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[Federal Register: July 24, 2008 (Volume 73, Number 143)]
[Proposed Rules]
[Page 43313-43342]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jy08-35]
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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
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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.
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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: http://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
http://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 http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the docket index
available at http://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 http://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 (http://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 (http://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.
(http://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 (http://www.epa.gov/champ) and on the related risk-
based prioritization page (http://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 (http://cs3-hq.oecd.org/
scripts/hpv) and EPA's voluntary HPV Challenge Program website (http://
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 http://
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: http://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: http://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: http://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 (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 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 (http://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 (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
[[Page 43323]]
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.
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 Sec. 799.5087(j) of the proposed
regulatory text.
All of the proposed testing requirements are listed in Table 2 in
Sec. 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'' 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,
http://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 Sec. 799.5087(h) of the proposed
regulatory text. EPA concludes that ASTM's withdrawal of E 324-99 does
not have negative 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 Sec. 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 (Sec. 799.6755--shake flask) will work and
Method B (ASTM E 1147-92(2005)) and Method C (Sec. 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 n-octanol/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.
[[Page 43324]]
Table 2.--Test Requirements for the n-Octanol/water Partition
Coefficient Endpoint
------------------------------------------------------------------------
Test Requirements
Testing Category and References Special Conditions
------------------------------------------------------------------------
Physical/chemical properties n-Octanol/water n-Octanol/water
partition partition
coefficient (log coefficient or log
10 basis) or log Kow:
Kow: Which method is
The appropriate required, if any,
log Kow test, if is determined by
any, would be the test
selected from substance's
those listed in estimated log Kow
this column--see as follows:
Special log Kow < 0: no
Conditions in the testing required.
adjacent column.. log Kow range 0-1:
Method A: 40 CFR Method A or B.
799.6755 (shake log Kow range > 1-
flask). 4: Method A or B
Method B: ASTM E or C.
1147-92(2005) log Kow range > 4-
(liquid 6: Method B or C.
chromatography). log Kow > 6: Method
Method C: 40 CFR C.
799.6756 Test sponsors must
(generator provide in the
column). 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
Testing Category and References Special Conditions
------------------------------------------------------------------------
Physical/chemical properties Water solubility: Water solubility:
The appropriate Which method is
method to use, if required, if any,
any, to test for would be
water solubility determined by the
would be selected test substance's
from those listed estimated water
in this column-- solubility. Test
see Special sponsors must
Conditions in the provide in the
adjacent column.. final study report
Method A: ASTM E the underlying
1148-02 (shake rationale for the
flask). method and pH
Method B: 40 CFR selected. In order
799.6784 (shake to ensure
flask). environmental
Method C: 40 CFR relevance, EPA
799.6784 (column highly recommends
elution). that the selected
Method D: 40 CFR study be conducted
799.6786 starting at pH 7.
(generator > 5,000 milligram/
column). 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 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).
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
[[Page 43325]]
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 Sec.
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
Sec. 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 Sec. 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 Sec. 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 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
Sec. 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 Sec.
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[deg] 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 Sec. 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 Sec. 799.5087(j) of the proposed
regulatory text). Consistent with the voluntary HPV Challenge Program,
EPA is proposing to 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, http://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/
[[Page 43326]]
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 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 Sec.
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 more different chemical species (not
including impurities). Table 2 in Sec. 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
[[Page 43327]]
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
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 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.
[[Page 43328]]
Table 4.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
Tier 1 (Persons initially required to Tier 2 (Persons not initially
comply) required to comply)
------------------------------------------------------------------------
Persons who manufacture (as defined at A. Persons who manufacture (as
TSCA section 3(7)), or intend to defined at TSCA section 3(7))
manufacture, a test rule substance, or intend to manufacture a
and who are not listed under Tier 2 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 non-isolated
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 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 Sec. 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 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 Sec. 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
[[Page 43329]]
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 Sec. 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., Sec. 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 Sec. 799.5087(c)(4)-(c)(7) and Sec.
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 Sec. 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:
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 Sec. 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 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 Sec. 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: http://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.''
[[Page 43330]]
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.
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 initia |
