Testing of Certain High Production Volume Chemicals; Second Group of Chemicals, 43314-43342 [E8-16992]
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Federal Register / Vol. 73, No. 143 / Thursday, July 24, 2008 / Proposed Rules
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 799
[EPA–HQ–OPPT–2007–0531; FRL–8373–9]
RIN 2070–AD16
Testing of Certain High Production
Volume Chemicals; Second Group of
Chemicals
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
ebenthall on PRODPC60 with PROPOSALS3
AGENCY:
SUMMARY: EPA is proposing a test rule
under section 4(a)(1)(B) of the Toxic
Substances Control Act (TSCA) to
require manufacturers, importers, and
processors of certain high production
volume (HPV) chemical substances to
conduct testing to obtain screening level
data for health and environmental
effects and chemical fate. EPA has
preliminarily determined that: Each of
the 19 chemical substances included in
this proposed rule is produced in
substantial quantities and that there is
or may be substantial human exposure
to each of them; there are insufficient
data to reasonably determine or predict
the effects on health or the environment
of the manufacture, distribution in
commerce, processing, use, or disposal
of the chemicals, or of any combination
of these activities; and the testing
program proposed here is necessary to
develop such data. Data developed
under this proposed rule will provide
critical information about the
environmental fate and potential
hazards associated with these chemicals
which, when combined with
information about exposure and uses,
will allow the Agency and others to
evaluate potential health and
environmental risks and to take
appropriate follow-up action. Persons
who export or intend to export any
chemical substance included in the final
rule would be subject to the export
notification requirements in TSCA
section 12(b)(1) and at 40 CFR part 707,
subpart D. EPA has also taken steps, as
described in this document, to consider
animal welfare and to provide
instructions on ways to reduce or in
some cases eliminate animal testing,
while at the same time ensuring that the
public health is protected.
DATES: Comments must be received on
or before October 22, 2008.
Written requests to present oral
comments must be received on or before
October 22, 2008.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
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number EPA–HQ–OPPT–2007–0531, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001.
• Hand Delivery: OPPT Document
Control Office (DCO), EPA East Bldg.,
Rm. 6428, 1201 Constitution Ave., NW.,
Washington, DC. Attention: Docket ID
Number EPA–HQ–OPPT–2007–0531.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2007–0531. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov website is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
placed in the docket and made available
on the Internet. If you submit an
electronic comment, EPA recommends
that you include your name and other
contact information in the body of your
comment and with any disk or CD-ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses. For additional information
about EPA’s public docket, visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Follow
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the on-line instructions to view the
docket index or access available
documents. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, will be publicly
available only in hard copy. Publicly
available docket materials are available
electronically at https://
www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
Federal holidays. The telephone number
of the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
to show photographic identification,
pass through a metal detector, and sign
the EPA visitor log. All visitor bags are
processed through an X-ray machine
and subject to search. Visitors will be
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
FOR FURTHER INFORMATION CONTACT: For
general information contact: Colby
Lintner, Regulatory Coordinator,
Environmental Assistance Division
(7408M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 554–1404; e-mail address:
TSCA-Hotline@epa.gov.
For technical information contact:
Paul Campanella or John Schaeffer,
Chemical Control Division (7405M),
Office of Pollution Prevention and
Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
numbers: (202) 564–8091 or (202) 564–
8173; e-mail addresses:
campanella.paul@epa.gov or
schaeffer.john@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you manufacture (defined
by statute to include import) or process
any of the chemical substances that are
listed in § 799.5087(j) of the proposed
regulatory text. Any use of the term
‘‘manufacture’’ in this document will
encompass ‘‘import,’’ unless otherwise
stated. In addition, as described in Unit
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V., once the Agency issues a final rule,
any person who exports, or intends to
export, any of the chemical substances
included in the final rule will be subject
to the export notification requirements
in TSCA section 12(b)(1) and at 40 CFR
part 707, subpart D. Potentially affected
entities may include, but are not limited
to:
• Manufacturers (defined by statute to
include importers) of one or more of the
19 subject chemical substances (NAIC
codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
• Processors of one or more of the 19
subject chemical substances (NAIC
codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
Unit IV.E. and consult § 799.5087(b) of
the proposed regulatory text. If you have
any questions regarding the
applicability of this action to a
particular entity, consult either of the
technical persons listed under FOR
FURTHER INFORMATION CONTACT.
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B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD-ROM that
you mail to EPA, mark the outside of the
disk or CD-ROM that you mail to EPA,
mark the outside of the disk or CD-ROM
as CBI and then identify electronically
within the disk or CD-ROM the specific
information that is claimed as CBI. In
addition to one complete version of the
comment that includes information
claimed as CBI, a copy of the comment
that does not contain the information
claimed as CBI must be submitted for
inclusion in the public docket.
Information so marked will not be
disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
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information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
C. Can I Request an Opportunity to
Present Oral Comments to the Agency?
You may submit a request for an
opportunity to present oral comments.
This request must be made in writing.
If such a request is received on or before
October 22, 2008, EPA will hold a
public meeting on this proposed rule in
Washington, DC. This written request
must be submitted to the mailing or
hand delivery addresses provided under
ADDRESSES. If such a request is received,
EPA will announce the scheduling of
the public meeting in a subsequent
document in the Federal Register. If a
public meeting is announced, and if you
are interested in attending or presenting
oral and/or written comments at the
public meeting, you should follow the
instructions provided in the subsequent
Federal Register document announcing
the public meeting.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to issue a test rule
under TSCA section 4(a)(1)(B) (15
U.S.C. 2603(a)(1)(B)) that would require
manufacturers and processors of 19
chemical substances to conduct testing
for environmental fate (including five
tests for physical/chemical properties
and biodegradation), ecotoxicity (in fish,
Daphnia, and algae), acute toxicity,
genetic toxicity (gene mutations and
chromosomal aberrations), repeat dose
toxicity, and developmental and
reproductive toxicity. The chemicals are
HPV chemicals, i.e., chemicals with a
production/import volume equal to or
greater than 1 million pounds (lbs.) per
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year. A detailed discussion regarding
efforts to enhance the availability of
screening level hazard and
environmental fate information about
HPV chemicals can be found in a
Federal Register notice which
published on December 26, 2000 (Ref.
1).
The tests are screening level tests
which are part of the Screening
Information Data Set (SIDS) (see Unit
II.D.). Some or all of these tests are being
proposed as required tests for a
particular chemical substance,
depending upon what data are already
available for that substance.
This action also follows an earlier
testing action for certain HPV chemicals
(see ‘‘Testing of Certain High Production
Volume Chemicals; Proposed Rule’’
(Ref. 2) and ‘‘Testing of Certain High
Production Volume Chemicals; Final
Rule’’ (Ref. 3).
At a future date, EPA plans to propose
testing for additional HPV chemicals as
the Agency learns more about the
chemicals with respect to human
exposure, release, and sufficiency of
data and experience available on the
potential hazards.
B. What is the Agency’s Authority for
Taking this Action?
EPA is proposing this test rule under
section 4(a)(1)(B) of TSCA (15 U.S.C.
2603(a)(1)(B)).
Section 2(b)(1) of TSCA (15 U.S.C.
2601(b)(1)) states that it is the policy of
the United States that ‘‘adequate data
should be developed with respect to the
effect of chemical substances and
mixtures on health and the environment
and that the development of such data
should be the responsibility of those
who manufacture [which is defined by
statute to include import] and those
who process such chemical substances
and mixtures[.]’’ To implement this
policy, TSCA section 4(a)(1) mandates
that EPA require by rule that
manufacturers and/or processors of
chemical substances and mixtures
conduct testing if the Administrator
finds that:
(1)(A)(i) the manufacture, distribution in
commerce, processing, use, or disposal of a
chemical substance or mixture, or that any
combination of such activities, may present
an unreasonable risk of injury to health or the
environment,
(ii) there are insufficient data and
experience upon which the effects of such
manufacture, distribution in commerce,
processing, use, or disposal of such substance
or mixture or of any combination of such
activities on health or the environment can
reasonably be determined or predicted, and
(iii) testing of such substance or mixture
with respect to such effects is necessary to
develop such data; or
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(B)(i) a chemical substance or mixture is or
will be produced in substantial quantities,
and (I) it enters or may reasonably be
anticipated to enter the environment in
substantial quantities or (II) there is or may
be significant or substantial human exposure
to such substance or mixture,
(ii) there are insufficient data and
experience upon which the effects of the
manufacture, distribution in commerce,
processing, use, or disposal of such substance
or mixture or of any combination of such
activities on health or the environment can
reasonably be determined or predicted, and
(iii) testing of such substance or mixture
with respect to such effects is necessary to
develop such data [.]
If EPA makes these findings for a
chemical substance or mixture, the
Administrator shall require by rule that
testing be conducted on that chemical
substance or mixture to develop data
about health or environmental effects
for which there is an insufficiency of
data and experience, and which are
relevant to a determination that the
manufacture, distribution in commerce,
processing, use, or disposal of the
chemical substance or mixture, or any
combination of such activities, does or
does not present an unreasonable risk of
injury to health or the environment.
TSCA section 4(a)(1).
Once the Administrator has made a
finding under TSCA section 4(a)(1)(A)
or 4(a)(1)(B), EPA may require any type
of health or environmental effects
testing necessary to address unanswered
questions about the effects of the
chemical substance or mixture that are
relevant to whether the manufacture,
distribution in commerce, processing,
use, or disposal of the chemical
substance or mixture, or any
combination of such activities, presents
an unreasonable risk of injury to health
or the environment. EPA need not limit
the scope of testing required to the
factual basis for the TSCA section
4(a)(1)(A)(i) or (B)(i) findings. This
approach is explained in more detail in
EPA’s TSCA section 4(a)(1)(B) Final
Statement of Policy (‘‘B’’ policy) (Ref. 4,
pp. 28738–28739).
In this proposed rule, EPA would use
its broad TSCA section 4(a) authority to
obtain data necessary to support the
development of preliminary or
‘‘screening level’’ hazard and risk
characterizations for certain HPV
chemical substances specified in Table
2 in § 799.5087(j) of the proposed
regulatory text. EPA has made
preliminary findings for these chemical
substances under TSCA section
4(a)(1)(B) that: They are produced in
substantial quantities; there is or may be
substantial human exposure to them;
existing data are insufficient to
determine or predict their health and
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environmental effects; and testing is
necessary to develop such data.
C. Why is EPA Taking this Action?
On April 21, 1998, EPA initiated a
national effort to empower citizens by
providing them with knowledge about
the most widespread chemicals in
commerce. A major objective of this
effort is to make certain basic
information about the environmental
fate and potential health and
environmental hazards associated with
HPV chemicals available to the public.
Mechanisms to collect or, where
necessary, develop needed data on U.S.
HPV chemicals include the voluntary
HPV Challenge Program, certain
international efforts, and TSCA section
4 rules.
1. Voluntary HPV Challenge Program.
The voluntary HPV Challenge Program,
officially launched in late 1998, was
created to ensure that a baseline set of
data on approximately 2,800 HPV
chemicals would be made available to
EPA and the public. HPV chemicals are
manufactured or imported in amounts
equal to or greater than 1 million lbs.
per year and were identified for this
program through data reported under
the TSCA Inventory Update Rule (IUR)
during 1990.
The data set sought by the voluntary
HPV Challenge Program is known as the
Screening Information Data Set (SIDS)
that was developed by the Organization
for Economic Cooperation and
Development (OECD), of which the
United States is a member. SIDS
provides an internationally agreed upon
set of test data for screening high
production volume chemicals for
human and environmental hazards, and
will assist the Agency and others to
make an informed, preliminary
judgment about the hazards of HPV
chemicals.
Since the Program’s inception in
1998, industry chemical manufacturers
and importers have participated in the
Challenge by sponsoring 2,250
chemicals. More than 350 companies
and 100 consortia have sponsored
chemicals directly in the Program while
additional companies/consortia have
sponsored chemicals indirectly in an
international counterpart to the
voluntary HPV Challenge Program, the
International Council of Chemical
Associations (ICCA) HPV Initiative.
HPV chemicals that are not sponsored
in the Program may be subject to a test
rule under TSCA section 4 where,
among other things, these chemicals
lack needed testing. The voluntary HPV
Challenge Program is further described
in a Federal Register document which
published on December 26, 2000 (Ref. 1)
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and on the voluntary HPV Challenge
Program website (https://www.epa.gov/
chemrtk).
Under the voluntary HPV Challenge
Program, alternatives to the testing
proposed under this proposed rule were
available. For example, under the OECD
HPV SIDS Program, some instances
have been identified where, using
chemical category approaches, less than
a full set of SIDS tests for every
chemical in the category has been
judged sufficient for screening purposes.
In addition, the OECD HPV SIDS
Program allows some use of structure
activity relationship (SAR) analysis for
individual chemicals. These strategies
have the potential to reduce the time
required to complete the program, the
number of tests actually conducted, and
the number of test animals needed.
EPA advocated the use of categories
or SAR approaches in the voluntary
HPV Challenge Program and provided
support for their use by developing
guidance documents to assist industry
and others in constructing scientifically
defensible categories (Ref. 45) and SAR
(Ref. 48). While EPA encouraged the use
of scientifically appropriate categories
of related chemicals and SAR under the
voluntary HPV Challenge Program,
these approaches are not included in
this proposed rule. EPA has not
identified any chemicals in this
proposal for which category and SAR
approaches would be appropriate. In
addition, EPA believes that the
incorporation of such elements in a test
rule would require complex, time
consuming, and intensive procedural
steps, such as multi-phase rulemaking,
without a corresponding benefit.
In the proposed test rule (Ref. 2) for
the final HPV SIDS test rule (Ref. 3),
EPA specifically solicited comments
and suggestions on procedures that
would allow inclusion of such
approaches in TSCA section 4 HPV
SIDS rulemaking. The procedures
suggested by commenters on that
proposed rule would have required
complex, time consuming, and resourceintensive procedural steps, such as
multi-phase rulemaking. As a result,
EPA did not incorporate these
suggestions into the final rule. In
addition, EPA did not identify, nor did
the commenters bring to EPA’s
attention, any possibilities that would
have allowed inclusion of a category or
SAR approach within the final test rule
for any specific chemicals included in
the final test rule (Ref. 19).
Although the Agency believes that
none of the chemicals included in this
proposed rule appear to be candidates
for category or SAR approaches, persons
who believe that a chemical under this
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proposed rule can be dealt with using a
category or SAR approach are
encouraged to submit appropriate
information, along with their rationale
which substantiates this belief, during
the comment period on this proposed
rule. If, based on submitted information
and other information available to EPA,
the Agency determines that a chemical
is appropriate for consideration under a
category or SAR approach, and that
practicable measures are available at the
time to modify the proposed testing
requirement, EPA will take such
measures as are necessary to avoid
unnecessary testing in the final rule.
2. Certain international efforts. The
voluntary HPV Challenge Program is
designed to make maximum use of
scientifically adequate existing test data
and to avoid unnecessary and
duplicative testing of U.S. HPV
chemicals. Therefore, EPA is continuing
to participate in the voluntary
international efforts, complementary to
the voluntary HPV Challenge Program,
that are being coordinated by the OECD
to secure basic hazard information on
HPV chemicals in use worldwide,
including some of those on the U.S.
(1990) HPV chemicals list (Ref. 5). This
includes agreements to sponsor a U.S.
HPV chemical under either the OECD
HPV SIDS Program (Ref. 6), including
sponsorship by OECD member countries
beyond the United States, or the
international HPV Initiative that is being
organized by the ICCA (Ref. 7).
The OECD HPV SIDS Program seeks
the development of test data, if such
data are not already available, related to
6 health and environmental effects
endpoints for international HPV
chemicals (see Unit II.D.). The SIDS data
set has been internationally agreed upon
by the 29 member countries of the
OECD as providing the minimum data
set required to make an informed
preliminary judgment about the hazards
of a given HPV chemical.
The ICCA consists of representatives
of chemical industry trade associations
from the United States, Europe, Japan,
Australia, Canada, Mexico, Brazil, New
Zealand, and Argentina. The intended
goal of the ICCA HPV Initiative was to
complete screening-level hazard
assessments on 1,000 ‘‘high priority’’
chemicals. Most of the chemicals on the
ICCA working list (Ref. 7) are also U.S.
HPV chemicals. The ICCA testing/
assessment work is tied directly to that
under the OECD HPV SIDS Program.
Any U.S. HPV chemicals that are
handled under the OECD HPV SIDS
Program or the ICCA HPV Initiative are
considered by EPA to be ‘‘sponsored’’
and are not anticipated to be addressed
in the voluntary HPV Challenge
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Program unless the international
commitments are not met. Nor does EPA
intend to evaluate these chemicals for
possible TSCA section 4 HPV SIDS
rulemaking unless the international
commitments are not met.
The OECD HPV SIDS Program and the
ICCA HPV Initiative are further
described in the Federal Register
document announcing the voluntary
HPV Challenge Program (Ref. 1) and on
the OECD website (Ref. 6) and ICCA
website (Ref. 7).
3. TSCA rulemaking. U.S. data needs
which remain unmet in the voluntary
HPV Challenge Program or through
international efforts may be addressed
through TSCA section 4 rulemakings,
such as the final test rule promulgated
by EPA on March 16, 2006 (Ref. 3). This
proposed rule is the second TSCA
section 4 HPV SIDS rule, and addresses
the unmet data needs of 19 chemicals.
Data collected and/or developed
under a final rule based on this proposal
and the voluntary HPV Challenge
Program, when combined with
information about exposure and uses,
will allow the Agency and others to
better assess the potential risk to health
and the environment from these
chemicals. EPA intends to make the
information collected under the final
rule available to the public, other
Federal agencies, and any other
interested parties on its website (https://
www.epa.gov/chemrtk) and in the
public docket for the final rule. As
appropriate, this information will be
used to ensure a scientifically sound
basis for risk assessment/management
actions. This effort will serve to further
the Agency’s goal of identifying and
controlling human and environmental
risks as well as providing greater
protection and knowledge to the public.
By using the same approach to testing
as that of the OECD HPV SIDS Program,
EPA is assuring that the data developed
under this proposed rulemaking activity
and the voluntary HPV Challenge
Program will be comparable to the data
being developed in other countries,
thereby enabling an international
sharing of data and the prevention of
unnecessary and duplicative testing. See
Refs.1 and 2, pp. 81662–81664, for
further information about the voluntary
HPV Challenge Program and
international efforts.
D. Why is this Proposal Focusing on
HPV Chemicals and SIDS Testing?
This proposal pertains to HPV
chemicals, which are manufactured or
imported in amounts equal to or greater
than 1 million lbs. per year. Although
those chemicals cover only about 11%
of the chemical substances on the TSCA
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Inventory (see TSCA sections 8(a) and
8(b)), using TSCA Inventory information
available in 1988 (Ref. 8, p. 32296), that
small percentage of the TSCA Inventory
accounted for 95% of total chemical
production in the United States.
Testing under this proposal pertains
to SIDS testing because SIDS is a battery
of tests agreed upon by the international
community through OECD, of which the
United States is a member country, as
appropriate for screening HPV chemical
substances for toxicity and produces
information relevant to understanding
the basic health and environmental
hazards and fate of HPV chemicals. The
content of SIDS was agreed upon at the
13th Joint Meeting of the OECD
Chemicals Group and Management
Committee of the Special Programme on
the Control of Chemicals (Refs. 9 and
10). The United States believes these are
the right tests for basic screening of U.S.
HPV chemicals for health and
environmental effects and
environmental fate.
• SIDS testing evaluates the following
six testing endpoints (Ref. 6):
• Acute toxicity.
• Repeat dose toxicity.
• Developmental and reproductive
toxicity.
• Genetic toxicity (gene mutations and
chromosomal aberrations).
• Ecotoxicity (studies in fish,
Daphnia, and algae).
• Environmental fate (including
physical/chemical properties (melting
point, boiling point, vapor pressure, noctanol/water partition coefficient, and
water solubility), photolysis, hydrolysis,
transport/distribution, and
biodegradation).
While data on the six SIDS endpoints do
not fully characterize a chemical’s
toxicity and fate, they provide a
consistent minimum set of information
that can be used to help assess the
relative risks of chemicals and whether
additional testing or assessment is
necessary.
E. How Does EPA’s HPV Work Relate to
that of OECD?
As noted in Unit II.C.2., the OECD
HPV SIDS Program is complementary to
the voluntary HPV Challenge Program.
However, EPA’s definition of an HPV
chemical differs from that of the OECD.
EPA defines an HPV chemical as having
an annual production or importation
volume of 1 million lbs. or more. OECD
defines an HPV chemical as having an
annual production volume of 2.2
million lbs. (equivalent to 1 million
kilograms (kg)) reported in any member
country.
The presence of a chemical on the
OECD’s list of HPV chemicals was and
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continues to be accepted by OECD
member countries as providing a
sufficient indicator of potential
exposure to warrant testing at the SIDS
level (Ref. 11). EPA, however, does not
believe that a production volume
threshold which is chosen for an
international program on existing
chemicals and which is the only trigger
for entry into that program should be
determinative of the threshold chosen
for ‘‘substantial production’’ under
TSCA section 4(a)(1)(B)(i). See EPA’s
‘‘B’’ policy (Ref. 4). Among the reasons
is that the TSCA section 4(a)(1)(B)(i)
finding of substantial production is not
the sole finding EPA must make to
require testing based on TSCA section
4(a)(1)(B). EPA must also find that there
is substantial release, or substantial or
significant human exposure under
TSCA sections 4(a)(1)(B)(i)(I) and (II). In
addition, EPA must find that data are
insufficient and testing is necessary
under TSCA sections 4(a)(1)(B)(ii) and
(iii). Accordingly, a finding that a
chemical is produced in substantial
quantities alone is not a sufficient basis
to require testing under TSCA section 4.
In response to EPA’s proposed ‘‘B’’
policy (Ref. 8), both the American
Chemistry Council (ACC), formerly the
Chemical Manufacturers Association
(CMA) and the Society of the Plastics
Industry, Inc., commented that EPA’s
proposed annual production-volume
threshold of 1 million lbs. is a
reasonable interpretation of ‘‘substantial
production’’ under TSCA (Refs. 12 and
13). Additionally, they indicated that
the OECD’s 2.2 million lb. threshold
would be preferable to achieve
consistency between EPA’s activities
under TSCA section 4 and the OECD
HPV SIDS Program. Although the
United States and OECD differ in their
definition of an HPV chemical and what
should trigger basic screening tests of an
HPV chemical, both the U.S. and OECD
HPV SIDS Programs are alike in their
information needs for an HPV chemical.
Both the U.S. and OECD HPV SIDS
Programs have identified the SIDS
battery of tests as the basic screening
tests needed to provide enough
information to support a screening level
assessment of the health and
environmental effects of a chemical.
F. Why is EPA Pursuing Hazard
Information on HPV Chemicals?
In 1998 EPA found that, of those nonpolymeric organic substances produced
or imported in amounts equal to or
greater than 1 million lbs. per year
based on 1990 IUR reporting, only 7%
had a full set of publicly available and
internationally recognized basic
screening test data for health and
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environmental effects (Ref. 14). Of the
over 2,800 U.S. HPV chemicals based on
1990 IUR data, 43% had no publicly
available basic hazard data. For the
remaining chemicals, limited amounts
of the data were available. This lack of
available hazard data compromises
EPA’s and others’ ability to determine
whether these HPV chemicals pose
potential risks to human health or the
environment, as well as the public’s
ability to know about the hazards of
chemicals that may be found in their
environment, their homes, their
workplaces, and the products they buy.
G. What is the Role of this Proposed
Rule and Any Future TSCA Section 4
HPV SIDS Rulemaking with Regard to
the Voluntary HPV Challenge Program?
As indicated in the December 26,
2000 Federal Register document
describing the voluntary HPV Challenge
Program (Ref. 1), EPA intends to use
rulemaking under TSCA, where
appropriate, to help fill data gaps not
addressed as part of the voluntary HPV
Challenge Program or international
efforts. EPA does not intend at this time
to evaluate U.S. HPV chemicals that
have been or are being handled through
the OECD HPV SIDS Program or under
a complementary program being
coordinated by the ICCA (Ref. 7) for
screening level testing under TSCA
section 4 HPV SIDS rulemaking,
although the Agency may revisit this
question if commitments under those
international programs are not met. See
Unit III.G. of Ref. 1 for more information
on these programs. EPA is evaluating
the extent to which additional nonsponsored HPV chemicals meet the
threshold criteria for rulemaking under
TSCA section 4.
H. How Would the Data Developed
Under this Test Rule Be Used?
Hazard data are used in risk
assessment and risk management, and
ultimately to inform the public and
promote the pollution prevention ethic.
Activities to ensure the availability of
basic hazard information on HPV
chemicals support EPA’s objectives.
EPA would use the data obtained
from this proposed rule to support
development of preliminary hazard and
risk assessments for the 19 chemical
substances subject to the rule. The data
would also be used by EPA to set
priorities for further testing that may
produce hazard information on these
chemical substances that may be needed
by EPA, other Federal agencies, the
public, industry, and others, to support
adequate risk assessments. As
appropriate, this information would be
used to ensure a scientifically sound
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basis for risk characterizations and risk
management actions. As such, this effort
would serve to further the Agency’s goal
of identifying and controlling human
and environmental risks as well as
providing greater knowledge and
protection to the public. In the past,
EPA has used data from test rules to
support such activities as the
development of water quality criteria,
Toxic Release Inventory (TRI) listings,
chemical advisories, and reduction of
workplace exposures.
Under the Security and Prosperity
Partnership of North America (SPP), a
trilateral effort to encourage greater
cooperation and information sharing
among the United States, Canada, and
Mexico (https://www.spp.gov), the
United States committed in August 2007
to assess and initiate needed action by
the end of 2012 on the approximately
6,750 chemicals produced above 25,000
lbs. per year in the United States.
(https://www.spp.gov/pdf/
spp_reg_coop_chemicals.pdf). To fulfill
these SPP commitments, EPA
established the Chemical Assessment
and Management Program (ChAMP).
Under ChAMP, EPA is developing
screening-level documents that
summarize basic hazard and exposure
information on HPV chemicals, identify
potential risks, note scientific issues and
uncertainties, and indicate the initial
priority being assigned by the Agency
for potential future appropriate action.
These screening-level documents are
based primarily on hazard, use, and
exposure data available to the Agency
through the voluntary HPV Challenge
Program and on EPA’s examination of
chemical use and exposure information
collected from the 2006 IUR as well as
data from readily available sources of
hazard and exposure information.
Information on ChAMP and the riskbased prioritization process for HPV
chemicals is available on the EPA’s
ChAMP website (https://www.epa.gov/
champ) and on the related risk-based
prioritization page (https://www.epa.gov/
hpv/hpvis/aboutrbd.htm).
The data obtained from a final test
rule based on this proposal would
furnish the basic hazard information
integral to this ChAMP process for the
19 chemical substances subject to the
rule.
Finally, because the SIDS data would
be comparable to the type of data agreed
to as being appropriate and being
developed by the OECD HPV SIDS
Program, the development of these data
would enable an international sharing of
data. As conceived by the OECD, the
SIDS battery of tests can be used by
governments and others worldwide to
conduct an initial assessment of the
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hazards and risks posed by HPV
chemicals and prioritize HPV chemicals
to identify those in need of additional,
more in-depth testing and assessment,
as well as those of lesser concern. Not
only could the data contribute to the
international effort, but also
international SIDS testing and
assessments can be used to fill the data
gaps identified as part of the voluntary
HPV Challenge Program. Additional
detailed information is available on the
SIDS website (https://cs3-hq.oecd.org/
scripts/hpv) and EPA’s voluntary HPV
Challenge Program website (https://
www.epa.gov/chemrtk).
Data collected or developed for each
sponsored chemical in the voluntary
HPV Challenge Program are provided in
the format of a ‘‘robust’’ (i.e., detailed)
summary. A robust summary contains
the technical information necessary to
adequately describe an experiment or
study and includes the objectives,
methods, results, and conclusions of the
full study report, which can either be an
experiment or in some cases an
estimation or prediction method. (See
Ref. 15; also at https://www.epa.gov/
HPV/pubs/general/robsumgd.htm). A
robust summary provides information
that would assist a technically qualified
person in making an independent
assessment of a given study, and thereby
facilitates the evaluation of existing data
and the identification of additional data
needs. EPA requests that existing data
relevant to the testing in this proposed
rule be submitted to the Agency in
robust summary format. For any data
developed under that final rule, EPA
will request that a robust summary of
the final report for each specific test be
submitted in addition to the required
final report itself (see § 799.5087(i) of
the proposed regulatory text). Persons
who respond to this request to submit
robust summaries are also encouraged to
submit the robust summary
electronically via the High Production
Volume Information System (HPVIS) to
allow for its ready incorporation into
HPVIS. Directions for electronic
submission of robust summary
information into HPVIS are provided at
https://iaspub.epa.gov/oppthpv/
metadata.html. This link will direct you
to the ‘‘HPVIS Quick Start and User’s
Guide.’’
I. How are Animal Welfare Issues Being
Considered in the HPV Initiative?
EPA recognizes the concerns that
have been expressed about the use of
test procedures that require the use of
animals. As discussed in Unit II.E. of
Ref. 1, EPA is making every effort to
ensure that as the HPV Initiative is
implemented (including TSCA section 4
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HPV SIDS test rules), unnecessary or
duplicative testing is avoided and the
use of animals is minimized. As a
general matter, EPA does not require
that tests on animals be conducted if an
alternative scientifically validated
method is found acceptable and
practically available for use. Where
testing must be conducted to develop
adequate data, the Agency is committed
to reducing the number of animals used
for testing, to replacing test methods
requiring animals with alternative test
methods when acceptable alternative
methods are available, and to refining
existing test methods to optimize animal
use when there is no substitute for
animal testing. EPA believes that these
reduction, replacement, and refinement
objectives are all important elements in
the overall consideration of alternative
testing methods.
The governmental and nongovernmental scientific community is
working to design, validate, and employ
new methods of toxicity testing that are
more accurate, less costly, and that
reduce the need to use live animals.
Over the years, significant research has
been pursued to develop and validate
non-animal test methods. U.S. scientists
in academia, government, and industry
have participated in both domestic and
international efforts to develop
alternative, non-animal tests. As part of
the enterprise, the National Institute of
Environmental Health Sciences (NIEHS)
established a Federal Interagency
Committee, the Interagency
Coordinating Committee on Validation
of Alternative Methods (ICCVAM), to
review the status and validation of
toxicological test methods including
those that are performed in vitro. EPA
scientists have contributed significantly
to this body of knowledge and are
continuing to play an important role in
the development of alternative test
methods for consideration.
In addition, as part of the voluntary
HPV Challenge Program, EPA asked
participants in that program to observe
certain testing principles, which are laid
out in an October 14, 1999 letter (Ref.
16). In this same letter, the Agency also
indicated its intention that related
TSCA rulemaking proceed in a manner
consistent with these principles. This
letter is available in the public docket
for this proposed rulemaking, as well as
on EPA’s ChemRTK website. In the
letter, EPA requested that participants
conduct a thoughtful, qualitative
analysis of existing data before testing.
This proposed rule reflects many of the
principles presented in the referenced
voluntary HPV Challenge Program
letter. Certain components of these
principles, however, are not pertinent to
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this proposed rule. For example, this
proposed rule does not require any
dermal toxicity testing or any terrestrial
toxicity testing.
III. EPA Proposed Findings
A. What is the Basis for EPA’s Proposal
to Test These Chemical Substances?
As indicated in Unit II.B., in order to
develop a rulemaking under TSCA
section 4(a) requiring the testing of
chemical substances or mixtures, EPA
must, among other things, make certain
findings regarding either risk (TSCA
section 4(a)(1)(A)(i)) or production
combined with either chemical release
or human exposure (TSCA section
4(a)(1)(B)(i)), with regard to those
chemicals. EPA is proposing to require
testing of the chemical substances
included in this proposed test rule
based on its preliminary findings under
TSCA section 4(a)(1)(B)(i) relating to
‘‘substantial’’ production and
‘‘substantial human exposure,’’ as well
as findings under TSCA sections
4(a)(1)(B)(ii) and (iii) relating to
sufficient data and the need for testing.
The chemical substances included in
this proposed rule are listed in Table 2
in § 799.5087(j) of the proposed
regulatory text along with their
Chemical Abstract Service (CAS)
registry numbers.
In EPA’s ‘‘B’’ policy (see Unit II.E.),
‘‘substantial production’’ of a chemical
substance or mixture is generally
considered to be aggregate production
(including import) volume equaling or
exceeding 1 million lbs. per year of that
chemical substance or mixture (Ref. 4,
p. 28747). The ‘‘B’’ policy also provides
guidelines that are generally considered
by EPA in evaluating whether there is
‘‘substantial human exposure’’ of
workers, consumers, and the general
population to a chemical substance or
mixture. Refer to EPA’s ‘‘B’’ policy for
further discussion on how EPA
generally evaluates chemicals or
mixtures under TSCA section
4(a)(1)(B)(i). For the reasons set out in
the ‘‘B’’ policy, EPA believes that the
guidance included in the ‘‘B’’ policy is
appropriate for consideration in this
proposed rule and EPA sees no reason
not to act consistently with the
guidelines with respect to the chemicals
included in this proposed rule.
EPA has found preliminarily that,
under TSCA section 4(a)(1)(B)(i), each of
the 19 chemical substances included in
this proposed rule is produced in
‘‘substantial’’ quantities (see Unit III.B.)
and that there is or may be ‘‘substantial
human exposure’’ to each chemical
substance (see Units III.C. and III.D.).
Also, for one substance, EPA has found
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preliminarily that, under TSCA section
4(a)(1)(B)(i), the substance enters or may
reasonably be anticipated to enter the
environment in substantial quantities
(see Unit III.E.). In addition, under
TSCA section 4(a)(1)(B)(ii), EPA has
preliminarily determined that there are
insufficient data and experience to
reasonably determine or predict the
effects of the manufacture, processing,
or use of these chemical substances, or
of any combination of such activities, on
human health or the environment (see
Unit III.F.). EPA has also found
preliminarily that testing the 19
chemical substances identified in this
proposed rule is necessary to develop
such data (TSCA section 4(a)(1)(B)(iii))
(see Unit III.F.). EPA has not identified
any ‘‘additional factors’’ as discussed in
the ‘‘B’’ policy (Ref. 4, p. 28746) to
cause the Agency to use decisionmaking
criteria other than those described in the
policy.
The chemical substances included in
this proposed rule are listed in
§ 799.5087(j) of the proposed regulatory
text along with their CAS numbers.
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B. Are These Chemical Substances
Produced and/or Imported in
Substantial Quantities?
EPA has made preliminary findings
that each of the chemical substances
included in this proposal is produced
and/or imported in an amount equal to
or greater than 1 million lbs. per year
(Ref. 18), based on information gathered
pursuant to the 2006 IUR which is the
most recently available compilation of
TSCA Inventory data. EPA believes that
these annual production and/or
importation volumes are ‘‘substantial’’
as that term is used with reference to
production in TSCA section
4(a)(1)(B)(i). (See also Ref. 4, p. 28746).
A discussion of EPA’s preliminary
‘‘substantial production’’ finding for
each chemical substance included in
this proposed rule is contained in a
separate document (See Ref. 18).
C. Are a Substantial Number of Workers
Exposed to These Chemicals?
EPA has made preliminary findings
that the manufacture, processing, and
use of the 19 chemical substances (Table
1.–Exposure Based Findings–
Substantial Human Exposure, Unit
III.D.) included in this action result or
may result in exposure of a substantial
number of workers to the chemical
substances.
This finding is based, in large part, on
information submitted in accordance
with the 2006 IUR. For chemicals whose
total production volume (manufactured
and imported) exceeded 300,000 lbs. at
a site during calendar year 2005,
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manufacturers and importers were
required to report the number of
potentially exposed workers during
industrial processing and use to the
extent the information was readily
obtainable. In addition, the submitters
are required to provide information
regarding the commercial and consumer
uses of the chemical substance.
EPA believes that an exposure of over
1,000 workers to a chemical substance
is ‘‘substantial’’ as that term is used
with reference to ‘‘human exposure’’ in
TSCA section 4(a)(1)(B)(i). EPA believes,
based on experience gained through
case-by-case analysis of existing
chemicals, that an exposure of 1,000
workers or more to a chemical substance
is a reasonable interpretation of the
phrase ‘‘substantial human exposure’’ in
TSCA section 4(a)(1)(B)(i); see Ref. 4).
Therefore, EPA’s preliminary finding is
that there is or may be substantial
human exposure (workers) to these 19
chemical substances.
In addition to the 2006 IUR data, EPA
also reviewed National Occupational
Exposure Survey (NOES) data
developed by the National Institute for
Occupational Safety and Health
(NIOSH). Based on the NOES data, EPA
found that more than 1,000 workers
were exposed to each of the 19 chemical
substances that are the subject of this
proposed rule. The NOES was a
nationwide data gathering project
conducted by NIOSH, which was
designed to develop national estimates
for the number of workers potentially
exposed to various chemical, physical
and biological agents and describe the
distribution of these potential
exposures. Begun in 1980 and
completed in 1983, the survey involved
a walk-through investigation by trained
surveyors of 4,490 facilities in 523
different types of industries. Surveyors
recorded potential exposures when a
chemical agent was likely to enter or
contact the worker’s body for a
minimum duration. These potential
exposures could be observed or inferred.
Information from these representative
facilities was extrapolated to generate
national estimates of potentially
exposed workers for more than 10,000
different chemicals (Refs. 20, 57, and
58). EPA also compared production
volumes from the 1986 IUR data
collection to the production volumes for
the 2006 IUR data collection. Of the 19
chemical substances in this proposed
rule, only one chemical’s production
volume decreased from 1986 to 2006.
The 2006 IUR production volume data
are consistent with NOES results, as the
production volumes for the remaining
chemical substances either stayed the
same or increased since 1986, thereby
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indicating that the usage of these
chemical substances is no less than
when NOES data were gathered.
EPA has performed a chemical-bychemical analysis for all 19 chemical
substances and carefully considered the
industrial process and use information
along with the commercial and
consumer use information from the
2006 IUR submissions. Commercial uses
are defined as ‘‘The use of a chemical
substance or mixture in a commercial
enterprise providing saleable goods or
services (e.g., dry cleaning
establishment, painting contractor)’’; 40
CFR 710.43. Detailed information from
the IUR submissions can be found in
‘‘Testing of Certain High Production
Volume Chemicals; Second Group of
Chemicals (Exposure Findings
Supporting Information)’’ (Ref. 18).
Based on the nature of the IUR uses,
EPA considers that chemicals with
reported commercial uses may result in
potential exposure to 1,000 workers or
more. The total number of workers
reported under the IUR is the sum of
information on both industrial workers
plus commercial use workers.
In 2003, EPA partially exempted
certain petroleum process streams
(including ‘‘Hydrocarbons, C>4’’ (CAS
No. 68647–60–9) and ‘‘Oils, reclaimed’’
(CAS No. 69029–75–0)) from reporting
certain processing and use data under
the TSCA section 8(a) IUR. The
exemption was not based on an
assessment of the toxicity of the process
streams but on the fact that the
chemicals are frequently processed,
transported, and stored in vessels that
minimize the potential for releases and
exposure to workers. (Federal Register
issue of January 7, 2003 (68 FR 848)
(FRL–6767–4) and Federal Register
issue of December 19, 2005 (71 FR
75059) (FRL–7743–9); available on-line
at: https://www.epa.gov/fedrgstr). Despite
the fact that the degree of exposure is
expected to be diminished to particular
workers because of the chemical
processing and handling practices used,
available data indicate that more than
1,000 workers are potentially exposed to
these chemicals, supporting the
preliminary finding of substantial
human exposure (Ref. 18).
D. Are a Substantial Number of
Consumers Exposed to These
Chemicals?
Based on 2006 IUR data, EPA has
made preliminary findings that the uses
of 13 of the chemical substances
included in this action result or may
result in exposure to a substantial
number of consumers (Ref. 18). EPA
reviewed the consumer use information
reported for the 2006 IUR and carefully
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considered the nature of those uses.
Upon completion of the review, EPA
concluded that the reported consumer
uses for the chemicals in this action
may result in at least 10,000 potentially
exposed consumers, thus meeting the
exposure based finding for consumers.
In addition to findings made based on
the 2006 IUR data, EPA has also made
consumer exposure based findings
based on the National Library of
Medicine (NLM) Household Products
Database (Ref. 18). The chemical
substances reported in the National
Library of Medicine (NLM) Household
Products Database are present in
multiple household products subject to
TSCA including hobby/craft products,
personal care products, home cleaning
products, home maintenance products,
and automotive products. The NLM
Household Products Database provides
information on the chemical ingredients
and their percentage in specific brands
of household products. Information in
the database is from a variety of publicly
available sources including brandspecific labels and Material Safety Data
Sheets when available from
manufacturers and manufacturers’
websites. Publicly available information
from the database is available on-line at:
https://householdproducts.nlm.nih.gov.
EPA believes that use of the consumer
products identified in the NLM
Household Products Database may
expose a substantial number of
consumers (i.e., greater than 10,000) to
these chemical substances. EPA believes
that an exposure of over 10,000
consumers to a chemical substance is
‘‘substantial’’ as that term is used with
reference to ‘‘human exposure’’ in TSCA
section 4(a)(1)(B)(i). EPA believes, based
on experience gained through case-bycase analysis of existing chemicals, that
an exposure of 10,000 consumers or
more to a chemical substance is a
reasonable interpretation of the phrase
‘‘substantial human exposure’’ in TSCA
section 4(a)(1)(B)(i). (See Ref. 4.)
Therefore, EPA’s preliminary finding is
that there is or may be substantial
human exposure (consumers) to these
chemical substances.
A discussion of EPA’s preliminary
‘‘substantial exposure’’ finding for
consumers is contained in a separate
document (see Ref. 18). The Agency
solicits comment regarding additional
information pertaining to numbers of
consumers potentially exposed to the
chemical substances identified in this
proposed rule.
TABLE 1.—EXPOSURE BASED FINDINGS—SUBSTANTIAL HUMAN EXPOSURE
CAS No.
Meet Exposure
Based CriteriaFor
Mfg & Industrial
Workers
2006 IUR
Production Volume
NOES (number of workers)
Meet Exposure Based
Criteria for
Commercial
Workers
75–07–0
> 100 million
(M)–500 M
X
216,533
X
78–11–5
> 1 M–10 M
X
2,650
> 10 M–50 M
X
6,187
89–32–7
> 1 M–10 M
X
> 1 M–10 M
X
118–82–1
> 1 M–10 M
119–61–9
X
X
69,243
X
X
X
120,009
X
X
> 1 M–10 M
X
41,516
X
X
144–62–7
> 1 M–10 M
X
142,000
X
X
149–44–0
> 1 M–10 M
X
239,465
X
X
2524–04–1
> 10 M–50 M
X
1,088
4719–04–4
> 10 M–50 M
X
225,251
X
X
6381–77–7
> 1 M–10 M
X
19,468
31138–65–5
> 1 M–10 M
X
74,165
X
X
66241–11–0
> 1 M–10 M
X
38,555
X
X
68187–76–8
> 1 M–10 M
X
11,164
X
X
68187–84–8
> 1 M–10 M
X
36,381
X
X
68479–98–1
> 10 M–50 M
X
4,121
68527–02–6
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X
1,926
110–44–1
NLM Household Chemicals
Database
X
84–65–1
Meet Substantial or
Significant
Release Criteria
X
Meet Exposure Based
Criteria for
Consumers
> 1 M–10 M
X
84,192
68647–60–9
> 1 Billion lbs.
X
1,257
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X
X
X
X
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E. Are Substantial Quantities of These
Chemicals Released to the
Environment?
EPA does not have readily available
data on environmental releases for most
of the 19 chemical substances in this
proposed rule. However, one substance,
acetaldehyde (CAS No. 75–07–0) is
included in TRI and has estimated
environmental release in 2005 of
13,567,452 lbs. (Ref. 18). TRI contains
information about releases of certain
chemicals and management of wastes at
a wide variety of sources, including
manufacturing operations, certain
service businesses, and Federal
facilities. Publicly available information
from the 2005 TRI reporting cycle is
available on-line at: https://
www.epa.gov/triexplorer. Two
additional chemicals (ethanedioic acid
and 1,3,5-triazine-1,3,5(2H,4H,6H)triethanol) also meet the substantial
release criteria based on the
environmental releases from their
reported IUR uses.
EPA believes that an environmental
release of a chemical substance in an
amount equal to or greater than 1
million lbs. per year or greater than 10%
of the reported production volume is
‘‘substantial’’ as that term is used with
reference to ‘‘enter the environment in
substantial quantities’’ in TSCA section
4(a)(1)(B)(i). (See Ref. 4).
The Agency solicits comment
regarding additional information
pertaining to the amount of
environmental release of the chemical
substances identified in this proposed
rule.
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F. Do Sufficient Data Exist for These
Chemical Substances?
In developing the testing
requirements for chemicals contained in
this proposed rule, available
information on chemical/physical
properties, environmental fate,
ecotoxicity, and human health effects
was searched using the data sources
outlined in the OECD guidelines found
in section 3.1 (Reliability, Relevance
and Adequacy) of the ‘‘Manual for the
Investigation of HPV Chemicals’’ (Ref. 6)
such as: Beilstein Database, CRC
Handbook of Chemistry and Physics,
Hawley’s Condensed Chemical
Dictionary, Illustrated Handbooks of
Physical-Chemical Properties and
Environmental Fate for Organic
Chemicals, Merck Index, Hazardous
Substances Data Bank (HSDB),
Toxicology Literature Online
(TOXLINE), and the National Technical
Information Service (NTIS). EPA also
searched for available data as
summarized in its HPV Information
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System (Ref. 56). For one HPV chemical,
data available from an EPA
reassessment of its use as an inert in
pesticides formulations were examined
(Ref. 21). When appropriate, the Federal
Research In Progress (FEDRIP) database
was also searched. Any information that
was obtained from these searches was
evaluated for data acceptability using
the guidelines described on EPA’s
voluntary HPV Challenge Program
website (https://www.epa.gov/chemrtk/
pubs/general/guidocs.htm): ‘‘Guidance
for Meeting the SIDS Requirements (The
SIDS Guide)’’ and ‘‘Guidance for
Assessing the Adequacy of Existing
Data.’’ Furthermore, data adequacy and
reliability were evaluated using the
OECD guidelines which can be found in
section 3.1 of the OECD ‘‘Manual for the
Investigation of HPV Chemicals’’ (Ref.
6).
It is worth noting that additional
testing is being proposed for five
chemicals that had been included in the
final TSCA section 4 HPV SIDS
rulemaking issued on March 16, 2006
(Ref. 3). EPA noted in the proposed (Ref.
2) and final rule (Ref. 3) for that first
HPV SIDS rulemaking that, for
chemicals for which some data were
available on one or more SIDS
endpoints, EPA was not requiring
testing at that time for those endpoints.
However, EPA stated at that time that no
definitive determination had been made
as to the adequacy of those existing data
for an initial assessment of a chemical’s
hazards or risks to health or the
environment. Consequently, in that final
rule, EPA stated that if EPA determines
that it needs additional data regarding
any of the chemical substances included
in the final rule, the Agency might seek
further health and/or environmental
effects testing for those chemical
substances. EPA has now completed its
assessment of the adequacy of the
available data for those endpoints that
were not included for these chemicals
in the first HPV SIDS rulemaking. In
some instances, EPA has made a
preliminary finding that, for some of the
SIDS endpoints, the existing data and
experience are not sufficient to enable
the effects of these substances on health
or the environment to reasonably be
determined or predicted. Therefore,
EPA has also proposed testing for those
endpoints in this proposed rule.
Section 799.5087(j) of the proposed
regulatory text lists each chemical and
the SIDS tests for which adequate data
are not currently available to the
Agency. The Agency preliminarily finds
that the existing data for one or more of
the SIDS testing endpoints for each of
the chemical substances listed in Table
2 of the proposed regulatory text
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(including environmental fate
(comprising five tests for physical/
chemical properties [melting point,
boiling point, vapor pressure, n-octanol/
water partition coefficient, and water
solubility] and biodegradation);
ecotoxicity (tests in fish, Daphnia, and
algae); acute toxicity; genetic toxicity
(gene mutations and chromosomal
aberrations); repeat dose toxicity; and
developmental and reproductive
toxicity) are insufficient to enable EPA
to reasonably determine or predict the
human health and environmental effects
resulting from manufacture, processing,
and use of these chemical substances.
EPA solicits comment concerning the
availability of existing studies on the
SIDS endpoints proposed in this
document on these chemical substances.
To the extent that additional studies
relevant to the testing proposed in this
rulemaking are known to exist, EPA
strongly encourages the submission of
this information as comments to the
proposed rule, including full citations
for publications and full copies of
unpublished studies. If EPA judges such
data to be sufficient, corresponding
testing will not be included in the final
rule. Commenters are also encouraged to
prepare a robust summary (Ref. 15) for
each such study to facilitate EPA’s
review of the full study report or
publication. Persons who respond to
this request to submit robust summaries
are also encouraged to submit the robust
summary electronically via the High
Production Volume Information System
(HPVIS) to allow for its ready
incorporation into HPVIS. Directions for
electronic submission of robust
summary information into HPVIS are
provided at https://iaspub.epa.gov/
oppthpv/metadata.html. This link will
direct you to the ‘‘HPVIS Quick Start
and User’s Guide.’’
As noted in Unit II.C.1., persons who
believe that adequate information
regarding a chemical subject to this
proposed rule can be developed using a
category or SAR approach are
encouraged to submit appropriate
information, along with their rationale
which substantiates this belief, during
the comment period on this proposed
rule. If, based on submitted information
and other information available to EPA,
the Agency agrees; EPA will take such
measures as are needed to avoid
unnecessary testing in the final rule.
G. Is Testing Necessary for These
Chemical Substances?
EPA would use the data obtained
from this proposed testing to support
development of preliminary hazard and
risk characterizations for these HPV
chemicals as part of the ChAMP process
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fulfilling the U.S. commitments under
the SPP to set initial priorities for
potential future appropriate action,
including possible further testing that
would produce more definitive hazard
information where needed on such
chemical substances. Such additional
information is needed by EPA, other
Federal agencies, the public, industry,
and others to ensure that adequate
hazard and risk assessments can be
conducted on these chemical
substances. EPA has used data from test
rules to support such activities as the
development of water quality criteria,
TRI listings, chemical advisories, and
input for actions resulting in reduction
of workplace exposures.
EPA preliminarily believes that
conducting the needed SIDS testing
identified for the 19 subject chemical
substances is necessary to provide data
relevant to a determination of whether
the manufacture, processing, and use of
the chemical substances does or does
not present an unreasonable risk of
injury to human health and the
environment.
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IV. Proposed Testing
A. What Testing is Being Proposed in
this Action?
EPA is proposing specific testing and
reporting requirements for the chemical
substances specified in § 799.5087(j) of
the proposed regulatory text.
All of the proposed testing
requirements are listed in Table 2 in
§ 799.5087(j) of the proposed regulatory
text and consist of a series of test
methods covering many of the
endpoints in the OECD HPV SIDS
testing battery. EPA, however, requires
that the American Society for Testing
and Materials (ASTM) or the TSCA test
guidelines at 40 CFR part 799 (TSCA
799 guidelines) be used because the
language in the TSCA 799 guidelines
makes clear which steps are mandatory
and which steps are only recommended.
EPA’s TSCA 799 guidelines, however,
have been harmonized with the OECD
guidelines. Accordingly, in order to
comply with this test rule, testing must
be conducted in accordance with the
specified mandatory and enforceable
requirements in the ASTM or TSCA 799
guidelines. Most of the proposed testing
requirements for a particular endpoint
are specified in one test standard. In the
case of certain endpoints, however, any
of multiple listed methods could be
used. For several of the proposed test
standards, EPA has identified and is
proposing certain ‘‘Special Conditions’’
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as discussed in this unit. The following
endpoints and proposed test standards
would be required under this proposed
rule.
1. Physical/chemical properties.
Melting Point: American Society for
Testing and Materials (ASTM) E 324–99
(Capillary tube) (Ref. 22).
Boiling Point: ASTM E 1719–05
(Ebulliometry) (Ref. 23).
Vapor Pressure: ASTM E 1782–03
(Thermal analysis) (Ref. 24).
n-Octanol/Water Partition
Coefficient:
Method A (40 CFR 799.6755—
shake flask)
Method B (ASTM E 1147–
92(2005)—liquid chromatography) (Ref.
25).
Method C (40 CFR 799.6756—
generator column).
Water Solubility:
Method A: (ASTM E 1148–02—
shake flask) (Ref. 26).
Method B (40 CFR 799.6784—
shake flask).
Method C (40 CFR 799.6784—
column elution).
Method D (40 CFR 799.6786—
generator column).
EPA is proposing, for those chemicals
for which melting points determinations
are needed, that melting points be
determined according to the method
ASTM E 324–99. Although ASTM
indicates on its website, https://
www.astm.org/cgi-bin/SoftCart.exe/
STORE/
filtrexx40.cgi?U+mystore+lien2117+L+E324+/usr6/htdocs/astm.org/
DATABASE.CART/WITHDRAWN/
E324.htm that ASTM E 324–99 has been
withdrawn, ASTM has explained that
ASTM E 324–99 was withdrawn
because:
The standard utilizes old, well-developed
technology; it is highly unlikely that any
additional [changes] and/or modifications
will ever be pursued by the E15 [committee].
The time and effort needed to maintain these
documents detract from the time available to
develop new standards which use modern
technology.
(Ref. 27)
Withdrawal of the method by ASTM
means only that ASTM no longer
continues to develop and improve the
method. It does not mean that ASTM no
longer considers the method to be valid.
ASTM still makes the method available
for informational purposes and it can
still be purchased from ASTM at the
address listed in § 799.5087(h) of the
proposed regulatory text. EPA
concludes that ASTM’s withdrawal of E
324–99 does not have negative
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implications on the validity of the
method; therefore, EPA is proposing, for
those chemicals for which melting
points determinations are needed, that
melting points be determined according
to the method ASTM E 324–99.
For the n-octanol/water partition
coefficient and water solubility
endpoints, EPA is proposing that certain
‘‘Special Conditions’’ be considered by
test sponsors in determining the
appropriate test method that would be
used from among those included for
these endpoints in Table 3 in
§ 799.5087(j) of the proposed regulatory
text.
For the ‘‘n-Octanol/Water Partition
Coefficient (log 10 basis)’’ endpoint, also
known as log Kow, EPA proposes that an
appropriate selection be made from
among three alternative methods for
measuring the substance’s n-octanol/
water partition coefficient. Prior to
determining the appropriate standard to
use, if any, to measure the n-octanol/
water partition coefficient, EPA is
recommending that the log Kow be
quantitatively estimated. EPA
recommends that the method described
in ‘‘Atom/Fragment Contribution
Method for Estimating Octanol-Water
Partition Coefficients’’ (Ref. 28) be used
in making such estimation. EPA is
proposing that test sponsors must
submit with the final study report the
underlying rationale for the test
standard selected for this endpoint. EPA
is proposing this approach in
recognition of the fact that depending
on the chemical substance’s log Kow, one
or more test methods may provide
adequate information for determining
the log Kow, but that in some instances
one particular test method may be more
appropriate In general, EPA believes
that the more hydrophobic a subject
chemical is, the less well Method A
(§ 799.6755—shake flask) will work and
Method B (ASTM E 1147–92(2005)) and
Method C (§ 799.6756—generator
column) become more suitable,
especially Method C. The proposed test
methodologies have been developed to
meet a wide variety of needs and, as
such, are silent on experimental
conditions related to pH. Therefore,
EPA proposes that all required noctanol/water partition coefficient tests
be conducted at pH 7 to ensure
environmental relevance. The proposed
test standards and log Kow ranges that
would determine which tests must be
conducted for this endpoint are shown
in Table 2 of this unit.
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TABLE 2.—TEST REQUIREMENTS FOR THE N-OCTANOL/WATER PARTITION COEFFICIENT ENDPOINT
Testing Category
Test Requirements and References
Special Conditions
Physical/chemical
properties
n-Octanol/water partition coefficient (log 10 basis)
or log Kow:
The appropriate log Kow test, if any, would be selected from those listed in this column—see Special Conditions in the adjacent column.
Method A: 40 CFR 799.6755 (shake flask)
Method B: ASTM E 1147–92(2005) (liquid chromatography)
Method C: 40 CFR 799.6756 (generator column)
n-Octanol/water partition coefficient or log Kow:
Which method is required, if any, is determined by the test substance’s estimated log Kow as follows:
log Kow < 0: no testing required.
log Kow range 0–1: Method A or B.
log Kow range > 1–4: Method A or B or C.
log Kow range > 4–6: Method B or C.
log Kow > 6: Method C.
Test sponsors must provide in the final study report the underlying
rationale for the method and pH selected. In order to ensure environmental relevance, EPA highly recommends that the selected
study be conducted at pH 7.
For the ‘‘Water Solubility’’ endpoint,
EPA proposes an appropriate selection
be made from among four alternative
methods for measuring that endpoint.
The test method used, if any, would be
determined by first quantitatively
estimating the test substance’s water
solubility. One recommended method
for estimating water solubility is
described in ‘‘Improved Method for
Estimating Water Solubility from
Octanol/Water Partition Coefficient’’
(Ref. 29). EPA is also proposing that test
sponsors be required to submit in the
final study report the underlying
rationale for the test standard selected
for this endpoint. The proposed test
methodologies have been developed to
meet a wide variety of needs and, as
such, are silent on experimental
conditions related to pH. Therefore,
EPA proposes that all required water
solubility tests be conducted starting at
pH 7 to ensure environmental relevance.
The estimated water solubility ranges
that EPA is proposing for use in
selecting an appropriate proposed test
standard are shown in Table 3 of this
unit.
TABLE 3.—TEST REQUIREMENTS FOR THE WATER SOLUBILITY ENDPOINT
Test Requirements and References
Special Conditions
Physical/chemical
properties
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Testing Category
Water solubility:
The appropriate method to use, if any, to test for
water solubility would be selected from those listed in this column—see Special Conditions in the
adjacent column.
Method A: ASTM E 1148–02 (shake flask)
Method B: 40 CFR 799.6784 (shake flask)
Method C: 40 CFR 799.6784 (column elution)
Method D: 40 CFR 799.6786 (generator column)
Water solubility:
Which method is required, if any, would be determined by the test
substance’s estimated water solubility. Test sponsors must provide in the final study report the underlying rationale for the method and pH selected. In order to ensure environmental relevance,
EPA highly recommends that the selected study be conducted
starting at pH 7.
> 5,000 milligram/Liter (mg/L): Method A or B.
> 10 mg/L—5,000 mg/L: Method A, B, C, or D.
> 0.001 mg/L—10 mg/L: Method C or D.
≤ 0.001 mg/L: No testing required.
2. Environmental fate and pathways.
Ready Biodegradation:
Method A: ASTM E1720–01
(Sealed vessel CO2 production test) (Ref.
30).
Method B: ISO 14593 (CO2
headspace test) (Ref. 31).
Method C: ISO 7827 (Method by
analysis of dissolved organic carbon
(DOC)) (Ref. 32).
Method D: ISO 9408
(Determination of oxygen demand in a
closed respirometer) (Ref. 33).
Method E: ISO 9439 (Carbon
dioxide evolution test) (Ref. 34).
Method F: ISO 10707 (Closed
bottle test) (Ref 35).
Method G: ISO 10708 (Two-phase
closed bottle test) (Ref. 36).
For the ‘‘Ready Biodegradation’’
endpoint, EPA proposes an appropriate
selection be made from among seven
alternative methods for measuring the
substance’s ready biodegradability. For
most test substances, EPA considers
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Method A (ASTM E1720–01) and
Method B (ISO 14593) to be generally
applicable, cost effective, and widely
accepted internationally. However, the
test method used, if any, will depend on
the physical and chemical properties of
the test substance, including its water
solubility. An additional document, ISO
10634 (Ref. 37), provides guidance for
selection of an appropriate test method
for a given test substance considering
the substances physical and chemical
properties. EPA is also proposing that
test sponsors be required to submit in
the final study report the underlying
rationale for the test standard selected
for this endpoint.
3. Aquatic toxicity.
Test Group 1:
Acute toxicity to fish (ASTM E
729–96(2002)) (Ref. 38).
Acute toxicity to Daphnia (ASTM
E 729–96(2002)) (Ref. 38).
Toxicity to plants (algae) (ASTM
E 1218–04e1) (Ref. 39).
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Test Group 2:
Chronic toxicity to Daphnia
(ASTM E 1193–97(2004)) (Ref. 40).
Toxicity to plants (algae) (ASTM
E 1218–04e1) (Ref. 39).
For the ‘‘Aquatic Toxicity’’ endpoint,
the OECD HPV SIDS Program recognizes
that, for certain chemicals, acute
toxicity studies are of limited value in
assessing the substances’ aquatic
toxicity. This issue arises when
considering chemical substances with
high log Kow values. In such cases,
toxicity is unlikely to be observed over
the duration of acute toxicity studies
because of reduced uptake and the
extended amount of time required for
such substances to reach steady state or
toxic concentrations in the test
organism. For such situations, the OECD
HPV SIDS Program recommends use of
chronic toxicity testing in Daphnia in
place of acute toxicity testing in fish and
Daphnia. EPA is proposing that the
aquatic toxicity testing requirement be
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determined based on the test
substance’s measured log Kow as
determined by using the approach
outlined in Unit IV.A.1., in the
discussion of ‘‘n-Octanol/Water
Coefficient,’’ and in Table 3 in
§ 799.5087(j) of the proposed regulatory
text. For test substances determined to
have a log Kow of less than 4.2, one or
more of the following tests (described as
‘‘Test Group 1’’ in Table 3 in
§ 799.5087(j) of the proposed regulatory
text) are proposed: Acute toxicity to fish
(ASTM E 729–96 (2002)); Acute toxicity
to Daphnia (ASTM E 729–96(2002)); and
Toxicity to plants (algae) (ASTM E
1218–04e1). For test substances
determined to have a log Kow that is
greater than or equal to 4.2, one or both
of the following tests (described as ‘‘Test
Group 2’’ in Table 3 in § 799.5087(j) of
the proposed regulatory text) are
proposed: Chronic toxicity to Daphnia
(ASTM E 1193–97(2004)) and Toxicity
to plants (algae) (ASTM E 1218–04e1).
As outlined in Table 3 in § 799.5087(j)
of the proposed regulatory text,
depending on the testing proposed in
Test Group 1, the Test Group 2 chronic
Daphnia test may substitute for either or
both the acute fish toxicity test and the
acute Daphnia test.
Using SAR, a log Kow of 4.2
corresponds with a fish
bioconcentration factor (BCF) of about
1,000 (Refs. 29, 41, and 42). A chemical
substance with a fish BCF value of 1,000
or more is characterized as having a
tendency to accumulate in living
organisms relative to the concentration
of the chemical in the surrounding
environment (Ref. 42). For the purposes
of this proposed rulemaking, EPA’s use
of a log Kow equal to or greater than 4.2
(which corresponds with a fish BCF
value of 1,000) is consistent with the
approach taken in the Agency’s Final
Policy Statement under TSCA section 5
entitled Category for Persistent,
Bioaccumulative, and Toxic New
Chemical Substances (Ref. 43). EPA has
also used a measured BCF that is equal
to or greater than 1,000 or, in the
absence of bioconcentration data, a log
P [same as log Kow] value equal to or
greater than 4.3 to help define the
potential of a new chemical substance to
cause significant adverse environmental
effects (Significant New Use Rules;
General Provisions For New Chemical
Follow-Up (Ref. 44) (See also 40 CFR
721.3.)). EPA considers the difference
between the log Kow of 4.3 cited in the
1989 Federal Register document and
the log Kow value of 4.2 cited in this
proposed rule to be negligible.
EPA recognizes that in some
circumstances, acute aquatic toxicity
testing (Test Group 1) may be relevant
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for certain chemical substances having a
log Kow equal to or greater than 4.2.
chemical substances that are dispersible
in water (e.g., surfactants, detergents,
aliphatic amines, and cationic dyes)
may have log Kow values greater than 4.2
and may still be acutely toxic to aquatic
organisms. For any chemical substance
listed in Table 3 in § 799.5087(j) of the
proposed regulatory text for which a test
sponsor believes that an alternative to
the log Kow threshold of 4.2 is
appropriate, the test sponsor may
request a modification of the test
standard in the final rule as described
in 40 CFR 790.55. Based upon the
supporting rationale provided by the
test sponsor, EPA may allow an
alternative threshold or method to be
used for determining whether acute or
chronic aquatic toxicity testing must be
performed for a specific substance. EPA
is soliciting public comment on this
approach as well as other alternative
approaches in this area.
4. Mammalian toxicity—acute.
Acute Inhalation Toxicity (rat):
Method A (40 CFR 799.9130).
Acute Oral Toxicity (rat): Method B
(ASTM E 1163–98(2002) (Ref. 59) or 40
CFR 799.9110(d)(1)(i)(A)).
For the ‘‘Mammalian Toxicity—
Acute’’ endpoint, EPA is proposing that
certain ‘‘Special Conditions’’ in the form
of the chemical substance’s physical/
chemical properties or physical state be
considered in determining the
appropriate test method that would be
used from among those included for this
endpoint in Table 3 in § 799.5087(j) of
the proposed regulatory text. The OECD
HPV SIDS Program recognizes that, for
most chemical substances, the oral route
of administration will suffice for this
endpoint. However, consistent with the
approach taken under the voluntary
HPV Challenge Program, EPA is
proposing that, for test substances that
are gases at room temperature (25° C),
the acute mammalian toxicity study be
conducted using inhalation as the
exposure route (described as Method A
(40 CFR 799.9130) in Table 3 in
§ 799.5087(j) of the proposed regulatory
text). In the case of a potentially
explosive test substance, care must be
taken to avoid the generation of
explosive concentrations. For all other
chemicals (i.e., those that are either
liquids or solids at room temperature),
EPA is proposing that the acute toxicity
testing be conducted via oral
administration using an ‘‘Up/Down’’
test method (described as Method B
(ASTM E 1163–98(2002) or 40 CFR
799.9110(d)(1)(i)(A)) in Table 3 in
§ 799.5087(j) of the proposed regulatory
text). Consistent with the voluntary HPV
Challenge Program, EPA is proposing to
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allow the use of the Neutral Red Uptake
(NRU) basal cytotoxicity assay to select
the starting dose for the acute oral
toxicity test. This test is included as a
special condition in Table 3 of the
proposed regulatory text. A document
developed by NIH/NIEHS provides
guidance on how to use the NRU assay
to estimate a starting dose for an acute
oral toxicity test (Ref. 50). Recent
versions of the standardized protocols
for the NRU assay are available at the
NIEHS/ICCVAM website, https://
iccvam.niehs.nih.gov/methods/
acutetox/invitrocyto/invcyt_proto.htm
(Refs. 51–53).
Dermal toxicity testing is not
proposed in this rulemaking, and the
Agency does not intend to include any
dermal toxicity testing in any TSCA
section 4 HPV SIDS rulemakings.
5. Mammalian toxicity—genotoxicity.
Gene mutations:
Bacterial Reverse Mutation Test
(in vitro): 40 CFR 799.9510.
Chromosomal damage:
In Vitro Mammalian Chromosome
Aberration Test (40 CFR 799.9537), or
the In Vivo Mammalian Bone Marrow
Chromosomal Aberration Test (rodents:
mouse (preferred species), rat, or
Chinese hamster) (40 CFR 799.9538), or
the In Vivo Mammalian Erythrocyte
Micronucleus Test (sampled in bone
marrow) (rodents: mouse (preferred
species), rat, or Chinese hamster) (40
CFR 799.9539).
Persons who would be required to
conduct testing for chromosomal
damage are encouraged to use in vitro
genetic toxicity testing (i.e., the
Mammalian Chromosome Aberration
Test) to generate the needed genetic
toxicity screening data, unless known
chemical properties preclude its use.
These could include, for example,
physical chemical properties or
chemical class characteristics. A
primary focus of both the voluntary
HPV Challenge Program and this
proposed rule is to implement this
program in a manner consistent with the
OECD HPV SIDS Program and as part of
a larger international activity with
global involvement. This proposed
approach provides the same degree of
flexibility as that which currently exists
under the OECD HPV SIDS testing
program (Ref. 6). A subject person who
uses one of the in vivo methods instead
of the in vitro method to address this
end-point would be required to submit
to EPA a rationale for conducting that
alternate test in the final study report.
6. Mammalian toxicity—repeated
dose/reproduction/developmental.
Combined Repeated Dose Toxicity
Study with the Reproduction/
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Developmental Toxicity Screening Test:
40 CFR 799.9365.
Reproduction/Developmental
Toxicity Screening Test: 40 CFR
799.9355.
Repeated Dose 28–Day Oral
Toxicity Study: 40 CFR 799.9305.
For the ‘‘Mammalian Toxicity—
Repeated Dose/Reproduction/
Developmental’’ endpoint, EPA
recommends the use of the Combined
Repeated Dose Toxicity Study with the
Reproduction/Developmental Toxicity
Screening Test (40 CFR 799.9365) as the
test of choice. EPA recognizes, however,
that there may be reasons to test a
particular chemical substance using
both the Reproduction/Developmental
Toxicity Screening Test (40 CFR
799.9355) and the Repeated Dose 28–
Day Oral Toxicity Study (40 CFR
799.9305) instead of the Combined
Repeated Dose Toxicity Study with the
Reproduction/Developmental Toxicity
Screening Test (40 CFR 799.9365). With
regard to such cases, EPA is proposing
that a subject person who uses the
combination of the Reproduction/
Developmental Toxicity Screening Test
and the Repeated Dose 28–Day Oral
Toxicity Study in place of the Combined
Repeated Dose Toxicity Study with
Reproduction/Developmental Toxicity
Screen would be required to submit to
EPA a rationale for conducting these
alternate tests in the final study reports.
Certain of the chemical substances for
which Mammalian Toxicity—Repeated
Dose/Reproduction/Developmental
testing is proposed may be used solely
as ‘‘closed system intermediates,’’ as
described in the EPA guidance
document developed for the voluntary
HPV Challenge Program (Ref. 46). As
described in that guidance, such
chemical substances may be eligible for
a reduced testing battery which
substitutes a developmental toxicity
study for the SIDS requirement to
address repeated dose (e.g., subchronic),
reproductive, and developmental
toxicity. In other words, since only the
developmental toxicity study would be
conducted for those chemical
substances that qualify for a reduced
testing battery, repeated dose (e.g.,
subchronic) and reproductive studies
would not be conducted. At the present
time, EPA does not have sufficient
information to know with any degree of
certainty which if any of the chemical
substances that are listed in the
proposed regulatory text are solely
closed system intermediates as defined
in the voluntary HPV Challenge
Program guidance document (Ref. 46).
Persons who believe that a chemical
substance fully satisfies the terms
outlined in the guidance document are
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encouraged to submit appropriate
information along with their comments
on this proposed rule which
substantiate this belief. If, based on
submitted information and other
information available to EPA, the
Agency believes that a chemical
substance is considered likely to meet
the requirements for use solely as a
closed system intermediate, EPA would
not address any developmental toxicity
testing needs in this proposed
rulemaking. In those cases in which the
Agency can determine that chemicals
are solely closed system intermediates,
it plans to handle them in accordance
with the existing OECD procedures.
B. When Would Any Testing Imposed by
this Proposed Rulemaking Begin?
The testing requirements contained in
this proposed rule are not effective until
and unless the Agency issues a final
rule. Based on the effective date of the
final rule, which is typically 30 days
after the publication of a final rule in
the Federal Register, the test sponsor
may plan the initiation of any required
testing as appropriate to submit the
required final report by the deadline
indicated as the number of months after
the effective date that would be shown
in § 799.5087(j) of the proposed
regulatory text.
C. How Would the Studies Proposed
Under this Test Rule be Conducted?
Persons required to comply with the
final rule would have to conduct the
necessary testing in accordance with the
testing and reporting requirements
established in the regulatory text of the
final rule, and with the TSCA Good
Laboratory Practice Standards (GLPS)
(40 CFR part 792).
D. What Form of Test Substances Would
be Tested Under this Rule?
EPA is proposing two distinct
approaches for identifying the specific
substances that would be tested under
this proposed rule, the application of
which would depend on whether the
substance is considered to be a ‘‘Class
1’’ or a ‘‘Class 2’’ substance. First
introduced when EPA compiled the
TSCA Chemical Substance Inventory,
the term Class 1 substance refers to a
chemical substance having a chemical
composition that consists of a single
chemical species (not including
impurities) that can be represented by a
specific, complete structure diagram. By
contrast, the term Class 2 substance
refers to a chemical substance having a
composition that cannot be represented
by a specific, complete chemical
structure diagram, because such a
substance generally contains two or
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more different chemical species (not
including impurities). Table 2 in
§ 799.5087(j) of the proposed regulatory
text identifies the listed chemical
substances as either Class 1 or Class 2
substances.
EPA is proposing that, for the Class 1
substances that are listed in the
proposed rule, the test substance have a
purity of 99% or greater. EPA has
generally applied this standard of purity
to the testing of Class 1 substances in
the past under TSCA section 4(a) testing
actions, except for substances where it
has been shown that such purity is
unattainable. EPA is soliciting comment
on whether a purity level of 99% or
greater cannot be attained for any of the
Class 1 substances listed in this
proposed rule. For the Class 2
substances that are listed in the
proposed rule, EPA is proposing that the
test substance be any representative
form of the chemical substance, to be
defined by the test sponsor(s).
In proposing a different approach for
identifying the substance to be tested
with regard to Class 2 substances, EPA
recognizes two characteristics which
further distinguish Class 1 from Class 2
substances. First, unlike for Class 1
substances, knowledge of the
composition of commercial Class 2
substances can vary in quality and
specificity from substance to substance.
The composition of the chemical
species which comprise a Class 2
substance may be:
• Well-characterized in terms of
molecular formulae, structural
diagrams, and compositional
percentages of all species present (for
example, methyl phenol);
• Less well-characterized, for
example, characterized only by
molecular formulae, non-specific
structural diagrams, and/or by
incomplete or unknown compositional
percentages of the species present (for
example, C12–C14 tert-alkyl amines); or
• Poorly characterized because all that
is known is the identity of only some of
the chemical species present and their
percentages of composition, or of only
the feedstocks and method of
manufacture used to manufacture the
substance (for example, nut shell liquor
of cashew).
Secondly, the composition of some
Class 2 substances may vary from one
manufacturer to another, or, for a single
manufacturer, from production run to
production run, because of small
variations in feedstocks, manufacturing
methods, or other production variables.
A ‘‘Class 2’’ designation most frequently
represents a group of chemical
substances comprising substances that
have similar combinations of different
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chemical species and/or that were
prepared from similar feedstocks using
similar production methods. By
contrast, Class 1 substances generally
represent a much narrower group of
substances for which the only variables
are their impurities. EPA believes that,
for purposes of this proposed rule, the
testing of any representative form of a
subject Class 2 substance would provide
the data necessary to support the
development of preliminary or
screening level hazard and risk
characterizations for the subject Class 2
substance. However, EPA would
encourage the selection of
representative forms of test substances
that meet industry or consensus
standards, where they exist. In
accordance with TSCA GLPS at 40 CFR
part 792, the final study report would be
required to include test substance
identification information, including
name, CAS number, strength, purity,
and composition, or other appropriate
characteristics. (See 40 CFR 792.185).
As an alternative to requiring the
testing of a representative form of a
Class 2 substance designated by a
person subject to the final rule, EPA is
considering whether the Agency should
specify the particular form of each
chemical substance that must be tested,
and, if so, what criteria EPA should use
to identify the particular representative
form that would be tested. EPA might
specify, for example, a form of a
substance that meets an industry or
consensus specification, if one exists, or
the form with the highest production
volume, which could potentially be
identified via information reported
under a TSCA section 8(a) rule, or by
other means.
Under both of the approaches
described in this unit, manufacturers
and processors of each chemical
substance listed in this proposed rule
would be jointly responsible for the
testing of a representative form of each
Class 2 substance.
To facilitate EPA’s review of
exemption applications under this
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alternative, the Agency would require
the submission of certain chemical
substance-identifying data, including
characteristics and properties of the
exemption applicant’s substance, such
as boiling point, melting point, chemical
analysis, additives (if any), and spectral
data information.
EPA solicits comment on the
proposed alternative approaches to the
testing of Class 2 substances included in
this proposed rule.
E. Would I Be Required to Test Under
this Rule?
Under TSCA section 4(a)(1)(B)(ii),
EPA has made preliminary findings that
there are insufficient data and
experience to reasonably determine or
predict health and environmental effects
resulting from the manufacture,
processing, or use of the chemical
substances listed in this proposed
rulemaking. As a result, under TSCA
section 4(b)(3)(B), manufacturers and
processors of these chemical substances,
and those who intend to manufacture or
process them, would be subject to the
rule with regard to those listed chemical
substances which they manufacture or
process.
1. Would I be subject to this rule? You
would be subject to this rule and may
be required to test if you manufacture
(which is defined by statute to include
import) or process, or intend to
manufacture or process, one or more
chemical substances listed in this
proposed rule during the time period
discussed in Unit IV.E.2. However, if
you do not know or cannot reasonably
ascertain that you manufacture or
process a listed test rule substance
(based on all information in your
possession or control, as well as all
information that a reasonable person
similarly situated might be expected to
possess, control, or know, or could
obtain without unreasonable burden),
you would not be subject to the rule for
that listed substance.
2. When would my manufacture or
processing (or my intent to do so) cause
me to be subject to this rule? You would
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be subject to this rule if you
manufacture or process, or intend to
manufacture or process, a chemical
substance listed in this proposed rule at
any time from the effective date of the
final test rule to the end of the test data
reimbursement period. The term
‘‘reimbursement period’’ is defined at 40
CFR 791.3(h) and may vary in length for
each substance to be tested under a final
TSCA section 4(a) test rule, depending
on what testing is required and when
testing is completed. See Unit IV.E.4.
3. Would I be required to test if I were
subject to the rule? It depends on the
nature of your activities. All persons
who would be subject to this TSCA
section 4(a) test rule, which, unless
otherwise noted in the regulatory text,
incorporates EPA’s generic procedures
applicable to TSCA section 4(a) test
rules (contained within 40 CFR part
790), would fall into one of two groups,
designated here as Tier 1 and Tier 2.
Persons in Tier 1 (those who would
have to initially comply with the final
rule) would either:
• Submit to EPA letters of intent to
conduct testing, conduct this testing,
and submit the test data to EPA, or
• Apply to and obtain from EPA
exemptions from testing.
Persons in Tier 2 (those who would
not have to initially comply with the
final rule) would not need to take any
action unless they are notified by EPA
that they are required to do so (because,
for example, no person in Tier 1 had
submitted a letter of intent to conduct
testing), as described in Unit IV.E.3.d.
Note that both persons in Tier 1 who
obtain exemptions and persons in Tier
2 would nonetheless be subject to
providing reimbursement to persons
who actually conduct the testing, as
described in Unit IV.E.4.
a. Who would be in Tier 1 and Tier
2? All persons who would be subject to
the final rule are considered to be in
Tier 1 unless they fall within Tier 2.
Table 4 of this unit describes who is in
Tier 1 and Tier 2.
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TABLE 4.—PERSONS SUBJECT TO THE RULE: PERSONS IN TIER 1 AND TIER 2
Tier 2 (Persons not initially required to comply)
Persons who manufacture (as defined at TSCA section 3(7)),
or intend to manufacture, a test rule substance, and who are
not listed under Tier 2
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Tier 1 (Persons initially required to comply)
A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to
manufacture a test rule substance solely as one or more of the following:
—As a byproduct (as defined at 40 CFR 791.3(c));
—As an impurity (as defined at 40 CFR 790.3);
—As a naturally occurring chemical substance (as defined at 40 CFR
710.4(b));—As a non-isolated intermediate (as defined at 40 CFR 704.3);
—As a component of a Class 2 substance (as described at 40 CFR
720.45(a)(1)(i));
—In amounts of less than 500 kg (1,100 lbs.) annually (as described at 40
CFR 790.42(a)(4)); or
—In small quantities solely for research and development (R and D) (as described at 40 CFR 790.42(a)(5)).
B. Persons who process (as defined at TSCA section 3(10)) or intend to
process a test rule substance (see 40 CFR 790.42(a)(2)).
Under 40 CFR 790.2, EPA may
establish procedures applying to
specific test rules that differ from the
generic procedures governing TSCA
section 4(a) test rules in 40 CFR part
790. For purposes of this proposed rule,
EPA is proposing to establish certain
requirements that differ from those
under 40 CFR part 790.
In this proposed test rule, EPA has
reconfigured the tiers in 40 CFR 790.42.
In addition to processors, manufacturers
of less than 500 kg (1,100 lbs.) per year
(‘‘small-volume manufacturers’’), and
manufacturers of small quantities for
research and development (‘‘R&D
manufacturers’’), EPA has added the
following persons to Tier 2: Byproduct
manufacturers, impurity manufacturers,
manufacturers of naturally occurring
substances, manufacturers of nonisolated intermediates, and
manufacturers of components of Class 2
substances. The Agency took
administrative burden and complexity
into account in determining who was to
be in Tier 1 in this proposed rule. EPA
believes that those persons in Tier 1
who would conduct testing under this
rule, when finalized, would generally be
large chemical manufacturers who, in
the experience of the Agency, have
traditionally conducted testing or
participated in testing consortia under
previous TSCA section 4(a) test rules.
The Agency also believes that
byproduct manufacturers, impurity
manufacturers, manufacturers of
naturally occurring substances,
manufacturers of non-isolated
intermediates, and manufacturers of
components of Class 2 substances
historically have not themselves
participated in testing or contributed to
reimbursement of those persons who
have conducted testing. EPA
understands that these manufacturers
may include persons for whom the
marginal transaction costs involved in
negotiating and administering testing
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arrangements are deemed likely to raise
the expense and burden of testing to a
level that is disproportional to the
additional benefits of including these
persons in Tier 1. Therefore, EPA does
not believe that the likelihood of the
persons proposed to be added to Tier 2
actually conducting the testing is
sufficiently high to justify burdening
these persons with Tier 1 requirements
(e.g., submitting requests for
exemptions). Nevertheless, these
persons, along with all other persons in
Tier 2, would be subject to
reimbursement obligations to persons
who actually conduct the testing, as
described in Unit IV.E.4.
TSCA section 4(b)(3)(B) requires all
manufacturers and/or processors of a
chemical substance to test that chemical
substance if EPA has made findings
under TSCA sections 4(a)(1)(A)(ii) or
4(a)(1)(B)(ii) for that chemical
substance, and issued a TSCA section
4(a) test rule requiring testing. However,
practicality must be a factor in
determining who is subject to a
particular test rule. Thus, persons who
do not know or cannot reasonably
ascertain that they are manufacturing or
processing a chemical substance subject
to this proposed rule, e.g.,
manufacturers or processors of a
chemical substance as a trace
contaminant who are not aware of and
cannot reasonably ascertain these
activities, would not be subject to the
rule. See Unit IV.E.1. and
§ 799.5087(b)(2) of the proposed
regulatory text.
b. Subdivision of Tier 2 entities. The
Agency is proposing to prioritize which
persons in Tier 2 would be required to
perform testing, if needed. Specifically,
the Agency is proposing that Tier 2
entities be subdivided into:
i. Tier 2A. Tier 2 manufacturers, i.e.,
those who manufacture, or intend to
manufacture, a test rule substance solely
as one or more of the following: A
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byproduct, an impurity, a naturally
occurring substance, a non-isolated
intermediate, a component of a Class 2
substance, in amounts less than 1,100
lbs. annually, or in small quantities
solely for research and development.
ii. Tier 2B. Tier 2 processors, i.e.,
those who process, or intend to process,
a test rule substance (in any form). The
terms ‘‘process’’ and ‘‘processor’’ are
defined by TSCA sections 3(10) and
3(11), respectively.
If the Agency needs testing from
persons in Tier 2, EPA would seek
testing from persons in Tier 2A before
proceeding to Tier 2B. It is appropriate
to require manufacturers in Tier 2A to
submit letters of intent to test or
exemption applications before
processors are called upon because the
Agency believes that testing costs are
traditionally passed by manufacturers
along to processors, enabling them to
share in the costs of testing (Ref. 54). In
addition, ‘‘[t]here are [typically] so
many processors [of a given test rule
chemical] that it would be difficult to
include them all in the technical
decisions about the tests and in the
financial decisions about how to
allocate the costs’’ (Ref. 55).
c. When would it be appropriate for a
person who would be required to
comply with the rule to apply for an
exemption rather than to submit a letter
of intent to conduct testing? You may
apply for an exemption if you believe
that the required testing will be
performed by another person (or a
consortium of persons formed under
TSCA section 4(b)(3)(A)). You can find
procedures relating to exemptions in 40
CFR 790.80 through 790.99, and
§ 799.5087(c)(2), (c)(5), (c)(7), and (c)(11)
of the proposed regulatory text. In this
rule, EPA would not require the
submission of equivalence data (i.e.,
data demonstrating that your substance
is equivalent to the substance actually
being tested) as a condition for approval
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of your exemption. Therefore, 40 CFR
790.82(e)(1) and 40 CFR 790.85 would
not apply to this test rule.
d. What would happen if I submitted
an exemption application? EPA believes
that requiring the collection of
duplicative data is unnecessarily
burdensome. As a result, if EPA has
received a letter of intent to test from
another source or has received (or
expects to receive) the test data that
would be required under this rule, the
Agency would conditionally approve
your exemption application under 40
CFR 790.87.
The Agency would terminate
conditional exemptions if a problem
occurs with the initiation, conduct, or
completion of the required testing, or
with the submission of the required data
to EPA. EPA may then require you to
submit a notice of intent to test or an
exemption application. See 40 CFR
790.93 and § 799.5087(c)(8) of the
proposed regulatory text. In addition,
the Agency would terminate a
conditional exemption if no letter of
intent to test has been received by
persons required to comply with the
rule. See, e.g., § 799.5087(c)(6) of the
proposed regulatory text. Note that the
provisions at 40 CFR 790.48(b) have
been incorporated into the regulatory
text of this rule; thus, persons subject to
this rule are not required to comply
with 40 CFR 790.48 itself (see
§ 799.5087(c)(4)–(c)(7) and
§ 799.5087(d)(3) of the proposed
regulatory text). Note that persons who
obtain exemptions or receive them
automatically would nonetheless be
subject to providing reimbursement to
persons who do actually conduct the
testing, as described in Unit IV.E.4.
e. What would my obligations be if I
were in Tier 2? If you are in Tier 2, you
would be subject to the rule and you
would be responsible for providing
reimbursement to persons in Tier 1, as
described in Unit IV.E.4. You are
considered to have an automatic
conditional exemption. You would not
need to submit a letter of intent to test
or an exemption application unless you
are notified by EPA that you are
required to do so.
If a problem occurs with the
initiation, conduct, or completion of the
required testing, or with the submission
of the required data to EPA, the Agency
may require you to submit a notice of
intent to test or an exemption
application. See 40 CFR 790.93 and
§ 799.5087(c)(10) of the proposed
regulatory text.
In addition, you would need to
submit a notice of intent to test or an
exemption application if:
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• No manufacturer in Tier 1 has
notified EPA of its intent to conduct
testing; and
• EPA has published a Federal
Register document directing persons in
Tier 2 to submit to EPA letters of intent
to conduct testing or exemption
applications. See § 799.5087(c)(4), (c)(5),
(c)(6), and (c)(7) of the proposed
regulatory text. The Agency would
conditionally approve an exemption
application under 40 CFR 790.87, if EPA
has received a letter of intent to test or
has received (or expects to receive) the
test data required under this rule. EPA
is not aware of any circumstances in
which test rule Tier 1 entities have
sought reimbursement from Tier 2
entities either through private
agreements or by soliciting the
involvement of the Agency under the
reimbursement regulations at 40 CFR
part 791.
f. What would happen if no one
submitted a letter of intent to conduct
testing? EPA anticipates that it will
receive letters of intent to conduct
testing for all of the tests specified and
chemical substances included in the
final rule. However, in the event it does
not receive a letter of intent for one or
more of the tests required by the final
rule for any of the chemical substances
in the rule within 30 days after the
publication of a Federal Register
document notifying Tier 2 processors of
the obligation to submit a letter of intent
to conduct testing or to apply for an
exemption from testing, EPA would
notify all manufacturers and processors
of the chemical substance of this fact by
certified letter or by publishing a
Federal Register document specifying
the test(s) for which no letter of intent
has been submitted. This letter or
Federal Register document would
additionally notify all manufacturers
and processors that all exemption
applications concerning the test(s) have
been denied, and would give them an
opportunity to take corrective action. If
no one has notified EPA of its intent to
conduct the required testing of the
chemical substance within 30 days after
receipt of the certified letter or
publication of the Federal Register
document, all manufacturers and
processors subject to the rule with
respect to that chemical substance who
are not already in violation of the rule
would be in violation of the rule.
4. How do the reimbursement
procedures work? In the past, persons
subject to test rules have independently
worked out among themselves their
respective financial contributions to
those persons who have actually
conducted the testing. However, if
persons are unable to agree privately on
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43329
reimbursement, they may take
advantage of EPA’s reimbursement
procedures at 40 CFR part 791,
promulgated under the authority of
TSCA section 4(c). These procedures
include: The opportunity for a hearing
with the American Arbitration
Association; publication by EPA of a
document in the Federal Register
concerning the request for a hearing;
and the appointment of a hearing officer
to propose an order for fair and
equitable reimbursement. The hearing
officer may base his or her proposed
order on the production volume formula
set out at 40 CFR 791.48, but is not
obligated to do so. Under this proposed
rule, amounts manufactured as
impurities would be included in
production volume (40 CFR 791.48(b)),
subject to the discretion of the hearing
officer (40 CFR 791.40(a)). The hearing
officer’s proposed order may become the
Agency’s final order, which is
reviewable in Federal court (40 CFR
791.60).
F. What Reporting Requirements are
Proposed Under this Test Rule?
You would be required to submit a
final report for a specific test by the
deadline indicated as the number of
months after the effective date of the
final rule, which would be shown in
§ 799.5087(j) of the proposed regulatory
text. A robust summary of the final
report for each specific test should be
submitted in addition to and at the same
time as the final report. The term
‘‘robust summary’’ is used to describe
the technical information necessary to
adequately describe an experiment or
study and includes the objectives,
methods, results, and conclusions of the
full study report which can be either an
experiment or in some cases an
estimation or prediction method.
Guidance for the compilation of robust
summaries is described in a document
entitled Draft Guidance on Developing
Robust Summaries (Ref. 15) which is
available at: https://www.epa.gov/HPV/
pubs/general/robsumgd.htm. Persons
who respond to this request to submit
robust summaries are also encouraged to
submit the robust summary
electronically via the High Production
Volume Information System (HPVIS) to
allow for its ready incorporation into
HPVIS. Directions for electronic
submission of robust summary
information into HPVIS are provided at
https://iaspub.epa.gov/oppthpv/
metadata.html. This link will direct you
to the ‘‘HPVIS Quick Start and User’s
Guide.’’
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G. What Would I Need to Do if I Cannot
Complete the Testing Required by the
Final Rule?
A company who submits a letter of
intent to test under the final rule and
who subsequently anticipates
difficulties in completing the testing by
the deadline set forth in the final rule
may submit a modification request to
the Agency, pursuant to 40 CFR 790.55.
EPA will determine whether
modification of the test schedule is
appropriate, and may first seek public
comment on the modification.
H. Would There Be Sufficient Test
Facilities and Personnel to Undertake
the Testing Proposed Under this Test
Rule?
EPA’s most recent analysis of
laboratory capacity (Ref. 47) indicates
that available test facilities and
personnel would adequately
accommodate the testing proposed in
this rule.
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I. Might EPA Seek Further Testing of the
Chemicals in this Proposed Test Rule?
If EPA determines that it needs
additional data regarding any of the
chemical substances included in this
proposed rule, the Agency would seek
further health and/or environmental
effects testing for these chemical
substances. Should the Agency decide
to seek such additional testing via a test
rule, EPA would initiate a separate
action for this purpose.
V. Export Notification
Any person who exports, or intends to
export, one of the chemical substances
contained in this proposed rule in any
form (e.g., as byproducts, impurities,
components of Class 2 substances, etc.)
will be subject to the export notification
requirements in TSCA section 12(b)(1)
and at 40 CFR part 707, subpart D, but
only after the final rule is issued and
only if the chemical is contained in the
final rule. Export notification is
generally not required for articles, as
provided by 40 CFR 707.60(b). Section
12(b) of TSCA states, in part, that any
person who exports or intends to export
to a foreign country a chemical
substance or mixture for which the
submission of data is required under
section 4 must notify the EPA
Administrator of such export or intent
to export. The Administrator in turn
will notify the government of the
importing country of EPA’s regulatory
action with respect to the chemical
substance.
VI. Economic Impacts
In addition, EPA has prepared an
economic assessment entitled Economic
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Analysis for the Proposed Section 4 Test
Rule for High Production Volume
Chemicals; Final Report (Ref. 17), a
copy of which has been placed in the
public docket for this proposed
rulemaking. This economic assessment
evaluates the potential for significant
economic impacts as a result of the
testing that would be required by this
proposal. The analysis covers 19
chemical substances. The total social
cost of providing test data on the 19
chemical substances that were evaluated
in this economic analysis is estimated to
be $4.4 million (Ref. 17).
While legally subject to this test rule,
processors of a subject chemical would
be required to comply with the
requirements of the rule only if they are
directed to do so by EPA as described
in § 799.5087(c)(5) and (c)(6) of the
proposed regulatory text. EPA would
only require processors to test if no
person in Tier 1 has submitted a notice
of its intent to conduct testing, or if
under 40 CFR 790.93, a problem occurs
with the initiation, conduct, or
completion of the required testing or the
submission of the required data to EPA.
Because EPA has identified at least one
manufacturer in Tier 1 for each subject
chemical, the Agency assumes that, for
each chemical substance in this
proposed rule, at least one such person
will submit a letter of intent to conduct
the required testing and that person will
conduct such testing and will submit
the test data to EPA. Because processors
would not need to comply with the
proposed rule initially, the economic
assessment does not address processors.
To evaluate the potential for an
adverse economic impact of testing on
manufacturers of the chemical
substances in this proposed rule, EPA
employed a screening approach that
estimated the impact of testing
requirements as a percentage of each
chemical substance’s sale price. This
measure compares annual revenues
from the sale of a chemical substance to
the annualized compliance cost for that
chemical to assess the percentage of
testing costs that can be accommodated
by the revenue stream generated by that
chemical over a number of years.
Compliance costs include costs of
testing and administering the testing, as
well as reporting costs. Annualized
compliance costs divide testing
expenditures into an equivalent,
constant yearly expenditure over a
longer period of time. To calculate the
percent price impact, testing costs
(including laboratory and administrative
expenditures) are annualized over 15
years using a 7% discount rate.
Annualized testing costs are then
divided by the estimated annual
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revenue of the chemical substance to
derive the cost-to-sales ratio. EPA
estimates the total annualized
compliance cost of testing for the 19
chemical substances evaluated in the
economic analysis to be $1.68 million
under the average cost scenario. In
addition, the TSCA section 12(b) export
notification requirements (included in
the total and annualized cost estimates)
that would be triggered by the final rule
are expected to have a negligible impact
on exporters. The estimated cost of the
TSCA section 12(b) export notification
requirements, which, under the final
rule, would be required for the first
export to a particular country of a
chemical subject to the rule, is
estimated to range from $25.56 per
notice to $80.22 per notice (Ref.17). The
Agency’s estimated total costs of testing
(including both laboratory and
administrative costs) annualized testing
cost, and public reporting burden hours
for this proposed rule are presented in
the economic assessment.
Under a least cost scenario, 16 out of
the 19 chemical substances (84%)
would have a price impact at less than
the 1% level. Similarly, 15 out of the 19
chemical substances (79%) would be
impacted at less than the 1% level
under an average cost scenario. Thus,
the potential for adverse economic
impact due to the proposed test rule is
low for at least 79% of the chemical
substances in this proposed rule.
Approximately 4 chemicals (21%) of the
19 chemical substances for which price
data are available would have a price
impact at a level greater than or equal
to 1% under the least (average) cost
scenario.
EPA believes, on the basis of these
calculations, that the proposed testing of
the chemical substances presents a low
potential for adverse economic impact
for the majority of the chemical
substances. Because the subject
chemical substances have relatively
large production volumes, the
annualized costs of testing, expressed as
a percentage of annual revenue, are very
small for most of the chemicals. There
are, however, some chemical substances
for which the price impact is expected
to exceed 1% of the revenue from that
chemical. The potential for adverse
economic impact is expected to be
higher for these chemical substances. In
these cases, companies may choose to
use revenue sources other than the
profits from the individual chemicals to
pay for testing. Smaller businesses are
less likely to have additional revenue
sources to cover the compliance costs in
this situation. Therefore, the Agency
also compared the costs of compliance
to company sales for small businesses.
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EPA does not provide quantitative
estimates of the benefits from these
tests. Ideally, a discussion of benefits
would focus on the additional benefits
to be gained from new information
relative to information that already
exists. Such an approach could examine
the value of new information provided
as a result of the test rule where such
information has not been publicly
available. Because of constraints on
information on the value of information,
our evaluation of benefits is qualitative
and does not address incremental
benefits. We believe, however, that the
net benefits of the new information are
positive.
VII. Public Comment
As discussed in Units III.D. and III.E.,
the Agency solicits comment regarding
additional information pertaining to
potential exposure of workers and
consumers, respectively, to the chemical
substances identified in this proposed
rule. Also, as discussed in Units III.F.,
the Agency solicits comment regarding
additional information pertaining to
environmental releases of the chemical
substances identified in this proposed
rule.
As discussed in Unit III.F., EPA is
soliciting comments which identify
existing data that may meet the
requirements of studies under this
proposed rule. To the extent that data
relevant to the testing specified in this
proposed rule are known to exist, EPA
strongly encourages the submission of
this information as comments to the
proposed rule. Data submitted to EPA to
meet the requirements of testing under
this proposed rule must be in the form
of full copies of unpublished studies or
full citations of published studies, and
may be accompanied by a robust
summary (Ref. 15). To the extent that
studies required under this proposed
rule are currently available, and the data
are judged sufficient by EPA, testing for
the endpoint/chemical combination will
not be required in the final rule based
on this proposed rule.
EPA also solicits public comment on
the test methods proposed and the
analysis detailing the burdens and costs
for the regulatory impacts resulting from
this rule.
In addition, EPA solicits comment on
the proposed and alternative approaches
to the testing of Class 2 substances,
whether the proposed approach for
testing Class 1 substances (i.e., that each
Class 1 substance be tested at a purity
of 99% or more) should be applied to
any Class 2 substances, and whether the
proposed or alternative approaches for
the testing of Class 2 substances (i.e.,
that a representative sample of each
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Class 2 substance be tested) should be
applied to any Class 1 substances.
VIII. Materials in the Docket
As indicated under ADDRESSES, a
docket has been established for this
proposed rulemaking under docket ID
number EPA–HQ–OPPT–2007–0531.
The following is a listing of the
documents that have been placed in the
public docket for this proposed rule.
The docket includes information
considered by EPA in developing this
proposed rule, including the documents
listed in this unit, which are physically
located in the docket. In addition,
interested parties should consult
documents that are referenced in the
documents that EPA has placed in the
public docket, regardless of whether
these referenced documents are
physically located in the public docket.
For assistance in locating documents
that are referenced in documents that
EPA has placed in the public docket,
but that are not physically located in the
docket, please consult the technical
contact listed under FOR FURTHER
INFORMATION CONTACT. The public
docket is available for review as
specified under ADDRESSES.
1. EPA. Data Collection and
Development on High Production
Volume (HPV) Chemicals. Notice.
Federal Register (65 FR 81686,
December 26, 2000) (FRL–6754–6).
2. EPA. Proposed Test Rule for the
Testing of Certain High Production
Volume Chemicals. Proposed Rule.
Federal Register (65 FR 81658,
December 26, 2000) (FRL–6758–4).
3. EPA. Final Test Rule for the Testing
of Certain High Production Volume
Chemicals. Final Rule. 40 CFR part 799.
Federal Register (71 FR 13708, March
16, 2006) (FRL–7335–2).
4. EPA. TSCA Section 4(a)(1)(B) Final
Statement of Policy. Notice. Federal
Register (58 FR 28736, May 14, 1993).
5. EPA, OPPT. HPV Challenge
Program Chemical List. This list is
updated periodically, and is available
on-line at: https://www.epa.gov/oppt/
chemrtk/pubs/update/hpvchmlt.htm.
6. OECD Secretariat. Manual for the
Investigation of HPV Chemicals. OECD
Programme on the Co-Operative
Investigation of High Production
Volume Chemicals. Paris, France.
September 2004. Available on-line at:
https://www.oecd.org/document/7/
0,2340,en_2649_34379_1947463_
1_1_1_1,00.htm.
7. International Council of Chemical
Associations (ICCA). ICCA HPV
Working List of Chemicals. October
2005. This list is updated periodically,
and is available on-line at: https://
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43331
www.cefic.org/activities/hse/mgt/hpv/
hpvinit.htm.
8. EPA. TSCA section 4(a)(1)(B)
Proposed Statement of Policy. Notice.
Federal Register (56 FR 32294, July 15,
1991).
9. OECD Secretariat. Summary Record
of the 13th Joint Meeting of the OECD
Chemicals Group and Management
Committee of the Special Programme on
the Control of Chemicals, November 8–
10, 1989. ENV/CHEM/CM/89.2.
February 1990.
10. OECD Secretariat. Proposal for
Further Work on the Investigation of
High Production Volume Chemicals.
OECD Chemicals Group and
Management Committee of the Special
Programme on the Control of Chemicals.
ENV/CHEM/CM/89.14. October 1989.
11. OECD. Decision-Recommendation
on the Co-Operative Investigation and
Risk Reduction of Existing Chemicals–
C(90)163/FINAL. January 31, 1991.
12. CMA (ACC). Comments on EPA’s
TSCA section 4(a)(1)(B) Proposed
Statement of Policy submitted to the
TSCA Public Docket Office, EPA.
September 13, 1991.
13. Epoxy Resin Systems Task Group
of the Society of the Plastics Industry,
Inc. Comments on EPA’s TSCA section
4(a)(1)(B) Proposed Statement of Policy
submitted to the TSCA Public Docket
Office, EPA. September 13, 1991.
14. EPA, Office of Pollution
Prevention and Toxics (OPPT).
Chemical Hazard Data Availability
Study: What Do We Really Know About
the Safety of High Production Volume
Chemicals? April 1998. Available online at: https://www.epa.gov/chemrtk/
pubs/general/hazchem.htm.
15. EPA, OPPT. Draft Guidance on
Developing Robust Summaries. October,
22, 1999. Available on-line at: https://
www.epa.gov/HPV/pubs/general/
robsumgd.htm.
16. EPA, Office of Prevention,
Pesticides and Toxic Substances
(OPPTS). Letter from Susan H. Wayland,
Deputy Assistant Administrator, to
participants in the voluntary HPV
Challenge Program. October 14, 1999.
Available on-line at https://
www.epa.gov/chemrtk/pubs/general/
ceoltr2.htm.
17. EPA, OPPT, Economics, Exposure
and Technology Division (EETD),
Economic and Policy Analysis Branch
(EPAB). Economic Analysis for the
Proposed Section 4 Test Rule for High
Production Volume Chemicals; Final
Report. February 2008.
18. EPA, OPPT, EETD. Testing of
Certain High Production Volume
Chemicals; Second Group of Chemicals
(Exposure Findings Supporting
Information). July 2008.
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19. EPA. OPPT. Chemical Information
and Testing Branch (CITB). Response to
public comments regarding testing of
certain high production volume
chemicals. May 31, 2005.
20. NIOSH. National occupational
exposure survey field guidelines. Vol. I.
Seta JA, Sundin DS, Pedersen DH, eds.
Cincinnati, OH: U.S. Department of
Health and Human Services, Centers for
Disease Control, National Institute for
Occupational Safety and Health, DHHS
(NIOSH) Publication No. 88–106. 1988.
Available on-line at: https://
www.cdc.gov/niosh/88-106.html.
21. EPA. Inert Reassessment—Oxalic
Acid (CAS Reg. No. 144–62–7). Action
Memorandum. From: Pauline Wagner,
Chief, Inert Ingredient Assessment
Branch, To: Lois A. Rossi, Director,
Registration Division. September 6,
2005.
22. American Society for Testing and
Materials International (ASTM
International). Standard Test Method for
Relative Initial and Final Melting Points
and the Melting Range of Organic
Chemicals. ASTM. E 324–99. 1999.
23. ASTM International. Standard
Test Method for Vapor Pressure of
Liquids by Ebulliometry. ASTM. E
1719–05. 2005.
24. ASTM International. Standard
Test Method for Determining Vapor
Pressure by Thermal Analysis. ASTM. E
1782–03. 2003.
25. ASTM International. Standard
Test Method for Partition Coefficient (nOctanol/Water) Estimation by Liquid
Chromatography. ASTM. E 1147–
92(2005). 2005.
26. ASTM International. Standard
Test Method for Measurements of
Aqueous Solubility. ASTM. E 1148–02.
2002.
27. 49. ASTM International. Question
about ASTM E 324. E-mail from Diane
Rehiel, ASTM, to Greg Schweer, CITB,
CCD, OPPT, EPA. September 15, 2004.
28. Meylan, W.M. and Howard, P.H.
Atom/Fragment Contribution Method
for Estimating Octanol-Water Partition
Coefficients. Journal of Pharmaceutical
Sciences. 84(1):83–92. 1995.
29. Meylan, W.M., Howard, P.H., and
Boethling, R.S. Improved Method for
Estimating Water Solubility From
Octanol/Water Partition Coefficient.
Environmental Toxicology and
Chemistry. 15(2):100–106. 1996.
30. ASTM International. Standard
Test Method for Determining Ready,
Ultimate, Biodegradability of Organic
Chemicals in a Sealed Vessel CO2
Production Test, ASTM E 1720–01.
2001.
31. International Organization for
Standardization (ISO). Water quality—
Evaluation of ultimate aerobic
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biodegradability of organic compounds
in aqueous medium—Method by
analysis of inorganic carbon in sealed
vessels (CO2 headspace test). ISO 14593.
1999.
32. ISO. Water quality—Evaluation in
an aqueous medium of the ‘‘ultimate’’
aerobic biodegradability of organic
compounds—Method by analysis of
dissolved organic carbon (DOC). ISO
7827. 1994.
33. ISO. Water quality—Evaluation of
ultimate aerobic biodegradability of
organic compounds in aqueous medium
by determination of oxygen demand in
a closed respirometer. ISO 9408. 1999.
34. ISO. Water quality—Evaluation of
ultimate aerobic biodegradability of
organic compounds in aqueous
medium—Carbon dioxide evolution
test. ISO 9439. 1999.
35. ISO. Water quality—Evaluation in
an aqueous medium of the ‘‘ultimate’’
aerobic biodegradability of organic
compounds—Method by analysis of
biochemical oxygen demand (closed
bottle test). ISO 10707. 1994.
36. ISO. Water quality—Evaluation in
an aqueous medium of the ultimate
aerobic biodegradability of organic
compounds—Determination of
biochemical oxygen demand in a twophase closed bottle test (available in
English only). ISO 10708. 1997.
37. ISO. Water quality—Guidance for
the preparation and treatment of poorly
water-soluble organic compounds for
the subsequent evaluation of their
biodegradability in an aqueous medium.
ISO 10634. 1995.
38. ASTM International. Standard
Guide for Conducting Acute Toxicity
Tests on Test Materials with Fishes,
Macroinvertebrates, and Amphibians.
ASTM. E 729–96(2002). 2002.
39. ASTM International. Standard
Guide for Conducting Static Toxicity
Tests with Microalgae. ASTM. E 1218–
04e1. 2004.
40. ASTM International. Standard
Guide for Conducting Daphnia magna
Life-Cycle Toxicity Tests. ASTM. E
1193–97(2004). 2004.
41. Veith, G.D. and Kosian, P.
Estimating bioconcentration potential
from octanol/water partition
coefficients, in Physical Behavior of
PCB’s in the Great Lakes (MacKay,
Paterson, Eisenreich, and Simmons,
eds.), Ann Arbor Science, Ann Arbor,
MI. 1982.
42. Bintein, S.; DeVillers, J.; and
Karcher, W. Nonlinear dependence of
fish bioconcentration on n-octanol/
water partition coefficient. SAR and
QSAR in Environmental Research, 1:29–
39. 1993.
43. EPA. Document containing EPA’s
Policy Statement under TSCA section 5
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entitled Category for Persistent,
Bioaccumulative, and Toxic New
Chemical Substances. Notice. Federal
Register (64 FR 60194, November 4,
1999) (FRL–6097–7). Available on-line
at: https://www.epa.gov/oppt/newchems/
pubs/pbtpolcy.htm.
44. EPA. Significant New Use Rules;
General Provisions for New Chemical
Follow-Up. Final Rule. Federal Register
(54 FR 31307, July 27, 1989).
45. EPA, OPPT. Development of
Chemical Categories in the HPV
Challenge Program (Draft). August 25,
1999. Available on-line at: https://
www.epa.gov/chemrtk/pubs/general/
categuid.htm.
46. EPA, OPPT. Guidance for Testing
Closed System Intermediates for the
HPV Challenge Program (Draft). March
17, 1999. Available on-line at: https://
www.epa.gov/oppt/chemrtk/pubs/
general/closed9.htm.
47. EPA, OPPT, EETD, EPAB.
Analysis of Laboratory Capacity to
Support U.S. EPA Chemical Testing
Program Initiatives. August 2004.
48. EPA, OPPT. The Use of StructureActivity Relationships (SAR) in the
High Production Volume Chemicals
Challenge Program. August 26, 1999.
Available on-line at: https://
www.epa.gov/chemrtk/pubs/general/
sarfinl1.htm.
49. EPA, OPPT, EETD, EPAB.
Economic Analysis in Support of the
TSCA 12(b) Information Collection
Request. October 30, 1998.
50. NIEHS 2001b. Guidance
Document on Using In Vitro Data to
Estimate In Vivo Starting Doses for
Acute Toxicity. NIH Publication No. 01–
4500. August 2001. Available on-line at:
https://iccvam.niehs.nih.gov/methods/
acutetox/inv_cyto_guide.htm.
51. NIEHS 2003a. Test Method
Protocol for Solubility Determination, in
vitro Cytotoxicity Validation Study—
Phase III. National Toxicology Program
(NTP) Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM). September 24,
2003. Available on-line at: https://
iccvam.niehs.nih.gov/methods/
acutetox/invitrocyto/invcyt_proto.htm.
52. NIEHS 2003b. Test Method
Protocol for the BALB/c 3T3 Neutral
Red Uptake Cytotoxicity Test, a Test for
Basal Cytotoxicity for an in vitro
Validation Study—Phase III. National
Toxicology Program (NTP) Interagency
Center for the Evaluation of Alternative
Toxicological Methods (NICEATM).
November 4, 2003. Available on-line at:
https://iccvam.niehs.nih.gov/methods/
acutetox/invitrocyto/invcyt_proto.htm.
53. NIEHS 2003c. Test Method
Protocol for the NHK Neutral Red
Uptake Cytotoxicity Test, a Test for
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Basal Cytotoxicity for an in vitro
Validation Study—Phase III. National
Toxicology Program (NTP) Interagency
Center for the Evaluation of Alternative
Toxicological Methods (NICEATM).
November 4, 2003. Available on-line at:
https://iccvam.niehs.nih.gov/methods/
acutetox/invitrocyto/invcyt_proto.htm.
54. EPA. Toxic Substances; Test Rule
Development and Exemption
Procedures. Interim Final Rule. 40 CFR
part 790. Federal Register (50 FR 20652,
May 17, 1985).
55. EPA. Toxic Substances Control
Act; Data Reimbursement. Final Rule.
40 CFR part 791. Federal Register (48
FR 31786, July 11, 1983).
56. EPA. OPPT. High Production
Volume Chemical Data Information
System (HPVIS). Data from HVPIS on 18
HPV chemicals. May 2008.
57. NIOSH. National occupational
exposure survey analysis of
management interview responses. Vol.
III. Pedersen DH, Sieber WK, eds.
Cincinnati, OH: U.S. Department of
Health and Human Services, Centers for
Disease Control, National Institute for
Occupational Safety and Health, DHHS
(NIOSH) Publication No. 89–103. 1989.
Available on-line at: https://
www.cdc.gov/niosh/89-103.html.
58. NIOSH. National occupational
exposure survey sampling methodology.
Vol. II. Sieber WK, ed. Cincinnati, OH:
U.S. Department of Health and Human
Services, Centers for Disease Control,
National Institute for Occupational
Safety and Health, DHHS (NIOSH)
Publication No. 89–102. 1989. Available
on-line at: https://www.cdc.gov/niosh/89102.html.
59. ASTM International. Standard
Test Method for estimating Acute Oral
Toxicity in Rats. ASTM E 1163–
98(2002). 2002.
IX. Statutory and Executive Order
Reviews
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A. Executive Order 12866
Under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993),
this proposed rule is not a ‘‘significant
regulatory action’’ subject to review by
the Office of Management and Budget
(OMB) under Executive Order 12866,
because it does not raise novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in section 3(f)(4)
of the Executive Order. Accordingly,
EPA did not submit this proposed
rulemaking to OMB for review under
Executive Order 12866.
EPA has prepared an economic
analysis of this proposed action, which
is contained in a document entitled
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Economic Analysis for the Proposed
Section 4 Test Rule for High Production
Volume Chemicals; Final Report (Ref.
17). A copy of the economic analysis is
available in the docket for this proposed
rule and is summarized in Unit VI.
B. Paperwork Reduction Act
This proposed rule does not impose
any new or amended paperwork
collection requirements that would
require additional review and/or
approval by OMB under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq. Although the activities are
approved, OMB has specified that the
additional burden associated with a new
test rule is not covered by the ICR until
the final rule is effective. The
information collection requirements
contained in TSCA section 4 test rules
have already been approved by OMB
under PRA, and have been assigned
OMB control number 2070–0033 (EPA
ICR No. 1139). In the context of
developing a new test rule, the Agency
must determine whether the total
annual burden covered by the approved
ICR needs to be amended to
accommodate the burden associated
with the new test rule. If so the Agency
must submit an Information Correction
Worksheet (ICW) to OMB and obtain
OMB approval of an increase in the total
approved annual burden in the OMB
inventory. The Agency’s estimated
burden for this test rule is provided in
the economic analysis (Ref. 17).
The information collection activities
related to export notification under
TSCA section 12(b)(1) are already
approved under OMB control number
2070–0030 (EPA ICR No. 0795). This
rulemaking does not propose any new
or changes to the export notification
requirements, and is not expected to
result in any substantive changes in the
burden estimates for EPA ICR No. 0795
that would require additional review
and/or approval by OMB.
Under PRA, an agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information that is subject to approval
under PRA, unless it displays a
currently valid OMB control number.
The OMB control numbers for the EPA
regulations codified in title 40 of the
CFR, after appearing in the preamble of
the final rule, are listed in 40 CFR part
9, displayed either by publication in the
Federal Register or by other appropriate
means, such as on the related collection
instrument or form, if applicable. The
display of OMB control numbers in
certain EPA regulations is consolidated
in 40 CFR part 9.
The standard chemical testing
program involves the submission of
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letters of intent to test (or exemption
applications), study plans, semi-annual
progress reports, test results, and some
administrative costs. For this proposed
rule, EPA estimates the public reporting
burden for all 19 chemicals is 9,008
hours, with an estimated burden per
chemical of 474 hours (Ref. 17). The
estimated burden of the information
collection activities related to export
notification is estimated to average 1
burden hour for each chemical/country
combination for an initial notification
and 0.5 hours for each subsequent
notification (Ref. 17). In estimating the
total burden hours approved for the
information collection activities related
to export notification, the Agency has
included sufficient burden hours to
accommodate any export notifications
that may be required by the Agency’s
issuance of final chemical test rules. As
such, EPA does not expect to need to
request an increase in the total burden
hours approved by OMB for export
notifications.
As defined by PRA and 5 CFR
1320.3(b), ‘‘burden’’ means the total
time, effort, or financial resources
expended by persons to generate,
maintain, retain, or disclose or provide
information to or for a Federal agency.
This includes the time needed to:
Review instructions; develop, acquire,
install, and utilize technology and
systems for the purposes of collecting,
validating, and verifying information,
processing and maintaining
information, and disclosing and
providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements; train personnel to be able
to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
Comments are requested on the
Agency’s need for this information, the
accuracy of the provided burden
estimates, and any suggested methods
for minimizing respondent burden,
including through the use of automated
collection techniques. Send comments
to EPA as part of your overall comments
on this proposed action in the manner
specified under ADDRESSES. In
developing the final rule, the Agency
will address any comments received
regarding the information collection
requirements contained in this proposal.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA), 5
U.S.C. 601 et seq., after considering the
potential economic impacts of this
proposed rule on small entities, the
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Agency hereby certifies that this
proposed rule would not have a
significant adverse economic impact on
a substantial number of small entities.
The factual basis for the Agency’s
determination is presented in the small
entity impact analysis prepared as part
of the economic analysis for this
proposed rule (Ref. 17), which is
summarized in Unit VI., and a copy of
which is available in the docket for this
proposed rulemaking. The following is
a brief summary of the factual basis for
this certification.
Under RFA, small entities include
small businesses, small organizations,
and small governmental jurisdictions.
For purposes of assessing the impacts of
this proposed rule on small entities,
small entity is defined in accordance
with the RFA as:
1. A small business as defined by the
Small Business Administration’s (SBA)
regulations at 13 CFR 121.201.
2. A small governmental jurisdiction
that is a government of a city, county,
town, school district, or special district
with a population of less than 50,000.
3. A small organization that is any
not-for-profit enterprise which is
independently owned and operated and
is not dominant in its field. Based on
the industry profile that EPA prepared
as part of the economic analysis for this
proposed rulemaking (Ref. 17), EPA has
determined that this proposed rule is
not expected to impact any small notfor-profit organizations or small
governmental jurisdictions. As such, the
Agency’s analysis presents only the
estimated potential impacts on small
business.
Two factors are examined in EPA’s
small entity impact analysis (Ref. 17) in
order to characterize the potential small
entity impacts of this proposed rule on
small business:
1. The size of the adverse economic
impact (measured as the ratio of the cost
to sales or revenue).
2. The total number of small entities
that experience the adverse economic
impact.
Section 601(3) of RFA establishes as
the default definition of ‘‘small
business’’ the definition used in section
3 of the Small Business Act, 15 U.S.C.
632, under which SBA establishes small
business size standards (13 CFR
121.201). For this proposed rulemaking,
EPA has analyzed the potential small
business impacts using the size
standards established under this default
definition. The SBA size standards,
which are primarily intended to
determine whether a business entity is
eligible for government programs and
preferences reserved for small
businesses (13 CFR 121.101), ‘‘seek to
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ensure that a concern that meets a
specific size standard is not dominant in
its field of operation.’’ (13 CFR
121.102(b)). See section 632(a)(1) of the
Small Business Act. In analyzing
potential impacts, RFA recognizes that
it may be appropriate at times to use an
alternate definition of small business.
As such, section 601(3) of RFA provides
that an agency may establish a different
definition of small business after
consultation with the SBA Office of
Advocacy and after notice and an
opportunity for public comment. Even
though the Agency has used the default
SBA definition of small business to
conduct its analysis of potential small
business impacts for this proposed rule,
EPA does not believe that the SBA size
standards are generally the best size
standards to use in assessing potential
small entity impacts with regard to
TSCA section 4(a) test rules.
The SBA size standard is generally
based on the number of employees an
entity in a particular industrial sector
may have. For example, in the chemical
manufacturing industrial sector (i.e.,
NAICS codes 325 and 324110),
approximately 98% of the firms would
be classified as small businesses under
the default SBA definition. The SBA
size standard for 75% of this industry
sector is 500 employees, and the size
standard for 23% of this industry sector
is either 750; 1,000; or 1,500 employees.
When assessing the potential impacts of
test rules on chemical manufacturers,
EPA believes that a standard based on
total annual sales may provide a more
appropriate means to judge the ability of
a chemical manufacturing firm to
support chemical testing without
significant costs or burdens.
EPA is currently determining what
level of annual sales would provide the
most appropriate size cutoff with regard
to various segments of the chemical
industry usually impacted by TSCA
section 4(a) test rules, but has not yet
reached a determination. As stated in
this unit, therefore, the factual basis for
RFA determination for this proposed
rule is based on an analysis using the
default SBA size standards. Although
EPA is not currently proposing to
establish an alternate definition for use
in the analysis conducted for this
proposed rule, the analysis for this
proposed rule also presents the results
of calculations using a standard based
on total annual sales (40 CFR 704.3).
EPA is interested in receiving comments
on whether the Agency should consider
establishing an alternate definition for
small business to use in the small entity
impact analyses for future TSCA section
4(a) test rules, and what size cutoff may
be appropriate.
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The SBA has developed 6 digit NAICS
code-specific size standards based on
employment thresholds. These size
standards range from 500 to 1,500
employees for the various 6 digit NAICS
codes that are potentially impacted (Ref.
17). For a conservative estimate of the
number of small businesses affected by
this proposed rule, the Agency chose an
employment threshold of less than
1,500 employees for all businesses
regardless of the NAICS-specific
threshold to determine small business
status.
For each manufacturer of the 19
chemicals covered by this proposed
rule, the parent company (ultimate
corporate entity, or UCE) was identified
and sales and employment data were
obtained for companies where data was
publicly available. The search
determined that there were 48 affected
UCEs. Sales and employment data could
be found for 45 and 46 of these UCEs
(88%), respectively.
Parent company sales data were
collected to identify companies that
qualified as a ‘‘small business’’ for
purposes of the RFA analysis. Based on
the SBA size standard applied (1,500
employees or less), 20 companies were
identified as small.
The potential significance of this
proposed rule’s impact on small
businesses was analyzed by examining
the number of small entities that
experienced different levels of costs as
a percentage of their sales. Small
businesses were placed in the following
categories on the basis of cost-to sales
ratios: less than 1%, greater than 1%,
and greater than 3%. This analysis was
conducted under both a least and
average cost scenario.
Of the 20 small businesses analyzed
for small business impacts, one
company had no sales data available.
Another two companies could not be
classified as small or large because there
were no employment data available, but
were still included in the small business
impact analysis. Of the 19 designated as
small businesses, none had cost-to-sales
ratios of greater than 1% under both the
least and average cost scenarios. For the
chemicals where sales data were
unavailable, EPA used the median sales
value sales of all other small businesses
equal to $15.4 million. The costs for the
three companies were estimated to be
well below 0.01% of this sales level.
Given these results, the Agency has
determined that there is not a significant
economic impact on a substantial
number of small entities as a result of
this proposed rule, if finalized.
The estimated cost of the TSCA
section 12(b)(1) export notification,
which, as a result of the final rule,
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would be required for the first export to
a particular country of a chemical
subject to the rule, is estimated to be
$80.22 for the first time that an exporter
must comply with TSCA section
12(b)(1) export notification
requirements, and $25.56 for each
subsequent export notification
submitted by that exporter (Refs. 17, 48,
and 49). EPA has concluded that the
costs of TSCA section 12(b)(1) export
notification would have a negligible
impact on exporters of the chemicals in
the final rule, regardless of the size of
the exporter.
Any comments regarding the impacts
that this action may impose on small
entities, or regarding whether the
Agency should consider establishing an
alternate definition of small business to
be used for analytical purposes for
future test rules and what size cutoff
may be appropriate, should be
submitted to the Agency in the manner
specified under ADDRESSES.
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D. Unfunded Mandates Reform Act
Pursuant to Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA),
Public Law 104–4, EPA has determined
that this proposed rulemaking does not
contain a Federal mandate that may
result in expenditures of $100 million or
more for State, local, and tribal
governments, in the aggregate, or the
private sector in any 1 year. It is
estimated that the total aggregate costs
of this proposed rule, which are
summarized in Unit VI., would be $4.4
million. The total annualized costs of
this proposed rule are estimated to be
$1.68 million. In addition, since EPA
does not have any information to
indicate that any State, local, or tribal
government manufactures or processes
the chemicals covered by this action
such that this rule would apply directly
to State, local, or tribal governments,
EPA has determined that this proposed
rule would not significantly or uniquely
affect small governments. Accordingly,
this proposed rule is not subject to the
requirements of sections 202, 203, 204,
and 205 of UMRA.
E. Executive Order 13132
Under Executive Order 13132,
entitled Federalism (64 FR 43255,
August 10, 1999), EPA has determined
that this proposed rule does not have
‘‘federalism implications’’ because it
will not have substantial direct effects
on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government, as
specified in the Executive Order. This
proposed rule would establish testing
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and recordkeeping requirements that
apply to manufacturers (including
importers) and processors of certain
chemicals. Because EPA has no
information to indicate that any State or
local government manufactures or
processes the chemical substances
covered by this action, this proposed
rule does not apply directly to States
and localities and will not affect State
and local governments. Thus, Executive
Order 13132 does not apply to this
proposed rule.
F. Executive Order 13175
Under Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000), EPA has
determined that this proposed rule does
not have tribal implications because it
will not have any affect on tribal
governments, on the relationship
between the Federal Government and
the Indian tribes, or on the distribution
of power and responsibilities between
the Federal Government and Indian
tribes, as specified in the Executive
Order. As indicated previously, EPA has
no information to indicate that any
tribal government manufactures or
processes the chemical substances
covered by this action. Thus, Executive
Order 13175 does not apply to this
proposed rule.
G. Executive Order 13045
This proposed rule is not subject to
Executive Order 13045, entitled
Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997),
because it does not establish an
environmental standard intended to
mitigate health or safety risks, will not
have an annual effect on the economy
of $100 million or more, nor does it
otherwise have a disproportionate effect
on children. This proposed rule would
establish testing and recordkeeping
requirements that apply to
manufacturers (including importers)
and processors of certain chemicals, and
would result in the development of data
about those chemicals that can
subsequently be used to assist the
Agency and others in determining
whether the chemicals in this proposed
rule present potential risks, allowing the
Agency and others to take appropriate
action to investigate and mitigate those
risks.
H. Executive Order 13211
This proposed rule is not subject to
Executive Order 13211, entitled Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
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43335
22, 2001), because it is unlikely to have
any significant adverse effect on the
supply, distribution, or use of energy.
I. National Technology Transfer and
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104–
113, section 12(d) (15 U.S.C. 272 note),
directs EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus standards
bodies. The NTTAA directs EPA to
provide Congress, through OMB,
explanations when the Agency decides
not to use available and applicable
voluntary consensus standards.
This proposed rule involves technical
standards because it proposes to require
the use of particular test methods. If the
Agency makes findings under TSCA
section 4(a), EPA is required by TSCA
section 4(b) to include specific
standards or test methods that are to be
used for the development of the data
required in the test rules issued under
TSCA section 4. For some of the testing
that would be required by this rule, EPA
is proposing the use of voluntary
consensus standards issued by ASTM
and ISO which evaluate the same type
of toxicity as the TSCA and OECD test
guidelines, where applicable. Copies of
the 17 ASTM and ISO standards
referenced in the proposed regulatory
text at § 799.5087(h) have been placed
in the docket for this proposed
rulemaking. You may obtain copies of
the ASTM standards from the American
Society for Testing and Materials, 100
Bar Harbor Dr., West Conshohocken, PA
19428–2959, and copies of the ISO
standards from the International
Organization for Standardization, Case
`
Postale, 56 CH-1211 Geneve 20
Switzerland. In the final rule, EPA
intends to seek approval from the
Director of the Federal Register for the
incorporation by reference of the ASTM
and ISO standards used in the final rule
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51.
EPA is not aware of any potentially
applicable voluntary consensus
standards which evaluate partition
coefficient (n-octanol/water) generator
column, water solubility (column
elution and generator column), acute
inhalation toxicity, bacterial reverse
mutations, in vivo mammalian bone
marrow chromosomal aberrations,
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combined repeated dose with
reproductive/developmental toxicity
screen, repeated dose 28–day oral
toxicity screen, or the reproductive
developmental toxicity screen which
could be considered in lieu of the TSCA
guidelines, 40 CFR 799.6756, 799.6784,
799.6786, 799.9130, 799.9510, 799.9538,
799.9365, 799.9305, and 799.9355,
respectively, upon which the test
standards in this proposed rule are
based. The Agency invites comment on
the potential use of voluntary consensus
standards in this proposed rulemaking,
and, specifically, invites the public to
identify potentially applicable
consensus standard(s) and to explain
why such standard(s) should be used
here.
J. Executive Order 12898
This proposed rule does not have an
adverse impact on the environmental
and health conditions in low-income
and minority communities that require
special consideration by the Agency
under Executive Order 12898, entitled
Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations (59 FR 7629, February 16,
1994). The Agency believes that the
information collected under this
proposed rule, if finalized, will assist
EPA and others in determining the
potential hazards and risks associated
with the chemicals covered by the rule.
Although not directly impacting
environmental justice-related concerns,
this information will better enable the
Agency to better protect human health
and the environment, including in lowincome and minority communities.
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals,
Hazardous substances, Laboratories,
Reporting and recordkeeping
requirements.
Dated: July 17, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention,
Pesticides and Toxic Substances.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
1. The authority citation for part 799
would continue to read as follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
2. By adding § 799.5087 to subpart D
of part 799 that would read as follows:
§ 799.5087 Chemical testing requirements
for certain high production volume
chemicals; second group of chemicals.
(a) What substances will be tested
under this section? Table 2 in paragraph
(j) of this section identifies the chemical
substances that must be tested under
this section. For the chemical
substances identified as ‘‘Class 1’’
substances in Table 2 in paragraph (j) of
this section, the purity of each
substance must be 99% or greater,
unless otherwise specified in this
section. For the chemical substances
identified as ‘‘Class 2’’ substances in
Table 2 in paragraph (j), a representative
form of each substance must be tested.
The representative form selected for a
given Class 2 substance should meet
industry or consensus standards where
they exist.
(b) Am I subject to this section? (1) If
you manufacture (including import) or
intend to manufacture, or process or
intend to process, any chemical
substance listed in Table 2 in paragraph
(j) of this section at any time from the
effective date of the final rule to the end
of the test data reimbursement period as
defined in 40 CFR 791.3(h), you are
subject to this section with respect to
that chemical substance.
(2) If you do not know or cannot
reasonably ascertain that you
manufacture or process a chemical
substance listed in Table 2 in paragraph
(j) of this section during the time period
described in paragraph (b)(1) of this
section (based on all information in
your possession or control, as well as all
information that a reasonable person
similarly situated might be expected to
possess, control, or know, or could
obtain without unreasonable burden),
you are not subject to this section with
respect to that chemical substance.
(c) If I am subject to this section, when
must I comply with it? (1) (i) Persons
subject to this section are divided into
two groups, as set forth in Table 1 of
this paragraph: Tier 1 (persons initially
required to comply) and Tier 2 (persons
not initially required to comply). If you
are subject to this section, you must
determine if you fall within Tier 1 or
Tier 2, based on Table 1 of this
paragraph.
TABLE 1.—PERSONS SUBJECT TO THE RULE: PERSONS IN TIER 1 AND TIER 2
Tier 2 (Persons not initially required to comply with this section)
Persons not otherwise specified in column 2 of this table that
manufacture (as defined at TSCA section 3(7)) or intend to
manufacture a chemical substance included in this section.
ebenthall on PRODPC60 with PROPOSALS3
Tier 1 (Persons initially required to comply with this section)
Tier 2A. Persons who manufacture (as defined at TSCA section 3(7)) or intend
to manufacture a chemical substance included in this section solely as one
or more of the following:
—As a byproduct (as defined at 40 CFR 791.3(c));
—As an impurity (as defined at 40 CFR 790.3);
—As a naturally occurring substance (as defined at 40 CFR 710.4(b));
—As a non-isolated intermediate (as defined at 40 CFR 704.3);
—As a component of a Class 2 substance (as described at 40 CFR
720.45(a)(1)(i));
—In amounts of less than 500 kilogram (kg) (1,100 lbs.) annually (as described
at 40 CFR 790.42(a)(4)); or
—For research and development (as described at 40 CFR 790.42(a)(5)).
B. Persons who process (as defined at TSCA section 3(10)) or intend to process a chemical substance included in this section (see 40 CFR
790.42(a)(2)).
(ii) Table 1 of paragraph (c)(1)(i) of
this section expands the list of persons
in Tier 2, that is those persons specified
in § 790.42(a)(2), (a)(4) and (a)(5) of this
chapter, who, while legally subject to
this section, must comply with the
requirements of this section only if
directed to do so by EPA under the
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circumstances set forth in paragraphs
(c)(4), (c)(5), (c)(6), (c)(7), and (c)(10) of
this section.
(2) If you are in Tier 1 with respect
to a chemical substance listed in Table
2 in paragraph (j) of this section, you
must, for each test required under this
section for that chemical substance,
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either submit to EPA a letter of intent
to test or apply to EPA for an exemption
from testing. The letter of intent to test
or the exemption application must be
received by EPA no later than 30 days
after the effective date of the final rule.
(3) If you are in Tier 2 with respect
to a chemical substance listed in Table
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2 in paragraph (j) of this section, you are
considered to have an automatic
conditional exemption and you will be
required to comply with this section
with regard to that chemical substance
only if directed to do so by EPA under
paragraphs (c)(5), (c)(7) or (c)(10) of this
section.
(4) If no person in Tier 1 has notified
EPA of its intent to conduct one or more
of the tests required by this section on
any chemical substance listed in Table
2 in paragraph (j) of this section within
30 days after the effective date of the
final rule, EPA will publish a Federal
Register document that would specify
the test(s) and the chemical substance(s)
for which no letter of intent has been
submitted and notify manufacturers in
Tier 2A of their obligation to submit a
letter of intent to test or to apply for an
exemption from testing.
(5) If you are in Tier 2A (as specified
in Table 1 in paragraph (c) of this
section) with respect to a chemical
substance listed in Table 2 in paragraph
(j) of this section, and if you
manufacture, or intend to manufacture,
this chemical substance as of [date 30
days after date of publication of the
final rule in the Federal Register], or
within 30 days after publication of the
Federal Register document described in
paragraph (c)(4) of this section, you
must, for each test specified for that
chemical substance in the document
described in paragraph (c)(4) of this
section, either submit to EPA a letter of
intent to test or apply to EPA for an
exemption from testing. The letter of
intent to test or the exemption
application must be received by EPA no
later than 30 days after publication of
the document described in paragraph
(c)(4) of this section.
(6) If no manufacturer in Tier 1 or Tier
2A has notified EPA of its intentto
conduct one or more of the tests
required by this section on any chemical
substance listed in Table 2 in paragraph
(j) of this section within 30 days after
the publication of the Federal Register
document described in paragraph (c)(4)
of this section, EPA will publish another
Federal Register document that would
specify the test(s) and the chemical
substance(s) for which no letter of intent
has been submitted, and notify
processors in Tier 2B of their obligation
to submit a letter of intent to test or to
apply for an exemption from testing.
(7) If you are in Tier 2B (as specified
in Table 1 in paragraph (c) of this
section) with respect to a chemical
substance listed in Table 2 in paragraph
(j) of this section, and if you process, or
intend to process, this chemical
substance as of [date 30 days after date
of publication of the final rule in the
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Federal Register], or within 30 days
after publication of the Federal Register
document described in paragraph (c)(6)
of this section, you must, for each test
specified for that chemical substance in
the document described in paragraph
(c)(6) of this section, either submit to
EPA a letter of intent to test or apply to
EPA for an exemption from testing. The
letter of intent to test or the exemption
application must be received by EPA no
later than 30 days after publication of
the document described in paragraph
(c)(6) of this section.
(8) If no manufacturer or processor
has notified EPA of its intent to conduct
one or more of the tests required by this
section for any of the chemical
substances listed in Table 2 in
paragraph (j) of this section within 30
days after the publication of the Federal
Register document described in
paragraph (c)(6) of this section, EPA will
notify all manufacturers and processors
of those chemical substances of this fact
by certified letter or by publishing a
Federal Register document specifying
the test(s) for which no letter of intent
has been submitted. This letter or
Federal Register document will
additionally notify all manufacturers
and processors that all exemption
applications concerning the test(s) have
been denied, and will give the
manufacturers and processors of the
chemical substance(s) an opportunity to
take corrective action.
(9) If no manufacturer or processor
has notified EPA of its intent to conduct
one or more of the tests required by this
section for any of the chemical
substances listed in Table 2 in
paragraph (j) of this section within 30
days after receipt of the certified letter
or publication of the Federal Register
document described in paragraph (c)(8)
of this section, all manufacturers and
processors subject to this section with
respect to that chemical substance who
are not already in violation of this
section will be in violation of this
section.
(10) If a problem occurs with the
initiation, conduct, or completion of the
required testing or the submission of the
required data with respect to a chemical
substance listed in Table 2 in paragraph
(j) of this section, under the procedures
in §§ 790.93 and 790.97 of this chapter,
EPA may initiate termination
proceedings for all testing exemptions
with respect to that chemical substance
and may notify persons in Tier 1 and
Tier 2 that they are required to submit
letters of intent to test or exemption
applications within a specified period of
time.
(11) If you are required to comply
with this section, but your manufacture
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or processing of, or intent to
manufacture or process, a chemical
substance listed in Table 2 in paragraph
(j) of this section begins after the
applicable compliance date referred to
in paragraphs (c)(2), (c)(5) or (c)(6) of
this section, you must either submit a
letter of intent to test or apply to EPA
for an exemption. The letter of intent to
test or the exemption application must
be received by EPA no later than the day
you begin manufacture or processing.
(d) What must I do to comply with
this section? (1) To comply with this
section you must either submit to EPA
a letter of intent to test, or apply to and
obtain from EPA an exemption from
testing.
(2) For each test with respect to which
you submit to EPA a letter of intent to
test, you must conduct the testing
specified in paragraph (h) of this section
and submit the test data to EPA.
(3) You must also comply with the
procedures governing test rule
requirements in part 790 of this chapter,
as modified by this section, including
the submission of letters of intent to test
or exemption applications, the conduct
of testing, and the submission of data;
Part 792—Good Laboratory Practice
Standards of this chapter; and this
section. The following provisions of 40
CFR part 790 do not apply to this
section: Paragraphs (a), (d), (e), and (f)
of § 790.45; paragraph (a)(2) and
paragraph (b) of §§ 790.80, 790.82(e)(1),
790.85, and 790.48.
(e) If I do not comply with this section,
when will I be considered in violation of
it? You will be considered in violation
of this section as of one day after the
date by which you are required to
comply with this section.
(f) How are EPA’s data reimbursement
procedures affected for purposes of this
section? If persons subject to this section
are unable to agree on the amount or
method of reimbursement for test data
development for one or more chemical
substances included in this section, any
person may request a hearing as
described in 40 CFR part 791. In the
determination of fair reimbursement
shares under this section, if the hearing
officer chooses to use a formula based
on production volume, the total
production volume amount will include
amounts of a chemical substance
produced as an impurity.
(g) Who must comply with the export
notification requirements? Any person
who exports, or intends to export, a
chemical substance listed in Table 2 in
paragraph (j) of this section is subject to
part 707, subpart D, of this chapter.
(h) How must I conduct my testing?
(1) The tests that are required for each
chemical substance are indicated in
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pursuant to 40 CFR 790.55. A robust
summary of the final report for each
specific test should be submitted in
addition to and at the same time as the
final report. The term ‘‘robust
summary’’ is used to describe the
technical information necessary to
adequately describe an experiment or
study and includes the objectives,
methods, results, and conclusions of the
full study report which can be either an
experiment or in some cases an
estimation or prediction method.
Guidance for the compilation of robust
summaries is described in a document
entitled Draft Guidance on Developing
Table 2 in paragraph (j) of this section.
The test methods that must be followed
are provided in Table 3 in paragraph (j)
of this section. You must proceed in
accordance with these test methods as
required according to Table 3 in
paragraph (j) of this section, or as
appropriate if more than one alternative
is allowed according to Table 3 in
paragraph (j) of this section.
(i) Reporting requirements. A final
report for each specific test for each
subject chemical substance must be
received by EPA by [date 13 months
after the effective date of the final rule]
unless an extension is granted in writing
Robust Summaries which is available at:
https://www.epa.gov/HPV/pubs/general/
robsumgd.htm.
(j) Designation of specific chemical
substances and testing requirements.
The chemical substances identified by
chemical name, Chemical Abstract
Service registry number (CAS No.), and
class in Table 2 of this paragraph must
be tested in accordance with the
requirements designated in Tables 2 and
3 of this paragraph, and the
requirements described in 40 CFR Part
792—Good Laboratory Practice
Standards:
TABLE 2.—CHEMICAL SUBSTANCES AND TESTING REQUIREMENTS
CAS No.
Chemical Name
Acetaldehyde
78–11–5
1,3-Propanediol,
dinitrate (ester)
84–65–1
Required Tests/ (See Table 3 of this paragraph)
1
C2, F2
1
C4
9,10-Anthracenedione
1
C6
89–32–7
1H,3H-Benzo[1,2-c:4,5-c’]difuran-1,3,5,7-tetrone
1
A3, A4, A5, B, C1, D, E1, F1
110–44–1
2,4-Hexadienoic acid, (E,E)-
1
C6, F2
118–82–1
Phenol,
dimethylethyl)-
1
C1
119–61–9
Methanone, diphenyl-
1
B, C2
144–62–7
Ethanedioic acid
1
A1, A2, A3, A5, B, C1, E2, F2
149–44–0
Methanesulfinic acid, hydroxy-, monosodium
salt
1
E1
2524–04–1
Phosphorochloridothioic acid, O,O-diethyl ester
1
A1, A2, A3, A4, A5, B, C1, E1, E2, F2
4719–04–4
1,3,5-Triazine-1,3,5(2H,4H,6H)-triethanol
1
C6
6381–77–7
D-erythro-Hex-2-enonic acid, g-lactone, monosodium salt
1
A4, B, C1
31138–65–5
D-gluco-Heptonic acid, monosodium salt, (2.xi.)-
1
A1, A2, A4, A5, B, C1, D, E1, E2, F1
66241–11–0
C.I. Leuco Sulphur Black 1
2
A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1
68187–76–8
Castor oil, sulfated, sodium salt
2
A1, A2, A4, A5, C1, D, E1, E2, F1
68187–84–8
Castor oil, oxidized
2
A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1
68479–98–1
Benzenediamine, ar,ar-diethyl-ar-methyl-
1
A1, A2, A3, A4, A5, C1, E1, E2, F1
68527–02–6
Alkenes, C12–24, chloro
2
A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1
68647–60–9
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Class
Hydrocarbons, C > 4
2
A2, A3, A5, B, C1, D, E1, E2, F1
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43339
TABLE 3.—KEY TO THE TEST REQUIREMENTS DENOTED BY ALPHANUMERIC SYMBOLS IN TABLE 2 OF THIS PARAGRAPH
Testing Category
Test
Test Requirements and References
Special Conditions
A
1. Melting Point: ASTM E 324–99 (capillary
tube)
2. Boiling Point: ASTM E 1719–05
(ebulliometry)
3. Vapor Pressure: ASTM E 1782–03 (thermal analysis)
4. n-Octanol/Water Partition Coefficient (log
10 basis) or log Kow: (See Special Conditions for the log Kow test requirement and
select the appropriate method to use, if
any, from those listed in this column.)
Method A: 40 CFR 799.6755 (shake
flask)
Method B: ASTM E 1147–92(2005) (liquid chromatography)
Method C: 40 CFR 799.6756 (generator
column)
5. Water Solubility: (See special conditions
for the water solubility test requirement
and select the appropriate method to use,
if any, from those listed in this column.)
Method A: ASTM E 1148-02 (shake
flask)
Method B: 40 CFR 799.6784 (shake
flask)
Method C: 40 CFR 799.6784 (column
elution)
Method D: 40 CFR 799.6786 (generator
column)
n-Octanol/water Partition Coefficient or log Kow:
Which method is required, if any, is determined by the test
substance’s estimated i log Kow as follows:
log Kow < 0: no testing required.
log Kow range 0–1: Method A or B.
log Kow range > 1–4: Method A or B or C.
log Kow range > 4–6: Method B or C.
log Kow > 6: Method C.
Test sponsors must provide in the final study report the underlying rationale for the method and pH selected. In
order to ensure environmental relevance, EPA highly recommends that the selected study be conducted at pH 7.
Water Solubility:
Which method is required, if any, is determined by the test
substance’s estimated ii water solubility. Test sponsors
must provide in the final study report the underlying rationale for the method and pH selected. In order to ensure environmental relevance, EPA highly recommends
that the selected study be conducted starting at pH 7.
> 5,000 mg/L: Method A or B.
> 10 mg/L—5,000 mg/L: Method A, B, C, or D.
> 0.001 mg/L—10 mg/L: Method C or D.
≤ 0.001 mg/L: no testing required.
Environmental Fate
and Pathways—
Ready Biodegradation
B
For B, consult ISO 10634 for guidance, and
choose one of the methods listed in this
column:
1. ASTM 1720–01 (sealed vessel CO2 production test)
OR
2. ISO 14593 (CO2 headspace test)
OR
3. ISO 7827 (analysis of DOC)
OR
4. ISO 9408 (determination of oxygen demand in a closed respirometer)
OR
5. ISO 9439 (CO2 evolution test)
OR
6. ISO 10707 (closed bottle test)
OR
7. ISO 10708 (two-phase closed bottle test)
Which method is required, if any, is determined by the test
substance’s physical and chemical properties, including
its water solubility. ISO 10634 provides guidance for selection of an appropriate test method for a given test substance. Test sponsors must provide in the final study report the underlying rationale for the method selected.
Aquatic Toxicity
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Physical/Chemical
Properties
C1
For C1, Test Group 1 or Test Group 2 listed
in this column must be used to fulfill the
testing requirements—See Special Conditions.
Test Group 1 for C1:
1. Acute Toxicity To Fish: ASTM E 729–
96(2002)
2. Acute Toxicity To Daphnia: ASTM E 729–
96(2002)
3. Toxicity To Plants (Algae): ASTM E 1218–
04e1
Test Group 2 for C1:
1. Chronic Toxicity To Daphnia: ASTM E
1193–97(2004)
2. Toxicity To Plants (Algae): ASTM E 1218–
04e1
The following are the special conditions for C1, C2, C3, C4,
C5, and C7 testing; there are no special conditions for
C6. Which test group is required is determined by the test
substance’s measured log KOW as obtained under Test
Category A, or using an existing measured log KOW. iii
If log Kow < 4.2: Test Group 1 is required.
If log Kow ≤ 4.2: Test Group 2 is required,
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TABLE 3.—KEY TO THE TEST REQUIREMENTS DENOTED BY ALPHANUMERIC SYMBOLS IN TABLE 2 OF THIS PARAGRAPH—
Continued
Testing Category
Test
Test Requirements and References
For C3, Test Group 1 or Test Group 2 listed
in this column must be used to fulfill the
testing requirements—See special conditions.
Test Group 1 for C3:
1. Acute Toxicity To Fish: ASTM E 729–96
(2002)
2. Toxicity To Plants (Algae): ASTM E 1218–
04e1
Test Group 2 for C3:
1. Chronic Toxicity To Daphnia: ASTM E
1193–97(2004)
2. Toxicity To Plants (Algae): ASTM E 1218–
04e1
C4
For C4, Test Group 1 or Test Group 2 listed
in this column must be used to fulfill the
testing requirements—See special conditions.
Test Group 1 for C4:
1. Acute Toxicity To Fish: ASTM E 729–96
(2002)
2. Acute Toxicity To Daphnia: ASTM E 729–
96 (2002)
Test Group 2 for C4:
1. Chronic Toxicity To Daphnia: ASTM E
1193–97 (2004)
2. [Reserved]
C5
For C5, Test Group 1 or Test Group 2 listed
in this column must be used to fulfill the
testing requirements—See special conditions.
Test Group 1 for C5:
1. Acute Toxicity To Daphnia: ASTM E 729–
96 (2002)
2. [Reserved]
Test Group 2 for C5:
1. Chronic Toxicity To Daphnia: ASTM E
1193–97 (2004)
2. [Reserved]
C6
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For C2, Test Group 1 or Test Group 2 listed
in this column must be used to fulfill the
testing requirements—See special conditions.
Test Group 1 for C2:
1. Acute Toxicity To Daphnia: ASTM E 729–
96 (2002)
2. Toxicity To Plants (Algae): ASTM E 1218–
04e1
Test Group 2 for C2:
1. Chronic Toxicity To Daphnia: ASTM E
1193–97(2004)
2. Toxicity To Plants (Algae): ASTM E 1218–
04e1
C3
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Special Conditions
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TABLE 3.—KEY TO THE TEST REQUIREMENTS DENOTED BY ALPHANUMERIC SYMBOLS IN TABLE 2 OF THIS PARAGRAPH—
Continued
Testing Category
Test
Test Requirements and References
Special Conditions
C7
For C7, Test Group 1 or Test Group 2 listed
in this column must be used to fulfill the
testing requirements—See special conditions.
Test Group 1 for C7:
1. Acute Toxicity To Fish: ASTM E 729–96
(2002)
2. [Reserved]
Test Group 2 for C7:
1. Chronic Toxicity To Daphnia: ASTM E
1193–97 (2004)
2. [Reserved]
Mammalian Toxicity—
Acute
D
See special conditions for this test requirement and select the method that must be
used from those listed in this column.
Method A: Acute Inhalation Toxicity (rat): 40
CFR 799.9130
Method B: EITHER:
1. Acute (Up/Down) Oral Toxicity (rat):
ASTM E 1163–98 (2002)
OR
2. Acute (Up/Down) Oral Toxicity (rat): 40
CFR 799.9110(d)(1)(i)(A)
Which testing method is required is determined by the test
substance’s physical state at room temperature (25°C).
For those test substances that are gases at room temperature, Method A is required; otherwise, use either of
the two methods listed under Method B.
In Method B, 40 CFR 799.9110(d)(1)(i)(A) refers to the
OECD 425 Up/Down Procedure. iv
Estimating starting dose for Method B: Data from the neutral red uptake basal cytotoxicity assay v using normal
human keratinocytes or mouse BALB/c 3T3 cells may be
used to estimate the starting dose.
Mammalian Toxicity—
Genotoxicity
E1
Bacterial Reverse Mutation Test (in vitro): 40
CFR 799.9510
None
E2
Conduct any one of the following three tests
for chromosomal damage:
In vitro Mammalian Chromosome Aberration
Test: 40 CFR 799.9537
OR
Mammalian Bone Marrow Chromosomal Aberration Test (in vivo in rodents: mouse
(preferred species), rat, or Chinese hamster): 40 CFR 799.9538
OR
Mammalian Erythrocyte Micronucleus Test
[sampled in bone marrow] (in vivo in rodents: mouse (preferred species), rat, or
Chinese hamster): 40 CFR 799.9539
Persons required to conduct testing for chromosomal damage are encouraged to use the in vitro Mammalian Chromosome Aberration Test (40 CFR 799.9537) to generate
the needed data unless known chemical properties (e.g.,
physical/chemical properties, chemical class characteristics) preclude its use. A subject person who uses one of
the in vivo methods instead of the in vitro method to address a chromosomal damage test requirement must submit to EPA a rationale for conducting that alternate test in
the final study report.
F1
Combined Repeated Dose Toxicity Study
with the Reproduction/Developmental Toxicity Screening Test: 40 CFR 799.9365
OR
Reproduction/Developmental
Toxicity
Screening Test: 40 CFR 799.9355
AND
Repeated Dose 28–Day Oral Toxicity Study
in rodents: 40 CFR 799.9305
Where F1 is required, EPA recommends use of the Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (40 CFR
799.9365). However, there may be valid reasons to test a
particular chemical using both 40 CFR 799.9355 and 40
CFR 799.9305 to fill Mammalian Toxicity—Repeated
Dose/Reproduction/Developmental data needs. A subject
person who uses the combination of 40 CFR 799.9355
and 40 CFR 799.9305 in place of 40 CFR 799.9365 must
submit to EPA a rationale for conducting these alternate
tests in the final study reports. Where F2 or F3 is required, no rationale for conducting the required test need
be provided in the final study report.
F2
Reproduction/Developmental
Toxicity
Screening Test: 40 CFR 799.9355
F3
Repeated Dose 28–Day Oral Toxicity Study
in rodents: 40 CFR 799.9305
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Mammalian Toxicity—
Repeated Dose/Reproduction/Developmental
i. EPA recommends, but does not require, that log KOW be quantitatively estimated prior to initiating this study. One method, among many
similar methods, for estimating log KOW is described in the article entitled Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients by W.M. Meylan and P.H. Howard in the Journal of Pharmaceutical Sciences. 84(1):83–92. January 1992. This reference is
available under docket ID number EPA–HQ–OPPT–2007–0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located at 1301
Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
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ii. EPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating this study. One method, among
many similar methods, for estimating water solubility is described in the article entitled Improved Method for Estimating Water Solubility From Octanol/Water Partition Coefficient by W.M. Meylan, P.H. Howard, and R.S. Boethling in Environmental Toxicology and Chemistry. 15(2):100–106.
1996. This reference is available under docket ID number EPA–HQ–OPPT–2007–0531 at the EPA Docket Center, Rm. 3334 in the EPA West
Bldg. located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
iii. Chemical substances that are dispersible in water may have log Kow values greater than 4.2 and may still be acutely toxic to aquatic organisms. Test sponsors who wish to conduct Test Group 1 studies on such chemicals may request a modification to the test standard as described
in 40 CFR 790.55. Based upon the supporting rationale provided by the test sponsor, EPA may allow an alternative threshold or method be used
for determining whether acute or chronic aquatic toxicity testing be performed for a specific substance.
iv. The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available under docket ID number EPA–HQ–OPPT–2007–
0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays.
v. The neutral red uptake basal cytotoxicity assay, which may be used to estimate the starting dose for the mammalian toxicity-acute endpoint,
is available under docket ID number EPA–HQ–OPPT–2007–0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located at 1301
Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
(k) Effective date. This section is
effective on [date 30 days after date of
publication of the final rule in the
Federal Register].
[FR Doc. E8–16992 Filed 7–23–08; 8:45am]
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]]>Agencies
[Federal Register Volume 73, Number 143 (Thursday, July 24, 2008)]
[Proposed Rules]
[Pages 43314-43342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16992]
[[Page 43313]]
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Part III
Environmental Protection Agency
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40 CFR Part 799
Testing of Certain High Production Volume Chemicals; Second Group of
Chemicals; Proposed Rule
Federal Register / Vol. 73, No. 143 / Thursday, July 24, 2008 /
Proposed Rules
[[Page 43314]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[EPA-HQ-OPPT-2007-0531; FRL-8373-9]
RIN 2070-AD16
Testing of Certain High Production Volume Chemicals; Second Group
of Chemicals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing a test rule under section 4(a)(1)(B) of the
Toxic Substances Control Act (TSCA) to require manufacturers,
importers, and processors of certain high production volume (HPV)
chemical substances to conduct testing to obtain screening level data
for health and environmental effects and chemical fate. EPA has
preliminarily determined that: Each of the 19 chemical substances
included in this proposed rule is produced in substantial quantities
and that there is or may be substantial human exposure to each of them;
there are insufficient data to reasonably determine or predict the
effects on health or the environment of the manufacture, distribution
in commerce, processing, use, or disposal of the chemicals, or of any
combination of these activities; and the testing program proposed here
is necessary to develop such data. Data developed under this proposed
rule will provide critical information about the environmental fate and
potential hazards associated with these chemicals which, when combined
with information about exposure and uses, will allow the Agency and
others to evaluate potential health and environmental risks and to take
appropriate follow-up action. Persons who export or intend to export
any chemical substance included in the final rule would be subject to
the export notification requirements in TSCA section 12(b)(1) and at 40
CFR part 707, subpart D. EPA has also taken steps, as described in this
document, to consider animal welfare and to provide instructions on
ways to reduce or in some cases eliminate animal testing, while at the
same time ensuring that the public health is protected.
DATES: Comments must be received on or before October 22, 2008.
Written requests to present oral comments must be received on or
before October 22, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2007-0531, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2007-0531. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-0531. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at https://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Follow the on-line
instructions to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at https://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. The telephone number of the EPA/DC Public Reading
Room is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
For technical information contact: Paul Campanella or John
Schaeffer, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone numbers:
(202) 564-8091 or (202) 564-8173; e-mail addresses:
campanella.paul@epa.gov or schaeffer.john@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture
(defined by statute to include import) or process any of the chemical
substances that are listed in Sec. 799.5087(j) of the proposed
regulatory text. Any use of the term ``manufacture'' in this document
will encompass ``import,'' unless otherwise stated. In addition, as
described in Unit
[[Page 43315]]
V., once the Agency issues a final rule, any person who exports, or
intends to export, any of the chemical substances included in the final
rule will be subject to the export notification requirements in TSCA
section 12(b)(1) and at 40 CFR part 707, subpart D. Potentially
affected entities may include, but are not limited to:
Manufacturers (defined by statute to include importers) of
one or more of the 19 subject chemical substances (NAIC codes 325 and
324110), e.g., chemical manufacturing and petroleum refineries.
Processors of one or more of the 19 subject chemical
substances (NAIC codes 325 and 324110), e.g., chemical manufacturing
and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit IV.E. and
consult Sec. 799.5087(b) of the proposed regulatory text. If you have
any questions regarding the applicability of this action to a
particular entity, consult either of the technical persons listed under
FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and
then identify electronically within the disk or CD-ROM the specific
information that is claimed as CBI. In addition to one complete version
of the comment that includes information claimed as CBI, a copy of the
comment that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket. Information so marked
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
C. Can I Request an Opportunity to Present Oral Comments to the Agency?
You may submit a request for an opportunity to present oral
comments. This request must be made in writing. If such a request is
received on or before October 22, 2008, EPA will hold a public meeting
on this proposed rule in Washington, DC. This written request must be
submitted to the mailing or hand delivery addresses provided under
ADDRESSES. If such a request is received, EPA will announce the
scheduling of the public meeting in a subsequent document in the
Federal Register. If a public meeting is announced, and if you are
interested in attending or presenting oral and/or written comments at
the public meeting, you should follow the instructions provided in the
subsequent Federal Register document announcing the public meeting.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to issue a test rule under TSCA section 4(a)(1)(B)
(15 U.S.C. 2603(a)(1)(B)) that would require manufacturers and
processors of 19 chemical substances to conduct testing for
environmental fate (including five tests for physical/chemical
properties and biodegradation), ecotoxicity (in fish, Daphnia, and
algae), acute toxicity, genetic toxicity (gene mutations and
chromosomal aberrations), repeat dose toxicity, and developmental and
reproductive toxicity. The chemicals are HPV chemicals, i.e., chemicals
with a production/import volume equal to or greater than 1 million
pounds (lbs.) per year. A detailed discussion regarding efforts to
enhance the availability of screening level hazard and environmental
fate information about HPV chemicals can be found in a Federal Register
notice which published on December 26, 2000 (Ref. 1).
The tests are screening level tests which are part of the Screening
Information Data Set (SIDS) (see Unit II.D.). Some or all of these
tests are being proposed as required tests for a particular chemical
substance, depending upon what data are already available for that
substance.
This action also follows an earlier testing action for certain HPV
chemicals (see ``Testing of Certain High Production Volume Chemicals;
Proposed Rule'' (Ref. 2) and ``Testing of Certain High Production
Volume Chemicals; Final Rule'' (Ref. 3).
At a future date, EPA plans to propose testing for additional HPV
chemicals as the Agency learns more about the chemicals with respect to
human exposure, release, and sufficiency of data and experience
available on the potential hazards.
B. What is the Agency's Authority for Taking this Action?
EPA is proposing this test rule under section 4(a)(1)(B) of TSCA
(15 U.S.C. 2603(a)(1)(B)).
Section 2(b)(1) of TSCA (15 U.S.C. 2601(b)(1)) states that it is
the policy of the United States that ``adequate data should be
developed with respect to the effect of chemical substances and
mixtures on health and the environment and that the development of such
data should be the responsibility of those who manufacture [which is
defined by statute to include import] and those who process such
chemical substances and mixtures[.]'' To implement this policy, TSCA
section 4(a)(1) mandates that EPA require by rule that manufacturers
and/or processors of chemical substances and mixtures conduct testing
if the Administrator finds that:
(1)(A)(i) the manufacture, distribution in commerce, processing,
use, or disposal of a chemical substance or mixture, or that any
combination of such activities, may present an unreasonable risk of
injury to health or the environment,
(ii) there are insufficient data and experience upon which the
effects of such manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combination
of such activities on health or the environment can reasonably be
determined or predicted, and
(iii) testing of such substance or mixture with respect to such
effects is necessary to develop such data; or
[[Page 43316]]
(B)(i) a chemical substance or mixture is or will be produced in
substantial quantities, and (I) it enters or may reasonably be
anticipated to enter the environment in substantial quantities or
(II) there is or may be significant or substantial human exposure to
such substance or mixture,
(ii) there are insufficient data and experience upon which the
effects of the manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combination
of such activities on health or the environment can reasonably be
determined or predicted, and
(iii) testing of such substance or mixture with respect to such
effects is necessary to develop such data [.]
If EPA makes these findings for a chemical substance or mixture,
the Administrator shall require by rule that testing be conducted on
that chemical substance or mixture to develop data about health or
environmental effects for which there is an insufficiency of data and
experience, and which are relevant to a determination that the
manufacture, distribution in commerce, processing, use, or disposal of
the chemical substance or mixture, or any combination of such
activities, does or does not present an unreasonable risk of injury to
health or the environment. TSCA section 4(a)(1).
Once the Administrator has made a finding under TSCA section
4(a)(1)(A) or 4(a)(1)(B), EPA may require any type of health or
environmental effects testing necessary to address unanswered questions
about the effects of the chemical substance or mixture that are
relevant to whether the manufacture, distribution in commerce,
processing, use, or disposal of the chemical substance or mixture, or
any combination of such activities, presents an unreasonable risk of
injury to health or the environment. EPA need not limit the scope of
testing required to the factual basis for the TSCA section
4(a)(1)(A)(i) or (B)(i) findings. This approach is explained in more
detail in EPA's TSCA section 4(a)(1)(B) Final Statement of Policy
(``B'' policy) (Ref. 4, pp. 28738-28739).
In this proposed rule, EPA would use its broad TSCA section 4(a)
authority to obtain data necessary to support the development of
preliminary or ``screening level'' hazard and risk characterizations
for certain HPV chemical substances specified in Table 2 in Sec.
799.5087(j) of the proposed regulatory text. EPA has made preliminary
findings for these chemical substances under TSCA section 4(a)(1)(B)
that: They are produced in substantial quantities; there is or may be
substantial human exposure to them; existing data are insufficient to
determine or predict their health and environmental effects; and
testing is necessary to develop such data.
C. Why is EPA Taking this Action?
On April 21, 1998, EPA initiated a national effort to empower
citizens by providing them with knowledge about the most widespread
chemicals in commerce. A major objective of this effort is to make
certain basic information about the environmental fate and potential
health and environmental hazards associated with HPV chemicals
available to the public. Mechanisms to collect or, where necessary,
develop needed data on U.S. HPV chemicals include the voluntary HPV
Challenge Program, certain international efforts, and TSCA section 4
rules.
1. Voluntary HPV Challenge Program. The voluntary HPV Challenge
Program, officially launched in late 1998, was created to ensure that a
baseline set of data on approximately 2,800 HPV chemicals would be made
available to EPA and the public. HPV chemicals are manufactured or
imported in amounts equal to or greater than 1 million lbs. per year
and were identified for this program through data reported under the
TSCA Inventory Update Rule (IUR) during 1990.
The data set sought by the voluntary HPV Challenge Program is known
as the Screening Information Data Set (SIDS) that was developed by the
Organization for Economic Cooperation and Development (OECD), of which
the United States is a member. SIDS provides an internationally agreed
upon set of test data for screening high production volume chemicals
for human and environmental hazards, and will assist the Agency and
others to make an informed, preliminary judgment about the hazards of
HPV chemicals.
Since the Program's inception in 1998, industry chemical
manufacturers and importers have participated in the Challenge by
sponsoring 2,250 chemicals. More than 350 companies and 100 consortia
have sponsored chemicals directly in the Program while additional
companies/consortia have sponsored chemicals indirectly in an
international counterpart to the voluntary HPV Challenge Program, the
International Council of Chemical Associations (ICCA) HPV Initiative.
HPV chemicals that are not sponsored in the Program may be subject to a
test rule under TSCA section 4 where, among other things, these
chemicals lack needed testing. The voluntary HPV Challenge Program is
further described in a Federal Register document which published on
December 26, 2000 (Ref. 1) and on the voluntary HPV Challenge Program
website (https://www.epa.gov/chemrtk).
Under the voluntary HPV Challenge Program, alternatives to the
testing proposed under this proposed rule were available. For example,
under the OECD HPV SIDS Program, some instances have been identified
where, using chemical category approaches, less than a full set of SIDS
tests for every chemical in the category has been judged sufficient for
screening purposes. In addition, the OECD HPV SIDS Program allows some
use of structure activity relationship (SAR) analysis for individual
chemicals. These strategies have the potential to reduce the time
required to complete the program, the number of tests actually
conducted, and the number of test animals needed.
EPA advocated the use of categories or SAR approaches in the
voluntary HPV Challenge Program and provided support for their use by
developing guidance documents to assist industry and others in
constructing scientifically defensible categories (Ref. 45) and SAR
(Ref. 48). While EPA encouraged the use of scientifically appropriate
categories of related chemicals and SAR under the voluntary HPV
Challenge Program, these approaches are not included in this proposed
rule. EPA has not identified any chemicals in this proposal for which
category and SAR approaches would be appropriate. In addition, EPA
believes that the incorporation of such elements in a test rule would
require complex, time consuming, and intensive procedural steps, such
as multi-phase rulemaking, without a corresponding benefit.
In the proposed test rule (Ref. 2) for the final HPV SIDS test rule
(Ref. 3), EPA specifically solicited comments and suggestions on
procedures that would allow inclusion of such approaches in TSCA
section 4 HPV SIDS rulemaking. The procedures suggested by commenters
on that proposed rule would have required complex, time consuming, and
resource-intensive procedural steps, such as multi-phase rulemaking. As
a result, EPA did not incorporate these suggestions into the final
rule. In addition, EPA did not identify, nor did the commenters bring
to EPA's attention, any possibilities that would have allowed inclusion
of a category or SAR approach within the final test rule for any
specific chemicals included in the final test rule (Ref. 19).
Although the Agency believes that none of the chemicals included in
this proposed rule appear to be candidates for category or SAR
approaches, persons who believe that a chemical under this
[[Page 43317]]
proposed rule can be dealt with using a category or SAR approach are
encouraged to submit appropriate information, along with their
rationale which substantiates this belief, during the comment period on
this proposed rule. If, based on submitted information and other
information available to EPA, the Agency determines that a chemical is
appropriate for consideration under a category or SAR approach, and
that practicable measures are available at the time to modify the
proposed testing requirement, EPA will take such measures as are
necessary to avoid unnecessary testing in the final rule.
2. Certain international efforts. The voluntary HPV Challenge
Program is designed to make maximum use of scientifically adequate
existing test data and to avoid unnecessary and duplicative testing of
U.S. HPV chemicals. Therefore, EPA is continuing to participate in the
voluntary international efforts, complementary to the voluntary HPV
Challenge Program, that are being coordinated by the OECD to secure
basic hazard information on HPV chemicals in use worldwide, including
some of those on the U.S. (1990) HPV chemicals list (Ref. 5). This
includes agreements to sponsor a U.S. HPV chemical under either the
OECD HPV SIDS Program (Ref. 6), including sponsorship by OECD member
countries beyond the United States, or the international HPV Initiative
that is being organized by the ICCA (Ref. 7).
The OECD HPV SIDS Program seeks the development of test data, if
such data are not already available, related to 6 health and
environmental effects endpoints for international HPV chemicals (see
Unit II.D.). The SIDS data set has been internationally agreed upon by
the 29 member countries of the OECD as providing the minimum data set
required to make an informed preliminary judgment about the hazards of
a given HPV chemical.
The ICCA consists of representatives of chemical industry trade
associations from the United States, Europe, Japan, Australia, Canada,
Mexico, Brazil, New Zealand, and Argentina. The intended goal of the
ICCA HPV Initiative was to complete screening-level hazard assessments
on 1,000 ``high priority'' chemicals. Most of the chemicals on the ICCA
working list (Ref. 7) are also U.S. HPV chemicals. The ICCA testing/
assessment work is tied directly to that under the OECD HPV SIDS
Program.
Any U.S. HPV chemicals that are handled under the OECD HPV SIDS
Program or the ICCA HPV Initiative are considered by EPA to be
``sponsored'' and are not anticipated to be addressed in the voluntary
HPV Challenge Program unless the international commitments are not met.
Nor does EPA intend to evaluate these chemicals for possible TSCA
section 4 HPV SIDS rulemaking unless the international commitments are
not met.
The OECD HPV SIDS Program and the ICCA HPV Initiative are further
described in the Federal Register document announcing the voluntary HPV
Challenge Program (Ref. 1) and on the OECD website (Ref. 6) and ICCA
website (Ref. 7).
3. TSCA rulemaking. U.S. data needs which remain unmet in the
voluntary HPV Challenge Program or through international efforts may be
addressed through TSCA section 4 rulemakings, such as the final test
rule promulgated by EPA on March 16, 2006 (Ref. 3). This proposed rule
is the second TSCA section 4 HPV SIDS rule, and addresses the unmet
data needs of 19 chemicals.
Data collected and/or developed under a final rule based on this
proposal and the voluntary HPV Challenge Program, when combined with
information about exposure and uses, will allow the Agency and others
to better assess the potential risk to health and the environment from
these chemicals. EPA intends to make the information collected under
the final rule available to the public, other Federal agencies, and any
other interested parties on its website (https://www.epa.gov/chemrtk)
and in the public docket for the final rule. As appropriate, this
information will be used to ensure a scientifically sound basis for
risk assessment/management actions. This effort will serve to further
the Agency's goal of identifying and controlling human and
environmental risks as well as providing greater protection and
knowledge to the public. By using the same approach to testing as that
of the OECD HPV SIDS Program, EPA is assuring that the data developed
under this proposed rulemaking activity and the voluntary HPV Challenge
Program will be comparable to the data being developed in other
countries, thereby enabling an international sharing of data and the
prevention of unnecessary and duplicative testing. See Refs.1 and 2,
pp. 81662-81664, for further information about the voluntary HPV
Challenge Program and international efforts.
D. Why is this Proposal Focusing on HPV Chemicals and SIDS Testing?
This proposal pertains to HPV chemicals, which are manufactured or
imported in amounts equal to or greater than 1 million lbs. per year.
Although those chemicals cover only about 11% of the chemical
substances on the TSCA Inventory (see TSCA sections 8(a) and 8(b)),
using TSCA Inventory information available in 1988 (Ref. 8, p. 32296),
that small percentage of the TSCA Inventory accounted for 95% of total
chemical production in the United States.
Testing under this proposal pertains to SIDS testing because SIDS
is a battery of tests agreed upon by the international community
through OECD, of which the United States is a member country, as
appropriate for screening HPV chemical substances for toxicity and
produces information relevant to understanding the basic health and
environmental hazards and fate of HPV chemicals. The content of SIDS
was agreed upon at the 13\th\ Joint Meeting of the OECD Chemicals Group
and Management Committee of the Special Programme on the Control of
Chemicals (Refs. 9 and 10). The United States believes these are the
right tests for basic screening of U.S. HPV chemicals for health and
environmental effects and environmental fate.
SIDS testing evaluates the following six testing endpoints
(Ref. 6):
Acute toxicity.
Repeat dose toxicity.
Developmental and reproductive toxicity.
Genetic toxicity (gene mutations and chromosomal
aberrations).
Ecotoxicity (studies in fish, Daphnia, and algae).
Environmental fate (including physical/chemical properties
(melting point, boiling point, vapor pressure, n-octanol/water
partition coefficient, and water solubility), photolysis, hydrolysis,
transport/distribution, and biodegradation).
While data on the six SIDS endpoints do not fully characterize a
chemical's toxicity and fate, they provide a consistent minimum set of
information that can be used to help assess the relative risks of
chemicals and whether additional testing or assessment is necessary.
E. How Does EPA's HPV Work Relate to that of OECD?
As noted in Unit II.C.2., the OECD HPV SIDS Program is
complementary to the voluntary HPV Challenge Program. However, EPA's
definition of an HPV chemical differs from that of the OECD. EPA
defines an HPV chemical as having an annual production or importation
volume of 1 million lbs. or more. OECD defines an HPV chemical as
having an annual production volume of 2.2 million lbs. (equivalent to 1
million kilograms (kg)) reported in any member country.
The presence of a chemical on the OECD's list of HPV chemicals was
and
[[Page 43318]]
continues to be accepted by OECD member countries as providing a
sufficient indicator of potential exposure to warrant testing at the
SIDS level (Ref. 11). EPA, however, does not believe that a production
volume threshold which is chosen for an international program on
existing chemicals and which is the only trigger for entry into that
program should be determinative of the threshold chosen for
``substantial production'' under TSCA section 4(a)(1)(B)(i). See EPA's
``B'' policy (Ref. 4). Among the reasons is that the TSCA section
4(a)(1)(B)(i) finding of substantial production is not the sole finding
EPA must make to require testing based on TSCA section 4(a)(1)(B). EPA
must also find that there is substantial release, or substantial or
significant human exposure under TSCA sections 4(a)(1)(B)(i)(I) and
(II). In addition, EPA must find that data are insufficient and testing
is necessary under TSCA sections 4(a)(1)(B)(ii) and (iii). Accordingly,
a finding that a chemical is produced in substantial quantities alone
is not a sufficient basis to require testing under TSCA section 4.
In response to EPA's proposed ``B'' policy (Ref. 8), both the
American Chemistry Council (ACC), formerly the Chemical Manufacturers
Association (CMA) and the Society of the Plastics Industry, Inc.,
commented that EPA's proposed annual production-volume threshold of 1
million lbs. is a reasonable interpretation of ``substantial
production'' under TSCA (Refs. 12 and 13). Additionally, they indicated
that the OECD's 2.2 million lb. threshold would be preferable to
achieve consistency between EPA's activities under TSCA section 4 and
the OECD HPV SIDS Program. Although the United States and OECD differ
in their definition of an HPV chemical and what should trigger basic
screening tests of an HPV chemical, both the U.S. and OECD HPV SIDS
Programs are alike in their information needs for an HPV chemical. Both
the U.S. and OECD HPV SIDS Programs have identified the SIDS battery of
tests as the basic screening tests needed to provide enough information
to support a screening level assessment of the health and environmental
effects of a chemical.
F. Why is EPA Pursuing Hazard Information on HPV Chemicals?
In 1998 EPA found that, of those non-polymeric organic substances
produced or imported in amounts equal to or greater than 1 million lbs.
per year based on 1990 IUR reporting, only 7% had a full set of
publicly available and internationally recognized basic screening test
data for health and environmental effects (Ref. 14). Of the over 2,800
U.S. HPV chemicals based on 1990 IUR data, 43% had no publicly
available basic hazard data. For the remaining chemicals, limited
amounts of the data were available. This lack of available hazard data
compromises EPA's and others' ability to determine whether these HPV
chemicals pose potential risks to human health or the environment, as
well as the public's ability to know about the hazards of chemicals
that may be found in their environment, their homes, their workplaces,
and the products they buy.
G. What is the Role of this Proposed Rule and Any Future TSCA Section 4
HPV SIDS Rulemaking with Regard to the Voluntary HPV Challenge Program?
As indicated in the December 26, 2000 Federal Register document
describing the voluntary HPV Challenge Program (Ref. 1), EPA intends to
use rulemaking under TSCA, where appropriate, to help fill data gaps
not addressed as part of the voluntary HPV Challenge Program or
international efforts. EPA does not intend at this time to evaluate
U.S. HPV chemicals that have been or are being handled through the OECD
HPV SIDS Program or under a complementary program being coordinated by
the ICCA (Ref. 7) for screening level testing under TSCA section 4 HPV
SIDS rulemaking, although the Agency may revisit this question if
commitments under those international programs are not met. See Unit
III.G. of Ref. 1 for more information on these programs. EPA is
evaluating the extent to which additional non-sponsored HPV chemicals
meet the threshold criteria for rulemaking under TSCA section 4.
H. How Would the Data Developed Under this Test Rule Be Used?
Hazard data are used in risk assessment and risk management, and
ultimately to inform the public and promote the pollution prevention
ethic. Activities to ensure the availability of basic hazard
information on HPV chemicals support EPA's objectives.
EPA would use the data obtained from this proposed rule to support
development of preliminary hazard and risk assessments for the 19
chemical substances subject to the rule. The data would also be used by
EPA to set priorities for further testing that may produce hazard
information on these chemical substances that may be needed by EPA,
other Federal agencies, the public, industry, and others, to support
adequate risk assessments. As appropriate, this information would be
used to ensure a scientifically sound basis for risk characterizations
and risk management actions. As such, this effort would serve to
further the Agency's goal of identifying and controlling human and
environmental risks as well as providing greater knowledge and
protection to the public. In the past, EPA has used data from test
rules to support such activities as the development of water quality
criteria, Toxic Release Inventory (TRI) listings, chemical advisories,
and reduction of workplace exposures.
Under the Security and Prosperity Partnership of North America
(SPP), a trilateral effort to encourage greater cooperation and
information sharing among the United States, Canada, and Mexico (http:/
/www.spp.gov), the United States committed in August 2007 to assess and
initiate needed action by the end of 2012 on the approximately 6,750
chemicals produced above 25,000 lbs. per year in the United States.
(https://www.spp.gov/pdf/spp_reg_coop_chemicals.pdf). To fulfill
these SPP commitments, EPA established the Chemical Assessment and
Management Program (ChAMP). Under ChAMP, EPA is developing screening-
level documents that summarize basic hazard and exposure information on
HPV chemicals, identify potential risks, note scientific issues and
uncertainties, and indicate the initial priority being assigned by the
Agency for potential future appropriate action. These screening-level
documents are based primarily on hazard, use, and exposure data
available to the Agency through the voluntary HPV Challenge Program and
on EPA's examination of chemical use and exposure information collected
from the 2006 IUR as well as data from readily available sources of
hazard and exposure information. Information on ChAMP and the risk-
based prioritization process for HPV chemicals is available on the
EPA's ChAMP website (https://www.epa.gov/champ) and on the related risk-
based prioritization page (https://www.epa.gov/hpv/hpvis/aboutrbd.htm).
The data obtained from a final test rule based on this proposal
would furnish the basic hazard information integral to this ChAMP
process for the 19 chemical substances subject to the rule.
Finally, because the SIDS data would be comparable to the type of
data agreed to as being appropriate and being developed by the OECD HPV
SIDS Program, the development of these data would enable an
international sharing of data. As conceived by the OECD, the SIDS
battery of tests can be used by governments and others worldwide to
conduct an initial assessment of the
[[Page 43319]]
hazards and risks posed by HPV chemicals and prioritize HPV chemicals
to identify those in need of additional, more in-depth testing and
assessment, as well as those of lesser concern. Not only could the data
contribute to the international effort, but also international SIDS
testing and assessments can be used to fill the data gaps identified as
part of the voluntary HPV Challenge Program. Additional detailed
information is available on the SIDS website (https://cs3-hq.oecd.org/
scripts/hpv) and EPA's voluntary HPV Challenge Program website (https://
www.epa.gov/chemrtk).
Data collected or developed for each sponsored chemical in the
voluntary HPV Challenge Program are provided in the format of a
``robust'' (i.e., detailed) summary. A robust summary contains the
technical information necessary to adequately describe an experiment or
study and includes the objectives, methods, results, and conclusions of
the full study report, which can either be an experiment or in some
cases an estimation or prediction method. (See Ref. 15; also at https://
www.epa.gov/HPV/pubs/general/robsumgd.htm). A robust summary provides
information that would assist a technically qualified person in making
an independent assessment of a given study, and thereby facilitates the
evaluation of existing data and the identification of additional data
needs. EPA requests that existing data relevant to the testing in this
proposed rule be submitted to the Agency in robust summary format. For
any data developed under that final rule, EPA will request that a
robust summary of the final report for each specific test be submitted
in addition to the required final report itself (see Sec. 799.5087(i)
of the proposed regulatory text). Persons who respond to this request
to submit robust summaries are also encouraged to submit the robust
summary electronically via the High Production Volume Information
System (HPVIS) to allow for its ready incorporation into HPVIS.
Directions for electronic submission of robust summary information into
HPVIS are provided at https://iaspub.epa.gov/oppthpv/metadata.html.
This link will direct you to the ``HPVIS Quick Start and User's
Guide.''
I. How are Animal Welfare Issues Being Considered in the HPV
Initiative?
EPA recognizes the concerns that have been expressed about the use
of test procedures that require the use of animals. As discussed in
Unit II.E. of Ref. 1, EPA is making every effort to ensure that as the
HPV Initiative is implemented (including TSCA section 4 HPV SIDS test
rules), unnecessary or duplicative testing is avoided and the use of
animals is minimized. As a general matter, EPA does not require that
tests on animals be conducted if an alternative scientifically
validated method is found acceptable and practically available for use.
Where testing must be conducted to develop adequate data, the Agency is
committed to reducing the number of animals used for testing, to
replacing test methods requiring animals with alternative test methods
when acceptable alternative methods are available, and to refining
existing test methods to optimize animal use when there is no
substitute for animal testing. EPA believes that these reduction,
replacement, and refinement objectives are all important elements in
the overall consideration of alternative testing methods.
The governmental and non-governmental scientific community is
working to design, validate, and employ new methods of toxicity testing
that are more accurate, less costly, and that reduce the need to use
live animals. Over the years, significant research has been pursued to
develop and validate non-animal test methods. U.S. scientists in
academia, government, and industry have participated in both domestic
and international efforts to develop alternative, non-animal tests. As
part of the enterprise, the National Institute of Environmental Health
Sciences (NIEHS) established a Federal Interagency Committee, the
Interagency Coordinating Committee on Validation of Alternative Methods
(ICCVAM), to review the status and validation of toxicological test
methods including those that are performed in vitro. EPA scientists
have contributed significantly to this body of knowledge and are
continuing to play an important role in the development of alternative
test methods for consideration.
In addition, as part of the voluntary HPV Challenge Program, EPA
asked participants in that program to observe certain testing
principles, which are laid out in an October 14, 1999 letter (Ref. 16).
In this same letter, the Agency also indicated its intention that
related TSCA rulemaking proceed in a manner consistent with these
principles. This letter is available in the public docket for this
proposed rulemaking, as well as on EPA's ChemRTK website. In the
letter, EPA requested that participants conduct a thoughtful,
qualitative analysis of existing data before testing. This proposed
rule reflects many of the principles presented in the referenced
voluntary HPV Challenge Program letter. Certain components of these
principles, however, are not pertinent to this proposed rule. For
example, this proposed rule does not require any dermal toxicity
testing or any terrestrial toxicity testing.
III. EPA Proposed Findings
A. What is the Basis for EPA's Proposal to Test These Chemical
Substances?
As indicated in Unit II.B., in order to develop a rulemaking under
TSCA section 4(a) requiring the testing of chemical substances or
mixtures, EPA must, among other things, make certain findings regarding
either risk (TSCA section 4(a)(1)(A)(i)) or production combined with
either chemical release or human exposure (TSCA section 4(a)(1)(B)(i)),
with regard to those chemicals. EPA is proposing to require testing of
the chemical substances included in this proposed test rule based on
its preliminary findings under TSCA section 4(a)(1)(B)(i) relating to
``substantial'' production and ``substantial human exposure,'' as well
as findings under TSCA sections 4(a)(1)(B)(ii) and (iii) relating to
sufficient data and the need for testing. The chemical substances
included in this proposed rule are listed in Table 2 in Sec.
799.5087(j) of the proposed regulatory text along with their Chemical
Abstract Service (CAS) registry numbers.
In EPA's ``B'' policy (see Unit II.E.), ``substantial production''
of a chemical substance or mixture is generally considered to be
aggregate production (including import) volume equaling or exceeding 1
million lbs. per year of that chemical substance or mixture (Ref. 4, p.
28747). The ``B'' policy also provides guidelines that are generally
considered by EPA in evaluating whether there is ``substantial human
exposure'' of workers, consumers, and the general population to a
chemical substance or mixture. Refer to EPA's ``B'' policy for further
discussion on how EPA generally evaluates chemicals or mixtures under
TSCA section 4(a)(1)(B)(i). For the reasons set out in the ``B''
policy, EPA believes that the guidance included in the ``B'' policy is
appropriate for consideration in this proposed rule and EPA sees no
reason not to act consistently with the guidelines with respect to the
chemicals included in this proposed rule.
EPA has found preliminarily that, under TSCA section 4(a)(1)(B)(i),
each of the 19 chemical substances included in this proposed rule is
produced in ``substantial'' quantities (see Unit III.B.) and that there
is or may be ``substantial human exposure'' to each chemical substance
(see Units III.C. and III.D.). Also, for one substance, EPA has found
[[Page 43320]]
preliminarily that, under TSCA section 4(a)(1)(B)(i), the substance
enters or may reasonably be anticipated to enter the environment in
substantial quantities (see Unit III.E.). In addition, under TSCA
section 4(a)(1)(B)(ii), EPA has preliminarily determined that there are
insufficient data and experience to reasonably determine or predict the
effects of the manufacture, processing, or use of these chemical
substances, or of any combination of such activities, on human health
or the environment (see Unit III.F.). EPA has also found preliminarily
that testing the 19 chemical substances identified in this proposed
rule is necessary to develop such data (TSCA section 4(a)(1)(B)(iii))
(see Unit III.F.). EPA has not identified any ``additional factors'' as
discussed in the ``B'' policy (Ref. 4, p. 28746) to cause the Agency to
use decisionmaking criteria other than those described in the policy.
The chemical substances included in this proposed rule are listed
in Sec. 799.5087(j) of the proposed regulatory text along with their
CAS numbers.
B. Are These Chemical Substances Produced and/or Imported in
Substantial Quantities?
EPA has made preliminary findings that each of the chemical
substances included in this proposal is produced and/or imported in an
amount equal to or greater than 1 million lbs. per year (Ref. 18),
based on information gathered pursuant to the 2006 IUR which is the
most recently available compilation of TSCA Inventory data. EPA
believes that these annual production and/or importation volumes are
``substantial'' as that term is used with reference to production in
TSCA section 4(a)(1)(B)(i). (See also Ref. 4, p. 28746). A discussion
of EPA's preliminary ``substantial production'' finding for each
chemical substance included in this proposed rule is contained in a
separate document (See Ref. 18).
C. Are a Substantial Number of Workers Exposed to These Chemicals?
EPA has made preliminary findings that the manufacture, processing,
and use of the 19 chemical substances (Table 1.-Exposure Based
Findings-Substantial Human Exposure, Unit III.D.) included in this
action result or may result in exposure of a substantial number of
workers to the chemical substances.
This finding is based, in large part, on information submitted in
accordance with the 2006 IUR. For chemicals whose total production
volume (manufactured and imported) exceeded 300,000 lbs. at a site
during calendar year 2005, manufacturers and importers were required to
report the number of potentially exposed workers during industrial
processing and use to the extent the information was readily
obtainable. In addition, the submitters are required to provide
information regarding the commercial and consumer uses of the chemical
substance.
EPA believes that an exposure of over 1,000 workers to a chemical
substance is ``substantial'' as that term is used with reference to
``human exposure'' in TSCA section 4(a)(1)(B)(i). EPA believes, based
on experience gained through case-by-case analysis of existing
chemicals, that an exposure of 1,000 workers or more to a chemical
substance is a reasonable interpretation of the phrase ``substantial
human exposure'' in TSCA section 4(a)(1)(B)(i); see Ref. 4). Therefore,
EPA's preliminary finding is that there is or may be substantial human
exposure (workers) to these 19 chemical substances.
In addition to the 2006 IUR data, EPA also reviewed National
Occupational Exposure Survey (NOES) data developed by the National
Institute for Occupational Safety and Health (NIOSH). Based on the NOES
data, EPA found that more than 1,000 workers were exposed to each of
the 19 chemical substances that are the subject of this proposed rule.
The NOES was a nationwide data gathering project conducted by NIOSH,
which was designed to develop national estimates for the number of
workers potentially exposed to various chemical, physical and
biological agents and describe the distribution of these potential
exposures. Begun in 1980 and completed in 1983, the survey involved a
walk-through investigation by trained surveyors of 4,490 facilities in
523 different types of industries. Surveyors recorded potential
exposures when a chemical agent was likely to enter or contact the
worker's body for a minimum duration. These potential exposures could
be observed or inferred. Information from these representative
facilities was extrapolated to generate national estimates of
potentially exposed workers for more than 10,000 different chemicals
(Refs. 20, 57, and 58). EPA also compared production volumes from the
1986 IUR data collection to the production volumes for the 2006 IUR
data collection. Of the 19 chemical substances in this proposed rule,
only one chemical's production volume decreased from 1986 to 2006. The
2006 IUR production volume data are consistent with NOES results, as
the production volumes for the remaining chemical substances either
stayed the same or increased since 1986, thereby indicating that the
usage of these chemical substances is no less than when NOES data were
gathered.
EPA has performed a chemical-by-chemical analysis for all 19
chemical substances and carefully considered the industrial process and
use information along with the commercial and consumer use information
from the 2006 IUR submissions. Commercial uses are defined as ``The use
of a chemical substance or mixture in a commercial enterprise providing
saleable goods or services (e.g., dry cleaning establishment, painting
contractor)''; 40 CFR 710.43. Detailed information from the IUR
submissions can be found in ``Testing of Certain High Production Volume
Chemicals; Second Group of Chemicals (Exposure Findings Supporting
Information)'' (Ref. 18). Based on the nature of the IUR uses, EPA
considers that chemicals with reported commercial uses may result in
potential exposure to 1,000 workers or more. The total number of
workers reported under the IUR is the sum of information on both
industrial workers plus commercial use workers.
In 2003, EPA partially exempted certain petroleum process streams
(including ``Hydrocarbons, C>4'' (CAS No. 68647-60-9) and ``Oils,
reclaimed'' (CAS No. 69029-75-0)) from reporting certain processing and
use data under the TSCA section 8(a) IUR. The exemption was not based
on an assessment of the toxicity of the process streams but on the fact
that the chemicals are frequently processed, transported, and stored in
vessels that minimize the potential for releases and exposure to
workers. (Federal Register issue of January 7, 2003 (68 FR 848) (FRL-
6767-4) and Federal Register issue of December 19, 2005 (71 FR 75059)
(FRL-7743-9); available on-line at: https://www.epa.gov/fedrgstr).
Despite the fact that the degree of exposure is expected to be
diminished to particular workers because of the chemical processing and
handling practices used, available data indicate that more than 1,000
workers are potentially exposed to these chemicals, supporting the
preliminary finding of substantial human exposure (Ref. 18).
D. Are a Substantial Number of Consumers Exposed to These Chemicals?
Based on 2006 IUR data, EPA has made preliminary findings that the
uses of 13 of the chemical substances included in this action result or
may result in exposure to a substantial number of consumers (Ref. 18).
EPA reviewed the consumer use information reported for the 2006 IUR and
carefully
[[Page 43321]]
considered the nature of those uses. Upon completion of the review, EPA
concluded that the reported consumer uses for the chemicals in this
action may result in at least 10,000 potentially exposed consumers,
thus meeting the exposure based finding for consumers.
In addition to findings made based on the 2006 IUR data, EPA has
also made consumer exposure based findings based on the National
Library of Medicine (NLM) Household Products Database (Ref. 18). The
chemical substances reported in the National Library of Medicine (NLM)
Household Products Database are present in multiple household products
subject to TSCA including hobby/craft products, personal care products,
home cleaning products, home maintenance products, and automotive
products. The NLM Household Products Database provides information on
the chemical ingredients and their percentage in specific brands of
household products. Information in the database is from a variety of
publicly available sources including brand-specific labels and Material
Safety Data Sheets when available from manufacturers and manufacturers'
websites. Publicly available information from the database is available
on-line at: https://householdproducts.nlm.nih.gov.
EPA believes that use of the consumer products identified in the
NLM Household Products Database may expose a substantial number of
consumers (i.e., greater than 10,000) to these chemical substances. EPA
believes that an exposure of over 10,000 consumers to a chemical
substance is ``substantial'' as that term is used with reference to
``human exposure'' in TSCA section 4(a)(1)(B)(i). EPA believes, based
on experience gained through case-by-case analysis of existing
chemicals, that an exposure of 10,000 consumers or more to a chemical
substance is a reasonable interpretation of the phrase ``substantial
human exposure'' in TSCA section 4(a)(1)(B)(i). (See Ref. 4.)
Therefore, EPA's preliminary finding is that there is or may be
substantial human exposure (consumers) to these chemical substances.
A discussion of EPA's preliminary ``substantial exposure'' finding
for consumers is contained in a separate document (see Ref. 18). The
Agency solicits comment regarding additional information pertaining to
numbers of consumers potentially exposed to the chemical substances
identified in this proposed rule.
Table 1.--Exposure Based Findings--Substantial Human Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Meet Exposure Meet
2006 IUR Based Meet Exposure Meet Exposure Substantial or NLM Household
CAS No. Production CriteriaFor Mfg NOES (number of Based Criteria Based Criteria Significant Chemicals
Volume & Industrial workers) for Commercial for Consumers Release Database
Workers Workers Criteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
75-07-0 > 100 million X 216,533 X X X
(M)-500 M
--------------------------------------------------------------------------------------------------------------------------------------------------------
78-11-5 > 1 M-10 M X 2,650 X ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
84-65-1 > 10 M-50 M X 6,187 X X ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
89-32-7 > 1 M-10 M X 1,926 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
110-44-1 > 1 M-10 M X 69,243 X X X
--------------------------------------------------------------------------------------------------------------------------------------------------------
118-82-1 > 1 M-10 M X 120,009 X X ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
119-61-9 > 1 M-10 M X 41,516 X X X
--------------------------------------------------------------------------------------------------------------------------------------------------------
144-62-7 > 1 M-10 M X 142,000 X X X X
--------------------------------------------------------------------------------------------------------------------------------------------------------
149-44-0 > 1 M-10 M X 239,465 X X ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
2524-04-1 > 10 M-50 M X 1,088 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
4719-04-4 > 10 M-50 M X 225,251 X X X X
--------------------------------------------------------------------------------------------------------------------------------------------------------
6381-77-7 > 1 M-10 M X 19,468 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
31138-65-5 > 1 M-10 M X 74,165 X X ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
66241-11-0 > 1 M-10 M X 38,555 X X ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
68187-76-8 > 1 M-10 M X 11,164 X X ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
68187-84-8 > 1 M-10 M X 36,381 X X X
--------------------------------------------------------------------------------------------------------------------------------------------------------
68479-98-1 > 10 M-50 M X 4,121 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
68527-02-6 > 1 M-10 M X 84,192 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
68647-60-9 > 1 Billion lbs. X 1,257 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 43322]]
E. Are Substantial Quantities of These Chemicals Released to the
Environment?
EPA does not have readily available data on environmental releases
for most of the 19 chemical substances in this proposed rule. However,
one substance, acetaldehyde (CAS No. 75-07-0) is included in TRI and
has estimated environmental release in 2005 of 13,567,452 lbs. (Ref.
18). TRI contains information about releases of certain chemicals and
management of wastes at a wide variety of sources, including
manufacturing operations, certain service businesses, and Federal
facilities. Publicly available information from the 2005 TRI reporting
cycle is available on-line at: https://www.epa.gov/triexplorer. Two
additional chemicals (ethanedioic acid and 1,3,5-triazine-
1,3,5(2H,4H,6H)-triethanol) also meet the substantial release criteria
based on the environmental releases from their reported IUR uses.
EPA believes that an environmental release of a chemical substance
in an amount equal to or greater than 1 million lbs. per year or
greater than 10% of the reported production volume is ``substantial''
as that term is used with reference to ``enter the environment in
substantial quantities'' in TSCA section 4(a)(1)(B)(i). (See Ref. 4).
The Agency solicits comment regarding additional information
pertaining to the amount of environmental release of the chemical
substances identified in this proposed rule.
F. Do Sufficient Data Exist for These Chemical Substances?
In developing the testing requirements for chemicals contained in
this proposed rule, available information on chemical/physical
properties, environmental fate, ecotoxicity, and human health effects
was searched using the data sources outlined in the OECD guidelines
found in section 3.1 (Reli
