Both categories had been included in Sec. 1180.7(b) as examples of
potentially inappropriate transfers, so no significant substantive
change is intended.
Comment: NTIS and the Government Printing Office should exchange
electronic bibliographic records to facilitate bibliographic control
activities.
NTIS Response: The recommendation, if implemented, should provide
the customers of each agency with enhanced ability to find and order
government information. NTIS will be pleased to discuss an exchange of
tapes with the Superintendent of Documents at any time.
Section 1180.2
Comment: The definition of ``agency'' permits certain subunits of
the parent agency to deal directly with NTIS and bypass the cabinet
officer above them.
NTIS Response: To ensure general consistency with other Technology
Administration programs, the final regulations adopt the definition of
``federal agency'' employed in the Stevenson-Wydler Technology
Innovation Act of 1980. However, NTIS recognizes that this definition
contributes to the problem described in the comment at least insofar as
it specifically identifies the military departments as agencies even
though they are part of the Department of Defense, which is itself an
agency within the meaning of that Act. Accordingly, the final
regulations include a statement in section 1180.11 (``Relation to Other
Laws and Procedures'') clarifying that agencies that are subunits of
other agencies must comply with the procedures of the parent agency.
NTIS will not deal directly with these subunits as freestanding
agencies except as approved by the parent.
Comment: By referring to STEI ``which results from federally funded
research and development activities'' in the definition of the phrase
``federally funded,'' the regulation may be interpreted to refer only
to products generated under R&D funding categories.
NTIS Response: The quoted language appears in section 108 of the
ATPA and nothing in that section suggests a narrow reading that
conditions the requirement on technical funding categories.
Comment: The definition of ``final'' should not automatically
exclude interim STEI reports as they often contain valuable information
and the final report may not be issued for some time.
NTIS Response: The definition of ``final'' in section 1180.2 has
been modified to indicate that such reports may be transferred.
Comment: The definition of ``product'' should not include software
because that would unduly disrupt the agency's software distribution
mechanism.
NTIS Response: Section 108 of the ATPA expressly refers to software
and NTIS cannot read that out of the statute. Section 1180.7 contains a
procedure for exempting products or categories of products in
appropriate cases, such as harm to a dissemination program.
Comment: The definition of STEI is too broad in that it sweeps in
significant amounts of business-related information.
NTIS Response: The definition of STEI is not intended to cover all
business-related information. The second part of the definition is
obtained from a 1954 Comptroller General opinion (34 Comp. Gen. 58)
construing the Act of September 9, 1950, 64 Stat. 823, as amended (15
U.S.C. 1151 et seq.), which required the Secretary of Commerce to
maintain a clearinghouse for the collection and dissemination of STEI.
According to the opinion, ``technical information'' can embrace matters
beyond the restricted field of applied science and mechanical arts.
However, the definition in the Comptroller General opinion should
itself be read as limited to information which has a direct
relationship to business, industry or technology. Also, the second part
of the definition in the rule limits STEI to information that would be
of value to consumers of scientific or engineering information, as
determined by the agency transferring the information. Most
importantly, NTIS will work with liaison officers to ensure that the
results of applying the definition under this rule are not burdensome
to agencies or to NTIS.
Section 1180.4
Comment: The requirement that product formats conform to NTIS
guidelines is burdensome.
NTIS Response: The guidelines simply catalog existing formats in
order of preference by NTIS. However, they are only guidelines, not
requirements. The language has been modified to make it clearer that
the formats are to be used to the extent practicable.
Comment: The requirement to advise NTIS of the terms of copyright
licenses reserved to the Government are unnecessary because some
agencies surrender all rights in exchange from royalty-free government
purpose rights.
NTIS Response: The regulation in no way tells agencies what rights
they should or should not retain. Agency practices vary and the
regulation is simply intended to ensure that nothing is transferred to
NTIS that NTIS is precluded from disseminating because the Government
lacks appropriate dissemination rights.
Note: Section 1180.4(a) also contains a new paragraph relating
to material not printed by the Government Printing Office. The
purpose of this addition is explained more fully in the analysis of
comments pertaining to Sec. 1180.11.
Section 1180.5
Comment: The regulation requires final STEI products to be
submitted within fifteen days of public dissemination but is silent as
to when summaries of new and on-going research described in section
1180.3 is to be submitted.
NTIS Response: The final regulation clarifies that the fifteen day
requirement also pertains to unclassified research summaries that have
been made available for public dissemination through any distribution
channel.
Comment: Transfer within fifteen days of public dissemination may
be impractical or inappropriate.
NTIS Response: Providing NTIS with a copy of a product two weeks
after it has been made available for public dissemination is not
unreasonable and reflects the direction in section 108 of the ATPA that
federal agencies transfer covered materials in a timely manner.
Section 1180.6
Comment: The size and scope of the agency's programs make it
difficult to give NTIS pre-production notice so as to allow it to ride
printing orders.
NTIS Response: Section 1180.6 has been slightly modified to make it
clear that this procedure is permissive and need not be used by
agencies that conclude that it would be unduly burdensome.
Comment: The regulation should exempt the commenting agency from
the requirement to allow NTIS to ride its production orders for
security reasons.
NTIS Response: Section 1180.6 has been modified to clarify that
this requirement is not mandatory. However, agencies that do not use
this method must find alternative means of ensuring that NTIS receives
copies of all products required to be transferred.
Comment: NTIS should work with the commenting agency to ride its
printing requisitions and make arrangements to share costs recovered
from the dissemination of products.
NTIS Response: NTIS will consider all appropriate proposals from
agencies to achieve these purposes.
Section 1180.7
Comment: The regulation should not apply to STEI products available
through the Government Printing Office.
NTIS Response: NTIS has a statutory mandate to maintain an STEI
information clearinghouse, to establish and maintain a permanent
repository of unclassified STEI, and to operate on a cost recovery
basis without recourse to appropriations. NTIS achieves these different
objectives by maintaining a comprehensive collection that is of
particular value to business and other consumers who want access to a
broad range of materials in and out of print, who want them quickly,
and to whom time spent shopping in various places is a significant
cost. The practical effect of this suggestion would be to reduce the
value of NTIS' collection and essentially leave it with those
unprofitable items that GPO cannot sell. The enactment of Section 108
of the ATPA suggests that Congress wanted to strengthen, not weaken,
NTIS' ability to serve the needs of STEI users and industry and to
operate on a self-sustaining basis.
Comment: This section inappropriately allows NTIS to overrule
agency decisions as to whether information ought to be released and to
overrule agency decisions to use dissemination channels other than
NTIS.
NTIS Response: The regulation leaves discretion to agencies to
determine whether information should be released. The regulation
expressly disclaims the intent to preclude agencies from also using
other channels (Section 1180.11(b)). However, the regulation does
preclude agencies from unilaterally bypassing NTIS when the agency has
decided that the information should be disseminated. It is expected
that agencies and NTIS will negotiate cooperatively to identify
products or classes of products that the agency intends to make
available through channels other than NTIS.
Comment: Provisions calling for agreement between the agency head
and NTIS regarding alternative methods of compliance or whether
transfers would be inappropriate are issues that should be in the sole
discretion of the agency.
NTIS Response: NTIS has an obligation to ensure that the basic
requirements of the American Technology Preeminence Act are satisfied
and does not believe that agencies can unilaterally exempt themselves
from its provisions. NTIS will work closely with agency liaisons to
resolve problems that may from time to time arise. However, as noted
above, the basic issue of whether a product should be publicly
disseminated is up to the agency and is unaffected by Section 1180.7.
Comment: The regulation should specifically exempt the commenting
agency's ongoing research because national security concerns preclude
public dissemination.
NTIS Response: The regulations apply only to unclassified
information and only to information intended for public dissemination.
Section 1108.8
Comment: A reference in Sec. 1180.8(a)(1) to items produced at
Government facilities should be changed to refer to items produced by
the Government as the latter is more inclusive and production site is
largely irrelevant.
NTIS Response: NTIS has made the suggested change.
Comment: To preclude proliferation of affiliates within an agency,
the concurrence of an agency's initial and primary affiliate should be
required before additional affiliates are appointed.
NTIS Response: Section 1180.8 has been amended to adopt this
recommendation.
Comment: A commenting agency requested that the regulation
explicitly designate it as an affiliate.
NTIS Response: NTIS will designate a number of affiliates over
time. Designating them by regulation is impractical. NTIS expects that
the Department of Energy's Office of Scientific and Technical
Information, the Department of Defense's Defense Technical Information
Center and the National Aeronautics and Space Administration's
Scientific and Technical Information Office will be among those
organizations initially designated as affiliates by NTIS.
Section 1180.11
Comment: This section should be expanded to clarify the relation of
the regulation to a number of other laws and procedures relating to the
release, protection, and dissemination of Government information, such
as the Freedom of Information Act, requirements to protect certain
sensitive material, and requirements to make information available for
distribution to Depository Libraries (which issue is discussed in more
detail in the following comments).
NTIS Response: NTIS has made the suggested changes and has
reorganized Sec. 1180.4 to reflect them more clearly.
Comment: To ensure compliance with agency clearance procedures, the
regulation should specify for certain agencies the identity of the
offices that are required to approve direct transmissions of STEI
products to NTIS by contractors, grantees, and employees.
NTIS Response: NTIS has concluded that the identification of an
agency's appropriate clearance officials should be left to individual
agencies through their internal procedures and should not be covered by
NTIS regulations. The final regulation does not adopt this
recommendation but NTIS has modified the proposed regulation to delete
the one specific reference that had been included.
Comment: The regulation will weaken the effectiveness of the
Depository Library (DL) Program if agencies erroneously assume that
STEI products submitted to NTIS will automatically be supplied to the
Libraries by NTIS. Various recommendations were made, such as
clarifying that submission to NTIS in no way relieved agencies of their
obligations to provide documents to the Libraries or requiring NTIS to
make such products available to the Libraries on behalf of the
originating agencies.
NTIS Response: NTIS has added new provisions that (1) reemphasize
agency responsibilities for compliance with all DL requirements
(Section 1180.11(a)(5)); (2) provide DL's with information about new
products added to NTIS' inventory (Section 1180.11(d) (1)-(2)); and (3)
establish a procedure through which NTIS can assist agencies in meeting
their DL requirements with respect to STEI submitted to NTIS under this
regulation (Section 1180.4(a) and 1180(d) (3)-(6)).
The final regulations contain a new Sec. 1180.4(a)(4) which
requires agencies, when preparing a product for transfer to NTIS, to
advise NTIS as to whether products not printed by GPO have been made
available for depository distribution by GPO. In addition, it has added
a new Sec. 1180.11(d) which establishes a general framework for
handling products so identified.
Under this framework, DL's will be provided free online access to a
current listing of all products that NTIS accepts as part of its
permanent respository (Section 1180.11(d)(1)). They will be given a
reasonable time to order products not previously made available to them
(Section 1180.11(d)(2)). NTIS will bundle the requests and refer them
back to the originating agency to be filled (new Sec. 1180.11(d)(3)) or
fill the order itself if NTIS and the originating agency have entered
into appropriate agreements regarding reimbursement (Section
1180.11(d)(4)).
In the near future NTIS expects to develop a system through which
DL's, at no charge to them, may have electronic access to full texts of
STEI products. When this is operational, agencies will be able to
fulfill their obligations to the DL's effortlessly and at no additional
cost simply by providing NTIS with the product in a format prescribed
by NTIS as suitable for online dissemination under this system (Section
1180.11(d)(5)).
The new regulations will also obligate DL's to protect the
information provided to them (Section 1180.11(d)(6)). This is important
because the improper disclosure of this valuable information could
seriously erode NTIS's ability to operate on a self-sustaining basis.
For example, improper dissemination of the list of products could
significantly reduce the rental value of NTIS's bibliographic database
as an income-producing asset.
Comment: The regulation should clarify that the requirement to make
publications available under the Depository Library Program extends to
publications in electronic formats.
NTIS Response: NTIS cannot issue interpretations of statutes it
does not administer and that would be binding on other agencies. Such
matters are more appropriately covered by OMB Circular A-130.
Appendix
Comment: The Appendix should be modified to indicate that it is
inapplicable to a commenting agency's contractors and grantees.
NTIS Response: The Appendix includes model language that agencies
may choose to employ if they elect to allow their contractors and
grantees to submit products directly to NTIS. The regulations already
make clear that contractors and grantees of this agency must obtain
prior agency approval from an identified office before submitting such
information directly to NTIS.
Executive Order 12866
This regulation has been reviewed by the Office of Information and
Regulatory Affairs of the Office of Management and Budget under
Executive Order 12886.
Executive Order 12372
NTIS has determined that these procedures do not affect directly
any state or local government and that consultations with state and
local officials are not required.
Executive Order 12612
NTIS has determined that these procedures do not contain policies
with any federalism implications within the meaning of this Order.
Regulatory Flexibility Act
The General Counsel has certified to the Chief Counsel for Advocacy
of the Small Business Administration that this rule, which applies only
to the transfer by federal agencies of federally funded STEI, will not
have a significant economic impact on a substantial number of small
entities.
Paperwork Reduction Act
This rule does not contain any information collection requirement
subject to the Paperwork Reduction Act.
Environmental Evaluation
NTIS has determined that this regulation will have no significant
impact on the quality of the environment and that neither an
environmental assessment nor an Environmental Impact Statement is
needed.
List of Subjects in 15 CFR Part 1180
Scientific, technical and engineering information.
Issued in Springfield, Virginia, on December 28, 1993.
Ron Lawson,
Acting Director.
Accordingly, title 15 of the Code of Federal Regulations is amended
by adding part 1180 as follows:
PART 1180--TRANSFER BY FEDERAL AGENCIES OF SCIENTIFIC, TECHNICAL
AND ENGINEERING INFORMATION TO THE NATIONAL TECHNICAL INFORMATION
SERVICE
Sec.
1180.1 Purpose and scope.
1180.2 Definitions.
1180.3 General rule.
1180.4 Preparing a product for transfer.
1180.5 Timeliness.
1180.6 Production of additional copies.
1180.7 Exceptions.
1180.8 Appointment of Agency Liaison Officers.
1180.9 Affiliates.
1180.10 NTIS permanent repository.
1180.11 Relation to other laws and procedures.
Appendix to Part 1180--Sample Funding Agreement Clause for Direct
Submission of Products
Authority: Sec. 108 of Pub. L. 102-245, 106 Stat. 7 (15 U.S.C.
3704b-2).
Sec. 1180.1 Purpose and scope.
(a) The purpose of this regulation is to facilitate public access
to the vast amount of scientific, technical and engineering information
(STEI) that is produced by and for federal agencies.
(b) This regulation provides a variety of methods for federal
agencies to adopt to ensure the timely transfer to the National
Technical Information Service (NTIS) of all unclassified STEI that is
available for public dissemination and that results from federal
funding. It is issued pursuant to the authority contained in Section
108 of the American Technology Preeminence Act (Pub. L. 102-245).
Sec. 1180.2 Definitions.
Agency means a federal agency as that term is defined in Section 4
of the Stevenson-Wydler Technology Innovation Act of 1980, as amended
(15 U.S.C. 3703(8));
Director means the Director of the National Technical Information
Service.
Federally funded refers to STEI which results from federal research
and development activities funded in whole or in part with federal
funds, whether performed by the agency itself or by contractors,
grantees, cooperative research partners, joint venture partners, or
under any similar arrangement involving federal funds.
Final when used to describe an STEI product means a product that
the originating agency or contractor/grantee thereof intends for public
dissemination and may exclude interim status reports routinely
furnished to agencies by contractors and grantees for monitoring and
other internal purposes and which are not intended for public
dissemination.
Product includes, but is not limited to, any report, manual,
standard, specification, book, paper, chart, map, graph, data
collection, data file, data compilation, software, audio/video
production, technology application assessment generated pursuant to
Section 11(c) of the Stevenson-Wydler Technology Innovation Act of 1980
(15 U.S.C. 3710(c)), as well as materials pertaining to training
technology and other federally owned or originated technologies, and
applies to items produced in-house or outside the agency through the
Government Printing Office, its contractors, Federal Prison Industries
or any other producer, provided that such material is intended by the
agency for public dissemination.
Scientific, technical and engineering information means--
(1) Basic and applied research that results from the efforts of
scientists and engineers in any medium (including new theory and
information obtained from experimentation, observation, instrumentation
or computation in the form of text, numeric data or images), and
(2) Information that bears on business and industry generally, such
as economic information, market information and related information, if
the agency determines such information would be of value to consumers
of the information described in paragraph (1) of this definition.
Summary means information relating to an ongoing research project
likely to result in a final product.
Sec. 1180.3 General rule.
Unless an exception applies under section 1180.7, each federal
agency shall, within the time period specified in this regulation,
transfer to NTIS--
(a) At least one copy of every final STEI product resulting from
the agency's federally funded research and development activities, and
(b) A summary of the agency's new and on-going research that is
likely to result in a final STEI product
if such final product or summary is unclassified and is intended by the
agency for public dissemination.
Sec. 1180.4 Preparing a product for transfer.
(a) Every final STEI product or summary shall, to the extent
practicable, be prepared in a format that is consistent with one of the
various formats found in NTIS guidelines. In addition, every such
product shall--
(1) Be accompanied by a report documentation page (SF 298) or its
electronic equivalent;
(2) Be in a form capable of high quality reproduction appropriate
to the medium;
(3) In the case of software, be accompanied by relevant
documentation, such as operating manuals, but not including printed
source code; and
(4) In the case of a product not printed by the Government Printing
Office, be accompanied by a statement as to whether the product has
been made available for depository distribution by the Government
Printing Office.
(b) Each federal agency shall transfer or have transferred to NTIS
those STEI products funded by it that are protected by copyright only
if there is a license reserved to the Government. In such cases, the
agency shall inform NTIS of the terms of the license. Suggested
language for inclusion in agency funding instruments is contained in
the Appendix to this part.
(c) If an agency has generated or funded an STEI product which
should be available for public dissemination but has embedded within it
any copyrighted material, the designated liaison appointed pursuant to
Sec. 1180.8 should work with NTIS to determine if it would be
appropriate to seek a license from the copyright holder in order to
make the STEI product available.
Sec. 1180.5 Timeliness.
A single copy of a final product or summary described in
Sec. 1180.3 must be transferred to NTIS within fifteen days of the date
it is first made available for public dissemination through any
distribution channel, and, whenever practical, as soon as it has been
approved by the agency for final printing or other reproduction, unless
the agency and the Director have otherwise agreed.
Sec. 1180.6 Production of additional copies.
Unless the agency determines that such action would not be
feasible, it shall make appropriate arrangements to enable NTIS, from
time to time and at NTIS's own discretion and expense, to ride agency
printing and other reproduction orders.
Sec. 1180.7 Exceptions.
(a) An agency shall not be required to take any further action to
submit a copy of a final STEI product to NTIS or one of its affiliates
if--
(1) It has designated NTIS to receive a single copy of each STEI
product once it has been produced, has made the arrangements specified
in Sec. 1180.6, if appropriate, and has made arrangements to receive
appropriate certification from a contractor, grantee or other external
performer of federally funded research that a copy has been sent to
NTIS or one of its affiliates within the appropriate time period
pursuant to obligations incurred in the applicable funding agreement
(see Appendix to this part) or pursuant to such other system as the
agency has established to ensure timely transfer;
(2) The agency and the Director have executed an appropriate
agreement or memorandum of understanding establishing an alternative
system for compliance; or
(3) The federally funded STEI is protected by copyright for which
no license has been reserved to the Government that would allow
distribution by NTIS;
(4) The product is an agency generated article that is published in
a privately produced journal; or
(5) The agency and the Director, pursuant to paragraph (b) of this
section, have agreed that the transfer of a product otherwise covered
by these regulations would not be appropriate.
(b) An agency and the Director shall be deemed to be in agreement
within the meaning of paragraph (a)(3) of this section if the Director
has not objected within 30 days to an agency's written notification of
its determination that timely transfer of a product or category of
products would not be appropriate under section 108 of the American
Technology Preeminence Act. Examples of inappropriate transfers
include:
(1) Transfers that could cause significant harm to an agency's
existing dissemination program that is operating on a cost recovery
basis, is operating in compliance with the policies described by OMB
Circular A-130, and for which special arrangements that would permit
supplemental distribution by NTIS cannot be negotiated.
(2) Federally funded STEI that has received, or is likely to
receive, widespread distribution to most potential users at no charge.
Sec. 1180.8 Appointment of Agency Liaison Officers.
The head of each agency shall appoint or designate an officer or
employee to serve as the STEI Liaison. The Liaison shall, to the extent
authorized by the head of the agency--
(1) In cooperation with the Director, determine what products or
summaries produced by the Government shall be transferred to NTIS on an
ongoing basis;
(2) Determine which funding agreements are to require contractors
and grantees to submit products directly to NTIS (for which purpose the
Appendix to this part contains suggested language that agencies may
wish to include in applicable funding instruments);
(3) Appoint additional liaison officers for major units or
components of an agency if the Director and Liaison officer agree this
would further the purposes of this regulation; and
(4) Enter into appropriate agreements with the Director and perform
any other agency responsibilities described in this regulation.
Sec. 1180.9 Affiliates.
(a) The Director may recognize any federal agency or component of
an agency as an affiliate for the purpose of receiving, on behalf of
NTIS, any STEI product that is required to be transferred under these
regulations if NTIS has entered into a memorandum of understanding with
the Liaison Officer under which the recognized affiliate agrees to the
ongoing transfer of all STEI products to NTIS in a timely manner and
otherwise agrees to assume the role of an affiliate.
(b) A transfer by an agency to an approved affiliate shall be
deemed a transfer to NTIS within the meaning of these regulations.
Sec. 1180.10 NTIS permanent repository.
A product, or category of product, will normally be accepted and
maintained as part of NTIS' permanent repository as a service to
agencies unless the Director advises the Liaison Officer that it has
not been so accepted. In general, transferred products will not be
accepted if they have not been properly prepared as required by Section
1180.4 or if NTIS believes that the cost of adding them to the
repository will significantly exceed anticipated benefits to the public
as measured by foreseeable demand. A product announced by NTIS as being
available from NTIS shall be deemed to have been accepted by NTIS as
part of its permanent repository.
Sec. 1180.11 Relation to other laws and procedures.
(a) Nothing in these regulations shall be deemed to exempt an
agency from any of the following requirements:
(1) Compliance with the Freedom of Information Act (5 U.S.C. 552);
(2) Compliance with any requirements to protect material that
contains classified national security information;
(3) Compliance with requirements to protect personal or other
information that may not be disclosed without appropriate authority
under applicable laws and procedures, such as the Privacy Act (5 U.S.C.
552a);
(4) Compliance with laws and regulations applicable to federal
records under Title 44 of the United States Code or regulations issued
by the National Archives and Records Administration (36 CFR, chapter
XII);
(5) Compliance with requirements to distribute publications through
the Depository Library Program either directly or through NTIS as
prescribed in subsection (d) of this section; and
(6) In the case of an agency that is also a component of an agency
as that term is defined in Sec. 1180.2, compliance with all applicable
requirements and procedures of the parent agency regarding these
regulations.
(b) Nothing in these regulations shall be deemed to require an
agency to take any of the following actions:
(1) To use NTIS as an agency's exclusive distribution channel;
(2) To transfer to NTIS information on matters that are
specifically authorized under criteria established by an Executive
Order to be kept secret in the interest of national defense or foreign
policy and are in fact properly classified pursuant to such Executive
Order; or
(3) to transfer, produce, or disseminate any other information that
is required by law to be withheld, which the agency is authorized to
withhold, or which is not intended by the agency for public
dissemination.
(c) No contractor, grantee, or employee of a Federal agency shall
submit a final STEI product directly to NTIS unless authorized to do so
by the Liaison or the Liaison's designate, which authorization may be
provided in an approved funding agreement (see Appendix to this part).
(d) In order to facilitate cooperation between agencies and the
Depository Libraries--
(1) NTIS will, as soon as possible, but not later than six months
from the effective date of these regulations, provide each Depository
Library at no charge, online access to a current list of all final STEI
products provided to NTIS under these regulations that have been
entered into the NTIS system.
(2) The online system described in subsection (d) of this section
will include an option that will allow each Depository Library thirty
days from the date a product is added to the online listing to identify
a product that it wishes to receive and that has not otherwise been
made available to it.
(3) NTIS will accumulate these requests and, within a reasonable
time, transfer them to the originating agency for fulfillment of each
of the identified products.
(4) In lieu of the procedures described in paragraph (d)(3) of this
section, NTIS will offer to enter into simple cost recovery
arrangements with the originating agency to duplicate and ship the
identified products to the requesting Libraries in the format that the
agency determines to be most cost effective, including microfiche,
paper, diskette, or disc.
(5) NTIS will also establish, as soon as practical, a system of
full text online access to final STEI products for the Depository
Libraries at no charge to them. Those final STEI products provided to
NTIS in a format prescribed by NTIS as suitable for online
dissemination under this system will be made available to the Libraries
at no charge to the originating agency, will be maintained online
indefinitely, and will be available to the Libraries without regard to
the thirty day selection time limit described in paragraph (d)(2) of
this section.
(6) The services in this paragraph will be provided to Depository
Libraries on the condition that they agree to ensure that online access
to the NTIS listing described in paragraph (d)(1) of this section is
restricted to the Library and its staff and that the full text products
provided online pursuant to paragraph (d)(5) of this section are
available only to the community served by that Library.
Appendix to Part 1180--Sample Funding Agreement Clause for Direct
Submission of Products
Agencies electing to allow for their contractors, grantees, etc. to
submit final products directly to NTIS are encouraged to employ a
provision similar to the following in the applicable funding agreement:
``The (contractor)/(recipient) shall certify to the
(contracting) (grants) officer--
``(1) a copy of all scientific, technical and engineering
information products created or finalized in whole or in part with
the funds requested has been or will be transferred to NTIS or a
recognized affiliate (at the same time that it is provided to the
sponsoring agency) (when the agency has determined that the product
is approved for public dissemination) but no later than fifteen days
after it is first made available for public dissemination through
any other distribution channel, and
``(2) NTIS, or a recognized affiliate, has been advised as to
whether the product is protected by copyright and, if so, a copy of
the terms of any licenses reserved to the Government has been sent
to NTIS, along with a copy of the SF 298.''
[FR Doc. 93-32098 Filed 12-29-93; 1:02 pm]
BILLING CODE 3510-04-M
Complete official Federal Register PDF
FR Doc. 93-32063 Panel Review Under Article 1904 of the North American Free Trade Agreement
[Federal Register Volume 59, Number 1 (Monday, January 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-32063]
[[Page Unknown]]
[Federal Register: January 3, 1994]
_______________________________________________________________________
Part VI
Department of Commerce
_______________________________________________________________________
International Trade Administration
_______________________________________________________________________
19 CFR Part 356
Panel Review Under Article 1904 of the North American Free Trade
Agreement; Final Rule
DEPARTMENT OF COMMERCE
International Trade Administration
19 CFR Part 356
Docket No. 931247-3347
Panel Review Under Article 1904 of the North American Free Trade
Agreement
AGENCY: International Trade Administration, Department of Commerce.
ACTION: Interim-final rule and request for comments.
-----------------------------------------------------------------------
SUMMARY: Title IV of the North American Free Trade Agreement
Implementation Act of 1993 (``NAFTA Act''), establishes procedures for
review by a binational panel of United States antidumping and
countervailing duty final determinations involving products from Canada
or the United Mexican States (``free trade area countries'' as defined
by 19 U.S.C. 1516a(f)(10)) and for requesting panel review of free
trade area country antidumping and countervailing duty final
determinations involving products of the United States. Title IV of the
NAFTA Act implements Chapter Nineteen of the North American Free Trade
Agreement (``Agreement''). As authorized by section 402(g) of the NAFTA
Act, these regulations are intended to implement certain administrative
procedures required by Article 1904 of the Agreement and the NAFTA Act.
These regulations replace corresponding regulations issued pursuant to
the United States-Canada Free Trade Agreement.
DATES: These regulations take effect on January 1, 1994, or on the date
that the Agreement enters into force if that date is subsequent to
January 1, 1994. The International Trade Administration will publish a
document giving notice of the effective date of these regulations if
the effective date is not January 1, 1994.
Written comment must be received not later than March 2, 1994.
ADDRESSES: Address written comments to Stacy J. Ettinger, Attorney-
Advisor, Office of the Chief Counsel for Import Administration, room B-
099, U.S. Department of Commerce, 14th and Constitution Avenue, NW.,
Washington, DC 20230.
FOR FURTHER INFORMATION CONTACT: Lisa B. Koteen, 202-482-0836, or Stacy
J. Ettinger, 202-482-4618.
SUPPLEMENTARY INFORMATION:
Background
Chapter Nineteen of the Agreement establishes a mechanism for
resolving disputes between the United States and free trade area
countries with respect to antidumping and countervailing duty cases.
The central feature of the mechanism is the replacement of domestic
judicial review of determinations in antidumping and countervailing
duty cases involving imports from free trade area countries with review
by independent binational panels. The United States and the involved
free trade area country will continue to apply their own national
antidumping and countervailing duty laws to goods imported from the
other country. In such cases, independent binational panels acting in
place of national courts will expeditiously review final determinations
under these laws to decide whether they are consistent with the
antidumping or countervailing duty law of the country that made the
determination. These determinations include final antidumping and
countervailing duty determinations by the Department of Commerce (``the
Department''), and final injury determinations by the International
Trade Commission.
The Agreement provides that only the involved governments may
invoke the panel review process; however, the governments of the
involved countries will automatically trigger panel review in response
to a timely request from any person who otherwise could have challenged
the determination in court. Counsel for (or representative of)
interested parties that were parties to the administrative proceeding
that is being challenged will argue before the panel, as they would
before a court. The Agreement also requires that the United States and
the free trade area countries protect sensitive business information
against unlawful disclosure in the panel review process.
Title IV of the NAFTA Act (Pub. L. 103-182, 107 Stat. 2057) amends
United States law to implement Chapter Nineteen of the Agreement by
limiting judicial review in cases involving free trade area country
merchandise, establishing procedures whereby private parties may
request binational panel review, providing an organizational structure
for administering United States responsibilities under Chapter
Nineteen, and making other conforming amendments to United States law.
More specifically, section 402(g) of the NAFTA Act authorizes the
Department, as the administering authority under Title VII of the
Tariff Act of 1930 (``Act''), to issue regulations to implement Chapter
Nineteen of the Agreement.
These regulations are intended to implement certain administrative
procedures required by Chapter Nineteen of the Agreement before an
administrative proceeding has been sent to the Court of International
Trade or a binational panel, as well as the administrative
responsibilities of the Department that continue during and after panel
review. These regulations replace corresponding regulations issued
pursuant to the United States-Canada Free Trade Agreement. These
regulations are necessary to provide for notice of intent to seek
judicial review, request for panel review, notice of receipt by the
Government of a free trade area country of scope determinations,
continued suspension of liquidation, release of business proprietary
and privileged information under protective order during a panel
review, and sanctions for violations of such protective orders. The
Department currently is reviewing procedures for release of business
proprietary information under protective order during antidumping and
countervailing duty administrative proceedings. Any changes made in
procedures as a result of that review will be considered for
incorporation into these regulations. The procedures for proceedings
before binational panels are being implemented through Rules of
Procedure negotiated by the United States and the free trade area
countries. These regulations complement the Rules of Procedure and
should be used in conjunction with the Rules.
Administrative Procedure Act
This interim rule is exempt from all requirements of section 553 of
the Administrative Procedure Act (5 U.S.C. 553), including notice and
opportunity to comment and delay of the effective date, because it
implements Chapter Nineteen of the Agreement and thus relates to a
foreign affairs function of the United States.
Executive Order 12866
This rule was not reviewed by the Office of Management and Budget
under Executive Order 12866.
Paperwork Reduction Act
This rule does not contain a collection of information subject to
the requirements of the Paperwork Reduction Act of 1980 (44 U.S.C. 3501
et seq.). The collections of information contained in these regulations
occur within the course of ongoing investigations or actions initiated
prior to the determinations that are reviewable by binational panels
under the Agreement. Thus they are not covered by the Paperwork
Reduction Act. See 5 CFR 1320.3(c).
Regulatory Flexibility Act
The Regulatory Flexibility Act does not apply to this rule because
the rule was not required to be promulgated as a proposed rule before
issuance as a final rule by section 553 of the Administrative Procedure
Act or by any other law. Accordingly, neither an initial nor final
Regulatory Flexibility Analysis has been or will be prepared.
Executive Order 12612
This rule does not contain policies with Federalism implications
sufficient to warrant preparation of a Federalism assessment under
Executive Order 12612 (52 FR 41685, October 30, 1987).
Entry Into Force
It is anticipated that the Agreement will enter into force on
January 1, 1994. The Office of the United States Trade Representative
will confirm in a Federal Register notice the precise date of the
Agreement's entry into force.
List of Subjects in 19 CFR Part 356
Antidumping, Canada, Countervailing duty, Imports, Judicial review,
Penalties, Trade agreements, United Mexican States.
19 CFR Part 356 is revised to read as follows:
PART 356--PROCEDURES AND RULES FOR IMPLEMENTING ARTICLE 1904 OF THE
NORTH AMERICAN FREE TRADE AGREEMENT
Subpart A--Scope and Definitions
Sec.
356.1 Scope.
356.2 Definitions.
Subpart B--Procedures for Commencing Review of Final Determinations
356.3 Notice of intent to commence judicial review.
356.4 Request for panel review.
356.5 [Reserved]
356.6 Receipt of notice of a scope determination by the Government
of a FTA country.
356.7 Request to determine when the Government of a FTA country
received notice of a scope determination.
356.8 Continued suspension of liquidation.
Subpart C--Proprietary and Privileged Information
356.9 Persons authorized to receive proprietary information.
356.10 Procedures for obtaining access to proprietary information.
356.11 Procedures for obtaining access to privileged information.
Subpart D--Violation of a Protective Order or a Disclosure Undertaking
356.12 Sanctions for violation of a protective order or disclosure
undertaking.
356.13 Suspension of rules.
356.14 Report of violation and investigation.
356.15 Initiation of proceedings.
356.16 Charging letter.
356.17 Request to charge.
356.18 Interim sanctions.
356.19 Request for a hearing.
356.20 Discovery.
356.21 Subpoenas.
356.22 Prehearing conference.
356.23 Hearing.
356.24 Proceeding without a hearing.
356.25 Witnesses.
356.26 Initial decision.
356.27 Final decision.
356.28 Reconsideration.
356.29 Confidentiality.
356.30 Sanctions for violations of a protective order for
privileged information.
Authority: 19 U.S.C. 1516a and 1677f(f), unless otherwise noted.
Subpart A--Scope and Definitions
Sec. 356.1 Scope.
This part sets forth procedures and rules for the implementation of
Article 1904 of the North American Free Trade Agreement under the
Tariff Act of 1930, as amended by title IV of the North American Free
Trade Agreement Implementation Act of 1993 (19 U.S.C. 1516a and
1677f(f)). This part is authorized by section 402(g) of the North
American Free Trade Agreement Implementation Act of 1993.
Sec. 356.2 Definitions.
For purposes of this part:
(a) Act means the Tariff Act of 1930, as amended;
(b) Administrative law judge means the person appointed under 5
U.S.C. 3105 who presides over the taking of evidence as provided by
subpart D of this part;
(c) Affected party means a person against whom sanctions have been
proposed for alleged violation of a protective order or disclosure
undertaking but who is not a charged party;
(d) Agreement means the North American Free Trade Agreement between
Canada, the United Mexican States and the United States, signed on
December 17, 1992; or, with respect to binational panel or
extraordinary challenge proceedings underway as of such date, or any
binational panel or extraordinary challenge proceedings that may
proceed between Canada and the United States following any withdrawal
from the Agreement by Canada or the United States, the United States-
Canada Free Trade Agreement between Canada and the United States, which
came into force on January 1, 1989;
(e) APO Sanctions Board means the Administrative Protective Order
Sanctions Board;
(f) Article 1904 Panel Rules means the NAFTA Article 1904 Panel
Rules, negotiated pursuant to Article 1904 of the North American Free
Trade Agreement between Canada, the United Mexican States and the
United States, and any subsequent amendments; or, with respect to
binational panel proceedings underway as of such date, or any
binational panel proceedings that may proceed between the Canada and
the United States following any withdrawal from the Agreement by Canada
or the United States, the Article 1904 Panel Rules, as amended, which
came into force on January 1, 1989;
(g) Authorized agency of a free trade area country means:
(1) In the case of Canada, any Canadian government agency that is
authorized by Canadian law to request the Department to initiate
proceedings to impose sanctions for an alleged violation of a
disclosure undertaking; and
(2) In the case of Mexico, any Mexican government agency that is
authorized by Mexican law to request the Department to initiate
proceedings to impose sanctions for an alleged violation of a
disclosure undertaking;
(h) Binational panel means a binational panel established pursuant
to Annex 1901.2 to Chapter Nineteen of the Agreement for the purpose of
reviewing a final determination;
(i) Charged party means a person who is charged by the Deputy Under
Secretary with violating a protective order or a disclosure
undertaking;
(j) Chief Counsel means the Chief Counsel for Import
Administration, U.S. Department of Commerce, or designee;
(k) Days means calendar days, except that a deadline which falls on
a weekend or holiday shall be extended to the next working day;
(l) Department means the U.S. Department of Commerce;
(m) Deputy Under Secretary means the Deputy Under Secretary for
International Trade, U.S. Department of Commerce;
(n) Director means an Office Director under the Deputy Assistant
Secretary for Investigations, U.S. Department of Commerce, or designee,
if the panel review is of a final determination by the Department under
section 751 of the Act, or an Office Director under the Deputy
Assistant Secretary for Compliance, or designee, if the panel review is
of a final determination by the Department under section 705(a) or
735(a) of the Act;
(o) Disclosure undertaking means:
(1) In the case of Canada, the Canadian mechanism for protecting
proprietary or privileged information during proceedings pursuant to
Article 1904 of the Agreement, as prescribed by subsection 77.21(2) of
the Special Import Measures Act, as amended; and
(2) In the case of Mexico, the Mexican mechanism for protecting
proprietary or privileged information during proceedings pursuant to
Article 1904 of the Agreement, as prescribed by the Ley de Comercio
Exterior and its regulations;
(p) Extraordinary challenge committee means the committee
established pursuant to Annex 1904.13 to Chapter Nineteen of the
Agreement to review decisions of a panel or conduct of a panelist;
(q) Final determination means ``final determination'' as defined by
Article 1911 of the Agreement;
(r) Free trade area country or FTA country means ``free trade area
country'' as defined by section 516A(f)(10) of the Act (19 U.S.C.
1516a(f)(10));
(s) Investigating authority means the competent investigating
authority that issued the final determination subject to review and
includes, in respect of the issuance, amendment, modification or
revocation of a protective order or disclosure undertaking, any person
authorized by the investigating authority;
(t) Lesser-included sanction means a sanction of the same type but
of more limited scope than the proposed sanction for violation of a
protective order or disclosure undertaking; thus, a one-year bar on
representation before the Department is a lesser-included sanction of a
proposed seven-year bar;
(u) Letter of transmittal means a document marked according to the
requirements of 19 CFR 353.31(e)(2)(i)-(v) or 355.31(e)(2)(i)-(v);
(v) Official publication means:
(1) In the case of Canada, the Canada Gazette;
(2) In the case of Mexico, the Diario Oficial de la Federacion; and
(3) In the case of the United States, the Federal Register;
(w) Panel review means review of a final determination pursuant to
Chapter Nineteen of the Agreement;
(x) Party to the proceeding means a person that would be entitled,
under section 516A of the Act (19 U.S.C. 1516a), to commence
proceedings for judicial review of a final determination;
(y) Participant means a party to the proceeding that files a
Complaint or a Notice of Appearance in a panel review, and the
Department;
(z) Parties means, in an action under subpart D of this part, the
Department and the charged party or affected party;
(aa) Person means, an individual, partnership, corporation,
association, organization, or other entity;
(bb) Privileged information means:
(1) With respect to a panel review of a final determination made in
Canada, information of the investigating authority that is subject to
the solicitor-client privilege under the laws of Canada, or that
constitutes part of the deliberative process with respect to the final
determination, and with respect to which the privilege has not been
waived;
(2) With respect to a panel review of a final determination made in
Mexico:
(i) Information of the investigating authority that is subject to
attorney-client privilege under the laws of Mexico; or
(ii) Internal communications between officials of the Secretaria de
Comercio y Fomento Industrial in charge of antidumping and
countervailing duty investigations or communications between those
officials and other government officials, where those communications
constitute part of the deliberative process with respect to the final
determination; and
(3) With respect to a panel review of a final determination made in
the United States, information of the investigating authority that is
subject to the attorney-client, attorney work product or government
deliberative process privilege under the laws of the United States and
with respect to which the privilege has not been waived;
(cc) Proprietary information means:
(1) With respect to a panel review of a final determination made in
Canada, information referred to in subsection 84(3) of the Special
Import Measures Act, as amended, or subsection 45(3) of the Canadian
International Trade Tribunal Act, as amended, with respect to which the
person who designated or submitted the information has not withdrawn
the person's claim as to the confidentiality of the information;
(2) With respect to a panel review of a final determination made in
Mexico, informacion confidencial, as defined under article 80 of the
Ley de Comercio Exterior and its regulations; and
(3) With respect to a panel review of a final determination made in
the United States, business proprietary information under section
777(f) of the Act (19 U.S.C. 1677f(f)) and information the disclosure
of which the Department has decided is limited under the procedures
adopted pursuant to Article 1904.14 of the Agreement, including
business or trade secrets; production costs; terms of sale; prices of
individual sales, likely sales, or offers; names of customers,
distributors, or suppliers; exact amounts of the subsidies received and
used by a person; names of particular persons from whom proprietary
information was obtained; and any other business information the
release of which to the public would cause substantial harm to the
competitive position of the submitter;
(dd) Protective order means a protective order issued by the
Department under 19 CFR 356.10(c) or 356.11(c);
(ee) Scope determination means a determination by the Department,
reviewable under section 516A(a)(2)(B)(vi) of the Act (19 U.S.C.
1516a(a)(2)(B)(vi), as to whether a particular type of merchandise is
within the class or kind of merchandise described in an existing
finding of dumping or an antidumping or countervailing duty order
covering free trade area country merchandise;
(ff) Secretariat means the Secretariat established pursuant to
Article 2002 of the Agreement and includes the Secretariat sections
located in Canada, Mexico and the United States;
(gg) Secretary means the Secretary of the Canadian section of the
Secretariat, the Secretary of the Mexican section of the Secretariat,
or the Secretary of the United States section of the Secretariat and
includes any person authorized to act on behalf of the Secretary;
(hh) Service address means the address of the counsel of record for
a person, including any facsimile number submitted with that address,
or, where a person is not represented by counsel, the address set out
by the person in a Request for Panel Review, Complaint or Notice of
Appearance as the address at which the person may be served, including
any facsimile number submitted with that address, or where a Change of
Service Address has been filed by a person, the new service address set
out as the service address in that form, including any facsimile number
submitted with that address;
(ii) Service list means, with respect to a panel review of a final
determination made in the United States, the list maintained by the
investigating authority of persons who have been served in the
proceeding leading to the final determination;
(jj) Under Secretary means the Under Secretary for International
Trade, U.S. Department of Commerce, or designee;
(kk) United States section of the Secretariat means, for the
purposes of filing, United States Secretary, NAFTA Secretariat, room
2061, U.S. Department of Commerce, 14th and Constitution Avenue, NW.,
Washington, DC 20230.
Subpart B--Procedures for Commencing Review of Final Determinations
Sec. 356.3 Notice of intent to commence judicial review.
A party to a proceeding who intends to commence judicial review of
a final determination made in the United States shall file a Notice of
Intent to Commence Judicial Review, which shall contain such
information, and be in such form, manner, and style, including service
requirements, as prescribed by the Article 1904 Panel Rules, within 20
days after:
(a) The date of publication in the Federal Register of the final
determination; or
(b) The date on which the notice of the final determination was
received by the Government of the FTA country if the final
determination was not published in the Federal Register.
Sec. 356.4 Request for panel review.
A party to a proceeding who seeks panel review of a final
determination shall file a Request for Panel Review, which shall
contain such information, and be in such form, manner, and style,
including service requirements, as prescribed by the Article 1904 Panel
Rules, within 30 days after:
(a) The date of publication in the official publication of the
final determination; or
(b) The date on which the notice of the final determination was
received by the United States Government or the Government of the FTA
country if the final determination was not published in the official
publication.
Sec. 356.5 [Reserved.]
Sec. 356.6 Receipt of notice of a scope determination by the
Government of a FTA country.
(a) Where the Department has made a scope determination, notice of
such determination shall be deemed received by the Government of a FTA
country when a certified copy of the determination is delivered to the
chancery of the Embassy of the FTA country during its normal business
hours.
(b) Where feasible, the Department, or an agent therefor, will
obtain a certificate of receipt signed by a person authorized to accept
delivery of documents to the Embassy of the FTA country acknowledging
receipt of the scope determination. The certificate will describe
briefly the document being delivered to the Embassy of the FTA country,
state the date and time of receipt, and include the name and title of
the person who signs the certificate. The certificate will be retained
by the Department in its public files pertaining to the scope
determination at issue.
Sec. 356.7 Request to determine when the Government of a FTA country
received notice of a scope determination.
(a) Pursuant to section 516A(g)(10) of the Act (19 U.S.C.
1516a(g)(10)), any party to the proceeding may request in writing from
the Department the date on which the Government of a FTA country
received notice of a scope determination made by the Department.
(b) A request shall be made by filing a written request and the
correct number of copies in accordance with the requirements set forth
in 19 CFR 353.31(d) and (e)(2) or 355.31(d) and (e)(2) with the
Secretary of Commerce, Attention: Import Administration, Central
Records Unit, room B-099, U.S. Department of Commerce, 14th and
Constitution Avenue, NW., Washington, DC 20230. A letter of transmittal
must be bound to the original and each copy as the first page of the
request.
(c) The requesting party shall serve a copy of the Request to
Determine When the Government of [insert name of applicable FTA
country] Received Notice of a Scope Determination by first class mail
or personal service on any interested party on the Department's service
list in accordance with the service requirements listed in 19 CFR
353.31(g) or 355.31(g).
(d) The Department will respond to the request referred to in
paragraph (b) of this section within five business days of receipt.
Sec. 356.8 Continued suspension of liquidation.
(a) In general. In the case of an administrative determination
specified in clause (iii) or (vi) of section 516A(a)(2)(B) of the Act
(19 U.S.C. 1516a(a)(2)(B)(iii) and (vi)) and involving free trade area
country merchandise, the Department shall not order liquidation of
entries of merchandise covered by such a determination until the forty-
first day after the date of publication of the notice described in
clause (iii) or receipt of the determination described in clause (vi),
as appropriate. If requested, the Department will order the continued
suspension of liquidation of such entries in accordance with the terms
of paragraphs (b), (c), and (d) of this section.
(b) Eligibility to request continued suspension of liquidation. (1)
A participant in a binational panel review that was a domestic party to
the proceeding, as described in section 771(9)(C), (D), (E), (F), or
(G) of the Act (19 U.S.C. 1677(9)(C), (D), (E), (F) and (G)), may
request continued suspension of liquidation of entries of merchandise
covered by the administrative determination under review by the panel
and that would be affected by the panel review.
(2) A participant in a binational panel review that was a party to
the proceeding, as described in section 771(9)(A) of the Act (19 U.S.C.
1677(9)(A)), may request continued suspension of liquidation of the
merchandise which it manufactured, produced, exported, or imported and
which is covered by the administrative determination under review by
the panel.
(c) Request for continued suspension of liquidation. A request for
continued suspension of liquidation must include:
(1) The name of the final determination subject to binational panel
review and the case number assigned by the Department;
(2) The caption of the binational panel proceeding;
(3) The name of the requesting participant;
(4) The requestor's status as a party to the proceeding and as a
participant in the binational panel review; and
(5) The specific entries to be suspended by name of manufacturer,
producer, exporter, or U.S. importer.
(d) Filing and service. (1) A request for Continued Suspension of
Liquidation must be filed with the Assistant Secretary for Import
Administration, room B-099, 14th and Constitution Avenue, NW.,
Washington, DC 20230, in accordance with the requirements set forth in
19 CFR 353.31(d) and (e)(2) or 355.31(d) and (e)(2). A letter of
transmittal must be bound to the original and each copy as the first
page of the request. The envelope and the first page of the request
must be marked: Panel Review--Request for Continued Suspension of
Liquidation. The request may be made no earlier than the date on which
the first request for binational panel review is filed.
(2) The requesting party shall serve a copy of the Request for
Continued Suspension of Liquidation on the United States Secretary and
all parties to the proceeding in accordance with the requirements of 19
CFR 353.31(g) or 19 CFR 355.31(g).
(e) Termination of Continued Suspension. Upon completion of the
panel review, including any panel review of remand determinations and
any review by an extraordinary challenge committee, the Department will
order liquidation of entries, the suspension of which was continued
pursuant to this section.
Subpart C--Proprietary and Privileged Information
Sec. 356.9 Persons authorized to receive proprietary information.
Persons described in paragraphs (a), (d), (e), (f) and (g) of this
section shall, and persons described in paragraphs (b) and (c) of this
section may, be authorized by the Department to receive access to
proprietary information if they comply with this subpart and such other
conditions imposed upon them by the Department:
(a) The members of, and appropriate staff of, a binational panel or
extraordinary challenge committee;
(b) Counsel to participants in panel reviews and professionals
retained by, or under the direction or control of such counsel,
provided that the counsel or professional does not participate in
competitive decision-making activity (such as advice on production,
sales, operations, or investments, but not legal advice) for the
participant represented or for any person who would gain competitive
advantage through knowledge of the proprietary information sought;
(c) Other persons who are retained or employed by and under the
direction or control of a counsel or professional, panelist, or
committee member who has been issued a protective order, such as
paralegals, law clerks, and secretaries, if such other persons are:
(1) Not involved in the competitive decision-making of a
participant to the panel review or for any person who would gain
competitive advantage through knowledge of the proprietary information
sought; and
(2) Have agreed to be bound by the terms set forth on the
application for protective order of the counsel or professional,
panelist, or committee member;
(d) Each Secretary and every member of the staff of the
Secretariat;
(e) Such officials of the United States Government (other than an
officer or employee of the investigating authority that issued the
final determination subject to review) as the United States Trade
Representative informs the Department require access to proprietary
information for the purpose of evaluating whether the United States
should seek an extraordinary challenge committee review of a panel
determination;
(f) Such officials of the Government of a FTA country as an
authorized agency of the FTA country informs the Department require
access to proprietary information for the purpose of evaluating whether
the FTA country should seek an extraordinary challenge committee review
of a panel determination; and
(g) Every court reporter, interpreter and translator employed in a
panel or extraordinary challenge committee review.
Sec. 356.10 Procedures for obtaining access to proprietary
information.
(a) Persons who must file an application for disclosure under
protective order. In order to be permitted access to proprietary
information in the administrative record of a final determination under
review by a panel, all persons described in Secs. 356.9 (a), (b), (d),
(e), (f) and (g) shall file an application for a protective order. The
procedures for applying for a protective order described in paragraph
(b) of this section apply as well to amendments or modifications filed
by persons described in Sec. 356.9.
(b) Procedures for applying for a protective order--(1) Contents of
applications. (i) The Department has adopted application forms for
disclosure of proprietary information which are available from the
United States section of the Secretariat or the Central Records Unit,
room B-099, U.S. Department of Commerce, 14th and Constitution Avenue,
NW., Washington, DC 20230. The application forms may be amended from
time to time.
(ii) Such forms require the applicant to submit a personal sworn
statement stating, in addition to such other terms as the Department
may require, that the applicant shall:
(A) Not disclose any proprietary information obtained under
protective order and not otherwise available to the applicant, to any
person other than:
(1) An official of the Department involved in the particular panel
review in which the proprietary information is part of the
administrative record;
(2) The person from whom the information was obtained;
(3) A person who has been granted access to the proprietary
information at issue under Sec. 356.9; and
(4) A person employed by and under the direction or control of a
counsel or professional, panelist, or committee member who has been
issued a protective order, such as a paralegal, law clerk, or secretary
if such person:
(i) Is not involved in competitive decision-making for a
participant in the panel review or for any person that would gain
competitive advantage through knowledge of the proprietary information
sought; and
(ii) Has agreed to be bound by the terms set forth in the
application for protective order by the counsel, professional,
panelist, or committee member;
(B) Not use any of the proprietary information not otherwise
available to the applicant for purposes other than proceedings pursuant
to Article 1904 of the Agreement;
(C) Upon completion of the panel review, or at such earlier date as
may be determined by the Department, return to the Department or
certify to the Department the destruction of all documents released
under the protective order and all other documents containing the
proprietary information (such as briefs, notes, or charts based on any
such information received under the protective order); and
(D) Acknowledge that breach thereof may subject the signatory to
sanctions under Sec. 356.12.
(2) Timing of application for disclosure under protective order--
(i) Persons described in Sec. 356.9(a) (panelists, etc.). A person
described in Sec. 356.9(a) may file an application after a Notice of
Request for Panel Review has been filed with the Secretariat.
(ii) Persons described in Sec. 356.9(b) (counsel, etc.). A person
described in Sec. 356.9(b) may file an application at any time but not
before that person files a Complaint or a Notice of Appearance.
(iii) Persons described in Sec. 356.9(d) (Secretaries, etc.). A
person described in Sec. 356.9(d) shall file an application immediately
upon assuming official responsibilities in the Secretariat.
(iv) Persons described in Sec. 356.9 (e), (f) or (g) (designated
Government officials or court reporters, etc.). A person described in
Sec. 356.9 (e), (f) or (g) shall file an application before seeking or
obtaining access to proprietary information.
(3) Filing of applications. A person described in Sec. 356.9 (a),
(b), (d), (e), (f) or (g) shall file the completed original and five
copies of an application with the United States section of the
Secretariat which, in turn, shall submit the original and one copy of
the application to the Department. A letter of transmittal must be
bound to the original and each copy as the first page of the document.
(4) Service of applications--(i) Persons described in
Secs. 356.9(b) (counsel, etc.). A person described in Sec. 356.9(b) who
files an application before the expiration of the time period fixed
under the Article 1904 Panel Rules for filing a Notice of Appearance in
the panel review shall serve one copy of the application on each person
listed on the service list in accordance with paragraphs (b)(4) (ii)
and (iii) of this section. In any other case, such person shall serve
one copy of the application on each participant, other than the
investigating authority, in accordance with paragraphs (b)(4) (ii) and
(iii) of this section.
(ii) Method of service. A document may be served by:
(A) Delivering a copy of the document to the service address of the
participant;
(B) Sending a copy of the document to the service address of the
participant by facsimile transmission or by expedited delivery courier
or expedited mail service; or
(C) Personal service on the participant.
(iii) Proof and date of service. A proof of service shall appear
on, or be affixed to, the document. Where a document is served by
expedited delivery courier or expedited mail service, the date of
service set out in the affidavit of service or certificate of service
shall be the day on which the document is consigned to the expedited
delivery courier service or expedited mail service.
(5) Release to employees of panelists, committee members, and
counsel or professionals. A person described in Sec. 356.9(c),
including a paralegal, law clerk, or secretary, may be permitted access
to proprietary information disclosed under protective order by the
counsel, professional, panelist, or extraordinary challenge committee
member who retains or employs such person, if such person has agreed to
the terms of the protective order issued to the counsel, professional,
panelist, or extraordinary challenge committee member, by signing and
dating a completed copy of the application for protective order of the
representative counsel, professional, panelist or extraordinary
challenge committee member in the location indicated in that
application.
(6) Counsel or professional who retains access to proprietary
information under a protective order issued during the administrative
proceeding. A person described in Sec. 356.9(b) who has been granted
access to proprietary information under protective order during an
administrative proceeding that resulted in a final determination that
becomes the subject of panel review may, if permitted by the terms of
the protective order previously issued by the Department, retain such
information until the applicant receives a protective order under this
part.
(c) Issuance and service of protective orders--(1) Persons
described in Sec. 356.9(a) (panelists, etc.). (i) Upon receipt by the
Department of an application from a person described in Sec. 356.9(a),
the Department will issue a protective order authorizing disclosure of
proprietary information included in the administrative record of the
final determination that is the subject of the panel review at issue.
The Department shall transmit the original and four copies of the
protective order to the United States section of the Secretariat which,
in turn, shall transmit the original to the applicant and serve one
copy of the order on each participant, other than the investigating
authority, in accordance with paragraphs (b)(4) (ii) and (iii) of this
section.
(ii) A member of a binational panel or extraordinary challenge
committee proceeding initiated under the United States-Canada Free
Trade Agreement to whom the Department issues a protective order must
countersign the protective order and return one copy of the
countersigned protective order to the United States section of the
Secretariat.
(2) Persons described in Secs. 356.9 (b) or (c) (counsel, etc., or
paralegals, etc.)--(i) Opportunity to object to disclosure. The
Department will not rule on an application filed by a person described
in Sec. 356.9(b) until at least ten days after the request is filed,
unless there is compelling need to rule more expeditiously. Unless the
Department has indicated otherwise, any person may file an objection to
the application within seven days of filing of the application. Any
such objection shall state the specific reasons in the view of such
person why the application should not be granted. One copy of the
objection shall be served on the applicant and on all persons who were
served with the application. Service shall be made in accordance with
paragraphs (b)(4) (ii) and (iii) of this section. Any reply to an
objection will be considered if it is filed before the Department
renders a decision.
(ii) Timing of decisions on applications. Normally, the Department
will render a decision to approve or deny an application within 14
days. If any person files an objection, the Department will normally
render the decision within 30 days.
(iii) Approval of applications. If appropriate, the Department will
issue a protective order permitting the release of proprietary
information to the applicant.
(iv) Denial of applications. If the Department denies an
application, it shall issue a letter notifying the applicant of its
decision and the reasons therefor.
(v) Issuance of protective orders. If the Department issues a
protective order to a person described in Sec. 356.9(b), that person
shall immediately file four copies of the protective order with the
United States section of the Secretariat and shall serve one copy of
the order on each participant, other than the investigating authority,
in accordance with paragraphs (b)(4) (ii) and (iii) of this section.
(3) Persons described in Sec. 356.9 (d) or (g) (Secretaries, etc.,
or court reporters, etc.). Upon receipt by the Department of an
application from a person described in Sec. 356.9 (d) or (g), the
Department will issue a protective order authorizing disclosure of
proprietary information to the applicant. The Department shall transmit
the original and four copies of the protective order to the United
States section of the Secretariat.
(4) Persons described in Sec. 356.9 (e) or (f) (designated
Government officials). (i) Upon receipt by the Department of an
application from a person described in Sec. 356.9 (e) or (f), the
Department will issue a protective order authorizing disclosure of
proprietary information included in the record of the panel review at
issue. The Department shall transmit the original and four copies of
the protective order to the United States section of the Secretariat
which, in turn, shall transmit the original to the applicant and serve
one copy of the document on each participant, other than the
investigating authority, in accordance with paragraphs (b)(4) (ii) and
(iii) of this section.
(d) Modification or revocation of protective orders--(1)
Notification. If any person believes that changed conditions of fact or
law, or the public interest, may require that a protective order issued
pursuant to paragraph (c) of this section be modified or revoked, in
whole or in part, such person may notify the Department in writing. The
notification shall state the changes desired and the changed
circumstances warranting such action and shall include materials and
argument in support thereof. Such notification shall be served by the
person submitting it upon the person to whom the protective order was
issued. Responses to the notification may be filed within 20 days after
the notification is filed unless the Department indicates otherwise.
The Department may also consider such action on its own initiative.
(2) Issuance of modification or revocation. If the Department
modifies or revokes a protective order pursuant to paragraph (d) of
this section, the Department shall transmit the original and four
copies of the modification or Notice of Revocation to the United States
section of the Secretariat which, in turn, shall transmit the original
to the person to whom the protective order was issued and serve one
copy on each participant, other than the investigating authority, in
accordance with paragraphs (b)(4) (ii) and (iii) of this section.
Sec. 356.11 Procedures for obtaining access to privileged information.
(a) Persons who may apply for access to privileged information
under protective order and filing of applications--(1) Panelists. (i)
If a panel decides that in camera examination of a document containing
privileged information in an administrative record is necessary in
order for the panel to determine whether the document, or portions
thereof, should be disclosed under a Protective Order for Privileged
Information, each panelist who is to conduct the in camera review,
pursuant to the rules of procedure adopted by the United States and the
free trade area countries to implement Article 1904 of the Agreement,
shall submit an application for disclosure of the privileged
information under Protective Order for Privileged Information to the
United States section of the Secretariat for filing with the
Department; and
(ii) If a panel orders disclosure of a document containing
privileged information, any panelist who has not filed an application
pursuant to paragraph (a)(1)(i) of this section shall submit an
application for disclosure of the privileged information under a
Protective Order for Privileged Information to the United States
section of the Secretariat for filing with the Department.
(2) Designated officials of the United States Government. Where, in
the course of a panel review, the panel has reviewed privileged
information under a Protective Order for Privileged Information, and
the issue to which such information pertains is relevant to the
evaluation of whether the United States should request an extraordinary
challenge committee, each official of the United States Government
(other than an officer or employee of the investigating authority that
issued the final determination subject to review) whom the United
States Trade Representative informs the Department requires access for
the purpose of such evaluation shall file the completed original and
five copies of an application for a Protective Order for Privileged
Information with the United States section of the Secretariat which, in
turn, shall submit the original and one copy of the application to the
Department.
(3) Designated officials of the government of a FTA country. Where,
in the course of a panel review, the panel has reviewed privileged
information under a Protective Order for Privileged Information, and
the issue to which such information pertains is relevant to the
evaluation of whether the Government of an involved FTA country should
request an extraordinary challenge committee, each official of the
Government of the involved FTA country whom an authorized agency of the
involved FTA country informs the Department requires access for the
purpose of such evaluation shall file the completed original and five
copies of an application for a Protective Order for Privileged
Information with the United States section of the Secretariat which, in
turn, shall submit the original and one copy of the application to the
Department.
(4) Members of an extraordinary challenge committee. Where an
extraordinary challenge record contains privileged information and a
Protective Order for Privileged Information was issued to counsel or
professionals representing participants in the panel review at issue,
each member of the extraordinary challenge committee shall submit an
application for a Protective Order for Privileged Information to the
United States section of the Secretariat for filing with the
Department.
(5) Counsel or a professional under the direction or control of
counsel. If the panel decides, in accordance with the Article 1904
Rules, that disclosure of a document containing privileged information
is appropriate, a counsel or a professional under the direction or
control of counsel identified in such a decision as entitled to release
of information under a Protective Order for Privileged Information
shall submit an application for a Protective Order for Privileged
Information. Any such person shall:
(i) File the completed original and five copies of an application
with the United States section of the Secretariat which, in turn, shall
submit the original and one copy of the application to the Department;
and
(ii) As soon as the deadline fixed under the Article 1904 Panel
Rules for filing a Notice of Appearance in the panel review has passed,
shall serve a copy of the application on each participant, other than
the investigating authority, in accordance with paragraphs (b)(4) (ii)
and (iii) of this section.
(6) Other designated persons. If the panel decides, in accordance
with the Article 1904 Panel Rules, that disclosure of a document
containing privileged information is appropriate, any person identified
in such a decision as entitled to release of information under a
Protective Order for Privileged Information, e.g., a Secretary,
Secretariat staff, court reporters, interpreters and translators, or a
member of the staff of a panelist or extraordinary challenge committee
member, shall submit an application for release under Protective Order
for Privileged Information to the United States section of the
Secretariat for filing with the Department.
(b) Contents of applications for release under protective order for
privileged information. (1) The Department has adopted application
forms for disclosure of privileged information which are available from
the United States section of the Secretariat and the Central Records
Unit, room B-099, U.S. Department of Commerce, 14th and Constitution
Avenue NW., Washington, DC 20230. These forms may be amended from time
to time.
(2) Such forms require the applicant for release of privileged
information under Protective Order for Privileged Information to submit
a personal sworn statement stating, in addition to such other
conditions as the Department may require, that the applicant shall:
(i) Not disclose any privileged information obtained under
protective order to any person other than:
(A) An official of the Department involved in the particular panel
review in which the privileged information is part of the record;
(B) A person who has furnished a similar application and who has
been issued a Protective Order for Privileged Information concerning
the privileged information at issue; and
(C) A person retained or employed by counsel, a professional, a
panelist or extraordinary challenge committee member who has been
issued a Protective Order for Privileged Information, such as a
paralegal, law clerk, or secretary, if such person has agreed to be
bound by the terms set forth in the application for Protective Order
for Privileged Information of the counsel, professional, panelist or
extraordinary challenge committee member by signing and dating the
completed application at the location indicated in such application;
(ii) Use such information solely for purposes of the proceedings
under Article 1904 of the Agreement;
(iii) Upon completion of the panel review, or at such earlier date
as may be determined by the Department, return to the Department or
certify to the Department the destruction of all documents released
under the Protective Order for Privileged Information and all other
documents containing the privileged information (such as briefs, notes,
or charts based on any such information received under the Protective
Order for Privileged Information); and
(iv) Acknowledge that breach thereof may subject the signatory to
sanctions under Secs. 356.12 and 356.30.
(c) Issuance of protective orders for privileged information.--(1)
Panelists, designated government officials and members of an
extraordinary challenge committee. (i) Upon receipt of an application
for protective order under this section from a panelist, designated
government official or member of an extraordinary challenge committee,
the Department shall issue a Protective Order for Privileged
Information. The Department shall transmit the original and four copies
of the protective order to the United States section of the Secretariat
which, in turn, shall transmit the original to the applicant and serve
one copy of the order on each participant, other than the investigating
authority, in accordance with Secs. 356.10(b)(4) (ii) and (iii).
(ii) If the Department issues a Protective Order for Privileged
Information to a member of a binational panel or extraordinary
challenge proceeding initiated under the United States-Canada Free
Trade Agreement, that person must countersign the protective order and
return one copy of the countersigned protective order to the United
States section of the Secretariat.
(2) Counsel or a professional under the direction or control of
counsel. Upon receipt of an application for protective order under this
section from a counsel or a professional under the direction or control
of counsel, the Department shall issue a Protective Order for
Privileged Information. If the Department issues a protective order to
such person, that person shall immediately file four copies of the
protective order with the United States section of the Secretariat and
shall serve one copy of the order on each participant, other than the
investigating authority, in accordance with Secs. 356.10(b)(4) (ii) and
(iii).
(3) Other designated persons described paragraph (a)(6) of this
section. Upon receipt of an application for protective order under this
section from a designated person described in paragraph (a)(6) of this
section, the Department shall issue a Protective Order for Privileged
Information. The Department shall transmit the original and four copies
of the protective order to the United States section of the
Secretariat.
(d) Modification or revocation of protective order for privileged
information.--(1) Notification. If any person believes that changed
conditions of fact or law, or the public interest, may require that a
Protective Order for Privileged Information be modified or revoked, in
whole or in part, such person may notify the Department in writing. The
notification shall state the changes desired and the changed
circumstances warranting such action and shall include materials and
argument in support thereof. Such notification shall be served by the
person submitting it upon the person to whom the Protective Order for
Privileged Information was issued. Responses to the notification may be
filed within 20 days after the notification is filed unless the
Department indicates otherwise. The Department may also consider such
action on its own initiative.
(2) Issuance of modification or revocation. If the Department
modifies or revokes a Protective Order for Privileged Information
pursuant to paragraph (d) of this section, the Department shall
transmit the original and four copies of the modification or Notice of
Revocation to the United States section of the Secretariat which, in
turn, shall transmit the original to the person to whom the protective
order was issued and serve one copy on each participant, other than the
investigating authority, in accordance with Secs. 356.10(b)(4) (ii) and
(iii).
Subpart D--Violation of a Protective Order or a Disclosure
Undertaking
Sec. 356.12 Sanctions for violation of a protective order or
disclosure undertaking.
(a) A person, other than a person exempted from this part by the
provisions of section 777f(f)(4) of the Act (19 U.S.C. 1677f(f)(4)),
determined under this part to have violated a protective order or a
disclosure undertaking may be subjected to any or all or the following
sanctions:
(1) Liable to the United States for a civil penalty not to exceed
$100,000 for each violation;
(2) Barred from appearing before the Department to represent
another for a designated time period from the date of publication in an
official publication of a notice that a violation has been determined
to exist;
(3) Denied access to proprietary information for a designated time
period from the date of publication in an official publication of a
notice that a violation has been determined to exist;
(4) Other appropriate administrative sanctions, including striking
from the record of the panel review any information or argument
submitted by, or on behalf of, the violating party or the party
represented by the violating party; terminating any proceeding then in
progress; or revoking any order then in effect; and
(5) Required to return material previously provided by the
investigating authority, and all other materials containing the
proprietary information, such as briefs, notes, or charts based on any
such information received under a protective order or a disclosure
undertaking.
(b) (1) The firm of which a person determined to have violated a
protective order or a disclosure undertaking is a partner, associate,
or employee; any partner, associate, employer, or employee of such
person; and any person represented by such person may be barred from
appearing before the Department for a designated time period from the
date of publication in an official publication of notice that a
violation has been determined to exist or may be subjected to the
sanctions set forth in paragraph (a) of this section, as appropriate.
(2) Each person against whom sanctions are proposed under paragraph
(b)(1) of this section is entitled to all the administrative rights set
forth in this subpart separately and apart from rights provided to a
person subject to sanctions under paragraph (a) of this section,
including the right to a charging letter, right to representation, and
right to a hearing, but subject to joinder or consolidation by the
administrative law judge under Sec. 356.23(b).
Sec. 356.13 Suspension of rules.
Upon request by the Deputy Under Secretary, a charged or affected
party, or the APO Sanctions Board, the administrative law judge may
modify or waive any rule in this subpart upon determining that no party
will be unduly prejudiced and the ends of justice will thereby be
served and upon notice to all parties.
Sec. 356.14 Report of violation and investigation.
(a) An employee of the Department or any other person who has
information indicating that the terms of a protective order or a
disclosure undertaking have been violated will provide the information
to a Director or the Chief Counsel.
(b) Upon receiving information which indicates that a person may
have violated the terms of a protective order or an undertaking, the
Director will conduct an investigation concerning whether there was a
violation of a protective order or a disclosure undertaking, and who
was responsible for the violation, if any. For purposes of this
subpart, the Director will be supervised by the Deputy Under Secretary
with guidance from the Chief Counsel. The Director will conduct an
investigation only if the information is received within 30 days after
the alleged violation occurred or, as determined by the Director, could
have been discovered through the exercise of reasonable and ordinary
care.
(c) The Director will provide a report of the investigation to the
Deputy Under Secretary, after review by the Chief Counsel, no later
than 180 days after receiving information concerning a violation. Upon
the Director's request, and if extraordinary circumstances exist, the
Deputy Under Secretary may grant the Director up to an additional 180
days to conduct the investigation and submit the report.
(d) The following examples of actions that constitute violations of
an administrative protective order shall serve as guidelines to each
person subject to a protective order. These examples do not represent
an exhaustive list. Evidence that one of the acts described in the
guidelines has been committed, however, shall be considered by the
Director as reasonable cause to believe a person has violated a
protective order within the meaning of Sec. 356.15.
(1) Disclosure of proprietary information to any person not granted
access to that information by protective order, including an official
of the Department or member of the Secretariat staff not directly
involved with the panel review pursuant to which the proprietary
information was released, an employee of any other United States,
foreign government or international agency, or a member of the United
States Congress, the Canadian Parliament, or the Mexican Congress.
(2) Failure to follow the detailed procedures outlined in the
protective order for safeguarding proprietary information, including
maintaining a log showing when each proprietary document is used, and
by whom, and requiring all employees who obtain access to proprietary
information (under the terms of a protective order granted their
employer) to sign and date a copy of that protective order.
(3) Loss of proprietary information.
(4) Failure to return or destroy all copies of the original
documents and all notes, memoranda, and submissions containing
proprietary information at the close of the proceeding for which the
data were obtained by burning or shredding of the documents or by
erasing electronic memory, computer disk, or tape memory, as set forth
in the protective order.
(5) Failure to delete proprietary information from the public
version of a brief or other correspondence filed with the Secretariat.
(6) Disclosure of proprietary information during a public hearing.
(e) Each day of a continuing violation shall constitute a separate
violation.
Sec. 356.15 Initiation of proceedings.
(a) If the Deputy Under Secretary concludes, after an investigation
and report by the Director under Sec. 356.14(c) and consultation with
the Chief Counsel, that there is reasonable cause to believe that a
person has violated a protective order or a disclosure undertaking and
that sanctions are appropriate for the violation, the Deputy Under
Secretary will, at the Deputy Under Secretary's discretion, either
initiate a proceeding under this subpart by issuing a charging letter
as set forth in Sec. 356.16 or request that the authorized agency of
the involved FTA country initiate a proceeding by issuing a request to
charge as set forth in Sec. 356.17. In determining whether sanctions
are appropriate and, if so, what sanctions to impose, the Deputy Under
Secretary will consider the nature of the violation, the resulting
harm, and other relevant circumstances of the case. The Deputy Under
Secretary will decide whether to initiate a proceeding no later than 60
days after receiving a report of the investigation.
(b) If the Department receives a request to charge from an
authorized agency of a FTA country, the Deputy Under Secretary will
promptly initiate proceedings under this part by issuing a charging
letter as set forth in Sec. 356.16.
Sec. 356.16 Charging letter.
(a) Contents of letter. The Deputy Under Secretary will initiate
proceedings by issuing a charging letter to each charged party and
affected party which includes:
(1) A statement of the allegation that a protective order or a
disclosure undertaking has been violated and the basis thereof;
(2) A statement of the proposed sanctions;
(3) A statement that the charged or affected party is entitled to
review the documents or other physical evidence upon which the charge
is based and the method for requesting access to, or copies of, such
documents;
(4) A statement that the charged or affected party is entitled to a
hearing before an administrative law judge if requested within 30 days
of the date of service of the charging letter and the procedure for
requesting a hearing, including the name, address, and telephone number
of the person to contact if there are further questions;
(5) A statement that the charged or affected party has a right, if
a hearing is not requested, to submit documentary evidence to the
Deputy Under Secretary and an explanation of the method for submitting
evidence and the date by which it must be received; and
(6) A statement that the charged or affected party has a right to
retain counsel at the party's own expense for purposes of
representation.
(b) Settlement and amendment of the charging letter. The Deputy
Under Secretary may amend, supplement, or withdraw the charging letter
at any time with the approval of an administrative law judge if the
interests of justice would thereby be served. If a hearing has not been
requested, the Deputy Under Secretary will ask the Under Secretary to
appoint an administrative law judge to make this determination. If a
charging letter is withdrawn after a request for a hearing, the
administrative law judge will determine whether the withdrawal will bar
the Deputy Under Secretary from seeking sanctions at a later date for
the same alleged violation. If there has been no request for a hearing,
or if supporting information has not been submitted under Sec. 356.28,
the withdrawal will not bar future actions on the same alleged
violation. The Deputy Under Secretary and a charged or affected party
may settle a charge brought under this Subpart by mutual agreement at
any time after service of the charging letter; approval of the
administrative law judge or the APO Sanctions Board is not necessary.
(c) Service of charging letter on a resident of the United States.
(1) Service of a charging letter on a United States resident will be
made by:
(i) Mailing a copy by registered or certified mail addressed to the
charged or affected party at the party's last known address;
(ii) Leaving a copy with the charged or affected party or with an
officer, a managing or general agent, or any other agent authorized by
appointment or by law to receive service for the party; or
(iii) Leaving a copy with a person of suitable age and discretion
who resides at the party's last known dwelling.
(2) Service made in the manner described in paragraph (c)(1) (ii)
or (iii) of this section shall be evidenced by a certificate of service
signed by the person making such service, stating the method of service
and the identity of the person with whom the charging letter was left.
(d) Service of charging letter on a non-resident. If applicable
laws or intergovernmental agreements or understandings make the methods
of service set forth in paragraph (c) of this section inappropriate or
ineffective, service of the charging letter on a person who is not a
resident of the United States may be made by any method that is
permitted by the country in which the person resides and that, in the
opinion of the Deputy Under Secretary, satisfies due process
requirements under United States law with respect to notice in
administrative proceedings.
Sec. 356.17 Request to charge.
Upon deciding to initiate a proceeding pursuant to Sec. 356.15, the
Deputy Under Secretary will request the authorized agency of the
involved FTA country to initiate a proceeding for imposing sanctions
for violation of a protective order or a disclosure undertaking by
issuing a letter of request to charge that includes a statement of the
allegation that a protective order or a disclosure undertaking has been
violated and the basis thereof.
Sec. 356.18 Interim sanctions.
(a) If the Deputy Under Secretary concludes, after issuing a
charging letter under Sec. 356.16 and before a final decision is
rendered, that interim sanctions are necessary to protect the interests
of the Department, an authorized agency of the involved FTA country, or
others, including the protection of proprietary information, the Deputy
Under Secretary may petition an administrative law judge to impose such
sanctions.
(b) The administrative law judge may impose interim sanctions
against a person upon determining that:
(1) There is probable cause to believe that there was a violation
of a protective order or a disclosure undertaking and the Department is
likely to prevail in obtaining sanctions under this subpart;
(2) The Department, authorized agency of the involved FTA country,
or others are likely to suffer irreparable harm if the interim
sanctions are not imposed; and
(3) The interim sanctions are a reasonable means for protecting the
rights of the Department, authorized agency of the involved FTA
country, or others while preserving to the greatest extent possible the
rights of the person against whom the interim sanctions are proposed.
(c) Interim sanctions which may be imposed include any sanctions
that are necessary to protect the rights of the Department, authorized
agency of the involved FTA country, or others, including, but not
limited to:
(1) Denying a person further access to proprietary information;
(2) Barring a person from representing another person before the
Department;
(3) Barring a person from appearing before the Department; and
(4) Requiring the person to return material previously provided by
the Department or the investigating authority of the involved FTA
country, and all other materials containing the proprietary
information, such as briefs, notes, or charts based on any such
information received under a protective order or disclosure
undertaking.
(d) The Deputy Under Secretary will notify the person against whom
interim sanctions are sought of the request for interim sanctions and
provide to that person the material submitted to the administrative law
judge to support the request. The notice will include a reference to
the procedures of this section.
(e) A person against whom interim sanctions are proposed has a
right to oppose the request through submission of material to the
administrative law judge. The administrative law judge has discretion
to permit oral presentations and to allow further submissions.
(f) The administrative law judge will notify the parties of the
decision on interim sanctions and the basis therefor within five days
of the conclusion of oral presentations or the date of final written
submissions.
(g) If interim sanctions have been imposed, the investigation and
any proceedings under this Subpart will be conducted on an expedited
basis.
(h) An order imposing interim sanctions may be revoked at any time
by the administrative law judge and expires automatically upon the
issuance of a final order.
(i) The administrative law judge may reconsider imposition of
interim sanctions on the basis of new and material evidence or other
good cause shown. The Deputy Under Secretary or a person against whom
interim sanctions have been imposed may appeal a decision on interim
sanctions to the APO Sanctions Board, if such an appeal is certified by
the administrative law judge as necessary to prevent undue harm to the
Department or authorized agency of the involved FTA country, a person
against whom interim sanctions have been imposed or others, or is
otherwise in the interests of justice. Interim sanctions which have
been imposed remain in effect while an appeal is pending, unless the
administrative law judge determines otherwise.
(j) The Deputy Under Secretary may request an administrative law
judge to impose emergency interim sanctions to preserve the status quo.
Emergency interim sanctions may last no longer than 48 hours, excluding
weekends and holidays. The person against whom such emergency interim
sanctions are proposed need not be given prior notice or an opportunity
to oppose the request for sanctions. The administrative law judge may
impose emergency interim sanctions upon determining that the Department
or authorized agency of the involved FTA country is, or others are,
likely to suffer irreparable harm if such sanctions are not imposed and
that the interests of justice would thereby be served. The
administrative law judge will promptly notify a person against whom
emergency sanctions have been imposed of the sanctions and their
duration.
(k) If a hearing has not been requested, the Deputy Under Secretary
will request that the Under Secretary appoint an administrative law
judge for making determinations under this section.
(l) The Deputy Under Secretary will notify the Secretariat
concerning the imposition or revocation of interim sanctions or
emergency interim sanctions.
Sec. 356.19 Request for a hearing.
(a) Any party may request a hearing by submitting a written request
to the Under Secretary within 30 days after the date of service of the
charging letter. However, the Deputy Under Secretary may request a
hearing only if the interests of justice would thereby be served.
(b) Upon timely receipt of a request for a hearing, the Under
Secretary will appoint an administrative law judge to conduct the
hearing and render an initial decision.
Sec. 356.20 Discovery.
(a) Voluntary discovery. All parties are encouraged to engage in
voluntary discovery procedures regarding any matter, not privileged,
which is relevant to the subject matter of the pending sanctions
proceeding.
(b) Limitations on discovery. The administrative law judge shall
place such limits upon the kind or amount of discovery to be had or the
period of time during which discovery may be carried out as shall be
consistent with the time limitations set forth in this Part.
(c) Interrogatories and requests for admissions or production of
documents. A party may serve on any other party interrogatories,
requests for admissions, or requests for production of documents for
inspection and copying, and the party may then apply to the
administrative law judge for such enforcement or protective order as
that party deems warranted concerning such discovery. The party will
serve a discovery request at least 20 days before the scheduled date of
a hearing, if a hearing has been requested and scheduled, unless the
administrative law judge specifies a shorter time period. Copies of
interrogatories, requests for admissions, and requests for production
of documents and responses thereto will be served on all parties.
Matters of fact or law of which admission is requested will be deemed
admitted unless, within a period designated in the request (at least 10
days after the date of service of the request, or within such further
time as the administrative law judge may allow), the party to whom the
request is directed serves upon the requesting party a sworn statement
either adm
FR Doc. 93-32063 Panel Review Under Article 1904 of the North American Free Trade Agreement
itting or denying specifically the matters of which admission
is requested or setting forth in detail the reasons why the party
cannot truthfully either admit or deny such matters.
(d) Depositions. Upon application of a party and for good cause
shown, the administrative law judge may order the taking of the
testimony of any person who is a party, or under the control or
authority of a party, by deposition and the production of specified
documents or materials by the person at the deposition. The application
shall state the purpose of the deposition and shall set forth the facts
sought to be established through the deposition.
(e) Supplementation of responses. A party who has responded to a
request for discovery with a response that was complete when made is
under no duty to supplement the party's response to include information
thereafter acquired, except as follows:
(1) A party is under a duty to seasonably supplement the party's
response with respect to any question directly addressed to:
(i) The identity and location of persons having knowledge of
discoverable matters; and
(ii) The identity of each person expected to be called as an expert
witness at a hearing, the subject matter on which the witness is
expected to testify, and the substance of the testimony.
(2) A party is under a duty to seasonably amend a prior response if
the party obtains information upon the basis of which the party:
(i) Knows the response was incorrect when made; or
(ii) Knows that the response, though correct when made, is no
longer true, and the circumstances are such that a failure to amend the
response is in substance a knowing concealment.
(3) A duty to supplement responses may be imposed by order of the
administrative law judge, agreement of the parties, or at any time
prior to a hearing through new requests for supplementation of prior
responses.
(f) Enforcement. The administrative law judge may order a party to
answer designated questions, to produce specified documents or items,
or to take any other action in response to a proper discovery request.
If a party does not comply with such an order, the administrative law
judge may make any determination or enter any order in the proceedings
as the administrative law judge deems reasonable and appropriate. The
administrative law judge may strike related charges or defenses in
whole or in part, or may take particular facts relating to the
discovery request to which the party failed or refused to respond as
being established for purpose of the proceeding in accordance with the
contentions of the party seeking discovery. In issuing a discovery
order, the administrative law judge will consider the necessity to
protect proprietary information and will not order the release of
information in circumstances where it is reasonable to conclude that
such release will lead to unauthorized dissemination of such
information.
Sec. 356.21 Subpoenas.
(a) Application for issuance of a subpoena. An application for
issuance of a subpoena requiring a person to appear and depose or
testify at the taking of a deposition or at a hearing shall be made to
the administrative law judge. An application for issuance of a subpoena
requiring a person to appear and depose or testify and to produce
specified documents, papers, books, or other physical exhibits at the
taking of a deposition, at a prehearing conference, at a hearing, or
under any other circumstances, shall be made in writing to the
administrative law judge and shall specify the material to be produced
as precisely as possible, showing the general relevancy of the material
and the reasonableness of the scope of the subpoena.
(b) Use of subpoena for discovery. Subpoenas may be used by any
party for purposes of discovery or for obtaining documents, papers,
books, or other physical exhibits for use in evidence, or for both
purposes. When used for discovery purposes, a subpoena may require a
person to produce and permit the inspection and copying of
nonprivileged documents, papers, books, or other physical exhibits
which constitute or contain evidence relevant to the subject matter
involved and which are in the possession, custody, or control of such
person.
(c) Application for subpoenas for nonparty department records or
personnel or for records or personnel of other Government agencies. (1)
An application for issuance of a subpoena requiring the production of
nonparty documents, papers, books, physical exhibits, or other material
in the records of the Department, or requiring the appearance of an
official or employee of the Department, or requiring the production of
records or personnel of other Government agencies shall specify as
precisely as possible the material to be produced, the nature of the
information to be disclosed, or the expected testimony of the official
or employee, and shall contain a statement showing the general
relevancy of the material, information, or testimony and the
reasonableness of the scope of the application, together with a showing
that such material, information, or testimony or their substantial
equivalent could not be obtained without undue hardship by alternative
means.
(2) Such applications shall be ruled upon by the administrative law
judge. To the extent that the motion is granted, the administrative law
judge shall provide such terms and conditions for the production of the
material, the disclosure of the information, or the appearance of the
official or employee as may appear necessary and appropriate for the
protection of the public interest.
(3) No application for a subpoena for production of documents
grounded upon the Freedom of Information Act (5 U.S.C. 552) shall be
entertained by the administrative law judge.
(d) Motion to limit or quash. Any motion to limit or quash a
subpoena shall be filed within 10 days after service thereof, or within
such other time as the administrative law judge may allow.
(e) Ex parte rulings on applications for subpoenas. Applications
for the issuance of subpoenas pursuant to this section may be made ex
parte, and, if so made, such applications and rulings thereon shall
remain ex parte unless otherwise ordered by the administrative law
judge.
(f) Role of the Under Secretary. If a hearing has not been
requested, the party seeking enforcement will ask the Under Secretary
to appoint an administrative law judge to rule on applications for
issuance of a subpoena under this section.
Sec. 356.22 Prehearing conference.
(a)(1) If an administrative hearing has been requested, the
administrative law judge will direct the parties to attend a prehearing
conference to consider:
(i) Simplification of issues;
(ii) Obtaining stipulations of fact and of documents to avoid
unnecessary proof;
(iii) Settlement of the matter;
(iv) Discovery; and
(v) Such other matters as may expedite the disposition of the
proceedings.
(2) Any relevant and significant stipulations or admissions will be
incorporated into the initial decision.
(b) If a prehearing conference is impractical, the administrative
law judge will direct the parties to correspond with each other or to
confer by telephone or otherwise to achieve the purposes of such a
conference.
Sec. 356.23 Hearing.
(a) Scheduling of hearing. The administrative law judge will
schedule the hearing at a reasonable time, date, and place, which will
be in Washington, DC, unless the administrative law judge determines
otherwise based upon good cause shown, that another location would
better serve the interests of justice. In setting the date, the
administrative law judge will give due regard to the need for the
parties adequately to prepare for the hearing and the importance of
expeditiously resolving the matter.
(b) Joinder or consolidation. The administrative law judge may
order joinder or consolidation if sanctions are proposed against more
than one party or if violations of more than one protective order or
disclosure undertaking are alleged if to do so would expedite
processing of the cases and not adversely affect the interests of the
parties.
(c) Hearing procedures. Hearings will be conducted in a fair and
impartial manner by the administrative law judge, who may limit
attendance at any hearing or portion thereof if necessary or advisable
in order to protect proprietary information from improper disclosure.
The rules of evidence prevailing in courts of law shall not apply, and
all evidentiary material the administrative law judge determines to be
relevant and material to the proceeding and not unduly repetitious may
be received into evidence and given appropriate weight. The
administrative law judge may make such orders and determinations
regarding the admissibility of evidence, conduct of examination and
cross-examination, and similar matters as are necessary or appropriate
to ensure orderliness in the proceedings. The administrative law judge
will ensure that a record of the hearing will be taken by reporter or
by electronic recording, and will order such part of the record to be
sealed as is necessary to protect proprietary information.
(d) Rights of parties. At a hearing each party shall have the right
to:
(1) Introduce and examine witnesses and submit physical evidence;
(2) Confront and cross-examine adverse witnesses;
(3) Present oral argument; and
(4) Receive a transcript or recording of the proceedings, upon
request, subject to the administrative law judge's orders regarding
sealing the record.
(e) Representation. Each charged or affected party has a right to
represent himself or herself or to retain private counsel for that
purpose. The Chief Counsel will represent the Department, unless the
General Counsel of the Department determines otherwise. The
administrative law judge may disallow a representative if such
representation constitutes a conflict of interest or is otherwise not
in the interests of justice and may debar a representative for
contumacious conduct relating to the proceedings.
(f) Ex parte communications. The parties and their representatives
may not make any ex parte communications to the administrative law
judge concerning the merits of the allegations or any matters at issue,
except as provided in Sec. 356.18(j) regarding emergency interim
sanctions.
Sec. 356.24 Proceeding without a hearing.
If no party has requested a hearing, the Deputy Under Secretary,
within 40 days after the date of service of a charging letter, will
submit for inclusion into the record and provide each charged or
affected party information supporting the allegations in the charging
letter. Each charged or affected party has the right to file a written
response to the information and supporting documentation within 30 days
after the date of service of the information provided by the Deputy
Under Secretary unless the Deputy Under Secretary alters the time
period for good cause. The Deputy Under Secretary may allow the parties
to submit further information and argument.
Sec. 356.25 Witnesses.
Witnesses summoned before the Department shall be paid the same
fees and mileage that are paid witnesses in the courts of the United
States.
Sec. 356.26 Initial decision.
(a) Initial decision. The administrative law judge, if a hearing
was requested, or the Deputy Under Secretary will submit an initial
decision to the APO Sanctions Board, providing copies to the parties.
The administrative law judge or the Deputy Under Secretary will
ordinarily issue the decision within 20 days of the conclusion of the
hearing, if one was held, or within 15 days of the date of service of
final written submissions. The initial decision will be based solely on
evidence received into the record and the pleadings of the parties.
(b) Findings and conclusions. The initial decision will state
findings and conclusions as to whether a person has violated a
protective order or a disclosure undertaking; the basis for those
findings and conclusions; and whether the sanctions proposed in the
charging letter, or lesser included sanctions, should be imposed
against the charged or affected party. The administrative law judge or
the Deputy Under Secretary may impose sanctions only upon determining
that the preponderance of the evidence supports a finding of violation
of a protective order or a disclosure undertaking and that the
sanctions are warranted against the charged or affected party.
(c) Finality of decision. If the APO Sanctions Board has not issued
a decision on the matter within 60 days after issuance of the initial
decision, the initial decision becomes the final decision of the
Department.
Sec. 356.27 Final decision.
(a) APO Sanctions Board. Upon request of a party, the initial
decision will be reviewed by the members of the APO Sanctions Board.
The Board consists of the Under Secretary for International Trade, who
shall serve as Chairperson, the Under Secretary for Economic Affairs,
and the General Counsel.
(b) Comments on initial decision. Within 30 days after issuance of
the initial decision, a party may submit written comments to the APO
Sanctions Board on the initial decision, which the Board will consider
when reviewing the initial decision. The parties have no right to an
oral presentation, although the Board may allow oral argument in its
discretion.
(c) Final decision by the APO Sanctions Board. Within 60 days but
not sooner than 30 days after issuance of an initial decision, the APO
Sanctions Board may issue a final decision which adopts the initial
decision in its entirety; differs in whole or in part from the initial
decision, including the imposition of lesser included sanctions; or
remands the matter to the administrative law judge or the Deputy Under
Secretary for further consideration. The only sanctions that the Board
can impose are those sanctions proposed in the charging letter or
lesser included sanctions.
(d) Content's of final decision. If the final decision of the APO
Sanctions Board does not remand the matter and differs from the initial
decision, it will state findings and conclusions which differ from the
initial decision, if any, the basis for those findings and conclusions,
and the sanctions which are to be imposed, to the extent they differ
from the sanctions in the initial decision.
(e) Public notice of sanctions. If the final decision is that there
has been a violation of a protective order or a disclosure undertaking
and that sanctions are to be imposed, notice of the decision will be
published in the Federal Register and forwarded to the United States
section of the Secretariat. Such publication will be no sooner than 30
days after issuance of a final decision or after a motion to reconsider
has been denied, if such a motion was filed. If the final decision is
made in a proceeding based upon a request to charge by an authorized
agency of an FTA country, the decision will be forwarded to the
Secretariat of the involved FTA country for transmittal to the
authorized agency of the FTA country for publication in the official
publication or other appropriate action. The Deputy Under Secretary
will also provide such information to the ethics panel or other
disciplinary body of the appropriate bar associations or other
professional associations whenever the Deputy Under Secretary subjects
a charged or affected party to a sanction under Sec. 356.12(a)(2) and
to any Federal agency likely to have an interest in the matter and will
cooperate in any disciplinary actions by any association or agency.
Sec. 356.28 Reconsideration.
Any party may file a motion for reconsideration with the APO
Sanctions Board. The party must state with particularity the grounds
for the motion, including any facts or points of law which the party
claims the APO Sanctions Board has overlooked or misapplied. The party
may file the motion within 30 days of the issuance of the final
decision or the adoption of the initial decision as the final decision,
except that if the motion is based on the discovery of new and material
evidence which was not known, and could not reasonably have been
discovered through due diligence prior to the close of the record, the
party shall file the motion within 15 days of the discovery of the new
and material evidence. The party shall provide a copy of the motion to
all other parties. Opposing parties may file a response within 30 days
of the date of service of the motion. The response shall be considered
as part of the record. The parties have no right to an oral
presentation on a motion for reconsideration, but the Board may permit
oral argument at its discretion. If the motion to reconsider is
granted, the Board will review the record and affirm, modify, or
reverse the original decision or remand the matter for further
consideration to an administrative law judge or the Deputy Under
Secretary, as warranted.
Sec. 356.29 Confidentiality.
(a) All proceedings involving allegations of a violation of a
protective order or a disclosure undertaking shall be kept confidential
until such time as the Department makes a final decision under these
regulations, which is no longer subject to reconsideration, imposing a
sanction.
(b) The charged party or counsel for the charged party will be, to
the extent possible, granted access to proprietary information in these
proceedings, as necessary, under administrative protective order,
consistent with the provisions of Sec. 356.10.
Sec. 356.30 Sanctions for violations of a protective order for
privileged information.
The provisions of this subpart shall apply to persons who are
alleged to have violated a Protective Order for Privileged Information.
Dated: December 28, 1993.
Jeffrey E. Garten,
Under Secretary for International Trade.
[FR Doc. 93-32063 Filed 12-30-93; 8:45 am]
BILLING CODE 3510-DS-P
Complete official Federal Register PDF
FR Doc. 93-32044 Revisions to Oil Pipeline Regulations Pursuant to the Energy Policy Act of 1992
[Federal Register Volume 59, Number 1 (Monday, January 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-32044]
[[Page Unknown]]
[Federal Register: January 3, 1994]
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DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
18 CFR Parts 341, 342, 343, 344, 345, 347, 360, 361, and 375
[Docket No. RM93-11-001]
Revisions to Oil Pipeline Regulations Pursuant to the Energy
Policy Act of 1992
Issued December 22, 1993
AGENCY: Federal Energy Regulatory Commission, DOE.
ACTION: Final rule; briefs on limited issue.
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SUMMARY: On October 22, 1993, the Commission issued a final rule in
this proceeding, revising its regulations of oil pipelines to provide a
simplified and generally applicable method for regulating oil pipeline
rates by use of an index for setting rate ceilings for such rates. On
December 9, 1993, Sinclair Oil Corporation and the National Council of
Farmer Cooperatives filed a brief addressing the issue of the selection
of an index for use in the indexing system adopted in the final rule.
The Commission has determined that additional information on the choice
of an index will add to the record of this rulemaking; therefore, the
Commission is affording an opportunity for others to file briefs on
this issue.
DATES: Briefs are due on or before January 21, 1994.
ADDRESSES: All filings should refer to Docket No. RM93-11-001 and
should be addressed to: Office of the Secretary, Federal Energy
Regulatory Commission, 825 North Capitol Street, NE., Washington, DC
20426.
FOR FURTHER INFORMATION CONTACT:
Harris S. Wood, Office of the General Counsel, Federal Energy
Regulatory Commission, 825 North Capitol Street, NE., Washington, DC
20426, (202) 208-0696.
Order Granting Rehearing for the Purpose of Further Consideration
and Allowing Briefs on Limited Issue
On October 22, 1993, the Commission issued Order No. 561, its Final
Rule in this proceeding.\1\ Rehearing of Order No. 561 has been
requested by numerous parties.
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\1\65 FERC 61,109 (1993); 58 FR 58753 (November 4, 1993).
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In order to afford additional time for consideration of the issues
raised in the requests for rehearing, it is necessary to grant
rehearing for the limited purpose of further consideration.
On December 9, 1993, Sinclair Oil Corporation and the National
Council of Farmer Cooperatives filed a motion to file a ``Brief in
Response to Certain Issues Raised in Requests for Rehearing of Order
No. 561.'' The brief addresses the issue of the selection of an index
for use in the indexing system adopted in the Final Rule. On December
16, 1993, Phillips Pipe Line Company filed an answer in opposition to
the motion.
Under Rule 713(d)(2) of the Commission's Rules of Practice and
Procedure,2 the Commission may allow parties to file briefs on one
or more issues presented by a request for rehearing. Thus, although
answers to rehearing requests are not permitted by the rules, the
consideration of briefs is an accepted procedure. The Commission has
determined that additional information on the choice of an index will
add to the record of this rulemaking. Therefore, the brief filed by
Sinclair and the Farmer Cooperatives will be accepted for filing, and
the Commission will afford an opportunity for others to file briefs on
this issue.
---------------------------------------------------------------------------
\2\18 CFR 385.713(d)(2).
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The Commission orders:
(A) Rehearing of the Commission's order issued on October 22, 1993,
is hereby granted for the purpose of further consideration.
(B) Interested parties may file briefs no later than January 21,
1994, addressing the issue of what index should be used in the indexing
system adopted in the Final Rule.
By the Commission.
Lois D. Cashell,
Secretary.
[FR Doc. 93-32044 Filed 12-30-93; 8:45 am]
BILLING CODE 6717-01-P
Complete official Federal Register PDF
FR Doc. 93-32034 CERCLA Administrative Hearing Procedures for Claims Asserted Against the Superfund
[Federal Register Volume 59, Number 1 (Monday, January 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-32034]
[[Page Unknown]]
[Federal Register: January 3, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 305
[FRL-4818-1]
RIN 2050-AC26
CERCLA Administrative Hearing Procedures for Claims Asserted
Against the Superfund
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
promulgating a final rule to implement section 112 of the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980
(CERCLA). CERCLA section 112 outlines procedures for payments of claims
authorized pursuant to CERCLA section 111. Furthermore, EPA uses the
procedures authorized by CERCLA section 112 to reimburse parties for
response costs incurred pursuant to CERCLA section 122. EPA reimburses
the parties through payment of claims asserted against the Hazardous
Substance Superfund (the Fund). The claims authority allows EPA to
reimburse a person for the costs incurred for responding to an actual
or threatened release of hazardous substances, pollutants, or
contaminants if that person has received prior approval
(preauthorization) from EPA to conduct a response action. If EPA denies
all or part of a claim against the Fund for the costs incurred in
conducting a preauthorized response action, the adversely affected
claimant may request an administrative hearing to review that decision.
This final rule establishes procedures to request such a hearing and
governs the course of the proceeding following the request.
EFFECTIVE DATE: This final rule is effective February 2, 1994.
ADDRESSES: The official record for this rulemaking is in the Superfund
Docket, located at the United States Environmental Protection Agency,
401 M Street, SW., Room M 2615, Washington, DC 20460. The record is
available for inspection by appointment only (Telephone--202-260-3046)
between the hours of 9 a.m. and 4 p.m., Monday through Friday,
excluding legal holidays. As provided in 40 CFR part 2, a reasonable
fee may be charged for copying services.
FOR FURTHER INFORMATION CONTACT: Hugo Paul Fleischman, U.S.
Environmental Protection Agency, Office of Emergency and Remedial
Response, Hazardous Site Control Division, (Mail Code--5203G), 401 M
Street, SW., Washington, DC 20460; Telephone--703-603-8769. An
alternative contact is the Superfund Hotline; 1-800-424-9346 (TDD 800-
553-7672), or in the Washington, DC area, (703) 920-9810 (TDD 703-486-
3323).
SUPPLEMENTARY INFORMATION: The contents of today's preamble are listed
in the following outline:
I. Background
II. Response to Comments
III. Summary of Supporting Analyses
I. Background
EPA is today promulgating the final CERCLA administrative hearing
procedures for claims asserted against the Superfund. Today's rule is
based on an interim final rule with request for comments promulgated on
February 8, 1993, at 58 FR 7704. The rationale for the rule and a
discussion of its background and procedures may be found there. One
commenter made two specific comments on the interim final rule.
II. Response to Comments
EPA received one comment in two specific areas. The first portion
of the comment noted that ``most procedures litigation rules, including
the Federal Rules of Civil Procedure (FRCP), provide that Saturdays,
Sundays, and legal holidays shall not be counted in calculating short
time limits (e.g., ten days or less).'' The commenter went on to note
that the rule was at odds with such procedures. EPA notes that while
the rule is not identical to the FRCP, there is a good reason for such
departure. The procedures in this rule are designed to allow expedited
hearings in accord with the time frames provided in CERCLA section 112.
Nevertheless, litigants may seek an extension of the time for the
Presiding Officer to render a final order in the case, or may extend
that time frame by agreement of all parties. See 40 CFR 305.4(c).
Furthermore, litigants may seek extensions of time for the filing of
pleadings, documents, or motions. See 40 CFR 305.6(b). Therefore,
because of the need for expedition, and the availability of extensions
provided elsewhere in the rule, EPA believes that no change to the rule
is necessary.
The second portion of the comment noted that the ``service'' rules
``do not provide for service of documents on Federal agencies . . .
from which we infer that the rules are not intended to apply to such.''
That inference is incorrect. Because the rule applied to Federal
agencies that are potentially responsible parties, EPA has corrected
the final rule by adding procedures to serve Federal agencies at
Sec. 305.5(b)(1)(v). The amended rule provides that ``(S)ervice upon an
officer or agency of the United States shall be made by delivering a
copy of the document to the officer or agency, or in any manner
prescribed for service by applicable regulations. If the agency is a
corporation, the document shall be served as prescribed in paragraph
(iii) of this section.'' Like the rest of the rule, the new service
provision is modeled on 40 CFR part 22.
The commenter also raised a ``related question'' regarding the
manner and means by which Federal agencies are to be compensated for
the costs they incur pursuant to the NCP and related plans. Such
comment does not relate to the interim final rule and has been directed
to the appropriate EPA official for response.
III. Summary of Supporting Analyses
Proposed and final rules issued by Federal Agencies are subject to
several statutes and executive orders. These include Executive Order
12291 (superseded by Executive Order 12866 on September 1, 1993), the
Regulatory Flexibility Act, and the Paperwork Reduction Act.
A. Executive Order Review
This rulemaking was submitted and reviewed by the Office of
Management and Budget under Executive Order 12291. The rulemaking was
non-major under the requirements of that Executive Order. Therefore, no
Regulatory Impact Analysis was prepared.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980 requires that a Regulatory
Flexibility Analysis be performed for all rules that are likely to have
a ``significant economic impact on a substantial number of small
entities.'' EPA certifies that this rule will not have a significant
economic impact on a substantial number of small entities because all
authorized costs and expenses are payable from the Fund. Further, this
final rule imposes no capital expenditures, nor any compliance
requirements on any business.
C. Paperwork Reduction Act
The final rule contains no information collection requirements
which require approval by the Office of Management and Budget pursuant
to 44 U.S.C. 3501 et seq.
List of Subjects in 40 CFR Part 305
Environmental protection, Administrative practice and procedures,
Chemicals, Hazardous materials, Reporting and recordkeeping
requirements, Superfund, Waste treatment and disposal.
Dated: December 16, 1993.
Carol M. Browner,
Administrator.
40 CFR part 305 is amended as follows:
PART 305--COMPREHENSIVE ENVIRONMENTAL RESPONSE, COMPENSATION, AND
LIABILITY ACT (CERCLA) ADMINISTRATIVE HEARING PROCEDURES FOR CLAIMS
AGAINST THE SUPERFUND
1. The authority citation for part 305 continues to read as
follows:
Authority: 42 U.S.C. 9601 et seq.; E.O. 12580, 52 FR 2923, 3
CFR, 1987 Comp. p. 193.
2. Section 305.5 is amended by adding paragraph (b)(2)(v) to read
as follows:
Sec. 305.5 Filing, service, and form of pleadings and documents.
* * * * *
(b) * * *
(2) * * *
(v) Service upon an officer of agency of the United States shall be
made by delivering a copy of the document to the officer or agency, or
in any manner prescribed for service by applicable regulations. If the
agency is a corporation, the document shall be served as prescribed in
paragraph (b)(2)(iii) of this section.
* * * * *
[FR Doc. 93-32034 Filed 12-30-93; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 93-32010 Northeast Multispecies Fishery
[Federal Register Volume 59, Number 1 (Monday, January 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-32010]
[[Page Unknown]]
[Federal Register: January 3, 1994]
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 651
[Docket No. 931243-3343; I.D. No. 112293A]
Northeast Multispecies Fishery
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic
Atmospheric Administration (NOAA), Commerce.
ACTION: Emergency interim rule.
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SUMMARY: The Secretary of Commerce (Secretary) amends the regulations
implementing the Fishery Management Plan for the Northeast Multispecies
Fishery (FMP). This emergency interim rule implements: A 500-pound
(226.8 kg) possession limit of haddock for all vessels permitted under
50 CFR 651.4 and to all vessels in possession of haddock from or in the
exclusive economic zone (EEZ), except scallop dredge vessels, which are
prohibited from possessing or landing haddock; a January through May
closure of the area known as Closed Area II, except for lobster pot
vessels and scallop dredge vessels; an expansion of Closed Area II by
20 minutes longitude to the west and 15 minutes latitude to the south,
along its existing western and southern boundaries, intersecting with
the Regulated Mesh Boundary line; a suspension of the February through
May closure of the area known as Closed Area I, except for vessels
using sink gillnet gear; a prohibition on transfer of fish at sea; and
a ban on pair trawling in the multispecies fishery. The intended effect
of this rule is to provide protection to depleted haddock and cod
stocks.
EFFECTIVE DATES: January 3, 1994, through April 2, 1994.
ADDRESSES: Copies of the Environmental Assessment (EA) supporting this
action may be obtained from Richard B. Roe, Regional Director, National
Marine Fisheries Service, One Blackburn Drive, Gloucester, MA 01930.
FOR FURTHER INFORMATION CONTACT: Patricia A. Kurkul (Senior Fishery
Policy Analyst, Northeast Region, NMFS), 508-281-9252.
SUPPLEMENTARY INFORMATION: The primary Northeast multispecies
(groundfish) species have declined to record or near record low levels
of stock abundance due largely to record high fishing mortality caused
by increased fishing effort. To correct this, the New England Fishery
Management Council (Council) developed Amendment 5 to the FMP, which
has been submitted to the Secretary for review under the Magnuson
Fishery Conservation and Management Act (Magnuson Act) and other
applicable law. Amendment 5 contains proposals that the Council
believes will eliminate the overfished condition of cod and yellowtail
flounder over a 5-year period and haddock over a 10-year period. The
measures proposed include: Reductions in fishing time; a moratorium on
new permits; an increased minimum net mesh size; modifications to
existing closed areas; additional closed areas and control areas for
juvenile fish; possession limits on regulated species when possessing
small mesh on board; and a possession limit on haddock. A proposed rule
to implement these measures was published on October 27, 1993 (58 FR
57774). However, a proposed possession limit of 5,000 pounds (2,268 kg)
for haddock contained in Amendment 5 was disapproved on September 30,
1993. The Director, Northeast Region, NMFS (Regional Director) advised
the Council on September 30, 1993, that the proposed haddock possession
limit offered inadequate protection for that species, and the Council
should seriously consider whether any haddock should be landed.
The Council previously recommended that an emergency action
implemented last June, which prohibited the use of pair trawls and
imposed a 2,500-pound (1,134-kg) haddock trip limit, be extended for an
additional 90 days. This request was denied and the emergency action
expired on September 7, 1993. The disapproval was based on the fact
that haddock are not concentrated during the period of time covered by
the extension and, therefore, the recommended management measures were
not warranted under emergency rulemaking. The Regional Director
requested the Council to consider more restrictive measures, including
a meaningful trip limit for haddock. This was reiterated when the
Council was informed that the 5,000-pound (2,268-kg) haddock trip limit
proposed in Amendment 5 had been disapproved.
Of particular concern are the haddock stocks on both Georges Bank
and in the Gulf of Maine, which are at all-time low levels of
abundance. Adult stock biomass is lower now than at any point since the
inception of stock assessments. Haddock landings in 1993, which reflect
stock condition, are expected to be the lowest in recorded history. The
stock condition and landings will continue to decline until such time
that meaningful measures are implemented that will eliminate the
overfished condition of the stocks and reduce the exploitation rate to
levels that will allow significant rebuilding to take place.
The Council discussed this issue at its October 1993 meeting in
conjunction with its discussion of an amendment to replace the
disapproved portions of Amendment 5. The Council voted to develop an
amendment to implement a 4,000-pound (1,814-kg) haddock trip limit and
to increase the annual Closed Area II closed season from February
through May, to January through June. The Council also voted to rescind
the geographical expansion of Closed Area II proposed in Amendment 5,
in part, as a compromise to the industry for imposing a longer time
period for the closure. This represented a departure from Amendment 5,
which calls for immediate expansion of the size of Closed Area II and,
in year 3 and thereafter, an expansion in the duration of the closed
season.
After adopting amended language for the disapproved measure in
Amendment 5, the Council voted to request emergency Secretarial action
to implement the same measures beginning January 1, 1994. In addition,
the Council requested emergency implementation, beginning January 1,
1994, of a suspension of the closure of Closed Area I to vessels using
other than sink gillnet gear and a prohibition on pair trawling, both
of which are proposed in Amendment 5. NMFS determined, however, that
some of the emergency measures recommended by the Council were
inadequate to provide sufficient protection of these stocks, and that
more restrictive measures must be implemented to provide essential
protection particularly in light of new analysis of the condition of
the haddock stocks.
The Regional Director presented the new analysis of the condition
of the stocks to the Council at its November 23 Multispecies Oversight
Committee meeting and at its December 8-9 Council meeting and, in
response, the Council amended its recommendation on emergency action.
The Council proposed: An immediate closure of the expanded Closed Area
II (beginning January 1, 1994); a prohibition on pair trawling; a
haddock possession limit between 500 (226.8 kg) and 1,000 pounds (453.6
kg), at the discretion of the Regional Director, and a request that the
Regional Director consider whether scallop dredges should be prohibited
from the haddock spawning area during the closure of Area II.
The Secretary concurs with the Council's recommendation and the
Regional Director's determination that the haddock possession limit
should be 500 pounds (226.8 kg). In making these determinations, the
Secretary took into consideration that the haddock stocks are severely
depleted. The 1992 spawning stock level for the Georges Bank stock is
estimated to be 13,000 metric tons (mt), which is significantly lower
than the 130,000 mt required to provide a maximum sustainable yield of
50,000 mt. The most recent assessment of the Georges Bank haddock stock
conducted by the NMFS Stock Assessment Workshop determined that the
fishing mortality rate in 1991 was 0.52. More recent information from a
Canadian assessment indicates that the 1992 fishing mortality rate was
0.6 and is likely to be higher in 1993.
In determining an overfishing definition for the Georges Bank
haddock stock, the Council chose a percent maximum spawning potential
(%MSP) of 30 percent, which is equivalent to a fishing mortality rate
of 0.4. If this rate were achieved, it would maintain the stock at its
present level over the long term. Given the low stock level, though,
this would not be enough to allow rebuilding to take place. Rebuilding
can only be achieved if the fishing mortality rate is reduced well
below this level. Based upon past history, it is estimated that an
exploitation rate of about 0.1 (10 percent annual removal of the stock
each year) would allow rebuilding to occur. This occurred for several
years prior to a large incoming year class of haddock in 1975, which
allowed the spawning stock to rebuild.
The current exploitation rate of haddock is approximately 0.37. A
500-pound (226.8 kg) haddock possession limit is expected to reduce the
exploitation rate to about 0.1. Achieving this rate will be possible
only if the trip limit is low enough to discourage targeting of haddock
and highgrading, and it does not compromise enforcement efforts. The
500-pound (226.8 kg) possession limit is considered to be the average
number of pounds of haddock per trip that would still be caught
incidental to fishing for other species. Although any possession limit
can provide incentive to target a species, 500 pounds (226.8 kg) is
believed to be low enough to discourage targeting if vessel operators
comply with the limit. A trip limit could also encourage
``highgrading,'' (i.e., filling the trip limit with the highest value
fish and discarding the rest). The prevalence of this problem will
depend to some extent on the willingness of vessel operators to move
out of an area with concentrations of haddock. Both of these potential
situations will be closely monitored and appropriate action taken by
the Regional Director in the event they are determined to be problems.
Finally, a trip limit is expected to make enforcement of these haddock
measures problematic. Compliance with the measures will also be closely
monitored, and should enforceability become compromised, appropriate
action will be taken by the Regional Director, including the
possibility of implementing a prohibition on the possession of haddock
by all vessels. To improve enforceability, this rule prohibits transfer
of fish at sea, requires haddock to be stored separately from other
fish, and requires all vessels to carry a standardized tote so the
amount of haddock on board can be measured at sea.
The expansion of Closed Area II in area and time will provide
additional protection to the concentrations of haddock that occur in
the area in this time period. The January closure will ensure that
haddock beginning to concentrate in the area are provided the fullest
protection. The expansion in size of the closed area is based on
information obtained from interviews with fishermen, which indicate
that large amounts of haddock are taken just outside the closed area.
Allowing the use of mobile gear in Closed Area I is justified
because there have been few if any haddock present in the area for the
last 10 years. This has been confirmed by research trawl surveys
conducted by the NMFS Northeast Fisheries Science Center (NEFSC). The
closure remains in effect for sink gillnet gear because of possible
interaction between the gear and endangered or threatened marine
mammals.
In addition to the expansion and early closure, the Secretary has
determined that, because scallop vessels fish in Closed Area II during
the period when haddock are congregated to spawn, all scallop dredge
vessels should be prohibited from landing or possessing haddock to
ensure that such vessels do not target these concentrations of haddock.
While the Council requested that the Regional Director consider the
question of whether scallop dredges should be prohibited from the area
during the closure, and not a prohibition on landings, the information
provided by the NEFSC does not support precluding scallopers from the
closed area. Therefore, the lesser action is taken to reduce the impact
on scallopers yet provide some protection to spawning haddock.
The Secretary has determined that it is appropriate to include a
pair trawl prohibition in this emergency rule. Many in the fishing
industry believe that a prohibition on pair trawl gear in the
multispecies fishery is warranted as an emergency measure because it is
a highly efficient gear, and its unlimited use during a period of
severely declining haddock and cod stocks is counterproductive to the
goal of reducing effort in an overfished fishery. Information from the
NEFSC for 1992 indicates that, for some vessel classes, catch rates
increase by a factor of 5.85 when using the gear. As a result, there
has been an increase in its use in recent years. This prohibition is
also included in proposed Amendment 5.
Classification
The Secretary has determined that this rule is necessary to respond
to an emergency situation and is consistent with the Magnuson Act and
other applicable law.
The Secretary finds for good cause that the reasons justifying
promulgation of this rule on an emergency basis also make it
impracticable and contrary to the public interest to provide notice and
opportunity for public comment upon, or to delay for 30 days the
effective date of these emergency regulations, under the provisions of
sections 553(b) and (d) of the Administrative Procedure Act. However,
all of the measures have received some public comment during Council
meetings and in connection with the development of Amendment 5 to the
FMP. Implementation of these emergency measures will provide much
needed immediate protection to the declining haddock and cod stocks.
This rule is exempt from the requirements of the Regulatory
Flexibility Act to prepare a regulatory flexibility analysis because
the rule is issued without opportunity for prior public comment, and
none has been prepared.
List of Subjects in 50 CFR Part 651
Fishing, Fisheries, Vessel permits and fees.
Dated: December 27, 1993.
Nancy Foster,
Deputy Assistant Administrator for Fisheries, National Marine Fisheries
Service.
For the reasons set out in the preamble, 50 CFR part 651 is amended
as follows:
PART 651--NORTHEAST MULTISPECIES FISHERY
1. The authority citation for part 651 continues to read as
follows:
Authority: 16 U.S.C. 1801 et seq.
2. In Sec. 651.2, the definitions for bottom-tending gillnet or
sink gillnet gear, dredge or dredge gear, offload, pair trawl or pair
trawling, scallop dredge vessel, standard box, standard tote, and
transfer are temporarily added, in alphabetical order, effective
January 3, 1994 through April 2, 1994, to read as follows:
Sec. 651.2 Definitions.
* * * * *
Bottom-tending gillnet or sink gillnet means any gillnet, anchored
or otherwise, that is designed to be, capable of being, or is fished on
or near the bottom in the lower third of the water column.
Dredge or dredge gear means gear consisting of a mouth frame
attached to a holding bag constructed of metal rings, or any other
modification to this design, that can or is used in the harvest of
Atlantic sea scallops.
Offload means to begin to remove, to remove, to pass over the rail,
or otherwise take away fish from any vessel.
Pair trawl or pair trawling means to tow or towing a single net
between two vessels for the purpose of, or that is capable of, catching
multispecies finfish.
Scallop dredge vessel means any fishing vessel that uses or is
equipped for using dredge gear and that has been issued or has applied
for a Federal scallop permit.
Standard box means a box, typically constructed of wax-saturated
cardboard or wood, designed to hold 125 pounds (56.6 kg) of fish plus
ice, and that has a volume of not more than 5,100 cubic inches (2.95
cubic feet or 83.57 cubic dm).
Standard tote means a box typically constructed of plastic,
designed to hold 100 pounds (45.3 kg) of fish plus ice, and that has a
liquid capacity of 70 liters, or a volume of not more than 4320 cubic
inches (2.5 cubic feet or 70.79 cubic dm).
Transfer means to begin to remove, to pass over the rail, or
otherwise take away fish from any vessel and move them to another
conveyance.
* * * * *
3. In Sec. 651.7, paragraphs (a)(3), (a)(4), (a)(5), (a)(6),
(a)(7), (b)(15), (b)(16), (b)(17), (b)(18), (b)(19), (b)(20), and
(b)(21) are temporarily added and paragraph (b)(11) is temporarily
suspended effective January 3, 1994, through April 2, 1994, to read as
follows:
Sec. 651.7 Prohibitions.
(a) * * *
(3) Land haddock from, or possess haddock on board, a sea scallop
dredge vessel as specified in Sec. 651.28(a).
(4) Land, or possess on board a vessel, more than 500 pounds (226.8
kg) of haddock as specified in Sec. 651.28(b) or violate any of the
other provisions specified in Sec. 651.28(b).
(5) Land or possess multispecies finfish harvested by means of pair
trawling except under the provisions of Sec. 651.20(d).
(6) Fish for multispecies finfish by means of pair trawling.
(7) Land, offload, remove, or otherwise transfer or attempt to
land, offload, remove, or otherwise transfer fish from one vessel to
another vessel.
(b) * * *
(15) Use, set, haul back, fish with, or have on board a vessel a
sink gillnet in the area and during the time period described in
Sec. 651.21(c)(1).
(16) Enter the area described in Sec. 651.21(c)(2) on a fishing
vessel during the time period specified in Sec. 651.21(c)(2), except as
specified in Sec. 651.21(c)(3).
(17) Land haddock from, or possess haddock on board, a sea scallop
dredge vessel as specified in Sec. 651.28(a).
(18) Land, or possess on board a vessel, more than 500 pounds
(226.8 kg) of haddock in, or harvested from, the EEZ as specified in
Sec. 651.28(b) or violate any of the other provisions specified in
Sec. 651.28(b).
(19) Land or possess multispecies finfish harvested in, or from,
the EEZ by means of pair trawling, except under the provisions of
Sec. 651.20(d).
(20) Fish for multispecies finfish in the EEZ by means of pair
trawling.
(21) Land, offload, remove, or otherwise transfer, or attempt to
land, offload, remove or otherwise transfer multispecies finfish from
one vessel to another vessel, unless the multispecies finfish were
harvested by a recreational fishing vessel or such vessels have not
been issued a Federal multispecies permit and fish for multispecies
finfish exclusively in state waters.
* * * * *
4. In Sec. 651.20, paragraph (g) is temporarily added effective
January 3, 1994, through April 2, 1994, to read as follows:
Sec. 651.20 Regulated mesh area and gear limitations.
* * * * *
(g) No vessel issued a permit under Sec. 651.4 may pair trawl for
multispecies finfish, as defined under Sec. 651.2, except under the
provisions of paragraph (d) of this section.
5. In Sec. 651.21, paragraphs (a) introductory text, (a)(1),
(a)(2), and (a)(3) are temporarily suspended, and paragraph (c) is
temporarily added effective January 3, 1994, through April 2, 1994, to
read as follows:
Sec. 651.21 Closed areas.
* * * * *
(c) Georges Bank. No person or vessel may fish within the following
areas subject to the conditions and/or exceptions of this section.
(1) Closed Area I. No fishing vessel or person on a fishing vessel
may use, set, haul back, fish with, or have on board a vessel a sink
gillnet during the months of February through May in the area known as
Closed Area I (Figure 6), which is bounded by six straight lines
connecting the following points in the order stated:
------------------------------------------------------------------------
Point Latitude Longitude
------------------------------------------------------------------------
CI1....... 40 deg.53' N. 68 deg.53' W.
CI2....... 41 deg.35' N. 68 deg.30' W.
CI3....... 41 deg.50' N. 68 deg.45' W.
CI4....... 41 deg.50' N. 69 deg.00' W.
CI5....... 41 deg.30' N. 69 deg.00' W.
CI6....... 41 deg.30' N. 69 deg.23' W.
CI1....... 40 deg.53' N. 68 deg.53' W.
------------------------------------------------------------------------
(2) Closed Area II. No fishing vessel or person on a fishing vessel
may fish in, or be in, the area known as Closed Area II (Figure 6)
during the months of January through May, except as specified in
paragraph (c)(3) of this section. Closed Area II is bounded by four
straight lines connecting the following points in the order stated:
------------------------------------------------------------------------
Point Latitude Longitude
------------------------------------------------------------------------
CII1...... 41 deg.00' N. 67 deg.20' W.
CII2...... 41 deg.00' N. 66 deg.35.8' W.
G5........ 41 deg.18.6' N. 66 deg.24.8' W. (the U.S.-
Canada Maritime Boundary)
CII3...... 42 deg.22' N. 67 deg.20' W. (the U.S.-Canada
Maritime Boundary)
CII1...... 41 deg.00' N. 67 deg.20' W.
------------------------------------------------------------------------
(3) Exceptions. Paragraph (c)(2) of this section does not apply to
persons on fishing vessels or fishing vessels:
(i) Fishing with or using pot gear designed and used to take
lobsters;
(ii) Fishing with or using dredges designed and used to take
scallops; or
(iii) Seeking safe haven from storm conditions in waters adjacent
to the western edge of Closed Area II. Such fishing vessels may transit
through Closed Area II providing that:
(A) Gale, storm or hurricane conditions are posted for the area by
the National Weather Service;
(B) Such vessels do not fish in the area;
(C) Fishing gear is stowed in accordance with Sec. 651.20(f); and
(D) The vessel provides notice to patrolling U.S. Coast Guard
aircraft or vessel in the vicinity of Georges Bank by high frequency
radio (2.182 khz) of its intention to transit the closed area and the
time and position when the vessel enters the area and the time and
position when the vessel exits the closed area.
6. Sections 651.28 and 651.29 are temporarily added effective
January 3, 1994, through April 2, 1994, to read as follows:
Sec. 651.28 Haddock possession limits.
(a) Scallop dredge vessels.
(1) No person owning or operating a scallop dredge vessel issued a
permit under Sec. 651.4 may land, or possess on board a vessel,
haddock.
(2) No person operating a scallop dredge vessel may possess haddock
in, or harvested from, the EEZ.
(b) Other vessels.
(1) No person owning or operating a vessel issued a permit under
Sec. 651.4 may land, or possess on a vessel, more than 500 pounds
(226.8 kg) of haddock.
(2) No person may possess on a vessel more than 500 pounds (226.8
kg) of haddock in, or harvested from, the EEZ.
(3) Vessels subject to the haddock possession limit shall have on
board the vessel at least one standard box or one standard tote.
(4) The haddock stored on board the vessel shall be retained
separately from the rest of the catch and shall be readily available
for inspection and for measurement by placement of the haddock in a
standard box or standard tote if requested by an authorized officer.
(5) The haddock possession limit is equal to 500 pounds (226.8 kg)
or its equivalent as measured by the volume of 4 standard boxes or 5
standard totes.
Sec. 651.29 Transfer-at-sea.
(a) Vessels permitted under Sec. 651.4 are prohibited from
transferring or attempting to transfer fish from one vessel to another
vessel.
(b) All vessels are prohibited from transferring or attempting to
transfer multispecies finfish from one vessel to another vessel.
7. Figure 2 to part 651 is temporarily suspended, effective January
3, 1994, through April 2, 1994, and Figure 6 is temporarily added
effective January 3, 1994, through April 2, 1994.
BILLING CODE 3510-22-P
TR03JA94.009
[FR Doc. 93-32010 Filed 12-28-93; 3:22 pm]
BILLING CODE 3510-22-C
Complete official Federal Register PDF
FR Doc. 93-31928 Adjustments to Basis of Stock and Indebtedness to Shareholders of S Corporations and Treatment of Distributions by S Corporations to Shareholders
[Federal Register Volume 59, Number 1 (Monday, January 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31928]
[[Page Unknown]]
[Federal Register: January 3, 1994]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 1 and 602
[TD 8508]
RIN 1545-AE26
Adjustments to Basis of Stock and Indebtedness to Shareholders of
S Corporations and Treatment of Distributions by S Corporations to
Shareholders
AGENCY: Internal Revenue Service, Treasury.
ACTION: Final regulations.
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SUMMARY: This document contains final regulations under section 1367 of
the Internal Revenue Code relating to adjustments to the basis of a
shareholder's stock in an S corporation and the basis of indebtedness
of an S corporation to a shareholder. This document also contains final
regulations under section 1368 of the Internal Revenue Code relating to
the treatment of distributions by an S corporation to its shareholders.
Changes to the applicable law were made by the Subchapter S Revision
Act of 1982, the Technical Corrections Act of 1982, the Tax Reform Act
of 1984, and the Tax Reform Act of 1986. The final regulations affect S
corporations and their shareholders and are necessary to provide them
with the guidance they need to comply with the applicable tax law.
EFFECTIVE DATE: These regulations are effective on January 1, 1994 and
apply to taxable years beginning on and after January 1, 1994.
FOR FURTHER INFORMATION CONTACT: Deane M. Burke (202) 622-3080 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
Paperwork Reduction Act
The collections of information contained in these final regulations
have been reviewed and approved by the Office of Management and Budget
in accordance with the requirements of the Paperwork Reduction Act (44
U.S.C. 3504(h)) under control number 1545-1139. The estimated annual
burden per respondent varies from .05 to .2 hour, depending on
individual circumstances, with an estimated average of .1 hour.
These estimates are an approximation of the average time expected
to be necessary for a collection of information. They are based on such
information as is available to the Internal Revenue Service. Individual
respondents may require greater or less time, depending on their
particular circumstances.
Comments concerning the accuracy of this burden estimate and
suggestions for reducing this burden should be directed to the Internal
Revenue Service, Attn: IRS Reports Clearance Officer, PC:FP,
Washington, DC 20224, and to the Office of Management and Budget,
Attention: Desk Officer for the Department of the Treasury, Office of
Information and Regulatory Affairs, Washington, DC 20503.
Background
This document amends 26 CFR part 1 that provides rules under
sections 1367 and 1368 of the Internal Revenue Code of 1986 (Code), as
amended. The amendments conform the regulations to amendments made to
sections 1367 and 1368 by sections 2 and 6 of the Subchapter S Revision
Act of 1982, section 305 of the Technical Corrections Act of 1982,
sections 721(d), (r), and (w) and 722(e)(2) of the Tax Reform Act of
1984, and section 1879(m)(1)(B) of the Tax Reform Act of 1986.
On June 9, 1992, the Federal Register published a notice of
proposed rulemaking (57 FR 24426) (the proposed regulations) concerning
adjustments to basis of stock and indebtedness to shareholders of S
corporations and treatment of distributions by S corporations to
shareholders. Because no one requested to testify, the Service
cancelled a public hearing scheduled for September 14, 1992. The
Service, however, received written comments on the proposed
regulations. After consideration of all of the comments, the proposed
regulations are adopted as revised by this Treasury decision.
Explanation of Provisions
The final regulations provide rules under section 1367 regarding
adjustments to the basis of a shareholder's stock in an S corporation
and the basis of indebtedness of an S corporation to a shareholder. The
final regulations also provide rules under section 1368 regarding the
treatment of distributions by an S corporation to its shareholders.
Except for modifications in response to the comments, which were
generally favorable, these final regulations generally provide the same
rules as the proposed regulations.
I. Adjustments to Basis of Stock
A. Separate Basis Approach
The proposed regulations provided a separate basis approach
(comparable to the basis of a shareholder in C corporation stock) for
determining adjustments to the basis of a shareholder's stock in an S
corporation. The proposed regulations also provided a spillover rule
that allowed a shareholder to apply losses and deductions in excess of
the basis of a share of stock to which such items are attributable
against the remaining bases of all other shares of stock owned by a
shareholder. The Service invited and received comments on whether
another approach such as an aggregate/average basis (comparable to the
basis of a partner in a partnership interest) should be used for
purposes of sections 1367, 1368, and 1012.
Commentators generally favored the separate basis approach with the
spillover rule in the proposed regulations. The final regulations
therefore retain this rule. In response to comments, the final
regulations clarify that the spillover rule applies to basis
adjustments for distributions to shareholders as well as to adjustments
for pro rata shares of passthrough items of losses or deductions.
B. Ordering Rule
Under the proposed regulations, adjustments are made to the basis
of a share of stock in the following order: (1) increases for income
items (including tax-exempt income) and The excess of deductions for
depletion over basis for non-oil and gas properties; (2) decreases for
noncapital, nondeductible expenses and certain oil and gas depletion
deductions; (3) decreases for items of loss or deduction; and (4)
decreases for distributions. The Service invited and received several
comments regarding the ordering rules.
Some commentators suggested that decreases to basis for
distributions should occur prior to decreases for any losses or
deductions, noncapital, nondeductible expenses, and oil and gas
depletion deductions. The legislative history on this issue is
contradictory. On the one hand, the committee reports state that the S
corporation rules for adjusting basis generally will be analogous to
those provided for partnerships (which adjust basis first for
distributions, then for losses and deductions). On the other hand, the
reports also state that ``income and loss for any corporate taxable
year will apply to adjust basis before the distribution rules apply for
that year.'' See H.R. Rep. No. 826, 97th Cong., 2d Sess. 17 (1982); S.
Rep. No. 640, 97th Cong., 2d Sess. 18 (1982). The language of the loss
limitation rule of section 1366(d)(1) suggests that losses are to be
applied against basis prior to distributions. Section 1366(d)(1)
provides that ``[t]he aggregate amount of losses and deductions taken
into account by a shareholder * * * for a taxable year shall not exceed
the sum of (A) the adjusted basis of the shareholder's stock in the S
corporation (determined with regard to [increases for income and
depletion items]), and (B) the shareholder's adjusted basis in any debt
of the S corporation * * * '' Because of the specific statement in the
legislative history, and the implication in section 1366(d)(1), the
Service and the Treasury Department believe that it is appropriate to
require adjustments for losses and deductions prior to adjustments for
distributions. Thus, the final regulations retain the ordering rule of
the proposed regulations.
Commentators also suggested that decreases to basis for items of
loss or deduction should occur prior to decreases for noncapital,
nondeductible expenses and oil and gas depletion deductions. In
response to the comments, the final regulations provide that decreases
for items of loss or deduction may precede decreases for noncapital,
nondeductible expenses and oil and gas depletion deductions if a
shareholder agrees that noncapital, nondeductible expenses in excess of
basis and certain oil and gas depletion deductions will reduce basis in
succeeding taxable years.
II. Adjustments to Debt Basis and Open Account Debt
The Service invited comments regarding the proper treatment of open
account debt (advances to an S corporation by a shareholder that are
not represented by separate written instruments and that are typically
treated as one account by the S corporation) for purposes of reducing
and restoring basis in indebtedness. In particular, the Service asked
for comments on whether it is appropriate to treat each advance as a
separate debt or all advances as a single debt. Several commentators
suggested that the final regulations should provide a rule treating
open account debt as a single debt for all advances by a shareholder.
In response to comments, and for reasons of administrative simplicity,
the final regulations provide that all open account debt held by a
shareholder is to be treated as a single debt for purposes of reducing
and restoring basis of debt.
III. Elections Under Section 1368
The proposed regulations provide that if a shareholder disposes of
20 percent or more of the corporation's issued shares of stock in one
or more transactions during any thirty-day period during the taxable
year of the corporation (qualifying disposition), the corporation may
elect to treat the taxable year as if it consists of separate taxable
years, the first of which ends on the date on which the shareholder
disposes of 20 percent or more of the corporation's issued stock. Some
commentators suggested that the election for qualifying dispositions of
stock should be expanded to include any 20 percent or greater
disposition of stock (whether by a sale or exchange, by a redemption
treated as an exchange, or by a stock issuance). In response to
comments, the final regulations modify the rule in the proposed
regulations to permit the election for other dispositions of an S
corporation's stock.
IV. Rules Relating to the Accumulated Adjustments Account
Under the final regulations, only S corporations with earnings and
profits must maintain an accumulated adjustments account (AAA) to
determine the tax effect of distributions during S years and the post-
termination transition period as defined in section 1377(b)(1). An S
corporation without earnings and profits does not need to maintain the
AAA in order to determine the tax effect of distributions.
Nevertheless, if an S corporation without earnings and profits engages
in certain transactions to which section 381(a) applies, such as a
merger into an S corporation with C corporation earnings and profits,
the S corporation must be able to calculate its AAA at the time of the
merger for purposes of determining the tax effect of post-merger
distributions.
A. Adjustments to AAA
One commentator suggested that adjustments to the AAA should mirror
the statutory scheme for adjustments to basis in stock under section
1367, at least in the context of dividend distributions. Under the
proposed regulations, a distribution taxed to a shareholder under
section 1368(b)(2) (because it exceeds a shareholder's stock basis)
reduces the AAA balance. The commentator recommended that the AAA
should be decreased only by the portion of a distribution to which
section 1368(b)(1) applies. In effect, under the commentator's
suggestion, adjustments to the AAA would mirror adjustments to a
shareholder's basis in stock and would limit reduction of the AAA to
nontaxable distributions.
Section 1368(e)(1)(A) provides that the AAA is adjusted in a manner
similar to basis in stock and S corporation debt, but does not require
that it mirror shareholder level adjustments to basis in stock and S
corporation debt. Furthermore, the rule in the proposed regulations is
more consistent with the fact that the AAA is a corporate level
account. The Service and the Treasury Department believe that the
commentator's approach would create unnecessary complexity and
uncertainty in the administration of the statute. The AAA is a
corporate level account and an S corporation, which does not generally
need to track a shareholder's basis in its stock, would need to
determine a shareholder's basis to adjust the AAA upon a distribution.
Therefore, the final regulations do not adopt this commentator's
suggested approach regarding adjustments to the AAA for distributions.
B. Redemption Distributions
Section 1368(e)(1)(B) provides that in the case of a redemption
distribution that is treated as an exchange of stock under section
302(a) or section 303(a) (redemption distribution), the corporation's
AAA is adjusted in an amount equal to the ratable share of the
corporation's AAA attributable to the redeemed stock. In the case of a
taxable year in which ordinary distributions and redemption
distributions occur, the proposed regulations require an S corporation
to determine the ratable share of the AAA attributable to redeemed
stock under the method used to determine the pro rata portion of total
earnings and profits attributable to shares redeemed in a C
corporation. See Rev. Rul. 74-338, 1974-2 C.B. 101, and Rev. Rul. 74-
339, 1974-2 C.B. 103. The Service invited and received comments
regarding alternative approaches that appropriately reduce the AAA in
the case of ordinary and redemption distributions.
While commentators generally acknowledged that the redemption rule
in the proposed regulations is workable, they suggested the rule is
unnecessarily complex. In response to comments, the final regulations
modify the redemption rule. Under the final regulations, adjustments to
the AAA are made first for passthrough items, second for ordinary
distributions, and third for redemption distributions. For redemption
distributions, an S corporation is required to adjust the AAA in an
amount equal to the ratable share of the AAA attributable to the
redeemed stock. The corporation also independently adjusts earnings and
profits under the normal rules for C corporations.
V. Effective Date and Transition Rule
The final regulations under sections 1367 and 1368 apply to taxable
years of the corporation beginning on or after January 1, 1994. For
taxable years beginning before January 1, 1994, both the adjustments to
the basis of a shareholder's stock and any indebtedness of the S
corporation to a shareholder and the treatment of distributions by the
S corporation to its shareholders must be determined in a reasonable
manner. For purposes of the preceding sentence, return positions
consistent with Secs. 1.1367-1, 1.1367-2, 1.1368-1, 1.1368-2, and
1.1368-3 (other than the deemed dividend election under Sec. 1.1368-
1(f)(3)) are reasonable.
Special Analysis
It has been determined that this Treasury decision is not a
significant regulatory action as defined in Executive Order 12866. It
has also been determined that section 553(b) of the Administrative
Procedure Act (5 U.S.C. chapter 5) and the Regulatory Flexibility Act
(5 U.S.C. chapter 6) do not apply to these regulations, and, therefore,
a Regulatory Flexibility Analysis is not required. Pursuant to section
7805(f) of the Internal Revenue Code, the notice of proposed rulemaking
was submitted to the Chief Counsel for Advocacy of the Small Business
Administration for comment on its impact on small business.
Drafting Information
The principal author of these final regulations is Deane M. Burke
of the Office of Assistant Chief Counsel (Passthroughs and Special
Industries), Internal Revenue Service. However, other personnel from
the Internal Revenue Service and Treasury Department participated in
their development.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and recordkeeping requirements.
Adoption of Amendments to the Regulations
Accordingly, 26 CFR parts 1 and 602 are amended as follows:
PART 1--INCOME TAXES
Paragraph 1. The authority citation for part 1 is amended by adding
the following citations in numerical order:
Authority: 26 U.S.C. 7805 * * *
Section 1.1368-1(f) and (g) also issued under 26 U.S.C. 1377(c).
Section 1.1368-2(b) also issued under 26 U.S.C. 1368(c).
Par. 2. Sections 1.1367-0 through 1.1367-3 and 1.1368-0 through
1.1368-4 are added to read as follows:
Sec. 1.1367-0 Table of contents.
The following table of contents is provided to facilitate the use
of Secs. 1.1367-1 through 1.1367-3.
Sec. 1.1367-1 Adjustments to basis of shareholder's stock in an S
corporation.
(a) In general.
(1) Adjustments under section 1367.
(2) Applicability of other Internal Revenue Code provisions.
(b) Increase in basis of stock.
(1) In general.
(2) Amount of increase in basis of individual shares.
(c) Decrease in basis of stock.
(1) In general.
(2) Noncapital, nondeductible expenses.
(3) Amount of decrease in basis of individual shares.
(d) Time at which adjustments to basis of stock are effective.
(1) In general.
(2) Adjustment for nontaxable item.
(3) Effect of election under section 1377(a)(2) or Sec. 1.1368-
1(g)(2).
(e) Ordering rules.
(f) Elective ordering rule.
(g) Examples.
Sec. 1.1367-2 Adjustments to basis of indebtedness to shareholder.
(a) In general.
(b) Reduction in basis of indebtedness.
(1) General rule.
(2) Termination of shareholder's interest in corporation during
taxable year.
(3) Multiple indebtedness.
(c) Restoration of basis.
(1) General rule.
(2) Multiple indebtedness.
(d) Time at which adjustments to basis of indebtedness are
effective.
(1) In general.
(2) Effect of election under section 1377(a)(2) or Sec. 1.1368-
1(g)(2).
(e) Examples.
Sec. 1.1367-3 Effective date and transition rule.
Sec. 1.1367-1 Adjustments to basis of shareholder's stock in an S
corporation.
(a) In general--(1) Adjustments under section 1367.
This section provides rules relating to adjustments required by
section 1367 to the basis of a shareholder's stock in an S corporation.
Paragraph (b) of this section provides rules concerning increases in
the basis of a shareholder's stock, and paragraph (c) of this section
provides rules concerning decreases in the basis of a shareholder's
stock.
(2) Applicability of other Internal Revenue Code provisions. In
addition to the adjustments required by section 1367 and this section,
the basis of stock is determined or adjusted under other applicable
provisions of the Internal Revenue Code.
(b) Increase in basis of stock--(1) In general. Except as provided
in Sec. 1.1367-2(c) (relating to restoration of basis of indebtedness
to the shareholder), the basis of a shareholder's stock in an S
corporation is increased by the sum of the items described in section
1367(a)(1). The increase in basis described in section 1367(a)(1)(C)
for the excess of the deduction for depletion over the basis of the
property subject to depletion does not include the depletion deduction
attributable to oil or gas property. See section 613(A)(c)(11).
(2) Amount of increase in basis of individual shares. The basis of
a shareholder's share of stock is increased by an amount equal to the
shareholder's pro rata portion of the items described in section
1367(a)(1) that is attributable to that share, determined on a per
share, per day basis in accordance with section 1377(a).
(c) Decrease in basis of stock--(1) In general. The basis of a
shareholder's stock in an S corporation is decreased (but not below
zero) by the sum of the items described in section 1367(a)(2).
(2) Noncapital, nondeductible expenses. For purposes of section
1367(a)(2)(D), expenses of the corporation not deductible in computing
its taxable income and not properly chargeable to a capital account
(noncapital, nondeductible expenses) are only those items for which no
loss or deduction is allowable and do not include items the deduction
for which is deferred to a later taxable year. Examples of noncapital,
nondeductible expenses include (but are not limited to) the following:
illegal bribes, kickbacks, and other payments not deductible under
section 162(c); fines and penalties not deductible under section
162(f); expenses and interest relating to tax-exempt income under
section 265; losses for which the deduction is disallowed under section
267(a)(1); the portion of meals and entertainment expenses disallowed
under section 274; and the two-thirds portion of treble damages paid
for violating antitrust laws not deductible under section 162.
(3) Amount of decrease in basis of individual shares. The basis of
a shareholder's share of stock is decreased by an amount equal to the
shareholder's pro rata portion of the passthrough items and
distributions described in section 1367(a)(2) attributable to that
share, determined on a per share, per day basis in accordance with
section 1377(a). If the amount attributable to a share exceeds its
basis, the excess is applied to reduce (but not below zero) the
remaining bases of all other shares of stock in the corporation owned
by the shareholder in proportion to the remaining basis of each of
those shares.
(d) Time at which adjustments to basis of stock are effective--(1)
In general. The adjustments described in section 1367(a) to the basis
of a shareholder's stock are determined as of the close of the
corporation's taxable year, and the adjustments generally are effective
as of that date. However, if a shareholder disposes of stock during the
corporation's taxable year, the adjustments with respect to that stock
are effective immediately prior to the disposition.
(2) Adjustment for nontaxable item. An adjustment for a nontaxable
item is determined for the taxable year in which the item would have
been includible or deductible under the corporation's method of
accounting for federal income tax purposes if the item had been subject
to federal income taxation.
(3) Effect of election under section 1377(a)(2) or Sec. 1.1368-
1(g)(2). If an election under section 1377(a)(2) (to terminate the year
in the case of the termination of a shareholder's interest) or under
Sec. 1.1368-1(g)(2) (to terminate the year in the case of a qualifying
disposition) is made with respect to the taxable year of a corporation,
this paragraph (d) applies as if the taxable year consisted of separate
taxable years, the first of which ends at the close of the day on which
either the shareholder's interest is terminated or a qualifying
disposition occurs, whichever the case may be.
(e) Ordering rules. For any taxable year, except as provided in
paragraph (f) of this section, the adjustments required by section
1367(a) are made in the following order:
(1) Any increase in basis attributable to the income items
described in section 1367(a)(1) (A) and (B) and the excess of the
deductions for depletion described in section 1367(a)(1)(C);
(2) Any decrease in basis attributable to noncapital, nondeductible
expenses described in section 1367(a)(2)(D) and the oil and gas
depletion deduction described in section 1367(a)(2)(E);
(3) Any decrease in basis attributable to items of loss or
deduction described in section 1367(a)(2) (B) and (C); and
(4) Any decrease in basis attributable to a distribution by the
corporation described in section 1367(a)(2)(A).
(f) Elective ordering rule. A shareholder may elect to decrease
basis under paragraph (e)(3) of this section prior to decreasing basis
under paragraph (e)(2) of this section. If a shareholder makes this
election, any amount described in paragraph (e)(2) of this section that
is in excess of the shareholder's basis in stock and indebtedness is
treated, solely for purposes of this section, as an amount described in
paragraph (e)(2) of this section in the succeeding taxable year. A
shareholder makes the election under this paragraph by attaching a
statement to the shareholder's timely filed original or amended return
that states that the shareholder agrees to the carryover rule of the
preceding sentence. Once a shareholder makes an election under this
paragraph with respect to an S corporation, the shareholder must
continue to use the rules of this paragraph for that S corporation in
future taxable years unless the shareholder receives the permission of
the Commissioner.
(g) Examples. The following examples illustrate the principles of
Sec. 1.1367-1. In each example, the corporation is a calendar year S
corporation:
Example 1. Adjustments to basis of stock in general. (i) On
December 31, 1994, A owns a block of 50 shares of stock with an
adjusted basis per share of $6 in Corporation S. On December 31,
1994, A purchases for $400 an additional block of 50 shares of stock
with an adjusted basis of $8 per share. Thus, A holds 100 shares of
stock for each day of the 1995 taxable year. For S's 1995 taxable
year, A's pro rata share of the amount of the items described in
section 1367(a)(1)(A) (relating to increases in basis of stock) is
$300, and A's pro rata share of the amount of the items described in
section 1367(a)(2) (B) and (D) (relating to decreases in basis of
stock) is $500. S makes a distribution to A in the amount of $100
during 1995.
(ii) Pursuant to the ordering rules of paragraph (e) of this
section, A increases the basis of each share of stock by $3 ($300/
100 shares) and decreases the basis of each share of stock by $5
($500/100 shares). Then A reduces the basis of each share by $1
($100/100 shares) for the distribution. Thus, on January 1, 1996, A
has a basis of $3 per share in his original block of 50 shares
($6+$3-$5 -$1) and a basis of $5 per share in the second block of 50
shares ($8+$3-$5-$1).
Example 2. Adjustments attributable to basis of individual
shares of stock. (i) On December 31, 1993, B owns one share of S
corporation's 10 outstanding shares of stock. The basis of B's share
is $30. On July 2, 1994, B purchases from another shareholder two
shares for $25 each. During 1994, S corporation has no income or
deductions but incurs a loss of $365. Under section 1377(a)(1)(A)
and paragraph (c)(3) of this section, the amount of the loss
assigned to each day of S's taxable year is $1.00 ($365/365 days).
For each day, $.10 is allocated to each outstanding share ($1.00
amount of loss assigned to each day/10 shares).
(ii) B owned one share for 365 days and, therefore, reduces the
basis of that share by the amount of loss attributable to it, i.e.,
$36.50 ($.10 x 365 days). B owned two shares for 182 days and,
therefore, reduces the basis of each of those shares by the amount
of the loss attributable to each, i.e., $18.20 ($.10 x 182 days).
(iii) The bases of the shares are decreased as follows:
----------------------------------------------------------------------------------------------------------------
Excess basis
Share Original basis Decrease Adjusted basis reduction
----------------------------------------------------------------------------------------------------------------
No. 1............................... $30.00 $36.50 $0 $6.50
No. 2............................... 25.00 18.20 6.80 0
No. 3............................... 25.00 18.20 6.80 0
-------------------
Total remaining basis........... ................. ................. 13.60 .................
----------------------------------------------------------------------------------------------------------------
(iv) Because the decrease in basis attributable to share No. 1
exceeds the basis of share No. 1 by $6.50 ($36.50 - $30.00), the
excess is applied to reduce the bases of shares No. 2 and No. 3 in
proportion to their remaining bases. Therefore, the bases of share
No. 2 and share No. 3 are each decreased by an additional $3.25
($6.50 x $6.80/$13.60). After this decrease, Share No. 1 has a
basis of zero, Share No. 2 has a basis of $3.55, and Share No. 3 has
a basis of $3.55.
Example 3. Effects of section 1377(a)(2) election and
distribution on basis of stock. (i) On January 1, 1994, individuals
B and C each own 50 of the 100 shares of issued and outstanding
stock of Corporation S. B's adjusted basis in each share of stock is
$120, and C's is $80. On June 30, 1994, S distributes $6,000 to B
and $6,000 to C. On June 30, 1994, B sells all of her S stock for
$10,000 to D. S elects under section 1377(a)(2) to treat its 1994
taxable year as consisting of two taxable years, the first of which
ends at the close of June 30, the date on which B terminates her
interest in S.
(ii) For the period January 1, 1994, through June 30, 1994, S
has nonseparately computed income of $6,000 and a separately stated
deduction item of $4,000. Therefore, on June 30, 1994, B and C,
pursuant to the ordering rules of paragraph (e) of this section,
increase the basis of each share by $60 ($6,000/100 shares) and
decrease the basis of each share by $40 ($4,000/100 shares). Then B
and C reduce the basis of each share by $120 ($12,000/100 shares)
for the distribution.
(iii) The basis of B's stock is reduced from $120 to $20 per
share ($120+$60-$40-$120). The basis of C's stock is reduced from
$80 to $0 per share ($80+$60-$40-$120). See section 1368 and
Sec. 1.1368-1 (c) and (d) for rules relating to the tax treatment of
the distributions.
(iv) Pursuant to paragraph (d)(3) of this section, the net
reduction in the basis of B's shares of the S stock required by
section 1367 and this section is effective immediately prior to B's
sale of her stock. Thus, B's basis for determining gain or loss on
the sale of the S stock is $20 per share, and B has a gain on the
sale of $180 ($200-$20) per share.
Sec. 1.1367-2 Adjustments to basis of indebtedness to shareholder.
(a) In general. This section provides rules relating to adjustments
required by subchapter S to the basis of indebtedness of an S
corporation to a shareholder. For purposes of this section, shareholder
advances not evidenced by separate written instruments and repayments
on the advances (open account debt) are treated as a single
indebtedness. The basis of indebtedness of the S corporation to a
shareholder is reduced as provided in paragraph (b) of this section and
restored as provided in paragraph (c) of this section.
(b) Reduction in basis of indebtedness--(1) General rule. If, after
making the adjustments required by section 1367(a)(1) for any taxable
year of the S corporation, the amounts specified in section 1367(a)(2)
(B), (C), (D), and (E) (relating to losses, deductions, noncapital,
nondeductible expenses, and certain oil and gas depletion deductions)
exceed the basis of a shareholder's stock in the corporation, the
excess is applied to reduce (but not below zero) the basis of any
indebtedness of the S corporation to the shareholder held by the
shareholder at the close of the corporation's taxable year. Any such
indebtedness that has been satisfied by the corporation, or disposed of
or forgiven by the shareholder, during the taxable year, is not held by
the shareholder at the close of that year and is not subject to basis
reduction.
(2) Termination of shareholder's interest in corporation during
taxable year. If a shareholder terminates his or her interest in the
corporation during the taxable year, the rules of this paragraph (b)
are applied with respect to any indebtedness of the S corporation held
by the shareholder immediately prior to the termination of the
shareholder's interest in the corporation.
(3) Multiple indebtedness. If a shareholder holds more than one
indebtedness at the close of the corporation's taxable year or, if
applicable, immediately prior to the termination of the shareholder's
interest in the corporation, the reduction in basis is applied to each
indebtedness in the same proportion that the basis of each indebtedness
bears to the aggregate bases of the indebtedness to the shareholder.
(c) Restoration of basis--(1) General rule. If, for any taxable
year of an S corporation beginning after December 31, 1982, there has
been a reduction in the basis of an indebtedness of the S corporation
to a shareholder under section 1367(b)(2)(A), any net increase in any
subsequent taxable year of the corporation is applied to restore that
reduction. For purposes of this section, net increase with respect to a
shareholder means the amount by which the shareholder's pro rata share
of the items described in section 1367(a)(1) (relating to income items
and excess deduction for depletion) exceed the items described in
section 1367(a)(2) (relating to losses, deductions, noncapital,
nondeductible expenses, certain oil and gas depletion deductions, and
certain distributions) for the taxable year. These restoration rules
apply only to indebtedness held by a shareholder as of the beginning of
the taxable year in which the net increase arises. The reduction in
basis of indebtedness must be restored before any net increase is
applied to restore the basis of a shareholder's stock in an S
corporation. In no event may the shareholder's basis of indebtedness be
restored above the adjusted basis of the indebtedness under section
1016(a), excluding any adjustments under section 1016(a)(17) for prior
taxable years, determined as of the beginning of the taxable year in
which the net increase arises.
(2) Multiple indebtedness. If a shareholder holds more than one
indebtedness as of the beginning of a corporation's taxable year, any
net increase is applied first to restore the reduction of basis in any
indebtedness repaid (in whole or in part) in that taxable year to the
extent necessary to offset any gain that would otherwise be realized on
the repayment. Any remaining net increase is applied to restore each
outstanding indebtedness in proportion to the amount that the basis of
each outstanding indebtedness has been reduced under section
1367(b)(2)(A) and paragraph (b) of this section and not restored under
section 1367(b)(2)(B) and this paragraph (c).
(d) Time at which adjustments to basis of indebtedness are
effective--(1) In general. The amounts of the adjustments to basis of
indebtedness provided in section 1367(b)(2) and this section are
determined as of the close of the corporation's taxable year, and the
adjustments are generally effective as of the close of the
corporation's taxable year. However, if the shareholder is not a
shareholder in the corporation at that time, these adjustments are
effective immediately before the shareholder terminates his or her
interest in the corporation. If a debt is disposed of or repaid in
whole or in part before the close of the taxable year, the basis of
that indebtedness is restored under paragraph (c) of this section,
effective immediately before the disposition or the first repayment on
the debt during the taxable year.
(2) Effect of election under section 1377(a)(2) or Sec. 1.1368-
1(g)(2). If an election is made under section 1377(a)(2) (to terminate
the year in the case of the termination of a shareholder's interest) or
under Sec. 1.1368-1(g)(2) (to terminate the year in the case of a
qualifying disposition), this paragraph (d) applies as if the taxable
year consisted of separate taxable years, the first of which ends at
the close of the day on which the shareholder either terminates his or
her interest in the corporation or disposes of a substantial amount of
stock, whichever the case may be.
(e) Examples. The following examples illustrate the principles of
Sec. 1.1367-2. In each example, the corporation is a calendar year S
corporation. The lending transactions described in the examples do not
result in foregone interest (within the meaning of section 7872(e)(2)),
original issue discount (within the meaning of section 1273), or total
unstated interest (within the meaning of section 483(b)).
Example 1. Reduction in basis of indebtedness. (i) A has been
the sole shareholder in Corporation S since 1992. In 1993, A loans S
$1,000 (Debt No. 1), which is evidenced by a ten-year promissory
note in the face amount of $1,000. In 1996, A loans S $5,000 (Debt
No. 2), which is evidenced by a demand promissory note. On December
31, 1996, the basis of A's stock is zero; the basis of Debt No. 1
has been reduced under paragraph (b) of this section to $0; and the
basis of Debt No. 2 has been reduced to $1,000. On January 1, 1997,
A loans S $4,000 (Debt No. 3), which is evidenced by a demand
promissory note. For S's 1997 taxable year, the sum of the amounts
specified in section 1367(a)(1) (in this case, nonseparately
computed income and the excess deduction for depletion) is $6,000,
and the sum of the amounts specified in section 1367(a)(2) (B), (D),
and (E) (in this case, items of separately stated deductions and
losses, noncapital, nondeductible expenses, and certain oil and gas
depletion deductions--there is no nonseparately computed loss) is
$10,000. Corporation S makes no payments to A on any of the loans
during 1997.
(ii) The $4,000 excess of loss and deduction items is applied to
reduce the basis of each indebtedness in proportion to the basis of
that indebtedness over the aggregate bases of the indebtedness to
the shareholder (determined immediately before any adjustment under
section 1367(b)(2)(A) and paragraph (b) of this section is effective
for the taxable year). Thus, the basis of Debt No. 2 is reduced in
an amount equal to $800 ($4,000 (excess) x $1,000 (basis of Debt No.
2)/$5,000 (total basis of all debt)). Similarly, the basis in Debt
No. 3 is reduced in an amount equal to $3,200 ($4,000 x $4,000/
$5,000). Accordingly, on December 31, 1997, A's basis in his stock
is zero and his bases in the three debts are as follows:
----------------------------------------------------------------------------------------------------------------
1/1/96 12/31/96 1/1/97 12/31/97 1/1/98
Debt basis reduction basis reduction basis
----------------------------------------------------------------------------------------------------------------
No. 1................................................ $1,000 $1,000 $0 $0 $0
No. 2................................................ 5,000 4,000 1,000 800 200
No. 3................................................ ......... ........... 4,000 3,200 800
----------------------------------------------------------------------------------------------------------------
Example 2. Restoration of basis of indebtedness. (i) The facts
are the same as in Example 1. On July 1, 1998, S completely repays
Debt No. 3, and, for S's 1998 taxable year, the net increase (within
the meaning of paragraph (c) of this section) with respect to A
equals $4,500.
(ii) The net increase is applied first to restore the bases in
the debts held on January 1, 1998, before any of the net increase is
applied to increase A's basis in his shares of S stock. The net
increase is applied to restore first the reduction of basis in
indebtedness repaid in 1998. Any remaining net increase is applied
to restore the bases of the outstanding debts in proportion to the
amount that each of these outstanding debts have been reduced
previously under paragraph (b) of this section and have not been
restored. As of December 31, 1998, the total reduction in A's debts
held on January 1, 1998 equals $9,000. Thus, the basis of Debt No. 3
is restored by $3,200 (the amount of the previous reduction) to
$4,000. A's basis in Debt No. 3 is treated as restored immediately
before that debt is repaid. Accordingly, A does not realize any gain
on the repayment. The remaining net increase of $1,300
($4,500-$3,200) is applied to restore the bases of Debt No. 1 and
Debt No. 2. As of December 31, 1998, the total reduction in these
outstanding debts is $5,800 ($9,000-$3,200). The basis of Debt No. 1
is restored in an amount equal to $224 ($1,300 x $1,000/$5,800).
Similarly, the basis in Debt No. 2 is restored in an amount equal to
$1,076 ($1,300 x $4,800/$5,800). On December 31, 1998, A's basis in
his S stock is zero and his bases in the two remaining debts are as
follows:
------------------------------------------------------------------------
Original Amount Amount 12/31/98
basis reduced 1/1/98 basis restored basis
------------------------------------------------------------------------
$1,000....... $1,000 $0 $224 $224
5,000........ 4,800 200 1,076 1,276
------------------------------------------------------------------------
Example 3. Full restoration of basis in indebtedness when debt
is repaid in part during the taxable year. (i) C has been a
shareholder in Corporation S since 1992. In 1997, C loans S $1,000.
S issues its note to C in the amount of $1,000, of which $950 is
payable on March 1, 1998, and $50 is payable on March 1, 1999. On
December 31, 1997, C's basis in all her shares of S stock is zero
and her basis in the note has been reduced under paragraph (b) of
this section to $900. For 1998, the net increase (within the meaning
of paragraph (c) of this section) with respect to C is $300.
(ii) Because C's basis of indebtedness was reduced in a prior
taxable year under Sec. 1.1367-2(b), the net increase for 1998 is
applied to restore this reduction. The restored basis cannot exceed
the adjusted basis of the debt as of the beginning of the first day
of 1998, excluding prior adjustments under section 1367, or $1,000.
Therefore, $100 of the $300 net increase is applied to restore the
basis of the debt from $900 to $1,000 effective immediately before
the repayment on March 1, 1998. The remaining net increase of $200
increases C's basis in her stock.
Example 4. Determination of net increase--distribution in excess
of increase in basis. (i) D has been the sole shareholder in
Corporation S since 1990. On January 1, 1996, D loans S $10,000 in
return for a note from S in the amount of $10,000 of which $5,000 is
payable on each of January 1, 2000, and January 1, 2001. On December
31, 1997, the basis of D's shares of S stock is zero, and his basis
in the note has been reduced under paragraph (b) of this section to
$8,000. During 1998, the sum of the items under section 1367(a)(1)
(relating to increases in basis of stock) with respect to D equals
$10,000 (in this case, nonseparately computed income), and the sum
of the items under section 1367(a)(2)(B), (C), (D), and (E)
(relating to decreases in basis of stock) with respect to D equals
$0. During 1998, S also makes distributions to D totaling $11,000.
This distribution is an item that reduces basis of stock under
section 1367(a)(2)(A) and must be taken into account for purposes of
determining whether there is a net increase for the taxable year.
Thus, for 1998, there is no net increase with respect to D because
the amount of the items provided in section 1367(a)(1) do not exceed
the amount of the items provided in section 1367(a)(2).
(ii) Because there is no net increase with respect to D for
1998, none of the 1997 reduction in D's basis in the indebtedness is
restored. The $10,000 increase in basis under section 1367(a)(1) is
applied to increase D's basis in his S stock. Under section
1367(a)(2)(A), the $11,000 distribution with respect to D's stock
reduces D's basis in his shares of S stock to $0. See section 1368
and Sec. 1.1368-1 (c) and (d) for the tax treatment of the $1,000
distribution in excess of D's basis.
Example 5. Distributions less than increase in basis. (i) The
facts are the same as in Example 4, except that in 1998 S makes
distributions to D totaling $8,000. On these facts, for 1998, there
is a net increase with respect to D of $2,000 (the amount by which
the items provided in section 1367(a)(1) exceed the amount of the
items provided in section 1367(a)(2)).
(ii) Because there is a net increase of $2,000 with respect to D
for 1998, $2,000 of the $10,000 increase in basis under section
1367(a)(1) is first applied to restore D's basis in the indebtedness
to $10,000 ($8,000 + $2,000). Accordingly, on December 31, 1998, D
has a basis in his shares of S stock of $0 ($0 + $8,000 (increase in
basis remaining after restoring basis in indebtedness)--$8,000
(distribution)) and a basis in the note of $10,000.
Sec. 1.1367-3 Effective date and transition rule.
Sections 1.1367-1 and 1.1367-2 apply to taxable years of a
corporation beginning on or after January 1, 1994. For taxable years
beginning before January 1, 1994, the adjustments to the basis of a
shareholder's stock and the basis of indebtedness of an S corporation
to a shareholder must be determined in a reasonable manner, taking into
account the statute and the legislative history. Return positions
consistent with Secs. 1.1367-1 and 1.1367-2 are reasonable.
Sec. 1.1368-0 Table of contents.
The following table of contents is provided to facilitate the use
of Secs. 1.1368-1 through 1.1368-4.
Sec. 1.1368-1 Distributions by S corporations.
(a) In general.
(b) Date distribution made.
(c) S corporation with no earnings and profits.
(d) S corporation with earnings and profits.
(1) General treatment of distribution.
(2) Previously taxed income.
(e) Certain adjustments taken into account.
(f) Elections relating to source of distributions.
(1) In general.
(2) Election to distribute earnings and profits first.
(i) In general.
(ii) Previously taxed income.
(iii) Corporation with subchapter C and subchapter S earnings
and profits.
(3) Election to make a deemed dividend.
(4) Election to forego previously taxed income.
(5) Time and manner of making elections.
(i) For earnings and profits.
(ii) For previously taxed income and deemed dividends.
(iii) Corporate statement regarding elections.
(iv) Irrevocable elections.
(g) Special rules.
(1) Election to terminate year under section 1377 or
Sec. 1.1368-1(g)(2).
(2) Election in case of a qualifying disposition.
(i) In general.
(ii) Effect of the election.
(iii) Time and manner of making election.
Sec. 1.1368-2 Accumulated adjustments account (AAA).
(a) Accumulated adjustments account.
(1) In general.
(2) Increases to the AAA.
(3) Decreases to the AAA.
(i) In general.
(ii) Extent of allowable reduction.
(iii) Decrease to the AAA for distributions.
(4) Ordering rules for the AAA.
(b) Distributions in excess of the AAA.
(1) In general.
(2) Amount of the AAA allocated to each distribution.
(c) Distribution of money and loss property.
(1) In general.
(2) Allocating the AAA to loss property.
(d) Adjustment in the case of redemptions, reorganizations, and
divisions.
(1) Redemptions.
(i) General rule.
(ii) Special rule for years in which a corporation makes both
ordinary and redemption distributions.
(iii) Adjustments to earnings and profits.
(2) Reorganizations.
(3) Corporate separations to which section 368(a)(1)(D) applies.
(e) Election to terminate year under section 1377(a)(2) or
Sec. 1.1368-1(g)(2).
Sec. 1.1368-3 Examples.
Sec. 1.1368-4 Effective date and transition rule.
Sec. 1.1368-1 Distributions by S corporations.
(a) In general. This section provides rules for distributions made
by an S corporation with respect to its stock which, but for section
1368(a) and this section, would be subject to section 301(c) and other
rules of the Internal Revenue Code that characterize a distribution as
a dividend.
(b) Date distribution made. For purposes of section 1368, a
distribution is taken into account on the date the corporation makes
the distribution, regardless of when the distribution is treated as
received by the shareholder.
(c) S corporation with no earnings and profits. A distribution made
by an S corporation that has no accumulated earnings and profits as of
the end of the taxable year of the S corporation in which the
distribution is made is treated in the manner provided in section
1368(b).
(d) S corporation with earnings and profits--(l) General treatment
of distribution. Except as provided in paragraph (d)(2) of this
section, a distribution made with respect to its stock by an S
corporation that has accumulated earnings and profits as of the end of
the taxable year of the S corporation in which the distribution is made
is treated in the manner provided in section 1368(c)(1), (2), and (3).
See section 316 and Sec. 1.316-2 for provisions relating to the
allocation of earnings and profits among distributions.
(2) Previously taxed income. This paragraph (d)(2) applies to
distributions by a corporation that has both accumulated earnings and
profits and previously taxed income (within the meaning of section
1375(d)(2), as in effect prior to its amendment by the Subchapter S
Revision Act of 1982, and the regulations thereunder) with respect to
one or more shareholders. In the case of such a distribution, that
portion remaining after the application of section 1368(c)(1) (relating
to distributions from the accumulated adjustments account (AAA) as
defined in Sec. 1.1368-2(a)) is treated in the manner provided in
section 1368(b) (relating to S corporations without earnings and
profits) to the extent that portion is a distribution of money and does
not exceed the shareholder's net share immediately before the
distribution of the corporation's previously taxed income. The AAA and
the earnings and profits of the corporation are not decreased by that
portion of the distribution. Any distribution remaining after the
application of this paragraph (d)(2) is treated in the manner provided
in section 1368(c)(2) and (3).
(e) Certain adjustments taken into account. Paragraphs (c) and (d)
of this section are applied only after taking into account--
(1) The adjustments to the basis of the shares of a shareholder's
stock described in section 1367 (without regard to section
1367(a)(2)(A)) (relating to decreases attributable to distributions not
includible in income) for the S corporation's taxable year; and
(2) The adjustments to the AAA required by section 1368(e)(1)(A)
(but without regard to the adjustments for distributions under
Sec. 1.1368-2(a)(3)(iii)) for the S corporation's taxable year.
(f) Elections relating to source of distributions--(1) In general.
An S corporation may modify the application of paragraphs (c) and (d)
of this section by electing (pursuant to paragraph (f)(5) of this
section)--
(i) To distribute earnings and profits first as described in
paragraph (f)(2) of this section;
(ii) To make a deemed dividend as described in paragraph (f)(3) of
this section; or
(iii) To forego previously taxed income as described in paragraph
(f)(4) of this section.
(2) Election to distribute earnings and profits first--(i) In
general. An S corporation with accumulated earnings and profits may
elect under this paragraph (f)(2) for any taxable year to distribute
earnings and profits first as provided in section 1368(e)(3). Except as
provided in paragraph (f)(2)(ii) of this section, distributions made by
an S corporation making this election are treated as made first from
earnings and profits under section 1368(c)(2) and second from the AAA
under section 1368(c)(1). Any remaining portion of the distribution is
treated in the manner provided in section 1368(b). This election is
effective for all distributions made during the year for which the
election is made.
(ii) Previously taxed income. If a corporation to which paragraph
(d)(2) of this section (relating to corporations with previously taxed
income) applies makes the election provided in this paragraph (f)(2)
for the taxable year, and does not make the election to forego
previously taxed income under paragraph (f)(4) of this section,
distributions by the S corporation during the taxable year are treated
as made first, from previously taxed income under paragraph (d)(2) of
this section; second, from earnings and profits under section
1368(c)(2); and third, from the AAA under section 1368(c)(1). Any
portion of a distribution remaining after the previously taxed income,
earnings and profits, and the AAA are exhausted is treated in the
manner provided in section 1368(b).
(iii) Corporation with subchapter C and subchapter S earnings and
profits. If an S corporation that makes the election provided in this
paragraph (f)(2) has both subchapter C earnings and profits (as defined
in section 1362(d)(3)(B)) and subchapter S earnings and profits in a
taxable year of the corporation in which the distribution is made, the
distribution is treated as made first from subchapter C earnings and
profits, and second from subchapter S earnings and profits. Subchapter
S earnings and profits are earnings and profits accumulated in a
taxable year beginning before January 1, 1983 (or in the case of a
qualified casualty insurance electing small business corporation or a
qualified oil corporation, earnings and profits accumulated in any
taxable year), for which an election under subchapter S of chapter 1 of
the Internal Revenue Code was in effect.
(3) Election to make a deemed dividend. An S corporation may elect
under this paragraph (f)(3) to distribute all or part of its subchapter
C earnings and profits through a deemed dividend. If an S corporation
makes the election provided in this paragraph (f)(3), the S corporation
will be considered to have made the election provided in paragraph
(f)(2) of this section (relating to the election to distribute earnings
and profits first). The amount of the deemed dividend may not exceed
the subchapter C earnings and profits of the corporation on the last
day of the taxable year, reduced by any actual distributions of
subchapter C earnings and profits made during the taxable year. The
amount of the deemed dividend is considered, for all purposes of the
Internal Revenue Code, as if it were distributed in money to the
shareholders in proportion to their stock ownership, received by the
shareholders, and immediately contributed by the shareholders to the
corporation, all on the last day of the corporation's taxable year.
(4) Election to forego previously taxed income. An S corporation
may elect to forego distributions of previously taxed income. If such
an election is made, paragraph (d)(2) of this section (relating to
corporations with previously taxed income) does not apply to any
distribution made during the taxable year. Thus, distributions by a
corporation that makes the election to forego previously taxed income
for a taxable year under this paragraph (f)(4) and does not make the
election to distribute earnings and profits first under paragraph
(f)(2) of this section are treated in the manner provided in section
1368(c) (relating to distributions by corporations with earnings and
profits). Distributions by a corporation that makes both the election
to distribute earnings and profits first under paragraph (f)(2) of this
section and the election to forego previously taxed income under this
paragraph (f)(4), are treated in the manner provided in paragraph
(f)(2)(i) of this section.
(5) Time and manner of making elections--(i) For earnings and
profits. If an election is made under paragraph (f)(2) of this section
to distribute earnings and profits first, see section 1368(e)(3)
regarding the consent required by shareholders.
(ii) For previously taxed income and deemed dividends. If an
election is made to forego previously taxed income under paragraph
(f)(4) of this section or to make a deemed dividend under paragraph
(f)(3) of this section, consent by each ``affected shareholder,'' as
defined in section 1368(e)(3)(B), is required.
(iii) Corporate statement regarding elections. A corporation makes
an election for a taxable year under this paragraph (f) by attaching a
statement to a timely filed original or amended return required to be
filed under section 6037 for that taxable year. In the statement, the
corporation must identify the election it is making under Sec. 1.1368-
1(f) and must state that each shareholder consents to the election. An
officer of the corporation must sign under penalties of perjury the
statement on behalf of the corporation. A statement of election to make
a deemed dividend under this paragraph must include the amount of the
deemed dividend that is distributed to each shareholder.
(iv) Irrevocable elections. The elections under this paragraph (f)
are irrevocable and are effective only for the taxable year for which
they are made. In applying the preceding sentence to elections under
this paragraph (f), an election to terminate the taxable year under
section 1377(a)(2) or Sec. 1.1368-1(g)(2) is disregarded.
(g) Special rules--(1) Election to terminate year under section
1377 or Sec. 1.1368-1(g)(2). If an election is made under section
1377(a)(2) (to terminate the year when a shareholder terminates his or
her interest in the corporation) or under paragraph (g)(2) of this
section (to terminate the year when there is a qualifying disposition),
this section applies as if the taxable year consisted of separate
taxable years, the first of which ends at the close of the day on which
the shareholder terminates his or her interest in the corporation or on
which there is a qualifying disposition of stock, whichever the case
may be.
(2) Election in case of a qualifying disposition-- (i) In general.
In the case of a qualifying disposition, a corporation may elect under
this paragraph (g)(2)(i) to treat the year as if it consisted of
separate taxable years, the first of which ends at the close of the day
on which the qualifying disposition occurs. A qualifying disposition
is--
(A) A disposition by a shareholder of 20 percent or more of the
outstanding stock of the corporation in one or more transactions during
any thirty-day period during the corporation's taxable year;
(B) A redemption treated as an exchange under section 302(a) or
section 303(a) of 20 percent or more of the outstanding stock of the
corporation from a shareholder in one or more transactions during any
thirty-day period during the corporation's taxable year; or
(C) An issuance of an amount of stock equal to or greater than 25
percent of the previously outstanding stock to one or more new
shareholders during any thirty-day period during the corporation's
taxable year.
(ii) Effect of the election. A corporation making an election under
paragraph (g)(2)(i) of this section must treat the taxable year as
separate taxable years for purposes of allocating items of income and
loss; making adjustments to the AAA, earnings and profits, and basis;
and determining the tax effect of distributions under section 1368(b)
and (c). An election made under paragraph (g)(2)(i) of this section may
be made upon the occurrence of any qualifying disposition. Dispositions
of stock that are taken into account as part of a qualifying
disposition are not taken into account in determining whether a
subsequent qualifying disposition has been made.
(iii) Time and manner of making election. A corporation makes an
election under paragraph (g)(2)(i) of this section for a taxable year
by attaching a statement to a timely filed original or amended return
required to be filed under section 6037 for a taxable year (without
regard to the election under paragraph (g)(2)(i) of this section). In
the statement, the corporation must state that it is electing for the
taxable year under Sec. 1.1368-1(g)(2)(i) to treat the taxable year as
if it consisted of separate taxable years. The corporation also must
set forth facts in the statement relating to the qualifying disposition
(e.g., sale, gift, stock issuance, or redemption), and state that each
shareholder who held stock in the corporation during the taxable year
(without regard to the election under paragraph (g)(2)(i) of this
section) consents to this election. An officer of the corporation must
sign under penalties of perjury the statement on behalf of the
corporation. For purposes of this election, a shareholder of the
corporation for the taxable year is a shareholder as described in
section 1362(a)(2). A single election statement may be filed for all
elections made under paragraph (g)(2)(i) of this section for the
taxable year. An election made under paragraph (g)(2)(i) of this
section is irrevocable.
Sec. 1.1368-2 Accumulated adjustments account (AAA).
(a) Accumulated adjustments account--(1) In general. The
accumulated adjustments account is an account of the S corporation and
is not apportioned among shareholders. The AAA is relevant for all
taxable years beginning on or after January 1, 1983, for which the
corporation is an S corporation. On the first day of the first year for
which the corporation is an S corporation, the balance of the AAA is
zero. The AAA is increased in the manner provided in paragraph (a)(2)
of this section and is decreased in the manner provided in paragraph
(a)(3) of this section. For the adjustments to the AAA in the case of
redemptions, reorganizations, and corporate separations, see paragraph
(d) of this section.
(2) Increases to the AAA. The AAA is increased for the taxable year
of the corporation by the sum of the following items with respect to
the corporation for the taxable year:
(i) The items of income described in section 1366(a)(1)(A) other
than income that is exempt from tax;
(ii) Any nonseparately computed income determined under section
1366(a)(1)(B); and
(iii) The excess of the deductions for depletion over the basis of
property subject to depletion unless the property is an oil or gas
property the basis of which has been allocated to shareholders under
section 613A(c)(11).
(3) Decreases to the AAA--(i) In general. The AAA is decreased for
the taxable year of the corporation by the sum of the following items
with respect to the corporation for the taxable year--
(A) The items of loss or deduction described in section
1366(a)(1)(A);
(B) Any nonseparately computed loss determined under section
1366(a)(1)(B);
(C) Any expense of the corporation not deductible in computing its
taxable income and not properly chargeable to a capital account, other
than--
(1) Federal taxes attributable to any taxable year in which the
corporation was a C corporation; and
(2) Expenses related to income that is exempt from tax; and
(D) The sum of the shareholders' deductions for depletion for any
oil or gas property held by the corporation described in section
1367(a)(2)(E).
(ii) Extent of allowable reduction. The AAA may be decreased under
paragraph (a)(3)(i) of this section below zero. The AAA is decreased by
noncapital, nondeductible expenses under paragraph (a)(3)(i)(C) of this
section even though a portion of the noncapital, nondeductible expenses
is not taken into account by a shareholder under Sec. 1.1367-1(f)
(relating to the elective ordering rule). The AAA is also decreased by
the entire amount of any loss or deduction even though a portion of the
loss or deduction is not taken into account by a shareholder under
section 1366(d)(1) or is otherwise not currently deductible under the
Internal Revenue Code. However, in any subsequent taxable year in which
the loss or deduction or noncapital, nondeductible expense is treated
as incurred by the corporation with respect to the shareholder under
section 1366(d)(2) or Sec. 1.1367-1(f) (or in which the loss or
deduction is otherwise allowed to the shareholder), no further
adjustment is made to the AAA.
(iii) Decrease to the AAA for distributions. The AAA is decreased
(but not below zero) by any portion of a distribution to which section
1368(b) or (c)(1) applies.
(4) Ordering Rules for the AAA. For any taxable year, the
adjustments to the AAA are made in the following order:
(i) The AAA is increased under paragraph (a)(2) of this section
before it is decreased under paragraph (a)(3) of this section for the
taxable year;
(ii) The AAA is decreased under paragraph (a)(3)(i) of this section
before it is decreased under paragraph (a)(3) (iii) of this section;
(iii) The AAA is decreased (but not below zero) by any portion of
an ordinary distribution to which section 1368(b) or (c)(1) applies;
and
(iv) The AAA is adjusted (whether negative or positive) for
redemption distributions under paragraph (d)(1) of this section.
(b) Distributions in excess of the AAA--(1) In general. A portion
of the AAA (determined under paragraph (b)(2) of this section) is
allocated to each of the distributions made for the taxable year if--
(i) An S corporation makes more than one distribution of property
with respect to its stock during the taxable year of the corporation
(including an S short year as defined under section 1362(e)(1)(A));
(ii) The AAA has a positive balance at the close of the year; and
(iii) The sum of the distributions made during the corporation's
taxable year exceeds the balance of the AAA at the close of the year.
(2) Amount of the AAA allocated to each distribution. The amount of
the AAA allocated to each distribution is determined by multiplying the
balance of the AAA at the close of the current taxable year by a
fraction, the numerator of which is the amount of the distribution and
the denominator of which is the amount of all distributions made during
the taxable year. For purposes of this paragraph (b)(2), the term all
distributions made during the taxable year does not include any
distribution treated as from earnings and profits or previously taxed
income pursuant to an election made under section 1368(e)(3) and
Sec. 1.1368-1(f)(2). See paragraph (d)(1) of this section for rules
relating to the adjustments to the AAA for redemptions and
distributions in the year of a redemption.
(c) Distribution of money and loss property--(1) In general. The
amount of the AAA allocated to a distribution under this section must
be further allocated (under paragraph (c)(2) of this section) if the
distribution--
(i) Consists of property the adjusted basis of which exceeds its
fair market value on the date of the distribution and money;
(ii) Is a distribution to which Sec. 1.1368-1(d)(1) applies; and
(iii) Exceeds the amount of the corporation's AAA properly
allocable to that distribution.
(2) Allocating the AAA to loss property. The amount of the AAA
allocated to the property other than money is equal to the amount of
the AAA allocated to the distribution multiplied by a fraction, the
numerator of which is the fair market value of the property other than
money on the date of distribution and the denominator of which is the
amount of the distribution. The amount of the AAA allocated to the
money is equal to the amount of the AAA allocated to the distribution
reduced by the amount of the AAA allocated to the property other than
money.
(d) Adjustment in the case of redemptions, reorganizations, and
divisions--(l) Redemptions--(i) General Rule. In the case of a
redemption distribution by an S corporation that is treated as an
exchange under section 302(a) or section 303(a) (a redemption
distribution), the AAA of the corporation is adjusted in an amount
equal to the ratable share of the corporation's AAA (whether negative
or positive) attributable to the redeemed stock as of the date of the
redemption.
(ii) Special rule for years in which a corporation makes both
ordinary and redemption distributions. In any year in which a
corporation makes one or more distributions to which section 1368(a)
applies (ordinary distributions) and makes one or more redemption
distributions, the AAA of the corporation is adjusted first for any
ordinary distributions and then for any redemption distributions.
(iii) Adjustments to earnings and profits. Earnings and profits are
adjusted under section 312 independently of any adjustments made to the
AAA.
(2) Reorganizations. An S corporation acquiring the assets of
another S corporation in a transaction to which section 381(a)(2)
applies will succeed to and merge its AAA (whether positive or
negative) with the AAA (whether positive or negative) of the
distributor or transferor S corporation as of the close of the date of
distribution or transfer. Thus, the AAA of the acquiring corporation
after the transaction is the sum of the AAAs of the corporations prior
to the transaction.
(3) Corporate separations to which section 368(a)(l)(D) applies. If
an S corporation with accumulated earnings and profits transfers a part
of its assets constituting an active trade or business to another
corporation in a transaction to which section 368(a)(l)(D) applies, and
immediately thereafter the stock and securities of the controlled
corporation are distributed in a distribution or exchange to which
section 355 (or so much of section 356 as relates to section 355)
applies, the AAA of the distributing corporation immediately before the
transaction is allocated between the distributing corporation and the
controlled corporation in a manner similar to the manner in which the
earnings and profits of the distributing corporation are allocated
under section 312 (h). See Sec. 1.312-10(a).
(e) Election to terminate year under section 1377(a)(2) or
Sec. 1.1368-1(g)(2). If an election is made under section 1377(a)(2)
(to terminate the year in the case of termination of a shareholder's
interest) or Sec. 1.1368-1(g)(2) (to terminate the year in the case of
a qualifying disposition), this section applies as if the taxable year
consisted of separate taxable years, the first of which ends at the
close of the day on which the shareholder terminated his or her
interest in the corporation or makes a substantial disposition of
stock, whichever the case may be.
Sec. 1.1368-3 Examples.
The principles of Secs. 1.1368-1 and 1.1368-2 are illustrated by
the examples below. In each example Corporation S is a calendar year
corporation:
Example 1. Distributions by S corporations without C corporation
earnings and profits. (i) Corporation S, an S corporation, has no
earnings and profits as of January 1, 1996, the first day of its
1996 taxable year. S's sole shareholder, A, holds 10 shares of S
stock with a basis of $1 per share as of that date. On March 1,
1996, S makes a distribution of $38 to A. For S's 1996 taxable year,
A's pro rata share of the amount of the items described in section
1367(a)(1) (relating to increases in basis of stock) is $50 and A's
pro rata share of the amount of the items described in section
1367(a)(2) (B) through (D) (relating to decreases in basis of stock
for items other than distributions) is $26.
(ii) Under section 1368(d)(1) and Sec. 1.1368-1(e)(1), the
adjustments to the bases of A's stock in S described in section 1367
are made before the distribution rules of section 1368 are applied.
Thus, A's basis per share in the stock is $3.40 ($1 + [($50-$26) /
10 shares]) before taking into account the distribution. Under
section 1367(a)(2)(A), the basis of A's stock is decreased by
distributions to A that are not includible in A's income. Under
Sec. 1.1367-1(c)(3), the amount of the distribution that is
attributable to each share of A's stock is $3.80 ($38 distribution /
10 shares). However, A only has a basis of $3.40 in each share, and
basis may not be reduced below zero. Therefore, the basis of each
share of his stock is reduced by $3.40 to zero, and the remaining
$4.00 of the distribution ([$3.80-$3.40] x 10 shares) is treated as
gain from the sale or exchange of property. As of January 1, 1997, A
has a basis of $0 in his shares of S stock.
Example 2. Distributions by S corporations with C corporation
earnings and profits. (i) Corporation S properly elects to be an S
corporation beginning January 1, 1997, and as of that date has
accumulated earnings and profits of $30. B, an individual and sole
shareholder of Corporation S, has 10 shares of S stock with a basis
of $12 per share. In addition, B lends $30 to S evidenced by a
demand note.
(ii) During 1997, S has a nonseparately computed loss of $150. S
makes no distributions to B during 1997. Under section 1366(d)(1), B
is allowed a loss equal to $150, the amount equal to the sum of B's
bases in his shares of stock and his basis in the debt. Under
section 1367, the loss reduces B's adjusted basis in his stock and
debt to $0. Under Sec. 1.1368-2(a)(3), S's AAA as of December 31,
1997, has a deficit of $150 as a result of S's loss for the year.
(iii) For 1998, S has $220 of separately stated income and
distributes $110 to B. The balance in the AAA (negative $150 from
1997) is increased by $220 for S's income for the year and decreased
to $0 for the portion of the distribution that is treated as being
from the AAA ($70). Under Sec. 1.1367-2(c), B's net increase is
$150, determined by reducing the $220 of income by the $70 of the
distribution not includible in income by B. Thus, B's basis in the
debt is fully restored to $30, and B's basis in S stock (before
accounting for the distribution) is increased from zero to $19 per
share ([$220-$30 applied to the debt] / 10). Thirty dollars of the
distribution is considered a dividend to the extent of S's $30 of
earnings and profits, and the remaining $10 of the distribution
reduces B's basis in the S stock. Thus, B's basis in the S stock as
of December 31, 1998, is $11 per share ($19-[$70 AAA distribution /
10]--[10 distribution treated as a reduction in basis / 10]). The
balance in the AAA is $0, S's earnings and profits are $0, and B's
basis in the loan is $30.
Example 3. Election in case of disposition of substantial amount
of stock. (i) Corporation S, an S corporation, has earnings and
profits of $3,000 and a balance in the AAA of $1,000 on January 1,
1997. C, an individual and the sole shareholder of Corporation S,
has 100 shares of S stock with a basis of $10 per share. On July 3,
1997, C sells 50 shares of his S stock to D, an individual, for
$250. For 1997, S has taxable income of $1,000, of which $500 was
earned on or before July 3, 1997, and $500 earned after July 3,
1997. During its 1997 taxable year, S distributes $1,000 to C on
February 1 and $1,000 to each of C and D on August 1. S does not
make the election under section 1368(e)(3) and Sec. 1.1368-1(f)(2)
to distribute its earnings and profits before its AAA. S makes the
election under Sec. 1.1368-1(g)(2) to treat its taxable year as if
it consisted of separate taxable years, the first of which ends at
the close of July 3, 1997, the date of the qualifying disposition.
(ii) Under section Sec. 1.1368-1(g)(2), for the period ending on
July 3, 1997, S's AAA is $500 ($1,000 (AAA as of January 1, 1997) +
$500 (income earned from January 1, 1997 through July 3, 1997)--
$1,000 (distribution made on February 1, 1997)). C's bases in his
shares of stock is decreased to $5 per share ($10 (original basis) +
$5 (increase per share for income)--$10 (decrease per share for
distribution)).
(iii) The AAA is adjusted at the end of the taxable year for the
period July 4 through December 31, 1997. It is increased from $500
(AAA as of the close of July 3, 1997) to $1,000 for the income
earned during this period and is decreased by $1,000, the portion of
the distribution ($2,000 in total) made to C and D on August 1 that
does not exceed the AAA. The $1,000 portion of the distribution that
remains after the AAA is reduced to zero is attributable to earnings
and profits. Therefore C and D each have a dividend of $500, which
does not affect their basis or S's AAA. The earnings and profits
account is reduced from $3,000 to $2,000.
(iv) As of December 31, 1997, C and D have bases in their shares
of stock of zero ($5 (basis as of July 4)+$5 ($500 income/100
shares)--$10 ($1,000 distribution/100 shares)). C and D each will
report $500 as dividend income, which does not affect their basis or
S's AAA.
Example 4. Election to distribute earnings and profits first.
(i) Corporation S has been a calendar year C corporation since 1975.
For 1982, S elects for the first time to be taxed under subchapter
S, and during 1982 has $60 of earnings and profits. As of December
31, 1995, S has an AAA of $10 and earnings and profits of $160,
consisting of $100 of subchapter C earnings and profits and $60 of
subchapter S earnings and profits. For 1996, S has $200 of taxable
income and the AAA is increased to $210 (before taking distributions
into account). During 1996, S distributes $240 to its shareholders.
With its 1996 tax return, S properly elects under section 1368(e)(3)
and Sec. 1.1368-1(f)(2) to distribute its earnings and profits
before its AAA.
(ii) Because S elected to distribute its earnings and profits
before its AAA, the first $100 of the distribution is characterized
as a distribution from subchapter C earnings and profits; the next
$60 of the distribution is characterized as a distribution from
subchapter S earnings and profits. Because $160 of the distribution
is from earnings and profits, the shareholders of S have a $160
dividend. The remaining $80 of the distribution is a distribution
from S's AAA and is treated by the shareholders as a return of
capital or gain from the sale or exchange of property, as
appropriate, under Sec. 1.1368-1(d)(1). S's AAA, as of December 31,
1996, equals $130 ($210-$80).
Example 5. Distributions in excess of the AAA. (i) On January 1,
1995, Corporation S has $40 of earnings and profits and a balance in
the AAA of $100. S has two shareholders, E and F, each of whom own
50 shares of S's stock. For 1995, S has taxable income of $50, which
increases the AAA to $150 as of December 31, 1995 (before taking
into account distributions made during 1995). On February 1, 1995, S
distributes $60 to each shareholder. On September 1, 1995, S
distributes $30 to each shareholder. S does not make the election
under section 1368(e)(3) and Sec. 1.1368-1(f)(2) to distribute its
earnings and profits before its AAA.
(ii) The sum of the distributions exceed S's AAA. Therefore,
under Sec. 1.1368-2(b), a portion of S's $150 balance in the AAA as
of December 31, 1995, is allocated to each of the February 1 and
September 1 distributions based on the respective sizes of the
distributions. Accordingly, S must allocate $100 ($150 (AAA) x ($120
(February 1 distribution)/$180 (the sum of the distributions))) of
the AAA to the February 1 distribution, and $50 ($150 x ($60/$180))
to the September 1 distribution. The portions of the distributions
to which the AAA is allocated are treated by the shareholder as a
return of capital or gain from the sale or exchange of property, as
appropriate. The remainder of the two distributions is treated as a
dividend to the extent that it does not exceed S's earnings and
profits. E and F must each report $10 of dividend income for the
February 1 distribution. For the September 1 distribution, E and F
must each report $5 of dividend income.
Example 6. Ordinary and redemption distributions in the same
taxable year. (i) On January 1, 1995, Corporation S, an S
corporation, has $20 of earnings and profits and a balance in the
AAA of $10. S has two shareholders, G and H, each of whom owns 50
shares of S's stock. For 1995, S has taxable income of $16, which
increases the AAA to $26 as of December 31, 1995 (before taking into
account distributions made during 1995). On February 1, 1995, S
distributes $10 to each shareholder. On December 31, 1995, S redeems
for $13 all of shareholder G's stock in a redemption that is treated
as a sale or exchange under section 302(a).
(ii) The sum of the ordinary distributions does not exceed S's
AAA. Therefore, S must reduce the $26 balance in the AAA by $20 for
the February 1 ordinary distribution. The portions of the
distribution by which the AAA is reduced are treated by the
shareholders as a return of capital or gain from the sale or
exchange of property. S must adjust the remaining AAA, $6, in an
amount equal to the ratable share of the remaining AAA attributable
to the redeemed stock, or $3 (50% x $6).
(iii) S also must adjust the earnings and profits of $20 in an
amount equal to the ratable share of the earnings and profits
attributable to the redeemed stock. Therefore, S adjusts the
earnings and profits by $10 (50% x $20), the ratable share of the
earnings and profits attributable to the redeemed stock.
Sec. 1.1368-4 Effective date and transition rule.
Sections 1.1368-1, 1.1368-2, and 1.1368-3 apply to taxable years of
a corporation beginning on or after January 1, 1994. For taxable years
beginning before January 1, 1994, the treatment of distributions by an
S corporation to its shareholders must be determined in a reasonable
manner, taking into account the statute and the legislative history.
Except with regard to the deemed dividend rule under Sec. 1.1368-
1(f)(3), return positions consistent with Secs. 1.1368-1, 1.1368-2, and
1.1368-3 are reasonable.
PART 602--OMB CONTROL NUMBERS UNDER THE PAPERWORK REDUCTION ACT
Par. 12. The authority citation for part 602 continues to read:
Authority: 26 U.S.C. 7805.
Par. 13. Section 602.101(c) is amended by adding the following
entries in numerical order to the table to read as follows:
Sec. 602.101 OMB Control numbers.
* * * * *
(c) * * *
------------------------------------------------------------------------
Current OMB
CFR part or section where identified control Number
------------------------------------------------------------------------
* * * * *
1.1367-1(f).......................................... 1545-1139
1.1368-1(f)(2)....................................... 1545-1139
1.1368-1(f)(3)....................................... 1545-1139
1.1368-1(f)(4)....................................... 1545-1139
1.1368-1(g)(2)....................................... 1545-1139
* * * * *
------------------------------------------------------------------------
Margaret Milner Richarson,
Commissioner of Internal Revenue.
Approved: December 21, 1993.
Leslie Samuels,
Assistant Secretary of the Treasury (Tax Policy).
[FR Doc. 93-31928 Filed 12-30-93; 8:45 am]
BILLING CODE 4830-01-U
Complete official Federal Register PDF
FR Doc. 93-31908 Airworthiness Directives; General Electric CT7 Series Turboprop and Turboshaft Engines
[Federal Register Volume 59, Number 1 (Monday, January 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31908]
Federal Register / Vol. 59, No. 1 / Monday, January 3, 1994 /
[[Page Unknown]]
[Federal Register: January 3, 1994]
VOL. 59, NO. 1
Monday, January 3, 1994
=======================================================================
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 92-ANE-08; Amendment 39-8781; AD 93-25-17]
Airworthiness Directives; General Electric CT7 Series Turboprop
and Turboshaft Engines
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This amendment adopts a new airworthiness directive (AD),
applicable to General Electric (GE) CT7 series turboprop and turboshaft
engines. This proposal would require the removal from service of
certain gas generator turbine (GGT) rotor assembly parts that were
plasma-sprayed during manufacture. This amendment is prompted by
material testing that indicates that the plasma-spray process reduces
the low cycle fatigue (LCF) capability of the material. The actions
specified by this AD are intended to prevent fatigue cracks that can
result in uncontained engine failure.
DATES: Effective February 2, 1994.
The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register, as
of February 2, 1994.
ADDRESSES: The service information referenced in this AD may be
obtained from General Electric Aircraft Engines, 1000 Western Avenue,
Lynn, Massachusetts 01910. This information may be examined at the FAA,
New England Region, Office of the Assistant Chief Counsel, Attn: Rules
Docket No. 92-ANE-08, 12 New England Executive Park, Burlington,
Massachusetts 01803-5299; or at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20001.
FOR FURTHER INFORMATION CONTACT: Barbara G. Caufield, Aerospace
Engineer, Engine Certification Branch, ANE-141, Engine Certification
Office, FAA, New England Region, Engine and Propeller Directorate,
Aircraft Certification Service, 12 New England Executive Park,
Burlington, Massachusetts 01803-5299; telephone (617) 238-7146; fax
(617) 238-7199.
SUPPLEMENTARY INFORMATION: A proposal to amend part 39 of the Federal
Aviation Regulations to include an airworthiness directive (AD) that is
applicable to General Electric CT7 series turboprop and turboshaft
engines was published in the Federal Register on November 13, 1992 (57
FR 53862). That action proposed to require the removal from service of
certain gas generator turbine (GGT) rotor assembly parts that were
plasma-sprayed during manufacture, and replacement with serviceable
parts. The actions would be required to be accomplished in accordance
with GE CT7 Turboprop Service Bulletin (SB) A72-252, dated August 31,
1990; and GE CT7 Turboshaft SB A72-17 and SB A72-18, both dated
September 10, 1990.
Interested persons have been afforded an opportunity to participate
in the making of this amendment. Due consideration has been given to
the comments received.
One commenter supports the rule as proposed.
One commenter observes that the economic analysis in the proposed
AD is based on 23 engines being affected by the AD, when, in fact,
there are only 11 engines containing a combination of 23 parts. The FAA
concurs. The wording of the economic analysis for the final rule has
been changed accordingly.
After careful review of the available data, including the comments
noted above, the FAA has determined that air safety and the public
interest require the adoption of the rule as proposed.
The FAA estimates that 11 engines (containing 23 affected parts)
installed on aircraft of U.S. registry will be affected by this AD,
that it will take approximately 7 work hours per engine to accomplish
the required actions, and that the average labor rate is $55 per work
hour. Required parts will cost approximately $8,255 per engine. Based
on these figures, the total cost impact of the AD on U.S. operators is
estimated to be $95,040. The manufacturer has advised the FAA that a
pro-rata credit allowance will be granted for labor and parts required
to accomplish these removals and replacements at a GE authorized
service or overhaul facility. Based on this information, the FAA has
determined that the total cost impact of the AD on U.S. operators would
be approximately $5,940 ($540 per engine).
The regulations adopted herein will 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 final
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this action (1) is
not a ``significant regulatory action'' under Executive Order 12866;
(2) is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and (3) 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 final evaluation has been prepared for this action
and it is contained in the Rules Docket. A copy of it may be obtained
from the Rules Docket at the location provided under the caption
ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends 14 CFR part
39 of the Federal Aviation Regulations as follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. App. 1354(a), 1421 and 1423; 49 U.S.C.
106(g); and 14 CFR 11.89.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by adding the following new
airworthiness directive:
93-25-17. General Electric: Amendment 39-8781. Docket No. 93-ANE-08.
Applicability: General Electric (GE) Models CT7-5A2, -7A, and -
9C Turboprop Engines; and Models CT7-2A, and -6 Turboshaft Engines,
incorporating gas generator turbine (GGT) disks and cooling plates,
as listed by Part Number (P/N) and Serial Number (S/N) in GE CT7
Turboprop Service Bulletin (SB) A72-252, dated August 31, 1990; GE
CT7 Turobshaft SB A72-17, and GE CT7 Turboshaft SB A72-18, both
dated September 10, 1990, installed on, but not limited to, Saab
340A, Casa CN235-10, Bell 214ST, and European Helicopter Industries
EH101.
Compliance: Required as indicated, unless accomplished
previously.
To prevent fatigue cracks that can result in uncontained engine
failure, accomplish the following:
(a) Remove from service the affected GE Model(s) CT7-5A2, -7A,
and -9C engines GGT rotor stage 1 and 2 disks, and stage 2 forward
and aft cooling plates, prior to exceeding the ``Max total allowable
cycles''; as listed in GE CT7 Turboprop SB A72-252, dated August 31,
1990, and replace with serviceable parts.
(b) Remove from service the affected GE Model(s) CT7-6 engine
GGT rotor stage 1 disk and stage 2 forward cooling plate prior to
exceeding the ``Max total allowable cycles''; as listed in GE CT7
Turboprop SB A72-17, dated September 10, 1990, and replace with
serviceable parts.
(c) Remove from service the affected GE Model(s) CT7-2A engine
GGT rotor stage 2 disk and stage 2 forward cooling plate prior to
exceeding the ``Max total allowable cycles''; as listed in GE CT7
Turboshaft SB A72-8, dated September 10, 1990, and replace with
serviceable parts.
(d) 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, Engine Certification Office. The
request should be forwarded through an appropriate FAA Principal
Maintenance Inspector, who may add comments and then send it to the
Manager, Engine Certification Office.
Note: Information concerning the existence of approved
alternative methods of compliance with this airworthiness directive,
if any, may be obtained from the Engine Certification Office.
(e) Special flight permits may be issued, in accordance with FAR
21.197 and 21.199, to operate the airplane to a location where the
requirements of this AD can be accomplished.
(f) The removals and replacements of the affected rotor stage
disks and cooling plates shall be done in accordance with the
following service bulletins:
------------------------------------------------------------------------
Document No. Page No. Issue Date
------------------------------------------------------------------------
GE CT7 Turboprop 1-13............ Original........ Aug 31, 1990
SB A72-252.
Total pages: 13
GE CT7 Turboshaft 1-4............. Original........ Sep 10, 1990
SB A72-17.
Total pages: 4
GE CT7 Turboshaft 1-4............. Original........ Sep 10, 1990
SB A72-18.
Total pages: 4
------------------------------------------------------------------------
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 General Electric Aircraft
Engines, 1000 Western Avenue, Lynn, Massachusetts 01910. Copies may
be inspected at the FAA, New England Region, Office of the Assistant
Chief Counsel, Attn: Rules Docket No. 92-ANE-08, 12 New England
Executive Park, Burlington, Massachusetts; or at the Office of the
Federal Register, 800 North Capitol Street NW., suite 700,
Washington, DC.
(g) This amendment becomes effective on February 2, 1994.
Issued in Burlington, Massachusetts, on December 21, 1993.
Jay J. Pardee,
Acting Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 93-31908 Filed 12-30-93; 8:45 am]
BILLING CODE 4910-13-P
Complete official Federal Register PDF
FR Doc. 93-31907 Airworthiness Directives; Allied-Signal Aerospace Company, Garrett Engine Division, TFE731 Series Turbofan Engines
[Federal Register Volume 59, Number 1 (Monday, January 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31907]
[[Page Unknown]]
[Federal Register: January 3, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 39
[Docket No. 93-ANE-71; Amendment 39-8780; AD 93-25-16]
Airworthiness Directives; Allied-Signal Aerospace Company,
Garrett Engine Division, TFE731 Series Turbofan Engines
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule, request for comments.
-----------------------------------------------------------------------
SUMMARY: This amendment supersedes an existing airworthiness directive
(AD), applicable to Allied-Signal Aerospace Company, Garrett Engine
Division, TFE731 series turbofan engines, that currently requires an
improved, more definitive eddy current inspection, and replacement, if
necessary, of certain fan disks for cracks. This amendment requires an
additional 30 fan disks to be inspected. This amendment is prompted by
the examination of fan disk eddy current inspection tapes using more
definitive inspection criteria. The actions specified by this AD are
intended to prevent an uncontained fan disk failure.
DATES: Effective January 18, 1994.
The incorporation by reference of Allied-Signal Propulsion Engines
ASB No. TFE731-A72-3504, Revision 1, dated July 2, 1993, is approved by
the Director of the Federal Register as of January 18, 1994.
The incorporation by reference of Allied-Signal Aerospace Company,
Garrett Engine Division, ASB No. TFE731-A72-3504, dated November 25,
1992, was approved previously by the Director of the Federal Register
as of April 9, 1993 (58 FR 16113, March 25, 1993).
Comments for inclusion in the Rules Docket must be received on or
before March 4, 1994.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), New England Region, Office of the Assistant Chief
Counsel, Attention: Rules Docket No. 93-ANE-71, 12 New England
Executive Park, Burlington, MA 01803-5299.
The service information referenced in this AD may be obtained from
AlliedSignal Engines, Aviation Services Division, Data Distribution,
Dept. 64-3/2102-1M, P.O. Box 29003, Phoenix, AZ 85038-9003; telephone
(602) 365-2548. This information may be examined at the FAA, New
England Region, Office of the Assistant Chief Counsel, Burlington, MA;
or at the Office of the Federal Register, 800 North Capitol Street,
NW., suite 700, Washington, DC.
FOR FURTHER INFORMATION CONTACT: Joseph Costa, Aerospace Engineer, Los
Angeles Aircraft Certification Office, FAA, Transport Airplane
Directorate, 3229 East Spring Street, Long Beach, CA 90806-2425;
telephone (310) 988-5246, fax (310) 988-5210.
SUPPLEMENTARY INFORMATION: On February 19, 1993, the Federal Aviation
Administration (FAA) issued AD 92-26-09, Amendment 39-8503 (58 FR
16113, March 25, 1993), to require an improved, more definitive eddy
current inspection of certain fan disks for cracks, and replacement, if
necessary, of these fan disks. That action was prompted by reports of
an uncontained failure of a fan disk on an Allied-Signal Aerospace
Company, Garrett Engine Division, Model TFE731-3 turbofan engine. The
FAA investigation determined that a fatigue crack originated in the aft
acute corner of the dovetail slot. The fan disk had accumulated a total
of 5291 cycles in service (CIS) at the time of the failure, and had
been eddy current inspected in 1990 when the disk had accumulated 4055
CIS. The fan disk displayed evidence of broaching grooves produced
during the manufacture of the blade dovetail slots. These machining
grooves may have contributed to the disk failure. From a metallurgical
analysis, the FAA has determined that the failed fan disk had dovetail
cracks which were not detected at the time of the eddy current
inspection. A review of the eddy current inspection process used to
inspect this disk and all disks inspected prior to May 1991 revealed
that the process will not reliably detect this type of crack on these
disks. Fan disk cracks, if not detected, could result in an uncontained
fan disk failure.
Since the issuance of that AD, the FAA has determined that an
additional 30 fan disks will require inspection, or replacement, if
necessary. In addition, the Applicability Section of AD 92-26-09
identified the Learjet 55 series as one aircraft that might have an
affected engine installed. The FAA has since learned that no Learjet 55
series aircraft has an affected engine, and therefore, deletes the
Learjet 55 series from that list of aircraft. Finally, AlliedSignal
Propulsion Engines has issued Revision 1 to AlliedSignal Propulsion
Engines Alert Service Bulletin (ASB) No. TFE731-A72-3504. This AD
incorporates this revision.
The FAA has reviewed and approved the technical contents of Allied-
Signal Aerospace Company, Garrett Engine Division, ASB No. TFE731-A72-
3504, dated November 25, 1992, and AlliedSignal Propulsion Engines ASB
No. TFE731-A72-3504, Revision 1, dated July 2, 1993, that describe
procedures for an improved, more definitive eddy current inspection of
these fan disks for cracks.
Since an unsafe condition has been identified that is likely to
exist or develop on other engines of this same type design, this AD
supersedes AD 92-26-09 to require inspection of an additional 30 fan
disks. Fan disks inspected in accordance with the existing AD, 92-26-
09, need not be inspected again. The inspection schedule for fan disks
not yet inspected in accordance with the existing AD, however, remains
the same, using April 9, 1993, the effective date of AD 92-26-09 as the
starting point. The actions are required to be accomplished in
accordance with the service bulletins described previously.
Since a situation exists that requires the immediate adoption of
this regulation, it is found that notice and opportunity for prior
public comment hereon are impracticable, and that good cause exists for
making this amendment effective in less than 30 days.
Comments Invited
Although this action is in the form of a final rule that involves
requirements affecting flight safety and, thus, was not preceded by
notice and an opportunity for public comment, comments are invited on
this rule. Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments as they may desire.
Communications should identify the Rules Docket number and be submitted
in triplicate to the address specified under the caption ``ADDRESSES.''
All communications received on or before the closing date for comments
will be considered, and this rule may be amended in light of the
comments received. Factual information that supports the commenter's
ideas and suggestions is extremely helpful in evaluating the
effectiveness of the AD action and determining whether additional
rulemaking action would be needed.
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify the 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 that
summarizes each FAA-public contact concerned with the substance of this
AD 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 93-ANE-71.'' The postcard will be date stamped and
returned to the commenter.
The regulations adopted herein will 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 final
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
The FAA has determined that this regulation is an emergency
regulation that must be issued immediately to correct an unsafe
condition in aircraft, and is not a ``significant regulatory action''
under Executive Order 12866. It has been determined further that this
action involves an emergency regulation under DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979). If it is determined
that this emergency regulation otherwise would be significant under DOT
Regulatory Policies and Procedures, a final regulatory evaluation will
be prepared and placed in the Rules Docket. A copy of it, if filed, may
be obtained from the Rules Docket at the location provided under the
caption ``ADDRESSES.''
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends 14 CFR part
39 of the Federal Aviation Regulations as follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. App. 1354(a), 1421 and 1423; 49 U.S.C.
106(g); and 14 CFR 11.89.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by removing Amendment 39-8503, (58 FR
16113, March 25, 1993), and by adding a new airworthiness directive,
Amendment 39-8780, to read as follows:
93-25-16 Allied-Signal Aerospace Company, Garrett Engine Division:
Amendment 39-8780. Docket 93-ANE-71. Supersedes AD 92-26-09,
Amendment 39-8503.
Applicability: Allied-Signal Aerospace Company, Garrett Engine
Division, TFE731-2, -3, and -3R series turbofan engines installed on
but not limited to Sabreliner NA-265-65 (Sabreliner 65); Israel
Aircraft Industries 1124 series (Westwind); Avions Marcel Dassault
Falcon 10, 50, 100 series; Learjet 35, 36, and 31 (M31) series;
British Aerospace BAe HS125 series; and Lockheed 1329-23, -25 series
(731 Jetstar, Jetstar II) aircraft.
Compliance: Required as indicated, unless accomplished
previously.
To prevent an uncontained fan disk failure, accomplish the
following:
(a) For all disks previously eddy current inspected in
accordance with the requirements of AD 92-26-09, no further action
is required.
(b) Remove prior to further flight fan disk Part Number (P/N)
3073539-2 or 3072162-2 with Serial Number (S/N) 8-18040-6300, in
accordance with Allied-Signal Aerospace Company, Garrett Engine
Division, Alert Service Bulletin (ASB) No. TFE731-A72-3504, dated
November 25, 1992, or AlliedSignal Propulsion Engines ASB No.
TFE731-A72-3504, Revision 1, dated July 2, 1993, and replace with a
serviceable disk.
(c) Eddy current inspect fan disks, P/N 3072162-1 through -4,
3073436-1 through -4, 3073539-2, and 3074529-2, in accordance with
Allied-Signal Aerospace Company, Garrett Engine Division, ASB No.
TFE731-A72-3504, dated November 25, 1992, or AlliedSignal Propulsion
Engines ASB No. TFE731-A72-3504, Revision 1, dated July 2, 1993, and
if necessary, replace with a serviceable disk, as follows:
(1) For fan disks listed by S/N in Table 2 of Allied-Signal
Aerospace Company, Garrett Engine Division, ASB No. TFE731-A72-3504,
dated November 25, 1992, or AlliedSignal Propulsion Engines ASB No.
TFE731-A72-3504, Revision 1, dated July 2, 1993, inspect, and if
necessary, replace with a serviceable disk within 50 cycles in
service (CIS) after April 9, 1993 (effective date of AD 92-26-09).
(2) For the 10 added fan disks listed by S/N in Table 3 of
AlliedSignal Propulsion Engines ASB No. TFE731-A72-3504, Revision 1,
dated July 2, 1993, with 5000 or more CIS since new on the effective
date of this AD, inspect, and if necessary, replace with a
serviceable disk, within the next 50 CIS after the effective date of
this AD.
(3) For fan disks listed by S/N in Table 3 of AlliedSignal
Propulsion Engines ASB No. TFE731-A72-3504, Revision 1, dated July
2, 1993, other than the 10 added fan disks, with 5000 or more CIS
since new on April 9, 1993, (effective date of AD 92-26-09),
inspect, and if necessary, replace with a serviceable disk, within
the next 50 CIS after April 9, 1993 (effective date of AD 92-26-09).
(4) For the 10 added fan disks listed by S/N in Table 3 of
Allied-Signal Propulsion Engines ASB No. TFE731-A72-3504, Revision
1, dated July 2, 1993, with less than 5000 CIS since new on the
effective date of this AD, inspect, and if necessary, replace with a
serviceable disk within the next 100 CIS after the effective date of
this AD, or prior to accumulating 5050 CIS since new, whichever
occurs first.
(5) For fan disks listed by S/N in Table 3 of AlliedSignal
Propulsion Engines ASB No. TFE731-A72-3504, Revision 1, dated July
2, 1993, other than the 10 added fan disks, with less than 5000 CIS
since new on April 9, 1993, (effective date of AD 92-26-09),
inspect, and if necessary, replace with a serviceable disk, within
the next 100 CIS after April 9, 1993 (effective date of AD 92-26-
09), or prior to accumulating 5050 CIS since new, whichever occurs
first.
(6) For fan disks listed by S/N in Table 4 of Allied-Signal
Propulsion Engines ASB No. TFE731-A72-3504, Revision 1, dated July
2, 1993, inspect, and if necessary, replace with a serviceable disk,
within the next 100 CIS after the effective date of this AD.
(d) 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, Los Angeles Aircraft Certification
Office. The request should be forwarded through an appropriate FAA
Maintenance Inspector, who may add comments and then send it to the
Manager, Los Angeles Aircraft Certification Office.
Note: Information concerning the existence of approved
alternative methods of compliance with this airworthiness directive,
if any, may be obtained from the Los Angeles Aircraft Certification
Office.
(e) Special flight permits may be issued in accordance with FAR
21.197 and 21.199 to operate the aircraft to a location where the
requirements of this AD can be accomplished.
(f) The inspection, and replacement, if necessary, shall be done
in accordance with the following service documents:
----------------------------------------------------------------------------------------------------------------
Document No. Pages Revision Date
----------------------------------------------------------------------------------------------------------------
Allied-Signal Propulsion 1-28.................... 1........................... July 2, 1993.
Engines ASB No. TFE731-A72-
3504.
Total pages: 28.........
Allied-Signal Aerospace 1-24.................... Original.................... November 25, 1992.
Company, Garrett Engine
Division, ASB No. TFE731-
A72-3504.
Total pages: 24.........
----------------------------------------------------------------------------------------------------------------
The incorporation by reference of AlliedSignal Propulsion
Engines ASB No. TFE731-A72-3504, Revision 1, dated July 2, 1993, is
approved by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. The incorporation by reference of
Allied-Signal Aerospace Company, Garrett Engine Division, ASB No.
TFE731-A72-3504, dated November 25, 1992, was approved previously by
the Director of the Federal Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51 as of April 9, 1993 (58 FR 16113, March 25,
1993). Copies may be obtained from AlliedSignal Engines, Aviation
Services Division, Data Distribution, Dept. 64-3/2102-1M, P.O. Box
29003, Phoenix, AZ 85038-9003; telephone (602) 365-2548. Copies may
be inspected at the FAA, New England Region, Office of the Assistant
Chief Counsel, 12 New England Executive Park, Burlington, MA; or at
the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC.
(g) This amendment becomes effective on January 18, 1994.
Issued in Burlington, Massachusetts, on December 21, 1993.
Jay J. Pardee,
Acting Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 93-31907 Filed 12-30-93; 8:45 am]
BILLING CODE 4910-13-P
Complete official Federal Register PDF
FR Doc. 93-31852 Rules for Determining the Country of Origin of a Good for Purposes of Annex 311 of the NAFTA and Rules of Origin Applicable to Imported Merchandise; Rule and Proposed Rule
[Federal Register Volume 59, Number 1 (Monday, January 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31852]
[[Page Unknown]]
[Federal Register: January 3, 1994]
_______________________________________________________________________
Part II
Department of the Treasury
_______________________________________________________________________
Customs Service
_______________________________________________________________________
19 CFR Part 4, et al.
Rules for Determining the Country of Origin of a Good for Purposes of
Annex 311 of the NAFTA and Rules of Origin Applicable to Imported
Merchandise; Rule and Proposed Rule
DEPARTMENT OF THE TREASURY
Customs Service
19 CFR Parts 12, 102, and 134
RIN 1515-AB34
[T.D. 94-4]
Rules for Determining the Country of Origin of a Good for
Purposes of Annex 311 of the North American Free Trade Agreement
AGENCY: U.S. Customs Service, Department of the Treasury.
ACTION: Interim regulations; solicitation of comments.
-----------------------------------------------------------------------
SUMMARY: This document establishes the rules for determining when the
country of origin of a good is one of the parties to the North American
Free Trade Agreement for purposes of Annex 311 of that Agreement. This
agreement was implemented under the North American Free-Trade Agreement
Implementation Act, Public Law 103-182, 107 Stat. 437 (December 8,
1993).
DATES: This interim rule is effective January 1, 1994. Comments must be
received on or before April 4, 1994.
ADDRESSES: Written comments (preferably in triplicate) may be addressed
to U.S. Customs Service, 1301 Constitution Avenue, NW., Franklin Court,
Washington, DC 20229, and they may be inspected at the Regulations
Branch located at 1099 14th St. NW., Suite 4000, Washington, DC.
FOR FURTHER INFORMATION CONTACT: Sandra L. Gethers, Office of
Regulations and Rulings (202-482-6980).
SUPPLEMENTARY INFORMATION:
Background
Paragraph 1 of Annex 311 of the North American Free-Trade Agreement
(NAFTA), entitled ``Country of Origin Marking,'' provides that the
parties shall establish ``MARKING RULES'' to determine when a good is a
good of a NAFTA country, i.e., whether the country of origin of a good
is either the United States, Canada, and Mexico, for the following
purposes specified in that Annex: (1) country of origin marking; (2)
Annex 300-B (Textile and Apparel Goods); and (3) Annex 302.2 (Tariff
Elimination).
The interim regulations established in this document represent
fulfillment of the United States obligations under Annex 311. These
interim regulations will be effective on January 1, 1994, for all goods
imported into the United States for purposes of determining whether or
not the country of origin of such goods is either Canada, Mexico or the
United States.
In a separate Notice of Proposed Rulemaking published in today's
Federal Register, the Customs Service is proposing to establish
identical rules for determining the country of origin of all imported
goods for all purposes under the Customs and related laws.
The Customs Service, however, will also honor all existing written
rulings issued pursuant to part 177 of this chapter (19 CFR part 177)
during the interim period of these regulations.
Discussion of Interim Regulations
Section 102.0 Scope
Section 102.0 sets forth the purposes previously identified under
Annex 311, for which the rules in this part will be used. These rules
are considered the ``Marking Rules'' for purposes of that Annex.
Section 102.1 Definitions
Section 102.1, ``Definitions'', sets forth the definitions of terms
that will be used in part 102. It is of note that some of the defined
terms, such as ``wholly obtained or produced'' in paragraph (g) will be
used only in Sec. 102.11, ``General Rules'', while other terms, such as
the definition for ``material,'' will be used in several sections in
this part, including in many of the specific rules in Sec. 102.20. Of
special note is the definition of ``material'', another term that is
used throughout this part. Under paragraph (k), the term, ``material''
is defined as including ``parts'', ``ingredients'', subassemblies'',
and ``components'', terms which are used interchangeably in this part.
Section 102.11 General Rules
Section 102.11, ``General Rules,'' sets forth the required
hierarchy for determining country of origin under this part, unless
otherwise specified in another provision of this part. Paragraphs
(a)(1) through (a)(3) of Sec. 102.11 set forth the three common
circumstances in which the country of origin of a good is determined.
First, the country of origin can be the country in which the good is
``wholly obtained or produced'' as defined in Sec. 102.1(g). For
example, cattle born and raised in Texas are wholly obtained or
produced in the United States. If the good is not wholly obtained or
produced in a single country, paragraph (a)(2) provides that the
country of origin can be the country in which the good is produced
exclusively from domestic materials. For example, if a desk is produced
in Canada from Canadian lumber and from hardware produced in Canada
from imported steel, which under part 102, became a product of Canada,
the desk is produced in Canada ``exclusively from domestic materials.''
If, however, a good is neither wholly obtained or produced in a single
country, nor produced in a country exclusively from domestic materials,
the country of origin of a good may be determined to be the country in
which the foreign materials contained in the good met the requirements
of the specific rules provided under Sec. 102.20 for the good. For
example, imported textile rubberized thread classified under heading
5604, Harmonized Tariff Schedule of the United States (HTSUS), which is
produced in Mexico from synthetic yarn of Taiwanese origin (classified
under heading 5509, HTSUS) and from Malaysian rubber thread (classified
under heading 4007, HTSUS) is a product of Mexico. The rule under
Sec. 102.20 that is applicable to the imported good (heading 5604,
HTSUS) states: ``A change to heading 5602 through 5605 from a heading
outside that group.'' Since the non-Mexican origin (i.e., foreign)
materials contained in the good were classified in headings outside the
group of headings 5602 through 5605, HTSUS, a change from these
materials to the textile rubberized thread in heading 5604, HTSUS, is
allowed, and the country in which this change occurred, i.e., Mexico,
is the country of origin.
Paragraphs (b) through (d) of Sec. 102.11, set forth the
circumstances and criteria for determining the country of origin of
goods when such determination cannot be made pursuant to
Sec. 102.11(a). Under current practice and case law, if a good is not
wholly obtained or produced in a single country and the processes to
which the foreign materials in the good were subjected, did not result
in a substantial transformation of such materials, country of origin
generally is determined on the basis of the component or material which
imparts the essential character of the good. Consistent with current
practice in this regard, paragraph (b) of Sec. 102.11 provides that
unless the good is classified under the HTSUS as a ``set'', the country
or countries of origin of the good is the country or countries of
origin of the single material that imparts the essential character of
the good. This paragraph further provides that if the single material
imparting the essential character to the good is fungible and
commingled, the country of origin may be determined on the basis of an
inventory management method, such as (``FIFO'' or ``LIFO'') as provided
under the Appendix to part 181 of the Customs Regulations.
Paragraph (c) of Sec. 102.11 reflects current practice whereby
multiple countries of origin may exist for goods that are classified as
``sets'', and for goods classified as ``mixtures'' or ``composite
goods'' to which no single component can be found to impart their
essential character. However, only the countries of origin of the
materials meriting equal consideration for determining the essential
character of the good would constitute the country or countries of
origin of the good. For example, the countries of origin of a cutlery
and dinnerware packaged set from Mexico, which includes 12 knives from
Mexico, 12 forks from Korea, 12 spoons from Taiwan, and a plastic case
from Japan would be as follows: Mexico, Taiwan and Korea. The plastic
case from Japan did not merit equal consideration in determining the
essential character of the set.
If a good is not a set, mixture or composite good and the country
of origin of the good is not determined under paragraphs (a) and (b) of
Sec. 102.11, paragraph (d) provides that the country of origin of the
good is the last country in which the good underwent production, other
than ``minor processing'' as defined in Sec. 102.1(l) or ``simple
assembly'' as defined in Sec. 102.1(h), unless the assembled materials
originate in different countries. In the latter instance, the country
of origin, indeed, will be the country of assembly even if the assembly
was simple. It is important to note, however, that the determination of
country of origin on the basis of the country in which a ``simple
assembly'' has occurred, will only be reached after it has been
concluded that no single material imparts the essential character to
the good and the good is not classified as a set, mixture or composite
good under the HTSUS.
Section 102.12 Fungible Goods
Section 102.12 sets forth the requirement that in all cases, the
country of origin of commingled fungible goods (e.g., Canadian and
Russian wheat or U.S. and Mexican raw or frozen corn), shall be the
country or countries of origin of all of the commingled goods. If,
however, direct physical identification of the country of origin is
impractical, as in Sec. 102.11(b)(2), this section allows the country
or countries of origin to be determined on the basis of an inventory
management method provided under the Appendix to part 181 of the
Customs Regulations.
Section 102.13 De Minimis
Section 102.13 also codifies a common practice in country of origin
determinations based upon the substantial transformation rule, whereby
foreign materials of de minimis amounts are disregarded in
determinations of whether the processing of foreign materials resulted
in ``a new and different article.'' Similarly, Sec. 102.13 provides
that foreign materials, which do not meet the requirements of the
specific tariff rules under Sec. 102.20 and which do not exceed the
specified minimum values or quantities, shall be disregarded for
purposes of determining whether the requirements of Sec. 102.18 are
met. Of note, however, is the fact that this provision will not apply
to many food and agricultural products provided in the first several
chapters of the HTSUS.
Section 102.14 Goods Returned
Note 2(a), Subchapter II, Chapter 98, HTSUS, provides that goods of
U.S. origin which are exported from, and returned to, the United States
after having been advanced in value or improved in condition by any
process of manufacture or other means are to be treated as ``foreign
articles'' and subject to full duty upon return to the United States,
unless otherwise exempt under that subchapter. Section 102.14
incorporates this rule of law into the general context of the rules of
origin. Under this section, any good which is advanced in value or
improved in condition outside of the United States shall not be
considered a product of the United States. Rather, the last foreign
country in which ``production'' occurred is the country of origin of
such goods. The terms ``production,'' ``advanced in value,'' and
``improved in condition'' are defined in Sec. 102.1. For example,
unassembled T-shirt components of U.S. origin, which are exported to
Mexico for assembly into T-shirts (an advancement in value and/or
improvement in condition), upon return are goods of Mexico,
notwithstanding that under Secs. 102.11(a) and 102.20, the country of
origin of the assembled T-shirts would have been determined to be of
U.S. origin. Of particular note, is the fact that when Sec. 102.14 is
applicable, it is the basis for determining origin, notwithstanding any
other provision of part 102.
In connection with this provision, certain provisions of part 134
(``Country of Origin Marking'') of this Chapter are amended. Section
134.43 is amended to allow special types of marking of goods for which
country of origin is determined under this provision. In addition,
Sec. 134.32 is amended to except from country of origin marking
requirements, non-textile goods that are exported from and returned to
the United States after having been advanced in value and improved in
condition as a result of repairs and alterations.
Section 102.15 Disregarded Materials
This section reflects existing practice by identifying those
materials normally associated with a good, which are routinely
disregarded in determining whether the good is a new and different
article of commerce. Section 102.15 codifies existing practice by
specifying those insignificant materials such as, packaging,
accessories that are classified with the good, etc., which should be
disregarded when determining whether or not the specific tariff rules
under Sec. 102.20 have been met.
Section 102.16 Goods and Its Parts; Parts of Parts
This section is intended to reconcile the new rules based upon the
tariff classification approach with the systemic problems that arise
when a good and its parts are classified in the same HTSUS heading or
subheading or where there exist a specific tariff classification for
parts which can include anything from the most minor or insignificant
part to the most highly developed subassembly. In these instances, this
section proposes to allow country of origin determinations to be made
on a case-by-case basis, as they are now. Thus, when the specific
tariff classification rule cannot be met because the good and its parts
are classified in the same heading or subheading, this rule will allow
significant operations to be recognized as conferring origin, when such
operations result in new and different article, having a new name,
character, and use. Of note is the fact that this section does not
apply to textile and apparel goods (chapters 50-63, HTSUS).
Section 102.17 Non-Qualifying Operations
This section reflects existing practice not to allow simple
operations which do not materially alter the good to cause a change in
the country of origin of the good, even though there may have been a
change in some minor aspect of the good. For example, simple packaging
of components of a set without the manufacture of any of such
components will not be allowed to make the country of origin of the
set, the country in which the packaging occurred, even if requirements
under the specific rules set forth in Sec. 102.20 were met. Also of
note in this provision is the anti-circumvention rule, which
disqualifies any operation, the sole object of which is to circumvent
the proper operation of these rules. In such instances, the operation
usually will be viewed as one having no practical business purpose and
resulting in no material change in the good.
Section 102.18 Rules of Interpretation
This section provides the interpretation of two concepts that are
common in the operation of these rules: Essential Character and General
Rules of Interpretation 2(a).
The General Rule of Interpretation (GRI) 2(a) of the HTSUS
generally provides that any reference in a heading to an article shall
be taken to include a reference to that article incomplete or
unfinished, provided that, as entered, the incomplete or unfinished
article has the essential character of the complete or finished article
(or failing to be classified as complete finished by virtue of this
rule), entered unassembled or disassembled.
Paragraph (a) clarifies that when GRI 2(a) is stated as a condition
or proviso in a specific rule, such proviso will operate to disallow
changes from a part to a unfinished good or to an unassembled good
which is classified as the good pursuant to GRI 2(a). Such changes in
classification can occur as a result of simple operations or as a
result of collecting all of the parts for a good in a single country
and such collection is classified as the good in its unassembled state
pursuant to GRI 2(a). You will note that the GRI 2(a) proviso appears
more often in the specific tariff rules for the machinery chapters, and
that this rule is specifically applicable to all of the specific rules
for chapters 84 and 85, HTSUS.
Paragraph (b) regarding ``essential character'' is included in the
Rules of Interpretation and not under Sec. 102.1 Definitions, because
of its significant place in the hierarchy of these rules. It is the
``essential character'' concept which is used to determine country of
origin, whenever a good is not wholly obtained or produced in a single
country or does not meet the specific tariff rules in Sec. 102.20. For
purposes of promoting uniformity in these determinations, this
provision includes as examples, the specific factors identified in the
Explanatory Notes for General Rule of Interpretation 3(b) of the HTSUS,
which have been applied for nearly five years. Of particular note,
however, is the fact that this provision expressly requires that one
first look to the origin of the material that did not meet the
requirement under the specific rules in determining which material
imparts the ``essential character'' of a good. If there is a single
material that imparts the essential character of a good and that
material originates in a single country, then by operation of
Sec. 102.11(b), the country of origin of that material, will be the
country of origin of the good, unless the good is classified as a set.
Section 102.19 NAFTA Preference Override
This provision is only applicable to goods for which a claim for
duty preference under the NAFTA has been made. Thus, if a good is not
covered by a NAFTA certificate of origin, this provision is not
applicable in any way. The provision ensures that in the event that the
application of the rules under Sec. 102.11 (a) or (b) results in a good
not being determined to be a good of a single NAFTA party (Mexico,
Canada or United States), the country of origin of such good, if
claimed for NAFTA preference, will be the last NAFTA country in which
the good underwent any ``production'' other than ``minor processing''.
Both ``production'' and ``minor processing'' are defined in Sec. 102.1.
Section 102.20 Specific Tariff Rules
Section 102.20 presents the specific tariff classification changes
and/or other operations, which are specifically required in order for
country of origin to be determined on the basis of operations performed
on the foreign materials contained in a good. This section, which is
applicable only to goods that are not ``wholly obtained or produced
entirely in a single country'' or are not produced in a single country
exclusively from domestic materials, codifies the current ``substantial
transformation'' standard. The rules in this section are set forth for
each HTSUS chapter. The applicable rule is determined by the HTSUS
tariff classification that is applicable to the finished good at the
time the country of origin determination is being made. The specific
rules for certain HTSUS chapters contain notes which govern the
operation of the rules specified thereunder. See, for example,
Sec. 102.20(k), the specific tariff rules for section XI--Chapters 50-
63, HTSUS, and Sec. 102.20(f), the specific tariff rules for certain
chemical chapters in Section VI, HTSUS.
Finally, it is important to note the specific rules do not operate
in a vacuum. All of these rules are subject to the restrictions which
appear in other sections of this part, such as Sec. 102.17 ``Non-
Qualifying Operations'' and section 102.14 ``Goods Returned.''
Comments
Before adopting these interim regulations as a final rule,
consideration will be given to any written comments timely submitted to
Customs. Comments submitted will be available for public inspection in
accordance with the Freedom of Information Act (5 U.S.C. 552),
Sec. 1.4, Treasury Department Regulations (31 CFR 1.4), and
Sec. 103.11(b), Customs Regulations (19 CFR 103.11(b)), on regular
business days between the hours of 9 a.m. and 4:30 p.m. at the
Regulations Branch, Office of Regulations and Rulings, U.S. Customs
Service, Franklin Court, 1099 14th Street, NW., Suite 4000, Washington,
DC.
Comments submitted in response to this Federal Register document,
need not be duplicated in response to the Notice of Proposed Rulemaking
document relating to the Rules of Origin published in today's Federal
Register. Comments in response to one document will be considered
during the review of both documents.
Inapplicability of Notice and Delayed Effective Date Requirements, the
Regulatory Flexibility Act, and Executive Order 12866
Pursuant to the provisions of 5 U.S.C. 553(a), public notice is
inapplicable to these interim regulations because they are within the
foreign affairs function of the United States. A failure to have
regulations in place, setting forth the procedures implementing the
preferential tariff treatment and related provisions of the North
American Free Trade Agreement, on the date the North American Free
Trade Agreement Implementation Act is effective, January 1, 1994, would
provoke undesirable international consequences. In addition, because
these regulations establish procedures which the public needs to know
in order to claim the benefit of a tariff preference under the North
American Free Trade Agreement Implementation Act, it is determined
pursuant to 5 U.S.C. 553(b)(B), that notice and public procedures are
impracticable, unnecessary, and contrary to the public interest.
Furthermore, for the above reasons, it is determined that good cause
exists under the provisions of 5 U.S.C. 553 (d)(1) and (d)(3) for
dispensing with a delayed effective date. Because no notice of proposed
rulemaking is required for interim regulations, the provisions of the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply. Because
this document involves a foreign affairs function of the United States
and implements an international agreement, it is not subject to the
provisions of E.O. 12866.
List of Subjects
19 CFR Part 12
Customs duties and inspection, Labeling, Marking, Reporting and
recordkeeping requirements, Textiles and textile products.
19 CFR Part 102
Customs duties and inspections, Imports, Reporting and
recordkeeping requirements, Rules of origin, Trade agreements.
19 CFR Part 134
Country of origin, Customs duties and inspection, Imports,
Labeling, Marking, Packaging and containers.
Amendments to the Regulations
For the reasons set forth above, chapter 1 of title 19, Code of
Federal Regulations (19 CFR chapter 1) is amended by adding part 102
and amending parts 12 and 134 as set forth below:
PART 12--SPECIAL CLASSES OF MERCHANDISE
1. The general authority citation for part 12 continues to read as
follows:
Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 8,
Harmonized Tariff Schedule of the United States (HTSUS)), 1304,
1624.
2. In Sec. 12.130:
a. paragraph (b) is amended by adding a sentence at the end;
b. paragraph (d) is amended by adding a sentence at the end of the
introductory text; and
c. paragraph (e)(1) is amended by removing the word ``An'' and
adding, in its place, the words ``Except for products of which the
origin is Canada or Mexico (the origin of such products is determined
pursuant to the procedures set forth in Part 102 of this chapter),
an''.
The additions read as follows:
Sec. 12.130 Textiles and textile products country of origin.
* * * * *
(b) Country of origin. * * * However, the origin of products of
Canada and Mexico are determined pursuant to the procedures set forth
in part 102 of this chapter.
* * * * *
(d) Criteria for determining country of origin. * * * However, the
origin of products of Canada and Mexico are determined pursuant to the
procedures set forth in part 102 of this chapter.
* * * * *
3. A new part 102 is added to read as follows:
PART 102--RULES OF ORIGIN
Sec.
102.0 Scope.
Subpart A--General
102.1 Definitions.
Subpart B--Rules of Origin
102.11 General rules.
102.12 Fungible goods.
102.13 De Minimis.
102.14 Goods returned.
102.15 Disregarded materials.
102.16 Goods and its parts; parts of parts.
102.17 Non-qualifying operations.
102.18 Rules of interpretation.
102.19 NAFTA preference override.
102.20 Specific rules by tariff classification.
Authority: 19 U.S.C. 66, 1202 (General Note 8, Harmonized Tariff
Schedule of the United States (HTSUS)), 1624, and the North American
Free-Trade Agreement Implementation Act, Pub.L. 103-182, 107 Stat.
2057.
Sec. 102.0 Scope.
This part sets forth rules for determining the country of origin of
imported goods, i.e., when a good is a good of a party for the purposes
specified in paragraph 1 of Annex 311 of the North American Free-Trade
Agreement (``NAFTA''). These specific purposes are: (1) Country of
origin marking; (2) determining the rate of duty and staging category
applicable to originating textile and apparel goods as set out in
Section 2 (Tariff Elimination) of Annex 300-B (Textile and Apparel
Goods); (3) determining the rate of duty and staging category
applicable to an originating good as set out in Annex 302.2 (Tariff
Elimination).
Subpart A--General
Sec. 102.1 Definitions.
(a) Advanced in Value. ``Advanced in value'' means an increase in
the value of a good as a result of production with respect to that
good.
(b) Commingled. ``Commingled'' means physically combined or mixed.
(c) Direct Physical Identification. ``Direct physical
identification'' means identification by visual or other organoleptic
examination.
(d) Domestic Material. ``Domestic material'' means a material whose
country of origin as determined under these rules is the same country
as the country in which the good is produced.
(e) Foreign Material. ``Foreign material'' means a material whose
country of origin as determined under these rules is not the same
country as the country in which the good is produced.
(f) Fungible Goods or Fungible Materials. ``Fungible goods or
fungible materials'' means goods or materials that are interchangeable
for commercial purposes and whose properties are essentially identical.
(g) A Good Wholly Obtained or Produced. ``A good wholly obtained or
produced'' in a country means:
(1) A mineral good extracted in that country;
(2) A vegetable or plant good harvested in that country;
(3) A live animal born and raised in that country;
(4) A good obtained from hunting, trapping or fishing in that
country;
(5) A good (fish, shellfish and other marine life) taken from the
sea by vessels registered or recorded with that country and flying its
flag;
(6) A good produced on board factory ships from the goods referred
to in paragraph (g)(5) of this section, provided such factory ships are
registered or recorded with that country and fly its flag;
(7) A good taken by that country or a person of that country from
the seabed or beneath the seabed outside territorial waters, provided
that country has rights to exploit such seabed;
(8) A good taken from outer space, provided they are obtained by
that country or a person of that country;
(9) Waste and scrap derived from:
(i) Production in a country, or
(ii) Used goods collected in that country provided such goods are
fit only for the recovery of raw materials; and
(10) A good produced in that country exclusively from goods
referred to in paragraphs (g)(1) through (10) of this section or from
their derivatives, at any stage of production.
(h) Harmonized System. ``Harmonized System'' means the Harmonized
Commodity Description and Coding System, including its general rules of
Interpretation, Section Notes and Chapter Notes, as adopted and
implemented by the United States.
(i) Improved in Condition. ``Improved in condition'' means the
enhancement of the physical condition of a good as a result of
production with respect to that good.
(j) Incorporated. ``Incorporated'' means physically incorporated
into a good as a result of production with respect to that good.
(k) Indirect Materials. ``Indirect materials'' means a good used in
the production, testing or inspection of another good but not
physically incorporated into that other good, or a good used in the
maintenance of buildings or the operation of equipment associated with
the production of that other good, including:
(1) Fuel and energy;
(2) Tools, dies and molds;
(3) Spare parts and materials used in the maintenance of equipment
and buildings;
(4) Lubricants, greases, compounding materials and other materials
used in production or used to operate equipment and buildings;
(5) Gloves, glasses, footwear, clothing, safety equipment and
supplies;
(6) Equipment, devices, and supplies used for testing or inspecting
the goods;
(7) Catalysts and solvents; and
(8) Any other goods that are not incorporated into the good but
whose use in the production of the good can reasonably be demonstrated
to be a part of that production.
(l) Material. ``Material'' means a good that is incorporated into
another good as a result of production with respect to that other good,
and includes parts, ingredients, subassemblies, and components.
(m) Minor processing. ``Minor processing'' means the following:
(1) Mere dilution with water or another substance that does not
materially alter the characteristics of the good;
(2) Cleaning, including removal of rust, grease, paint, or other
coatings;
(3) Application of preservative or decorative coatings, including
lubricants, protective encapsulation, preservative or decorative paint,
or metallic coatings;
(4) Trimming, filing or cutting off small amounts of excess
materials;
(5) Unloading, reloading or any other operation necessary to
maintain the good in good condition;
(6) Putting up in measured doses, packing, repacking, packaging,
repackaging;
(7) Testing, marking, sorting, or grading;
(8) Ornamental or finishing operations incidental to textile good
production designed to enhance the marketing appeal or the ease of care
of the product, such as dyeing and printing, embroidery and appliques,
pleating, hemstitching, stone or acid washing, permanent pressing, or
the attachment of accessories notions, findings and trimmings; or
(9) Repairs and alterations, washing, laundering, or sterilizing.
(n) Production. ``Production'' means growing, mining, harvesting,
fishing, trapping, hunting, manufacturing, processing or assembling a
good.
(o) Simple Assembly. ``Simple assembly'' means the fitting together
of five or fewer parts all of which are foreign (excluding fasteners
such as screws, bolts, etc.) by bolting, gluing, soldering, sewing or
by other means without more than minor processing.
(p) Substantial Transformation. ``Substantial transformation''
means production which results in a new and different article, with a
new name, character, and use.
(q) Value. ``Value'' means, with respect to Sec. 102.13,
(1) In the case of a good, its customs value or transaction value
within the meaning of the Appendix to part 181 of this chapter; or
(2) In the case of a material, its customs value or value within
the meaning of the Appendix to part 181 of this chapter.
Subpart B--Rules of Origin
Sec. 102.11 General rules.
(a) The country of origin of a good is the country in which:
(1) The good is wholly obtained or produced;
(2) The good is produced exclusively from domestic materials; or
(3) Each foreign material incorporated in that good undergoes an
applicable change in tariff classification set out in Sec. 102.20 and
satisfies any other applicable requirements of that section, and all
other applicable requirements of these rules are satisfied.
(b) Except for a good that is specifically described in the
Harmonized System as a set, or is classified as a set pursuant to
General Rule of Interpretation 3, where the country of origin cannot be
determined under paragraph (a), the country of origin of the good:
(1) Is the country or countries of origin of the single material
that imparts the essential character of the good, or
(2) If the material that imparts the essential character of the
good is fungible, has been commingled, and direct physical
identification of the origin of the commingled material is not
practical, the country or countries of origin may be determined on the
basis of an inventory management method provided under the Appendix to
part 181 of the Customs Regulations.
(c) Where the country of origin cannot be determined under
paragraph (b)(1) or (2) and the good is specifically described in the
Harmonized System as a set or mixture, or classified as a set, mixture
or composite good pursuant to General Rule of Interpretation 3, the
country of origin of the good is the country or countries of origin of
all materials that merit equal consideration for determining the
essential character of the good.
(d) Where the country of origin of a good cannot be determined
under paragraph (b) (1) through (3), the country of origin of the good
is:
(1) The last country in which the good underwent production, other
than by simple assembly or minor processing, or
(2) If the good is produced by simple assembly:
(i) The country in which the good is assembled if the parts that
merit equal consideration as imparting the essential character of the
good do not have the same country of origin, or
(ii) The country of origin of the parts assembled into the good
that merit equal consideration as imparting the essential character of
the good if all those parts have the same country of origin.
Sec. 102.12 Fungible goods.
When fungible goods of different countries of origin are commingled
the country of origin of the goods:
(a) Is the countries of origin of those commingled goods; or
(b) If the good is fungible, has been commingled, and direct
physical identification of the origin of the commingled good is not
practical, the country or countries of origin may be determined on the
basis of an inventory management method provided under the Appendix to
part 181 of the Customs Regulations.
Sec. 102.13 De Minimis.
(a) Except as otherwise provided in paragraphs (b) and (c), foreign
materials that do not undergo the applicable change in tariff
classification set out in Sec. 102.20 or satisfy the other applicable
requirements of that section when incorporated into a good shall be
disregarded in determining the country of origin of the good if the
value of those materials is no more than 7 percent of the value of the
good or 10 percent of the value of a good of Chapter 22, Harmonized
System.
(b) Paragraph (a) does not apply to a foreign material incorporated
in a good provided for in Chapters 1, 2, 3, 4, 7, 8, 11, 12, 15, 17, or
20 of the Harmonized System.
(c) Foreign components or materials that do not undergo the
applicable change in tariff classification set out in Sec. 102.20 or
satisfy the other applicable requirements of that section when
incorporated into a good classified in Chapter 50 through 63 of the
Harmonized System shall be disregarded in determining the country of
origin of the good if the total weight of those components or materials
is not more than 7 percent of the total weight of the good.
Sec. 102.14 Goods returned.
No good, last advanced in value or improved in condition outside
the United States has United States origin. If under either Sec. 102.11
or 102.16 such a good is determined to be a good of the United States,
that determination will be disregarded and the country of origin of the
good will be the last foreign country in which the good underwent
production, other than minor processing. However, if the good undergoes
only minor processing outside the United States, the country of origin
of the good is the last country in which the good underwent production,
including minor processing.
Sec. 102.15 Disregarded materials.
(a) The following materials shall be disregarded when determining
whether the good undergoes the applicable change in tariff
classification set out in Sec. 102.20, or satisfies the other
applicable requirements of that section:
(1) Packaging materials and containers in which a good is packaged
for retail sale that are classified with the good;
(2) Accessories, spare parts or tools delivered with the good that
are classified with the good and shipped with the good;
(3) Packing materials and containers in which a good is packed for
shipment; and
(4) Indirect materials.
Sec. 102.16 Good and its parts; parts of parts.
(a) If a good is produced in one country but one or more of the
foreign materials incorporated into the good do not undergo an
applicable change in tariff classification provided in Sec. 102.20
because:
(1) The good was imported into the country in an unassembled or
disassembled form but was classified as an assembled good pursuant to
General Rule of Interpretation 2(a) of the Harmonized System, the
country of origin of a good is the country in which the good was
produced provided that the production of the good results in a
substantial transformation of those parts; or
(2) The heading for the good provides for both the good itself and
its parts and is not further subdivided into subheadings, or the
subheading for the good provides for both the good itself and its
parts, the country of origin of a good is the country in which the good
was produced provided that the production of the good results in a
substantial transformation of those parts.
(b) If a subassembly and its parts are classified together in a
parts heading that is not further subdivided into subheadings or in a
parts subheading, the country of origin of the subassembly is the
country in which the subassembly is produced, provided, that production
results in a substantial transformation.
(c) This section does not apply to chapters 50-63, Harmonized
System.
Sec. 102.17 Non-qualifying operations.
A foreign material shall not be considered to have undergone the
applicable change in tariff classification set out in Sec. 102.20, or
satisfy the other applicable requirements of that Section by reason of:
(a) A change in end-use;
(b) Dismantling or disassembly;
(c) Simple packing, repacking or retail packaging without more than
minor processing;
(d) Mere dilution with water or another substance that does not
materially alter the characteristics of the material; or
(e) Any process or work in respect of which it may be demonstrated,
on the basis of the preponderance of evidence, that the sole object was
to circumvent these rules.
Sec. 102.18 Rules of interpretation.
(a) General Rule of Interpretation 2(a). (1) When General Rule of
Interpretation 2(a) is stated under a rule for a good in Sec. 102.20 as
a basis for disallowing a specific change in tariff classification
under that rule this means the change will be disallowed if it is made
from one tariff provision to another by virtue of:
(i) The collection of parts being classified as if it were an
assembled good pursuant to General Rule of Interpretation 2(a); or
(ii) The assembly of parts into a subassembly that is still not a
complete or finished good, but is classified as a complete or finished
good pursuant to General Rule of Interpretation 2(a).
(2) Paragraph (a) shall not apply to assembled goods that were
previously assembled into a good, and then disassembled for convenience
of packing, handling or transport.
(b) Essential Character. (1) For purposes of determining essential
character of a good under Sec. 102.11, various factors may be examined
depending upon the type of the good. These include one or more of the
following:
(i) The nature of the material or component;
(ii) Bulk;
(iii) Quantity;
(iv) Weight;
(v) Value;
(vi) Role of a constituent material in relation to the use of the
goods; or
(vii) Other relevant factors.
(2) For purposes of applying Sec. 102.11, only domestic and foreign
materials (including self-produced materials) that are classified in a
tariff provision from which a change in tariff classification is not
allowed in the rule for the good set out in Sec. 102.20 shall be taken
into consideration in determining the parts or materials that determine
the essential character of the good.
Sec. 102.19 NAFTA preference override.
Notwithstanding any provision of these rules other than
Sec. 102.11(a) or (b) or Sec. 102.14, if a good originates under
Chapter Four of the NAFTA, and the country of origin of that good is
not determined to be a single NAFTA country under Sec. 102.11(a) or
(b), the country of origin of the good is the last NAFTA country in
which the good underwent production other than minor processing,
provided that a Certificate of Origin has been completed and signed for
the good.
Sec. 102.20 Specific rules by tariff classification.
The following rules are the rules specified in Sec. 102.11(a)(3)
and other sections of this part:
------------------------------------------------------------------------
HTSUS Tariff shift and/or other requirements
------------------------------------------------------------------------
(a) Section I: Chapters 1 through 5
------------------------------------------------------------------------
01.01-01.06.............. A change to heading 01.01 through 01.06 from
any other chapter.
02.01-02.09.............. A change to heading 02.01 through 02.09 from
any other chapter.
0210.11-0210.20.......... A change to subheading 0210.11 through
0210.20 from any other chapter.
0210.90.................. A change to subheading 0210.90 from any other
chapter; or
A change to edible meals and flours of
subheading 0210.90 from any product other
than edible meals and flours of chapter 2.
03.01-03.03.............. A change to heading 03.01 through 03.03 from
any other chapter.
03.04.................... A change to heading 03.04 from any other
chapter; or
A change to fillets of heading 03.04 from any
other heading.
0305.10.................. A change to subheading 0305.10 from any other
subheading.
0305.20.................. A change to subheading 0305.20 from any other
chapter.
0305.30.................. A change to subheading 0305.30 from any other
subheading.
0305.41-0305.69.......... A change to subheading 0305.41 through
0305.69 from any other chapter; or
03.06.................... A change to heading 03.06 from any other
chapter.
03.07.................... A change to heading 03.07 from any other
chapter; or
A change to edible meals and flours from
within Chapter 3.
04.01.................... A change to heading 04.01 from any other
chapter.
0402.10-0402.29.......... A change to subheading 0402.10 through
0402.29 from any other chapter.
0402.91-0402.99.......... A change to subheading 0402.91 through
0402.99 from any other chapter.
0403.10.................. A change to subheading 0403.10 from any other
subheading.
0403.990................. A change to subheading 0403.90 from any other
chapter; or
A change to sour cream, or kephir from any
other product of Chapter 4.
0404..................... A change to heading 0404 from any other
heading.
0405-0406................ A change to heading 0405 through 0406 from
any other heading, including another heading
within that group.
0407-0410................ A change to heading 0407 through 0410 from
any other chapter.
05.01-05.11.............. A change to heading 05.01 through 05.11 from
any other chapter.
------------------------------------------------------------------------
(b) Section II: Chapters 6 through 14
------------------------------------------------------------------------
Note: Nothwithstanding the specific rules of this section, an
agricultural or horticultural good grown in the territory of a country
shall be treated as a good of that country even if grown from seed or
bulbs, root stock, cuttings, slips or other live parts of plants,
imported from a foreign country.
------------------------------------------------------------------------
06.01-06.02.............. A change to heading 06.01 through 06.02 from
any other heading, including another heading
within that group.
06.03-06.04.............. A change to heading 06.03 through 06.04 from
any other heading, including another heading
within that group, except from heading
06.02.
07.01-07.09.............. A change to heading 07.01 through 07.09 from
any other chapter.
07.10.................... A change to heading 07.10 from any other
chapter.
07.11.................... A change to heading 07.11 from any other
chapter.
07.12.................... A change to heading 07.12 from any other
chapter, or
A change to powdered vegetables of 07.12 from
any other product of chapter 7, if put up
for retail sale.
07.13-07.14.............. A change to heading 07.13 through 07.14 from
any other chapter.
08.01-08.10.............. A change to heading 08.01 through 08.10 from
any other chapter.
08.11.................... A change to heading 08.11 from any other
chapter.
08.12.................... A change to heading 08.12 from any other
chapter.
08.13.................... A change to heading 08.13 from any other
chapter.
08.14.................... A change to heading 08.14 from any other
chapter.
0901.11-0901.12.......... A change to subheading 0901.11 through
0901.12 from any other chapter.
0901.21-0901.22.......... A change to subheading 0901.21 through
0901.22 from any subheading outside that
group.
0901.30.................. A change to subheading 0901.30 from any other
chapter.
0901.40.................. A change to subheading 0901.40 from any other
chapter.
09.02-09.03.............. A change to heading 09.02 through 09.03 from
any other chapter.
09.04-09.10.............. A change to heading 09.04 through 09.10 from
any other chapter, or
A change to crushed, ground, or powdered
products of heading 09.04 through 09.10 from
within chapter 9, if put up for retail sale;
or
A change to subheading 0910.91 from any other
subheading, provided that a single spice
ingredient of foreign origin constitutes no
more than 60 percent by weight of the good.
10.01-10.08.............. A change to heading 10.01 through 10.8 from
any other chapter.
11.01-11.06.............. A change to heading 11.01 through 11.06 from
any other chapter.
11.07.................... A change to heading 11.07 from any other
chapter.
11.08-11.09.............. A change to heading 11.08 through 11.09 from
any other heading, including another heading
within that group.
12.01-12.07.............. A change to heading 12.01 through 12.07 from
any other chapter.
12.08.................... A change to heading 12.08 from any other
heading.
12.9-12.14............... A change to heading 12.09 through 12.14 from
any other chapter.
13.01-13.02.............. A change to heading 13.01 through 13.02 from
any other chapter.
14.01-14.04.............. A change to heading 14.01 through 14.04 from
any other chapter.
------------------------------------------------------------------------
(c) Section III: Chapter 15
------------------------------------------------------------------------
15.01-15.06.............. A change to heading 15.01 through 15.06 from
any other chapter.
1507.10.................. A change to subheading 1507.10 from any other
chapter.
1507.90.................. A change to subheading 1507.90 from any other
chapter.
1508.10.................. A change to subheading 1508.10 from any other
chapter.
1508.90.................. A change to subheading 1508.90 from any other
chapter.
1509.10.................. A change to subheading 1509.10 from any other
chapter.
1509.90.................. A change to subheading 1509.90 from any other
chapter.
15.10.................... A change to heading 15.10 from any other
chapter.
1511.10.................. A change to subheading 1511.10 from any other
chapter.
1511.90.................. A change to subheading 1511.90 from any other
chapter.
1512.11.................. A change to subheading 1512.11 from any other
chapter.
1512.19.................. A change to subheading 1512.19 from any other
chapter.
1512.21.................. A change to subheading 1512.21 from any other
chapter.
1512.29.................. A change to subheading 1512.29 from any other
chapter.
1513.11.................. A change to subheading 1513.11 from any other
chapter.
1513.19.................. A change to subheading 1513.19 from any other
chapter.
1513.21.................. A change to subheading 1513.21 from any other
chapter.
1513.29.................. A change to subheading 1513.29 from any other
chapter.
1514.10.................. A change to subheading 1514.10 from any other
chapter.
1514.90.................. A change to subheading 1514.90 from any other
chapter.
1515.11.................. A change to subheading 1515.11 from any other
chapter.
1515.19.................. A change to subheading 1515.19 from any other
chapter.
1515.21.................. A change to subheading 1515.21 from any other
chapter.
1515.29.................. A change to subheading 1515.29 from any other
chapter.
15.16.................... A change to heading 15.16 from any other
chapter.
1517.10.................. A change to subheading 1517.10 from any other
heading.
1517.90.................. A change to subheading 1517.90 from any other
chapter.
1518..................... A change to heading 15.18 from any other
heading.
1519.11-1519.13.......... A change to subheading 1519.11 through
1519.13 from any other heading, except from
heading 15.20.
1519.19.................. A change to subheading 1519.19 from any other
subheading.
1519.20.................. A change to subheading 1519.20 from any other
heading, except from heading 15.20.
1520.10.................. A change to subheading 1520.10 from any other
heading, except from heading 15.19.
1520.90.................. A change to subheading 1520.90 from any other
subheading.
15.21-15.22.............. A change to heading 15.21 through 15.22 from
any other chapter.
------------------------------------------------------------------------
(d) Section IV: Chapters 16 through 24
------------------------------------------------------------------------
16.01-16.05.............. A change to heading 16.01 through 16.05 from
any other chapter.
17.01-17.02.............. A change to heading 17.01 through 17.02 from
any other chapter.
17.03.................... A change to heading 17.03 from any other
chapter.
17.04.................... A change to heading 17.04 from any other
heading.
18.01-18.03.............. A change to heading 18.01 through 18.03 from
any other chapter.
18.04.................... A change to heading 18.04 from any other
heading, except from heading 1803.
18.05.................... A change to heading 18.05 from any other
heading, except from subheading 1803.20.
1806.10.................. A change to subheading 1806.10 from any other
heading except from heading 1805 or from
Chapter 17; or
A change from Chapter 17 provided that the
good contains less than 65 percent by dry
weight of sugar.
1806.20.................. A change to subheading 1806.20 from any other
heading except from Chapter 17; or
A change from Chapter 17 provided that the
good contains less than 65 percent by dry
weight of sugar.
1806.31.................. A change to subheading 1806.31 from any other
subheading.
1806.32.................. A change to subheading 1806.32 from any other
subheading.
1806.90.................. A change to subheading 1806.90 from any other
subheading.
1901.10.................. A change to subheading 1901.10 from any other
subheading.
1901.20.................. A change to subheading 1901.20 from any other
subheading.
1901.90.................. A change to subheading 1901.90 from any other
heading, or;
A change to a product of subheading 1901.90
from any other product within heading 19.01
if that change results in a substantial
transformation.
1902.11-1902.19.......... A change to subheading 1902.11 through
1902.19 from any other heading.
1902.20.................. A change to subheading 1902.20 from any other
subheading.
1902.30-1902.40.......... A change to subheading 1902.30 through
1902.40 from any other heading.
19.03-19.05.............. A change to heading 19.03 through 19.05 from
any other heading, including another heading
within that group.
------------------------------------------------------------------------
Chapter 20 Note: Notwithstanding the specific rules of this chapter,
fruit, nut and vegetable preparations of Chapter 20 that have been
prepared or preserved merely by freezing, by packing (including
canning) in water, brine or natural juices, or by roasting, either dry
or in oil (including processing incidental to freezing, packing, or
roasting), shall be treated as a good of the country in which the fresh
good was produced.
------------------------------------------------------------------------
20.01-20.07.............. A change to heading 20.01 through 20.07 from
any other chapter.
2008.11.................. A change to subheading 2008.11 from any other
chapter, provided that change is not the
result of mere blanching of peanuts.
2008.19-2008.99.......... A change to subheading 2008.19 through
2008.99 from any other chapter, [US provided
that change is not the result of mere
blanching of nuts].
2009.11-2009.30.......... A change to subheading 2009.11 through
2009.30 from any other chapter.
2009.40-2009.80.......... A change to subheading 2009.40 through
2009.80 from any other chapter.
2009.90.................. A change to subheading 2009.90 from any other
chapter; or
A change to subheading 2009.90 from any other
subheading; provided that a single juice
ingredient of foreign origin, or juice
ingredients from a single foreign country,
constitute in single strength form no more
than 60 percent by volume of the good.
21.01.................... A change to heading 21.01 from any other
heading.
21.02.................... A change to heading 21.02 from any other
heading.
2103.10.................. A change to subheading 2103.10 from any other
heading.
2103.20.................. A change to subheading 2103.20 from any other
heading.
2103.30.................. A change to subheading 2103.30 from any other
subheading; or
A change to prepared mustard of subheading
2103.30 from mustard flour or meal.
2103.90.................. A change to subheading 2103.90 from any other
subheading; or
A change to any item of subheading 2103.90
from within subheading 2103.90, if that
change results in a substantial
transformation.
2104.10.................. A change to subheading 2104.10 from any other
subheading.
2104.20.................. A change to subheading 2104.20 from any other
subheading.
21.05.................... A change to heading 21.05 from any other
heading.
2106.10.................. A change to subheading 2106.10 from any other
subheading.
2106.90.................. A change to subheading 2106.90 from any other
subheading except from Chapter 4, Chapter
17, heading 2009, subheading 1901.90 or
subheading 2202.90; or
A change to subheading 2106.90 from Chapter 4
or subheading 1901.90 provided that the good
contains no more than 50 percent of milk
solids by weight; or
A change to subheading 2106.90 from Chapter
17 provided that the good contains less than
65 percent by dry weight of sugar; or
A change to subheading 2106.90 from heading
2009 or subheading 2202.90 provided that a
single juice ingredient of foreign origin,
or juice ingredients from a single foreign
country, constitute in single strength form
no more than 60 percent by volume of the
good.
22.01.................... A change to heading 22.01 from any other
chapter.
2202.10.................. A change to sweetened and/or flavored waters
of subheading 2202.10 from any other
chapter; or
A change to other beverages of subheading
2202.10 from any other heading.
2202.90.................. A change to subheading 2202.90 from any other
subheading, except from Chapter 4 or heading
19.01, 20.09 or 21.06; or
A change to subheading 2106.90 from Chapter 4
or heading 19.01 provided that the good
contains no more than 50 percent of milk
solids by weight; or
A change to subheading 2202.90 from heading
20.09 or subheading 2106.90 provided that a
single juice ingredient of foreign origin,
or juice ingredients from a single foreign
country, constitute in single strength form
no more than 60 percent by volume of the
good.
22.03.................... A change to heading 22.03 from any other
heading.
2204.10-2204.29.......... A change to subheading 2204.10 through
2204.29 from any other subheading outside
that group.
2204.30.................. A change to subheading 2204.30 from any other
heading.
22.05.................... A change to heading 22.05 from any other
heading, except from heading 22.04: or
A change to vermouth of heading 22.05 from
heading 2204.
22.06.................... A change to heading 22.06 from any other
heading.
22.07.................... A change to heading 22.07 from any other
heading except from heading 22.08.
2208.10-2208.50.......... A change to subheading 2208.10 through
2208.50 from any other subheading outside
that group.
2208.90.................. A change to subheading 2208.90 from any other
subheading, except from subheading 2208.10;
or
A change to cordials, liqueurs, kirschwasser
or ratafia of subheading 2208.90
(2208.90.45) from any other product.
22.09.................... A change to heading 22.09 from any other
heading.
23.01-23.08.............. A change to heading 23.01 through 23.08 from
any other chapter.
2309.10.................. A change to subheading 2309.10 from any other
heading.
2309.90.................. A change to subheading 2309.90 from any other
heading, except from Chapter 4 or heading
1901; or
A change to subheading 2309.90 from Chapter 4
or heading 1901 provided that the good
contains no more than 50 percent of milk
solids by weight.
24.01.................... A change to heading 24.01 from any other
chapter.
24.02-24.03.............. A change to heading 24.02 through 24.03 from
any other heading, including another heading
within that group.
------------------------------------------------------------------------
(e) Section V: Chapters 25 through 27
------------------------------------------------------------------------
25.01-25.16.............. A change to heading 25.01 through 25.16 from
any other heading, including another heading
within that group.
2517.10-2517.20.......... A change to heading 2517.10 through 2517.20
from any other heading.
2517.30.................. A change to subheading 2517.30 from any other
subheading.
2517.41-2517.49.......... A change to heading 2517.41 through 2517.49
from any other heading.
25.18-25.30.............. A change to heading 25.18 through 25.30 from
any other heading.
26.01-26.21.............. A change to heading 26.01 through 26.21 from
any other heading, including another heading
within that group.
(1)...................... For purposes of this chapter, a ``chemical
reaction'' is defined as a process in which
chemical bonds in molecules are broken and
new chemical bonds are formed between the
fragmented molecules and/or added elements
so that one or more of the original bond/s
no longer link the same chemical element/s
or functional group/s.
2701-2706................ A change to heading 2701 through 2706 from
any other heading, including any heading
within the group.
2707.10-2707.99.......... A change to subheading 2707.10 through
2707.99 from any other heading; or
A change to subheading 2707.10 through
2707.99 from any other subheading, including
any subheading within the group, provided
that the good resulting from such change is
the product of a ``chemical reaction'' as
defined in Note 1.
2708-2709................ A change to heading 2708 through 2709 from
any other heading, including any heading
FR Doc. 93-31852 Rules for Determining the Country of Origin of a Good for Purposes of Annex 311 of the NAFTA and Rules of Origin Applicable to Imported Merchandise; Rule and Proposed Rule
within the group.
2710..................... A change to heading 2710 from any other
heading; or
A change to any good of heading 2710 from any
other good of heading 2710, provided that
the good resulting from such change is the
product of a ``chemical reaction'' as
defined in Note 1.
2711.11.................. A change to subheading 2711.11 from any other
subheading, except from subheading 2711.21.
2711.12-2711.19.......... A change to subheading 2711.12 through
2711.19 from any other subheading, including
any subheading within the group, except from
subheading 2711.29.
2711.21.................. A change to subheading 2711.21 from any other
subheading, except from subheading 2711.11.
2711.29.................. A change to subheading 2711.29 from any other
subheading, except from subheading 2711.12
through 2711.21.
2712-2714................ A change to heading 2712 through 2714 from
any other heading, including any heading
within the group.
2715..................... A change to heading 2715 from any other
heading, except from heading 2714 or
subheading 2713.20.
2716..................... A change to heading 2716 from any other
heading.
------------------------------------------------------------------------
(f) Section VI: Chapters 28 through 38
------------------------------------------------------------------------
Notes: 1. Chemical reaction origin rule--
Any good of chapters 28, 29, 31, 32 or 38 that is the product of a
chemical reaction shall be considered to be a good of the country in
which the reaction occurred.
A chemical reaction is defined as a process in which chemical bonds in
molecules are broken and new chemical bonds are formed between the
fragmented molecules and/or added elements so that one or more of the
original bond/s no longer link the same chemical element/s or functional
group/s.
Notwithstanding any of the line-by-line rules, the ``chemical
reaction'' rule may be applied to any good classified in the above
chapters.
2. Separation Prohibition--
A foreign material/component will not be deemed to have satisfied all
applicable requirements of these marking rules by reason of a change
from one classification to another merely as the result of the
separation of one or more individual materials or components from a man-
made mixture unless the isolated material/component, itself, also
underwent a chemical reaction.
------------------------------------------------------------------------
2801.10-2801.30.......... A change to subheading 2801.10 through
2801.30 from any other subheading, including
any subheading within the group.
2802..................... A change to heading 2802 from any other
heading, except from heading 2503.
2803..................... A change to heading 2803 from any other
heading.
2804.10-2804.50.......... A change to subheading 2804.10 through
2804.50 from any other subheading, including
any subheading within the group.
2804.61-2804.69.......... A change to subheading 2804.61 through
2804.69 from any other subheading outside
the group.
2804.70-2804.90.......... A change to subheading 2804.70 through
2804.90 from any other subheading, including
any subheading within the group.
2805..................... A change to heading 2805 from any other
heading.
2806.10-2806.20.......... A change to subheading 2806.10 through
2806.20 from any other subheading, including
any subheading within the group.
2807-2808................ A change to heading 2807 through 2808 from
any other heading, including any heading
within the group.
2809.10-2809.20.......... A change to subheading 2809.10 through
2809.20 from any other subheading, including
any subheading within the group.
2810..................... A change to heading 2810 from any other
heading.
2811.11.................. A change to subheading 2811.11 from any other
subheading.
2811.19.................. A change to subheading 2811.19 from any other
subheading, except from subheading 2811.22.
2811.21.................. A change to subheading 2811.21 from any other
subheading.
2811.22.................. A change to subheading 2811.22 from any other
subheading, except from subheading 2505.10,
2506.10, or 2811.19.
2811.23-2811.29.......... A change to subheading 2811.23 through
2811.29 from any other subheading, including
any subheading within the group.
2812.10-2813.90.......... A change to subheading 2812.10 through
2813.90 from any other subheading, including
any subheading within the group.
2814..................... A change to heading 2814 from any other
heading.
2815.11-2815.12.......... A change to subheading 2815.11 through
2815.12 from any other subheading outside
the group.
2815.20-2815.30.......... A change to subheading 2815.20 through
2815.30 from any other subheading, including
any subheading within the group.
2816.10.................. A change to subheading 2816.10 from any other
subheading.
2816.20.................. A change to subheading 2816.20 from any other
subheading, except from subheading 2530.90.
2816.30.................. A change to subheading 2816.30 from any other
subheading.
2817..................... A change to heading 2817 from any other
heading, except from heading 2608.
2818.10-2818.30.......... A change to subheading 2818.10 through
2818.30 from any other subheading, including
any subheading within the group, except from
heading 2606 or subheading 2620.40.
2819.10-2819.90.......... A change to subheading 2819.10 through
2819.90 from any other subheading, including
any subheading within the group.
2820.10-2820.90.......... A change to subheading 2820.10 through
2820.90 from any other subheading, including
any subheading within the group, except from
subheading 2530.90 or from heading 2602.
2821.10.................. A change to subheading 2821.10 from any other
subheading.
2821.20.................. A change to subheading 2821.20 from any other
subheading, except from subheading 2530.30,
or 2601.11 through 2601.20.
2822..................... A change to heading 2822 from any other
heading, except from heading 2605.
2823..................... A change to heading 2823 from any other
heading.
2824.10-2824.90.......... A change to subheading 2824.10 through
2824.90 from any other subheading, including
any subheading within the group, except from
heading 2607.
2825.10-2825.40.......... A change to subheading 2825.10 through
2825.40 from any other subheading, including
any subheading within the group.
2825.50.................. A change to subheading 2825.50 from any other
subheading, except from heading 2603.
2825.60.................. A change to subheading 2825.60 from any other
subheading, except from subheading 2615.10.
2825.70.................. A change to subheading 2825.70 from any other
subheading, except from subheading 2613.10.
2825.80.................. A change to subheading 2825.80 from any other
subheading, except from subheading 2617.10.
2825.90.................. A change to subheading 2825.90 from any other
subheading, provided that the good of this
subheading is the product of a ``chemical
reaction'' as defined in Note 1.
2826.11-2833.19.......... A change to subheading 2826.11 through
2833.19 from any other subheading, including
any subheading within the group.
2833.21.................. A change to subheading 2833.21 from any other
subheading, except from subheading 2530.20.
2833.22-2833.26.......... A change to subheading 2833.22 through
2833.26 from any other subheading, including
any subheading within the group.
2833.27.................. A change to subheading 2833.27 from any other
subheading, except from subheading 2511.10.
2833.29.................. A change to subheading 2833.29 from any other
subheading, except from heading 2520.
2833.30-2833.40.......... A change to subheading 2833.30 through
2833.40 from any other subheading, including
any subheading within the group.
2834.10-2834.29.......... A change to subheading 2834.10 through
2834.29 from any other subheading, including
any subheading within the group.
2835.10-2835.25.......... A change to subheading 2835.10 through
2835.25 from any other subheading, including
any subheading within the group.
2835.26.................. A change to subheading 2835.26 from any other
subheading, except from heading 2510.
2835.29-2935.39.......... A change to subheading 2835.29 through
2835.39 from any other subheading, including
any subheading within the group.
2836.10.................. A change to subheading 2836.10 from any other
subheading.
2836.20.................. A change to subheading 2836.20 from any other
subheading, except from subheading 2530.90.
2836.30-2836.40.......... A change in subheading 2836.30 through
2836.40 from any other subheading, including
any subheading within the group.
2836.50.................. A change to subheading 2836.50 from any other
subheading, except from heading 2509,
subheading 2517.41 or 2517.49, heading 2521,
or subheading 2530.90.
2836.60.................. A change to subheading 2836.60 from any other
subheading, except from subheading 2511.20.
2836.70.................. A change to subheading 2836.70 from any other
subheading, except from heading 2607.
2836.91.................. A change to subheading 2836.91 from any other
subheading.
2836.92.................. A change to subheading 2836.92 from any other
subheading, except from subheading 2530.90.
2836.93.................. A change to subheading 2836.93 from any other
subheading, except from subheading 2617.90.
2836.99.................. A change to subheading 2836.99 from any other
subheading, provided that the good of this
subheading is the product of a ``chemical
reaction'' as defined in Note 1.
2837.11-2837.20.......... A change to subheading 2837.11 through
2837.20 from any other subheading, including
any subheading within the group.
2838..................... A change to heading 2838 from any other
heading.
2839.11-2839.19.......... A change to subheading 2839.11 through
2839.19 from any other subheading, outside
the group.
2839.20-2839.90.......... A change to subheading 2839.20 through
2839.90 from any other subheading, including
any subheading within the group.
2840.11-2840.20.......... A change to subheading 2840.11 through
2840.20 from any other subheading outside
the group, except from subheading 2528.10.
2840.30.................. A change to subheading 2840.30 from any other
subheading.
2841.10-2841.40.......... A change to subheading 2841.10 through
2841.40 from any other subheading, including
any subheading within the group.
2841.50.................. A change to subheading 2841.50 from any other
subheading, except from heading 2610.
2841.60.................. A change to subheading 2841.60 from any other
subheading.
2841.70.................. A change to subheading 2841.70 from any other
subheading, except from subheading 2613.90.
2841.80.................. A change to subheading 2841.80 from any other
subheading, except from heading 2611.
2841.90.................. A change to subheading 2841.90 from any other
subheading, provided that the good of this
subheading is the product of a ``chemical
reaction'' as defined in Note 1.
2842.10.................. A change to subheading 2843.10 from any other
subheading.
2842.90.................. A change to subheading 2842.90 from any other
subheading, provided that the good of this
subheading is the product of a ``chemical
reaction'' as defined in Note 1.
2843.10.................. A change to subheading 2843.10 from any other
subheading, except from heading 7106, 7108,
7110, or 7112.
2843.21-2843.29.......... A change to subheading 2843.21 through
2843.29 from any other subheading, including
any subheading within the group.
2843.30-2843.90.......... A change to subheading 2843.30 through
2843.90 from any other subheading, including
any subheading within the group, except from
subheading 2616.90.
2844.10.................. A change to subheading 2844.10 from any other
subheading, except from subheading 2612.10.
2844.20.................. A change to subheading 2844.20 from any other
subheading.
2844.30.................. A change to subheading 2844.30 from any other
subheading, except from subheading 2844.20.
2844.40-2844.50.......... A change to subheading 2844.40 through
2844.50 from any other subheading, including
any subheading within the group.
2845..................... A change to heading 2845 from any other
heading.
2846..................... A change to heading 2846 from any other
heading, except from subheading 2530.90.
2847..................... A change to subheading 2847 from any other
heading.
2848.10-2849.90.......... A change to subheading 2848.10 through
2849.90 from any other subheading, including
any subheading within the group.
2850-2851................ A change to heading 2850 through 2851 from
any other heading, including any heading
within the group.
2901.10-2901.90.......... A change to subheading 2901.10 through
2901.90 from any other subheading, including
any subheading within the group, except from
acyclic petroleum oils of heading 2710, or
subheading 2711.13, 2711.14, 2711.19 or
2711.29.
2902.11.................. A change to subheading 2902.11 from any other
subheading.
2902.19.................. A change to subheading 2902.19 from any other
subheading, except from non-aromatic cyclic
petroleum oils of subheading 2707.50,
2707.99, or heading 2710.
2902.20.................. A change to subheading 2902.20 from any other
subheading, except from subheading 2707.10,
2707.50, or 2707.99.
2902.30.................. A change to subheading 2902.30 from any other
subheading, except from subheading 2707.20,
2707.50, or 2707.99.
2902.41-2902.44.......... A change to subheading 2902.41 through
2902.44 from any other subheading, including
any subheading within the group, except from
subheading 2707.30, 2707.50 or 2707.99.
2902.50.................. A change to subheading 2902.50 from any other
subheading.
2902.60.................. A change to subheading 2902.60 from any other
subheading, except from subheading 2707.30,
2707.50, 2707.99, or heading 2710.00.
2902.70-2902.90.......... A change to subheading 2902.70 through
2902.90 from any other subheading, including
any subheading within the group, except from
subheading 2707.50, 2707.99 or heading 2710.
2903.11-2904.90.......... A change to subheading 2903.11 through
2904.90 from any other subheading, including
any subheading within the group.
2905.11-2905.21.......... A change to subheading 2905.11 through
2905.21 from any other subheading, including
any subheading within the group.
2905.22-2905.29.......... A change to subheading 2905.22 through
2905.29 from any other subheading, including
any subheading within the group, except from
subheading 1301.90, 3301.90 or 3805.90.
2905.31-2905.50.......... A change to subheading 2905.31 through
2905.50 from any other subheading, including
any subheading within the group.
2906.11.................. A change to subheading 2906.11 from any other
subheading, except from subheading 3301.24
or 3301.25.
2906.12-2906.13.......... A change to subheading 2906.12 through
2906.13 from any other subheading, including
any subheading within the group.
2906.14.................. A change to subheading 2906.14 from any other
subheading, except from heading 3805.
2906.19.................. A change to subheading 2906.19 from any other
subheading, except from subheading 3301.90
or 3805.90.
2906.21.................. A change to subheading 2906.21 from any other
subheading.
2906.29.................. A change to subheading 2906.29 from any other
subheading, except from subheading 2707.60
or 3301.90.
2907.11.................. A change to subheading 2907.11 from any other
subheading, except from subheading 2707.60.
2907.12-2907.22.......... A change to subheading 2907.12 through
2907.22 from any other subheading, including
any subheading within the group, except from
subheading 2707.99.
2907.23.................. A change to subheading 2907.23 from any other
subheading.
2907.29-2907.30.......... A change to subheading 2907.29 through
2907.30 from any other subheading, including
any subheading within the group, except from
subheading 2707.99.
2908..................... A change to heading 2908 from any other
heading.
2909.11-2909.49.......... A change to subheading 2909.11 through
2909.49 from any other subheading, including
any subheading within the group.
2909.50.................. A change to subheading 2909.50 from any other
subheading, except from subheading 3301.90.
2909.60.................. A change to subheading 2909.60 from any other
subheading.
2910.10-2910.90.......... A change to subheading 2910.10 through
2910.90 from any other subheading, including
any subheading within the group.
2911..................... A change to heading 2911 from any other
heading.
2912.11-2912.13.......... A change to subheading 2912.11 through
2912.13 from any other subheading, including
any subheading within the group.
2912.19-2912.49.......... A change to subheading 2912.19 through
2912.49 from any other subheading, including
any subheading within the group, except from
subheading 3301.90.
2912.50-2912.60.......... A change to subheading 2912.50 through
2912.60 from any other subheading, including
any subheading within the group.
2913..................... A change to heading 2913 from any other
heading.
2914.11-2914.19.......... A change to subheading 2914.11 through
2914.19 from any other subheading, including
any subheading within the group, except from
subheading 3301.90.
2914.21-2914.22.......... A change to subheading 2914.21 through
2914.22 from any other subheading, including
any subheading within the group.
2914.23.................. A change to subheading 2914.23 from any other
subheading, except from subheading 3301.90.
2914.29.................. A change to subheading 2914.29 from any other
subheading, except from subheading 3301.90
or 3805.90.
2914.30-2914.70.......... A change to subheading 2914.30 through
2914.70 from any other subheading, including
any subheading within the group, except from
subheading 3301.90.
2915.11-2915.35.......... A change to subheading 2915.11 through
2915.35 from any other subheading, including
any subheading within the group.
2915.39.................. A change to subheading 2915.39 from any other
subheading, except from subheading 3301.90.
2915.40-2915.90.......... A change to subheading 2915.40 through
2915.90 from any other subheading, including
any subheading within the group.
2916.11-2916.20.......... A change to subheading 2916.11 through
2916.20 from any other subheading, including
any subheading within the group.
2916.31-2916.39.......... A change to subheading 2916.31 through
2916.39 from any other subheading, including
any subheading within the group, except from
subheading 3301.90.
2917.11-2917.39.......... A change to subheading 2917.11 through
2917.39 from any other subheading, including
any subheading within the group.
2918.11-2918.22.......... A change to subheading 2918.11 through
2918.22 from any other subheading, including
any subheading within the group.
2923..................... A change to subheading 2918.23 from any other
subheading, except from subheading 3301.90.
2918.29-2918.30.......... A change to subheading 2918.29 through
2918.30 from any other subheading, including
any subheading within the group.
2918.90.................. A change to subheading 2918.90 from any other
subheading, except from heading 3301.90.
2919..................... A change to subheading 2919 from any other
heading.
2920.10-2926.90.......... A change to subheading 2920.10 through
2926.90 from any other subheading, including
any subheading within the group.
2927-2928................ A change to heading 2927 through 2928 from
any other heading, including any heading
within the group.
2929.10-2930.90.......... A change to subheading 2929.10 through
2930.90 from any other subheading, including
any subheading within the group.
2931..................... A change to heading 2931 from any other
heading.
2932.11-2932.90.......... A change to subheading 2932.11 through
2932.90 from any other subheading, including
any subheading within the group, except from
subheading 3301.90.
2933.11-2934.90.......... A change to subheading 2933.11 through
2934.90 from any other subheading, including
any subheading within the group.
2935..................... A change to heading 2935 from any other
heading.
2936.10-2936.29.......... A change to subheading 2936.10 through
2936.29 from any other subheading, including
any subheading within the group.
2936.90.................. A change to subheading 2936.90 from any other
subheading, except from subheading 2936.10
through 2936.29.
2937-2941................ A change to heading 2937 through 2941 from
any other heading, including any heading
within the group.
2942..................... A change to heading 2942 from any other
chapter.
3001.10.................. A change to subheading 3001.10 from any other
subheading, except from subheading 0206.10
through 0208.90 or 0305.20, heading 0504 or
0510, or subheading 0511.99, unless the
change from these provisions is to a powder
of this subheading.
3001.20-3001.90.......... A change to subheading 3001.20 through
3001.90 from any other subheading, including
any subheading with the group.
3002.10-3002.90.......... A change to subheading 3002.10 through
3002.90 from any other subheading, including
any subheading within the group.
3003.10.................. A change to subheading 3003.10 from any other
subheading, except from subheading 2941.10,
2941.20 or 3003.20.
3003.20.................. A change to subheading 3003.20 from any other
subheading, except from subheading 2941.30
through 2941.90.
3003.31.................. A change to subheading 3003.31 from any other
subheading, except from subheading 2937.91.
3003.39.................. A change to subheading 3003.39 from any other
subheading, except from hormones or their
derivatives classified in chapter 29.
3003.40.................. A change to subheading 3003.40 from any other
subheading, except from heading 1211,
subheading 1302.11, 1302.19, 1302.20,
1302.39, or from any alkaloids or their
derivatives classified in chapter 29.
3003.90.................. A change to subheading 3003.90 from any other
subheading, provided that the domestic
content of the therapeutic or prophylactic
component(s) is no less than 40 percent by
weight of the total therapeutic or
prophylactic content.
3004.10.................. A change to subheading 3004.10 from any other
subheading, except from subheading 2941.10,
2941.20, 3003.10 or 3003.20.
3004.20.................. A change to subheading 3004.20 from any other
subheading, except from subheading 2941.30
through 2941.90, or 3003.20.
3004.31.................. A change to subheading 3004.31 from any other
subheading, except from subheading 2937.91,
3003.31 or 3003.39.
3004.32.................. A change to subheading 3004.32 from any other
subheading, except from subheading 3003.39,
or any adrenal cortical hormone/s classified
in chapter 29.
3004.39.................. A change to subheading 3004.39 from any other
subheading, except from subheading 3003.39,
or any hormone/s or its/their derivative/s
classified in chapter 29.
3004.40.................. A change to subheading 3004.40 from any other
subheading, except from heading 1211,
subheading 1302.11, 1302.19, 1302.20,
1302.39, 3003.40, or any alkaloid/s or its/
their derivative/s provided for in chapter
29.
3004.50.................. A change to subheading 3004.50 from any other
subheading, except from subheading 3003.90,
or any vitamin/s classified in chapter 29,
or products of heading 2936.
3004.9................... A change to subheading 3004.90 from any other
subheading, except from subheading 3003.90,
provided that the domestic content of the
therapeutic or prophylactic component/s is
no less than 40 percent by weight of the
total therapeutic or prophylactic content.
3005.10.................. A change to subheading 3005.10 from any other
subheading.
3005.90.................. A change to subheading 3005.90 from any other
subheading, except from Section XI,
Harmonized System, unless the change is to a
good of this subheading that is impregnated
or coated with pharmaceutical substance/s.
3006.10.................. A change to subheading 3006.10 from any other
subheading, except from subheading 1212.20
or 4206.10.
3006.20-3006.60.......... A change to subheading 3006.20 through
3006.60 from any other subheading, including
any subheading within the group.
3101..................... A change to heading 3101 from any other
heading, except from subheading 2301.20 or
powders and meals of subheading 0506.90,
heading 0508, or subheading 0511.91 or
0511.99.
3102.10-3102.21.......... A change to subheading 3102.10 through
3102.21 from any other subheading, including
any subheading within the group.
------------------------------------------------------------------------
(g) Section VII: Chapters 39 through 40
------------------------------------------------------------------------
3901-3915............... A change to heading 3901 through 3915 from
any other heading, including any heading
within the group, provided that the domestic
polymer content is no less than 40 percent
by weight of the total polymer content.
3916.10-3918.90.......... A change to subheading 3916.10 through
3918.90 from any other subheading, including
any subheading within the group.
3919.10-3919.90.......... A change to subheading 3919.10 through
3919.90 from any other subheading outside
the group.
3920.10-3921.90.......... A change to subheading 3920.10 through
3921.90 from any other subheading including
any subheading within the group.
3922-3926................ A change to heading 3922 through 3926 from
any other heading, including any heading
within the group.
4001.10-4001.22.......... A change to subheading 4001.10 through
4001.22 from any other subheading, including
any subheading within the group.
4001.29.................. A change to subheading 4001.29 from any other
subheading, except from subheading 4001.21
or 4001.22.
4001.30.................. A change to subheading 4001.30 from any other
subheading.
4002.11-4002.70.......... A change to subheading 4002.11 through
4002.70 from any other subheading, including
any subheading within the group.
4002.80-4002.99.......... A change to subheading 4002.80 through
4002.99 from any other subheading, including
any subheading within the group, provided
that the domestic rubber content is no less
than 40 percent by weight of the total
rubber content.
4003-4004................ A change to heading 4003 through 4004 from
any other heading, including any heading
within the group.
4005..................... A change to heading 4005 from any other
heading, except from heading 4001 or 4002.
4006-4010................ A change to heading 4006 through 4010 from
any other heading, including any heading
within the group.
4011.10-4012.90.......... A change to subheading 4011.10 through
4012.90 from any other subheading, including
any subheading within the group.
4013..................... A change to heading 4013 from any other
heading.
4014.10-4014.90.......... A change to subheading 4014.10 through
4014.90 from any other subheading, including
any subheading within the group.
4015..................... A change to heading 4015 from any other
heading.
4016.10-4016.99.......... A change to subheading 4016.10 through
4016.99 from any other subheading, including
any subheading within the group.
4017..................... A change to heading 4017 from any other
heading.
------------------------------------------------------------------------
(h) Section VIII: Chapters 41 through 43
------------------------------------------------------------------------
4104-4103................ A change to heading 41.01 through 41.03 from
any other chapter.
4104-4107................ A change to heading 41.04 through 41.07 from
any other heading, including another heading
within that group; or
A change to finished leather of heading 4104
through 4107 from wet blue hides or leather.
4108-4111................ A change to heading 41.08 through 41.11 from
any other heading, including another heading
within that group.
4201..................... A change to heading 42.01 from any other
heading.
4202.11.................. A change to subheading 4202.11 from any other
heading.
4202.12-4202.22.......... A change to subheadings 4202.12 through
4202.22 from any other heading provided that
the change does not result from the assembly
of imported cut components.
4202.29.................. A change to subheading 4202.29 from any other
heading.
4202.31-4202.32.......... A change to subheadings 4202.31 through
4202.32 from any other heading provided that
the change does not result from the assembly
of imported cut components.
4202.39.................. A change to subheading 4202.39 from any other
heading.
4202.91-4202.99.......... A change to subheadings 4202.91 through
4202.99 from any other heading provided that
the change does not result from the assembly
of imported cut components.
4203-4206................ A change to headings 42.03 through 42.06 from
any other heading, including another heading
within the group.
43.01.................... A change to heading 43.01 from any other
chapter.
4302.11-4302.20.......... A change to subheading 4302.11 through
4302.20 from any other heading.
4302.30.................. A change to subheading 4302.30 from any other
subheading provided that the change does not
result from the assembly of imported cut fur
components.
4303-4304................ A change to headings 43.03 through 43.04 from
any other heading, including another heading
within that group.
------------------------------------------------------------------------
(i) Section IX: Chapters 44 through 46
------------------------------------------------------------------------
4401-4411................ A change to headings 44.01 through 44.11 from
any other heading, including another heading
within that group.
4412..................... A change to headings 4412 from any other
heading; or
A change to surface-covered plywood of 4412
from any other plywood that is not surface-
covered, or is surface-covered only with a
clear or transparent material which does not
obscure the grain, texture, or markings of
the face ply.
4413-4421................ A change to headings 44.13 through 44.21 from
any other heading, including another heading
within that group.
4501..................... A change to heading 45.01 from any other
heading.
4502..................... A change to heading 45.02 from any other
heading except from heading 4501.
4503-4504................ A change to headings 45.03 through 45.04 from
any other heading, including another heading
within that group.
4601..................... A change to subheading 4601.10 through
4601.99 from any other subheading, including
another subheading within that group.
4602..................... A change to heading 46.02 from any other
heading.
------------------------------------------------------------------------
(j) Section X: Chapters 47 through 49
------------------------------------------------------------------------
4701-4702................ A change to headings 47.01 through 47.02 from
any other heading including a heading within
that group.
4703.11-4704.29.......... A change to subheadings 4703.11 through
4704.29 from any other subheading, including
another subheading within that group.
4705-4707................ A change to headings 47.05 through 47.07 from
any other heading, including another heading
within that group.
4801-4807................ A change to headings 48.01 through 48.07 from
any other heading, including another heading
within that group.
4808.10.................. A change to subheadings 4808.10 from any
other heading.
4808.20-4808.30.......... A change to subheadings 4808.20 through
4808.30 from any other heading except from
4804.
4808.90.................. A change to subheading 4808.90 from any other
chapter.
4809..................... A change to heading 48.09 from any other
heading.
4810-4814................ A change to headings 48.10 through 48.14 from
any other heading, including another heading
within that group.
4815..................... A change to heading 48.15 from any other
heading.
4816..................... A change to heading 48.16 from any other
heading, except from heading 48.09.
4817-4822................ A change to headings 48.17 through 48.22 from
any other heading, including another heading
within that group.
4823.11.................. A change to 4823.11 from any other
subheading.
4823.19.................. A change to 4823.19 from any other
subheading.
4823.20-4823.59.......... A change to subheading 4823.20 through
4823.59 from any other chapter; or
A change to 4823.20 through 4823.59 from
within chapter 48 if that change is a result
of a substantial transformation.
4823.60.................. A change to 4823.60 from any other
subheading.
4823.70-4823.90.......... A change to subheading 4823.70 through
4823.90 from any other chapter; or
A change to 4823.70 through 4823.90 from
within chapter 48 if that change is a result
of a substantial transformation.
4901-4911................ A change to heading 49.01 through 49.11 from
any other heading, including another heading
within that group.
------------------------------------------------------------------------
(k) SECTION XI: Chapters 50 through 63
------------------------------------------------------------------------
Notes: (1) For the purposes of Chapters 50 through 63, the following
definitions will apply:
a. The term ``greige'', as used in chapters 50 through 55, 58, and 60,
means that the fabric has not been subjected to any wet or dry
finishing operations after it was formed.
b. The phrase ``major parts'', as used in chapters 61 and 62, means
integral components of the garment, but does not include such parts as
collars, cuffs, waistbands, plackets, pockets, linings, paddings,
accessories, or the like.
c. The phrase ``knit to shape'', as used in chapters 61 and 62, refers
to any made up major part (as defined above) of a garment which, prior
to the fabric being cut, has the same shape, or closely resembles the
shape, of that component as used in the garment.
d. The phrase ``fully lined, fully padded, or fully insulated'', as used
in chapters 61 and 62, means that the body of the garment, together
with its sleeves and/or legs, is entirely lined, padded, or insulated,
but this does not include waistbands less than fifteen centimeters
wide, cuffs less than ten centimeters wide, plackets, collars, shoulder
straps, and the like).
e. The term ``tailored'', as used in chapters 61 and 62, refers to
noncasual garments of the type normally worn for business or social
purposes where some degree of formality is required, and garments of
virtually identical construction. These garments have been permanently
shaped and usually have trim, fitted lines obtained by careful cutting,
seaming, and pressing.
(2) Where a tariff shift rule in chapters 61 or 62 involves the assembly
of a garment, the rule is satisfied only when the entire assembly of
all major parts occurs in one country.
(3) For the purposes of Section 102.11(b) of the General Rules, except
for sets, where a good classifiable in Chapter 61 through 63 does not
meet the tariff shift requirements of the heading or subheading under
which it is classifiable, the country of origin of that good shall be
the single country where the component which determines the
classification of that good was cut or formed (e.g. knit to shape),
provided all major parts were cut or formed in a single country.
------------------------------------------------------------------------
5001-5003................ A change to heading 5001 through 5003 from
any other chapter.
5004-5006................ A change to heading 5004 through 5006 from
any heading outside that group.
5007..................... A change to heading 5007 from any other
heading; or
A change from greige fabric of heading 5007
to finished fabric of heading 5007 by dyeing
and printing, plus two or more of the
following finishing operations--bleaching,
shrinking, fulling, napping, decating,
permanent stiffening, weighting, permanent
embossing, or moireing.
5101-5105................ A change to heading 5101 through 5105 from
any other chapter.
5106-5110................ A change to heading 5106 through 5110 from
any heading outside that group.
5111-5113................ A change to heading 5111 through 5113 from
any heading outside that group; or
A change from greige fabric of headings 5111
through 5113 to finished fabric of those
same headings by dyeing and printing, plus
two or more of the following finishing
operations--bleaching, shrinking, fulling,
napping, decating, permanent stiffening,
weighting, permanent embossing, or moireing.
5201-5203................ A change to heading 5201 through 5203 from
any other chapter.
5204-5207................ A change to heading 5204 through 5207 from
any heading outside that group.
5208-5212................ A change to heading 5208 through 5212 from
any heading outside that group; or
A change from greige fabric of heading 5208
through 5512 to finished fabric of those
same headings by dyeing and printing, plus
two or more of the following finishing
operations--bleaching, shrinking, fulling,
napping, decating, permanent stiffening,
weighting, permanent embossing, or moireing.
5301-5305................ A change to heading 5301 through 5305 from
any other chapter.
5306-5308................ A change to heading 5306 through 5308 from
any heading outside that group.
5309-5311................ A change to heading 5309 through 5311 from
any heading outside that group; or
A change from greige fabric of heading 5309
through 5311 to finished fabric of those
same headings by dyeing and printing, plus
two or more of the following finishing
operations--bleaching, shrinking, fulling,
napping, decating, permanent stiffening,
weighting, permanent embossing, or moireing.
5401-5403................ A change to heading 5401 through 5403 from
any other chapter.
5404-5405................ A change to heading 5404 through 5405 from
any other chapter except from headings 3920
and 3921.
5406..................... A change to heading 5406 from any other
chapter.
5407-5408................ A change to heading 5407 through 5408 from
any heading outside that group; or
A change from greige fabric of heading 5111
through 5113 to finished fabric of those
same headings by dyeing and printing, plus
two or more of the following finishing
operations--bleaching, shrinking, fulling,
napping, decating, permanent stiffening,
weighting, permanent embossing, or moireing.
5501-5507................ A change to heading 5501 through 5507 from
any other heading except heading 5401
through 5405.
5508-5511................ A change to heading 5508 through 5511 from
any heading outside that group.
5512-5516................ A change to heading 5512 through 5516 from
any heading outside that group; or
A change from greige fabric of heading 5512
through 5516 to finished fabric of those
same headings by dyeing and printing, plus
two or more of the following finishing
operations--bleaching, shrinking, fulling,
napping, decating, permanent stiffening,
weighting, permanent embossing, or moireing.
5601..................... A change to heading 5601 from any other
heading.
5602-5605................ A change to heading 5602 through 5605 from
any heading outside that group.
5606..................... A change to heading 5606 from any other
heading except from heading 5004 through
5006, 5106 through 5110, 5204 through 5207,
5306 through 5308, 5401 through 5406, and
5508 through 5511.
5607..................... (1) A change to twine, cordage, ropes, and
cables, neither plaited or braided, nor
covered or sheathed with rubber or plastics,
of heading 5607, from any other heading
except heading 5004 through 5006, 5106
through 5110, 5204 through 5207, 5306
through 5308, 5401 through 5406, and 5508
through 5511; or
(2) A change to twine, cordage, ropes, and
cables, either plaited or braided, or
covered or sheathed with rubber or plastics,
of heading 5607, from any other heading.
5608..................... A change to heading 5608 from any other
heading except heading 5804.
5609..................... A change to heading 5609 from any other
heading except from heading 5004 through
5007, 5106 through 5113, 5204 through 5212,
5306 through 5311, 5401 through 5408, 5508
through 5516, and 5607.
5701-5705................ A change to heading 5701 through 5705 from
any other chapter.
5801-5802................ A change to heading 5801 through 5802 from
any heading outside that group; or
A change from greige fabric of heading 5801
to 5802 to finished fabric of those same
headings by dyeing and printing, plus two or
more of the following finishing operations--
bleaching, shrinking, fulling, napping,
decating, permanent stiffening, weighting,
permanent embossing, or moireing.
5803..................... A change to heading 5803 from any other
heading.
5804..................... A change to heading 5804 from any other
heading; or
A change from greige fabric of heading 5804
to finished fabric of that same heading by
dyeing and printing, plus two or more of the
following finishing operations--bleaching,
shrinking, fulling, napping, decating,
permanent stiffening, weighting, permanent
embossing, or moireing.
5805..................... A change to heading 5805 from any other
heading.
5806.10-5806.39.......... A change to subheading 5806.10 through
5806.39 from any heading except from heading
5007, 5111 through 5113, 5208 through 5212,
5309 through 5311, 5407 through 5408, and
5512 through 5516; or
A change from greige fabric of subheading
5806.10 to 5806.39 to finished fabric of
those same subheadings by dyeing and
printing, plus two or more of the following
finishing operations--bleaching, shrinking,
fulling, napping, decating, permanent
stiffening, weighting, permanent embossing,
or moireing.
5806.40.................. A change to subheading 5806.40 from any other
heading.
5807..................... (1) For labels and similar articles, a change
to heading 5807 from any other heading
except heading 5007, 5111 through 5113, 5208
through 5212, 5309 through 5311, 5407
through 5408, 5512 through 5516, and heading
5806.
(2) For badges and similar articles, a change
to heading 5807 from any other heading
except subheading 6307.90.
5808.10.................. A change to subheading 5808.10 from any other
heading.
5808.90.................. (1) For ornamental trimmings, a change to
subheading 5808.90 from any other heading.
(2) For tassels, pompons and similar
articles, a change to subheading 5808.90
from any heading except from heading 5004
through 5006, 5106 through 5110, 5204
through 5207, 5306 through 5308, 5401
through 5406, and 5508 through 5511.
5809..................... A change to heading 5809 from any other
heading.
5810..................... (1) Where the weight of the embroidery equals
or exceeds the weight of the ground fabric,
a change of the ground fabric to heading
5810 from any other heading; or
(2) Where the weight of the embroidery is
less than the weight of the ground fabric, a
change of the ground fabric to heading 5810
from any other chapter except heading 5007,
5111 through 5113, 5208 through 5212, 5309
through 5311, 5407 through 5408, 5512
through 5516, 5602, 5603, 5608, 5903, 5907,
6001, and 6002.
5811..................... A change to heading 5811 from any other
heading except heading 5007, 5111 through
5113, 5208 through 5212, 5309 through 5311,
5407 through 5408, 5512 through 5516, 5601
through 5603, 5806, 5809 through 5810, 6002,
and subheading 6307.90; or
A change to heading 5811 from any other
heading, provided that the outer fabric or
fabrics are dyed and printed in the same
country where the quilting is done.
5901-5902................ A change to heading 5901 through 5902 from
any other heading.
5903..................... A change to heading 5903 from any other
heading except heading 5007, 5111 through
5113, 5208 through 5212, 5309 through 5311,
5407 through 5408, 5512 through 5516, 5803,
5806.31 through 5806.39, 5808, and 6002; or
(1) For woven fabric, a change to heading
5903 from any other heading, provided that
the impregnation, coating, covering, or
lamination accounts for at least 15 percent
of the total weight of the fabric; or
(2) For knit fabric, a change to heading 5903
from any other heading, provided that the
impregnation, coating covering, or
lamination accounts for at least 20 percent
of the total weight of the fabric.
5904-5906................ A change to heading 5904 through 5906 from
any other heading.
5907..................... A change to heading 5907 from any other
heading except heading 5007, 5111 through
5113, 5208 through 5212, 5309 through 5311,
5407 through 5408, 5512 through 5516, 5803,
5806, 5808, and 6002; or
(1) For woven fabric, a change to heading
5907 from any other heading, provided that
the impregnation, coating, covering, or
lamination accounts for at least 15 percent
of the total weight of the fabric; or
(2) For knit fabric, a change to heading 5907
from any other heading, provided that the
impregnation, coating, covering, or
lamination accounts for at least 20 percent
of the total weight of the fabric.
5908-5910................ A change to heading 5908 through 5910 from
any other heading.
5911..................... A change to heading 5911 from any other
heading except heading 5602 through 5603.
6001..................... A change to heading 6001 from any other
heading; or
A change from greige fabric of heading 6001
to finished fabric of that same heading by
dyeing and printing, plus two or more of the
following finishing operations--bleaching,
shrinking, compacting, napping, shearing, or
calendering; or
A change to fabric of heading 6001
impregnated, coated, covered, or laminated
with rubber, plastics, or other substances,
from fabric of that same heading provided
that the impregnation, coating, covering, or
lamination accounts for at least 20 percent
of the weight of the entire fabric.
6002..................... A change to heading 6002 from any heading
outside that group; or
A change from greige fabric of heading 6002
to finished fabric of heading 6002 by dyeing
and printing, plus two or more of the
following finishing operations--bleaching,
shrinking, compacting, napping, shearing, or
calendering.
6101..................... A change to heading 6101 from any other
chapter; or
FR Doc. 93-31852 Rules for Determining the Country of Origin of a Good for Purposes of Annex 311 of the NAFTA and Rules of Origin Applicable to Imported Merchandise; Rule and Proposed Rule
A change to assembled garments of heading
6101, except (1) Anoraks, windbreakers, and
similar articles, not fully lined, fully
padded, or fully insulated, and (2) capes,
cloaks, and similar articles, from either
subheading 6117.90 or subheading 6217.90,
provided that no major part has been knit to
shape; or
A change from unassembled garment components
classified in heading 6101 as a result of
the application of GRI 2(a), except (1)
Anoraks, windbreakers, and similar articles,
not fully lined, fully padded, or fully
insulated, and (2) capes, cloaks, and
similar articles, to assembled garments,
provided that no major part has been knit to
shape.
6102..................... A change to heading 6102 from any other
chapter; or
A change to assembled garments of heading
6102, except (1) Anoraks, windbreakers, and
similar articles, not fully lined, fully
padded, or fully insulated, and (2) capes,
cloaks, and similar articles, from either
subheading 6117.90 or subheading 6217.90,
provided that no major part has been knit to
shape; or
A change from unassembled garment components
classified in heading 6102 as a result of
the application of GRI 2(a), except (1)
Anoraks, windbreakers, and similar articles,
not fully lined, fully padded, or fully
insulated, and (2) capes, cloaks, and
similar articles, to assembled garments,
provided that no major part has been knit to
shape.
6103..................... A change to heading 6103 from any other
chapter; or
6103.11-6103.19--........ A change to assembled garments of subheading
6103.11 through 6103.19 from subheading
6117.90; or
A change to assembled garments from
unassembled parts classified in subheading
6103.11 through 6103.19 as a result of the
application of GRI 2(a), provided that no
major part has been knit to shape.
6103.21-6103.29--........ Each garment in an ensemble shall be treated
separately and the marking rule applicable
to each garment is the rule that would apply
if the garment were separately entered;
6103.31-6103.39--........ A change to assembled garments of subheading
6103.31 through 6103.39 from either
subheading 6117.90 or subheading 6217.90,
provided that no major part has been knit to
shape; or
A change to assembled garments from
unassembled parts classified in subheading
6103.31 through 6103.39 as a result of the
application of GRI 2(a), provided that no
major part has been knit to shape;
6103.41-6103.49--........ A change to assembled fully lined, fully
padded, or fully insulated bib and brace
overalls or to fully lined tailored
trousers, of subheading 6103.41 through
6103.49, from either subheading 6117.90 or
subheading 6217.90, provided that no major
part has been knit to shape; or
A change to assembled fully lined, fully
padded, or fully insulated bib and brace
overalls, or to fully lined tailored
trousers, from unassembled parts classified
in subheading 6103.41 through 6103.49 as a
result of the application of GRI 2(a),
provided that no major part has been knit to
shape.
6104..................... A change to heading 6104 from any other
chapter; or
6104.11-6104.19--........ A change to assembled garments of subheading
6104.11 through 6104.19 from subheading
6117.90, provided that no major part has
been knit to shape; or
A change to assembled garments from
unassembled parts classified in subheading
6104.11 through 6104.19 as a result of the
application of GRI 2(a), provided that no
major part has been knit to shape;
6104.21-6104.29--........ Each garment in an ensemble shall be treated
separately and the marking rule applicable
to each garment is the rule that would apply
if the garment were separately entered;
6104.31-6104.39--........ A change to assembled garments of subheading
6104.31 through 6104.39 from either
subheading 6117.90 or subheading 6217.90,
provided that no major part has been knit to
shape; or
A change to assembled garments from
unassembled parts classified in subheading
6104.31 through 6104.39 as a result of the
application of GRI 2(a), provided that no
major part has been knit to shape;
6104.41-6104.49--........ A change to assembled tailored garments
consisting of five or more major parts, of
subheading 6104.41 through 6104.49, from
either subheading 6117.90 or subheading
6217.90, provided that no major part has
been knit to shape; or
A change to assembled tailored garments
consisting of five or more major parts from
unassembled parts classified in subheading
6104.41 through 6104.49 as a result of the
application of GRI 2(a), provided that no
major part has been knit to shape;
6104.51-6104.59--........ A change to subheading 6104.51 through
6104.59 from any other chapter.
6104.61-6104.69--........ A change to assembled fully lined, fully
padded, or fully insulated bib and brace
overalls, or to fully lined tailored
trousers, of subheading 6104.61 through
6104.69 from either subheading 6117.90 or
subheading 6217.90, provided that no major
part has been knit to shape; or
A change to assembled fully lined, fully
padded, or fully insulated bib and brace
overalls, or to fully lined tailored
trousers, from unassembled parts classified
in subheading 6104.61 through 6104.69 as a
result of the application of GRI 2(a),
provided that no major part has been knit to
shape.
6105..................... A change to heading 6105 from any other
chapter; or
A change to assembled tailored long sleeve
shirts with collars, cuffs, full-front
openings with plackets, and yokes, or to
assembled fully lined, fully padded or fully
insulated shirts, of heading 6105, from
subheading either 6117.90 or subheading
6217.90, provided that no major part has
been knit to shape; or
A change to assembled tailored long sleeve
shirts with collars, cuffs, full-front
openings with plackets, and yokes, or to
assembled fully lined, fully padded or fully
insulated shirts from unassembled parts
classified in heading 6105 as a result of
the application of GRI 2(a), provided that
no major part has been knit to shape.
6106..................... A change to heading 6106 from any other
chapter; or
A change to assembled tailored long sleeve
shirts, or shirt blouses, with collars,
cuffs, full-front openings with plackets,
and yokes, or to tailored long sleeve
blouses without full front openings, with
collars, cuffs, and yokes, or to assembled
fully lined, fully padded, or fully
insulated shirts, or heading 6106, from
either subheading 6117.90 or subheading
6217.90, provided that no major part has
been knit to shape; or
A change to assembled tailored long sleeve
shirts, or shirt blouses, with collars,
cuffs, full-front openings with plackets,
and yokes, or to tailored long sleeve
blouses without full front openings, with
collars, cuffs, and yokes, or to assembled
fully lined, fully padded, or fully
insulated shirts, from unassembled parts
classified in heading 6106 as a result of
the application of GRI 2(a), provided that
no major part has been knit to shape.
6107-6109................ A change to heading 6107 through 6109 from
any other chapter.
6110..................... A change to heading 6110 from any other
chapter; or
A change to assembled fully lined, fully
padded, or fully insulated long sleeve
garments of heading 6110, from either
subheading 6117.90 or subheading 6217.90,
provided that no major part has been knit to
shape; or
A change to assembled fully lined, fully
padded, or fully insulated long sleeve
garments from unassembled parts classified
in heading 6110 as a result of the
application of GRI 2(a), provided that no
major part has been knit to shape.
6111..................... A change to heading 6111 from any other
chapter, except chapter 95; or
A change to assembled fully lined, fully
padded, or fully insulated outer garments of
heading 6111 from either subheading 6117.90
or subheading 6217.90, provided that no
major part has been knit to shape; or
A change to assemble fully lined, fully
padded, or fully insulated outer garments
from unassembled parts classified in heading
6111 as a result of the application of GRI
2(a), provided that no major part has been
knit to shape.
6112..................... A change to heading 6112 from any other
chapter; or
6112.11-6112.20-- A change to assembled fully lined garments of
subheading 6112.11 through 6112.20, from
either subheading 6117.90 of subheading
6217.90, provided that no major part has
been knit to shape; or
A change to assembled fully lined garments
from unassembled parts classified in
subheading 6112.11 through 6112.20 as a
result of the application of GRI 2(a),
provided that no major part has been knit to
shape.
6113..................... A change to heading 6113 from any other
chapter; or
A change to assembled fully lined, fully
padded, or fully insulated garments of
heading 6113, from either subheading 6117.90
or subheading 6217.90, provided that no
major part has been knit to shape; or
A change to assembled fully lined, fully
padded, or fully insulated garments from
unassembled parts classified in heading 6113
as a result of the application of GRI 2(a),
provided that no major part has been knit to
shape.
6114..................... A change to heading 6114 from any other
chapter; or
A change to assembled fully lined, fully
padded, or fully insulated garments,
consisting of five or more major parts, of
heading 6114, from either subheading 6117.90
or subheading 6217.90, provided that no
major part has been knit to shape; or
A change to assembled fully lined, fully
padded, or fully insulated garments,
consisting of five or more major parts, from
unassembled parts classified in heading 6114
as a result of the application of GRI 2(a),
provided that no major part has been knit to
shape.
6115-6117................ A change to heading 6115 through 6117 from
any other chapter.
6201..................... A change to heading 6201 from any other
chapter, provided that no major part has
been knit to shape; or
A change to assembled garments of heading
6201, except (1) Anoraks, windbreakers, and
similar articles, not fully lined, fully
padded, or fully insulated, and (2) capes,
cloaks, and similar articles, from either
subheading 6217.90 or subheading 6117.90,
provided that no major part has been knit to
shape; or
A change from unassembled garment components
classified in heading 6201 as a result of
the application of GRI 2(a), except (1)
Anoraks, windbreakers, and similar articles,
not fully lined, fully padded, or fully
insulated, and (2) capes, cloaks, and
similar articles, to assembled garments,
provided that no major part has been knit to
shape.
6202..................... A change to heading 6202 from any other
chapter; or
A change to assembled garments of heading
6202, except (1) Anoraks, windbreakers, and
similar articles, not fully lined, fully
padded, or fully insulated, and (2) capes,
cloaks, and similar articles, from either
subheading 6217.90 or subheading 6117.90,
provided that no major part has been knit to
shape; or
A change from unassembled garment components
classified in heading 6202 as a result of
the application of GRI 2(a), except (1)
Anoraks, windbreakers, and similar articles,
not fully lined, fully padded, or fully
insulated, and (2) capes, cloaks, and
similar articles, to assembled garments,
provided that no major part has been knit to
shape.
6203..................... A change to heading 6203 from any other
chapter, provided that no major part has
been knit to shape; or
6203.11-6203.19.......... A change to assembled garments of subheading
6203.11 through 6203.19 from subheading
6217.90; or
A change to assembled garments from
unassembled parts classified in subheading
6203.11 through 6203.19 as a result of the
application of GRI 2(a);
6203.21-6203.29--........ Each garment in an ensemble shall be treated
separately and the marking rule applicable
to each garment is the rule that would apply
if the garment were separately entered;
6203.31-6203.39--........ A change to assembled garments of subheading
6203.31 through 6203.39 from either
subheading 6217.90 or subheading 6117.90,
provided that no major part has been knit to
shape; or
A change to assembled garments from
unassembled parts classified in subheading
6203.31-6203.39 as a result of the
application of GRI 2(a), provided that no
major part has been knit to shape;
6203.41-6203.49--........ A change to subheading 6203.41 through
6203.49 from any other chapter, provided
that no major part has been knit to shape;
A change to assembled fully lined, fully
padded, or fulling insulated bib and brace
overalls, or to fully lined tailored
trousers, of subheading 6203.41 through
6203.49 from either subheading 6217.90 or
subheading 6117.90, provided that no major
part has been knit to shape; or
A change to assembled fully lined, fully
padded, or fully insulated bib and brace
overalls, or to fully lined tailored
trousers, from unassembled parts classified
in subheading 6203.41 through 6203.49 as a
result of the application of GRI 2(a),
provided that no major part has been knit to
shape.
6204..................... A change to heading 6204 from any other
chapter, provided that no major part has
been knit to shape; or
6204.11-6204.19--........ A change to assembled garments of subheading
6204.11 through 6203.14 from subheading
6217.90; or
A change to assembled garments from
unassembled parts classified in subheading
6204.11 through 6204.19 as a result of the
application of GRI 2(a);
6204.21-6204.29--........ Each garment in an ensemble shall be treated
separately and the marking rule applicable
to each garment is the rule that would apply
if the garment were separately entered;
6204.31-6204.39--........ A change to assembled garments of subheading
6204.31 through 6204.39 from either
subheading 6217.90 or subheading 6117.90,
provided that no major part has been knit to
shape; or
A change to assembled garments from
unassembled parts classified in subheading
6204.31 through 6204.39, as a result of the
application of GRI 2(a), provided that no
major part has been knit to shape;
6204.41-6204.49--........ A change to assembled tailored garments
consisting of five or more major parts, of
subheading 6204.41 through 6204.49, from
either subheading 6217.90 or subheading
6117.90, provided that no major part has
been knit to shape; or
A change to assembled tailored garments
consisting of five or more major parts, from
unassembled parts classified in subheading
6204.41-6204.49 as a result of the
application of GRI 2(a), provided that no
major part has been knit to shape;
6204.51-6204.59--........ A change to subheading 6204.51 through
6204.59 from any other chapter, provided
that no major part has been knit to shape;
6204.61-6204.69--........ A change to assembled fully lined, fully
padded, or fully insulated bib and brace
overalls, or to fully lined tailored
trousers, of subheading 6204.61 through
6204.69, from either subheading 6217.90 or
subheading 6117.90, provided that no major
part has been knit to shape; or
A change to assembled fully lined, fully
padded, or fully insulated bib and brace
overalls, or to fully lined tailored
trousers, from unassembled parts classified
in subheading 6204.61 through 6204.69 as a
result of the application of GRI 2(a),
provided that no major part has been knit to
shape.
6205..................... A change to heading 6205 from any other
chapter, provided that no major part has
been knit to shape; or
A change to assembled tailored long sleeve
shirts with collars, cuffs, full-front
openings with plackets, and shoulder yokes,
or to assembled fully lined, fully padded,
or fully insulted shirts, of heading 6205,
from either subheading 6217.90 or subheading
6117.90, provided that no major part has
been knit to shape; or
A change to assembled tailored long sleeve
shirts with collars, cuffs, full-front
openings with plackets, and shoulder yokes,
or to assembled fully lined, fully padded,
or fully insulated shirts from unassembled
parts classified in heading 6205 as a result
of the application of GRI 2(a), provided
that no major part has been knit to shape.
6206..................... A change to heading 62.06 from any other
chapter, provided that no major part has
been knit to shape; or
A change to assembled tailored long sleeve
shirts with collars, cuffs, full-front
openings with plackets, and yokes, or to
assembled tailored long sleeve blouses
without full front openings, with collars,
cuffs, and yokes, or to assembled fully
lined, fully padded, fully insulated shirts
of heading 6206, from either subheading
6217.90 or subheading 6117.90, provided that
no major part has been knit to shape; or
A change to assembled tailored long sleeve
shirts with collars, cuffs, full-front
openings with plackets, and yokes, or to
assembled tailored long sleeve blouses
without full-front openings, with collars,
cuffs, and yokes, or to assembled fully
lined, fully padded, fully insulated shirts,
from unassembled parts classified in heading
6206 as a result of the application of GRI
2(a), provided that no major part has been
knit to shape.
6207-6208................ A change to heading 6207 through 6208 from
any other chapter, provided that no major
part has been knit to shape.
6209..................... A change to heading 6209 from any other
chapter except from chapter 95, provided
that no major part has been knit to shape;
or
A change to assembled fully lined, fully
padded, or fully insulated outer garments of
heading 6209, from either subheading 6217.90
or subheading 6117.90, provided that no
major part has been knit to shape; or
A change to assembled fully lined, fully
padded, or fully insulated outer garments
from unassembled parts classified in heading
6209 as a result of the application of GRI
2(a), provided that no major part has been
knit to shape.
6210..................... A change to heading 6210 from any other
chapter, provided that no major part has
been knit to shape; or
A change to assembled fully lined, fully
padded, or fully insulated long sleeve
garments of heading 6210, from either
subheading 6217.90 or subheading 6117.90,
provided that no major part has been knit to
shape; or
A change to assembled fully lined, fully
padded, or fully insulated long sleeve
garments, from unassembled parts classified
in heading 6210 as a result of the
application of GRI 2(a), provided that no
major part has been knit to shape.
6211..................... A change to heading 6211 from any other
chapter, provided that no major part has
been knit to shape; or
6211.20--................ A change to assembled garments of subheading
6211.20 from either subheading 6217.90 or
subheading 6117.90, provided that no major
part has been knit to shape; or
A change to assembled garments from
unassembled parts classified in subheading
6211.20 as a result of the application of
GRI 2(a), provided that no major part has
been knit to shape; or
6211.31-6211.49--........ A change to assembled fully lined, fully
padded, or fully insulated garments
consisting of five or more major parts, of
subheading 6211.31 through 6211.49, from
either subheading 6217.90 or subheading
6117.90, provided that no major part has
been knit to shape; or
A change to assembled fully lined, fully
padded, or fully insulated garments
consisting of five or more major parts, from
unassembled parts classified in subheading
6211.20 as a result of the application of
GRI 2(a), provided that no major part has
been knit to shape.
6212..................... A change to heading 6212 from any other
chapter, provided that no major part has
been knit to shape.
6213-6214................ A change to heading 6213 through 6214 from
any other chapter except from heading 5007,
5111 through 5113, 5208 through 5212, 5309
through 5311, 5407 through 5408, 5512
through 5516, 5602 through 5603, 5801
through 5806, 5808 through 5811, 5901, 5903,
and 5906 through 5907, provided that no
major part has been knit to shape.
6215-6217................ A change to heading 6215 through 6217 from
any other chapter.
6301.10.................. A change to subheading 6301.10 from any other
heading.
6301.20-6301.90.......... A change to subheading 6301.20 through
6301.90 from any other heading except from
heading 5007, 5111 through 5113, 5208
through 5212, 5309 through 5311, 5407
through 5408, 5512 through 5516, 5602
through 5603, 5801 through 5802, 5809
through 5811, 5903, 5907, and 6001 through
6002.
6302..................... (1) Except for quilted goods provided for in
(2) below, a change to heading 6302 from any
other heading except heading 5007, 5111
through 5113, 5208 through 5212, 5309
through 5311, 5407 through 5408, 5512
through 5516, 5602 through 5603, 5801
through 5804, 5806, 5809 through 5810, 5901,
5903, 5906 through 5907, and 6001 through
6002;
(2) For quilted goods, either (a) A change to
heading 6302 from any other heading except
subheading 6307.90, provided that both the
cutting of the top and bottom fabrics, and
the entire assembly of the quilted goods,
are done in one country; or (b) If (a) is
not satisfied, then the country of origin
shall be the country which produced the
fabric, or fabrics, which impart the
essential character to the goods.
6303..................... (1) For quilted goods, a change to heading
6303 from any other heading except
subheading 6307.90, provided that both the
cutting of the top and bottom fabrics, and
the entire assembly of the quilted goods,
are done in one country. If this rule is not
satisfied, then the country of origin shall
be the country which produced the fabric, or
fabrics, which impart the essential
character to the goods; or
(2) For curtains, drapes, or valances, except
for goods provided for in (1) Above, a
change to heading 6303 from any other
heading, provided that the change is the
result of at least cutting on all sides,
hemming the cut edges, and a significant
sewing or assembly operation.
(3) For goods not meeting paragraphs (1) or
(2) above, and all other goods, a change to
heading 6303 from any other heading except
heading 5007, 5111 through 5113, 5208
through 5212, 5309 through 5311, 5407
through 5408, 5512 through 5516, 5602
through 5603, 5801 through 5804, 5806, 5809
through 5810, 5901, 5903, 5906 through 5907,
and 6001 through 6002.
6304..................... (1) Except for quilted goods, pillow covers,
and pillow shams provided for in (2) and (3)
below, a change to heading 6304 from any
other heading except heading 5007, 5111
through 5113, 5208 through 5212, 5309
through 5311, 5407 through 5408, 5512
through 5516, 5602 through 5603, 5801
through 5804, 5806, 5809 through 5810, 5901,
5903 through 5904, 5906 through 5907, and
6001 through 6002;
(2) For quilted goods, a change to heading
6304 from any other heading except
subheading 6307.90, provided that both the
cutting of the top and bottom fabrics, and
the entire assembly of the quilted goods,
are done in one country. If this rule is not
satisfied, then the country of origin shall
be the country which produced the fabric, or
fabrics, which impart the essential
character to the goods;
(3) For pillow covers and pillow shams, a
change to heading 6304 from any other
heading.
6305..................... A change to heading 6305 from any other
heading except from heading 5007, 5111
through 5113, 5208 through 5212, 5309
through 5311, 5407 through 5408, 5512
through 5516, 5602 through 5603, 5801
through 5802, 5809 through 5811, 5903, 5907,
and 6001 through 6002.
6306.11-6306.19.......... For tarpaulins and sunblinds, a change to
subheading 6306.11 through 6306.19 from any
other heading except from heading 5007, 5111
through 5113, 5208 through 5212, 5309
through 5311, 5407 through 5408, 5512
through 5516, 56.03, 5801 through 5802, 5809
through 5811, 5903, 5906 through 5907, and
6001 through 6002.
(2) For awnings, a change to subheading
6306.11 through 6306.19 from any other
chapter.
6306.21-6306.49.......... A change to subheading 6306.21 through
6306.49 from any other chapter.
6306.91-6306.99.......... A change to subheading 6306.91 through
6306.99 from any other heading, except
subheading 6307.90, provided that the change
is the result of more than cutting and
hemming processes.
6307.10.................. A change to subheading 6307.10 from any
heading except from heading 5007, 5111
through 5113, 5208 through 5212, 5309
through 5311, 5407 through 5408, 5512
through 5516, 5602 through 5603, 5801
through 5804, 5806, 5809 through 5811, 5903,
5907, and 6001 through 6002.
6307.20.................. A change to subheading 6307.20 from any other
heading.
6307.90.................. A change to subheading 6307.90 from any other
heading provided that the change is the
result of at least cutting and a significant
sewing or assembly operation.
6308..................... The country of origin of each article in the
set which merits consideration in the
determination of the essential character of
the set.
6309..................... The country where the goods were last
collected and packaged for shipment.
6310..................... For worn out articles, the country where the
goods were last collected and packaged for
shipment;
For all other goods, a change to heading 6310
from any other heading.
------------------------------------------------------------------------
(l) Section XII: Chapters 64 through 67
------------------------------------------------------------------------
Chapter 64: Note: For purposes of this chapter, the term ``formed
uppers'' means uppers, with closed bottoms, which have been shaped by
lasting, molding or otherwise but not by simply closing at the bottom.
------------------------------------------------------------------------
6401-6405................ A change to heading 6401 through 6405 from
any tariff item outside that group, except
from formed uppers
6406.10.................. A change to 6406.10 from any other
subheading.
6406.20-6406.99.......... A change to subheadings 6406.20 through
6406.99 from any other chapter.
6501-6502................ A change to headings 6501-6502 from any other
heading outside that group.
6503-6506................ A change to headings 6503-6506 from any other
heading outside that group, except headings
6501 through 6502; or
A change to headings 6503-6506 from heading
6501 by means of a blocking process; or
A change to headings 6503-6506 from heading
6502, provided that the change is the result
of at least three processing steps (e.g.
dyeing, blocking, trimming, or adding a
sweatband).
6507..................... A change to heading 6507 from any other
heading.
6601..................... A change to heading 6601 from any other
heading.
6602..................... A change to heading 6602 from any other
heading.
6603.10.................. A change to heading 6603.10 from any other
heading.
6603.20.................. A change to heading 6603.20 from any other
heading; or
A change from 6603.90 except when that change
is pursuant to GRI 2(a).
6603.90.................. A change to heading 6603.90 from any other
heading.
6701..................... A change to heading 6701 from any other
heading; or
A change to articles of feather or down of
heading 6701 from feathers or down.
6702-6704................ A change to heading 6702-6704 from any other
heading, including another heading within
that group.
------------------------------------------------------------------------
(m) Section XIII: Chapters 68 through 70
------------------------------------------------------------------------
6801-6811................ A change to heading 6801 through 6809 from
any other heading, including another heading
within that group.
6809.11.................. A change to subheading 6809.11 from any other
heading.
6809.19.................. A change to subheading 6809.19 from any other
heading.
6809.90.................. A change to subheading 6809.90 from any other
subheading.
6810.11.................. A change to subheading 6810.11 from any other
heading.
6810.19.................. A change to subheading 6810.19 from any other
heading.
6810.91.................. A change to subheading 6819.91 from any other
subheading.
6810.99.................. A change to subheading 6810.99 from any other
heading.
6811.10.................. A change to subheading 6811.10 from any other
heading.
6811.20.................. A change to subheading 6811.20 from any other
heading.
6811.30.................. A change to subheading 6811.30 from any other
heading.
6811.90.................. A change to subheading 6811.90 from any other
heading; or
A change to 6811.90 from any other
subheading, if that change results in a
substantial transformation.
6812.10.................. A change to subheading 6812.10 from any other
heading.
6812.20.................. A change to subheading 6812.20 from any other
subheading.
6812.30.................. A change to subheading 6812.30 from any other
subheading, except subheading 6812.20.
6812.40.................. A change to subheading 6812.40 from any other
subheading.
6812.50.................. A change to subheading 6812.50 from any other
subheading.
6812.60-6812.70.......... A change to subheading 6812.60 through
6812.70 from any subheading outside that
group.
6812.90.................. A change to subheading 6812.90 from any other
heading; or
A change to 6812.90 from within 6812 if that
change results in a substantial
transformation.
6813..................... A change to heading 6813 from any other
heading.
6814.10.................. A change to subheading 6814.10 from any other
heading.
6814.90.................. A change to subheading 6814.90 from any other
heading; or
A change to 6814.90 from 6814.10 if that
change results in a substantial
transformation.
6815..................... A change to subheading 6815.10 through
6815.99 from any other subheading, including
within that group.
6901-6914................ A change to heading 6901 through 6914 from
any other chapter.
7001..................... A change to heading 7001 from any other
heading.
7002..................... A change to heading 7002 from any other
heading.
7003-7006................ A change to heading 7003 through 7006 from
any heading outside that group.
7007..................... A change to heading 7007 from any other
heading.
7008..................... A change to heading 7008 from any other
heading.
7009.10.................. A change to heading 7009.10 from any other
subheading.
7009.91-7009.92.......... A change to heading 7009.91 through 7009.92
from any other heading.
7010-7018................ A change to heading 7010 through 7018 from
any other heading, except from heading 7020;
or
A change to heading 7010 through 7018 from
heading 7020 if that change results in a
substantial transformation.
7019.10.................. A change to heading 7019.10 from any other
heading.
7019.20.................. A change to heading 7019.20 from any other
subheading.
7019.31-7019.32.......... A change to heading 7019.31 through 7019.32
from any other subheading outside that
group.
7019.39.................. A change to heading 7019.39 from any other
subheading.
7019.90.................. A change to heading 7019.90 from any other
heading; or
A change to heading 7019.90 from within 7019
if that change results in a substantial
transformation.
7020..................... A change to heading 7020 from any other
heading, except from heading 7010 through
7018: or
A change to heading 7020 from heading 7010
through 7018 if that change results in a
substantial transformation.
------------------------------------------------------------------------
(n) Section XIV: Chapter 71
------------------------------------------------------------------------
7101..................... A change to heading 7101 from any other
heading, except heading 0307.
7102-7103................ A change to heading 7102 through 7103 from
any other chapter.
7104-7105................ A change to heading 7104 through 7105 from
any other heading, including another heading
within that group.
7106..................... A change to heading 7106 from any other
chapter.
7107..................... A change to heading 7107 from any other
chapter, except from chapter 72 through 76,
or chapter 78 through 83.
7108..................... A change to heading 7108 from any other
chapter.
7109..................... A change to heading 7109 from any other
chapter, except from chapter 72 through 76,
or chapter 78 through 83.
7110..................... A change to heading 7110 from any other
chapter.
7111..................... A change to heading 7111 from any other
chapter, except from chapter 72 through 76,
or chapter 78 through 83.
7112..................... A change to heading 7112 from any other
heading.
7113-7115................ A change to subheading of heading 7113
through 7115 from any other subheading,
including to a subheading within that group.
7116..................... A change to heading 7116 from any other
heading, except that pearls, temporarily or
permanently strung but without the addition
of clasps or other ornamental features of
precious metals or stones, shall have the
origin of the pearls.
7117-7118................ A change to heading 7117-7118 from any other
heading, including a heading within that
group.
------------------------------------------------------------------------
(o) Section XV: Chapters 72 through 83
------------------------------------------------------------------------
72.01-72.06.............. A change to heading 72.01 through 72.06 from
any other heading, including another heading
within that group.
72.07.................... A change to heading 72.07 from any other
heading except 7206.
72.08.................... A change to heading 72.08 from any other
heading.
72.09.................... A change to heading 72.09 from any other
heading except 7208 or 7211.
72.10.................... A change to heading 72.10 from any other
heading except 7208-7212.
72.11.................... A change to heading 72.11 from any other
heading except 7208-7209.
72.12.................... A change to heading 72.12 from any other
heading except 7208-7211.
72.13.................... A change to heading 72.13 from any other
heading.
72.14.................... A change to heading 72.14 from any other
heading except from heading 72.13.
72.15.................... A change to heading 72.15 from any other
heading, except from heading 72.13 through
72.14.
72.16.................... A change to heading 72.16 from any other
heading, except from heading 72.08 through
72.15.
72.17.................... A change to heading 72.17 from any other
heading, except from heading 72.13 through
72.15.
72.18.................... A change to heading 72.18 from any other
heading.
72.19-72.20.............. A change to heading 72.19 through 72.20 from
any other heading outside that group.
72.21-72.22.............. A change to heading 72.21 through 72.22 from
any other heading outside that group.
72.23.................... A change to heading 72.23 from any other
heading, except from heading 72.21 through
72.22.
72.24.................... A change to heading 72.24 from any other
heading.
72.25-72.26.............. A change to heading 72.25 through 72.26 from
any other heading outside that group.
72.27-72.28.............. A change to heading 72.27 through 72.28 from
any other heading outside that group.
72.29.................... A change to heading 72.29 from any other
heading, US: except from heading 72.27
through 72.28.
73.01-73.07.............. A change to heading 73.01 through 73.07 from
any other heading, including within that
group.
73.08.................... A change to heading 73.08 from any other
heading, except for changes resulting from
the following processes performed on angles,
shapes, or sections of heading 72.16:
(a) drilling, punching, notching, cutting,
cambering, or sweeping, whether performed
individually or in combination:
(b) adding attachments or weldments for
composite construction;
(c) adding attachments for handling purposes;
(d) adding weldments, connectors or
attachments to H-sections or I-sections;
provided that the maximum dimension of the
weldments, connectors, or attachments is not
greater than the dimension between the inner
surfaces of the flanges of the H-sections or
I-sections.
(e) painting, galvanizing, or otherwise
coating; or
(f) adding a simple base plate without
stiffening elements, individually or in
combination with drilling, punching,
notching, or cutting, to create an article
suitable as a column.
73.09-73.14.............. A change to heading, 73.12 through 73.14 from
any other heading, including another heading
within that group.
7315.11-7315.12.......... A change to subheading 7415.11 through
7315.12 from any other heading; or
A change to subheading 7315.11 through
7315.12 from subheading 7315.19 or 7315.90
except when that change is pursuant to
General Rule of Interpretation 2(a).
7315.19.................. A change to subheading 7315.19 from any other
subheading.
7315.20-7315.89.......... A change to subheading 7315.20 through
7315.89 from any other heading; or
A change to subheading 7315.20 through
7315.89 from subheading 7315.90 except when
that change is pursuant to General Rule of
Interpretation 2(a).
7315.90.................. A change to subheading 7315.90 from any other
subheading.
73.16.................... A change to heading 73.16 from any other
heading, except from heading 73.12 or 73.15.
73.17-73.18.............. A change to heading 73.17 through 73.18 from
any other heading, including another heading
within that group.
73.19.................... A change to heading 73.19 from any other
heading.
73.20.................... A change to heading 73.20 from any other
heading.
7321.11-7321.83.......... A change to subheading 7321.11 through
7321.83 from any other heading; or
A change to subheading 7321.11 through
7321.83 from heading 7321.90 except when
classified pursuant to General Rule of
Interpretation 2(a).
7321.90.................. A change to subheading 7321.90 from any other
heading.
73.22-73.23.............. A change to heading 73.22 through 73.23 from
any other heading, including another heading
within that group.
7324.10-7324.29.......... A change to subheading 7324.10 through
7324.29 from any other subheading, including
another subheading within that group.
7324.90.................. A change to subheading 7324.90 from any other
subheading.
73.25-73.26.............. A change to heading 73.25 through 73.26 from
any other heading, including another heading
within that group.
74.01-74.07.............. A change to heading 74.01 through 74.07 from
any other heading, including another heading
within that group.
7408..................... A change to heading 7408 from any other
heading US: except from heading 74.07.
74.09.................... A change to heading 74.09 from any other
heading.
74.10.................... A change to heading 74.10 from any other
heading, except from plate, sheet or strip
of heading 7409 of a thickness less than
5mm.
74.11-74.18.............. A change to heading 74.11 through 74.18 from
any other heading, including another heading
within that group.
7419.10-7419.99.......... A change to subheading 7419.10-7419.99 from
any other subheading, including another
subheading within that group.
75.01.................... A change to heading 75.01 from any other
heading.
7502..................... A change to subheading 7502 from any other
heading.
75.03.................... A change to heading 75.03 from any other
heading.
75.04.................... A change to heading 75.04 from any other
heading.
7505.11-7505.22.......... A change to heading 75.05 from any other
heading subheading, including another
subheading within that group.
75.06.................... A change to heading 75.06 from any other
heading; or
A change to foil, not exceeding 0.15mm in
thickness from any other good of heading
7506, provided that there has been a
reduction in thickness of no less than 50
percent.
7507.11-7508.00.......... A change to subheading 7507.11-7508.00 from
any other subheading, including another
subheading within that group.
76.01-76.04.............. A change to heading 76.01 through 76.04 from
any other heading, including another heading
within that group.
76.05.................... A change to heading 76.05 from any other
heading, except from heading 76.04.
76.06-76.15.............. A change to heading 76.06 through 76.15 from
any other heading, including another heading
within that group.
7616.10-7616.90.......... A change to subheading 7616.10-7616.90 from
any other subheading, including another
subheading within that group.
78.01-78.03.............. A change to heading 78.01 through 78.03 from
any other heading, including another heading
within that group.
7804.11-7804.20.......... A change to subheading 7804.11-7804.20 from
any other subheading, including another
subheading within that group; or
A change to any of the following goods of
this heading, including from materials also
classified under this heading; powder except
from flakes; flakes except from powder;
plates except from sheets or strip; sheets
except from plate or strip; strip except
from sheets or plate.
78.05-78.06.............. A change to heading 78.05 through 78.06 from
any other heading, including another heading
within that group; or
A change to any of the following goods of
this heading, including from materials also
classified under this heading: tubes except
from pipes; pipes except from tubes; tube or
pipe fittings except from tubes or pipes;
cables/stranded wire/plaited bands.
79.01-79.06.............. A change to heading 79.01 through 79.06 from
any other heading, including another heading
within that group; or
A change to any of the following goods of
this heading, including from materials also
classified under this heading; matte;
unwrought; powder except from flakes; flakes
except from powder; bars except from rods or
profiles; rods except from bars or profiles;
profiles except from rods or bars; wire
except from rod; plates except from sheets
or strip; sheets except from plate or strip;
strip except from sheets or plate; foil;
except from sheet or strip, tubes except
from pipes; pipes except from tubes; tube or
FR Doc. 93-31852 Rules for Determining the Country of Origin of a Good for Purposes of Annex 311 of the NAFTA and Rules of Origin Applicable to Imported Merchandise; Rule and Proposed Rule
pipe fittings except from tubes or pipes;
7907.10-7907.90.......... A change to subheading 7907.10-7907.90 from
any other subheading, including another
subheading within that group.
8001..................... A change to heading 8001 from any other
heading.
80.02-80.04.............. A change to heading 80.02 through 80.04 from
any other heading, including another heading
within that group; or
A change to any of the following goods of
this heading, including from materials also
classified under this heading: bars except
from rods or profiles; rods except from bars
or profiles; profiles except from rods or
bars; wire except from rod, plates except
from sheets or strip; sheets except from
plate or strip; strip except from sheets or
plate.
8005.10-8005.20.......... A change to subheading 8005.10-8005.20 from
any other subheading, including another
subheading within that group.
80.06-80.07.............. A change to heading 80.06 through 80.07 from
any other heading, including another heading
within that group; or
A change to any of the following goods of
this heading, including from materials also
classified under this heading: tubes except
from pipes; pipes except from tubes; tube or
pipe fittings except from tubes or pipes;
cables/stranded wire/plaited bands.
------------------------------------------------------------------------
Chapter 81 Note: Waste and scrap are products of the country in which
they are collected.
------------------------------------------------------------------------
8101.10-8101.92......... A change to subheading 8101.10 through
8101.92 from any other subheading, including
another subheading within that group; or
A change to any of the following goods of
this heading, including from materials also
classified under this heading: matte;
unwrought; bars except from rods or
profiles; rods except from bars or rofiles;
profiles except from rods or bars; plates
except from sheets or strip; sheets except
from plate or strip; strip except from
sheets or plate; foil except from sheet and
strip.
8101.93.................. A change to subheading 8101.93 from any other
subheading, except subheading 8101.92.
8101.99.................. A change to subheading 8101.99 from any other
subheading; or
A change to any of the following goods of
this heading, including from materials also
classified under this heading: tubes except
from pipes; pipes except from tubes; tube or
pipe fittings except from tubes or pipes;
cables/stranded wire/plaited bands.
8102.10-8102.92.......... A change to subheading 8102.10 through
8102.92 from any other subheading, including
another subheading within that group; or
A change to any of the following goods of
this heading, including from materials also
classified under this heading: matte;
unwrought; bars except from rods or
profiles; rods except from bars or profiles;
profiles except from rods or bars; plates
except from sheets or strip; sheets except
from plate or strip; strip except from
sheets or plate; foil except from sheet and
strip.
8102.93.................. A change to subheading 8102.93 from any other
subheading, except from subheading 8102.92.
8102.99.................. A change to subheading 8102.99 from any other
subheading.
8103.10-8113.00.......... A change to subheading 8103.10-8113.00 from
any other subheading, including another
subheading within that group; or
A change to any of the following goods of
this heading, including from materials also
classified under this heading: matte;
Unwrought; powder except from flakes; flakes
except from powder; bars except from rods or
profiles; rods except from bars or profiles;
profiles except from rods or bars; wire
except from rod; plates except from sheets
or strip; sheets except from plate or strip;
strip except from sheets or plate; foil
except from sheet or strip; tubes except
from pipes; pipes except from tubes; tube or
pipe fittings except from tubes or pipes;
cables/stranded wire/plaited bands.
8201.10-8202.40.......... A change to subheading 8201.10-8202.40 from
any other subheading, including another
subheading within that group.
8202.91.................. A change to subheading 8202.91 from any other
subheading, except subheading 8202.99.
8202.99.................. A change to subheading 8202.99 from any other
heading.
8203.10-8207.90.......... A change to subheading 8203.10-8207.90 from
any other subheading, including another
subheading within that group.
82.08-82.15.............. A change to heading 82.08 through 82.15 from
any other heading, including another heading
within that group.
8301.10-8301.50.......... A change to subheading 8301.10 through
8301.40 from any other subheading, including
within that group, except a change from
subheading 8301.60 when that change is
pursuant to GRI 2(a).
8301.60-8301.70.......... A change to subheading 8301.60 through
8301.70 from any other chapter.
8302.10-8302.60.......... A change to subheading 8302.10 through
8302.60 from any other subheading, including
another subheading within that group.
83.03-83.04.............. A change to heading 83.03 through 83.04 from
any other heading, including another heading
within that group.
8305.10-8305.90.......... A change to subheading 8305.10 through
8305.90 from any other subheading, including
another subheading within that group.
83.06-83.07.............. A change to heading 83.06 through 83.07 from
any other heading, including another heading
within that group.
8308.10-8308.90.......... A change to subheading 8308.10 through
8308.90 from any other subheading, including
another subheading within that group.
83.09-83.10.............. A change to heading 83.09 through 83.10 from
any other heading, including another heading
within that group.
8311.10-8311.90.......... A change to subheading 8311.10 through
8311.90 from any other subheading, including
another subheading within that group.
------------------------------------------------------------------------
(p) Section XVI: Chapters 84 through 85
------------------------------------------------------------------------
Note: Tariff changes within Chapters 84 and 85 which occur only as a
result of the application of General Rule of Interpretation 2(a) of the
HTS shall not be sufficient to confer origin.
------------------------------------------------------------------------
8401.10.................. A change to subheading 8401.10 from any other
subheading.
8401.20.................. A change to subheading 8401.20 from any other
subheading or from parts provided for in
8401.20.
8401.30.................. A change to subheading 8401.30 from any other
subheading.
8401.40.................. A change to subheading 8401.40 from any other
heading.
8402.11-8402.12.......... A change to subheading 8402.11 through
8402.12 from any other subheading outside
that group.
8402.19-8402.20.......... A change to 8402.19 through 8402.20 from any
other subheading, including a subheading
within that group.
8402.90.................. A change to subheading 8402.90 from any other
heading, except headings 7303, 7304, 7305 or
7306, unless the change from these headings
involve bending to shape.
8403.10.................. A change to subheading 8403.10 from any other
subheading.
8403.90.................. A change to subheading 8403.90 from any other
heading.
8404.10-8404.20.......... A change to subheading 8404.10 through
8404.20 from any other subheading, including
another subheading within that group.
8404.90.................. A change to subheading 8404.90 from any other
heading.
8405.10.................. A change to subheading 8405.10 from any other
subheading.
8405.90.................. A change to subheading 8405.90 from any other
heading.
8406.11-8406.19.......... A change to subheading 8406.11 through
8406.19 from any other subheading, including
another subheading within that group.
8406.90.................. A change to subheading 8406.90 from any other
heading.
84.07.................... A change to heading 84.07 from any other
heading.
84.08.................... A change to heading 84.08 from any other
heading.
8409.10.................. A change to subheading 8409.10 from any other
heading.
8409.91-8409.99.......... A change to subheading 8409.91 through
8409.99 from any other heading, except a
change resulting from a simple assembly.
8410.11-8410.13.......... A change to subheading 8410.11 through
8410.13 from any other subheading outside
that group.
8410.90.................. A change to subheading 8410.90 from any other
heading.
8411.11-8411.82.......... A change to subheading 8411.11 through
8411.82 from any other subheading outside
that group.
8411.91-8411.99.......... A change to subheading 8411.91 through
8411.99 from any other heading.
8412.10-8412.80.......... A change to subheading 8412.10 through
8412.80 from any other subheading, including
another subheading within that group.
8412.90.................. A change to subheading 8412.90 from any other
heading.
8413.11-8413.82.......... A change to subheading 8413.11 through
8413.82 from any other subheading, including
another subheading within that group.
8413.91.................. A change to subheading 8413.91 from any other
heading.
8413.92.................. A change to subheading 8413.92 from any other
heading.
8414.10-8414.80.......... A change to subheading 8414.10 through
8414.80 from any other subheading, including
another subheading within that group.
8414.90.................. A change to subheading 8414.90 from any other
heading.
8415.10-8415.83.......... A change to subheading 8415.10 through
8415.83 from any other subheading, except a
change within that group resulting from a
simple assembly.
8415.90.................. A change to subheading 8415.90 from any other
heading, except a change resulting from a
simple assembly.
8416.10-8416.30.......... A change to subheading 8416.10 through
8416.30 from any other subheading, including
another subheading within that group.
8416.90.................. A change to subheading 8416.90 from any other
heading.
8417.10-8417.80.......... A change to subheading 8417.10 through
8417.80 from any other subheading, including
another subheading within that group.
8417.90.................. A change to subheading 8417.90 from any other
heading.
8418.10-8418.91.......... A change to subheading 8418.10 through
8418.91 from any other subheading, including
another subheading within that group.
8418.99.................. A change to subheading 8418.99 from any other
heading, except headings 7303, 7304, 7305 or
7306, unless the change from these headings
involves bending to shape.
8419.11-8419.89.......... A change to subheading 8419.11 through
8419.89 from any other subheading, including
another subheading within that group.
8419.90.................. A change to subheading 8419.90 from any other
heading, except headings 7303, 7304, 7305,
or 7306, unless the change from these
headings involves bending to shape, and
except a change from headings 8404 or 8501,
when resulting from a simple assembly.
8420.10.................. A change to subheading 8420.10 from any other
subheading.
8420.91.................. A change to subheading 8420.91 from any other
heading.
8420.99.................. A change to subheading 8420.99 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8421.11-8421.39.......... A change to subheading 8421.11 through
8421.39 from any other subheading, including
another subheading within that group.
8421.91.................. A change to subheading 8421.91 from any other
heading.
8421.99.................. A change to subheading 8421.99 from any other
heading.
8422.11-8422.40.......... A change to subheading 8422.11 through
8422.40 from any other subheading, including
another subheading within that group.
8422.90.................. A change to subheading 8422.90 from any other
heading, except heading 8501.
8423.10-8423.89.......... A change to subheading 8423.10 through
8423.89 from any other subheading, including
another subheading within that group.
8423.90.................. A change to subheading 8423.90 from any other
heading.
8424.10-8424.89.......... A change to subheading 8424.10 through
8424.89 from any other subheading, including
another subheading within that group.
8424.90.................. A change to subheading 8424.90 from any other
heading, except subheadings 8414.40 or
8414.80
8425.11-8430.69.......... A change to subheading 8425.11 through
8430.69 from any other subheading, including
another subheading within that group.
84.31.................... A change to heading 84.31 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8432.10-8432.80.......... A change to subheading 8432.10 through
8432.80 from any other subheading, including
another subheading within that group.
8432.90.................. A change to subheading 8432.90 from any other
heading.
8433.11-8433.60.......... A change to subheading 8433.11 through
8433.60 from any other subheading, including
another subheading within that group.
8433.90.................. A change to subheading 8433.90 from any other
heading, except headings 8407 or 8408 when
resulting from a simple assembly.
8434.10-8434.20.......... A change to subheading 8434.10 through
8434.20 from any other subheading, including
another subheading within that group.
8434.90.................. A change to subheading 8434.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8435.10.................. A change to subheading 8435.10 from any other
subheading.
8435.90.................. A change to subheading 8435.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8436.10-8436.80.......... A change to subheading 8436.10 through
8436.80 from any other subheading, including
another subheading within that group.
8436.91.................. A change to subheading 8436.91 from any other
heading.
8436.99.................. A change to subheading 8436.99 from any other
heading, except for headings 8407, 8408 or
8501 when resulting from a simple assembly.
8437.10-8437.80.......... A change to subheading 8437.10 through
8437.80 from any other subheading, including
another subheading within that group.
8437.90.................. A change to subheading 8437.90 from any other
heading, except for headings 8407, 8408 or
8501 when resulting from a simple assembly
8438.10-8438.80.......... A change to subheading 8438.10 through
8438.80 from any other subheading, including
another subheading within that group.
8438.90.................. A change to subheading 8438.90 from any other
heading, except for headings 8407, 8408 or
8501 when resulting from a simple assembly
8439.10-8439.30.......... A change to subheading 8439.10 through
8439.30 from any other subheading, including
another subheading within that group.
8439.91.................. A change to subheading 8439.91 from any other
heading, except for headings 8407, 8408 or
8501 when resulting from a simple assembly.
8439.99.................. A change to subheading 8439.99 from any other
heading, except for headings 8407, 8408 or
8501 when resulting from a simple assembly.
8440.10.................. A change to subheading 8440.10 from any other
subheading.
8440.90.................. A change to subheading 8440.90 from any other
heading, except for headings 8407, 8408 or
8501 when resulting from a simple assembly.
8441.10-8441.80.......... A change to subheading 8441.10 through
8441.80 from any other subheading, including
another subheading within that group.
8441.90.................. A change to subheading 8441.90 from any other
heading, except for headings 8407, 8408 or
8501 when resulting from a simple assembly.
8442.10-8442.30.......... A change to subheading 8442.10 through
8442.30 from any other subheading outside
that group.
8442.40.................. A change to subheading 8442.40 from any other
heading, except for heading or 8501 when
resulting from a simple assembly.
8442.50.................. A change to subheading 8442.50 from any other
heading.
8443.11-8443.60.......... A change to subheading 8443.11 through
8443.60 from any other subheading outside
that group.
8443.90.................. A change to subheading 8443.90 from any other
heading, except for heading 8501 when
resulting from a simple assembly.
84.44.................... A change to heading 84.44 from any other
heading.
8445.11-8447.90.......... A change to subheading 8445.11 through
8447.90 from any other subheading outside
that group.
8448.11-8448.19.......... A change to subheading 8448.11 through
8448.19 from any other subheading, except a
change resulting from a simple assembly.
8448.19.................. A change to subheading 8448.19 from any other
subheading, except a change resulting from a
simple assembly.
8448.20-8448.59.......... A change to subheading 8448.20 through
8448.59 from any other heading, except for
heading 8501.
84.49.................... A change to subheading 84.49 from any other
heading.
8450.11-8450.20.......... A change to subheading 8450.11 through
8450.20 from any other subheading, including
another subheading within that group.
8450.90.................. A change to subheading 8450.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8451.10-8451.80.......... A change to subheading 8451.10 through
8451.80 from any other subheading, including
another subheading within that group.
8451.90.................. A change to subheading 8451.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8452.10-8452.29.......... A change to subheading 8452.10 through
8452.29 from any other subheading outside
that group.
8452.30-8452.40.......... A change to subheading 8452.30-8452.40 from
any other subheading, including another
subheading within that group.
8452.90.................. A change to subheading 8452.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8453.10-8453.80.......... A change to subheading 8453.10 through
8453.80 from any other subheading, including
another subheading within that group.
8453.90.................. A change to subheading 8453.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8454.10-8454.30.......... A change to subheading 8454.10 through
8454.30 from any other subheading, including
another subheading within that group.
8454.90.................. A change to subheading 8454.90 from any other
heading.
8455.10-8455.22.......... A change to subheading 8455.10 through
8455.22 from any other subheading, including
another subheading within that group.
8455.30.................. A change to subheading 8455.30 from any other
heading.
8455.90.................. A change to subheading 8455.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8456.10-8456.90.......... A change to subheading 8456.10 through
8456.90 from any other heading.
8457.10.................. A change to subheading 8457.10 from any other
heading except from headings 84.58 through
8465 when resulting from a simple assembly.
8457.20-8465.99.......... A change to subheading 8457.20 through
8465.99 from any other heading, including
another heading within that group.
8466.10-8466.94.......... A change to subheading 8466.10 through
8466.94 from any other heading outside that
group, except heading 8501 when resulting
from a simple assembly.
8467.11-8467.89.......... A change to subheading 8467.11 through
8467.89 from any other subheading, including
another subheading within that group.
8467.91-8467.99.......... A change to subheading 8467.91 through
8467.99 from any other heading, except
heading 8407.
8468.10-8468.80.......... A change to subheading 8468.10 through
8468.80 from any other subheading, including
another subheading within that group.
8468.90.................. A change to subheading 8468.90 from any other
heading.
8469.10-8469.39.......... A change to subheading 8469.10 through
8469.39 from any subheading outside that
group.
8470.10-8471.91.......... A change to subheading 8470.10 through
8471.91 from any other subheading, except
when resulting from a simple assembly.
8471.92-8472.90.......... A change to subheading 8471.92 through
8472.90 from any other subheading, except
when resulting from a simple assembly.
8473..................... A change to heading 8473 from any other
heading, except heading 8501.
8474.10-8474.80.......... A change to subheading 8474.10 through
8474.80 from any other subheading, except
when resulting from a simple assembly.
8474.90.................. A change to subheading 8474.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8475.10-8475.20.......... A change to subheading 8475.10 through
8475.20 from any other subheading, including
another subheading within that group.
8475.90.................. A change to subheading 8475.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8476.11-8476.19.......... A change to subheading 8476.11 through
8476.19 from any other subheading outside
that group.
8476.90.................. A change to subheading 8476.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8477.10-8477.80.......... A change to subheading 8477.10 through
8477.80 from any other subheading, including
another subheading within that group.
8477.90.................. A change to subheading 8477.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8478.10.................. A change to subheading 8478.10 from any other
subheading.
8478.90.................. A change to subheading 8478.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8479.10-8479.89.......... A change to subheading 8479.10 through
8479.89 from any other subheading, including
another subheading within that group.
8479.90.................. A change to subheading 8479.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8480..................... A change to heading 8480 from any other
heading.
8481.10-8481.80.......... A change to subheading 8481.10 through
8481.80 from any other heading, or from
subheading 8481.90 except when resulting
from a simple assembly.
8481.90.................. A change to subheading 8481.90 from any other
heading.
8482.10-8482.80.......... (i) A change to subheading 8482.10 through
8482.80 from any other heading, or;
(ii) A change to subheading 8482.10 through
8482.80 from any other subheading, including
another subheading within that group,
provided that either the inner and outer
races are domestic materials, or the balls/
rollers are domestic materials.
8482.91-8482.99.......... A change from 8482.91 through 8482.99 from
any other heading.
8483.10.................. A change to subheading 8483.10 from any other
subheading.
8483.20.................. A change to subheading 8483.20 from any other
subheading, except from subheading 8482.10
through 8482.80.
8483.30-8483.60.......... A change to subheading 8483.30 through
8483.60 from any other subheading, including
another subheading within that group.
8483.90.................. A change to subheading 8483.90 from any other
heading.
8484.10-8484.90.......... A change to subheading 8484.10 through
8484.90 from any other subheading, including
another subheading within that group.
8485..................... A change to subheading 8485 from any other
heading.
8501..................... A change to heading 8501 from any other
heading.
8502..................... A change to heading 8502 from any other
heading.
8503..................... A change to heading 8503 from any other
heading.
8504.10-8504.50.......... A change to subheading 8504.10 through
8504.50 from any other subheading, outside
that group.
8504.90.................. A change to subheading 8504.90 from any other
heading.
8505.11-8505.30.......... A change to subheading 8505.11 through
8505.30 from any other subheading, including
another subheading within that group.
8505.90.................. A change to subheading 8505.90 from any other
heading.
8506.11-8506.20.......... A change to subheading 8506.11 through
8506.20 from any other subheading, including
another subheading within that group.
8506.90.................. A change to subheading 8506.90 from any other
heading.
8507.10-8507.80.......... A change to subheading 8507.10 through
8507.80 from any other subheading, including
another subheading within that group.
8507.90.................. A change to subheading 8507.90 from any other
heading.
8508.10-8508.80.......... A change to subheading 8508.10 through
8508.80 from any other subheading, including
another subheading within that group.
8508.90.................. A change to subheading 8508.90 from any other
heading, except heading 8501 when resulting
from simple assembly.
8509.10-8509.80.......... A change to subheading 8509.10 through
8509.80 from any other subheading, including
another subheading within that group.
8509.90.................. A change to subheading 8509.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8510.10-8510.20.......... A change to subheading 8510.10 through
8510.20 from any other subheading, including
another subheading within that group.
8510.90.................. A change to subheading 8510.90 from any other
heading, except heading 8501 when resulting
from a simple assembly.
8511.10-8511.80.......... A change to subheading 8511.10 through
8511.80 from any other subheading, including
another subheading within that group.
8511.90.................. A change to subheading 8511.90 from any other
heading.
8512.10-8512.30.......... A change to subheading 8512.10 through
8512.30 from any subheading outside that
group.
8512.40.................. A change to subheading 8512.40 from any other
subheading, except when resulting from a
simple assembly.
8512.90.................. A change to subheading 8512.90 from any other
heading.
8513.10.................. A change to subheading 8513.10 from any other
subheading.
8513.90.................. A change to subheading 8513.90 from any other
heading.
8514.10-8514.40.......... A change to subheading 8514.10 through
8514.40 from any other subheading, including
another subheading within that group.
8514.90.................. A change to subheading 8514.90 from any other
heading.
8515.11-8515.80.......... A change to subheading 8515.11 through
8515.80 from any other subheading, outside
that group.
8515.90.................. A change to subheading 8515.90 from any other
heading.
8516.10-8516.79.......... A change to subheading 8516.10 through
8516.79 from any other subheading, including
another subheading within that group.
8516.80.................. A change to subheading 8516.80 from any other
heading.
8516.90.................. A change to subheading 8516.90 from any other
heading.
8517.10-8517.82.......... A change to subheading 8517.10 through
8517.82 from any other subheading, including
another subheading within that group, except
when resulting from a simple assembly.
8517.90.................. A change to subheading 8517.90 from any other
heading.
8518.10-8518.50.......... A change to subheading 8518.10 through
8518.50 from any other heading.
8518.90.................. A change to subheading 8518.90 from any other
heading.
8519.10-8521.90.......... A change to subheading 8519.10 through
8521.90 from any other subheading, including
another subheading within that group.
8522..................... A change to heading 8522 from any other
heading.
8523..................... A change to heading 8523 from any other
heading.
8524..................... A change to heading 8524 from any other
heading.
8525.10-8525.20.......... A change to subheading 8525.10 through
8525.20 from any other subheading outside
that group.
8525.30.................. A change to subheading 8525.30 from any other
subheading.
8526.10-8526.92.......... A change to subheading 8526.10 through
8526.92 from any other subheading, including
another subheading within that group.
8527.11-8527.90.......... A change to subheading 8527.11 through
8527.90 from any other subheading, including
another subheading within that group.
8528.10-8528.20.......... A change to subheading 8528.10 through
8528.20 from any other subheading, including
another subheading within that group.
8529..................... A change to heading 8529 from any other
heading.
8530.10-8530.80.......... A change to subheading 8530.10 through
8530.80 from any other subheading, including
another subheading within that group.
8530.90.................. A change to subheading 8530.90 from any other
heading.
8531.10-8531.80.......... A change to subheading 8531.10 through
8531.80 from any other subheading, including
another subheading within that group, except
when resulting from a simple assembly.
8531.90.................. A change to subheading 8531.90 from any other
heading.
8532.10-8532.30.......... A change to subheading 8532.10 through
8532.30 from any other subheading, including
another subheading within that group.
8532.90.................. A change to subheading 8532.90 from any other
heading.
8533.10-8533.40.......... A change to subheading 8533.10 through
8533.40 from any other subheading, including
another subheading within that group.
8533.90.................. A change to subheading 8533.90 from any other
heading.
8534..................... A change to heading 8534 from any other
heading.
8535.10-8535.90.......... A change to subheading 8535.10 through
8535.90 from any other subheading, including
another subheading within that group.
8536.10-8536.90.......... A change to subheading 8536.10 through
8536.90 from any other subheading, including
another subheading within that group.
8537..................... A change to heading 8537 from any other
heading.
8538..................... A change to heading 8538 from any other
heading.
8539.10-8539.40.......... A change to subheading 8539.10 through
8539.40 from any other subheading, including
another subheading within that group.
8539.90.................. A change to subheading 8539.90 from any other
heading.
8540.11-8540.89.......... A change to subheading 8540.11 through
8540.89 from any other subheading, including
another subheading within that group.
8540.91-8540.99.......... A change to subheading 8540.91 through
8540.99 from any other subheading, including
another subheading within that group, except
when resulting from a simple assembly.
8541-8542................ A change to heading 8541 through 8542 from
any other subheading including another
subheading within that group, or from an
unmounted chip, die or wafer provided for in
8541 or 8542, or, a change to any programmed
chips from any unprogrammed chips.
8543.10-8543.80.......... A change to subheading 8543.10 through
8543.30 from any other subheading, including
another subheading within that group.
8543.90.................. A change to subheading 8543.90 from any other
heading.
8544.11-8544.70.......... A change to subheading 8544.11 through
8544.70 from any other subheading, except
when resulting from a simple assembly.
8545-8548................ A change to heading 8545 through 8548 from
any other subheading, including another
subheading within that group.
------------------------------------------------------------------------
(q) Section XVII: Chapters 86 through 89
------------------------------------------------------------------------
8601..................... A change to heading 8601 from any other
heading.
8602..................... A change to heading 8602 from any other
heading.
8603-8606................ A change to heading 8603 through 8606 from
any heading including a heading within that
group, except from heading 8607 when that
change is pursuant to GRI 2(a).
8607.11.................. A change to subheading 8607.11 from any other
subheading, except from subheading 8607.12,
and except from subheading 8607.19 when that
change is pursuant to GRI 2(a).
8607.12.................. A change to subheading 8607.12 from any other
subheading, except subheading 8607.11, and
except from subheading 8607.19 when that
change is pursuant to GRI 2(a).
8607.19.................. A change to subheading 8607.19 from any other
subheading.
8607.21-8607.99.......... A change to subheading 8607.21 through
8607.99 from any other heading, except to
mounted brake linings and pads of subheading
8607.21 through 8607.99 from subheading
6813.10.
8608..................... A change to heading 8608 from any other
heading.
8609..................... A change to heading 8609 from any other
heading, except heading 7309 through 7311.
8701-8705................ A change to heading 8701-8705 from any other
heading except heading 8706.
8706..................... A change to heading 8706 from any other
heading.
8707..................... A change to heading 8707 from any other
heading, except a change from subheading
8708.29 if that change is pursuant to GRI
2(a).
------------------------------------------------------------------------
Note: Any change to heading 8708 from subheadings 8709.90, 8716.90,
8431.20 and 8431.49 shall not be considered to satisfy a required
change in tariff classification.
------------------------------------------------------------------------
8708.10-8708.29.......... A change to subheading 8708.10 through
8708.29 from any other subheading.
8708.31.................. A change to subheading 8708.31 from any other
heading, except to mounted brake linings and
pads of subheading 8708.31 from subheading
6813.10.
8708.39.................. A change to subheading 8708.39 from any other
heading.
8708.40.................. A change to subheading 8708.40 from any other
subheading, except from subheading 8708.99
when that change is pursuant to GRI 2(a).
8708.50.................. A change to subheading 8708.50 from any other
subheading, except from subheading 8708.99
when that change is pursuant to GRI 2(a).
8708.60.................. A change to subheading 8708.60 from any other
subheading.
8708.70.................. A change to subheading 8708.70 from any other
subheading.
8708.80.................. A change to subheading 8708.80 from any other
subheading, except from subheading 8708.99
when that change is pursuant to GRI 2(a).
8708.91.................. A change to subheading 8708.91 from any other
subheading, except from subheading 8708.99
when that change is pursuant to GRI 2(a).
8708.92.................. A change to subheading 8708.92 from any other
subheading.
8708.93.................. A change to subheading 8708.93 from any other
subheading.
8708.94.................. A change to subheading 8708.94 from any other
subheading, except from subheading 8708.99
when that change is pursuant to GRI 2(a).
8708.99.................. A change to subheading 8708.99 from any other
chapter; or
A change to subheading 8708.99 from any other
subheading US/Mex [provided there is a
substantial transformation].
8709.11-8709.19.......... A change to subheading 8709.11 through
8709.19 from any other subheading outside
that group, except a change from subheading
8709.90 if that change is pursuant to GRI
2(a).
8709.90.................. A change to subheading 8709.90 from any other
heading, except subheading 8431.20 or
heading 8708.
8710..................... A change to heading 8710 from any other
heading.
8711-8713................ A change to heading 8711 through 8713 from
any other heading, including another heading
within that group, except a change from
heading 8714 if that change is pursuant to
GRI 2(a).
8714..................... A change to heading 8714 from any other
heading, except a change from subheading
6813.10 to mounted brake linings or pads of
heading 8714.
8715..................... A change to heading 8715 from any other
heading.
8716.10-8716.80.......... A change to subheading 8716.10 through
8716.80 from any other heading, except a
change from subheading 8716.90 if that
change is pursuant to GRI 2(a).
8716.90.................. A change to subheading 8716.90 from any other
heading except a change from subheading
8709.90, and 8431.49.
8801-8802................ A change to heading 8801 through 8802 from
any heading outside that group, except from
subheading 8803 pursuant to GRI 2(a).
8803.10-8803.90.......... A change to subheading 8803.10 through
8803.90 from any other subheading within
that group.
8804-8805................ A change to heading 8804 through 8805 from
any other heading, within that group.
8901-8903................ A change to heading 8901 through 8903 from
any heading outside that group.
8904..................... A change to heading 8904 from any other
heading.
8905..................... A change to heading 8905 from any other
chapter.
8906-8907................ A change to heading 8906 through 8907 from
any other heading, including another heading
within that group except from heading 8903
and 8905.
8908..................... A change to heading 8908 from any other
chapter.
------------------------------------------------------------------------
(r) Section XVIII: Chapters 90 through 92
------------------------------------------------------------------------
9001.10................. A change to subheading 9001.10 from any other
subheading, including another subheading
within that group, except from subheading
8544.70.
9001.20-9001.30.......... A change to subheading 9001.20 through
9001.30 from any other subheading, including
another subheading within that group.
9001.40-9001.90.......... A change to subheading 9001.40 through
9001.90 from any other subheading, including
another subheading within that group, except
from lens blanks of subheadings 7014.00 and
7015.10.
9002.11-9002.90.......... A change to subheading 9002.11 through
9002.90 from any other subheading, including
another subheading within that group, except
from subheading 9001.90 and lens blanks of
subheading 7014.00.
9003.11-9003.19.......... (i) A change to subheading 9003.11 through
9003.19 from any other heading, or
(ii) A change to subheading 9003.11 through
9003.19 from any other subheading, including
another subheading within that group, except
from subheading 9003.90, unless the temples
or fronts are domestically produced.
9003.90.................. A change to subheading 9003.90 from any other
heading.
9004..................... A change to heading 9004 from any other
heading, except from subheading 9001.40 or
9001.50.
9005.10-9005.80.......... A change to subheading 9005.10 through
9005.80 from any other subheading, including
another subheading within that group.
9005.90.................. A change to subheading 9005.90 from any other
heading, except from headings 9001 and 9002.
9006.10-9006.69.......... A change to subheading 9006.10 through
9006.69 from any other subheading, including
another subheading with that group.
9006.91-9006.99.......... A change to subheading 9006.91 through
9006.99 from any other heading.
9007.11-9007.29.......... A change to subheading 9007.11 through
9007.29 from any other subheading, including
another subheading within that group.
9007.91-9007.92.......... A change to subheading 9007.91 through
9007.92 from any other heading, except from
lenses of heading 9002, when resulting from
a simple assembly.
9008.10-9008.40.......... A change to subheading 9008.10 through
9008.40 from any other subheading, including
another subheading within that group.
9008.90.................. A change to subheading 9008.90 from any other
heading, except from lenses of heading 9002,
when resulting from a simple assembly.
9009.11-9009.30.......... A change to subheading 9009.11 through
9009.30 from any other subheading, including
another subheading within that group.
9009.90.................. A change to subheading 9009.90 from any other
heading.
9010.10-9010.30.......... A change to subheading 9010.10 through
9010.30 from any other subheading, including
another subheading within that group.
9010.90.................. A change to subheading 9010.90 from any other
heading.
9011.10-9011.80.......... A change to subheading 9011.10 through
9011.80 from any other subheading, including
another subheading within that group.
9011.90.................. A change to subheading 9011.90 from any other
heading.
9012.10.................. A change to subheading 9012.10 from any other
subheading, including another subheading
within that group.
9012.90.................. A change to subheading 9012.90 from any other
heading.
9013.10.................. A change to subheading 9013.10 from any other
subheading, including another subheading
within that group, except from optical
telescopes of subheading 9005.80.
9013.20-9013.80.......... A change to subheading 9013.20 through
9013.80 from any other subheading, including
another subheading within that group.
9013.90.................. A change to subheading 9013.90 from any other
subheading, including another subheading
within that group, except from subheading
9002.19, when resulting from a simple
assembly.
9014.10-9014.80.......... A change to subheading 9014.10 through
9014.80 from any other subheading, including
another subheading within that group.
9014.90.................. A change to subheading 9014.90 from any other
heading.
9015.10-9015.80.......... A change to subheading 9015.10 through
9015.80 from any other subheading, including
another subheading within that group.
9015.90.................. A change to subheading 9015.90 from any other
heading.
9016..................... A change to heading 9016 from any other
heading.
9017.10-9017.80.......... A change to subheading 9017.10 through
9017.80 from any other subheading, including
another subheading within that group.
9017.90.................. A change to subheading 9017.90 from any other
heading.
9018.11-9018.19.......... A change to subheading 9018.11 through
9018.19 from any other subheading, including
another subheading within that group, except
from electrocardiographs, or patient
monitoring systems from printed circuit
assemblies, when resulting from a simple
assembly.
9018.20-9018.32.......... A change to subheading 9018.20 through
9018.32 from any other subheading, including
another subheading within that group.
9018.39.................. A change to subheading 9018.39 from any other
subheading, including another subheading
within that group, except from surgical
tubing of subheading 4009.10, when resulting
from a simple assembly.
9018.41-9018.50.......... A change to subheading 9018.41 through
9018.50 from any other subheading, including
another subheading within that group.
9018.90.................. A change to subheading 9018.90 from any other
subheading, including another subheading
within that group, except from subheading
9001.90, when resulting from a simple
assembly, or synthetic rubber of heading
4002, when resulting from a simple assembly;
or
A change to defibrillators from printed
circuit assemblies, except when resulting
from a simple assembly.
9019.10-9019.20.......... A change to subheading 9019.10 through
9019.20 from any other subheading, including
another subheading within that group.
9020..................... A change to heading 9020 from any other
heading.
9021.11.................. A change to subheading 9021.11 from any other
subheading, including another subheading
within that group.
9021.19.................. A change to subheading 9021.19 from any other
subheading, including another subheading
within that group, except from nails of
heading 7317, when resulting from a simple
assembly or screws of heading 7318, when
resulting from a simple assembly.
9021.21-9021.90.......... A change to subheading 9021.21 through
9021.90 from any other subheading, including
another subheading within that group.
9022.11-9022.90.......... A change to subheading 9022.11 through
9022.90 from any other subheading, including
another subheading within that group.
9023..................... A change to heading 9023 from any other
heading.
9024.10-9024.80.......... A change to subheading 9024.10 through
9024.80 from any other subheading, including
another subheading within that group.
9024.90.................. A change to subheading 9024.90 from any other
heading.
9025.11-9025.80.......... A change to subheading 9025.11 through
9025.80 from any other subheading, including
another subheading within that group.
9025.90.................. A change to subheading 9025.90 from any other
heading.
9026.10-9026.80.......... A change to subheading 9026.10 through
9026.80 from any other subheading, including
another subheading within that group.
9026.90.................. A change to subheading 9026.90 from any other
heading.
9027.10-9027.90.......... A change to subheading 9027.10 through
9027.90 from any other subheading, including
another subheading within that group.
9028.10-9028.30.......... A change to subheading 9028.10 through
9028.30 from any other subheading, including
another subheading within that group.
9028.90.................. A change to subheading 9028.90 from any other
heading.
9029.10-9029.20.......... A change to subheading 9029.10 through
9029.20 from any other subheading, including
another subheading within that group.
9029.90.................. A change to subheading 9029.90 from any other
heading.
9030.10-9030.89.......... A change to subheading 9030.10 through
9030.89 from any other subheading, including
another subheading within that group.
9030.90.................. A change to subheading 9030.90 from any other
heading.
9031.10-9031.80.......... A change to subheading 9031.10 through
9031.80 from any other subheading, including
another subheading within that group.
9031.90.................. A change to subheading 9031.90 from any other
heading.
9032.10-9032.89.......... A change to subheading 9032.10 through
9032.89 from any other subheading, including
another subheading within that group.
9032.90.................. A change to subheading 9032.90 from any other
subheading, including another subheading
within that group, except from heading 8537,
when resulting from a simple assembly.
9033..................... A cha
FR Doc. 93-31852 Rules for Determining the Country of Origin of a Good for Purposes of Annex 311 of the NAFTA and Rules of Origin Applicable to Imported Merchandise; Rule and Proposed Rule
nge to heading 9033 from any other
heading.
9101-9107................ A change to heading 9101 through 9107 from
any heading outside that group, except
heading 9108 through 9110.
9108-9109................ A change to heading 9108 through 9109 from
any heading outside that group, except
heading 9110.
9110..................... A change to heading 9110 from any other
heading, except from subheading 9114.90; or
A change to heading 9110 from subheading
9114.90 if there had been a substantial
transformation.
9111.10-9111.80.......... A change to subheading 9111.10 through
9111.80 from any subheading outside that
group, except from subheading 9111.90 when
the change is pursuant to GRI 2(a).
9111.90.................. A change to subheading 9111.90 from any other
heading.
9112.10-9112.80.......... A change to subheading 9112.10 through
9112.80 from any subheading outside that
group, except from subheading 9112.90 if the
change is pursuant to GRI 2(a).
9112.90.................. A change to subheading 9112.90 from any other
heading.
9113..................... A change to heading 9113 from any other
heading.
9114..................... A change to heading 9114 from any other
heading.
9201-9208................ A change to heading 9201 through 9208 from
any other heading, including a heading
within that group, except a change from
heading 9209 if that change is pursuant to
GRI 2(a).
9209..................... A change to heading 9209 from any other
heading.
------------------------------------------------------------------------
(s) Section XIX: Chapter 93
------------------------------------------------------------------------
9301-9304................ A change to heading 9301 through 9304 from
any other heading, including a heading
within that group, except from a change to
heading 9305 when that change is pursuant to
GRI 2(a).
9305..................... A change to heading 9305 from any other
heading.
9306..................... A change to heading 9306 from any other
heading.
9307..................... A change to heading 9307 from any other
heading.
------------------------------------------------------------------------
(t) Section XX: Chapters 94 through 96
------------------------------------------------------------------------
9401.10-9401.80.......... A change to subheading 9401.10 through
9401.80 from any subheading outside that
group, except subheading 9403.10 through
9403.80, and except a change from subheading
9401.90 or 9403.90 when that change is
pursuant to GRI 2(a).
9401.90.................. A change to subheading 9401.90 from any other
heading, except from subheading 9403.90; or
A change to subheading 9401.90 from
subheading 9403.90 if that change results in
a substantial transformation.
9402..................... A change to heading 9402 from any other
heading, except from subheading 9401.10-
9401.80, 9403.10-9403.80, and except a
change from subheading 9401.90 or 9403.90
when that change is pursuant to GRI 2(a).
9403.10-9403.80.......... A change to subheading 9403.10 through
9403.80 from any subheading outside that
group, except from subheading 9401.10
through 9401.80, and except a change from
subheading 9401.90 or 9403.90 when that
change is pursuant to GRI 2(a).
9403.90.................. A change to subheading 9403.90 from any other
heading, except from subheading 9401.90; or
A change to subheading 9403.90 from
subheading 9403.90 if that change results in
a substantial transformation.
9404.10-9404.30.......... A change to subheading 9404.10 through
9404.30 from any subheading outside that
group.
9404.90.................. A change to subheading 9404.90 from any other
heading.
9405.10-9405.60.......... A change to subheading 9405.10 through
9405.60 from any subheading outside that
group, except a change from subheading
9405.91 through 9405.99 if that change
pursuant to GRI 2(a).
9405.91-9405.99.......... A change to subheading 9405.91 through
9405.99 from any other heading.
9406..................... A change to heading 9406 from any other
heading.
9501..................... A change to heading 9501 from any other
chapter except from heading 8714 if that
change is pursuant to GRI 2(a).
9502.10.................. A change to subheading 9502.10 from any other
subheading, except from skins for stuffed
dolls (9502.99.10).
9502.91.................. A change to subheading 9502.91 from any other
chapter except from heading 6111 and 6209.
9502.99.................. A change to subheading 9502.99 from any other
heading, except from subheadings 9503.41
through 9503.49.
9503.10-9503.30.......... A change to subheading 9503.10 through
9503.30 from any other subheading including
another subheading within that group.
9503.41-9503.49.......... A change to toys of subheading 9503.41
through 9503.49 from any other heading; or
A change to toys of subheading 9503.41
through 9503.49 from parts and accessories
of subheading 9503.41 through 9503.49; or
A change to parts and accessories of 9503.41
through 9503.49 from any other heading,
except from heading 9502, 6111, or 6209.
9503.50-9503.60.......... A change to subheading 9503.50 through
9503.60 from any other subheading, including
another subheading within that group.
9503.70-9503.90.......... A change to subheading 9503.70 through
9503.90 from any other chapter.
9504.10-9506.99.......... A change to heading 9504.10 through 9506.99
from any other subheading, including within
that group.
9507.10-9507.30.......... A change to subheading 9507.10 through
9507.30 from any other chapter.
9507.10-9507.30.......... A change to subheading 9507.10 through
9507.30 from any other chapter.
9507.90.................. A change to subheading 9507.90 from any other
subheading, except from heading 5004 through
5006, 5402.10 through 5402.49, 5406.10
through 5406.20, 5603 and 5404.
9508..................... A change to heading 9508 from any other
heading.
9601..................... A change to heading 9601 from any other
heading.
9602..................... A change to heading 9602 from any other
heading.
9603..................... A change to heading 9603 from any other
heading.
9604-9605................ A change to heading 9604 through 9605 from
any other heading, including another heading
within that group.
9606.10.................. A change to subheading 9606.10 from any other
heading.
9606.21-9606.29.......... A change to subheading 9606.21 through
9606.29 from any other heading; or
A change to subheading 9606.21 through
9606.29 from any other subheading if there
is a substantial transformation.
9606.30.................. A change to subheading 9606.30 from any other
heading.
9607.11-9607.19.......... A change to subheading 9607.11 through
9607.19 from any other subheading, except a
change from subheading 9607.20 when that
change is pursuant to GRI 2(a).
9607.20.................. A change to subheading 9607.20 from any other
subheading.
9608.10-9608.40.......... A change to subheading 9608.10 through
9608.40 from any other subheading including
another subheading within that group, except
from subheading 9608.60.
9608.50.................. A change to 9608.50 from any other heading.
9608.60-9608.99.......... A change to subheading 9608.60 through
9608.99 from any other subheading including
another subheading within that group.
9609.10.................. A change to subheading 9609.10 from any other
subheading.
9609.20.................. A change to subheading 9609.20 from any other
chapter.
9609.90.................. A change to subheading 9609.90 from any other
chapter.
9610-9612................ A change to heading 9610 through 9612 from
any other heading, including another heading
within that group.
9613.10-9613.20.......... A change to subheading 9613.10 through
9613.20 from any other subheading outside
that group.
9613.30-9613.80.......... A change to subheading 9613.30 through
9613.80 from any other subheading, including
from a subheading within that group.
9913.90.................. A change to subheading 9613.90 from any other
heading.
9614.10.................. A change to subheading 9614.10 from any other
heading except from heading 4407.
9614.20.................. A change to subheading 9614.20 from any other
subheading.
9614.90.................. A change to subheading 9614.90 from any other
heading.
9615.11-9615.90.......... A change to subheading 9615.11 through
9615.90 from any other subheading including
another subheading within that group.
9616-9618................ A change to heading 9616 through 9618 from
any other heading, including another heading
within that group
------------------------------------------------------------------------
(u) Section XXI: Chapter 97
------------------------------------------------------------------------
9701-9706................ A change to 9701 through 9706 from any other
subheading, including another subheading
within that group.
------------------------------------------------------------------------
PART 134--COUNTRY OF ORIGIN MARKING
4. The authority citation for part 134 continues to read as
follows:
Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 8,
Harmonized Tariff Schedule of the United States (HTSUS)), 1304,
1624.
5. Section 134.32 is amended by adding a new paragraph (r) to read
as follows:
Sec. 134.32 General exceptions to marking requirements.
* * * * *
(r) Except for articles that are included within the scope of
Sec. 12.130 of this Chapter, articles of United States origin
(determined as such under part 102 of this Chapter prior to exportation
from the U.S.) that are exported for repairs or alterations and
returned.
* * * * *
6. Section 134.43 is amended by adding a new paragraph (e) to read
as follows:
Sec. 134.43 Methods of marking specific articles.
* * * * *
(e) Articles returned to the U.S. after having been advanced in
value or improved in condition outside the United States. Where the
country of origin of an article is determined in accordance with
Sec. 102.14, part 102 of this Chapter, such article, at the choice of
the importer, exporter or producer of the good, may be marked, as
appropriate, in a manner such as the following:
(1) Assembled in (name of foreign country) from U.S components;
(2) Further processed in (name of country of origin) from U.S.
materials;
(3) Product of (name of foreign country) made from U.S. components;
or
(4) Product of (name of foreign country).
George J. Weise,
Commissioner of Customs.
Approved: December 17, 1993.
John P. Simpson,
Deputy Assistant Secretary of the Treasury.
[FR Doc. 93-31852 Filed 12-30-93; 8:45 am]
BILLING CODE 4820-02-P
Complete official Federal Register PDF
FR Doc. 93-31820 Occupational Safety and Health Standards for Cadmium in Shipyard Employment and Construction
[Federal Register Volume 59, Number 1 (Monday, January 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31820]
[[Page Unknown]]
[Federal Register: January 3, 1994]
_______________________________________________________________________
Part III
Department of Labor
_______________________________________________________________________
Occupational Safety and Health Administration
_______________________________________________________________________
29 CFR Parts 1915 and 1926
Standard for Cadmium in Shipyard Employment and in Construction Work;
Reprint With Corrections and Technical Amendments; Final Rule
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Parts 1915 and 1926
Occupational Safety and Health Standards for Cadmium in Shipyard
Employment and Construction
AGENCY: Occupational Safety and Health Administration, Department of
Labor.
ACTION: Final rule; miscellaneous corrections, technical amendments,
and redesignation.
-----------------------------------------------------------------------
SUMMARY: The Occupational Safety and Health Administration (OSHA) is
correcting an error stemming from the wording of the amendatory
language of the final rule that incorporated applicable General
Industry standards for toxic substances into the Occupational Safety
and Health Standards for Shipyard Employment. The final rule, which
appeared in the Federal Register on July 1, 1993, had the effect of
mistakenly inferring that the cadmium standard for shipyard employment
from the Code of Federal Regulations was being deleted though the
preamble made it clear it was retained. This correction reprints the
full text of the cadmium standard as published on September 14, 1992,
and incorporates changes from an April 23, 1993, document that made
corrections and amendments to the original publication. In addition,
several cross-references regarding employee records are being amended
to reflect the designation of a new section in the shipyard employment
standards, and a number of effective dates are being converted to dates
certain.
In addition, OSHA is redesignating the cadmium standard for
construction employment, also published in the same September 14
document, into a different subpart. The redesignation merges it in with
the newly created subpart that contains specific toxic substance
standards for construction.
EFFECTIVE DATE: July 1, 1993.
FOR FURTHER INFORMATION CONTACT: Mr. James F. Foster, OSHA Office of
Public Affairs, Room N-3647, U.S. Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210, telephone (202) 219-8151.
SUPPLEMENTARY INFORMATION:
Background
The final regulations which are the subject of this action was
published in the Federal Register on June 30 and July 1, 1993 (58 FR
35076 and 35512, respectively). Up until then, most health standards
applicable to shipyard employment and construction were not codified in
the parts of title 29 of the Code of Federal Regulations that contained
the bulk of the standards applicable to shipyards (part 1915) and
construction (part 1926). These toxic substance standards were made
applicable by cross-reference to subpart Z of the general industry
standards (part 1910) and other parts and documents.
The Shipyard Employment Standard Advisory Committee (SESAC)
recommended that OSHA incorporate all toxic substance standards
covering shipyards into 29 CFR part 1915. As a first step to carry out
this recommendation, when OSHA issued the cadmium standard on September
14, 1992 (57 FR 42102), it created a subpart Z in part 1915 to include
health standards applicable to shipyards and included the cadmium
standard in subpart Z as Sec. 1915.1027. On April 23, 1993 (58 FR
21780), OSHA published a document that made corrections and amendments
to the September 14 document. As a second step, OSHA published a
technical amendment in the July 1, 1993, issue of the Federal Register,
which incorporated a comprehensive subpart Z into 29 CFR part 1915. The
July 1 document included the other toxic substance standards besides
cadmium, and added certain related standards applicable to shipyards.
In similar fashion to what SESAC sought, the Advisory Committee for
Construction Safety and Health also asked that OSHA incorporate the
general industry standards deemed applicable to construction into
OSHA's construction standards. This incorporation of the pertinent 1910
standards into part 1926 was accomplished on June 30, 1993 (58 FR
35076), and in doing so, OSHA created a subpart Z in part 1926, for the
applicable specific toxic substance standards.
Need for Correction
As published, the July 1 final regulation contained amendatory
language that had the effect of removing the regulatory text and
appendixes of Sec. 1915.1027--Cadmium, by mistake. The preamble of that
document made it clear that the Cadmium standard remained applicable to
shipyard employment (58 FR 35513). This document reinserts the
regulatory text and appendices of Sec. 1915.1027 into subpart Z--Toxic
and Hazardous Substances of part 1915 along with the corrections and
amendments made on April 23, 1993.
In addition, in the July 1 document, the text of existing
Sec. 1910.20, entitled ``Access to employee exposure and medical
records,'' was reprinted as an additional standard in part 1915, to add
it to the shipyard employment standards as new Sec. 1915.1120. OSHA is
changing cross-references in paragraphs (m) and (n) of the cadmium
standard to reflect the designation for the new section regarding
employee records within part 1915. These changes are to
Sec. 1915.1027(m)(4)(iii)(H), where the reference to ``Sec. 1910.20(g)
(1) and (2)'' is changed to read ``Sec. 1915.1120(g) (1) and (2)''; in
Sec. 1915.1027(n) (1)(iii), (3)(iii), and (5)(i), the reference to ``29
CFR 1910.20'' is changed to read ``Sec. 1915.1120 of this part''; and
in Sec. 1915.1027(n)(6), the reference to ``29 CFR 1910.20(h)'' is
changed to read ``Sec. 1915.1120(h) of this part.''
In this document, OSHA is also converting a number of effective
dates that were not computed to dates certain. As published on
September 14, 1992, the standard included over a dozen effective dates
that were based on the effective dates of the cadmium document, such as
for 60 and 90 days after the section or standard became effective.
These dates, set out in paragraphs (p)(2)(i)-(viii) (57 FR 42399) are
being computed in this document. The following list details the
specific instances where these changes are made:
In Sec. 1915.1027(p)(2)(i), the words ``60 days after the
effective date of this standard'' are changed to read ``February 12,
1993'';
In Sec. 1915.1027(p)(2)(vi)(A), the words ``60 days after
the effective date of this section'' are changed to read ``February 12,
1993'';
In Sec. 1915.1027(p)(2) (ii) and (iii), the words ``90
days after the effective date of this section'' are changed to read
``March 15, 1993'';
In Sec. 1915.1027(p)(2) (vii) and (viii), the words ``90
days after the effective date of this standard'' are changed to read
``March 15, 1993'';
In Sec. 1915.1027(p)(2)(i), the words ``120 days after the
effective date of this standard'' are changed to read ``April 14,
1993'';
In Sec. 1915.1027(p)(2) (ii) and (iii), the words ``150
days after the effective date of this section'' are changed to read
``May 14, 1993'';
In Sec. 1915.1027(p)(2) (vii) and (viii), the words ``180
days after the effective date of this standard'' are changed to read
``June 14, 1993'';
In Sec. 1915.1027(p)(2) (iv) and (iv)(B), the words ``1
year after the effective date of this section'' are changed to read
``December 14, 1993''; and
In Sec. 1915.1027(p)(2)(v), the words ``two (2) years
after the effective date of this section'' are changed to read
``December 14, 1994.''
When it was published in the same September 14, 1992, document, at
57 FR 42452, the cadmium standard for construction was codified as
Sec. 1926.63 in subpart D, which covers occupational health and
environmental controls. With the publication of the June 30, 1993,
document that created a separate subpart Z for specific toxic
substances within OSHA's construction standards, it follows that the
cadmium standard belongs with the new subpart. Therefore, this document
is redesignating Sec. 1926.63 as Sec. 1926.1127, to place it in the
appropriate place subpart Z of the construction standards.
In addition, in the June 30 document, the text of existing
Sec. 1910.20, entitled ``Access to employee exposure and medical
records,'' was reprinted as an additional standard in part 1926, to add
it to the construction standards as new Sec. 1926.33. OSHA is amending
cross-references in paragraphs (m) and (n) of the cadmium standard
(redesignated as Sec. 1926.1127) to reflect the designation for the new
section regarding employee records within part 1926. These changes are
to paragraph (m)(4)(iii)(H), where the reference to ``Sec. 1910.20(g)
(1) and (2)'' is changed to read ``Sec. 1926.33(g) (1) and (2)''; in
paragraphs (n) (1)(iii), (3)(iii), and (5)(i), where the reference to
``29 CFR 1910.20'' is changed to read ``Sec. 1926.33 of this part'';
and in paragraph (n)(6), the reference to ``29 CFR 1910.20(h)'' is
changed to read ``Sec. 1926.33(h) of this part.''
The corrections and technical amendments in this document are not
substantive regulatory actions, and therefore are not required to have
notice, comment, or an advance effective date. They are being made
retroactively effective, as of July 1, 1993, to make it clear that the
cadmium standard has been in effect covering shipyard employment since
December 14, 1992. The cadmium standard remained in effect subsequent
to the July 1, 1993, Federal Register document, as was OSHA's clearly
expressed intent.
List of Subjects
29 CFR Part 1915
Air contaminants, Hazardous materials, Hazard communication,
Laboratories, Medical records, Occupational safety and health,
Recordkeeping, Shipyards, Shipbuilding, Ship repairing, Shipbreaking,
Toxic chemicals.
29 CFR Part 1926
Construction industry, Hazardous materials, Occupational safety and
health, Protective equipment.
Authority and Signature
This document was prepared under the direction of Joseph A. Dear,
Assistant Secretary of Labor for Occupational Safety and Health, U.S.
Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210.
Accordingly, pursuant to sections 4, 6, and 8 of the Occupational
Safety and Health Act (29 U.S.C. 653, 655, and 657); section 107 of the
Contract Work Hours and Safety Standards Act (Construction Safety Act)
(40 U.S.C. 333); section 41 Longshore and Harbor Workers Compensation
Act (33 U.S.C. 941); section 4 of the Administrative Procedure Act (5
U.S.C. 553); and Secretary of Labor's Order No. 1-90 (55 FR 9033); OSHA
is issuing these corrections and technical amendments.
Signed at Washington, DC, 17th day of December, 1993.
Joseph A. Dear,
Assistant Secretary of Labor.
Accordingly, 29 CFR part 1915, subpart Z is corrected by the
following amendment:
PART 1915--OCCUPATIONAL SAFETY AND HEALTH STANDARDS FOR SHIPYARD
EMPLOYMENT
1. The authority citation for subpart Z of part 1915 continues to
read as follows:
Authority: Sections 4, 6, 8 Occupational Safety and Health Act,
29 U.S.C. 653, 655, 657; Sec. 4 of the Administrative Procedure Act,
5 U.S.C. 553; Secretary of Labor's Orders 12-71 (36 FR 8754), 8-76
(41 FR 25059), 9-83 (48 FR 35736), or 1-90 (55 FR 9033), as
applicable; and 29 CFR part 1911.
Subpart Z--Toxic and Hazardous Substances [Amended]
2. Subpart Z of part 1915 is corrected by adding the text and
appendices of Sec. 1915.1027 as follows:
Sec. 1915.1027 Cadmium.
(a) Scope. This standard applies to all occupational exposures to
cadmium and cadmium compounds, in all forms, and in all industries
covered by the Occupational Safety and Health Act, except the
construction-related industries, which are covered under 29 CFR
1926.63.
(b) Definitions.
Action level (AL) is defined as an airborne concentration of
cadmium of 2.5 micrograms per cubic meter of air (2.5 g/m\3\),
calculated as an 8-hour time-weighted average (TWA).
Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, or designee.
Authorized person means any person authorized by the employer and
required by work duties to be present in regulated areas or any person
authorized by the OSH Act or regulations issued under it to be in
regulated areas.
Director means the Director of the National Institute for
Occupational Safety and Health (NIOSH), U.S. Department of Health and
Human Services, or designee.
Employee exposure and similar language referring to the air cadmium
level to which an employee is exposed means the exposure to airborne
cadmium that would occur if the employee were not using respiratory
protective equipment.
Final medical determination is the written medical opinion of the
employee's health status by the examining physician under paragraphs
(l)(3)-(12) of this section or, if multiple physician review under
paragraph (l)(13) of this section or the alternative physician
determination under paragraph (l)(14) of this section is invoked, it is
the final, written medical finding, recommendation or determination
that emerges from that process.
High-efficiency particulate air (HEPA) filter means a filter
capable of trapping and retaining at least 99.97 percent of mono-
dispersed particles of 0.3 micrometers in diameter.
Regulated area means an area demarcated by the employer where an
employee's exposure to airborne concentrations of cadmium exceeds, or
can reasonably be expected to exceed the permissible exposure limit
(PEL).
This section means this cadmium standard.
(c) Permissible Exposure Limit (PEL). The employer shall assure
that no employee is exposed to an airborne concentration of cadmium in
excess of five micrograms per cubic meter of air (5 g/m\3\),
calculated as an eight-hour time-weighted average exposure (TWA).
(d) Exposure monitoring--(1) General. (i) Each employer who has a
workplace or work operation covered by this section shall determine if
any employee may be exposed to cadmium at or above the action level.
(ii) Determinations of employee exposure shall be made from
breathing zone air samples that reflect the monitored employee's
regular, daily 8-hour TWA exposure to cadmium.
(iii) Eight-hour TWA exposures shall be determined for each
employee on the basis of one or more personal breathing zone air
samples reflecting full shift exposure on each shift, for each job
classification, in each work area. Where several employees perform the
same job tasks, in the same job classification, on the same shift, in
the same work area, and the length, duration, and level of cadmium
exposures are similar, an employer may sample a representative fraction
of the employees instead of all employees in order to meet this
requirement. In representative sampling, the employer shall sample the
employee(s) expected to have the highest cadmium exposures.
(2) Specific. (i) Initial monitoring. Except as provided for in
paragraphs (d)(2)(ii) and (d)(2)(iii) of this section, the employer
shall monitor employee exposures and shall base initial determinations
on the monitoring results.
(ii) Where the employer has monitored after September 14, 1991,
under conditions that in all important aspects closely resemble those
currently prevailing and where that monitoring satisfies all other
requirements of this section, including the accuracy and confidence
levels of paragraph (d)(6) of this section, the employer may rely on
such earlier monitoring results to satisfy the requirements of
paragraph (d)(2)(i) of this section.
(iii) Where the employer has objective data, as defined in
paragraph (n)(2) of this section, demonstrating that employee exposure
to cadmium will not exceed the action level under the expected
conditions of processing, use, or handling, the employer may rely upon
such data instead of implementing initial monitoring.
(3) Monitoring Frequency (periodic monitoring). (i) If the initial
monitoring or periodic monitoring reveals employee exposures to be at
or above the action level, the employer shall monitor at a frequency
and pattern needed to represent the levels of exposure of employees and
where exposures are above the PEL to assure the adequacy of respiratory
selection and the effectiveness of engineering and work practice
controls. However, such exposure monitoring shall be performed at least
every six months. The employer, at a minimum, shall continue these
semi-annual measurements unless and until the conditions set out in
paragraph (d)(3)(ii) of this section are met.
(ii) If the initial monitoring or the periodic monitoring indicates
that employee exposures are below the action level and that result is
confirmed by the results of another monitoring taken at least seven
days later, the employer may discontinue the monitoring for those
employees whose exposures are represented by such monitoring.
(4) Additional monitoring. The employer also shall institute the
exposure monitoring required under paragraphs (d)(2)(i) and (d)(3) of
this section whenever there has been a change in the raw materials,
equipment, personnel, work practices, or finished products that may
result in additional employees being exposed to cadmium at or above the
action level or in employees already exposed to cadmium at or above the
action level being exposed above the PEL, or whenever the employer has
any reason to suspect that any other change might result in such
further exposure.
(5) Employee notification of monitoring results. (i) Within 15
working days after the receipt of the results of any monitoring
performed under this section, the employer shall notify each affected
employee individually in writing of the results. In addition, within
the same time period the employer shall post the results of the
exposure monitoring in an appropriate location that is accessible to
all affected employees.
(ii) Wherever monitoring results indicate that employee exposure
exceeds the PEL, the employer shall include in the written notice a
statement that the PEL has been exceeded and a description of the
corrective action being taken by the employer to reduce employee
exposure to or below the PEL.
(6) Accuracy of measurement. The employer shall use a method of
monitoring and analysis that has an accuracy of not less than plus or
minus 25 percent ( 25%), with a confidence level of 95
percent, for airborne concentrations of cadmium at or above the action
level, the permissible exposure limit (PEL), and the separate
engineering control air limit (SECAL).
(e) Regulated areas--(1) Establishment. The employer shall
establish a regulated area wherever an employee's exposure to airborne
concentrations of cadmium is, or can reasonably be expected to be in
excess of the permissible exposure limit (PEL).
(2) Demarcation. Regulated areas shall be demarcated from the rest
of the workplace in any manner that adequately establishes and alerts
employees of the boundaries of the regulated area.
(3) Access. Access to regulated areas shall be limited to
authorized persons.
(4) Provision of respirators. Each person entering a regulated area
shall be supplied with and required to use a respirator, selected in
accordance with paragraph (g)(2) of this section.
(5) Prohibited activities. The employer shall assure that employees
do not eat, drink, smoke, chew tobacco or gum, or apply cosmetics in
regulated areas, carry the products associated with these activities
into regulated areas, or store such products in those areas.
(f) Methods of compliance--(1) Compliance hierarchy. (i) Except as
specified in paragraphs (f)(1) (ii), (iii) and (iv) of this section the
employer shall implement engineering and work practice controls to
reduce and maintain employee exposure to cadmium at or below the PEL,
except to the extent that the employer can demonstrate that such
controls are not feasible.
(ii) Except as specified in paragraphs (f)(1) (iii) and (iv) of
this section, in industries where a separate engineering control air
limit (SECAL) has been specified for particular processes (See Table 1
in this paragraph (f)(1)(ii)), the employer shall implement engineering
and work practice controls to reduce and maintain employee exposure at
or below the SECAL, except to the extent that the employer can
demonstrate that such controls are not feasible.
Table 1.--Separate Engineering Control Airborne Limits (SECALs) for
Processes in Selected Industries
------------------------------------------------------------------------
SECAL
Industry Process (g/
m3)
------------------------------------------------------------------------
Nickel cadmium battery.... Plate making, plate 50
preparation.
All other processes........... 15
Zinc/Cadmium refining*.... Cadmium refining, casting, 50
melting, oxide production,
sinter plant.
Pigment manufacture....... Calcine, crushing, milling, 50
blending.
All other processes........... 15
Stabilizers*.............. Cadmium oxide charging, 50
crushing, drying, blending.
Lead smelting*............ Sinter plant, blast furnace, 50
baghouse, yard area.
Plating*.................. Mechanical plating............ 15
------------------------------------------------------------------------
*Processes in these industries that are not specified in this table must
achieve the PEL using engineering controls and work practices as
required in f(1)(i).
(iii) The requirement to implement engineering and work practice
controls to achieve the PEL or, where applicable, the SECAL does not
apply where the employer demonstrates the following:
(A) The employee is only intermittently exposed; and
(B) The employee is not exposed above the PEL on 30 or more days
per year (12 consecutive months).
(iv) Wherever engineering and work practice controls are required
and are not sufficient to reduce employee exposure to or below the PEL
or, where applicable, the SECAL, the employer nonetheless shall
implement such controls to reduce exposures to the lowest levels
achievable. The employer shall supplement such controls with
respiratory protection that complies with the requirements of paragraph
(g) of this section and the PEL.
(v) The employer shall not use employee rotation as a method of
compliance.
(2) Compliance program. (i) Where the PEL is exceeded, the employer
shall establish and implement a written compliance program to reduce
employee exposure to or below the PEL by means of engineering and work
practice controls, as required by paragraph (f)(1) of this section. To
the extent that engineering and work practice controls cannot reduce
exposures to or below the PEL, the employer shall include in the
written compliance program the use of appropriate respiratory
protection to achieve compliance with the PEL.
(ii) Written compliance programs shall include at least the
following:
(A) A description of each operation in which cadmium is emitted;
e.g., machinery used, material processed, controls in place, crew size,
employee job responsibilities, operating procedures, and maintenance
practices;
(B) A description of the specific means that will be employed to
achieve compliance, including engineering plans and studies used to
determine methods selected for controlling exposure to cadmium, as well
as, where necessary, the use of appropriate respiratory protection to
achieve the PEL;
(C) A report of the technology considered in meeting the PEL;
(D) Air monitoring data that document the sources of cadmium
emissions;
(E) A detailed schedule for implementation of the program,
including documentation such as copies of purchase orders for
equipment, construction contracts, etc.;
(F) A work practice program that includes items required under
paragraphs (h), (i), and (j) of this section;
(G) A written plan for emergency situations, as specified in
paragraph (h) of this section; and
(H) Other relevant information.
(iii) The written compliance programs shall be reviewed and updated
at least annually, or more often if necessary, to reflect significant
changes in the employer's compliance status.
(iv) Written compliance programs shall be provided upon request for
examination and copying to affected employees, designated employee
representatives as well as to the Assistant Secretary, and the
Director.
(3) Mechanical ventilation. (i) When ventilation is used to control
exposure, measurements that demonstrate the effectiveness of the system
in controlling exposure, such as capture velocity, duct velocity, or
static pressure shall be made as necessary to maintain its
effectiveness.
(ii) Measurements of the system's effectiveness in controlling
exposure shall be made as necessary within five working days of any
change in production, process, or control that might result in a
significant increase in employee exposure to cadmium.
(iii) Recirculation of air. If air from exhaust ventilation is
recirculated into the workplace, the system shall have a high
efficiency filter and be monitored to assure effectiveness.
(iv) Procedures shall be developed and implemented to minimize
employee exposure to cadmium when maintenance of ventilation systems
and changing of filters is being conducted.
(g) Respirator protection--(1) General. Where respirators are
required by this section, the employer shall provide them at no cost to
the employee and shall assure that they are used in compliance with the
requirements of this section. Respirators shall be used in the
following circumstances:
(i) Where exposure levels exceed the PEL, during the time period
necessary to install or implement feasible engineering and work
practice controls;
(ii) In those maintenance and repair activities and during those
brief or intermittent operations where exposures exceed the PEL and
engineering and work practice controls are not feasible or are not
required;
(iii) In regulated areas, as prescribed in paragraph (e) of this
section;
(iv) Where the employer has implemented all feasible engineering
and work practice controls and such controls are not sufficient to
reduce exposures to or below the PEL;
(v) In emergencies;
(vi) Wherever an employee who is exposed to cadmium at or above the
action level requests a respirator;
(vii) Wherever an employee is exposed above the PEL in an industry
to which a SECAL is applicable; and
(viii) Wherever an employee is exposed to cadmium above the PEL and
engineering controls are not required under paragraph (f)(1)(iii) of
this section.
(2) Respirator selection. (i) Where respirators are required under
this section, the employer shall select and provide the appropriate
respirator as specified in Table 2 in this paragraph (g)(2)(i). The
employer shall select respirators from among those jointly approved as
acceptable protection against cadmium dust, fume, and mist by the Mine
Safety and Health Administration (MSHA) and by the National Institute
for Occupational Safety and Health (NIOSH) under the provisions of 30
CFR part 11.
Table 2.--Respiratory Protection for Cadmium
----------------------------------------------------------------------------------------------------------------
Airborne concentration or condition of usea Required respirator typeb
----------------------------------------------------------------------------------------------------------------
10 x or less............................. A half mask, air-purifying respirator equipped with a HEPAc
filter.d
25 x or less............................. A powered air-purifying respirator (``PAPR'') with a loose-fitting
hood or helmet equipped with a HEPA filter, or a supplied-air
respirator with a loose-fitting hood or helmet facepiece operated
in the continuous flow mode.
50 x or less............................. A full facepiece air-purifying respirator equipped with a HEPA
filter, or a powered air-purifying respirator with a tight-fitting
half mask equipped with a HEPA filter, or a supplied air
respirator with a tight-fitting half mask operated in the
continuous flow mode.
250 x or less............................ A powered air-purifying respirator with a tight-fitting full
facepiece equipped with a HEPA filter, or a supplied-air
respirator with a tight-fitting full facepiece operated in the
continuous flow mode.
1000 x or less........................... A supplied-air respirator with half mask or full facepiece operated
in the pressure demand or other positive pressure mode.
>1000 x or unknown concentrations........ A self-contained breathing apparatus with a full facepiece operated
in the pressure demand or other positive pressure mode, or a
supplied-air respirator with a full facepiece operated in the
pressure demand or other positive pressure mode and equipped with
an auxiliary escape type self-contained breathing apparatus
operated in the pressure demand mode.
Fire fighting.............................. A self-contained breathing apparatus with full facepiece operated
in the pressure demand or other positive pressure mode.
----------------------------------------------------------------------------------------------------------------
aConcentrations expressed as multiple of the PEL.
bRespirators assigned for higher environmental concentrations may be used at lower exposure levels. Quantitative
fit testing is required for all tight-fitting air purifying respirators where airborne concentration of
cadmium exceeds 10 times the TWA PEL (10 x 5 g/m3=50 g/m3). A full facepiece respirator is
required when eye irritation is experienced.
cHEPA means High Efficiency Particulate Air.
dFit testing, qualitative or quantitative, is required.
SOURCE: Respiratory Decision Logic, NIOSH, 1987.
(ii) The employer shall provide a powered, air-purifying respirator
(PAPR) in lieu of a negative pressure respirator wherever:
(A) An employee entitled to a respirator chooses to use this type
of respirator; and
(B) This respirator will provide adequate protection to the
employee.
(3) Respirator program. (i) Where respiratory protection is
required, the employer shall institute a respirator protection program
in accordance with 29 CFR 1910.134.
(ii) The employer shall permit each employee who is required to use
an air purifying respirator to leave the regulated area to change the
filter elements or replace the respirator whenever an increase in
breathing resistance is detected and shall maintain an adequate supply
of filter elements for this purpose.
(iii) The employer shall also permit each employee who is required
to wear a respirator to leave the regulated area to wash his or her
face and the respirator facepiece whenever necessary to prevent skin
irritation associated with respirator use.
(iv) If an employee exhibits difficulty in breathing while wearing
a respirator during a fit test or during use, the employer shall make
available to the employee a medical examination in accordance with
paragraph (l)(6)(ii) of this section to determine if the employee can
wear a respirator while performing the required duties.
(v) No employee shall be assigned a task requiring the use of a
respirator if, based upon his or her most recent examination, an
examining physician determines that the employee will be unable to
continue to function normally while wearing a respirator. If the
physician determines the employee must be limited in, or removed from
his or her current job because of the employee's inability to wear a
respirator, the limitation or removal shall be in accordance with
paragraphs (l) (11) and (12) of this section.
(4) Respirator fit testing. (i) The employer shall assure that the
respirator issued to the employee is fitted properly and exhibits the
least possible facepiece leakage.
(ii) For each employee wearing a tight-fitting, air purifying
respirator (either negative or positive pressure) who is exposed to
airborne concentrations of cadmium that do not exceed 10 times the PEL
(10 x 5 g/m\3\ = 50 g/m\3\), the employer shall
perform either quantitative or qualitative fit testing at the time of
initial fitting and at least annually thereafter. If quantitative fit
testing is used for a negative pressure respirator, a fit factor that
is at least 10 times the protection factor for that class of
respirators (Table 2 in paragraph (g)(2)(i) of this section) shall be
achieved at testing.
(iii) For each employee wearing a tight-fitting air purifying
respirator (either negative or positive pressure) who is exposed to
airborne concentrations of cadmium that exceed 10 times the PEL (10 x
5 g/m\3\ = 50 g/m\3\), the employer shall perform
quantitative fit testing at the time of initial fitting and at least
annually thereafter. For negative-pressure respirators, a fit factor
that is at least 10 times the protection factor for that class of
respirators (Table 2 in paragraph (g)(2)(i) of this section) shall be
achieved during quantitative fit testing.
(iv) For each employee wearing a tight-fitting, supplied-air
respirator or self-contained breathing apparatus, the employer shall
perform quantitative fit testing at the time of initial fitting and at
least annually thereafter. This shall be accomplished by fit testing an
air purifying respirator of identical type facepiece, make, model, and
size as the supplied air respirator or self-contained breathing
apparatus that is equipped with HEPA filters and tested as a surrogate
(substitute) in the negative pressure mode. A fit factor that is at
least 10 times the protection factor for that class of respirators
(Table 2 in paragraph (g)(2)(i) of this section) shall be achieved
during quantitative fit testing. A supplied-air respirator or self-
contained breathing apparatus with the same type facepiece, make,
model, and size as the air purifying respirator with which the employee
passed the quantitative fit test may then be used by that employee up
to the protection factor listed in Table 2 for that class of
respirators.
(v) Fit testing shall be conducted in accordance with appendix C of
this section.
(h) Emergency situations. The employer shall develop and implement
a written plan for dealing with emergency situations involving
substantial releases of airborne cadmium. The plan shall include
provisions for the use of appropriate respirators and personal
protective equipment. In addition, employees not essential to
correcting the emergency situation shall be restricted from the area
and normal operations halted in that area until the emergency is
abated.
(i) Protective work clothing and equipment--(1) Provision and use.
If an employee is exposed to airborne cadmium above the PEL or where
skin or eye irritation is associated with cadmium exposure at any
level, the employer shall provide at no cost to the employee, and
assure that the employee uses, appropriate protective work clothing and
equipment that prevents contamination of the employee and the
employee's garments. Protective work clothing and equipment includes,
but is not limited to:
(i) Coveralls or similar full-body work clothing;
(ii) Gloves, head coverings, and boots or foot coverings; and
(iii) Face shields, vented goggles, or other appropriate protective
equipment that complies with 29 CFR 1910.133.
(2) Removal and storage. (i) The employer shall assure that
employees remove all protective clothing and equipment contaminated
with cadmium at the completion of the work shift and do so only in
change rooms provided in accordance with paragraph (j)(1) of this
section.
(ii) The employer shall assure that no employee takes cadmium-
contaminated protective clothing or equipment from the workplace,
except for employees authorized to do so for purposes of laundering,
cleaning, maintaining, or disposing of cadmium contaminated protective
clothing and equipment at an appropriate location or facility away from
the workplace.
(iii) The employer shall assure that contaminated protective
clothing and equipment, when removed for laundering, cleaning,
maintenance, or disposal, is placed and stored in sealed, impermeable
bags or other closed, impermeable containers that are designed to
prevent dispersion of cadmium dust.
(iv) The employer shall assure that bags or containers of
contaminated protective clothing and equipment that are to be taken out
of the change rooms or the workplace for laundering, cleaning,
maintenance or disposal shall bear labels in accordance with paragraph
(m)(3) of this section.
(3) Cleaning, replacement, and disposal. (i) The employer shall
provide the protective clothing and equipment required by paragraph
(i)(1) of this section in a clean and dry condition as often as
necessary to maintain its effectiveness, but in any event at least
weekly. The employer is responsible for cleaning and laundering the
protective clothing and equipment required by this paragraph to
maintain its effectiveness and is also responsible for disposing of
such clothing and equipment.
(ii) The employer also is responsible for repairing or replacing
required protective clothing and equipment as needed to maintain its
effectiveness. When rips or tears are detected while an employee is
working they shall be immediately mended, or the worksuit shall be
immediately replaced.
(iii) The employer shall prohibit the removal of cadmium from
protective clothing and equipment by blowing, shaking, or any other
means that disperses cadmium into the air.
(iv) The employer shall assure that any laundering of contaminated
clothing or cleaning of contaminated equipment in the workplace is done
in a manner that prevents the release of airborne cadmium in excess of
the permissible exposure limit prescribed in paragraph (c) of this
section.
(v) The employer shall inform any person who launders or cleans
protective clothing or equipment contaminated with cadmium of the
potentially harmful effects of exposure to cadmium and that the
clothing and equipment should be laundered or cleaned in a manner to
effectively prevent the release of airborne cadmium in excess of the
PEL.
(j) Hygiene areas and practices--(1) General. For employees whose
airborne exposure to cadmium is above the PEL, the employer shall
provide clean change rooms, handwashing facilities, showers, and
lunchroom facilities that comply with 29 CFR 1910.141.
(2) Change rooms. The employer shall assure that change rooms are
equipped with separate storage facilities for street clothes and for
protective clothing and equipment, which are designed to prevent
dispersion of cadmium and contamination of the employee's street
clothes.
(3) Showers and handwashing facilities. (i) The employer shall
assure that employees who are exposed to cadmium above the PEL shower
during the end of the work shift.
(ii) The employer shall assure that employees whose airborne
exposure to cadmium is above the PEL wash their hands and faces prior
to eating, drinking, smoking, chewing tobacco or gum, or applying
cosmetics.
(4) Lunchroom facilities. (i) The employer shall assure that the
lunchroom facilities are readily accessible to employees, that tables
for eating are maintained free of cadmium, and that no employee in a
lunchroom facility is exposed at any time to cadmium at or above a
concentration of 2.5 g/m\3\.
(ii) The employer shall assure that employees do not enter
lunchroom facilities with protective work clothing or equipment unless
surface cadmium has been removed from the clothing and equipment by
HEPA vacuuming or some other method that removes cadmium dust without
dispersing it.
(k) Housekeeping. (1) All surfaces shall be maintained as free as
practicable of accumulations of cadmium.
(2) All spills and sudden releases of material containing cadmium
shall be cleaned up as soon as possible.
(3) Surfaces contaminated with cadmium shall, wherever possible, be
cleaned by vacuuming or other methods that minimize the likelihood of
cadmium becoming airborne.
(4) HEPA-filtered vacuuming equipment or equally effective
filtration methods shall be used for vacuuming. The equipment shall be
used and emptied in a manner that minimizes the reentry of cadmium into
the workplace.
(5) Shoveling, dry or wet sweeping, and brushing may be used only
where vacuuming or other methods that minimize the likelihood of
cadmium becoming airborne have been tried and found not to be
effective.
(6) Compressed air shall not be used to remove cadmium from any
surface unless the compressed air is used in conjunction with a
ventilation system designed to capture the dust cloud created by the
compressed air.
(7) Waste, scrap, debris, bags, containers, personal protective
equipment, and clothing contaminated with cadmium and consigned for
disposal shall be collected and disposed of in sealed impermeable bags
or other closed, impermeable containers. These bags and containers
shall be labeled in accordance with paragraph (m)(2) of this section.
(l) Medical surveillance--(1) General--(i) Scope. (A) Currently
exposed--The employer shall institute a medical surveillance program
for all employees who are or may be exposed to cadmium at or above the
action level unless the employer demonstrates that the employee is not,
and will not be, exposed at or above the action level on 30 or more
days per year (twelve consecutive months); and,
(B) Previously exposed--The employer shall also institute a medical
surveillance program for all employees who prior to the effective date
of this section might previously have been exposed to cadmium at or
above the action level by the employer, unless the employer
demonstrates that the employee did not prior to the effective date of
this section work for the employer in jobs with exposure to cadmium for
an aggregated total of more than 60 months.
(ii) To determine an employee's fitness for using a respirator, the
employer shall provide the limited medical examination specified in
paragraph (l)(6) of this section.
(iii) The employer shall assure that all medical examinations and
procedures required by this standard are performed by or under the
supervision of a licensed physician, who has read and is familiar with
the health effects section of appendix A to this section, the
regulatory text of this section, the protocol for sample handling and
laboratory selection in appendix F to this section, and the
questionnaire of appendix D to this section. These examinations and
procedures shall be provided without cost to the employee and at a time
and place that is reasonable and convenient to employees.
(iv) The employer shall assure that the collecting and handling of
biological samples of cadmium in urine (CdU), cadmium in blood (CdB),
and beta-2 microglobulin in urine (2-M) taken from
employees under this section is done in a manner that assures their
reliability and that analysis of biological samples of cadmium in urine
(CdU), cadmium in blood (CdB), and beta-2 microglobulin in urine
(2-M) taken from employees under this section is
performed in laboratories with demonstrated proficiency for that
particular analyte. (See appendix F to this section.)
(2) Initial examination. (i) The employer shall provide an initial
(preplacement) examination to all employees covered by the medical
surveillance program required in paragraph (l)(1)(i) of this section.
The examination shall be provided to those employees within 30 days
after initial assignment to a job with exposure to cadmium or no later
than 90 days after the effective date of this section, whichever date
is later.
(ii) The initial (preplacement) medical examination shall include:
(A) A detailed medical and work history, with emphasis on: Past,
present, and anticipated future exposure to cadmium; any history of
renal, cardiovascular, respiratory, hematopoietic, reproductive, and/or
musculo-skeletal system dysfunction; current usage of medication with
potential nephrotoxic side-effects; and smoking history and current
status; and
(B) Biological monitoring that includes the following tests:
(1) Cadmium in urine (CdU), standardized to grams of creatinine (g/
Cr);
(2) Beta-2 microglobulin in urine (2-M), standardized
to grams of creatinine (g/Cr), with pH specified, as described in
appendix F to this section; and
(3) Cadmium in blood (CdB), standardized to liters of whole blood
(lwb).
(iii) Recent Examination: An initial examination is not required to
be provided if adequate records show that the employee has been
examined in accordance with the requirements of paragraph (l)(2)(ii) of
this section within the past 12 months. In that case, such records
shall be maintained as part of the employee's medical record and the
prior exam shall be treated as if it were an initial examination for
the purposes of paragraphs (l)(3) and (4) of this section.
(3) Actions triggered by initial biological monitoring. (i) If the
results of the initial biological monitoring tests show the employee's
CdU level to be at or below 3 g/g Cr, 2-M level
to be at or below 300 g/g Cr and CdB level to be at or below 5
g/lwb, then:
(A) For currently exposed employees, who are subject to medical
surveillance under paragraph (l)(1)(i)(A) of this section, the employer
shall provide the minimum level of periodic medical surveillance in
accordance with the requirements in paragraph (l)(4)(i) of this
section; and
(B) For previously exposed employees, who are subject to medical
surveillance under paragraph (l)(1)(i)(B) of this section, the employer
shall provide biological monitoring for CdU, 2-M, and CdB
one year after the initial biological monitoring and then the employer
shall comply with the requirements of paragraph (l)(4)(v) of this
section.
(ii) For all employees who are subject to medical surveillance
under paragraph (l)(1)(i) of this section, if the results of the
initial biological monitoring tests show the level of CdU to exceed 3
g/g Cr, the level of 2-M to exceed 300
g/g Cr, or the level of CdB to exceed 5 g/lwb, the
employer shall:
(A) Within two weeks after receipt of biological monitoring
results, reassess the employee's occupational exposure to cadmium as
follows:
(1) Reassess the employee's work practices and personal hygiene;
(2) Reevaluate the employee's respirator use, if any, and the
respirator program;
(3) Review the hygiene facilities;
(4) Reevaluate the maintenance and effectiveness of the relevant
engineering controls;
(5) Assess the employee's smoking history and status;
(B) Within 30 days after the exposure reassessment, specified in
paragraph (l)(3)(ii)(A) of this section, take reasonable steps to
correct any deficiencies found in the reassessment that may be
responsible for the employee's excess exposure to cadmium; and,
(C) Within 90 days after receipt of biological monitoring results,
provide a full medical examination to the employee in accordance with
the requirements of paragraph (l)(4)(ii) of this section. After
completing the medical examination, the examining physician shall
determine in a written medical opinion whether to medically remove the
employee. If the physician determines that medical removal is not
necessary, then until the employee's CdU level falls to or below 3
g/g Cr, 2-M level falls to or below 300
g/g Cr and CdB level falls to or below 5 g/lwb, the
employer shall:
(1) Provide biological monitoring in accordance with paragraph
(l)(2)(ii)(B) of this section on a semiannual basis; and
(2) Provide annual medical examinations in accordance with
paragraph (l)(4)(ii) of this section.
(iii) For all employees who are subject to medical surveillance
under paragraph (l)(1)(i) of this section, if the results of the
initial biological monitoring tests show the level of CdU to be in
excess of 15 g/g Cr, or the level of CdB to be in excess of 15
g/lwb, or the level of 2-M to be in excess of
1,500 g/g Cr, the employer shall comply with the requirements
of paragraphs (l)(3)(ii)(A)-(B) of this section. Within 90 days after
receipt of biological monitoring results, the employer shall provide a
full medical examination to the employee in accordance with the
requirements of paragraph (l)(4)(ii) of this section. After completing
the medical examination, the examining physician shall determine in a
written medical opinion whether to medically remove the employee.
However, if the initial biological monitoring results and the
biological monitoring results obtained during the medical examination
both show that: CdU exceeds 15 g/g Cr; or CdB exceeds 15
g/lwb; or 2-M exceeds 1500 g/g Cr, and
in addition CdU exceeds 3 g/g Cr or CdB exceeds 5 g/
liter of whole blood, then the physician shall medically remove the
employee from exposure to cadmium at or above the action level. If the
second set of biological monitoring results obtained during the medical
examination does not show that a mandatory removal trigger level has
been exceeded, then the employee is not required to be removed by the
mandatory provisions of this paragraph. If the employee is not required
to be removed by the mandatory provisions of this paragraph or by the
physician's determination, then until the employee's CdU level falls to
or below 3 g/g Cr, 2-M level falls to or below
300 g/g Cr and CdB level falls to or below 5 g/lwb,
the employer shall:
(A) Periodically reassess the employee's occupational exposure to
cadmium;
(B) Provide biological monitoring in accordance with paragraph
(l)(2)(ii)(B) of this section on a quarterly basis; and
(C) Provide semiannual medical examinations in accordance with
paragraph (l)(4)(ii) of this section.
(iv) For all employees to whom medical surveillance is provided,
beginning on January 1, 1999, and in lieu of paragraphs (l)(3)(i)-(iii)
of this section:
(A) If the results of the initial biological monitoring tests show
the employee's CdU level to be at or below 3 g/g Cr,
2-M level to be at or below 300 g/g Cr and CdB
level to be at or below 5 g/lwb, then for currently exposed
employees, the employer shall comply with the requirements of paragraph
(l)(3)(i)(A) of this section, and for previously exposed employees, the
employer shall comply with the requirements of paragraph (l)(3)(i)(B)
of this section;
(B) If the results of the initial biological monitoring tests show
the level of CdU to exceed 3 g/g Cr, the level of
2-M to exceed 300 g/g Cr, or the level of CdB to
exceed 5 g/lwb, the employer shall comply with the
requirements of paragraphs (l)(3)(ii)(A)-(C) of this section; and,
(C) If the results of the initial biological monitoring tests show
the level of CdU to be in excess of 7 g/g Cr, or the level of
CdB to be in excess of 10 g/lwb, or the level of
2-M to be in excess of 750 g/g Cr, the employer
shall: Comply with the requirements of paragraphs (l)(3)(ii)(A)-(B) of
this section; and, within 90 days after receipt of biological
monitoring results, provide a full medical examination to the employee
in accordance with the requirements of paragraph (l)(4)(ii) of this
section. After completing the medical examination, the examining
physician shall determine in a written medical opinion whether to
medically remove the employee. However, if the initial biological
monitoring results and the biological monitoring results obtained
during the medical examination both show that: CdU exceeds 7
g/g Cr; or CdB exceeds 10 g/lwb; or 2-M
exceeds 750 g/g Cr, and in addition CdU exceeds 3 g/g
Cr or CdB exceeds 5 g/liter of whole blood, then the physician
shall medically remove the employee from exposure to cadmium at or
above the action level. If the second set of biological monitoring
results obtained during the medical examination does not show that a
mandatory removal trigger level has been exceeded, then the employee is
not required to be removed by the mandatory provisions of this
paragraph. If the employee is not required to be removed by the
mandatory provisions of this paragraph or by the physician's
determination, then until the employee's CdU level falls to or below 3
g/g Cr, 2-M level falls to or below 300
g/g Cr and CdB level falls to or below 5 g/lwb, the
employer shall: periodically reassess the employee's occupational
exposure to cadmium; provide biological monitoring in accordance with
paragraph (l)(2)(ii)(B) of this section on a quarterly basis; and
provide semiannual medical examinations in accordance with paragraph
(l)(4)(ii) of this section.
(4) Periodic medical surveillance. (i) For each employee who is
covered under paragraph (l)(1)(i)(A) of this section, the employer
shall provide at least the minimum level of periodic medical
surveillance, which consists of periodic medical examinations and
periodic biological monitoring. A periodic medical examination shall be
provided within one year after the initial examination required by
paragraph (l)(2) of this section and thereafter at least biennially.
Biological sampling shall be provided at least annually, either as part
of a periodic medical examination or separately as periodic biological
monitoring.
(ii) The periodic medical examination shall include:
(A) A detailed medical and work history, or update thereof, with
emphasis on: Past, present and anticipated future exposure to cadmium;
smoking history and current status; reproductive history; current use
of medications with potential nephrotoxic side-effects; any history of
renal, cardiovascular, respiratory, hematopoietic, and/or musculo-
skeletal system dysfunction; and as part of the medical and work
history, for employees who wear respirators, questions 3-11 and 25-32
in Appendix D to this section;
(B) A complete physical examination with emphasis on: Blood
pressure, the respiratory system, and the urinary system;
(C) A 14 inch by 17 inch, or a reasonably standard sized posterior-
anterior chest X-ray (after the initial X-ray, the frequency of chest
X-rays is to be determined by the examining physician);
(D) Pulmonary function tests, including forced vital capacity (FVC)
and forced expiratory volume at 1 second (FEV1);
(E) Biological monitoring, as required in paragraph (l)(2)(ii)(B)
of this section;
(F) Blood analysis, in addition to the analysis required under
paragraph (l)(2)(ii)(B) of this section, including blood urea nitrogen,
complete blood count, and serum creatinine;
(G) Urinalysis, in addition to the analysis required under
paragraph (l)(2)(ii)(B) of this section, including the determination of
albumin, glucose, and total and low molecular weight proteins;
(H) For males over 40 years old, prostate palpation, or other at
least as effective diagnostic test(s); and
(I) Any additional tests deemed appropriate by the examining
physician.
(iii) Periodic biological monitoring shall be provided in
accordance with paragraph (l)(2)(ii)(B) of this section.
(iv) If the results of periodic biological monitoring or the
results of biological monitoring performed as part of the periodic
medical examination show the level of the employee's CdU,
2-M, or CdB to be in excess of the levels specified in
paragraphs (l)(3) (ii) or (iii); or, beginning on January 1, 1999, in
excess of the levels specified in paragraphs (l)(3) (ii) or (iv) of
this section, the employer shall take the appropriate actions specified
in paragraphs (l)(3)(ii)-(iv) of this section.
(v) For previously exposed employees under paragraph (l)(1)(i)(B)
of this section:
(A) If the employee's levels of CdU did not exceed 3 g/g
Cr, CdB did not exceed 5 g/lwb, and 2-M did not
exceed 300 g/g Cr in the initial biological monitoring tests,
and if the results of the followup biological monitoring required by
paragraph (l)(3)(i)(B) of this section one year after the initial
examination confirm the previous results, the employer may discontinue
all periodic medical surveillance for that employee.
(B) If the initial biological monitoring results for CdU, CdB, or
2-M were in excess of the levels specified in paragraph
(l)(3)(i) of this section, but subsequent biological monitoring results
required by paragraph (l)(3)(ii)-(iv) of this section show that the
employee's CdU levels no longer exceed 3 g/g Cr, CdB levels no
longer exceed 5 g/lwb, and 2-M levels no longer
exceed 300 g/g Cr, the employer shall provide biological
monitoring for CdU, CdB, and 2-M one year after these
most recent biological monitoring results. If the results of the
followup biological monitoring, specified in this paragraph, confirm
the previous results, the employer may discontinue all periodic medical
surveillance for that employee.
(C) However, if the results of the follow-up tests specified in
paragraph (l)(4)(v)(A) or (B) of this section indicate that the level
of the employee's CdU, 2-M, or CdB exceeds these same
levels, the employer is required to provide annual medical examinations
in accordance with the provisions of paragraph (l)(4)(ii) of this
section until the results of biological monitoring are consistently
below these levels or the examining physician determines in a written
medical opinion that further medical surveillance is not required to
protect the employee's health.
(vi) A routine, biennial medical examination is not required to be
provided in accordance with paragraphs (l)(3)(i) and (l)(4) of this
section if adequate medical records show that the employee has been
examined in accordance with the requirements of paragraph (l)(4)(ii) of
this section within the past 12 months. In that case, such records
shall be maintained by the employer as part of the employee's medical
record, and the next routine, periodic medical examination shall be
made available to the employee within two years of the previous
examination.
(5) Actions triggered by medical examinations. (i) If the results
of a medical examination carried out in accordance with this section
indicate any laboratory or clinical finding consistent with cadmium
toxicity that does not require employer action under paragraph (l)(2),
(3) or (4) of this section, the employer, within 30 days, shall
reassess the employee's occupational exposure to cadmium and take the
following corrective action until the physician determines they are no
longer necessary:
(A) Periodically reassess: The employee's work practices and
personal hygiene; the employee's respirator use, if any; the employee's
smoking history and status; the respiratory protection program; the
hygiene facilities; and the maintenance and effectiveness of the
relevant engineering controls;
(B) Within 30 days after the reassessment, take all reasonable
steps to correct the deficiencies found in the reassessment that may be
responsible for the employee's excess exposure to cadmium;
(C) Provide semiannual medical reexaminations to evaluate the
abnormal clinical sign(s) of cadmium toxicity until the results are
normal or the employee is medically removed; and
(D) Where the results of tests for total proteins in urine are
abnormal, provide a more detailed medical evaluation of the toxic
effects of cadmium on the employee's renal system.
(6) Examination for respirator use. (i) To determine an employee's
fitness for respirator use, the employer shall provide a medical
examination that includes the elements specified in paragraph (l)(6)(i)
(A)-(D) of this section. This examination shall be provided prior to
the employee's being assigned to a job that requires the use of a
respirator or no later than 90 days after this section goes into
effect, whichever date is later, to any employee without a medical
examination within the preceding 12 months that satisfies the
requirements of this paragraph.
(A) A detailed medical and work history, or update thereof, with
emphasis on: Past exposure to cadmium; smoking history and current
status; any history of renal, cardiovascular, respiratory,
hematopoietic, and/or musculoskeletal system dysfunction; a description
of the job for which the respirator is required; and questions 3-11 and
25-32 in appendix D to this section;
(B) A blood pressure test;
(C) Biological monitoring of the employee's levels of CdU, CdB and
2-M in accordance with the requirements of paragraph
(l)(2)(ii)(B) of this section, unless such results already have been
obtained within the previous 12 months; and
(D) Any other test or procedure that the examining physician deems
appropriate.
(ii) After reviewing all the information obtained from the medical
examination required in paragraph (l)(6)(i) of this section, the
physician shall determine whether the employee is fit to wear a
respirator.
(iii) Whenever an employee has exhibited difficulty in breathing
during a respirator fit test or during use of a respirator, the
employer, as soon as possible, shall provide the employee with a
periodic medical examination in accordance with paragraph (l)(4)(ii) of
this section to determine the employee's fitness to wear a respirator.
(iv) Where the results of the examination required under paragraph
(l)(6)(i), (ii), or (iii) of this section are abnormal, medical
limitation or prohibition of respirator use shall be considered. If the
employee is allowed to wear a respirator, the employee's ability to
continue to do so shall be periodically evaluated by a physician.
(7) Emergency examinations. (i) In addition to the medical
surveillance required in paragraphs (l)(2)-(6) of this section, the
employer shall provide a medical examination as soon as possible to any
employee who may have been acutely exposed to cadmium because of an
emergency.
(ii) The examination shall include the requirements of paragraph
(l)(4)(ii) of this section, with emphasis on the respiratory system,
other organ systems considered appropriate by the examining physician,
and symptoms of acute overexposure, as identified in paragraphs II
(B)(1)-(2) and IV of appendix A to this section.
(8) Termination of employment examination. (i) At termination of
employment, the employer shall provide a medical examination in
accordance with paragraph (l)(4)(ii) of this section, including a chest
X-ray, to any employee to whom at any prior time the employer was
required to provide medical surveillance under paragraphs (l)(1)(i) or
(l)(7) of this section. However, if the last examination satisfied the
requirements of paragraph (l)(4)(ii) of this section and was less than
six months prior to the date of termination, no further examination is
required unless otherwise specified in paragraphs (l)(3) or (l)(5) of
this section;
(ii) However, for employees covered by paragraph (l)(1)(i)(B) of
this section, if the employer has discontinued all periodic medical
surveillance under paragraph (l)(4)(v) of this section, no termination
of employment medical examination is required.
(9) Information provided to the physician. The employer shall
provide the following information to the examining physician:
(i) A copy of this standard and appendices;
(ii) A description of the affected employee's former, current, and
anticipated duties as they relate to the employee's occupational
exposure to cadmium;
(iii) The employee's former, current, and anticipated future levels
of occupational exposure to cadmium;
(iv) A description of any personal protective equipment, including
respirators, used or to be used by the employee, including when and for
how long the employee has used that equipment; and
(v) relevant results of previous biological monitoring and medical
examinations.
(10) Physician's written medical opinion. (i) The employer shall
promptly obtain a written, signed medical opinion from the examining
physician for each medical examination performed on each employee. This
written opinion shall contain:
(A) The physician's diagnosis for the employee;
(B) The physician's opinion as to whether the employee has any
detected medical condition(s) that would place the employee at
increased risk of material impairment to health from further exposure
to cadmium, including any indications of potential cadmium toxicity;
(C) The results of any biological or other testing or related
evaluations that directly assess the employee's absorption of cadmium;
(D) Any recommended removal from, or limitation on the activities
or duties of the employee or on the employee's use of personal
protective equipment, such as respirators;
(E) A statement that the physician has clearly and carefully
explained to the employee the results of the medical examination,
including all biological monitoring results and any medical conditions
related to cadmium exposure that require further evaluation or
treatment, and any limitation on the employee's diet or use of
medications.
(ii) The employer promptly shall obtain a copy of the results of
any biological monitoring provided by an employer to an employee
independently of a medical examination under paragraphs (l)(2) and
(l)(4) of this section, and, in lieu of a written medical opinion, an
explanation sheet explaining those results.
(iii) The employer shall instruct the physician not to reveal
orally or in the written medical opinion given to the employer specific
findings or diagnoses unrelated to occupational exposure to cadmium.
(11) Medical Removal Protection (MRP)--(i) General. (A) The
employer shall temporarily remove an employee from work where there is
excess exposure to cadmium on each occasion that medical removal is
required under paragraph (l)(3), (l)(4), or (l)(6) of this section and
on each occasion that a physician determines in a written medical
opinion that the employee should be removed from such exposure. The
physician's determination may be based on biological monitoring
results, inability to wear a respirator, evidence of illness, other
signs or symptoms of cadmium-related dysfunction or disease, or any
other reason deemed medically sufficient by the physician.
(B) The employer shall medically remove an employee in accordance
with paragraph (l)(11) of this section regardless of whether at the
time of removal a job is available into which the removed employee may
be transferred.
(C) Whenever an employee is medically removed under paragraph
(l)(11) of this section, the employer shall transfer the removed
employee to a job where the exposure to cadmium is within the
permissible levels specified in that paragraph as soon as one becomes
available.
(D) For any employee who is medically removed under the provisions
of paragraph (l)(11)(i) of this section, the employer shall provide
follow-up biological monitoring in accordance with (l)(2)(ii)(B) of
this section at least every three months and follow-up medical
examinations semi-annually at least every six months until in a written
medical opinion the examining physician determines that either the
employee may be returned to his/her former job status as specified
under paragraph (l)(11)(iv)-(v) of this section or the employee must be
permanently removed from excess cadmium exposure.
(E) The employer may not return an employee who has been medically
removed for any reason to his/her former job status until a physician
determines in a written medical opinion that continued medical removal
is no longer necessary to protect the employee's health.
(ii) Where an employee is found unfit to wear a respirator under
paragraph (l)(6)(ii) of this section, the employer shall remove the
employee from work where exposure to cadmium is above the PEL.
(iii) Where removal is based on any reason other than the
employee's inability to wear a respirator, the employer shall remove
the employee from work where exposure to cadmium is at or above the
action level.
(iv) Except as specified in paragraph (l)(11)(v) of this section,
no employee who was removed because his/her level of CdU, CdB and/or
2-M exceeded the medical removal trigger levels in
paragraph (l)(3) or (l)(4) of this section may be returned to work with
exposure to cadmium at or above the action level until the employee's
levels of CdU fall to or below 3 g/g Cr, CdB falls to or below
5 g/lwb, and 2-M falls to or below 300
g/g Cr.
(v) However, when in the examining physician's opinion continued
exposure to cadmium will not pose an increased risk to the employee's
health and there are special circumstances that make continued medical
removal an inappropriate remedy, the physician shall fully discuss
these matters with the employee, and then in a written determination
may return a worker to his/her former job status despite what would
otherwise be unacceptably high biological monitoring results.
Thereafter, the returned employee shall continue to be provided with
medical surveillance as if he/she were still on medical removal until
the employee's levels of CdU fall to or below 3 g/g Cr, CdB
falls to or below 5 g/lwb, and 2-M falls to or
below 300 g/g Cr.
(vi) Where an employer, although not required by paragraph
(l)(11)(i)-(iii) of this section to do so, removes an employee from
exposure to cadmium or otherwise places limitations on an employee due
to the effects of cadmium exposure on the employee's medical condition,
the employer shall provide the same medical removal protection benefits
to that employee under paragraph (l)(12) of this section as would have
been provided had the removal been required under paragraph (l)(11)(i)-
(iii) of this section.
(12) Medical Removal Protection Benefits (MRPB). (i) The employer
shall provide MRPB for up to a maximum of 18 months to an employee each
time and while the employee is temporarily medically removed under
paragraph (l)(11) of this section.
(ii) For purposes of this section, the requirement that the
employer provide MRPB means that the employer shall maintain the total
normal earnings, seniority, and all other employee rights and benefits
of the removed employee, including the employee's right to his/her
former job status, as if the employee had not been removed from the
employee's job or otherwise medically limited.
(iii) Where, after 18 months on medical removal because of elevated
biological monitoring results, the employee's monitoring results have
not declined to a low enough level to permit the employee to be
returned to his/her former job status:
(A) The employer shall make available to the employee a medical
examination pursuant to this section in order to obtain a final medical
determination as to whether the employee may be returned to his/her
former job status or must be permanently removed from excess cadmium
exposure; and
(B) The employer shall assure that the final medical determination
indicates whether the employee may be returned to his/her former job
status and what steps, if any, should be taken to protect the
employee's health.
(iv) The employer may condition the provision of MRPB upon the
employee's participation in medical surveillance provided in accordance
with this section.
(13) Multiple physician review. (i) If the employer selects the
initial physician to conduct any medical examination or consultation
provided to an employee under this section, the employee may designate
a second physician to:
(A) Review any findings, de
FR Doc. 93-31820 Occupational Safety and Health Standards for Cadmium in Shipyard Employment and Construction
terminations, or recommendations of the
initial physician; and
(B) Conduct such examinations, consultations, and laboratory tests
as the second physician deems necessary to facilitate this review.
(ii) The employer shall promptly notify an employee of the right to
seek a second medical opinion after each occasion that an initial
physician provided by the employer conducts a medical examination or
consultation pursuant to this section. The employer may condition its
participation in, and payment for, multiple physician review upon the
employee doing the following within fifteen (15) days after receipt of
this notice, or receipt of the initial physician's written opinion,
whichever is later:
(A) Informing the employer that he or she intends to seek a medical
opinion; and
(B) Initiating steps to make an appointment with a second
physician.
(iii) If the findings, determinations, or recommendations of the
second physician differ from those of the initial physician, then the
employer and the employee shall assure that efforts are made for the
two physicians to resolve any disagreement.
(iv) If the two physicians have been unable to quickly resolve
their disagreement, then the employer and the employee, through their
respective physicians, shall designate a third physician to:
(A) Review any findings, determinations, or recommendations of the
other two physicians; and
(B) Conduct such examinations, consultations, laboratory tests, and
discussions with the other two physicians as the third physician deems
necessary to resolve the disagreement among them.
(v) The employer shall act consistently with the findings,
determinations, and recommendations of the third physician, unless the
employer and the employee reach an agreement that is consistent with
the recommendations of at least one of the other two physicians.
(14) Alternate physician determination. The employer and an
employee or designated employee representative may agree upon the use
of any alternate form of physician determination in lieu of the
multiple physician review provided by paragraph (l)(13) of this
section, so long as the alternative is expeditious and at least as
protective of the employee.
(15) Information the employer must provide the employee. (i) The
employer shall provide a copy of the physician's written medical
opinion to the examined employee within two weeks after receipt
thereof.
(ii) The employer shall provide the employee with a copy of the
employee's biological monitoring results and an explanation sheet
explaining the results within two weeks after receipt thereof.
(iii) Within 30 days after a request by an employee, the employer
shall provide the employee with the information the employer is
required to provide the examining physician under paragraph (l)(9) of
this section.
(16) Reporting. In addition to other medical events that are
required to be reported on the OSHA Form No. 200, the employer shall
report any abnormal condition or disorder caused by occupational
exposure to cadmium associated with employment as specified in Chapter
(V)(E) of the Reporting Guidelines for Occupational Injuries and
Illnesses.
(m) Communication of cadmium hazards to employees--(1) General. In
communications concerning cadmium hazards, employers shall comply with
the requirements of OSHA's Hazard Communication Standard, 29 CFR
1910.1200, including but not limited to the requirements concerning
warning signs and labels, material safety data sheets (MSDS), and
employee information and training. In addition, employers shall comply
with the following requirements:
(2) Warning signs. (i) Warning signs shall be provided and
displayed in regulated areas. In addition, warning signs shall be
posted at all approaches to regulated areas so that an employee may
read the signs and take necessary protective steps before entering the
area.
(ii) Warning signs required by paragraph (m)(2)(i) of this section
shall bear the following information:
DANGER
CADMIUM
CANCER HAZARD
CAN CAUSE LUNG AND KIDNEY DISEASE
AUTHORIZED PERSONNEL ONLY
RESPIRATORS REQUIRED IN THIS AREA
(iii) The employer shall assure that signs required by this
paragraph are illuminated, cleaned, and maintained as necessary so that
the legend is readily visible.
(3) Warning labels. (i) Shipping and storage containers containing
cadmium, cadmium compounds, or cadmium contaminated clothing,
equipment, waste, scrap, or debris shall bear appropriate warning
labels, as specified in paragraph (m)(3)(ii) of this section.
(ii) The warning labels shall include at least the following
information:
DANGER
CONTAINS CADMIUM
CANCER HAZARD
AVOID CREATING DUST
CAN CAUSE LUNG AND KIDNEY DISEASE
(iii) Where feasible, installed cadmium products shall have a
visible label or other indication that cadmium is present.
(4) Employee information and training. (i) The employer shall
institute a training program for all employees who are potentially
exposed to cadmium, assure employee participation in the program, and
maintain a record of the contents of such program.
(ii) Training shall be provided prior to or at the time of initial
assignment to a job involving potential exposure to cadmium and at
least annually thereafter.
(iii) The employer shall make the training program understandable
to the employee and shall assure that each employee is informed of the
following:
(A) The health hazards associated with cadmium exposure, with
special attention to the information incorporated in appendix A to this
section;
(B) The quantity, location, manner of use, release, and storage of
cadmium in the workplace and the specific nature of operations that
could result in exposure to cadmium, especially exposures above the
PEL;
(C) The engineering controls and work practices associated with the
employee's job assignment;
(D) The measures employees can take to protect themselves from
exposure to cadmium, including modification of such habits as smoking
and personal hygiene, and specific procedures the employer has
implemented to protect employees from exposure to cadmium such as
appropriate work practices, emergency procedures, and the provision of
personal protective equipment;
(E) The purpose, proper selection, fitting, proper use, and
limitations of respirators and protective clothing;
(F) The purpose and a description of the medical surveillance
program required by paragraph (l) of this section;
(G) The contents of this section and its appendices; and
(H) The employee's rights of access to records under Sec. 1915.1120
(e) and (g).
(iv) Additional access to information and training program and
materials.
(A) The employer shall make a copy of this section and its
appendices readily available without cost to all affected employees and
shall provide a copy if requested.
(B) The employer shall provide to the Assistant Secretary or the
Director, upon request, all materials relating to the employee
information and the training program.
(n) Recordkeeping--(1) Exposure monitoring. (i) The employer shall
establish and keep an accurate record of all air monitoring for cadmium
in the workplace.
(ii) This record shall include at least the following information:
(A) The monitoring date, duration, and results in terms of an 8-
hour TWA of each sample taken;
(B) The name, social security number, and job classification of the
employees monitored and of all other employees whose exposures the
monitoring is intended to represent;
(C) A description of the sampling and analytical methods used and
evidence of their accuracy;
(D) The type of respiratory protective device, if any, worn by the
monitored employee;
(E) A notation of any other conditions that might have affected the
monitoring results.
(iii) The employer shall maintain this record for at least thirty
(30) years, in accordance with Sec. 1915.1120 of this part.
(2) Objective data for exemption from requirement for initial
monitoring. (i) For purposes of this section, objective data are
information demonstrating that a particular product or material
containing cadmium or a specific process, operation, or activity
involving cadmium cannot release dust or fumes in concentrations at or
above the action level even under the worst-case release conditions.
Objective data can be obtained from an industry-wide study or from
laboratory product test results from manufacturers of cadmium-
containing products or materials. The data the employer uses from an
industry-wide survey must be obtained under workplace conditions
closely resembling the processes, types of material, control methods,
work practices and environmental conditions in the employer's current
operations.
(ii) The employer shall establish and maintain a record of the
objective data for at least 30 years.
(3) Medical surveillance. (i) The employer shall establish and
maintain an accurate record for each employee covered by medical
surveillance under paragraph (l)(1)(i) of this section.
(ii) The record shall include at least the following information
about the employee:
(A) Name, social security number, and description of the duties;
(B) A copy of the physician's written opinions and an explanation
sheet for biological monitoring results;
(C) A copy of the medical history, and the results of any physical
examination and all test results that are required to be provided by
this section, including biological tests, X-rays, pulmonary function
tests, etc., or that have been obtained to further evaluate any
condition that might be related to cadmium exposure;
(D) The employee's medical symptoms that might be related to
exposure to cadmium; and
(E) A copy of the information provided to the physician as required
by paragraph (l)(9)(ii)-(v) of this section.
(iii) The employer shall assure that this record is maintained for
the duration of employment plus thirty (30) years, in accordance with
Sec. 1915.1120 of this part.
(4) Training. The employer shall certify that employees have been
trained by preparing a certification record which includes the identity
of the person trained, the signature of the employer or the person who
conducted the training, and the date the training was completed. The
certification records shall be prepared at the completion of training
and shall be maintained on file for one (1) year beyond the date of
training of that employee.
(5) Availability. (i) Except as otherwise provided for in this
section, access to all records required to be maintained by paragraphs
(n)(1)-(4) of this section shall be in accordance with the provisions
of Sec. 1915.1120 of this part.
(ii) Within 15 days after a request, the employer shall make an
employee's medical records required to be kept by paragraph (n)(3) of
this section available for examination and copying to the subject
employee, to designated representatives, to anyone having the specific
written consent of the subject employee, and after the employee's death
or incapacitation, to the employee's family members.
(6) Transfer of records. Whenever an employer ceases to do business
and there is no successor employer to receive and retain records for
the prescribed period or the employer intends to dispose of any records
required to be preserved for at least 30 years, the employer shall
comply with the requirements concerning transfer of records set forth
in Sec. 1915.1120(h) of this part.
(o) Observation of monitoring--(1) Employee observation. The
employer shall provide affected employees or their designated
representatives an opportunity to observe any monitoring of employee
exposure to cadmium.
(2) Observation procedures. When observation of monitoring requires
entry into an area where the use of protective clothing or equipment is
required, the employer shall provide the observer with that clothing
and equipment and shall assure that the observer uses such clothing and
equipment and complies with all other applicable safety and health
procedures.
(p) Dates--(1) Effective date. This section shall become effective
December 14, 1992.
(2) Start-up dates. All obligations of this section commence on the
effective date except as follows:
(i) Exposure monitoring. Except for small businesses (nineteen (19)
or fewer employees), initial monitoring required by paragraph (d)(2) of
this section shall be completed as soon as possible and in any event no
later than February 12, 1993. For small businesses, initial monitoring
required by paragraph (d)(2) of this section shall be completed as soon
as possible and in any event no later than April 14, 1993.
(ii) Regulated areas. Except for small business, defined under
paragraph (p)(2)(i) of this section, regulated areas required to be
established by paragraph (e) of this section shall be set up as soon as
possible after the results of exposure monitoring are known and in any
event no later than March 15, 1993. For small businesses, regulated
areas required to be established by paragraph (e) of this section shall
be set up as soon as possible after the results of exposure monitoring
are known and in any event no later than May 14, 1993.
(iii) Respiratory protection. Except for small businesses, defined
under paragraph (p)(2)(i) of this section, respiratory protection
required by paragraph (g) of this section shall be provided as soon as
possible and in any event no later than 90 days after the effective
date of this section. For small businesses, respiratory protection
required by paragraph (g) of this section shall be provided as soon as
possible and in any event no later than March 15, 1993.
(iv) Compliance program. Written compliance programs required by
paragraph (f)(2) of this section shall be completed and available for
inspection and copying as soon as possible and in any event no later
than December 14, 1993.
(v) Methods of compliance. The engineering controls required by
paragraph (f)(1) of this section shall be implemented as soon as
possible and in any event no later than December 14, 1994. Work
practice controls shall be implemented as soon as possible. Work
practice controls that are directly related to engineering controls to
be implemented in accordance with the compliance plan shall be
implemented as soon as possible after such engineering controls are
implemented.
(vi) Hygiene and lunchroom facilities. (A) Handwashing facilities,
permanent or temporary, shall be provided in accordance with 29 CFR
1910.141 (d)(1) and (2) as soon as possible and in any event no later
than February 12, 1993.
(B) Change rooms, showers, and lunchroom facilities shall be
completed as soon as possible and in any event no later than December
14, 1993.
(vii) Employee information and training. Except for small
businesses, defined under paragraph (p)(2)(i) of this section, employee
information and training required by paragraph (m)(4) of this section
shall be provided as soon as possible and in any event no later than
March 15, 1993. For small businesses, employee information and training
required by paragraph (m)(4) of this standard shall be provided as soon
as possible and in any event no later than June 14, 1993.
(viii) Medical surveillance. Except for small businesses, defined
under paragraph (p)(2)(i) of this section, initial medical examinations
required by paragraph (l) of this section shall be provided as soon as
possible and in any event no later than March 15, 1993. For small
businesses, initial medical examinations required by paragraph (l) of
this section shall be provided as soon as possible and in any event no
later than June 14, 1993.
(q) Appendices. (1) Appendix C to this section is incorporated as
part of this section, and compliance with its contents is mandatory.
(2) Except where portions of appendices A, B, D, E, and F to this
section are expressly incorporated in requirements of this section,
these appendices are purely informational and are not intended to
create any additional obligations not otherwise imposed or to detract
from any existing obligations.
Appendix A to Sec. 1915.1027--Substance Safety Data Sheet
Cadmium
I. Substance Identification
A. Substance: Cadmium.
B. 8-Hour, Time-weighted-average, Permissible Exposure Limit
(TWA PEL):
1. TWA PEL: Five micrograms of cadmium per cubic meter of air 5
g/m3, time-weighted average (TWA) for an 8-hour
workday.
C. Appearance: Cadmium metal--soft, blue-white, malleable,
lustrous metal or grayish-white powder. Some cadmium compounds may
also appear as a brown, yellow, or red powdery substance.
II. Health Hazard Data
A. Routes of Exposure. Cadmium can cause local skin or eye
irritation. Cadmium can affect your health if you inhale it or if
you swallow it.
B. Effects of Overexposure.
1. Short-term (acute) exposure: Cadmium is much more dangerous
by inhalation than by ingestion. High exposures to cadmium that may
be immediately dangerous to life or health occur in jobs where
workers handle large quantities of cadmium dust or fume; heat
cadmium-containing compounds or cadmium-coated surfaces; weld with
cadmium solders or cut cadmium-containing materials such as bolts.
2. Severe exposure may occur before symptoms appear. Early
symptoms may include mild irritation of the upper respiratory tract,
a sensation of constriction of the throat, a metallic taste and/or a
cough. A period of 1-10 hours may precede the onset of rapidly
progressing shortness of breath, chest pain, and flu-like symptoms
with weakness, fever, headache, chills, sweating and muscular pain.
Acute pulmonary edema usually develops within 24 hours and reaches a
maximum by three days. If death from asphyxia does not occur,
symptoms may resolve within a week.
3. Long-term (chronic) exposure. Repeated or long-term exposure
to cadmium, even at relatively low concentrations, may result in
kidney damage and an increased risk of cancer of the lung and of the
prostate.
C. Emergency First Aid Procedures.
1. Eye exposure: Direct contact may cause redness or pain. Wash
eyes immediately with large amounts of water, lifting the upper and
lower eyelids. Get medical attention immediately.
2. Skin exposure: Direct contact may result in irritation.
Remove contaminated clothing and shoes immediately. Wash affected
area with soap or mild detergent and large amounts of water. Get
medical attention immediately.
3. Ingestion: Ingestion may result in vomiting, abdominal pain,
nausea, diarrhea, headache and sore throat. Treatment for symptoms
must be administered by medical personnel. Under no circumstances
should the employer allow any person whom he retains, employs,
supervises or controls to engage in therapeutic chelation. Such
treatment is likely to translocate cadmium from pulmonary or other
tissue to renal tissue. Get medical attention immediately.
4. Inhalation: If large amounts of cadmium are inhaled, the
exposed person must be moved to fresh air at once. If breathing has
stopped, perform cardiopulmonary resuscitation. Administer oxygen if
available. Keep the affected person warm and at rest. Get medical
attention immediately.
5. Rescue: Move the affected person from the hazardous exposure.
If the exposed person has been overcome, attempt rescue only after
notifying at least one other person of the emergency and putting
into effect established emergency procedures. Do not become a
casualty yourself. Understand your emergency rescue procedures and
know the location of the emergency equipment before the need arises.
III. Employee Information
A. Protective Clothing and Equipment.
1. Respirators: You may be required to wear a respirator for
non-routine activities; in emergencies; while your employer is in
the process of reducing cadmium exposures through engineering
controls; and where engineering controls are not feasible. If
respirators are worn in the future, they must have a joint Mine
Safety and Health Administration (MSHA) and National Institute for
Occupational Safety and Health (NIOSH) label of approval. Cadmium
does not have a detectable odor except at levels well above the
permissible exposure limits. If you can smell cadmium while wearing
a respirator, proceed immediately to fresh air. If you experience
difficulty breathing while wearing a respirator, tell your employer.
2. Protective Clothing: You may be required to wear impermeable
clothing, gloves, foot gear, a face shield, or other appropriate
protective clothing to prevent skin contact with cadmium. Where
protective clothing is required, your employer must provide clean
garments to you as necessary to assure that the clothing protects
you adequately. The employer must replace or repair protective
clothing that has become torn or otherwise damaged.
3. Eye Protection: You may be required to wear splash-proof or
dust resistant goggles to prevent eye contact with cadmium.
B. Employer Requirements.
1. Medical: If you are exposed to cadmium at or above the action
level, your employer is required to provide a medical examination,
laboratory tests and a medical history according to the medical
surveillance provisions under paragraph (1) of this standard. (See
summary chart and tables in this appendix A.) These tests shall be
provided without cost to you. In addition, if you are accidentally
exposed to cadmium under conditions known or suspected to constitute
toxic exposure to cadmium, your employer is required to make special
tests available to you.
2. Access to Records: All medical records are kept strictly
confidential. You or your representative are entitled to see the
records of measurements of your exposure to cadmium. Your medical
examination records can be furnished to your personal physician or
designated representative upon request by you to your employer.
3. Observation of Monitoring: Your employer is required to
perform measurements that are representative of your exposure to
cadmium and you or your designated representative are entitled to
observe the monitoring procedure. You are entitled to observe the
steps taken in the measurement procedure, and to record the results
obtained. When the monitoring procedure is taking place in an area
where respirators or personal protective clothing and equipment are
required to be worn, you or your representative must also be
provided with, and must wear the protective clothing and equipment.
C. Employee Requirements.--You will not be able to smoke, eat,
drink, chew gum or tobacco, or apply cosmetics while working with
cadmium in regulated areas. You will also not be able to carry or
store tobacco products, gum, food, drinks or cosmetics in regulated
areas because these products easily become contaminated with cadmium
from the workplace and can therefore create another source of
unnecessary cadmium exposure.
Some workers will have to change out of work clothes and shower
at the end of the day, as part of their workday, in order to wash
cadmium from skin and hair. Handwashing and cadmium-free eating
facilities shall be provided by the employer and proper hygiene
should always be performed before eating. It is also recommended
that you do not smoke or use tobacco products, because among other
things, they naturally contain cadmium. For further information,
read the labeling on such products.
IV. Physician Information
A. Introduction.--The medical surveillance provisions of
paragraph (1) generally are aimed at accomplishing three main
interrelated purposes: First, identifying employees at higher risk
of adverse health effects from excess, chronic exposure to cadmium;
second, preventing cadmium-induced disease; and third, detecting and
minimizing existing cadmium-induced disease. The core of medical
surveillance in this standard is the early and periodic monitoring
of the employee's biological indicators of: (a) Recent exposure to
cadmium; (b) cadmium body burden; and (c) potential and actual
kidney damage associated with exposure to cadmium.
The main adverse health effects associated with cadmium
overexposure are lung cancer and kidney dysfunction. It is not yet
known how to adequately biologically monitor human beings to
specifically prevent cadmium-induced lung cancer. By contrast, the
kidney can be monitored to provide prevention and early detection of
cadmium-induced kidney damage. Since, for non-carcinogenic effects,
the kidney is considered the primary target organ of chronic
exposure to cadmium, the medical surveillance provisions of this
standard effectively focus on cadmium-induced kidney disease. Within
that focus, the aim, where possible, is to prevent the onset of such
disease and, where necessary, to minimize such disease as may
already exist. The by-products of successful prevention of kidney
disease are anticipated to be the reduction and prevention of other
cadmium-induced diseases.
B. Health Effects.--The major health effects associated with
cadmium overexposure are described below.
1. Kidney: The most prevalent non-malignant disease observed
among workers chronically exposed to cadmium is kidney dysfunction.
Initially, such dysfunction is manifested as proteinuria. The
proteinuria associated with cadmium exposure is most commonly
characterized by excretion of low-molecular weight proteins (15,000
to 40,000 MW) accompanied by loss of electrolytes, uric acid,
calcium, amino acids, and phosphate. The compounds commonly excreted
include: beta-2-microglobulin (2-M), retinol binding
protein (RBP), immunoglobulin light chains, and lysozyme. Excretion
of low molecular weight proteins are characteristic of damage to the
proximal tubules of the kidney (Iwao et al., 1980).
It has also been observed that exposure to cadmium may lead to
urinary excretion of high-molecular weight proteins such as albumin,
immunoglobulin G, and glycoproteins (Ex. 29). Excretion of high-
molecular weight proteins is typically indicative of damage to the
glomeruli of the kidney. Bernard et al., (1979) suggest that damage
to the glomeruli and damage to the proximal tubules of the kidney
may both be linked to cadmium exposure but they may occur
independently of each other.
Several studies indicate that the onset of low-molecular weight
proteinuria is a sign of irreversible kidney damage (Friberg et al.,
1974; Roels et al., 1982; Piscator 1984; Elinder et al., 1985; Smith
et al., 1986). Above specific levels of 2-M associated
with cadmium exposure it is unlikely that 2-M levels
return to normal even when cadmium exposure is eliminated by removal
of the individual from the cadmium work environment (Friberg, Ex.
29, 1990).
Some studies indicate that such proteinuria may be progressive;
levels of 2-M observed in the urine increase with time
even after cadmium exposure has ceased. See, for example, Elinder et
al., 1985. Such observations, however, are not universal, and it has
been suggested that studies in which proteinuria has not been
observed to progress may not have tracked patients for a
sufficiently long time interval (Jarup, Ex. 8-661).
When cadmium exposure continues after the onset of proteinuria,
chronic nephrotoxicity may occur (Friberg, Ex. 29). Uremia results
from the inability of the glomerulus to adequately filter blood.
This leads to severe disturbance of electrolyte concentrations and
may lead to various clinical complications including kidney stones
(L-140-50).
After prolonged exposure to cadmium, glomerular proteinuria,
glucosuria, aminoaciduria, phosphaturia, and hypercalciuria may
develop (Exs. 8-86, 4-28, 14-18). Phosphate, calcium, glucose, and
amino acids are essential to life, and under normal conditions,
their excretion should be regulated by the kidney. Once low
molecular weight proteinuria has developed, these elements dissipate
from the human body. Loss of glomerular function may also occur,
manifested by decreased glomerular filtration rate and increased
serum creatinine. Severe cadmium-induced renal damage may eventually
develop into chronic renal failure and uremia (Ex. 55).
Studies in which animals are chronically exposed to cadmium
confirm the renal effects observed in humans (Friberg et al., 1986).
Animal studies also confirm problems with calcium metabolism and
related skeletal effects which have been observed among humans
exposed to cadmium in addition to the renal effects. Other effects
commonly reported in chronic animal studies include anemia, changes
in liver morphology, immunosuppression and hypertension. Some of
these effects may be associated with co-factors. Hypertension, for
example, appears to be associated with diet as well as cadmium
exposure. Animals injected with cadmium have also shown testicular
necrosis (Ex. 8-86B).
2. Biological Markers
It is universally recognized that the best measures of cadmium
exposures and its effects are measurements of cadmium in biological
fluids, especially urine and blood. Of the two, CdU is
conventionally used to determine body burden of cadmium in workers
without kidney disease. CdB is conventionally used to monitor for
recent exposure to cadmium. In addition, levels of CdU and CdB
historically have been used to predict the percent of the population
likely to develop kidney disease (Thun et al., Ex. L-140-50; WHO,
Ex. 8-674; ACGIH, Exs. 8-667, 140-50).
The third biological parameter upon which OSHA relies for
medical surveillance is Beta-2-microglobulin in urine
(2-M), a low molecular weight protein. Excess
2-M has been widely accepted by physicians and
scientists as a reliable indicator of functional damage to the
proximal tubule of the kidney (Exs. 8-447, 144-3-C, 4-47, L-140-45,
19-43-A).
Excess 2-M is found when the proximal tubules can
no longer reabsorb this protein in a normal manner. This failure of
the proximal tubules is an early stage of a kind of kidney disease
that commonly occurs among workers with excessive cadmium exposure.
Used in conjunction with biological test results indicating abnormal
levels of CdU and CdB, the finding of excess 2-M can
establish for an examining physician that any existing kidney
disease is probably cadmium-related (Trs. 6/6/90, pp. 82-86, 122,
134). The upper limits of normal levels for cadmium in urine and
cadmium in blood are 3 g Cd/gram creatinine in urine and 5
gCd/liter whole blood, respectively. These levels were
derived from broad-based population studies.
Three issues confront the physicians in the use of
2-M as a marker of kidney dysfunction and material
impairment. First, there are a few other causes of elevated levels
of 2-M not related to cadmium exposures, some of which
may be rather common diseases and some of which are serious diseases
(e.g., myeloma or transient flu, Exs. 29 and 8-086). These can be
medically evaluated as alternative causes (Friberg, Ex. 29). Also,
there are other factors that can cause 2-M to degrade
so that low levels would result in workers with tubular dysfunction.
For example, regarding the degradation of 2-M, workers
with acidic urine (pH<6) might have 2-M levels that
are within the ``normal'' range when in fact kidney dysfunction has
occurred (Ex. L-140-1) and the low molecular weight proteins are
degraded in acid urine. Thus, it is very important that the pH of
urine be measured, that urine samples be buffered as necessary (See
appendix F.), and that urine samples be handled correctly, i.e.,
measure the pH of freshly voided urine samples, then if necessary,
buffer to pH>6 (or above for shipping purposes), measure pH again
and then, perhaps, freeze the sample for storage and shipping. (See
also appendix F.) Second, there is debate over the pathological
significance of proteinuria, however, most world experts believe
that 2-M levels greater than 300 g/g Cr are
abnormal (Elinder, Ex. 55, Friberg, Ex. 29). Such levels signify
kidney dysfunction that constitutes material impairment of health.
Finally, detection of 2-M at low levels has often been
considered difficult, however, many laboratories have the capability
of detecting excess 2-M using simple kits, such as the
Phadebas Delphia test, that are accurate to levels of 100 g
2-M/g Cr U (Ex. L-140-1).
Specific recommendations for ways to measure 2-M
and proper handling of urine samples to prevent degradation of
2-M have been addressed by OSHA in appendix F, in the
section on laboratory standardization. All biological samples must
be analyzed in a laboratory that is proficient in the analysis of
that particular analyte, under paragraph (l)(1)(iv). (See appendix
F). Specifically, under paragraph (l)(1)(iv), the employer is to
assure that the collecting and handling of biological samples of
cadmium in urine (CdU), cadmium in blood (CdB), and beta-2
microglobulin in urine (2-M) taken from employees is
collected in a manner that assures reliability. The employer must
also assure that analysis of biological samples of cadmium in urine
(CdU), cadmium in blood (CdB), and beta-2 microglobulin in urine
(2-M) taken from employees is performed in
laboratories with demonstrated proficiency for that particular
analyte. (See appendix F.)
3. Lung and Prostate Cancer
The primary sites for cadmium-associated cancer appear to be the
lung and the prostate (L-140-50). Evidence for an association
between cancer and cadmium exposure derives from both
epidemiological studies and animal experiments. Mortality from
prostate cancer associated with cadmium is slightly elevated in
several industrial cohorts, but the number of cases is small and
there is not clear dose-response relationship. More substantive
evidence exists for lung cancer.
The major epidemiological study of lung cancer was conducted by
Thun et al., (Ex. 4-68). Adequate data on cadmium exposures were
available to allow evaluation of dose-response relationships between
cadmium exposure and lung cancer. A statistically significant excess
of lung cancer attributed to cadmium exposure was observed in this
study even when confounding variables such as co-exposure to arsenic
and smoking habits were taken into consideration (Ex. L-140-50).
The primary evidence for quantifying a link between lung cancer
and cadmium exposure from animal studies derives from two rat
bioassay studies; one by Takenaka et al., (1983), which is a study
of cadmium chloride and a second study by Oldiges and Glaser (1990)
of four cadmium compounds.
Based on the above cited studies, the U.S. Environmental
Protection Agency (EPA) classified cadmium as ``B1'', a probable
human carcinogen, in 1985 (Ex. 4-4). The International Agency for
Research on Cancer (IARC) in 1987 also recommended that cadmium be
listed as ``2A'', a probable human carcinogen (Ex. 4-15). The
American Conference of Governmental Industrial Hygienists (ACGIH)
has recently recommended that cadmium be labeled as a carcinogen.
Since 1984, NIOSH has concluded that cadmium is possibly a human
carcinogen and has recommended that exposures be controlled to the
lowest level feasible.
4. Non-carcinogenic Effects
Acute pneumonitis occurs 10 to 24 hours after initial acute
inhalation of high levels of cadmium fumes with symptoms such as
fever and chest pain (Exs. 30, 8-86B). In extreme exposure cases
pulmonary edema may develop and cause death several days after
exposure. Little actual exposure measurement data is available on
the level of airborne cadmium exposure that causes such immediate
adverse lung effects, nonetheless, it is reasonable to believe a
cadmium concentration of approximately 1 mg/m3 over an eight
hour period is ``immediately dangerous'' (55 FR 4052, ANSI; Ex. 8-
86B).
In addition to acute lung effects and chronic renal effects,
long term exposure to cadmium may cause other severe effects on the
respiratory system. Reduced pulmonary function and chronic lung
disease indicative of emphysema have been observed in workers who
have had prolonged exposure to cadmium dust or fumes (Exs. 4-29, 4-
22, 4-42, 4-50, 4-63). In a study of workers conducted by Kazantzis
et al., a statistically significant excess of worker deaths due to
chronic bronchitis was found, which in his opinion was directly
related to high cadmium exposures of 1 mg/m3 or more (Tr. 6/8/
90, pp. 156-157).
Cadmium need not be respirable to constitute a hazard.
Inspirable cadmium particles that are too large to be respirable but
small enough to enter the tracheobronchial region of the lung can
lead to bronchoconstriction, chronic pulmonary disease, and cancer
of that portion of the lung. All of these diseases have been
associated with occupational exposure to cadmium (Ex. 8-86B).
Particles that are constrained by their size to the extra-thoracic
regions of the respiratory system such as the nose and maxillary
sinuses can be swallowed through mucocillary clearance and be
absorbed into the body (ACGIH, Ex. 8-692). The impaction of these
particles in the upper airways can lead to anosmia, or loss of sense
of smell, which is an early indication of overexposure among workers
exposed to heavy metals. This condition is commonly reported among
cadmium-exposed workers (Ex. 8-86-B).
C. Medical Surveillance
In general, the main provisions of the medical surveillance
section of the standard, under paragraphs (l)(1)-(17) of the
regulatory text, are as follows:
1. Workers exposed above the action level are covered;
2. Workers with intermittent exposures are not covered;
3. Past workers who are covered receive biological monitoring
for at least one year;
4. Initial examinations include a medical questionnaire and
biological monitoring of cadmium in blood (CdB), cadmium in urine
(CdU), and Beta-2-microglobulin in urine (2-M);
5. Biological monitoring of these three analytes is performed at
least annually; full medical examinations are performed biennially;
6. Until five years from the effective date of the standard,
medical removal is required when CdU is greater than 15 g/
gram creatinine (g Cr), or CdB is greater than 15 g/liter
whole blood (lwb), or 2-M is greater than 1500
g/g Cr, and CdB is greater than 5 g/lwb or CdU is
greater than 3 g/g Cr;
7. Beginning five years after the standard is in effect, medical
removal triggers will be reduced;
8. Medical removal protection benefits are to be provided for up
to 18 months;
9. Limited initial medical examinations are required for
respirator usage;
10. Major provisions are fully described under section (l) of
the regulatory text; they are outlined here as follows:
A. Eligibility
B. Biological monitoring
C. Actions triggered by levels of CdU, CdB, and 2-
M (See Summary Charts and Tables in Attachment-1.)
D. Periodic medical surveillance
E. Actions triggered by periodic medical surveillance (See
appendix A Summary Chart and Tables in Attachment-1.)
F. Respirator usage
G. Emergency medical examinations
H. Termination examination
I. Information to physician
J. Physician's medical opinion
K. Medical removal protection
L. Medical removal protection benefits
M. Multiple physician review
N. Alternate physician review
O. Information employer gives to employee
P. Recordkeeping
Q. Reporting on OSHA form 200
11. The above mentioned summary of the medical surveillance
provisions, the summary chart, and tables for the actions triggered
at different levels of CdU, CdB and 2-M (in appendix A
Attachment-1) are included only for the purpose of facilitating
understanding of the provisions of paragraphs (l)(3) of the final
cadmium standard. The summary of the provisions, the summary chart,
and the tables do not add to or reduce the requirements in paragraph
(l)(3).
D. Recommendations to Physicians
1. It is strongly recommended that patients with tubular
proteinuria are counseled on: The hazards of smoking; avoidance of
nephrotoxins and certain prescriptions and over-the-counter
medications that may exacerbate kidney symptoms; how to control
diabetes and/or blood pressure; proper hydration, diet, and exercise
(Ex. 19-2). A list of prominent or common nephrotoxins is attached.
(See appendix A Attachment-2.)
2. DO NOT CHELATE; KNOW WHICH DRUGS ARE NEPHROTOXINS OR ARE
ASSOCIATED WITH NEPHRITIS.
3. The gravity of cadmium-induced renal damage is compounded by
the fact there is no medical treatment to prevent or reduce the
accumulation of cadmium in the kidney (Ex. 8-619). Dr. Friberg, a
leading world expert on cadmium toxicity, indicated in 1992, that
there is no form of chelating agent that could be used without
substantial risk. He stated that tubular proteinuria has to be
treated in the same way as other kidney disorders (Ex. 29).
4. After the results of a workers' biological monitoring or
medical examination are received the employer is required to provide
an information sheet to the patient, briefly explaining the
significance of the results. (See Attachment 3 of this appendix A.)
5. For additional information the physician is referred to the
following additional resources:
a. The physician can always obtain a copy of the preamble, with
its full discussion of the health effects, from OSHA's Computerized
Information System (OCIS).
b. The Docket Officer maintains a record of the rulemaking. The
Cadmium Docket (H-057A), is located at 200 Constitution Ave. NW.,
room N-2625, Washington, DC 20210; telephone: 202-219-7894.
c. The following articles and exhibits in particular from that
docket (H-057A):
------------------------------------------------------------------------
Exhibit No. Author and paper title
------------------------------------------------------------------------
8-447....... Lauwerys et. al., Guide for physicians, ``Health
Maintenance of Workers Exposed to Cadmium,'' published by
the Cadmium Council.
4-67........ Takenaka, S., H. Oldiges, H. Konig, D. Hochrainer, G.
Oberdorster. ``Carcinogenicity of Cadmium Chloride
Aerosols in Wistar Rats''. JNCI 70:367-373, 1983. (32)
4-68........ Thun, M.J., T.M. Schnoor, A.B. Smith, W.E. Halperin, R.A.
Lemen. ``Mortality Among a Cohort of U.S. Cadmium
Production Workers--An Update.'' JNCI 74(2):325-33, 1985.
(8)
4-25........ Elinder, C.G., Kjellstrom, T., Hogstedt, C., et al.,
``Cancer Mortality of Cadmium Workers.'' Brit. J. Ind.
Med. 42:651-655, 1985. (14)
4-26........ Ellis, K.J. et al., ``Critical Concentrations of Cadmium
in Human Renal Cortex: Dose Effect Studies to Cadmium
Smelter Workers.'' J. Toxicol. Environ. Health 7:691-703,
1981. (76)
4-27........ Ellis, K.J., S.H. Cohn and T.J. Smith. ``Cadmium
Inhalation Exposure Estimates: Their Significance with
Respect to Kidney and Liver Cadmium Burden.'' J. Toxicol.
Environ. Health 15:173-187, 1985.
4-28........ Falck, F.Y., Jr., Fine, L.J., Smith, R.G., McClatchey,
K.D., Annesley, T., England, B., and Schork, A.M.
``Occupational Cadmium Exposure and Renal Status.'' Am.
J. Ind. Med. 4:541, 1983. (64)
8-86A....... Friberg, L., C.G. Elinder, et al., ``Cadmium and Health a
Toxicological and Epidemiological Appraisal, Volume I,
Exposure, Dose, and Metabolism.'' CRC Press, Inc., Boca
Raton, FL, 1986. (Available from the OSHA Technical Data
Center)
8-86B....... Friberg, L., C.G. Elinder, et al., ``Cadmium and Health: A
Toxicological and Epidemiological Appraisal, Volume II,
Effects and Response.'' CRC Press, Inc., Boca Raton, FL,
1986. (Available from the OSHA Technical Data Center)
L-140-45.... Elinder, C.G., ``Cancer Mortality of Cadmium Workers'',
Brit. J. Ind. Med., 42, 651-655, 1985.
L-140-50.... Thun, M., Elinder, C.G., Friberg, L, ``Scientific Basis
for an Occupational Standard for Cadmium, Am. J. Ind.
Med., 20; 629-642, 1991.
------------------------------------------------------------------------
V. Information Sheet
The information sheet (appendix A Attachment-3.) or an equally
explanatory one should be provided to you after any biological
monitoring results are reviewed by the physician, or where
applicable, after any medical examination.
Appendix A
Attachment 1--Appendix A Summary Chart and Tables A and B of Actions
Triggered by Biological Monitoring
Appendix A Summary Chart: Section (1)(3) Medical Surveillance
Categorizing Biological Monitoring Results
(A) Biological monitoring results categories are set forth in
Appendix A Table A for the periods ending December 31, 1998 and for
the period beginning January 1, 1999.
(B) The results of the biological monitoring for the initial
medical exam and the subsequent exams shall determine an employee's
biological monitoring result category.
Actions Triggered by Biological Monitoring
(A)
(i) The actions triggered by biological monitoring for an
employee are set forth in Appendix A Table B.
(ii) The biological monitoring results for each employee under
section (1)(3) shall determine the actions required for that
employee. That is, for any employee in biological monitoring
category C, the employer will perform all of the actions for which
there is an X in column C of Appendix A Table B.
(iii) An employee is assigned the alphabetical category (``A''
being the lowest) depending upon the test results of the three
biological markers.
(iv) An employee is assigned category A if monitoring results
for all three biological markers fall at or below the levels
indicated in the table listed for category A.
(v) An employee is assigned category B if any monitoring result
for any of the three biological markers fall within the range of
levels indicated in the table listed for category B, providing no
result exceeds the levels listed for category B.
(vi) An employee is assigned category C if any monitoring result
for any of the three biological markers are above the levels listed
for category C.
(B) The user of Appendix A Tables A and B should know that these
tables are provided only to facilitate understanding of the relevant
provisions of paragraph (l)(3) of this section. Appendix A Tables A
and B are not meant to add to or subtract from the requirements of
those provisions.
Appendix A Table A
Categorization of Biological Monitoring Results
Applicable Through 1998 Only
----------------------------------------------------------------------------------------------------------------
Monitoring result categories
Biological marker ----------------------------------------------
A B C
----------------------------------------------------------------------------------------------------------------
Cadmium in urine (CdU) (g/g creatinine)................. 3 and 15 >15
2-microglobulin (2-M) (g/g creatinine) 300 and 1500 >1500*
Cadmium in blood (CdB) (g/liter whole blood)............ 5 and 15 >15
----------------------------------------------------------------------------------------------------------------
* If an employee's 2-M levels are above 1,500 g/g creatinine, in order for mandatory medical
removal to be required (See Appendix A Table B.), either the employee's CdU level must also be >3 g/g
creatinine or CdB level must also be >5 g/liter whole blood.
Applicable Beginning January 1, 1999
----------------------------------------------------------------------------------------------------------------
Monitoring result categories
Biological marker ----------------------------------------------
A B C
----------------------------------------------------------------------------------------------------------------
Cadmium in urine (CdU) (g/g creatinine)................. 3 and 7 >7
2-microglobulin (2-M) (g/g creatinine) 300 and 750 >750*
Cadmium in blood (CdB) (g/liter whole blood)............ 5 and 10 >10
----------------------------------------------------------------------------------------------------------------
* If an employee's 2-M levels are above 750 g/g creatinine, in order for mandatory medical
removal to be required (See Appendix A Table B.), either the employee's CdU level must also be >3 g/g
creatinine or CdB level must also be >5 g/liter whole blood.
Appendix A Table B--Actions Determined by Biological Monitoring
This table presents the actions required based on the monitoring
result in Appendix A Table A. Each item is a separate requirement in
citing non-compliance. For example, a medical examination within 90
days for an employee in category B is separate from the requirement to
administer a periodic medical examination for category B employees on
an annual basis.
------------------------------------------------------------------------
Monitoring result category
Required actions -----------------------------------
A\1\ B\1\ C\1\
------------------------------------------------------------------------
(1) Biological monitoring:
(a) Annual...................... X .......... ..........
(b) Semiannual.................. .......... X ..........
(c) Quarterly................... .......... .......... X
(2) Medical examination:
(a) Biennial.................... X .......... ..........
(b) Annual...................... .......... X ..........
(c) Semiannual.................. .......... .......... X
(d) Within 90 days.............. .......... X X
(3) Assess within two weeks:
(a) Excess cadmium exposure..... .......... X X
(b) Work practices.............. .......... X X
(c) Personal hygiene............ .......... X X
(d) Respirator usage............ .......... X X
(e) Smoking history............. .......... X X
(f) Hygiene facilities.......... .......... X X
(g) Engineering controls........ .......... X X
(h) Correct within 30 days...... .......... X X
(i) Periodically assess .......... .......... X
exposures.
(4) Discretionary medical removal... .......... X X
(5) Mandatory medical removal....... .......... .......... X\2\
------------------------------------------------------------------------
\1\For all employees covered by medical surveillance exclusively because
of exposures prior to the effective date of this standard, if they are
in Category A, the employer shall follow the requirements of
paragraphs (l)(3)(i)(B) and (l)(4)(v)(A). If they are in Category B or
C, the employer shall follow the requirements of paragraphs
(l)(4)(v)(B)-(C).
\2\See footnote Appendix A Table A.
Appendix A--Attachment-2: List of Medications
A list of the more common medications that a physician, and the
employee, may wish to review is likely to include some of the
following: (1) Anticonvulsants: Paramethadione, phenytoin,
trimethadone; (2) antihypertensive drugs: Captopril, methyldopa; (3)
antimicrobials: Aminoglycosides, amphotericin B, cephalosporins,
ethambutol; (4) antineoplastic agents: Cisplatin, methotrexate,
mitomycin-C, nitrosoureas, radiation; (4) sulfonamide diuretics:
Acetazolamide, chlorthalidone, furosemide, thiazides; (5)
halogenated alkanes, hydrocarbons, and solvents that may occur in
some settings: Carbon tetrachloride, ethylene glycol, toluene;
iodinated radiographic contrast media; nonsteroidal anti-
inflammatory drugs; and, (7) other miscellaneous compounds:
Acetominophen, allopurinol, amphetamines, azathioprine, cimetidine,
cyclosporine, lithium, methoxyflurane, methysergide, D-
penicillamine, phenacetin, phenendione. A list of drugs associated
with acute interstitial nephritis includes: (1) Antimicrobial drugs:
Cephalosporins, chloramphenicol, colistin, erythromycin, ethambutol,
isoniazid, para-aminosalicylic acid, penicillins, polymyxin B,
rifampin, sulfonamides, tetracyclines, and vancomycin; (2) other
miscellaneous drugs: Allopurinol, antipyrene, azathioprine,
captopril, cimetidine, clofibrate, methyldopa, phenindione,
phenylpropanolamine, phenytoin, probenecid, sulfinpyrazone,
sulfonamid diuretics, triamterene; and, (3) metals: Bismuth, gold.
This list have been derived from commonly available medical
textbooks (e.g., Ex. 14-18). The list has been included merely to
facilitate the physician's, employer's, and employee's
understanding. The list does not represent an official OSHA opinion
or policy regarding the use of these medications for particular
employees. The use of such medications should be under physician
discretion.
Attachment 3--Biological Monitoring and Medical Examination Results
Employee---------------------------------------------------------------
Testing Date-----------------------------------------------------------
Cadmium in Urine ______ g/g Cr--Normal Levels:
3 g/g Cr.
Cadmium in Blood ______ g/lwb--Normal Levels:
5 g/lwb.
Beta-2-microglobulin in Urine ______ g/g Cr--Normal
Levels: 300 g/g Cr.
Physical Examination Results: N/A ______ Satisfactory ______
Unsatisfactory ______ (see physician again).
Physician's Review of Pulmonary Function Test: N/A ______ Normal
______ Abnormal ______.
Next biological monitoring or medical examination scheduled for--------
The biological monitoring program has been designed for three
main purposes: 1) to identify employees at risk of adverse health
effects from excess, chronic exposure to cadmium; 2) to prevent
cadmium-induced disease(s); and 3) to detect and minimize existing
cadmium-induced disease(s).
The levels of cadmium in the urine and blood provide an estimate
of the total amount of cadmium in the body. The amount of a specific
protein in the urine (beta-2-microglobulin) indicates changes in
kidney function. All three tests must be evaluated together. A
single mildly elevated result may not be important if testing at a
later time indicates that the results are normal and the workplace
has been evaluated to decrease possible sources of cadmium exposure.
The levels of cadmium or beta-2-microglobulin may change over a
period of days to months and the time needed for those changes to
occur is different for each worker.
If the results for biological monitoring are above specific
``high levels'' [cadmium urine greater than 10 micrograms per gram
of creatinine (g/g Cr), cadmium blood greater than 10
micrograms per liter of whole blood (g/lwb), or beta-2-
microglobulin greater than 1000 micrograms per gram of creatinine
(g/g Cr)], the worker has a much greater chance of
developing other kidney diseases.
One way to measure for kidney function is by measuring beta-2-
microglobulin in the urine. Beta-2-microglobulin is a protein which
is normally found in the blood as it is being filtered in the
kidney, and the kidney reabsorbs or returns almost all of the beta-
2-microglobulin to the blood. A very small amount (less than 300
g/g Cr in the urine) of beta-2-microglobulin is not
reabsorbed into the blood, but is released in the urine. If cadmium
damages the kidney, the amount of beta-2-microglobulin in the urine
increases because the kidney cells are unable to reabsorb the beta-
2-microglobulin normally. An increase in the amount of beta-2-
microglobulin in the urine is a very early sign of kidney
dysfunction. A small increase in beta-2-microglobulin in the urine
will serve as an early warning sign that the worker may be absorbing
cadmium from the air, cigarettes contaminated in the workplace, or
eating in areas that are cadmium contaminated.
Even if cadmium causes permanent changes in the kidney's ability
to reabsorb beta-2-microglobulin, and the beta-2-microglobulin is
above the ``high levels'', the loss of kidney function may not lead
to any serious health problems. Also, renal function naturally
declines as people age. The risk for changes in kidney function for
workers who have biological monitoring results between the ``normal
values'' and the ``high levels'' is not well known. Some people are
more cadmium-tolerant, while others are more cadmium-susceptible.
For anyone with even a slight increase of beta-2-microglobulin,
cadmium in the urine, or cadmium in the blood, it is very important
to protect the kidney from further damage. Kidney damage can come
from other sources than excess cadmium-exposure so it is also
recommended that if a worker's levels are ``high'' he/she should
receive counseling about drinking more water; avoiding cadmium-
tainted tobacco and certain medications (nephrotoxins,
acetaminophen); controlling diet, vitamin intake, blood pressure and
diabetes; etc.
Appendix B to Sec. 1915.1027--Substance Technical Guidelines for
Cadmium
I. Cadmium Metal.
A. Physical and Chemical Data.
1. Substance Identification.
Chemical name: Cadmium.
Formula: Cd.
Molecular Weight: 112.4.
Chemical Abstracts Service (CAS) Registry No.: 7740-43-9.
Other Identifiers: RETCS EU9800000; EPA D006; DOT 2570 53.
Synonyms: Colloidal Cadmium: Kadmium (German): CI 77180.
2. Physical data.
Boiling point: (760 mm Hg): 765 degrees C.
Melting point: 321 degrees C.
Specific Gravity: (H[email protected] 20 deg.C): 8.64.
Solubility: Insoluble in water; soluble in dilute nitric acid
and in sulfuric acid.
Appearance: Soft, blue-white, malleable, lustrous metal or
grayish-white powder.
B. Fire, Explosion and Reactivity Data.
1. Fire.
Fire and Explosion Hazards: The finely divided metal is
pyrophoric, that is the dust is a severe fire hazard and moderate
explosion hazard when exposed to heat or flame. Burning material
reacts violently with extinguishing agents such as water, foam,
carbon dioxide, and halons.
Flash point: Flammable (dust).
Extinguishing media: Dry sand, dry dolomite, dry graphite, or
sodimum chloride.
2. Reactivity.
Conditions contributing to instability: Stable when kept in
sealed containers under normal temperatures and pressure, but dust
may ignite upon contact with air. Metal tarnishes in moist air.
Incompatibilities: Ammonium nitrate, fused: Reacts violently or
explosively with cadmium dust below 20 deg.C. Hydrozoic acid:
Violent explosion occurs after 30 minutes. Acids: Reacts violently,
forms hydrogen gas. Oxidizing agents or metals: Strong reaction with
cadmium dust. Nitryl fluoride at slightly elevated temperature:
Glowing or white incandescence occurs. Selenium: Reacts
exothermically. Ammonia: Corrosive reaction. Sulfur dioxide:
Corrosive reaction. Fire extinguishing agents (water, foam, carbon
dioxide, and halons): Reacts violently. Tellurium: Incandescent
reaction in hydrogen atmosphere.
Hazardous decomposition products: The heated metal rapidly forms
highly toxic, brownish fumes of oxides of cadmium.
C. Spill, Leak and Disposal Procedures.
1. Steps to be taken if the materials is released or spilled. Do
not touch spilled material. Stop leak if you can do it without risk.
Do not get water inside container. For large spills, dike spill for
later disposal. Keep unnecessary people away. Isolate hazard area
and deny entry. The Superfund Amendments and Reauthorization Act of
1986 Section 304 requires that a release equal to or greater than
the reportable quantity for this substance (1 pound) must be
immediately reported to the local emergency planning committee, the
state emergency response commission, and the National Response
Center (800) 424-8802; in Washington, DC metropolitan area (202)
426-2675.
II. Cadmium Oxide.
A. Physical and Chemical Date.
1. Substance identification.
Chemical name: Cadmium Oxide.
Formula: CdO.
Molecular Weight: 128.4.
CAS No.: 1306-19-0.
Other Identifiers: RTECS EV1929500.
Synonyms: Kadmu tlenek (Polish).
2. Physical data.
Boiling point (760 mm Hg): 950 degrees C decomposes.
Melting point: 1500 deg.C.
Specific Gravity: (H[email protected] deg.C): 7.0.
Solubility: Insoluble in water; soluble in acids and alkalines.
Appearance: Red or brown crystals.
B. Fire, Explosion and Reactivity Data.
1. Fire.
Fire and Explosion Hazards: Negligible fire hazard when exposed
to heat or flame.
Flash point: Nonflammable.
Extinguishing media: Dry chemical, carbon dioxide, water spray
or foam.
2. Reactivity.
Conditions contributing to instability: Stable under normal
temperatures and pressures.
Incompatibilities: Magnesium may reduce CdO2 explosively on
heating.
Hazardous decomposition products: Toxic fumes of cadmium.
C. Spill Leak and Disposal Procedures.
1. Steps to be taken if the material is released or spilled. Do
not touch spilled material. Stop leak if you can do it without risk.
For small spills, take up with sand or other absorbent material and
place into containers for later disposal. For small dry spills, use
a clean shovel to place material into clean, dry container and then
cover. Move containers from spill area. For larger spills, dike far
ahead of spill for later disposal. Keep unnecessary people away.
Isolate hazard area and deny entry. The Superfund Amendments and
Reauthorization Act of 1986 Section 304 requires that a release
equal to or greater than the reportable quantity for this substance
(1 pound) must be immediately reported to the local emergency
planning committee, the state emergency response commission, and the
National Response Center (800) 424-8802; in Washington, DC
metropolitan area (202) 426-2675.
III. Cadmium Sulfide.
A. Physical and Chemical Data.
1. Substance Identification.
Chemical name: Cadmium sulfide.
Formula: CdS.
Molecular weight: 144.5.
CAS No. 1306-23-6.
Other Identifiers: RTECS EV3150000.
Synonyms: Aurora yellow; Cadmium Golden 366; Cadmium Lemon
Yellow 527; Cadmium Orange; Cadmium Primrose 819; Cadmium Sulphide;
Cadmium Yellow; Cadmium Yellow 000; Cadmium Yellow Conc. Deep;
Cadmium Yellow Conc. Golden; Cadmium Yellow Conc. Lemon; Cadmium
Yellow Conc. Primrose; Cadmium Yellow Oz. Dark; Cadmium Yellow
Primrose 47-1400; Cadmium Yellow 10G Conc.; Cadmium Yellow 892;
Cadmopur Golden Yellow N; Cadmopur Yellow: Capsebon; C.I. 77199;
C.I. Pigment Orange 20; CI Pigment Yellow 37; Ferro Lemon Yellow;
Ferro Orange Yellow; Ferro Yellow; Greenockite; NCI-C02711.
2. Physical data.
Boiling point (760 mm. Hg): sublines in N2 at 980 deg.C.
Melting point: 1750 degrees C (100 atm).
Specific Gravity: (H[email protected] 20 deg.C): 4.82.
Solubility: Slightly soluble in water; soluble in acid.
Appearance: Light yellow or yellow-orange crystals.
B. Fire, Explosion and Reactivity Data.
1. Fire.
Fire and Explosion Hazards: Neglible fire hazard when exposed to
heat or flame.
Flash point: Nonflammable.
Extinguishing media: Dry chemical, carbon dioxide, water spray
or foam.
2. Reactivity.
Conditions contributing to instability: Generally non-reactive
under normal conditions. Reacts with acids to form toxic hydrogen
sulfide gas.
Incompatibilities: Reacts vigorously with iodinemonochloride.
Hazardous decomposition products: Toxic fumes of cadmium and
sulfur oxides.
C. Spill Leak and Disposal Procedures.
1. Steps to be taken if the material is released or spilled. Do
not touch spilled material. Stop leak if you can do it without risk.
For small, dry spills, with a clean shovel place material into
clean, dry container and cover. Move containers from spill area. For
larger spills, dike far ahead of spill for later disposal. Keep
unnecessary people away. Isolate hazard and deny entry.
IV. Cadmium Chloride.
A. Physical and Chemical Data.
1. Substance Identification.
Chemical name: Cadmium chloride.
Formula: CdCl2.
Molecular weight: 183.3.
CAS No. 10108-64-2.
Other Identifiers: RTECS EY0175000.
Synonyms: Caddy; Cadmium dichloride; NA 2570 (DOT); UI-CAD;
dichlorocadmium.
2. Physical data.
Boiling point (760 mm Hg): 960 degrees C.
Melting point: 568 degrees C.
Specific Gravity: (H2O=1 @ 20 deg.C): 4.05.
Solubility: Soluble in water (140 g/100 cc); soluble in acetone.
Appearance: Small, white crystals.
B. Fire, Explosion and Reactivity Data.
1. Fire.
Fire and Explosion Hazards: Negligible fire and negligible
explosion hazard in dust form when exposed to heat or flame.
Flash point: Nonflamable.
Extinguishing media: Dry chemical, carbon dioxide, water spray
or foam.
2. Reactivity.
Conditions contributing to instability: Generally stable under
normal temperatures and pressures.
Incompatibilities: Bromine triflouride rapidly attacks cadmium
chloride. A mixture of potassium and cadmium chloride may produce a
strong explosion on impact.
Hazardous decomposition products: Thermal ecompostion may
release toxic fumes of hydrogen chloride, chloride, chlorine or
oxides of cadmium.
C. Spill Leak and Disposal Procedures.
1. Steps to be taken if the materials is released or spilled. Do
not touch spilled material. Stop leak if you can do it without risk.
For small, dry spills, with a clean shovel place material into
clean, dry container and cover. Move containers from spill area. For
larger spills, dike far ahead of spill for later disposal. Keep
unnecessary people away. Isolate hazard and deny entry. The
Superfund Amendments and Reauthorization Act of 1986 Section 304
requires that a release equal to or greater than the reportable
quantity for this substance (100 pounds) must be immediately
reported to the local emergency planning committee, the state
emergency response commission, and the National Response Center
(800) 424-8802; in Washington, DC Metropolitan area (202) 426-2675.
Appendix C to Sec. 1915.1027--Qualitative and Quantitative Fit
Testing Procedures
I. Fit Test Protocols
A. General: The employer shall include the following provisions
in the fit test procedures. These provisions apply to both
qualitative fit testing (QLFT) and quantitative fit testing (QNFT).
All testing is to be conducted annually.
1. The test subject shall be allowed to pick the most
comfortable respirator from a selection including respirators of
various sizes from different manufacturers. The selection shall
include at least three sizes of elastomeric facepieces of the type
of respirator that is to be tested, i.e., three sizes of half mask;
or three sizes of full facepiece. Respirators of each size must be
provided from at least two manufacturers.
2. Prior to the selection process, the test subject shall be
shown how to put on a respirator, how it should be positioned on the
face, how to set strap tension and how to determine a comfortable
fit. A mirror shall be available to assist the subject in evaluating
the fit and positioning the respirator. This instruction may not
constitute the subject's formal training on respirator use; it is
only a review.
3. The test subject shall be informed that he/she is being asked
to select the respirator which provides the most comfortable fit.
Each respirator represents a different size and shape, and if
fitted, maintained and used properly, will provide substantial
protection.
4. The test subject shall be instructed to hold each facepiece
up to the face and eliminate those which obviously do not give a
comfortable fit.
5. The more comfortable facepieces are noted; the most
comfortable mask is donned and worn at least five minutes to assess
comfort. Assistance in assessing comfort can be given by discussing
the points in item 6 below. If the test subject is not familiar with
using a particular respirator, the test subject shall be directed to
don the mask several times and to adjust the straps each time to
become adept at setting proper tension on the straps.
6. Assessment of comfort shall include reviewing the following
points with the test subject and allowing the test subject adequate
time to determine the comfort of the respirator:
(a) Position of the mask on the nose;
(b) Room for eye protection;
(c) Room to talk; and
(d) Position of mask on face and cheeks.
7. The following criteria shall be used to help determine the
adequacy of the respirator fit:
(a) Chin properly placed;
(b) Adequate strap tension, not overly tightened;
(c) Fit across nose bridge;
(d) Respirator of proper size to span distance from nose to
chin;
(e) Tendency of respirator to slip; and
(f) Self-observation in mirror to evaluate fit and respirator
position.
8. The test subject shall conduct the negative and positive
pressure fit checks as described below or in ANSI Z88.2-1980. Before
conducting the negative or positive pressure test, the subject shall
be told to seat the mask on the face by moving the head from side-
to-side and up and down slowly while taking in a few slow deep
breaths. Another facepiece shall be selected and retested if the
test subject fails the fit check tests.
(a). Positive pressure test. Close off the exhalation valve and
exhale gently onto the facepiece. The face fit is considered
satisfactory if a slight positive pressure can be built up inside
the facepiece without any evidence of outward leakage of air at the
seal. For most respirators this method of leak testing requires the
wearer to first remove the exhalation valve cover before closing off
the exhalation valve and then carefully replacing it after the test.
(b). Negative pressure test. Close off the inlet opening of the
canister or cartridge(s) by covering with the palm of the hand(s) or
by replacing the filter seal(s). Inhale gently so that the facepiece
collapses slightly, and hold the breath for ten seconds. If the
facepiece remains in its slightly collapsed condition and no inward
leakage of air is detected, the tightness of the respirator is
considered satisfactory.
9. The test shall not be conducted if there is any hair growth
between the skin and the facepiece sealing surface, such as stubble
beard growth, beard, or long sideburns which cross the respirator
sealing surface. Any type of apparel which interferes with a
satisfactory fit shall be altered or removed.
10. If a test subject exhibits difficulty in breathing during
the tests, she or he shall be referred to a physician trained in
respiratory disease or pulmonary medicine to determine, in
accordance with paragraph (l)(2) and (3) of this standard, whether
the test subject can wear a respirator while performing her or his
duties.
11. The test subject shall be given the opportunity to wear the
successfully fitted respirator for a period of two weeks. If at any
time during this period the respirator becomes uncomfortable, the
test subject shall be given the opportunity to select a different
facepiece and to be retested.
12. The employer shall maintain a record of the fit test
administered to an employee. The record shall contain at least the
following information:
(a) Name of employee;
(b) Type of respirator;
(c) Brand, size of respirator;
(d) Date of test; and
(e) Where QNFT is used, the fit factor and strip chart recording
or other recording of the results of the test. The record shall be
maintained until the next fit test is administered.
13. Exercise regimen. Prior to the commencement of the fit test,
the test subject shall be given a description of the fit test and
the test subject's responsibilities during the test procedure. The
description of the process shall include a description of the test
exercises that the subject will be performing. The respirator to be
tested shall be worn for at least 5 minutes before the start of the
fit test.
14. Test Exercises. The test subject shall perform exercises, in
the test environment, in the manner described below:
(a) Normal breathing. In a normal standing position, without
talking, the subject shall breathe normally.
(b) Deep breathing. In a normal standing position, without
talking, the subject shall breathe slowly and deeply, taking care so
as to not hyperventilate.
(c) Turning head side to side. Standing in place, the subject
shall slowly turn his/her head from side to side
FR Doc. 93-31820 Occupational Safety and Health Standards for Cadmium in Shipyard Employment and Construction
between the extreme
positions on each side. The head shall be held at each extreme
momentarily so the subject can inhale at each side.
(d) Moving head up and down. Standing in place, the subject
shall slowly move his/her head up and down. The subject shall be
instructed to inhale in the up position (i.e., when looking toward
the ceiling).
(e) Talking. The subject shall talk out loud slowly and loud
enough so as to be heard clearly by the test conductor. The subject
can read from a prepared text such as the Rainbow Passage, count
backward from 100, or recite a memorized poem or song.
(f) Grimace. The test subject shall grimace by smiling or
frowning.
(g) Bending over. The test subject shall bend at the waist as if
he/she were to touch his/her toes. Jogging in place shall be
substituted for this exercise in those test environments such as
shroud type QNFT units which prohibit bending at the waist.
(h) Normal breathing. Same as exercise 1. Each test exercise
shall be performed for one minute except for the grimace exercise
which shall be performed for 15 seconds. The test subject shall be
questioned by the test conductor regarding the comfort of the
respirator upon completion of the protocol. If it has become
uncomfortable, another model of respirator shall be tried.
B. Qualitative Fit Test (QLFT) Protocols
1. General
(a) The employer shall assign specific individuals who shall
assume full responsibility for implementing the respirator
qualitative fit test program.
(b) The employer shall assure that persons administering QLFTs
are able to prepare test solutions, calibrate equipment and perform
tests properly, recognize invalid tests, and assure that test
equipment is in proper working order.
(c) The employer shall assure that QLFT equipment is kept clean
and well maintained so as to operate within the parameters for which
it was designed.
2. Isoamyl Acetate Protocol
(a) Odor threshold screening. The odor threshold screening test,
performed without wearing a respirator, is intended to determine if
the individual tested can detect the odor of isoamyl acetate.
(1) Three 1-liter glass jars with metal lids are required.
(2) Odor free water (e.g. distilled or spring water) at
approximately 25 degrees C shall be used for the solutions.
(3) The isoamyl acetate (IAA) (also known as isopentyl acetate)
stock solution is prepared by adding 1 cc of pure IAA to 800 cc of
odor free water in a 1 liter jar and shaking for 30 seconds. A new
solution shall be prepared at least weekly.
(4) The screening test shall be conducted in a room separate
from the room used for actual fit testing. The two rooms shall be
well ventilated and shall not be connected to the same recirculating
ventilation system.
(5) The odor test solution is prepared in a second jar by
placing 0.4 cc of the stock solution into 500 cc of odor free water
using a clean dropper or pipette. The solution shall be shaken for
30 seconds and allowed to stand for two to three minutes so that the
IAA concentration above the liquid may reach equilibrium. This
solution shall be used for only one day.
(6) A test blank shall be prepared in a third jar by adding 500
cc of odor free water.
(7) The odor test and test blank jars shall be labeled 1 and 2
for jar identification. Labels shall be placed on the lids so they
can be periodically peeled, dried off and switched to maintain the
integrity of the test.
(8) The following instruction shall be typed on a card and
placed on the table in front of the two test jars (i.e., 1 and 2):
``The purpose of this test is to determine if you can smell banana
oil at a low concentration. The two bottles in front of you contain
water. One of these bottles also contains a small amount of banana
oil. Be sure the covers are on tight, then shake each bottle for two
seconds. Unscrew the lid of each bottle, one at a time, and sniff at
the mouth of the bottle. Indicate to the test conductor which bottle
contains banana oil.''
(9) The mixtures used in the IAA odor detection test shall be
prepared in an area separate from where the test is performed, in
order to prevent olfactory fatigue in the subject.
(10) If the test subject is unable to correctly identify the jar
containing the odor test solution, the IAA qualitative fit test
shall not be performed.
(11) If the test subject correctly identifies the jar containing
the odor test solution, the test subject may proceed to respirator
selection and fit testing.
(b) Isoamyl acetate fit test--
(1) The fit test chamber shall be similar to a clear 55-gallon
drum liner suspended inverted over a 2-foot diameter frame so that
the top of the chamber is about 6 inches above the test subject's
head. The inside top center of the chamber shall have a small hook
attached.
(2) Each respirator used for the fitting and fit testing shall
be equipped with organic vapor cartridges or offer protection
against organic vapors. The cartridges or masks shall be changed at
least weekly.
(3) After selecting, donning, and properly adjusting a
respirator, the test subject shall wear it to the fit testing room.
This room shall be separate from the room used for odor threshold
screening and respirator selection, and shall be well ventilated, as
by an exhaust fan or lab hood, to prevent general room
contamination.
(4) A copy of the test exercises and any prepared text from
which the subject is to read shall be taped to the inside of the
test chamber.
(5) Upon entering the test chamber, the test subject shall be
given a 6-inch by 5-inch piece of paper towel, or other porous,
absorbent, single-ply material, folded in half and wetted with 0.75
cc of pure IAA. The test subject shall hang the wet towel on the
hook at the top of the chamber.
(6) Allow two minutes for the IAA test concentration to
stabilize before starting the fit test exercises. This would be an
appropriate time to talk with the test subject; to explain the fit
test, the importance of his/her cooperation, and the purpose for the
head exercises; and to demonstrate some of the exercises.
(7) If at any time during the test, the subject detects the
banana like odor of IAA, the respirator fit is inadequate. The
subject shall quickly exit from the test chamber and leave the test
area to avoid olfactory fatigue.
(8) If the respirator fit was inadequate, the subject shall
return to the selection room and remove the respirator, repeat the
odor sensitivity test, select and put on another respirator, return
to the test chamber and again begin the procedure described in
paragraph (I)(B)(2)(b) (1) through (7) of this appendix. The process
continues until a respirator that fits well has been found. Should
the odor sensitivity test be failed, the subject shall wait about 5
minutes before retesting. Odor sensitivity will usually have
returned by this time.
(9) When a respirator is found that passes the test, its
efficiency shall be demonstrated for the subject by having the
subject break the face seal and take a breath before exiting the
chamber.
(10) When the test subject leaves the chamber, the subject shall
remove the saturated towel and return it to the person conducting
the test. To keep the test area from becoming contaminated, the used
towels shall be kept in a self sealing bag so there is no
significant IAA concentration build-up in the test chamber during
subsequent tests.
3. Irritant Fume Protocol
(a) The respirator to be tested shall be equipped with high-
efficiency particulate air (HEPA) filters.
(b) The test subject shall be allowed to smell a weak
concentration of the irritant smoke before the respirator is donned
to become familiar with its characteristic odor.
(c) Break both ends of a ventilation smoke tube containing
stannic oxychloride, such as the MSA part No. 5645, or equivalent.
Attach one end of the smoke tube to a low flow air pump set to
deliver 200 milliliters per minute.
(d) Advise the test subject that the smoke can be irritating to
the eyes and instruct the subject to keep his/her eyes closed while
the test is performed.
(e) The test conductor shall direct the stream of irritant smoke
from the smoke tube towards the face seal area of the test subject.
He/she shall begin at least 12 inches from the facepiece and
gradually move to within one inch, moving around the whole perimeter
of the mask.
(f) The exercises identified in section I. A. 14 above shall be
performed by the test subject while the respirator seal is being
challenged by the smoke.
(g) Each test subject passing the smoke test without evidence of
a response shall be given a sensitivity check of the smoke from the
same tube once the respirator has been removed to determine whether
he/she reacts to the smoke. Failure to evoke a response shall void
the fit test.
(h) The fit test shall be performed in a location with exhaust
ventilation sufficient to prevent general contamination of the
testing area by the test agent.
4. Saccharin Solution Aerosol Protocol
The entire screening and testing procedure shall be explained to
the test subject prior to the conduct of the screening test.
(a) Taste threshold screening. The saccharin taste threshold
screening, performed without wearing a respirator, is intended to
determine whether the individual being tested can detect the taste
of saccharin.
(1) Threshold screening as well as fit testing subjects shall
wear an enclosure about the head and shoulders that is approximately
12 inches in diameter by 14 inches tall with at least the front
portion clear and that allows free movements of the head when a
respirator is worn. An enclosure substantially similar to the 3M
hood assembly, parts # FT 14 and # FT 15 combined, is adequate.
(2) The test enclosure shall have a \3/4\ inch hole in front of
the test subject's nose and mouth area to accommodate the nebulizer
nozzle.
(3) The test subject shall don the test enclosure. Throughout
the threshold screening test, the test subject shall breathe through
his/her wide open mouth with tongue extended.
(4) Using a DeVilbiss Model 40 Inhalation Medication Nebulizer
the test conductor shall spray the threshold check solution into the
enclosure. This nebulizer shall be clearly marked to distinguish it
from the fit test solution nebulizer.
(5) The threshold check solution consists of 0.83 grams of
sodium saccharin USP in 1 cc of warm water. It can be prepared by
putting 1 cc of the fit test solution (see (b)(5) below) in 100 cc
of distilled water.
(6) To produce the aerosol, the nebulizer bulb is firmly
squeezed so that it collapses completely, then released and allowed
to fully expand.
(7) Ten squeezes are repeated rapidly and then the test subject
is asked whether the saccharin can be tasted.
(8) If the first response is negative, ten more squeezes are
repeated rapidly and the test subject is again asked whether the
saccharin is tasted.
(9) If the second response is negative, ten more squeezes are
repeated rapidly and the test subject is again asked whether the
saccharin is tasted.
(10) The test conductor will take note of the number of squeezes
required to solicit a taste response.
(11) If the saccharin is not tasted after 30 squeezes (step 10),
the test subject may not perform the saccharin fit test.
(12) If a taste response is elicited, the test subject shall be
asked to take note of the taste for reference in the fit test.
(13) Correct use of the nebulizer means that approximately 1 cc
of liquid is used at a time in the nebulizer body.
(14) The nebulizer shall be thoroughly rinsed in water, shaken
dry, and refilled at least each morning and afternoon or at least
every four hours.
(b) Saccharin solution aerosol fit test procedure
(1) The test subject may not eat, drink (except plain water), or
chew gum for 15 minutes before the test.
(2) The fit test uses the same enclosure described in (a) above.
(3) The test subject shall don the enclosure while wearing the
respirator selected in section (a) above. The respirator shall be
properly adjusted and equipped with a particulate filter(s).
(4) A second DeVilbiss Model 40 Inhalation Medication Nebulizer
is used to spray the fit test solution into the enclosure. This
nebulizer shall be clearly marked to distinguish it from the
screening test solution nebulizer.
(5) The fit test solution is prepared by adding 83 grams of
sodium saccharin to 100 cc of warm water.
(6) As before, the test subject shall breathe through the open
mouth with tongue extended.
(7) The nebulizer is inserted into the hole in the front of the
enclosure and the fit test solution is sprayed into the enclosure
using the same number of squeezes required to elicit a taste
response in the screening test.
(8) After generating the aerosol the test subject shall be
instructed to perform the exercises in section I.A. 14 above.
(9) Every 30 seconds the aerosol concentration shall be
replenished using one half the number of squeezes as initially.
(10) The test subject shall indicate to the test conductor if at
any time during the fit test the taste of saccharin is detected.
(11) If the taste of saccharin is detected, the fit is deemed
unsatisfactory and a different respirator shall be tried''.
C. Quantitative Fit Test (QNFT) Protocol
1. General
(a) The employer shall assign specific individuals who shall
assume full responsibility for implementing the respirator
quantitative fit test program.
(b) The employer shall ensure that persons administering QNFT
are able to calibrate equipment and perform tests properly,
recognize invalid tests, calculate fit factors properly and assure
that test equipment is in proper working order.
(c) The employer shall assure that QNFT equipment is kept clean
and well maintained so as to operate at the parameters for which it
was designed.
2. Definitions
(a) Quantitative fit test. The test is performed in a test
chamber. The normal air-purifying element of the respirator is
replaced by a high-efficiency particulate air (HEPA) filter in the
case of particulate QNFT aerosols or a sorbent offering contaminant
penetration protection equivalent to high-efficiency filters where
the QNFT test agent is a gas or vapor.
(b) Challenge agent means the aerosol, gas or vapor introduced
into a test chamber so that its concentration inside and outside the
respirator may be measured.
(c) Test subject means the person wearing the respirator for
quantitative fit testing.
(d) Normal standing position means standing erect and straight
with arms down along the sides and looking straight ahead.
(e) Maximum peak penetration method means the method of
determining test agent penetration in the respirator as determined
by strip chart recordings of the test. The highest peak penetration
for a given exercise is taken to be representative of average
penetration into the respirator for that exercise.
(f) Average peak penetration method means the method of
determining test agent penetration into the respirator utilizing a
strip chart recorder, integrator, or computer. The agent penetration
is determined by an average of the peak heights on the graph or by
computer integration, for each exercise except the grimace exercise.
Integrators or computers which calculate the actual test agent
penetration into the respirator for each exercise will also be
considered to meet the requirements of the average peak penetration
method.
(g) ``Fit Factor'' means the ration of challenge agent
concentration outside with respect to the inside of a respirator
inlet covering (facepiece or enclosure).
3. Apparatus
(a) Instrumentation. Aerosol generation, dilution, and
measurement systems using corn oil or sodium chloride as test
aerosols shall be used for quantitative fit testing.
(b) Test chamber. The test chamber shall be large enough to
permit all test subjects to perform freely all required exercises
without disturbing the challenge agent concentration or the
measurement apparatus. The test chamber shall be equipped and
constructed so that the challenge agent is effectively isolated from
the ambient air, yet uniform in concentration throughout the
chamber.
(c) When testing air-purifying respirators, the normal filter or
cartridge element shall be replaced with a high-efficiency
particulate filter supplied by the same manufacturer.
(d) The sampling instrument shall be selected so that a strip
chart record may be made of the test showing the rise and fall of
the challenge agent concentration with each inspiration and
expiration at fit factors of at least 2,000. Integrators or
computers which integrate the amount of test agent penetration
leakage into the respirator for each exercise may be used provided a
record of the readings is made.
(e) The combination of substitute air-purifying elements,
challenge agent and challenge agent concentration in the test
chamber shall be such that the test subject is not exposed in excess
of an established exposure limit for the challenge agent at any time
during the testing process.
(f) The sampling port on the test specimen respirator shall be
placed and constructed so that no leakage occurs around the port
(e.g. where the respirator is probed), a free air flow is allowed
into the sampling line at all times and so that there is no
interference with the fit or performance of the respirator.
(g) The test chamber and test set up shall permit the person
administering the test to observe the test subject inside the
chamber during the test.
(h) The equipment generating the challenge atmosphere shall
maintain the concentration of challenge agent inside the test
chamber constant to within a 10-percent variation for the duration
of the test.
(i) The time lag (interval between an event and the recording of
the event on the strip chart or computer or integrator) shall be
kept to a minimum. There shall be a clear association between the
occurrence of an event inside the test chamber and its being
recorded.
(j) The sampling line tubing for the test chamber atmosphere and
for the respirator sampling port shall be of equal diameter and of
the same material. The length of the two lines shall be equal.
(k) The exhaust flow from the test chamber shall pass through a
high-efficiency filter before release.
(l) When sodium chloride aerosol is used, the relative humidity
inside the test chamber shall not exceed 50 percent.
(m) The limitations of instrument detection shall be taken into
account when determining the fit factor.
(n) Test respirators shall be maintained in proper working order
and inspected for deficiencies such as cracks, missing valves and
gaskets, etc.
4. Procedural Requirements
(a) When performing the initial positive or negative pressure
test the sampling line shall be crimped closed in order to avoid air
pressure leakage during either of these tests.
(b) An abbreviated screening isoamyl acetate test or irritant
fume test may be utilized in order to quickly identify poor fitting
respirators which passed the positive and/or negative pressure test
and thus reduce the amount of QNFT time. When performing a screening
isoamyl acetate test, combination high-efficiency organic vapor
cartridges/canisters shall be used.
(c) A reasonably stable challenge agent concentration shall be
measured in the test chamber prior to testing. For canopy or shower
curtain type of test units the determination of the challenge agent
stability may be established after the test subject has entered the
test environment.
(d) Immediately after the subject enters the test chamber, the
challenge agent concentration inside the respirator shall be
measured to ensure that the peak penetration does not exceed 5
percent for a half mask or 1 percent for a full facepiece
respirator.
(e) A stable challenge concentration shall be obtained prior to
the actual start of testing.
(f) Respirator restraining straps shall not be overtightened for
testing. The straps shall be adjusted by the wearer without
assistance from other persons to give a reasonable comfortable fit
typical of normal use.
(g) The test shall be terminated whenever any single peak
penetration exceeds 5 percent for half masks and 1 percent for full
facepiece respirators. The test subject shall be refitted and
retested. If two of the three required tests are terminated, the fit
shall be deemed inadequate.
(h) In order to successfully complete a QNFT, three successful
fit tests are required. The results of each of the three independent
fit tests must exceed the minimum fit factor needed for the class of
respirator (e.g. half mask respirator, full facepiece respirator).
(i) Calculation of fit factors.
(1) The fit factor shall be determined for the quantitative fit
test by taking the ratio of the average chamber concentration to the
concentration inside the respirator.
(2) The average test chamber concentration is the arithmetic
average of the test chamber concentration at the beginning and at
the end of the test.
(3) The concentration of the challenge agent inside the
respirator shall be determined by one of the following methods:
(i) Average peak concentration;
(ii) Maximum peak concentration;
(iii) Integration by calculation of the area under the
individual peak for each exercise. This includes computerized
integration.
(j) Interpretation of test results. The fit factor established
by the quantitative fit testing shall be the lowest of the three fit
factor values calculated from the three required fit tests.
(k) The test subject shall not be permitted to wear a half mask,
or full facepiece respirator unless a minimum fit factor equivalent
to at least 10 times the hazardous exposure level is obtained.
(l) Filters used for quantitative fit testing shall be replaced
at least weekly, or whenever increased breathing resistance is
encountered, or when the test agent has altered the integrity of the
filter media. Organic vapor cartridges/canisters shall be replaced
daily (when used) or sooner if there is any indication of
breakthrough by a test agent.
Appendix D to Sec. 1915.1027--Occupational Health History Interview
With Reference to Cadmium Exposure
Directions
(To be read by employee and signed prior to the interview)
Please answer the questions you will be asked as completely and
carefully as you can. These questions are asked of everyone who works
with cadmium. You will also be asked to give blood and urine samples.
The doctor will give your employer a written opinion on whether you are
physically capable of working with cadmium. Legally, the doctor cannot
share personal information you may tell him/her with your employer. The
following information is considered strictly confidential. The results
of the tests will go to you, your doctor and your employer. You will
also receive an information sheet explaining the results of any
biological monitoring or physical examinations performed.
If you are just being hired, the results of this interview and
examination will be used to:
(1) Establish your health status and see if working with cadmium
might be expected to cause unusual problems,
(2) Determine your health status today and see if there are changes
over time,
(3) See if you can wear a respirator safely.
If you are not a new hire:
OSHA says that everyone who works with cadmium can have periodic
medical examinations performed by a doctor. The reasons for this are:
(a) If there are changes in your health, either because of cadmium
or some other reason, to find them early,
(b) to prevent kidney damage.
Please sign below.
I have read these directions and understand them:
----------------------------------------------------------------------
Employee signature
----------------------------------------------------------------------
Date
Thank you for answering these questions. (Suggested Format)
Name-------------------------------------------------------------------
Age--------------------------------------------------------------------
Social Security #------------------------------------------------------
Company----------------------------------------------------------------
Job--------------------------------------------------------------------
Type of Preplacement Exam:
[ ] Periodic
[ ] Termination
[ ] Initial
[ ] Other
Blood Pressure---------------------------------------------------------
Pulse Rate-------------------------------------------------------------
1. How long have you worked at the job listed above?
[ ] Not yet hired
[ ] Number of months
[ ] Number of years
2. Job Duties etc.
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
3. Have you ever been told by a doctor that you had bronchitis?
[ ] Yes
[ ] No
If yes, how long ago?
[ ] Number of months
[ ] Number of years
4. Have you ever been told by a doctor that you had emphysema?
[ ] Yes
[ ] No
If yes, how long ago?
[ ] Number of years
[ ] Number of months
5. Have you ever been told by a doctor that you had other lung
problems?
[ ] Yes
[ ] No
If yes, please describe type of lung problems and when you had
these problems
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
6. In the past year, have you had a cough?
[ ] Yes
[ ] No
If yes, did you cough up sputum?
[ ] Yes
[ ] No
If yes, how long did the cough with sputum production last?
[ ] Less than 3 months
[ ] 3 months or longer
If yes, for how many years have you had episodes of cough with
sputum production lasting this long?
[ ] Less than one
[ ] 1
[ ] 2
[ ] Longer than 2
7. Have you ever smoked cigarettes?
[ ] Yes
[ ] No
8. Do you now smoke cigarettes?
[ ] Yes
[ ] No
9. If you smoke or have smoked cigarettes, for how many years have
you smoked, or did you smoke?
[ ] Less than 1 year
[ ] Number of years
What is or was the greatest number of packs per day that you
have smoked?
[ ] Number of packs
If you quit smoking cigarettes, how many years ago did you quit?
[ ] Less than 1 year
[ ] Number of years
How many packs a day do you now smoke?
[ ] Number of packs per day
10. Have you ever been told by a doctor that you had a kidney or
urinary tract disease or disorder?
[ ] Yes
[ ] No
11. Have you ever had any of these disorders?
Kidney stones................................... [] Yes [] No
Protein in urine................................ [] Yes [] No
Blood in urine.................................. [] Yes [] No
Difficulty urinating............................ [] Yes [] No
Other kidney/Urinary disorders.................. [] Yes [] No
Please describe problems, age, treatment, and follow up for any
kidney or urinary problems you have had:
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
12. Have you ever been told by a doctor or other health care
provider who took your blood pressure that your blood pressure was
high?
[ ] Yes
[ ] No
13. Have you ever been advised to take any blood pressure
medication?
[ ] Yes
[ ] No
14. Are you presently taking any blood pressure medication?
[ ] Yes
[ ] No
15. Are you presently taking any other medication?
[ ] Yes
[ ] No
16. Please list any blood pressure or other medications and describe
how long you have been taking each one:
Medicine:
----------------------------------------------------------------------
----------------------------------------------------------------------
-----------------------------------------------------------------------
How Long Taken
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
17. Have you ever been told by a doctor that you have diabetes?
(sugar in your blood or urine)
[ ] Yes
[ ] No
If yes, do you presently see a doctor about your diabetes?
[ ] Yes
[ ] No
If yes, how do you control your blood sugar?
[ ] Diet alone
[ ] Diet plus oral medicine
[ ] Diet plus insulin (injection)
18. Have you ever been told by a doctor that you had:
Anemia.......................................... [] Yes [] No
A low blood count?.............................. [] Yes [] No
19. Do you presently feel that you tire or run out of energy sooner
than normal or sooner than other people your age?
[ ] Yes
[ ] No
If yes, for how long have you felt that you tire easily?
[ ] Less than 1 year
[ ] Number of years
20. Have you given blood within the last year?
[ ] Yes
[ ] No
If yes, how many times?
[ ] Number of times
How long ago was the last time you gave blood?
[ ] Less than 1 month
[ ] Number of months
21. Within the last year have you had any injuries with heavy
bleeding?
[ ] Yes
[ ] No
If yes, how long ago?
[ ] Less than 1 month
[ ] Number of months
Describe:--------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
22. Have you recently had any surgery?
[ ] Yes
[ ] No
If yes, please describe:-----------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
23. Have you seen any blood lately in your stool or after a bowel
movement?
[ ] Yes
[ ] No
24. Have you ever had a test for blood in your stool?
[ ] Yes
[ ] No
If yes, did the test show any blood in the stool?
[ ] Yes
[ ] No
What further evaluation and treatment were done?-----------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
The following questions pertain to the ability to wear a
respirator. Additional information for the physician can be found in
The Respiratory Protective Devices Manual.
25. Have you ever been told by a doctor that you have asthma?
[ ] Yes
[ ] No
If yes, are you presently taking any medication for asthma? Mark
all that apply.
[ ] Shots
[ ] Pills
[ ] Inhaler
26. Have you ever had a heart attack?
[ ] Yes
[ ] No
If yes, how long ago?
[ ] Number of years
[ ] Number of months
27. Have you ever had pains in your chest?
[ ] Yes
[ ] No
If yes, when did it usually happen?
[ ] While resting
[ ] While working
[ ] While exercising
[ ] Activity didn't matter
28. Have you ever had a thyroid problem?
[ ] Yes
[ ] No
29. Have you ever had a seizure or fits?
[ ] Yes
[ ] No
30. Have you ever had a stroke (cerebrovascular accident)?
[ ] Yes
[ ] No
31. Have you ever had a ruptured eardrum or a serious hearing
problem?
[ ] Yes
[ ] No
32. Do you now have a claustrophobia, meaning fear of crowded or
closed in spaces or any psychological problems that would make it
hard for you to wear a respirator?
[ ] Yes
[ ] No
The following questions pertain to reproductive history.
33. Have you or your partner had a problem conceiving a child?
[ ] Yes
[ ] No
If yes, specify:
[ ] Self
[ ] Present mate
[ ] Previous mate
34. Have you or your partner consulted a physician for a fertility
or other reproductive problem?
[ ] Yes
[ ] No
If yes, specify who consulted the physician:
[ ] Self
[ ] Spouse/partner
[ ] Self and partner
If yes, specify diagnosis made:----------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
35. Have you or your partner ever conceived a child resulting in a
miscarriage, still birth or deformed offspring?
[ ] Yes
[ ] No
If yes, specify:
[ ] Miscarriage
[ ] Still birth
[ ] Deformed offspring
If outcome was a deformed offspring, please specify type:--------------
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
36. Was this outcome a result of a pregnancy of:
[ ] Yours with present partner
[ ] Yours with a previous partner
37. Did the timing of any abnormal pregnancy outcome coincide with
present employment?
[ ] Yes
[ ] No
List dates of occurrences:---------------------------------------------
----------------------------------------------------------------------
38. What is the occupation of your spouse or partner?
----------------------------------------------------------------------
----------------------------------------------------------------------
For Women Only
39. Do you have menstrual periods?
[ ] Yes
[ ] No
Have you had menstrual irregularities?
[ ] Yes
[ ] No
If yes, specify type:--------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
If yes, what was the approximate date this problem began?--------------
----------------------------------------------------------------------
Approximate date problem stopped?--------------------------------------
----------------------------------------------------------------------
For Men Only
40. Have you ever been diagnosed by a physician as having prostate
gland problem(s)?
[ ] Yes
[ ] No
If yes, please describe type of problem(s) and what was done to
evaluate and treat the problem(s):-------------------------------------
----------------------------------------------------------------------
Appendix E to Sec. 1915.1027--Cadmium in Workplace Atmospheres
Method Number: ID-189
Matrix: Air
OSHA Permissible Exposure Limits: 5 g/m\3\ (TWA), 2.5
g/m\3\ (Action Level TWA)
Collection Procedure: A known volume of air is drawn through a 37-mm
diameter filter cassette containing a 0.8-m mixed cellulose
ester membrane filter (MCEF).
Recommended Air Volume: 960 L
Recommended Sampling Rate: 2.0 L/min
Analytical Procedure: Air filter samples are digested with nitric
acid. After digestion, a small amount of hydrochloric acid is added.
The samples are then diluted to volume with deionized water and
analyzed by either flame atomic absorption spectroscopy (AAS) or
flameless atomic absorption spectroscopy using a heated graphite
furnace atomizer (AAS-HGA).
Detection Limits:
Qualitative: 0.2 g/m\3\ for a 200 L sample by Flame AAS,
0.007 g/m\3\ for a 60 L sample by AAS-HGA
Quantitative: 0.70 g/m\3\ for a 200 L sample by Flame AAS,
0.025 g/m\3\ for a 60 L sample by AAS-HGA
Precision and Accuracy: (Flame AAS Analysis and AAS-HGA Analysis):
Validation Level: 2.5 to 10 g/m\3\ for a 400 L air vol,
1.25 to 5.0 g/m\3\ for a 60 L air vol
CV1 (pooled): 0.010, 0.043
Analytical Bias: +4.0%, -5.8%
Overall Analytical Error: 6.0%, 14.2%
Method Classification: Validated
Date: June, 1992
Inorganic Service Branch II, OSHA Salt Lake Technical Center,
Salt Lake City, Utah
Commercial manufacturers and products mentioned in this method
are for descriptive use only and do not constitute endorsements by
USDOL-OSHA. Similar products from other sources can be substituted.
1. Introduction
1.1. Scope
This method describes the collection of airborne elemental
cadmium and cadmium compounds on 0.8-m mixed cellulose
ester membrane filters and their subsequent analysis by either flame
atomic absorption spectroscopy (AAS) or flameless atomic absorption
spectroscopy using a heated graphite furnace atomizer (AAS-HGA). It
is applicable for both TWA and Action Level TWA Permissible Exposure
Level (PEL) measurements. The two atomic absorption analytical
techniques included in the method do not differentiate between
cadmium fume and cadmium dust samples. They also do not
differentiate between elemental cadmium and its compounds.
1.2. Principle
Airborne elemental cadmium and cadmium compounds are collected
on a 0.8-m mixed cellulose ester membrane filter (MCEF).
The air filter samples are digested with concentrated nitric acid to
destroy the organic matrix and dissolve the cadmium analytes. After
digestion, a small amount of concentrated hydrochloric acid is added
to help dissolve other metals which may be present. The samples are
diluted to volume with deionized water and then aspirated into the
oxidizing air/acetylene flame of an atomic absorption
spectrophotometer for analysis of elemental cadmium.
If the concentration of cadmium in a sample solution is too low
for quantitation by this flame AAS analytical technique, and the
sample is to be averaged with other samples for TWA calculations,
aliquots of the sample and a matrix modifier are later injected onto
a L'vov platform in a pyrolytically-coated graphite tube of a Zeeman
atomic absorption spectrophotometer/graphite furnace assembly for
analysis of elemental cadmium. The matrix modifier is added to
stabilize the cadmium metal and minimize sodium chloride as an
interference during the high temperature charring step of the
analysis (5.1., 5.2.).
1.3. History
Previously, two OSHA sampling and analytical methods for cadmium
were used concurrently (5.3., 5.4.). Both of these methods also
required 0.8-m mixed cellulose ester membrane filters for
the collection of air samples. These cadmium air filter samples were
analyzed by either flame atomic absorption spectroscopy (5.3.) or
inductively coupled plasma/atomic emission spectroscopy (ICP-AES)
(5.4.). Neither of these two analytical methods have adequate
sensitivity for measuring workplace exposure to airborne cadmium at
the new lower TWA and Action Level TWA PEL levels when consecutive
samples are taken on one employee and the sample results need to be
averaged with other samples to determine a single TWA.
The inclusion of two atomic absorption analytical techniques in
the new sampling and analysis method for airborne cadmium permits
quantitation of sample results over a broad range of exposure levels
and sampling periods. The flame AAS analytical technique included in
this method is similar to the previous procedure given in the
General Metals Method ID-121 (5.3.) with some modifications. The
sensitivity of the AAS-HGA analytical technique included in this
method is adequate to measure exposure levels at 1/10 the Action
Level TWA, or lower, when less than full-shift samples need to be
averaged together.
1.4. Properties (5.5.)
Elemental cadmium is a silver-white, blue-tinged, lustrous metal
which is easily cut with a knife. It is slowly oxidized by moist air
to form cadmium oxide. It is insoluble in water, but reacts readily
with dilute nitric acid. Some of the physical properties and other
descriptive information of elemental cadmium are given below:
CAS No.
7440-43-9
Atomic Number
48
Atomic Symbol
Cd
Atomic Weight
112.41
Melting Point
321 deg.C
Boiling Point
765 deg.C
Density
8.65 g/mL (25 deg.C)
The properties of specific cadmium compounds are described in
reference 5.5.
1.5. Method Performance
A synopsis of method performance is presented below. Further
information can be found in Section 4.
1.5.1. The qualitative and quantitative detection limits for the
flame AAS analytical technique are 0.04 g (0.004
g/mL) and 0.14 g (0.014 g/mL) cadmium,
respectively, for a 10 mL solution volume. These correspond,
respectively, to 0.2 g/m\3\ and 0.70 g/m\3\ for a
200 L air volume.
1.5.2. The qualitative and quantitative detection limits for the
AAS-HGA analytical technique are 0.44 ng (0.044 ng/mL) and 1.5 ng
(0.15 ng/mL) cadmium, respectively, for a 10 mL solution volume.
These correspond, respectively, to 0.007 g/m\3\ and 0.025
g/m\3\ for a 60 L air volume.
1.5.3. The average recovery by the flame AAS analytical
technique of 17 spiked MCEF samples containing cadmium in the range
of 0.5 to 2.0 times the TWA target concentration of 5 g/
m\3\ (assuming a 400 L air volume) was 104.0% with a pooled
coefficient of variation (CV1) of 0.010. The flame analytical
technique exhibited a positive bias of +4.0% for the validated
concentration range. The overall analytical error (OAE) for the
flame AAS analytical technique was 6.0%.
1.5.4. The average recovery by the AAS-HGA analytical technique
of 18 spiked MCEF samples containing cadmium in the range of 0.5 to
2.0 times the Action Level TWA target concentration of 2.5
g/m\3\ (assuming a 60 L air volume) was 94.2% with a pooled
coefficient of variation (CV1) of 0.043. The AAS-HGA analytical
technique exhibited a negative bias of -5.8% for the validated
concentration range. The overall analytical error (OAE) for the AAS-
HGA analytical technique was 14.2%.
1.5.5. Sensitivity in flame atomic absorption is defined as the
characteristic concentration of an element required to produce a
signal of 1% absorbance (0.0044 absorbance units). Sensitivity
values are listed for each element by the atomic absorption
spectrophotometer manufacturer and have proved to be a very valuable
diagnostic tool to determine if instrumental parameters are
optimized and if the instrument is performing up to specification.
The sensitivity of the spectrophotometer used in the validation of
the flame AAS analytical technique agreed with the manufacturer
specifications (5.6.); the 2 g/mL cadmium standard gave an
absorbance reading of 0.350 abs. units.
1.5.6. Sensitivity in graphite furnace atomic absorption is
defined in terms of the characteristic mass, the number of picograms
required to give an integrated absorbance value of 0.0044
absorbance-second (5.7.). Data suggests that under Stabilized
Temperature Platform Furnace (STPF) conditions (see Section 1.6.2.),
characteristic mass values are transferable between properly
functioning instruments to an accuracy of about 20% (5.2.). The
characteristic mass for STPF analysis of cadmium with Zeeman
background correction listed by the manufacturer of the instrument
used in the validation of the AAS-HGA analytical technique was 0.35
pg. The experimental characteristic mass value observed during the
determination of the working range and detection limits of the AAS-
HGA analytical technique was 0.41 pg.
1.6. Interferences
1.6.1. High concentrations of silicate interfere in determining
cadmium by flame AAS (5.6.). However, silicates are not
significantly soluble in the acid matrix used to prepare the
samples.
1.6.2. Interferences, such as background absorption, are reduced
to a minimum in the AAS-HGA analytical technique by taking full
advantage of the Stabilized Temperature Platform Furnace (STPF)
concept. STPF includes all of the following parameters (5.2.):
a. Integrated Absorbance,
b. Fast Instrument Electronics and Sampling Frequency,
c. Background Correction,
d. Maximum Power Heating,
e. Atomization off the L'vov platform in a pyrolytically coated
graphite tube,
f. Gas Stop during Atomization,
g. Use of Matrix Modifiers.
1.7. Toxicology (5.14.)
Information listed within this section is synopsis of current
knowledge of the physiological effects of cadmium and is not
intended to be used as the basis for OSHA policy. IARC classifies
cadmium and certain of its compounds as Group 2A carcinogens
(probably carcinogenic to humans). Cadmium fume is intensely
irritating to the respiratory tract. Workplace exposure to cadmium
can cause both chronic and acute effects. Acute effects include
tracheobronchitis, pneumonitis, and pulmonary edema. Chronic effects
include anemia, rhinitis/anosmia, pulmonary emphysema, proteinuria
and lung cancer. The primary target organs for chronic disease are
the kidneys (non-carcinogenic) and the lungs (carcinogenic).
2. Sampling
2.1. Apparatus
2.1.1. Filter cassette unit for air sampling: A 37-mm diameter
mixed cellulose ester membrane filter with a pore size of 0.8-
m contained in a 37-mm polystyrene two- or three-piece
cassette filter holder (part no. MAWP 037 A0, Millipore Corp.,
Bedford, MA). The filter is supported with a cellulose backup pad.
The cassette is sealed prior to use with a shrinkable gel band.
2.1.2. A calibrated personal sampling pump whose flow is
determined to an accuracy of 5% at the recommended flow
rate with the filter cassette unit in line.
2.2. Procedure
2.2.1. Attach the prepared cassette to the calibrated sampling
pump (the backup pad should face the pump) using flexible tubing.
Place the sampling device on the employee such that air is sampled
from the breathing zone.
2.2.2. Collect air samples at a flow rate of 2.0 L/min. If the
filter does not become overloaded, a full-shift (at least seven
hours) sample is strongly recommended for TWA and Action Level TWA
measurements with a maximum air volume of 960 L. If overloading
occurs, collect consecutive air samples for shorter sampling periods
to cover the full workshift.
2.2.3. Replace the end plugs into the filter cassettes
immediately after sampling. Record the sampling conditions.
2.2.4. Securely wrap each sample filter cassette end-to-end with
an OSHA Form 21 sample seal.
2.2.5. Submit at least one blank sample with each set of air
samples. The blank sample should be handled the same as the other
samples except that no air is drawn through it.
2.2.6. Ship the samples to the laboratory for analysis as soon
as possible in a suitable container designed to prevent damage in
transit.
3. Analysis
3.1. Safety Precautions
3.1.1. Wear safety glasses, protective clothing and gloves at
all times.
3.1.2. Handle acid solutions with care. Handle all cadmium
samples and solutions with extra care (see Sect. 1.7.). Avoid their
direct contact with work area surfaces, eyes, skin and clothes.
Flush acid solutions which contact the skin or eyes with copious
amounts of water.
3.1.3. Perform all acid digestions and acid dilutions in an
exhaust hood while wearing a face shield. To avoid exposure to acid
vapors, do not remove beakers containing concentrated acid solutions
from the exhaust hood until they have returned to room temperature
and have been diluted or emptied.
3.1.4. Exercise care when using laboratory glassware. Do not use
chipped pipets, volumetric flasks, beakers or any glassware with
sharp edges exposed in order to avoid the possibility of cuts or
abrasions.
3.1.5. Never pipet by mouth.
3.1.6. Refer to the instrument instruction manuals and SOPs
(5.8., 5.9.) for proper and safe operation of the atomic absorption
spectrophotometer, graphite furnace atomizer and associated
equipment.
3.1.7. Because metallic elements and other toxic substances are
vaporized during AAS flame or graphite furnace atomizer operation,
it is imperative that an exhaust vent be used. Always ensure that
the exhaust system is operating properly during instrument use.
3.2. Apparatus for Sample and Standard Preparation
3.2.1. Hot plate, capable of reaching 150 deg.C, installed in
an exhaust hood.
3.2.2. Phillips beakers, 125 mL.
3.2.3. Bottles, narrow-mouth, polyethylene or glass with
leakproof caps: used for storage of standards and matrix modifier.
3.2.4. Volumetric flasks, volumetric pipets, beakers and other
associated general laboratory glassware.
3.2.5. Forceps and other associated general laboratory
equipment.
3.3. Apparatus for Flame AAS Analysis
3.3.1. Atomic absorption spectrophotometer consisting of a(an):
Nebulizer and burner head
Pressure regulating devices capable of maintaining constant oxidant
and fuel pressures
Optical system capable of isolating the desired wavelength of
radiation (228.8 nm)
Adjustable slit
Light measuring and amplifying device
Display, strip chart, or computer interface for indicating the
amount of absorbed radiation
Cadmium hollow cathode lamp or electrodeless discharge lamp (EDL)
and power supply
3.3.2. Oxidant: compressed air, filtered to remove water, oil
and other foreign substances.
3.3.3. Fuel: standard commercially available tanks of acetylene
dissolved in acetone; tanks should be equipped with flash arresters.
Caution: Do not use grades of acetylene containing solvents
other than acetone because they may damage the PVC tubing used in
some instruments.
3.3.4. Pressure-reducing valves: two gauge, two-stage pressure
regulators to maintain fuel and oxidant pressures somewhat higher
than the controlled operating pressures of the instrument.
3.3.5. Exhaust vent installed directly above the
spectrophotometer burner head.
3.4. Apparatus for AAS-HGA Analysis
3.4.1. Atomic absorption spectrophotometer consisting of a(an):
Heated graphite furnace atomizer (HGA) with argon purge system
Pressure-regulating devices capable of maintaining constant argon
purge pressure
Optical system capable of isolating the desired wavelength of
radiation (228.8 nm)
Adjustable slit
Light measuring and amplifying device
Display, strip chart, or computer interface for indicating the
amount of absorbed radiation (as integrated absorbance, peak area)
Background corrector: Zeeman or deuterium arc. The Zeeman background
corrector is recommended
Cadmium hollow cathode lamp or electrodeless discharge lamp (EDL)
and power supply
Autosampler capable of accurately injecting 5 to 20 L
sample aliquots onto the L'vov Platform in a graphite tube
3.4.2. Pyrolytically coated graphite tubes containing solid,
pyrolytic L'vov platforms.
3.4.3. Polyethylene sample cups, 2.0 to 2.5 mL, for use with the
autosampler.
3.4.4. Inert purge gas for graphite furnace atomizer: compressed
gas cylinder of purified argon.
3.4.5. Two gauge, two-stage pressure regulator for the argon gas
cylinder.
3.4.6. Cooling water supply for graphite furnace atomizer.
3.4.7. Exhaust vent installed directly above the graphite
furnace atomizer.
3.5. Reagents
All reagents should be ACS analytical reagent grade or better.
3.5.1. Deionized water with a specific conductance of less than
10 S.
3.5.2. Concentrated nitric acid, HNO3.
3.5.3. Concentrated hydrochloric acid, HCl.
3.5.4. Ammonium phosphate, monobasic, NH4H2PO4.
3.5.5. Magnesium nitrate, Mg(NO3)2 6H2O.
3.5.6. Diluting solution (4% HNO3, 0.4% HCl): Add 40 mL
HNO3 and 4 mL HCl carefully to approximately 500 mL deionized
water and dilute to 1 L with deionized water.
3.5.7. Cadmium standard stock solution, 1,000 g/mL: Use
a commercially available certified 1,000 g/mL cadmium
standard or, alternatively, dissolve 1.0000 g of cadmium metal in a
minimum volume of 1:1 HCl and dilute to 1 L with 4% HNO3.
Observe expiration dates of commercial standards. Properly dispose
of commercial standards with no expiration dates or prepared
standards one year after their receipt or preparation date.
3.5.8. Matrix modifier for AAS-HGA analysis: Dissolve 1.0 g
NH4H2PO4 and 0.15 g Mg(NO3)2
6H2O in approximately 200 mL deionized water. Add 1 mL
HNO3 and dilute to 500 mL with deionized water.
3.5.9 Nitric Acid, 1:1 HNO3/DI H2O mixture: Carefully
add a measured volume of concentrated HNO3 to an equal volume
of DI H2O.
3.5.10. Nitric acid, 10% v/v: Carefully add 100 mL of
concentrated HNO3 to 500 mL of DI H2O and dilute to 1 L.
3.6. Glassware Preparation
3.6.1. Clean Phillips beakers by refluxing with 1:1 nitric acid
on a hot plate in a fume hood. Thoroughly rinse with deionized water
and invert the beakers to allow them to drain dry.
3.6.2. Rinse volumetric flasks and all other glassware with 10%
nitric acid and deionized water prior to use.
3.7. Standard Preparation for Flame AAS Analysis
3.7.1. Dilute stock solutions: Prepare 1, 5, 10 and 100
g/mL cadmium standard stock solutions by making appropriate
serial dilutions of 1,000 g/mL cadmium standard stock
solution with the diluting solution described in Section 3.5.6.
3.7.2. Working standards: Prepare cadmium working standards in
the range of 0.02 to 2.0 g/mL by making appropriate serial
dilutions of the dilute stock solutions with the same diluting
solution. A suggested method of preparation of the working standards
is given below.
------------------------------------------------------------------------
Standard
solution Aliquot Final
Working standard (g/mL) (g/ (mL) vol.
mL) (mL)
------------------------------------------------------------------------
0.02................................... 1 10 500
0.05................................... 5 5 500
0.1.................................... 10 5 500
0.2.................................... 10 10 500
0.5.................................... 10 25 500
1...................................... 100 5 500
2...................................... 100 10 500
------------------------------------------------------------------------
Store the working standards in 500-mL, narrow-mouth polyethylene
or glass bottles with leak proof caps. Prepare every twelve months.
3.8. Standard Preparation for AAS-HGA Analysis
3.8.1. Dilute stock solutions: Prepare 10, 100 and 1,000 ng/mL
cadmium standard stock solutions by making appropriate ten-fold
serial dilutions of the 1,000 g/mL cadmium standard stock
solution with the diluting solution described in Section 3.5.6.
3.8.2. Working standards: Prepare cadmium working standards in
the range of 0.2 to 20 ng/mL by making appropriate serial dilutions
of the dilute stock solutions with the same diluting solution. A
suggested method of preparation of the working standards is given
below.
------------------------------------------------------------------------
Standard Final
Working standard (ng/mL) solution Aliquot vol.
(ng/mL) (mL) (mL)
------------------------------------------------------------------------
0.2....................................... 10 2 100
0.5....................................... 10 5 100
1......................................... 10 10 100
2......................................... 100 2 100
5......................................... 100 5 100
10........................................ 100 10 100
20........................................ 1,000 2 100
------------------------------------------------------------------------
Store the working standards in narrow-mouth polyethylene or
glass bottles with leakproof caps. Prepare monthly.
3.9. Sample Preparation
3.9.1. Carefully transfer each sample filter with forceps from
its filter cassette unit to a clean, separate 125-mL Phillips beaker
along with any loose dust found in the cassette. Label each Phillips
beaker with the appropriate sample number.
3.9.2. Digest the sample by adding 5 mL of concentrated nitric
acid (HNO3) to each Phillips beaker containing an air filter
sample. Place the Phillips beakers on a hot plate in an exhaust hood
and heat the samples until approximately 0.5 mL remains. The sample
solution in each Phillips beaker should become clear. If it is not
clear, digest the sample with another portion of concentrated nitric
acid.
3.9.3. After completing the HNO3 digestion and cooling the
samples, add 40 L (2 drops) of concentrated HCl to each air
sample solution and then swirl the contents. Carefully add about 5
mL of deionized water by pouring it down the inside of each beaker.
3.9.4. Quantitatively transfer each cooled air sample solution
from each Phillips beaker to a clean 10-mL volumetric flask. Dilute
each flask to volume with deionized water and mix well.
3.10. Flame AAS Analysis
Analyze all of the air samples for their cadmium content by
flame atomic absorption spectroscopy (AAS) according to the
instructions given below.
3.10.1. Set up the atomic absorption spectrophotometer for the
air/acetylene flame analysis of cadmium according to the SOP (5.8.)
or the manufacturer's operational instructions. For the source lamp,
use the cadmium hollow cathode or electrodeless discharge lamp
operated at the manufacturer's recommended rating for continuous
operation. Allow the lamp to warm up 10 to 20 min or until the
energy output stabilizes. Optimize conditions such as lamp position,
burner head alignment, fuel and oxidant flow rates, etc. See the SOP
or specific instrument manuals for details. Instrumental parameters
for the Perkin-Elmer Model 603 used in the validation of this method
are given in Attachment 1.
3.10.2. Aspirate and measure the absorbance of a standard
solution of cadmium. The standard concentration should be within the
linear range. For the instrumentation used in the validation of this
method a 2 g/mL cadmium standard gives a net absorbance
reading of about 0.350 abs. units (see Section 1.5.5.) when the
instrument and the source lamp are performing to manufacturer
specifications.
3.10.3. To increase instrument response, scale expand the
absorbance reading of the aspirated 2 g/mL working standard
approximately four times. Increase the integration time to at least
3 seconds to reduce signal noise.
3.10.4. Autozero the instrument while aspirating a deionized
water blank. Monitor the variation in the baseline absorbance
reading (baseline noise) for a few minutes to insure that the
instrument, source lamp and associated equipment are in good
operating condition.
3.10.5. Aspirate the working standards and samples directly into
the flame and record their absorbance readings. Aspirate the
deionized water blank immediately after every standard or sample to
correct for and monitor any baseline drift and noise. Record the
baseline absorbance reading of each deionized water blank. Label
each standard and sample reading and its accompanying baseline
reading.
3.10.6. It is recommended that the entire series of working
standards be analyzed at the beginning and end of the analysis of a
set of samples to establish a concentration-response curve, ensure
that the standard readings agree with each other and are
reproducible. Also, analyze a working standard after every five or
six samples to monitor the performance of the spectrophotometer.
Standard readings should agree within 10 to 15% of the
readings obtained at the beginning of the analysis.
3.10.7. Bracket the sample readings with standards during the
analysis. If the absorbance reading of a sample is above the
absorbance reading of the highest working standard, dilute the
sample with diluting solution and reanalyze. Use the appropriate
dilution factor in the calculations.
3.10.8. Repeat the analysis of approximately 10% of the samples
for a check of precision.
3.10.9. If possible, analyze quality control samples from an
independent source as a check on analytical recovery and precision.
3.10.10. Record the final instrument settings at the end of the
analysis. Date and label the output.
3.11. AAS-HGA Analysis
Initially analyze all of the air samples for their cadmium
content by flame atomic absorption spectroscopy (AAS) according to
the instructions given in Section 3.10. If the concentration of
cadmium in a sample solution is less than three times the
quantitative detection limit [0.04 g/mL (40 ng/mL) for the
instrumentation used in the validation] and the sample results are
to be averaged with other samples for TWA calculations, proceed with
the AAS-HGA analysis of the sample as described below.
3.11.1. Set up the atomic absorption spectrophotometer and HGA
for flameless atomic absorption analysis of cadmium according to the
SOP (5.9.) or the manufacturer's operational instructions and allow
the instrument to stabilize. The graphite furnace atomizer is
equipped with a pyrolytically coated graphite tube containing a
pyrolytic platform. For the source lamp, use a cadmium hollow
cathode or electrodeless discharge lamp operated at the
manufacturer's recommended setting for graphite furnace operation.
The Zeeman background corrector and EDL are recommended for use with
the L'vov platform. Instrumental parameters for the Perkin-Elmer
Model 5100 spectrophotometer and Zeeman HGA-600 graphite furnace
used in the validation of this method are given in Attachment 2.
3.11.2. Optimize the energy reading of the spectrophotometer at
228.8 nm by adjusting the lamp position and the wavelength according
to the manufacturer's instructions.
3.11.3. Set up the autosampler to inject a 5-L aliquot
of the working standard, sample or reagent blank solution onto the
L'vov platform along with a 10-L overlay of the matrix
modifier.
3.11.4. Analyze the reagent blank (diluting solution, Section
3.5.6.) and then autozero the instrument before starting the
analysis of a set of samples. It is recommended that the reagent
blank be analyzed several times during the analysis to assure the
integrated absorbance (peak area) reading remains at or near zero.
3.11.5. Analyze a working standard approximately midway in the
linear portion of the working standard range two or three times to
check for reproducibility and sensitivity (see sections 1.5.5. and
1.5.6.) before starting the analysis of samples. Calculate the
experimental characteristic mass value from the average integrated
absorbance reading and injection volume of the analyzed working
standard. Compare this value to the manufacturer's suggested value
as a check of proper instrument operation.
3.11.6. Analyze the reagent blank, working standard, and sample
solutions. Record and label the peak area (abs-sec) readings and the
peak and background peak profiles on the printer/plotter.
3.11.7. It is recommended the entire series of working standards
be analyzed at the beginning and end of the analysis of a set of
samples. Establish a concentration-response curve and ensure
standard readings agree with each other and are reproducible. Also,
analyze a working standard after every five or six samples to
monitor the performance of the system. Standard readings should
agree within 15% of the readings obtained at the
beginning of the analysis.
3.11.8. Bracket the sample readings with standards during the
analysis. If the peak area reading of a sample is above the peak
area reading of the highest working standard, dilute the sample with
the diluting solution and reanalyze. Use the appropriate dilution
factor in the calculations.
3.11.9. Repeat the analysis of approximately 10% of the samples
for a check of precision.
3.11.10. If possible, analyze quality control samples from an
independent source as a check of analytical recovery and precision.
3.11.11. Record the final instrument settings at the end of the
analysis. Date and label the output.
3.12. Calculations
Note: Standards used for HGA analysis are in ng/mL. Total
amounts of cadmium from calculations will be in ng (not g)
unless a prior conversion is made.
3.12.1. Correct for baseline drift and noise in flame AAS
analysis by subtracting each baseline absorbance reading from its
corresponding working standard or sample absorbance reading to
obtain the net absorbance reading for each standard and sample.
3.12.2. Use a least squares regression program to plot a
concentration-response curve of net absorbance reading (or peak area
for HGA analysis) versus concentration (g/mL or ng/mL) of
cadmium in each working standard.
3.12.3. Determine the concentration (g/mL or ng/mL) of
cadmium in each sample from the resulting concentration-response
curve. If the concentration of cadmium in a sample solution is less
than three times the quantitative detection limit [0.04 g/
mL (40 ng/mL) for the instrumentation used in the validation of the
method] and if consecutive samples were taken on one employee and
the sample results are to be averaged with other samples to
determine a single TWA, reanalyze the sample by AAS-HGA as described
in Section 3.11. and report the AAS-HGA analytical results.
3.12.4. Calculate the total amount (g or ng) of cadmium
in each sample from the sample solution volume (mL) :
W=(C)(sample vol, mL)(DF)
Where:
W=Total cadmium in sample
C=Calculated concentration of cadmium
DF=Dilution Factor (if applicable)
3.12.5. Make a blank correction for each air sample by
subtracting the total amount of cadmium in the corresponding blank
sample from the total amount of cadmium in the sample.
3.12.6. Calculate the concentration of cadmium in an air sample
(mg/m\3\ or g/m\3\) by using one of the following
equations:
mg/m\3\=Wbc/(Air vol sampled, L)
or
g/m\3\=(Wbc)(1,000 ng/g)/(Air vol sampled, L)
Where:
Wbc=blank corrected total g cadmium in the sample.
(1g=1,000 ng)
4. Backup Data
4.1. Introduction
4.1.1. The purpose of this evaluation is to determine the
analytical method recovery, working standard range, and qualitative
and quantitative detection limits of the two atomic absorption
analytical techniques included in this method. The evaluation
consisted of the following experiments:
1. An analysis of 24 samples (six samples each at 0.1, 0.5, 1
and 2 times the TWA-PEL) for the analytical method recovery study of
the flame AAS analytical technique.
2. An analysis of 18 samples (six samples each at 0.5, 1 and 2
times the Action Level TWA-PEL) for the analytical method recovery
study of the AAS-HGA analytical technique.
3. Multiple analyses of the reagent blank and a series of
standard solutions to determine the working standard range and the
qualitative and quantitative detection limits for both atomic
absorption analytical techniques.
4.1.2. The analytical method recovery results at all test levels
were calculated from concentration-response curves and statistically
examined for outliers at the 99% confidence level. Possible outliers
were determined using the Treatment of Outliers test (5.10.). In
addition, the sample results of the two analytical techniques, at
0.5, 1.0 and 2.0 times their target concentrations, were tested for
homogeneity of variances also at the 99% confidence level.
Homogeneity of the coefficients of variation was determined using
the Bartlett's test (5.11.). The overall analytical error (OAE) at
the 95% confidence level was calculated using the equation (5.12.):
OAE=[|Bias|+(1.96)(CV1(pooled))(100%)]
4.1.3. A derivation of the International Union of Pure and
Applied Chemistry (IUPAC) detection limit equation (5.13.) was used
to determine the qualitative and quantitative detection limits for
both atomic absorption analytical techniques:
Cld=k(sd)/m (Equation 1)
Where:
Cld=the smallest reliable detectable concentration an
analytical instrument can determine at a given confidence level.
k=3 for the Qualitative Detection Limit at the 99.86% Confidence
Level
=10 for the Quantitative Detection Limit at the 99.99%
Confidence Level.
sd=standard deviation of the reagent blank (Rbl) readings.
m=analytical sensitivity or slope as calculated by linear
regression.
4.1.4. Collection efficiencies of metallic fume and dust
atmospheres on 0.8-m mixed cellulose ester membrane filters
are well documented and have been shown to be excellent (5.11.).
Since elemental cadmium and the cadmium component of cadmium
compounds are nonvolatile, stability studies of cadmium spiked MCEF
samples were not performed.
4.2. Equipment
4.2.1. A Perkin-Elmer (PE) Model 603 spectrophotometer equipped
with a manual gas control system, a stainless steel nebulizer, a
burner mixing chamber, a flow spoiler and a 10 cm. (one-slot) burner
head was used in the experimental validation of the flame AAS
analytical technique. A PE cadmium hollow cathode lamp, operated at
the manufacturer's recommended current setting for continuous
operation (4 mA), was used as the source lamp. Instrument parameters
are listed in Attachment 1.
4.2.2. A PE Model 5100 spectrophotometer, Zeeman HGA-600
graphite furnace atomizer and AS-60 HGA autosampler were used in the
experimental validation of the AAS-HGA analytical technique. The
spectrophotometer was equipped with a PE Series 7700 professional
computer and Model PR-310 printer. A PE System 2 cadmium
electrodeless discharge lamp, operated at the manufacturer's
recommended current setting for modulated operation (170 mA), was
used as the source lamp. Instrument parameters are listed in
Attachment 2.
4.3. Reagents
4.3.1. J.T. Baker Chem. Co. (Analyzed grade) concentrated nitric
acid, 69.0-71.0%, and concentrated hydrochloric acid, 36.5-38.0%,
were used to prepare the samples and standards.
4.3.2. Ammonium phosphate, monobasic, NH4H2PO4
and magnesium nitrate, Mg(NO3)2 6H2O, both
manufactured by the Mallinckrodt Chem. Co., were used to prepare the
matrix modifier for AAS-HGA analysis.
4.4. Standard Preparation for Flame AAS Analysis
4.4.1. Dilute stock solutions: Prepared 0.01, 0.1, 1, 10 and 100
g/mL cadmium standard stock solutions by making appropriate
serial dilutions of a commercially available 1,000 g/mL
cadmium standard stock solution (RICCA Chemical Co., Lot# A102) with
the diluting solution (4% HNO3, 0.4% HCl).
4.4.2. Analyzed Standards: Prepared cadmium standards in the
range of 0.001 to 2.0 g/mL by pipetting 2 to 10 mL of the
appropriate dilute cadmium stock solution into a 100-mL volumetric
flask and diluting to volume with the diluting solution. (See
Section 3.7.2.)
4.5. Standard Preparation for AAS-HGA Analysis
4.5.1. Dilute stock solutions: Prepared 1, 10, 100 and 1,000 ng/
mL cadmium standard stock solutions by making appropriate serial
dilutions of a commercially available 1,000 g/mL cadmium
standard stock solution (J.T. Baker Chemical Co., Instra-analyzed,
Lot# D22642) with the diluting solution (4% HNO3, 0.4% HCl).
4.5.2. Analyzed Standards: Prepared cadmium standards in the
range of 0.1 to 40 ng/mL by pipetting 2 to 10 mL of the appropriate
dilute cadmium stock solution into a 100-mL volumetric flask and
diluting to volume with the diluting solution. (See Section 3.8.2.)
4.6. Detection Limits and Standard Working Range for Flame AAS Analysis
4.6.1. Analyzed the reagent blank solution and the entire series
of cadmium standards in the range of 0.001 to 2.0 g/mL
three to six times according to the instructions given in Section
3.10. The diluting solution (4% HNO3, 0.4% HCl) was used as the
reagent blank. The integration time on the PE 603 spectrophotometer
was set to 3.0 seconds and a four-fold expansion of the absorbance
reading of the 2.0 g/mL cadmium standard was made prior to
analysis. The 2.0 g/mL standard gave a net absorbance
reading of 0.350 abs. units prior to expansion in agreement with the
manufacturer's specifications (5.6.).
4.6.2. The net absorbance readings of the reagent blank and the
low concentration Cd standards from 0.001 to 0.1 g/mL and
the statistical analysis of the results are shown in Table I. The
standard deviation, sd, of the six net absorbance readings of the
reagent blank is 1.05 abs. units. The slope, m, as calculated by a
linear regression plot of the net absorbance readings (shown in
Table II) of the 0.02 to 1.0 g/mL cadmium standards versus
their concentration is 772.7 abs. units/(g/mL).
4.6.3. If these values for sd and the slope, m, are used in Eqn.
1 (Sect. 4.1.3.), the qualitative and quantitative detection limits
as determined by the IUPAC Method are:
Cld=(3)(1.05 abs. units)/(772.7 abs. units/(g/mL))
= 0.0041 g/mL for the qualitative detection limit.
Cld=(10)(1.05 abs. units)/(772.7 abs. units/g/mL))
=0.014 g/mL for the quantitative detection limit.
The qualitative and quantitative detection limits for the flame AAS
analytical technique are 0.041 g and 0.14 g
cadmium, respectively, for a 10 mL solution volume. These
correspond, respectively, to 0.2 g/m3 and 0.70
g/m3 for a 200 L air volume.
4.6.4. The recommended Cd standard working range for flame AAS
analysis is 0.02 to 2.0 g/mL. The net absorbance readings
of the re
FR Doc. 93-31820 Occupational Safety and Health Standards for Cadmium in Shipyard Employment and Construction
agent blank and the recommended working range standards and
the statistical analysis of the results are shown in Table II. The
standard of lowest concentration in the working range, 0.02
g/mL, is slightly greater than the calculated quantitative
detection limit, 0.014 g/mL. The standard of highest
concentration in the working range, 2.0 g/mL, is at the
upper end of the linear working range suggested by the manufacturer
(5.6.). Although the standard net absorbance readings are not
strictly linear at concentrations above 0.5 g/mL, the
deviation from linearity is only about 10% at the upper end of the
recommended standard working range. The deviation from linearity is
probably caused by the four-fold expansion of the signal suggested
in the method. As shown in Table II, the precision of the standard
net absorbance readings are excellent throughout the recommended
working range; the relative standard deviations of the readings
range from 0.009 to 0.064.
4.7. Detection Limits and Standard Working Range for AAS-HGA Analysis
4.7.1. Analyzed the reagent blank solution and the entire series
of cadmium standards in the range of 0.1 to 40 ng/mL according to
the instructions given in Section 3.11. The diluting solution (4%
HNO3, 0.4% HCl) was used as the reagent blank. A fresh aliquot
of the reagent blank and of each standard was used for every
analysis. The experimental characteristic mass value was 0.41 pg,
calculated from the average peak area (abs-sec) reading of the 5 ng/
mL standard which is approximately midway in the linear portion of
the working standard range. This agreed within 20% with the
characteristic mass value, 0.35 pg, listed by the manufacturer of
the instrument (5.2.).
4.7.2. The peak area (abs-sec) readings of the reagent blank and
the low concentration Cd standards from 0.1 to 2.0 ng/mL and
statistical analysis of the results are shown in Table III. Five of
the reagent blank peak area readings were zero and the sixth reading
was 1 and was an outlier. The near lack of a blank signal does not
satisfy a strict interpretation of the IUPAC method for determining
the detection limits. Therefore, the standard deviation of the six
peak area readings of the 0.2 ng/mL cadmium standard, 0.75 abs-sec,
was used to calculate the detection limits by the IUPAC method. The
slope, m, as calculated by a linear regression plot of the peak area
(abs-sec) readings (shown in Table IV) of the 0.2 to 10 ng/mL
cadmium standards versus their concentration is 51.5 abs-sec/(ng/
mL).
4.7.3. If 0.75 abs-sec (sd) and 51.5 abs-sec/(ng/mL) (m) are
used in Eqn. 1 (Sect. 4.1.3.), the qualitative and quantitative
detection limits as determined by the IUPAC method are:
Cld= (3)(0.75 abs-sec)/(51.5 abs-sec/(ng/mL)
= 0.044 ng/mL for the qualitative detection limit.
Cld= (10)(0.75 abs-sec)/(51.5 abs-sec/(ng/mL) = 0.15 ng/mL for
the quantitative detection limit.
The qualitative and quantitative detection limits for the AAS-HGA
analytical technique are 0.44 ng and 1.5 ng cadmium, respectively,
for a 10 mL solution volume. These correspond, respectively, to
0.007 g/m3 and 0.025 g/m3 for a 60 L air
volume.
4.7.4. The peak area (abs-sec) readings of the Cd standards from
0.2 to 40 ng/mL and the statistical analysis of the results are
given in Table IV. The recommended standard working range for AAS-
HGA analysis is 0.2 to 20 ng/mL. The standard of lowest
concentration in the recommended working range is slightly greater
than the calculated quantitative detection limit, 0.15 ng/mL. The
deviation from linearity of the peak area readings of the 20 ng/mL
standard, the highest concentration standard in the recommended
working range, is approximately 10%. The deviations from linearity
of the peak area readings of the 30 and 40 ng/mL standards are
significantly greater than 10%. As shown in Table IV, the precision
of the peak area readings are satisfactory throughout the
recommended working range; the relative standard deviations of the
readings range from 0.025 to 0.083.
4.8. Analytical Method Recovery for Flame AAS Analysis
4.8.1. Four sets of spiked MCEF samples were prepared by
injecting 20 L of 10, 50, 100 and 200 g/mL dilute
cadmium stock solutions on 37 mm diameter filters (part no. AAWP 037
00, Millipore Corp., Bedford, MA) with a calibrated micropipet. The
dilute stock solutions were prepared by making appropriate serial
dilutions of a commercially available 1,000 g/mL cadmium
standard stock solution (RICCA Chemical Co., Lot# A102) with the
diluting solution (4% HNO3, 0.4% HCl). Each set contained six
samples and a sample blank. The amount of cadmium in the prepared
sets were equivalent to 0.1, 0.5, 1.0 and 2.0 times the TWA PEL
target concentration of 5 g/m3 for a 400 L air volume.
4.8.2. The air-dried spiked filters were digested and analyzed
for their cadmium content by flame atomic absorption spectroscopy
(AAS) following the procedure described in Section 3. The 0.02 to
2.0 g/mL cadmium standards (the suggested working range)
were used in the analysis of the spiked filters.
4.8.3. The results of the analysis are given in Table V. One
result at 0.5 times the TWA PEL target concentration was an outlier
and was excluded from statistical analysis. Experimental
justification for rejecting it is that the outlier value was
probably due to a spiking error. The coefficients of variation for
the three test levels at 0.5 to 2.0 times the TWA PEL target
concentration passed the Bartlett's test and were pooled.
4.8.4. The average recovery of the six spiked filter samples at
0.1 times the TWA PEL target concentration was 118.2% with a
coefficient of variation (CV1) of 0.128. The average recovery
of the spiked filter samples in the range of 0.5 to 2.0 times the
TWA target concentration was 104.0% with a pooled coefficient of
variation (CV1) of 0.010. Consequently, the analytical bias
found in these spiked sample results over the tested concentration
range was +4.0% and the OAE was 6.0%.
4.9. Analytical Method Recovery for AAS-HGA Analysis
4.9.1. Three sets of spiked MCEF samples were prepared by
injecting 15 L of 5, 10 and 20 g/mL dilute cadmium
stock solutions on 37 mm diameter filters (part no. AAWP 037 00,
Millipore Corp., Bedford, MA) with a calibrated micropipet. The
dilute stock solutions were prepared by making appropriate serial
dilutions of a commercially available certified 1,000 g/mL
cadmium standard stock solution (Fisher Chemical Co., Lot# 913438-
24) with the diluting solution (4% HNO3, 0.4% HCl). Each set
contained six samples and a sample blank. The amount of cadmium in
the prepared sets were equivalent to 0.5, 1 and 2 times the Action
Level TWA target concentration of 2.5 g/m3 for a 60 L
air volume.
4.9.2. The air-dried spiked filters were digested and analyzed
for their cadmium content by flameless atomic absorption
spectroscopy using a heated graphite furnace atomizer following the
procedure described in Section 3. A five-fold dilution of the spiked
filter samples at 2 times the Action Level TWA was made prior to
their analysis. The 0.05 to 20 ng/mL cadmium standards were used in
the analysis of the spiked filters.
4.9.3. The results of the analysis are given in Table VI. There
were no outliers. The coefficients of variation for the three test
levels at 0.5 to 2.0 times the Action Level TWA PEL passed the
Bartlett's test and were pooled. The average recovery of the spiked
filter samples was 94.2% with a pooled coefficient of variation
(CV1) of 0.043. Consequently, the analytical bias was -5.8% and
the OAE was 14.2%.
4.10. Conclusions
The experiments performed in this evaluation show the two atomic
absorption analytical techniques included in this method to be
precise and accurate and have sufficient sensitivity to measure
airborne cadmium over a broad range of exposure levels and sampling
periods.
5. References
5.1. Slavin, W. Graphite Furnace AAS--A Source Book; Perkin-
Elmer Corp., Spectroscopy Div.: Ridgefield, CT , 1984; p. 18 and pp.
83-90.
5.2. Grosser, Z., Ed.; Techniques in Graphite Furnace Atomic
Absorption Spectrophotometry; Perkin-Elmer Corp., Spectroscopy Div.:
Ridgefield, CT, 1985.
5.3. Occupational Safety and Health Administration Salt Lake
Technical Center: Metal and Metalloid Particulate in Workplace
Atmospheres (Atomic Absorption) (USDOL/OSHA Method No. ID-121). In
OSHA Analytical Methods Manual 2nd ed. Cincinnati, OH: American
Conference of Governmental Industrial Hygienists, 1991.
5.4. Occupational Safety and Health Administration Salt Lake
Technical Center: Metal and Metalloid Particulate in Workplace
Atmospheres (ICP) (USDOL/OSHA Method No. ID-125G). In OSHA
Analytical Methods Manual 2nd ed. Cincinnati, OH: American
Conference of Governmental Industrial Hygienists, 1991.
5.5. Windholz, M., Ed.; The Merck Index, 10th ed.; Merck & Co.:
Rahway, NJ, 1983.
5.6. Analytical Methods for Atomic Absorption Spectrophotometry,
The Perkin-Elmer Corporation: Norwalk, CT, 1982.
5.7. Slavin, W., D.C. Manning, G. Carnrick, and E. Pruszkowska:
Properties of the Cadmium Determination with the Platform Furnace
and Zeeman Background Correction. Spectrochim. Acta 38B:1157-1170
(1983).
5.8. Occupational Safety and Health Administration Salt Lake
Technical Center: Standard Operating Procedure for Atomic
Absorption. Salt Lake City, UT: USDOL/OSHA-SLTC, In progress.
5.9. Occupational Safety and Health Administration Salt Lake
Technical Center: AAS-HGA Standard Operating Procedure. Salt Lake
City, UT: USDOL/OSHA-SLTC, In progress.
5.10. Mandel, J.: Accuracy and Precision, Evaluation and
Interpretation of Analytical Results, The Treatment of Outliers. In
Treatise On Analytical Chemistry, 2nd ed., Vol.1, edited by I. M.
Kolthoff and P. J. Elving. New York: John Wiley and Sons, 1978. pp.
282-285.
5.11. National Institute for Occupational Safety and Health:
Documentation of the NIOSH Validation Tests by D. Taylor, R. Kupel,
and J. Bryant (DHEW/NIOSH Pub. No. 77-185). Cincinnati, OH: National
Institute for Occupational Safety and Health, 1977.
5.12. Occupational Safety and Health Administration Analytical
Laboratory: Precision and Accuracy Data Protocol for Laboratory
Validations. In OSHA Analytical Methods Manual 1st ed. Cincinnati,
OH: American Conference of Governmental Industrial Hygienists (Pub.
No. ISBN: 0-936712-66-X), 1985.
5.13. Long, G.L. and J.D. Winefordner: Limit of Detection--A
Closer Look at the IUPAC Definition. Anal.Chem. 55:712A-724A (1983).
5.14. American Conference of Governmental Industrial Hygienists:
Documentation of Threshold Limit Values and Biological Exposure
Indices. 5th ed. Cincinnati, OH: American Conference of Governmental
Industrial Hygienists, 1986.
Table I.--Cd Detection Limit Study
[Flame AAS Analysis]
------------------------------------------------------------------------
Absorbance
STD (g/mL) reading at 228.8 Statistical analysis
nm
------------------------------------------------------------------------
Reagent blank............. 52 n=6.
43 mean=3.50.
43 std dev=1.05.
CV=0.30.
0.001..................... 66 n=6.
24 mean=5.00.
66 std dev=1.67.
CV=0.335.
0.002..................... 57 n=6.
73 mean=5.50.
74 std dev=1.76.
CV=0.320.
0.005..................... 77 n=6.
88 mean=7.33.
86 std dev=0.817.
CV=0.111.
0.010..................... 109 n=6.
1013 mean=10.3.
1010 std dev=1.37.
CV=0.133.
0.020..................... 2023 n=6.
2022 mean=20.8.
2020 std dev=1.33.
CV=0.064.
0.050..................... 4242 n=6.
4242 mean=42.5.
4245 std dev=1.22.
CV=0.029.
0.10...................... 84 n=3.
80 mean=82.3.
83 std dev=2.08.
CV=0.025.
------------------------------------------------------------------------
Table II.--Cd Standard Working Range Study
[Flame AAS Analysis]
------------------------------------------------------------------------
Absorbance
STD (g/mL) reading at 228.8 Statistical analysis
nm
------------------------------------------------------------------------
Reagent blank............. 52 n=6.
43 mean=3.50.
43 std dev=1.05.
CV=0.30.
0.020..................... 2023 n=6.
2022 mean=20.8.
2020 std dev=1.33.
CV=0.064.
0.050..................... 4242 n=6.
4242 mean=42.5.
4245 std dev=1.22.
CV=0.029.
0.10...................... 84 n=3.
80 mean=82.3.
83 std dev=2.08.
CV=0.025.
0.20...................... 161 n=3.
161 mean=160.0.
158 std dev=1.73.
CV=0.011.
0.50...................... 391 n=3.
389 mean=391.0.
393 std dev=2.00.
CV=0.005.
1.00...................... 760 n=3.
748 mean=753.3.
752 std dev=6.11.
CV=0.008.
2.00...................... 1416 n=3.
1426 mean=1414.3.
1401 std dev=12.6.
CV=0.009.
------------------------------------------------------------------------
Table III.--Cd Detection Limit Study
[AAS-HGA Analysis]
------------------------------------------------------------------------
Peak area
readings x
STD (ng/mL) 103 at 228.8 Statistical analysis
nm
------------------------------------------------------------------------
Reagent blank.............. 00 n=6.
01 mean=0.167.
00 std dev=0.41.
CV=2.45.
0.1........................ 86 n=6.
57 mean=7.7.
137 std dev=2.8.
CV=0.366.
0.2........................ 1113 n=6.
1112 mean=11.8.
1212 std dev=0.75.
CV=0.064.
0.5........................ 2833 n=6.
2628 mean=28.8.
2830 std dev=2.4.
CV=0.083.
1.0........................ 5255 n=6.
5658 mean=54.8.
5454 std dev=2.0.
CV=0.037.
2.0........................ 101112 n=6.
110110 mean=108.8.
110110 std dev=3.9.
CV=0.036.
------------------------------------------------------------------------
Table IV.--Cd Standard Working Range Study
[AAS-HGA Analysis]
------------------------------------------------------------------------
Peak area
readings x
STD (ng/mL) 103 at 228.8 Statistical analysis
nm
------------------------------------------------------------------------
0.2........................ 1113 n=6.
1112 mean=11.8.
1212 std dev=0.75.
CV=0.064.
0.5........................ 2833 n=6.
2628 mean=28.8.
2830 std dev=2.4.
CV=0.083.
1.0........................ 5255 n=6.
5658 mean=54.8.
5454 std dev=2.0.
CV=0.037.
2.0........................ 101112 n=6.
110110 mean=108.8.
110110 std dev=3.9.
CV=0.036.
5.0........................ 247265 n=6.
268275 mean=265.5.
259279 std dev=11.5.
CV=0.044.
10.0....................... 495520 n=6.
523513 mean=516.7.
516533 std dev=12.7.
CV=0.025.
20.0....................... 950953 n=6.
951958 mean=941.8.
949890 std dev=25.6.
CV=0.027.
30.0....................... 12691291 n=6.
13031307 mean=1293.
12951290 std dev=13.3.
CV=0.010.
40.0....................... 15051567 n=6.
15351567 mean=1552.
15661572 std dev=26.6.
CV=0.017.
------------------------------------------------------------------------
Table V.--Analytical Method Recovery
[Flame AAS Analysis]
----------------------------------------------------------------------------------------------------------------
Test level 0.5 x 1.0 x 2.0 x
-------------------------------- Percent g ------------ Percent g ------------ Percent
g rec. taken g rec. taken g rec.
g taken found found found
----------------------------------------------------------------------------------------------------------------
1.00............... 1.0715 107.2 2.00 2.0688 103.4 4.00 4.1504 103.8
1.00............... 1.0842 108.4 2.00 2.0174 100.9 4.00 4.1108 102.8
1.00............... 1.0842 108.4 2.00 2.0431 102.2 4.00 4.0581 101.5
1.00............... *1.0081 *100.8 2.00 2.0431 102.2 4.00 4.0844 102.1
1.00............... 1.0715 107.2 2.00 2.0174 100.9 4.00 4.1504 103.8
1.00............... 1.0842 108.4 2.00 2.0045 100.2 4.00 4.1899 104.7
----------------------------------------------------------------------------------------------------------------
n= 5 6 6
mean= 107.9 101.6 103.1
std dev= 0.657 1.174 1.199
CV1= 0.006 0.011 0.012
CV1 (pooled)=0.010
*Rejected as an outlier--this value did not pass the outlier T-test at the 99% confidence level.
------------------------------------------------------------------------
Test level 0.1 x
-------------------------------------------------------- Percent rec.
g taken g found
------------------------------------------------------------------------
0.200............................... 0.2509 125.5
0.200............................... 0.2509 125.5
0.200............................... 0.2761 138.1
0.200............................... 0.2258 112.9
0.200............................... 0.2258 112.9
0.200............................... 0.1881 94.1
------------------------------------------------------------------------
n=.................................. 6
mean=............................... 118.2
std dev=............................ 15.1
CV1=................................ 0.128
Table VI.--Analytical Method Recovery
[AAS-HGA analysis]
----------------------------------------------------------------------------------------------------------------
Test level 0.5 x 1.0 x 2.0 x
------------------------------------ Percent ng taken ----------- Percent ng taken ----------- Percent
ng taken ng found rec. ng found rec. ng found rec.
----------------------------------------------------------------------------------------------------------------
75...................... 71.23 95.0 150 138.00 92.0 300 258.43 86.1
75...................... 71.47 95.3 150 138.29 92.2 300 258.46 86.2
75...................... 70.02 93.4 150 136.30 90.9 300 280.55 93.5
75...................... 77.34 103.1 150 146.62 97.7 300 288.34 96.1
75...................... 78.32 104.4 150 145.17 96.8 300 261.74 87.2
75...................... 71.96 95.9 150 144.88 96.6 300 277.22 92.4
----------------------------------------------------------------------------------------------------------------
n= 6 6 6
mean= 97.9 94.4 90.3
std dev= 4.66 2.98 4.30
CV1= 0.048 0.032 0.048
CV1(pooled)=0.043
Attachment 1
Instrumental Parameters for Flame AAS Analysis
Atomic Absorption Spectrophotometer (Perkin-Elmer Model 603)
Flame: Air/Acetylene--lean, blue
Oxidant Flow: 55
Fuel Flow: 32
Wavelength: 228.8 nm
Slit: 4 (0.7 nm)
Range: UV
Signal: Concentration (4 exp)
Integration Time: 3 sec
Attachment 2
Instrumental Parameters for HGA Analysis
Atomic Absorption Spectrophotometer (Perkin-Elmer Model 5100)
Signal Type: Zeeman AA
Slitwidth: 0.7 nm
Wavelength: 228.8 nm
Measurement: Peak Area
Integration Time: 6.0 sec
BOC Time: 5 sec
BOC=Background Offset Correction.
Zeeman Graphite Furnace (Perkin-Elmer Model HGA-600)
----------------------------------------------------------------------------------------------------------------
Ramp time Hold time Temp. ( Argon flow
Step (sec) (sec) deg.C) (mL/min) Read (sec)
----------------------------------------------------------------------------------------------------------------
1) Predry........................................... 5 10 90 300 ..........
2) Dry.............................................. 30 10 140 300 ..........
3) Char............................................. 10 20 900 300 ..........
4) Cool Down........................................ 1 8 30 300 ..........
5) Atomize.......................................... 0 5 1600 0 -1
6) Burnout.......................................... 1 8 2500 300 ..........
----------------------------------------------------------------------------------------------------------------
Appendix F to Sec. 1915.1027--Nonmandatory Protocol for Biological
Monitoring
1.00 Introduction
Under the final OSHA cadmium rule (29 CFR part 1910), monitoring
of biological specimens and several periodic medical examinations
are required for eligible employees. These medical examinations are
to be conducted regularly, and medical monitoring is to include the
periodic analysis of cadmium in blood (CDB), cadmium in urine (CDU)
and beta-2-microglobulin in urine (B2MU). As CDU and B2MU are to be
normalized to the concentration of creatinine in urine (CRTU), then
CRTU must be analyzed in conjunction with CDU and B2MU analyses.
The purpose of this protocol is to provide procedures for
establishing and maintaining the quality of the results obtained
from the analyses of CDB, CDU and B2MU by commercial laboratories.
Laboratories conforming to the provisions of this nonmandatory
protocol shall be known as ``participating laboratories.'' The
biological monitoring data from these laboratories will be evaluated
by physicians responsible for biological monitoring to determine the
conditions under which employees may continue to work in locations
exhibiting airborne-cadmium concentrations at or above defined
actions levels (see paragraphs (l)(3) and (l)(4) of the final rule).
These results also may be used to support a decision to remove
workers from such locations.
Under the medical monitoring program for cadmium, blood and
urine samples must be collected at defined intervals from workers by
physicians responsible for medical monitoring; these samples are
sent to commerical laboratories that perform the required analyses
and report results of these analyses to the responsible physicians.
To ensure the accuracy and reliability of these laboratory analyses,
the laboratories to which samples are submitted should participate
in an ongoing and efficacious proficiency testing program.
Availability of proficiency testing programs may vary with the
analyses performed.
To test proficiency in the analysis of CDB, CDU and B2MU, a
laboratory should participate either in the interlaboratory
comparison program operated by the Centre de Toxicologie du Quebec
(CTQ) or an equivalent program. (Currently, no laboratory in the
U.S. performs proficiency testing on CDB, CDU or B2MU.) Under this
program, CTQ sends participating laboratories 18 samples of each
analyte (CDB, CDU and/or B2MU) annually for analysis. Participating
laboratories must return the results of these analyses to CTQ within
four to five weeks after receiving the samples.
The CTQ program pools analytical results from many participating
laboratories to derive consensus mean values for each of the samples
distributed. Results reported by each laboratory then are compared
against these consensus means for the analyzed samples to determine
the relative performance of each laboratory. The proficiency of a
participating laboratory is a function of the extent of agreement
between results submitted by the participating laboratory and the
consensus values for the set of samples analyzed.
Proficiency testing for CRTU analysis (which should be performed
with CDU and B2MU analyses to evaluate the results properly) also is
recommended. In the U.S., only the College of American Pathologists
(CAP) currently conducts CRTU proficiency testing; participating
laboratories should be accredited for CRTU analysis by the CAP.
Results of the proficiency evaluations will be forwarded to the
participating laboratory by the proficiency-testing laboratory, as
well as to physicians designated by the participating laboratory to
receive this information. In addition, the participating laboratory
should, on request, submit the results of their internal Quality
Assurance/Quality Control (QA/QC) program for each analytic
procedure (i.e., CDB, CDU and/or B2MU) to physicians designated to
receive the proficiency results. For participating laboratories
offering CDU and/or B2MU analyses, QA/QC documentation also should
be provided for CRTU analysis. (Laboratories should provide QA/QC
information regarding CRTU analysis directly to the requesting
physician if they perform the analysis in-house; if CRTU analysis is
performed by another laboratory under contract, this information
should be provided to the physician by the contract laboratory.)
QA/QC information, along with the actual biological specimen
measurements, should be provided to the responsible physician using
standard formats. These physicians then may collate the QA/QC
information with proficiency test results to compare the relative
performance of laboratories, as well as to facilitate evaluation of
the worker monitoring data. This information supports decisions made
by the physician with regard to the biological monitoring program,
and for mandating medical removal.
This protocol describes procedures that may be used by the
responsible physicians to identify laboratories most likely to be
proficient in the analysis of samples used in the biological
monitoring of cadmium; also provided are procedures for record
keeping and reporting by laboratories participating in proficiency
testing programs, and recommendations to assist these physicians in
interpreting analytical results determined by participating
laboratories. As the collection and handling of samples affects the
quality of the data, recommendations are made for these tasks.
Specifications for analytical methods to be used in the medical
monitoring program are included in this protocol as well.
In conclusion, this document is intended as a supplement to
characterize and maintain the quality of medical monitoring data
collected under the final cadmium rule promulgated by OSHA (29 CFR
part 1910). OSHA has been granted authority under the Occupational
Safety and Health Act of 1970 to protect workers from the effects of
exposure to hazardous substances in the work place and to mandate
adequate monitoring of workers to determine when adverse health
effects may be occurring. This nonmandatory protocol is intended to
provide guidelines and recommendations to improve the accuracy and
reliability of the procedures used to analyze the biological samples
collected as part of the medical monitoring program for cadmium.
2.0 Definitions
When the terms below appear in this protocol, use the following
definitions.
Accuracy: A measure of the bias of a data set. Bias is a
systematic error that is either inherent in a method or caused by
some artifact or idiosyncracy of the measurement system. Bias is
characterized by a consistent deviation (positive or negative) in
the results from an accepted reference value.
Arithmetic Mean: The sum of measurements in a set divided by the
number of measurements in a set.
Blind Samples: A quality control procedure in which the
concentration of analyte in the samples should be unknown to the
analyst at the time that the analysis is performed.
Coefficient of Variation: The ratio of the standard deviation of
a set of measurements to the mean (arithmetic or geometric) of the
measurements.
Compliance Samples: Samples from exposed workers sent to a
participating laboratory for analysis.
Control Charts: Graphic representations of the results for
quality control samples being analyzed by a participating
laboratory.
Control Limits: Statistical limits which define when an analytic
procedure exceeds acceptable parameters; control limits provide a
method of assessing the accuracy of analysts, laboratories, and
discrete analytic runs.
Control Samples: Quality control samples.
F/T: The measured amount of an analyte divided by the
theoretical value (defined below) for that analyte in the sample
analyzed; this ratio is a measure of the recovery for a quality
control sample.
Geometric Mean: The natural antilog of the mean of a set of
natural log-transformed data.
Geometric Standard Deviation: The antilog of the standard
deviation of a set of natural log-transformed data.
Limit of Detection: Using a predefined level of confidence, this
is the lowest measured value at which some of the measured material
is likely to have come from the sample.
Mean: A central tendency of a set of data; in this protocol,
this mean is defined as the arithmetic mean (see definition of
arithmetic mean above) unless stated otherwise.
Performance: A measure of the overall quality of data reported
by a laboratory.
Pools: Groups of quality-control samples to be established for
each target value (defined below) of an analyte. For the protocol
provided in attachment 3, for example, the theoretical value of the
quality control samples of the pool must be within a range defined
as plus or minus () 50% of the target value. Within each
analyte pool, there must be quality control samples of at least 4
theoretical values.
Precision: The extent of agreement between repeated, independent
measurements of the same quantity of an analyte.
Proficiency: The ability to satisfy a specified level of analyte
performance.
Proficiency Samples: Specimens, the values of which are unknown
to anyone at a participating laboratory, and which are submitted by
a participating laboratory for proficiency testing.
Quality or Data Quality: A measure of the confidence in the
measurement value.
Quality Control (QC) Samples: Specimens, the value of which is
unknown to the analyst, but is known to the appropriate QA/QC
personnel of a participating laboratory; when used as part of a
laboratory QA/QC program, the theoretical values of these samples
should not be known to the analyst until the analyses are complete.
QC samples are to be run in sets consisting of one QC sample from
each pool (see definition of ``pools'' above).
Sensitivity: For the purposes of this protocol, the limit of
detection.
Standard Deviation: A measure of the distribution or spread of a
data set about the mean; the standard deviation is equal to the
positive square root of the variance, and is expressed in the same
units as the original measurements in the data set.
Standards: Samples with values known by the analyst and used to
calibrate equipment and to check calibration throughout an analytic
run. In a laboratory QA/QC program, the values of the standards must
exceed the values obtained for compliance samples such that the
lowest standard value is near the limit of detection and the highest
standard is higher than the highest compliance sample or QC sample.
Standards of at least three different values are to be used for
calibration, and should be constructed from at least 2 different
sources.
Target Value: Those values of CDB, CDU or B2MU which trigger
some action as prescribed in the medical surveillance section of the
regulatory text of the final cadmium rule. For CDB, the target
values are 5, 10, and 15 g/l. For CDU, the target values
are 3, 7, and 15 g/g CRTU. For
2MU, the target values are 300, 750, and
1500 g/g CRTU. (Note that target values may vary as a
function of time.)
Theoretical Value (or Theoretical Amount): The reported
concentration of a quality-control sample (or calibration standard)
derived from prior characterizations of the sample.
Value or Measurement Value: The numerical result of a
measurement.
Variance: A measure of the distribution or spread of a data set
about the mean; the variance is the sum of the squares of the
differences between the mean and each discrete measurement divided
by one less than the number of measurements in the data set.
3.0 Protocol
This protocol provides procedures for characterizing and
maintaining the quality of analytic results derived for the medical
monitoring program mandated for workers under the final cadmium
rule.
3.1 Overview
The goal of this protocol is to assure that medical monitoring
data are of sufficient quality to facilitate proper interpretation.
The data quality objectives (DQOs) defined for the medical
monitoring program are summarized in Table 1. Based on available
information, the DQOs presented in Table 1 should be achievable by
the majority of laboratories offering the required analyses
commercially; OSHA recommends that only laboratories meeting these
DQOs be used for the analysis of biological samples collected for
monitoring cadmium exposure.
Table 1.--Recommended Data Quality Objectives (DQOs) for the Cadmium Medical Monitoring Program
----------------------------------------------------------------------------------------------------------------
Precision
Analyte/concentration pool Limit of detection (CV) (%) Accuracy
----------------------------------------------------------------------------------------------------------------
Cadmium in blood............. 0.5 g/l............. ........... 1 g/l or 15% of
the mean.
2 g/l ............................. 40
>2 g/l.......... ............................. 20
Cadmium in urine............. 0.5 g/g creatinine.. ........... 1 g/l or 15% of
the mean.
2 g/l ............................. 40
creatinine.
>2 g/l ............................. 20
creatinine.
-2-microglobulin in 100 g/g creatinine.. 5 15% of the mean.
urine: 100 g/g
creatine.
----------------------------------------------------------------------------------------------------------------
To satisfy the DQOs presented in Table 1, OSHA provides the
following guidelines:
1. Procedures for the collection and handling of blood and urine
are specified (Section 3.4.1 of this protocol);
2. Preferred analytic methods for the analysis of CDB, CDU and
B2MU are defined (and a method for the determination of CRTU also is
specified since CDU and B2MU results are to be normalized to the
level of CRTU).
3. Procedures are described for identifying laboratories likely
to provide the required analyses in an accurate and reliable manner;
4. These guidelines (Sections 3.2.1 to 3.2.3, and Section 3.3)
include recommendations regarding internal QA/QC programs for
participating laboratories, as well as levels of proficiency through
participation in an interlaboratory proficiency program;
5. Procedures for QA/QC record keeping (Section 3.3.2), and for
reporting QC/QA results are described (Section 3.3.3); and,
6. Procedures for interpreting medical monitoring results are
specified (Section 3.4.3).
Methods recommended for the biological monitoring of eligible
workers are:
1. The method of Stoeppler and Brandt (1980) for CDB
determinations (limit of detection: 0.5 g/l);
2. The method of Pruszkowska et al. (1983) for CDU
determinations (limit of detection: 0.5 g/l of urine); and,
3. The Pharmacia Delphia test kit (Pharmacia 1990) for the
determination of B2MU (limit of detection: 100 g/l urine).
Because both CDU and B2MU should be reported in g/g
CRTU, an independent determination of CRTU is recommended. Thus,
both the OSHA Salt Lake City Technical Center (OSLTC) method (OSHA,
no date) and the Jaffe method (Du Pont, no date) for the
determination of CRTU are specified under this protocol (i.e.,
either of these 2 methods may be used). Note that although detection
limits are not reported for either of these CRTU methods, the range
of measurements expected for CRTU (0.9-1.7 g/l) are well
above the likely limit of detection for either of these methods
(Harrison, 1987).
Laboratories using alternate methods should submit sufficient
data to the responsible physicians demonstrating that the alternate
method is capable of satisfying the defined data quality objectives
of the program. Such laboratories also should submit a QA/QC plan
that documents the performance of the alternate method in a manner
entirely equivalent to the QA/QC plans proposed in Section 3.3.1.
3.2 Duties of the Responsible Physician
The responsible physician will evaluate biological monitoring
results provided by participating laboratories to determine whether
such laboratories are proficient and have satisfied the QA/QC
recommendations. In determining which laboratories to employ for
this purpose, these physicians should review proficiency and QA/QC
data submitted to them by the participating laboratories.
Participating laboratories should demonstrate proficiency for
each analyte (CDU, CDB and B2MU) sampled under the biological
monitoring program. Participating laboratories involved in analyzing
CDU and B2MU also should demonstrate proficiency for CRTU analysis,
or provide evidence of a contract with a laboratory proficient in
CRTU analysis.
3.2.1 Recommendations for Selecting Among Existing Laboratories
OSHA recommends that existing laboratories providing commercial
analyses for CDB, CDU and/or B2MU for the medical monitoring program
satisfy the following criteria:
1. Should have performed commercial analyses for the appropriate
analyte (CDB, CDU and/or B2MU) on a regular basis over the last 2
years;
2. Should provide the responsible physician with an internal QA/
QC plan;
3. If performing CDU or B2MU analyses, the participating
laboratory should be accredited by the CAP for CRTU analysis, and
should be enrolled in the corresponding CAP survey (note that
alternate credentials may be acceptable, but acceptability is to be
determined by the responsible physician); and,
4. Should have enrolled in the CTQ interlaboratory comparison
program for the appropriate analyte (CDB, CDU and/or B2MU).
Participating laboratories should submit appropriate
documentation demonstrating compliance with the above criteria to
the responsible physician. To demonstrate compliance with the first
of the above criteria, participating laboratories should submit the
following documentation for each analyte they plan to analyze (note
that each document should cover a period of at least 8 consecutive
quarters, and that the period designated by the term ``regular
analyses'' is at least once a quarter):
1. Copies of laboratory reports providing results from regular
analyses of the appropriate analyte (CDB, CDU and/or B2MU);
2. Copies of 1 or more signed and executed contracts for the
provision of regular analyses of the appropriate analyte (CDB, CDU
and/or B2MU); or,
3. Copies of invoices sent to 1 or more clients requesting
payment for the provision of regular analyses of the appropriate
analyte (CDB, CDU and/or B2MU). Whatever the form of documentation
submitted, the specific analytic procedures conducted should be
identified directly. The forms that are copied for submission to the
responsible physician also should identify the laboratory which
provided these analyses.
To demonstrate compliance with the second of the above criteria,
a laboratory should submit to the responsible physician an internal
QA/QC plan detailing the standard operating procedures to be adopted
for satisfying the recommended QA/QC procedures for the analysis of
each specific analyte (CDB, CDU and/or B2MU). Procedures for
internal QA/QC programs are detailed in Section 3.3.1 below.
To satisfy the third of the above criteria, laboratories
analyzing for CDU or B2MU also should submit a QA/QC plan for
creatinine analysis (CRTU); the QA/QC plan and characterization
analyses for CRTU must come from the laboratory performing the CRTU
analysis, even if the CRTU analysis is being performed by a contract
laboratory.
Laboratories enrolling in the CTQ program (to satisfy the last
of the above criteria) must remit, with the enrollment application,
an initial fee of approximately $100 per analyte. (Note that this
fee is only an estimate, and is subject to revision without notice.)
Laboratories should indicate on the application that they agree to
have proficiency test results sent by the CTQ directly to the
physicians designated by participating laboratories.
Once a laboratory's application is processed by the CTQ, the
laboratory will be assigned a code number which will be provided to
the laboratory on the initial confirmation form, along with
identification of the specific analytes for which the laboratory is
participating. Confirmation of participation will be sent by the CTQ
to physicians designated by the applicant laboratory.
3.2.2 Recommended Review of Laboratories Selected to Perform Analyses
Six months after being selected initially to perform analyte
determinations, the status of participating laboratories should be
reviewed by the responsible physicians. Such reviews should then be
repeated every 6 months or whenever additional proficiency or QA/QC
documentation is received (whichever occurs first).
As soon as the responsible physician has received the CTQ
results from the first 3 rounds of proficiency testing (i.e., 3 sets
of 3 samples each for CDB, CDU and/or B2MU) for a participating
laboratory, the status of the laboratory's continued participation
should be reviewed. Over the same initial 6-month period,
participating laboratories also should provide responsible
physicians the results of their internal QA/QC monitoring program
used to assess performance for each analyte (CDB, CDU and/or B2MU)
for which the laboratory performs determinations. This information
should be submitted using appropriate forms and documentation.
The status of each participating laboratory should be determined
for each analyte (i.e., whether the laboratory satisfies minimum
proficiency guidelines based on the proficiency samples sent by the
CTQ and the results of the laboratory's internal QA/QC program). To
maintain competency for analysis of CDB, CDU and/or B2MU during the
first review, the laboratory should satisfy performance requirements
for at least 2 of the 3 proficiency samples provided in each of the
3 rounds completed over the 6-month period. Proficiency should be
maintained for the analyte(s) for which the laboratory conducts
determinations.
To continue participation for CDU and/or B2MU analyse,
laboratories also should either maintain accreditation for CRTU
analysis in the CAP program and participate in the CAP surveys, or
they should contract the CDU and B2MU analyses to a laboratory which
satisfies these requirements (or which can provide documentation of
accreditation/participation in an equivalent program).
The performance requirement for CDB analysis is defined as an
analytical result within 1 g/l blood or 15% of
the consensus mean (whichever is greater). For samples exhibiting a
consensus mean less than 1 g/l, the performance requirement
is defined as a concentration between the detection limit of the
analysis and a maximum of 2 g/l. The purpose for redefining
the acceptable interval for low CDB values is to encourage proper
reporting of the actual values obtained during measurement;
laboratories, therefore, will not be penalized (in terms of a narrow
range of acceptability) for reporting measured concentrations
smaller than 1 g/l.
The performance requirement for CDU analysis is defined as an
analytical result within 1 g/l urine or 15% of
the consensus mean (whichever is greater). For samples exhibiting a
consensus mean less than 1 g/l urine, the performance
requirement is defined as a concentration between the detection
limit of the analysis and a maximum of 2 g/l urine.
Laboratories also should demonstrate proficiency in creatinine
analysis as defined by the CAP. Note that reporting CDU results,
other than for the CTQ proficiency samples (i.e., compliance
samples), should be accompanied with results of analyses for CRTU,
and these 2 sets of results should be combined to provide a measure
of CDU in units of g/g CRTU.
The performance requirement for B2MU is defined as analytical
results within 15% of the consensus mean. Note that
reporting B2MU results, other than for CTQ proficiency samples
(i.e., compliance samples), should be accompanied with results of
analyses for CRTU, and these 2 sets of results should be combined to
provide a measure of B2MU in units of g/g CRTU.
There are no recommended performance checks for CRTU analyses.
As stated previously, laboratories performing CRTU analysis in
support of CDU or B2MU analyses should be accredited by the CAP, and
participating in the CAP's survey for CRTU.
Following the first review, the status of each participating
laboratory should be reevaluated at regular intervals (i.e.,
corresponding to receipt of results from each succeeding round of
proficiency testing and submission of reports from a participating
laboratory's internal QA/QC program).
After a year of collecting proficiency test results, the
following proficiency criterion should be added to the set of
criteria used to determine the participating laboratory's status
(for analyzing CDB, CDU and/or B2MU): A participating laboratory
should not fail performance requirements for more than 4 samples
from the 6 most recent consecutive rounds used to assess proficiency
for CDB, CDU and/or B2MU separately (i.e., a total of 18 discrete
proficiency samples for each analyte). Note that this requirement
does not replace, but supplements, the recommendation that a
laboratory should satisfy the performance criteria for at least 2 of
the 3 samples tested for each round of the program.
3.2.3 Recommendations for Selecting Among Newly-Formed Laboratories
(or Laboratories that Previously Failed to Meet the Protocol
Guidelines)
OSHA recommends that laboratories that have not previously
provided commercial analyses of CDB, CDU and/or B2MU (or have done
so for a period less than 2 years), or which have provided these
analyses for 2 or more years but have not conformed previously with
these protocol guidelines, should satisfy the following provisions
for each analyte for which determinations are to be made prior to
being selected to analyze biological samples under the medical
monitoring program:
1. Submit to the responsible physician an internal QA/QC plan
detailing the standard operating procedures to be adopted for
satisfying the QA/QC guidelines (guidelines for internal QA/QC
programs are detailed in Section 3.3.1);
2. Submit to the responsible physician the results of the
initial characterization analyses for each analyte for which
determinations are to be made;n
3. Submit to the responsible physician the results, for the
initial 6-month period, of the internal QA/QC program for each
analyte for which determinations are to be made (if no commercial
analyses have been conducted previously, a minimum of 2 mock
standardization trials for each analyte should be completed per
month for a 6-month period);
4. Enroll in the CTQ program for the appropriate analyte for
which determinations are to be made, and arrange to have the CTQ
program submit the initial confirmation of participation and
proficiency test results directly to the designated physicians. Note
that the designated physician should receive results from 3
completed rounds from the CTQ program before approving a laboratory
for participation in the biological monitoring program;
5. Laboratories seeking participation for CDU and/or B2MU
analyses should submit to the responsible physician documentation of
accreditation by the CAP for CRTU analyses performed in conjunction
with CDU and/or B2MU determinations (if CRTU analyses are conducted
by a contract laboratory, this laboratory should submit proof of CAP
accreditation to the responsible physician); and,
6. Documentation should be submitted on an appropriate form.
To participate in CDB, CDU and/or B2MU analyses, the laboratory
should satisfy the above criteria for a minimum of 2 of the 3
proficiency samples provided in each of the 3 rounds of the CTQ
program over a 6-month period; this procedure should be completed
for each appropriate analyte. Proficiency should be maintained for
each analyte to continue participation. Note that laboratories
seeking participation for CDU or B2MU also should address the
performance requirements for CRTU, which involves providing evidence
of accreditation by the CAP and participation in the CAP surveys (or
an equivalent program).
The performance requirement for CDB analysis is defined as an
analytical result within 1 g/l or 15% of the
consensus mean (whichever is greater). For samples exhibiting a
consensus mean less than 1 g/l, the performance requirement
is defined as a concentration between the detection limit of the
analysis and a maximum of 2 g/l. The purpose of redefining
the acceptable interval for low CDB values is to encourage proper
reporting of the actual values obtained during measurement;
laboratories, therefore, will not be penalized (in terms of a narrow
range of acceptability) for reporting measured concentrations less
than 1 g/l.
The performance requirement for CDU analysis is defined as an
analytical result within 1 g/l urine or 15% of
the consensus mean (whichever is greater). For samples exhibiting a
consensus mean less than 1 g/l urine, the performance
requirement is defined as a concentration that falls between the
detection limit of the analysis and a maximum of 2 g/l
urine. Performance requirements for the companion CRTU analysis
(defined by the CAP) also should be met. Note that reporting CDU
results, other than for CTQ proficiency testing should be
accompanied with results of CRTU analyses, and these 2 sets of
results should be combined to provide a measure of CDU in units of
g/g CRTU.
The performance requirement for B2MU is defined as an analytical
result within 15% of the consensus mean. Note that
reporting B2MU results, other than for CTQ proficiency testing
should be accompanied with results of CRTU analysis, these 2 sets of
results should be combined to provide a measure of B2MU in units of
g/g CRTU.
Once a new laboratory has been approved by the responsible
physician for conducting analyte determinations, the status of this
approval should be reviewed periodically by the responsible
physician as per the criteria presented under Section 3.2.2.
Laboratories which have failed previously to gain approval of
the responsible physician for conducting determinations of 1 or more
analytes due to lack of compliance with the criteria defined above
for existing laboratories (Section 3.2.1), may obtain approval by
satisfying the criteria for newly-formed laboratories defined under
this section; for these laboratories, the second of the above
criteria may be satisfied by submitting a new set of
characterization analyses for each analyte for which determinations
are to be made.
Reevaluation of these laboratories is discretionary on the part
of the responsible physician. Reevaluation, which normally takes
about 6 months, may be expedited if the laboratory can achieve 100%
compliance with the proficiency test criteria using the 6 samples of
each analyte submitted to the CTQ program during the first 2 rounds
of proficiency testing.
For laboratories seeking reevaluation for CDU or B2MU analysis,
the guidelines for CRTU analyses also should be satisfied, including
accreditation for CRTU analysis by the CAP, and participation in the
CAP survey program (or accreditation/participation in an equivalent
program).
3.2.4 Future Modifications to the Protocol Guidelines
As participating laboratories gain experience with analyses for
CDB, CDU and B2MU, it is anticipated that the performance achievable
by the majority of laboratories should improve until it approaches
that reported by the research groups which developed each method.
OSHA, therefore, may choose to recommend stricter performance
guidelines in the future as the overall performance of participating
laboratories improves.
3.3 Guidelines for Record Keeping and Reporting
To comply with these guidelines, participating laboratories
should satisfy the above-stated performance and proficiency
recommendations, as well as the following internal QA/QC, record
keeping, and reporting provisions.
If a participating laboratory fails to meet the provisions of
these guidelines, it is recommended that the responsible physician
disapprove further analyses of biological samples by that laboratory
until it demonstrates compliance with these guidelines. On
disapproval, biological samples should be sent to a laboratory that
can demonstrate compliance with these guidelines, at least until the
former laboratory is reevaluated by the responsible physician and
found to be in compliance.
The following record keeping and reporting procedures should be
practiced by participating laboratories.
3.3.1 Internal Quality Assurance/Quality Control Procedures
Laboratories participating in the cadmium monitoring program
should develop and maintain an internal quality assurance/quality
control (QA/QC) program that incorporates procedures for
establishing and maintaining control for each of the analytic
procedures (determinations of CDB, CDU and/or B2MU) for which the
laboratory is seeking participation. For laboratories analyzing CDU
and/or B2MU, a QA/QC program for CRTU also should be established.
Written documentation of QA/QC procedures should be described in
a formal QA/QC plan; this plan should contain the following
information: Sample acceptance and handling procedures (i.e., chain-
of-custody); sample preparation procedures; instrument parameters;
calibration procedures; and, calculations. Documentation of QA/QC
procedures should be sufficient to identify analytical problems,
define criteria under which analysis of compliance samples will be
suspended, and describe procedures for corrective actions.
3.3.1.1 QA/QC procedures for establishing control of CDB and CDU
analyses
The QA/QC program for CDB and CDU should address, at a minimum,
procedures involved in calibration, establishment of control limits,
internal QC analyses and maintaining control, and corrective-action
protocols. Participating laboratory should develop and maintain
procedures to assure that analyses of compliance samples are within
control limits, and that these procedures are documented thoroughly
in a QA/QC plan.
A nonmandatory QA/QC protocol is presented in Attachment 1. This
attachment is illustrative of the procedures that should be
addressed in a proper QA/QC program.
Calibration. Before any analytic runs are conducted, the
analytic instrument should be calibrated. Calibration should be
performed at the beginning of each day on which QC and/or compliance
samples are run. Once calibration is established, QC or compliance
samples may be run. Regardless of the type of samples run, about
every fifth sample should serve as a standard to assure that
calibration is being maintained.
Calibration is being maintained if the standard is within
15% of its theoretical value. If a standard is more than
15% of its theoretical value, the run has exceeded
control limits due to calibration error; the entire set of samples
then should be reanalyzed after recalibrating or the results should
be recalculated based on a statistical curve derived from that set
of standards.
It is essential that the value of the highest standard analyzed
be higher than the highest sample analyzed; it may be necessary,
therefore, to run a high standard at the end of the run, which has
been selected based on results obtained over the course of the run
(i.e., higher than any standard analyzed to that point).
Standards should be kept fresh; as samples age, they should be
compared with new standards and replaced if necessary.
Internal Quality Control Analyses. Internal QC samples should be
determined interspersed with analyses of compliance samples. At a
minimum, these samples should be run at a rate of 5% of the
compliance samples or at least one set of QC samples per analysis of
compliance samples, whichever is greater. If only 2 samples are run,
they should contain different levels of cadmium.
Internal QC samples may be obtained as commercially-available
reference materials and/or they may be internally prepared.
Internally-prepared samples should be well characterized and traced,
or compared to a reference material for which a consensus value is
available.
Levels of cadmium contained in QC samples should not be known to
the analyst prior to reporting the results of the analysis.
Internal QC results should be plotted or charted in a manner
which describes sample recovery and laboratory control limits.
Internal Control Limits. The laboratory protocol for evaluating
internal QC analyses per control limits should be clearly defined.
Limits may be based on statistical methods (e.g., as 2s from the
laboratory mean recovery), or on proficiency testing limits (e.g.,
1 g or 15% of the mean, whichever is greater).
Statistical limits that exceed 40% should be reevaluated
to determine the source error in the analysis.
When laboratory limits are exceeded, analytic work should
terminate until the source of error is determined and corrected;
compliance samples affected by the error should be reanalyzed. In
addition, the laboratory protocol should address any unusual trends
that develop which may be biasing the results. Numerous, consecutive
results above or below laboratory mean recoveries, or outside
laboratory statistical limits, indicate that problems may have
developed.
Corrective Actions. The QA/QC plan should document in detail
specific actions taken if control limits are exceeded or unusual
trends develop. Corrective actions should be noted on an appropriate
form, accompanied by supporting documentation.
In addition to these actions, laboratories should include
whatever additional actions are necessary to assure that accurate
data are reported to the responsible physicians.
Reference Materials. The following reference materials may be
available:
Cadmium in Blood (CDB)
1. Centre de Toxicologie du Quebec, Le Centre Hospitalier de
l'Universite Laval, 2705 boul. Laurier, Quebec, Que., Canada G1V
4G2. (Prepared 6 times per year at 1-15 g Cd/l.)
2. H. Marchandise, Community Bureau of Reference-BCR,
Directorate General XII, Commission of the European Communities,
200, rue de la Loi, B-1049, Brussels, Belgium. (Prepared as Bl CBM-1
at 5.37 g Cd/l, and Bl CBM-2 at 12.38 g Cd/l.)
3. Kaulson Laboratories Inc., 691 Bloomfield Ave., Caldwell, NJ
07006; tel: (201) 226-9494, FAX (201) 226-3244. (Prepared as #0141
[As, Cd, Hg, Pb] at 2 levels.)
Cadmium in Urine (CDU)
1. Centre de Toxicologie du Quebec, Le Centre Hospitalier de
l'Universite Laval, 2705 boul. Laurier, Quebec, Que., Canada G1V
4G2. (Prepared 6 times per year.)
2. National Institute of Standards and Technology (NIST), Dept.
of Commerce, Gaithersburg, MD; tel: (301) 975-6776. (Prepared as SRM
2670 freeze-dried urine [metals]; set includes normal and elevated
levels of metals; cadmium is certified for elevated level of 88.0
g/l in reconstituted urine.)
3. Kaulson Laboratories Inc., 691 Bloomfield Ave., Caldwell, NJ
07006; tel: (201) 226-9494, FAX (201) 226-3244. (Prepared as #0140
[As, Cd, Hg, Pb] at 2 levels.)
3.3.1.2 QA/QC procedures for establishing control of B2MU
A written, detailed QA/QC plan for B2MU analysis should be
developed. The QA/QC plan should contain a protocol similar to those
protocols developed for the CDB/CDU analyses. Differences in
analyses may warrant some differences in the QA/QC protocol, but
procedures to ensure analytical integrity should be developed and
followed.
Examples of performance summaries that can be provided include
measurements of accuracy (i.e., the means of measured values versus
target values for the control samples) and precision (i.e., based on
duplicate analyses). It is recommended that the accuracy and
precision measurements be compared to those reported as achievable
by the Pharmacia Delphia kit (Pharmacia 1990) to determine if and
when unsatisfactory analyses have arisen. If the measurement error
of 1 or more of the control samples is more than 15%, the run
exceeds control limits. Similarly, this decision is warranted when
the average CV for duplicate samples is greater than 5%.
3.3.2 Procedures for Record Keeping
To satisfy reporting requirements for commercial analyses of
CDB, CDU and/or B2MU performed for the medical monitoring program
mandated under the cadmium rule, participating laboratories should
maintain the following documentation for each analyte:
1. For each analytic instrument on which analyte determinations
are made, records relating to the most recent calibration and QC
sample analyses;
2. For these instruments, a tabulated record for each analyte of
those determinations found to be within and outside of control
limits over the past 2 years;
3. Results for the previous 2 years of the QC sample analyses
conducted under the internal QA/QC program (this information should
be: Provided for each analyte for which determinations are made and
for each analytic instrument used for this purpose, sufficient to
demonstrate that internal QA/QC programs are being executed
properly, and consistent with data sent to responsible physicians.
4. Duplicate copies of monitoring results for each analyte sent
to clients during the previous 5 years, as well as associated
information; supporting material such as chain-of-custody forms also
should be retained; and,
5. Proficiency test results and related materials received while
participating in the CTQ interlaboratory program over the past 2
years; results also should be tabulated to provide a serial record
of relative error (derived per Section 3.3.3 below).
3.3.3 Reporting Procedures
Participating laboratories should maintain these documents: QA/
QC program plans; QA/QC status reports; CTQ proficiency program
reports; and, analytical data reports. The information that should
be included in these reports is summarized in Table 2; a copy of
each report should be sent to the responsible physician.
Table 2.--Reporting Procedures for Laboratories Participating in the
Cadmium Medical Monitoring Program
------------------------------------------------------------------------
Frequency (time
Report frame) Contents
------------------------------------------------------------------------
1 QA/QC Program Plan. Once (initially)..... A detailed description of
the QA/QC protocol to be
established by the
laboratory to maintain
control of analyte
determinations.
2 QA/QC Status Report Every 2 months....... Results of the QC samples
incorporated into regular
runs for each instrument
(over the period since
the last report).
3 Proficiency Report. Attached to every Results from the last full
data report. year of proficiency
samples submitted to the
CTQ program and Results
FR Doc. 93-31820 Occupational Safety and Health Standards for Cadmium in Shipyard Employment and Construction
of the 100 most recent QC
samples incorporated into
regular runs for each
instrument.
4 Analytical Data For all reports of Date the sample was
Report. data results. received; Date the sample
was analyzed; Appropriate
chain-of-custody
information; Types of
analyses performed;
Results of the requested
analyses and Copy of the
most current proficiency
report.
------------------------------------------------------------------------
As noted in Section 3.3.1, a QA/QC program plan should be
developed that documents internal QA/QC procedures (defined under
Section 3.3.1) to be implemented by the participating laboratory for
each analyte; this plan should provide a list identifying each
instrument used in making analyte determinations.
A QA/QC status report should be written bimonthly for each
analyte. In this report, the results of the QC program during the
reporting period should be reported for each analyte in the
following manner: The number (N) of QC samples analyzed during the
period; a table of the target levels defined for each sample and the
corresponding measured values; the mean of F/T value (as defined
below) for the set of QC samples run during the period; and, use of
X2s (as defined below) for the set of QC samples run
during the period as a measure of precision.
As noted in Section 2, an F/T value for a QC sample is the ratio
of the measured concentration of analyte to the established (i.e.,
reference) concentration of analyte for that QC sample. The equation
below describes the derivation of the mean for F/T values, X (with N
being analyzed the total number of samples analyzed):
TR03JA94.000
The standard deviation, s, for these measurements is derived using
the following equation (note that 2s is twice this value):
TR03JA94.001
The nonmandatory QA/QC protocol (see Attachment 1) indicates
that QC samples should be divided into several discrete pools, and a
separate estimate of precision for each pools then should be
derived. Several precision estimates should be provided for
concentrations which differ in average value. These precision
measures may be used to document improvements in performance with
regard to the combined pool.
Participating laboratories should use the CTQ proficiency
program for each analyte. Results of the this program will be sent
by CTQ directly to physicians designated by the participating
laboratories. Proficiency results from the CTQ program are used to
establish the accuracy of results from each participating
laboratory, and should be provided to responsible physicians for use
in trend analysis. A proficiency report consisting of these
proficiency results should accompany data reports as an attachment.
For each analyte, the proficiency report should include the
results from the 6 previous proficiency rounds in the following
format:
1. Number (N) of samples analyzed;
2. Mean of the target levels, (1/N)i,
with Ti being a consensus mean for the sample;
3. Mean of the measurements, (1/N)i, with
Mi being a sample measurement;
4. A measure of error defined by:
(1/N)(Ti-Mi)\2\
Analytical data reports should be submitted to responsible
physicians directly. For each sample, report the following
information: The date the sample was received; the date the sample
was analyzed; appropriate chain-of-custody information; the type(s)
of analyses performed; and, the results of the analyses. This
information should be reported on a form similar to the form
provided an appropriate form. The most recent proficiency program
report should accompany the analytical data reports (as an
attachment).
Confidence intervals for the analytical results should be
reported as X2s, with X being the measured value and 2s
the standard deviation calculated as described above.
For CDU or B2MU results, which are combined with CRTU
measurements for proper reporting, the 95% confidence limits are
derived from the limits for CDU or B2MU, (p), and the limits for
CRTU, (q), as follows:
TR03JA94.002
For these calculations, Xp is the measurement and
confidence limits for CDU or B2MU, and Yq is the
measurement and confidence limit for CRTU.
Participating laboratories should notify responsible physicians
as soon as they receive information indicating a change in their
accreditation status with the CTQ or the CAP. These physicians
should not be expected to wait until formal notice of a status
change has been received from the CTQ or the CAP.
3.4 Instructions to Physicians
Physicians responsible for the medical monitoring of cadmium-
exposed workers must collect the biological samples from workers;
they then should select laboratories to perform the required
analyses, and should interpret the analytic results.
3.4.1 Sample Collection and Holding Procedures
Blood Samples. The following procedures are recommended for the
collection, shipment and storage of blood samples for CDB analysis
to reduce analytical variablility; these recommendations were
obtained primarily through personal communications with J.P. Weber
of the CTQ (1991), and from reports by the Centers for Disease
Control (CDC, 1986) and Stoeppler and Brandt (1980).
To the extent possible, blood samples should be collected from
workers at the same time of day. Workers should shower or thoroughly
wash their hands and arms before blood samples are drawn. The
following materials are needed for blood sample collection: Alcohol
wipes; sterile gauze sponges; band-aids; 20-gauge, 1.5-in. stainless
steel needles (sterile); preprinted labels; tourniquets; vacutainer
holders; 3-ml ``metal free'' vacutainer tubes (i.e., dark-blue
caps), with EDTA as an anti-coagulant; and, styrofoam vacutainer
shipping containers.
Whole blood samples are taken by venipuncture. Each blue-capped
tube should be labeled or coded for the worker and company before
the sample is drawn. (Blue-capped tubes are recommended instead of
red-capped tubes because the latter may consist of red coloring
pigment containing cadmium, which could contaminate the samples.)
Immediately after sampling, the vacutainer tubes must be thoroughly
mixed by inverting the tubes at least 10 times manually or
mechanically using a Vortex device (for 15 sec). Samples should be
refrigerated immediately or stored on ice until they can be packed
for shipment to the participating laboratory for analysis.
The CDC recommends that blood samples be shipped with a ``cool
pak'' to keep the samples cold during shipment. However, the CTQ
routinely ships and receives blood samples for cadmium analysis that
have not been kept cool during shipment. The CTQ has found no
deterioration of cadmium in biological fluids that were shipped via
parcel post without a cooling agent, even though these deliveries
often take 2 weeks to reach their destination.
Urine Samples. The following are recommended procedures for the
collection, shipment and storage of urine for CDU and B2MU analyses,
and were obtained primarily through personal communications with
J.P. Weber of the CTQ (1991), and from reports by the CDC (1986) and
Stoeppler and Brandt (1980).
Single ``spot'' samples are recommended. As B2M can degrade in
the bladder, workers should first empty their bladder and then drink
a large glass of water at the start of the visit. Urine samples then
should be collected within 1 hour. Separate samples should be
collected for CDU and B2MU using the following materials: Sterile
urine collection cups (250 ml); small sealable plastic bags;
preprinted labels; 15-ml polypropylene or polyethylene screw-cap
tubes; lab gloves (``metal free''); and, preservatives (as
indicated).
The sealed collection cup should be kept in the plastic bag
until collection time. The workers should wash their hands with soap
and water before receiving the collection cup. The collection cup
should not be opened until just before voiding and the cup should be
sealed immediately after filling. It is important that the inside of
the container and cap are not touched by, or come into contact with,
the body, clothing or other surfaces.
For CDU analyzes, the cup is swirled gently to resuspend any
solids, and the 15-ml tube is filled with 10-12 ml urine. The CDC
recommends the addition of 100 l concentrated HNO3 as
a preservative before sealing the tube and then freezing the sample.
The CTQ recommends minimal handling and does not acidify their
interlaboratory urine reference materials prior to shipment, nor do
they freeze the sample for shipment. At the CTQ, if the urine sample
has much sediment, the sample is acidified in the lab to free any
cadmium in the precipitate.
For B2M, the urine sample should be collected directly into a
polyethylene bottle previously washed with dilute nitric acid. The
pH of the urine should be measured and adjusted to 8.0 with 0.1 N
NaOH immediately following collection. Samples should be frozen and
stored at -20 deg.C until testing is performed. The B2M in the
samples should be stable for 2 days when stored at 2-8 deg.C, and
for at least 2 months at -20 deg.C. Repeated freezing and thawing
should be avoided to prevent denaturing the B2M (Pharmacia 1990).
3.4.2 Recommendations for Evaluating Laboratories
Using standard error data and the results of proficiency testing
obtained from CTQ, responsible physicians can make an informed
choice of which laboratory to select to analyze biological samples.
In general, laboratories with small standard errors and little
disparity between target and measured values tend to make precise
and accurate sample determinations. Estimates of precision provided
to the physicians with each set of monitoring results can be
compared to previously-reported proficiency and precision estimates.
The latest precision estimates should be at least as small as the
standard error reported previously by the laboratory. Moreover,
there should be no indication that precision is deteriorating (i.e.,
increasing values for the precision estimates). If precision is
deteriorating, physicians may decide to use another laboratory for
these analyses. QA/QC information provided by the participating
laboratories to physicians can, therefore, assist physicians in
evaluating laboratory performance.
3.4.3 Use and Interpretation of Results
When the responsible physician has received the CDB, CDU and/or
B2MU results, these results must be compared to the action levels
discussed in the final rule for cadmium. The comparison of the
sample results to action levels is straightforward. The measured
value reported from the laboratory can be compared directly to the
action levels; if the reported value exceeds an action level, the
required actions must be initiated.
4.0 Background
Cadmium is a naturally-occurring environmental contaminant to
which humans are continually exposed in food, water, and air. The
average daily intake of cadmium by the U.S. population is estimated
to be 10-20 g/day. Most of this intake is via ingestion,
for which absorption is estimated at 4-7% (Kowal et al. 1979). An
additional nonoccupational source of cadmium is smoking tobacco;
smoking a pack of cigarettes a day adds an additional 2-4 g
cadmium to the daily intake, assuming absorption via inhalation of
25-35% (Nordberg and Nordberg 1988; Friberg and Elinder 1988; Travis
and Haddock 1980).
Exposure to cadmium fumes and dusts in an occupational setting
where air concentrations are 20-50 g/m\3\ results in an
additional daily intake of several hundred micrograms (Friberg and
Elinder 1988, p. 563). In such a setting, occupational exposure to
cadmium occurs primarily via inhalation, although additional
exposure may occur through the ingestion of material via
contaminated hands if workers eat or smoke without first washing.
Some of the particles that are inhaled initially may be ingested
when the material is deposited in the upper respiratory tract, where
it may be cleared by mucociliary transport and subsequently
swallowed.
Cadmium introduced into the body through inhalation or ingestion
is transported by the albumin fraction of the blood plasma to the
liver, where it accumulates and is stored principally as a bound
form complexed with the protein metallothionein. Metallothionein-
bound cadmium is the main form of cadmium subsequently transported
to the kidney; it is these 2 organs, the liver and kidney, in which
the majority of the cadmium body burden accumulates. As much as one
half of the total body burden of cadmium may be found in the kidneys
(Nordberg and Nordberg 1988).
Once cadmium has entered the body, elimination is slow; about
0.02% of the body burden is excreted per day via urinary/fecal
elimination. The whole-body half-life of cadmium is 10-35 years,
decreasing slightly with increasing age (Travis and Haddock 1980).
The continual accumulation of cadmium is the basis for its
chronic noncarcinogenic toxicity. This accumulation makes the kidney
the target organ in which cadmium toxicity usually is first observed
(Piscator 1964). Renal damage may occur when cadmium levels in the
kidney cortex approach 200 g/g wet tissue-weight (Travis
and Haddock 1980).
The kinetics and internal distribution of cadmium in the body
are complex, and depend on whether occupational exposure to cadmium
is ongoing or has terminated. In general, cadmium in blood is
related principally to recent cadmium exposure, while cadmium in
urine reflects cumulative exposure (i.e., total body burden)
(Lauwerys et al. 1976; Friberg and Elinder 1988).
4.1 Health Effects
Studies of workers in a variety of industries indicate that
chronic exposure to cadmium may be linked to several adverse health
effects including kidney dysfunction, reduced pulmonary function,
chronic lung disease and cancer (Federal Register 1990). The primary
sites for cadmium-associated cancer appear to be the lung and the
prostate.
Cancer. Evidence for an association between cancer and cadmium
exposure comes from both epidemiological studies and animal
experiments. Pott (1965) found a statistically significant elevation
in the incidence of prostate cancer among a cohort of cadmium
workers. Other epidemiology studies also report an elevated
incidence of prostate cancer; however, the increases observed in
these other studies were not statistically significant (Meridian
Research, Inc. 1989).
One study (Thun et al. 1985) contains sufficiently quantitative
estimates of cadmium exposure to allow evaluation of dose-response
relationships between cadmium exposure and lung cancer. A
statistically significant excess of lung cancer attributed to
cadmium exposure was found in this study, even after accounting for
confounding variables such as coexposure to arsenic and smoking
habits (Meridian Research, Inc. 1989).
Evidence for quantifying a link between lung cancer and cadmium
exposure comes from a single study (Takenaka et al. 1983). In this
study, dose-response relationships developed from animal data were
extrapolated to humans using a variety of models. OSHA chose the
multistage risk model for estimating the risk of cancer for humans
using these animal data. Animal injection studies also suggest an
association between cadmium exposure and cancer, particularly
observations of an increased incidence of tumors at sites remote
from the point of injection. The International Agency for Research
on Cancer (IARC) (Supplement 7, 1987) indicates that this, and
related, evidence is sufficient to classify cadmium as an animal
carcinogen. However, the results of these injection studies cannot
be used to quantify risks attendant to human occupational exposures
due to differences in routes of exposure (Meridian Research, Inc.
1989).
Based on the above-cited studies, the U.S. Environmental
Protection Agency (EPA) classifies cadmium as ``B1,'' a probable
human carcinogen (USEPA 1985). IARC in 1987 recommended that cadmium
be listed as a probable human carcinogen.
Kidney Dysfunction. The most prevalent nonmalignant effect
observed among workers chronically exposed to cadmium is kidney
dysfunction. Initially, such dysfunction is manifested by
proteinuria (Meridian Research, Inc. 1989; Roth Associates, Inc.
1989). Proteinuria associated with cadmium exposure is most commonly
characterized by excretion of low-molecular weight proteins (15,000-
40,000 MW), accompanied by loss of electrolytes, uric acid, calcium,
amino acids, and phosphate. Proteins commonly excreted include
-2-microglobulin (B2M), retinol-binding protein (RBP),
immunoglobulin light chains, and lysozyme. Excretion of low
molecular weight proteins is characteristic of damage to the
proximal tubules of the kidney (Iwao et al. 1980).
Exposure to cadmium also may lead to urinary excretion of high-
molecular weight proteins such as albumin, immunoglobulin G, and
glycoproteins (Meridian Research, Inc. 1989; Roth Associates, Inc.
1989). Excretion of high-molecular weight proteins is indicative of
damage to the glomeruli of the kidney. Bernard et al. (1979) suggest
that cadmium-associated damage to the glomeruli and damage to the
proximal tubules of the kidney develop independently of each other,
but may occur in the same individual.
Several studies indicate that the onset of low-molecular weight
proteinuria is a sign of irreversible kidney damage (Friberg et al.
1974; Roels et al. 1982; Piscator 1984; Elinder et al. 1985; Smith
et al. 1986). For many workers, once sufficiently elevated levels of
B2M are observed in association with cadmium exposure, such levels
do not appear to return to normal even when cadmium exposure is
eliminated by removal of the worker from the cadmium-contaminated
work environment (Friberg, exhibit 29, 1990).
Some studies indicate that cadmium-induced proteinuria may be
progressive; levels of B2MU increase even after cadmium exposure has
ceased (Elinder et al. 1985). Other researchers have reached similar
conclusions (Frieburg testimony, OSHA docket exhibit 29, Elinder
testimony, OSHA docket exhibit 55, and OSHA docket exhibits 8-86B).
Such observations are not universal, however (Smith et al. 1986;
Tsuchiya 1976). Studies in which proteinuria has not been observed,
however, may have initiated the reassessment too early (Meridian
Research, Inc.1989; Roth Associates, Inc. 1989; Roels 1989).
A quantitative assessment of the risks of developing kidney
dysfunction as a result of cadmium exposure was performed using the
data from Ellis et al. (1984) and Falck et al. (1983). Meridian
Research, Inc. (1989) and Roth Associates, Inc. (1989) employed
several mathematical models to evaluate the data from the 2 studies,
and the results indicate that cumulative cadmium exposure levels
between 5 and 100 g-years/m\3\ correspond with a one-in-a-
thousand probability of developing kidney dysfunction.
When cadmium exposure continues past the onset of early kidney
damage (manifested as proteinuria), chronic nephrotoxicity may occur
(Meridian Research, Inc. 1989; Roth Associates, Inc. 1989). Uremia,
which is the loss of the glomerulus' ability to adequately filter
blood, may result. This condition leads to severe disturbance of
electrolyte concentrations, which may result in various clinical
complications including atherosclerosis, hypertension, pericarditis,
anemia, hemorrhagic tendencies, deficient cellular immunity, bone
changes, and other problems. Progression of the disease may require
dialysis or a kidney transplant.
Studies in which animals are chronically exposed to cadmium
confirm the renal effects observed in humans (Friberg et al. 1986).
Animal studies also confirm cadmium-related problems with calcium
metabolism and associated skeletal effects, which also have been
observed among humans. Other effects commonly reported in chronic
animal studies include anemia, changes in liver morphology,
immunosuppression and hypertension. Some of these effects may be
associated with cofactors; hypertension, for example, appears to be
associated with diet, as well as with cadmium exposure. Animals
injected with cadmium also have shown testicular necrosis.
4.2 Objectives for Medical Monitoring
In keeping with the observation that renal disease tends to be
the earliest clinical manifestation of cadmium toxicity, the final
cadmium standard mandates that eligible workers must be medically
monitored to prevent this condition (as well as cadmimum-induced
cancer). The objectives of medical-monitoring, therefore, are to:
Identify workers at significant risk of adverse health effects from
excess, chronic exposure to cadmium; prevent future cases of
cadmium-induced disease; detect and minimize existing cadmium-
induced disease; and, identify workers most in need of medical
intervention.
The overall goal of the medical monitoring program is to protect
workers who may be exposed continuously to cadmium over a 45-year
occupational lifespan. Consistent with this goal, the medical
monitoring program should assure that:
1. Current exposure levels remain sufficiently low to prevent
the accumulation of cadmium body burdens sufficient to cause disease
in the future by monitoring CDB as an indicator of recent cadmium
exposure;
2. Cumulative body burdens, especially among workers with
undefined historical exposures, remain below levels potentially
capable of leading to damage and disease by assessing CDU as an
indicator of cumulative exposure to cadmium; and,
3. Health effects are not occurring among exposed workers by
determining B2MU as an early indicator of the onset of cadmium-
induced kidney disease.
4.3 Indicators of Cadmium Exposure and Disease
Cadmium is present in whole blood bound to albumin, in
erythrocytes, and as a metallothionein-cadmium complex. The
metallothionein-cadmium complex that represents the primary
transport mechanism for cadmium delivery to the kidney. CDB
concentrations in the general, nonexposed population average 1
g Cd/l whole blood, with smokers exhibiting higher levels
(see Section 5.1.6). Data presented in Section 5.1.6 shows that 95%
of the general population not occupationally exposed to cadmium have
CDB levels less than 5 g Cd/l.
If total body burdens of cadmium remain low, CDB concentrations
indicate recent exposure (i.e., daily intake). This conclusion is
based on data showing that cigarette smokers exhibit CDB
concentrations of 2-7 g/l depending on the number of
cigarettes smoked per day (Nordberg and Nordberg 1988), while CDB
levels for those who quit smoking return to general population
values (approximately 1 g/l) within several weeks (Lauwerys
et al. 1976). Based on these observations, Lauwerys et al. (1976)
concluded that CDB has a biological half-life of a few weeks to less
than 3 months. As indicated in Section 3.1.6, the upper 95th
percentile for CDB levels observed among those who are not
occupationally exposed to cadmium is 5 g/l, which suggests
that the absolute upper limit to the range reported for smokers by
Nordberg and Nordberg may have been affected by an extreme value
(i.e., beyond 2 above the mean).
Among occupationally-exposed workers, the occupational history
of exposure to cadmium must be evaluated to interpret CDB levels.
New workers, or workers with low exposures to cadmium, exhibit CDB
levels that are representative of recent exposures, similar to the
general population. However, for workers with a history of chronic
exposure to cadmium, who have accumulated significant stores of
cadmium in the kidneys/liver, part of the CDB concentrations appear
to indicate body burden. If such workers are removed from cadmium
exposure, their CDB levels remain elevated, possibly for years,
reflecting prior long-term accumulation of cadmium in body tissues.
This condition tends to occur, however, only beyond some threshold
exposure value, and possibly indicates the capacity of body tissues
to accumulate cadmium which cannot be excreted readily (Friberg and
Elinder 1988; Nordberg and Nordberg 1988).
CDU is widely used as an indicator of cadmium body burdens
(Nordberg and Nordberg 1988). CDU is the major route of elimination
and, when CDU is measured, it is commonly expressed either as
g Cd/l urine (unadjusted), g Cd/l urine (adjusted
for specific gravity), or g Cd/g CRTU (see Section 5.2.1).
The metabolic model for CDU is less complicated than CDB, since CDU
is dependentin large part on the body (i.e., kidney) burden of
cadmium. However, a small proportion of CDU still be attributed to
recent cadmium exposure, particularly if exposure to high airborne
concentrations of cadmium occurred. Note that CDU is subject to
larger interindividual and day-to-day variations than CDB, so
repeated measurements are recommended for CDU evaluations.
CDU is bound principally to metallothionein, regardless of
whether the cadmium originates from metallothionein in plasma or
from the cadmium pool accumulated in the renal tubules. Therefore,
measurement of metallothionein in urine may provide information
similar to CDU, while avoiding the contamination problems that may
occur during collection and handling urine for cadmium analysis
(Nordberg and Nordberg 1988). However, a commercial method for the
determination of metallothionein at the sensitivity levels required
under the final cadmium rule is not currently available; therefore,
analysis of CDU is recommended.
Among the general population not occupationally exposed to
cadmium, CDU levels average less than 1 g/l (see Section
5.2.7). Normalized for creatinine (CRTU), the average CDU
concentration of the general population is less than 1 g/g
CRTU. As cadmium accumulates over the lifespan, CDU increases with
age. Also, cigarette smokers may eventually accumulate twice the
cadmium body burden of nonsmokers, CDU is slightly higher in smokers
than in nonsmokers, even several years after smoking cessation
(Nordberg and Nordberg 1988). Despite variations due to age and
smoking habits, 95% of those not occupationally exposed to cadmium
exhibit levels of CDU less than 3 g/g CRTU (based on the
data presented in Section 5.2.7).
About 0.02% of the cadmium body burden is excreted daily in
urine. When the critical cadmium concentration (about 200 ppm) in
the kidney is reached, or if there is sufficient cadmium-induced
kidney dysfunction, dramatic increases in CDU are observed (Nordberg
and Nordberg 1988). Above 200 ppm, therefore, CDU concentrations
cease to be an indicator of cadmium body burden, and are instead an
index of kidney failure.
Proteinuria is an index of kidney dysfunction, and is defined by
OSHA to be a material impairment. Several small proteins may be
monitored as markers for proteinuria. Below levels indicative of
proteinuria, these small proteins may be early indicators of
increased risk of cadmium-induced renal tubular disease. Analytes
useful for monitoring cadmium-induced renal tubular damage include:
1. -2-Microglobulin (B2M), currently the most widely
used assay for detecting kidney dysfunction, is the best
characterized analyte available (Iwao et al. 1980; Chia et al.
1989);
2. Retinol Binding Protein (RBP) is more stable than B2M in
acidic urine (i.e., B2M breakdown occurs if urinary pH is less than
5.5; such breakdown may result in false [i.e., low] B2M values
[Bernard and Lauwerys, 1990]);
3. N-Acetyl-B-Glucosaminidase (NAG) is the analyte of an assay
that is simple, inexpensive, reliable, and correlates with cadmium
levels under 10 g/g CRTU, but the assay is less sensitive
than RBP or B2M (Kawada et al. 1989);
4. Metallothionein (MT) correlates with cadmium and B2M levels,
and may be a better predictor of cadmium exposure than CDU and B2M
(Kawada et al. 1989);
5. Tamm-Horsfall Glycoprotein (THG) increases slightly with
elevated cadmium levels, but this elevation is small compared to
increases in urinary albumin, RBP, or B2M (Bernard and Lauwerys
1990);
6. Albumin (ALB), determined by the biuret method, is not
sufficiently sensitive to serve as an early indicator of the onset
of renal disease (Piscator 1962);
7. Albumin (ALB), determined by the Amido Black method, is
sensitive and reproducible, but involves a time-consuming procedure
(Piscator 1962);
8. Glycosaminoglycan (GAG) increases among cadmium workers, but
the significance of this effect is unknown because no relationship
has been found between elevated GAG and other indices of tubular
damage (Bernard and Lauwerys 1990);
9. Trehalase seems to increase earlier than B2M during cadmium
exposure, but the procedure for analysis is complicated and
unreliable (Iwata et al. 1988); and,
10. Kallikrein is observed at lower concentrations among
cadmium-exposed workers than among normal controls (Roels et al.
1990).
Of the above analytes, B2M appears to be the most widely used
and best characterized analyte to evaluate the presence/absence, as
well as the extent of, cadmium-induced renal tubular damage (Kawada,
Koyama, and Suzuki 1989; Shaikh and Smith 1984; Nogawa 1984).
However, it is important that samples be collected and handled so as
to minimize B2M degradation under acidic urine conditions.
The threshold value of B2MU commonly used to indicate the
presence of kidney damage 300 g/g CRTU (Kjellstrom et al.
1977a; Buchet et al. 1980; and Kowal and Zirkes 1983). This value
represents the upper 95th or 97.5th percentile level of urinary
excretion observed among those without tubular dysfunction (Elinder,
exbt L-140-45, OSHA docket H057A). In agreement with these
conclusions, the data presented in Section 5.3.7 of this protocol
generally indicate that the level of 300 g/g CRTU appears
to define the boundary for kidney dysfunction. It is not clear,
however, that this level represents the upper 95th percentile of
values observed among those who fail to demonstrate proteinuria
effects.
Although elevated B2MU levels appear to be a fairly specific
indicator of disease associated with cadmium exposure, other
conditions that may lead to elevated B2MU levels include high fevers
from influenza, extensive physical exercise, renal disease unrelated
to cadmium exposure, lymphomas, and AIDS (Iwao et al. 1980; Schardun
and van Epps 1987). Elevated B2M levels observed in association with
high fevers from influenza or from extensive physical exercise are
transient, and will return to normal levels once the fever has
abated or metabolic rates return to baseline values following
exercise. The other conditions linked to elevated B2M levels can be
diagnosed as part of a properly-designed medical examination.
Consequently, monitoring B2M, when accompanied by regular medical
examinations and CDB and CDU determinations (as indicators of
present and past cadmium exposure), may serve as a specific, early
indicator of cadmium-induced kidney damage.
4.4 Criteria for Medical Monitoring of Cadmium Workers
Medical monitoring mandated by the final cadmium rule includes a
combination of regular medical examinations and periodic monitoring
of 3 analytes: CDB, CDU and B2MU. As indicated above, CDB is
monitored as an indicator of current cadmium exposure, while CDU
serves as an indicator of the cadmium body burden; B2MU is assessed
as an early marker of irreversible kidney damage and disease.
The final cadmium rule defines a series of action levels that
have been developed for each of the 3 analytes to be monitored.
These action levels serve to guide the responsible physician through
a decision-making process. For each action level that is exceeded, a
specific response is mandated. The sequence of action levels, and
the attendant actions, are described in detail in the final cadmium
rule.
Other criteria used in the medical decision-making process
relate to tests performed during the medical examination (including
a determination of the ability of a worker to wear a respirator).
These criteria, however, are not affected by the results of the
analyte determinations addressed in the above paragraphs and,
consequently, will not be considered further in these guidelines.
4.5 Defining to Quality and Proficiency of the Analyte Determinations
As noted above in Sections 2 and 3, the quality of a measurement
should be defined along with its value to properly interpret the
results. Generally, it is necessary to know the accuracy and the
precision of a measurement before it can be properly evaluated. The
precision of the data from a specific laboratory indicates the
extent to which the repeated measurements of the same sample vary
within that laboratory. The accuracy of the data provides an
indication of the extent to which these results deviate from average
results determined from many laboratories performing the same
measurement (i.e., in the absence of an independent determination of
the true value of a measurement). Note that terms are defined
operationally relative to the manner in which they will be used in
this protocol. Formal definitions for the terms in italics used in
this section can be found in the list of definitions (Section 2).
Another data quality criterion required to properly evaluate
measurement results is the limit of detection of that measurement.
For measurements to be useful, the range of the measurement which is
of interest for biological monitoring purposes must lie entirely
above the limit of detection defined for that measurement.
The overall quality of a laboratory's results is termed the
performance of that laboratory. The degree to which a laboratory
satisfies a minimum performance level is referred to as the
proficiency of the laboratory. A successful medical monitoring
program, therefore, should include procedures developed for
monitoring and recording laboratory performance; these procedures
can be used to identify the most proficient laboratories.
5.0 Overview of Medical Monitoring Tests for CDB, CDU, B2MU and CRTU
To evaluate whether available methods for assessing CDB, CDU,
B2MU and CRTU are adequate for determining the parameters defined by
the proposed action levels, it is necessary to review procedures
available for sample collection, preparation and analysis. A variety
of techniques for these purposes have been used historically for the
determination of cadmium in biological matrices (including CDB and
CDU), and for the determination of specific proteins in biological
matrices (including B2MU). However, only the most recent techniques
are capable of satisfying the required accuracy, precision and
sensitivity (i.e., limit of detection) for monitoring at the levels
mandated in the final cadmium rule, while still facilitating
automated analysis and rapid processing.
5.1 Measuring Cadmium in Blood (CDB)
Analysis of biological samples for cadmium requires strict
analytical discipline regarding collection and handling of samples.
In addition to occupational settings, where cadmium contamination
would be apparent, cadmium is a ubiquitous environmental
contaminant, and much care should be exercised to ensure that
samples are not contaminated during collection, preparation or
analysis. Many common chemical reagents are contaminated with
cadmium at concentrations that will interfere with cadmium analysis;
because of the widespread use of cadmium compounds as colored
pigments in plastics and coatings, the analyst should continually
monitor each manufacturer's chemical reagents and collection
containers to prevent contamination of samples.
Guarding against cadmium contamination of biological samples is
particularly important when analyzing blood samples because cadmium
concentrations in blood samples from nonexposed populations are
generally less than 2 g/l (2 ng/ml), while occupationally-
exposed workers can be at medical risk to cadmium toxicity if blood
concentrations exceed 5 g/l (ACGIH 1991 and 1992). This
narrow margin between exposed and unexposed samples requires that
exceptional care be used in performing analytic determinations for
biological monitoring for occupational cadmium exposure.
Methods for quantifying cadmium in blood have improved over the
last 40 years primarily because of improvements in analytical
instrumentation. Also, due to improvements in analytical techniques,
there is less need to perform extensive multi-step sample
preparations prior to analysis. Complex sample preparation was
previously required to enhance method sensitivity (for cadmium), and
to reduce interference by other metals or components of the sample.
5.1.1 Analytical Techniques Used to Monitor Cadmium in Biological
Matrices
Table 3.--Comparison of Analytical Procedures/Instrumentation for Determination of Cadmium in Biological Samples
----------------------------------------------------------------------------------------------------------------
Limit of
Analytical procedure detection [ng/ Specified biological Reference Comments
(g or ml)] matrix
----------------------------------------------------------------------------------------------------------------
Flame Atomic Absorption 1.0 Any matrix............. Perkin-Elmer (1982)... Not sensitive enough
Spectroscopy (FAAS). for biomonitoring
without extensive
sample digestion,
metal chelation and
organic solvent
extraction.
Graphite Furnace Atomic 0.04 Urine.................. Pruszkowska et al. Methods of choice for
Absorption (1983). routine cadmium
Spectroscopy (GFAAS). analysis.
0.2 Blood.................. Stoeppler and Brandt
0 (1980).
Inductively-Coupled 2.0 Any matrix............. NIOSH (1984A)......... Requires extensive
Argon-Plasma Atomic sample preparation
Emission Spectroscopy and concentration of
(ICAP AES). metal with chelating
resin. Advantage is
simultaneous analyses
for as many as 10
metals from 1 sample.
Neutron Activation 1.5 In vivo (liver)........ Ellis et al. (1983)... Only available in vivo
Gamma Spectroscopy method for direct
(NA). determination of
cadmium body tissue
burdens; expensive;
absolute
determination of
cadmium in reference
materials.
Isotope Dilution Mass <1.0 Any matrix............. Michiels and DeBievre Suitable for absolute
Spectroscopy (IDMS). (1986). determination of
cadmium in reference
materials; expensive.
Differential Pulse <1.0 Any matrix............. Stoeppler and Brandt Suitable for absolute
Anodic Stripping (1980). determination of
Voltammetry (DPASV). cadmium in reference
materials; efficient
method to check
accuracy of
analytical method.
----------------------------------------------------------------------------------------------------------------
A number of analytical techniques have been used for determining
cadmium concentrations in biological materials. A summary of the
characteristics of the most widely employed techniques is presented
in Table 3. The technique most suitable for medical monitoring for
cadmium is atomic absorption spectroscopy (AAS).
To obtain a measurement using AAS, a light source (i.e., hollow
cathode or lectrode-free discharge lamp) containing the element of
interest as the cathode, is energized and the lamp emits a spectrum
that is unique for that element. This light source is focused
through a sample cell, and a selected wavelength is monitored by a
monochrometer and photodetector cell. Any ground state atoms in the
sample that match those of the lamp element and are in the path of
the emitted light may absorb some of the light and decrease the
amount of light that reaches the photodetector cell. The amount of
light absorbed at each characteristic wavelength is proportional to
the number of ground state atoms of the corresponding element that
are in the pathway of the light between the source and detector.
To determine the amount of a specific metallic element in a
sample using AAS, the sample is dissolved in a solvent and aspirated
into a high-temperature flame as an aerosol. At high temperatures,
the solvent is rapidly evaporated or decomposed and the solute is
initially solidified; the majority of the sample elements then are
transformed into an atomic vapor. Next, a light beam is focused
above the flame and the amount of metal in the sample can be
determined by measuring the degree of absorbance of the atoms of the
target element released by the flame at a characteristic wavelength.
A more refined atomic absorption technique, flameless AAS,
substitutes an electrothermal, graphite furnace for the flame. An
aliquot (10-100 l) of the sample is pipetted into the cold
furnace, which is then heated rapidly to generate an atomic vapor of
the element.
AAS is a sensitive and specific method for the elemental
analysis of metals; its main drawback is nonspecific background
absorbtion and scattering of the light beam by particles of the
sample as it decomposes at high temperatures; nonspecific absorbance
reduces the sensitivity of the analytical method. The problem of
nonspecific absorbance and scattering can be reduced by extensive
sample pretreatment, such as ashing and/or acid digestion of the
sample to reduce its organic content.
Current AAS instruments employ background correction devices to
adjust electronically for background absorbtion and scattering. A
common method to correct for background effects is to use a
deuterium arc lamp as a second light source. A continuum light
source, such as the deuterium lamp, emits a broad spectrum of
wavelengths instead of specific wavelengths characteristic of a
particular element, as with the hollow cathode tube. With this
system, light from the primary source and the continuum source are
passed alternately through the sample cell. The target element
effectively absorbs light only from the primary source (which is
much brighter than the continuum source at the characteristic
wavelengths), while the background matrix absorbs and scatters light
from both sources equally. Therefore, when the ratio of the two
beams is measured electronically, the effect of nonspecific
background absorption and scattering is eliminated. A less common,
but more sophisticated, backgrond correction system is based on the
Zeeman effect, which uses a magnetically-activated light polarizer
to compensate electronically for nonspecific absorbtion and
scattering.
Atomic emission spectroscopy with inductively-coupled argon
plasma (AES-ICAP) is widely used to analyze for metals. With this
instrument, the sample is aspirated into an extremely hot argon
plasma flame, which excites the metal atoms; emission spectra
specific for the sample element then are generated. The quanta of
emitted light passing through a monochrometer are amplified by
photomultiplier tubes and measured by a photodetector to determine
the amount of metal in the sample. An advantage of AES-ICAP over AAS
is that multi-elemental analyses of a sample can be performed by
simultaneously measuring specific elemental emission energies.
However, AES-ICAP lacks the sensitivity of AAS, exhibiting a limit
of detection which is higher than the limit of detection for
graphite-furnace AAS (Table 3).
Neutron activation (NA) analysis and isotope dilution mass
spectrometry (IDMS) are 2 additional, but highly specialized,
methods that have been used for cadmium determinations. These
methods are expensive because they require elaborate and
sophisticated instrumentation.
NA analysis has the distinct advantage over other analytical
methods of being able to determine cadmium body burdens in specific
organs (e.g., liver, kidney) in vivo (Ellis et al. 1983). Neutron
bombardment of the target transforms cadmium-113 to cadmium-114,
which promptly decays (<10-14 sec) to its ground state,
emitting gamma rays that are measured using large gamma detectors;
appropriate shielding and instrumentation are required when using
this method.
IDMS analysis, a definitive but laborious method, is based on
the change in the ratio of 2 isotopes of cadmium (cadmium 111 and
112) that occurs when a known amount of the element (with an
artificially altered ratio of the same isotopes [i.e., a cadmium 111
``spike''] is added to a weighed aliquot of the sample (Michiels and
De Bievre 1986).
5.1.2 Methods Developed for CDB Determinations
A variety of methods have been used for preparing and analyzing
CDB samples; most of these methods rely on one of the analytical
techniques described above. Among the earliest reports, Princi
(1947) and Smith et al. (1955) employed a colorimetric procedure to
analyze for CDB and CDU. Samples were dried and digested through
several cycles with concentrated mineral acids (HNO3 and
H2SO4) and hydrogen peroxide (H2O2). The digest
was neutralized, and the cadmium was complexed with
diphenylthiocarbazone and extracted with chloroform. The dithizone-
cadmium complex then was quantified using a spectrometer.
Colorimetric procedures for cadmium analyses were replaced by
methods based on atomic absorption spectroscopy (AAS) in the early
1960s, but many of the complex sample preparation procedures were
retained. Kjellstrom (1979) reports that in Japanese, American and
Swedish laboratories during the early 1970s, blood samples were wet
ashed with mineral acids or ashed at high temperature and wetted
with nitric acid. The cadmium in the digest was complexed with metal
chelators including diethyl dithiocarbamate (DDTC), ammonium
pyrrolidine dithiocarbamate (APDC) or diphenylthiocarbazone
(dithizone) in ammonia-citrate buffer and extracted with methyl
isobutyl ketone (MIBK). The resulting solution then was analyzed by
flame AAS or graphite-furnace AAS forcadmium determinations using
deuterium-lamp background correction.
In the late 1970s, researchers began developing simpler
preparation procedures. Roels et al. (1978) and Roberts and Clark
(1986) developed simplified digestion procedures. Using the Roberts
and Clark method, a 0.5 ml aliquot of blood is collected and
transferred to a digestion tube containing 1 ml concentrated
HNO3. The blood is then digested at 110 deg.C for 4 hours. The
sample is reduced in volume by continued heating, and 0.5 ml 30%
H2O2 is added as the sample dries. The residue is
dissolved in 5 ml dilute (1%) HNO3, and 20 l of sample
is then analyzed by graphite-furnace AAS with deuterium-background
correction.
The current trend in the preparation of blood samples is to
dilute the sample and add matrix modifiers to reduce background
interference, rather than digesting the sample to reduce organic
content. The method of Stoeppler and Brandt (1980), and the
abbreviated procedure published in the American Public Health
Association's (APHA) Methods for Biological Monitoring (1988), are
straightforward and are nearly identical. For the APHA method, a
small aliquot (50-300 l) of whole blood that has been
stabilized with ethylenediaminetetraacetate (EDTA) is added to 1.0
ml 1MHNO3, vigorously shaken and centrifuged. Aliquots (10-25
l) of the supernatant then are then analyzed by graphite-
furnace AAS with appropriate background correction.
Using the method of Stoeppler and Brandt (1980), aliquots (50-
200 l) of whole blood that have been stabilized with EDTA
are pipetted into clean polystyrene tubes and mixed with 150-600
l of 1 M HNO3. After vigorous shaking, the solution is
centrifuged and a 10-25 l aliquot of the supernatant then
is analyzed by graphite-furnace AAS with appropriate background
correction.
Claeys-Thoreau (1982) and DeBenzo et al. (1990) diluted blood
samples at a ratio of 1:10 with a matrix modifier (0.2% Triton X-
100, a wetting agent) for direct determinations of CDB. DeBenzo et
al. also demonstrated that aqueous standards of cadmium, instead of
spiked, whole-blood samples, could be used to establish calibration
curves if standards and samples are treated with additional small
volumes of matrix modifiers (i.e., 1% HNO3, 0.2% ammonium
hydrogenphosphate and 1 mg/ml magnesium salts).
These direct dilution procedures for CDB analysis are simple and
rapid. Laboratories can process more than 100 samples a day using a
dedicated graphite-furnace AAS, an auto-sampler, and either a
Zeeman- or a deuterium-background correction system. Several authors
emphasize using optimum settings for graphite-furnace temperatures
during the drying, charring, and atomization processes associated
with the flameless AAS method, and the need to run frequent QC
samples when performing automated analysis.
5.1.3 Sample Collection and Handling
Sample collection procedures are addressed primarily to identify
ways to minimize the degree of variability that may be introduced by
sample collection during medical monitoring. It is unclear at this
point the extent to which collection procedures contribute to
variability among CDB samples. Sources of variation that may result
from sampling procedures include time-of-day effects and
introduction of external contamination during the collection
process. To minimize these sources, strict adherence to a sample
collection protocol is recommended. Such a protocol must include
provisions for thorough cleaning of the site from which blood will
be extracted; also, every effort should be made to collect samples
near the same time of day. It is also important to recognize that
under the recent OSHA blood-borne pathogens standard (29 CFR
1910.1030), blood samples and certain body fluids must be handled
and treated as if they are infectious.
5.1.4 Best Achievable Performance
The best achievable performance using a particular method for
CDB determinations is assumed to be equivalent to the performance
reported by research laboratories in which the method was developed.
For their method, Roberts and Clark (1986) demonstrated a limit
of detection of 0.4 g Cd/l in whole blood, with a linear
response curve from 0.4 to 16.0 g Cd/l. They report a
coefficient of variation (CV) of 6.7% at 8.0 g/l.
The APHA (1988) reports a range of 1.0-25 g/l, with a
CV of 7.3% (concentration not stated). Insufficient documentation
was available to critique this method.
Stoeppler and Brandt (1980) achieved a detection limit of 0.2
g Cd/l whole blood, with a linear range of 0.4-12.0
g Cd/l, and a CV of 15-30%, for samples at <1.0 g/
l. Improved precision (CV of 3.8%) was reported for CDB
concentrations at 9.3 g/l.
5.1.5 General Method Performance
For any particular method, the performance expected from
commercial laboratories may be somewhat lower than that reported by
the research laboratory in which the method was developed. With
participation in appropriate proficiency programs and use of a
proper in-house QA/QC program incorporating provisions for regular
corrective actions, the performance of commercial laboratories is
expected to approach that reported by research laboratories. Also,
the results reported for existing proficiency programs serve as a
gauge of the likely level of performance that currently can be
expected from commercial laboratories offering these analyses.
Weber (1988) reports on the results of the proficiency program
run by the Centre de Toxicologie du Quebec (CTQ). As indicated
previously, participants in that program receive 18 blood samples
per year having cadmium concentrations ranging from 0.2-20
g/l. Currently, 76 laboratories are participating in this
program. The program is established for several analytes in addition
to cadmium, and not all of these laboratories participate in the
cadmium proficiency-testing program.
Under the CTQ program, cadmium results from individual
laboratories are compared against the consensus mean derived for
each sample. Results indicate that after receiving 60 samples (i.e.,
after participation for approximately three years), 60% of the
laboratories in the program are able to report results that fall
within 1 g/l or 15% of the mean, whichever is
greater. (For this procedure, the 15% criterion was applied to
concentrations exceeding 7 g/l.) On any single sample of
the last 20 samples, the percentage of laboratories falling within
the specified range is between 55 and 80%.
The CTQ also evaluates the performance of participating
laboratories against a less severe standard: 2
g/l or 15% of the mean, whichever is greater (Weber 1988);
90% of participating laboratories are able to satisfy this standard
after approximately 3 years in the program. (The 15% criterion is
used for concentrations in excess of 13 g/l.) On any single
sample of the last 15 samples, the percentage of laboratories
falling within the specified range is between 80 and 95% (except for
a single test for which only 60% of the laboratories achieved the
desired performance).
Based on the data presented in Weber (1988), the CV for analysis
of CDB is nearly constant at 20% for cadmium concentrations
exceeding 5 g/l, and increases for cadmium concentrations
below 5 g/l. At 2 g/l, the reported CV rises to
approximately 40%. At 1 g/l, the reported CV is
approximately 60%.
Participating laboratories also tend to overestimate
concentrations for samples exhibiting concentrations less than 2
g/l (see Figure 11 of Weber 1988). This problem is due in
part to the proficiency evaluation criterion that allows reporting a
minimum 2.0 g/l for evaluated CDB samples.
There is currently little economic or regulatory incentive for
laboratories participating in the CTQ program to achieve greater
accuracy for CDB samples containing cadmium at concentrations less
than 2.0 g/l, even if the laboratory has the experience and
competency to distinguish among lower concentrations in the samples
obtained from the CTQ.
The collective experience of international agencies and
investigators demonstrate the need for a vigorous QC program to
ensure that CDB values reported by participating laboratories are
indeed reasonably accurate. As Friberg (1988) stated:
``Information about the quality of published data has often been
lacking. This is of concern as assessment of metals in trace
concentrations in biological media are fraught with difficulties
from the collection, handling, and storage of samples to the
chemical analyses. This has been proven over and over again from the
results of interlaboratory testing and quality control exercises.
Large variations in results were reported even from `experienced'
laboratories.''
The UNEP/WHO global study of cadmium biological monitoring set a
limit for CDB accuracy using the maximum allowable deviation method
at Y=X(0.1X+1) for a targeted concentration of 10
g Cd/l (Friberg and Vahter 1983). The performance of
participating laboratories over a concentration range of 1.5-12
g/l was reported by Lind et al. (1987). Of the 3 QC runs
conducted during 1982 and 1983, 1 or 2 of the 6 laboratories failed
each run. For the years 1983 and 1985, between zero and 2
laboratories failed each of the consecutive QC runs.
In another study (Vahter and Friberg 1988), QC samples
consisting of both external (unknown) and internal (stated)
concentrations were distributed to laboratories participating in the
epidemiology research. In this study, the maximum acceptable
deviation between the regression analysis of reported results and
reference values was set at Y=X(0.05X+0.2) for a
concentration range of 0.3-5.0 g Cd/l. It is reported that
only 2 of 5 laboratories had acceptable data after the first QC set,
and only 1 of 5 laboratories had acceptable data after the second QC
set. By the fourth QC set, however, all 5 laboratories were judged
proficient.
The need for high quality CDB monitoring is apparent when the
toxicological and biological characteristics of this metal are
considered; an increase in CDB from 2 to 4 g/l could cause
a doubling of the cadmium accumulation in the kidney, a critical
target tissue for selective cadmium accumulation (Nordberg and
Nordberg 1988).
Historically, the CDC's internal QC program for CDB cadmium
monitoring program has found achievable accuracy to be
10% of the true value at CDB concentrations
5.0 g/l (Paschal 1990). Data on the performance
of laboratories participating in this program currently are not
available.
5.1.6 'Observed CDB Concentrations
As stated in Section 4.3, CDB concentrations are representative
of ongoing levels of exposure to cadmium. Among those who have been
exposed chronically to cadmium for extended periods, however, CDB
may contain a component attributable to the general cadmium body
burden.
5.1.6.1 CDB Concentrations Among Unexposed Samples
Numerous studies have been conducted examining CDB
concentrations in the general population, and in control groups used
for comparison with cadmium-exposed workers. A number of reports
have been published that present erroneously high values of CDB
(Nordberg and Nordberg 1988). This problem was due to contamination
of samples during sampling and analysis, and to errors in analysis.
Early AAS methods were not sufficiently sensitive to accurately
estimate CDB concentrations.
Table 4 presents results of recent studies reporting CDB levels
for the general U.S. population not exposed occupationally to
cadmium. Other surveys of tissue cadmium using U.S. samples and
conducted as part of a cooperative effort among Japan, Sweden and
the U.S., did not collect CDB data because standard analytical
methodologies were unavailable, and because of analytic problems
(Kjellstrom 1979; SWRI 1978).
Table 4.--Blood Cadmium Concentrations of U.S. Population Not Occupationally Exposed to Cadmiuma
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Lower 95th Upper 95th
No. in Smoking Arithmetic mean Absolute Geometric percentile of percentile of
Study No. study Sex Age habitsb (S.D.)c range or mean (GSD)e distributionf distributionf Reference
(n) (95% CI)d
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1....................................... 80 M 4 to 69 NS,S 1.13 0.35-3.3 0.982.1 (0.5-5.0) g(0) g(5.8) Ellis et al. (1983).
3....................................... 24 M Adults NS 0.62.1 (0.5-7.3) g(0) g(5.6) Mueller et al. (1989).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
aConcentrations reported in g Cd/l blood unless otherwise stated.
bNS--never smoked; S--current cigarette smoker.
cA.S.D.--Arithmetic Standard Deviation.
dC.I.--Confidence Interval.
eG.S.D.--Geometric Standard Deviation.
f Based on assumed lognormal distribution.
g Based on assumed normal distribution.
Arithmetic and/or geometric means and standard deviations are
provided in Table 4 for measurements among the populations defined
in each study listed. The range of reported measurements and/or the
95% upper and lower confidence intervals for the means are presented
when this information was reported in a study. For studies reporting
either an arithmetic or geometric standard deviation along with a
mean, the lower and upper 95th percentile for the distribution also
were derived and reported in the table.
The data provided in Table 4 from Kowal et al. (1979) are from
studies conducted between 1974 and 1976 evaluating CDB levels for
the general population in Chicago, and are considered to be
representative of the U.S. population. These studies indicate that
the average CDB concentration among those not occupationally exposed
to cadmium is approximately 1 g/l.
In several other studies presented in Table 4, measurements are
reported separately for males and females, and for smokers and
nonsmokers. The data in this table indicate that similar CDB levels
are observed among males and females in the general population, but
that smokers tend to exhibit higher CDB levels than nonsmokers.
Based on the Kowal et al. (1979) study, smokers not occupationally
exposed to cadmium exhibit an average CDB level of 1.4 g/l.
In general, nonsmokers tend to exhibit levels ranging to 2
g/l, while levels observed among smokers range to 5
g/l. Based on the data presented in Table 4, 95% of those
not occupationally exposed to cadmium exhibit CDB levels less than 5
g/l.
5.1.6.2 CDB Concentrations Among Exposed Workers
Table 5 is a summary of results from studies reporting CDB
levels among workers exposed to cadmium in the work place. As in
Table 4, arithmetic and/or geometric means and standard deviations
are provided if reported in the listed studies. The absolute range,
or the 95% confidence interval around the mean, of the data in each
study are provided when reported. In addition, the lower and upper
95th percentile of the distribution are presented for each study in
which a mean and corresponding standard deviation were reported.
Table 5 also provides estimates of the duration, and level, of
exposure to cadmium in the work place if these data were reported in
the listed studies. The data presented in Table 5 suggest that CDB
levels are dose related. Sukuri et al. (1983) show that higher CDB
levels are observed among workers experiencing higher work place
exposure. This trend appears to be true of every one of the studies
listed in the table.
CDB levels reported in Table 5 are higher among those showing
signs of cadmium-related kidney damage than those showing no such
damage. Lauwerys et al. (1976) report CDB levels among workers with
kidney lesions that generally are above the levels reported for
workers without kidney lesions. Ellis et al. (1983) report a similar
observation comparing workers with and without renal dysfunction,
although they found more overlap between the 2 groups than Lauwerys
et al.
Table 5--Blood Cadmium in Workers Exposed to Cadmium in the Workplace
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concentrations of Cadmium in blooda
Mean ----------------------------------------------------------------------------------------------
Study Work environment (worker population Number Employment concentration Absolute
number monitored) in study in years of cadmium in Arithmetic mean range or Geometric Lower 95th Upper 95th
(mean) air (g/ (S.D.)b (95% mean percentile of percentile of Reference
m3) C.I.)c (GSD)d rangee ()f rangee ()f
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1........ Ni-Cd battery plant and Cd production plant: 3-40 90 Lauwerys et al.
1976.
(Workers without kidney lesions)............. 96 ............ ............... 21.41.9 .......... .......... (18) (25)
(Workers with kidney lesions)................ 25 ............ ............... 38.83.8 .......... .......... (32) (45)
2........ Ni-Cd battery plant: Adamsson et al.
(1979).
(Smokers).................................... 7 (5) 10.1 22.7 7.3-67.2
(Nonsmokers)................................. 8 (9) 7.0 7.0 4.9-10.5
3........ Cadmium alloy plant: Sukuri et al.
1982.
(High exposure group)........................ 7 (10.6) [1,000-5 yrs; 20.87.1 .......... .......... (7.3) (34)
(Low exposure group)......................... 9 (7.3) 40-5 yrs] 7.11.1 .......... .......... (5.1) (9.1)
4........ Retrospective study of workers with renal 19 15-41 .............. Roels et al.
problems: 1982.
(Before removal)............................. ........ (27.2) ............... 39.93.7 11-179 .......... (34) (46)
(After removal).............................. ........ (4.2)g ............... 14.15.6 5.7-27.4 .......... (4.4) (24)
5........ Cadmium production plant: Ellis et al.
1983.
(Workers without renal dysfunction).......... 33 1-34 ............... 155.7 7-31 .......... (5.4) (25)
(Workers with renal dysfunction)............. 18 10-34 ............... 248.5 10-34 .......... (9.3) (39)
6........ Cd-Cu alloy plant............................ 75 Up to 39 ............... ................... .......... 8.85.3 2.2-18.8 .......... (1.3) (19) Mueller et al.
1989.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
aConcentrations reported in g Cd/l blood unless otherwise stated.
bS.D.--Standard Deviation.
cC.I.--Confidence Interval.
FR Doc. 93-31820 Occupational Safety and Health Standards for Cadmium in Shipyard Employment and Construction
dG.S.D.--Geometric Standard Deviation.
e Based on assumed lognormal distribution.
f Based on assumed normal distribution.
g Years following removal.
The data in Table 5 also indicate that CDB levels are higher
among those experiencing current occupational exposure than those
who have been removed from such exposure. Roels et al. (1982)
indicate that CDB levels observed among workers experiencing ongoing
exposure in the work place are almost entirely above levels observed
among workers removed from such exposure. This finding suggests that
CDB levels decrease once cadmium exposure has ceased.
A comparison of the data presented in Tables 4 and 5 indicates
that CDB levels observed among cadmium-exposed workers is
significantly higher than levels observed among the unexposed
groups. With the exception of 2 studies presented in Table 5 (1 of
which includes former workers in the sample group tested), the lower
95th percentile for CDB levels among exposed workers are greater
than 5 g/l, which is the value of the upper 95th percentile
for CDB levels observed among those who are not occupationally
exposed. Therefore, a CDB level of 5 g/l represents a
threshold above which significant work place exposure to cadmium may
be occurring.
5.1.7 Conclusions and Recommendations for CDB
Based on the above evaluation, the following recommendations are
made for a CDB proficiency program.
5.1.7.1 Recommended Method
The method of Stoeppler and Brandt (1980) should be adopted for
analyzing CDB. This method was selected over other methods for its
straightforward sample-preparation procedures, and because
limitations of the method were described adequately. It also is the
method used by a plurality of laboratories currently participating
in the CTQ proficiency program. In a recent CTQ interlaboratory
comparison report (CTQ 1991), analysis of the methods used by
laboratories to measure CDB indicates that 46% (11 of 24) of the
participating laboratories used the Stoeppler and Brandt methodology
(HNO3 deproteinization of blood followed by analysis of the
supernatant by GF-AAS). Other CDB methods employed by participating
laboratories identified in the CTQ report include dilution of blood
(29%), acid digestion (12%) and miscellaneous methods (12%).
Laboratories may adopt alternate methods, but it is the
responsibility of the laboratory to demonstrate that the alternate
methods meet the data quality objectives defined for the Stoeppler
and Brandt method (see section 5.1.7.2 below).
5.1.7.2 Data Quality Objectives
Based on the above evaluation, the following data quality
objectives (DQOs) should facilitate interpretation of analytical
results.
Limit of Detection. 0.5 g/l should be achievable using
the Stoeppler and Brandt method. Stoeppler and Brandt (1980) report
a limit of detection equivalent to 0.2 g/l in
whole blood using 25 l aliquots of deproteinized, diluted
blood samples.
Accuracy. Initially, some of the laboratories performing CDB
measurements may be expected to satisfy criteria similar to the less
severe criteria specified by the CTQ program, i.e., measurements
within 2 g/l or 15% (whichever is greater) of the target
value. About 60% of the laboratories enrolled in the CTQ program
could meet this criterion on the first proficiencey test (Weber
1988).
Currently, approximately 12 laboratories in the CTQ program are
achieving an accuracy for CDB analysis within the more severe
constraints of 1 g/l or 15% (whichever is
greater). Later, as laboratories gain experience, they should
achieve the level of accuracy exhibited by these 12 laboratories.
The experience in the CTQ program has shown that, even without
incentives, laboratories benefit from the feedback of the program;
after they have analyzed 40-50 control samples from the program,
performance improves to the point where about 60% of the
laboratories can meet the stricter criterion of 1
g/l or 15% (Weber 1988). Thus, this stricter target
accuracy is a reasonable DQO.
Precision. Although Stoeppler and Brandt (1980) suggest that a
coefficient of variation (CV) near 1.3% (for a 10 g/l
concentration) is achievable for within-run reproducibility, it is
recognized that other factors affecting within- and between-run
comparability will increase the achievable CV. Stoeppler and Brandt
(1980) observed CVs that were as high as 30% for low concentrations
(0.4 g/l), and CVs of less than 5% for higher
concentrations.
For internal QC samples (see section 3.3.1), laboratories should
to attain an overall precision near 25%. For CDB samples with
concentrations less than 2 g/l, a target precision of 40%
is reasonable, while precisions of 20% should be achievable for
concentrations greater than 2 g/l. Although these values
are more strict than values observed in the CTQ interlaboratory
program reported by Webber (1988), they are within the achievable
limits reported by Stoeppler and Brandt (1980).
5.1.7.3 Quality Assurance/Quality Control
Commercial laboratories providing measurement of CDB should
adopt an internal QA/QC program that incorporates the following
components: Strict adherence to the selected method, including all
calibration requirements; regular incorporation of QC samples during
actual runs; a protocol for corrective actions, and documentation of
these actions; and, participation in an interlaboratory proficiency
program. Note that the nonmandatory QA/QC program presented in
Attachment 1 is based on the Stoeppler and Brandt method for CDB
analysis. Should an alternate method be adopted, the laboratory
should develop a QA/QC program satisfying the provisions of Section
3.3.1.
5.2 Measuring Cadmium in Urine (CDU)
As in the case of CDB measurement, proper determination of CDU
requires strict analytical discipline regarding collection and
handling of samples. Because cadmium is both ubiquitous in the
environment and employed widely in coloring agents for industrial
products that may be used during sample collection, preparation and
analysis, care should be exercised to ensure that samples are not
contaminated during the sampling procedure.
Methods for CDU determination share many of the same features as
those employed for the determination of CDB. Thus, changes and
improvements to methods for measuring CDU over the past 40 years
parallel those used to monitor CDB. The direction of development has
largely been toward the simplification of sample preparation
techniques made possible because of improvements in analytic
techniques.
5.2.1 Units of CDU Measurement
Procedures adopted for reporting CDU concentrations are not
uniform. In fact, the situation for reporting CDU is more
complicated than for CDB, where concentrations are normalized
against a unit volume of whole blood.
Concentrations of solutes in urine vary with several biological
factors (including the time since last voiding and the volume of
liquid consumed over the last few hours); as a result, solute
concentrations should be normalized against another characteristic
of urine that represents changes in solute concentrations. The 2
most common techniques are either to standardize solute
concentrations against the concentration of creatinine, or to
standardize solute concentrations against the specific gravity of
the urine. Thus, CDU concentrations have been reported in the
literature as ``uncorrected'' concentrations of cadmium per volume
of urine (i.e., g Cd/l urine), ``corrected'' concentrations
of cadmium per volume of urine at a standard specific gravity (i.e.,
g Cd/l urine at a specific gravity of 1.020), or
``corrected'' mass concentration per unit mass of creatinine (i.e.,
g Cd/g creatinine). (CDU concentrations [whether
uncorrected or corrected for specific gravity, or normalized to
creatinine] occasionally are reported in nanomoles [i.e., nmoles] of
cadmium per unit mass or volume. In this protocol, these values are
converted to g of cadmium per unit mass or volume using 89
nmoles of cadmium=10 g.)
While it is agreed generally that urine values of analytes
should be normalized for reporting purposes, some debate exists over
what correction method should be used. The medical community has
long favored normalization based on creatinine concentration, a
common urinary constituent. Creatinine is a normal product of tissue
catabolism, is excreted at a uniform rate, and the total amount
excreted per day is constant on a day-to-day basis (NIOSH 1984b).
While this correction method is accepted widely in Europe, and
within some occupational health circles, Kowals (1983) argues that
the use of specific gravity (i.e., total solids per unit volume) is
more straightforward and practical (than creatinine) in adjusting
CDU values for populations that vary by age or gender.
Kowals (1983) found that urinary creatinine (CRTU) is lower in
females than males, and also varies with age. Creatinine excretion
is highest in younger males (20-30 years old), decreases at middle
age (50-60 years), and may rise slightly in later years. Thus,
cadmium concentrations may be underestimated for some workers with
high CRTU levels.
Within a single void urine collection, urine concentration of
any analyte will be affected by recent consumption of large volumes
of liquids, and by heavy physical labor in hot environments. The
absolute amount of analyte excreted may be identical, but
concentrations will vary widely so that urine must be corrected for
specific gravity (i.e., to normalize concentrations to the quantity
of total solute) using a fixed value (e.g., 1.020 or 1.024).
However, since heavy-metal exposure may increase urinary protein
excretion, there is a tendency to underestimate cadmium
concentrations in samples with high specific gravities when
specific-gravity corrections are applied.
Despite some shortcomings, reporting solute concentrations as a
function of creatinine concentration is accepted generally; OSHA
therefore recommends that CDU levels be reported as the mass of
cadmium per unit mass of creatinine (g/g CTRU).
Reporting CDU as g/g CRTU requires an additional
analytical process beyond the analysis of cadmium: Samples must be
analyzed independently for creatinine so that results may be
reported as the ratio of cadmium to creatinine concentrations found
in the urine sample. Consequently, the overall quality of the
analysis depends on the combined performance by a laboratory on
these 2 determinations. The analysis used for CDU determinations is
addressed below in terms of g Cd/l, with analysis of
creatinine addressed separately. Techniques for assessing creatinine
are discussed in Section 5.4.
Techniques for deriving cadmium as a ratio of CRTU, and the
confidence limits for independent measurements of cadmium and CRTU,
are provided in Section 3.3.3.
5.2.2 Analytical Techniques Used to Monitor CDU
Analytical techniques used for CDU determinations are similar to
those employed for CDB determinations; these techniques are
summarized in Table 3. As with CDB monitoring, the technique most
suitable for CDU determinations is atomic absorption spectroscopy
(AAS). AAS methods used for CDU determinations typically employ a
graphite furnace, with background correction made using either the
deuterium-lamp or Zeeman techniques; Section 5.1.1 provides a
detailed description of AAS methods.
5.2.3 Methods Developed for CDU Determinations
Princi (1947), Smith et al. (1955), Smith and Kench (1957), and
Tsuchiya (1967) used colorimetric procedures similar to those
described in the CDB section above to estimate CDU concentrations.
In these methods, urine (50 ml) is reduced to dryness by heating in
a sand bath and digested (wet ashed) with mineral acids. Cadmium
then is complexed with dithiazone, extracted with chloroform and
quantified by spectrophotometry. These early studies typically
report reagent blank values equivalent to 0.3 g Cd/l, and
CDU concentrations among nonexposed control groups at maximum levels
of 10 g Cd/l--erroneously high values when compared to more
recent surveys of cadmium concentrations in the general population.
By the mid-1970s, most analytical procedures for CDU analysis
used either wet ashing (mineral acid) or high temperatures (>400
deg.C) to digest the organic matrix of urine, followed by cadmium
chelation with APDC or DDTC solutions and extraction with MIBK. The
resulting aliquots were analyzed by flame or graphite-furnace AAS
(Kjellstrom 1979).
Improvements in control over temperature parameters with
electrothermal heating devices used in conjunction with flameless
AAS techniques, and optimization of temperature programs for
controlling the drying, charring, and atomization processes in
sample analyses, led to improved analytical detection of diluted
urine samples without the need for sample digestion or ashing. Roels
et al. (1978) successfully used a simple sample preparation,
dilution of 1.0 ml aliquots of urine with 0.1 N HNO3, to
achieve accurate low-level determinations of CDU.
In the method described by Pruszkowska et al. (1983), which has
become the preferred method for CDU analysis, urine samples were
diluted at a ratio of 1:5 with water; diammonium hydrogenphosphate
in dilute HNO3 was used as a matrix modifier. The matrix
modifier allows for a higher charring temperature without loss of
cadmium through volatilization during pre-atomization. This
procedure also employs a stabilized temperature platform in a
graphite furnace, while nonspecific background absorbtion is
corrected using the Zeeman technique. This method allows for an
absolute detection limit of approximately 0.04 g Cd/l
urine.
5.2.4 Sample Collection and Handling
Sample collection procedures for CDU may contribute to
variability observed among CDU measurements. Sources of variation
attendant to sampling include time-of-day, the interval since
ingestion of liquids, and the introduction of external contamination
during the collection process. Therefore, to minimize contributions
from these variables, strict adherence to a sample-collection
protocol is recommended. This a protocol should include provisions
for normalizing the conditions under which urine is collected. Every
effort also should be made to collect samples during the same time
of day.
Collection of urine samples from an industrial work force for
biological monitoring purposes usually is performed using ``spot''
(i.e., single-void) urine with the pH of the sample determined
immediately. Logistic and sample-integrity problems arise when
efforts are made to collect urine over long periods (e.g., 24 hrs).
Unless single-void urines are used, there are numerous opportunities
for measurement error because of poor control over sample
collection, storage and environmental contamination.
To minimize the interval during which sample urine resides in
the bladder, the following adaption to the ``spot'' collection
procedure is recommended: The bladder should first be emptied, and
then a large glass of water should be consumed; the sample may be
collected within an hour after the water is consumed.
5.2.5 Best Achievable Performance
Performance using a particular method for CDU determinations is
assumed to be equivalent to the performance reported by the research
laboratories in which the method was developed. Pruszkowska et al.
(1983) report a detection limit of 0.04 g/l CDU, with a CV
of <4% between 0-5 g/l. The CDC reports a minimum CDU
detection limit of 0.07 g/l using a modified method based
on Pruszkowska et al. (1983). No CV is stated in this protocol; the
protocol contains only rejection criteria for internal QC parameters
used during accuracy determinations with known standards (Attachment
8 of exhibit 106 of OSHA docket H057A). Stoeppler and Brandt (1980)
report a CDU detection limit of 0.2 g/l for their
methodology.
5.2.6 General Method Performance
For any particular method, the expected initial performance from
commercial laboratories may be somewhat lower than that reported by
the research laboratory in which the method was developed. With
participation in appropriate proficiency programs, and use of a
proper in-house QA/QC program incorporating provisions for regular
corrective actions, the performance of commercial laboratories may
be expected to improve and approach that reported by a research
laboratories. The results reported for existing proficiency programs
serve to specify the initial level of performance that likely can be
expected from commercial laboratories offering analysis using a
particular method.
Weber (1988) reports on the results of the CTQ proficiency
program, which includes CDU results for laboratories participating
in the program. Results indicate that after receiving 60 samples
(i.e., after participating in the program for approximately 3
years), approximately 80% of the participating laboratories report
CDU results ranging between 2 g/l or 15% of the
consensus mean, whichever is greater. On any single sample of the
last 15 samples, the proportion of laboratories falling within the
specified range is between 75 and 95%, except for a single test for
which only 60% of the laboratories reported acceptable results. For
each of the last 15 samples, approximately 60% of the laboratories
reported results within 1 g or 15% of the mean,
whichever is greater. The range of concentrations included in this
set of samples was not reported.
Another report from the CTQ (1991) summarizes preliminary CDU
results from their 1991 interlaboratory program. According to the
report, for 3 CDU samples with values of 9.0, 16.8, 31.5 g/
l, acceptable results (target 2 g/l or 15% of
the consensus mean, whichever is greater) were achieved by only 44-
52% of the 34 laboratories participating in the CDU program. The
overall CVs for these 3 CDU samples among the 34 participating
laboratories were 31%, 25%, and 49%, respectively. The reason for
this poor performance has not been determined.
A more recent report from the CTQ (Weber, private communication)
indicates that 36% of the laboratories in the program have been able
to achieve the target of 1 g/l or 15% for more
than 75% of the samples analyzed over the last 5 years, while 45% of
participating laboratories achieved a target of 2
g/l or 15% for more than 75% of the samples analyzed over
the same period.
Note that results reported in the interlaboratory programs are
in terms of g Cd/l of urine, unadjusted for creatinine. The
performance indicated, therefore, is a measure of the performance of
the cadmium portion of the analyses, and does not include variation
that may be introduced during the analysis of CRTU.
5.2.7 Observed CDU Concentrations
Prior to the onset of renal dysfunction, CDU concentrations
provide a general indication of the exposure history (i.e., body
burden)(see Section 4.3). Once renal dysfunction occurs, CDU levels
appear to increase and are no longer indicative solely of cadmium
body burden (Friberg and Elinder 1988).
5.2.7.1 Range of CDU Concentrations Observed Among Unexposed Samples
Surveys of CDU concentrations in the general population were
first reported from cooperative studies among industrial countries
(i.e., Japan, U.S. and Sweden) conducted in the mid-1970s. In
summarizing these data, Kjellstrom (1979) reported that CDU
concentrations among Dallas, Texas men (age range: <9-59 years;
smokers and nonsmokers) varied from 0.11-1.12 g/l
(uncorrected for creatinine or specific gravity). These CDU
concentrations are intermediate between population values found in
Sweden (range: 0.11-0.80 g/l) and Japan (range: 0.14-2.32
g/l).
Kowal and Zirkes (1983) reported CDU concentrations for almost
1,000 samples collected during 1978-79 from the general U.S. adult
population (i.e., nine states; both genders; ages 20-74 years). They
report that CDU concentrations are lognormally distributed; low
levels predominated, but a small proportion of the population
exhibited high levels. These investigators transformed the CDU
concentrations values, and reported the same data 3 different ways:
g/l urine (unadjusted), g/l (specific gravity
adjusted to 1.020), and g/g CRTU. These data are summarized
in Tables 6 and 7.
Based on further statistical examination of these data,
including the lifestyle characteristics of this group, Kowal (1988)
suggested increased cadmium absorption (i.e., body burden) was
correlated with low dietary intakes of calcium and iron, as well as
cigarette smoking.
CDU levels presented in Table 6 are adjusted for age and gender.
Results suggest that CDU levels may be slightly different among men
and women (i.e., higher among men when values are unadjusted, but
lower among men when the values are adjusted, for specific gravity
or CRTU). Mean differences among men and women are small compared to
the standard deviations, and therefore may not be significant.
Levels of CDU also appear to increase with age. The data in Table 6
suggest as well that reporting CDU levels adjusted for specific
gravity or as a function of CRTU results in reduced variability.
Table 6--Urine Cadmium Concentrations in the U.S. Adult Population:
Normal and Concentration-Adjusted Values By Age and Sex1
------------------------------------------------------------------------
Geometric means (and geometric standard
deviations)
-----------------------------------------------
SG-adjusted2 Creatine-
Unadjusted (g/l adjusted
(g/l) at 1.020) (g/g)
------------------------------------------------------------------------
Sex:
Male (n=484)........ 0.55 (2.9) 0.73 (2.6) 0.55 (2.7)
Female (n=498)...... 0.49 (3.0) 0.86 (2.7) 0.78 (2.7)
Age:
20-29 (n=222)....... 0.32 (3.0) 0.43 (2.7) 0.32 (2.7)
30-39 (n=141)....... 0.46 (3.2) 0.70 (2.8) 0.54 (2.7)
40-49 (n=142)....... 0.50 (3.0) 0.81 (2.6) 0.70 (2.7)
50-59 (n=117)....... 0.61 (2.9) 0.99 (2.4) 0.90 (2.3)
60-69 (n=272)....... 0.76 (2.6) 1.16 (2.3) 1.03 (2.3)
------------------------------------------------------------------------
1From Kowal and Zirkes 1983.
2SC-adjusted is adjusted for specific gravity.
Table 7--Urine Cadmium Concentrations in the U.S. Adult Population:
Cumulative Frequency Distribution of Urinary Cadmium (N=982)1
[In percentage]
------------------------------------------------------------------------
SG-adjusted Creatine-
Range of concentrations Unadjusted (g/l adjusted
(g/l) at 1.020) (g/g)
------------------------------------------------------------------------
<0.5.................... 43.9 28.0 35.8
0.6-1.0................. 71.7 56.4 65.6
1.1-1.5................. 84.4 74.9 81.4
1.6-2.0................. 91.3 84.7 88.9
2.1-3.0................. 97.3 94.4 95.8
3.1-4.0................. 98.8 97.4 97.2
4.1-5.0................. 99.4 98.2 97.9
5.1-10.0................ 99.6 99.4 99.3
10.0-20.0............... 99.8 99.6 99.6
------------------------------------------------------------------------
1Source: Kowal and Zirkes (1983).
The data in the Table 6 indicate the geometric mean of CDU
levels observed among the general population is 0.52 g Cd/l
urine (unadjusted), with a geometric standard deviation of 3.0.
Normalized for creatinine, the geometric mean for the population is
0.66 g/g CRTU, with a geometric standard deviation of 2.7.
Table 7 provides the distributions of CDU concentrations for the
general population studied by Kowal and Zirkes. The data in this
table indicate that 95% of the CDU levels observed among those not
occupationally exposed to cadmium are below 3 g/g CRTU.
5.2.7.2 Range of CDU Concentrations Observed Among Exposed Workers
Table 8 is a summary of results from available studies of CDU
concentrations observed among cadmium-exposed workers. In this
table, arithmetic and/or geometric means and standard deviations are
provided if reported in these studies. The absolute range for the
data in each study, or the 95% confidence interval around the mean
of each study, also are provided when reported. The lower and upper
95th percentile of the distribution are presented for each study in
which a mean and corresponding standard deviation were reported.
Table 8 also provides estimates of the years of exposure, and the
levels of exposure, to cadmium in the work place if reported in
these studies. Concentrations reported in this table are in
g/g CRTU, unless otherwise stated.
Table 8--Urine Cadmium Concentrations in Workers Exposed to Cadmium in the Workplace
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concentration of cadmium in Urinea
Mean -----------------------------------------------------------------------------------------------------
Study Work environment (worker population Number Employment Concentration Absolute
number monitored) in Study in years of cadmium in Arithmetic mean range or Geometric Lower 95th Upper 95th
(n) (mean) air (g/ (S.D.)b (95% mean percentile of percentile of Reference
m3) C.I.)c (GSD)d rangee ()f rangee ()f
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1........ Ni-Cd battery plant and Cd production ........ 3-40 90 ................... .......... .......... .............. .............. Lauwerys et al. 1976.
plant.
(Workers without kidney lesions)...... 96 ............ ............... 16.316. .......... .......... (0) (44) .......................
7
(Workers with kidney lesions)......... 25 ............ ............... 48.242. .......... .......... (0) (120) .......................
6
2........ Ni-Cd battery plant................... ........ ............ ............... ................... .......... .......... .............. .............. Adamsson et al. (1979).
(Smokers)............................. 7 (5) 10.1 5.5 1.0-14.7 .......... .............. .............. .......................
(Nonsmokers).......................... 8 (9) 7.0 3.6 0.5-9.3 .......... .............. .............. .......................
3........ Cadmium salts production facility..... 148 (15.4) ............... 15.8 2-150 .......... .............. .............. Butchet et al. 1980.
4........ Retrospective study of workers with 19 15-41 ............... ................... .......... .......... .............. .............. Roels et al. 1982.
renal problems.
(Before removal)...................... ........ (27.2) ............... 39.428. 10.8-117 .......... (0) (88) .......................
1
(After removal)....................... ........ (4.2)g ............... 16.49.0 80-42.3 .......... (1.0) (32) .......................
5........ Cadmium production plant.............. ........ ............ ............... ................... .......... .......... .............. .............. Ellis et al. 1983.
(Workers without renal dysfunction)... 33 1-34 ............... 9.46.9 2-27 .......... (0) (21) .......................
(Workers with renal dysfunction)...... 18 10-34 ............... 22.812. 8-55 .......... (1) (45) .......................
7
6........ Cd-Cu alloy plant..................... 75 Up to 39 Note h 6.99.4 .......... .......... (0) (23) Mason et al. 1988.
7........ Cadmium recovery operation............ 45 (19) 87 9.36.9 .......... .......... (0) (21) Thun et al. 1989.
8........ Pigment manufacturing plant........... 29 (12.8) 0.18-3.0 ................... 0.2-9.5 1.1 .............. .............. Mueller et al. 1989.
9........ Pigment manufacturing plant........... 26 (12.1) 3.0 ................... .......... 1.25aConcentrations are reported in g/g Cr.
bS.D.--Standard Deviation.
cC.I.--Confidence Interval.
dG.S.D.--Geometric Standard Deviation.
e Based on assumed lognormal distribution.
f Based on assumed normal distribution.
g Years following removal.
h Equivalent to 50 for 20-22 yrs.
Data in Table 8 from Lauwerys et al. (1976) and Ellis et al.
(1983) indicate that CDU concentrations are higher among those
exhibiting kidney lesions or dysfunction than among those lacking
these symptoms. Data from the study by Roels et al. (1982) indicate
that CDU levels decrease among workers removed from occupational
exposure to cadmium in comparison to workers experiencing ongoing
exposure. In both cases, however, the distinction between the 2
groups is not as clear as with CDB; there is more overlap in CDU
levels observed among each of the paired populations than is true
for corresponding CDB levels. As with CDB levels, the data in Table
8 suggest increased CDU concentrations among workers who experienced
increased overall exposure.
Although a few occupationally-exposed workers in the studies
presented in Table 8 exhibit CDU levels below 3 g/g CRTU,
most of those workers exposed to cadmium levels in excess of the PEL
defined in the final cadmium rule exhibit CDU levels above 3
g/g CRTU; this level represents the upper 95th percentile
of the CDU distribution observed among those who are not
occupationally exposed to cadmium (Table 7).
The mean CDU levels reported in Table 8 among occupationally-
exposed groups studied (except 2) exceed 3 g/g CRTU.
Correspondingly, the level of exposure reported in these studies
(with 1 exception) are significantly higher than what workers will
experience under the final cadmium rule. The 2 exceptions are from
the studies by Mueller et al. (1989) and Kawada et al. (1990); these
studies indicate that workers exposed to cadmium during pigment
manufacture do not exhibit CDU levels as high as those levels
observed among workers exposed to cadmium in other occupations.
Exposure levels, however, were lower in the pigment manufacturing
plants studied. Significantly, workers removed from occupational
cadmium exposure for an average of 4 years still exhibited CDU
levels in excess of 3 g/g CRTU (Roels et al. 1982). In the
single-exception study with a reported level of cadmium exposure
lower than levels proposed in the final rule (i.e., the study of a
pigment manufacturing plant by Kawada et al. 1990), most of the
workers exhibited CDU levels less than 3 g/g CRTU (i.e.,
the mean value was only 1.3 g/g CRTU). CDU levels among
workers with such limited cadmium exposure are expected to be
significantly lower than levels of other studies reported on Table
8.
Based on the above data, a CDU level of 3 g/g CRTU
appear to represent a threshold above which significant work place
exposure to cadmium occurs over the work span of those being
monitored. Note that this threshold is not as distinct as the
corresponding threshold described for CDB. In general, the
variability associated with CDU measurements among exposed workers
appears to be higher than the variability associated with CDB
measurements among similar workers.
5.2.8 Conclusions and Recommendations for CDU
The above evaluation supports the following recommendations for
a CDU proficiency program. These recommendations address only
sampling and analysis procedures for CDU determinations
specifically, which are to be reported as an unadjusted g
Cd/l urine. Normalizing this result to creatinine requires a second
analysis for CRTU so that the ratio of the 2 measurements can be
obtained. Creatinine analysis is addressed in Section 5.4. Formal
procedures for combining the 2 measurements to derive a value and a
confidence limit for CDU in g/g CRTU are provided in
Section 3.3.3.
5.2.8.1 Recommended Method
The method of Pruszkowska et al. (1983) should be adopted for
CDU analysis. This method is recommended because it is simple,
straightforward and reliable (i.e., small variations in experimental
conditions do not affect the analytical results).
A synopsis of the methods used by laboratories to determine CDU
under the interlaboratory program administered by the CTQ (1991)
indicates that more than 78% (24 of 31) of the participating
laboratories use a dilution method to prepare urine samples for CDU
analysis. Laboratories may adopt alternate methods, but it is the
responsibility of the laboratory to demonstrate that the alternate
methods provide results of comparable quality to the Pruszkowska
method.
5.2.8.2 Data Quality Objectives
The following data quality objectives should facilitate
interpretation of analytical results, and are achievable based on
the above evaluation.
Limit of Detection. A level of 0.5 g/l (i.e.,
corresponding to a detection limit of 0.5 g/g CRTU,
assuming 1 g CRT/l urine) should be achievable. Pruszkowska et al.
(1983) achieved a limit of detection of 0.04 g/l for CDU
based on the slope the the curve for their working standards (0.35
pg Cd/0.0044, A signal=1% absorbance using GF-AAS).
The CDC reports a minimum detection limit for CDU of 0.07
g/l using a modified Pruszkowska method. This limit of
detection was defined as 3 times the standard deviation calculated
from 10 repeated measurements of a ``low level'' CDU test sample
(Attachment 8 of exhibit 106 of OSHA docket H057A).
Stoeppler and Brandt (1980) report a limit of detection for CDU
of 0.2 g/l using an aqueous dilution (1:2) of the urine
samples.
Accuracy. A recent report from the CTQ (Weber, private
communication) indicates that 36% of the laboratories in the program
achieve the target of 1 g/l or 15% for more
than 75% of the samples analyzed over the last 5 years, while 45% of
participating laboratories achieve a target of 2
g/l or 15% for more than 75% of the samples analyzed over
the same period. With time and a strong incentive for improvement,
it is expected that the proportion of laboratories successfully
achieving the stricter level of accuracy should increase. It should
be noted, however, these indices of performance do not include
variations resulting from the ancillary measurement of CRTU (which
is recommended for the proper recording of results). The low cadmium
levels expected to be measured indicate that the analysis of
creatinine will contribute relatively little to the overall
variability observed among creatinine-normalized CDU levels (see
Section 5.4). The initial target value for reporting CDU under this
program, therefore, is set at 1 g/g CRTU or 15%
(whichever is greater).
Precision. For internal QC samples (which are recommended as
part of an internal QA/QC program, Section 3.3.1), laboratories
should attain an overall precision of 25%. For CDB samples with
concentrations less than 2 g/l, a target precision of 40%
is acceptable, while precisions of 20% should be achievable for CDU
concentrations greater than 2 g/l. Although these values
are more stringent than those observed in the CTQ interlaboratory
program reported by Webber (1988), they are well within limits
expected to be achievable for the method as reported by Stoeppler
and Brandt (1980).
5.2.8.3 Quality Assurance/Quality Control
Commercial laboratories providing CDU determinations should
adopt an internal QA/QC program that incorporates the following
components: Strict adherence to the selected method, including
calibration requirements; regular incorporation of QC samples during
actual runs; a protocol for corrective actions, and documentation of
such actions; and, participation in an interlaboratory proficiency
program. Note that the nonmandatory program presented in Attachment
1 as an example of an acceptable QA/QC program, is based on using
the Pruszkowska method for CDU analysis. Should an alternate method
be adopted by a laboratory, the laboratory should develop a QA/QC
program equivalent to the nonmandatory program, and which satisfies
the provisions of Section 3.3.1.
5.3 Monitoring -2-Microglobulin in Urine (B2MU).
As indicated in Section 4.3, B2MU appears to be the best of
several small proteins that may be monitored as early indicators of
cadmium-induced renal damage. Several analytic techniques are
available for measuring B2M.
5.3.1 Units of B2MU Measurement
Procedures adopted for reporting B2MU levels are not uniform. In
these guidelines, OSHA recommends that B2MU levels be reported as
g/g CRTU, similar to reporting CDU concentrations.
Reporting B2MU normalized to the concentration of CRTU requires an
additional analytical process beyond the analysis of B2M:
Independent analysis for creatinine so that results may be reported
as a ratio of the B2M and creatinine concentrations found in the
urine sample. Consequently, the overall quality of the analysis
depends on the combined performance on these 2 analyses. The
analysis used for B2MU determinations is described in terms of
g B2M/l urine, with analysis of creatinine addressed
separately. Techniques used to measure creatinine are provided in
Section 5.4. Note that Section 3.3.3 provides techniques for
deriving the value of B2M as function of CRTU, and the confidence
limits for independent measurements of B2M and CRTU.
5.3.2 Analytical Techniques Used to Monitor B2MU
One of the earliest tests used to measure B2MU was the radial
immunodiffusion technique. This technique is a simple and specific
method for identification and quantitation of a number of proteins
found in human serum and other body fluids when the protein is not
readily differentiated by standard electrophoretic procedures. A
quantitative relationship exists between the concentration of a
protein deposited in a well that is cut into a thin agarose layer
containing the corresponding monospecific antiserum, and the
distance that the resultant complex diffuses. The wells are filled
with an unknown serum and the standard (or control), and incubated
in a moist environment at room temperature. After the optimal point
of diffusion has been reached, the diameters of the resulting
precipition rings are measured. The diameter of a ring is related to
the concentration of the constituent substance. For B2MU
determinations required in the medical monitoring program, this
method requires a process that may be insufficient to concentrate
the protein to levels that are required for detection.
Radioimmunoassay (RIA) techniques are used widely in immunologic
assays to measure the concentration of antigen or antibody in body-
fluid samples. RIA procedures are based on competitive-binding
techniques. If antigen concentration is being measured, the
principle underlying the procedure is that radioactive-labeled
antigen competes with the sample's unlabeled antigen for binding
sites on a known amount of immobile antibody. When these 3
components are present in the system, an equilibrium exists. This
equilibrium is followed by a separation of the free and bound forms
of the antigen. Either free or bound radioactive-labeled antigen can
be assessed to determine the amount of antigen in the sample. The
analysis is performed by measuring the level of radiation emitted
either by the bound complex following removal of the solution
containing the free antigen, or by the isolated solution containing
the residual-free antigen. The main advantage of the RIA method is
the extreme sensitivity of detection for emitted radiation and the
corresponding ability to detect trace amounts of antigen.
Additionally, large numbers of tests can be performed rapidly.
The enzyme-linked immunosorbent assay (ELISA) techniques are
similar to RIA techniques except that nonradioactive labels are
employed. This technique is safe, specific and rapid, and is nearly
as sensitive as RIA techniques. An enzyme-labeled antigen is used in
the immunologic assay; the labeled antigen detects the presence and
quantity of unlabeled antigen in the sample. In a representative
ELISA test, a plastic plate is coated with antibody (e.g., antibody
to B2M). The antibody reacts with antigen (B2M) in the urine and
forms an antigen-antibody complex on the plate. A second anti-B2M
antibody (i.e., labeled with an enzyme) is added to the mixture and
forms an antibody-antigen-antibody complex. Enzyme activity is
measured spectrophotometrically after the addition of a specific
chromogenic substrate which is activated by the bound enzyme. The
results of a typical test are calculated by comparing the
spectrophotometric reading of a serum sample to that of a control or
reference serum. In general, these procedures are faster and require
less laboratory work than other methods.
In a fluorescent ELISA technique (such as the one employed in
the Pharmacia Delphia test for B2M), the labeled enzyme is bound to
a strong fluorescent dye. In the Pharmacia Delphia test, an antigen
bound to a fluorescent dye competes with unlabeled antigen in the
sample for a predetermined amount of specific, immobile antibody.
Once equilibrium is reached, the immobile phase is removed from the
labeled antigen in the sample solution and washed; an enhancement
solution then is added that liberates the fluorescent dye from the
bound antigen-antibody complex. The enhancement solution also
contains a chelate that complexes with the fluorescent dye in
solution; this complex increases the fluorescent properties of the
dye so that it is easier to detect.
To determine the quantity of B2M in a sample using the Pharmacia
Delphia test, the intensity of the fluorescence of the enhancement
solution is measured. This intensity is proportional to the
concentration of labeled antigen that bound to the immobile antibody
phase during the initial competition with unlabeled antigen from the
sample. Consequently, the intensity of the fluorescence is an
inverse function of the concentration of antigen (B2M) in the
original sample. The relationship between the fluorescence level and
the B2M concentration in the sample is determined using a series of
graded standards, and extrapolating these standards to find the
concentration of the unknown sample.
5.3.3 Methods Developed for B2MU Determinations
B2MU usually is measured by radioimmunoassay (RIA) or enzyme-
linked immunosorbent assay (ELISA); however, other methods
(including gel electrophoresis, radial immunodiffusion, and
nephelometric assays) also have been described (Schardun and van
Epps 1987). RIA and ELISA methods are preferred because they are
sensitive at concentrations as low as micrograms per liter, require
no concentration processes, are highly reliable and use only a small
sample volume.
Based on a survey of the literature, the ELISA technique is
recommended for monitoring B2MU. While RIAs provide greater
sensitivity (typically about 1 g/l, Evrin et al. 1971),
they depend on the use of radioisotopes; use of radioisotopes
requires adherence to rules and regulations established by the
Atomic Energy Commission, and necessitates an expensive
radioactivity counter for testing. Radioisotopes also have a
relatively short half-life, which corresponds to a reduced shelf
life, thereby increasing the cost and complexity of testing. In
contrast, ELISA testing can be performed on routine laboratory
spectrophotometers, do not necessitate adherence to additional rules
and regulations governing the handling of radioactive substances,
and the test kits have long shelf lives. Further, the range of
sensitivity commonly achieved by the recommended ELISA test (i.e.,
the Pharmacia Delphia test) is approximately 100 g/l
(Pharmacia 1990), which is sufficient for monitoring B2MU levels
resulting from cadmium exposure. Based on the studies listed in
Table 9 (Section 5.3.7), the average range of B2M concentrations
among the general, nonexposed population falls between 60 and 300
g/g CRTU. The upper 95th percentile of distributions,
derived from studies in Table 9 which reported standard deviations,
range between 180 and 1,140 g/g CRTU. Also, the Pharmacia
Delphia test currently is the most widely used test for assessing
B2MU.
5.3.4 Sample Collection and Handling
As with CDB or CDU, sample collection procedures are addressed
primarily to identify ways to minimize the degree of variability
introduced by sample collection during medical monitoring. It is
unclear the extent to which sample collection contributes to B2MU
variability. Sources of variation include time-of-day effects, the
interval since consuming liquids and the quantity of liquids
consumed, and the introduction of external contamination during the
collection process. A special problem unique to B2M sampling is the
sensitivity of this protein to degradation under acid conditions
commonly found in the bladder. To minimize this problem, strict
adherence to a sampling protocol is recommended. The protocol should
include provisions for normalizing the conditions under which the
urine is collected. Clearly, it is important to minimize the
interval urine spends in the bladder. It also is recommended that
every effort be made to collect samples during the same time of day.
Collection of urine samples for biological monitoring usually is
performed using ``spot'' (i.e., single-void) urine. Logistics and
sample integrity become problems when efforts are made to collect
urine over extended periods (e.g., 24 hrs). Unless single-void
urines are used, numerous opportunities exist for measurement error
because of poor control over sample collection, storage and
environmental contamination.
To minimize the interval that sample urine resides in the
bladder, the following adaption to the ``spot'' collection procedure
is recommended: The bladder should be emptied and then a large glass
of water should be consumed; the sample then should be collected
within an hour after the water is consumed.
5.3.5 Best Achievable Performance
The best achievable performance is assumed to be equivalent to
the performance reported by the manufacturers of the Pharmacia
Delphia test kits (Pharmacia 1990). According to the insert that
comes with these kits, QC results should be within 2 SDs
of the mean for each control sample tested; a CV of less than or
equal to 5.2% should be maintained. The total CV reported for test
kits is less than or equal to 7.2%.
5.3.6 General Method Performance
Unlike analyses for CDB and CDU, the Pharmacia Delphia test is
standardized in a commercial kit that controls for many sources of
variation. In the absence of data to the contrary, it is assumed
that the achievable performance reported by the manufacturer of this
test kit will serve as an achievable performance objective. The CTQ
proficiency testing program for B2MU analysis is expected to use the
performance parameters defined by the test kit manufacturer as the
basis of the B2MU proficiency testing program.
Note that results reported for the test kit are expressed in
terms of g B2M/l of urine, and have not been adjusted for
creatinine. The indicated performance, therefore, is a measure of
the performance of the B2M portion of the analyses only, and does
not include variation that may have been introduced during the
analysis of creatinine.
5.3.7 Observed B2MU Concentrations
As indicated in Section 4.3, the concentration of B2MU may serve
as an early indicator of the onset of kidney damage associated with
cadmium exposure.
5.3.7.1 Range of B2MU Concentrations Among Unexposed Samples
Most of the studies listed in Table 9 report B2MU levels for
those who were not occupationally exposed to cadmium. Studies noted
in the second column of this table (which contain the footnote
``d'') reported B2MU concentrations among cadmium-exposed workers
who, nonetheless, showed no signs of proteinuria. These latter
studies are included in this table because, as indicated in Section
4.3, monitoring B2MU is intended to provide advanced warning of the
onset of kidney dysfunction associated with cadmium exposure, rather
than to distinguish relative exposure. This table, therefore,
indicates the range of B2MU levels observed among those who had no
symptoms of renal dysfunction (including cadmium-exposed workers
with none of these symptoms).
Table 9--B-2-Microglobulin Concentrations Observed in Urine Among Those Not Occupationally Exposed to Cadmium
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lower 95th Upper 95th
Study No. No. in study Geometric mean Geometric standard percentile of percentile of Reference
deviation distributiona distributiona
--------------------------------------------------------------------------------------------------------------------------------------------------------
1............ 133 mb............... 115 g/gc... 4.03................ 12.................. 1,140 g/gc. Ishizaki et al. 1989.
2............ 161 fb............... 146 g/gc... 3.11................ 23.................. 940 g/gc... Ishizaki et al. 1989.
3............ 10................... 84 g/g..... .................... .................... .................... Ellis et al. 1983.
4............ 203.................. 76 g/l..... .................... .................... .................... Stewart and Hughes 1981.
5............ 9.................... 103 g/g.... .................... .................... .................... Chia et al. 1989.
6............ 47d.................. 86 g/L..... 1.9................. 30 g/l..... 250 g/L.... Kjellstrom et al. 1977.
7............ 1,000e............... 68.1 g/gr 3.1 m & f........... <10 g/gr 320 g/gr Kowal 1983.
Crf. Crh. Crh.
8............ 87................... 71 g/gi.... .................... 7h.................. 200h................ Buchet et al. 1980.
9............ 10................... 0.073 mg/24h........ .................... .................... .................... Evrin et al. 1971.
10........... 59................... 156 g/g.... 1.1j................ 130................. 180................. Mason et al. 1988.
11........... 8.................... 118 g/g.... .................... .................... .................... Iwao et al. 1980.
12........... 34................... 79 g/g..... .................... .................... .................... Wibowo et al. 1982.
13........... 41 m................. .................... .................... .................... 400 g/gr Falck et al. 1983.
Crk.
14........... 35n.................. 67.................. .................... .................... .................... Roels et al. 1991.
15........... 31d.................. 63.................. .................... .................... .................... Roels et al. 1991.
16........... 36d.................. 77i................. .................... .................... .................... Miksche et al. 1981.
17........... 18n.................. 130................. .................... .................... .................... Kawada et al. 1989.
18........... 32p.................. 122................. .................... .................... .................... Kawada et al. 1989.
19........... 18d.................. 295................. 1.4................. 170................. 510................. Thun et al. 1989.
--------------------------------------------------------------------------------------------------------------------------------------------------------
a--Based on an assumed lognormal distribution
b--m = males, f = females
c--Aged general population from non-polluted area; 47.9% population aged 50-69; 52.1% 70 years of age; values reported in study
d--Exposed workers without proteinuria
e--492 females, 484 males
f--Creatinine-adjusted; males = 68.1 g/g Cr, females = 64.3 g/g Cr
h--Reported in the study
i--Arithmetic mean
j--Geometric standard error
k--Upper 95% tolerance limits: for Falck this is based on the 24 hour urine sample
n--Controls
p--Exposed synthetic resin and pigment workers without proteinuria; Cadmium in urine levels up to 10 g/g Cr
To the extent possible, the studies listed in Table 9 provide
geometric means and geometric standard deviations for measurements
among the groups defined in each study. For studies reporting a
geometric standard deviation along with a mean, the lower and upper
95th percentile for these distributions were derived and reported in
the table.
The data provided from 15 of the 19 studies listed in Table 9
indicate that the geometric mean concentration of B2M observed among
those who were not occupationally exposed to cadmium is 70-170
g/g CRTU. Data from the 4 remaining studies indicate that
exposed workers who exhibit no signs of proteinuria show mean B2MU
levels of 60-300 g/g CRTU. B2MU values in the study by Thun
et al. (1989), however, appear high in comparison to the other 3
studies. If this study is removed, B2MU levels for those who are not
occupationally exposed to cadmium are similar to B2MU levels found
among cadmium-exposed workers who exhibit no signs of kidney
dysfunction. Although the mean is high in the study by Thun et al.,
the range of measurements reported in this study is within the
ranges reported for the other studies.
Determining a reasonable upper limit from the range of B2M
concentrations observed among those who do not exhibit signs of
proteinuria is problematic. Elevated B2MU levels are among the signs
used to define the onset of kidney dysfunction. Without access to
the raw data from the studies listed in Table 9, it is necessary to
rely on reported standard deviations to estimate an upper limit for
normal B2MU concentrations (i.e., the upper 95th percentile for the
distributions measured). For the 8 studies reporting a geometric
standard deviation, the upper 95th percentiles for the distributions
are 180-1140 g/g CRTU. These values are in general
agreement with the upper 95th percentile for the distribution (i.e.,
631 g/g CRTU) reported by Buchet et al. (1980). These upper
limits also appear to be in general agreement with B2MU values
(i.e., 100-690 g/g CRTU) reported as the normal upper limit
by Iwao et al. (1980), Kawada et al. (1989), Wibowo et al. (1982),
and Schardun and van Epps (1987). These values must be compared to
levels reported among those exhibiting kidney dysfunction to define
a threshold level for kidney dysfunction related to cadmium
exposure.
5.3.7.2 Range of B2MU Concentrations Among Exposed Workers
Table 10 presents results from studies reporting B2MU
determinations among those occupationally exposed to cadmium in the
work place; in some of these studies, kidney dysfunction was
observed among exposed workers, while other studies did not make an
effort to distinguish among exposed workers based on kidney
dysfunction. As with Table 9, this table provides geometric means
and geometric standard deviations for the groups defined in each
study if available. For studies reporting a geometric standard
deviation along with a mean, the lower and upper 95th percentiles
for the distributions are derived and reported in the table.
Table 10.--2-Microglobulin Concentrations Observed in Urine Among Occupationally-Exposed Workers
----------------------------------------------------------------------------------------------------------------
Concentration of 2-microglobulin in
urine
-------------------------------------------------
Study number N Geometric mean Geom. Reference
(g/ Std. Dev. L 95% of U 95% of
g)a rangeb rangeb
----------------------------------------------------------------------------------------------------------------
1.......................... 1,424 160 6.19 8.1 3,300 Ishizaki et al. 1989.
2.......................... 1,754 260 6.50 12 5,600 Ishizaki et al. 1989.
3.......................... 33 210 ......... ......... ......... Ellis et al. 1983.
4.......................... 65 210 ......... ......... ......... Chia et al. 1989.
5.......................... c44 5,700 6.49 d300 d98,000 Kjellstrom et al. 1977.
6.......................... 148 e180 ......... f110 f280 Buchet et al. 1980.
7.......................... 37 160 3.90 17 1,500 Kenzaburo et al. 1979.
8.......................... c45 3,300 8.70 d310 d89,000 Mason et al. 1988.
9.......................... c10 6,100 5.99 f650 f57,000 Falck et al. 1983.
10......................... c11 3,900 2.96 d710 d15,000 Elinder et al. 1985.
11......................... c12 300 ......... ......... ......... Roels et al. 1991.
12......................... g8 7,400 ......... ......... ......... Roels et al. 1991.
13......................... c23 h1,800 ......... ......... ......... Roels et al. 1989.
14......................... 10 690 ......... ......... ......... Iwao et al. 1980.
15......................... 34 71 ......... ......... ......... Wibowo et al. 1982.
16......................... c15 4,700 6.49 d590 d93,000 Thun et al. 1989.
----------------------------------------------------------------------------------------------------------------
aUnless otherwise stated.
bBased on an assumed lognormal distribution.
cAmong workers diagnosed as having renal dysfunction; for Elinder this means 2 levels greater than 300
micrograms per gram creatinine (g/gr Cr); for Roels, 1991, range=31-35, 170 g2/gr
Cr and geometric mean=63 among healthy workers; for Mason 2>300 g/gr Cr.
dBased on a detailed review of the data by OSHA.
eArithmetic mean.
fReported in the study.
gRetired workers.
h1,800 g2/gr Cr for first survey; second survey=1,600; third survey=2,600; fourth
survey=2,600; fifth survey=2,600.
The data provided in Table 10 indicate that the mean B2MU
concentration observed among workers experiencing occupational
exposure to cadmium (but with undefined levels of proteinuria) is
160-7400 g/g CRTU. One of these studies reports geometric
means lower than this range (i.e., as low as 71 g/g CRTU);
an explanation for this wide spread in average concentrations is not
available.
Seven of the studies listed in Table 10 report a range of B2MU
levels among those diagnosed as having renal dysfunction. As
indicated in this table, renal dysfunction (proteinuria) is defined
in several of these studies by B2MU levels in excess of 300
g/g CRTU (see footnote ``c'' of Table 10); therefore, the
range of B2MU levels observed in these studies is a function of the
operational definition used to identify those with renal
dysfunction. Nevertheless, a B2MU level of 300 g/g CRTU
appears to be a meaningful threshold for identifying those having
early signs of kidney damage. While levels much higher than 300
g/g CRTU have been observed among those with renal
dysfunction, the vast majority of those not occupationally exposed
to cadmium exhibit much lower B2MU concentrations (see Table 9).
Similarly, the vast majority of workers not exhibiting renal
dysfunction are found to have levels below 300 g/g CRTU
(Table 9).
The 300 g/g CRTU level for B2MU proposed in the above
paragraph has support among researchers as the threshold level that
distinguishes between cadmium-exposed workers with and without
kidney dysfunction. For example, in the guide for physicians who
must evaluate cadmium-exposed workers written for the Cadmium
Council by Dr. Lauwerys, levels of B2M greater than 200-300
g/g CRTU are considered to require additional medical
evaluation for kidney dysfunction (exhibit 8-447, OSHA docket
H057A). The most widely used test for measuring B2M (i.e., the
Pharmacia Delphia test) defines B2MU levels above 300 g/l
as abnormal (exhibit L-140-1, OSHA docket H057A).
Dr. Elinder, chairman of the Department of Nephrology at the
Karolinska Institute, testified at the hearings on the proposed
cadmium rule. According to Dr. Elinder (exhibit L-140-45, OSHA
docket H057A), the normal concentration of B2MU has been well
documented (Evrin and Wibell 1972; Kjellstrom et al. 1977a; Elinder
et al. 1978, 1983; Buchet et al. 1980; Jawaid et al. 1983; Kowal and
Zirkes, 1983). Elinder stated that the upper 95 or 97.5 percentiles
for B2MU among those without tubular dysfunction is below 300
g/g CRTU (Kjellstrom et al. 1977a; Buchet et al. 1980;
Kowal and Zirkes, 1983). Elinder defined levels of B2M above 300
g/g CRTU as ``slight'' proteinuria.
5.3.8 Conclusions and Recommendations for B2MU
Based on the above evaluation, the following recommendations are
made for a B2MU proficiency testing program. Note that the following
discussion addresses only sampling and analysis for B2MU
determinations (i.e., to be reported as an unadjusted g
B2M/l urine). Normalizing this result to creatinine requires a
second analysis for CRTU (see section 5.4) so that the ratio of the
2 measurements can be obtained.
5.3.8.1 Recommended Method
The Pharmacia Delphia method (Pharmacia 1990) should be adopted
as the standard method for B2MU determinations. Laboratories may
adopt alternate methods, but it is the responsibility of the
laboratory to demonstrate that alternate methods provide results of
comparable quality to the Pharmacia Delphia method.
5.3.8.2 Data Quality Objectives
The following data quality objectives should facilitate
interpretation of analytical results, and should be achievable based
on the above evaluation.
Limit of Detection. A limit of 100 g/l urine should be
achievable, although the insert to the test kit (Pharmacia 1990)
cites a detection limit of 150 g/l; private conversations
with representatives of Pharmacia, however, indicate that the lower
limit of 100 g/l should be achievable provided an
additional standard of 100 g/l B2M is run with the other
standards to derive the calibration curve (section 3.3.1.1). The
lower detection limit is desirable due to the proximity of this
detection limit to B2MU values defined for the cadmium medical
monitoring program.
Accuracy. Because results from an interlaboratory proficiency
testing program are not available currently, it is difficult to
define an achievable level of accuracy. Given the general
performance parameters defined by the insert to the test kits,
however, an accuracy of 15% of the target value appears
achievable.
Due to the low levels of B2MU to be measured generally, it is
anticipated that the analysis of creatinine will contribute
relatively little to the overall variability observed among
creatinine-normalized B2MU levels (see section 5.4). The initial
level of accuracy for reporting B2MU levels under this program
should be set at 15%.
Precision. Based on precision data reported by Pharmacia (1990),
a precision value (i.e., CV) of 5% should be achievable over the
defined range of the analyte. For internal QC samples (i.e.,
recommended as part of an internal QA/QC program, section 3.3.1),
laboratories should attain precision near 5% over the range of
concentrations measured.
5.3.8.3 Quality Assurance/Quality Control
Commercial laboratories providing measurement of B2MU should
adopt an internal QA/QC program that incorporates the following
components: Strict adherence to the Pharmacia Delphia method,
including calibration requirements; regular use of QC samples during
routine runs; a protocol for corrective actions, and documentation
of these actions; and, participation in an interlaboratory
proficiency program. Procedures that may be used to address internal
QC requirements are presented in Attachment 1. Due to differences
between analyses for B2MU and CDB/CDU, specific values presented in
Attachment 1 may have to be modified. Other components of the
program (including characterization runs), however, can be adapted
to a program for B2MU.
5.4 Monitoring Creatinine in Urine (CRTU)
Because CDU and B2MU should be reported relative to
concentrations of CRTU, these concentrations should be determined in
addition CDU and B2MU determinations.
5.4.1 Units of CRTU Measurement
CDU should be reported as g Cd/g CRTU, while B2MU
should be reported as g B2M/g CRTU. To derive the ratio of
cadmium or B2M to creatinine, CRTU should be reported in units of g
crtn/l of urine. Depending on the analytical method, it may be
necessary to convert results of creatinine determinations
accordingly.
5.4.2 Analytical Techniques Used To Monitor CRTU
Of the techniques available for CRTU determinations, an
absorbance spectrophotometric technique and a high-performance
liquid chromatography (HPLC) technique are identified as acceptable
in this protocol.
5.4.3 Methods Developed for CRTU Determinations
CRTU analysis performed in support of either CDU or B2MU
determinations should be performed using either of the following 2
methods:
1. The Du Pont method (i.e., Jaffe method), in which creatinine
in a sample reacts with picrate under alkaline conditions, and the
resulting red chromophore is monitored (at 510 nm) for a fixed
interval to determine the rate of the reaction; this reaction rate
is proportional to the concentration of creatinine present in the
sample (a copy of this method is provided in Attachment 2 of this
protocol); or
2. The OSHA SLC Technical Center (OSLTC) method, in which
creatinine in an aliquot of sample is separated using an HPLC column
equipped with a UV detector; the resulting peak is quantified using
an electrical integrator (a copy of this method
FR Doc. 93-31820 Occupational Safety and Health Standards for Cadmium in Shipyard Employment and Construction
is provided in
Attachment 3 of this protocol).
5.4.4 Sample Collection and Handling
CRTU samples should be segregated from samples collected for CDU
or B2MU analysis. Sample-collection techniques have been described
under section 5.2.4. Samples should be preserved either to stabilize
CDU (with HNO3) or B2MU (with NaOH). Neither of these
procedures should adversely affect CRTU analysis (see Attachment 3).
5.4.5 General Method Performance
Data from the OSLTC indicate that a CV of 5% should be
achievable using the OSLTC method (Septon, L private communication).
The achievable accuracy of this method has not been determined.
Results reported in surveys conducted by the CAP (CAP 1991a,
1991b and 1992) indicate that a CV of 5% is achievable. The accuracy
achievable for CRTU determinations has not been reported.
Laboratories performing creatinine analysis under this protocol
should be CAP accredited and should be active participants in the
CAP surveys.
5.4.6 Observed CRTU Concentrations
Published data suggest the range of CRTU concentrations is 1.0-
1.6 g in 24-hour urine samples (Harrison 1987). These values are
equivalent to about 1 g/l urine.
5.4.7 Conclusions and Recommendations for CRTU
5.4.7.1 Recommended Method
Use either the Jaffe method (Attachment 2) or the OSLTC method
(Attachment 3). Alternate methods may be acceptable provided
adequate performance is demonstrated in the CAP program.
5.4.7.2 Data Quality Objectives
Limit of Detection. This value has not been formally defined;
however, a value of 0.1 g/l urine should be readily achievable.
Accuracy. This value has not been defined formally; accuracy
should be sufficient to retain accreditation from the CAP.
Precision. A CV of 5% should be achievable using the recommended
methods.
6.0 References
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Attachment 1--Nonmandatory Protocol for an Internal Quality Assurance/
Quality Control Program
The following is an example of the type of internal quality
assurance/quality control program that assures adequate control to
satisfy OSHA requirements under this protocol. However, other
approaches may also be acceptable.
As indicated in Section 3.3.1 of the protocol, the QA/QC program
for CDB and CDU should address, at a minimum, the following:
Calibration;
Establishment of control limits;
Internal QC analyses and maintaining control; and
Corrective action protocols.
This illustrative program includes both initial characterization
runs to establish the performance of the method and ongoing analysis
of quality control samples intermixed with compliance samples to
maintain control.
Calibration
Before any analytical runs are conducted, the analytic
instrument must be calibrated. This is to be done at the beginning
of each day on which quality control samples and/or compliance
samples are run. Once calibration is established, quality control
samples or compliance samples may be run. Regardless of the type of
samples run, every fifth sample must be a standard to assure that
the calibration is holding.
Calibration is defined as holding if every standard is within
plus or minus () 15% of its theoretical value. If a
standard is more than plus or minus 15% of its theoretical value,
then the run is out of control due to calibration error and the
entire set of samples must either be reanalyzed after recalibrating
or results should be recalculated based on a statistical curve
derived from the measurement of all standards.
It is essential that the highest standard run is higher than the
highest sample run. To assure that this is the case, it may be
necessary to run a high standard at the end of the run, which is
selected based on the results obtained over the course of the run.
All standards should be kept fresh, and as they get old, they
should be compared with new standards and replaced if they exceed
the new standards by 15%.
Initial Characterization Runs and Establishing Control
A participating laboratory should establish four pools of
quality control samples for each of the analytes for which
determinations will be made. The concentrations of quality control
samples within each pool are to be centered around each of the four
target levels for the particular analyte identified in Section 4.4
of the protocol.
Within each pool, at least 4 quality control samples need to be
established with varying concentrations ranging between plus or
minus 50% of the target value of that pool. Thus for the medium-high
cadmium in blood pool, the theoretical values of the quality control
samples may range from 5 to 15 g/l, (the target value is 10
g/l). At least 4 unique theoretical values must be
represented in this pool.
The range of theoretical values of plus or minus 50% of the
target value of a pool means that there will be overlap of the
pools. For example, the range of values for the medium-low pool for
cadmium in blood is 3.5 to 10.5 g/l while the range of
values for the medium-high pool is 5 to 15 g/l. Therefore,
it is possible for a quality control sample from the medium-low pool
to have a higher concentration of cadmium than a quality control
sample from the medium-high pool.
Quality control samples may be obtained as commercially
available reference materials, internally prepared, or both.
Internally prepared samples should be well characterized and traced
or compared to a reference material for which a consensus value for
concentration is available. Levels of analyte in the quality control
samples must be concealed from the analyst prior to the reporting of
analytical results. Potential sources of materials that may be used
to construct quality control samples are listed in Section 3.3.1 of
the protocol.
Before any compliance samples are analyzed, control limits must
be established. Control limits should be calculated for every pool
of each analyte for which determinations will be made and control
charts should be kept for each pool of each analyte. A separate set
of control charts and control limits should be established for each
analytical instrument in a laboratory that will be used for analysis
of compliance samples.
At the beginning of this QA/QC program, control limits should be
based on the results of the analysis of 20 quality control samples
from each pool of each analyte. For any given pool, the 20 quality
control samples should be run on 20 different days. Although no more
than one sample should be run from any single pool on a particular
day, a laboratory may run quality control samples from different
pools on the same day. This constitutes a set of initial
characterization runs.
For each quality control sample analyzed, the value F/T (defined
in the glossary) should be calculated. To calculate the control
limits for a pool of an analyte, it is first necessary to calculate
the mean, X, of the F/T values for each quality control sample in a
pool and then to calculate its standard deviation, s. Thus, for the
control limit for a pool, X is calculated as:
TR03JA94.003
and s is calculated as
TR03JA94.004
where N is the number of quality control samples run for a pool.
The control limit for a particular pool is then given by the
mean plus or minus 2 standard deviations (X 2s). The
control limits may be no greater than 40% of the mean F/T value. If
three standard deviations are greater than 40% of the mean F/T
value, then analysis of compliance samples may not begin.\1\
Instead, an investigation into the causes of the large standard
deviation should begin, and the inadequacies must be remedied. Then,
control limits must be reestablished which will mean repeating the
running 20 quality control samples from each pool over 20 days.
---------------------------------------------------------------------------
\1\Note that the value, ``40%'' may change over time as
experience is gained with the program.
---------------------------------------------------------------------------
Internal Quality Control Analyses and Maintaining Control
Once control limits have been established for each pool of an
analyte, analysis of compliance samples may begin. During any run of
compliance samples, quality control samples are to be interspersed
at a rate of no less than 5% of the compliance sample workload. When
quality control samples are run, however, they should be run in sets
consisting of one quality control sample from each pool. Therefore,
it may be necessary, at times, to intersperse quality control
samples at a rate greater than 5%.
There should be at least one set of quality control samples run
with any analysis of compliance samples. At a minimum, for example,
4 quality control samples should be run even if only 1 compliance
sample is run. Generally, the number of quality control samples that
should be run are a multiple of four with the minimum equal to the
smallest multiple of four that is greater than 5% of the total
number of samples to be run. For example, if 300 compliance samples
of an analyte are run, then at least 16 quality control samples
should be run (16 is the smallest multiple of four that is greater
than 15, which is 5% of 300).
Control charts for each pool of an analyte (and for each
instrument in the laboratory to be used for analysis of compliance
samples) should be established by plotting F/T versus date as the
quality control sample results are reported. On the graph there
should be lines representing the control limits for the pool, the
mean F/T limits for the pool, and the theoretical F/T of 1.000.
Lines representing plus or minus () 2s should also be
represented on the charts. A theoretical example of a control chart
is presented in Figure 1.
Figure 1.--Theoretical Example of a Control Chart for a Pool of an Analyte
1.162 (Upper Control
Limit)
X
1.096 (Upper 2
Line)
X
X ..... 1.000 (Theoretical
Mean)
X X 0.964 (Mean)
X X
X
X 0.832 (Lower 2
Line)
X
0.766 (Lower Control
Limit)
March 2 2 3 5 6 9 10 13 16 17
----------------------------------------------------------------------------------------------------------------
All quality control samples should be plotted on the chart, and
the charts should be checked for visual trends. If a quality control
sample falls above or below the control limits for its pool, then
corrective steps must be taken (see the section on corrective
actions below). Once a laboratory's program has been established,
control limits should be updated every 2 months.
The updated control limits should be calculated from the results
of the last 100 quality control samples run for each pool. If 100
quality control samples from a pool have not been run at the time of
the update, then the limits should be based on as many as have been
run provided at least 20 quality control samples from each pool have
been run over 20 different days.
The trends that should be looked for on the control charts are:
1. 10 consecutive quality control samples falling above or below
the mean;
2. 3 consecutive quality control samples falling more than 2s
from the mean (above or below the 2s lines of the chart); or
3. the mean calculated to update the control limits falls more
than 10% above or below the theoretical mean of 1.000.
If any of these trends is observed, then all analysis must be
stopped, and an investigation into the causes of the errors must
begin. Before the analysis of compliance samples may resume, the
inadequacies must be remedied and the control limits must be
reestablished for that pool of an analyte. Reestablishment of
control limits will entail running 20 sets of quality control
samples over 20 days.
Note that alternative procedures for defining internal quality
control limits may also be acceptable. Limits may be based, for
example, on proficiency testing, such as 1 g
or 15% of the mean (whichever is greater). These should be clearly
defined.
Corrective Actions
Corrective action is the term used to describe the
identification and remediation of errors occurring within an
analysis. Corrective action is necessary whenever the result of the
analysis of any quality control sample falls outside of the
established control limits. The steps involved may include simple
things like checking calculations of basic instrument maintenance,
or it may involve more complicated actions like major instrument
repair. Whatever the source of error, it must be identified and
corrected (and a Corrective Action Report (CAR) must be completed.
CARs should be kept on file by the laboratory.
Attachment 2--Creatinine in Urine (JAFFE PROCEDURE)
* Note: Numbered superscripts refer to the bibliography.
Intended use: The CREA pack is used in the Du Pont ACA
discrete clinical analyzer to quantitatively measure creatinine in
serum and urine.
Summary: The CREA method employs a modification of the kinetic
Jaffe reaction reported by Larsen. This method has been reported to
be less susceptible than conventional methods to interference from
non-creatinine, Jaffe-positive compounds.\2\
---------------------------------------------------------------------------
\2\Larsen, K, Clin Chem Acta 41, 209 (1972).
---------------------------------------------------------------------------
A split sample comparison between the CREA method and a
conventional Jaffe procedure on Autoanalyzer showed a good
correlation. (See SPECIFIC PERFORMANCE CHARACTERISTICS).
Autoanalyzer, is a registered trademark of Technicon
Corp., Tarrytown, NY.
Principles of Procedure: In the presence of a strong base such
as NaOH, picrate reacts with creatinine to form a red chromophore.
The rate of increasing absorbance at 510 nm due to the formation of
this chromophore during a 17.07-second measurement period is
directly proportional to the creatinine concentration in the sample.
TR03JA94.005
Reagents:
------------------------------------------------------------------------
Compartmenta Form Ingredient Quantityb
------------------------------------------------------------------------
No. 2, 3, & 4..... Liquid............ Picrate.......... 0.11 mmol.
6................. Liquid............ NaOH (for pH
adjustment)c .
------------------------------------------------------------------------
a. Compartments are numbered 1-7, with compartment #7 located closest to
pack fill position #2.
b. Nominal value at manufacture.
c. See PRECAUTIONS.
Precautions: Compartment #6 contains 75L of 10 N NaOH;
avoid contact; skin irritant; rinse contacted area with water.
Comply with OSHA'S Bloodborne Pathogens Standard while handling
biological samples (29 CFR 1910.1039).
Used packs contain human body fluids; handle with appropriate
care.
FOR IN VITRO DIAGNOSTIC USE
MIXING & DILUTING
Mixing and diluting are automatically performed by the
ACA discrete clinical analyzer. The sample cup must
contain sufficient quantity to accommodate the sample volume plus
the ``dead volume''; precise cup filling is not required.
Sample Cup Volumes (L)
------------------------------------------------------------------------
Standard Microsystem
Analyzer ---------------------------------------------------
Dead Total Dead Total
------------------------------------------------------------------------
II, III............. 120 3000 10 500
IV, SX.............. 120 3000 30 500
V................... 90 3000 10 500
------------------------------------------------------------------------
Storage of Unprocessed Packs: Store at 2-8 deg.C. Do not freeze.
Do not expose to temperatures above 35 deg.C or to direct sunlight.
Expiration: Refer to EXPIRATION DATE on the tray label.
Specimen Collection: Serum or urine can be collected and stored
by normal procedures.\3\
---------------------------------------------------------------------------
\3\Tietz, NW, Fundamentals of Clinical Chemistry, W. B. Saunders
Co., Philadelphia, PA, 1976, pp 47-52, 1211.
---------------------------------------------------------------------------
Known Interfering Substances\4\
---------------------------------------------------------------------------
\4\Supplementary information pertaining to the effects of
various drugs and patient conditions on in vivo or in vitro
diagnostic levels can be found in ``Drug Interferences with Clinical
Laboratory Tests,'' Clin. Chem 21 (5) (1975), and ``Effects of
Disease on Clinical Laboratory Tests,'' Clin Chem, 26 (4) 1D-476D
(1980).
---------------------------------------------------------------------------
Serum Protein Influence--Serum protein levels exert a
direct influence on the CREA assay. The following should be taken
into account when this method is used for urine samples and when it
is calibrated:
Aqueous creatinine standards or urine specimens will give CREA
results depressed by approximately 0.7 mg/dL [62 mol/L] \5\
and will be less precise than samples containing more than 3 g/dL
[30 g/L] protein.
---------------------------------------------------------------------------
\5\ Systeme International d'unites (S.I. Units) are in brackets.
---------------------------------------------------------------------------
All urine specimens should be diluted with an albumin solution
to give a final protein concentration of at least 3 g/dL [30 g/L].
Du Pont Enzyme Diluent (Cat. #790035-901) may be used for this
purpose.
High concentration of endrogenous bilirubin (>20 mg/dL
[>342 mol/L]) will give depressed CREA results (average
depression 0.8 mg/dL [71 mol/L]).\6\
---------------------------------------------------------------------------
\6\Watkins, R. Fieldkamp, SC, Thibert, RJ, and Zak, B, Clin
Chem, 21, 1002 (1975).
---------------------------------------------------------------------------
Grossly hemolyzed (hemoglobin >100 mg/dL [>62
mol/L]) or visibly lipemic specimens may cause falsely
elevated CREA results.7,8
---------------------------------------------------------------------------
\7\Kawas, EE, Richards, AH, and Bigger, R, An Evaluation of a
Kinetic Creatinine Test for the Du Pont ACA, Du Pont Company,
Wilmington, DE (February 1973). (Reprints available from DuPont
Company, Diagnostic Systems)
\8\Westgard, JO, Effects of Hemolysis and Lipemia on ACA
Creatinine Method, 0.200 L, Sample Size, Du Pont Company,
Wilmington, DE (October 1972).
---------------------------------------------------------------------------
The following cephalosporin antibiotics do not
interfere with the CREA method when present at the concentrations
indicated. Systematic inaccuracies (bias) due to these substances
are less than or equal to 0.1 mg/dL [8.84 mol/L] at CREA
concentrations of approximately 1 mg/dL [88 mol/L].
------------------------------------------------------------------------
Peak serum levela,b,c Drug concentration
Antibiotic ---------------------------------------------
mg/dL [mmol/L] mg/dL [mmol/L]
------------------------------------------------------------------------
Cephaloridine............. 1.4 0.3 25 6.0
Cephalexin................ 0.6-2.0 0.2-0.6 25 7.2
Cephamandole.............. 1.3-2.5 0.3-0.5 25 4.9
Cephapirin................ 2.0 D0.4 25 5.6
Cephradine................ 1.5-2.0 0.4-0.6 25 7.1
Cefazolin................. 2.5-5.0 0.55-1.1 50 11.0
------------------------------------------------------------------------
aPhysicians' Desk Reference, Medical Economics Company, 33 Edition,
1979.
bHenry, JB, Clinical Diagnosis and Management by Laboratory Methods,
W.B. Saunders Co., Philadelphia, PA 1979, Vol. III.
cKrupp, MA, Tierney, LM Jr., Jawetz, E, Roe, RI, Camargo, CA, Physicians
Handbook, Lange Medical Publications, Los Altos, CA, 1982 pp 635-636.
The following cephalosporin antibiotics have been shown
to affect CREA results when present at the indicated concentrations.
System inaccuracies (bias) due to these substances are greater that
0.1 mg/dL [8.84 mol/L] at CREA concentrations of:
------------------------------------------------------------------------
Peak serum levela,b Drug concentration
Antibiotic --------------------------------------------------------
mg/dL [mmol/L] mg/dL [mmol/L] Effect
------------------------------------------------------------------------
Cephalothin.... 1-6 0.2-1.5 100 25.2
20-25%
Cephoxitin..... 2.0 0.5 5.0 1.2
35-40%
------------------------------------------------------------------------
aHenry, JB, Clinical Diagnosis and Management by Laboratory Methods,
W.B. Saunders Co., Philadelphia, PA 1979, Vol. III.
bSarah, AJ, Koch, TR, Drusano, GL, Celoxitin Falsely Elevates Creatinine
Levels, JAMA 247, 205-206 (1982).
The single wavelength measurement used in this method
eliminates interference from chromophores whose 510 nm absorbance is
constant throughout the measurement period.
Each laboratory should determine the acceptability of
its own blood collection tubes and serum separation products.
Variations in these products may exist between manufacturers and, at
times, from lot to lot.
Procedure:
Test Materials
------------------------------------------------------------------------
II, III Du IV, SX Du Pont V Du Pont Cat.
Item Pont Cat. No. Cat. No. No.
------------------------------------------------------------------------
ACA CREA
Analytical Test Pack... 701976901 701976901 701976901
Sample System Kit or.... 710642901 710642901 713697901
Micro Sample System Kit
and.................... 702694901 710356901 NA
Micro Sample System
Holders................ 702785000 NA NA
DYLUX
Photosensitive......... .............. .............. ..............
Printer Paper........... 700036000 NA NA
Thermal Printer Paper... NA 710639901 713645901
Du Pont Purified Water.. 704209901 710615901 710815901
Cell Wash Solution...... 701864901 710664901 710864901
------------------------------------------------------------------------
Test Steps
The operator need only load the sample kit and appropriate test
pack(s) into a properly prepared ACA discrete clinical
analyzer. It automatically advances the pack(s) through the test
steps and prints a result(s). See the Instrument Manual of the
ACA analyzer for details of mechanical travel of the test
pack(s).
Preset Creatinine (CREA)--Test Conditions
Sample Volume: 200 L
Diluent: Purified Water
Temperature: 37.0 0.1 deg.C
Reaction Period: 29 seconds
Type of Measurement: Rate
Measurement Period: 17.07 seconds
Wavelength: 510 nm
Units: mg/dL [mol/L]
CALIBRATION
The general calibration procedure is described in the
Calibration/Verification chapter of the Manuals.
The following information should be considered when calibrating
the CREA method.
Assay Range: 0-20 mg/mL [0-1768 mol/L] \9\.
---------------------------------------------------------------------------
\9\ For the results in S.I. units [mol/L] the
conversion factory is 88.4.
---------------------------------------------------------------------------
Reference Material: Protein containing primary
standards\10\ or secondary calibrators such as Du Pont Elevated
Chemistry Control (Cat. #790035903) and Normal Chemistry Control
(Cat.\#790035905)\11\.
---------------------------------------------------------------------------
\10\Refer to the Creatinine Standard Preparation and Calibration
Procedure available on request from a Du Pont Representative.
\11\If the Du Pont Chemistry Controls are being used, prepare
them according to the instructions on the product insert sheets.
---------------------------------------------------------------------------
Suggested Calibration Levels: 1,5,20, mg/mL [88, 442, 1768
mol/L].
Calibration Scheme: 3 levels, 3 packs per level.
Frequency: Each new pack lot. Every 3 months for any one
pack lot.
Preset Creatinine (CREA) Test Conditions
------------------------------------------------------------------------
ACA
Item ACA II analyzer III, IV, SX, V
analyzer
------------------------------------------------------------------------
Count by................... One (1)................... NA
[Five (5)]................
Decimal point location..... 0.0 mg/dL................. 000.0 mg/dL
[000.0 mol/L].... [000 mol/L]
Assigned starting point or 999.8..................... -1.000 E1
offset Co [9823.]................... [-8.840 E2]
Scale factor or assigned... 0.2000.................... 2.004 E-1a
mg/dL/counta..............
Linear Term C1a............ [0.3536 mol/L/ [1.772E1]
count].
------------------------------------------------------------------------
a The preset scale factor (linear term) was derived from the molar
absorptivity of the indicator and is based on an absorbance to
activity relationship (sensitivity) of 0.596 (mA/min)/(U/L). Due to
small differences in filters and electronic components between
instruments, the actual scale factor (linear term) may differ slightly
from that given above.
Quality Control
Two types of quality control procedures are recommended:
General Instrument Check. Refer to the Filter Balance
Procedure and the Absorbance Test Method described in the ACA
Analyzerinstrument Manual. Refer also to the ABS Test Methodology
literature.
Creatinine Method Check. At least once daily run a CREA test on
a solution of known creatinine activity such as an assayed control
or calibration standard other than that used to calibrate the CREA
method. For further details review the Quality Assurance Section of
the Chemistry Manual. The result obtained should fall within
acceptable limits defined by the day-to-day variability of the
system as measured in the user's laboratory. (See SPECIFIC
PERFORMANCE CHARACTERISTICS for guidance.) If the result falls
outside the laboratory's acceptable limits, follow the procedure
outlined in the Chemistry Troubleshooting Section of the Chemistry
Manual.
A possible system malfunction is indicated when analysis of a
sample with five consecutive test packs gives the following results:
------------------------------------------------------------------------
Level SD
------------------------------------------------------------------------
1 mg/dL.......................................... >0.15 mg/dL
[88 mol/L].............................. [>13 mol/L]
20 mg/dL......................................... >0.68 mg/dL
[1768 mol/L]............................ [>60 mol/L]
------------------------------------------------------------------------
Refer to the procedure outlined in the Trouble Shooting Section
of the Manual.
Results
The ACA analyzer automatically calculates and prints
the CREA result in mg/dL [mol/L].
Limitation of Procedure
Results >20 mg/dL [1768 mol/L]:
Dilute with suitable protein base diluent. Reassay.
Correct for diluting before reporting.
The reporting system contains error messages to warn the
operator of specific malfunctions. Any report slip containing a
letter code or word immediately following the numerical value should
not be reported. Refer to the Manual for the definition of error
codes.
Reference Interval
SERUM:a,b
Males 0.8-1.3 md/dL
[71-115 mol/L]
Females 0.6-1.0 md/dL
[53-88 mol/L]
URINE:c
Males 0.6-2.5 g/24 hr
[53-221 mmol/24 hr]
Females 0.6-1.5 g/24 hr
[53-133 mmol/24 hr]
a Gadsden, RH, and Phelps, CA, A Normal Range Study of Amylase in Urine
and Serum on the Du Pont ACA, Du Pont Company, Wilmington, DE (March
1978). (Reprints available from DuPont Company, Diagnostic Systems)
b Reference interval data obtained from 200 apparently healthy
individuals (71 males, 129 females) between the ages of 19 and 72.
c Dicht, JJ, Reference Intervals for Serum Amylase and Urinary
Creatinine on the Du Pont ACA Discrete Clinical Analyzer, Du
Pont Company, Wilmington, DE (November 1984).
Each laboratory should establish its own reference intervals for
CREA as performed on the analyzer.
Specific Performance Characteristics\12\
---------------------------------------------------------------------------
\12\ All specific performance characteristics tests were run
after normal recommended equipment quality control checks were
performed (see Instrument Manual).
---------------------------------------------------------------------------
Reproducibilitya
------------------------------------------------------------------------
Standard deviation (%
CV)
Material Mean -------------------------
Within-run Between-day
------------------------------------------------------------------------
Lyophilized...................... 1.3 0.05 (3.7) 0.05 (3.7)
Control.......................... [115] [4.4] [4.4]
Lyophilized...................... 20.6 0.12 (0.6) 0.37 (1.8)
Control.......................... [1821] [10.6] [32.7]
------------------------------------------------------------------------
a Specimens at each level were analyzed in duplicate for twenty days.
The within-run and between-day standard deviations were calculated by
the analysis of variance method.
Correlation--Regression Statisticsa
------------------------------------------------------------------------
Correlation
Comparative method Slope Intercept coefficient n
------------------------------------------------------------------------
Autoanalyzer... 1.03 0.03[2.7] 0.997 260
------------------------------------------------------------------------
a Model equation for regression statistics is:
Result of ACA Analyzer = Slope (Comparative method result) +
intercept
Assay Range *
0.0-20.0 mg/dl
[0-1768 mol]
* See REPRODUCIBILITY for method performance within the assay
range.Analytical Specificity
See KNOWN INTERFERING SUBSTANCES section for details.
Bibliography
Larsen, K, Clin Chem Acta 41, 209 (1972).
Tietz, NW, Fundamentals of Clinical Chemistry, W. B. Saunders
Co., Philadelphia, PA, 1976, pp 47-52, 1211.
Supplementary information pertaining to the effects of various
drugs and patient conditions on in vivo or in vitro diagnostic
levels can be found in ``Drug Interferences with Clinical Laboratory
Tests,'' Clin. Chem 21 (5) (1975), and ``Effects of Disease on
Clinical Laboratory Tests,'' Clin Chem, 26 (4) 1D-476D (1980).
Watkins, R. Fieldkamp, SC, Thibert, RJ, and Zak, B, Clin Chem,
21, 1002 (1975).
Kawas, EE, Richards, AH, and Bigger, R, An Evaluation of a
Kinetic Creatinine Test for the Du Pont ACA, Du Pont Company,
Wilmington, DE (February 1973). (Reprints available from DuPont
Company, Diagnostic Systems)
Westgard, JO, Effects of Hemolysis and Lipemia on ACA Creatinine
Method, 0.200 L, Sample Size, Du Pont Company, Wilmington,
DE (October 1972).
Physicians' Desk Reference, Medical Economics Company, 33
Edition, 1979.
Henry, JB, Clinical Diagnosis and Management by Laboratory
Methods, W.B. Saunders Co., Philadelphia, PA 1979, Vol. III.
Krupp, MA, Tierney, LM Jr., Jawetz, E, Roe, RI, Camargo, CA,
Physicians Handbook, Lange Medical Publications, Los Altos, CA, 1982
pp 635-636.
Sarah, AJ, Koch, TR, Drusano, GL, Celoxitin Falsely Elevates
Creatinine Levels, JAMA 247, 205-206 (1982).
Gadsden, RH, and Phelps, CA, A Normal Range Study of Amylase in
Urine and Serum on the Du Pont ACA, Du Pont Company, Wilmington, DE
(March 1978). (Reprints available from DuPont Company, Diagnostic
Systems)
Dicht, JJ, Reference Intervals for Serum Amylase and Urinary
Creatinine on the Du Pont ACA Discrete Clinical Analyzer,
Du Pont Company, Wilmington, DE (November 1984).
Attachment 3--Analysis of Creatinine for the Normalization of Cadmium
and Beta-2-Microglobulin Concentrations in Urine (OSLTC Procedure)
Matrix: Urine
Target Concentration: 1.1 g/L (this amount is representative of
creatinine concentrations found in urine).
Procedure: A 1.0 mL aliquot of urine is passed through a C18 SEP-
PAK (Waters Associates). Approximately 30 mL of HPLC (high
performance liquid chromatography) grade water is then run through
the SEP-PAK. The resulting solution is diluted to volume in a 100-mL
volumetric flask and analyzed by HPLC using an ultraviolet (UV)
detector.
Special Requirements: After collection, samples should be
appropriately stabilized for cadmium (Cd) analysis by using 10% high
purity (with low Cd background levels) nitric acid (exactly 1.0 mL
of 10% nitric acid per 10 mL of urine) or stabilized for Beta-2-
Microglobulin (B2M) by taking to pH 7 with dilute NaOH (exactly 1.0
mL of 0.11 N NaOH per 10 mL of urine). If not immediately analyzed,
the samples should be frozen and shipped by overnight mail in an
insulated container.
Date: January 1992.
Chemists: David B. Armitage,
Duane Lee,
Organic Service Branch II, OSHA Technical Center, Salt Lake City, Utah.
1. General Discussion
1.1. Background
1.1.1. History of procedure
Creatinine has been analyzed by several methods in the past. The
earliest methods were of the wet chemical type. As an example,
creatinine reacts with sodium picrate in basic solution to form a
red complex, which is then analyzed colorimetrically (Refs. 5.1. and
5.2.).
Since industrial hygiene laboratories will be analyzing for Cd
and B2M in urine, they will be normalizing those concentrations to
the concentration of creatinine in urine. A literature search
revealed several HPLC methods (Refs. 5.3., 5.4., 5.5. and 5.6.) for
creatinine in urine and because many industrial hygiene laboratories
have HPLC equipment, it was desirable to develop an industrial
hygiene HPLC method for creatinine in urine. The method of Hausen,
Fuchs, and Wachter was chosen as the starting point for method
development. SEP-PAKs were used for sample clarification and cleanup
in this method to protect the analytical column. The urine aliquot
which has been passed through the SEP-PAK is then analyzed by
reverse-phase HPLC using ion-pair techniques.
This method is very similar to that of Ogata and Taguchi (Ref.
5.6.), except they used centrifugation for sample clean-up. It is
also of note that they did a comparison of their HPLC results to
those of the Jaffe method (a picric acid method commonly used in the
health care industry) and found a linear relationship of close to
1:1. This indicates that either HPLC or colorimetric methods may be
used to measure creatinine concentrations in urine.
1.1.2. Physical properties (Ref. 5.7.)
Molecular weight: 113.12
Molecular formula: C4-H7-N3-O
Chemical name: 2-amino-1,5-dihydro-1-methyl-4H-imidazol-4-one
CAS#: 60-27-5
Melting point: 300 deg.C (decomposes)
Appearance: white powder
Solubility: soluble in water; slightly soluble in alcohol;
practically insoluble in acetone, ether, and chloroform
Synonyms: 1-methylglycocyamidine, 1-methylhydantoin-2-imide
Structure: see Figure #1
TR03JA94.006
1.2 Advantages
1.2.1. This method offers a simple, straightforward, and
specific alternative method to the Jaffe method.
1.2.2. HPLC instrumentation is commonly found in many
industrial hygiene laboratories.
2. Sample Stabilization Procedure
2.1. Apparatus
Metal-free plastic container for urine sample.
2.2. Reagents
2.2.1. Stabilizing Solution--1) Nitric acid (10%, high purity
with low Cd background levels) for stabilizing urine for Cd analysis
or 2) NaOH, 0.11 N, for stabilizing urine for B2M analysis.
2.2.2. HPLC grade water
2.3. Technique
2.3.1. Stabilizing solution is added to the urine sample (see
section 2.2.1.). The stabilizing solution should be such that for
each 10 mL of urine, add exactly 1.0 mL of stabilizer solution.
(Never add water or urine to acid or base. Always add acid or base
to water or urine.) Exactly 1.0 mL of 0.11 N NaOH added to 10 mL of
urine should result in a pH of 7. Or add 1.0 mL of 10% nitric acid
to 10 mL of urine.
2.3.2. After sample collection seal the plastic bottle securely
and wrap it with an appropriate seal. Urine samples should be frozen
and then shipped by overnight mail (if shipping is necessary) in an
insulated container. (Do not fill plastic bottle too full. This will
allow for expansion of contents during the freezing process.)
2.4. The Effect of Preparation and Stabilization Techniques on
Creatinine Concentrations
Three urine samples were prepared by making one sample acidic,
not treating a second sample, and adjusting a third sample to pH 7.
The samples were analyzed in duplicate by two different procedures.
For the first procedure a 1.0 mL aliquot of urine was put in a 100-
mL volumetric flask, diluted to volume with HPLC grade water, and
then analyzed directly on an HPLC. The other procedure used SEP-
PAKs. The SEP-PAK was rinsed with approximately 5 mL of methanol
followed by approximately 10 mL of HPLC grade water and both rinses
were discarded. Then, 1.0 mL of the urine sample was put through the
SEP-PAK, followed by 30 mL of HPLC grade water. The urine and water
were transferred to a 100-mL volumetric flask, diluted to volume
with HPLC grade water, and analyzed by HPLC. These three urine
samples were analyzed on the day they were obtained and then frozen.
The results show that whether the urine is acidic, untreated or
adjusted to pH 7, the resulting answer for creatinine is essentially
unchanged. The purpose of stabilizing the urine by making it acidic
or neutral is for the analysis of Cd or B2M respectively.
Comparison of Preparation and Stabilization Techniques
------------------------------------------------------------------------
w/o SEP-PAK with SEP- PAK
Sample (g/L (g/L
creatinine) creatinine)
------------------------------------------------------------------------
Acid...................................... 1.10 1.10
Acid...................................... 1.11 1.10
Untreated................................. 1.12 1.11
Untreated................................. 1.11 1.12
pH7....................................... 1.08 1.02
pH7....................................... 1.11 1.08
------------------------------------------------------------------------
2.5. Storage
After 4 days and 54 days of storage in a freezer, the samples
were thawed, brought to room temperature and analyzed using the same
procedures as in section 2.4. The results of several days of storage
show that the resulting answer for creatinine is essentially
unchanged.
Storage Data
----------------------------------------------------------------------------------------------------------------
4 days 54 days
---------------------------------------------------------------
Sample W/o SEP-PAK g/ With SEP-PAK g/ W/o SEP-PAK g/ With SEP-PAK g/
L creatinine L creatinine L creatinine L creatinine
----------------------------------------------------------------------------------------------------------------
Acid............................................ 1.09 1.09 1.08 1.09
Acid............................................ 1.10 1.10 1.09 1.10
Acid............................................ .............. .............. 1.09 1.09
Untreated....................................... 1.13 1.14 1.09 1.11
Untreated....................................... 1.15 1.14 1.10 1.10
Untreated....................................... .............. .............. 1.09 1.10
pH 7............................................ 1.14 1.13 1.12 1.12
pH 7............................................ 1.14 1.13 1.12 1.12
pH 7............................................ .............. .............. 1.12 1.12
----------------------------------------------------------------------------------------------------------------
2.6. lnterferences
None.
2.7. Safety precautions
2.7.1. Make sure samples are properly sealed and frozen before
shipment to avoid leakage.
2.7.2. Follow the appropriate shipping procedures.
The following modified special safety precautions are based on
those recommended by the Centers for Disease Control (CDC)(Ref.
5.8.) and OSHA's Bloodborne Pathogens standard (29 CFr 1910.1039).
2.7.3. Wear gloves, lab coat, and safety glasses while handling
all human urine products. Disposable plastic, glass, and paper
(pipet tips, gloves, etc.) that contact urine should be placed in a
biohazard autoclave bag. These bags should be kept in appropriate
containers until sealed and autoclaved. Wipe down all work surfaces
with 10% sodium hypochlorite solution when work is finished.
2.7.4. Dispose of all biological samples and diluted specimens
in a biohazard autoclave bag at the end of the analytical run.
2.7.5. Special care should be taken when handling and dispensing
nitric acid. Always remember to add acid to water (or urine). Nitric
acid is a corrosive chemical capable of severe eye and skin damage.
Wear metal-free gloves, a lab coat, and safety glasses. If the
nitric acid comes in contact with any part of the body, quickly wash
with copious quantities of water for at least 15 minutes.
2.7.6. Special care should be taken when handling and dispensing
NaOH. Always remember to add base to water (or urine). NaOH can
cause severe eye and skin damage. Always wear the appropriate
gloves, a lab coat, and safety glasses. If the NaOH comes in contact
with any part of the body, quickly wash with copious quantities of
water for at least 15 minutes.
3. Analytical Procedure
3.1. Apparatus
3.1.1. A high performance liquid chromatograph equipped with
pump, sample injector and UV detector.
3.1.2. A C18 HPLC column; 25 cm x 4.6 mm I.D.
3.1.3. An electronic integrator, or some other suitable means of
determining analyte response.
3.1.4. Stripchart recorder.
3.1.5. C18 SEP-PAKs (Waters Associates) or equivalent.
3.1.6. Luer-lock syringe for sample preparation (5 mL or 10 mL).
3.1.7. Volumetric pipettes and flasks for standard and sample
preparation.
3.1.8. Vacuum system to aid sample preparation (optional).
3.2. Reagents
3.2.1. Water, HPLC grade.
3.2.2. Methanol, HPLC grade.
3.2.3. PlC B-7 (Waters Associates) in small vials.
3.2.4. Creatinine, anhydrous, Sigma Chemical Corp., purity not
listed.
3.2.5. 1-Heptanesulfonic acid, sodium salt monohydrate.
3.2.6. Phosphoric acid.
3.2.7. Mobile phase. It can be prepared by mixing one vial of
PlC B-7 into a 1 L solution of 50% methanol and 50% water. The
mobile phase can also be made by preparing a solution that is 50%
methanol and 50% water with 0.005M heptanesulfonic acid and
adjusting the pH of the solution to 3.5 with phosphoric acid.
3.3. Standard preparation
3.3.1. Stock standards are prepared by weighing 10 to 15 mg of
creatinine. This is transferred to a 25-mL volumetric flask and
diluted to volume with HPLC grade water.
3.3.2. Dilutions to a working range of 3 to 35 g/mL are
made in either HPLC grade water or HPLC mobile phase (standards give
the same detector response in either solution).
3.4. Sample preparation
3.4.1. The C18 SEP-PAK is connected to a Luer-lock syringe. It
is rinsed with 5 mL HPLC grade methanol and then 10 mL of HPLC grade
water. These rinses are discarded.
3.4.2. Exactly 1.0 mL of urine is pipetted into the syringe. The
urine is put through the SEP-PAK into a suitable container using a
vacuum system.
3.4.3. The walls of the syringe are rinsed in several stages
with a total of approximately 30 mL of HPLC grade water. These
rinses are put through the SEP-PAK into the same container. The
resulting solution is transferred to a 100-mL volumetric flask and
then brought to volume with HPLC grade water.
3.5. Analysis (conditions and hardware are those used in this
evaluation.)
3.5.1. Instrument conditions
Column.......... Zorbax ODS, 5-6 m particle size; 25
cm x 4.6 mm I.D.
Mobile phase.... See Section 3.2.7.
Detector........ Dual wavelength UV; 229 nm (primary) 254 nm
(secondary),
Flow rate....... 0.7 mL/minute.
Retention time.. 7.2 minutes.
Sensitivity..... 0.05 AUFS.
Injection volume 20 L.
3.5.2. Chromatogram (See Figure #2).
3.6. Interferences
3.6.1. Any compound that has the same retention time as
creatinine and absorbs at 229 nm is an interference.
3.6.2. HPLC conditions may be varied to circumvent
interferences. In addition, analysis at another UV wavelength (i.e.
254 nm) would allow a comparison of the ratio of response of a
standard to that of a sample. Any deviations would indicate an
interference.
TR03JA94.007
3.7. Calculations
3.7.1. A calibration curve is constructed by plotting detector
response versus standard concentration (See Figure #3).
3.7.2. The concentration of creatinine in a sample is determined
by finding the concentration corresponding to its detector response.
(See Figure #3).
3.7.3. The g/mL creatinine from section 3.7.2. is then
multiplied by 100 (the dilution factor). This value is equivalent to
the micrograms of creatinine in the 1.0 mL stabilized urine aliquot
or the milligrams of creatinine per liter of urine. The desired
unit, g/L, is determined by the following relationship:
TR03JA94.008
g/ mg/L
mL ---------
g/L= ------------- =
1000 1000
3.7.4. The resulting value for creatinine is used to normalize
the urinary concentration of the desired analyte (A) (Cd or B2M) by
using the following formula.
g A/L
g A/g (experimental)
creatinine= -------------------------
g/L creatinine
Where A is the desired analyte. The protocol of reporting such
normalized results is g A/g creatinine.
3.8. Safety precautions. See section 2.7.
4. Conclusions
The determination of creatinine in urine by HPLC is a good
alternative to the Jaffe method for industrial hygiene laboratories.
Sample clarification with SEP-PAKs did not change the amount of
creatinine found in urine samples. However, it does protect the
analytical column. The results of this creatinine in urine procedure
are unaffected by the pH of the urine sample under the conditions
tested by this procedure. Therefore, no special measures are
required for creatinine analysis whether the urine sample has been
stabilized with 10% nitric acid for the Cd analysis or brought to a
pH of 7 with 0.11 NaOH for the B2M analysis.
5. References
5.1. Clark, L.C.; Thompson, H.L.; Anal. Chem. 1949, 21, 1218.
5.2. Peters, J.H.; J. Biol. Chem. 1942, 146, 176.
5.3. Hausen, V.A.; Fuchs, D.; Wachter, H.; J. Clin. Chem. Clin.
Biochem. 1981, 19, 373-378.
5.4. Clark, P.M.S.; Kricka, L.J.; Patel, A.; J. Liq. Chrom.
1980, 3(7), 1031-1046.
5.5. Ballerini, R.; Chinol, M.; Cambi, A.; J. Chrom. 1979, 179,
365-369.
5.6. Ogata, M.; Taguchi, T.; Industrial Health 1987, 25, 225-
228.
5.7. ``Merck Index'', 11th ed.; Windholz, Martha Ed.; Merck:
Rahway, N.J., 1989; p. 403.
5.8. Kimberly, M.; ``Determination of Cadmium in Urine by
Graphite Furnace Atomic Absorption Spectrometry with Zeeman
Background Correction.'' Centers for Disease Control, Atlanta,
Georgia, unpublished, update 1990.
PART 1926 -- [Amended]
Subpart Z--Toxic and Hazardous Substances
1. The authority citation for subpart Z of 29 CFR part 1926
continues to read as follows:
Authority: Sections 6 and 8, Occupational Safety and Health Act,
29 U.S.C. 655, 657; Secretary of Labor's Orders Nos. 12-71 (36 FR
8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736) or 1-90 (55 FR 9033)
as applicable; and 29 CFR part 1911.
Section 1926.1102 not issued under 29 U.S.C. 655 or 29 CFR part
1911; also issued under 5 U.S.C. 653.
Section 1926.1103 through 1926.1118 also issued under 29 U.S.C.
653.
Section 1926.1128 also issued under 29 U.S.C. 653.
Section 1926.1145 and 1926.1147 also issued under 29 U.S.C. 653.
Section 1926.1148 also issued under 29 U.S.C. 653.
2. In part 1926, Sec. 1926.63, Cadmium, is redesignated as
Sec. 1926.1127.
3. In paragraph (m)(4)(iii)(H) of (newly redesignated)
Sec. 1926.1127, the reference to ``Sec. 1910.20(g)(1) and (2)'' is
changed to read ``Sec. 1926.33(g) (1) and (2)''; in Sec. 1926.1127(n)
(1)(iii), (3)(iii), and (5)(i), the reference to ``29 CFR 1910.20'' is
changed to read ``Sec. 1926.33 of this part''; and in
Sec. 1926.1127(n)(6), the reference to ``29 CFR 1910.20(h)'' is changed
to read ``Sec. 1926.33(h) of this part.''
[FR Doc. 93-31820 Filed 12-30-93; 8:45 am]
BILLING CODE 4510-26-F
Complete official Federal Register PDF
FR Doc. 93-31710 Collection of Debts by Federal Tax Refund Offset
[Federal Register Volume 59, Number 1 (Monday, January 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31710]
[[Page Unknown]]
[Federal Register: January 3, 1994]
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EQUAL EMPLOYMENT OPPORTUNITY COMMISSION
29 CFR Part 1650
Collection of Debts by Federal Tax Refund Offset
AGENCY: Equal Employment Opportunity Commission.
ACTION: Interim final rule.
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SUMMARY: The Equal Employment Opportunity Commission (EEOC) is amending
its regulations, pursuant to the Deficit Reduction Act of 1984, to add
regulations on procedures for the collection of debts by Federal tax
refund offset. This rule outlines the procedures that EEOC will follow
for collection of a past-due, legally enforceable debt owed to EEOC by
referring such debt to the internal Revenue Service (IRS) for offset
against any overpayment of tax.
DATES: The interim final rule is effective on January 3, 1994. Comments
must be received by March 4, 1994.
ADDRESSES: Written comments should be addressed to Frances Hart,
Executive Officer, Office of Executive Secretariat, Equal Employment
Opportunity Commission, room 10402, 1801 L Street, NW., Washington, DC
20507.
FOR FURTHER INFORMATION CONTACT:
Nicholas M. Inzeo, Associate Legal Counsel, Thomas J. Schlageter,
Assistant Legal Counsel, or Daniel T. Riordan, Staff Attorney, at (202)
663-4669.
Copies of this interim final rule are available, upon request, in
the following alternate formats: Large print, braille, electronic file
on computer disk, and audio-tape. Copies may be obtained from the EEOC
Publications Center by calling (800) 669-3362 (voice) or (800) 800-3302
(TDD).
SUPPLEMENTARY INFORMATION: Section 2653 of the Deficit Reduction Act of
1984, 31 U.S.C. 3720A, was designed to make significant improvements in
a Federal agency's ability to collect a past-due, legally enforceable
debt owed by a taxpayer through offset by the IRS against an
overpayment of Federal tax. The Deficit Reduction Act also amended the
Internal Revenue Code of 1954 by adding subsection 6402(d) providing
that the Secretary of the Treasury shall: (1) Reduce the amount of any
overpayment due any person by the amount of a past-due, legally
enforceable debt owed to any Federal agency upon receiving notice from
the agency that such person owes the debt, (2) pay the reduction to the
agency, and (3) notify the person making the overpayment that the
overpayment has been reduced to satisfy such debt.
These regulations contain the procedures for collecting debts due
to the Commission. The individual owing the past-due, legally
enforceable debt will be notified of the debt and given the opportunity
to submit evidence concerning the existence or amount of the debt. Any
evidence received will be considered by Commission officials prior to
submitting any claim to the IRS for collection.
The Commission has determined that this rule does not constitute a
major rule for the purposes of Executive Order 12291. The Commission
also certifies under 5 U.S.C. 605(b), enacted by the Regulatory
Flexibility Act (Pub. L. 96-354), that the rule will not result in a
significant impact on a substantial number of small employers. For this
reason, a regulatory flexibility analysis is not required.
For the Commission.
Tony E. Gallegos,
Chairman.
For the reasons set forth in the preamble, title 29, chapter XIV of
the Code of Federal Regulations is amended by adding part 1650 to read
as follows:
PART 1650--DEBT COLLECTION
Subpart A--[Reserved]
Subpart B--Procedures for the Collection of Debts by Federal Tax Refund
Offset
Sec.
1650.201 Purpose.
1650.202 Past-due legally enforceable debt.
1650.203 Notification of intent to collect.
1650.204 Reasonable attempt to notify.
1650.205 Consideration of evidence submitted as a result of
notification of intent
1650.206 Notification to Internal Revenue Service.
1650.207 Administrative charges.
Authority: 31 U.S.C. 3720A
Subpart A--[Reserved]
Subpart B--Procedures for the Collection of Debts by Federal Tax Refund
Offset
Authority: 31 U.S.C. 3720A.
Sec. 1650.201 Purpose.
This subpart establishes procedures for EEOC to refer past-due
legally enforceable debts to the Internal Revenue Service (IRS) for
offset against the income tax refunds of persons owing debts to EEOC.
It specifies the agency procedures and the rights of the debtor
applicable to claims referred under the Federal Tax Refund Offset
Program for the collection of debts owned to EEOC.
Sec. 1650.202 Past-due legally enforceable debt.
A past-due legally enforceable debt for referral to the IRS is a
debt that resulted from any statute administered by EEOC and:
(a) Is an obligation of a debtor who is a natural person;
(b) Except in the case of a judgment debt, has been delinquent at
least 3 months but not more than 10 years at the time the offset is
made;
(c) Is at least $25.00;
(d) Cannot be currently collected pursuant to the salary offset
provisions of 5 U.S.C. 5514(a)(1);
(e) Is ineligible for administrative offset under 31 U.S.C. 3716(a)
by reason of 31 U.S.C. 3716(c)(2) or cannot be collected by
administrative offset under 31 U.S.C. 3716(a) by the EEOC against
amounts payable to or on behalf of the debtor by or on behalf of the
EEOC;
(f) With respect to which EEOC has given the debtor at least 60
days from the date of notification to present evidence that all or part
of the debt is not past-due or legally enforceable, has considered
evidence presented by such debtor, and has determined that an amount of
such debt is past-due and legally enforceable;
(g) Has been disclosed by EEOC to a consumer reporting agency is
authorized by 31 U.S.C. 3711(f), unless the consumer reporting agency
would be prohibited from reporting such information by 15 U.S.C. 1681c,
or unless the amount of the debt does not exceed $100.00;
(h) EEOC's records do not contain evidence that the person owing
that debt (or his or her spouse) has filed for bankruptcy under title
11 of the United States Code; and
(i) EEOC can clearly establish at the time of the referral that the
automatic stay under 11 U.S.C. 362 has been lifted or is no longer in
effect with respect to the person owing the debt or his or her spouse,
and the debt was not discharged in the bankruptcy proceeding.
Sec. 1650.203 Notification of intent to collect.
(a) Notification before submission to the IRS. A request for
reduction of an IRS income tax refund will be made only after EEOC
makes a determination that an amount is owed and past-due and gives or
makes a reasonable attempt to give the debtor 60 days written
notification of intent to collect by Federal tax refund offset.
(b) Contents of Notification. EEOC's notification of intent to
collect by Federal tax refund offset shall provide:
(1) The amount of the debt;
(2) That unless the debt is repaid within 60 days from the date of
EEOC's notification of intent, EEOC intends to collect the debt by
requesting the IRS to offset an amount equal to the amount of the debt
and all accumulating interest and other charges against any overpayment
of tax after liabilities subject to 26 U.S.C. 6402(a) and (c) have been
satisfied;
(3) A mailing address for forwarding any written correspondence and
a contact and a toll-free or collect telephone number for any
questions; and
(4) That the debtor may present evidence to EEOC that all or part
of the debt is not past due or legally enforceable by--
(i) Sending a written request for a review of the evidence to the
address provided in the notification;
(ii) Stating in the request for review the amount disputed and the
reasons why the debtor believes that the debt is not past-due or is not
legally enforceable; or
(iii) Including in the request for review any documents that the
debtor wishes to be considered to stating that the additional
information will be submitted within the remainder of the 60-day
period.
Sec. 1650.204 Reasonable attempt to notify.
In order to constitute a reasonable attempt to notify the debtor,
EEOC must have used a mailing address for the debtor obtained from the
IRS pursuant to 26 U.S.C. 6103(m)(2) within a period of 1 year
preceding the attempt to notify the debtor, unless EEOC receives clear
and concise notification from the debtor that notices from the agency
are to be sent to an address different from the address obtained from
IRS. Clear and concise notification means that the debtor has provided
the agency with written notification, including the debtor's name and
identifying number (as defined in 26 CFR 301.6109-1), the debtor's new
address, and the debtor's intent to have the agency notices sent to the
new address.
Sec. 1650.205 Consideration of evidence submitted as a result of
notification of intent. '
(a) Consideration of evidence. If, as a result of the notification
of intent, EEOC receives notice that the debtor will submit additional
evidence or receives additional evidence from the debtor within the
prescribed time period, any referral to the IRS will be stayed until
EEOC--
(1) Considers the evidence presented by the debtor;
(2) Determines whether or not all or a portion of the debt is still
past-due and legally enforceable; and
(3) Notifies the debtor of its determination.
Failure to submit the evidence within 60 days from the date of
notification will result in an automatic referral of the debt to IRS
without further action by EEOC.
(b) Notification to the debtor. Following its review of the
evidence, EEOC will issue a written decision notifying the debtor
whether EEOC has sustained, amended, or canceled its determination that
the debt is past-due and legally enforceable. The notice will advise
the debtor of any further action to be taken and explain the supporting
rationale for the decision.
(1) EEOC will notify the debtor of its intent to refer the debt to
the IRS for offset against the debtor's Federal income tax refund if it
sustains its decision that the debt is past-due and legally
enforceable. EEOC will also notify the debtor whether the amount of the
debt remains the same or is modified.
(2) EEOC will not refer the debt to the IRS for offset against the
debtor's Federal income tax refund if it reverses its decision that the
debt is past-due and legally enforceable.
Sec. 1650.206 Notification to Internal Revenue Service.
(a) Except as noted in paragraph (b) of this section, after EEOC's
initial notification and referral of a debt to IRS for offset against a
debtor's Federal income tax refund, EEOC will promptly notify IRS of
any changes in the notification, if EEOC--
(1) Determines that an error has been made with respect to the
information contained in the notification;
(2) Receives a payment or credits a payment to the account of the
debtor named in the notification that reduces the amount of the debt
referred to IRS for offset;
(3) Receives notification that the individual owing the debt has
filed for bankruptcy under title 11 of the United States Code or has
been adjudicated bankrupt and the debt has been discharged;
(4) Receives notification that an offset was made at a time when
the automatic stay provisions of 11 U.S.C. 362 were in effect; or
(5) Refunds all or part of the offset amount to the debtor.
(b) EEOC shall not request the IRS to increase the amount of a debt
owed by a debtor named in EEOC's original notification to IRS.
(c) If the amount of a debt is reduced after referral by EEOC and
offset by the IRS, EEOC will refund to the debtor any excess amount and
will promptly notify the IRS of any refund made by EEOC.
Sec. 1650.207 Administrative charges.
All administrative charges incurred in connection with the referral
of the debts to the IRS will be assessed on the debt and thus increase
the amount of the offset.
[FR Doc. 93-31710 Filed 12-30-93; 8:45 am]
BILLING CODE 6570-01-M
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