EPA Test Guidelines
(Office of Toxic Substances)
Includes:
o Toxic Substances: Test Rule Development
and Exemption Procedures: Final Rule
(10/10/84)
o Enforcement Response Policy for Test
Rules under Section 4 of the Toxic
Substances Control Act (5/28/86)
o Polyhalogenated Dibenzo-p-
Dioxins/Dibenzofurans: Testing and
Reporting Requirements: Final Rule
(6/5/87)
o Alternative Methodology for Acute
Toxicity Testing (9/22/88)
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Toxic Substances: Test
Rule Development and Exemption
Procedures
-------
Wednesday
October 10, 1984
Part II
Environmental
Protection Agency
40 CFR Part 790
Toxic Substances; Test Rule
Development and Exemption Procedures;
Final Rule
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"9774
Federal Register / Vol. 49. No. 197 / Wednesday, October 10, 1984 / Rules and Regulations _
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 790
[OPTS-42052; FRL 2613-2]
Toxic Substances; Test Rule
Development and Exemption
Procedures
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is promulgating a
procedural rule describing a process it
will use to develop certain test rules
under section 4(a) of TSCA and to grant
exemptions from those test rules under
section 4(c) of TSCA. This rule sets forth
certain methods for prescribing how
data are to be developed in response to
test rules and describes the procedures
which persons subject to them must
follow in order to obtain testing
exemptions or receive EPA's approval to
conduct testing.
EFFECTIVE DATE: Effective on November
9.1984.
FOR FURTHER INFORMATION CONTACT:
Edward A. Klein, Director, TSCA
Assistance Office (TS-799), Office of
Toxic Substances, Environmental
Protection Agency, Room E-543, 401 M
Street, SW., Washington, D.C. 20460,
Toll Free: (800-424-9065), In
Washington, D.C.: (554-1404), Outside
the United States: (Operator-202-554-
1404).
SUPPLEMENTARY INFORMATION: This rule
prescribes how data are to be developed
in response to test rules and describes
the procedures to follow to obtain test
exemptions or approval to conduct
testing.
I. Introduction
When the Environmental Protection
Agency (EPA) promulgates a test rule
under section 4 of the Toxic Substances
Control Act (15 U.S.C. 2601 el seq.) the
responsibility for required tests is borne
jointly by all manufacturers (including
importers) and/or processors of the
subject chemical, depending on which
activities give rise to the testing
requirement. Those persons subject to a
test rule who do not directly sponsor
testing must apply to EPA for exemption
from testing. The test sponsor must
conduct the required testing according
to the standards provided in the test
rule.
This rule establishes EPA's
procedures for test rule development
under TSCA section 4(a), for granting
exemptions from test rules and for
providing standards for the conduct of
those tests. It includes changes in the
Agency's original approach which were
made in response to comments received
on the Proposed Statement of Exemption
Policy and Procedures as published in
the Federal Register of July 18,1980 (45
FR 48512), and Changes in Test
Standards Policy and Test Rule
Development Process as published in
the Federal Register of March 26,1982
(47 FR 13012). EPA is including both of
these procedures in this final rule
because the processes are inter-related.
This rule does not include exemption
procedures for chemicals being tested
under a category-based rule. The
Agency has not arrived at a final policy
concerning the conduct of such testing.
Final exemption procedures for
category-based rules will be issued prior
to or in conjunction with EPA's first
category-based test rule.
Test rule development procedures,
described in the Federal Register of
March 28,1982, were proposed for
codification in Part 799 as part of
specific chemical test rules (47 FR 18386,
April 29,1982; 48 FR 23080, May 23,1983;
48 FR 23088, May 23,1983; 48 FR 30699,
July 5,1983; 48 FR 57686, December 30,
1983; 49 FR 430, January 4,1984; 49 FR
438, January 4,1984; 49 FR 456, January
4,1984; 49 FR 899, January 6,1984; 49 FR
1760, January 13,1984). The final
procedures are being codified as general
test rule development procedures in Part
790.
The proposed exemption procedures,
as published in the Federal Register of
July 18,1980 were planned to be
codified in 40 CFR Part 770. The final
rule has been redesignated as part 790.
The following table is provided to aid
readers in relating sections in the
proposed procedures to the
corresponding sections in the final rule.
CONVERSION TABLE
CONVERSION TABLE—Continued
Pro-
posed
rula
Part
770
770.400
770.401
770.402
770.405
770.406
770.420
770.410
770.410
\
Section Mia
Scope, purpose, and authority
Applicability
Confidentiality ., .
Phase I test nils
Persona subject to Phase 1 test rula
Submission of latter of infant to test or
exemption application.
Procedure if no one submits a latter of
intent to conduct testing.
Submission of proposed study plans
Proposed Phase H teat rule ..,
Final Phasa II test rule
Modification of study plans during con-
duct of study.
Submiss.cn of exemption applications
Content of exemption cpp'.caton.
Submission of equivalence data
Approval of exemption applications
Denial of exemption application
Final
rule Pert
790
7901
790.2
7903
7805
780.7
790.20
790.22
790.25
790.28
790.30
790.32
79034
790.35
79039
7S0.80
790.82
790.85
790.87
790.88
Pro-
posed
rula
Part
770
770.430
770431
770.440
Section title
Appeal of donisl of exemption applica-
tion.
Termination of conditional exemption
Statement of financial responsibility
Final
ruia Part
790
790.90
790.93
79097
790.99
II. Statutory Background
Section 4(a) of TSCA authorizes EPA
to require manufacturers (including
importers) and/or processors of
identified chemical substances and
mixtures to test the chemicals in
accordance with applicable EPA test
rules. Section 4(b) of TSCA requires that
each section 4(a) test rule identify the
chemical substance or mixture for which
testing is being required, and provide
standards for the development of test
data. These standards are to prescribe
the health and environmental effects,
and information relating to toxicity,
persistence and other characteristics
which affect health and the environment
for which test data are to be developed
and, to the extent necessary to assure
development of adequate and reliable
data, the manner in which the data are
to^be developed, the test protocol or
methodology to be employed, and such
other requirements as are necessary to
provide such assurance (section
Manufacturers or processors required
by rule to sponsor testing may do so
either individually, or jointly through
formation of a testing consortium
(section 4(b)(3)(A)). Alternatively, they
may choose to apply for a testing
exemption under TSCA section 4(c)
based on the belief that the required
testing will be performed by another
person subject to the rule. In order to
approve an exemption application, EPA
must find that: (1) The applicant's
product is equivalent to the substance or
mixture for which test data have been
submitted or are being developed, and
(2) data submitted by the applicant
under a section 4 test rule would be
duplicative of data already submitted or
being developed pursuant to the rule.
TSCA does not define what
constitutes "duplicative data" or what
criteria should be used in determining
whether chemicals are "equivalent."
However, TSCA's legislative history
states that Congress expected EPA's
Administrator to consider whether any
additives or impurities in the substance
or mixture for which the exemption is !
being sought might cause "significant"
differences in test data and thereby
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Federal Register / Vol. 49, No. 197 / i/Vednesday, October 10, 1984 / Rules and Regulations 39775
render the substances "nonequivalent"
(H.R. No. 94-1879 94th Cong., 2d Sess. 9/
23/76, p. 61. Legis. Hist. 674). For
purposes of determHing equivalence
under section 4, EPA interprets this to
mean thai the Agency must take into
consideration the presence of any
additive or impurity in e chemical xvhich
might cause di'fprrnces in test data
which are significant for the purpose of
assessing the risk associated with tiie
chemical. That is. if the presence of such
an additive or impurity is likely to
produce differences in the test data
which raay affect those data's velue in
assess;n
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39776 Federal Register / Vol. 49, No. 197 / Wednesday, October 10, 1984 / Rules and Regulations
test rule promulgated under section 4 of
TSCA that are designated as two phase.
B. Exemptions
The Agency has not changed its
approach to determining whether data
that would be generated by testing an
exemption applicant's chemical would
be duplicative of those which will be
under development. If the exemption
applicant demonstrates his chemical to
be equivalent to one which is being or
will be tested according to the study
plans adopted in the Phase II rule, EPA
will consider this condition to have been
met.
In response to industry comments that
EPA had not adequately explained what
criteria would be used to evaluate
equivalence, the Agency has modified
its approach to the issue. Rather than
leave substantiation of equivalence
claims to the discretion of the exemption
applicant, EPA will provide guidance
concerning equivalence substantiation
in each proposed test rule. As proposed,
EPA will grant a conditional exemption
provided that the applicant's chemical is
equivalent to the one which is to be
tested and that study plans have been
approved for all of the required tests.
Unless otherwise indicated in the test
rule, only manufacturers (including
importers) will be expected to submit
exemption applications or study plans.
Normally, processors will share the
testing costs with the manufacturer
through the pricing mechanism.
However, if the exposure or risk upon
which the test rule is based is
associated with processing as well as
manufacturing or with other down-
stream activities (use, distribution in
commerce, and disposal], and if
manufacturers fail to submit study
plans, the Agency will publish a notice
in the Federal Register and call upon
processors to submit study plans or
exemption applications.
V. Discussion of Final Rule
A. Steps in Test Rule Development
EPA's decision to utilize a two-phase
rulemaking process employing test
guidelines rather than mandatory test
methodologies was made in response to
comments that its original approach
could prevent test sponsors from using
new, more economical testing
methodologies or making modifications
in the recommended protocol that would
yield more reliable data when testing a
specific chemical. In order to provide
this flexibility, while retaining EPA's
opportunity to assure that the tests are
designed so as to yield adequate and
reliable data, the Agency is adopting a
two-phase process composed of the
following steps:
1. Proposals of a Phase I test rule. The
proposed Phase I rule will discuss who
should conduct testing (manufacturers
or processors or both), the health and
environmental effects or other
characteristics for which testing will be
required, appropriate Good Laboratory
Practice requirements, EPA's
recommendations for testing
methodologies, and the representative
substance or substances to be tested.
Selection of a representative test
substance or substances will be made
based on information available in the
literature and data EPA has received
from industry, environmental groups
and other members of the public. In
making this selection, EPA will consider
the effects of additives and impurities
and how they might affect the risk
which various forms or formulations of
the chemical may present to human
health or the environment.
Normally, EPA expects to select a
single test substance to be
representative of all forms of the
chemical subject to the rule. Under these
circumstances all other forms of the
subject chemical will be considered
"equivalent" for purposes of granting
exemptions. In those rare cases in which
the effects of additives and impurities or
other differences in forms of the subject
chemical make it necessary to test more
than one test substance, the Phase I rule
will define the substances for which the
Agency proposes to require testing, its
rationale for choosing those test
substances, and how it proposes to
determine equivalence.
2. Public comment on proposed Phase
I rule. The Agency will accept comment
on its proposal for 60 days. Comments
will be solicited on EPA's findings under
section 4(a), on the particular health or
environmental effects or other
characteristics for which testing is
proposed, and on the test substance or
substances proposed to be tested. EPA
will be particularly interested in
obtaining comment on additives and
impurities which may significantly affect
the outcome of testing. Commercial
chemical formulations may contain
many additives or contaminants which
may or may not create differences in
test data significant for assessing the
risk which that chemical presents to
human health or the environment. To
test each of the many individual
components of a commercial chemical
separately would be costly, time
consuming, and in most cases
unnecessary. Therefore, EPA will ask
the assistance of the public in
identifying any additives and impurities
which may be lexicologically significant
as relating to a particular chemical
under consideration. Public comments
on EPA's proposed test substance(s) and
its criteria for determining equivalence
will be used to supplement information
obtained earlier in the information-
gathering phase of the test rule
development process and may lead EPA
to modify its proposals.
Shifting consideration of equivalency
to an earlier phase of rulemaking will
also address the concern expressed by
several commenters that EPA was
inappropriately assuming the burden of
proving equivalency by assuming that,
absent evidence to the contrary, a single
test substance was representative of all
forms of the chemical subject to the test
rule. It was never the Agency's intent to
disregard information concerning the
effects of contaminants or to ignore such
data in selecting a test substance. In the
process adopted today, by considering
additives and impurities early in the
rulemaking process, the Agency will be
better able to select representative test
substances and to determine whether
additives or impurities may make a
significant difference in a chemical's
effects and what types of data should be
required to substantiate equivalency
claims. The burden for providing
equivalence information remains on the
applicant; but it will be submitted in
response to specific Agency guidance in
the final Phase I test rule. It is in the
public interest to eliminate unnecessary
data submissions whenever possible by
specifying what data are needed.
The Natural Resources Defense
Council (NRDC) commented, and the
Agency agrees, that EPA cannot
guarantee that it will be able to identify.
in advance, all of the lexicologically
significant impurities in a chemical
required to be tested. Nevertheless, due
to the many diverse ways in which
chemicals may be marketed or used, to
absolutely "guarantee" that data
generated will provide full answers for
the many forms of a chemical, each form
of the chemical would need to be tested
at huge costs to society. Test rules are
designed to gather information
concerning subjects about which
existing information is limited. They are,
by necessity, written in a climate of
uncertainty. Congress limited the time
available for Agency response to ITC
designations to 12 months (section
4(e)(l)(A)). A chemical designated for
testing consideration may be
manufactured in a vanety of
formulations and mixtures which can
contain may additives and impurities.
Any of these may or may not create
significant differences in the data which
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Federal Register / Vol. 49, No. 197 / Wednesday. October 10, 1984 / Rules and Regulations 39777
are obtained from testing. Just as it is
impractical and unnecessary to require
testing for all effects for all chemicals,
so it is infeasible to require or evaluate
detailed information concerning all of
the additives and impurities that may be
present. The Agency believes that by
considering the effects of additives and
impurities early in the rulemaking
process, and by soliciting aid from the
public in identifying those which may
significantly affect test results, it is
making the most efficient use
practicable of the time and resources
available for assessing risk.
Potential exemption applicants and
other members of the public will have
an opportunity to carefully examine
EPA's plans for selection of test
substances and determination of
equivalence in the Phase I rule. It will
also establish how equivalency claims
are to be supported and judged. By
commenting on EPA's proposals in the
Phase I rule, the public will have an
opportunity to provide information
which may modify those plans.
3. Publication affinal Phase I test
rule. After considering public comments,
EPA will publish a final Phase I rule
specifying the health and environmental
effects and other characteristics for
which data are required to be
developed, a reference to guidelines for
the development of test data, the
persons responsible for testing, and the
required test substance(s), and, if more
than one substance is to be tested, it
will also give instructions for showing
equivalence. The rule will specify who
must respond by submitting either a
notice of intent to conduct testing or an
application for exemption based on the
belief that testing will be performed by
another. Who must respond and the
form of the required response will vary
as follows:
a. Persons subject to final Phase I test
rule. Although both manufacturers and
processors may be found under section
4(b)(3)(B) to be responsible for testing,
EPA expects that only manufacturers
ordinarily will be subject to the
reporting provisions of the test rule.
Once the test rule is in effect, 44 days
after publication in the Federal Register,
each current manufacturer will have 30
days to submit, for each required test,
either a letter of intent to perform the
test or an application for exemption.
Each manufacturer who submits a letter
of intent to perform a specific test will
be obligated, first, to submit, within 90
days of the effective date of the Phase I
test rule, a proposed study plan for that
test and, ultimately, to perform testing.
If manufacturers perform all the
required tests, processors will not be
required to test or to submit exemption
applications. EPA will automatically
grant such processors exemptions
without requiring the submission of
exemption applications.
Manufacturers who wish to sponsor
testing as part of a consortium may
submit a single letter of intent to test
provided that all members of the
consortium sign it. If the rule requires
testing of more than one representative
substance, each member of the
consortium must also provide
equivalence data.
EPA believes that processors will
rarely be called upon to sponsor testing
directly. However, if the test rule's
findings are based solely on exposure
associated with processing, the rule will
require processors to submit notices of
intent to test or exemption applications
and to follow the same study plan
submission and approval steps as
described in this rule for manufacturers.
It is expected that, in most cases,
testing will be performed by the
manufacturers and that part of the cost
of testing will be passed on to
processors through the pricing
mechanism, thereby enabling them to
share in the costs of testing. However, in
those instances where manufacturers
(including importers) and processors are
jointly responsible under TSCA for the
conduct and financing of testing,
processors will be called upon to
sponsor tests if manufacturers fail to do
so, or may be required to provide
reimbursement directly to those
sponsoring this testing unless the
exposure or possible risk associated
with the chemical is due solely to
manufacturing. (See Data
Reimbursement rule 40 CFR 791.45.)
If no manufacturer submits a letter of
intent to perform a particular test within
the 30-day period, EPA will publish a
notice hi the Federal Register to notify
all processors of the subject chemical.
The notice will state that EPA has not
received letters of intent to perform
certain tests and that current processors
will have 30 days to submit, for each
test remaining, either a letter of intent to
perform the test or an exemption
application for that test Each processor
who submits a letter of intent to perform
a specific test will be obligated, first, to
submit, within 90 days of the publication
of the Federal Register notice, a
proposed study plan for the test and,
ultimately, to perform the testing.
If no manufacturer or processor
submits a letter of intent to perform a
particular test, EPA will notify all
manufacturers and processors, either by
letter or by notice in the Federal
Register, that all exemption applications
will be denied and that within 30 days
all manufacturers and processors will be
in violation of the rule until a proposed
study plan is submitted for that test.
Any person not manufacturing the
chemical at the time the rule goes into
effect or within the first 30 days after the
rule goes into effect, who later begins
manufacturing before the end of the
reimbursement period, will be required
to submit a letter of intent to test or an
exemption application for each required
test by the day the person begins
manufacture. If EPA has published a
notice in the Federal Register telling
processors to submit letters of intent or
exemption applications for certain tests,
any person not processing the chemical
at the time the rule goes into effect or
within 30 days after the publication of
the notice, who later begins processing
before the end of the reimbursement
period, will be required to submit a
letter of intent to test or an exemption
application for each test specified in the
Federal Register notice by the day the
person begins processing.
b. Submission of letter of intent to test
or exemption application. Those
responding to a Phase I test rule may do
so either by submitting a letter of intent
to perform testing, or by requesting an
exemption from one or more of those
testing requirements based on the belief
that the tests will be performed by
another.
Letters of intent to conduct testing
must specify which study or studies the
respondent will sponsor and, if more
than one substance is to be tested,
which test substance will be used in
those studies. EPA will consider such
notices as commitments to perform
testing.
. Exemption applications must list the
test requirements for which an
exemption is being sought and discuss
the applicant's basis for believing that
the tests will be performed by another
party. If more than one representative
substance is to be tested, the applicant
must also state which test substance it
believes its chemical to be equivalent to
and support this assertion with the types
of data called for in the test rule.
All responses must include the
following:
i. The name, address and phone
number of the applicant and the rule to
which it is responding.
ii. The name, address and telephone
number of the appropriate individual
EPA should contact for further
information.
iii. For applicants participating in a
testing consortium, the names of all
consortium members and the identity of
the primary spokesperson for the
consortium.
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39778 Federal Register / Vol. 49, No. 19/ / Wednesday, October 10, 1984 / Rules and Regulations
iv. The test requirements for which
the applicant intends to submit study
plans and conduct testing.
v. The test requirements, if any, for
which the applicant is requesting an
exemption, and its basis for believing
that the tests will be performed by
another.
Responses must also include any
additional information called for in the
test rule. In those cases in which more
than one representative form of the
chemical is to be tested this will include:
(1) For those indicating an intent to
test—which test substance the submitter
intends to use in each of the planned
tests.
(2) For those requesting exemptions—
the test substance the applicant believes
its product to be equivalent to and all
data supporting this assertion which
were required in the test rule.
4. Submission of study plans. All
those who submitted letters of intent to
conduct tests must submit study plans
for those tests unless EPA agrees to
their substitution of an exemption
application in instances where more
than one company indicates an intent to
sponsor equivalent tests. If testing is to
be sponsored by a consortium, its
spokesperson may submit study plans
on behalf of all those who have given
EPA notice of their intent to participate
in that consortium. The procedural rule
published today requires proposed study
plans to be submitted by manufacturers
within 90 days after the effective date of
the Phase I rule unless: (1) The plans are
being submitted by processors after
manufacturers failed to do so; or (2) the
Agency has granted those responsible
for preparing the plans an extension of
the deadline. In the first case,
processors must submit study plans
within SO days from the publication of
the notice requiring them to submit
letters of intent.
Some commenters remarked that
EPA's plan to allow 30 days for
formation of a testing consortium and/or
to indicate an intent to test, with an
additional 60 days for study plan
development, may not give sponsors
adequate time. EPA's experience in
negotiating testing agreements indicates
that, in most cases, the 90 days allotted
for development of study plans will be
sufficient. However, if unusual
circumstances make this difficult, EPA
may grant requests for additional time
for study plan development on a case-
by-case basis.
Unless EPA has granted additional
time for study plan development,
manufacturers who indicate thay will
perform testing, but do not submit
proposed study plans within 90 days
after the effective date of the rule, will
be considered in violation of the test
rule. Processors who indicate they will
test, but do not submit a study plan by
90 days after the publication of the
Federal Register notice requiring them to
submit letters of intent, will be
considered in violation of the rule.
The categories of information which
must be contained in the proposed study
plans are described in EPA's Good
Laboratory Practice (CLP) Standards for
use in testing under the Toxic
Substances Control Act (40 CFR Part
792). They include the proposed test
protocols and the rationale for their
selection, as well as the identities of the
sponsor(s) and the testing organization,
and proposed schedule for conducting
the testing and submitting required
reports to EPA.
Test protocols must comply with
EPA's GLP requirements and any
specific requirements given in the test
rule. TSCA, Organization for Economic
Cooperation and Development (OECD),
and Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) guidelines, as
well as methods described in the
scientific literature, may be referenced
in the test rules as guidance for test
methodology development. Sponsors
may elect to use one of the protocols
referenced in these guidelines, or they
may develop their own. If testing is to be
sponsored jointly by members of a
consortium, that member who has been •
designated primary contact with EPA
should submit study plans on behalf of
the entire group.
5. Proposed Phase II rule. The
proposed study plans will be made
available for a 45-day public comment
period during a second phase of the
rulemaking. The proposed Phase II test
rule will summarize the proposed study
plans and inform the public that the
detailed plans are available for review
in EPA's public docket. The Agency will
hold a public meeting if one is
requested. Following the comment
period, EPA will evaluate the proposed
study plans in view of public comments
and the data requirements in the test
rule. The Agency will require whatever
modifications of the study plans that it
finds necessary to assure the
development of adequate and reliable
data for the purposes of the test rule. If
substantial issues arise or substantial
modifications of the study plans are
required, the Agency may extend the 45-
day comment period.
The Agency's evaluation of the study
plans will include an assessment of the
quality of the study design, including
evidence of adherence to EPA GLP
Standards, a determination as to
whether the study as proposed will yield
the proper types of data for the purposes
of the test rule, and an assessment of the
probability that the study design can be
successfully implemented within the
time specified in the test rule. These
Specific considerations will vary with
the chemical being tested and the types
of tests required in each test rule. The
Agency cannot, therefore, as one
commenter suggested, discuss all of the
criteria for study plan evaluation in this
procedural rule. Certain aspects of the
evaluation will vary with the type of
testing being required and the purposes
for which the data are to be developed.
Specific guidance concerning the factors
which EPA considers important in the
design of specific studies will be
provided in the individual test rules and
the testing guidelines referenced in
those rules.
6. Evaluation of exemption
applications. During the comment period
on proposed study plans, EPA will
examine exemption applications. Its
review will be to determine that
properly completed exemption
applications have been received from all
those not sponsoring testing or
participating in a consortium sponsoring
testing, and to evaluate equivalency
claims. When a single representative
substance is to be tested, all forms of
the chemical will be considered
equivalent to it, and the Agency will
contact the applicant only if information
is missing or unclear.
If two or more chemical substances
are to be tested, equivalency claims will
be assessed according to the criteria in
the test rule. If the Agency finds an
equivalency claim to be in error, or if
information needed to make an
equivalency determination is missing.
the applicant will be notified. If the
equivalency claim is being questioned
because supporting data are inadequate,
the applicant will be given 15 days to
provide explanatory information. If EPA
finds the applicant's chemical
equivalent to a different test substance
than was claimed in its application, EPA
will notify the applicant in writing and
explain why.
Exemption applications will receive
notification that their applications for
equivalency have been accepted or
rejected. Those who have met the
requirement for showing equivalency
will be eligible for exemptions after
study plans have been approved.
7. Final Phase II test rule. The Phase II
test rule will summarize the testing
requirements set forth in the Phase I
rule, and the study plans which were
approved and adopted by EPA for
conducting those tests. It will also note
that exemption applicants have been
granted conditional exemptions.
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Federal Register / Vol. 49, No. 197 / Wednesday, October 10, 1984 / Rules and Regulations 3S779
Exemptions will be granted on the
condition that the required testing ia
completed according to the study plans
and the data submitted according to the
prescribed schedules. The approved
study plans will describe, in detail, the
manner in which the study is to be
conducted and will include protocols,
rationale, testing facilities, schedules
and reporting requirements. The study
plans will serve as enforceable test
requirements for the test rule and will
constitute the chemical-specific test
standards required by TSCA section
4(b)(l)(B). The study plans adopted in
the Phase II test rule will also specify
the time period during which persons
subject to the test rule must submit test
data as required by TSCA section
This approach to providing test
standards differs from EPA's May 9, •
1979 (44 FR 27334) proposal in that the
Agency will be providing standards for
the development of data in the approved
study plans, rather than through
separate promulgation of standardized
test methodology requirements. EPA hao
noted the point made by the Natural
Resources Defense Council, that this
approach may pose a greater
administrative burden for the Agency
than the use of codified test standards.
EPA does not, however, agree that this
burden will be BO great that it will
outweigh the benefit derived by
allowing for the tailoring of test
methodologies to specific testing
requirements. Industry will not be the
sole beneficiary of this approach. In
addition to providing potential test
sponsors the flexibility in test design
requested in their comments, the revised
approach allows EPA more control over
the final testing scheme through the
study plan approval process. By
modifying protocols after public
comment, the Agency will be able to
tailor the test designs to the needs
expressed in the specific test rules ia a
way that would not have been possible
under a system of annually updated
standardized methodologies.
Public comment on proposed etudy
plans is an important part of thio
tailoring process. EPA disagrees with
those commenters ivho believed that the
requirement for submission of study
plans should be eliminated or that only
a genera] study design should be
incorporated in the final test rule.
_ General information concerning study
objectives and methods will not provide
EPA or the public with needed
assurance that data are being developed
in an adequate and reliable manner.
Detailed protocols, schedules and
reporting requirements are needed as
well. Nor does EPA believe that it would
be in the best interests of the regulated
industries or the public aa a whole to, as
one commenter suggested, allow data to
be developed with only general
guidance and then require that testing
be repeated if data were fo^nd to be
inadequate. Such repetition would
impose additional costs on the regulated
industries, which would ultimately be
passed on to the consuming public,
would impose unnecessary
administrative burdens on the Agency,
and would cause serious delays in the
identification and control of health and
environmental risks.
Additionally, generic test standards
developed for use on a number of
chemicals might make chemical-specific
test modifications which would produce
fully adequate and reliable data at a
reduced cost more difficult.
Modifications which reduce testing
costs for industry can be expected to
reduce costs to the public ct large and
are to be encouraged so long au they do
not jeopardize the validity or reliability
of the data under development. More
flexibility to allow for such
modifications is provided for under the
Agency's revised test rule development
process.
The same commenter who advocated
retaining rigid generic test methodology
requirements for incorporation into
chemical-specific rules approved of the
two-phase test rule development
process proposal only if it would result
in the publication of a final rule
containing specific test protocols within
a year of EPA's receipt of the FTC's
recommendations. The Agency
maintains that such a schedule is
impracticable and is not required under
the law. Using the approach set forth in
this notice, the Agency will satisfy
TSCA's reqairement that a rulemaking
proceeding, if required, be "initiated"
within 12 months of a chemical's
designation by the ITC. At the same
time it will alloxv public participation in
the evaluation of testing plans, and the
tailoring of those plans to chemical-
specific testing needs.
8. Approval of exemption
applications. Provided that the first
condition for granting exemptions
(equivalence to the test substance] has
been satisfied, the second,
duplics'-iveness of data, xviO be
considered to have been met and
conditional exemptions will be granted
following EPA's approval of the study
plans. Exemption applicants will be
notified by certified mail or in the final
Phase n rale thay they have received
conditional exemptions. The exemptions
will be conditional because they will be
given based on the assumption that the
test sponsors will complete the required
testing according to the specifications
and schedules in the adopted study
plans. TSCA section 4(c)(4](B) provides
that if an exemption is granted
prospectively (that is on the trasia that
one or more persons are developing teat
data, rather than on the basis of prior
test data submissions), the Agency must
terminate the exemption if any test
sponsor has not complied with the test
rule.
9. Appeal of exemption denials.
Persons whose exemption applications
are denied will be notified by certified
mail or by Federal Register notice and
may appeal that denial. Appeals must
be filed with EPA within 30 days of the
receipt of the letter or publication of the
Federal Register notice denying the
exemption. Appeals should include a
detailed explanation of why the
applicant disagrees with EPA's decision.
The applicant may request a hearing.
EPA will notify applicants of its decision
within 60 days after EPA receives the
appeal or 60 days after the hearing if the
request for a hearing is granted.
10. Termination of conditional
exemptions. Exemptions granted
prospectively in the Phase II rule are
conditional. The Agency will terminate
the exemption if the test sponsors do not
comply with the test rule. If EPA
determines that one or more of the test
requirements contained in a test rule has
not been fully complied with either
because: (a) No one subject to the rule
has started testing by the date specified
in the rule, (b) data required by the rule
were not submitted by the date specified
in the rule, or (c) data were not
generated according to cpproved
potocols or in accordance with EPA's;
Good Laboratory Practice requiremanta,
EPA will notify holders of exemptions
based on that testing by certified letter
or Federal Register notice as to itc basis
for believing that the testing supporting
the exemptions has not satisfied the test
rale's requirements and of EPA's intent
to terminate those conditional
exemptions.
Such exemption holders may file
written comments concerning EPA's
intent to terminate such exemptions and
may request en opportunity for a
hearing to refute EPA's tenative decision
or may submit a letter of intent to
conduct the required test. Comments,
hearing requests and letters of intent to
test must be in writing and must be
received by EPA within 30 days of
receipt of the letter or publication of the
Federal Register notice announcing the
Agency's intent to terminate the
exemptions. Persons who notify EPA of
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39780 Federal Register / Vol. 49, No. 197 / Wednesday. October 10, 1984 / Rules and Regulations
their intent to conduct a test must
submit study plan modifications ..,,.,•
concerning test sponsor, test facility and
schedules within 60 days of receipt of
the letter or notice announcing EPA's
intent to terminate the exemptions. The
comments and hearing requests should
include a brief statement of the basis for
the exemption holder's belief that the
conditional exemption should not be
terminated. If an exemption holder
requests a hearing, a single hearing will
be held by EPA to address the concerns
of all conditional exemption holders
objecting to the termination unless
confidentiality claims preclude a joint
hearing. Exemption holders will receive
written notification of EPA's final
decision as to whether the exemption
will be terminated.
If the Agency finds it necessary to
terminate conditional exemptions, it will
notify the exemption holders to that
effect, will explain the reason for the
Agency's decision and will give
instructions as to what actions the
former exemption holders must take to
avoid being found in violation of the test
rule.
B. Confidentiality Issues
In addition to the topics discussed in
the preceding sections of this preamble,
the Agency also received comments
concerning certain confidentiality
aspects of its test rule and exemption
process.
1. Proposed confidentiality policy and
public comment. Under section 14(c) of
TSCA, any person submitting data
under the Act may assert a claim of
confidentiality with regard to any piece
of information. Sections 14 (a) and (b) of
TSCA provide the criteria for the
Agency's decision on whether a
particular claim of confidentiality
should be upheld by the Agency. As a
general rule, under section 14(a) the
Agency may not disclose trade secrets
and commercial or financial information
obtained from a person and privileged
or confidential. Section 14(a) contains
several exceptions to this general rule of
non-disclosure. Among these is section
14(a)(4), which provides that information
may be disclosed "when relevant in any
proceeding under this Act, except that
disclosure in such a proceeding shall be
made in such manner as to preserve
confidentiality to the extent practicable
without impairing the proceeding."
Section 14(b) substantially modifies the
effect of section 14(a) by stating that if
the information submitted to EPA is a
"health and safety study" section 14(a)
does not prohibit disclosure of the
information unless it "discloses
processes used in the manufacturing or
processing of a chemical substance or
mixture, or in the case of a
mixture, * * * disclos[es] the portion of
the mixture comprised by any of the
chemical substances in the mixture."
In the proposed exemption policy,
EPA discussed what types of
information submitted in conjunction
with exemptions might be considered
confidential, and how EPA intended to
treat such claims. The Agency indicated
that it regarded as "health and safety"
data the identity and analysis of the test
substance, the processes of
manufacturing and processing of the test
substance (to the extent necessary to
identify the test substance), information
on test protocols, and biological
information submitted to establish
equivalence. Under section 14(b), any of
this information which revealed
"process" or "mixture" information
would normally be withheld; however,
EPA reserved the right to release such
data under section 14(a)(4) if the Agency
determined this was necessary to avoid
impairment of the test rule proceeding.
Furthermore, the Agency indicated that
it could not conceive of a situation in
which the identity of the testing lab
would be held confidential. EPA
indicated that it did not consider
information on the identity of the test
sponsor or joint sponsors, or on the
identity of exemption applicants to be
health and safety data. However, the
Agency stated that it was considering
disclosing this information, under the
authority of section 14(a)(4), to facilitate
the exemption and reimbursement
process. Finally, EPA proposed that
persons submitting a claim of
confidentiality for the identity of the
principal test sponsor, identity of the
test substance, or the process for
manufacturing or processing the test
substance, be required to substantiate
these claims at the time the information
is submitted to EPA.
Public comments generally concurred
with EPA's belief that exemption
application and study plan information
would not usually be considered
confidential by the submitter. Some
commenters noted their view that, in
any case, the entire study plan should
be considered health and safety data
and made public unless to do so
revealed process or mixture information,
On the other hand, many industry
comments indicate a belief that the
Agency's definition of health and safety
study is too broad, and that only
information "directly" related to the
chemical substance's effects or
constituting the basis for a study's
conclusions falls into this category. In
particular, these commenters objected to
the general policy of including identity
of the test substance and test protocol
information as underlying data to a
health and safety study. A comment also
stated that, although identity of the
testing laboratory would rarely be
claimed confidential, if the submitter
established grounds for confidential
treatment, this information could only
be released in accordance with section
14(a}(4). Finally, several commenters
stated that there is no justification under
TSCA for requiring that certain
confidentiality claims be substantiated
at the time the information is submitted.
2. Final confidentiality procedures
and policy. Since the proposal, many
aspects of EPA's test rule process have
been modified. In addition, EPA has
reexamined the need for disclosure of
information in the process. As is
explained below, because of these
changes, many of the issues raised in the
comments have been eliminated.
The question of confidential treatment
for the identity of the test substance
submitted by a test sponsor has been
largely eliminated by the revisions to
EPA's test rule development process.
Comments pointed out that
confidentiality only becomes an issue
when EPA fails to specify a test
substance. However, EPA will always
specify a test substance or test
substances in the final Phase I test rule.
If a tester believes that the test
substance's identity is not confidential
per se, but rather because it is linked
with the test sponsor's identification, it
can address this problem by claiming its
corporate identity to be confidential
business information, as discussed
below.
Under EPA's final exemption
procedures, if the Agency identifies a
single test substance, persons applying
for exemption will not be required to
provide any specific information on the
identity of the substance they are
manufacturing, because either all
varieties of the chemical substance will
be equivalent to the test substances, or
the test rule itself will define which
substances are equivalent to the test
substance. (If a person believes that the
fact that it is manufacturing a substance
equivalent to the test substance is
confidential business information, it
would be necessary for the person to
claim its corporate identity
confidential.) However, if EPA identifies
more than one test substance, an
exemption applicant will be required to
indicate to which of the chosen test
substances equivalence is claimed, the
identity of the applicant's substance,
and to submit required data supporting
this assertion. If a confidentiality claim
is established adequately for the
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— -—-•-•--- . • _ i
identity of the substance that the
exemption applicant manufactures or
processes, EPA will not disclose the
identity of the applicant.
If the exemption applicant claims data
supporting its equivalence claim to be
confidential, EPA will generally judge
the confidentiality of this information
under section 14(a) of TSCA. However,
the Agency will generally consider data
from biological tests submitted in
support of a claim of equivalence to be
health arid safety data, and under
section 14{b) such data will be withheld
only if it would reveal "process" or
"proportions of a mixture," which such
information would not generally do.
Manufacturers and processors may also
in some cases be required to submit
information on the manufacturing
process for their substance, or
proportions of a mixture, in order to
establish equivalence. EPA will
withhold this information if the
submitter adequately asserts the claim
that it is confidential business
information.
EPA has reevaluated its proposed
approach to the question of claims of
confidentiality of the identity of the test
sponsor. The Agency continues to
believe that this information would
rarely, if ever, be claimed confidential.
EPA would expect it to be claimed
confidential only when a person wishes
to avoid disclosing that it manufactures
or processes the substance subject to
the rule. If a valid claim of
confidentiality is asserted, the Agency
no longer intends generally to disclose
this information under section 14(a)(4) to
facilitate the reimbursement process.
The study sponsor is responsible, in the
first instance, for paying the cost of the
testing. If the sponsor, for whatever
reason, does not seek reimbursement
from an exemption holder, there would
be no need to reveal the sponsor's
identity. If the sponsor seeks
reimbursement from any person, the
sponsor can arrange for a third party to
represent it in negotiations or in a
reimbursement proceeding under the
Agency's rules. Only if the
confidentiality of the test sponsor's
identity prevented a full and fair
resolution of a formal reimbursement
dispute would EPA consider it
necessary to reveal this information
under the authority of section 14(a)(4).
A claim of confidentiality for the
identity of an exemption applicant poses
a somewhat different problem. An
exemption holder has an obligation
under TSCA to provide reimbursement
to the test sponsor. The test sponsor or a
person who has already paid
reimbursement to a test sponsor, and
thus may wish a contribution from
others subject to the rule, are the only
persons who have a specific need to
identify the exemption holders so that
they can seek reimbursement from them.
If exemption applicants assert a claim of
confidentiality, EPA will withhold this
information until the Agency receives a
notification from a test sponsor of an
intent to seek reimbursement from
exemption holders. Then, under EPA
confidentiality procedures, EPA will
notify the exemption holders that it
intends to release this information under
section 14{a)(4) unless the exemption
holder immediately takes steps to
contact the requesting party (directly, or
through an intermediary) or proposes a
way for the reimbursement process to
proceed without release of the exempted
company's identity.
Under EPA's current process for
developing enforceable test standards
for test rules, the final Phase II test rule
for a substance will specify the
protocols which must be used for a
particular test. While comments
asserted that a study plan submitted by
a party could contain confidential
business information, EPA does not
believe any test sponsor could assert a
valid claim for confidentiality for the
design of the proposed study. However,
if such a claim were asserted, EPA
believes that such protocol information
is clearly included in the concept of
"data underlying a health and safety
study" and thus would disclose such
information. The only statutory basis
under section 14(b) for withholding such
information would be that it revealed
"process" or "mixture" information, and
EPA cannot envision how a testing
protocol could reveal such data. EPA
will withhold this information only if the
submitter substantiates the claim that it
is confidential business information.
The only circumstance suggested by
the comments under which the identity
of the laboratory performing a test
would be confidential would be if the
test sponsor's identity were confidential
and revealing the name of the lab would
reveal the identity of the test sponsor.
EPA has concluded that the identity of
the lab performing a test is data
underlying a health and safety study
because the quality of testing may vary
according to the caliber of the
laboratory performing the test.
Therefore, the disclosure of such
information is governed by section 14(b)
and would be released. EPA does not
believe that revealing the identity of a
lab would ever reveal process or
mixture information. If a test sponsor is
concerned about revealing its identity, it
should select a test lab whose identity
would not reveal this information.
EPA is requiring that test sponsors
substantiate at the time of submission
confidentiality claims for certain types
of study plan information. EPA believes
that unexpected disruption to the
process may result if substantiation is
not required at the time study plan
information is submitted. EPA believes
that its revised approach will severely
limit the necessity for confidentiality
claims and that this requirement for
substantiation will not place a
significant burden on the regulated
industry.
VI. Rulemaking Record
EPA has established a public record
for this rulemaking, docket number
[OPTS-42052], which contains the
following information:
(1) Federal Register notices pertaining
directly to this rule consisting of:
(a) Notice of proposed rule pertaining to
exemptions (45 FR 48512).
(b) Proposed rule related notice describing
changes in EPA's test standards policy and
test rule development process (47 FR 13012).
(2) Federal Register notices related to this
rule consisting of:
(a) Proposed health effects testing
standards (44 FR 27334 and 44 FR 44054).
(b) Proposed chemical fate and ecological
effects testing standards 45 FR 77332).
(c) Final rule concerning EPA's good
laboratory practice standards (48 FR 53922).
(d) Final rule concerning data
reimbursement (48 FR 31786).
(3) List of comments pertaining to this rule.
(4) List of comment submitters.
(5) Written communications pertaining to
this rule.
This record, which includes basic
information considered by the Agency in
developing this proposal and
appropriate Federal Register notices, is
available for inspection in the OPTS
Reading Room, Room E-107, 401 M St.,
SW., Washington, D.C., from 8:00 a.m. to
4:00 p.m., Monday through Friday,
except legal holidays. The Agency will
supplement the record with additional
information as it is received.
VII. Classification of Rule
Under Executive Order 12291, EPA
must judge whether a regulation is
"Major" and, therefore, subject to the
requirement of a Regulatory Impact
Analysis. This rule on test rule
development and exemption application
procedures is not major because it does
not meet any of the criteria set forth in
section l(b) of the Order. The regulation
is a procedural rule and will have
virtually no effect on the economy. The
rule describes the process EPA will use
to develop test rules under section 4(a)
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of TSCA and to grant exemptions from
those test rules under section 4{c) of
TSCA. It will not cause major price or
cost increases but rather provides a
mechanism to avoid duplicative testing,
thereby reducing costs to the regulated
community. The regulation will not
significantly affect competition,
employment, investment, productivity,
innovation, or the ability of U.S.-based
enterprises to compete with foreign-
based enterprises in domestic or export
markets; rather, it encourages the
development of innovative and cost-
effective testing methodologies.
This rule was submitted to the Office
of Management and Budget (OMB) for
review as required by Executive Order
12291. Any comments from OMB to EPA,
and any EPA response to those
comments, will be included in the
rulemaking record.
VIII. Regulatory Flexibility Act
Under the Regulatory Flexibility Act
(15 U.S.C. 601 et seq., Pub. L 96-354.
Sept. 19,1980), EPA is certifying that this
rule will not have a significant impact
on a substantial number of small
entities.
By facilitating an exemption process
in which a single manufacturer or
processor can sponsor tests on behalf of
all those subject to a TSCA section 4
test rule, this rule reduces the
administrative and financial burden
which those testing rules might
otherwise impose on regulated
industries. The impact which test rules
are expected to have on small entities
was discussed in the Dichloromethane,
Nitrobenzene, and 1,1,1-Trichloroethane
Proposed Rule, published in the Federal
Register of June 5,1981 (46 FR 303CO).
The revised exemption procedures
described in this rule are expected to
present an even smaller burden to the
exemption applicant than those referred
to in that test rule because test rules will
henceforth give specific guidance as to
what types of data, if any, are required
to support equivalence assertions. This
will reduce the possibility that an
applicant may submit more data than
the Agency requires to make a decision.
EPA's decision to provide testing
guidance in the form of suggested
guidelines rather than required protocols
is also expected to reduce the
administrative and financial burden on
affected industries. Under this approach,
firms whose existing testing facilities or
practices differ from those described in
EPA's recommended protocols need not
modify their procedures unless EPA
finds that these variations are great
enough to significantly affect the data
generated. Therefore, companies
sponsoring testing are less likely to find
it necessary to codify existing testing
practices and will have more flexibility
in selecting new ones.
IX. Paperwork Reduction Act
The information collection
requirements contained in this rule have
been approved by tha Office of
Management and Budget (OMB) under
the provisions of the Paperwork
Reduction Act of 1980,44 U.S.C. 3501 et
seq. and have been assigned OMB
control number2070-0033.
List of Subjects in 40 CFR Part 790
Testing, Exemptions, Environmental
protection, Hazardous materials,
Chemicals.
Dated: September 28,1984.
William D. Ruckelshaus,
Administrator.
Therefore, Chapter I of 40 CFR is
amended by adding a new Part 790 to
read as follows:
PART 790—TEST RULE
DEVELOPMENT AMD EXEMPTION
PROCEDURES
Subpart A—General Provisions
Sec.
790.1 Scope, purpose, and authority.
7S0.2 Applicability.
700.3 Definitions.
790.5 Submission of information.
790.7 Confidentiality.
Subpcrt B—Two Phcso Test Bute
Development
790.20 Phase I test rule.
790.22 Persons subject to Phase 1 test rule.
7S0.25 Submission of letter of intent to test
or exemption application.
790.28 Procedure if no one submits a letter
of intent to conduct testicj.
790.30 Submission of proposed study plena.
790.32 Proposed Phase 0 test rule.
790.34 Final Phase II test rule.
790.35 Modification of study plans during
conduct of study.
790.39 Failure to comply with a test rule.
Subpcrto C-D—[Rsccrvcd]
Subpcrt E—Exemptions
790.80 Submission of exemption
applications.
790.82 Content of exemption application.
790.85 Submission of equivalence data.
790.87 Approval of exemption applications.
790.88 Denial of exemption application.
790.90 Appeal of denial of exemption
application.
790.93 Termination of conditional
exemption.
790.97 Hearing procedures.
790.99 Statement of financial responsibility.
Authority: [TSCA, 15 U.S.C. 2603(b)(3)(A),
2603(c)].
Subpart A—General Provisions
§ 790.1 Scope, purpose, end cuthcrity.
(a) This part establishes the
procedureo to be used in promulgating
test rules under section 4(a) of the Act
and sets forth the process by which
exemptions from those test rules will be
granted.
(b)(l) Section 4(a) of the Act
authorizes EPA to require manufacturers
and processors of chemical substances
and mixtures to test chemical
substances and mixtures for health and/
or environmental effects.
(2) Sections 4(b)(l) and 3(12)(A) of the
Act specify that each test rule must
include standards for the development
of test data which prescribe the "health
and environmental effects" and the
"information relating to toxicity,
persistence, and other characteristics
which affect health and the
environment" for which test data are to
be developed.
(3) Sections 4(b)(l) and 3(12) of the
Act authorize EPA to prescribe the
manner in which tests are to be
conducted in the development of such
data and any other such requirements as
are necessary to assure the development
of adequate and reliable data.
(4) Section 4(c) of the Act permits any
person subject to a test rule promulgated
under section 4(aJ of the Act to request
an exemption from the requirements of
such a rule. The Administrator is
directed to approve an application for
exemption if he/she determines that:
(i) The chemical to which the
application pertains is equivalent to one
for which data have been or are being
developed pursuant to the same testing
rule; and
(ii) Submission of additional data by
the applicant would be duplicative of
data already submitted or under
development.
(5) Section 4(b)(3)(A) of the Act
authorizes the Administrator to permit
two or more persons subject to a test
rule to designate one of themselves or a
qualified third party to conduct testing
and submit data on their behalf.
(6) Sections 4(c)(3) and 4(c)(4) of thb
Act provide that persons receiving
exemptions provide reimbursement to
all those persons who have contributed
or are contributing to financing the
development of the data on the basis of
which the exemption was granted. Such
reimbursement is to be for a portion of
the costs incurred. If the persons
involved cannot agree on the amount
and method of reimbursement, EPA is
required to order the person granted the
exemption to provide fair and equitable
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39783
reimbursement to the appropriate
parties.
§780.2 Applicability.
This part is applicable to
manufacturers and processors of
chemical substances or mixtures who
are subject to the testing requirements
of a rule promulgated under section 4(a)
of the Act. These procedures are
applicable to each test rule in Part 799 of
this Chapter unless otherwise stated in
specific test rules in Part 799 of this
Chapter.
§ 790.3 Definitions.
Terms defined in the Act and not
explicitly defined herein are used with
the meaning given in the Act. For the
purpose of this part:
"Act" means the Toxic Substances
Control Act, 15 U.S.C. 2601 et seq
"Additive" means a chemical
substance that is intentionally added to
another chemical substance to improve
its stability or impart some other
desirable quality.
"Chemical" means a chemical
substance or mixture.
"Consortium" means an association of
manufacturers and/or processors who
have made an agreement to jointly
sponsor testing.
"EPA" means the U.S. Environmental
Protection Agency.
"Equivalence data" means chemical
data or biological test data intended to
show that two substances or mixtures
are equivalent.
"Equivalent" means that a chemical
substance or mixture is able to represent
or substitute for another in a test or
series of tests, and that the data from
one substance can be used to make
scientific and regulatory decisions
concerning the other substance.
"Exemption" means an exemption
from a testing requirement of a test rule
promulgated under section 4 of the Act
and Part 799 of this Chapter.
"Impurity" means a chemical
substance which is unintentionally
present with another chemical
substance.
"Joint sponsor" means a person who
sponsors testing pursuant to section
4(b)(3)(A) of the Act.
"Joint sponsorship" means the
sponsorship of testing by two or more
persons in accordance with section
4(b)(3)(A) of the Act.
"Person" means an individual,
partnership, corporation, association.
scientific or academic establishment, or
organizational unit thereof, and any
other legal entity.
"Principal sponsor" means an
individual sponsor or the joint sponsor
who assumes primary responsibility for
the direction of a study and for oral and
written communication with EPA.
"Protocol" means the plan and
procedures which are to be followed in
conducting a test.
"Reimbursement period" refers to a
period that begins when the data from
the last non-duplicative test to be
completed under a test rule are
submitted to EPA and ends after an
amount of time equal to that which had
been required to develop data or after
five years, whichever is later.
"Sponsor" means the person or
persons who design, direct and finance
the testing of a substance or mixture
subject to a test rule in Part 799 of this
chapter.
"Test substance" means the form of
chemical substance or mixture that is
specified for use in testing.
§ 790.5 Submission of information.
All submissions to EPA under this
part must bear the Code of Federal
Regulations (CFR) section number of the
subject chemical test rule (e.g. § 799.4400
for 1,1,1-trichloroethane) and must be
addressed to:
Document Control Office (TS-793), Office of
Pesticides and Toxic Substances,
Environmental Protection Agency.
Washington, D.C. 20460.
In addition, a copy of the cover memo
for all submissions must be addressed
to:
Director. Compliance Monitoring Staff (EN-
342), Office of Pesticides and Toxic
Substances, Environmental Protection
Agency. Washington, D.C. 20460.
§790.7 Confidentiality.
(a) Any person subject to the
requirements of a test rule promulgated
under section 4 of the Act may assert a
claim of confidentiality for certain
information submitted to EPA in
response to the test rule. Any
information claimed as confidential will
be treated in accordance with the
procedures in Part 2 of this title and
section 14 of the Act. Failure to assert a
claim of confidentiality at the time the
information is submitted will result in
the information being made available to
the public without further notice to the
submitter.
(b) A claim of confidentiality must be
asserted by circling or otherwise
marking the specific information
claimed as confidential and designating
it with the words "confidential business
information," "trade secret," or another
appropriate phrase indicating its
confidential character.
(c) If a person asserts a claim of
confidentiality for study plan
information described in § 790.30(c)(l)
(iii)(D). (iv), (v), and (vi) of the part, the
person must provide a detailed written
substantiation of the claim by answering
the questions in this paragraph. Failure
to provide written substantiation at the
time the study plan information is
submitted will be considered a waiver
of the claim of confidentiality, and the
study plan information will be disclosed
to the public without further notice.
(1) Would disclosure of the study plan
information disclose processes used in
the manufacture or processing of a
chemical substance or mixture?
Describe how this would occur.
(2) Would disclosure of the study plan
information disclose the portion of a
mixture comprised by any of the
substances in the mixture? Describe
how this would occur.
(3) What harmful effects to your
competitive position, if any, do you
think would result from disclosure of
this information? How would a
competitor use such information? How
substantial would the harmful effects
be? What is the causal relationship
between disclosure and the harmful
effects?
(4) For what period of time should
confidential treatment be given? Until a
specific date, the occurrence of a
specific event, or permanently? Why?
(5) What measures have you taken to
guard against disclosure of this
information to others?
(6) To what extent has this
information been disclosed to others?
What precautions have been taken in
connection with such disclosures?
(7) Has this information been
disclosed to the public in any forms?
Describe the circumstances.
(8) Has the information been disclosed
in a patent?
(9) Has EPA, another Federal agency.
or any Federal court made any pertinent
confidentiality determination regarding
this information? If so, copies of such
determinations must be included in the
substantiation.
(d) If the substantiation provided
under paragraph (c) of this section
contains information which the
submitter considers confidential, the
submitter must assert a separate claim
of confidentiality for that information at
the time of submission in accordance
with paragraph (b) of this section.
Subpart B—Two Phase Test Rule
Development
§ 790.20 Phase I test rule.
(a) If EPA determines that it is
necessary to test a chemical substance
or mixture under section 4 of the Act, it
will promulgate a Phase I test rule in
Part 799 of this chapter through a notice-
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39784 Federal Register / Vol. 49, No. 197 / Wednesday, October 10, 1984 / Rules and Regulations
and-comment rulemaking which
specifies the following:
(1) Identification of the chemical for
which testing is required under the rule.
(2) The health or environmental effect
or effects or other characteristics for
which testing is being required.
(3) Which test substance(s) must be
tested.
(4] A reference to appropriate
guidelines for the development of test
data.
(5) The EPA Good Laboratory Practice
requirements for the required testing.
(6) Who must submit either letters of
intent to conduct testing or exemption
applications.
(7) What types of data EPA will
examine in determining equivalence if
more than one test substance is to be
tested.
(b) [Reserved],
§ 790.22 Persons cubjact to Preso1 test
ru!o.
(a) Each Phase I test rule will specify
whether manufacturers, processors, or
both are subject to the requirement for
testing of the subject chemical under
section 4(b)(3)(B) of the Act and will
indicate who will be required to submit
letters of intent to submit study plans
and to conduct testing.
(1) If testing is being required to allow
evaluation of risks:
(i) Primarily associated with
manufacture of the chemical, or
(ii) Associated with both manufacture
and processing of the chemical, or
(iii) Associated with distribution in
commerce, use, and/or disposal
activities concerning the chemical, each
manufacturer of the chemical will be
subject and must respond to the test
rule. While legally subject to the test
rule in circumstances described in
paragraph (a](l) (ii) and (iii) of this
section, processors of the chemical have
no obligation to respond unless directed
to do so in a subsequent notice as set
forth in § 790.28(b) or § 790.39(a)(2) of
this part.
(2) If testing is being required to allow
evaluation of risks associated soley with
processing of the chemical, processors
will be subject and must respond to the
test rule.
(b) [Reserved].
§ 790.25 Submission of tetter of intent to
test or exemption application.
(a) No later than 30 days after the
effective date of a Phase I test rule, each
person subject to that rule and required
to respond to that rule as provided in
§ 790.22(a) must, for each test required,
either notify EPA by letter of their intent
to submit study plans and to conduct
testing or submit to EPA an application
for an exemption from the study plan
submission and testing requirements for
the test
(b) EPA will consider letters of intent
to test as commitments to submit study
plans and to sponsor the tests for which
they are submitted unless EPA agrees to
the substitution of an exemption
application in instances where more
than one person indicates an intent to
sponsor equivalent tests. Each letter of
intent to conduct testing must include:
(1) Identification of test rule.
(2) Name, address, and telephone
number of the firm(s) which will be
sponsoring the tests.
(3) Name, address, and telephone
number of the appropriate individual to
contact for further information.
(4) For sponsors participating in a
testing consortium—a listing of other
members of the consortium signed by
each member, and a designation of who
is to serve as principal sponsor.
(5) A list of the testing requirements
for which the sponsor(s) intends to
oubmit study plans and conduct tests.
(6) If EPA is requiring testing of more
than one representative substance—
which test substance the sponsor(s)
intends to use in each of the tests.
(c) Any person not manufacturing or
processing the subject chemical as of the
effective date of the final Phase I test
rule or by 30 days after the effective
date of the rule or, when both
manufacturers and processors are
subject to the rule, not processing as of
the effective date of the final Phase I
test rule or by 30 days after publication
of the Federal Register notice described
in § 790.28(b)(2) of this part who, before
the end of the reimbursement period,
manufactures or processes the test
chemical and who is subject to and
required to respond to the test rule must
submit the letter of intent to test or
exemption application required by
paragraph (a) of this section or
§ 790.28{b)(3) of this part by the date
manufacture or processing begins.
(d) Manufacturers subject to a Phase I
test rule who do not submit to EPA
either a letter of their intent to conduct
tests or a request for an exemption from
testing for each test for which testing is
required in a Phase I test rule will be
considered in violation of that rule
beginning on the 31st day after the
effective date of the Phase I test rule or
on the date manufacturer begins as
described in paragraph (c) of this
section.
(e) Processors subject to a Phase I test
rule and required to respond pursuant to
§ 790.22(a)(2) or a Federal Register
notice as described in § 790.28(b)(2) of
this part who do not submit to EPA
either a letter of their intent to conduct
tests or a request for an exemption for
each test for which testing is required in
a Phase I test rule will be considered in
violation of that rule beginning on the
31st day after the effective date of the
Phase I test rule or 31 days after
publication of the Federal Register
notice described in § 790.28(b){2) of this
part or on the date processing begins as
described in paragraph (c) of this
section, as appropriate.
§ 790.28 Procedure If no OIK cubmlts a
(otter of Intent to conduct testing.
(a) If only manufacturers are subject
to rule. (1) This paragraph applies if
testing is being required solely to allow
evaluation of risks associated with
manufacturing and the final Phase I test
rule states that manufacturers only are
responsible for testing.
(2) If no manufacturer subject to the
rule has notified EPA of its intent to
conduct one or more of the required
tests within 30 days after the effective
date of the final Phase I test rale, EPA
will notify all the manufacturers by
certified mail or publish a notice in the
Federal Register of this fact specifying
the tests for which no letter of intent has
been submitted and will give the
manufacturers an opportunity to take
corrective action. If no manufacturer
submits a letter of intent to conduct one
or more of the required tests within 30
days after receipt of the certified letter
or publication of the Federal Register
notice described in this paragraph, all
manufacturers subject to the rule will be
in violation of the test rule from the 31st
day after receipt of the certified letter or
publication of the Federal Register
notice described in this paragraph until
a proposed study plan has been
submitted for each required test.
(b) If manufacturers and processors
are subject to the rule. (1) This
paragraph applies if testing is being
required to allow evaluation of risks
associated with manufacturing and
processing or with distribution in
commerce, use or disposal of the
chemical and the final Phase I test rule
states that manufacturers and
processors are responsible for testing.
(2) If no manufacturer subject to the
rule has notified EPA of its intent to
conduct testing for one or more of the
required tests within 30 days after the
effective date of the final Phase I test
rule, EPA will publish a notice in the
Federal Registar of this fact specifying
the tests for which no letter of intent has
been submitted.
(3) No later than 30 days from the date
of publication of the Federal Register
notice described above in paragraph
(b)(2J of this section, each person
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Federal Register / Vol. 49, No. 197 / Wednesday, October 10, 1984 / Rules and Regulations 39785
processing the subject chemical as of the
effective date of the final Phase I test
rule or by 30 days after the date of
publication of the Federal Register
notice described in paragraph (b)(2) of
this section must, for each test specified
in the Federal Register notice, either
notify EPA by letter of their intent to
submit study plans and conduct testing
or submit to EPA an application for an
exemption from the study plan
submission and testing requirements for
the test.
(4) If no manufacturer or processor of
the test chemical has submitted a letter
of intent to conduct one or more of the
required tests within 30 days from the
date of publication of the Federal
Register notice described in paragraph
(b)(2) of this section, EPA will notify all
manufacturers and processors by
certified mail or publish a Federal
Register notice of this fact specifying the
tests for which no letter of intent has
been submitted. This letter or Federal
Register notice will give the
manufacturers and processors an
opportunity to take corrective action. If
no person submits a letter of intent to
conduct one or more of the required
tests within 30 days after receipt of the
certified letter or publication of the
Federal Register notice, all
manufacturers and processors subject to
the rule will be in violation of the test
rule from the 31st day after receipt of the
certified letter or publication of the
Federal Register notice until a proposed
study plan has been submitted for each
required test.
(c) Only processors are subject to
rule. (1) This paragraph applies if testing
is being required solely to allow
evaluation of risks associated with
processing and the final Phase I test rule
states that only processors are
responsible for testing.
(2) If no processor subject to the rule
has notified EPA of its intent to conduct
one or more of the required tests within
30 days after the effective date of the
test rule, EPA will notify all the
processors by certified mail or publish a
notice in the Federal Register of this
fact, specifying the tests for which no
letter of intent has been submitted and
give the processors an opportunity to
take corrective action. If no processor
submits a letter of intent to conduct one
or more of the required tests within 30
days after receipt of the certified letter
or publication of the Federal Register
notice described in this paragraph, all
processors subject to the rule will be in
violation of the test rule from the 31st
day after receipt of the certified letter or
publication of the Federal Register
notice described in this paragraph until
a proposed study plan has been
submitted for each required test.
§ 790.30 Submission of proposed study
plans.
(a) Who must submit study plans. (1)
Persons who notify EPA of their intent
to conduct tests must submit proposed
study plans for those tests on or before
90 days after the effective date of the „
Phase I rule; or, for processors
responding to the notice described in
§ 790.28(b)(2) of this part, 90 days after
the publication date of that notice; or 60
days after the date manufacture or
processing begins as described in
§ 790.25(c) of this part, as appropriate.
Only one set of study plans should be
prepared and submitted by persons who
are jointly sponsoring testing. Study
plans must be prepared according to the
requirements of this subpart and Part
792 of this chapter.
(2) Any person subject to a test rule
may submit a proposed study plan for
any test required by the rule at any time,,
regardless of whether the person
previously submitted an application for
exemption from testing for that test.
(3) Unless EPA has granted an
extension of time for submission of
study plans, manufacturers who notify
EPA that they intend to conduct testing
and who do not submit proposed study
plans for those tests on or before 90
days after the effective date of the Phase
I test rule or 60 days after the date"
manufacture begins as described in
§ 790.25(c) of this part will be
considered in violation of the test rule
as if no letter of intent to test had been
submitted.
(4) Unless EPA has granted an
extension of time for submission of
study plans, processors who notify EPA
that they intend to conduct testing and
who do not submit proposed study plans
for those tests on or before 90 days after
the effective date of the Phase I test rule
or 90 days after the publication date of
the notice described in § 790.28(b)(2) of
this part, or 60 days after the date
processing begins as described in
§ 790.25(c) of this part, as appropriate,
will be considered in violation of the
test rule as if no letter of intent to test
had been submitted.
(b) Extensions of time for submission
of study plans. (1) The Agency may
grant requests for additional time for
study plan development on a case-by-
case basis. Requests for additional time
for study plan development must be
made in writing to EPA. Each extension
request must demonstrate why that
extension should be granted. EPA will
notify the submitter by certified mail of
EPA's decision to grant or deny an
extension request.
(2) Persons who have been granted an
extension of time for submission of
study plans as described in paragraph
(b)(l) of this section and who do not
submit proposed study plans in
accordance with the new deadline
granted by EPA will be considered in
violation of the test rule as if no letter of
intent to test had been submitted.
(c) Content of study plans. (1) All
study plans are required to contain the
following information:
(i) Identity of the test rule.
(ii) The specific test requirements of
that rule to be covered by the study
plan.
(iii)(A) The names and addresses of
the test sponsors.
(B) The names, addresses and
telephone numbers of the responsible
administrative officials and project
manager(s) in the principal sponsor's
organization.
(C) The name, address, and telephone
number of the appropriate individual to
contact for oral and written
communications with EPA.
(D)(7) The names and addresses of the
testing facilities and the names,
addresses, and telephone numbers of
the testing facilities, administrative
officials and project manager(s)
responsible for the testing.
(2) Brief summaries of the training and
experience of each professional
involved in the study, including study
director, veterinarian(s), toxicologist(s),
pathologist(s), chemist(s),
microbiologist(s), and laboratory
assistants.
(iv) Identity and data on the chemical
substance(s) being tested, including
physical constants, spectral data,
chemical analysis, and stability under
test and storage conditions, as
appropriate.
(v) Study protocol, including rationale
for species/strain selection; dose
selection (and supporting data); route(s)
or method(s) of exposure; description of
diet to be used and its source, including
nutrients and contaminants and their
concentrations; for in vitro test systems,
a description of culture medium and its
source; and a summary of expected
spontaneous chronic diseases (including
tumors), genealogy, and life span.
(vi) Schedule for initiation and
completion of each short-term test and
of each major phase of long-term tests;
schedule for submission of interim
progress and final reports to EPA.
(2) Information required under
paragraph (c)(l)(iii)(D) of this section is
not required in proposed study plans if
the information is not available at the
time of study plan submission; however.
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3978S Federal Register / Vol. 49, No. 197 / Wednesday, October 10, 1984 / Rules and Regulations
the information must be submitted
before the initiation of testing.
(d) Incomplete study plans. Upon
receipt of a proposed study plan, EPA
will review the study plan to determine
whether it complies \vith paragraph (c)
of this section. If EPA dsttrmines thai
the proposed study plan dees not
comply with paragraph (c) of this
section, EPA will notify the submitter
that the submission is incomplete and
will identify the deficiencies and the
steps necessary to complete the
submission. The submitter will have 15
days from the day it receives this notice
to submit appropriate information to
make the study plan complete. If the
submitter fails to provide appropriate
information to complete the study plan
on or before 15 days after receipt of the
notice, the submitter will be considered
in violation of the test rule as if no letter
of intent to conduct the test had been
submitted.
§ 750.32 Propound Pfcsso El teat ruto.
If EPA determines that the proposed
study plan complies with § 790.30(c) of
this part, EPA will publish a proposed
Phase II test rule in the Federal Register
requesting comments on the ability of
the study plan to ensure that data from
the test will be reliable and adequate.
EPA will provide a 45-day comment
period and will provide an opportunity
for an oral presentation upon the
request of any person. EPA may extend
the comment period if it appears from
the nature of the issues raised by EPA's
review or from public comments that
further comment is warranted.
§ 7C0.34 Rnr! Ph=c^ II test rule.
After receiving end considering public
comment, EPA wil! adopl the study plan,
including the time deadline: and
reporting schedules, as proposed or as
modified in response to EPA review and
public comments, in a final Phase II test
rule as test standards and schedules for
the required testing.
§ 760.35 bonification of ctedy piano
during conduct ol study.
(a) Application. Any test aponsor who
wishes to modify the adopted ctudy plan
for any test required under a test rule
must submit an application in
accordance with thio paragraph.
Application for modification m_st be
made in writing to the Director,
Compliance Monitoring Staff (EN-342),
Office of Pesticides and Toxic
Substances, EPA, cr by phone, xvith
written confirmation to follow within 10
working days. Applications must include
appropriate explanation of why the
modification is necessary.
(b) Adoption. To the extent feasible,
EPA will seek public comment on all
substantive changes in study plans. EPA
will issue a notice in the Federal
Register requesting comments on
requested modifications. However, EPA
will act on the requested modification
without seeking public comment if
either:
(1) EPA believes that an immediate
modification to a study plan is
necessary in order to preserve the
accuracy or validity of an ongoing study,
or
(2) EPA determines that a
modification clearly does not poca any
substantive issues. EPA w ill notify the
sponsor of EPA'o approval or
disapproval. When EPA approves a
modification, it will publish a notice in
the Federal Register indicating that the
study plan has been modified.
§ 730.39 ralluro to comply with c test rulo.
(a)(l) Persons who notified EPA of
their intent to conduct a test required in
a test rule in Part 799 of this chapter and
who fail to conduct the test in
accordance with the test standards and
schedules adopted in the final Phase II
test rule, or as modified in accordance
with § 790.35 of this part, xvill be in
violation of the rule.
(2)(i] If a person fails to conduct a test
in accordance with the test standards
and schedules adopted in the test rule,
EPA will notify each holder of an
affected conditional exemption by
certified letter or b;- notice in the
Federal Register that all conditional
exemptions from performance of that
test will be terminated unless, within 30
days of receipt of the csrtif:od letter or
thu publication of the notice, a person
subject to the m'-a provides adequate
informatk-n to rebut EPA'u preliminary
decision or notifies EPA by letter that
they intend to parfoi-m that lest in
accordance tvith the test standards
adopted in the tett rula. Exemption
holders nuy also request a hearing in
accordance rrlth the procedures in
§ 790.93 and § 793.97 of this part
(ii) Within 63 days of receipt of the
certified lettar or publication of tha
Federal Register notice described in
paragraph (a)(2)(i) of this section,
persona who notify EPA of their intent
to conduct a test must submit the tVudy
plan information described in
§ 780.30(c)(l) (ii:), Jiv), and (vi) of this
part that requires modification jom that
in the test standards and schedules
adopted in the test rule. EPA will adopt
modifications to the test standards end
schedules in accordance with the
procedures described in § 7S3.35(b) of
this part.
(iii) If no person subject to the rules
provides adequate information to rebut
EPA's preliminary decision or notifies
EPA by letter of its intent to conduct the
required test, EPA will notify all
affected exemption holders by certified
letter or Federal Register notice that all
conditional exemptions for performance
of that test are lemma ted.
(b) Any person who fails or refuses to
comply with any aspect of this Part or a
test rule under Part 799 of this chapter is
in violation of section 15 of the Act. EPA
will treat violations of the Good
Laboratory Practice standards as
indicated in 3 792.17 of this part.
Subparta C-D— [Rsservsd]
Si±pert is—Isejrc^titnc;
§ 790.CO SuJsidlsslon of exemption
applications.
(a) Who should file applications. (I]
Any manufacturer or processor subject
to a test rule i- ?B rt 793 of this chapter
may submit ca application to EPA for an
exemption f-on; submitting propped
study plans for and from performing any
or all of the tests required under the test
rule.
(2) Processors will not be required to
apply for an exemption or conduct
testing unless EPA so specifics in a tesl
rule or in a special Federal IlegLler
notice aa described in {j 79Q.28;b^2) of
this part under the following
circumstance si:
(i) !f testing is being required to tllow
evaluation of risks associated with
manufacturing and prooesr,;ng or with
distribution in commurce, disposal or
use of the chemical« ~c* rnar^factu^rs
do not submit not:r.;;(s) of intent to
conduct the rstjuL-sd '.e.'-ting; or
(ii) If testing b boing required solely to
allow evaluation of risks ataocia^au
with processing of the chemical.
(b) When applications must be filed.
Exemption applications nms>t be fijeu
within 30 days of the effective date of
the final Phase 1 test rule or, if being
submitted in response to the Federal
Register notice described in
| 790.28tb)[2J of this part, v. ilhm 30 days
of tiie publication of thai notice.
Exemption applications must be filed by
the data manufacture or processing
begins by any person nol manufacturing
or processing the subject chemical aa of
the effective date 01 the final Phase 1
test rale or by 30 days after the effective
date of the Phase I test rule, or, when
both manulacturera and processors are
subject to the rule, not processing as of
the effective date of Ihe final Phase 1
test rule or by 30 days after publication
of the Fedei .7! Register notice described
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Federal Register / Vol. 49, No. 197 / Wednesday, October 10, 1984 / Rules and Regulations 39787
in § 790.28(b)(2) of this part who, before
the end of the reimbursement period,
manufactures or processes the test
substance and who is subject to the
requirement to submit either a letter of
intent to test or an exemption
application.
(c) Scope of application. A person
may appty for an exemption from all, or
one or more, specific testing
requirements in a test rule in Part 799 of
this chapter.
§ 790.82 Content of exemption
application.
The exemption application must
contain:
(a) The identity of the test rule and
specific testing requirements) from
which an exemption is sought.
(b) Name, address, and telephone
number of applicant.
(c) Name, address, and telephone
number of appropriate individual to
contact for further information.
(d)(l) If required in the test rule to
establish equivalence:
(i) The chemical identity of the test
substance on which the application is
based.
(ii) Equivalence data specified in
§ 790.85 of this part.
(2) If a test rule requires testing of a
single representative substance, EPA
will consider all forms of the chemical
subject to that rule to be equivalent and
will not require the submission of
equivalence data as described in
§ 790.85 of this part.
§ 790.85 Submission of equivalence data.
If EPA requires in a test rule
promulgated under section 4 of the Act
the testing of two or more test
substances which are forms of the same
chemical, each exemption applicant
must submit the following data:
(a) The chemical identity of each
technical grade chemical substance or
mixture manufactured and/or processed
by the applicant for which the
exemption is sought. The exact type of
identifying data required will be
specified in the test rule, but may
include all characteristics and
properties of the applicant's substance
or mixture, such as boiling point, melting
point, chemical analysis (including
identification and amount of impurities),
additives, spectral data, and other
physical or chemical information that
may be relevant in determining that the
applicant's substance or mixture is
equivalent to the specific test substance.
(b) The basis for the applicant's belief
that the substance or mixture is
equivalent to the test substance or
mixture.
(c) Any other data which exemption
applicants are directed to submit in the
test rule which may bear on a
determination of equivalence. This may.
include a description of the process by
which each technical grade chemical
substance or mixture for which an
exemption is sought is manufactured or
processed prior to use or distribution in
commerce by the applicant.
§ 790.87 Approval of exemption
applications.
(a) EPA will conditionally approve
exemption applications if:
(1) EPA has received a complete
proposed study plan for the testing from
which exemption is sought and has
adopted the study plan, as proposed or
modified, as test standards in a final
Phase II test rule, and
(2) The chemical substance or mixture
with respect to which the application
was submitted is equivalent to a test
substance or mixture for which the
required data have been or are being
submitted in accordance with a final
Phase II test rule, and
(3) Submission of the required test
data concerning that chemical substance
or mixture would be duplicative of data
which have been or are being submitted
to EPA in accordance with a test rule.
(b)(l) If a single representative
substance .is to be tested under a test
rule, EPA will consider all forms of the
chemical subject to that rule to be
equivalent and will contact the
exemption applicant only if information
is missing or unclear.
(2) If two or more representative
substances are to be tested under a test
rule, EPA will evaluate equivalence
claims made in each exemption
application according to the criteria
discussed in the test rule.
(i) If EPA finds an equivalence claim
to be in error or inadequately supported,
the applicant will be notified by
certified mail. The applicant will be
given 15 days to provide clarifying
information.
(ii) Exemption applicants will be
notified that equivalence has been
accepted or rejected.
(c) The final Phase II test rule which
adopts the study plans or a letter by
certified mail will give exemption
applicants final notice that they have
received a conditional exemption. All
conditional exemptions thus granted are
contingent upon the test sponsors'
successful completion of testing
according to the specifications in the
approved study plans.
§ 790.88 Denial of exemption application.
(a) EPA may deny any exemption
application if:
(1) EPA determines that the applicant
has failed to demonstrate that the
applicant's chemical is equivalent to the
test substance; or
(2) The exemption applicant fails to
submit any of the information specified
in § 790.82 of this part; or
(3) The exemption applicant fails to
submit any of the information specified
in § 790.85 of this part if required in the
test rule; or
(4) EPA has not received an adequate
study plan for the test for which
exemption is sought; or
(5) The study sponsor(s) fails to
initiate the required testing by the
deadlines adopted in the final Phase II
test rule; or
(6) The study sponsor(s) fails to
submit data as required in the test
standard and deadlines for submission
of test data as adopted in the final Phase
II test rule or as modified in accordance
with § 790.35 of this part.
(b) EPA will notify the exemption
applicant by certified mail or Federal
Register notice of EPA's determination
that the exemption application is
denied.
§ 790.90 Appeal of denial of exemption
application.
(a) Within 30 days after receipt of
notification that EPA has denied an
application for exemption, the applicant
may file an appeal with EPA.
(b) The appeal shall indicate the basis
for the applicant's request for
reconsideration.
(c)(l) The applicant may also include
a request for a hearing. Hearings will be
held according to the procedures
described in § 790.97 of this part.
(2) Hearing requests must be in
writing and must be received by EPA
within 30 days of receipt of the letter or
publication of the Federal Register
notice described in § 790.88(b) of this
part. Hearing requests must provide
reasons why a hearing is necessary.
(d) If EPA determines that there are
material issues of fact, then the request
for a hearing will be granted. If EPA
denies a hearing request, EPA will base
its decision on the written submission.
(e) EPA will notify the applicant of its
decision within 60 days after EPA
receives the appeal described in
paragraph (a) of this section or within 60
days after completion of a hearing
described in paragraph (c) of this
section.
(f) The filing of an appeal from the
denial of an exemption shall not act to
stay the applicant's legal obligation
under section 4 of the Act.
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39788 Federal Register / Vol. 49, No. 197 / Wednesday. October 10, 1984 / Rules and Regulations
§ 790.93 Termination of conditional
exemption.
(a) EPA shall terminate a conditional
exemption if it determines that:
[I] The test which provided the basis
for approval of the exemption
application has not been started by the
deadlines for initiation of testing
adopted in the final Phase II test rule or
modified in accordance with § 790.35 of
this part; or
(2) Data required by the test rule have
not been generated in accordance with
the test standards or submitted in
accordance with the deadlines for
submission of test data that were
adopted in the final Phase II test rule or
modified in accordance with § 790.35 of
this part; or
(3) The testing has not been conducted
or the data have not been generated in
accordance with the Good Laboratory
Practice requirements in Part 792 of this
chapter.
(b) If EPA determines that one or more
of the criteria listed in paragraph (a) of
this section has been met, EPA will
notify each holder of an affected
conditional exemption by certified mail
or Federal Register notice of EPA's
intent to terminate that conditional
exemption.
(c) Within 30 days after receipt of a
letter of notification or publication of a
notice in the Federal Register that EPA
intends to terminate a conditional
exemption, the exemption holder may
submit information to rebut EPA's
preliminary decision or notify EPA by
letter of its intent to conduct the
required test.
(d)(l) The exemption holder may also
include a request for a hearing. Hearings
will be held in accordance with the
procedures set forth in § 790.97 of this
part.
(2] Hearing requests must be in
writing and must be received by EPA
within 30 days of receipt of the letter or
publication in the Federal Register
notice described in paragraph (b) of this
section.
(e) EPA will notify the exemption
holder by certified letter or by Federal
Register notice of EPA's final decision
concerning termination of conditional
exemptions.
§ 790.97 Hearing procedures.
(a) Hearing requests must be in
writing to EPA and must include the
applicant's basis for appealing EPA's
decision.
Jb) If more than one applicant has
requested a hearing on similar grounds,
all of those appeals will be considered
at the same hearing unless
confidentiality claims preclude a joint
hearing.
(c) EPA will notify each applicant of
EPA's decision within 60 days after the
hearing.
§ 790.99 Statement of financial
responsibility.
Each applicant for an exemption shall
submit the following sworn statement
with his application:
1 understand that if this application is
granted before the reimbursement period
described in section 4(c)(3)(B) of TSCA
expires, I must pay fair and equitable
reimbursement to the person or persons who
incurred or shared in the costs of complying
with the requirement to submit data and upon
whose data the granting of my application
was based.
|FR Doc. 84-28717 Filed 10-fMM; «:45 am|
BILLING CODE 65SO-50-M
-------
Enforcement Response
Policy for Test Rules. . .
-------
sssz,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
MEMORANDUM
SUBJECT:
FROM:
TO:
MAF 28 B86
OFrice OF
PESTICIDES AND TOXIC SUBSTANCE!
Enforcement Response Policy
for TSCA §4 Test Rules
I ^t* I
A. E. Conroy II, Director (^ / I
Office of Compliance Monitoring (EN-34y/
Addressees
Attached is the final Enforcement Response Policy (ERP) for
TSCA §4 Test Rules. This ERP addresses test rules only. A
separate ERP was issued by the Office of Compliance Monitoring
(OCM) on April 9, 1985 to address violations of the TSCA §4 Good
Laboratory Practices Rule which appears at 40 CFR Part 792. The.
interim final rule for test rules appears at 50 FR 20652 (May
17, 1985) and amends 40 CFR Part 790 which was published in the
Federal Register on October 10, 1984 (49 FR 39774).
Thank you for reviewing and commenting on the draft policy.
The comments and responses are attached for your information. If
you h-ave any questions concerning the ERP, please call Richard
Green of my staff at (FTS) 382-5567.
Attachments
-------
MAT 28 1966
ENFORCEMENT RESPONSE POLICY
FOR TEST RULES UNDER
SECTION 4 OF THE
TOXIC SUBSTANCES CONTROL ACT
OFFICE OF COMPLIANCE MONITORING
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
-------
ENFORCEMENT RESPONSE POLICY FOR TSCA §4 TEST RULES
PAGE
OVERVIEW ' 1
APPLICABILITY 1
LEVELS OF ACTION 1-2
NOTICES OF NONCOMPLIANCE 1-2
CIVIL PENALTIES 2
CRIMINAL SANCTIONS 2
ASSESSMENT OF CIVIL PENALTIES 2-7
GRAVITY BASED PENALTY MATRIX 3
NATURE 3
EXTENT 3
CIRCUMSTANCES . 4-5
CONTINUING VIOLATIONS 5-6
MULTIPLE VIOLATIONS 6-7
ADJUSTMENT FACTORS 7
Voluntary Disclosure 7
Immediate Voluntary Disclosure 7
Gains from Noncompliance 7
APPENDIX - Chart for Penalty Calculations
-------
TSCA SECTION 4 TEST RULES
ENFORCEMENT RESPONSE POLICY
OVERVIEW
Under section 4 of the Toxic Substances Control Act (TSCA),
EPA is authorized to promulgate rules which require that
selected chemical substances or mixtures be tested to evaluate
concerns for specific effects on human health or the environment.
The Agency shall promulgate a TSCA §4 test rule if it finds that
a) the substance or mixture may present an unreasonable risk of
injury to health or the environment or b) it enters or may enter
into the environment in substantial quantities or it poses or may
pose significant human exposure. EPA must also find that there
are insufficient data and experience to reasonably determine
health and environmental effects and that testing is necessary
to develop such data.
APPLICABILITY
Specific Chemical Substance and Mixture Test Rules (40 CFR
799) apply to persons who manufacture or intend to manufacture
(including import) and/or persons who process or intend to
process specific chemical substances or mixtures identified in
40 CFR 799, Subpart B during the period commencing with the
effective date of the specific test rule until the end of the
reimbursement period. Each set of testing requirements in
Subpart B specifies whether those requirements apply to
manufacturers, processors, or both. This policy does not address
violations which are associated with good laboratory practice
(GLP) requirements for these specific test rules. However, the
Office of Compliance Monitoring (OCM) issued a separate
enforcement response policy on April 9, 1985 to address GLP
vi olati ons.
LEVELS OF ACTION
NOTICES OF NONCOMPLIANCE (NON)
All notices of noncompliance will involve minor violations
of the TSCA §4 test rule which are not considered substantive.
An example would be the submission of a timely letter of
intent to conduct testing or a timely request for exemption from
testing for each required test but failure to provide all the
required information. However, the submitter provides the
additional information to the Office of Toxic Substances (OTS)
by a date acceptable to and specified by OTS.
-------
-2-
CIVIL PENALTIES
Assessment of civil penalties will be appropriate for most
violations -of a TSCA §4 test rule. Specific violations are
addressed in the ASSESSMENT OF CIVIL PENALTIES section under the
CIRCUMSTANCES subsection.
CRIMINAL SANCTIONS
In some instances, the magnitude of a particular violation
or the number of repeat offenses will warrant the use of criminal
sanctions under TSCA §16 or 18 U.S.C. 2 or 1001.
Several factors distinguish criminal cases from
administrative or civil actions. First, criminal sanctions will
ordinarily be limited to cases in which the violation is
accompanied by evidence of "guilty knowledge" or intent on the
part of the responsible party. TSCA imposes criminal penalties
only for violations of the Statute which are "knowingly or
willfully" committed. For example, criminal prosecution may be
appropriate where manufacturer or processor management personnel
make a decision to- violate the TSCA §4 test rule by falsifying
data or intentionally concealing data through omission or
selective reporting.
ASSESSMENT OF CfVIL PENALTIES
EPA will assess penalties against each manufacturer or
processor in violation of a TSCA §4 test rule. The following
Gravity-Based Civil Penalty (GBP) Matrix will be applied when
assessing civil penalties.
GRAVITY-BASED PENALTY MATRIX
Ci rcumstances
(probability of damages)
Extent
A
Major
of Potential Damage
B
Signi f icant
C
Mi nor
High Range:
1 $25,000 17,000 5,000
2 ...
Mid
Low
Range :
3
4
Range
5
6
15
10
5
2
,000
,000
,000
,000
10
6
3
1
,000
,000
,000
,300
1,500
1,000
500
200
-------
-3-
The following general criteria will be applied in making
Gravity Based Penalty determinations for violations of TSCA §4
test rules.
NATURE
All violations of TSCA §4 test rules will constitute "hazard
assessment" violations, as defined in the TSCA Civil Penalty
Policy (45 FR 59771, September 10, 1980).
EXTENT
The TSCA Civil Penalty Policy provides for three measures
of the extent of a violation: Major, Significant, and Minor.
Extent is used to take into consideration the degree, range, or
scope of the violation. The criteria are generally based upon
the disruption to an EPA review due to the increased time to
generate acceptable data. The following criteria will apply to
this considerati on:
A) Major - Studies requiring at least 90 days to perform.
Examples would include two-year bioassays and avian
reproduction tests.
B) Significant - Studies requiring at least 14 days but
less than 90 days to perform. Examples would include
a 21-day Daphnid chronic toxicity test and a 21 to 42
day hen acute delayed neurotoxicity test.
C) Minor - Studies requiring less than 14 days to perform.
Examples would include a 48-hour EC50 Daphnid acute
toxicity test and a rat oral LD50 test.
Note: The time periods are the time spent in the laboratory
exclusive of the time spent to write reports, analyze
data, etc.
CIRCUMSTANCES
The matrix retains five levels of the "Circumstances" axis.
The following criteria will apply to this consideration.
1) High Range (Level 1) - Violations which seriously impair
the Agency's ability to evaluate the hazards of chemicals.
Level 1 violations include the following categories:
Level 1
(1) Falsification of submitted data.
(2) Failure to test.
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-4-
•(3) Failure to complete required testing after making
a commitment to conduct testing.
(4) Failure to adhere to test standards or failure to
obtain written EPA approval on modifications to test
standards before effecting changes which results in an
OTS determination that the failure seriously impairs
the Agency's ability to evaluate the substance (GLP
violations addressed in a separate ERP).
(5) Failure to submit letter of intent to test or a valid
request for exemption from testing more than 60 days
after the letter of intent to test is required.
(6) Submitting a letter of intent to test or a valid
request for exemption from testing more than 60 days
after the letter of intent to test is required.
2) Middle Range (Levels 3 and 4) - Violations which impair
the Agency's ability to evaluate chemicals in an important
but less than critical way. Level 3 and 4 violations
include the following categories:
Level 3
(1) Completing a study but submitting it to EPA more than
30 days after the required date without having an EPA
written approved modification to the schedule.
(2) Failure to adhere to test standards or failure to
obtain written EPA approval on modifications to test
standards before effecting changes which results in an
OTS determination that the Agency's ability to evaluate
the substance is impaired in an important but less
than critical way.
(3) Failure to submit study plans or submitting study plans
more than 30 days after the required date taking into
consideration any extensions approved in writing by
EPA.
(4) Submitting letters of intent to test or submitting a
valid request for exemption from testing more than 30
but within 60 days after the letter of intent to test
is required.
Level 4
(1) Failure to submit or submitting interim progress
reports more than 30 days after the documents are
required.
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-5-
3) L'ow Range (Levels 5 and 6) - Violations which minimally
impair the Agency's ability to evaluate the hazards of a
chemical. Level 5 and 6 violations include the following
categories:
Level 5
(1) Completing a study and submitting it to EPA more than
15 but within 30 days after the required date but
without an EPA written approved modification to the
schedule.
(2) Submitting a letter of intent to test or valid request
for exemption from testing more than 15 but within 30
days after the letter of intent to test is required.
(3) Submitting study plans, interim progress reports or
submitting final reports more than 15 but within 30
days after the required date without an EPA written
approved modification to the schedule.
(4) Initiating a study after the date indicated in the
approved study plan without an EPA written approved
modification to the schedule but the final report is
submitted by the required date and accepted by EPA
(late initiated studies resulting in late final reports
shall be dealt with as late final reports or late study
submi ssions) .
(5) Failure to adhere to test standards or failure to
obtain written EPA approval on modifications to test
standards before effecting changes which results in an
OTS determination that the Agency's ability to evaluate
the substance is minimally impaired.
Level 6
(1) Categories 1, 2, and 3 described under Level 5 above
if submitted not more than 15 days after the required
date.
CONTINUING VIOLATIONS
Under section 16 of TSCA, EPA may assess penalties for each
day a violation continues. Per day assessments will apply when
the gravity of the violation warrants a higher penalty than can
be assessed through a single day penalty assessment.
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-6-
Continuing violations include the following categories
described in the CIRCUMSTANCES subsection of this ERP:
(1) Falsification of data.
(2) Failure to test.
(3) Failure to complete tests after making a commitment to
conduct testing.
(4) Failure to adhere to test standards, or failure to
obtain written EPA approval on modifications to test
standards before effecting changes which results in a
serious impairment or impairment in an important but
less than critical way of the Agency's ability to
evaluate the substance.
(5) Failure to submit or late submission of letters of
intent to test after required date.
(6) Failure to submit valid requests or submission of
invalid requests for exemption from testing after the
letter of intent to test is required.
The period of violation should apply from the date the
violative action begins to the date EPA grants a modification to
the standards or schedule. The number of days for the violation
shall be calculated based on the number of days a manufacturer
manufactures (imports); or when a processor is required to test,
the number of days a processor processes .a substance during the
entire violative period. When a person both processes and
manufactures during the violative period, the number of days
shall be based on the greater of the two (either processing or
manufacture only when the test rule requires manufacturers and .
processors to test. If the rule requires only the manufacturer
to test, then the violative period is based on the days of
manufacture. If a single batch is manufactured or processed in
more than one day, each batch shall be calculated as one day in
violation, except for continuous operations. Two or more batches
manufactured or processed in a single day at the same site shall
be calculated as one day in violation.
MULTIPLE VIOLATIONS
Multiple violations will apply to situations where a single
manufacturer or processor, or consortium commits to perform more
than one test required by a TSCA §4 test rule. Each test found
with violations shall warrant the assessment of a separate
penalty.
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-7-
Multiple violations include all of the categories described
in the CIRCUMSTANCES subsection of this ERP except for certain
instances involving failure to submit study plans. A multiple
violation situation shall not exist for study plans if they
address all r.equired tests under one test rule and are submitted
at the same time by one company or consortium.
ADJUSTMENT FACTORS
Once the GBP has been determined, upward and downward
adjustments to the penalty amount may be made in consideration
of culpability, history of violations, ability to pay, and such
other natters as justice may require. EPA will apply these
adjustment factors as described in the TSCA Civil Penalty Policy
(45 FR 59770, September 10, 1980.). Considerations unique to
TSCA §4 test rules are discussed below.
1. Voluntary Disclosure
Penalty reductions up to 25% will be applied for voluntary
disclosure of violations by manufacturers or processors subject
to a TSCA $4 rule. To be eligible, a manufacturer or processor
must make the disclosure prior to being notified of a pending
inspection and prior to EPA receiving any information relating .
to the alleged violation. This reduction may be made in
calculating the proposed penalty before issuing a civil
complaint. The complaint should state the original penalty, the
reduced penalty, and the reason for reduction. All other
reductions in the GBP should be made after the complaint is
i ssued .
2. Immediate Voluntary Disclosure
In cases where manufacturers or processors subject to a TSCA
§4 rule report potential violations to EPA within 30 days of
having reason to believe that they may have a violation,
additional penalty reductions up to 25% may be applied.
3. Gains from Noncompliance
Noncompliance with a TSCA §4 test rule may enable a person
to accrue significant economic gains, since the responsible
party may not expend the necessary funds to properly conduct
the required testing or to conduct the test at all. Gains may
also be realized because EPA does not regulate many substances
or mixtures until required testing is submitted and evaluated.
Therefore, the penalty policy specifies that violations likely
to result in economic gain result in level 1 penalty calculations
for each day the chemical is manufactured, processed or imported.
The extent category for level 1 violations depends on the type
of study, i.e., chronic, subchronic, or acute and is therefore
relative to the costs for such tests. In settling cases, the
Agency should assure that the final penalty is greater than the
economic gain.
-------
^^^ - Hazard Assessment only
I^BBMSTANCES
LEVEL 1 ^
*+ 1) Falsification of submitted data
*+ 2) Failure to test
*+ 3) Failure to complete required tests after making commitment to conduct testing
*+ 4) Failure to adhere to test standard- ir failure to obtain writtr" EPA approval on
modifications to test standards befim: whit; ults in an OTS
determination that the Agency's ability .ubstain.e Is seriously impaired
*+ 5) Failure to submit letter of Intent to test or a vo,.u i equest for exemption from
testing more than 60 days after the letter of Intent to test 1s required
*+ 6) Submitting a letter of Intent to test more than 60 days after the required date
+ 7) Submitting a valid request for exemption more than 60 days after the letter of Intent
to test Is required
LEVEl 2
Level 3
+ 1) Completing a study but falling to submit it to EPA more than 30 days after the
required date without having an approved modification to the schedule
+ 2) Failure to adhere to test standards or failure to obtain written EPA approval on
modifications to test standards before effecting changes which results in an OTS
determination that the Agency's ability to evaluate the substance 1s impaired in
an Important but less than critical way
3) Failure to submit study plans**or submitting study plans more than 30 days after the
required date taking into consideration any extensions approved 1n writing by EPA
+* 4) Submitting a letter of Intent to test more than 30 but within 60 days after the
requi red date
+ 5) Submitting a valid request for exemption from testing more than 30 but within 60 days
after the letter of intent to test Is required
LEVEL 4
+ 1) Failure to submit or submitting Interim progress reports more than 30 days after the
documents are required
LEVEL 5
+ 1) Completing a study and submitting it to EPA more than 15 days but within 30
days after the required date but without an approved modification to the schedule
*+ 2) Submitting a letter of intent to test more than 15 but within 30 days after the
required date
+ 3) Submitting a valid request for exemption from testing more than 15 but within 30 days
after the letter of Intent to test Is required
+ 4) Submitting study plans**, Interim progress reports or submitting final reports more
than 15 days but within 30 days after the required date without an EPA written
approved modification to the schedule
5) Initiating a study after the date Indicated in the approved study plan without an
EPA written approved modification to the schedule but the final report Is submitted
by the requi red date and accepted by EPA
6) Failure to adhere to test standards or failure to obtain written EPA approval on
modifications to test standards before effecting changes which results in an OTS
determination that the Agency's ability to evaluate the substance Is minimally Impaired
LEVtL 6
+ 1) Same as numbers 1, 2*, 3, or 4 under level 5 violations except submitted within 15 days
after the required date
EXTENT C
MAJOR
$25,000
-
$15,000
$10,000
$ 5.000
$ 2.000
)F POTENTM
SlGNff-ICAlP
'
$17,000
1
$10,000
$ 6,000
$ 3,000
$ 1.300
• MARE
PWNOR
r
$5,000
-
$1 ,500
$1,000
$ 500
$ 200
** A multiple violation situation shall not exist if study plans to address all required tests are
One tp«;t mlp hv one cnmoanv or consortium
-------
Polyhalogenated Dibenzo-p-
Dioxins/Dibenzofurans: Testin
-------
Friday
June 5, 1987
Part II
g?
•stf
Environmental
Protection Agency
40 CFR Parts 707 and 766
Polyhalogenated Dibenzo-p-Dioxins/
Dibenzofurans; Testing and Reporting
Requirements; Final Rule
•1
p
-------
21412 Federal Register / Vol. 52. No. 108 / Friday, |unc 5, 190" / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 707 and 766
[OPTS-83002C; FRL-3212-11
Polyhalogenated Dibenzo-p-Dioxins/
Dibenzofurans; Testing and Reporting
Requirements
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This document promulgates
regulations under sections 4 and 8 of the
Toxic Substances Control Act (TSCA).
15 U.S.C. 2603 and 2607 for certain
chemicals which may be contaminated
with certain chlorinated and brominated
dibenzo-p-dioxins (HDDs) and
dibenzofurans (HDFs). HMDs and HDFs
have been recognized as having
potential public health and
environmental significance because of
their potential for industrial toxic effect
at very low doses. The regulations
promulgated under this document
require analytical testing for certain
chemicals for HDD/HDF contamination.
submission of existing test data on
contamination of these chemicals with
HDDs/HDFs, submission of health and
safety studies on HDDs/HDFs, and
submission of worker allegations of
significant adverse reactions to HDDs/
HDFs. A summary of the requirements
of this rule is set forth under
SUPPLEMENTARY INFORMATION, below.
DATES: In accordance with 40 CFR 23.5.
this rule shall be promulgated for
purposes of judicial review at 1 p.m.
eastern standard time on June 19,1987.
This rule shall be effective on July 6,
1987.
FURTHER INFORMATION CONTACT:
Edward A. Klein, Director, TSCA
Assistance Office (TS-799), Office of
Toxic Substances, Environmental
Protection Agency, Rm. E-543, 401 M
Street SW.. Washington, DC 20460,
Telephone: (202-554-1404).
SUPPLEMENTARY INFORMATION: This rule
requires manufacturers and importers of
12 organic chemicals to test their
chemicals for the presence of certain
chlorinated and brominated dibenzo-p-
dioxins and dibenzofurans. This testing
will also be required for 20 additional
organic chemicals not currently
manufactured or imported in the United
States if their manufacture or
importation should resume. -
Manufacturers, importers, and
processors of the 12 chemicals must also
submit existing test data on
contamination of these chemicals with
HDDs or HDFs, health and safety
studies on HDDs/HDFs, and consumer
or worker allegations of significant
adverse reactions to HDDs/HDFs; the
same information on the 20 additional
chemicals is required should
manufacture or importation resume.
If either the testing required under this
rule, or the existing test data on
contamination submitted under this rule
show that any of these chemicals
contain any HDDs/HDFs in
concentrations above the Levels of
Quantitation (LOQ) designated in this
rule, the manufacturers and/or
importers must submit the following
information with respect to the
chemicals: (1) Production volume,
process, use. exposure, and disposal
data: (2) unpublished health and safety
studies, and (3) records of allegations of
significant adverse reactions.
This rule also requires the submission
of process and reaction condition data
by importers and manufacturers of
chemical substances made from any of
29 precursor chemicals to determine
whether there is a need for dioxin and
furan testing of the chemical substances
made from these precursor chemicals.
If testing of a chemical under this rule
shows the chemical does not contain
HDDs/HDFs, this rule provides for
termination of export notification
normally required under section 12(b) of
TSCA, 15 U.S.C. 2611(b), for a chemical
subject to section 4 test rules.
I. Organization of this Final Rule
This is a final rule issued after
consideration of comments submitted in
response to a proposed rule published in
the Federal Register of December 19,
1985 (50 FR 51794), an amendment to the
proposed rule published in the Federal
Register of October 23,1986 (51 FR
37612), and all relevant information
submitted to or otherwise obtained by
EPA.
The preamble to this final rule begins
with the historical background (Unit II),
and continues with a short summary of
changes from the provisions proposed
(Unit III). Unit IV discusses findings and
considerations under section 4 of TSCA:
Unit V discusses costs of testing and
reporting: and Unit VI discusses the
availability of testing facilities and
personnel to perform the proposed
testing. Unit VII discusses EPA's
rationale for issuing information
gathering rules under section 8 of TSCA.
Unit VIII discusses the relationship of
this rule to export notification
requirements under section 12(b) of
TSCA; Unit IX discusses compliance
and enforcement; Unit X describes the
rulemaking record: and Unit XI lists
references used by EPA in preparing this
rule. Requirements EPA must meet
under other authorities before it may
issue a rule are discussed in Unit XII.
II. Background
A. Regulation of HDDs/HDFs
EPA has long recognized the potential
public health and environmental
significance of 2,3,7,8-
tetrachlorodibenzo-p-dioxin (2,3,7,8-
TCDD). 2,3,7,8-TCDD exhibits delayed
biological response in many species and
is lethal at exceptionally low doses to
aquatic organisms, birds, and some
mammals. It has been shown to be
carcinogenic, teratogenic, fetotoxic. and
acnegenic. In addition. 2,3.7,8-TCDD has
been shown to adversely affect the
immune response in mammals. EPA also
recognizes the potential health
significance of a variety of tetra- through
hepta-halogenated dibenzo-p-dioxins
and dibenzofurans (HDDs and HDFs)
that are structurally related to 2.3,7,8-
TCDD in that they are chlorinated or
brominated at the 2,3,7 and 8 positions
on the molecular structure (Refs. 5 and
15). Limited in vivo and in vitro data
support the structure-activity based
argument that laterally substituted
2,3,7,8-HDDs/HDFs share qualitative
toxicity properties with 2,3,7,8-TCDD.
There is also evidence that 2,3,7,8-
TCDD. some of the other HDDs/HDFs
and by implication the remainder of til
HDDs/HDFs may be hazardous to
human health and the environment at
low levels. These 2,3,7,8-substituted
tetra- through hepta- dibenzo-p-dioxins
and dibenzofurans, as well as 2.3,7,8-
TCDD. are the subjects of this
rulemaking. Hereafter, unless otherwise
stated, this document will refer to tetra-
through hepta- chlorinated and
brominated dioxins and dibenzofurans
substituted at the 2,3.7 and 8 positions
as a group by using the term "HDDs/
HDFs." The 2,3,7,8-HDDs/HDFs have
been measured in a number of
commercial chemicals (Ref. 43). EPA has
reason to believe that they also appear
in a number of other commercial
chemicals which are structurally similar
to those in which HDDs/HDFs have
been measured, and are manufactured
under conditions favorable to HDD/
HDF formation.
EPA's National Dioxin Strategy (Ref.
32), issued in December 1983. offers a
comprehensive overview of EPA's past,
present, and planned activities in this
area. EPA's past regulatory efforts on
HDDs/HDFs focused on a number of
products and processes that could
generate HDDs and HDFs or could
otherwise lead to human or
environmental exposure to these
substances. These activities were
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Federal Register / Vol. 52. No. 108 / Friday, June 5. 1037 / Rules and Regulations
21413
in the preamble to the proposed rule
nder Unit I. Since that time EPA has
the following additional actions:
A final agreement between EPA and
manufacturers of wood preserving
products containing pentachlorophenol,
subject to regulation under the Federal
Insecticide. Fungicide, and Rodenticide
Act (FIFRA) was reached regarding
analysis and maximum permissible
limits in pentachlorophenol for HDDs;
(2) treatment standards under the
Resource Conservation and Recovery
Act (RCRA) for dioxin-containing
hazardous waste were proposed January
14,1986 (51 FR 1602), and promulgated
November 7.1986 (51 FR 40572, 40615);
(3) cancellation of the dioxin-
contaminated herbicides 2,4,5-Tand
silvex were completed in February 1985;
(4) a notice of intent to cancel most non-
wood preservative registrations of
pentachlorophenol was published on
January 21.1987 (52 FR 2282); (5) a
Dioxin Update Committee (Ref. 40) of
scientific experts was convened to
determine their views in the areas of
human health effects, immunotoxicity,
bioavailability, mechanism of action
and appropriate risk assessment
procedures for 2,3,7,8-TCDD; and (6) a
favorable review was issued by the
Science Advisory Board of the
Bplication of Toxicity Equivalency
Hctors developed by Drs. Barnes and
Kllin to estimate the toxicity of
congeners of HDDs/HDFs other than
2.3.7,8-TCDD (Ref. 35). In addition, the
following regulatory activities are
underway within EPA to control or
eliminate potential human or
environmental exposure to HDDs/HDFs:
RCRA listing of HDDs/HDFs as "acutely
hazardous" wastes; RCRA land ban
disposal rule; evaluation of waste
streams from pentachlorophenol wood
treaters; municipal waste combustion
guidelines and evaluation of ash
residues from municipal combustion;
establishment of National Pollutant
Discharge Effluent Standards (NPDES)
discharge limits, and numerous
Supcrfund site cleanup activities.
B. Background to This Final Rule
On October 22,1984, the
Environmental Defense Fund and the
National Wildlife Federation filed a
citizens' petition under section 21 of
TSCA, 15 U.S.C. 2620. The petition (Ref.
14) requested that EPA commence
certain regulatory actions related to
certain HDDs and HDFs and initiate
related investigations and research.
More specifically, the petitioners
ked EPA to use its authority under
, to analyze aggregate hazards
Id by multi-media releases of the
Tcific HDDs/HDFs subject to this rule
(those substituted at the 2.3,7 and 8
positions on the benzene rings) and to
take action under TSCA to commence
an integrated, multi-media effort to
reduce the risks from the release of
these chemicals.
Although the petitioners
acknowledged that EPA in its Dioxin
Strategy (Ref. 32) has recognized the
need for a multi-media approach in
cleaning up contamination, they believe
that EPA has not taken sufficient action
to prevent future contamination from the
continued generation of HDDs and
HDFs as contaminants during the
manufacture of other chemicals and
materials. The petitioners requested that
EPA take a number of specific
regulatory and information-gathering
steps under TSCA to regulate the
HDDs/HDFs generically, as a class of
chemicals.
EPA decided that, in general, it would
deny the request to regulate the
specified HDDs/HDFs under a multi-
media TSCA approach for two reasons:
(1) The Agency was already proceeding
to gather extensive data and initiate
regulation under other, more appropriate
statutes, and (2) EPA did not have the
data needed to make a finding of
unreasonable risk under section 6 of
TSCA, the provision of the Act that
authorizes substantive regulation of
chemicals. EPA did decide, however, to
grant part of the petition and on
December 19,1985 (50 FR 51794)
proposed this rulemaking under sections
4 and 8 of TSCA to gather additional
information on HDDs/HDFs in
commercial chemicals. EPA will review
the data submitted as a result of this
rule to decide whether additional
regulatory action under section 6 of
TSCA is warranted to limit or control
the further manufacture, processing,
distribution in commerce, and/or use of
chemicals contaminated with HDDs/
HDFs.
EPA received 13 comments to the
proposed rule during the public
comment period, which closed on
February 18,1986. On March 4,1986,
EPA held a public hearing in
Washington, DC where three
organizations presented testimony. A
transcript of this meeting is in the public
docket file for this rule. EPA also held a
meeting closed to the public on March 4,
1986, at the request of Great Lakes
Chemical Co. (Great Lakes), to receive
confidential business information (CBI)
from Great Lakes and to request
additional CBI on listed chemicals
manufactured by the company. A
transcript of the meeting and a copy of
letters in which EPA requested specific
data are included in the rulemaking
record for this rule. A second public
meeting ivas held April 22, 1980. in
Washington. DC, at the request of the
Chemical Manufacturers' Association
(CMA), to allow CMA to present the
Agency with a proposal for an
alternative procedure for collecting the
needed data. This procedure and EPA's
evaluation of it are discussed under Unit
IV of this preamble.
As a result of comments made at
these meetings and other information
received by EPA, the Agency amended
the proposed rule and solicited public
views and data on whether to collect
process and reaction condition data on
18 additional chlorinated and
brominated benzenes under section 8(a)
of TSCA (51 FR 37612, October 23,1986).
The Agency received five comments to
that proposed amendment and responds
to those comments in appropriate
sections of this preamble.
Also in response to comments, EPA
has amended 40 CFR Part 707 to provide
for termination of reporting for export
purposes under section 12(b) of TSCA
when testing shows no contamination of
a chemical by HDDs/HDFs above the
LOQs.
EPA has considered all the comments
received and other relevant information
obtained by the Agency, and has
modified other parts of the rule
appropriately. The comments are
addressed under the appropriate
sections of this preamble.
EPA believes that production,
processing, distribution, use. and
disposal of the listed chemicals may
present an unreasonable risk of injury to
human health and the environment
because of their potential for
contamination by chlorinated and
brominated dibenzo-p-dioxins and
dibenzofurans. EPA believes these
contaminants may present a health risk
at very low levels, down to 0.1 part per
billion (ppb) for 2,3.7.8-TCDD, the most
toxic congener, and for 2,3,7.8-
tetrabromodibenzo-p-dioxin (TBDD),
believed to be equally as toxic.
Therefore, this target level of
quantitation has been set for 2.3.7,8-
TCDD and 2,3,7,8-TBDD, with higher
levels for the remaining congeners
based on toxicity equivalent to that of
2,3,7.8-TCDD. These levels are targets,
and EPA expects testing laboratories to
make a good faith effort to reach these
targets. EPA's Director of the Office of
Toxic Substances (OTS) will determine
whether good faith efforts are made,
advised by a panel of experts in
analytical chemistry convened by EPA.
In cases where good faith efforts are
made. EPA will accept results higher
than the target LOQs. EPA also believes
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21414
Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations
th;il the differences in cost to test for
I ID.Ds/HDF at 0.1 ppb or 10 ppb or even
100 ppb are very small because the
major part of the cost of testing is
incurred by separation of matrix and
clean-up of sample, and this cost will be
approximately the same for these levels.
III. Comparison of Proposed and Final
Rule
A. Testing Requirements Under Section
4
Under section 4 of TSCA, explained in
the proposed rule under Unit II.B.. EPA
proposed to require testing of 14
currently manufactured or imported
chemicals and 20 chemicals not
currently manufactured or imported. In
this rule, EPA is requiring testing for
HDD/HDF contamination of 12 currently
manufactured or imported chemicals,
and 20 chemicals not currently
manufactured or imported if their
manufacture or importation resumes.
The two chemicals removed from the list
are 2,4-Dichlorophenoxyacetic acid and
2,4-Dichlorophenoxybutyric acid.
chemicals which are both pesticides and
pesticide intermediates. Contamination
of these two chemicals by HDDs/HDFs
will be determined by a Data Call-In
Program conducted under FIFRA. The 12
chemicals, which are subject to testing
as of the promulgation date of this rule.
are listed below with their Chemical
Abstract Services (CAS] registry
numbers.
CAS No.
I
Chemical name
CAS No.
79-94-7
118-75-2
118-79-6
120-83-2
1163-19-5
1162-45-2
21850-44-2
25327-89-3
32534-61-9
32536-52-0
37853-59-1
55205-38-4
Chemical name
Tetrabromobisphenol-A.
2.3.5.6-Tetractiloro-2.5-cydohexadien«-1.4.
dione.
2.4.6-Tribromophenol.
2.4-DicMofopheool.
Oecabrocnodiphenytoiide.
Teuatxomo6isphenot-A.oisettxwylate
TetrabfomobisphenoJ-A.t}is*2.3-
dibromopropylether.
Allyl emer of letrabnxnoOisphenol-A
Pentabromodipheny1o«ide.
Octabiomodipnenyloxida.
1,2-Bis-ethane.
TetrabfomoOisphenoi-A diactylale.
(EPA has assumed that a chemical is
currently manufactured if it was
manufactured since January 1,1984.)
The 20 chemicals, which will be
subject to testing after their manufacture
or importation resumes, are listed
below.
CAS No.
79-95-a
87-10-5
87-65-0
95-77-2
95-95-4
99-28-5
120-36-5
320-72-9
488-47-1
Chemical name
Tetract*xotJispHeno»-A.
3,4.5-f ritoromosalicrianKJe.
2.6 OictilotopOenol
3.4-Oeftkxophanol.
2.4.5-TnctWxopnanol.
2.6-Oibromo-4-oitTOphenol.
2[2.4-cM
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Federal Register / Vol. 52. No. 108 / Friday, June 5, 1987 / Rules and Regulations
21415
of pesticide products, 2.4-
Dichlorophenoxyacetic acid and 2,4-
Dichlorophenoxybutyric acid, were
deleted from the list of chemicals to be
tested. LOQs were modified to take into
account Toxic Equivalency Factors
(TEFs) developed by EPA for the
different HDD/HDF congeners. The
timeframes for submission of protocols
and test results have been modified.
QA/QC requirements have been
adjusted. Testing for one chemical
manufactured by Dow Chemical
Company (Dow) has been excluded as a
result of comments submitted on the
proposed rule. The rule provides
procedures whereby companies may
present to EPA information that may
convince the Agency to exclude their
chemicals from testing or waive the
testing requirements.
Finally, the regulations under TSCA
section 12(b) have been amended to
provide termination of reporting for
export purposes when data have been
submitted showing no HDDs/HDFs
present above the LOQs. These changes
and the reasons therefor are discussed
in the appropriate places later in this
preamble.
B. Reporting Requirements Under
Section 8
Under section 8(a) of TSCA, EPA may
require chemical manufacturers and
processors to maintain such records and
submit such reports as the Agency may
reasonably require. EPA has determined
that certain chemical manufacturers
must submit information to assist the
Agency in evaluating the risk from
chemicals potentially contaminated with
HDDs/HDFs. The data required to be
submitted under section 8 will be used
to complete a comprehensive overview
of uses, exposures, risks, and
advantages of chemicals containing or
potentially containing the HDDs/HDFs
so that EPA may assess the need for and
nature of future regulatory control
measures.
This rule requires manufacturers
(including importers) and processors of
the 12 chemicals listed for testing to
submit, 90 days after the effective date
of this rule, any available test results.
with necessary protocols, which show
the results of any existing testing of their
chemicals for concentrations of HDDs/
HDFs. These test data may also be used
to support an exclusion from testing.
Persons who manufacture or import any
of the 20 chemicals not currently in
production must submit this information
within 90 days of the resumption of
manufacture or importation.
The manufacturers, importers, and
processors of the 12 chemicals must also
submit, under section 8(c) of TSCA.
allegations in their possession of
significant adverse reactions to HDDs/
HDFs and. under section 8(d) of TSCA.
any unpublished health and safety
studies they may have on HDDs/HDFs.
This information must be submitted to
EPA within 90 days from the effective
date of this rule, or 90 days after the
person begins manufacture or import.
whichever is later.
In addition, should the testing
conducted under this rule or the existing
test data submitted under section 8 of
TSCA show that particular chemicals
contain HDDs/HDFs above the
designated LOQs, the manufacturers
(including importers) of those particular
chemicals must submit, under section
8(a), production volume, process and
reaction conditions, exposure, use and
disposal data as specified on EPA Form
7710-51. Submitters may request copies
of the form from the TSCA Assistance
Office, or submit the data required by
the form. In addition, these
manufacturers and importers must then
submit, under section 8(c) of TSCA,
records of alleged adverse reactions to
the tested chemicals, and, under section
8(d) of TSCA. unpublished health and
safety studies on the tested chemicals.
This section 8(a), (c). and (d)
information must be submitted 90 days
after the submission of a positive test
result as defined at § 766.3.
If testing data from this rule show that
for a particular chemical some
manufacturers report HDDs/HDFs
significantly above the designated LOQs
and others show no contamination, EPA
may require through publication of a
notice in the Federal Register, that all
manufacturers and importers of that
chemical submit process and reaction
condition data. This means that
manufacturers who have reported no
contamination may be required to
supply data.
Finally, under section 8(a) of TSCA,
manufacturers (except small
manufacturers) of chemicals using any
of certain listed precursor chemicals as
feedstocks or intermediates must submit
data on manufacturing process and
reaction conditions for the chemicals
they manufacture using these
precursors. These precursor chemicals
are not themselves contaminated, but
can. during further processing and under
certain reaction conditions, lead to
formation of HDDs/HDFs in other
chemicals. Should EPA learn from this
data gathering process that reaction
conditions favorable to HDD/HDF
formation exist, EPA may propose
additional chemicals for testing.
The original December 1985 proposal
listed 12 precursor chemicals. After
considering comments, however, EPA
amended the proposal and opened a
comment period to accept comments on
the addition of 18 chlorinated and
brominated benzenes to the list of
precursor chemicals.
One of these 18 added chemicals,
pentachloronitrobenzene (PCNB), was
removed from the list after comments
received in response to the proposed
amendment showed that this chemical is
not currently manufactured in the U.S.,
is imported only for use as a registered
active ingredient (pesticide use only),
and as such is regulated under FIFRA.
All details concerning manufacturing
process, intermediates, reactions and
product chemistry for this chemical have
been submitted to EPA as required
under FIFRA's special Data Call-In letter
of May 8,1985. Because this chemical is
not subject to TSCA jurisdiction at this
time, it has been deleted. Should EPA
receive information indicating that
PCNB manufacture or importation
resumes for non-pesticidal uses subject
to jurisdiction under TSCA. this
chemical may again be added to the list
of precursors subject to the reporting
requirements outlined above. This final
rule thus incorporates all 29 chemicals
into the precursor list.
The complete list of the 29 precursor
chemicals appears below.
CAS No.
85-22-3
87-61-6
87-84-3
69-61-2
89-64-5
89-69-0
92-04-6
94-74-€
94-81-5
95-50-1
95-56-7
95-57-8
95-88-5
95-94-3
97-50-7
99-30-9
99-54-7
106-37-6
106-46-7
108-70-3
108-86-1
108-90-7
117-18-0
120-82-1
348-51-6
350-30-1
615-67-8
626-39-1
827-94-1
Chemical name
PentabromoemytBenzeoe.
1,2,3-Tncnkxooeniena.
1.2.3.4.5, Pentalxomoe-chkxocyclohexane.
t .4-Oicf*xo-2-nitrobenzene.
2,4.5-Tricftloronrtrobenzene.
2-CWoro-4-phenytpfienol.
j 4-Oloro-o-lolo
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21416 FedtraJ Register / Vol. 52. No. 106 / Friday. June 5. 1987 / Rules and Regulations
other than process and reaction
condition! hava been •liminatad That*
changes and the reasons thtrtfor art
discussed in the appropriate placet in
this preamble.
IV. Findings and Consideratioas
A. Findings Under Section 4(a)
Section 4 of TSCA suthorizes EPA to
require, by rule, that chemical
manufacturers or processors conduct
tests to develop data relevant to the
determination that the chemicals do or
do not present an unreasonable risk of
injury to health or the environment EPA
must make a number of findings before
it may issue a section 4 rule. Under
section 4(a)(l)(A). EPA must find that a
chemical may present an unreasonable
risk of injury to health or the
environment, that there art insufficient
data and experience upon which the
effects of activities involving the
chemical can reasonably be determined
or predicted, and that testing of the
chemical is necesasary to develop such
data.
EPA makes four findings under
section 4(a)(1)fA) of TSCA with respect
to the 32 chemicals listed in this final
rule. First. EPA finds that these
chemicals may present an unreasonable
risk of injury to health or the
environment because they may be
contaminated with HDOs/HDPs. which
may be highly toxic even at trace levels.
Second. EPA Finds that there are
insufficient data upon which the effects
of these chemicals on health or the
environment could reasonably be
determined because EPA has very little
data on whether there is any HDD/HDP
contamination and. if so, the levels of
such contamination. Third. EPA finds
(hat analytical testing is necessary to
develop data on HOD/HDP contaminant
levels because such testing is the only
way to determine conclusively whether
and at what levels HDDs/HDPs art
present. Fourth. EPA finds that thia
analytical testing is relevant to
determining whether activities involving
the 32 substances do or do not pnttat
an unreasonable risk. Further, EPA fladt
that the cost of testing for the [
of these contaminanta at the levels
proposed by EPA is reasonsble given
the potentially highly toxic nature of
these HDOs/HDFs.
In support of these findings. EPA
adopts the analysis set forth in the
preamble to the proposed rule under
Unit IV.A. and V.. modified aa discussed
below. These modifications were made
as a result of consideration of comments
and other relevant information. Below.
EPA discusses the comments received
on its proposed findings, and the
Agency's response. Discussion of each
comment also contains a reference to
the ptnon(s) who submitted it
1. EPA 'i legal authority to require
analytic totting under lection 4 of
TSCA—Comment 1: EPA lacks legal
authority under section 4 of TSCA to
require analytical testing for impurities
in chemicals. Section 4 does not
explicitly refer to testing for
contamination, but rather limits EPA to
requiring testing on "health and
environmental effects." Section
4{b)(2)(A) describes the -effects" and
"characteristics" for which testing is
permitted and does not mention tests for
contamination. This position is
supported by the legislative history. Aa
early Senate version of TSCA (S. 776
(1973)) contained specific language
allowing contaminant testing. That
language waa left out of the final version
of TSCA, thus indicating that Congress
did not intend to allow contaminant
testing under section 4. (CMA pp. 8-9;
Vulcan p. 1).
Retponie to Comment 1: EPA
disagrees with this narrow reading of
TSCA. EPA interprets section 4 to allow
the testing of chemicals to obtain data
relevant to a determination of
unreasonable risk. These data include
the types of information which would be
generated by testing under the proposed
rule. EPA rejects the position taken by
these eommenters. which would hmit
section 4 to toxitity testing, rather than
"effects" testing.
Section 4(a) provides that EPA. after
making certain findings, may require
testing of a chemical—
to develop data... which are relevant to a
determination that... (the chemical) does or
does not present MI unreasonable risk of
injury to health or the environment
Section 4
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Federal Register./ Vol. 52. No. 106 / Friday. |une 5. 1967 / Rules and Regulations
211V
history for the deletion of the
"magnitude of expoturt" language.
EPA vicwt the latjUlative history at
supportive, of itt paeitian. Both S. TTtt
•nd the final venioa of TSCA Indians
an intention thai "rtlayant" facton be
tested. Then it an additional parallnl
between the two versions, indicating
they both refer to the tame typ«t of
letting. S. 778 refert to factors relevant
to health effects and magnitude of
expoaure; TSCA refers to factors
relevant to "unreasonable risk." Plainly.
unreasonable rlak includes element! of
toxicity and expoaure.
CMA't interpretation of the legislative
history, regardless of the effect of
deleting the "magnitude of exposure"
language, dots not affect this rule.
Contaminant testing, at noted above, is
"effects" testing.
2. Comment* en SPA 'i approach to
this rule—Comment £ Before requiring
testing under section 4 of TSCA on
HDDs/HDFt, EPA should oat TSCA
section 8(a) authority to collect
extensive exposure data, specifically
information on production, process, use.
and dispoeal. Only then can EPA
determine whether there may be an
unreasonable risk requiring testing
under section 4(a). This approach
(collecting section 8(a) information
before proposing section 4 testing rules)
is the Agency's standard approach to
responding to recommendations for
testing chemicals made by the
Interagency Testing Committee (ITC1
under section 4(e) of TSCA. The Agency
could use the SNUR provision to gather
information on the chemicals. (CMA at
pp. 2-4: Dow at p. 2: Great Lakes at p. 2:
pp. 3/4 in comments to proposed
amendment adding additional precursor
chemicals).
Retponte to Comment £ EPA
disagrees with this comment The
amount of exposure information needed
to test under section 4 of TSCA. which
requires a finding that a chaakai "may"
present an unreasonable riak. need not
be at extensive aa dint needed to
regulate under section 8 of TSCA. which
requires a finding that a *H"**"«i "will"
present an unreasonable riak. The
comments confuee the type of
information and level of detail needed to
issue a section 4 testing rule with
information needed to issue
requirements under section 8 of TSCA.
Furthermore, when EPA has
information, as it doea for HDDs/HDFs,
that a chemical may be highly toxic at
very low levels, the amount-of exposure
data needed to make a section 4(a)
Finding may be even lesa definitive. For
HDDs/HDFs the major uncertainties are
their presence and levels of
concentration in commercial chemicals.
If HDDs/HDFs are present even at low
levels, the toxicity of that chemical may
be high baaed on the impurity.
In addition. EPA believes that it
would be counterproductive to obtain
section 8(a) expoaure data on chemkala
potentially contaminated with HDDs/
HDFi if testing shows that these
contaminant* are in fact not present
This would alto delay the Agency's
ability to concentrate its attention on
those chemicals contaminated and to
determine whether regulation to reduce
exposure is necessary. Only if
contamination it present above the
LOQs will EPA collect the detailed
process, reaction condition, production.
use. expoaure. and dispoeal date to
determine whether the chemical does in
fact present an unreasonable riak of
harm to human health or the
environment
Finally. EPA disagrees with the
suggestion that instead of section 4
testing rules. SNURa under section S(a)
of TSCA should be used to gather
information on particular uses of the
chemicals subject to this rule. EPA
believes d» logic behind this comment
is ravened. Doing a SNUR befon testing
these chemicals would only prolong the.
regulatory process unnecessarily. The- '
Agency should Brat gather general
information on HDD/HDP levels in the
manufactured chemical and then
consider whedMr particular downstream
uses should be subject to regulatory
requirements. At thai point EPA could
decide such ieauea aa whether potential
downstream utea should be subject to
SNURs or whether substantive
regulatory requirements under section 6
of TSCA should be promulgated.
Further, gadtering information on
specific ueea first would be
counterproductive, since it la a useless
exercise to promulgate a SNUR it in
fact HDOe/HDFs are not present in die
manufactured chemical Finally, a SNUR
could not be used to obtain information
on ongoing use*.
Comment i EPA must establish an
expotun pattern for each chemical to be
tested. (CMA at pp. 2 and 4).
Retponse to Comment Jr EPA does not
agree. At noted above, information
required to make a section 4(a)
unreasonable riak finding it not aa
extensive at that required to regulate
under TSCA section A. Furthermore.
under section 28 of TSCA EPA it
authorised to take action under the Act
with respect to categories of chemicals.
Categories of chemicals include groups
that an similar in molecular structure.
in physical, chemical or biological
properties, in mode of entrance into the
human body or into the environment or
in some other way suitable for
. classification. The chemicals lubiect to
this rule all have the possibility of being
contaminated with HDDs/HDFs based
oo chemical structure, known pathways
to contamination, and manufacturing
conditiona which an conducive to the
formation of HDDs/HDFs. The HDDs/
HDFs an alto suitable for
categorisation alto because, as
discussed more fully in the preamble of
the proposed rule snd elsewhere in this
preamble. HDDs/HDFs are structurally
similar, certain of the HDDs/HDFs ire
highly toxic even at low exposure levels.
then an numerous important physical/
chemical similarities between the
HDDs/HDFs and these physical
similarities have been related to the
induction of toxic effects. Thus. EPA is
justified in considering these chemicals
as a class for section 4 testing purposes
EPA believes there is potential for
human expotun to each of the 32
chemicals when they are manufactured.
processed, distributed in commerce.
used or disposed of at the levels of
concern stated in this rule.
Comment 4: In order to set analytic
targets for impurity analysis (LOQs).
EPA mutt collect txposure data on each
individual chemical using section 8(a) of
TSCA. (CMA at pp. 3 and 4:/p. 4 in
comments to proposed amendment
adding precursors).
Responte to Comment 4: EPA
disagrees. As with the comments
discussed above, this comment confuses
the data needed to determine a level at
which testing will be required with the
"action" level at which regulation may
be imposed under section 0 of TSCA.
The preamble to the proposed rule made
this distinction clear (SO FR 31800
(column 2)). EPA indicated that any
action level would be derived for each
individual chemical based on its
contamination levels and its potential
for exposure, and taking into account
cost of testing snd benefit to society
resulting from information generated by
such testing. For testing purposes the
Agency chose levels that could possibly
present risks of concern, using generic
exposure scenarios, choosing the worst
cases to ensure that EPA has adequate
data to evaluate any potential risk
resulting from low levels of all 7 HDDs
and 8 HDFs occurring in a single
chemical Thus, the Agency can catch in
itt analytical net any use that could
potentially cause unreasonable risk.
Comment £; EPA hat adequate
information under TSCA not only to
require testing under section 4. but also
has all date needed to regulate the
chemicals immediately under section 6.
and should do so. (EDF p. 2).
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21418 Federal Register / Vol. 52.-No. 108 / Friday. June 5. 1987 / Rules and Regulations
Response to Comment 5; EPA
disagrees. EPA lacks Important data
required to make the finding of
unreasonable htk required by section 8,
as detailed to iti response to tho EOF/
SWF Petition at SO FR 4428 (January 30,
1965). EPA hii determined that It can
find that the listed chemicals may
present an unreasonable risk, as
required by section 4 of TSCA. and
therefore can gather the data needed to
determine whether these chemicals
present an unreasonable risk and
whether regulation of these chemicals
under section 0 of TSCA it appropriate
Comment & EPA has not
demonstrated that reduction* below at
ppb are feasible for all HDDs and 1.0
ppb for all HDFs. EPA only referenced
Dow Chemical Company's studies of
2.3.7.8-TCDD reductions during tht
manufacture of a pesticide. 2.4.S-T; these
studies only show reduction of one
congener to a 10 ppb level. (CMA at pp.
22 and 23). This comment apparently, is
meant to support the position that EPA
cannot make a finding of unreasonable
risk for purposes of this rule.
Response to Comment &• This
comment also confuses the nature of the
TSCA section 4(a) finding with the
TSCA section 8(a) finding. EPA can
justify testing a chemical based on the
limited data indicating that Dow waa
able to reduce 2.3.7,ft-TCDD levels in its
product, thereby showing that regulation
may be feasible (Ref. 12). EPA does not
comment on whether such information
would justify setting particular
contaminant levels in products.
Comment 7: The risks from exposure
to contaminants at low levels may be
much lower than predicted, based on the
low nsk from exposure to the substance
itself. Reducing the level of impurities
will have negligible effects on risks from
use of the commercial substance. The
unreasonable risk determination must
be made on the risk from the
commercial substance as marketed:
other determinations are uselesa from •
risk reduction standpoint. (Dow at pp. S
and 6).
Response to Comment 7: The effect of
an impurity on risk, of course, depend*
on the nature of the impurity. The data
on contamination of the chemical with
HDDs/HDFs. gathered from this
rulemaking. will be used by EPA to
examine the risk from exposure to the
chemical when the Agency considers ~
regulation under section 8 of TSCA.
Comment 8: EPA must consider the
conditions of use for the chemicals
listed for testing, especially when the
conditions involve elevated
temperatures which increase the
possibility of exposure to both residual
HDDs/HDFs and newly formed HDDs/
HDFs. Plastics workers are commonly
exposed to decomposition products
during equipment plugging and/or
malfunctions, and firefighters and
consumers are exposed to such products
during fire-related exposures. (Workers'
Institute for Safety and Health pp. 1 and
2).
Response to Comment * EPA has
considered worker exposure to e
chemical contaminated with low levels
of HDDs/HDFs in its generic exposure
scenarios. Issues of combustion
products which may poee an
unreasonable risk are not immediately
applicable to a consideration of whether
to test a chemical for HDDs/HDFs. If
such contamination is found, however.
this issue will be considered in the
determination of unreasonable risk
under section 6.
Comment 9: CMA believes that all
companies required to test will be
willing to do so if the program is a
reasonable one. The key to CMA's
reasonable program is establishment of
reasonable LOQs. based on a full
exposure and risk assessment for each
chemical, and on demonstrated
capability to analyse HDDs/HDFs in
chemical matrices. The companies
required to test will be willing to begin
by summer (1968) and provide results
within 1 year. (Transcript to April 22
meeting, pp. S and ft p. 4 in comments to
proposed amendment adding additional
precursors.) CMA also believes the
companies would be willing to provide
the section 8 data required to establish
exposure for each chemical to determine
a reasonable LOQ besed both on
exposure and capability. (Transcript at
pp. 7 and 8.)
Response to Comment ft EPA's
concerns with a voluntary testing
program lie chiefly in the lack of
enforcement powers, and the potential
for lost time if CMA and EPA could not
arrive at an agreement on the testing
conditions. CMA implies that the
Agency must collect exposure data for
each chemical and perform a risk
assessment to set an LOQ for each
HDD/HDP for each chemical. Then the
Agency must further revise its LOQ
based on what has been done In the
past to analyse HDDs/HDFs in
commercial chemicals. EPA refected .
that approach in response to comments
2 and 3. However, to meet CMA's
concerns about the low level of the
LOQs as proposed. EPA has adjusted
the LOQs somewhat based on toxidty
equivalencies to 2,3.7.8-TCDD. This
system allows higher LOQs for higher
halogenated HDDs/HDFs. which CMA
has said will be the more difficult
congeners to analyse. EPA has also set
the LOQ not as an inflexible level, but
rather as a target to be met if possible
given a reasonable amount of time both
for an experienced enalyst and for
required equipment. All of these
adjustments should considerably reduce
CMA's concerns.
3. Comments on propoted findings
under section 4fof—4. Unreasonable
risk. EPA bases its unreasonable risk
determination on the analysis contained
in the preamble to the proposed rule (50
FR 51797-51800 and 51805-51806). The
data and analysis described therein
with the modifications discussed below
justify a finding under TSCA section
4(a) that the chemicals subject to this
rule may present an unreasonable risk.
such that testing of the chemicals for
HDDs/HDF is required at the LOQs
described in this rule. The toxic
potential of HDDs/HDFs carry
considerable weight in making this
determination. Two of the HDDs/HDFs
which have been tasted for
carrinogenicity an quantitatively
estimated to be potent carcinogens.
Many of the remaining HDDs/HDFs. all
of which an structurally similar to the
two which have been tested in long term
studies, have been shown to produce
toxic effects in animals and exhibit
biological activity in in vitro and in vivo
studies at very low levels. These HDDs/
HDFs may be present aa impurities in
certain chemicals based upon reactions
which can reasonably be expected to
occur under conditions expected to exist
during their manufacturing processes.
Therefore, people may be exposed to
these chemicals and their associated
impurities during production, processing.
distribution in commerce, use. and
disposal of these chemicals, and may
thereby be at risk of potential adverse
health effects associated with these
impurities.
There is an indication that exposure
to chemicals contaminated with 2.3.7.8*
TCDD at levels as low aa 0.1 ppb may
pose a significant risk to workers who
manufacture the chemicala. Therefore.
the testing levels have been set as low
as reasonably attainable, with target
LOQs beginning at 0.1 ppb and
adjustments for esch congener based on
its toxidty relative to that of 2.3.7.8-
TCDD. the most toxic congener. EPA
expects manufacturers to make good
faith efforts to reach the target levels.
but will allow reporting of higher levels
if it determines, based on review of the
protocol and the results of testing under
those protocols, that the manufacturer
has made a good faith effort to measure
HDDs/HDFs ss low as possible In his or
her chemical. An additional reason for
targeting 0.1 ppb as the LOQ for 13.7.8-
TCDD is that the specification of this
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Federal Register / Vol. 52. No. 108 / Friday. June 5. 1987 / Rules and
LOQ as a target at the outset of the
methods development program (or •
particular product can be factored into
the estimated costs necessary to achieve
the target LOQ. therefore, the actual
cost per sample should not be
significantly affected. If the requirement
for a higher target LOQ were specified
at the outset of preliminary method
development and then lowered after
initial method development were
completed, an increase in cost of
analysis per sample would be expected
due to requirements for total reanalysis.
EPA has found no reason to alter its
determination that the overall costs of
testing an reasonable. Se« Unit V.
below.
Elimination or preclusion from the
market due to cost of testing for
individual manufacturers and individual
chemicals has been considered, and
EPA has allowed manufacturers to file a
request for exclusion from the testing
requirements if the manufacturer can
also show that the chemical will not
present an unreasonable risk of injury to
health or th« environment Additional
reasons for which an exclusion from
testing may be granted are: (1) The
manufacturing process is such that
conditions which may lead to formation
of HDDs/HDFs are not present (2) tho
pre-existing test data are adequate
under this rule: and (3) the chemical in
produced in quantities of 100 kilograms
or less per year and is used for research
and development purposes. Discussion
of the comments on toxicity and
exposure appears below. Discussion of
the comments on cost appears in Unit V.
(i) Toxicity. The toxicity discussion in
the preamble to the proposed rule (SO FR
51797-51798) applies to EPA's toxicity
finding on HDDs/HDFs. One isomer,
2.3.7.8-TCDD has been estimated by
EPA's Carcinogen Assessment Croup
(CAC) to be the most potent of 55
suspected human carcinogens (50 Fit
51798. column 1). The other HDDs/HDFs
subject to this rule appear to be
qualitatively similar to 2.3.7,8-TCDO in
their toxic action and appear to have
strong structural and chemical
reactivities similar to 24,7.8-TCDD (50
FR 51798). As discussed below. EPA
sees no reason to change these basic
aspects of its toxicity finding. However,
EPA has changed its determination in
one retpect. Rather than considering all
HDDs/HDFs to be as toxic as 2.3.7 ,8-
TCDD. EPA has used TEF* to relate the
toxicity of each HDD/HDF to the
toxicity of 2,3.7.8-TCDO. These TEPs
have been developed by the EPA iind
have been favorably reviewed by the
Agency s Science Advisory Board (SAB)
(Ref. 35). In addition, all comment!
submitted in response to EPA's proposal
were favorable to use of the TEFs.
Comment 10: EPA has overestimated
the toxic potential of HDDs/HDFs. This
is because EPA incorrectly relies on the
incremental cancer risk for lifetime
exposure to 2.3.7 8-TCDD developed by
the Agency's CAC. This calculation is
that the incremental cancer risk is 1 in a
million if an individual is exposed to
0.008 picograms per kilogram of body
weight per day (pg/kg/day) based on a
linear low-dose model. Instead. EPA
should base its determination of potency
on a No Observed Effect Level (NOEL).
such as that developed in an analysis by
the Canadian Ministry of Environment
(Environment Canada). Environment
Canada recommends a maximum
Allowable Daily Intake (ADI) for 2.3.7.8-
TCDD of 10 pg/kg/day. which is 1.000
times higher than the EPA risk level.
(CMA at pp. 14 and IS.) The
Environment Canada assessment is
more appropriate because it is based on
the determination that 2.3.7.8-TCDD is
an animal cancer promoter and not a
cancer initiator. Thus, the linear no-
threshold model used by EPA is not
appropriate. (Dow at pp. 4.)
Retponse to Comment 10: EPA
disagrees that it has overestimated
carcinogenic potency for purposes of
this rule. Rather EPA has employed a
scientifically acceptable method to
determine potency. This determination
applied a no-threshhold. linear low-
dose, multi-stage mathematical model to
the results of a 2.3.7.8-TCDD feeding
study by Kociba 1978 (see Ref. 34) that
showed statistically significant
incidences of tumors in the liver, lungs.
hard palate, and nasal turbinates of
female rat*.
EPA believes that the no-threshold.
linear low-dose modal Is appropriate for
a number of reasons. First while there is
no conclusive proof that 2.3.7.8-TCDD Is
a cancer initiator, the biological half-life
and prolonged retention time of this
compound in the human body may result
in "promoter effect" which is essentially
irreversible (Ref. 28). Thus, although
2.3.7.8-TCDD is not a proven cancer
initiator, the no-threshold, linear low-
dose model is appropriate because of
the plausible mechanistic model of
tumorigenesis. which suggest! that there
is some risk of tumor formation at any
level of exposure. Second, for chronic
exposure of 2.3.7.8-TCDD. experimental
evidence suggests a linear dose-
response relationship in the low dose
region for tumorigenesis and enzyme
induction (Ref. 38). Finally, for 2.3.7.8-
TCDD the mechanisms of
carcinogenesis (the biochemical changes
that ultimately result in the
manifestations of cancer) are unknown.
See EPA's Health Assessment
Document for Polychlormated Diber.zo-
p-Dioxins at pages 2 through 7 (hereafter
"HAD") (Ref. 34): also see Ref. 27
According to the Office of Science and
Technology Policy (OSTP). (50 FR 10371.
March 14.1985). a linear low-dose
model, such as the one used by EPA. is
the preferred risk assessment approach
if mechanisms of carcinogenesis for a
chemical are not known. The EPA
Guidelines for Carcinogenic Risk
Assessment (51 FR 33881. September 24.
1988) agree with the OSTP policy on this
point
With respect to the promoter versus
initiator issue. EPA agrees that all
evidence points to the fact that 2.3.7 a-
TCDD. and by implication the HDDs/
HDFs in this rule, are potent cancer
promoters. However, current EPA policy
is contained in the Agency s Gu:dsimes
for Risk Assessment and the HAD.
which concludes that 2.3.7.8-TCDD
should also be treated as a cancer
initiator as well as a promoter, based on
a series of animal studies with 2.3.7.8-
TCDD and other compounda (Ref 34 at
11-58 and ll-Sfl). This approach is
endorsed by EPA's SAB (Ref. 3S). While
it is true that some experts believe that
2.3.7.8-TCDD is only a cancel promoter.
and not a cancer initiator (Ref. 38). and
that some agencies in other countr.es
have acted on that belief. EPA has. at
least for purposes of this testing rale.
maintained the current Agency position
to treat the HDDs/HDFs as complete
carcinogens (capable of both pro-notion
and initiation).
In any case, the promoter vs. initiator
issue may be irrelevant for risk
assessment purposes, even if 2.3.7.8-
TCDD is only a promoter. The threshold
model is appropriate for a promoter if
the effects from the promoter are
assumed to be reversible if the promoter
is removed. Thus, one may estimate a
level (reference dose) which would be
accepted to be without risk of harmful
effects in humans by applying an
uncertainty factor to a threshold or
NOEL level. Because retention time and
biological half-life of 2.3.7.8-TCDD is so
long (up to 8 years: Ref. 26). and because
its "promoting action" may not be
reversible, it may not be possible to
estimate a Reference Dose for use in a
threshold model which takes into
account the manifestation of prolonged
effects from multiple promoters/
initiators. EPA believes that this
approach more completely addresses
the question of simultaneous exposure
to multiple initiators in the environment
at the same time, as well as exposure to
accumulative doses of compounds with
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120
Federal Register / Vol. 52. No. IQfl / Friday. June 5. 1987 / Rules and Regulation*
g half-lives in the human body, such
:.3.7.8-TCDD.
'.nvironmenl Canada based ill
ermination that 10 pg/kg/day fa an
:eptable level of exposure to 13.7.8-
DO m humans on th« fact that
icoductive and cancer studie* show
observable effects in animals at a
se of 0.001 ug/kg/day. and set this
el as the NOEL The NOEL is the
el at which there would be no
ference in risk between the
pulations exposed to 2.3.7.8-TCDD
d populations not exposed. A safety
:tor of 100 was applied in order to
•we at the 10 pg/kg/day level. Such an
proach does not addnas the question
simultaneous exposure to multiple
tiators in the environment at the MOM
ne. and exposure to accumulative
'ses of compounds with long half-lives
the human body, such aa 2J.7A-
3DD.
Thus, the difference between the 10
i/kg/day level adopted by
ivironment Canada and the 0.008 pg/
j/day level used by EPA reflect
fferences in views of the mechanism
' action by which these compounds
feet their toxicity. as well aa
tempting to estimate the effect of
ultiple or additive initiators. EPA'i
D proach is therefore acceptable from a
.-gulatory standpoint.
Comment 11: Evidence against EPA's
nduly high estimates of toxic potency
>r HDDs/HDFs can be seen in results
om human epidemiology studies.
xposures to 2.3.7.S-TCDD among
erbicide manufacturing workers were
igh enough to produce readily
uscernible cancer excesses if potency
s ere as high as EPA suggests. No such
'xcesses have been found. Further, if
LPA's potency values were correct, and
' background exposures to HDDs/HDFs
iO to 40 years ago were similar to
Current background exposures, aa
raggested by Czuczwa, et al. fRefs. 9
tnd 10). a discernible upward trend in
:ancer mortality beginning 15 to 20
.ears ago would have been observed.
This is not the case. In both the
lerbicide worker study and the
predicted background levels, the number
of excess cancer deaths predicted by
EPA exceeds the sensitivity of
measurement by a factor of 10.
Therefore, the EPA potency estimate ia
at least ten times too large. (CMA at pp.
15 and 16.)
Responte to Comment II: EPA
disagrees that the results from the •
epidemiology studies cited above show
that EPA's estimate of the potency level
for 2.3.7.8-TCDD ia too high. EPA has
always maintained that the Agency's
estimate of toxic potency for 2,3.73-
TCDD is in fact an upper limit that is.
the Agency does not think that the
potency is nkeiy to be greater than the
given estimate and. in fact, may be less.
While it may be true that the real
potency may be something less than
EPA's suggested upper Krrrit. it is not
clear that the scientific data base
available at this time presents evidence
strong enough to support some other
(lower) estimate.
Further, epidemiologic studies are
inherently capable of detecting only
comparatively large incidence* of
cancer, and confounding factor* such aa
long latency periods, bias, and poor
exposure characterization often affect
the adequacy of the study. The use of
data by Cmexwa. et al. cannot be uaed
to identify general population exposure
levels, because neither study waa of a
statistical design from which one could
infer general U.S. exposure*. Czuczwa
studied two lakes in Michigan, Lake
Siskiwit and Lake Huron. These studies
of the lake sediments show that HDD*/
HDFs were deposited in lake sediment*
beginning around 1940. generally
increasing thereafter, and that the
distribution of congener* found
corresponds with present-day
concentrations of congener* associated
with emissions from combustion of fuel
and wastes. While these studies were
not directly intended to addnaa the
question of general environmental levels
of HDDs/HDFs. Czuczwa notaa that the
levels of HDD* and HDFs in the Great
Lake* Basin may be higher than ia other
areas of dM U.S. doe to heavy chemical
production and waste incineration.
Commenters suggested a comparison
between general background levels of
HDDs/HDFs and cancer mortality
trends. Such a comparison is limited due
to the inability to characterize general
population background exposure to
HDD*/HDF». While EPA ha* no reason
to believe that tite HDD/KDF levels
found by Czuczwa. et al., at*
representative of levels in the r**t of the
U&. than doe* appear to be a plausible
basts for the hypothesis that background
levels of HDDs/HDFs exist in the
general population. The source* of the**
background level* are likely to be
dispersed, and could include pout
source* (such a* suggested by
Czuczwa'* Great Lake* Basin data
above) that lead to general
contaaiinadon of the food *>«•<«- up to
and including mother's milk, for
example.
- If on* hypothesized that general
population exposures have been
increasing in the last 30 to 40 years.
although it is not possible to identify
level or magnitude of increase, one
might expect to see increases in cancer
mortality. In reality, however, the
incidence of most forms of cancer is
generally steady or declining, with the
notable exception of lung cancer
(directly attributable to cigarette
smoking), which is on the increase,
particularly among women. Without a
definitive link between general
background levels of HDDs/HDFs in the
environment as well as in the general
population, and the current increase or
decrease of specific types of cancer, the
increase (or decrease) in excess cancer
mortality attributable to exposure to
HDDs/HDFs in the environment or the
individual cannot be accurately
predicted, as suggested above by CMA.
Examination of total neoplastic
mortality is insensitive for this type of
ecologic analysis due to a high
background incidence, but examination
of site-specific mortality can yield
information. It is not unreasonable to
look at connective tissue and soft tissue
cancer mortality since a limited amount
of evidence suggests this may be a
target site. From this ecologic
examination, an increase in connective
tissue and soft tissue cancer mortality
rates is seen for all race* (white and
nonwhite) and sexes (male and female).
The epidemiologic evidence from both
Sweden and New Zealand regarding
HDD exposure from contaminated
herbicide* and the incidence of cancer
in human* have been subjected to
considerable scrutiny due to poorly
characterized exposure estimates and
other confounding factors, but
emphasizes that the epidemidogical
inference supporting the relationship
between human exposures to phcnoxy
herbicide* contaminated with TCDD
and the occurrence of soft tissue
sarcoma remains strong. EPA believes
the association reported m the two
Swedish soft tissue sarcoma studies are
strong enough to make it unlikely that
they have resulted entirely from random
variation*, bias, or confounding factors.
A similar view has been expressed by
Dr. Aaron Blair, of the National Cancer
Institute (NCI), who after evaluating
existing human data regarding dioxin
and cancer summarized that.
The eBidenuoloaic tvideace rttardMia.
dioxin txposer* and cancer is ooatndicMry.
In fact the cootrtdictioB is ithkiaa. On one
haad we have the Scandinavian studies
when ttrikina sxcasses of lymphoma (VfoU)
tnd soft tissue sarcomas (3-4 (old) occur tnd
on ths other band studies from New ZMlaod
find no risk or only skifht nsk of these
tumors. As it stands BOW the tpidtiruoloaic
dsts are not persuasive reaardina one
interpretation over the other. The high
rctauvt risk teen ia to Swedish ituditt.
however, cannot bt dismissed (Kef. 40).
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Federal Register / Vol. 52. No. 108 / Fnuay. |une 5. I9»r / Rules and Regulations
21421
Regarding the analysis of HDDs/
HDFs in adipoM tiuiM from penoni
from the St. Louis, Mo. ana. the analysis
of 35 samples, of whkh 8 showed
detectable HDD/HDP levels, is too small
a sample size to be representative of the
U.S. population as a whole. Furthermore.
the samples were not taken from a
statistically-designed study. The
epidemiologic itudies are limited in thitir
ability to be compared with the animal-
based prediction of human cancer risk.
The issue of determining exposures in
epidemiologic studies is a perennial one.
confounded even more by the potentinl
for background exposure and the
existence of background levels in the
general population, as discussed above.
Although scientific conjecture and
subsequent relative studies in the U.S.
and elsewhere have not yet resolved
these discrepancies. EPA maintains that
this suggestive link ts indicative of the
unresolved concern relating 2,3.7.8-
TCOD exposure to cancer in humans.
Until these concerns are resolved. EPA
will continue to interpret these studios
as suggestive evidence of the potential
carcinogenic effect of 2.3,7,8-TCDO.
Comment 12: EPA has overlooked die
fact that animal species vary greatly in
their toxic response to HDDs/HDFs.
(CMA at p. 14.)
Response to Comment U EPA is
aware that there is a wide species
difference in toxicity for HDDs/HDFs.
For 2.3.7,8-TCDD. science has been
unable to determine why such variation
exists, or where humans fit into the
spectrum of other mammals. This issue
was discussed in an EPA SAB hearing
November 4.1966. where the SAB noted
that the species difference in toxic
responses to different HDDs/HDFs is
likely to be due to genetic, metabolism.
and absorption factors. The SAB
acknowledged the lack of data In these
areas and encouraged EPA to sponsor
research on metabolism and on
carcmogenicity of untested congeners.
In the absence of data. EPA cannot
say that the human is more or less
sensitive than any other species. EPA's
Carcinogenicity Riak Assessment
Guidelines indicate that for regulatory
purposes EPA will choose me moot
sensitive species. For HDDs/HDFs.
moreover, the cause for concern in that
those HDDs/HDFs which have been
tested show toxic responses at very low
levels. See Unit IV.A.lY of the
proposed rule.
Comment 13: EPA assumes without
verification that all HDDs/HDFs are
carcinogenic although most have never
been tested for carcmogenicity. (CMA at
P-14).
Response to Comment 13: This
comment misinterprets the nature of
EPA's decision in this rulemaking. EPA
acknowledges that few of the HDDs/
HDFs have actually been tested for
carcinogemcity. Only 2.3.7,8-TCDD and
a mixture of 2.3.7.8-substituted Hx CDDs,
have been tested, but they an the most
potent animal carcinogens evaluated by
EPA to date. The basis of the
lexicological finding in this rule is the
structural activity relationships among
the HDDs/HDFs. Experimental data
have accumulated which dearly
indicate a link between intracalluhu
biochemical mechanism and whole
animal toxicities from exposure to
HDDs/HDFs. The occurrence of these
biochemical phenomena appear to be
closely related to the structure of the
HDDs /HDFs: me more similar the
structure to 2.3.7.8-TCDO the more toxic
is the compound. (Refs. 3.21. and 22).
Limited in vivo and in vitro data support
the structure/activity argument that
2.3.7.8-substituted HDDs/HDFs share
qualitative toxicity properties with
2.3.7.8-TCDD (see SO FR 51798). This
similarity of response is noted in a wide
range of toxic endpoints including
limited carcmogenicity and
teratogenicity results. Therefore it is
prudent to consider that similar HDDs/
HDFs have similar toxic potentials.
including carcinogemcity (Ref. 4).
Comment 14: EPA incorrectly refers to
"suggestive" epidemiological evidence
linking 2.3.7,8-TCDD to the occurrence of
cancer. All studies other than those of a
single investigator have not found any
such link and this study has been
subjected to significant criticism. (CMA
at p. 14).
Response to Comment 14: EPA does
not mean to state that epidemiological
studies an persuasive regarding any
interpretation. The epidemiological
evidence is contradictory. See Response
to Comment 11 above. However, the
high relative risk of certain Swedish
studies of herbicide workers cannot be
totally dismissed. Furthermore, a recent
study of fanners in Kansas provides
additional evidence that epidemiological
evidence is suggestive of a positive link
between excess cancers and exposure to
a HDD-containing herbicide (Ref. 18).
Comment 15; In setting LOQs EPA
should use the Toxic Equivalency
Factors (TEFs) developed by the
Agency. (Dow at p. fc March 4.1960.
Hearing Transcript at pp. 12 and 13.20
and 21: CMA at pp. 39 and 40).
Response to Comment 1& EPA
requested comment on die use of its
TEFs in the preamble to the proposed
rule. SO FR 51800. column 2. Since that
time the concept has been reviewed
favorably by the Agency's Risk
Assessment Forum, the Risk
Assessment Council, and the SAB (Ref.
35). Moreover, the response both from
comments and from the public meetings
was favorable toward using TEFs to set
LOQe. although the various parties
recommended different approaches to
their use. CMA advocated using the
TEFs along with actual exposures to
each congener to develop LOQs. In
contrast, the Environmental Defense
Fund (EDF) recommended applying the
TEFs so that the sum of all HDD/HDF
congeners found in any chemical would
not exceed 0.1 ppb. This would involve
an analysis to determine which
congeners were present, and an
application of the TEFs to determine the
level of quantitation for each. (March 4.
1988. Hearing Transcript at pp. 33 and
34). This would necessitate levels in the
parts per trillion range, which EPA
believes is not generally achievable in
chemical matrices, based on experience
in EPA laboratories.
Since EPA has elected to treat the
chemicals as a class for purposes of this
rule. EPA has rejected setting LOQs on a
chemical-by-chemical basis, as noted
above in response to comment 4. With
respect to EDFs scheme. EPA believes
that these LOQs would be too low to be
reasonably and accurately measured.
EPA has decided to use OJ ppb as a
target level for 2,3.7.8-TCDD. because
the Agency's generic assessment of nsk
shows a potential worst-case risk from
dermal exposure to workers from that
congener present at that level, and has
set target LOQs for all other congeners
at some level above 0.1 ppb because
those congeners are. according to the
TEF scheme, likely to be less toxic than
2.3.7,8-TCDD.
With regard to the brominated
species. EPA had a different problem
since the TEFs have been set only for
chlorinated HDDs/HDFs. Thus. EPA had
the choice of setting the LOQs for the
brominated HDDs/HDFs at the same
level as their chlorinated counterparts.
based on the assumption that the
brominated counterpart is equally toxic.
or of leaving the LOQ for brominated
HDDs/HDFs at the proposed level of 0,1
ppb. Very little data have been collected
on brominated HDDs/HDFs. but that
which have been collected suggest that
brominated HDDs/HDFs are generally
as toxic as their chlorinated analogues
(Ref. 25V
For purposes of this rule. EPA has
assumed equal toxicity. and has
adiusted the LOQs for brominated
HDDs/HDFs to match those of their
chlorinated analogues.
The new LOQs are as follows: 0.1 ppb
for T.HDDs: 0.2 ppb for PjHDDs. 2.S ppb
for Hx«HDDs; 100 ppb for Hp,HDDs: 1.0
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21422
Federal Register / VoL 52; No. 108 / Friday. Jun* 5. 1987 / Rules and Regulations
ppb for T.HDFs; 1.0 ppb for PtHDFs: 10
ppb for Hx«HDFs; 100 ppb for HpiHDFi
Comment i& EPA should slimiaatc
the heptahalogenated omgsnsw from
the testing requirement because toxjdty
for these congener* \t orders of
magnitude lest than that of 2JJ.fcV
TCDD. (CMA at p. 42).
Response to Comment 16: EPA agrees
that its TEF scheme indicatca that tha
heptahalogenated congener* are
considerably less toxic than ZJJ.ft-
TCDD. but does not agne that they
should be dropped from the testing
requirement. In chemicals which have
been tested, such as pentachlorophenoL
the heptachlorinated dioxins are present
in such large quantities that they could
produce a toxic effect even though their
individual toxicity is many times lower
than that of 2.3.7 8-TCDD (Refs. 4 and 8).
In addition, the higher halogenated
congeners have a tendency to
dehaiogenate in the presence of light to
lower halogenated. end more toxic.
congeners. (April 22.198ft Hearing
Transcript at pp. 46 and 47: comments
submitted by Cambridge Isotope
Laboratories (CIL)). There Is also some
evidence that higher halogenated
HDDs/HDFs may have loiter half livee
in the human body, thereby enhancing
their toxic potential (Ref. 28). For these
reasons EPA has not removed the
heptahaiogenated congeners from tha
testing requirement but has adjusted th*
LOQs based on the TEFs.
Comment 17: EPA should not have
excluded iodinated and fluoriaaiad
species from this rule. Studies suggest
that fluonnated dioxioa are mote
biologically active than chlonaaled or
brominated ones and there is the
possibility that fluonnated compounds
could replace chlorinated or brominated
compounds. (March 4.1986. Hearing
Transcript at p. 9; EOF at p. & p. 2 in
comments to proposed amendment
adding additional precursors).
Response to Comment 17: EPA has
decided not to focus on the fluorinated
and iodinated compounds in this rule.
Straight substitution of fluorine or iodine
for chlorine or bromine produces*
compounds with considerably different
physicochemical and biological
properties, thus indicating that fluorine
and iodinated compounds would not be
good substitutes for chlorinated or
bromineted compounds as commercial
products. However, it is possible that ~
fluorinated and ioamated compound*
(which may theoretically be predveposed.
to HDD/HDF contamination) may be
used to formulate commercial chemical
products on an increasingly larger scale
in the future. At the present time.
however, the use of these compounds in
the manufacture of commercial chemical
products is small in comparison to the
number of products using chlorinated or
brominated chemicals.
Development of the analytical
methodology, indudmg appropriate
standards, necaaaary to enswt accurate
analysis with appropriate QAVQC
procedures for the xxbnated and
fluonnated compounds does art appear
to be coat effective at this time. There m
no indication that any commercial
laboratory is attempting to make such
standards, sad the coat of developing
standards was one of the major coats of
this final rasa.
EPA may receive Information, either
as a result of the reporting requirements
in thia rule, or front iaformetion reported
to the Agency in response to
requirements promulgated andar TSCA
or other statutes, on the production, a**,
or disposal of these wdmatad or
fluonnated compounds, m the event mas
information indicate* dial these)
chemicals are being wed on an
increasingly frequent basis to replace
chlorine and bromine in the manufacture
of chemicals to which persons may be
exposed. EPA will investigate, as it baa
for tha chlorinated and brominated
chemical compounds in thai final rule.
the potential for contamination with
HDDs/HDFs. the likelihood of
subsequent human exposure and tha
potential for unreasonable risk.
(ii) Expofun. EPA's proposed rob
estimated exposure to tha HDDe/HDFs
subject to thia rule by analysing the
risks that could theoretically occur tf the
chemicals subiect to testing ware
contaminated with 2.3.7.9-TCDD. and by
implication the other HDOa/HDFs, in
the 0.1 ppb to 1.0 pom rang**. The
Agency applied these rentes to
representative exposure acenanoa
consisting of dermal exposure to a
household cleaner and to dmmtenls in
the workplace. Theoretical risks
resulting from the 0.1 ppb and 1.01
contamination levels in the
ipreeaatativesxpi
calculated using Lifetime Avar*** Dafly
DOS* (LADD) vahies in the multistage
linear low-dose modal discussed above.
(See 30 FR S17t»-«17W). The risks
ranged from a theoretical 1 In 1
occurrence for occupational dermal
exposure at a contaminant ami of 1 .
ppm to an individual riak level of
approximately 4 m 10 million for
consumer exposure to household
cleaners contaminated at 0.1 pah.
EPA acknowledges that anch of th*
exposure analysis m the piuposal
indicated a higher riak than may be
expected- however, after analysing th*
comments on its exposure modeling. die
Agency has concluded that for uui puses
of this rule, the 0.1 ppb LOQ is an
appropriate target level for testing
2.3.7.g»TCDD. This is based on
modifications to the existing
occupational exposure scenario, which
indicates there could be potential risk to
chemical workers from 2.3.7 frTCDD
exposure at 0.1 ppb. The same target
LOQ has been set for 2.37.8-TBDD. As
noted above, the target LOQ* for the
other HDO*/HDF* have been adhnted
upward using the TEFs. Analysis for any
HDOs/HDFs in chemical matrices down
to 0.1 ppb will be very difficult, but
especially difficult for higher
halogenated HDDs/HDFs. However, the
toxicity of tha HDDs/HDFs in this case
may be expected to decrease with the
degree of halogenation. so that use of
the TEFs adjusts the LOQs upward for
the higher halogenated congeners. EPA
has also sat tha LOQs sa a target since
the levels sat may aot be achievable in
some chemical matrices. A review of the
cost of analysis on a par-sample basis at
the** target levels indicated that the
differences in costs associated with
analysis at higher levels are not
appreciably stgnrfkant if the target LOQ
is specified at the outset in analytical
method development If the target LOQ
were established at a higher level before
allocation of resources for method
development then lowered to e more
conservative target level, an increase in
cost per analysis would be expected
because of reenelyst* at the lower level.
The exposure scenarios show that the
risks posed by expmme to workers at
the 1 ppm range mey be rob*tan rial.
Therefore, EPA has decided that the
modified occupational dermal exposure
scenario provides an adequate basis for
choosing 0.1 ppb as die sppropriate
target testing level for the tetra HDD/
HDF congeners, which an those of
greatest concern to the Agency.
Choosing the 0.1 ppb level as the lowest
testing level will allow EPA to evaluate
any of the potential risks resulting from
low levels of all the HDDs/HDFs once
the testing data are submitted, and wiO
allow the Agency to catch in its
analytical net any use that could
potentially causa unreasonable risk.
including possible new uses.
m addition, it is better to analyse
these compounds at low levels when
they are first created, rather than wait
until they have entered environmental
pathways, such as food chains and
water supplies, and may have caused
widespread contamination. In addition.
because these compounds are difficult
to monitor et trace levels in th*
environment using standard technique*.
they are bast analysed when they are
first created m the manufacturing
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Federal Regisfer / Vol. 52. No. 108 / Friday. June 5, 1987 / Rules and Reaul
a i! o r. s
21123
process for later prediction of
environmental contamination.
EPA'i responat* to comment* on its
expoeun analyti* an discussed below.
Comment /* EPA'i coniumer
exposure scenario based on a household
cleaner is not representative of the uses
of the chemicals subject to this rule.
since none of those chemicals are used
in such products and many are used
almost exclusively in application! in
which they are bound into polymeric
matrices and thus are unavailable for
human exposure. In fact the household
cleaner scenario is baaed on use of
phenolic compounds la pesticides,
which are not subject to TSCA
jurisdiction. (CMA at pp. II and 19.)
Responu to Com/run* It EPA
concludes that the hooeahold cleaner
scenario ia relevant to this rulemaking.
While that specific scenario need by EPA
on household cleaners ia baaed on a
pesticide uaa not subject to regulation
under TSCA. EPA haa no indication that
the eham^u subject to thia role may
not be in products intended for similar
use* that may be subject to TSCA. For
•example^ no coounenla indicated that
particular chemical* an not or could not
be used for some kind of sprayed
application or might not have some
potential high expoaure patten. Indeed.
there ia some evidence that the uoe of
certain chemicals may possibly result la
high expoeore pattern*, moat notiibiy
compounda u*ed as additive or blended
Tire ntardant*. or aa dye carriers for
textile dyes. An additive fire retardant ia
topically applied to the desired
material* (e.g.. fabric wood, synthetic*),
rather than incorporated into the
product matrix by physical bonding or
chemical reactivity (Ret 13).
Since EPA has wn indication that
chemicals related to <*tt*"f
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21424
Federal Register / Vol. '52. No. 108 / Friday. June 3. 1987 / Rules and Regulation*
these types of spills, cleanup efforts, or
improper handling practices.
In response to comments regarding
the reasonableness of EPA's estimate of
worker exposure. EPA re-evaluated its
occupational exposure estimates. EPA
contacted representatives of OSHA.
MOSH. the American Industrial
Hygienists and the American Council of
Government Industrial Hygienists to
solicit data on the reasonableness of
EPA s exposure assumptions (Ref. 42).
Although EPA's contacts were unable to
provide estimates for the entire
chemical synthesis industry (because of
substantial differences among the
processes, worker activities and
industrial hygiene practices), they did
agree that the assumption that a skin
area equal to both hands, exposed to a
chemical each day. is too high. Baaed on
their information EPA believes a more
reasonable estimate range* from the
area of 1 hand to the area of one-half of
l hand exposed to the chemical
substance during each time, or event
when the worker is exposed or an
estimate of 10 percent of the skin area
equivalent to 2 hands exposed each day.
To estimate the number of times a
worker is exposed to a chemical each
year. EPA used aa a surrogate an
estimate of 77 as the average number of
drumming, bagging and transfer
operations per year. Then EPA
calculated the LADD assuming that both
an area equal to one-half of 1 hand and
an area equal to 1 hand, was exposed to
the chemical substance each time. The
LADD for one half of 1 hand exposed, if
the chemical is contaminated at 0.1 ppb
132x10'' ng/kg/day. The LADD for 1
hand exposed, if the chemical is
contaminated at 0.1 ppb. is 4xlO~^ both
LADD'i result in a risk of 10'*. If the
assumption is made that only 10 percent
of the skin area of a worker's 2 handa
will be exposed to the chemical
substance each work day. the LADD la
2x10"'. again resulting in a risk of 10"*
(Ref 42).
Minor differences in several other
assumptions account for the remaining
difference in the LADDs. but these
differences are insignificant For
example. EPA assumed the liquid (Urn
thickness on exposed skin surfaces at
l.axKT' cm: the density of the liquid at
1.38 gm/cm*. and the number of yean of
exposure at 70 years. CMA assumed
liquid film thickness at 1.3x10"'cm. a
liquid density of 1.3 gm/cm' and 55
years for lifetime exposure. .
EPA believes that CMA's suggestion
of an average dermal exposure of less
than 2 cm' skin surface per year is
unrealistic based on normal chemical
manufacturing practices, including
accidental spills and resulting cleanup
efforts involving lack of protective
clothing, and even isolated Instances of
worker negligence in handling such
chemical substances. Unless the event is
serious or widespread enough to cause a
slowdown or halt of the production
process, the event usually goes
unreported. The estimate of skin area
exposed during chemical manufacture
by the personnel contacted by EPA are
orders of magnitude larger than CMA's 2
OB'per year (Ref. 42).
Comment 22: Hypothetical worker
Inhalation exposures show extremely
low LADDs and would not justify the
LOQs In this rule. (CMA at p. 21).
Retponte to Comment 22: Because of
the very low vapor pressure of 2.3.7.8-
TCDD in its pure form (1.7x10**mm/
HgL inhalation toxicity scenarios were
included in a support document (Ref. 43)
but were not used to calculate
exposures for purposes of this rule.
These calculations can provide LADDs
which may be useful in assessing an
overall estimate of risk when considered
with risk estimates based on other
route* of exposure but taken alone, do
not allow a meaningful evaluation of
potential risk. While EPA is unable to
state whether risk from inhalation
exposure, alone, is significant such risk
adds to the Agency's concern when
considered with risk from poaaible
dermal exposure.
(Hi) ExcJuiiont and waiver*. EPA will
exclude chemicals from testing based
upon submission of prior test data which
satisfy TSCA section 4(a)(l)(a)(i)
requirements, or submission of detailed
process and reaction condition data
which show that conditions known to be
conducive to HDD/HDP formation are
not present EPA will waive testing
requirements for any chemical produced
in quantities of 100 kg/year or less for
purposes of research and development
When production of that chemical
exceeds 100 kg/year, the waiver expires,
and the producer then becomes subject
to the testing requirements in this nile.
EPA will also waive testing
requirements for those developmental
chemicals that due to the cost* of
testing, either will be taken off the
market or will not reach the market
Whfle EPA believes diet a potentially
highly toxic chemical should not be .
marketed if It cannot bear the coats of
testing, the Agency will consider a
waiver to testing in appropriate
circumstances.
If a manufacturer has a developmental
chemical that due to the costs of testing.
either will be taken off the market or
will not reach the market it may apply
for a waiver by submitting information
to EPA that shows such advene market
effects. EPA will evaluate that
information to determine whether the
manufacturer's allegations of market
effect* will, in fact occur. If EPA agrees
with the manufacturer, the Agency will
then weigh the potential risks of the
chemical against the costs of testing to
determine whether testing is warranted
under this rule even at the
developmental stage. EPA will grant the
waiver, with appropriate condition*, if
the riik* do not outweigh the costs of
testing for that particular chemical.
These criteria are similar to those EPA
employs in evaluating whether chemical
substances should be restricted under
section 5(e) ofTSCA.
EPA expects this waiver to be
applicable only to chemicals
manufactured in amounts of no more
than 2JOOO to SjQOO total pounds
annually. Preliminary analysis of data
submitted for this rule shows that this
waiver will apply to only one chemical
produced by Am Specialty Products
Division, which was recently sold to
Honehead Industries.
b. Insufficient data. In the preamble to
the proposed rule EPA stated that, with
theexception of some data on 2J.7>
TCDD and even less data on several
related congener*, the Agency ha* little
or no data on concentration* of HDD*/ ,
HDF* in commercial chemical* upon
which to base a determination of
unreasonable risk (58 PR 51800). EPA
received comments relative to this issue
on two chemicals, and discusses those
comment* below. As a mult of the data
submitted the Agency ha* excluded 1
grade of decabromodiphenyl oxide
produced by DOW. for which a 2-year
bioassay and an analysis for HDDs/
HDFs in the test article was done. For
Tetrabromobisphenol-A. the odier
chemical on which comments were
received with respect to insufficient
data, the Agency sees no reason to
change its determination that existing
data is insufficient and thus testing is
necessary to obtain that data.
Comment 23: Existing bioassay data
plus chemical analysis for HDDs/HDFs
for decabromodiphenyl oxide provide
all data needed to show absence of
unreasonable risk. Acute. 28-day
feeding, mutagenicity and 2-year feeding
studies found no significant advene
toxicologic effects for
decabromodiphenyl oxide. An analysis
of the test article used in these studies
for the presence of HDDs/HDFs
revealed none present st 1.0 ppb. the
lowest level achievable in the analysis.
(CMA p. 24. Dow pp. 5-6).
Retponte to Comment 23: EPA has
examined the data submitted on
decabromodiphenyl oxide in which
toxicology and carcinogenesis studies
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Federal Regular / Vol. 52. No. 108 / Friday, [une 5. 1987 / Rules and Regulations 21425
were performed by NTP. •long with a
chemical analyst* for the presence of
HDOe/HDFt. Tbt toxicolo«y and
cardnogeneala stadlea wire perfonaed
on both r»ti and mice, at doses of 0.
25.000 and 50.000 ppm in the diet
Result* included increased incidences of
neoplastic nodules of the liver in low
dose males, and in high dose group)) of
each sex equivocal evidence of
carcinogenicity for male mice as shown
by increased incidences of
hepatoceilular adenoma* or carcinoma*
(combined) in the low dose group and of
thyroid gland follicular cell adenoma* or
carcinoma* (combined) in both dosed
group*, and n» evidence of
carcinogenidty for female mice. An
accompanying analysis by NT? with
appropriate QA/QC and wing CC/MS.
showed no HDDs/HDFs in the 2
samples analyzed at the level of 1 ppb.
While EPA doe* not necessarily concur
with the fact that the testa show no
unreasonable risk, the Agency does
agree that tasting under this rule would
not be warranted, in view of the
extensive bioassay data combined with
existing teat data with adequate QA/
QC Therefore. EPA will exempt tho
grade of decabromodiphenyl oxide
produced by Dow for the research NTP
project provided Dow can supply
evidence showing which grade was
produced for the NTP project If Dow
produces other grades by different
processes, or produces by the tame
process a grade in which higher
temperature* or more alkaline
condition* occur, that grade will have to
be tested under this rale.
Comment 24: The Interagency Testing
Committee (TTC) ha* determined that
Tetrabromobi*phenol-A (TBBPA) should
not be recommended for health effort*
testing, and EPA ha* accepted that
recommendation. Thus, the compound.
containing whatever HDD/HDF
impurities may be preaent ha* already
been found to demonstrate abeeaca of
unreasonable riak. (CMA pp. M and 28
and Dow pp. S and 6).
Response to Comment 34: BPA did not
find that TBBPA did not present an
unreasonable riak to human health in
accepting the fTCa recommendation to
not require health effect* testing. A
determination that a chemical doett not
present an unreasonable risk can only
be made after extensive'testing. The
issue of contamination by HDDS/HDFs
waa not cxamined-at the time TBBPA
was evaluated a* a candidate far testing
by the CTC and the short-term tests
which showed low mammalian toxicity
would not be capable of identifying the
latent toxic effects characteristic of
2.3.7.8-TCDD. However, in September
1966. a paper was presented which
showed HDD contamination of TBBPA
(Ref. 30). Therefore, there ia a basis for
requiring testing of TBBPA in this final
rule, and this rinding ia not inconsistent
with EPA's earlier decision not to
include health effects tatting of TBBPA.
c Necatsity for totting. EPA has
determined dial testing it necessary to
generate data on which to base toxicity
and expoaura. because such data are
fundamental to the assessment of risk.
and because the analytical data
generated by required testing in this
Final rule ia currently not available in
any accessible or oabie form for
purposes of sseessing dieee potentiei
risk*. No comment* other than those
already addressed In comments 23 and
24 above were received on the necessity
for testing.
EPA has decided, however, that It is
not necessary to test under TSCA two
chemicals originally proposed for
testing. These chemicals an 2.4-
Dichlorophenoxyacetie acid (2,4-D) and
2.4-Dichlorephenoxybutyric add (2.4-
DB). Both an registered pesticides aa
well aa isolated intermediates used to
produce pesticides. Used as pesticide*.
they are subject to testing under FIFRA.
Used as pesticide intermediates, they
are subject to testing under TSCA. At
the time mis rule we* proposed, plan*
had not been completed to require
testing of these pesticides under FIFRA.
so they were listed In the proposed rule.
EPA plan* to require under FIFRA
equivalent tasting of pesticide* for
contamination by HDDs/HDFs. EPA
believes that testing these two
chemical* under TSCA would be
duplicative and unnecessary.
particularly since EPA does not expect
them to be used for non-pesticide
purpose*. Accordingly, they will not be
subject to the testing provitiona of thi*
final rule under TSCA. but instead an
subject to the FIFRA Data Call-in
program. They will be subject to the
same letting provisions aa chemicala
listed for testing in this final rule.
including target LOQs. the same
methods. QA/QC procedures, and under
the same deadlines as the chemicala
listed for letting in thi* final rule.
EPA ha* also examined another
chemical that ha* both peatidde u*e*. *•
well aa non-peaticide uae* subject to
TSCA jurisdiction, and ha* decided.
similarly, that testing i* not neceeaary
under thi* rule because that chemical ia
being tested under Data Call-In
provision* of FIFRA. Thi* chemical
pentachlorophenoi waa net originally
proposed for testing, but EPA
subsequently learned net it ha* non-
pesticide uses. Nevertheless. EPA has
decided that testing under TSCA is not
necessary for pentachlorophenol
because such testing would be
dupiicative of the testing under FIFRA.
However, because pentschlorophenol
has use* other than ss s pesticide, data
collected through the OPP Data Call-In
will be available for OTS review and
evaluation.
8. Requirement Under Section 41 b)
Section 4(b) of TSCA. discussed in
detail in the preamble to the proposed
rule (SO FR 51797. cols. 1 snd 2). requires
EPA to deal with a number of issues
before promulgating a test rule. Section
4(b)(l) sets forth three additional issues
to be Included in a test rule. First. EPA
must identify the chemical substances
for which testing is required under the
rule. Second. EPA is to include
"standards for the development of teat
data." Third, section 4(b) requires EPA
to specify the period within which
persons required to conduct tests shall
submit data to EPA, In determining the
standards for development of test data
and the period for submission of data.
EPA's considerations shall include the
relative costs of the various test
protocols and methodologies that may
be required and the reasonably
foreseeable availability of facilities and
personnel needed to perform the testing
required. Section 4(b)(3|(B) sets forth the
criteria for determining who should test.
The preamble to the proposed rule
discusses the section 4(b) considerations
(SO FR 51800). Below. EPA discusses the
comments received on these issues and
the changes the Agency has made to its
final regulation.
1. Identification of substances to be
tested, EPA chose the chemicals for
testing baaed on two broad criteria.
Some chemicals have actually been
tested in the past and found to contain
2.3.7.8-substituted HDDs/HDFs. The
others are chemicals which EPA has
good reason to believe are contaminated
based on structural similarities with the
chemicala actually tested, and the use of
manufacturing process conditions
believed to aid the tormation of dioxms
and dibemofunns. Thus, these listed
chemical* contain carbon and utilize
chlorinated and/or brominated
compound* in their manufacture and are
manufactured under circumstances that
include high temperature or pressure
and the pretence of alkaline conditions.
Contamination of the listed chemicals
i* expected to occur during manufacture.
Thus, the focus of the testing is on
detecting contamination st the beginning
of the manufacturing chain to allow EPA
to drew conclusions about the degree of
contamination dunng further processing
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21426 Ffdtni Regiater / Vol. 52. No. 109 / Friday. June S. 1987 / Rules and Regulations
or the chemical. Comment* on chemical
identification are discumd below.
Comment 25; The procHi and
reaction condition* under which
brominated phenolica an produced
make it unlikely that dioxin* or furana of
concern will be formed. These chemical*
should be removed from the liat of
chemicals to be tested. (Great Lakes p.
17: p. 4 in comments to proposed
amendment adding additional
precursors: Ameribrom p. 2.)
Response to Comment 23;
Confidential data detailing the
manufacturing process and reaction
conditions were submitted by these
commentera. These coounenten
provided detailed dau to substantiate
their claim that the processes under
which certain chemicals are produced
are different from those assumed by
EPA. and that reaction conditions art
such that HDDs/HDFs would not be
expected to form. EPA has asked
several clarifying questions about the
process and reaction condition data
submitted. The response to these
questions will form the basis for a
decision by EPA to exclude or waive a
company from testing certain specific
chemicals based on a process different
from that expected by EPA and reaction
conditions not expected to form HDDs/
HDFs.
Even if the exclusions or waivers are
granted. EPA will not remove the
chemicals from the list, however, since
another manufacturer may use the
process specified by EPA to produce
these chemicals, thus making production
of HDDs/HDFs likely.
Comment 26: EPA's list of chemicals
to be tested is too narrow, and must be
broadened to include all chemical*
likely to be contaminated with HDDs/
HDFs. as were included on the list of 238
chemicals from which EPA chose those
to be tested under this rule. (EOF at p. 5:
p. 2 of comments to proposed
amendment adding additional
precursors.)
Response to Comment 26; EPA
disagrees. The list of 238 chemical*
which was widely circulated in July
1985. to get early comment front all
segments of the community meat
involved with HDD/HDF ajutytii. wa*
compiled from every available rafcrac*
in which chemical* theorized to contain
HDDs/HDFs were listed. It* purpose
was as a starting point for additional _
analysis. Its circulation was to get input
on chemicals or classes of chemical*
which should or shouldn't be included
and the reasons therefor. The
breakdown of this list is detailed in
Reference 43 to this rule. EPA first
looked for chemical* which in the past
have been tested and found to contain
HDDs/HDFs. Chemicals structurally
similar to the** chemical*, with a
theoretical chemical pathway to HDD/
HDF formation, and manufactured under
condition* likely to produce HDD*/
HDFs have been listed for testing. For
the other chemical*, there is not a strong
theoretical basil at present to conclude
that the chemical* are contaminated
with significant level* of HDDs/HDFs,
due to lack of any documented pathway
for HDD/HDF formation and lack of
favorable proces* condition*. In several
cases chemicals were not listed because
contamination would occur from a
contaminated feedstock chemical, which
wa* already listed. The rationale it that
a chemical testing contaminated will
undergo further investigation, including
investigation of contamination of all
chemicals produced from the known
contaminated chemical. Thus testing at
this time is not indicated for the
downstream chemicals. Finally, those
chemicals with use* only a* pesticides
were separated into a separate liat
The result of this selection process is
the list of 32 chemical*. 12 manufactured
and 20 not currently manufactured.
which are required to be tested under
this rule.
Comment 27: EPA ha* omitted the
halogenated aniline* and benzene* and
moit diethyl ether* from consideration
for testing, although the publication
"Dioxina" (Ref. IS) and the support
document (Ref. 43) cite the** chemical*
as highly likely to be contaminated
Further, it is well known that heating
halogenated benzene* will yield PHDDs.
(EOF p. 4.)
Response to Comment 27: EPA
disagrees that halogenated aniline* and
diethyl ether* should be added a* a
class of compound*. Although the
halogenated aniline* were cited a*
highly likely to be contaminated (Ref.
43). the formation of HDDs/HDFs during
their manufacture is dependent on
specific reaction criteria of heat
pressure, alkalinity and duration of
reaction employed in manufacturing the
chemical. In most cases such condition*
are not believed to be present In their
manufacture. However, several
halogenated aniline* art listed a*
precursor chemical*, since they are
believed to be conducive to the
formation of HDDs/HDFs. and the
application of heat during the synthesis
of other chemical* could produce HDD*/
HDF* in those other chemical*.
Conversely, pentachlorobenzene. which
may be predisposed to HDD/HDP
contamination during synthesis, would
require dechlorination in an aerobic
environment at high temperature* to
produce chlorinated dioxin* or furtns.
This combination of reaction conditions
Is unlikely under current manufactunng
processes.
Diethyl ether* are not discussed in
either Reference 43 or in the publication
"Dioxin*" (Ref. IS).
A* • result of BDFs comments snd
additional information received after
publication of the proposed rule. EPA
issued en amendment to the proposed
rule (51 FR 37612: October 23.1886).
proposing to add 18 chlorinated and
brominated benzenes to the original list
of 12 precursor chemical*. This rule
add* 17 of those chemicals to the
category of precursor chemicals and
requires reporting under section 8(a) of
TSCA on chemicals made from those
precursor*. If process and reaction
condition data submitted show that
HDDs/HDFs are likely to be formed.
additional chemical* may be listed for
testing.
Comment 28: EPA should require
testing of precursor chemicals. (EDF p.
5.)
Response to Comment 2& EPA
disagree*. The precursor chemicals are
listed separately because they do not
meet EPA's criteria for testing, namely.
the reaction conditions needed to form
HDDs/HDEs are not present All
published research shows that heat.
pressure and alkalinity, or some
combination of these conditions, are
needed for the formation of HDDs/
HDFs.
These chemicals are listed as
precursors because the application of
the listed conditions during further
chemical processing may occur, and
may produce HDDs/HDFs in the final
chemical substance produced. Reporting
of process data and reaction conditions
will help EPA determine whether any of
the chemical* manufactured from these
precursor* should be proposed for
testing.
Comment 29: EPA does not specify
what grade of substance must be tested.
(Dow p. 19.)
Response to Comment 29: EPA
requires that manufacturers test
chemicals which are listed in this final
rule in all grade* normally marketed in
active commerce only if manufacture
occur* by different processes. If
manufacturing occur* by the same
process under variable conditions, the
test substance may be a single grade:
the grade subject to the most intense
heat and alkalinity for the longest
duration. If these two factors do not
differ for the various grades, the test
substance should be the grade with the
highest volume of sale*. In the test
protocol the manufacturer must tell the
Agency how many grade* of the
chemical are produced and describe the
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Federal Register / Vol. 52. No. 108 / Friday. Une 5. 1987 / Rules and Resuiauor.s
2142"
reasoni for choosing the gride to be
tested.
2. Standard! for tta dtvtlopmnt of
test data. This tena i* defined under
section 3(12) of TSCA and refer* to the
prescription of the information for which
test data are to be developed and any
analysis to be performed on such data. It
also includes the manner in which the
data are to be developed, the
specification of any test protocol or
methodology, and any other
requirements needed to provide
assurance of the reliability aad
adequacy of the data. These standards
should be differentiated from analytical
standards, which are reference chemical
materials used to calibrate aad
quantitate specific substance*.
a. Centra/ analytical method
consideration. The analytical
procedures specified in this final rule for
the quantitative measurement of HDDs/
HDFs in commercial products include:
(1) The quantitative extraction or
partitioning of the analytee frosn the
commercial product (2) separation of
the HDDs/HDFs from interferences
present in the extract: and (3)
separation, identification and
quantitatio.n of HDD/HDF congeners.
using high-resolution gaa
chromatography (HRGC) and Ugh-
resolution mass spectrometrjr (HRMS) or
low-resolution mass spectronetry
(LRMS). if it can be shown to be ss
effective as HRMS for a partialair
matrix
The most significant differ
analysis of HDDs/HDFs in i
products in comparison with
environmental and biological i
will be the extraction and cleanup
procedures. The physical and chemical
properties of environmental aad
biological matrices are typical*-
different enough from the properties of
the analytes to allow relative aaao of
separation. In contrast the cnsunarcial
products, in moat case*, may bat
structurally similar to the analytM.
complicating the separation aad
necessitating the complete raaapval of
the matrix to avoid interferancav in the
final determination (Raf. 24). Tie
analyst is therefor* confronted with a
choice of two basic option in achieving
final analysis: (l) The analyst can
develop sample preparation pnceduna
that effectively separata the coamerciai
product matrix from the HDOa/HDFs
that allow for LRMS analysis at the
LOQs designated m this final rate: or (2)
the analyst can elect to prepare samples
in which i>ome potential interference
remains, but rely on the resolvtag
capabilities of HRMS to dlstingauih the
difference from HDDs and HDFs and
in the
iijrcial
pies
potential interference at the LOQ. The
option for use of LRMS is viable only to
the extent that the analyst can
demonstrate that the LOQ specified in
this final rule can be achieved using this
method.
b. Detection method. In the proposed
rule. EPA chose HRCC/HRMS as the
analytical method of detection (see 50
FR 51801. unit IV.B.2.0.).
Comment 30; EPA has failed to
consider that the differences in the
nature of halogenated compounds would
present problems in loss of sample
during the detailed extraction and
cleanup procedures necessary to
prepare samples for analysis by HRCC/
MS. Dow states that extensive
experience exists with samples of the
chlorinated species, while very little
work has been done on the brominated
species. Dow predicts that problems
with chemical reactivity and heat and
light stability will present major
problems in preparing these brominated
species for analysis. (Dow p. 14: CMA p.
45).
Response to Comment 30: EPA agrees
with these observations, and. based
partly on these comments, has extended
the required reporting deadline for
submission of study plans for the
analysis of totally brominated
compounds for an additional year after
the effective date of this final rule. The
deadline for reporting the results of
analyses of these compounds is within 6
months after EPA review of these study
plans.
EPA has extended these deadlines
because of the lack of experience in
analyzing brominated compounds for
HDDs/HDFs at these low levels. An
extension of a year will provide time to
modify and perfect for brominated
compounds the methods used to analyze
chlorinated compounds. The additional
time also allows more freedom in
scheduling available laboratory capacity
to perform these analyse*.
Comment 31: Dow noted that the
HRMS recommended for testing would
not scan the atomic mas* unit rang* but
would use single ion monitoring.
Because of the difference in atomic mass
between chlorine and bromine. Dow
asserts, many of the instruments used
for molecular ion* up to •
octachlorodioxin* and octachlorofuran*
are not suitable for any brominated
materials above the tribrominated
compound* (e.g., tetra thru hepta). This
will result in the necessity of procuring a
separate instrument for detection of the
chlorinated and brominated congener*.
Dow note* that their instrument a
quadrupole mas* spectrometer with
molecular ion capability up to 600
atomic mass units, would allow ar.aiv; s
up to and including the pentabrommatea
congeners, but would not allow similar
analysis of hexa- or heptabrommated
congener*. (Dow p. 14).
Response to Comment 31: EPA agrees
that Dow may need a separate
instrument to analyze for higher
brominated HDDs/HDFs. but notes that
newer quadrupole instruments capable
of extending detection at the higher
atomic mass units required for the
brominated HDDs/HDFs are available
(Ref. 36). EPA recognizes that the
analyses of these compounds can
possibly best be achieved using
magnetic sector focusing instruments.
This final rule does not define the
resolution mode (increment of mass/
mass of interest) necessary to complete
the analysis. Since HRMS magnetic
sector instruments may be operated :n
either high or low resolution muu'es. the
analyst has the opportunity :o der.r.e
instrument parameters to meet the
requirements for a specific analysis.
This does not mean that
manufacturers required to analyze
brominated dioxina and furans must
make large additional investments m
new intnunentation solely for the
purpose of completing analyses for these
chemicals. EPA expects thauhese
manufacturers will make arrangements
to contract these analyses out or lease
time on available instruments using
their own analytical support staff to
perform analyses, rather than commit
the funds necessary to purchase these
instruments.
c. Method sensitivity. As EPA
discussed in the proposed rule a chief
concern in using any analytical method
is the ability to achieve the desired level
of detection/quantitation.
Comment 3Z There is a definite
possibility of decreasing analytic
sensitivity as the analyses for the more
highly substituted HDDs/HDFs are
attempted. There are three reasons for
this predicted loss in sensitivity: (l) The
additional halogens will result in lower
volatility and thus greater tendency for
the compound to either adsorb or find
cold sites in the column, thereby
preventing elution or detection: (2] the
mass spectrometer will experience a
loss in sensitivity as the degree of
halogenation of a congener increases.
because the mass spectrometer detects
molecule*, rather than grams of
substance. Thus, higher halogenated
congener*, having fewer molecules than
lower halogenated congeners, will be
more difficult to detect and quantify (3)
a considerable additional loss m
sensitivity (40 to 50 percent) can be
expected in going from tetra to hepta
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21428 Federal Register / Vol. 52. No. 108 / Friday. June 5. 1987 / Rules and Regulations
halogenated congener* because, in the
case of the tetra halogenated congeners.
3 major molecular ions carry
approximately 38 percent of tbt ion
current, while in the hepta balogeuated
congener, a major molecular ion* carry
23 percent of the ion current. Th«M 3
factors can be expected to mult in a
loss of SO percent analytical leniitivity
m going from the tetra to the hepta
halogenated congeners. (CMA p. 24).
Response to Comment 32 EPA did. in
fact, consider this situation, and
generally agrees with this comment on
the loss of analytical sensitivity.
However. LOQs have been adjusted
based on toxicity of the congeners
relative lo the toxicity of 2.X7.3-TCDD.
This adjustment has allowed the LOQ
for the heptahalogenated dioxiiu to riM
to 100 ppb. 3 orders of magnitude leu
sensitive than that proposed. The LOQ
for all congeners higher than tetn have
been adjusted so that all an lew
sensitive than the 0.1 ppb and 1 ppb
proposed for HDDs and HOP*
respectively. These adjusted LOQs
should more than compensate for the
predicted lost of analytical sensitivity
for the higher halogenated congener*.
since the loss of analytical sensitivity
from tetra- to heptahalogenated is only
50 percent, and the adjusted LOQs offer
a level 3 orders of magnitude higher.
d. Quality assurance/Quality control
fQA/QCI procedures. In the proposed
rule. EPA specified QA/QC
requirements, including reproduceability
of r 10 percent for at least 2 analyses of
the same isotopically labeled HDDs/
HDKs spiked to a concentration of the
LOQ. and determination of the LOQ by
recovery within 70 to 130 percent of the
amount spiked for the internal
calibration standard which haa run
through the entire chemical analysis.
Otherwise documented corrective
actions must be taken and the sample
set must be rerun.
Comment 33. EPA has set QA/QC
requirements that are far too stringent
Grummet et al. reported in their review
of a human adipose study (Rel 7) that 8
of the world's most experienced
laboratories in HDD/HDP analysis
reported highly variable results (*4~
more than 50 percent higher or lower
than background and spiked level*).
Recovery of spiked samples ranged from
27 to 100 percent. Grummet et al. also
found that, although interlaboratory
agreement is good for experimental
work, many values still differ by 100
percent or more, even in matrices
(tissue) that are not nearly so difficult to
extract or cleanup as chemical product
samples. Experienced laboratories.
Grummet observes, have not achieved
reproducible spiked sample results
"within ±10 percent of each other," and
recoveries "within 70 to 130 percent of
the amount spiked." as EPA specified.
and such an expectation on replicate
samples at the LOQ specified is not
scientifically sound. Analytical chemists
always strive for narrow limits but
recognize that this cannot be achieved
unless they are operating orders of
magnitude above the LOQ since that
value is defined as the limit where they
can first assign a legitimate quantitative
number to the concentration. The
generally accepted lower limit of
recovery has been 90 percent and
changing mis percentage of required
recovery could greatly increase the
protocol development and the analytic
costs." (Dow p. 15-20 CMA p. 30).
Response to Comment 33: EPA agree*
that the reproducibility and recovery
requirements are overly stringent for the
LOQs specified, and. based on the
observations outlined above, will accept
an adjustment in precision to ±20
percent, and an adjustment in recovery
to 90 to 190 percent. The internal
standards added at initial sample
preparation are subjected to each phase
of extraction, separation and cleanup as
experienced by the native HDDs/HDFs
which may be present in the sample.
Thus, the final qoantitation asing the
ratio of response* of the native HDD/
HDF to the internal standard pain
compensates for the recovery through
the method.
e. Analytical standards. In specifying
HRGC/HRMS to perform the analysis in
the proposed rule, several possible
methods of quantitarion were examined.
based on analytical standards of 2.3.7,8-
HDD/HDF compounds in concentrations
similar to the concentration range of
interest (0.1 ppb for 2.3.7.8-HDDs and 1.0
ppb for 2,3.7.8-HDFs) found in chemical
products to be tested.
Quantitation using internal standards
was selected as the preferred method in
the proposed rule, because the use of
internal standards can provide
continuous monitoring of extraction
efficiency and method precision in the
analysis ef actual product samples; thu*
the .internal standard* may provide
information on matrix effect*. Since the
HDD and HDF compound* of greatest
concern an those substituted at the
2.3.7.8 position*. EPA specified that
these compounds (isotopically labeled)
be used aa reference standard* in the
proposed rule. These analytic standard*
an expected to be available from at
least one manufacturer at the time this
rule become* effective. (See comment*
to the proposed rule submitted by
Cambridge Isotope Laboratories).
Comment 34: CMA's review of the
availability of standards required
indicates only 1 of the required 30
brominated and 23 of the 30 required
chlorinated standards are available.
(CMA p. 38).
Response to Comment 34: EPA relies
on comments submitted by Cambridge
Isotope Laboratories in which its
president. Or. Joel Bradley, states that
all chlorinated and brominated
standards required in the proposed rule
will be available by the time this rule is
promulgated, with the possible
exception of 1.2.3.4.8J.8- and
l-2.3.4.7.8.9-HpBDF.
3. Period for submission of test data.
EPA proposed that manufacturers
subject to the testing requirements of
this rule submit protocols developed for
the analytical methodology within 6
months after promulgation of a final
rule, and that test results for the listed
chemicals be submitted no later than l
year after EPA review of protocols for
analytical methodology.
Comment 35: EPA should extend the
time for completing the analyses for all .
chemicals, and analyses for brominated
congeners should be extended even
more. All previous work has been done
on chlorinated compounds, snd even
that is state-of-the-art. In addition, the ;
brominated HDDs/HDFs are expected
to present additional problems such as
chemical reactivity and heat and light
instability. (CMA p. 45: Dow p. 13: Ethyl
p.l: Vulcan p.l; Ameribrom p.l: Great
Lakes p.l).
Response to Comment 35: EPA agrees
that the time should be extended for
development of orotocols. since most of
the method* development work will be
done during that period. However, the
time allowed for actual analysis, once
the method has been developed, can be
decreased from 1 year to 8 months.
Further. EPA agrees that additional time
is needed to adapt and develop methods
for analysis of the brominated
congeners, since very little work has
been done in this ana. Therefore. EPA
has adjusted the schedule for
development of method* and submission
of protocol* to 1 year for predominantly
chlorinated compound* and 2 years for
predominantly brominated compounds.
Time for analysis has been adjusted to d
months after EPA review of the protocol.
Comment 36. EPA should require
tiered testing within the testing scheme
for brominated chemicals so that
brominated diphenyl ethers are tested
before brominated phenolic* and their
derivative*, and so that
Tetrabromobisphenol-A is tested before
any of it* derivative*. The rationale for
this scheme Is that the more difficult
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Federal Register / Vol. 52. No. IPS / Friday, lane 5. 1987 / Rules and Reaulatior.s
11429
analytical problems posed by the
brominated diphenyi ethen will
facilitate the development of in
analytical method for the phenolic*), and
that Tetrabromobiiphenol-A a* the
parent compound should be tested
before its derivatives, since the only
source of HDOs/HDFs in the derivatives
would be from the parent compound.
(Great Lakes, pp. 44 thru SO).
Response to Comment 3& EPA agrees
with the expected difficulty of testing
diphenyi ethers, since the molecult is so
similar to the HDF molecule that
separation of the matrix will be difficult.
However, the logic of testing the more
difficult compound first seems reversed.
In any case, the decision about which
compounds to test first is an internal
management decision to be nude by
each manufacturer depending en the
circumstances. EPA has added an extra
year to the timetable for testing of
brominated compounds, and believes
each manufacturer should determine
testing priorities within that time.
EPA listed the derivatives of
Tetrabromobisphenoi-A because the
-contamination is expected to result from
manufacturing conditions the same as or
similar to those for the parent
compound, not as a result of a
contaminated feedstock, as would be
the case if the contamination is
expected to result from the parent
compound. However. EPA will leave
testing order or priority up to each
manufacturer.
4. Persons required to test Persons
required to test has been fully discussed
in the preamble to the proposed rule
under Unit IV.B.4. (SO FR 51803. Dee. 19.
1985). EPA has found that there is
insufficient data and experience upon
which to determine or reasonably
predict the effects of the manufacture.
processing, distribution in commerce.
use. and disposal of the chemicals
subject to the testing requirements of
this rule. Therefore, in accordance with
section 4(b)(3|(B) of TSCA,
manufacturers and processors are
responsible for testing.
It is expected that in all cases subject
to this rule, testing will be performed by
each of the manufacturers on the moat
appropriate grade of-the substance they
produce, and that part of the coat of
testing will be passed on to the
processors through the pricing
mechanism, thereby enaBlkig them to
share in the costs of testing. Section 4(c)
of TSCA permits a- manufacturer to
obtain exemptions- from testing if the
substance it produces is equivalent to a
test substance and testing the substance
would result in generation of duplicative
data. A manufacturer will not be
permitted to obtain an exemption based
upon another manufacturer's testing
unless it can demonstrate that the
substance it produces is equivalent to
the substance being tested. A
manufacturer must designate the test
substance it behoves is equivalent to the
substance it produces and submit
detailed, complete process and reaction
condition data to substantiate its claims
of equivalence.
Processors will be called upon to
sponsor testing only if manufacturers
fail to do so; however, in some cases
processors may be required to provide
reimbursement directly to those
sponsoring this tasting. If the
manufacturer does not submit a letter of
intent to perform testing within the 45-
day period. EPA will issue a notice in
the Federal Register to notify all
processors of the subject chemical The
notice will state that EPA has not
received letters of intent to perform
testing and that current processors will
have 45 days to submit either a letter of
intent to perform the test or an
exemption application for such testing.
Each processor who submits a letter of
intent to perform testing will be
obligated to submit a proposed study
plan and. ultimately, to perform testing.
If processors are required to sponsor
testing, they may apply for exemptions
from testing by submitting process data
to demonstrate equivalence.
If no manufacturer or processor
submits a letter of intent to perform
testing. EPA will notify all
manufacturers and processors, either by
notice in the Federal Register or by
letter, that all exemption applications
will be denied and that within 30 days
all manufacturers and processors will be
in violation of the rule until a proposed
study plan is submitted for required
testing.
5. Chemical screening methods. In the
preamble to the proposed rule. EPA
noted that all chemical screening
methods investigated were either aa
expensive as the required testing or
were unreliable. EPA requested
comments and information on the
availability of a screening method which
could be used to determine whether the
full-scale analysis would be necessary.
Comment 37: EPA should allow a
manufacturer to test for the most likely
congener to form based on predictive
reaction chemistry, and if that congener
was not quantifiable, discontinue further
testing. Dow cited an analytical effort in
which reaction chemistry predicted that
dichloro dioxins would predominate.
and analysis ratified that prediction.
(Dow p. 10: April 22 Transcript pp. 88
and 87).
Response to Comment 37: EPA find*
three drawbacks to this approach. First
the predicted congener may or may not
be formed according to the most
probable reaction pathway. For
example. In the case of
pentachlorophenol. reaction conditions
favorable to the formation of dioxm
should yield a predominance of
octachlorodioxins as reaction products:
yet a large number of lower chlorinated
dioxins sre routinely observed as well.
Additionally, under this scheme, a
significant level of s congener different
from that predicted or analyzed for
would never be measured or reported.
Finally, any chemical subjected to this
type of screen would have to undergo
extraction and cleanup identical to that
required for the required HDD/HOF
analysis. Because extraction and
cleanup comprise most of the testing
cost for a given sample, very little
economic advantage would be realized
by adopting such a screen.
Comment 33: EPA should allow a
screen for total dioxins at a level of 0.1
ppb. and. if none were found, the
chemical could be considered "clean."
with no further analyses necessary.
Response to Comment 38: EPA finds
this approach acceptable in terms of
evaluating the chemical from a potential
health risk standpoint, but EPA did not
propose this screen, believing'it
unacceptable to manufacturers m degree
of difficulty and cost of the method. As
noted above in the Dow comment, the
chemical subjected to such a screen
would necessarily undergo extraction
and cleanup procedures identical to a
sample prepared for the standard HDD/
HDF analytical methods now in use:
thus EPA believes no substantial cost
saving would be realized, and the
manufacturer could incur large
additional costs to test for congeners if
the screen resulted in HDDs/HDFs
above the level of 0.1 ppb.
EPA has not found a perfect chemical
screening method which is acceptable
both in terms of sensitivity and cost
effectiveness when compered to the
analytical approach outlined in this final
rule. However. EPA will consider results
from a screen for total HDDs/HDFs at a
level of 0.1 ppb for HDDs/HDFs. or 0.1
ppb for HDDs and 1.0 ppb for HDFs. for
which a protocol must be submitted and
reviewed by EPA. The screen must be
carried out using acceptable methods as
described in the protocol reviewed by
EPA.
Should EPA identify a chemical
screening method which it believes
suitable both in terms of sensitivity and
cost. EPA may amend this rule to permit
submission of results from that method.
Since the publication of the proposed
rule. EPA has further investigated the
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21430
F«d«ral Register / Vol. 32.-No. 106 / Friday. June 5. 1987 / Rules and Regulations
possibility of chemical screens and ha*
identified the following chemical
screening methods:
a Derivative testing. Thic method
relies on the conversion of lowar
halogenated dioxin or furao compound*
to the octahalogenated configuration
and the analysis for the praaeaca of
these octahalogenated species. At
present there is disagreement among
industry and academia as to the efficacy
and validity of this method as a
predictor or screen for higher
substituted PHDDs/PHDFs. primarily
because of the unresolved issue of yield
(e.g.. to what degree the conversion from
the lower halogenated to the
octarwlogenated configuration takes
place). At least one investigator.
however, has had limited success in
converting lower substituted PCBs to
fully substituted octachlorinated
biphenyi (Ref. 30).
b. Reverse phase chromatognphy
with LTV detector. A calculated LOQ of
0.167 ppb has been achieved on internal
standards (5ng/30g) of isotopically
labeled 2.3.7.8-TCDD (Kef. 36). EPA baa
not yet determined whether this method
is applicable as a chemical screen in
terms of reliability or laboratory
reproducibility on a consistent basis.
c. Short column CC with halogen
detector. The halogen detector is a very
sensitive instrument which relies on
electron capture or conductivity
detection to calculate the amount of
haloqenated species. The short column
CC can be used to separate other
interferences which are normally not
able to be isolated using standard
methods for sample extraction and
cleanup However, one investigator
reported that in using this method in
analyzing pentachlorophenol. the
chlorinated diphenyl oxide almost never
separated, often giving false positives in
the analysis.
d. Total CC separation with MS a
detector. This method relies on the
separation of the various PHDD/PHDF
homologs using gas chromatography.
after which mass spectrometry ia nied
to detect the individual homoiog. Tm* to
made possible by defining the "window
of separation" for each homoksj,
8. Bioanafytical tcnening ant/took b
the preamble to the proposed rule, EPA
noted that it had investigated
radioimmunoaaaay (Ref*. l and BY.
arylhydrocarbon hydnxylaae (AHH)-
induction (Refs. « and 28): cytosol
receptor assay (Ref. 2): aa early life
stage bioassay (Ref. 17) and an in'vitn
keraunization assay (Ret 20). Aa
outlined in the proposed rule, the
primary advantages of the
radioimntunoasaay. the AHH east the
cytosol receptor aaaay are relatively low
cost and rapidity. The disadvantage of
these techniques in general is that they
do not necessarily respond to specific
isomers of HDDs and HDFs: they
respond to other compounds such aa
haJogenatad bipheayla. axobenienes.
and nonhalogenated polynuclear
aromatic hydrocarbon*, and each
tachnique is leas sensitive than
available mechanical analytical
method*. The in rttro keratinization or
E.L& bioaasays more recently have
provided poaaibly more specificity for
determining the presence of 2.3.7.8-
HDDs/HDFs. Both technique* have been
demonstrated to give roughly
comparable results with HRGC/MS
analysis of total PCDDs and PCDPs in a
PCS fire soot (Ref. 16). and fly ash from
a municipal incinerator (Ref. 17).
h ia important to note that each of the
bioassay techniques is most senattlve to
the presence of 2.3.7.8>TCDD a* opposed
to other HDDs/HDFs. It is speculated
that the relative response to other HDD*
and HDFs might be dependent oa
halogen substitution in the 24.7.8
position* and ultimately to the toxic
potential of the compound. It is also
important to not* that me rang* of
compounds evaluated with each of the**
bioassay techniques ia somewhat
limited. EPA believe* that evaluation of
commercial products for the presence of
HDD* and HDFs with any of these
bioassay technique* could b* a valuable
screening tool, particularly to terms of
time and resources necessary for the
chemical preparation and mstrumental
analyse* of the** chemical*. At thia
time. EPA doe* not have sufficient data
to determine the adequacy of these
bioanalytical techniques and whether
they an sensitive enough to achieve the
level and specificity of detection
necessary to quantitate 2.3,7.8-HDD*/
HDP* at vary low levels. Additionally.
the economic advantage of these
method* relies in large measure on the
number of sample* run; only in large
(bulk) analyses would significant
saving* in cost be realized over other
recommended method* such aa GCM&
etc. For such bulk sample analyses, the
method also must be standardized in
term* of reproducibility and reliability;
it muet b* available for routine analyse*
on a large scale. Thee* methods, whila-
currently undergoing further
development, are not yet acceptable for
screening purposes.
. V. Ecooosaic Analysis of Final Rah
A. Estimated Cost of Testing Program
Under Section 4(oMlMA)
This portion of the preamble presents
EPA's estimate of the total coat of this
rule and reviews the potential
marketplace effects identified by EPA.
The estimated costs and expected
impacts are discussed in detail in the
economic analysis prepared in support
of this rufemaking. Mnch of the
information reviewed in the economic
analysis is CBI and is not available for
public review. This analysis is in the
mlemaking record for this rule. A non-
CBI version of the economic analysis
has been prepared and is available for
public review. Estimated coats and
expected economic impacts of the
rulemaking are summarized below.
Information incorporated in the
economic analysis we* found in a
variety of sources: a detailed account of
the specific information sources used in
the economic analysts ia available in the
public record. In brief. EPA contractors
initially provided estimates of the
production volumes, process, and uses
of each chemical, aa well as the identity
of each manufacturing or importing firm.
These data were verified by review of
the available technical tilers rare, and by
direct contact between EPA and
representatives of the manufacturing
firms. In those case* where information
was not available directly from industry
sources or from the literature, estimates
were made from the best available '
information. Much of the Information
submitted to the EPA from
manufacturer* was claimed confidential.
Assessment of the potential for
significant adverse economic effects on
the chemical industry aa a direct result
of this rule waa performed using EPA's
standard method for aMaaariag impacts
of TSCA section 4 tasting rule*. The
economic analysis eatiaata* the costs of
conducting the required testing and
evaluate* the potential for significant
advene economic impact aa a result of
these test cost* by examining foar
market characteristics of each chemical:
(l) Price sensitivity of demand. (2)
industry cost characteristic*. (3)
industry structure, and (4) market
expectations. If there is no indication of
significant advene effect for an
individual chemical, no farther
economic anaryci* is performed:
however, if a potential for significant
advert* impact i* identified for a
specific chemical, a more
comprehensive and detailed analysis to
conducted which more precisely review*
the magnitude and distribution of
expected impact on that chemical. In
keeping with the wont-ease cost
methodology incorporated in the
economic analysis, at each point in the
analysis when a wide range of costs
can be justified, a highest cost scenario
has been assumed so •* not to
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Federal Register / Vol. 52. No. 108 / Friday. June 5. 1987 / Rules and Regulations 21431
underestimate the potential burden
borne by the firms subject to testing.
Of tho 32 chemicals subject to this
testing rule, 12 have been identified as
chemicals currently being manufactured
or imported. Fourteen firms have been
identified as manufacturers or importers
of one or more of these twelve
chemicals. Because each manufacturer
uses a unique production process and
unique equipment and raw materials
which could lead to contamination of
the chemical by HDDs/HDFs. each
manufacturer/importer is required to
test its own chemical product. In total
32 unique chemical products have been
identified by EPA as subject to this
testing rule.
The total cost for performing the
requisite testing on the 32 chemical
products is estimated at $2.37 million.
This estimate of the total cost of the
testing program is composed of three
elements: development of analytical
methods for the determination of HDDs/
HDFs in the subject chemicals, synthesis
of analytic standards, and the analysis
of each sample.
1. Methods Development. Testing for
the specified HDD/HDF congeners in
commercial chemical products will
require that methodologies for preparing
and testing samples be developed for
each chemical. Testing firms are free to
use the most cost effective method of
clean-up and analysis that they can
identify to meet the test requirements
and QA/QC requirements. EPA believes
that it is in the best interest of the
testing firms to coordinate their method
development activities in order to
minimize total cost.
EPA estimates that the upper bound
cost for methods development for the
testing specified in this rule is $1.25
million. In the economic analysis for the
proposed rule, EPA estimated methods
development costs at $600,000. In
comments to the proposed rule, several
commeriters questioned this cost
estimate, including Great Lakes
Chemical Company, which claimed that
the actual methods development costs
would be equivalent to 10 person-years
of analytic chemist labor valued at
S125.000 per person-year. The total cost
for methods development would then be
$1.25 million. Due to the difficulty of
projecting costs prior to the performance
of the methods development, EPA has
adopted this estimate as a reasonable
upper bound.
2. Synthesis of analytical standards.
To conduct the sample analyses, any
requisite analytical standards which are
not available will have to be
manufactured. The acquisition cost for
commercially available standards are
included in the cost of each sample
analysis, but costs for synthesizing and
producing standards that are not
commercially available upon the
promulgation of the rule are a unique
cost of the rule. EPA estimates that there
will be no unique cost for analytic
standard manufacture due to this rule.
In the economic analysis supporting
the proposed rule, the cost for analytic
standards was estimated at $182.000.
This estimate was based upon the
manufacture of 18 standards which were
unavailable at that time. In comments to
the proposed rule, one commenter,
Cambridge Isotope Laboratories (CIL),
responded that CIL was in the process
of manufacturing for commercial sale
the 18 unavailable standards.
Subsequent communications between
EPA and CIL have demonstrated to the
satisfaction of EPA that the standards
are indeed available at this time.
Therefore, costs for the synthesis of
analytical standards due to this rule are
estimated at $0.
Other commenters to the proposed
rule commented that the costs for
analytic standard synthesis were
underestimated because EPA had not
taken into account additional (non
2.3,7.8-substituted) standards which
would be required to conduct the sample
analyses. EPA has concluded that there
will be no additional cost because the
additional standards are not necessary
to conduct the sample analyses.
3. Sample analyses. The total cost for
sample analysts is estimated at
approximately $1.12 million. Each
sample analysis is expected to cost from
$2.000 to $5,000, and each chemical
product may be analyzed up to 7 times
for an upper bound testing cost of
$35,000 per chemical product. An
estimated 14 manufacturers will test an
estimated 32 sample sets for
approximately $1.12 million.
Costs for sample analysis are lower
than the sample analysis costs
estimated in the economic analysis for
the proposed rule. Two factors account
for the reduced cost estimate. The
number of chemicals subject to testing is
smaller—12 commercially available
chemicals in the final rule as opposed to
the 14 commercially available chemicals
included in the proposed rule. Secondly,
additional information on
manufacturers/importers gathered in the
interim following the publication of the
proposed rule has shown that some
firms originally identified as
manufacturers or importers of some
chemicals are not current manufacturers
or importers.
B. Anticipated Economic Impact Under
Section i(a/(l}(A}
A review of the costs allocated to
each manufacturer and chemical
indicates that the probability of
significant adverse economic impact for
seven chemicals is very low. However.
the cost analysis indicates potential for
significant adverse economic impact for
the five remaining chemicals. These five
chemicals were therefore reviewed in
greater detail. After further
investigation, EPA has determined that
the likelihood of adverse economic
impact of three of the five chemicals is
low. Each of the five chemicals is
discussed below. Specific costs
allocated to each chemical and the
impact level calculated for each
chemical are not reported here, in most
cases, because the data used in the cost
calculations are CBI.
1. Tetrabromobisphenol-A Diacrylate.
The calculated impact level for
Tetrabromobisphenol-A (TBBPA)
diacrylate indicates that the probability
of adverse economic impact is very high.
Further investigation into the market
characteristics of this chemical indicates
a high likelihood that the chemical will
be withdrawn from the market by its
manufacturer, ARCO Specialty
Chemicals. ARCO did not submit
comments to the proposed rule;
however, direct contact between EPA
and a representative from the
manufacturer verified that TBBPA
diacrylate is a low volume specialty
flame retardant which has been
manufactured on-a developmental basis
only. The annualized allocated test costs
for TBBPA diacrylate are confidential,
but are believed to be higher than the
manufacturer's annual revenue from the
product. Given these costs. Horsehead
Industries, which recently acquired
ARCO Specialty Chemicals, will
probably cease manufacture and
distribution of the chemical if faced with
the testing costs.
2. 2.3,5,6-Tetrachloro-2.5-
cyclohe\adiene-1.4-dione (Chloranil).
The estimated costs allocated to the
chemical chloranil raise the probability
of adverse economic impact. Further
investigation of the market
characteristics of chloranil indicates
that firms importing small amounts of
chloranil may cease importation
(similarly, firms which have in the past
imported chloranil may be prevented
from re-entering the market) due to the
testing costs. One or more firms
importing chloranil in significantly
higher volumes will be able to provide
any necessary supply displaced from the
other firms.
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21432
Federal Register / Vol. 52, No. 108 / Friday. June 5, 1987 / Rules and Regulations
Six firms are believed to be current or
recent importers of chloranil; however,
only one or two of the importing firms
arc also chloranil manufacturers. The
other importers purchase their supply of
chloranil directly from the
manufacturing firm(s). Due to the small
volumes believed to be imported by the
non-manufacturing firms, the annualized
allocated test costs represent a
substantial proportion of the revenue
attributable to chloranil. Therefore, it is
anticipated that the non-manufacturing
importers will exit the market (or avoid
re-entering the market) rather than
contribute to the testing program. The
firm(s) which are both manufacturers
and importers will then provide the
additional supply of chloranil and pay
for a greater portion of the testing costs.
The importing firms which may be
displaced from the market are among
the smallest firms subject to this
rulemaking. However, these firms import
relatively small quantities of chloranil,
and none are financially dependent
upon chloranil. Withdrawing from the
market for chloranil (or remaining out of
the market) will not adversely affect any
of the non-manufacturing importers.
3. Tetrabromobisphenol-A-Bis-2.3
dibromopropylether.
Tetrabromobisphenol-A-Bisctho\ylate,
and Allylether of Tetrabromobisphenol-
A. The estimated testing costs allocated
to each of these three chemicals
indicated the possibility of significant
adverse impact. Additional investigation
into the market characteristics of each
chemical indicates that the probability
of significant adverse impact is low.
Much of the information upon which this
conclusion is based is CBI and is
therefore not available for public
review. In general, this conclusion is
based upon the following observations:
(l) Each of these three chemicals is a
brominated flame retardant. Demand for
brominated flame retardants has
expanded rapidly, and market
expectations for brominated flame
retardants are optimistic; (2) EPA
believes that demand for each of these
chemicals is relatively insensitive to
changes in price because of a lack of
substitutes which are comparable in
terms of price and/or performance: and
(3) The structure of the markets for each
chemical supports the conclusion that
the testing costs will not cause a
significant adverse impact.
C. Testing Costs as a Barrier to Market
Entry
After this rule takes effect, any firm
wishing to initiate manufacture of any of
the 32 subject chemicals will incur costs
for methods development and sample
analysis. These costs will serve as a
barrier to entry into the markets for
these chemicals. This effect will be most
significant for firms wishing to initiate
production or importation of only a
small volume of one of the subject
chemicals. However, the regulation
provides an opportunity for obtaining
waivers from testing in certain
circumstances.
D. Costs of Reporting Under Section 8
1. Section 8(a): The costs of reporting
under section 8(a) are minimal. Under
the section 8(a) rule, submission of four
different sets of reports are specified: (1)
Submission of production process and
reaction conditions for chemicals
identified as precursors; (2) submission
of certain existing data for the 32
chemicals listed for testing in this rule;
(3) production volume, process and
reaction conditions, use, exposure, and
disposal data for chemicals testing
positive for HDDs/HDFs: and (4)
process and reaction conditions on
chemicals testing negative for HDDs/
HDFs may be required by EPA if any
other manufacturer of the same
chemical discovers HDD/HDF
contamination.
Three unique sets of information will
be submitted for the four reporting
categories outlined above. The first set
will be reported by firms manufacturing
or importing a chemical which tests
positive for HDDs/HDFs. These firms
must report to EPA on production
volume, use, exposure, disposal, and
process conditions under which their
products are manufactured. The second
set consists of firms manufacturing or
importing any of the 32 chemicals
subject to testing for which quantitative
analyses for HDDs/HDFs has already
been conducted. These firms will be
required to report test results and test
protocols, and the firms will fall into the
first set if the results submitted indicate
HDD/HDF contamination. The third set
is composed of processors ofprecursor
chemicals and manufacturers/importers
of chemicals free from HDD/HDF
contamination when at least one
manufacturer or importer of the same
chemical tests positive for HDD/HDF
contamination. Processors ofprecursor
chemicals will be required to submit
data on process and reaction conditions
for their chemical. If manufacturers/
importers "of chemicals free from HDD/
HDF contamination are required to
report, that determination will be made
in a rulemaking following the receipt
and evaluation of the testing data.
Reporting on previously conducted
tests should cost reporting firms from
$273 to $546 for each chemical
previously tested (Ref. 37). Those costs
include from 2 to 4 hours of managerial
i hour:
csJtfB
m
/Htt
labor to review the rule, 4 to 8 hour:
technical labor to collect the tes
methodology data, and 2 to 4 h/
clerical labor. Any firms report*
positive identification of HDD/HE
contamination will also be subject t>
costs detailed below.
Firms subject to reporting due to
positive results indicating contamin.
must report the following informatk
chemical production volume, use,
process and reaction conditions.
disposal, and exposure data. This
information should be submitted on
EPA form printed under § 766.64. It
estimated that completion of this foi
will require from 40 to 80 hours fron
industrial chemist and 1 process
engineer (Ref. 37). In addition, 4 to i,
hours of managerial time will be
required for initial review of the rul.
legal review of the rule, and final re
of the form. Four to 8 hours of cleric
time will be required for completior
the form. For firms reporting on mul
chemicals, managerial and clerical
may be a one time cost. The direct (
of filing the form will range from $1.
to $3,214 per chemical (Ref. 37).
Firms required to report because
manufacture a chemical made from
precursor chemical listed in this rul>
must provide their production anj
process and reaction conditions
direct costs of filing the form w\
the range of $944 to $2,551. The i
based on the contribution of from 2
60 hours of labor from 1 industrial
chemist and 1 process engineer, plu
managerial labor to review the
information and clerical labor to pi
the submission (Ref. 37).
2. Section 0(cj: Submission of twi
of adverse reaction conditions are
specified in this rule. Any reports o
significant adverse reactions to HD
HDFs must be submitted by
manufacturers of any of the 32
chemicals listed for testing in this i
Once the testing has been conducti
those firms finding a positive test n
indicating contamination by HDDs
HDFs for any of the 32 chemicals \\
subject to the second part of the se
8(c) Data Call-In for reports of
significant adverse reactions to the
chemicals testing positive for HDD
contamination.
Of the 32 chemicals subject to th
rule, an indeterminate number may
identified as contaminated with HI
HDFs. Without knowing the numbt-
firms which currently maintain rec
of significant adverse reaction due
HDD/HDF contamination and the_
number of contaminated chemijj
precise costs of the section 8(cf
requirement cannot be determir
us rul
and
e cw
I the
iir^|
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Federal Register / Vol. 52. No. 108 / Friday. June 5. 1987 / Rules and Regulations 21433
costs for any individual firm required to
report will be composed of the following
elements: review of the rule, file search
for records subject to reporting, review
of any records identified for CBI, costs
for copying identified records, and the
cost for submission to EPA.
Both fixed and variable costs will be
incurred by each firm manufacturing or
importing a chemical identified as
contaminated with HDDs/HDFs. It is
estimated that for each firm reporting, 1
to 2 hours of managerial labor will be
expended to review this rule, and 3 to 6
hours of technical labor will be
expended to search files for reports of
significant adverse reactions. For each
such report located, the reporting firm
will incur clerical costs to reproduce and
prepare the document for submission
and additional managerial costs to
review the report for CBI. The direct
costs for each firm subject to this Data
Call-In will be from $150 to $300, plus
$00 per 10 page report submitted (Ref.
38).
Every firm subject to the initial
section 8(c) requirement will incur costs
to review the rule and conduct a file
search. If any reports are located.
preparation and review of the response
to the Agency will entail additional
costs. Firms manufacturing or importing
chemicals which test positive for HDD/
(IDF contamination will also incur coats
for review of the rule, file search, an
response to the Agency. Though the
firms subject to the second part of the
section 8(c) requirement have reviewed
the rule previously to respond to the first
reporting requirement, it is assumed that
rule review and file search will be
repeated because of the time lag
between initial response and completion
of testing. The maximum total fixed cost
for the initial response will be from
S2.260 to $4,520 plus $80 per report of a
significant adverse reaction (Ref. 38).
Total cost of the section 8(c)
requirement for contaminated chemicals
will depend upon the number of
contaminated chemicals.
3. Section 8(d): Submission of two sets
of unpublished health and safety studies
are specified in the rule. Any
unpublished health and safety studies
for HDDs/HDFs must be submitted by
manufacturers of any of the listed
chemicals. Once testing has been
conducted, firms finding positive results
of HDD/HDF contamination will be
subject to this section 8(d) rule. Of the
chemicals subject to this rule, an
indeterminate number may be"
contaminated. Without knowing the
number contaminated, the precise costs
of the call-in cannot be determined.
Companies subject to this rule must
conduct file searches, copy the studies.
list studies in progress or known but not
in posession of the respondent, and
review the studies for CBI. Both fixed
and variable costs will be incurred by
each firm manufacturing or importing a
chemical identified as contaminated. It
is estimated that for each reporting firm,
1 to 2 hours of managerial labor will be
expended for initial review of this rule,
and 3 to 8 hours of technical labor will
be expended to search files for
unpublished health and safety studies.
Compiling and transcribing lists of
studies should take no more than 1
additional hour of clerical labor. For
each study located, the reporting firm
will incur additional clerical costs to
reproduce and prepare the document for
submission, and additional managerial
costs to review the report for CBI. The
direct costs for each firm subject to this
section 8(d) requirement will be from
$170 to $320, plus $80 per 15 page study
submitted (Ref. 39). Additional costs
may be incurred for submission of on-
going or newly initiated studies.
Every firm subject to the initial
reporting of unpublished health and
safety studies will incur costs to review
the rule and conduct a file search. If any
reports are located, preparation and
review of the response to EPA will
entail additional costs. Firms
manufacturing or importing chemicals
testing positive for HDD/HDF
contamination will also incur costs for
review of the rule, file search, and
response to the Agency. Firms subject to
the second part of the section 8(d)
reporting will have reviewed the rule
previously to respond to the first
requirement, but it is assumed that rule
review and file search will be repeated
because of the time lag between initial
response and test completion.
The maximum total fixed cost for the
initial response will be from $2.540 to
$4,810 plus $80 per study submitted (Ref.
39). Total cost of the section 8(d)
requirements for HDD/HDF
contaminated chemicals will depend
upon the number of chemicals testing
positive for contamination.
VI. Availability of Facilities
Section 4(b)(l)(C) of TSCA requires
that in the development of a test rule the
Administrator consider "the reasonably
foreseeable availability of the facilities
and personnel needed to perform the
testing required under the rule."
Pursuant to this requirement, EPA
conducted a survey of commercial
analytic testing laboratories to
determine the availability of facilities,
equipment, and personnel necessary to
perform the tests outlined in this final
rulfi (Ref. 41).
A list of 57 laboratories was compiled.
consisting of 17 laboratories with
current contracts under the EPA's
Superfund Contract Laboratory Program,
and 40 laboratories from the 1984
Directory of the American Council of
Independent Laboratories. Twenty-five
laboratories (the 17 EPA contract labs
and 8 others chosen at random) were
contacted by telephone.
The laboratory capacity survey
identified a number of commercial
analytical testing laboratories with high
resolution GC/MS systems and
experience using these systems, though
not necessarily experience with
detecting HDDs/HDFs in commercial
chemical products. In written comments
to the proposed rule and in a subsequent
public meeting, industry representatives
staled that testing 14 chemicals in 1 year
would strain the capacity of qualified
testing laboratories. EPA considered
these comments, and in response, is
extending the proposed time limit for
submission of test results for the 10
brominated chemicals by 1 year.
Information gathered in support of this
final rule shows a reduced likelihood of
straining the capacity of qualified
testing laboratories to perform the
requisite analyses. In the proposed rule,
14 chemicals were included in the list of
commercial chemicals subject to testing
requirements. EPA projected that 54 sets
of samples would require testing. For
this final rule, only 12 commercial
chemicals are subject to testing, and
EPA projects that 32 sets of samples will
be tested.
In addition to the commercial
laboratories identified in the laboratory-
capacity survey, CMA has submitted a
list of qualified laboratories in its
comments on the replicability of testing
results. Supplemented by non-
commercial laboratories (i.e.,
universities and in-house laboratories of
major chemical companies) such as
those identified by CMA, and given an
extra year to complete the analyses on
approximately one-half the number of
samples projected in the proposed rule,
testing should proceed without any
restrictions due to capacity availability.
VII. Section 8 Reporting
A. Reporting Under Section 8(a)
Under section 8(a)(l)(A) of TSCA,
EPA may require chemical
manufacturers and processors to
maintain such records and submit such
reports as the Agency may reasonably
require. The information to be submitted
is that which is known to or is
reasonably ascertainable by the person
making the report (section 8(a)(2j).
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21434 Federal Register / Vol. 52. No. 108 / Friday, June 5. 1987 / Rules and Regulations
Further, section 8(a)(l)(A) generally
exempts small manufacturers and
processors from recordkeeping and
reporting requirements, except in certain
limited circumstances. Of particular
relevance to this rule, section
8(a)(3)(A)(ii) authorizes EPA to override
the small manufacturer exemption for
chemicals subject to a rule proposed or
promulgated under section 4 of TSCA.
Section 8(a)(2j also notes that to the
extent feasible, EPA should not require
unnecessary or duplicative reporting.
Under section 8(a) of TSCA. EPA
proposed to require manufacturers of
chemicals listed for testing to submit
results of any testing, performed prior to
the effective date of this rule, which
shows concentrations of any HDDs/
HDFs in any of the chemicals listed for
testing. EPA also proposed to require
under TSCA section 8(a) that
manufacturers of any chemical in which
a positive test result is reported, report
production volume, process and reaction
conditions, exposure, use, and disposal
data on the EPA Form 7910-51, printed
under § 766.30(e)(5) in the proposed rule.
Also under TSCA section 8(a), EPA
proposed to require manufacturers
(except small manufacturers as defined
under § 766.3) of any chemical
manufactured using any of the
chemicals listed as precursors to report
production volume, process and reaction
conditions, use, exposure, and disposal
data for each such chemical, using the
Dioxin/Furan Report Form.
Comment 39: EPA should not require
extensive production and process
information on precursor chemicals and
should set a level of production below
which information need not be
submitted. The reporting required in the
proposal is excessive (Kodak p. 2).
Response to Comment 39: EPA
partially agrees with this comment, and
has set the level of production suggested
by Kodak below which information need
not be submitted. EPA disagrees about
the need for production and process
information: only with this data can EPA
determine whether other chemicals
should be listed for testing. To lessen
reporting requirements for chemicals
made from precursors, EPA has
eliminated all reporting of production
volume, use, exposure, and disposal
data, which is not needed for the
decision to require testing. EPA's intent
is to discover whether any additional
chemicals are manufactured under
conditions that could produce HDDs/
HDFs. For this purpose, only process
and reaction condition data are needed.
Since EPA has allowed an exemption
from testing for chemicals produced in
annual quantities of 100 kilograms or
less for research and development
purposes, it is reasonable to allow the
same exemption for chemicals produced
from precursor chemicals. Such
chemicals would not become testing
candidates. Therefore, a responsible
official from any chemical manufacturer
may certify that a chemical produced
from a listed precursor is produced in
quantities of 100 kilograms or less per
year, and used only for research and
development purposes, in lieu of
submitting process and reaction
condition information for that chemical.
Comment 40: EPA should specify the
conditions which favor HDD/HDF
formation and require reporting only in
situations where contamination is likely,
to reduce the reporting burden. (Kodak
p. 2; p. 1 in comment to proposed
amendment adding additional
precursors; EDF p. 3 in comments to
proposed amendment adding additional
precursors; CMA p. 8 in comments to
proposed amendment adding additional
precursors).
Response to Comment 40: These
conditions are set out and discussed in
the support document (Ref. 43) used by
EPA to select chemicals for testing.
These conditions have been applied to
confidential process and reaction data
sent to EPA by several manufacturers
seeking to convince EPA that these
conditions are not present during the
manufacturing process for their
chemicals. In reviewing the process data
submitted, EPA discovered several
borderline decision points, and made
decisions based not on a single factor.
such as heat, but on a combination of
factors, including duration of the
process, composition of the reaction
vessel, presence of oxygen, etc. If EPA
set out specific temperature, pressure,
and alkalinity conditions, it could miss a
large body of data that would be
borderline, and for which non-
submission could be justified. Therefore.
EPA prefers to make decisions on
whether there are additional chemicals
which are candidates for testing. EPA
has eliminated most of the reporting
requirements and kept only the process
and reaction condition data needed to
determine, on a case-by-case basis,
whether a chemical is manufactured
under one condition or a combination of
conditions that may lead to HDD/HDF
contamination.
Comment 41: EPA should consider a
small quantity exemption for specialty
and research and development purposes
for both chemicals to be tested and for
precursor chemicals. A reasonable cut-
off for this purpose is 100 kilograms per
. year. (Kodak p. 2).
Response to Comment 41: EPA agrees
with the small quantity exemption for
research and development portion of
this comment, and has added such
exemption in this final rule. EPA
believes it is not likely that a cher
produced in small quantities for
research and development purposes wi
cause an unreasonable risk, based on
the expectation that persons using sue!
a chemical will be trained to recognize
and protect against potential hazards
from such chemicals. Therefore, EPA
has added an exemption for both test
chemicals and chemicals made from
precursors which are produced in
quantities of 100 kilograms or less per
year, and which are used for research
and development purposes. Such a
determination cannot be made for
specialty chemicals not used only for
research and development, however,
without knowing specifically how such
chemicals are used and could be used.
B. Reporting Under Section 8(c) of TS(
Under section 8(c) of TSCA. EPA
proposed to require manufacturers of
chemicals listed for testing to submit
reports of significant adverse reactions
alleged to have been caused by HDDs,
HDFs. EPA also proposed to require
manufacturers of chemicals listed for
testing to submit. 90 days after
submission of a test result showing^!
contamination by HDDs/HDFs abH
the appropriate LOQ. reports of ^8
significant adverse reactions alleged tt
have been caused by the chemical
tested. All such submissions were to
follow the procedures set out in 40 CF1
Part 717.
The comments received on
submission of allegations of significan
adverse reactions asked for clarificati(
of the requirements. Clarification of
these requirements has been made in
this final rule.
C. Reporting Under Section 8(d) of
TSCA
Under section 8(d) of TSCA. EPA
proposed to require any chemical
manufacturers to submit health and
safety studies on any HDDs/HDFs, ai
manufacturers of chemicals listed for
testing for which contamination abovi
any LOQ is reported to submit, 90 daj
after submission of the positive test
result, all health and safety studies on
the tested chemical. All submissions
were required to follow the procedure
set out in Part 716 of this Chapter.
Comments received on reporting
under section 8(d) of TSCA requeste^
clarification of requirements. Such
clarification has been made in
rule.
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Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations 21435
VIII. Relationship to Section 12(b) of
TSCA
Section 12(b)(l) of TSCA provides for
notification to the Administrator of any
intention to export any chemical for
which submission of data is required
under section 4 of TSCA or section 5(b)
uf TSCA. The Administrator is required
to notify the government of any country
to which export occurs of the nature of
the requirement and the availability of
data submitted to the Agency for that
chemical.
Regulations requiring notification to
EPA of export or intended export of any
chemical for which data are required
under TSCA section 4 are codified at 40
CFR 707.60 through 707.75. They specify
who must notify the Agency, when
notification takes place, the required
contents of the notice, and permission to
assert a claim of confidentiality for any
of the information. EPA has interpreted
section 12(b) of TSCA and the
regulations under 40 CFR.707.60 through
707.75 to apply at the time a rule is
promulgated under section 4 of TSCA.
(See 45 FR 82850, December 16,1980).
However, the regulations and statute do
not specify a time when such
notification requirements will cease.
Comment 42: EPA's interpretation of
its regulations requires export
notification at the time a testing
requirement is issued under section 4 of
TSCA, rather than at the time when data
resulting from those requirements are
available. Such notification will unfairly
stigmatize a chemical, and should be
delayed until testing shows levels of
HDDs/HDFs above the LOQs. (CMA at
pp. 46 and 47).
Response to Comment 42: EPA
continues to believe that its previously
published interpretation of section 12(b)
and its regulations are appropriate.
Notification will commence in
accordance with applicable regulations.
El'A's notice to foreign governments,
however, will state that the Agency is
only testing for potential contamination
and is not imposing regulatory
constraints on these chemicals. The
intention of the notice will be to avoid
making any statements which unfairly
stigmatize the chemical. EPA has
concluded that it should specify for this
rule circumstances under which
notification requirements under section
12(b) may be terminated for specific
chemicals.
The results of the testing required
under this rule will yield definite
results—either they will show
contamination by HDDs/HDFs or no
contamination by HDDs/HDFs at the
target LOQs. If contamination of a
specific substance produced by a
specific processes shown, it is
appropriate to continue to require export
notification under section 12(b) so that
foreign governments can be provkled
with the testing results. However, if
there is no contamination shown at the
target LOQs for a spjecific substance
produced by a specific process, there is
no further concern for adverse health
effects resulting from HDD/HDF
contamination of that substance and,
thus, no reason for the manufacturer to
continue notification to EPA, or for EPA
to continue to notify the foreign
governments about that manufacturer's
exports.
Accordingly, EPA has concluded that
it is appropriate to amend its section
12(b) rule to end notification
requirements in such situations. The
amendment to 40 CFR Part 707 adding a
new § 707.72 provides that when test
results showing that a specific
substance produced by a specific
process has no HDDs/HDFs above the
target LOQs are submitted to EPA under
this test rule, export notification to EPA
is no longer required of any person who
is exporting that substance produced by
that process.
IX. Compliance and Enforcement
The Agency considers failure to
comply with any aspect of a section 4
rule to be a violation of section 15 of
TSCA. Section 15(1)(A) of TSCA makes
it unlawful for any person to fail or
refuse to comply with any rule or order
issued under section 4. Section 15(3) of
TSCA makes it unlawful for any person
to fail or refuse to: "(A) establish or
maintain records, (B) submit reports,
notices, or other information, or (C)
permit access to or copying of records
required by this Act or a rule" issued
under TSCA.
Additionally, TSCA section 15(4)
makes it unlawful for any person to fail
or refuse to permit entry or inspection as
required by section 11. Section ll(a)
applies to any "establishment, facility,
or other premises in which chemical
substances or mixtures are
manufactured, processed, stored, or held
before or after their distribution in
commerce. . . ." The Agency considers
a testing facility to be a place where the
chemical is held or stored and.
therefore, subject to inspection.
Laboratory inspections and data audits
will be conducted periodically in
accordance with the authority and
procedures outlined in TSCA section 11
by duly designated representatives of
the EPA for the purpose of determining
compliance with any final rule for
chemicals listed under § 766.20. These
inspections may be conducted to verify
that testing has begun, schedules are
being met, reports accurately reflect !hc;
underlying raw data and interpretations
and.evaluations, and to determine
compliance with TSCA Good
Laboratory Practices (CLP) standards
and the test standards established in the
rule.
EPA's authority to inspect a testing
facility is also derived from section
4(b)(l) of TSCA, which directs EPA to
promulgate standards for the
development of test data. These
standards are defined in section 3(12)(B)
of TSCA to include those requirements
necessary to assure that data developed
under testing rules are reliable and
adequate, and to include such other
requirements as are necessary to
provide such assurance. The Agency
maintains that laboratory inspections
ere necessary to provide this assurance.
Violators of TSCA are subject to
criminal and civil liability. Persons who
submit materially misleading or false
information in connection with the
requirement of any provision of this rule
may be subject to penalties which may
be calculated as if they never submitted
their data. Under the penalty provision
of section 16 of TSCA, any person who
violates section 15 could be subject to a
civil penalty of up to $25.000 for each
violation with each day of operation in
violation constituting a separate
violation. Knowing or willful violations
could lead to the imposition of criminal
penalties of up to $25,000 for each day of
violation and imprisonment for up to 1
year. In determining the amount of
penalty, EPA will take into account the
seriousness of the violation and the
degree of culpability of the violator as
well as all the other factors listed in
section 16. Other remedies are available
to EPA under section 17 of TSCA. such
as seeking an injunction to restrain
violations of TSCA section 4.
Individuals as well as corporations
could be subject to enforcement actions.
Sections 15 and 16 of TSCA apply to
"any person" who violates various
provisions of TSCA. EPA may. at its
discretion, proceed against individuals
as well as companies themselves. In
particular, this includes individuals who
report false information or who cause it
to be reported. In addition, the
submission of false, fictitious, or
fraudulent statements is a violation
under 18 U.S.C. 1001.
X. Rulemaking Record
EPA has established a record for this.
rulemaking (OPTS-B3002). This record
includes basic information considered
by the Agency in developing this final
rule and appropriate Federal Register
notices.
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2143G Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations
This record includes the following
kinds of information:
1. Federal Register notices pertaining
to this rule.
2. Study of availability of test
facilities and personnel.
3. Economic analyses.
4. Communications before proposal
consisting of written public and intra- or
interagency memoranda and comments
and summaries of telephone
conversations.
5. Reports—published and
unpublished factual materials.
6. Comments received in response to
the proposed rule and the proposed
amendment to the rule from the
following organizations:
Ameribrom. Incorporated
Cambridge Isotope Laboratories. Inc.
Chemical Manufacturers Association,
Inc.
Dow Chemical Company
Eastman Kodak Company
Ethyl Corporation
Environmental Defense Fond
Great Lakes Chemical Company
Imperial Chemicals. Inc.
Platte Chemical Company
Uniroyal Chemical. Inc.
Vulcan Chemicals. Inc.
Worker's Institute for Safety and Health
2.4-D Task Force
CB1, while part of the record, is not
available for public review. A public
version of the record, from which CBI
has been deleted, is available for
inspection in the OPTS Reading Room.
NE-G004. 401 M St.. SW.. Washington.
DC. from 8 a.m. to 4 p-rn., Monday
through Friday, except legal holidays.
XI. References
(1) Albro et al. "A Radioimmunoassay for
Chlorinated Dibenzo-p-Dioxins." Toxicology
and Applied Pharmacology. 50:137-148.1979.
(2) Bandiera et al. "Polychlorinated
dibenzofurans (PCDFs): Effects of structure
on binding to the 2.3,7,8-TCDD cytosolic
receptor protein. AHH induction and
toxicity." Toxicology. 32:131-144.1984.
(3) Bandiera et al. "Competitive binding to
cytosolic 2,3,7,S-TCDD receptor Effects of
structure on the affinities of substituted
halogenated biphenyls—a QSAR analysis."
Biochemical Pharmacology. 32:3803.1983.
(4) Bellin. J.S.. Barnes D.G.. "Health Hazard
Assessment for Chlorinated Dioxins and
Dibenzofurans Other than 2,3,7,8-TCDD."
Presented at the Symposium on advances in
health risk assessment for systemic toxicants
and chemical mixtures. Cincinnati. Ohio.
October 25.1984.
(5) Bomberger et al."Hexachlorobenzene:
Chemistry of formation andjdentified
sources." SRI draft report to USEPA. Office of
Pesticides and Toxic Substances. Contract
No. 68-02-3978.1984.
(6) Bradlaw, |.A, Casterline J.L.. Culture: A
Rapid Screen for Detection of Planar
Polychlorinated Organic Compounds."
Journal of Association of Official Analytical
Chemistry. 62:904-916. 1979.
(7) Grummet et al. Review and Trends in
the Analysis for PCDD/PCDF. Dow Chemical
Company Analytical Laboratories. 1986.
(8) Cull et al. "Polychlorodibenzo-P-Dioxins
and Dibenzofurans in Technical
Pentachlorophenol-Results of a Collaborative
Analytical Exercise." Chemospherc, 13:
10:1157-1165.1984.
(9) Czuczwa et al. "Potychlorinated
Dibenzodioxins and Dibenzofurans in
Sediments front Siskiwit Lake. Isle Royale."
Chemosphere. 14:6/7:623-626.1985.
(10) Czuczwa. J.M., Hites, R. A.
"Environmental Fate of Combustion-
Generated Polychlorinated Dioxins and
Furans." Environmental Science aad
Technology. 18:6:444-450.1984.
(11) Dioxins '84: Report on Dioxins. Update
to November 1984. Compiled by the Federal
Health Office, Federal Environmental
Agency. Federal Republic of Germany.
(12) Dow Chemical Company. Direct
testimony of David T. Buzzelli before EPA in
re: Docket No. 415 et al. Exhibit 810. Oct. 14.
1980.
(13) Dynamac Corporation. Environmental
Control Division. Pre-Regulatory Analysis of
Flame Retardants. EPA Contract No. 68-01-
6239. May 7.1982.
(14) Environmental Defense Fund and
National Wildlife Federation. Petition to EPA
to initiate rulemakings to prevent and reduce
environmental contamination by dioxins and
furans. October 22.1984.
(15) Esposito et al. USEPA. "Dioxins."
Cincinnati. Ohio. USEPA Industrial
Environmental Research Laboratory, EPA
600/2- 80-197.1980.
(16) Cierthy et al. "Application of an in
vitro Keratinization Assay to Extracts of Soot
From a Fire tn a PCB Containing
Transformer." In press. Fundamental ana"
Applied Toxicology. 1985.
(17) HelderT.H.. Seinen W..
"Standardization of an ELS Bioassay for
PCDDs and PCDFs." Chemosphere. 14:183-
193. 1983.
(18) Hoare et al. "Agricultural Herbicide
Use and Risk of Lymphoma and Soft Tissue
Sarcoma." Journal of the American Medical
Association. 256: 9:1141-1147. Sept 1986.
(19) Hutzinger et al. "Polychlorinated
Dibenzo-p-Dioxins and Dibenzofurans: A
Bioanalytical Approach." Chemosphere.
10:19- 25. 1981.
(20) Knutson. J.C.. Poland A..
"Keratinization of mouse teratome cell line
XB produced by 2.3,7,8-tetrachlorodibenzo-p-
dioxin: an in vitro model of toxicity." Cell
22:27-36.1960.
(21) Mason et al. "Polychlorinated
dibenzofurans (PCDFs) Correlation between
in vivo and in vitro structure-activity
relationships." Toxicology. 37:1.1985.
(22) McKinney et al. "Structure Specificity
and the Dioxin Receptor." Iru Chlorinated
Dioxins and Related Compounds: Impact on
the Environment." by Hutzmger et al. Ed.
Pergamon Prest, p. 367.1982.
(23) McKinney et al. "Development and
Reliability of a Radioimmunoassay for 2.37.8-
Tetrachlorodibenzo-p-Dioxin." In: Impact of
Chlorinated Dioxins and Related Compounds
on the Environment. Hutzinger, eds. Oxford:
Peragamon Press pp. 67-69.1981.
(24) Midwest Research Institute (MR1).
Guidelines for the Delermination of -
Polyhalogenated Dioxins and Dibenzofura^
in Commercial Products. EPA contract N<]^l
68-02-3938: MRI Project No. 8201-A(41). 1^
(25) Moore et al. "Comparative Toxicily of
3 Halogenated Dibenzofurans in Guinea Pigs.
Mice, and Rhesus Monkeys." N. Y. Academy
of Science Annual. 320. pp. 151-163.1979.
(26) Patterson et al. "2,3.7.8-
Tetraehlorodiberrzo-p-Dioxin Levels in
Adipose Tissue of Exposed and Control
Persons in Missouri." Journal of the
American Medical Association. Vol. 256.
19:2683-2686. November 21.1986.
(27) Poland. A, Knutson J.C.. "2.3.7,8-
Tetrachlorodibenzo-p Dioxin and Related
Halogenated Aromatic Hydrocarbons:
Examination of the Mechanism of Toxicity."
Annual Review Pharmacology and
Toxicology. 22:517.1982.
(28) Safe et al. Binding to the 2,3.7.8-TCDD
Receptor and AHH/EROD Induction: In vitru
QSAR. Banbury Report 18: Biological
Mechanisms of Dioxin Action. Cold Spring
Harbor Laboratory. 1984.
(29) Schwetz et al. "Toxicology of
Chlorinated Dibenzo-p-Dioxins."
Environmental Health Perspectives. 5:87-89.
1973.
(30) Thoma et al. "Polybrominated
Dibenzodioxins and Furans from the
Pyrolysis of Flame Retardants."
Chemosphere. Vol. 15, No. 5. pp. 649-652.
Pergamon Press. 1986.
(31) Thoma et aL "Polybrominated
Dibenzofurans (PBDF) and Dibenzodioxinjfl
(PBDD) from the Pyrolysis of Neat
Brominated Diphenylethers. Biphenyls a
Plastic Mixtures of These Compounds."
Chemosphere (In Press).
(32) USEPA OWRS. and OSWER. "Dioxin
Strategy." Washington. D.C. Office of Water
Regulations and Standards and Office of
Solid Waste and Emergency Response in
conjunction with the Dioxin Strategy Task
Force. 1983.
(33) USEPA. OW. "Ambient Water Qualiu
Criteria Document for 2.3.7,8-
Tetrachlorodibenzo-p Dioxin." Washington.
D.C. EPA 440/5-84-007.1984.
(34) USEPA. ORD. OHEA. and ECAO.
"Health Assessment Document for
Polychlorinated Dibenzo-p Dioxins."
September 1985.
(35) USEPA. Letter from Richard
Griesemer, Chairman. Dioxin Toxic
Equivalency Methodology Subcommittee. s>
Norton Nelson. Chairman. Executive
Committee, to Lee M. Thomas. Administral
EPA. November 4.1986. SAB-EC-87-008.
(36) USEPA OPTS and OTS. Personal
Communication from Dr. Stephen Billet. El'.
to Dr. Peter Tong. OTS. HERD. CREB. re:
Chemical Screening Methods for the
Detection of PHDDs and PHDFs. June 3.19H
(37) USEPA. OPTS. OTS and ETD.
Economic analysis of final section 8(a)
reporting rule for chemicals potentially
contaminated with potyhatogenated dibenz
p-dioxms and poly halogenated
dibenzofurans. December. 1986.
(38) USEPA. OPTS. OTS and ETD. A
Economic anaysis of final Data CalL-lnfl
TSCA section 8(c) of allegations of sigfl
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Federal Register / Vol. 52. No. 108 / Friday, June 5, 1987 / Rules and Regulations
21437
uilversu ro;u;tions for chemicals potentially
contaminated with polyhalogenated dibenzo-
p-dioxins and polyhalogenatcd
dibcnzufurans. December, 198«.
(39) USEPA, OPTS, OTS and ETD.
K'jonomic analysis for requirement under
TSCA section (d) for submission of
unpublished he'ilth and safety studies for
chemicals potentially contaminated with
polyhalogeniitcd dibenzo-p-dioxins and
polyhalogr;nated dibcnzofurans. December,
1986.
(40) USEPA. OPTS. Report of The Dioxin
Update Committee. Review of the
Toxicology, Unavailability,
Pharmacokinetics, Mechanism of Action, and
Human Risks Associated with Dioxins.
August 1986.
(41) USEPA, OPTS. OTS and ETD.
Economic analysis of final section 4 testing
rule for chemicals potentially contaminated
with polyhelogenated dibenzo-p-dioxins and
polyhalogonaled dibcnzofurans. January,
1987.
(42) USEPA, OPTS. OTS. Memo from
Denise M. Keehner, Chief, Chemical
Regulation Branch, Exposure Evaluation
Division, to the Rulemaking Record. May 4.
19«7.
(43) Versar, Inc. List of chemicals
contaminated or precursors to contamination
with incidentally generated polychlorinated
and polybrominated dibenzodioxins and
dibenzofurans. EPA contract No. 68-02-3968,
Task No. 48.1985.
XII. Other Regulatory Requirements
A. Executive Order 1229J
Under Executive Order 12291. EPA
must judge whether a regulation is
"Major" and, therefore, subject to the
requirement of a Regulatory Impact
Analysis. This test rule is not major
because it does not meet any of the
criteria set forth in section l(b) of the
Order. First, the effect on the economy is
not expected to exceed the advantages
to the public of testing 12 chemicals and
reporting on those contaminated, plus
some additional reporting. The total
costs of testing are expected to be S2.37
million. No significant increases in
prices are expected to occur as a result
of this rule, as reported in the economic
impact analysis. No significant adverse
effects are expected on competition,
employment, investment, productivity,
innovation or on the ability of United
States-based enterprises to compete
with foreign-based enterprises.
This final regulation was submitted to
the Office of Management and Budget
(OMB) for review as required by
Executive Order 12291. Any written
comments from OMB to EPA and any
EPA response to those comments, are
included in the rulemaking record.
D. Regulatory Flexibility Act
Under the Regulatory Flexibility Act
(15 U.S.C. 601 et seq.. Pub. L. 96-354,
September 19.1980), EPA Is certifying
that this test rule, if promulgated, will
not have a significant impact on a
substantial number of small businesses
because: (1) Very few small chemical
manufacturers and importers will be
required to test chemicals and report.
and (2) small manufacturers have been
exempted from a major reporting
requirement.
For this rule, the definition of small
business is the one codified at 40 CFR
704.3. For this certification, the total
annual sales figure of $4 million, or $40
million and less than 100.000 pounds
annual production was used as the
cutoff to denote small chemical
manufacturers and importers.
Of the firms likely to be required to
test, four qualify as small businesses.
These four firms do not represent a
substantial number of all small chemical
manufacturing firms. For each of these
four firms, amortized test and reporting
costs are projected to be less than 0.1
percent of annual sales, approximately
the same percentage experienced by
larger manufacturing and importing
companies.
C. Paperwork Reduction Act
OMB has approved the information
collection requirements contained in this
final rule under the provisions of the
Paperwork Reduction Act of 1980,44
U.S.C. 3501 et seq., and has assigned
OMB control numbers 2070-0033 for
reporting under section 4, 2070-0004 for
submission of health and safety studies
under section 8(d), 2070-0017 for
submission of allegations of significant
adverse reactions under section 8(c).
and 2070-0054 for submission of
information under section 8(a).
List of Subjects in 40 CFR Parts 707 and
766
Chemicals, Environmental protection.
Hazardous material. Health and safety,
Recordkecping and reporting
requirements, Significant adverse
reactions. Testing.
Da led: May 20,1967.
(oho A. Moore,
Assistant Administrator for Pesticides and
Toxic Substances.
Therefore, 40 CFR Chapter I is
amended as follows:
PART 707-[ AMENDED]
1. In Part 707:
a. The authority citation for Part 707
continues to read as follows:
Authority: IS U.S.C. 2611(b) and 2612.
b. By adding a new § 707.72 to
Subpart D to read as follows:
§ 707.72 Termination of reporting
requirements.
[a) The reporting requirements of
Subpart D of this Part are terminated for
certain specific chemical substances and
mixtures as set forth in this paragraph.
(1) When data required under Part 766
of this chapter have been submitted to
EPA for a specific chemical substance
produced by a specific process, and the
data show no positive test result as
defined in § 766.3 of this chapter,
reporting is no longer required by
persons who export or intend to export
that substance produced by that
process.
(2) [Reserved]
(b) (Reserved]
2. By adding Part 766 to read as
follows:
PART 766—OIBENZO-PARA-DIOXINS/
DIBENZOFURANS
Subpart A—General Provisions
S«x
76C.1 Scope and purpose.
766.2 Applicability and duration of this Part.
766.3 Definitions.
766.5 Compliance.
766.7 Submission of information.
766.10 Test standards.
766.12 Testing guidelines.
766.14 Contents of protocols.
766.16 Developing the analytical test
method.
766.18 Method sensitivity.
Subpart B—Specific Chemical Testing/
Reporting Requirements
766.20 Who must test.
766.25 Chemical substances for testing.
766.27 Congeners and LOQs for which
quantitation is required.
766 28 Expert review of protocols.
766.32 Exclusions and waivers.
766.35 Reporting requirements.
766.38 Reporting on precursor chemical
substances.
Authority: 15 U.S.C. 2603 and 2607.
§ 766.1 Scope and purpose.
(a) This Part identifies requirements
for testing under section 4 of the Toxic
Substances Control Act (TSCA). 15
U.S.C. 2603, to ascertain whether certain
specified chemical substances may be
contaminated with halogenated
dibenzodioxins (HDDs)/dibenzofurans
(HDFs) as defined in § 766.3, and
requirements for reporting under section
8 of TSCA, 15 U.S.C. 2807.
(b) Section 766.35(b) requires
manufacturers and processors of
chemical substances identified in
§ 766.25 to submit to EPA: (1) Any
existing test data showing analysis of
the chemical substances for
concentrations of HDDs/HDFs.
applicable protocols, and the results of
-------
21438 Federal Register. / Vol. 52. No. 108 / Friday, June 5. 1987 / Rules and Regulations
the analysis for HDDs/HDFs. (2)
allegations of significant adverse
reactions to HDDs/HDFs, compiled in
accordance with Part 717 of this chapter,
and (3) health and safety studies on the
HDDs/HDFs, in accordance with
applicable provisions of Part 716 of this
chapter.
{c) Section 7G6.35{a) requires
manufacturers and, under certain
circumstances, processors of chemical
substances identified in § 766.25 to
submit letters of intent to test and
protocols for the analysis of the
chemical substances for the presence of
HDDs/HDFs. Section 766.20 requires
these manufacturers and processors to
test their chemical substances for the
presence of HDDs/HDFs. Any
submissions must be in accordance with
the EPA Procedures Governing Testing
Consent Agreements and Test Rules
contained in Part 790 of this chapter and
any modifications to such procedures
contained in this Part.
(d) Section 766.32 specifies conditions
under which persons required to test
may request an exclusion or waiver
from testing.
(e) Deadlines for submission to EPA of
protocols, reports, studies, and test
results are specified in Part 790 Subpart
C and § 766.35.
(f) Sections 766.10.766.12, 766.14.
766.16, and 766.18 prescribe analytical
methods required; § 766.27 prescribes
target levels of quantitation (LOQ) for
each congener for which quantitation is
required.
(g) If results of existing tests or tests
performed under this Part indicate the
presence of HDDs/HDFs in the
identified chemical substance above the
LOQ specified in § 766.27. § 766.35(c)
requires the following additional
reporting on the specified chemicals:
production, process, use. exposure and
disposal data under section 8(a) of
TSCA: health and safety studies under
section 8(d) of TSCA; and reports of
allegations of significant adverse
reactions under section 8(c) of TSCA. In
some cases, additional reporting may be
required of manufacturers reporting no
contamination of the identified chemical
substances under § 766.35(c){2).
(h] Section 768.38 requires
manufacturers of chemical substances
produced from chemical substances
identified as possible precursors to
HDD/HDF formation, to report on
chemical substances produced from
such precursors..
§ 766.2 Applicability and duration of this
part
(a) Chemical substances subject to
testing. (1) This Part is applicable to
each person who, at any time during the
duration of this Part, manufactures
(and/or imports), or processes, a
chemical substance identified under
§ 766.25.
(2) The duration of this Part for any
testing requirement for any chemical
substance is the period commencing
with the effective date of this Part to the
end of the reimbursement period, as
defined in § 766.3. for each chemical
substance. All reporting requirements
for any chemical substance listed under
§ 766.25 shall be in effect for the same
period as the testing requirement.
(b) Precursor chemical substances. (1)
This Part is applicable to each person
who manufactures (and/or imports) a
chemical substance from any precursor
chemical substance identified in
§ 766.38.
(2) The requirement for precursor
reporting under § 766.38 shall be in
effect until three years after the effective
date of this Part.
(3) Small manufacturers are exempt
from reporting process and reaction
condition data on chemical substances
made from precursor chemical
substances listed under § 766.38.
§766.3 Definitions.
The definitions in section 3 of TSCA
and the definitions of §§ 704.3, 716.3,
717.3, and 790.3 of this chapter aho
apply to this Part.
"Congener" means any one particular
member of a dass of chemical
substances. A specific congener is
denoted by unique chemical structure,
for example 2.3,7,8-
tetrachlorodibenzofuran.
"Dibenzofuran" means any of a family
of compounds which has as a nucleus a
triple-ring structure consisting of two
benzene rings connected through a pair
of bridges between the benzene rings.
The bridges are a carbon-carbon bridge
and a carbon-oxygen-carbon bridge at
both substitution positions.
"Dibenzo-p-dioxin" or "dioxin" means
any of a family of compounds which has
as a nucleus a triple-ring structure
consisting of two benzene rings
connected through a pair of oxygen
atoms.
"Guidelines" means the Midwest
Research Institute (MRI) publication
Guidelines for the Determination of
Polyhalogenated Dioxins and
Dibenzofurans in Commercial Products,
EPA contract No. 68-02-3938; MRI
Project No. 8201-A(41), 1985.
"HDD" or "2.3,73-HDD" means any of
the dibenzo-p-dioxins totally chlorinated
or totally brominated at the following
' positions on the molecular structure:
2.3,7,8; 1.2.3.7.8:1.2.3.4.7.8; 1.2.3,6,7.8;
1.2.3.7,8,9; and 1,2.3.4,7,8,9.
"HDF" or "2,3.7.8-HDF" means any of
the dibenzofurans totally chlorinated
totally brominated at the following
positions on the molecular structure:
2,3.7,8; 1,2,3.7,8; 2.3.4,7.8; 1.2.3.4.7.8;
1,2.3,6.7,8; 1,2,3,7,8.9; 2,3,4.6.7.8;
1,2.3.4.6,7,8; and 1.2.3.4,7,8.9.
"Homolog" means a group of isomers
that have the same degree of
halogenation. For example, the
homologous class of tetrachlorodibenzo-
p-dioxins consists of all dibenzo-p-
dioxins containing four chlorine atoms.
When the homologous classes discussed
in this Part are referred to, the following
abbreviations for the prefix denoting the
number of halogens are used:
tetra-. T (4 atoms)
penta-, Pe (5 atoms)
hexa-. Hx (6 atoms)
hepta-, Hp (7 atoms)
"HRGC" means high resolution gas
chromatography.
"HRMS" means high resolution mass
spectrometry.
"Level of quantitation" or "LOQ"
means the lowest concentration at
which HDDs/HDFs can be reproducibly
measured in a specific chemical
substance within specified confidence
limits, as described in this Part.
"Polybrominated dibenzofurans"
refers to any member of a class of
dibenzofurans with txvo to eight brona
substituents.
"Polybrominated dibenzo-p-dioxin -,
"PBDD" means to any member of a class
of dibenzo-p-dioxins with two to eight
bromine substituents.
"Polychlorinated dibenzofuran"
means any member of a class of
dibenzofurans with two to eight chlorine
substituents.
"Polychlorinated dibenzo-p-dioxin" or
"PCDD" means any member of a class
of dibenzo-p-dioxins with two to eight
chlorine substituents.
"Polyhalogenated dibenzofuran" or
"PHDF" means any member of a class o
dibenzofurans containing two to eight
chlorine, bromine, or a combination of
chlorine and bromine substituents.
"Polyhalogenated dibenzo-p-dioxin"
or "PHDD" means any member of a
class of dibenzo-p-dioxins containing
two to eight chlorine substituents or twc
to eight bromine substituents.
"Positive test result" means; (1) Any
resolvable gas chroma tographic peak fo
any 2,3,7,8-HDD or HDF which exceeds
the LOQ listed under 5 766.27 for that
congener, or (2) exceeds LOQs approvei
by EPA under § 76&2S.
"Precursor" means a chemical
substance which is not contaminated
due to the process conditions under -
which it is manufactured, but becau
its molecular structure, and under
-------
Federal
Register / Vol. 52, No. 108 / Friday. June 5. 1987 / Rules and Regulations
21439
fuvorable process conditions, it may
or aid the formation of HDDs/
fcn other chemicals in which it is
i a feedstock or intermediate.
^" means quality assurance.
"QC" means quality control.
"Reimbursement period" means the
period that begins when the data from
the last test to be completed under this
Part for a specific chemical substance
listed in § 766.25 is submitted to EPA,
and ends after an amount of time equal
to that which had been required to
develop that data or 5 years, whichever
is later.
"TSCA" means the Toxic Substances
Control Act. 15 U.S.C. 2601 et seq.
§ 766.5 Compliance.
Any person who fails or refuses to
comply with any aspect of this Part is in
violation of section 15 of TSCA. Section
15(1) makes it unlawful for any person
to fail or refuse to comply with any rule
or order issued under section 4. Section
15(3) makes it unlawful for any person
to fail or refuse lo submit information
required under this Part Section 16
provides that a violation of section 15
renders a person liable to the United
States for a civil penalty and possible
criminal prosecution. Under section 17
of TSCA. the district courts of the
tes have jurisdiction
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21440
Federal Register / Vol. 52, No. 108 / Friday, June 5, 1907 / Rules and Regulations
reproducibly extracted, cleaned up, and
quantified to within ±20 percent of each
other. For each spiked product sample,
the signal to noise ratio for the
calibration standard peaks after
complete extraction and cleanup must
be 10:1 or greater. The recovery of the
internal calibration standards in the
extracted and cleaned up product
samples must be within 50 to 150
percent of the amount spiked, and the
results must be corrected for recovery.
Subpart B—Specific Chemical Testing/
Reporting Requirements
§776.20 Who must test
(a) Any person who manufactures.
imports, or processes a chemical
substance listed in § 766.25 must test
that chemical substance and must
submit appropriate information to EPA
according to the schedules described in
§ 766.35. Chemical substances
manufactured, imported or processed
between January 1.1984 and the date of
promulgation of this Part are subject to
testing upon the effective date of this
Part. All other chemical substances are
subject to testing immediately upon
manufacture, import or processing. EPA
expects that only manufacturers and
importers will perform testing, and that
the cost of testing will be passed on to
processors through the pricing
mechanism, thereby enabling them to
share in the cost of testing. However,
processors will be called upon to
sponsor testing should manufacturers
and importers fail to do so. A processor
may apply for an exemption from testing
upon certification to EPA that a
manufacturer or importer is testing the
chemical substance which that person
processes.
(b) If no manufacturer or importer
described in § 766.20 submits a letter of
intent to perform testing within the
period described under § 76G.35(a), or an
exemption application under § 790.45(a),
or a request for an exclusion or waiver
under § 766.32. EPA will issue a notice
in the Federal Register to notify all
processors of that chemical substance.
The notice will state that EPA has not
received any of the documents
described in the previous sentence, and
that current processors will have 30
days to submit either a letter of intent to
perform the test or submit an exemption
application.
(c) If no manufacturer, importer or
processor submits a letter of intent to
perform testing of a specific chemical
substance produced by a specific
process, EPA will notify all
manufacturers, importers, and
processors, either by notice in the
Federal Register or by letter, that all
exemption applications will be denied
and that within 30 days all
manufacturers, importers, and
processors will be in violation of this
Part until a proposed study plan is
submitted for required testing.
(d) Manufacturers, importers, and
processors who are subject to this Part
must comply with the test rule
development and exemption procedures
in Part 790 of this chapter, except as
modified in this Part.
§ 766.25 Chemical substances for testing.
(a) Listing of chemical substances.
Chemical substances required to be
tested for HDDs/HDFs under this rule
are listed in this section. The listing is
by Chemical Abstracts Service (CAS)
Number and common name.
Note.—For purposes of guidance only, EPA
lists the chemical substances subject to
testing under this Part in two classes—those
known to be manufactured or imported
between January 1,1984. and promulgation of
this Part, and those not known to be
manufactured or imported at the time of
promulgation of this Part.
(1) Chemicals substances known to be
manufactured between January 1,1984
and date of promulgation of this Part.
CAS No.
79-94-7
t18-75-2
118-79-6
120-83-2
1163-19-5
4162-45-2
21850-44-2
25327-89-3
32534-81-9
32536-52-0
37853-59-1
55205-38-4
Chemical name
Tetratxomobisphenol-A.
2.3.5.6-Tetrachloro-2.S-cydohexadiene-1.4.
dione.
2.4.6-Tribromophenol.
2.4-OichlofOphenol.
Decatxomodipnenyloxide.
Tetrabromobisphenol-A.bisetho«ylate.
TetrabronK>bisphenol-A-bis-2,3-dibromopropy1
ether.
Ally* ettier of tetrabromobisphenol-A.
Pemabromodiphenyloxide.
Octabromodiphenytoxide.
1.2-8is(tritxomopheno»y)-«thane.
Tetrabromobisphenol-A diacrylate.
(2) Chemicals not known to be
manufactured between January 1, 1984
and the date of promulgation of this
Part.
CAS No.
79-95-8
87-10-5
87-65-0
95-77-2
95-95-4
99-28-5
120-36-5
320-72-9
488-47-1
576-24-9
583-78-8
608-71-9
615-58-7
933-75-5
1940-42-7
2577-72-2
3772-94-9
37853-61-5
Chemical name
TetrachlofObispnenol-A.
3.4',5-Tribromosalicylanilide.
2.6-Oichlorophenol.
3.4-OichloTOphenol.
2.4.5-Tricnloroohenol.
2.6-Oibfomo-*-nitrophenol.
2[2.4-(Oichioropheno»y)l-propionic acid.
3.5-Oichkxosalicyclic acid.
Tetrabromocatechol.
2.3-Oichkxophenol.
2.5-Oichlorophenol.
2.4-Oibromophenol.
2.3.8-Tricnkxophenol.
4.Bromo-2.5-dich(orophenol.
3.S-Oitxomosalicyl«nilide.
PenttcMorophenrl laurale.
Blsmethytetner ol tetratxomobisphenol-A.
Alkylamine tetracNorophenate.
Teirabromobisphenol-B.
The^
yaM
tafl
on or
grades of the same chemical substance
only one grade need be tested. The
grade to be tested must be the gra
subject to the most intense heat a'
alkalinity for the longest duration i
time, manufactured under each differen-
process. If the heat, alkalinity and
duration of reaction do not differ for
various grades, the test substance must
be the grade of chemical substance will
the highest volume of sales. " -:.
§ 766.27 Congeners and LOQs for which
quantltation Is required. . ,.;v
Quantitation at the target LOQ showr
for each of the following HDDs/HDFs'
which may be present in the chemical
substances is required for the chemical
substances listed under § 766.25.
Analysis must take place for either '
chlorinated or brominated
dibenzodioxins or dibenzofurans, ';'\
whichever is predominantly expected d
occur in the chemical substance to be
tested. Only chlorinated and brominate
congeners need be quantified; for . .
chemical substances containing ' "
predominantly chlorine atoms, only
congeners totally chlorinated at the
numbered positions need be quantified;
for chemical substances containing .
predominantly bromine atoms, only'"'
congeners totally brominated at the vv
numbered positions need be quantiM
Chlorinated dioxins
2.3.7.8 TCOD
1 2378-PeCOO
1.2.3.4.7.8-HxCDO
1.2.3.6.7.8-HxCDD
1.2.3.7.8.9-HxCDD
1.2.3.4.6.7.8-HpCOD
2.3.7.8-TCOF
1.2.3.7.8-PeCOF
2.3.4,7.8-PeCDF
1.2.3.4.7.8-HxCOF
1.2.3.6,7.8-HxCOF
1.2.3.7.8.9-HxCDF
2 3 4 6 7.8-HxCOF
I.2.3.4.6.7.8-HPCOF
l.2.3.4.7.8.9-HpCOF
Brominated dioxins
2.3.7.8- TBDO
1.2.3.78*0800.... .....
1.2.3.4.7.8-HxBDO
1.2.3.6.7.8-HX80D
1.2.3,7.8,9-H«8DD
1.2.3.4.6.7.8-Hp80O
2.3.7.8-TBDF
1.2.3.7.8-Pe30f
2.3.4.7.8-Pe80F
1.2.3.4.7.8-Hx80F..
1.2.3.6,7,8-HxBOF
1.2.3.7,8.9-Hx80F
2.3.4.6.7.8-H«BOF
1.2.3.4.6.7.8-HpBOF
1.2.3.4.7.8.9-MpBDF
^^
0.1 ppb
0.5 ppb
2.5 ppb.
2.5 ppb.
2.5 ppb
100 ppb
1 ppb.
5 ppb.
5 ppb.
25 ppb.
25 ppb.
25 ppb
25 ppb
1 ppni.
1 ppni.
(b) Grade to be tested. If the same
process is used to manufacture all
§ 766.28 Expert review of protocols.
EPA will gather a panel of experts in
analysis of chemical matrices for HDD.
HDFs to review the protocols for testin
submitted to EPA. The panel members
will be employees of EPA and/or of
other U.S. Government agencies who
have had experience in analysis of
chemical matrices and/or chemical
wastes for HDDs/HDFs. The panel will
recommend to the Director, EPA Office
of Toxic Substances, whether the
protocol submitted is likely to allow
analysis down to the target LOQs, or if
not, whether the protocol represents a
good faith effort on the part of the i
to achieve the lowest possible LO(
The final determination to accept
mis a
etMft
4
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21440
Federal Register / Vol. 52. No. 108 / Friday, June 5, 1907 / Rules and Regulations
reproducibly extracted, cleaned up, and
quantified to within ±20 percent of each
other. For each spiked product sample,
the signal to noise ratio for the
calibration standard peaks after
complete extraction and cleanup must
be 10:1 or greater. The recovery of the
internal calibration standards in the
extracted and cleaned up product
samples must be within 50 to 150
percent of the amount spiked, and the
results must be corrected for recovery.
Subpart B—Specific Chemical Testing/
Reporting Requirements
§ 776.20 Who must test
(a) Any person who manufactures,
imports, or processes a chemical
substance listed in § 766.25 must test
that chemical substance and must
submit appropriate information to EPA
according to the schedules described in
§ 766.35. Chemical substances
manufactured, imported or processed
between January 1,1984 and the date of
promulgation of this Part are subject to
testing upon the effective date of this
Part. All other chemical substances are
subject to testing immediately upon
manufacture, import or processing. EPA
expects that only manufacturers and
importers will perform testing, and that
the cost of testing will be passed on to
processors through the pricing
mechanism, thereby enabling them to
share in the cost of testing. However,
processors will be called upon to
sponsor testing should manufacturers
and importers fail to do so. A processor
may apply for an exemption from testing
upon certification to EPA that a
manufacturer or importer is testing the
chemical substance which that person
processes.
(b) If no manufacturer or importer
described in § 766.20 submits a letter of
intent to perform testing within the
period described under § 760.35(a), or an
exemption application under § 790.45(a),
or a request for an exclusion or waiver
under § 766.32. EPA will issue a notice
in the Federal Register to notify all
processors of that chemical substance.
The notice will state that EPA has not
received any of the documents
described in the previous sentence, and
that current processors wil} have 30
days to submit either a letter of intent to
perform the test or submit an exemption
application.
(c) If no manufacturer, importer or
processor submits a letter of intent to
perform testing of a specific chemical
substance produced by a specific
process, EPA will notify all
manufacturers, importers, and
processors, either by notice in the
Federal Register or by letter, that all
exemption applications will be denied
and that within 30 days all
manufacturers, importers, and
processors will be in violation of this
Part until a proposed study plan is
submitted for required testing.
(d) Manufacturers, importers, and
processors who are subject to this Part
must comply with the test rule
development and exemption procedures
in Part 790 of this chapter, except as
modified in this Part.
§ 766.25 Chemical substances for testing.
(a) Listing of chemical substances.
Chemical substances required to be
tested for HDDs/HDFs under this rule
are listed in this section. The listing is
by Chemical Abstracts Service (CAS)
Number and common name.
Note.—For purposes of guidance only. EPA
lists the chemical substances subject to
testing under this Part in two classes—those
known to be manufactured or imported
between January 1.1984, and promulgation of
this Part, and those not known to be
manufactured or imported at the time of
promulgation of this Part.
(1) Chemicals substances known to be
manufactured between January 1.1984
and date of promulgation of this Part.
CAS No.
79-94-7
118-75-2
118-79-6
120-83-2
1163-19-5
4162-45-2
21850-44-2
25327-89-3
32534-81-9
32536-52-0
37853-59-1
55205-38-4
Chemical name
Tetrabromobisphenol-A.
2.3.5.6-Tetrachk>n>2.5-cyclohexadiene-1.4.
dione.
2.4.6-Tnoromophenol.
2,4-Oichlorophenol.
Oecabromodtphenyloxide.
Tetrabromobisphenol-A-bisethoxylate.
Tetrabromobisphenol-A-bis-2.3-dibromopropy1
ether.
Altyl ether of tetrabromobisphenol-A.
Pentabromodiphenyloxide.
Octabromodiphenyloxide.
1.2-Bis(tribrornophenoxy)-ethane.
Tetrabromobisphenol-A diacrylate.
(2) Chemicals not known to be
manufactured between January 1,1984
and the date of promulgation of this
Part.
CAS No.
79-95-8
87-10-5
87-65-0
95-77-2
95-95-4
99-28-5
120-36-5
320-72-9
488-47-1
576-24-9
583-78-8
608-71-9
615-58-7
933-75-5
1940-42-7
2577-72-2
3772-94-8
37853-61-5
Chemical name
Tetrachlorobisphenol-A.
3.4'.5-Tribromosalicylanilido.
2.6-Oichkxophenol.
3.4-Oichlorophenol.
2.4.5-Trichkxophenol.
2.6-&bfomo-4-oi(ropheool.
2[2.4-
-------
Federal Register / Vol. 52. No. 108 / Friday. June 5. 1987 / Rules and Regulations 21441
reject the protocol will be made by the
Director, Office of Toxic Substances.
EPA will review the submitted protocols
as rapidly as possible and will complete
the review within 90 days after receipt.
EPA may require submission of revised
protocols. Comments and
recommendations will be transmitted to
the submitter, and if revisions are
required, a final protocol must be
submitted to EPA within-90 days after
EPA transmits such recommendations.
§ 766.32 Exclusion* and waivers.
(a) Reasons for exclusions and
waivers. Any person subject to the
testing requirements of this Part may
request an exclusion or waiver from
testing for any one of the following
reasons:
(1) Exclusions may be gnwted if. (i)
Testing of the appropriate grade of the
chemical substance has already been
carried out, either analytical testing at
the lowest LOQ possible, with
appropriate QA/QC, or a well-designed
bioassay with appropriate QA/QC on
(ii) Process and reaction conditions of
the chemical substance such that no
HDOs/HDFs could be produced under
those conditions;
(2) Waivers may be granted if. (i) A
responsible company official certifies
that the chemical substance is produced
only in quantities of 100 kilograms or
less per year, only for research and
development purposes; or
(ii) In the judgement of EPA. the cost
of testing would drive the chemical
substance off the market, or prevent
resumption of manufacture or import of
the chemical substance, if it is not
currently manufactured, and the
chemical substance will be produced so
that no unreasonable risk will occur due
to its manufacture, import, processing.
distribution, use. or disposal. (In this
case, the manufacturer must submit to
EPA all data supporting the
determination.)
(iii) Waivers may be appropriately
conditioned with respect to such factors
as time and conditions of manufacture
or use. The grade of decabromodiphenyl
oxide produced by Dow Chemical
Company (Dow) for the National
Toxicology Program (NTP) bioassay on
that chemical is excluded from the
testing requirement under this Part.
Provided, however, that this exclusion
will not apply if Dow fails to supply to
EPA within 60 days of the effective date
of this section evidence showing which
grade was used for the NTPfeioassay.
(b) Timing. Exclusion or waiver
requests and detailed supporting data
must be submitted to EPA within 60
days from the effective date of this Part
for persons manufacturing, importing or
processing a chemical substance as of
the date of promulgation, or 60 days
prior to the date of resumption of
manufacture or import for a chemicaJ
substance produced by a specific
process if the chemical substance is not
manufactured, imported or processed as
of the date of promulgation.
(c) Publication. Within 10 days of
receipt of any exclusion or waiver
request, EPA •will issue in the Federal
Register a notice of such receipt. EPA
will also issue a notice of its decision on
each exclusion or waiver request within
60 days of receipt.
(d) Decision. The EPA Director of the
Office of Toxic Substances will make
the decision to grant or deny waivers or
exclusions.
§ 766.35 Reporting requirements.
(a) Letters of intent, exemption
applications, and protocols—(1) Letters
of Intent, (i) Persons who have
manufactured or imported chemical
substances listed under § 766.25
between January 1.1984, and the
effective date of this Part are required to
submit under § 790.45 of this chapter a
letter of intent to test or an exemption
application. These letters must be
submitted no later than September 3,
1987.
(ii) Persons who commence
manufacture, import or processing of a
chemical substance listed under § 766.25
that has not been manufactured,
imported or processed between January
1,1984 and the effective date of this Part
must submit under § 790.45 of this
chapter, within 60 days after the
commencement of manufacture, import,
or processing of the chemical substance,
a letter of intent to test or an exemption
application.
(iii) Persons who commence
manufacture, import or processing of a
chemical substance listed under § 766.25
between the effective date of this Part
and the end of the reimbursement period
for that particular chemical substance
produced by a specific process must
submit under § 790.45 of this chapter,
within 60 days after the commencement
of manufacture, import or processing of
the chemical substance, a letter of intent
to test or an exemption application.
(2) Protocols, (i) Each person who is
manufacturing or processing a chemical
substance listed in § 766.25 as of the
effective date of this Part who submits a
notice of intent to test under
§ 766.35(a)(l) must submit a protocol for
the test as follows:
(A) The protocols for each chlorinated
chemical substance produced by each
process to be tested must be submitted
to EPA no later than 12 months after the
effective date of this Part.
(B) The protocol for each brominated
chemical substance produced by each
process 1o be tested must be submitted
to EPA no later than 24 months after the
effective date of this Part.
(ii) For chemical substances produced
by a specific process not manufactured
or processed as of the effective date of
this Part, a person who begins
manufacture and submits a notice of
intent to test must submit protocols for
the test as follows:
(A) Protocols for testing must be
submitted 12 months after manufacture
begins for chlorinated chemical
substances.
(B) Protocols for testing must be
submitted 24 months after manufacture
begins for brominated chemical
substances.
(iii) For persons who have been
granted exemptions, waivers or
exclusions from testing, protocols must
be submitted 12 months after expiration
of the exemption, waiver or exclusion
for chlorinated chemical substances,
and 24 months after expiration of the
exemption, waiver or exclusion for
brominated chemical substances.
(b) Information that must be
submitted to EPA. (1) Persons who
manufacture or import a chemical
substance listed under § 766.25 must
report no later than October 5.1987 or
90 days after the person first
manufactures or imports the chemical
substance, whichever is later, the results
of all existing test data which show that
chemical substance has been tested for
the presence of HDDs/HDFs.
(2) Any manufacturer or importer of a
chemical substance listed in § 766.25 in
possession of unpublished health and
safety studies on HDDs/HDFs is
required to submit copies of such studies
to EPA no later than October 5.1987 or
90 days after the person first
manufactures or imports the chemical
substance, whichever is later. The
following provisions of Part 716 of this
chapter apply to submission of these
studies: §§ 716.3. 716.10(a) (1) and (4);
716.20(a) (1). (2), (3), (4). (7), (8) and (10):
716.25; 716.30; 716.35(a) (1). (2), and (4) (if
applicable]: 716.35 (b) and (c); 716.40 (a)
and (b); 716.50; 716.55; and 716.60(a)(2).
(3) No later than October 5,1987 or 90
days after the person first manufactures
or imports the substance listed in
§ 766.25, any manufacturer or importer
of a chemical substance listed in
§ 766.25 must submit records required to
be held under Part 717 of this chapter on
any HDDs/HDFs.
(4) Test results, (i) Test results must
be reported to EPA not later than 270
days after EPA's transmission of
comments or 180 days after a final
-------
21442 Federal Register / Vol. 52, No. 108 / Friday. June 5, 1987 / Rules and Regulations
protocol is submitted to EPA, whichever
is shorter.
(ii) For purposes of reporting test
results to EPA. and for further reporting
triggered by a positive test result under
§ 766.35{c), a positive test result is
defined at § 766.3.
(iii) Reporting of test results must
follow procedures set out in Part 790 of
this chapter, except as modified in this
Part.
(c) Information required to be
submitted to EPA after submission of a
positive test result. (1) Any person who
submits a positive test result for a
specific chemical substance listed under
§ 706.25 must submit to EPA no later
than 90 days after the date of
submission of the positive test result the
following:
(i) A completed form (EPA 7910-51)
for that chemical substance. The form
appears at paragraph (d)(5J of this
section and copies are available from
the TSCA Assistance Office. (TS-799),
Office of Toxic Substances, ....
Environmental Protection Agency, 401 M
St., SW., Washington, DC, 80460. One
form must be submitted for each
chemical substance for which a positive
test result has been submitted.
(ii) Health and safety studies for the
chemical substance for which a positive
test result has been reported. The
following provisions of Part 716 of this
chapter apply to submission of these
studies: §§ 716.3; 716.10 (a) (1), (2). (3)
and (4); 716.20; 716.25; 716.30; 716.35(a)
(1), (2), and (4). [if applicable]; 716.35 (b)
and (c): 716.40 (a) and (b); 716.50; 716.55;
716.60(a)(2).
(iii) Copies of records on the chei
substances required to be held undi
Part 717 of this chapter.
(2) If a positive test result on a
chemical substance is received fron
person but not from others, EPA m;i
issue a notice in the Federal Registc
listing that chemical substance and
requiring any person manufacturing
importing or processing that chemic
substance who has not submitted a
positive test result to submit the
information required in Part II of El
Form 7910-51 (appearing in § 76G.3f
Such a notice will be published onh
EPA needs additional process data
make a determination of unreasons
risk.
(d) Dioxin/Furan Reporting Form
BILLING CODE 6560-50-M
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Federal Register / Vol. 52. No. !08 / Friday. June 5, 1907 / Rales and Rog'ihitions
21443
P,l'|» I .» 6
c«iyH'Mifv,tim,ii
V>EPA
W.ishingion. DC 204CO
Dioxins/Furans Report
OWM 2Q70-0017
•A/Den completed. s«"d tins lorm 10.
Document Control Officer
Office of Toxic Substances, TS-793
US Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
For Agency Use Only
Document Control Number
Dock el Number
Part 1 — General Information
Section A — Submitter Identification
Mark (X) the "Confidential" box next to any subsection you claim as confidential.
Confi-
dential
1«. Person Name o) authorized official
SubTiitiing
Title
Company
Mailing address Inumber and street]
City. Slate, an) ZIP Code
Section B — Chemical Identity Information (Use a separate form for each chemical reported.)
Mark (XI the "Confidential" box next to any subsection you claim as confidential.
1 . Chemical name and CAS Registry Number
Part II — Process and Release Information
Section A — Flow Diagram
Mark (X) the "Confidential" box next to any subsection you claim as confidential.
Complete this section for each unit process. Provide a general process block (low diagram that identifies major unit
operations and treatment processes and indicate the types and points of release of byproducts and residuals. /See
example I attached./
(1) Include intermediates, coproducts and byproducts produced by the process.
(2i Proide a block (of each major unit operation (e.g.. reactor, washer, nitration, air emission control, aeration lagoon.
etc.I in the production process and in the residuals management process.
(31 Identify process input such as raw materials, reagents, and solvents by chemical or common name and CAS number,
and indicate the point of introduction with arrows
(4) For each unit operation in which the temperature is not ambient, specify temperature or temperature range in each
block of the flow diagram.
(5) Specify operating pressure or pressure range in each block of the flow diagram for each unit operation in which the
pressure is not atmospheric.
(61 Identify the composition o( the reaction vessel wherever one is used leg., stainless steel, glass lined/.
(7) Number all points in (he flow diagram from which the chemical substance will be released into thy environment.
(See example I)
LI Mark (x) this box if you attach a continuation she«?l
P^ fv.tm 7710 F-1 10 *««
-------
EXAMPLE I - PROCESS BLOCK FLOW DIAGRAM
PRODUCTION
PHENOL
CHLORINE
A1C1. CATALYST
CHLOROPHENOLS
RECYCLE
WASTEWATER TO
TREATMENT
T]
s.
50
(D
PENTACHLOROPHENOL
SPILLS. FLOOR SWEEPINGS
TO LANDFILL
STILL BOTTOMS
TO INCINERATOR
TREATMENT
WASTEWATER FROM
WASTEWATER
n r-NUM
CESSES
NEUTRALI-
ZATION
CLARIFIER
1 ^4\
PRODUCT: PENTACHLOROPHENOL
INTERMEDIATES: NONE
CO-PRODUCTS/BY-PRODUCTS: HCL
10% SLUDGE
TO LANDFILL
TREATED EFFLUENT TO
NPDES DISCHARGE
o
oc
-n
-i
a.
c
(t
tn
CO
O3
73
c.
cn
03
ro
•TO
C
O
3
-------
Federal Register / Vol. 52. No. 108 / Friilay. [nnf? 5, 19H7 / Rulos nnd Regulations
21445
P3Q-; 3 of (3
Section 8 — Environmental Release and Disposal
You must make separate confidentiality claims for thu release number and the amount of the substance released and oiher i eleasi* and disposal
information. Mark (x) the "Confidential" box next to each item you cljim 35 confidential.
.(1) — Enter the number of each release point (denuded in the process description, part II. Section A
(2| — Estimate the amount of the chemical substance released directly to tlie environment or intocontroltechnoiogytVr, ky.'dayar kg/batchl
(3) — Mark (x| this cofumn if entries in columns (1| and/ or (2| are confidential
(
-------
21446 Federal Register / Vol. 52. No. 108 / Friday. )une 5. 1987 / Rules and Regulations
Page 4 of 6
Part III — Production, Import, and Use Information
Mark f*t the "Confidential" box next to any item you claim as confidential.
1. Production volume — Report the production volume during the past 12 months of production. Also report the maximum
production volume lor any consecutive 1 2-month period during the past 3 years of production.
Past 12 -month production^/ year/ Manimum 12-month production (kg/yearl
Confi-
dential
2. Use Information — You must make separate confidentiality claims for the description of the category of use. the percent of production
volume devoted to each category, the formulation of the substance, and other use information. Mark (x)the "Confidential" box next to any
item you claim as confidential.
(1 ) — Describe each category of use of the chemical substance by function and application.
(2) — Mart (x| this column if entry in column (1 ) is confidential.
(3| — Estimate the percent of total production for the past 3 years devoted to each category of use.
(*l — Mark (x) this column if entry in column (3) is confidential.
(5) — Estimate the percent of the substance as formulated in mixtures, suspensions, emulsions, solutions, or gels as manufactured
for commercial purposes at sites under your control associated with each category of use.
(6) — Mark (x) this column if entry in column (5) is confidential.
(') — Mark (x) whether the use is site-limited, industrial, commercial, or consumer. Mark more than one column if appropriate.
(81 — Mark (x) this column if entries in column (7) are confidential.
Read the Instructiont Manual for examples.
Category of use
fl)
Confi-
dential
121
Production
(percent/
(31
Confi-
dential
(41
Formulation
(percent/
(51
Confi-
dential
(61
Mark M appropriate columnist
PI
Site-
limited
Indus-
trial
Com-
mercial
Con-
sumer
Confi-
dential
18)
l_l Mark (x) this box if you attach a continuation sheet.
3. Hazard Information — Include in the notice a copy or reasonable facsimile of any hazard warning statement, label.
material safely data sheet, or other information which will be provided to any person regarding
protective equipment or practices for the sale handling, transport, use, o< disposal ol th« new
chemical substance List in part IV any hazard inlormanon you include.
L_l Mark (K) this box if you attach hazard information
EPA Form 7710-51 (9-86)
-------
Federal Register / Vol. 52. No. 108 / Friday. June 5. 1987 / Rules and Regulations 21447
Page 5 ol 6
4. Occupational Exposure — You must make separate confidentiality claims tot the description of worker activity, physical form of lie
Substances, number ol workers e«posed. and duration of activity Mark («) the "Confidential " bo« next to any item you claim as confidential
(1)— Describe the activities in which workers may be exposed to (5)— Estimate the maximum number of workers involved in
the chemical substance. Include activities in which each activity
workers wear protective equipment 1C) — Mark («i this column if entry in column (5) is confidential
(2) — Mark (<) this column if entry in column (1) is confidential (7) and (81 — Estimate the maximum duration of the activity for
13) — Indicate the physical form(s) of the chemical substance at any worker in hours per day and days per y«ar.
the time of exposure. (9) — Mark (x) this column if entries in column (7) and/of (8) are
(4) — Mark (x) this column il entry in column (31 is confidential confidential
Worker Activity
in
Confi-
dential
121
Physical
Forms
131
Confi-
dential
141
Maximum number
151
Confi-
dential
(61
Maximum duration
Mrs/day
(71
Oays/yr
181
dential
19)
\ — 1 Mark (x) this box if you attach a continuation sheet.
EPA Form 771O-61 (9-86)
-------
21448
Federal Register / Vol. 52. No. 108 / Friday. lune 5, 1987 / Rules and Regulations
-» 6 o(6
Part IV — List of Attachments
Attach continuation sheets lor sections of the fo*m and optional information after this page. Clearly identify the attachment and the
section of the form to which it relates, if appropriate. Number consecutively the pages of the attachments. In column (2) below, enter the
inclusive page numbers of each attachment.
Mark («) the "Confidential" bo« neit to any attachment name you claim as confidential. Read the Instructions Manual for guidance on
how to claim any information in an attachment as confidential.
Attachment name
I'l
.
Attachment
page numbers
121
Confi-
dential
13)
LJ Mart (x) this box if you attach a continuation sheet. Enter the attachment name and number.
Certification
1 certify that to the best of my knowledge and belief:
1. The company named in part 1. section A. subsection la of this form manufactures, imports, or proceses.
other than in small quantities for research purposes, the substance identified in part 1. section B.
2. All information provided in this notice is complete and truthful as of the date of submission.
Signature of authorised official
Signature of agent lit applicable)
Date
Date
Confi-
dential
Confi-
dential
EPA Form 7710-61 (9-86)
-------
Federal Register / Vol. 52, No. 108 / Friday. June 5. 1987 / Rules and Regulations
21449
General
EPA Form 7710-51,
You must provide all information requested in this form to
the extent that it is known to or reasonably ascertainable
by you.
Part I — General Information
You must provide the chemical identity of the chemical
substance reported on, even if you claim the identity as
confidential.
Part II — Process and Release Information
You may need additional copies of part II. sections A and B
if there are several manufacture operations that you will
describe in the form. You should reproduce these sec-
tions as needed.
Part III — Production, Import, and Use Information
You must provide production volume, percent of produc-
tion used for each use category, and whether use is
industrial, commercial or consumer. Also included is a
copy of any hazard warning and a report of occupational
exposure. Copies may be made of any part of the form if
additional space is needed.
Part IV — List of Attachments
You should attach additional sheets if you do not have
enough space on the form to answer a question fully. In
part IV, list all attachments you include with the form.
Optional Information
You may include with the form any information that you
want EPA to consider in evaluating the substance.
Confidentiality Claims
You may claim any information in this form as confiden-
tial. To assert a claim on the form, mark (x) the "Confiden-
tial" box next to the information that you claim as confi-
dential. To assert a claim in an attachment, circle or
bracket the information you claim as confidential.
A. General Instructions
Complete the form using a typewriter or by printing legi-
bly in black ink. All information must be in English. Pro-
vide all information requested on the form to the extent
that you know or can reasonably ascertain it. You may
attach continuation sheets to any subsection or item on
the form. Mark (x) the appropriate box on the form if you
attach continuation sheets.
The use of the term "manufacture" in this form includes
both manufacture and import. Manufacturers and impor-
ters must fully comply with the information requirements
set forth in the Polyhalogenated Dibenzo-p-dioxins/
Dibenzofurans Testing and Reporting Requirements
Rule. However, importers are not required to submit any
data under section 8(a) of TSCA which relates solely to
exposure to humans or the environment outside the Uni-
ted States.
Any manufacturer or importer using this form may pho-
tocopy the form, sections of the form, or these instruc-
tions as frequently as needed.
Instructions
Dioxins/Furans Report
B. Certification
The official named in Part I, section A of the form, as the
person submitting the notice, must sign the certification
on page 6 of the form. This official is responsible for the
truth and accuracy of each statement in the certification.
C. Asserting Confidentiality Claims
A manufacturer or importer may assert a claim of confi-
dentiality for any information submitted to EPA on this
form. To assert confidentiality claims for specific informa-
tion on the form (e.g., submitter identity, process data, or
use information), mark (x) in the "Confidential" box on the
form located to the right of the information. Marking
these boxes will provide a quick reference for EPA to
determine what information is confidential, thus aiding
proper treatment of confidential business information.
Part I — General Information
Section A — Submitter Identification
Person submitting notice — Enter information on the
official who signed the general certification on page 6.
Section B — Chemical Identity Information
Chemical Name and CAS Registry Number — List the
common name and Chemical Abstracts Registry number,
if available, for the chemical on which you are reporting.
II. Process and Release Information
Section A — Flow Diagram
Flow diagram — Submit a block flow diagram for ea
major unit operation and treatment process involved
manufacturing the chemical on which you are reportin
Include the following information:
(1} identify the product process, and chemical interme-
diates, coproducts and byproducts produced by the
process;
(2) provide a block for each major unit operation (e.g.,
reactor, washer, filtration, air emission control, aera-
tion lagoon, etc.) in the production process and in the
residuals management process;
(3) identify all process input such as raw materials,
reagents, solvents, etc. by chemical or common name
and CAS number, and indicate the point of introduc-
tion with arrows;
(4) for each unit operation in which the temperature is
not ambient, specify temperature or temperature
range in each block of the flow diagram;
(5) specify operating pressure or pressure range in
each block of the flow diagram for each unit operation
in which pressure is not atmospheric;
(6) identify the composition of the reaction vessel
wherever one is used;
(7) number all points in the flow diagram from which
the chemical substance will be released into the envir-
onment. See the example provided.
I
EPA Form 7710-51 (9-86)
-------
21450
Federal Regi$ter / Vol. 52. No. 108 / Friday. June 5. 1907 / Rules and Regulations
Section B — Environmental Release and Disposal
Column (1) — For each release point indicated in the flow
diagram (part II, section A), enter the corresponding
number.
Column (2) — Estimate the amount of the chemical (in
kg/day for continuous operations or kg/batch for batch
operations) that will be released from the release point
before entering control technology. Base your estimate
on your maximum 12-month production volume.
Column (4) — Enter the medium (air. water, land) into
which the release stream discharges (whether or not
control technology is used).
Column (5) — For releases to the air and water, describe
the type of technology used (to control the release of the
chemical. Examples of control technologies include car-
bon filter, scrubber, and biological treatment (primary.
secondary, etc.). Give as complete a description as possi-
ble. Enter "none" if no control technology is used and the
substance is released directly to the environment. For
disposal on land, describe the landfill site construction
(including liners) and handling procedures. Describe
landfill containers.
Column(7)— Mark (x) the appropriate box and/or specify
other destinations of water releases.
Columns (3) and(6) — Note that you must make separate
confidentiality claims for the release number and amount
of chemical substance released and other release and
disposal information.
Part III — Production. Import, and Use Information
A. Production Information
Production volume — Report the production volume for
the past 12 months of production. Also report the maxi-
mum production volume for any consecutive 12-month
period during the past 3 years of manufacture. Provide
this information in kilograms. Include in your report the
amounts produced by persons under contract to you. If
part of the amount manufactured is for export, include
this amount in your reports.
B. Use Information
Column (1) — Identify each possible category of use of the
chemical substance by describing its function and appli-
cation. "Function" is related to the inherent physical and
chemical properties of the substance (e.g., degreaser,
catalyst, plasticizer, ultraviolet absorber). "Application"
refers to the use of the substance in particular processes
or products (e.g., a degreaser may be used for cleaning of
fabricated metal parts). Following are some examples of
how you should describe categories of use:
0 a disperse dye carrier for finishing polyester fibers
0 a cross-linking agent for epoxy-like coatings for metal
surfaces
0 a flame retardant for surface application on cotton
apparel, textile home furnishings, and exterior canvas
products
0 a surfactant in automobile spray wax
0 a colorant for paper and other cellulosics
Column (3) — Report the percent of the total production
volume during the past 12 months manufactured for each
category of use.
Column (5) T- Estimate the weight percent of the chemi-
cal substance contained in any formulated mixture, sus-
pension, emulsion, solution, or gel associated with each
category of use as manufactured for commercial pur-
poses at sites under your control. Where the substance is
distributed from your site neat, enter N/A for not
applicable.
For example:
Category of Use
Cross-linking agent
for epoxy type
coatings (or metal
surfaces
Flame retardant for
cotton apparel
Surfactant in
automobile
spray wax
Colorant for paper
and other
cellulosics
Formulated Pro-
duct as
Manufactured
none: distributed
neat
none: distributed
neat
spray auto wax
(suspension)
colorant (solution) 55
Percent of Chem-
ical Substance
N/A
N/A
Column (71 — Mark (x) to indicate if the category of use is
site-limited. Also mark (x) to indicate whether the use is
for industrial, commercial, and/or consumer use as
defined below. Mark more than one box, if appropriate.
For example, a surfactant in an automobile wax may have
a consumer use in liquid wax, a commercial use in auto
washes, and an industrial use by automobile manu-
facturers.
Site-limited: The substance is used only on the contig-
uous property unit where it is manufactured and not
intentionally distributed outside that site except for waste
disposal. This includes all factories, storage space, and
warehouses at the site. An example would be an inter-
mediate which is further reacted on-site to produce a
chemical product.
Industrialize chemical substance or products containing
the substance are used only at the site of other manufac-
turers or processors, e.g., textile dyeing, paint formula-
tion, use of a resin to manufacture an article.
Commercial: The chemical substance or products con-
taining the substance are used by a commercial enter-
prise providing a consumer service, e.g., use by commer-
cial dry cleaning establishments, use by painting
contractors, or use by roofers in commercial building
construction.
Consumer: The chemical substance or products contain-
ing the substance are used by private individuals in or
around a residence, or during recreation, or for any other
personal use or enjoyment, e.g., automotive polish, dyed
wearing apparel, household cleaners, etc.
Columns (2). (4), (6). 18) — Note that you must make
separate confidentiality claims for the description of the
category of use, the percent of production devoted to each
category, and other use information. The information in
this section is used to evaluate potential exposure of the
chemical. If you wish to provide any additional informa-
tion which would assist in this analysis, it may be submit-
ted as optional information.
EPA Form 7710-51 (9-86)
-------
Federal Register / Vol. 52. No. 108 / Friday. )une 5. 1907 / Rules and Regulations 21451
C. Hazard Information
Include with the form a copy or reasonable facsimile of
any hazard warning statement, label, material safety data
sheet, or other information which is provided to any per-
son regarding protective equipment or practices for the
safe transport, use or disposal of the chemical. Identify
any copies of hazard information or warnings that you
attach in Part IV, List of Attachments.
D. Occupational Exposure Information
Column 11) — Describe each specific activity in the opera-
tion during which workers may be exposed to the chemi-
cal. Such activities may include charging reactor vessels.
sampling for quality control, transferring materials from
one work area to another, drumming, bulk loading, chang-
ing filters, and cleaning equipment. Activities must be
described even if workers wear protective equipment or
clothing. (Recommended protective equipment should be
included as part of Hazard Information).
Column (3) — Indicate the physical form of the substance
at the time of exposure, e.g., solid (crystals, granules,
powder, dust), liquid (solution, paste, slurry, emulsion,
mist, spray), gas (vapor, fume), even if workers wear pro-
tective equipment.
Column (5) — Report the maximum number of workers
involved in each specific activity, based on the reported
maximum 12-month production volume.
Column (7) — Enter the maximum duration that any one
worker will engage in the activity in hours/day, e.g., 8
hours/day.
Column (8) — Enter the maximum duration that any one
worker will engage in the activity in days/year, based on
the reported maximum production volume, e.g., 200
days/year.
Columns (2). (4). (61. (9) — Note that you must make
separate confidentiality claims for the description of
worker activity, physical form of the chemical, number of
workers exposed, and duration of exposure.
Part IV — List of Attachments
Attach any continuation sheets for sections of the form
and any optional information, after the last page of the
form. Clearly identify the attachment and the section to
which it relates. Number consecutively the pages of the
attachments. Enter the total number of pages in the form
on the last line of the List of Attachments. Mark (x) the
"Confidential" box next to any attachment you claim as
confidential. See the section of these instructions titled
Confidentiality for guidance on claiming any information
confidential.
EPA Form 7710-51 (9-86)
BILLING CODE 656O-50-C
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21452 Federal Register / Vol. 52. No. 108 / Friday. June 5. 1987 / Rules and Regulations
Information collection
lirements under this section
ved by OMB are as follows:
CAS No.
Paragraph under 5 766.35
(b)
-------
.Alternative Methodology for
Acute Toxicity Testing
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
ornci or
fCSTICIDCI AND TOXIC SUBSTANCE:
SEP 22
Re: Revised Policy for Acute Toxicity Testing
Appended is a revised policy for evaluating the acute
toxicity of chemical exposures under the Federal Insecticide,
Fungicide and Rodenticide Act and the Toxic Substances Control
Act. This action builds upon a previous revision of the acute
toxicity testing strategy to reduce the use of experimental
animals while providing adequate information about chemical
safety.
The Environmental Protection Agency is disseminating this
notice to industry/ governmental bodies, scientific societies,
animal welfare groups and interested parties to apprise them of
our new position. The Agency's acute toxicity testing guidelines
are being revised to reflect the positions, articulated in this
policy.
Victor J.yTCimm
Acting Assistant Administrator
for Pesticides
and Toxic Substances
EAclosure
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Alternative Methodology for Acute Toxicity Testing
The Environmental Protection Agency announces a revision to
its approach to acute toxicity testing in fulfillment of actions
under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) and the Toxic Substances Control Act (TSCA). This
revision reflects the Agency's concern about animal welfare and
its continued efforts to reduce the impacts on animals of EPA's
testing requirements. While maintaining the tiered approach
adopted in 1984, the Agency now recommends (when appropriate) the
use of abbreviated test methods and consideration of using only
one sex, as a means of reducing the numbers of animals in
deriving important information on acute toxicity.
Background
EPA considers the evaluation of toxicity following short-
term exposure to a chemical (i.e., acute toxicity) to be a
limited but integral step in the assessment of the toxic
potential of a chemical substance under the regulatory framework
of its pesticide and toxic substances programs. The Agency also
supports measures dedicated to reduce the use of animals in
toxicity testing and conducts research on test methods which can
lead to further reduction or elimination of animal usage and
suffering. Through the careful selection of test methodology and
maximization of the data obtained from acute studies, EPA strives
to achieve a balance between the welfare of animals and the need
to utilize animals in evaluating chemical safety.
The approach to acute toxicity testing previously given
in EPA's Test Guidelines (U.S. Env. Prot. Agency, 1978; 1979)
emphasized the determination of the median lethal dose (L050)
with a 95% confidence interval. A 1984 update of the guidelines,
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published in 1985 (U.S. Env. Prot. Agency, 1985) stated that the
Agency discouraged the uses of the "classical" LD50 test
employing large numbers of animals for determination of lethality
only. Instead, the Agency emphasized the use of a tiered
approach to obtain acute toxicity data which reduced the number
of animals used, but maximized the amount of relevant
information that could be obtained from such testing. That
approach included the following:
a. Using Data From Structurally Related Chemicals. The Agency
encourages the review of existing acute toxicity information
on chemical substances that are structurally related to the
agent under investigation. Using this approach, one may be
able to compile enough information from these surrogate
chemicals to make preliminary safety evaluations that
reduce the need for further animal testing or which
indicate the type of testing to be pursued.
b. "Limit1* Test. When information on structural analogs is
inadequate, one should consider the "limit" test. The
relative toxicity of a chemical is determined by
professional judgement; for chemicals judged to be
relatively non-toxic, a single group of animals is given a
large dose of the agent. If no lethality is demonstrated,
no further testing for this information is pursued.
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c. Multifacated Testing. A three-dose multiple endpoint
evaluation may be important for those substances judged to
be relatively toxic or which demonstrate lethality in the
limit test. Using this procedure, animals are evaluated as
to the onset, duration, intensity, and reversibility of
behavioral effects, body weight changes and lethality; all
animals are submitted to gross necropsy. Histopathology and
certain follow-up studies may be warranted where there are
gross indications of target organ toxicity.
Present Revision.
EPA has reevaluated its data needs on acute toxicity and
continues to espouse the tiered approach that was developed in
the 1984 update. Thus, the first consideration for a chemical
for which there is no acute toxicity data, should be a review of
structurally related compounds, followed by the limit test when
appropriate. In those cases where testing beyond the limit test
is indicated, consideration should be given to well-designed
abbreviated test schemes which employ minimal numbers of animals,
as discussed below. In most cases, it is expected that these
tests can be structured to give enough information on acute
toxicity to obviate the need for further acute studies (e.g., the
three-dose multi-faceted testing approach). We continue to
stress the need for collecting information on behavioral
effects, gross pathology and lethality (as developed in "c"
above).
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While more complete animal testing may be necessary in some
cases (based on scientific evidence from the abbreviated test,
e.g., delayed toxicity, unusual central nervous system effects,
irreversible effects), the Agency generally supports limiting
such tests to those using the lowest feasible number of animals.
Several abbreviated methods to investigate acute toxicity
have been developed over the years. Some of them have rather
extensive data bases and have been validated against more
traditional test methods which estimate median lethal dose.
Their merit lies in the fact that they allow for the evaluation
of the full spectrum of acute responses; numerical calculations
can be made; and fewer animals may be employed in the generation
of the information than with most other approaches. For some
methods, statistical calculations are simple or are aided by
tables.
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5
EPA has investigated four methodologies that might be used.
These include (1) the approximate lethal dose method1 of
Deichmann and Le Blanc (1943); (2) the moving averages method2 of
Thompson (1947); (3) the up-and-down method3 of Dixon and Mood
(1948) and Dixon (1965); and (4) the cumulant method of Reed-
Muench4 (1938).
The methods vary as to the assumptions that are made, the
number of groups of animals and number of animals per group.
Toxicologists should be familiar with these differences before
employing a given method. For instance, the up-and-down method
is especially difficult to apply when chemicals induce delayed
toxic effects. Therefore, other methodologies may be more
appropriate. When an alternative method for acute toxicity
testing is selected, a rationale for such a selection should
accompany the submission. The Agency solicits discussions with
data generators on still other methods that may be employed.
1The approximate lethal dose method was further refined by
Deichmann and Mergard (1948); these authors performed eighty-
seven determinations (calculated by the methods of Behrens
(1929) and Bliss (1938)). The approximate lethal dose method was
also used by Kennedy et al. (1986).
2The moving averages method was refined by Weil (1952, 1983)
and Gad and Weil (1982), and was used by Smythe and Carpenter
(1944, 1948) and Smythe at- al. (1949, 1951, 1954, 1962).
3The up-and-down method was recently used and refined by
Bruce (1985, 1987) (calculated by the method of Bliss (1938)).
The up-and-down method was also used by Brownlee et al. (1953),
Dixon and Massey (1957), Klassen and Plaa (1967) and Hsi (1969).
4The Department of Defense has had considerable experience
using the Reed-Muench method with a large number of chemicals (F.
Vocci, personal communication); it has also been used by Lorenz
and Bogel (1973), Bhan (1974), Aubert and Amdral (1979), and
Thakur and Fezio (1981).
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The Agency emphasizes that parallel assays on male and
female animals to determine an approximate estimate of acute
toxicity need not be routinely determined, since male and female
animals of the same strain generally show only slight and
insignificant differences in susceptibility to toxic agents.
However, for some chemicals, one sex may be somewhat more
sensitive than the other (Muller and Kley (1982); Schut2 and
Fuchs (1982); (Bruce (1985)). Cassarett and Ooull (1980)
indicate that the class of compound is important in specific sex
differences. De Pass et al. (1984) showed that for 91 chemicals
tested for oral toxicity in rats, females were slightly more
sensitive than males (p<.001). Muller and Kley (1982) performed
152 parallel studies on male and female animals for which 129
showed no significant differences. However, when statistically
significant differences were observed (23 compounds), 17 were
more toxic to females. Therefore, consideration should be given
to limiting studies to the more sensitive sex. Previous history
on the class of chemical being evaluated would be helpful in
making this determination. For confirmation, a few animals of
the other sex should also be tested.
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7
In summary, EPA has modified its approach to acute toxicity
testing, recognizing that appropriate information for safety
evaluation can be developed using fewer animals than had been
recommended in the past. We strongly urge industry to use these
abbreviated test methodologies, whenever appropriate, as
replacement!! for the three-dose multifaceted method EPA
previously had recommended. Four such methodologies which might
be used have been identified; other methods may also be employed,
if adequate rationale can be provided. It is expected that
studies will still include behavioral observations, gross
necropsy and ancillary observations, as before.
EPA urges industry to begin submitting data obtained with
alternate methods which use fewer animals on a routine basis;
the Agency is planning to revise its testing guidelines to
incorporate the above guidance. We plan to accept only newly
generated industry data that conforms with our revised guidance
unless an adequate rationale (e.g., data generated in accordance
with regulatory requirements other than those of EPA) accompanies
the submisnion; data without a rationale may be returned to the
submitter.
The Agency encourages the public to comment on this
position and provide information on still other alternate
methodologies which have progressed to a stage of validation
which would be acceptable to the scientific community.
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References
Aubert M.F.A. and Amdral L. (1979). Potency Testing of
Veterinary Vaccines Containing Inactivated Virus. Comp. Immunol
Microbiol. Infect. Dis., 1, 341-349.
Behrens B. (1929). The Assay of Digitalis on Frogs. Arch.
Exptl. Path. Pharmakol., 140. 237-256.
Bhan A.K. (1974). Computing LD50 More Efficiently and Accurately
- A Modification of Reed-Muench Method. Indian Soc. Nucl.
Agricul. Biol., 2, 5-6.
Bliss C.I. (1938). Determination of the Small Dosage Mortality
Curve from Small Numbers. Quart. J. Year Book Pharm., 11. 192-
216.
Brownlee K.A., Hodges J.L. and Rosenblatt M. (1953). The Up-and-
Down Method With Small Samples. Amer. Statist. Assoc. J., 48.
262-277.
Bruce R.D. (1985). An Up-and-Down Procedure for Acute Toxicity
Testing. Fundam. Appl. Toxicol., 5_, 151-157.
Bruce R.D. (1987). A Confirmatory Study of the Up-and-Down
Method for Acute Oral Toxicity Testing. Fundam. Appl. Toxicol.,
1, 97-100.
Casarett L.J. and Doull J. (1980). Factors Influencing
Toxicology. In: Toxicology. The Basic Science of Poisons. J.
Doull, C.D. Klaasen and M.O. Amdur, eds., 77-88. New York:
Macmillan Publishing Co., Inc.
Deichmann W.B. and LeBlanc T.L. (1943). Determination of the
Approximate Lethal Dose with About Six Animals. J. Indust. Hyg.
Toxicol., IS, 415-417.
Deichmann W.B. and Mergard E.G. (1948). Comparative Evaluation
of Methods Employed to Express the Degree of Toxicity of a
Compound. J. Indust. Hyg. Toxicol., 30. 373-378.
De Pass L.R., Myers R.C., Weaver E.V. and Weil C.S. (1984). An
Assessment of the Importance of Number of Dosage Levels, Number
of Animals per Dosage Level, Sex and Method of LD50 and Slope
Calculation in Acute Toxicity Studies. In: Acute Toxicity
Testing; Alternative Approaches. A.M. Goldberg, ed. (Alternative
Methods in Toxicology, Vol. 2), 142-153. New York: Mary A.
Liebert, Inc., Publisher.
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9
References (contd.)
Dixon W.J. (1965). The Up-and-Down Method for Small Samples.
Amer. Statist. Assoc. J., 6fi, 967-978.
Dixon W.J. and Massey F.J. Jr. (1957). Sensitivity Experiments,
In: Introduction to Statistical Analysis. 318-327. New York:
McGraw-Hill.
Dixon W.J. and Mood A.M. (1948). A Method for Obtaining and
Analyzing Sensitivity Data. Amer. Statist. Assoc. J., 43. 109-
126.
Gad S.C. and Weil C.S. (1982). Statistics for Toxicologists.
In: Methods in Toxicolocrv. A.W. Hays, ed., 273-309. New York:
Raven Press.
Hsi, B.P. (1969). The Multiple Sample Up-and-Down Method in
Bioassay. Amer. Statist. Assoc. J., 64. 147-162.
Kennedy, G.L. Jr., Ferenz, R.L. and Burgess, B.A. (1986).
Estimation of Acute Oral Toxicity in Rats by Determination of the
Approximate Lethal Dose Rather Than the LD50. J. Appl. Toxicol.
6., 145-148.
Klassen, C.D. and Plaa, G.L. (1967). Relative Effects of Various
Chlorinated Hydrocarbons on Liver and Kidney Function in Dogs.
Toxicol. Appl. Pharmacol., 1£, 119-131.
Lorenz R.J. and Bogel K. (1973). Methods of Calculation. Method
of Reed and Muench. Laboratory Techniques in Rabies. WHO
Monograph Series 22, 3rd Ed., 329-335.
Muller H. and Kley H.P. (1982). Retrospective Study on the
Reliability of an "Approximate LD50"5 Determined with a Small
Number of Animals. Arch. Toxicol., 51. 189-196.
Reed L.J. and Muench H. (1938). A Simple Method for Estimating
Fifty Percent Endpoints. Amer. J. Indust. Hyg. Toxicol., 30.
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Schutz E. and Fuchs H. (1?«2). A New Approach to Minimizing the
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Hyg. Toxicol., 2$, 269.
5 "Approximate LD50" in the title of this paper is placed in
quotation marks so as not to confuse it with the method of
Deichman and Le Blanc (1943).
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10
References (contd.)
Smythe H.F. Jr. and Carpenter C.P. (1948). Further Experience
with the Range-Finding Test in the Industrial Toxicology
Laboratory. J. Indust. Hyg. Toxicol., 3_p_, 63.
Smythe H.F. Jr., Carpenter C.P. and Weil C.S. (1949). Range-
Finding Toxicity Data: List III. J. Indust. Hyg. Toxicol., 31.
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Smythe H.F. Jr., Carpenter C.P. and Weil C.S. (1951). Range-
Finding Toxicity Data: List IV. AMA Arch. Indust. Hyg. Occ.
Med., i, 119.
Smythe H.F. Jr., Carpenter C.P., Weil C.S. and Pozzani U.C.
(1954). Range-Finding Toxicity Data: List V. AMA Arch. Indust.
Hyg. Occ. Med. Ifi, 61.
Smythe H.F. Jr., Carpenter C.P., Weil C.S., Pozzani U.C., and
Striegel J.A. (1962). Range-Finding Toxicity Data: List VI.
Amer. Indust. Hyg. Assoc. J., 23. 95.
Thakur A.K. and Fezio W.L. (1981). A Computer Program for
Estimating LD50 and It's Confidence Limits Using Modified
Behrens-Reed-Muench Cumulant Method. Drug Chem. Toxicol., 1,
297-305.
Thompson, W.R. (1947). Use of Moving Averages and Interpolation
to Estimate Median Effective Dose. Bacteriol. Rev. 11. 115-145.
U.S. Environmental Protection Agency. (1978). Proposed
Guidelines for Registering Pesticides in the U.S. Hazard
Evaluation: Humans and Domestic Animals. Fed. Reg. 43. 37336-
37345; 37351-37356. (August 22).
U.S. Environmental Protection Agency. (1979). Proposed Health
Effects Teat Standards for Toxic Substances Control Act Test
Rules and Proposed Good Laboratory Practice Standards for Health
Effects. Fed. R«g. 4JL, 44054-44059; 44066-44067. (July 26).
U.S. Environmental Protection Agency. (1985). Health Effects
Testing Guidelines. Fed. Reg. 50, 39397-39398. (September 27)
Vocci. F. (1988). Personal Communication (Unpublished Data).
Weil C.S. (1952). Tables for Convenient Calculation of Median
Effective Dose (LD50 or ED50) and Instructions on Their Use.
Biometrics 8_, 249-263.
Weil C.S. (1983). Economical LD50 and Slope Determinations.
Drug Chem. Toxicol. £, 595-603.
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For general information and/or additional copies please call:
202-554-1404
For technical information call:
703-557-7492
Dr. Rinde
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