[Federal Register Volume 75, Number 37 (Thursday, February 25, 2010)]
[Proposed Rules]
[Pages 8575-8601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3734]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[EPA-HQ-OPPT-2009-0112; FRL-8805-8]
RIN 2070-AD16
Testing of Certain High Production Volume Chemicals; Third 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) that would require manufacturers,
importers, and processors of certain high production volume (HPV)
chemicals to conduct testing to obtain screening level data for health
and environmental effects and chemical fate.
DATES: Comments must be received on or before May 26, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2009-0112, 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-2009-0112. 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
[[Page 8576]]
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2009-0112. 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.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., 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
legal 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: [email protected].
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 number:
(202) 564-8091 or (202) 564-8173; e-mail address:
[email protected] or [email protected].
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. 799.5089(j) of the proposed
regulatory text. Any use of the term ``manufacture'' in this proposed
rule will encompass ``import,'' unless otherwise stated. In addition,
as described in Unit 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 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 29 subject chemical substances (NAIC codes 325 and
324110), e.g., chemical manufacturing and petroleum refineries.
Processors of one or more of the 29 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. 799.5089(b) of the proposed regulatory text. If you have
any questions regarding the applicability of this action to a
particular entity, consult either technical person 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 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.
[[Page 8577]]
If such a request is received on or before May 26, 2010, 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 the 29 chemical substances listed in this proposed rule
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), repeated dose toxicity, and developmental
and reproductive toxicity. The chemical substances are HPV chemicals,
i.e., chemical substances 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).
This proposed rule follows earlier testing actions for certain HPV
chemicals (see Refs. 2, 3, and 11).
This proposed TSCA section 4(a) test rule addresses some of the 207
remaining ``orphan'' HPV chemicals that were placed on the Priority
Testing List by the Interagency Testing Committee (ITC). For a summary,
see: ``Sixty-Third Report of the TSCA Interagency Testing Committee to
the Administrator of the Environmental Protection Agency; Receipt of
Report and Request for Comments; Notice'' (Ref. 9). ``Orphan'' chemical
substances are those HPV chemicals that were not sponsored for testing
under the voluntary HPV Challenge Program or under certain
international efforts (see Unit II.C.).
Of the 207 chemical substances, 159 no longer meet the HPV
criterion; 3 already have data that meets needs identified in this
proposed rule; and 16, while meeting the production volume criterion
for HPV, appear to lack the exposure data necessary to support TSCA
section 4(a)(1)(B) findings. Therefore, these 178 chemical substances
are not being considered for testing by EPA at this time. The remaining
29 chemical substances are addressed in this proposed TSCA section 4(a)
test rule. These conclusions are based primarily on information
reported in the 2006 TSCA Inventory Update Rule (IUR) (40 CFR part 710)
and a 2006 TSCA Preliminary Assessment Information Reporting (PAIR)
rule issued for the HPV orphan chemicals (Ref. 10). EPA also sought and
considered, when available, information from other data sources (e.g.,
the Toxics Release Inventory (TRI), the National Occupational Exposure
Survey (NOES)).
B. What is the Agency's Authority for Taking this Action?
EPA is proposing this test rule under TSCA section 4(a)(1)(B) (15
U.S.C. 2603(a)(1)(B)), which directs EPA to require by rule that
manufacturers and/or processors of chemical substances and mixtures
conduct testing, if the EPA Administrator finds that:
(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 [.]
Once the EPA Administrator has made a finding under TSCA section
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)(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 test 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 chemicals specified in Table 2 in Sec. 799.5089(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?
In April 1998, EPA initiated a national effort to make certain
basic information about the environmental fate and potential health and
environmental hazards associated with the most widespread chemicals in
commerce 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 (the
Organization for Economic Cooperation and Development (OECD) HPV
Screening Information Data Sets (SIDS) Program; and the International
Council of Chemical Associations (ICCA) HPV Initiative), and TSCA
section 4 test rules. The voluntary HPV Challenge Program 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 the voluntary HPV
Challenge Program through data reported under the IUR during 1990. The
SIDS data set sought by the voluntary HPV Challenge Program was
developed by OECD, of which the United States is a member. The SIDS
provides an internationally agreed upon set of test data for screening
HPV chemicals for human and environmental hazards, and assists the
Agency and others in making an informed, preliminary judgment about the
hazards of HPV chemicals.
The voluntary HPV Challenge Program was 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
[[Page 8578]]
coordinated by the OECD to secure basic hazard information on HPV
chemicals in use worldwide, including some of those on the 1990 U.S.
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).
Additional details regarding the voluntary HPV Challenge Program
and these international efforts were provided in the prior HPV TSCA
section 4 rules (Refs. 2, 3, and 11). It was EPA's position that U.S.
data needs that remained unmet in the voluntary HPV Challenge Program
or through international efforts could be addressed through TSCA
section 4 rulemakings, such as the final test rule published by EPA on
March 16, 2006 (Ref. 3). This proposed rule is the third TSCA section 4
HPV SIDS rule, and addresses the unmet data needs of 29 chemical
substances.
After EPA publishes the final rule based on the proposed rule, EPA
intends to make the information collected under the final rule
available to the public, other Federal agencies, and any other
interested parties. This information will be on its website (http://www.epa.gov/chemrtk) and in the docket for the final rule identified
under ADDRESSES. As appropriate, this information will be used to
ensure a scientifically sound basis for risk assessment/management
actions.
D. Why is this Proposed Rule Focusing on HPV Chemicals and SIDS
Testing?
This proposed rule pertains to HPV chemicals, which are
manufactured or imported in amounts equal to or greater than 1 million
lbs. per year, which EPA determined account for 95% of total chemical
production in the United States (Ref. 8, p. 32296). 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. 12). Of the over 2,800 U.S. HPV chemicals
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.
SIDS testing evaluates the following six testing endpoints (Ref.
6):
Acute toxicity.
Repeated 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).
Data on the six SIDS endpoints 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 Would the Data Developed Under this Test Rule Be Used?
EPA would use the data obtained from the rule proposed in this
document to support development of preliminary hazard and risk
assessments for the 29 HPV chemicals 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 HPV chemicals 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. EPA uses data from test rules
to support such activities as the development of water quality
criteria, TRI listings, chemical advisories, and reduction of workplace
exposures.
In addition, a key goal of the voluntary HPV Challenge Program was
making basic health and environmental effects data for HPV chemicals
available to the public as part of EPA's ``Right to Know'' Initiative.
A basic premise of the voluntary HPV Challenge Program is that the
public has a right to know about the hazards associated with chemicals
in their environment. Everyone--including industry, environmental
protection groups, animal welfare organizations, government groups, and
the general public, among others--can use the data provided through the
HPV Challenge Program, and also data collected on HPV chemicals through
other means, including TSCA section 4 testing, to make informed
decisions related to the human and the environmental hazards of
chemicals that they encounter in their daily lives.
F. 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 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.
III. EPA Proposed Findings
A. What is the Basis for EPA's Proposed Rule to Test These Chemical
Substances?
As indicated in Unit II.B., in order to promulgate a final rule
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 chemical substances. EPA is proposing to require
testing of the chemical substances included in this proposed rule based
on its preliminary findings under TSCA section 4(a)(1)(B)(i) relating
to ``substantial'' production and ``substantial human exposure,'' and/
or ``substantial release to the environment,'' 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
[[Page 8579]]
this proposed rule are listed in Table 2 in Sec. 799.5089(j) of the
proposed regulatory text along with their Chemical Abstract Service
(CAS) Registry numbers.
In EPA's B Policy (see Unit III.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).
EPA's B Policy also provides guidelines that are generally considered
by EPA in evaluating whether there is or may be ``substantial human
exposure'' of workers, consumers, and the general population to a
chemical substance or mixture or whether a chemical substance enters or
may reasonably be anticipated to enter the environment in substantial
quantities. Refer to EPA's B Policy for further discussion on how EPA
generally evaluates chemical substances or mixtures under TSCA section
4(a)(1)(B)(i). For the reasons set out in EPA's 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 that guidance with respect to the chemical substances
included in this proposed rule.
EPA has found preliminarily that, under TSCA section 4(a)(1)(B)(i),
each of the 29 chemical substances included in this proposed rule is
produced in ``substantial'' quantities (see Unit III.B.) and, for 27
chemical substances, that there is or may be ``substantial human
exposure'' to each chemical substance (see Units III.C. and III.D.).
Also, for 3 chemical substances (including the 2 for which EPA is not
able to make a preliminary finding regarding substantial human
exposure), EPA has found preliminarily that, under TSCA section
4(a)(1)(B)(i), the chemical 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 29
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 B Policy.
The chemical substances included in this proposed rule are listed
in Sec. 799.5089(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 proposed rule is produced and/or imported
in an amount equal to or greater than 1 million lbs. per year (Ref.
15). These findings are based on:
1. Information gathered in the 2006 IUR (40 CFR part 710), which is
the most recently available compilation of TSCA Inventory data.
2. A TSCA section 8(a) PAIR rule (Ref. 10), issued for those HPV
orphan chemicals which had been added to the ITC Priority Testing List
(Ref. 9). 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. 15).
C. Are a Substantial Number of Workers Exposed to These Chemicals?
EPA has made preliminary findings that the manufacture, processing,
and use of 27 of the 29 chemical substances (Table 1. of 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 (40 CFR part 710) and the 2006 PAIR rule
(Ref. 10). 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) (Ref. 4). Therefore,
EPA's preliminary finding is that there is or may be substantial human
exposure (workers) to 27 of these 29 chemical substances.
In addition to the 2006 IUR and the 2006 PAIR data collected on the
HPV orphan chemicals, EPA also reviewed NOES data developed by the
National Institute for Occupational Safety and Health (NIOSH) (Ref.
16). The NOES data indicates that more than 1,000 workers were exposed
to 7 of the 29 chemical substances that are the subject of this 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. 16, 51, and 52). For the 29 chemical substances in this proposed
rule, EPA compared production volumes from the 1986 IUR data collection
to the production volumes for the 2006 IUR and PAIR data collections.
For the 29 chemical substances in this proposed rule, there was no
decrease in production volume from 1986 to 2006. For the 7 chemical
substances for which EPA has NOES data indicating substantial worker
exposure, the 2006 IUR and 2006 PAIR production volume data are
consistent with the 1980's NOES results, in that production volumes for
these chemical substances either stayed the same or increased since
1986, thereby suggesting 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 29
chemical substances and carefully considered the industrial process and
use information along with the commercial and consumer use information
from the 2006 IUR and PAIR submissions. Commercial uses are defined as:
``The
[[Page 8580]]
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 the ``Testing of Certain High
Production Volume Chemicals-3 (Exposure Findings Supporting
Information)'' (Ref. 15). Based on the descriptions provided for the
IUR uses, EPA has preliminarily concluded that chemical substances with
certain reported commercial uses, such as painting contractor, etc.,
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. EPA's exposure
findings document (Ref. 15) discusses the basis of EPA's preliminary
``substantial exposure'' finding for workers. The Agency also solicits
comment regarding the number of workers potentially exposed to the
chemical substances identified in this proposed rule.
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 20 of the chemical substances included in this action result or
may result in exposure to a substantial number of consumers (Ref. 15).
EPA reviewed the consumer use information reported for the 2006 IUR and
carefully considered the nature of those uses. As stated in EPA's B
Policy, the Agency believes, based on experience gained through case-
by-case analysis of other chemical substances, that an exposure of
10,000 or more consumers to a chemical substance is a reasonable
interpretation of the phrase ``substantial human exposure'' in TSCA
section 4(a)(1)(B)(i) (Ref. 4). Upon completion of the review, EPA has
preliminarily concluded that the reported consumer uses for certain of
the chemical substances in this action may result in exposures to at
least 10,000 consumers, so there is substantial human exposure to these
chemical substances.
A discussion of the basis for EPA's preliminary ``substantial
exposure'' finding for consumers is contained in a separate document
(Ref. 15). The Agency solicits comment regarding the number of
consumers potentially exposed to the chemical substances identified in
this proposed rule, particularly on assumptions that are based on EPA's
experience with other chemical substances that there is or may be
``substantial human exposure'' to a chemical substance when that
chemical substance is used in certain consumer-use products, and is
produced at high production volume.
Table 1.--Exposure Based Findings--Substantial Human Exposure
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Production Volume Meet Exposure Meet Substantial
---------------------------------------- Based Criteria For NOES (number of Meet Exposure Meet Exposure or Significant 2006 IUR or PAIR
CAS No. Manufacturing & workers) Based Criteria for Based Criteria for Release Criteria commercial/
2006 IUR PAIR Industrial Workers Commercial Workers Consumers (PAIR) consumer use
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83-41-0 < 1 million (M) > 10M-50M X ..................
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96-22-0 > 10M-50M > 10M-50M X X
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98-09-9 > 1M-10M > 1M-10M X 851 X X X
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98-56-6 > 1M-10M > 1M-10M X X X X
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111-44-4 > 1M-10M < 1M X X X X
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127-68-4 > 1M-10M < 1M X 9,386 X ..................
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506-51-4 < 1M > 1M-10M X 1,281 X ..................
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506-52-5 < 1M > 1M-10M X 1,565 X ..................
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515-40-2 > 1M-10M > 1M-10M X X X X
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2494-89-5 > 1M-10M > 1M-10M X X X X
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5026-74-4 > 1M-10M > 1M-10M X 952 X ..................
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22527-63-5 > 1M-10M > 1M-10M X X X X
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24615-84-7 > 1M-10M < 1M X X X X
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25321-41-9 > 1M-10M < 1M X 2,843 X ..................
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25646-71-3 > 1M-10M < 1M X X X X
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52556-42-0 > 1M-10M > 1M-10M X X X X
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61788-76-9 > 10M-50M > 1M-10M X 176,314 X X X
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65996-79-4 > 10M-50M > 1M-10M X X X X
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65996-82-9 > 100M-1 billion > 100M-1B X X X X
(B)
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[[Page 8581]]
65996-89-6 > 1B > 1B X 761 X X X X
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65996-92-1 > 100M-1B > 100M-1B X X X X
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68082-78-0 > 1M-10M > 1M-10M X 41,153 X ..................
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68187-57-5 > 100M-1B > 100M-1B X X X X
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68442-60-4 > 1M-10M > 1M-10M X X X X
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68610-90-2 > 1M-10M > 1M-10M X X
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68988-22-7 > 10M-50M > 10M-50M X ..................
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70693-50-4 > 1M-10M > 1M-10M X X X X
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72162-15-3 > 1M-10M < 1M X 64,227 X ..................
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73665-18-6 > 50M-100M > 100M-1B X X X X
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E. Are Substantial Quantities of These Chemicals Released to the
Environment?
EPA has made preliminary findings that three chemical substances,
benzene, 1,2-dimethyl-3-nitro-acetaldehyde (CAS No. 83-41-0); tar oils,
coal (CAS No. 65996-89-6); and 1,4-benzenedicarboxylic acid, 1,4-
dimethyl ester, manuf. of, by-products from (CAS No. 68988-22-7) enter
or may reasonably be anticipated to enter the environment in
substantial quantities. These findings are based upon their reported
PAIR data.
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,
pp. 28736, 28746).
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), TOXLINE, and National
Technical Information Service (NTIS). EPA also searched for available
data as summarized in its HPV Information System (Ref. 50). 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 HPV Challenge Program website (http://www.epa.gov/chemrtk):
``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).
Section 799.5089(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 chemicals 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); repeated 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.
G. Can Other Data Meet the Requirements for the Testing Proposed in
this Action?
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.
13) for each such study to facilitate EPA's review of the full study
report or publication. Persons who respond to
[[Page 8582]]
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.''
Persons who believe that adequate information regarding a chemical
subject to this proposed rule can be developed using a category or the
Structure-Activity Relationships (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.
H. Is Testing Necessary for These Chemical Substances?
EPA knows of no other means to generate the SIDS data other than
the testing proposed in this document, and therefore believes that
conducting the needed SIDS testing identified for the 29 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. EPA also believes it's
important to make these data available to satisfy the ``Right-to-Know''
principles included in the HPV Challenge Program goals.
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. 799.5089(j) of the proposed
regulatory text.
All of the proposed testing requirements are listed in Table 2 in
Sec. 799.5089(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's TSCA 799 test guidelines (40 CFR part 799,
subparts E and H) have been harmonized with the OECD test guidelines.
However, EPA is specifying that the American Society for Testing and
Materials International (ASTM International) or the TSCA 799 test
guidelines be used rather than OECD test guidelines because the
language in the ASTM International standards and the TSCA 799 test
guidelines makes clear which steps are mandatory and which steps are
only recommended. Accordingly, in order to comply with the testing
proposed, EPA is proposing that testing must be conducted in accordance
with ASTM International or TSCA 799 test 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: ASTM E 324-99 (capillary tube) (Ref. 17).
Boiling Point: ASTM E 1719-05 (ebulliometry) (Ref. 18).
Vapor Pressure: ASTM E 1782-03 (thermal analysis) (Ref. 19).
n-Octanol/Water Partition Coefficient:
Method A (40 CFR 799.6755--shake flask).
Method B (ASTM E 1147-92(2005)--liquid chromatography) (Ref. 20).
Method C (40 CFR 799.6756--generator column).
Water Solubility:
Method A: (ASTM E 1148-02--shake flask) (Ref. 21).
Method B (40 CFR 799.6784--shake flask).
Method C (40 CFR 799.6784--column elution).
Method D (40 CFR 799.6786--generator column).
For those chemical substances needing melting points
determinations, EPA is proposing that melting points be determined
according to ASTM method E 324-99. Although ASTM International
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 International's withdrawal of the method means only that ASTM
International no longer continues to develop and improve the method. It
does not mean that ASTM International no longer considers the method to
be valid. ASTM International 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. 22)
ASTM International still makes the method available for
informational purposes and it can still be purchased from ASTM
International at the address listed in Sec. 799.5089(h) of the
proposed regulatory text.
EPA concludes that ASTM International's withdrawal of ASTM E 324-99
does not have negative implications on the validity of the method, and
EPA is proposing that melting points be determined according to ASTM E
324-99.
For the ``n-Octanol/Water Partition Coefficient (log 10 basis)''
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. 799.5089(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 chemical substance's n-Octanol/Water Partition
Coefficient (log 10 basis; ``log Kow''). 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. 23) 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 recognizing
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 (40 CFR
799.6755--shake flask) will work and Method B (ASTM E 1147-92(2005))
and Method C (40 CFR 799.6756--generator column) become more suitable,
especially Method C. The proposed test methodologies have been
developed to meet a wide variety of
[[Page 8583]]
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.
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. 24). 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 E 1720-01 (Sealed vessel CO2 production
test) (Ref. 25).
Method B: International Organization for Standardization (ISO)
14593 (CO2 headspace test) (Ref. 26).
Method C: ISO 7827 (Method by analysis of dissolved organic carbon
(DOC)) (Ref. 27).
Method D: ISO 9408 (Determination of oxygen demand in a closed
respirometer) (Ref. 28).
Method E: ISO 9439 (Carbon dioxide evolution test) (Ref. 29).
Method F: ISO 10707 (Closed bottle test) (Ref. 30).
Method G: ISO 10708 (Two-phase closed bottle test) (Ref. 31).
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 E 1720-01) 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. 32),
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. 33),
Acute toxicity to Daphnia (ASTM E 729-96(2002)) (Ref. 33), and
Toxicity to plants (algae) (ASTM E 1218-04e1) (Ref. 34).
Test Group 2:
Chronic toxicity to Daphnia (ASTM E 1193-97(2004)) (Ref. 35) and
Toxicity to plants (algae) (ASTM E 1218-04e1) (Ref. 34).
For the ``Aquatic Toxicity'' endpoint, the OECD HPV SIDS Program
recognizes that, for certain chemical substances, acute toxicity
studies are of limited
[[Page 8584]]
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 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. 799.5089(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. 799.5089(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.
799.5089(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. 799.5089(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. 24, 36, and 37). A
chemical 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 substance in the surrounding environment
(Ref. 37). For the purposes of this proposed rule, 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. 38). 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'' under TSCA sections 5
and 26(c) (Ref. 39; see also 40 CFR 721.3)). EPA considers the
difference between the log Kow of 4.3 cited in the 1989
Federal Register document (Ref. 39) and the log Kow value of
4.2 cited in this proposed TSCA section 4 test 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. 799.5089(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 test 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. 53)
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.
799.5089(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. 799.5089(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. 799.5089(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 (Ref. 52). This test is included as a Special Condition
in Table 3 of the proposed regulatory text. A document developed by
National Institutes of Health/National Insitute of Environmental Health
Sciences (NIH/NIEHS) provides guidance on how to use the NRU assay to
estimate a starting dose for an acute oral toxicity test (Ref. 44).
Recent versions of the standardized protocols for the NRU assay are
available at the NIEHS/Interagency Coordinating Committee on the
Validation of Alternative Methods (ICCVAM) website, http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm
(Refs. 45-47).
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
[[Page 8585]]
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/
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 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 chemicals 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. 40).
As described in that guidance, such chemicals 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 chemicals 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
chemicals that are listed in the proposed regulatory text are solely
closed system intermediates as defined in the voluntary HPV Challenge
Program guidance document (Ref. 40). Persons who believe that a
chemical 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 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
rule.
B. When Would any Testing Imposed by this Proposed Rule 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.
799.5089(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, with 40 CFR Part 790--Procedures Governing Testing Consent
Agreements and Test Rules (except for paragraphs (a), (d), (e), and (f)
of Sec. 790.45; Sec. 790.48; paragraph (a)(2) and paragraph (b) of
Sec. 790.80; paragraph (e)(1) of Sec. 790.82; and Sec. 790.85), and
with 40 CFR Part 792--Good Laboratory Practice Standards.
D. What Forms 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'' chemical substance.
First introduced when EPA compiled the TSCA Chemical Substance
Inventory, the term Class 1 chemical 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
chemical 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.
799.5089(j) of the proposed regulatory text identifies the listed
substances as either Class 1 or Class 2 chemical substances.
EPA is proposing that, for the Class 1 chemical 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 chemical substances in the past under TSCA section
4(a) testing actions, except for chemical 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 chemical substances listed in this proposed rule. For the
Class 2 chemical 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).
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 chemical 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
[[Page 8586]]
testing of Class 2 chemical 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 rule. 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 chemicals 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 chemical 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 chemical 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 the 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.
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
kilograms (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 configured the tiers in 40 CFR
790.42 as in previous HPV test rules (Refs. 3 and 7). 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 chemical
substances, manufacturers of non-isolated intermediates, and
manufacturers of components of Class 2 chemical 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 proposed 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 chemical
substances, manufacturers of non-isolated intermediates, and
manufacturers of components of Class 2 chemical 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
[[Page 8587]]
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. 799.5089b)(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-manufacturers, i.e., those who manufacture, or intend to
manufacture, a test rule chemical substance solely as one or more of
the following: A byproduct, an impurity, a naturally occurring chemical
substance, a non-isolated intermediate, a component of a Class 2
chemical substance, in amounts less than 1,100 lbs. annually, or in
small quantities solely for research and development.
ii. Tier 2B-processors, i.e., those who process, or intend to
process, a test rule chemical 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. 48). 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. 49).
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. 799.5089(c)(2), (c)(5), (c)(7), and
(c)(11) of the proposed regulatory text. In this proposed rule, EPA
would not require the submission of equivalence data (i.e., data
demonstrating that your chemical substance is equivalent to the
chemical substance actually being tested) as a condition for approval
of your exemption. Therefore, 40 CFR 790.82(e)(1) and 40 CFR 790.85
would not apply to this proposed 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. 799.5089(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. 799.5089(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
proposed rule; thus, persons subject to this rule are not required to
comply with 40 CFR 790.48 itself (see Sec. 799.5089(c)(4)-(c)(7) and
Sec. 799.5089(d)(3) of the proposed regulatory text). 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. There is no difference whether you are in Tier 2A or Tier 2B as
regards reimbursement. Concerning testing, if you are in Tier 2, 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. As previously noted, Tier 2A manufacturers would be notified to
test before Tier 2B processors (Unit IV.E.3.ii.).
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. 799.5089(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.
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. 799.5089(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
[[Page 8588]]
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 final 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
final rule with respect to that chemical substance who are not already
in violation of the final rule would be in violation of the final 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(a). 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. 799.5089(j) of
the proposed regulatory text. EPA is also proposing that a robust
summary of the final report for each specific test would be required to
be submitted electronically 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. 13). Persons who
respond to this request to submit robust summaries are also encouraged
to submit the robust summary electronically via the 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.'' EPA is soliciting
comment on this proposed reporting requirement.
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. 41)
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 initiate a separate
action for this purpose.
V. Export Notification
Any person who exports, or intends to export, one of the chemical
substances contained in this proposed rule in any form (e.g., as
byproducts, impurities, components of Class 2 chemical substances,
etc.) will be subject to the export notification requirements in TSCA
section 12(b)(1) and at 40 CFR part 707, subpart D, but only after the
final rule is issued and only if the chemical substance is contained in
the final rule. Export notification is generally not required for
articles, as provided by 40 CFR 707.60(b). Section 12(b) of TSCA
states, in part, that any person who exports or intends to export to a
foreign country a chemical substance or mixture for which the
submission of data is required under TSCA section 4 must notify the EPA
Administrator of such export or intent to export. The EPA Administrator
in turn will notify the government of the importing country of EPA's
regulatory action with respect to the chemical substance.
VI. Economic Impacts
EPA has prepared an economic assessment entitled ``Economic Impact
Analysis for the Proposed Section 4 Test Rule for High Production
Volume Chemicals-3'' (Ref. 14), a copy of which has been placed in the
docket for this proposed rule. This economic assessment evaluates the
potential for significant economic impacts as a result of the testing
that would be required by this proposed rule. The analysis covers 29
chemical substances. The total social cost of providing test data on
the 29 chemical substances that were evaluated in this economic
analysis is estimated to be $10.30 million assuming an average cost
scenario. Total costs of compliance to industry are estimated at $10.21
million (Ref. 14).
While legally subject to this test rule, processors of a subject
chemical would be required to comply with the requirements of the final
rule only if they are directed to do so by EPA as described in Sec.
799.5089(c)(5) and (c)(6) of the proposed regulatory text. EPA would
only require processors to test if no person in Tier 1 has submitted a
notice of its intent to conduct testing, or if under 40 CFR 790.93, a
problem occurs with the initiation, conduct, or
[[Page 8589]]
completion of the required testing or the submission of the required
data to EPA. Because EPA has identified at least one manufacturer in
Tier 1 for each subject chemical substance, the Agency assumes that,
for each chemical substance in this proposed rule, at least one such
person will submit a letter of intent to conduct the required testing
and that person will conduct such testing and will submit the test data
to EPA. Because processors would not need to comply with the proposed
rule initially, the economic assessment does not address processors.
To evaluate the potential for an adverse economic impact of testing
on manufacturers of the chemical substances in this proposed rule, EPA
employed an initial screening approach that estimated the impact of
testing requirements as a percentage of each chemical substance's sale
price. This measure compares annual revenues from the sale of a
chemical substance to the annualized compliance cost for that chemical
substance to assess the percentage of testing costs that can be
accommodated by the revenue stream generated by that chemical substance
over a number of years. Compliance costs include costs of testing and
administering the testing, as well as reporting costs. In addition,
they include the estimated cost of the TSCA section 12(b) export
notification requirements, which, under the final rule, would be
required for the first export to a particular country of a chemical
substance subject to the final rule, estimated to range from $26.86 per
notice to $85.70 per notice (Ref.14). These export notification
requirements (included in the total and annualized cost estimates) that
would be triggered by the final rule are expected to have a negligible
impact on exporters.
Annualized compliance costs divide testing expenditures into an
equivalent, constant yearly expenditure over a longer period of time.
To calculate the percent price impact, testing costs (including
laboratory and administrative expenditures) are annualized over 15
years using a 7% discount rate.
These annualized testing costs are then divided by the estimated
annual revenue of the chemical substance to derive a cost-to-sales
ratio.
The screening results suggest that under a least cost scenario, 17
out of the 29 chemical substances (59%) would have a price impact at
less than the 1% level. Similarly, 16 out of the 29 chemical substances
(55%) would be impacted at less than the 1% level under an average cost
scenario.
EPA believes, on the basis of these calculations, that the proposed
testing of the chemical substances presents a low potential for adverse
economic impact for the majority of chemical substances. Because the
subject chemical substances have relatively large production volumes,
the annualized costs of testing, expressed as a percentage of annual
revenue, are very small for most chemical substances. There are,
however, some chemical substances for which the price impact is
expected to exceed 1% of the revenue from that chemical substance. The
potential for adverse economic impact is expected to be higher for
these chemical substances. EPA, therefore, compared the annualized
costs of testing to company revenue for those chemical substances
because in these cases, companies may choose to use revenue sources
other than the profits from the individual chemical substances to pay
for testing. EPA estimates that the costs of testing will exceed 1% of
company revenue for one of the affected companies. Smaller businesses
are less likely to have additional revenue sources to cover the
compliance costs in this situation. Therefore, the Agency also compared
the costs of compliance to company sales for small businesses.
The benefits resulting from this proposed test rule are discussed
qualitatively in ``Economic Impact Analysis for the Proposed Section 4
Test rule for High Production Volume Chemicals-3'' (Ref. 14). EPA
believes that the net benefits of this proposed rule are positive, but
quantification of the benefits of the proposed rule would require more
specific information about use patterns and preferences than is
available.
VII. Public Comment
As discussed in Units III.C. and III.D., the Agency solicits
comment regarding additional information pertaining to potential
exposure of workers and consumers, respectively, to the chemical
substances identified in this proposed rule. Also, as discussed in Unit
III.E., the Agency solicits comment regarding additional information
pertaining to environmental releases of the chemical substances
identified in this proposed rule.
As discussed in Unit III.G., EPA is soliciting comments which
identify existing data that may meet the requirements of studies under
this proposed rule. To the extent that data relevant to the testing
specified in this proposed rule are known to exist, EPA strongly
encourages the submission of this information as comments to the
proposed rule. Data submitted to EPA to meet the requirements of
testing under this proposed rule must be in the form of full copies of
unpublished studies or full citations of published studies, and may be
accompanied by a robust summary (Ref. 13). To the extent that studies
required under this proposed rule are currently available, and the data
are judged sufficient by EPA, testing for the endpoint/chemical
combination will not be required in the final rule based on this
proposed rule.
EPA is also soliciting public comment on the proposed requirement
for submission of robust summaries, the test methods proposed, and the
analysis detailing the burdens and costs for the regulatory impacts
resulting from this proposed rule.
In addition, EPA solicits comment on the proposed and alternative
approaches to the testing of Class 2 chemical substances, whether the
proposed approach for testing Class 1 chemical substances (i.e., that
each Class 1 chemical substance be tested at a purity of 99% or more)
should be applied to any Class 2 chemical substances, and whether the
proposed or alternative approaches for the testing of Class 2 chemical
substances (i.e., that a representative sample of each Class 2
substance be tested) should be applied to any Class 1 chemical
substances.
VIII. Materials in the Docket
As indicated under ADDRESSES, a docket has been established for
this proposed rule under docket ID number EPA-HQ-OPPT-2009-0112. The
following is a listing of the documents that have been placed in the
docket for this proposed rule. The docket includes information
considered by EPA in developing this proposed rule, including the
documents listed in this unit, which are physically located in the
docket. In addition, interested parties should consult documents that
are referenced in the documents that EPA has placed in the docket,
regardless of whether these referenced documents are physically located
in the docket. For assistance in locating documents that are referenced
in documents that EPA has placed in the docket, but that are not
physically located in the docket, please consult either technical
person listed under FOR FURTHER INFORMATION CONTACT. The docket is
available for review as specified under ADDRESSES.
1. EPA. Data Collection and Development on High Production Volume
(HPV) Chemicals; Notice. Federal Register (65 FR 81686, December 26,
2000) (FRL-6754-6).
2. EPA. Testing of Certain High Production Volume Chemicals;
Proposed Rule. Federal Register (65 FR 81658, December 26, 2000) (FRL-
6758-4).
[[Page 8590]]
3. EPA. Testing of Certain High Production Volume Chemicals; Final
Rule. Federal Register (71 FR 13708, March 16, 2006) (FRL-7335-2).
4. EPA. TSCA Section 4(a)(1)(B) Final Statement of Policy; Criteria
for Evaluating Substantial Production, Substantial Release, and
Substantial or Significant Human Exposure; Notice. Federal Register (58
FR 28736, May 14, 1993).
5. EPA. OPPT. HPV Challenge Program Chemical List. This list is
available on-line at: http://www.epa.gov/oppt/chemrtk/pubs/update/hpvchmlt.htm.
6. OECD Secretariat. Manual for the Investigation of HPV Chemicals.
OECD Programme on the Co-Operative Investigation of High Production
Volume Chemicals. Paris, France. September 2004. Available on-line at:
http://www.oecd.org/document/7/0,2340,en_2649_34379_1947463_1_1_1_1,00.htm.
7. ICCA. ICCA HPV Working List of Chemicals. October 2005. This
list is updated periodically, and is available on-line at: http://www.cefic.org/activities/hse/mgt/hpv/hpvinit.htm.
8. EPA. TSCA Section 4(a)(1)(B) Proposed Statement of Policy;
Notice. Federal Register (56 FR 32294, July 15, 1991).
9. EPA. Sixty-Third Report of the TSCA Interagency Testing
Committee to the Administrator of the Environmental Protection Agency;
Receipt of Report and Request for Comments; Notice. Federal Register
(73 FR 65486, November 3, 2008) (FRL-8387-6).
10. EPA. Preliminary Assessment Information Reporting; Addition of
Certain Chemicals. Final Rule and Technical Corrections. Federal
Register (71 FR 47122, August 16, 2006) (FRL-7764-9).
11. EPA. Testing of Certain High Production Volume Chemicals;
Second Group of Chemicals; Proposed Rule. Federal Register (73 FR
43314, July 24, 2008) (FRL-8373-9).
12. EPA. Office of Pollution Prevention and Toxics (OPPT). Chemical
Hazard Data Availability Study: What Do We Really Know About the Safety
of High Production Volume Chemicals? April 1998. Available on-line at:
http://www.epa.gov/chemrtk/pubs/general/hazchem.htm.
13. EPA. OPPT. Draft Guidance on Developing Robust Summaries.
October, 22, 1999. Available on-line at: http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
14. EPA. OPPT. Economic Impact Analysis for the Proposed Section 4
Test Rule for High Production Volume Chemicals-3. Prepared by the OPPT
Economic and Policy Analysis Branch. December 2009.
15. EPA. OPPT. Testing of Certain High Production Volume Chemicals-
3 (Exposure Findings Supporting Information). Prepared by OPPT
Economics, Exposure and Technology Division. September 2009.
16. NIOSH. National occupational exposure survey field guidelines.
Vol. I. Seta JA, Sundin DS, Pedersen DH, eds. Cincinnati, OH: U.S.
Department of Health and Human Services, Centers for Disease Control,
National Institute for Occupational Safety and Health, DHHS (NIOSH)
Publication No. 88-106. Available on-line at: http://www.cdc.gov/niosh/88-106.html. 1988.
17. ASTM International. Standard Test Method for Relative Initial
and Final Melting Points and the Melting Range of Organic Chemicals.
ASTM E 324-99. 1999.
18. ASTM International. Standard Test Method for Vapor Pressure of
Liquids by Ebulliometry. ASTM E 1719-05. 2005.
19. ASTM International. Standard Test Method for Determining Vapor
Pressure by Thermal Analysis. ASTM. E 1782-03. 2003.
20. ASTM International. Standard Test Method for Partition
Coefficient (n-Octanol/Water) Estimation by Liquid Chromatography. ASTM
E 1147-92(2005). 2005.
21. ASTM International. Standard Test Method for Measurements of
Aqueous Solubility. ASTM E 1148-02. 2002.
22. ASTM International. Question about ASTM E 324. E-mail from
Diane Rehiel, ASTM, to Greg Schweer, CITB, CCD, OPPT, EPA. September
15, 2004.
23. Meylan, W.M. and Howard, P.H. Atom/Fragment Contribution Method
for Estimating Octanol-Water Partition Coefficients. Journal of
Pharmaceutical Sciences. Vol. 84(1):83-92. 1995.
24. Meylan, W.M., Howard, P.H., and Boethling, R.S. Improved Method
for Estimating Water Solubility From Octanol/Water Partition
Coefficient. Environmental Toxicology and Chemistry. Vol. 15(2):100-
106. 1996.
25. ASTM International. Standard Test Method for Determining Ready,
Ultimate, Biodegradability of Organic Chemicals in a Sealed Vessel
CO2 Production Test. ASTM E 1720-01. 2001.
26. ISO. Water quality -- Evaluation of ultimate aerobic
biodegradability of organic compounds in aqueous medium -- Method by
analysis of inorganic carbon in sealed vessels (CO2
headspace test). ISO 14593. 1999.
27. ISO. Water quality -- Evaluation in an aqueous medium of the
``ultimate'' aerobic biodegradability of organic compounds -- Method by
analysis of dissolved organic carbon (DOC). ISO 7827. 1994.
28. ISO. Water quality -- Evaluation of ultimate aerobic
biodegradability of organic compounds in aqueous medium by
determination of oxygen demand in a closed respirometer. ISO 9408.
1999.
29. ISO. Water quality -- Evaluation of ultimate aerobic
biodegradability of organic compounds in aqueous medium -- Carbon
dioxide evolution test. ISO 9439. 1999.
30. ISO. Water quality -- Evaluation in an aqueous medium of the
``ultimate'' aerobic biodegradability of organic compounds -- Method by
analysis of biochemical oxygen demand (closed bottle test). ISO 10707.
1994.
31. ISO. Water quality -- Evaluation in an aqueous medium of the
ultimate aerobic biodegradability of organic compounds -- Determination
of biochemical oxygen demand in a two-phase closed bottle test
(available in English only). ISO 10708. 1997.
32. ISO. Water quality -- Guidance for the preparation and
treatment of poorly water-soluble organic compounds for the subsequent
evaluation of their biodegradability in an aqueous medium. ISO 10634.
1995.
33. ASTM International. Standard Guide for Conducting Acute
Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and
Amphibians. ASTM E 729-96(2002). 2002.
34. ASTM International. Standard Guide for Conducting Static
Toxicity Tests with Microalgae. ASTM E 1218-04e1. 2004.
35. ASTM International. Standard Guide for Conducting Daphnia magna
Life-Cycle Toxicity Tests. ASTM E 1193-97(2004). 2004.
36. Veith, G.D. and Kosian, P. Estimating bioconcentration
potential from Octanol/Water Partition Coefficients, in Physical
Behavior of PCB's in the Great Lakes (MacKay, Paterson, Eisenreich, and
Simmons, eds.), Ann Arbor Science, Ann Arbor, MI. 1982.
37. Bintein, S.; DeVillers, J.; and Karcher, W. Nonlinear
dependence of fish bioconcentration on n-Octanol/Water Partition
Coefficient. SAR and QSAR in Environmental Research. Vol. 1, pp. 29-39.
1993.
38. EPA. Category for Persistent, Bioaccumulative, and Toxic New
Chemical Substances; Notice. Federal Register (64 FR 60194, November 4,
1999) (FRL-6097-7). Available on-line at: http://www.epa.gov/oppt/newchems/pubs/pbtpolcy.htm.
39. EPA. Significant New Use Rules; General Provisions for New
Chemical
[[Page 8591]]
Follow-Up; Final Rule. Federal Register (54 FR 31298, July 27, 1989).
40. EPA. OPPT. Guidance for Testing Closed System Intermediates for
the HPV Challenge Program (Draft) (March 17, 1999). Available on-line
at: http://www.epa.gov/oppt/chemrtk/pubs/general/closed9.htm.
41. EPA. Analysis of Laboratory Capacity to Support U.S. EPA
Chemical Testing Program Initiatives. Economic and Policy Analysis
Branch. Washington, DC. August 2004.
42. EPA. OPPT. The Use of Structure-Activity Relationships (SAR) in
the High Production Volume Chemicals Challenge Program. August 26,
1999. Available on-line at: http://www.epa.gov/chemrtk/pubs/general/sarfinl1.htm.
43. EPA. Economic Analysis in Support of the TSCA 12(b) Information
Collection Request, OPPT/EETD/EPAB. Washington, DC. October 30, 1998.
44. NIEHS 2001b. Guidance Document on Using In Vitro Data to
Estimate In Vivo Starting Doses for Acute Toxicity. NIH Publication No.
01-4500. August 2001. Available on-line at: http://iccvam.niehs.nih.gov/methods/acutetox/inv_cyto_guide.htm.
45. NIEHS 2003a. Test Method Protocol for Solubility Determination,
in vitro Cytotoxicity Validation Study--Phase III. National Toxicology
Program (NTP) Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM). September 24, 2003. Available on-line
at: http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm.
46. NIEHS 2003b. Test Method Protocol for the BALB/c 3T3 Neutral
Red Uptake Cytotoxicity Test, a Test for Basal Cytotoxicity for an in
vitro Validation Study--Phase III. NTP/NICEATM. November 4, 2003.
Available on-line at: http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm.
47. NIEHS 2003c. Test Method Protocol for the NHK Neutral Red
Uptake Cytotoxicity Test, a Test for Basal Cytotoxicity for an in vitro
Validation Study--Phase III. NTP/NICEATM. November 4, 2003. Available
on-line at: http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm.
48. EPA. Toxic Substances; Test Rule Development and Exemption
Procedures; Interim Final Rule. Federal Register (50 FR 20652, May 17,
1985).
49. EPA. Toxic Substances Control Act; Data Reimbursement; Final
Rule. Federal Register (48 FR 31786, July 11, 1983).
50. EPA. OPPT. High Production Volume Chemical Data Information
System (HPVIS). Data from HVPIS on 29 HPV chemicals. December 2009.
51. NIOSH. National occupational exposure survey analysis of
management interview responses. Vol. III. Pedersen, D.H. and Sieber,
W.K., eds. Cincinnati, OH. U.S. Department of Health and Human
Services, Centers for Disease Control, National Institute for
Occupational Safety and Health, DHHS (NIOSH) Publication No. 89-103.
Available on-line at: http://www.cdc.gov/niosh/89-103.html. 1989.
52. NIOSH. National occupational exposure survey sampling
methodology. Vol. II. Sieber, W.K., ed. Cincinnati, OH. U.S. Department
of Health and Human Services, Centers for Disease Control, National
Institute for Occupational Safety and Health, DHHS (NIOSH) Publication
No. 89-102. Available on-line at: http://www.cdc.gov/niosh/89-102.html.
1989.
53. ASTM International. Standard Test Method for estimating Acute
Oral Toxicity in Rats. ASTM E 1163-98(2002). 2002.
IX. Statutory and Executive Order Reviews
A. Executive Order 12866
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), this proposed rule is not a
``significant regulatory action'' subject to review by the Office of
Management and Budget (OMB) under Executive Order 12866.
EPA has prepared an economic analysis of this proposed action,
which is contained in a document entitled ``Economic Impact Analysis
for the Proposed Section 4 Test Rule for High Production Volume
Chemicals-3'' (Ref. 14). A copy of the economic analysis is available
in the docket for this proposed rule and is summarized in Unit VI.
B. Paperwork Reduction Act
This proposed rule does not impose any new or amended paperwork
collection requirements that would require additional review and/or
approval by OMB under the Paperwork Reduction Act (PRA) 44 U.S.C. 3501
et seq. Although the activities are approved, OMB has specified that
the additional burden associated with a new test rule is not covered by
the ICR until the final rule is effective. The information collection
requirements contained in TSCA section 4 test rules have already been
approved by OMB under PRA, and have been assigned OMB control number
2070-0033 (EPA ICR No. 1139). In the context of developing a new test
rule, the Agency must determine whether the total annual burden covered
by the approved ICR needs to be amended to accommodate the burden
associated with the new test rule. If so, the Agency must submit an
Information Correction Worksheet (ICW) to OMB and obtain OMB approval
of an increase in the total approved annual burden in the OMB
inventory. The Agency's estimated burden for this proposed test rule is
provided in the economic analysis (Ref. 14).
The information collection activities related to export
notification under TSCA section 12(b)(1) are already approved under OMB
control number 2070-0030 (EPA ICR No. 0795). This proposed rule does
not propose any new or changes to the export notification requirements,
and is not expected to result in any substantive changes in the burden
estimates for EPA ICR No. 0795 that would require additional review
and/or approval by OMB.
Under PRA, an agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information that is subject
to approval under PRA, unless it displays a currently valid OMB control
number. The OMB control numbers for the EPA regulations codified in
chapter 40 of the CFR, after appearing in the preamble of the final
rule, are listed in 40 CFR part 9, displayed either by publication in
the Federal Register or by other appropriate means, such as on the
related collection instrument or form, if applicable. The display of
OMB control numbers in certain EPA regulations is consolidated in 40
CFR part 9.
The standard chemical testing program involves the submission of
letters of intent to test (or exemption applications), study plans,
semi-annual progress reports, test results, and some administrative
costs. For this proposed rule, EPA estimates the public reporting
burden for all 29 chemical substances is 52,184 hours (average cost
scenario). EPA assumes that industry will form a ``task force'' or
panel to coordinate testing where appropriate. A panel may often
represent groups of chemical substances. EPA estimates 16 panels for
the proposed rule; with an estimated burden per panel of 3,262 hours
(average cost scenario) (Ref.14).
The estimated burden of the information collection activities
related to export notification is estimated to average 1 burden hour
for each chemical/country combination for an initial notification and
0.5 hours for each subsequent notification (Ref. 14). In estimating the
total burden hours approved for the information collection activities
related to export notification, the Agency has included sufficient
[[Page 8592]]
burden hours to accommodate any export notifications that may be
required by the Agency's issuance of final chemical test rules. As
such, EPA does not expect to need to request an increase in the total
burden hours approved by OMB for export notifications.
As defined by PRA and 5 CFR 1320.3(b), ``burden'' means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to: Review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing, and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information.
Comments are requested on the Agency's need for this information,
the accuracy of the provided burden estimates, and any suggested
methods for minimizing respondent burden, including through the use of
automated collection techniques. Send comments to EPA as part of your
overall comments on this proposed rule in the manner specified under
ADDRESSES. In developing the final rule, the Agency will address any
comments received regarding the information collection requirements
contained in this proposed rule.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., after considering the potential economic impacts
of this proposed rule on small entities, the Agency hereby certifies
that this proposed rule would not have a significant adverse economic
impact on a substantial number of small entities. The factual basis for
the Agency's determination is presented in the small entity impact
analysis prepared as part of the economic analysis for this proposed
rule (Ref. 14), which is summarized in Unit VI., and a copy of which is
available in the docket for this proposed rule. The following is a
brief summary of the factual basis for this certification.
Under RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impacts of this proposed rule on small entities, small
entity is defined in accordance with RFA as:
1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201.
2. A small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000.
3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
Based on the industry profile that EPA prepared as part of the economic
analysis for this proposed rule (Ref. 14), EPA has determined that this
proposed rule is not expected to impact any small not-for-profit
organizations or small governmental jurisdictions. As such, the
Agency's analysis presents only the estimated potential impacts on
small business.
Two factors are examined in EPA's small entity impact analysis
(Ref. 14) in order to characterize the potential small entity impacts
of this proposed rule on small business:
The size of the adverse economic impact (measured as the
ratio of the cost to sales or revenue).
The total number of small entities that experience the
adverse economic impact.
Section 601(3) of RFA establishes as the default definition of
``small business'' the definition used in section 3 of the Small
Business Act, 15 U.S.C. 632, under which SBA establishes small business
size standards (13 CFR 121.201). For this proposed rule, EPA has
analyzed the potential small business impacts using the size standards
established under this default definition. The SBA size standards,
which are primarily intended to determine whether a business entity is
eligible for government programs and preferences reserved for small
businesses (13 CFR 121.101), ``seek to ensure that a concern that meets
a specific size standard is not dominant in its field of operation.''
(13 CFR 121.102(b)). See section 632(a)(1) of the Small Business Act.
In analyzing potential impacts, RFA recognizes that it may be
appropriate at times to use an alternate definition of small business.
As such, section 601(3) of RFA provides that an agency may establish a
different definition of small business after consultation with the SBA
Office of Advocacy and after notice and an opportunity for public
comment. Even though the Agency has used the default SBA definition of
small business to conduct its analysis of potential small business
impacts for this proposed rule, EPA does not believe that the SBA size
standards are generally the best size standards to use in assessing
potential small entity impacts with regard to TSCA section 4(a) test
rules.
The SBA size standard is generally based on the number of employees
an entity in a particular industrial sector may have. For example, in
the chemical manufacturing industrial sector (i.e., NAICS code 325 and
NAICS code 324110), approximately 98% of the firms would be classified
as small businesses under the default SBA definition. The SBA size
standard for 75% of this industry sector is 500 employees, and the size
standard for 23% of this industry sector is either 750, 1,000, or 1,500
employees. When assessing the potential impacts of test rules on
chemical manufacturers, EPA believes that a standard based on total
annual sales may provide a more appropriate means to judge the ability
of a chemical manufacturing firm to support chemical testing without
significant costs or burdens.
EPA is currently determining what level of annual sales would
provide the most appropriate size cutoff with regard to various
segments of the chemical industry usually impacted by TSCA section 4(a)
test rules, but has not yet reached a determination. As stated in this
unit, therefore, the factual basis for the RFA determination for this
proposed rule is based on an analysis using the default SBA size
standards. Although EPA is not currently proposing to establish an
alternate definition for use in the analysis conducted for this
proposed rule, the analysis for this proposed rule also presents the
results of calculations using a standard based on total annual sales
(40 CFR 704.3). EPA is interested in receiving comments on whether the
Agency should consider establishing an alternate definition for small
business to use in the small entity impact analyses for future TSCA
section 4(a) test rules, and what size cutoff may be appropriate.
SBA has developed 6-digit NAICS code-specific size standards based
on employment thresholds. These size standards range from 500 to 1,500
employees for the various 6-digit NAICS codes that are potentially
affected (Ref. 14). For a conservative estimate of the number of small
businesses affected by the HPV rules, the Agency uses an employment
threshold of less than 1,500 employees for all businesses regardless of
the NAIC-specific threshold to determine small business status.
For each manufacturer of the 29 chemical substances covered by this
[[Page 8593]]
proposed rule, the parent company (ultimate corporate entity or UCE)
was identified and sales and employment data were obtained for
companies where data was publicly available. The search determined that
there were 54 affected UCEs. Sales and employment data could be found
for 52 of these UCEs (96%). Two companies could not be classified as
small or large because there were no employment data available, but
were still included in the small business impact analysis.
Parent company sales data were collected to identify companies that
qualified as a ``small business'' for purposes of RFA analysis. Based
on the SBA size standard applied (1,500 employees or less), 21
companies (39%) were identified as small.
The potential significance of this proposed rule's impact on small
businesses was analyzed by examining the number of small entities that
experienced different levels of costs as a percentage of their sales.
Small businesses were placed in the following categories on the basis
of cost-to sales ratios: Less than 1%, greater than 1%, and greater
than 3%. This analysis was conducted under both a least and average
cost scenario.
Of the 21 businesses designated as small business, none had cost-
to-sales ratios of greater than 1% and 3% under both the least and
average cost scenarios. For the chemical substances where sales data
were unavailable, EPA used the median sales value sales of all other
small businesses equal to $24.7 million. The costs for the two
companies were estimated to be well below 1% of this sales level. Given
these results, the Agency has determined that there is not a
significant economic impact on a substantial number of small entities
as a result of this proposed rule, if finalized.
The estimated cost of the TSCA section 12(b)(1) export
notification, which, as a result of the final rule, would be required
for the first export to a particular country of a chemical substance
subject to the final rule, is estimated to be $85.70 for the first time
that an exporter must comply with TSCA section 12(b)(1) export
notification requirements, and $26.86 for each subsequent export
notification submitted by that exporter (Refs. 14, 42, and 43). EPA has
concluded that the costs of TSCA section 12(b)(1) export notification
would have a negligible impact on exporters of the chemical substances
in the final rule, regardless of the size of the exporter.
Any comments regarding the impacts that this action may impose on
small entities, or regarding whether the Agency should consider
establishing an alternate definition of small business to be used for
analytical purposes for future test rules and what size cutoff may be
appropriate, should be submitted to the Agency in the manner specified
under ADDRESSES.
D. Unfunded Mandates Reform Act
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA), Public Law 104-4, EPA has determined that this proposed rule
does not contain a Federal mandate that may result in expenditures of
$100 million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any 1 year. It is estimated that
the total aggregate costs of this proposed rule to the private sector,
which are summarized in Unit VI., would be $10.21 million. The total
annualized costs of this proposed rule to the private sector are
estimated to be $3.61 and 3.89 million using a 3% and 7% discount rate
over 3 years (average cost scenario). In addition, since EPA does not
have any information to indicate that any State, local, or tribal
government manufactures or processes the chemical substances covered by
this action such that the final rule would apply directly to State,
local, or tribal governments, EPA has determined that this proposed
rule would not significantly or uniquely affect small governments.
Accordingly, this proposed rule is not subject to the requirements of
sections 202, 203, 204, and 205 of UMRA.
E. Executive Order 13132
Under Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999), EPA has determined that this proposed rule does not
have ``federalism implications'' because it will not have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in the Executive Order. This proposed rule would establish testing and
recordkeeping requirements that apply to manufacturers (including
importers) and processors of certain chemical substances. Because EPA
has no information to indicate that any State or local government
manufactures or processes the chemical substances covered by this
action, this proposed rule does not apply directly to States and
localities and will not affect State and local governments. Thus,
Executive Order 13132 does not apply to this proposed rule.
F. Executive Order 13175
Under Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has
determined that this proposed rule does not have tribal implications
because it will not have any affect on tribal governments, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in the Executive Order. As
indicated previously, EPA has no information to indicate that any
tribal government manufactures or processes the chemical substances
covered by this action. Thus, Executive Order 13175 does not apply to
this proposed rule.
G. Executive Order 13045
This proposed rule is not subject to Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997), because it does not
establish an environmental standard intended to mitigate health or
safety risks, will not have an annual effect on the economy of $100
million or more, nor does it otherwise have a disproportionate effect
on children. This proposed rule would establish testing and
recordkeeping requirements that apply to manufacturers (including
importers) and processors of certain chemical substances, and would
result in the development of data about those chemical substances that
can subsequently be used to assist the Agency and others in determining
whether the chemical substances in this proposed rule present potential
risks, allowing the Agency and others to take appropriate action to
investigate and mitigate those risks.
H. Executive Order 13211
This proposed rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations that Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001),
because it is unlikely to have any significant adverse effect on the
supply, distribution, or use of energy.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note), directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent
[[Page 8594]]
with applicable law or otherwise impractical. Voluntary consensus
standards are technical standards (e.g., materials specifications, test
methods, sampling procedures, and business practices) that are
developed or adopted by voluntary consensus standards bodies. The NTTAA
directs EPA to provide Congress, through OMB, explanations when the
Agency decides not to use available and applicable voluntary consensus
standards.
This proposed rule involves technical standards because it proposes
to require the use of particular test methods. If the Agency makes
findings under TSCA section 4(a), EPA is required by TSCA section 4(b)
to include specific standards or test methods that are to be used for
the development of the data required in the test rules issued under
TSCA section 4. For some of the testing that would be required by the
final rule, EPA is proposing the use of voluntary consensus standards
issued by ASTM International and ISO which evaluate the same type of
toxicity as the TSCA 799 test guidelines and OECD test guidelines,
where applicable. Copies of the 17 ASTM International and ISO standards
referenced in the proposed regulatory text at Sec. 799.5089(h) have
been placed in the docket for this proposed rule. You may obtain copies
of the ASTM International standards from the American Society for
Testing and Materials International, 100 Bar Harbor Dr., West
Conshohocken, PA 19428-2959, and copies of the ISO standards from the
International Organization for Standardization, Case Postale, 56 CH-
1211 Gen[egrave]ve 20 Switzerland. In the final rule, EPA intends to
seek approval from the Director of the Federal Register for the
incorporation by reference of the ASTM International and ISO standards
used in the final rule in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51.
EPA is not aware of any potentially applicable voluntary consensus
standards which evaluate partition coefficient (n-octanol/water)
generator column, water solubility (column elution and generator
column), acute inhalation toxicity, bacterial reverse mutations, in
vivo mammalian bone marrow chromosomal aberrations, combined repeated
dose with reproductive/developmental toxicity screen, repeated dose 28-
day oral toxicity screen, or the reproductive developmental toxicity
screen which could be considered in lieu of the TSCA 799 test
guidelines, 40 CFR 799.6756, 799.6784, 799.6786, 799.9130, 799.9510,
799.9538, 799.9365, 799.9305, and 799.9355, respectively, upon which
the test standards in this proposed rule are based. The Agency invites
comment on the potential use of voluntary consensus standards in this
proposed rule, and, specifically, invites the public to identify
potentially applicable consensus standard(s) and to explain why such
standard(s) should be used here.
J. Executive Order 12898
This proposed rule does not have an adverse impact on the
environmental and health conditions in low-income and minority
communities that require special consideration by the Agency under
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994). The Agency believes that
the information collected under this proposed rule, if finalized, will
assist EPA and others in determining the potential hazards and risks
associated with the chemical substances covered by this proposed rule.
Although not directly impacting environmental justice-related concerns,
this information will enable the Agency to better protect human health
and the environment, including in low-income and minority communities.
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances,
Laboratories, Reporting and recordkeeping requirements.
Dated: February 17, 2010.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 799-- IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND
MIXTURE TESTING REQUIREMENTS
1. The authority citation for part 799 continues to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
2. Add Sec. 799.5089 to subpart D of part 799 to read as follows:
Sec. 799.5089 Chemical testing requirements for certain high
production volume chemicals; third group of chemicals.
(a) What substances will be tested under this section? Table 2 in
paragraph (j) of this section identifies the chemical substances that
must be tested under this section. For the chemical substances
identified as ``Class 1'' chemical substances in Table 2 in paragraph
(j) of this section, the purity of each chemical substance must be 99%
or greater, unless otherwise specified in this section. For the
chemical substances identified as ``Class 2'' chemical substances in
Table 2 in paragraph (j), a representative form of each chemical
substance must be tested. The representative form selected for a given
Class 2 chemical substance should meet industry or consensus standards
where they exist.
(b) Am I subject to this section? (1) If you manufacture (including
import) or intend to manufacture, or process or intend to process, any
chemical substance listed in Table 2 in paragraph (j) of this section
at any time from the effective date of the final rule to the end of the
test data reimbursement period as defined in 40 CFR 791.3(h), you are
subject to this section with respect to that chemical substance.
(2) If you do not know or cannot reasonably ascertain that you
manufacture or process a chemical substance listed in Table 2 in
paragraph (j) of this section during the time period described in
paragraph (b)(1) of this section (based on all information in your
possession or control, as well as all information that a reasonable
person similarly situated might be expected to possess, control, or
know, or could obtain without unreasonable burden), you are not subject
to this section with respect to that chemical substance.
(c) If I am subject to this section, when must I comply with it?
(1) (i) Persons subject to this section are divided into two groups, as
set forth in Table 1 of this paragraph: Tier 1 (persons initially
required to comply) and Tier 2 (persons not initially required to
comply). If you are subject to this section, you must determine if you
fall within Tier 1 or Tier 2, based on Table 1 of this paragraph.
[[Page 8595]]
Table 1.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
Tier 2 (Persons not initially
Tier 1 (Persons initially required to required to comply with this
comply with this section) section)
------------------------------------------------------------------------
Persons not otherwise specified in Tier 2A. Persons who
column 2 of this table that manufacture (as defined at
manufacture (as defined at TSCA TSCA section 3(7)) or intend
section 3(7)) or intend to manufacture to manufacture a chemical
a chemical substance included in this substance included in this
section. section solely as one or more
of the following:
--As a byproduct (as defined at
40 CFR 791.3(c));
--As an impurity (as defined at
40 CFR 790.3);
--As a naturally occurring
substance (as defined at 40
CFR 710.4(b));
--As a non-isolated
intermediate (as defined at 40
CFR 704.3);
--As a component of a Class 2
substance (as described at 40
CFR 720.45(a)(1)(i));
--In amounts of less than 500
kilogram (kg) (1,100 lbs.)
annually (as described at 40
CFR 790.42(a)(4)); or
--For research and development
(as described at 40 CFR
790.42(a)(5)).
B. Persons who process (as
defined at TSCA section 3(10))
or intend to process a
chemical substance included in
this section (see 40 CFR
790.42(a)(2)).
------------------------------------------------------------------------
(ii) Table 1 of paragraph (c)(1)(i) of this section expands the
list of persons in Tier 2, that is those persons specified in Sec.
790.42(a)(2), (a)(4) and (a)(5) of this chapter, who, while legally
subject to this section, must comply with the requirements of this
section only if directed to do so by EPA under the circumstances set
forth in paragraphs (c)(4), (c)(5), (c)(6), (c)(7), and (c)(10) of this
section.
(2) If you are in Tier 1 with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, you must, for each
test required under this section for that chemical substance, either
submit to EPA a letter of intent to test or apply to EPA for an
exemption from testing. The letter of intent to test or the exemption
application must be received by EPA no later than 30 days after the
effective date of the final rule.
(3) If you are in Tier 2 with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, you are considered
to have an automatic conditional exemption and you will be required to
comply with this section with regard to that chemical substance only if
directed to do so by EPA under paragraphs (c)(5), (c)(7), or (c)(10) of
this section.
(4) If no person in Tier 1 has notified EPA of its intent to
conduct one or more of the tests required by this section on any
chemical substance listed in Table 2 in paragraph (j) of this section
within 30 days after the effective date of the final rule, EPA will
publish a Federal Register document that would specify the test(s) and
the chemical substance(s) for which no letter of intent has been
submitted and notify manufacturers in Tier 2A of their obligation to
submit a letter of intent to test or to apply for an exemption from
testing.
(5) If you are in Tier 2A (as specified in Table 1 in paragraph (c)
of this section) with respect to a chemical substance listed in Table 2
in paragraph (j) of this section, and if you manufacture, or intend to
manufacture, this chemical substance as of [30 days after date of
publication of the final rule in the Federal Register], or within 30
days after publication of the Federal Register document described in
paragraph (c)(4) of this section, you must, for each test specified for
that chemical substance in the document described in paragraph (c)(4)
of this section, either submit to EPA a letter of intent to test or
apply to EPA for an exemption from testing. The letter of intent to
test or the exemption application must be received by EPA no later than
30 days after publication of the Federal Register document described in
paragraph (c)(4) of this section.
(6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its
intent to conduct one or more of the tests required by this section on
any chemical substance listed in Table 2 in paragraph (j) of this
section within 30 days after the publication of the Federal Register
document described in paragraph (c)(4) of this section, EPA will
publish another Federal Register document that would specify the
test(s) and the chemical substance(s) for which no letter of intent has
been submitted, and notify processors in Tier 2B of their obligation to
submit a letter of intent to test or to apply for an exemption from
testing.
(7) If you are in Tier 2B (as specified in Table 1 in paragraph (c)
of this section) with respect to a chemical substance listed in Table 2
in paragraph (j) of this section, and if you process, or intend to
process, this chemical substance as of [30 days after date of
publication of the final rule in the Federal Register], or within 30
days after publication of the Federal Register document described in
paragraph (c)(6) of this section, you must, for each test specified for
that chemical substance in the Federal Register document described in
paragraph (c)(6) of this section, either submit to EPA a letter of
intent to test or apply to EPA for an exemption from testing. The
letter of intent to test or the exemption application must be received
by EPA no later than 30 days after publication of the Federal Register
document described in paragraph (c)(6) of this section.
(8) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the chemical substances listed in Table 2 in paragraph (j) of this
section within 30 days after the publication of the Federal Register
document described in paragraph (c)(6) of this section, EPA will notify
all manufacturers and processors of those chemical substances of this
fact by certified letter or by publishing a Federal Register document
specifying the test(s) for which no letter of intent has been
submitted. This letter or Federal Register document will additionally
notify all manufacturers and processors that all exemption applications
concerning the test(s) have been denied, and will give the
manufacturers and processors of the chemical substance(s) an
opportunity to take corrective action.
(9) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the chemical substances listed in Table 2 in paragraph (j) of this
section within 30 days after receipt of the certified letter or
publication of the Federal Register document described in paragraph
(c)(8) of this section, all manufacturers and processors subject to
this section with respect to that chemical substance who are not
already in violation of this
[[Page 8596]]
section will be in violation of this section.
(10) If a problem occurs with the initiation, conduct, or
completion of the required testing or the submission of the required
data with respect to a chemical substance listed in Table 2 in
paragraph (j) of this section, under the procedures in Sec. Sec.
790.93 and 790.97 of this chapter, EPA may initiate termination
proceedings for all testing exemptions with respect to that chemical
substance and may notify persons in Tier 1 and Tier 2 that they are
required to submit letters of intent to test or exemption applications
within a specified period of time.
(11) If you are required to comply with this section, but your
manufacture or processing of, or intent to manufacture or process, a
chemical substance listed in Table 2 in paragraph (j) of this section
begins after the applicable compliance date referred to in paragraphs
(c)(2), (c)(5), or (c)(6) of this section, you must either submit a
letter of intent to test or apply to EPA for an exemption. The letter
of intent to test or the exemption application must be received by EPA
no later than the day you begin manufacture or processing.
(d) What must I do comply with this section? (1) To comply with
this section you must either submit to EPA a letter of intent to test,
or apply to and obtain from EPA an exemption from testing.
(2) For each test with respect to which you submit to EPA a letter
of intent to test, you must conduct the testing specified in paragraph
(h) of this section and submit the test data to EPA.
(3) You must also comply with the procedures governing test rule
requirements in part 790 of this chapter, as modified by this section,
including the submission of letters of intent to test or exemption
applications, the submission of study plans prior to testing, the
conduct of testing, and the submission of data; Part 792--Good
Laboratory Practice Standards of this chapter; and this section. The
following provisions of 40 CFR part 790 do not apply to this section:
Paragraphs (a), (d), (e), and (f) of Sec. 790.45; Sec. 790.48;
paragraph (a)(2) and paragraph (b) of Sec. 790.80; paragraph (e)(1) of
Sec. 790.82; and Sec. 790.85.
(e) If I do not comply with this section, when will I be
considered in violation of it? You will be considered in violation of
this section as of 1 day after the date by which you are required to
comply with this section.
(f) How are EPA's data reimbursement procedures affected for
purposes of this section? If persons subject to this section are unable
to agree on the amount or method of reimbursement for test data
development for one or more chemical substances included in this
section, any person may request a hearing as described in 40 CFR part
791. In the determination of fair reimbursement shares under this
section, if the hearing officer chooses to use a formula based on
production volume, the total production volume amount will include
amounts of a chemical substance produced as an impurity.
(g) Who must comply with the export notification requirements? Any
person who exports, or intends to export, a chemical substance listed
in Table 2 in paragraph (j) of this section is subject to part 707,
subpart D, of this chapter.
(h) How must I conduct my testing? The tests that are required for
each chemical substance are indicated in Table 2 in paragraph (j) of
this section. The test methods that must be followed are provided in
Table 3 in paragraph (j) of this section. You must proceed in
accordance with these test methods as required according to Table 3 in
paragraph (j) of this section, or as appropriate if more than one
alternative is allowed according to Table 3 in paragraph (j) of this
section.
(i) Reporting requirements. A final report for each specific test
for each subject chemical substance must be received by EPA by [13
months after the effective date of the final rule] unless an extension
is granted in writing pursuant to 40 CFR 790.55. A robust summary of
the final report for each specific test shall be submitted
electronically 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'' which is available on-line at: http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
(j) Designation of specific chemical substances and testing
requirements. The chemical substances identified by chemical name,
Chemical Abstract Service Registry number (CAS No.), and class in Table
2 of this paragraph must be tested in accordance with the requirements
designated in Tables 2 and 3 of this paragraph, and the requirements
described in 40 CFR Part 792-Good Laboratory Practice Standards:
Table 2.--Chemical Substances and Testing Requirements
----------------------------------------------------------------------------------------------------------------
Required Tests (See
CAS No. Chemical Name Class Table 3 of this
section)
----------------------------------------------------------------------------------------------------------------
83-41-0 Benzene, 1,2-dimethyl-3- 1 A1, A2, A3, A4, A5, D,
nitro- E2, F1
----------------------------------------------------------------------------------------------------------------
96-22-0 3-Pentanone 1 E1, F2
----------------------------------------------------------------------------------------------------------------
98-09-9 Benzenesulfonyl 1 C2, E1, E2, F1
chloride
----------------------------------------------------------------------------------------------------------------
98-56-6 Benzene, 1-chloro-4- 1 A4, B, C1, F2
(trifluoromethyl)-
----------------------------------------------------------------------------------------------------------------
111-44-4 'Ethane, 1,1'-oxybis[2- 1 C6, F1
chloro-
----------------------------------------------------------------------------------------------------------------
127-68-4 Benzenesulfonic acid, 3- 1 A3, F2
nitro-, sodium salt
(1:1)
----------------------------------------------------------------------------------------------------------------
506-51-4 1-Tetracosanol 1 A2, A3, A4, A5, B, C1,
D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
506-52-5 1-Hexacosanol 1 A2, A3, A4, A5, C1, D,
E1, E2, F1
----------------------------------------------------------------------------------------------------------------
515-40-2 Benzene, (2-chloro-1,1- 1 A1, A3, A4, A5, B, C1,
dimethylethyl)- D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
[[Page 8597]]
2494-89-5 Ethanol, 2-[(4- 1 A1, A2, A3, A4, A5, B,
aminophenyl)sulfonyl]- C1, D, E1, E2, F1
, 1-(hydrogen sulfate)
----------------------------------------------------------------------------------------------------------------
5026-74-4 2-Oxiranemethanamine, N- 1 A1, A2, A3, A4, A5, B,
[4-(2- C2, F1
oxiranylmethoxy)phenyl
]-N-(2-oxiranylmethyl)-
----------------------------------------------------------------------------------------------------------------
22527-63-5 Propanoic acid, 2- 1 A1, A2, A3, A4, A5, B,
methyl-, 3- C1, D, E1, E2, F1
(benzoyloxy)-2,2,4-
trimethylpentyl ester
----------------------------------------------------------------------------------------------------------------
24615-84-7 2-Propenoic acid, 2- 1 A1, A2, A3, A4, A5, B,
carboxyethyl ester C1, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
25321-41-9 Benzenesulfonic acid, 1 A2, A3, A4, A5, B, C1,
dimethyl- D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
25646-71-3 Methanesulfonamide, N- 1 A1, A2, A3, A4, A5, B,
[2-[(4-amino-3- C1, F1
methylphenyl)ethylamin
o]ethyl]-, sulfate
(2:3)
----------------------------------------------------------------------------------------------------------------
52556-42-0 1-Propanesulfonic acid, 1 A1, A2, A3, A4, A5, B,
2-hydroxy-3-(2- C1, D, E1, E2, F1
propenyloxy)-, sodium
salt (1:1)
----------------------------------------------------------------------------------------------------------------
61788-76-9 Alkanes, chloro 2 A2, A3, A4, A5, B,
----------------------------------------------------------------------------------------------------------------
65996-79-4 Solvent naphtha (coal) 2 A3, A4, A5, B, C1, D,
E1, E2, F1
----------------------------------------------------------------------------------------------------------------
65996-82-9 Tar oils, coal 2 A3, A4, A5, B, C1, D,
E1, E2, F1
----------------------------------------------------------------------------------------------------------------
65996-89-6 Tar, coal, high- 2 A4, A5, B, C1, D, E1,
temperature E2, F1
----------------------------------------------------------------------------------------------------------------
65996-92-1 Distillates (coal tar) 2 A3, A4, A5, B, C1, D,
E1, E2, F2
----------------------------------------------------------------------------------------------------------------
68082-78-0 Lard, oil, Me esters 2 A1, A2, A3, A4, A5, B,
C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68187-57-5 Pitch, coal tar- 2 A4, A5, B, C6, D, E1,
petroleum E2, F1
----------------------------------------------------------------------------------------------------------------
68442-60-4 Acetaldehyde, reaction 2 A1, A2, A3, A4, A5, B,
products with C1, D, E1, E2, F1
formaldehyde, by-
products from
----------------------------------------------------------------------------------------------------------------
68610-90-2 2-Butenedioic acid (2E)- 2 A1, A2, A3, A4, A5, B,
, di-C8-18-alkyl C1, D, E1, E2, F1
esters
----------------------------------------------------------------------------------------------------------------
68988-22-7 1,4-Benzenedicarboxylic 2 A1, A2, A3, A4, A5, B,
acid, 1,4-dimethyl C1, D, E1, E2, F1
ester, manuf. of, by-
products from
----------------------------------------------------------------------------------------------------------------
70693-50-4 Phenol, 2,4-bis(1- 1 A1, A2, A3, A4, A5, B,
methyl-1-phenylethyl)- C1, D, E1, E2, F1
6-[2-(2-
nitrophenyl)diazenyl]-
----------------------------------------------------------------------------------------------------------------
72162-15-3 1-Decene, sulfurized 2 A2, A3, A4, A5, B, C1,
D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
73665-18-6 Extract residues 2 A2, A3, A4, A5, B, C1,
(coal), tar oil alk., D, E1, E2, F1
naphthalene distn.
residues
----------------------------------------------------------------------------------------------------------------
[[Page 8598]]
Table 3.--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2 of This Paragraph
----------------------------------------------------------------------------------------------------------------
Test Requirements and
Testing Category Test References Special Conditions
----------------------------------------------------------------------------------------------------------------
Physical/Chemical Properties A 1. Melting Point: ASTM n-Octanol/Water
E 324-99 (capillary Partition Coefficient
tube) or log Kow:
2. Boiling Point: ASTM Which method is
E 1719-05 required, if any, is
(ebulliometry). determined by the test
3. Vapor Pressure: ASTM substance's estimated
E 1782-03 (thermal \i\ log Kow as follows:
analysis). log Kow < 0: no testing
4. n-Octanol/Water required.
Partition Coefficient log Kow range 0-1:
(log 10 basis) or log Method A or B.
Kow: (See Special log Kow range > 1-4:
Conditions for the log Method A or B or C.
Kow test requirement log Kow range > 4-6:
and select the Method B or C.
appropriate method to log Kow > 6: Method C.
use, if any, from Test sponsors must
those listed in this provide in the final
column.). study report the
Method A: 40 CFR underlying rationale
799.6755 (shake flask). for the method and pH
Method B: ASTM E 1147- selected. In order to
92(2005) (liquid ensure environmental
chromatography). relevance, EPA highly
Method C: 40 CFR recommends that the
799.6756 (generator selected study be
column). conducted at pH 7.
5. Water Solubility: Water Solubility:
(See Special Which method is
Conditions for the required, if any, is
water solubility test determined by the test
requirement and select substance's estimated
the appropriate method \ii\ water solubility.
to use, if any, from Test sponsors must
those listed in this provide in the final
column.). study report the
Method A: ASTM E 1148- underlying rationale
02 (shake flask). for the method and pH
Method B: 40 CFR selected. In order to
799.6784 (shake flask). ensure environmental
Method C: 40 CFR relevance, EPA highly
799.6784 (column recommends that the
elution). selected study be
Method D: 40 CFR conducted starting at
799.6786 (generator pH 7.
column). > 5,000 mg/L: Method A
or B.
> 10 mg/L--5,000 mg/L:
Method A, B, C, or D.
> 0.001 mg/L--10 mg/L:
Method C or D.
<= 0.001 mg/L: no
testing required.
----------------------------------------------------------------------------------------------------------------
Environmental Fate and Pathways-- B For B, consult ISO Which method is
Ready Biodegradation 10634 for guidance, required, if any, is
and choose one of the determined by the test
methods listed in this substance's physical
column: and chemical
1. ASTM 1720-01 (sealed properties, including
vessel CO2 production its water solubility.
test). ISO 10634 provides
OR.................... guidance for selection
2. ISO 14593 (CO2 of an appropriate test
headspace test). method for a given test
OR.................... substance. Test
3. ISO 7827 (analysis sponsors must provide
of DOC). in the final study
OR.................... report the underlying
4. ISO 9408 rationale for the
(determination of method selected.
oxygen demand in a
closed respirometer).
OR....................
5. ISO 9439 (CO2
evolution test).
OR....................
6. ISO 10707 (closed
bottle test).
OR....................
7. ISO 10708 (two-phase
closed bottle test).
----------------------------------------------------------------------------------------------------------------
Aquatic Toxicity C1 For C1, Test Group 1 or The following are the
Test Group 2 listed in Special Conditions for
this column must be C1, C2, C3, C4, C5, and
used to fulfill the C7 testing; there are
testing requirements-- no Special Conditions
see Special for C6. Which test
Conditions. group is required is
Test Group 1 for C1:... determined by the test
1. Acute Toxicity To substance's measured
Fish: ASTM E 729- log KOW as obtained
96(2002). under Test Category A,
2. Acute Toxicity To or using an existing
Daphnia: ASTM E 729- measured log KOW. \iii\
96(2002). If log Kow < 4.2: Test
3. Toxicity To Plants Group 1 is required.
(Algae): ASTM E 1218- If log Kow >= 4.2: Test
04e1. Group 2 is required.
Test Group 2 for C1:...
1. Chronic Toxicity To
Daphnia: ASTM E 1193-
97(2004).
2. Toxicity To Plants
(Algae): ASTM E 1218-
04e1.
--------------------------------------------------
[[Page 8599]]
C2 For C2, Test Group 1 or ........................
Test Group 2 listed in
this column must be
used to fulfill the
testing requirements--
see Special
Conditions..
Test Group 1 for C2:...
1. Acute Toxicity To
Daphnia: ASTM E 729-
96(2002).
2. Toxicity To Plants
(Algae): ASTM E 1218-
04e1.
Test Group 2 for C2:...
1. Chronic Toxicity To
Daphnia: ASTM E 1193-
97(2004).
2. Toxicity To Plants
(Algae): ASTM E 1218-
04e1.
--------------------------------------------------
C3 For C3, Test Group 1 or ........................
Test Group 2 listed in
this column must be
used to fulfill the
testing requirements--
see Special
Conditions.
Test Group 1 for C3:...
1. Acute Toxicity To
Fish: ASTM E 729-
96(2002).
2. Toxicity To Plants
(Algae): ASTM E 1218-
04e1.
Test Group 2 for C3:...
1. Chronic Toxicity To
Daphnia: ASTM E 1193-
97(2004).
2. Toxicity To Plants
(Algae): ASTM E 1218-
04e1.
--------------------------------------------------
C4 For C4, Test Group 1 or ........................
Test Group 2 listed in
this column must be
used to fulfill the
testing requirements--
see Special
Conditions.
Test Group 1 for C4:...
1. Acute Toxicity To
Fish: ASTM E 729-
96(2002).
2. Acute Toxicity To
Daphnia: ASTM E 729-
96(2002).
Test Group 2 for C4:...
1. Chronic Toxicity To
Daphnia: ASTM E 1193-
97(2004).
2. [Reserved]..........
--------------------------------------------------
C5 For C5, Test Group 1 or ........................
Test Group 2 listed in
this column must be
used to fulfill the
testing requirements--
see Special
Conditions.
Test Group 1 for C5:...
1. Acute Toxicity To
Daphnia: ASTM E 729-
96(2002).
2. [Reserved]..........
Test Group 2 for C5:...
1. Chronic Toxicity To
Daphnia: ASTM E 1193-
97(2004).
2. [Reserved]..........
--------------------------------------------------
C6 Toxicity To Plants ........................
(Algae): ASTM E 1218-
04e1
--------------------------------------------------
[[Page 8600]]
C7 For C7, Test Group 1 or ........................
Test Group 2 listed in
this column must be
used to fulfill the
testing requirements--
see Special
Conditions.
Test Group 1 for C7:...
1. Acute Toxicity To
Fish: ASTM E 729-
96(2002).
2. [Reserved]..........
Test Group 2 for C7:...
1. Chronic Toxicity To
Daphnia: ASTM E 1193-
97(2004).
2. [Reserved]..........
----------------------------------------------------------------------------------------------------------------
Mammalian Toxicity--Acute D See Special Conditions Which testing method is
for this test required is determined
requirement and select by the test substance's
the method that must physical state at room
be used from those temperature (25[deg]C).
listed in this column. For those test
Method A: Acute substances that are
Inhalation Toxicity gases at room
(rat): 40 CFR 799.9130. temperature, Method A
Method B: EITHER:...... is required; otherwise,
1. Acute (Up/Down) Oral use either of the two
Toxicity (rat): ASTM E methods listed under
1163-98(2002). Method B.
OR.................... In Method B, 40 CFR
2. Acute (Up/Down) Oral 799.9110(d)(1)(i)(A)
Toxicity (rat): 40 CFR refers to the OECD 425
799.9110(d)(1)(i)(A). Up/Down Procedure. \iv\
Estimating starting dose
for Method B: Data from
the neutral red uptake
basal cytotoxicity
assay \v\ using normal
human keratinocytes or
mouse BALB/c 3T3 cells
may be used to estimate
the starting dose.
----------------------------------------------------------------------------------------------------------------
Mammalian Toxicity--Genotoxicity E1 Bacterial Reverse None
Mutation Test (in
vitro): 40 CFR
799.9510
---------------------------------------------------------------------------
E2 Conduct any one of the Persons required to
following three tests conduct testing for
for chromosomal chromosomal damage are
damage: encouraged to use the
In vitro Mammalian in vitro Mammalian
Chromosome Aberration Chromosome Aberration
Test: 40 CFR 799.9537. Test (40 CFR 799.9537)
OR.................... to generate the needed
Mammalian Bone Marrow data unless known
Chromosomal Aberration chemical properties
Test (in vivo in (e.g., physical/
rodents: mouse chemical properties,
(preferred species), chemical class
rat, or Chinese characteristics)
hamster): 40 CFR preclude its use. A
799.9538. subject person who uses
OR.................... one of the in vivo
Mammalian Erythrocyte methods instead of the
Micronucleus Test in vitro method to
[sampled in bone address a chromosomal
marrow] (in vivo in damage test requirement
rodents: mouse must submit to EPA a
(preferred species), rationale for
rat, or Chinese conducting that
hamster): 40 CFR alternate test in the
799.9539. final study report.
----------------------------------------------------------------------------------------------------------------
Mammalian Toxicity--Repeated Dose/ F1 Combined Repeated Dose Where F1 is required,
Reproduction/Developmental Toxicity Study with EPA recommends use of
the Reproduction/ the Combined Repeated
Developmental Toxicity Dose Toxicity Study
Screening Test: 40 CFR with the Reproduction/
799.9365 Developmental Toxicity
OR.................... Screening Test (40 CFR
Reproduction/ 799.9365). However,
Developmental Toxicity there may be valid
Screening Test: 40 CFR reasons to test a
799.9355. particular chemical
AND................... using both 40 CFR
Repeated Dose 28-Day 799.9355 and 40 CFR
Oral Toxicity Study in 799.9305 to fill
rodents: 40 CFR Mammalian Toxicity--
799.9305. Repeated Dose/
Reproduction/
Developmental data
needs. A subject person
who uses the
combination of 40 CFR
799.9355 and 40 CFR
799.9305 in place of 40
CFR 799.9365 must
submit to EPA a
rationale for
conducting these
alternate tests in the
final study reports.
Where F2 or F3 is
required, no rationale
for conducting the
required test need be
provided in the final
study report.
--------------------------------------------------
F2 Reproduction/ ........................
Developmental Toxicity
Screening Test: 40 CFR
799.9355
--------------------------------------------------
F3 Repeated Dose 28-Day ........................
Oral Toxicity Study in
rodents: 40 CFR
799.9305
----------------------------------------------------------------------------------------------------------------
i. EPA recommends, but does not require, that log KOW be quantitatively estimated prior to initiating this
study. One method, among many similar methods, for estimating log KOW is described in the article entitled
``Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients'' by W.M. Meylan and
P.H. Howard in the Journal of Pharmaceutical Sciences. 84(1):83-92. January 1992. This reference is available
under docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located
at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays.
[[Page 8601]]
ii. EPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating
this study. One method, among many similar methods, for estimating water solubility is described in the
article entitled ``Improved Method for Estimating Water Solubility From Octanol/Water Partition Coefficient''
by W.M. Meylan, P.H. Howard, and R.S. Boethling in Environmental Toxicology and Chemistry. 15(2):100-106.
1996. This reference is available under docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm.
3334 in the EPA West Bldg. located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays.
iii. Chemical substances that are dispersible in water may have log Kow values greater than 4.2 and may still be
acutely toxic to aquatic organisms. Test sponsors who wish to conduct Test Group 1 studies on such chemical
substances may request a modification to the test standard as described in 40 CFR 790.55. Based upon the
supporting rationale provided by the test sponsor, EPA may allow an alternative threshold or method be used
for determining whether acute or chronic aquatic toxicity testing be performed for a specific substance.
iv. The OECD 425 Up/Down Procedure, revised by OECD test guidelines in December 2001, is available under docket
ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located at 1301
Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays.
v. The neutral red uptake basal cytotoxicity assay, which may be used to estimate the starting dose for the
mammalian toxicity-acute endpoint, is available under docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket
Center, Rm. 3334 in the EPA West Bldg. located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m.
to 4:30 p.m., Monday through Friday, excluding legal holidays.
(k) Effective date. This section is effective on [30 days after
date of publication of the final rule in the Federal Register].
[FR Doc. 2010-3734 Filed 2-24-10; 8:45 am]
BILLING CODE 6560-50-S