[Federal Register Volume 76, Number 204 (Friday, October 21, 2011)]
[Rules and Regulations]
[Pages 65385-65410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27227]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[EPA-HQ-OPPT-2009-0112; FRL-8885-5]
RIN 2070-AJ86
Testing of Certain High Production Volume Chemicals; Third Group
of Chemicals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is promulgating this final rule under section 4(a)(1)(B)
of the Toxic Substances Control Act (TSCA) to require manufacturers,
importers, and processors to conduct testing to obtain screening level
data for health and environmental effects and chemical fate for 15 high
production volume (HPV) chemical substances listed in this final rule.
This test data is needed in order to help EPA to determine whether
these 15 HPV chemical substances pose a risk to human health and/or
environmental safety. Based on comments received by EPA on the proposed
rule for this final rule, EPA has determined that only 15 of the 29 HPV
chemical substances proposed for testing meet the criteria for testing
at this time.
DATES: This final rule is effective November 21, 2011.
The incorporation by reference of certain publications listed in
this final rule is approved by the Director of the Federal Register as
of November 21, 2011.
For purposes of judicial review, this final rule shall be
promulgated at 1 p.m. eastern daylight/standard time on November 7,
2011.
[[Page 65386]]
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2009-0112. All documents in the
docket are listed on the regulations.gov Web site. Although listed in
the index, some information is not publicly available; i.e.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office
of Pollution Prevention and Toxics (OPPT) Docket. The OPPT Docket is
located in the EPA Docket Center (EPA/DC), 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.
Submission of Information: See Unit V.E.3. of the SUPPLEMENTARY
INFORMATION for additional instructions for submission of information
(e.g., letters-of-intent-to-test, exemption requests, study plans,
final study reports).
Submission of information containing CBI and/or non-CBI material
may be submitted by one of the following methods:
Mail: Document Control Office (DCO) (7407M), Office of
Pollution Prevention and Toxics (OPPT), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attn:
40 CFR 799.5089; Docket ID Number EPA-HQ-OPPT-2009-0112.
Hand delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. E6428 ((202) 564-8930), Environmental Protection
Agency, 1201 Constitution Ave., NW., Washington, DC 20004, Attn: 40 CFR
799.5089; Docket ID Number EPA-HQ-OPPT-2009-0112.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Paul Campanella or John
Schaeffer, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone numbers:
(202) 564-8091 or (202) 564-8173; e-mail addresses:
[email protected] or [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. 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 regulatory text.
Any use of the term ``manufacture'' in this final rule will encompass
``import,'' unless otherwise stated. In addition, as described in Unit
VI., any person who exports, or intends to export, any of the chemical
substances included in this 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 15 HPV chemical substances (NAICS codes 325 and
324110), e.g., chemical manufacturing and petroleum refineries.
Processors of one or more of the 15 HPV chemical
substances (NAICS 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 V.E. and consult
Sec. 799.5089(b) of the regulatory text. If you have any questions
regarding the applicability of this action to a particular entity,
consult either of the technical persons listed under FOR FURTHER
INFORMATION CONTACT.
II. Background
A. What action is the agency taking?
EPA is promulgating this final rule under TSCA section 4(a)(1)(B)
(15 U.S.C. 2603(a)(1)(B)) that requires manufacturers and processors of
15 HPV chemical substances to conduct testing for environmental fate
(including 5 tests for physical/chemical properties and
biodegradation), ecotoxicity (in fish, Daphnia, and algae), acute
toxicity, genetic toxicity (gene mutations and chromosomal
aberrations), repeat dose toxicity, and developmental and reproductive
toxicity. The chemical substances are HPV chemicals (i.e., chemical
substances with a production/import volume equal to or greater than 1
million pounds (lb) per year). A detailed discussion regarding efforts
to enhance the availability of screening level hazard and environmental
fate information about HPV chemical substances can be found in a
Federal Register notice which published on December 26, 2000 (Ref. 1).
In the proposed rule for this final rule, published in the Federal
Register issue of February 25, 2010, EPA proposed Screening Information
Data Set (SIDS) testing for 29 HPV chemical substances (Ref. 2). EPA
received comments on the proposed rule. In consideration of those
comments, EPA changed some testing requirements for certain HPV
chemical substances and is not including certain other HPV chemical
substances in this final rule, as explained in Unit III. On the basis
that adequate data are available for certain proposed testing
endpoints, EPA reduced the number of tests required for two chemical
substances; for another chemical substance, EPA dropped all testing
requirements and is not including that chemical substance in this final
rule. In addition, EPA is not including 12 of the proposed chemical
substances in this final rule because data provided to EPA after the
proposed rule was published indicate that these chemical substances are
no longer HPV, no longer have substantial human exposure, or no longer
have substantial environmental release. Furthermore, EPA is deferring
final action for one chemical substance, as explained in Unit VIII.
This final rule requires testing for 15 of the 29 HPV chemical
substances originally proposed for testing in 2010.
This action follows earlier testing actions for certain HPV
chemical substances (see the proposed and final rules entitled:
``Testing of Certain High Production Volume Chemicals; Proposed Rule''
(Ref. 3); ``Testing of Certain High Production Volume Chemicals; Final
Rule'' (Ref. 4);
[[Page 65387]]
``Testing of Certain High Production Volume Chemicals; Second Group of
Chemicals; Proposed Rule'' (Ref. 5); and ``Testing of Certain High
Production Volume Chemicals; Second Group of Chemicals; Final Rule''
(Ref. 6)).
EPA also intends to propose testing for additional HPV chemical
substances in a proposed rule scheduled for publication in 2011.
B. What is the Agency's authority for taking this action?
This final rule is being promulgated under TSCA section 4(a) (15
U.S.C. 2603(a)), which directs EPA to require the development of data
relevant to assessing whether activities associated with chemical
substances and mixtures present an unreasonable risk of injury to
health or the environment, when appropriate findings are made. This is
the policy of the United States, which is articulated in TSCA section
2(b)(1) (15 U.S.C. 2603(b)(1)), which states:
* * * adequate data should be developed with respect to the
effect of chemical substances and mixtures on health and the
environment and that the development of such data should be the
responsibility of those who manufacture [which is defined by statute
to include import] and those who process such chemical substances
and mixtures[.]
To implement this policy, EPA is promulgating this final rule under
TSCA section 4(a)(1)(B) (15 U.S.C. 2603(a)(1)(B)). Section 4(a) of TSCA
mandates EPA 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 [.]
If EPA makes these findings for a chemical substance or mixture,
the EPA Administrator shall require by rule that testing be conducted
on that chemical substance or mixture to develop data about health or
environmental effects for which there is an insufficiency of data and
experience, and which are relevant to a determination that the
manufacture, distribution in commerce, processing, use, or disposal of
the chemical substance or mixture, or any combination of such
activities, does or does not present an unreasonable risk of injury to
health or the environment (TSCA section 4(a)(1)).
Once the EPA Administrator has made a finding under TSCA section
4(a)(1)(A) or 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)(A)(i) or 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 published in the Federal Register issue of May 14,
1993 (B Policy) (Ref. 7, p. 28738).
In this final rule, EPA is using 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 15 HPV chemical substances specified in Table 2 in Sec.
799.5089(j) of the regulatory text. Following consideration of the
public comments on the proposed rule (Ref. 2), EPA is making the
following findings for the 15 HPV chemical substances under TSCA
section 4(a)(1)(B): 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 available to
the public certain basic information about the environmental fate and
potential health and environmental hazards associated with the most
widespread chemical substances in commerce. Mechanisms to collect or,
where necessary, develop needed data on U.S. HPV chemical substances
include the HPV Challenge Program, certain international efforts (the
Organization for Economic Cooperation and Development (OECD) HPV SIDS
Program, the International Council of Chemical Associations (ICCA) HPV
Initiative), and TSCA section 4 test rules. HPV chemical substances are
manufactured or imported in amounts equal to or greater than 1 million
lb per year and were first identified for the HPV Challenge Program
through data reported under the 1990 Inventory Update Reporting (IUR)
rule. The HPV Challenge Program is a voluntary testing program created
by the United States to ensure that a baseline set of data on
approximately 2,800 HPV chemical substances would be made available to
EPA and the public. The SIDS data set sought by the 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 chemical substances for human and environmental hazards,
and assists the Agency and others in making an informed, preliminary
judgment about the hazards of HPV chemical substances.
The 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 chemical substances. Therefore, EPA
continues to participate in the voluntary international efforts,
complementary to the HPV Challenge Program, that OECD is coordinating
to secure basic hazard information on HPV chemical substances in use
worldwide, including some of those on the 1990 U.S. HPV chemical
substances list (Ref. 8). This includes agreements to sponsor a U.S.
HPV chemical substance under either the OECD HPV SIDS Program (Ref. 9),
including sponsorship by OECD member countries beyond the United
States, or the international HPV Initiative that is being organized by
ICCA (Ref. 10).
As EPA stated in the first TSCA section 4 HPV test rule, U.S. data
needs that remained unmet in the HPV Challenge Program or through
international efforts could be addressed through TSCA section 4
rulemakings, such as the final rule promulgated by EPA on March 16,
2006 (Ref. 4) and the final rule promulgated by EPA on January 7, 2011
(Ref. 6). This is the third TSCA section 4 HPV test rule; it addresses
unmet data needs for 15 HPV chemical substances.
EPA intends to make the information collected under this final rule
available to the public, other Federal agencies, and any other
interested parties on its Web site (http://www.epa.gov/chemrtk) and in
the docket for this final rule identified under ADDRESSES. As
appropriate, this information will be used to ensure a scientifically
sound basis for risk assessments and risk management actions.
[[Page 65388]]
D. Why is EPA focusing on HPV chemical substances and SIDS testing?
This final rule pertains to HPV chemical substances, which EPA has
determined account for 95% of total chemical production in the United
States (Ref. 11, p. 32296). Based on 1990 IUR reports, EPA found that
only 7% of non-polymeric organic HPV chemical substances 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 chemical substances, 43% had no publicly available basic
hazard data. For the remaining chemical substances, limited amounts of
the data were available. This lack of available hazard data compromises
EPA's and others' ability to determine whether these HPV chemical
substances pose risks to human health or the environment, as well as
the public's ability to know about the hazards of chemical substances
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.
9):
Acute toxicity.
Repeat dose toxicity.
Developmental and reproductive toxicity.
Genetic toxicity (gene mutations and chromosomal
aberrations).
Ecotoxicity (studies in fish, Daphnia, and algae).
Environmental fate (including physical/chemical properties
(melting point, boiling point, vapor pressure, n-octanol/water
partition coefficient, and water solubility), photolysis, hydrolysis,
transport/distribution, and biodegradation).
Data on the six SIDS endpoints provide a consistent minimum set of
information that can help to assess the relative risks of chemical
substances and whether additional testing or assessment is necessary.
E. How will the data developed under this final rule be used?
EPA will use the data obtained from this final rule to support
development of preliminary hazard and risk assessments for the 15 HPV
chemical substances subject to this final rule. The data will also be
used by EPA to set priorities for further testing that may produce
hazard information which may be needed by EPA, other Federal agencies,
the public, industry, and others, to support adequate risk assessments.
EPA uses data from TSCA section 4 test rules to support such actions as
the risk management decisions and activities under TSCA, development of
water quality criteria, Toxics Release Inventory (TRI) listings, and
reduction of workplace exposures.
As appropriate, this information will be used to ensure a
scientifically sound basis for risk assessments and risk management
actions. As such, this effort will serve to further the Agency's goal
of identifying and controlling human and environmental risks as well as
providing greater knowledge and protection to the public.
In addition, a key goal of the HPV Challenge Program was making
basic health and environmental effects data for HPV chemical substances
available to the public as part of EPA's ``Right to Know'' Initiative.
A basic premise of the HPV Challenge Program was that the public has a
right to know about the hazards associated with chemical substances in
their environment. Everyone--including industry, environmental
protection groups, animal welfare organizations, government groups, and
the general public--can use the data provided through the HPV Challenge
Program, and also data collected on HPV chemical substances through
other means, including TSCA section 4 testing, to make informed
decisions related to the human and the environmental hazards of
chemical substances that they encounter in their daily lives.
III. Response to Public Comments
EPA received a number of comments, which are available in the
docket, in response to the proposed rule (Ref. 2). A summary of those
comments and EPA's response to each comment are presented in the
document entitled ``Response to public comments regarding testing of
certain high production volume chemicals'' (Response to Public
Comments) (Ref. 13). The comments on the proposed rule were submitted
by the American Coke and Coal Chemicals Institute; Dover Chemical
Corporation; the Society of Chemical Manufacturers and Affiliates on
behalf of Bimax, Inc. and Rhodia, Inc.; Eastman Chemical Company; Nease
Corporation; the International Imaging Industry Association; Special
Materials Company; BASF Corporation; the American Chemistry Council;
Sasol North America, Inc.; the Chlorinated Paraffins Industry
Association; INVISTA S.[agrave].r.l.; Greenwich Chemical Consulting,
Inc., on behalf of Brenntag North America, Inc.; Kowa American
Corporation, Miami Chemical, Inc., and Univar U.S.A., Inc.; GE Water
and Process Technologies; and Special Materials Company. Comments were
also submitted by People for the Ethical Treatment of Animals (PETA);
the Physicians Committee for Responsible Medicine; the Alternatives
Research Development Foundation; and the American Anti-Vivisection
Society. EPA also received comments from a private citizen. In response
to these comments, EPA made the following changes to the regulatory
text in this final rule:
1. EPA is no longer requiring testing for the following 13 chemical
substances:
Benzene, 1,2-dimethyl-3-nitro- (Chemical Abstract Service
Registry Number (CASRN) 83-41-0).
3-Pentanone (CASRN 96-22-0).
1-Tetracosanol (CASRN 506-51-4).
1-Hexacosanol (CASRN 506-52-5).
2-Propenoic acid, 2-carboxyethyl ester (CASRN 24615-84-7).
Methanesulfonamide, N-[2-[(4-amino-3-
methylphenyl)ethylamino]ethyl]-, sulfate (2:3) (CASRN 25646-71-3).
Solvent naphtha (coal) (CASRN 65996-79-4).
Tar oils, coal (CASRN 65996-82-9).
Tar, coal, high temperature (CASRN 65996-89-6).
Distillates (coal tar) (CASRN 65996-92-1).
Pitch, coal tar-petroleum (CASRN 68187-57-5).
1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, manuf.
of, by-products from (CASRN 68988-22-7).
Extract residues (coal), tar oil alk., naphthalene distn.
residues (CASRN 73665-18-6).
These changes are further discussed in Unit VII.A. and in the
``Response to Public Comments'' document (Ref. 13).
2. N-octanol/water partition coefficient, log 10 basis (log
Kow); and reproductive/developmental toxicity testing are
not required for benzene, 1-chloro-4-(trifluoromethyl)- (CASRN 98-56-
6). The aquatic toxicity testing requirement for this chemical
substance has also been reduced. These changes are further discussed in
Unit VII.B. and in the ``Response to Public Comments'' document (Ref.
13).
3. Water solubility, ready biodegradation, aquatic toxicity, acute
mammalian toxicity, combined repeated-dose/reproductive/developmental
toxicity, and in vitro mutagenicity tests are not required for
benzenesulfonic acid, dimethyl (CASRN 25321-41-9). These changes are
further discussed in Unit VII.B. and in the ``Response to Public
Comments'' document (Ref. 13).
[[Page 65389]]
IV. Findings
A. What is the basis for EPA's final rule to test these chemical
substances?
As described in Unit II.B., in order to promulgate a rule under
TSCA section 4(a) requiring the testing of chemical substances or
mixtures, EPA must make certain findings of 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)), in addition to findings
(discussed in this unit) regarding the sufficiency of existing data
(TSCA section 4(a)(l)(A)(ii) or TSCA section 4(a)(1)(B)(ii)) and the
need for testing (TSCA section 4(a)(1)(A)(iii) or TSCA section
4(a)(1)(B)(iii)). EPA is requiring testing of the chemical substances
included in this final rule based on its findings under TSCA section
4(a)(1)(B)(i) relating to ``substantial production'' and ``substantial
human exposure,'' as well as findings under TSCA section 4(a)(1)(B)(ii)
and (iii) relating to sufficient data and the need for testing. The
chemical substances included in this final rule are listed in Table 2
in Sec. 799.5089(j) of the regulatory text, along with their CASRNs.
EPA generally considers ``substantial production'' and
``substantial exposure'' of a chemical substance or mixture under TSCA
section 4(a)(1)(B)(i) to be aggregate production (including import)
volume equaling or exceeding 1 million lb per year of that chemical
substance or mixture, and exposure of 1,000 workers or more, or 10,000
consumers or more, or 100,000 members of the general population or more
to a chemical substance or mixture. See EPA's B Policy (Ref. 7) for
further discussion on how EPA generally evaluates chemical substances
or mixtures under TSCA section 4(a)(1)(B)(i).
EPA finds that, under TSCA section 4(a)(1)(B)(i), each of the 15
HPV chemical substances included in this final rule is produced in
substantial quantities and that there is or may be substantial human
exposure to each chemical substance (Ref. 14). In addition, under TSCA
section 4(a)(1)(B)(ii), EPA finds 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. EPA
also finds that testing the 15 HPV chemical substances identified in
this final rule is necessary to develop such data (TSCA section
4(a)(1)(B)(iii)) (see Unit IV.F.). EPA has not identified any
additional factors as discussed in the B Policy (Ref. 7) to cause the
Agency to use decisionmaking criteria other than the general thresholds
described in the B Policy with respect to the chemical substances
included in this final rule.
The chemical substances included in this final rule are listed in
Sec. 799.5089(j) of the regulatory text along with their CASRNs. For a
chemical-by-chemical summary of each of the findings, see Table 1 of
this unit. Table 1 of this unit summarizes EPA's findings with respect
to worker and consumer exposure, and includes the production volume,
number of workers and broad use categories reported under IUR and
Preliminary Assessment Information Reporting (PAIR) rules, and from the
National Occupational Exposure Survey (NOES). For more details, see the
discussion which follows the table and also the Exposure Findings
Supporting Information document (Ref. 14).
Table 1--Exposure Based Findings
--------------------------------------------------------------------------------------------------------------------------------------------------------
2006 IUR
substantial human 2006 IUR or PAIR Meet exposure Meet exposure
CASRN 2006 IUR production exposure met NOES (number of commercial/ based criteria based criteria
(million lb) (= workers) consumer use for commercial for consumers
1,000 workers) workers
--------------------------------------------------------------------------------------------------------------------------------------------------------
98-09-9........................... 1 to <10............. ................. ................. X X X
98-56-6........................... 10 to <50............ ................. ................. X X X
111-44-4.......................... 1 to <10............. ................. ................. X X X
127-68-4.......................... 1 to <10............. ................. 9,386 ................. X .................
515-40-2.......................... 1 to <10............. ................. ................. X X X
2494-89-5......................... 1 to <10............. ................. ................. X X X
5026-74-4......................... 1 to <10............. X ................. ................. X .................
22527-63-5........................ 1 to <10............. ................. ................. X X X
25321-41-9........................ 1 to <10............. ................. 2,843 ................. X .................
52556-42-0........................ 1 to <10............. X ................. X X X
68082-78-0........................ 1 to <10............. ................. 41,153 ................. X .................
68442-60-4........................ 1 to <10............. ................. ................. X X X
68610-90-2........................ 1 to <10............. ................. ................. X ................. X
70693-50-4........................ 1 to <10............. ................. ................. X X X
72162-15-3........................ 1 to <10............. ................. 64,227 ................. X .................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: CASRN--Chemical Abstract Service Registry Number, IUR--Inventory Update Reporting, PAIR--Preliminary Assessment Information Reporting, NOES--
National Occupational Exposure Survey.
B. Are these chemical substances produced and/or imported in
substantial quantities?
EPA finds that each of the chemical substances included in this
final rule is produced or imported in an amount equal to or greater
than 1 million lb per year (Ref. 14); this finding is based on
information gathered pursuant to the 2006 IUR submissions (see 2006 CFR
edition for 40 CFR part 710), which is the most recently available
compilation of TSCA Chemical Substance Inventory data. EPA believes
that these annual production and/or importation volumes are
``substantial'' as that term is used with reference to production in
TSCA section 4(a)(1)(B)(i) (see Ref. 7, p. 28746). A discussion of
EPA's ``substantial production'' finding for each chemical substance
included in this final rule is contained in a separate document (Ref.
14).
C. Are a substantial number of workers exposed to these chemical
substances?
EPA finds that the manufacture, processing, and use of 14 of the 15
HPV chemical substances included in this action results or may result
in exposure of a substantial number of workers to the chemical
substances. These chemical substances are used in a wide variety of
industrial applications which result in potential exposures to workers,
as described in the exposure support
[[Page 65390]]
document for this final rule (Ref. 14). (Note: For the single chemical
substance for which EPA has not found substantial worker exposure, EPA
finds that there is substantial consumer exposure; see Table 1 and Ref.
14.)
This finding is based, in large part, on information submitted in
accordance with the 2006 IUR submissions (see 2006 CFR edition for 40
CFR part 710) and the 2006 PAIR (Ref. 15). For chemical substances
whose total production volume (manufactured and imported) exceeded
300,000 lb 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, submitters were
required to provide information regarding the commercial and consumer
uses of the chemical substance.
In accordance with the Agency's B Policy (Ref. 7), EPA believes, as
a general matter, that an exposure of 1,000 workers or more to a
chemical substance is ``substantial'' as that term is used with
reference to ``human exposure'' in TSCA section 4(a)(1)(B)(i) (Ref. 7).
EPA is not aware of any facts in this case that warrant departure from
that policy and finds that there is or may be substantial human
exposure (workers) to 14 of these 15 HPV chemical substances.
Besides the 2006 IUR and 2006 PAIR data, EPA also reviewed NOES
data developed by the National Institute for Occupational Safety and
Health (NIOSH). 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 chemical
substances (Refs. 16-18). For 4 of the 15 HPV chemical substances, the
NOES data also supports EPA's finding that 1,000 or more workers are
exposed to these chemical substances.
EPA also compared production volumes from the 1986 IUR data to the
production volumes for the 2006 IUR data. For the 15 HPV chemical
substances in this final rule, there was no decrease in production
volume from 1986 to 2006 (Ref. 14). For the chemical substances for
which EPA has NOES data, the 2006 IUR production volume data are
consistent with NOES results, as the production volumes for these seven
chemical substances either stayed the same or increased since 1986,
thereby indicating that the usage of these chemical substances is no
less than when NOES data were gathered, and, by inference (without
contradictory data) that worker exposure is also likely to have stayed
the same or increased.
EPA carefully considered the industrial and commercial processing
and use information reported for each of these 15 HPV chemical
substances in 2006 IUR and PAIR submissions. Commercial uses are
defined as, ``The use of a chemical substance or mixture in a
commercial enterprise providing saleable goods or services (e.g., dry
cleaning establishment, painting contractor)'' (see 2006 edition of the
CFR for 40 CFR 710.43). Detailed information from the 2006 IUR
submissions can be found in: ``Testing of Certain High Production
Volume Chemicals-3 (Exposure Findings Supporting Information)'' (Ref.
14). Based on the nature of the reported IUR uses, EPA considers that
chemical substances with reported commercial uses may result in
potential exposure to 1,000 workers or more. The total number of
workers reported under the 2006 IUR data is the sum of information on
industrial workers plus commercial use workers.
D. Are a substantial number of consumers exposed to these chemical
substances?
Based on 2006 IUR data, EPA finds that the uses of 9 of the 15 HPV
chemical substances included in this action result or may result in
exposure to a substantial number of consumers (Ref. 14). EPA reviewed
the consumer use information reported for the 2006 IUR data and
carefully considered the nature of those uses. Upon completion of the
review, EPA concluded that the reported consumer uses for these
chemical substances may result in at least 10,000 potentially exposed
consumers, thus meeting the exposure based finding for consumers.
In addition to findings made based on the 2006 IUR data, EPA has
also made consumer exposure-based findings for one additional chemical
substance based on the National Library of Medicine (NLM) Household
Products Database (HPD) (see Ref. 13). The chemical substances reported
in the HPD are present in multiple household products including hobby/
craft products, personal care products, home cleaning products, home
maintenance products, and automotive products. The HPD provides
information on the chemical ingredients and their percentage in
specific brands of household products. Information in the HPD is from a
variety of publicly available sources including brand-specific labels
and Material Safety Data Sheets, when available from manufacturers and
manufacturers' Web sites.
EPA finds that consumers' use of the products identified in the HPD
may expose a substantial number of consumers (i.e., 10,000 or more) to
the chemical substances in those products. EPA believes that an
exposure of 10,000 or more consumers to a chemical substance is
``substantial'' as that term is used with reference to ``human
exposure'' in TSCA section 4(a)(1)(B)(i) (Ref. 7). Therefore, EPA finds
that there is or may be substantial human exposure (consumers) to 10 of
these 15 HPV chemical substances.
A discussion of EPA's ``substantial exposure'' finding for
consumers is contained in a separate document (Ref. 14).
E. Does sufficient data exist for these chemical substances?
EPA has determined that for the 15 HPV chemical substances for
which testing is required under this final rule, there are either no
data available on SIDS testing endpoints or these data are insufficient
to reasonably determine or predict the effects on human health or the
environment that may result from exposures during the manufacturing,
processing, distribution in commerce, use, or disposal of the subject
chemical substances.
The finding of insufficient data is based on the results of
searches for data on SIDS endpoints by EPA, including available data as
summarized on its High Production Volume Information System (HPVIS)
(Refs. 1, 19, and 20). This finding is also based on the results of
EPA's review of studies/data identified by commenters in response to
the proposed rule or identified by EPA after the publication of the
proposed rule to this final rule. The studies and data submitted or
identified subsequent to the proposed rule were found to be sufficient
for some proposed tests of certain chemical substances and those tests
are not required for those chemical substances in this final rule (see
Unit VII.).
[[Page 65391]]
EPA encouraged the submission of existing data on SIDS testing
endpoints relevant to characterizing the hazard of those chemical
substances for which testing was proposed. All such submitted
information was carefully evaluated by EPA in the development of the
final testing requirements in this final rule. However, if persons
required to test under this final rule become aware of additional
relevant and scientifically adequate existing data (including
structure-activity relationships (SAR) information or a scientifically
defensible category approach) and submit this information to EPA before
testing is initiated, the Agency will consider such data to determine
if they satisfy the testing requirement and will take appropriate
necessary action to ensure that the testing in this final rule is no
longer required. Persons may submit such information as a requested
modification to the testing requirements under 40 CFR 790.55 at any
time at least 60 days before the reporting deadline for the test in
question.
F. Is testing necessary for these chemical substances?
As discussed in Unit II.D., data on SIDS testing endpoints,
including acute toxicity, repeat dose toxicity, developmental and
reproductive toxicity, genetic toxicity (gene mutations and chromosomal
aberrations), ecotoxicity (tests in fish, Daphnia, and algae), and
environmental fate (five tests for physical/chemical properties
[melting point, boiling point, vapor pressure, n-octanol/water
partition coefficient, and water solubility] and biodegradation), are
necessary to ascertain the health and environmental effects of the 15
HPV chemical substances in this final rule. EPA knows of no other means
to generate the SIDS data other than the testing described in this
final rule, and therefore believes that conducting the SIDS testing
identified for the 15 HPV 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 is important to make these data available to satisfy
the ``Right-to-Know'' principles included in the HPV Challenge Program
goals.
V. Final Rule
A. What testing is required by this final rule?
EPA is requiring specific testing and reporting requirements for
the chemical substances specified in Sec. 799.5089(j) of the
regulatory text. The testing requirements for each chemical are denoted
by alphanumeric symbols in Table 2 in Sec. 799.5089(j) of the
regulatory text. Table 3 in Sec. 799.5089(j) of the regulatory text
provides the key to identify the tests denoted by the alphanumeric
symbols and also lists special conditions that might apply when
conducting some of those tests. Test methods listed in Table 3 in Sec.
799.5089(j) of the regulatory text are grouped according to the
endpoint that they address. The endpoints and test standards required
under this final rule are listed in this unit. Also discussed in this
unit are the special conditions which EPA has identified and is
requiring for several of the required test standards.
1. Physical/Chemical Properties--a. Melting Point: ASTM
International (ASTM) E 324-99 (capillary tube) (Ref. 21) (or, for
substances liquid at room temperature, Freezing Point: OECD102 (melting
point/melting range) (Ref. 22)).
b. Boiling Point: ASTM E 1719-05 (ebulliometry) (Ref. 23).
c. Vapor Pressure: ASTM E 1782-08 (thermal analysis) (Ref. 24).
d. n-Octanol/Water Partition Coefficient: Method A (40 CFR
799.6755--shake flask).
e. Method B (ASTM E 1147-92 (Reapproved 2005)--liquid
chromatography) (Ref. 25).
f. Method C (40 CFR 799.6756--generator column).
g. Water Solubility: Method A (ASTM E 1148-02 (Reapproved 2008)--
shake flask) (Ref. 26).
h. Method B (40 CFR 799.6784--shake flask).
i. Method C (40 CFR 799.6784--column elution).
j. Method D (40 CFR 799.6786--generator column).
EPA is requiring, for those chemical substances for which melting
points determinations are needed, that melting points be determined
according to the method ASTM E 324-99. Though ASTM has withdrawn this
method, ASTM still makes the method available for informational
purposes and it can still be purchased from ASTM at the address listed
in Sec. 799.5089(h) of the regulatory text. ASTM has explained that
ASTM E 324-99 was withdrawn because:
The standard utilizes old, well-developed technology; it is
highly unlikely that any additional [changes] and/or modifications
will ever be pursued by the E15 [committee]. The time and effort
needed to maintain these documents detract from the time available
to develop new standards which use modern technology. (Ref. 27)
EPA concludes, therefore, that ASTM's withdrawal of ASTM E 324-99
does not have negative implications on the validity of the method.
However, where the chemical substance is a liquid at room
temperature a measured freezing point would meet the obligation to
report the melting point. However, ASTM E 324-99 (capillary tube) does
not specifically include instructions for determining freezing point.
Therefore, EPA is instead requiring OECD 102 (melting point/melting
range), which includes guidance for determining freezing point for
substances that are liquid at room temperature.
ASTM has updated and revised its test method for vapor pressure
(ASTM E 1782-08--thermal analysis) since the proposed rule was
published. Some material related to alternative test methods and some
unnecessary descriptive material was omitted in the revision, but the
test method itself is unchanged. The updated and revised method (ASTM E
1782-08--thermal analysis) is the required test method for the vapor
pressure endpoint in this final rule. Note: ASTM issues its test
methods under a fixed designation (e.g., E 1719): ``the number
immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A
number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last
revision or reapproval'' (Ref. 23).
In addition, ASTM has updated its test method for Measurement of
Aqueous Solubility (ASTM E 1148-02). The test method was reapproved in
2008. There was a minor change in ``Referenced Documents,'' but the
test method itself is unchanged. When required, the updated method
(ASTM E 1148-02 (Reapproved 2008)) is listed as the required test
method for the ``Water Solubility'' endpoint in this final rule (Ref.
26).
For the log Kow and water solubility endpoints, EPA is
requiring 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 regulatory text.
For the log Kow endpoint, EPA is requiring that an
appropriate selection be made from among three alternative
[[Page 65392]]
methods for measuring the chemical substance's log Kow.
Prior to determining the appropriate standard to use to measure the n-
octanol/water partition coefficient, EPA is recommending that the log
Kow be quantitatively estimated. EPA recommends that the
method described in ``Atom/Fragment Contribution Method for Estimating
Octanol-Water Partition Coefficients'' (Ref. 28) be used in making such
estimation. EPA is requiring that test sponsors must submit with the
final study report the underlying rationale for the test standard
selected for this endpoint. EPA is requiring this approach in
recognition of the fact that, depending on the chemical substance's log
Kow, one or more test methods may provide adequate
information for determining the log Kow, but that in some
instances one particular test method may be more appropriate. In
general, EPA believes that the more hydrophobic a subject chemical
substance is the more suitable Method B (ASTM E 1147-92 (Reapproved
2005)), and especially Method C (40 CFR 799.6756--generator column),
and the less suitable Method A (40 CFR 799.6755--shake flask), become.
The required 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 highly recommends that all required n-
octanol/water partition coefficient tests be conducted at pH 7 to
ensure environmental relevance. The required 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 Physical/Chemical Properties
------------------------------------------------------------------------
Test requirements
Testing category and references Special conditions
------------------------------------------------------------------------
Physical/chemical properties n-Octanol/water n-Octanol/water
partition partition
coefficient (log 10 coefficient (log 10
basis) or log Kow: basis) or log Kow:
Select from those Which method is
listed in this required, if any,
column--see Special is determined by
Conditions in the the test
adjacent column.. substance's
Method A: 40 CFR estimated log Kow
799.6755 (shake as follows:
flask). log Kow < 0: no
Method B: ASTM E testing required.
1147-92 (Reapproved log Kow range 0-1:
2005) (liquid Method A or B.
chromatography). log Kow range > 1-4:
Method C: 40 CFR Method A, B, or C.
799.6756 (generator log Kow range > 4-6:
column). Method B or C.
log Kow > 6: Method
C.
Test sponsors must
provide in the
final study report
the underlying
rationale for the
method and pH
selected. In order
to ensure
environmental
relevance, EPA
highly recommends
that the selected
study be conducted
at pH 7.
------------------------------------------------------------------------
Note: ASTM--ASTM International.
For the ``Water Solubility'' endpoint, EPA is requiring that the
appropriate selection be made from among four alternative methods for
measuring that endpoint. The test method used would be determined by
first quantitatively estimating the test substance's water solubility.
One recommended method for estimating water solubility is described in,
``Improved Method for Estimating Water Solubility from Octanol/Water
Partition Coefficient'' (Ref. 29). EPA is also requiring that test
sponsors submit in the final study report the underlying rationale for
the test standard selected for this endpoint. EPA also highly
recommends that all required water solubility tests be conducted
starting at pH 7 to ensure environmental relevance. Table 3 of this
unit shows the estimated water solubility ranges that EPA is requiring
for use in this final rule to select the appropriate test standard.
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 would be
any, to test for determined by the
water solubility test substance's
would be selected estimated water
from those listed solubility. Test
in this column--see sponsors must
Special Conditions provide in the
in the adjacent final study report
column.. the underlying
Method A: ASTM E rationale for the
1148-02 (Reapproved method and pH
2008) (shake flask). selected. In order
Method B: 40 CFR to ensure
799.6784 (shake environmental
flask). relevance, EPA
Method C: 40 CFR highly recommends
799.6784 (column that the selected
elution). study be conducted
Method D: 40 CFR starting at pH 7.
799.6786 (generator > 5,000 mg/L: Method
column).. 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.
------------------------------------------------------------------------
Note: ASTM--ASTM International, mg/L--milligram/liter.
2. Environmental Fate and Pathways--a. Ready Biodegradation: Method
A: ASTM E 1720-01 (Reapproved 2008) (sealed vessel CO2
production test) (Ref. 30).
b. Method B: International Organization for Standardization (ISO)
[[Page 65393]]
14593:1999(E) (CO2 headspace test) (Ref. 31).
c. Method C: ISO 7827:1994(E) (method by analysis of dissolved
organic carbon (DOC)) (Ref. 32).
d. Method D: ISO 9408:1999(E) (determination of oxygen demand in a
closed respirometer) (Ref. 33).
e. Method E: ISO 9439:1999(E) (carbon dioxide evolution test) (Ref.
34).
f. Method F: ISO 10707:1994(E) (closed bottle test) (Ref. 35).
g. Method G: ISO 10708:1997(E) (two-phase closed bottle test) (Ref.
36).
ASTM has updated its test method for Determining Ready, Ultimate,
Biodegradability of Organic Chemicals in a Sealed Vessel CO2
Production Test (ASTM E 1720-01). The test method was reapproved in
2008. There were minor changes, including the deletion of mention of
specific apparatus brands in the ``Apparatus'' section; however the
test method itself is unchanged. When required, the reapproved method
(ASTM E 1720-01 (Reapproved 2008)) is listed as the required test
method for the ``Ready Biodegradation'' endpoint in this final rule
(Ref. 30).
For the ``Ready Biodegradation'' endpoint, EPA is requiring that
the appropriate selection be made from among seven alternative methods
for measuring the test substance's ready biodegradability. For most
test substances, EPA considers Method A (ASTM E 1720-01 (Reapproved
2008)) and Method B (ISO 14593:1999(E)) to be generally applicable,
cost effective, and widely accepted internationally. However, the test
method used will depend on the physical and chemical properties of the
test substance, including its water solubility. An additional document,
ISO 10634:1995(E) (Ref. 37), provides guidance for selection of the
appropriate test method for a given test substance considering the test
substance's physical and chemical properties. EPA is also requiring
that test sponsors submit in the final study report the underlying
rationale for the test standard selected for this endpoint.
3. Aquatic Toxicity--a. Test Group 1:
i. Acute toxicity to fish (ASTM E 729-96 (Reapproved 2007)) (Ref.
38).
ii. Acute toxicity to Daphnia (ASTM E 729-96 (Reapproved 2007))
(Ref. 38).
iii. Toxicity to plants (algae) (ASTM E 1218-04 e\1\) (Ref. 39).
b. Test Group 2:
i. Chronic toxicity to Daphnia (ASTM E 1193-97 (Reapproved 2004))
(Ref. 40).
ii. Toxicity to plants (algae) (ASTM E 1218-04 e\1\) (Ref. 39).
ASTM has updated ASTM E 729-96 (Reapproved 2002), its test method
for Conducting Acute Toxicity Tests on Test Materials with Fishes,
Macroinvertebrates, and Amphibians. ASTM reapproved this test method in
2007. There were minor changes (for example, reference to the ASTM Web
site in place of the ``Annual Book of ASTM Standards,'' minor changes
in references and dates, titles of ASTM documents changed to correspond
to new titles, etc.) but the test method itself is unchanged. The
updated method (ASTM E 729-96 (Reapproved 2007)) is listed as the
required test method for the ``Aquatic Toxicity'' endpoints in this
final rule (Ref. 38).
For the ``Aquatic Toxicity'' endpoint, the OECD HPV SIDS Program
recognizes that, for certain chemical substances, acute toxicity
studies are of limited value in assessing the chemical 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 chemical 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 requiring 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 V.A.1., in the
discussion of ``n-Octanol/Water Coefficient,'' and in Table 3 in Sec.
799.5089(j) of the 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 regulatory text) are required: Acute toxicity to
fish (ASTM E 729-96 (Reapproved 2007)), Acute toxicity to Daphnia (ASTM
E 729-96 (Reapproved 2007)), and Toxicity to plants (algae) (ASTM E
1218-04 e\1\).
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
regulatory text) are required: Chronic toxicity to Daphnia (ASTM E
1193-97 (Reapproved 2004)) and/or Toxicity to plants (algae) (ASTM E
1218-04 e\1\). As outlined in Table 3 in Sec. 799.5089(j) of the
regulatory text, depending on the testing required 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.
For the purposes of this final rule, EPA's use of a log
Kow equal to or greater than 4.2 is consistent with the
approach taken in the Agency's final policy statement under TSCA
section 5, ``Category for Persistent, Bioaccumulative, and Toxic New
Chemical Substances'' (Ref. 41). Using SAR, a log Kow of 4.2
corresponds with a fish bioconcentration factor (BCF) of about 1,000
(Refs. 29, 42, and 43). A chemical substance with a fish BCF value of
1,000 or more is characterized as having a tendency to accumulate in
living organisms relative to the concentration of the chemical
substance in the surrounding environment (Ref. 43). EPA has also used a
measured BCF that is equal to or greater than 1,000 or, in the absence
of bioconcentration data, a log P [same as log Kow] value
equal to or greater than 4.3 to help define the potential of a new
chemical substance to cause significant adverse environmental effects
(Ref. 44). EPA considers the difference between the log Kow
of 4.3 cited in the 1989 Federal Register document (Ref. 46) and the
log Kow value of 4.2 cited in this final 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 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 this final rule as described in 40 CFR 790.55. Based upon
the supporting rationale provided by the test sponsor, EPA may allow an
alternative threshold or method to be used for determining whether
acute or chronic aquatic toxicity testing must be performed for a
specific substance.
4. Mammalian Toxicity--Acute--a. Acute Inhalation Toxicity (rat):
Method A (40 CFR 799.9130).
b. Acute Oral Toxicity (rat): Method B (ASTM E 1163-98 (Reapproved
2002) (Ref. 45) or 40 CFR 799.9110(d)(1)(i)(A)).
For the ``Mammalian Toxicity--Acute'' endpoint, EPA is requiring
that certain ``special conditions,'' such as the chemical substance's
physical/chemical properties or physical state, be considered in
determining the appropriate test method from among
[[Page 65394]]
those included for this endpoint in Table 3 in Sec. 799.5089(j) of the
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
HPV Challenge Program, EPA is requiring 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
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 chemical substances (i.e., those that are
either liquids or solids at room temperature), EPA is requiring that
acute toxicity testing be conducted via oral administration using an
``Up/Down'' test method (described as Method B (ASTM E 1163-98
(Reapproved 2002) or 40 CFR 799.9110(d)(1)(i)(A)) in Table 3 in Sec.
799.5089(j) of the regulatory text). Consistent with the HPV Challenge
Program, EPA is allowing the use of the Neutral Red Uptake (NRU) basal
cytotoxicity assay to select the starting dose for the acute oral
toxicity test. This test is included as a special condition in Table 3
in Sec. 799.5089(j) of the regulatory text. The National Institutes of
Environmental Health Sciences (NIEHS) provides guidance on how to use
the NRU assay to estimate a starting dose for an acute oral toxicity
test (Ref. 46). Recent versions of the standardized protocols for the
NRU assay are available at the NIEHS/Interagency Coordination Committee
on the Validation of Alternative Methods Web site (Refs. 47-49).
5. Mammalian Toxicity--Genotoxicity--a. Gene Mutations: Bacterial
Reverse Mutation Test (in vitro): 40 CFR 799.9510.
b. 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 required to conduct testing for chromosomal damage are
encouraged to use in vitro genetic toxicity testing (i.e., the
Mammalian Chromosome Aberration Test) to generate the needed genetic
toxicity screening data, unless known chemical properties preclude its
use. These could include, for example, physical chemical properties or
chemical class characteristics. A test sponsor 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 in the final study report a
rationale for conducting that alternate test.
6. Mammalian Toxicity--Repeated Dose/Reproduction/Developmental--a.
Combined Repeated Dose Toxicity Study with the Reproduction/
Developmental Toxicity Screening Test: 40 CFR 799.9365.
b. Reproduction/Developmental Toxicity Screening Test: 40 CFR
799.9355.
c. Repeated Dose 28-Day Oral Toxicity Study: 40 CFR 799.9305.
For the ``Mammalian Toxicity--Repeated Dose/Reproduction/
Developmental'' endpoint, EPA recommends the use of the Combined
Repeated Dose Toxicity Study with the Reproduction/Developmental
Toxicity Screening Test (40 CFR 799.9365) as the test of choice. EPA
recognizes, however, that there may be reasons to test a particular
chemical substance using both the Reproduction/Developmental Toxicity
Screening Test (40 CFR 799.9355) and the Repeated Dose 28-Day Oral
Toxicity Study (40 CFR 799.9305) instead of the Combined Repeated Dose
Toxicity Study with the Reproduction/Developmental Toxicity Screening
Test (40 CFR 799.9365). With regard to such cases, EPA is requiring
that a test sponsor 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 submit to EPA in the
final study report a rationale for conducting these alternate tests.
In the proposed rule (Ref. 2) to this final rule, EPA stated that
certain of the chemical substances for which mammalian toxicity--
repeated dose/reproduction/developmental toxicity testing is required
may be used solely as ``closed system intermediates'' (e.g., stored in
controlled on-site facilities; or with controlled transport, i.e., to a
limited number of locations within the same company or second parties
which use the chemical in a controlled way as an intermediate with a
well-known technology). A chemical substance that is intended to
undergo a further deliberate reaction to produce another industrial
substance is considered an intermediate. Intermediates which are
contained in closed systems and therefore have a limited potential for
exposure may be eligible for a reduced testing battery. In these
situations, such chemical substances may be eligible for a reduced
testing battery that substitutes a developmental toxicity study for the
SIDS requirement to address repeated dose, reproduction, and
developmental toxicity. EPA requested that commenters who believe their
chemical substance is used solely as a closed system intermediate
submit appropriate information along with their comments which
substantiate this belief, but EPA did not receive any comments from
potential test sponsors that their chemical substance was a closed
system intermediate.
B. When will the testing imposed by this final rule begin?
This final rule is effective 30 days after its publication in the
Federal Register. Once it is effective, the required testing must be
initiated in time to allow the required final report to be submitted
within 13 months of the effective date of this final rule (see Sec.
799.5089(i) of the regulatory text).
C. How must the studies required under this final rule be conducted?
Persons required to comply with this final rule must conduct the
necessary testing in accordance with the testing requirements listed in
Tables 2 and 3 in Sec. 799.5089(j) of the regulatory text, the
reporting requirements described in Sec. 799.5089(i) of the regulatory
text, and with Good Laboratory Practice Standards (GLPS) at 40 CFR part
792.
D. What form of test substances will be tested under this final rule?
EPA is specifying two distinct approaches for identifying the
specific chemical substances that would be tested under this final
rule, the application of which would depend on whether the chemical
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, a
Class 2 chemical substance has a composition that cannot be represented
by a specific, complete chemical structure diagram, because such a
chemical substance generally contains two or more different chemical
species (not including impurities). A ``Class 2'' designation most
frequently represents a group of chemical
[[Page 65395]]
substances that have similar combinations of different chemical species
and/or that were prepared from similar feedstocks using similar
production methods. By contrast, Class 1 chemical substances generally
represent a much narrower group of chemical substances for which the
only variables are their impurities. Table 2 in Sec. 799.5089(j) of
the regulatory text identifies the listed chemical substances as either
Class 1 or Class 2 chemical substances.
The ``Class 1'' chemical substances listed in Table 2 in Sec.
799.5089(j) of the regulatory text (i.e., 11 of the 15 HPV chemical
substances included in this final rule) must be tested at a purity of
at least 99%. In instances in which the test sponsor(s) believes that a
99% level of purity is unattainable for a given chemical substance, the
sponsor may request a modification under the procedures described in 40
CFR 790.55.
For the ``Class 2'' chemical substances listed in Table 2 in Sec.
799.5089(j) of the regulatory text (i.e., 4 of the 15 HPV chemical
substances included in this final rule), EPA is requiring that the
chemical substance tested be any representative form of the chemical
substance.
In requiring a different approach for identifying the chemical
substance to be tested with regard to Class 2 chemical substances, EPA
recognizes two characteristics which further distinguish Class 1 from
Class 2 chemical substances. First, unlike Class 1 chemical substances,
knowledge of the composition of commercial Class 2 chemical substances
can vary in quality and specificity from substance to substance.
The composition of the chemical species which comprise a Class 2
chemical substance may be:
Well-characterized in terms of molecular formulae,
structural diagrams, and compositional percentages of all species
present (for example, methyl phenol);
Less well-characterized, for example, characterized only
by molecular formulae, non-specific structural diagrams, and/or by
incomplete or unknown compositional percentages of the species present
(for example, C12-C14 tert-alkyl amines); or
Poorly characterized because all that is known is the
identity of only some of the chemical species present and their
percentages of composition, or of only the feedstocks and method of
manufacture used to manufacture the substance (for example, nut shell
liquor of cashew).
Secondly, the composition of some Class 2 chemical substances may
vary from one manufacturer to another, or, for a single manufacturer,
from production run to production run, because of small variations in
feedstocks, manufacturing methods, or other production variables.
EPA believes that, for purposes of this final rule, the testing of
any representative form of a subject Class 2 chemical substance would
provide the data necessary to support the development of preliminary or
screening level hazard and risk characterizations for the subject Class
2 chemical substance. However, EPA encourages the selection of
representative forms of test substances that meet industry or consensus
standards, where they exist. In accordance with TSCA GLPS at 40 CFR
part 792, the final study report would be required to include test
substance identification information, including name, CASRN, strength,
purity, and composition, or other appropriate characteristics (see 40
CFR 792.185).
E. Am I required to test under this final rule?
1. Am I subject to this final rule? You are subject to this final
rule and may be required to test if you manufacture (including import)
or process, or intend to manufacture or process, one or more chemical
substances listed in this final rule during the time period described
in Unit V.E.2. However, if you do not know or cannot reasonably
ascertain that you manufacture or process a chemical substance listed
in this final rule (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 final
rule for that listed chemical substance (See Sec. 799.5089(b)(2) of
the regulatory text).
2. When will my manufacture or processing (or my intent to do so)
cause me to be subject to this final rule? You are subject to this
final rule if you manufacture or process, or intend to manufacture or
process, a chemical substance listed in Table 2 in Sec. 799.5089(j) of
the regulatory text at any time from the effective date of this final
rule to the end of the test cost reimbursement period.
3. Will I be required to test if I am subject to this final rule?
It depends on the nature of your activities. All persons who are
subject to this final 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), fall
into one of two groups, designated here as Tier 1 and Tier 2.
Persons in Tier 1 must initially comply with this final rule. To
comply, they must 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.
See 40 CFR 790.5 (``Submission of information'') and 40 CFR 790.45
(``Submission of letter-of-intent-to-conduct-testing or exemption
application'') for details. (Note: In addition to the identifying
information specified in Sec. 790.5, EPA also requests that the docket
ID number EPA-HQ-OPPT-2009-0112 be included on the submission). For all
submissions under this part, six copies must be provided to EPA. All
submissions for this final rule, except those containing CBI, will be
entered into the docket under ``Supporting and Related Material.''
Addresses of the OPPT Document Control Office, where this information
should be sent, are found in this final rule under ``Submission of
Information.''
Persons in Tier 2:
Do not have to initially comply with this final rule.
Are not required to take any action unless EPA notifies
them to the contrary (because, for example, no person in Tier 1 had
submitted a letter-of-intent-to-conduct-testing), as described in Unit
V.E.3.f.
a. Who is in Tier 1 and Tier 2? Table 4 of this unit describes who
is in Tier 1 and Tier 2.
[[Page 65396]]
Table 4--Persons Subject to This Final Rule: 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 kgs (1,100 lb) annually
(as described at 40 CFR
790.42(a)(4)); or
--In small quantities solely
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 test
rule substance (see 40 CFR
790.42(a)(2)).
------------------------------------------------------------------------
Note: kgs--kilograms, TSCA--Toxic Substances Control Act.
Under 40 CFR 790.2, EPA may establish procedures for 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 final rule,
EPA has established certain requirements that differ from those under
40 CFR part 790.
In this final rule, EPA has reconfigured the tiers in 40 CFR
790.42. The Agency took administrative burden and complexity into
account in determining who was to be in Tier 1 in this final rule.
Tier 1 includes: 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.
Tier 2 includes:
Processors, manufacturers of less than 500 kilograms (kgs)
(1,100 lb) per year (small-volume manufacturers).
Manufacturers of small quantities for research and
development (R&D).
Byproduct manufacturers.
Impurity manufacturers.
Manufacturers of naturally occurring substances.
Manufacturers of non-isolated intermediates.
Manufacturers of components of Class 2 chemical
substances.
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 participated in testing or contributed
to reimbursement of those persons who have conducted testing. 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.
EPA understands that for some manufacturers the marginal
transaction costs involved in negotiating and administering testing
arrangements may 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 included in 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 V.E.4.
b. Subdivision of Tier 2 entities. In this final rule the Agency
has further subdivided which persons in Tier 2 would be required to
perform testing, if needed.
i. Tier 2A. Tier 2 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
substance, a non-isolated intermediate, a component of a Class 2
chemical substance, in amounts less than 1,100 lb annually, or in small
quantities solely for R&D.
ii. Tier 2B. Tier 2 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 section 3(10) and
TSCA section 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 persons in Tier
2B. It is appropriate to call upon manufacturers before processors
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. 50). In addition, ``[t]here are [typically] so
many processors [of a given test rule chemical substance] 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. 51).
c. When is it appropriate for a person required to comply with this
final 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)).
Procedures relating to exemptions are in 40 CFR 790.80 through 790.99,
and Sec. 799.5089(c)(2), (c)(5), (c)(7), and (c)(11) of the regulatory
text. In this final rule, EPA will not require the submission of
equivalence data (i.e., data demonstrating that the 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 790.85 do not apply to this final rule.
d. What will happen if I submit an exemption application? EPA
believes that requiring the collection of duplicative data is
unnecessarily burdensome. As a result, if EPA has
[[Page 65397]]
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
final 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
regulatory text for details on submitting this notice. In addition, the
Agency will terminate a conditional exemption if no letter-of-intent-
to-test has been received from persons required to comply with this
final rule. See, e.g., Sec. 799.5089(c)(6) of the regulatory text.
Note that persons who obtain exemptions or receive them automatically
would nonetheless be subject to providing reimbursement to persons who
do actually conduct the testing, as described in Unit V.E.4.
e. What are my obligations if I am in Tier 2? If you are in Tier 2,
you are subject to this final rule and you are responsible for
providing reimbursement to persons in Tier 1, as described in Unit
V.E.4. You are considered to have an automatic conditional exemption.
You do 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.
The Agency may require you to submit a notice-of-intent-to-test or
an exemption application if no manufacturer in Tier 1 has notified EPA
of its intent to conduct testing and EPA has published a Federal
Register document directing persons in Tier 2 to make the required
submissions (see Sec. 799.5089(c)(4), (c)(5), (c)(6), and (c)(7) of
the regulatory text), or if a problem occurs with the initiation,
conduct, or completion of the required testing, or with the submission
of the required data to EPA (see 40 CFR 790.93 and Sec.
799.5089(c)(10) of the regulatory text).
f. What will happen if no one submits a letter-of-intent-to-
conduct-testing? If no one in Tier 1 submits a letter-of-intent-to-test
within 30 days of the effective date of this final rule, EPA will
notify in a separate Federal Register document persons in Tier 2A
first, and then persons in Tier 2B of their obligation to submit a
letter-of-intent-to-test, or an exemption application (see Sec.
799.5089(c)(4) and (6) of the regulatory text). Persons in Tier 2A will
have 30 days from the date the document published in the Federal
Register to submit the required notice or exemption application. If no
one in Tier 2A makes the required notification, EPA will follow the
same procedure to notify persons in Tier 2B.
In the event that EPA does not receive a letter-of-intent for one
or more of the tests required for any of the chemical substances in
this final rule within 30 days after the publication of a Federal
Register document notifying persons in Tier 2B of the obligation to
submit a letter-of-intent-to-conduct-testing or to apply for an
exemption from testing, EPA will 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 will additionally notify all manufacturers and
processors that all exemption applications concerning the test(s) have
been denied, and will 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 this final rule
with respect to that chemical substance who are not already in
violation of this final rule would be in violation of this final rule
and would be subject to potential enforcement actions by EPA.
4. What are the reimbursement procedures? In the past, persons
subject to test rules have independently worked out among themselves
their respective financial contributions to those persons who have
actually conducted the testing. However, if persons are unable to agree
privately on reimbursement, they may take advantage of EPA's
reimbursement procedures at 40 CFR part 791, promulgated under the
authority of TSCA section 4(c). These procedures include: The
opportunity for a hearing with the American Arbitration Association;
publication by EPA of a document in the Federal Register concerning the
request for a hearing; and the appointment of a hearing officer to
propose an order for fair and equitable reimbursement. The hearing
officer may base his or her proposed order on the production volume
formula set out at 40 CFR 791.48, but is not obligated to do so. Under
this final 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 are the reporting requirements under this final rule?
Study plans must be submitted for each test for each chemical
substance 90 days after the effective date of this final rule, unless
an extension is granted in writing pursuant to 40 CFR 790.55. See 40
CFR 790.50 (submission of study plans) for what information the study
plan must contain. A final report must be submitted for each test for
each chemical substance 13 months after the effective date of this
final rule; i.e., by the deadline indicated in Sec. 799.5089(i) of the
regulatory text. Addresses of the OPPT Document Control Office, where
this information should be sent, are found in this final rule under
``Submission of Information.''
EPA also requests that a robust summary of the final report for
each specific test be submitted in addition to and at the same time as
the final report. The term ``robust summary'' is used to describe the
technical information necessary to adequately describe an experiment or
study and includes the objectives, methods, results, and conclusions of
the full study report which can be either an experiment or in some
cases an estimation or prediction method. Guidance for the compilation
of robust summaries is described in a document entitled ``Draft
Guidance on Developing Robust Summaries'' (Ref. 19). Persons who submit
a robust summary are also encouraged to submit it electronically via
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.''
G. What would I need to do if I cannot complete the testing required by
this final rule?
A company that submits a letter-of-intent-to-test under this final
rule and that 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. Will there be sufficient test facilities and personnel to undertake
the testing required under this final rule?
EPA's most recent analysis of laboratory capacity (Ref. 52)
indicates
[[Page 65398]]
that available test facilities and personnel would adequately
accommodate the testing specified in this final rule.
I. Might EPA seek further testing of the chemical substances in this
final rule?
If EPA determines that it needs additional data regarding any of
the chemical substances included in this final 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 that
purpose.
VI. Export Notification
Any person who exports, or intends to export, one of the chemical
substances contained in this final rule in any form (e.g., as
byproducts, impurities, components of Class 2 chemical substances,
etc.) is subject to the export notification requirements in TSCA
section 12(b)(1) and 40 CFR part 707, subpart D. 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.
VII. Decision Not To Require Testing for Certain Chemical Substances
A. TSCA Section 4(a)(1)(B)(i) Finding Not Made
Based on comments received on the proposed rule and findings, the
information before EPA at this point does not provide a basis to make
the findings of substantial production, release to the environment in
substantial quantities, and/or substantial human exposure for 12 of the
chemical substances included in the proposed rule. Comments indicated
that 11 of the chemical substances were not or are no longer produced
or imported in amounts equal to or greater than 1 million lb per year.
Comments also indicated that the proposed finding of ``enters or can be
reasonably anticipated to enter the environment in substantial
quantities'' cannot be made for an additional chemical substance.
Because the data provided show manufacture, human exposure, and/or
environmental release are below the B Policy thresholds (discussed in
Unit IV.A.) under TSCA section 4(a)(1)(B)(i), and because EPA has not
identified any additional factors as discussed in the B Policy (Ref. 7)
to cause the Agency to use decisionmaking criteria other than the
general thresholds described in the B Policy for these chemical
substances, EPA is not including these chemical substances in this
final rule. In the event new Chemical Data Reporting (CDR) data or
other data provide new or additional support for the TSCA section
4(a)(1)(B)(i) finding for any of these chemical substances, EPA will
take appropriate steps to proceed with a test rule for the chemical
substance(s).
Based on public comment, EPA no longer has the basis to find that
six chemical substances are produced or imported in amounts equal to or
greater than 1 million pounds per year. Therefore, these six chemical
substances are no longer included in this final rule: Benzene, 1,2-
dimethyl-3-nitro- (CASRN 83-41-0); 1-tetracosanol (CASRN 506-51-4); 1-
hexacosanol (CASRN 506-52-5); 2-propenoic acid, 2-carboxyethyl ester
(CASRN 24615-84-7); methanesulfonamide, N-[2-[(4-amino-3-
methylphenyl)ethylamino]ethyl]-, sulfate (2:3) (CASRN 25646-71-3); and
tar, coal, high-temp. (CASRN 65996-89-6).
Based on public comment, EPA no longer has the basis to find for an
additional six chemical substances that they have substantial human
exposure or substantial environmental release and so are also not
included in this final rule. These chemical substances are: Solvent
naphtha (coal) (CASRN 65996-79-4); tar oils, coal (CASRN 65996-82-9);
distillates (coal tar) (CASRN 65996-92-1); pitch, coal tar-petroleum
(CASRN 68187-57-5); 1,4-benzenedicarboxylic acid, 1,4-dimethyl ester,
manuf. of, by-products from (CARN 68988-22-7); and extract residues
(coal), tar oil alk., naphthalene distn. residues (CASRN 73665-18-6).
B. TSCA Section 4(a)(1)(B)(ii) Finding Not Made
For certain testing endpoints for certain chemical substances
listed in the proposed rule, EPA is not making the TSCA section
4(a)(1)(B)(ii) finding 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 * *
*'' and is not finalizing the proposed testing. Table 2 in Sec.
799.5089(j) of the regulatory text, which lists the chemical substances
and testing requirements, has been revised to reflect this. For one
chemical substance no testing is required; for two others, a more
limited set of testing is being required than was originally proposed.
Further discussion follows in Units VII.B.1.-3.
1. Mutagenicity endpoints and screening reproduction/developmental
toxicity of 3-pentanone (CASRN 96-22-0). As discussed in Unit E.2. of
the ``Response to Public Comments'' document (Ref. 13), EPA reviewed
additional data, including studies submitted by PETA (PETA submitted
these data on behalf of themselves and other Animal Welfare
Organizations (AWOs)) for 3-pentanone (CASRN 96-22-0). After reviewing
these data, EPA finds existing studies are adequate to evaluate
mutagenicity and reproduction/developmental toxicity and is not
finalizing the proposed testing for mutagenicity and reproduction/
developmental toxicity. Therefore, 3-pentanone is not included in this
final rule.
2. Log Kow, ready biodegradation, aquatic toxicity, and
screening reproduction/developmental toxicity of benzene, 1-chloro-4-
(trifluoromethyl)- (CASRN 98-56-6). As discussed in Unit E.3. of the
``Response to Public Comments'' document (Ref. 13), EPA reviewed
additional data, including studies submitted by the Greenwich Chemical
Consulting, Inc. (GCC) for benzene, 1-chloro-4-(trifluoromethyl)-.
After reviewing these data, EPA finds existing studies are adequate to
evaluate log Kow and screening reproduction/developmental
toxicity and is not finalizing the proposed testing for these
endpoints. In addition, EPA has reviewed the biodegradation studies and
aquatic toxicity studies. EPA considers the biodegradation studies to
be inadequate, so that test is required. While EPA considers the acute
fish and invertebrate testing to no longer be necessary, EPA is still
requiring an algal toxicity study.
3. Physical/chemical properties, ready biodegradation, aquatic
toxicity, acute mammalian toxicity, combined repeated-dose/screening
reproduction/developmental toxicity, and mutagenicity endpoints of
benzenesulfonic acid, dimethyl (CASRN 25321-41-9). As discussed in Unit
E.7. of the ``Response to Public Comments'' document (Ref. 13), EPA
reviewed additional data, including studies submitted by Nease
Corporation providing data for several analogue chemical substances for
benzenesulfonic acid, dimethyl. EPA finds these data acceptable to
fulfill all of the proposed testing endpoints with
[[Page 65399]]
the exception of these three physical/chemical (p-chem) properties:
Boiling point, vapor pressure and log Kow.
VIII. Decision to Defer Final Action for Chloroalkanes
EPA is deferring final action for chlorinated paraffins: Alkanes,
chloro (CASRN 61788-76-9). In addition to the proposed test rule (Ref.
2), EPA published an Action Plan for Short-Chain Chlorinated Paraffins
(SCCPs) and Other Chlorinated Paraffins (Ref. 53). There is currently
an unresolved issue regarding whether all the production previously
reported to the Agency under CASRN 61788-76-9 should in fact be covered
by that listing. Pending resolution of this issue, EPA will defer
making a final decision regarding test rule requirements for CASRN
61788-76-9, and will reevaluate the testing needs for CASRN 61788-76-9
based on future CDR reports.
IX. Economic Impacts
EPA has prepared an economic assessment entitled ``Economic Impact
Analysis for the Final Section 4 Test Rule for High Production Volume
Chemicals; Third Group of Chemicals'' (Ref. 53), a copy of which has
been placed in the docket for this final rule. This economic assessment
evaluates the potential for significant economic impacts as a result of
the testing required by this final rule. The analysis covers 15 HPV
chemical substances. The total cost of providing test data on the 15
HPV chemical substances that were evaluated in this economic analysis
is estimated to be $5.13 million (Ref. 54).
While legally subject to this final rule, processors of a subject
chemical substance would be required to comply with the requirements of
this 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 regulatory text. EPA would
only require processors to test if no person in Tier 1 has submitted a
notice of its intent to conduct testing, or if, under 40 CFR 790.93, a
problem occurs with the initiation, conduct, or completion of the
required testing or the submission of the required data to EPA. Because
EPA has identified at least one manufacturer in Tier 1 for each subject
chemical substance, the Agency assumes that, for each chemical
substance in this final 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 EPA
does not expect that processors will need to comply with this final
rule, 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 final rule, EPA
employed a screening approach that estimated the impact of testing
requirements as a percentage of each chemical substance's sale price.
This measure compares annual revenues from the sale of a chemical
substance to the annualized compliance cost for that chemical 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. Annualized compliance costs
divide testing expenditures into an equivalent, constant yearly
expenditure over a longer period of time. To calculate the percent
price impact, testing costs (including laboratory and administrative
expenditures) are annualized over 15 years using a 7% discount rate.
Annualized testing costs are then divided by the estimated annual
revenue of the chemical substance to derive the cost-to-sales ratio.
EPA estimates the total annualized compliance cost of testing for
the 15 HPV chemical substances evaluated in the economic analysis to be
$0.56 million under the average cost scenario. In addition, the TSCA
section 12(b) export notification requirements (included in the total
and annualized cost estimates) that would be triggered by this final
rule are expected to have a negligible impact on exporters. The
estimated cost of the TSCA section 12(b) export notification
requirements, which, under this final rule, would be required for the
first export to a particular country of a chemical substance subject to
this final rule, is estimated to range from $27.49 per notice to $86.99
per notice (Ref. 54). The Agency's estimated total costs of testing
(including both laboratory and administrative costs), annualized
testing cost, and public reporting burden hours for this final rule are
presented in the economic assessment.
Under a least cost scenario, 7 out of the 15 HPV chemical
substances (47%) would have a price impact at less than the 1% level.
Similarly, 5 out of the 15 HPV chemical substances (33%) would be
impacted at less than the 1% level under an average cost scenario.
Thus, the potential for adverse economic impact due to this final rule
is low for at least 33% of the chemical substances in this final rule.
Approximately 10 chemical substances (67%) of the 15 HPV chemical
substances for which price data are available would have a price impact
at a level greater than or equal to 1% under the average cost scenario.
EPA believes that the testing of the chemical substances in this
final rule presents a low potential for adverse economic impact for a
reasonable number of the chemical substances. Because the subject
chemical substances have relatively large production volumes, the
annualized costs of testing, expressed as a percentage of annual
revenue, are very small for nearly half of the 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. In these cases, companies may choose to use
revenue sources other than the profits from the individual chemical
substances to pay for testing. Smaller businesses are less likely to
have additional revenue sources to cover the compliance costs in this
situation. Therefore, the Agency also compared the costs of compliance
to company sales for small businesses. In that analysis, EPA found that
the costs of testing requirements in this final rule for chemical
substances produced by a specific company exceed 1% of company revenues
for only one of the affected companies.
EPA does not provide quantitative estimates of the benefits from
these tests. Ideally, a discussion of benefits would focus on the
additional benefits to be gained from new information relative to
information that already exists. Such an approach could examine the
value of new information provided as a result of this final rule where
such information has not been publicly available. Because of
constraints on information on the value of information, EPA's
evaluation of benefits is qualitative and does not address incremental
benefits. EPA believes, however, that the net benefits of the new
information are positive.
X. Materials in the Docket
As indicated under ADDRESSES, a docket was established for this
final 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 final rule. The docket includes information considered by EPA in
developing this final rule, including the documents listed in this
unit, which are physically located in the docket. In addition,
[[Page 65400]]
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, consult either of the technical persons 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; Third
Group of Chemicals. Proposed Rule. Federal Register (75 FR 8575,
February 25, 2010) (FRL-8805-8).
3. EPA. Testing of Certain High Production Volume Chemicals.
Proposed Rule. Federal Register (65 FR 81658, December 26, 2000)
(FRL-6758-4).
4. EPA. Testing of Certain High Production Volume Chemicals. Final
Rule. Federal Register (71 FR 13708, March 16, 2006) (FRL-7335-2).
5. 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).
6. EPA. Testing of Certain High Production Volume Chemicals; Second
Group of Chemicals. Final Rule. Federal Register (76 FR 1067,
January 7, 2011) (FRL-8846-9).
7. EPA. TSCA Section 4(a)(1)(B) Final Statement of Policy; Criteria
for Evaluating Substantial Production, Substantial Release,
Substantial or Significant Human Exposure. Notice. Federal Register
(58 FR 28736, May 14, 1993).
8. EPA, OPPT. HPV Challenge Program Chemical List. Available online
at: http:[sol][sol]www.epa./oppt/chemrtk/pubs/update/hpvchmlt.htm.
9. OECD Secretariat. OECD Programme on the Co-Operative
Investigation of High Production Volume Chemicals. Manual for the
Assessment of Chemicals. Paris, France. September 2004. Available
online at: http:[sol][sol]www.oecd.org/document/7/0,2340,en_2649_
34379_1947463_1_1_1_1,00.htm.
10. ICCA. ICCA HPV Working List of Chemicals. October 2005.
Available online at: http:[sol][sol]www.icca-chem.org/Home/ICCA-
initiatives/High-production-volume-chemicals-initiative-HPV.
11. EPA. TSCA Section 4(a)(1)(B) Proposed Statement of Policy.
Notice. Federal Register (56 FR 32294, July 15, 1991).
12. EPA, OPPT. Chemical Hazard Data Availability Study: What Do We
Really Know About the Safety of High Production Volume Chemicals?
April 1998. Available online at: http:[sol][sol]www.epa.gov/chemrtk/
pubs/general/hazchem.htm.
13. EPA, OPPT, Chemical Information and Testing Branch (CITB).
Response to public comments regarding testing of certain high
production volume chemicals. August 2010.
14. EPA, OPPT, Economics, Exposure and Technology Division (EETD).
Testing of Certain High Production Volume Chemicals-3 (Exposure
Findings Supporting Information). March 2011.
15. 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).
16. Department of Health and Human Services (DHHS), Centers for
Disease Control (CDC), NIOSH. National occupational exposure survey
field guidelines. Vol. I. Seta, J.A.; Sundin, D.S.; and Pedersen,
D.H., eds. Cincinnati, OH. DHHS (NIOSH) Publication No. 88-106.
1988. Available online at: http:[sol][sol]www.cdc.gov/niosh/88-
106.html.
17. DHHS, CDC, NIOSH. National occupational exposure survey analysis
of management interview responses. Vol. III. Pedersen, D.H. and
Sieber, W.K., eds. Cincinnati, OH. DHHS (NIOSH) Publication No. 89-
103. 1989. Available online at: http:[sol][sol]www.cdc.gov/niosh/89-
103.html.
18. DHHS, CDC, NIOSH. National occupational exposure survey sampling
methodology. Vol. II. Sieber, W.K., ed. Cincinnati, OH. DHHS (NIOSH)
Publication No. 89-102. 1989. Available online at:
http:[sol][sol]www.cdc.gov/niosh/89-102.html.
19. EPA, OPPT. Draft Guidance on Developing Robust Summaries.
October 22, 1999. Available online at: http:[sol][sol]www.epa.gov/
chemrtk/pubs/general/robsumgd.htm.
20. EPA, OPPT. High Production Volume Chemical Data Information
System (HPVIS). Data from HVPIS on eighteen HPV chemicals. May 2008.
21. ASTM International. Standard Test Method for Relative Initial
and Final Melting Points and the Melting Range of Organic Chemicals.
ASTM E 324-99. 1999.
22. OECD. Guideline for the Testing of Chemicals: Melting Point/
Melting Range. OECD 102. July 27, 1995.
23. ASTM International. Standard Test Method for Vapor Pressure of
Liquids by Ebulliometry. ASTM E 1719-05. 2005.
24. ASTM International. Standard Test Method for Determining Vapor
Pressure by Thermal Analysis. ASTM E 1782-08. 2008.
25. ASTM International. Standard Test Method for Partition
Coefficient (N-Octanol/Water) Estimation by Liquid Chromatography.
ASTM E 1147-92 (Reapproved 2005).
26. ASTM International. Standard Test Method for Measurements of
Aqueous Solubility. ASTM E 1148-02 (Reapproved 2008).
27. ASTM International. Question about ASTM E 324. E-mail from Diane
Rehiel, ASTM, to Greg Schweer, CITB, Chemical Control Division,
OPPT, EPA. September 15, 2004.
28. Meylan, W.M. and Howard, P.H. Atom/Fragment Contribution Method
for Estimating Octanol-Water Partition Coefficients. Journal of
Pharmaceutical Sciences. 84(1):83-92. 1995.
29. Meylan, W.M.; Howard, P.H.; and Boethling, R.S. Improved Method
for Estimating Water Solubility from Octanol/Water Partition
Coefficient. Environmental Toxicology and Chemistry. 15(2):100-106.
1996.
30. ASTM International. Standard Test Method for Determining Ready,
Ultimate, Biodegradability of Organic Chemicals in a Sealed Vessel
CO2 Production Test. ASTM E 1720-01 (Reapproved 2008).
31. International Organization for Standardization (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(E).
32. ISO. Water Quality--Evaluation in an Aqueous Medium of the
``Ultimate'' Aerobic Biodegradability of Organic Compounds--Method
by Analysis of Dissolved Organic Carbon (DOC). ISO 7827:1994(E).
33. ISO. Water Quality--Evaluation of Ultimate Aerobic
Biodegradability of Organic Compounds in Aqueous Medium by
Determination of Oxygen Demand in a Closed Respirometer. ISO
9408:1999(E).
34. ISO. Water Quality--Evaluation of Ultimate Aerobic
Biodegradability of Organic Compounds in Aqueous Medium--Carbon
Dioxide Evolution Test. ISO 9439:1999(E).
35. ISO. Water Quality--Evaluation in an Aqueous Medium of the
``Ultimate'' Aerobic Biodegradability of Organic Compounds--Method
by Analysis of Biochemical Oxygen Demand (Closed Bottle Test). ISO
10707:1994(E).
36. 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(E).
37. ISO. Water Quality--Guidance for the Preparation and Treatment
of Poorly Water-Soluble Organic Compounds for the Subsequent
Evaluation of Their Biodegradability in an Aqueous Medium. ISO
10634:1995(E).
38. ASTM International. Standard Guide for Conducting Acute Toxicity
Tests on Test Materials with Fishes, Macroinvertebrates, and
Amphibians. ASTM E 729-96 (Reapproved 2007).
39. ASTM International. Standard Guide for Conducting Static
Toxicity Tests with Microalgae. ASTM E 1218-04\e1\. 2004.
40. ASTM International. Standard Guide for Conducting Daphnia magna
Life-Cycle Toxicity Tests. ASTM E 1193-97 (Reapproved 2004).
[[Page 65401]]
41. EPA. Document containing EPA's Policy Statement under TSCA
section 5. Category for Persistent, Bioaccumulative, and Toxic New
Chemical Substances. Notice. Federal Register (64 FR 60194, November
4, 1999) (FRL-6097-7). Available online at: http://www.epa.gov/oppt/
newchems/pubs/pbtpolcy.htm.
42. Veith, G.D. and Kosian, P. Estimating bioconcentration potential
from octanol/water partition coefficients. Physical Behavior of
PCB's in the Great Lakes. (MacKay, Paterson, Eisenreich, and
Simmons, eds.). Ann Arbor Science, Ann Arbor, MI. 1982.
43. 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.
44. EPA. Significant New Use Rules; General Provisions for New
Chemical Followup. Final Rule. Federal Register (54 FR 31298, July
27, 1989).
45. ASTM International. Standard Test Method for estimating Acute
Oral Toxicity in Rats. ASTM E 1163-98 (Reapproved 2002).
46. 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 online at: http://iccvam.niehs.nih.gov/methods/acutetox/inv_cyto_guide.htm.
47. 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 online at: http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm.
48. 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 online at: http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm.
49. 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 online at: http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm.
50. EPA. Toxic Substances; Test Rule Development and Exemption
Procedures. Interim Final Rule. Federal Register (50 FR 20652,
20654, May 17, 1985).
51. EPA. Toxic Substances Control Act; Data Reimbursement. Final
Rule. Federal Register (48 FR 31786, July 11, 1983).
52. EPA, Economics and Policy Analysis Branch (EPAB). Analysis of
Laboratory Capacity to Support U.S. EPA Chemical Testing Program
Initiatives. Washington, DC. October 28, 2010.
53. EPA, OPPT. Short-Chain Chlorinated Paraffins (SCCPs) and Other
Chlorinated Paraffins. Action Plan. December 30, 2009. Available
online at: http://www.epa.gov/opptintr/existingchemicals/pubs/
actionplans/sccps_ap_2009_1230_final.pdf.
54. EPA, OPPT, EPAB. Economic Impact Analysis for the Final Section
4 Test Rule for High Production Volume Chemicals; Third Group of
Chemicals. April 14, 2011.
55. EPA, OPPT. The Use of Structure-Activity Relationships (SAR) in
the High Production Volume Chemicals Challenge Program. August 26,
1999. Available online at: http://www.epa.gov/chemrtk/pubs/general/
sarfinl1.htm.
56. EPA, OPPT, EETD, EPAB. Economic Analysis in Support of the TSCA
12(b) Information Collection Request. Washington, DC. October 30,
1998.
XI. 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 final rule is not a
``significant regulatory action'' subject to review by the Office of
Management and Budget (OMB) under Executive Order 12866, because it
does not raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
section 3(f)(4) of the Executive Order. Accordingly, EPA did not submit
this final rule to OMB for review under Executive Order 12866.
EPA has prepared an economic analysis of this action, which is
contained in a document entitled ``Economic Impact Analysis for the
Final Section 4 Test Rule for High Production Volume Chemicals; Third
Group of Chemicals'' (Ref. 54). A copy of the economic analysis is
available in the docket for this final rule and is summarized in Unit
IX.
B. Paperwork Reduction Act
This final 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. 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 approved EPA ICR No. 0795. The Agency's estimated burden
for this final rule is provided in the economic analysis (Ref. 54).
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 final rule does not
impose any new requirements 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, an
information collection request unless it displays a currently valid OMB
control number. The OMB control numbers for EPA's regulations are
listed in 40 CFR part 9 and included on the related collection
instrument. 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 final rule, EPA estimates the public
reporting burden for all 15 HPV chemical substances is 25,226 hours,
with an estimated burden per chemical substance of 1,682 hours (Ref.
54). The estimated burden of the information collection activities
related to export notification is estimated to average 1 burden hour
for each chemical substance/country combination for an initial
notification and 0.5 hours for each subsequent notification (Ref. 54).
In estimating the total burden hours approved for the information
collection activities related to export notification, the Agency has
included sufficient burden hours to accommodate any export
notifications that may be required by the Agency's issuance of final
test rules for chemical substances. 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
[[Page 65402]]
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.
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
on small entities, the Agency hereby certifies that this final rule
will not have a significant adverse economic impact on a substantial
number of small entities. The factual basis for this determination is
presented in the small entity impact analysis prepared as part of the
economic analysis for this final rule (Ref. 54), which is summarized in
Unit IX., and a copy of which is available in the docket for this final
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 final 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 final rule (Ref. 54), EPA has determined that this
final 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. 54) in order to characterize the potential small entity impacts
of this final 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 final 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 final 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 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
previously, therefore, the factual basis for the RFA determination for
this final 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 final
rule, the analysis for this final rule also presents the results of
calculations using a standard based on total annual sales (40 CFR
704.3).
The SBA has developed 6 digit NAICS code-specific size standards
based on employment thresholds. These size standards range from 500 to
1,500 employees for the various 6 digit NAICS codes that are
potentially impacted (Ref. 54). For a conservative estimate of the
number of small businesses affected by this final rule, the Agency
chose 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 15 HPV chemical substances covered by
this final rule, the parent company (ultimate corporate entity (UCE))
was identified and sales and employment data were obtained for
companies where data was publicly available. The search determined that
there were 31 affected UCEs. Sales and employment data could be found
for 30 of these UCEs (97%).
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), 13
companies (38%) were identified as small.
The potential significance of this final 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 13 small businesses included in the analysis, 1 company (8%)
had cost-to-sales ratios of greater than 1% under both the least and
average cost scenarios. For the single business where sales and
employment data were unavailable, EPA conducted an analysis to evaluate
the potential impact on this company using the median sales value sales
of all other small businesses equal to $24.3 million. The costs for the
company 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 final rule.
[[Page 65403]]
The estimated cost of the TSCA section 12(b)(1) export
notification, which, as a result of this final rule, would be required
for the first export to a particular country of a chemical substance
subject to this final rule, is estimated to be $86.99 for the first
time that an exporter must comply with TSCA section 12(b)(1) export
notification requirements, and $27.49 for each subsequent export
notification submitted by that exporter (Refs. 54-56). 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 this final rule, regardless of the size of the exporter.
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 final 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 final rule, which are summarized in
Unit IX., would be $5.08 million. The total annualized costs of this
final rule are estimated to be $1.81 million. 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 this final rule would apply directly
to State, local, or Tribal governments, EPA has determined that this
final rule would not significantly or uniquely affect small
governments. Accordingly, this final 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 final 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 final rule establishes 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 final 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 final 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 final rule does not have Tribal
implications because it will not have any effect 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 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 final rule.
G. Executive Order 13045
This final 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
final rule establishes testing and recordkeeping requirements that
apply to manufacturers (including importers) and processors of certain
chemical substances, and that will 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 final rule present potential risks, allowing the Agency and others
to take appropriate action to investigate and mitigate those risks.
H. Executive Order 13211
This final 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 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 final rule involves technical standards that require the use
of particular test methods. When 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 is required by this final rule, EPA is
requiring the use of voluntary consensus standards issued by ASTM and
ISO, and a OECD guideline, which evaluate the same type of toxicity as
the TSCA and OECD test methods, where applicable. Copies of the 17 ASTM
and ISO standards and 1 OECD guideline, referenced in Sec. 799.5089(h)
of the regulatory text, have been placed in the docket for this final
rule and may also be obtained by contacting the organizations that
produced these materials. The addresses for these organizations are
listed in the regulatory text of Sec. 799.5089(h). EPA received the
required approval from the Director of the Federal Register for the
incorporation by reference of the ASTM and ISO standards and OECD
guideline used in this 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 TSCA test methods, 40 CFR
799.6756, 799.6784, 799.6786, 799.9130, 799.9510, 799.9538, 799.9365,
799.9305, and 799.9355.
[[Page 65404]]
J. Executive Order 12898
This final 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 final rule will assist EPA and
others in determining the potential hazards and risks associated with
the chemical substances covered by this final rule. Although not
directly impacting environmental justice-related concerns, this
information will better enable the Agency to better protect human
health and the environment, including in low-income and minority
communities.
XII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances,
Incorporation by reference, Laboratories, Reporting and recordkeeping
requirements.
Dated: October 13, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, 40 CFR chapter I is amended as follows:
PART 799--[AMENDED]
0
3. The authority citation for part 799 continues to read as follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
0
4. Add new Sec. 799.5089 to subpart D to read as follows:
Sec. 799.5089 Chemical testing requirements for third group of high
production volume chemicals (HPV3).
(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 November 21, 2011 to the end of the test data
reimbursement period as defined in 40 CFR 791.3(h), you are subject to
this section with respect to that chemical substance.
(2) If you do not know or cannot reasonably ascertain that you
manufacture or process a chemical substance listed in Table 2 in
paragraph (j) of this section during the time period described in
paragraph (b)(1) of this section (based on all information in your
possession or control, as well as all information that a reasonable
person similarly situated might be expected to possess, control, or
know, or could obtain without unreasonable burden), you are not subject
to this section with respect to that chemical substance.
(c) If I am subject to this section, when must I comply with it?
(1)(i) Persons subject to this section are divided into two groups, as
set forth in Table 1 of this paragraph: Tier 1 (persons initially
required to comply) and Tier 2 (persons not initially required to
comply). If you are subject to this section, you must determine if you
fall within Tier 1 or Tier 2, based on Table 1 of this paragraph.
Table 1--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
Persons initially required to Persons not initially required to
comply with this section (Tier 1) comply with this section (Tier 2)
------------------------------------------------------------------------
Persons not otherwise specified in A. Persons who manufacture (as
column 2 of this table that defined at TSCA section 3(7)) or
manufacture (as defined at TSCA intend to manufacture a chemical
section 3(7)) or intend to substance included in this section
manufacture a chemical substance solely as one or more of the
included in this section. 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 kg
(1,100 lb) 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)).
------------------------------------------------------------------------
Note: kgs--kilograms, TSCA--Toxic Substances Control Act.
(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 40 CFR
790.42(a)(2), (a)(4), and (a)(5), 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
[[Page 65405]]
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 December
20, 2011.
(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
on or before December 20, 2011, 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 November 21, 2011, or within
30 days after publication of the Federal Register document described in
paragraph (c)(4) of this section, you must, for each test specified for
that chemical substance in the document described in paragraph (c)(4)
of this section, either submit to EPA a letter-of-intent-to-test or
apply to EPA for an exemption from testing. The letter-of-intent-to-
test or the exemption application must be received by EPA no later than
30 days after publication of the document described in paragraph (c)(4)
of this section.
(6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its
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 November 21, 2011, or within 30
days after publication of the Federal Register document described in
paragraph (c)(6) of this section, you must, for each test specified for
that chemical substance in the document described in paragraph (c)(6)
of this section, either submit to EPA a letter-of-intent-to-test or
apply to EPA for an exemption from testing. The letter-of-intent-to-
test or the exemption application must be received by EPA no later than
30 days after publication of the document described in paragraph (c)(6)
of this section.
(8) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the chemical substances listed in Table 2 in paragraph (j) of this
section within 30 days after the publication of the Federal Register
document described in paragraph (c)(6) of this section, EPA will notify
all manufacturers and processors of those chemical substances of this
fact by certified letter or by publishing a Federal Register document
specifying the test(s) for which no letter-of-intent has been
submitted. This letter or Federal Register document will additionally
notify all manufacturers and processors that all exemption applications
concerning the test(s) have been denied, and will give the
manufacturers and processors of the chemical substance(s) an
opportunity to take corrective action.
(9) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the chemical substances listed in Table 2 in paragraph (j) of this
section within 30 days after receipt of the certified letter or
publication of the Federal Register document described in paragraph
(c)(8) of this section, all manufacturers and processors subject to
this section with respect to that chemical substance who are not
already in violation of this section will be in violation of this
section.
(10) If a problem occurs with the initiation, conduct, or
completion of the required testing or the submission of the required
data with respect to a chemical substance listed in Table 2 in
paragraph (j) of this section, under the procedures in 40 CFR 790.93
and 790.97, 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 to comply with this section? (1) To comply with
this section you must either submit to EPA a letter-of-intent-to-test,
or apply to and obtain from EPA an exemption from testing.
(2) For each test with respect to which you submit to EPA a letter-
of-intent-to- test, you must submit a study plan and 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 40 CFR part 790 (except for those requirements listed
in this paragraph as not applicable to this section), including the
submission of letters-of-intent-to-test or exemption applications,
submission of study plans, the conduct of testing, and the submission
of data; 40 CFR part 792--Good Laboratory Practice Standards; 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; paragraphs (a)(2) and (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
[[Page 65406]]
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 40 CFR part
707, subpart D.
(h) How must I conduct my testing? (1) 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. Included in Table 3 in paragraph (j) of this section are the
following 18 test methods which are incorporated by reference:
(i) Standard Test Method for Relative Initial and Final Melting
Points and the Melting Range of Organic Chemicals, ASTM E 324-99,
approved September 10, 1999.
(ii) Standard Test Method for Partition Coefficient (N-Octanol/
Water) Estimation by Liquid Chromatography, ASTM E 1147-92
(Reapproved 2005), approved August 1, 2005.
(iii) Standard Guide for Conducting Acute Toxicity Tests on Test
Materials with Fishes, Macroinvertebrates, and Amphibians, ASTM E
729-96 (Reapproved 2007), approved October 1, 2007.
(iv) Standard Test Method for Measurements of Aqueous
Solubility, ASTM E 1148-02 (Reapproved 2008), approved February 1,
2008.
(v) Standard Test Method for Estimating Acute Oral Toxicity in
Rats, ASTM E 1163-98 (Reapproved 2002), approved October 10, 2002.
(vi) Standard Guide for Conducting Daphnia magna Life-Cycle
Toxicity Tests, ASTM E 1193-97 (Reapproved 2004), approved April 1,
2004.
(vii) Standard Guide for Conducting Static Toxicity Tests with
Microalgae, ASTM E 1218-04\e1\, approved April 1, 2004.
(viii) Standard Test Method for Vapor Pressure of Liquids by
Ebulliometry, ASTM E 1719-05, approved March 1, 2005.
(ix) Standard Test Method for Determining Ready, Ultimate,
Biodegradability of Organic Chemicals in a Sealed Vessel
CO2 Production Test. ASTM E 1720-01 (Reapproved 2008),
approved February 1, 2008.
(x) Standard Test Method for Determining Vapor Pressure by
Thermal Analysis, ASTM E 1782-08, approved March 1, 2008.
(xi) 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). First Edition, March 15, 1999. ISO 14593:1999(E).
(xii) Water Quality--Evaluation in an Aqueous Medium of the
``Ultimate'' Aerobic Biodegradability of Organic Compounds--Method
by Analysis of Dissolved Organic Carbon (DOC). Second Edition,
September 15, 1994. ISO 7827:1994(E).
(xiii) Water Quality--Evaluation of Ultimate Aerobic
Biodegradability of Organic Compounds in Aqueous Medium by
Determination of Oxygen Demand in a Closed Respirometer. Second
Edition, August 1, 1999. ISO 9408:1999(E).
(xiv) Water Quality--Evaluation of Ultimate Aerobic
Biodegradability of Organic Compounds in Aqueous Medium--Carbon
Dioxide Evolution Test. Second Edition, March 1, 1999. ISO
9439:1999(E).
(xv) 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). First
Edition, October 15, 1994. ISO 10707:1994(E).
(xvi) 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. First Edition, February 1, 1997. ISO 10708:1997(E).
(xvii) 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. First
Edition, August 15, 1995. ISO 10634:1995(E).
(xviii) Guideline for the Testing of Chemicals: Melting Point/
Melting Range. OECD 102. July 27, 1995.
(2) The Director of the Federal Register approved this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies of the ASTM standards from ASTM
International, 100 Bar Harbor Dr., P.O. Box C700, West Conshohocken, PA
19428-2959, telephone number: (610) 832-9585, Web address: http://www.astm.org; copies of the ISO standards from the International
Organization for Standardization, 1, ch. de la Voie-Creuse, CP 56, CH-
1211 Geneve 20, Switzerland, telephone number: +41-22-749-01-11, Web
address: http://www.iso.org; and copies of the OECD guideline from the
Organization for Economic Cooperation and Development, 2, rue
Andr[eacute] Pascal, 75775 Paris Cedex 16, France, telephone number:
+33-1-45-24-82-00, Web address: http://www.oecd.org. You may inspect
each standard and guideline at the EPA Docket Center (EPA/DC), Rm.
3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC, from
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. The materials are also available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call (202) 741-6030, or go
to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(i) Reporting requirements. A study plan for each specific test for
each subject chemical substance must be received by EPA by February 20,
2012 unless an extension is granted in writing pursuant to 40 CFR
790.55. A final report for each specific test for each subject chemical
substance must be received by EPA by December 21, 2012 unless an
extension is granted in writing pursuant to 40 CFR 790.55. EPA is also
requesting that a robust summary of the final report for each specific
test be submitted in addition to, and at the same time as, the final
report. The term ``robust summary'' is used to describe the technical
information necessary to adequately describe an experiment or study and
includes the objectives, methods, results, and conclusions of the full
study report which can be either an experiment or in some cases an
estimation or prediction method. Guidance for the compilation of robust
summaries is described in a document entitled ``Draft Guidance on
Developing Robust Summaries'' which is available online 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 (CASRN), 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 Table 3
CASRN Chemical name Class of this section)
----------------------------------------------------------------------------------------------------------------
98-09-9............................... Benzenesulfonyl chloride........ 1 C2, E1, E2, F1
98-56-6............................... Benzene, 1-chloro-4- 1 B, C6
(trifluoromethyl)-.
[[Page 65407]]
111-44-4.............................. Ethane, 1,1'-oxybis[2-chloro-... 1 C6, F1
127-68-4.............................. Benzenesulfonic acid, 3-nitro-, 1 A3, F2
sodium salt (1:1).
515-40-2.............................. Benzene, (2-chloro-1,1- 1 A1, A3, A4, A5, B, C1, D,
dimethylethyl)-. E1, E2, F1
2494-89-5............................. Ethanol, 2-[(4- 1 A1, A2, A3, A4, A5, B, C1,
aminophenyl)sulfonyl]-, 1- D, E1, E2, F1
(hydrogen sulfate).
5026-74-4............................. 2-Oxiranemethanamine, N-[4-(2- 1 A1, A2, A3, A4, A5, B, C2,
oxiranylmethoxy)phenyl]-N-(2- F1
oxiranylmethyl)-
22527-63-5............................ Propanoic acid, 2-methyl-, 3- 1 A1, A2, A3, A4, A5, B, C1,
(benzoyloxy)-2,2,4- D, E1, E2, F1
trimethylpentyl ester.
25321-41-9............................ Benzenesulfonic acid, dimethyl-. 1 A2, A3, A4
52556-42-0............................ 1-Propanesulfonic acid, 2- 1 A1, A2, A3, A4, A5, B, C1,
hydroxy-3-(2-propen-1-yloxy)-, D, E1, E2, F1
sodium salt (1:1).
68082-78-0............................ Lard, oil, Me esters............ 2 A1, A2, A3, A4, A5, B, C1,
D, E1, E2, F1
68442-60-4............................ Acetaldehyde, reaction products 2 A1, A2, A3, A4, A5, B, C1,
with formaldehyde, by-products D, E1, E2, F1
from
68610-90-2............................ 2-Butenedioic acid (2E)-, di-C8- 2 A1, A2, A3, A4, A5, B, C1,
18-alkyl esters. D, E1, E2, F1
70693-50-4............................ Phenol, 2,4-bis(1-methyl-1- 1 A1, A2, A3, A4, A5, B, C1,
phenylethyl)-6-[2-(2- D, E1, E2, F1
nitrophenyl)diazenyl]-.
72162-15-3............................ 1-Decene, sulfurized............ 2 A2, A3, A4, A5, B, C1, D,
E1, E2, F1
----------------------------------------------------------------------------------------------------------------
Table 3--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2 of This Paragraph
[Note: The ASTM and ISO test methods and the OECD guideline required in this paragraph are incorporated by
reference; see paragraph (h) of this section]
----------------------------------------------------------------------------------------------------------------
Test Test requirements and
Testing category symbol references Special conditions
----------------------------------------------------------------------------------------------------------------
Physical/chemical properties.......... A 1. Melting Point: ASTM n-Octanol/water Partition
International (ASTM) E 324-99 Coefficient (log 10 basis)
(capillary tube), if a or--log Kow:
Freezing Point: Organization Which method is required, if
for Economic Cooperation and any, is determined by the
Development (OECD) 102 test substance's estimated
(melting point/melting \i\ log Kow as follows:
range). log Kow < 0: no testing
2. Boiling Point: ASTM E 1719- required.
05 (ebulliometry).. log Kow range 0-1: Method A or
3. Vapor Pressure: ASTM E 1782- B.
08 (thermal analysis).. log Kow range > 1-4: Method A,
4. n-Octanol/Water Partition B, or C.
Coefficient (log 10 basis) or log Kow range > 4-6: Method B
log Kow: (See Special or C.
Conditions for the log Kow log Kow > 6: Method C.
test requirement and select Test sponsors must provide in
the appropriate method to the final study report the
use, if any, from those underlying rationale for the
listed in this column.). method and pH selected. In
Method A: 40 CFR 799.6755 order to ensure environmental
(shake flask).. relevance, EPA highly
Method B: ASTM E 1147-92 recommends that the selected
(Reapproved 2005) (liquid study be conducted at pH 7.
chromatography).. Water Solubility:
Method C: 40 CFR 799.6756 Which method is required, if
(generator column).. any, is determined by the
5. Water Solubility: (See test substance's estimated
Special Conditions for the \ii\ water solubility. Test
water solubility test sponsors must provide in the
requirement and select the final study report the
appropriate method to use, if underlying rationale for the
any, from those listed in method and pH selected. In
this column.). order to ensure environmental
Method A: ASTM E 1148-02 relevance, EPA highly
(Reapproved 2008) (shake recommends that the selected
flask).. study be conducted starting
Method B: 40 CFR 799.6784 at pH 7.
(shake flask).. > 5,000 milligram/Liter (mg/
Method C: 40 CFR 799.6784 L): Method A or B.
(column elution).. > 10 mg/L-5,000 mg/L: Method
Method D: 40 CFR 799.6786 A, B, C, or D.
(generator column).. > 0.001 mg/L-10 mg/L: Method C
or D.
<= 0.001 mg/L: No testing
required.
[[Page 65408]]
Environmental fate and pathways--ready B For B, consult International Which method is required, if
biodegradation. Organization for any, is determined by the
Standardization (ISO) test substance's physical and
10634:1995(E) for guidance, chemical properties,
and choose one of the methods including its water
listed in this column: solubility. ISO 10634:1995(E)
1. ASTM E 1720-01 (Reapproved provides guidance for
2008) (sealed vessel CO2 selection of an appropriate
production test) OR. test method for a given test
2. ISO 14593:1999(E) (CO2 substance. Test sponsors must
headspace test) OR. provide in the final study
3. ISO 7827:1994(E) (analysis report the underlying
of DOC) OR. rationale for the method
4. ISO 9408:1999(E) selected.
(determination of oxygen
demand in a closed
respirometer) OR.
5. ISO 9439:1999(E) (CO2
evolution test) OR.
6. ISO 10707:1994(E) (closed
bottle test) OR.
7. ISO 10708:1997(E) (two-
phase closed bottle test)..
Aquatic toxicity...................... C1 For C1, Test Group 1 or Test The following are the special
Group 2 listed in this column conditions for C1, C2, C3,
must be used to fulfill the C4, C5, and C7 testing; there
testing requirements--See are no special conditions for
Special Conditions. C6.
Test Group 1 for C1:.......... Which test group is required
1. Acute Toxicity to Fish: is determined by the test
ASTM E 729-96 (Reapproved substance's measured log Kow
2007).. as obtained under Test
2. Acute Toxicity to Daphnia: Category A, or using an
ASTM E 729-96 (Reapproved existing measured log
2007).. Kow.\iii\
3. Toxicity to Plants (Algae): If log Kow < 4.2: Test Group 1
ASTM E 1218-04 e\1\.. is required.
Test Group 2 for C1:.......... If log Kow [gteqt] 4.2: Test
1. Chronic Toxicity to Group 2 is required.
Daphnia: ASTM E 1193-97
(Reapproved 2004)..
2. Toxicity to Plants (Algae):
ASTM E 1218-04 e\1\..
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 (Reapproved
2007)..
2. Toxicity to Plants (Algae):
ASTM E 1218-04 e\1\..
Test Group 2 for C2:..........
1. Chronic Toxicity to
Daphnia: ASTM E 1193-97
(Reapproved 2004)..
2. Toxicity to Plants (Algae):
ASTM E 1218-04 e\1\..
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 (Reapproved
2007)..
2. Toxicity to Plants (Algae):
ASTM E 1218-04 e\1\..
Test Group 2 for C3:..........
1. Chronic Toxicity to
Daphnia: ASTM E 1193-97
(Reapproved 2004)..
2. Toxicity to Plants (Algae):
ASTM E 1218-04 e\1\..
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 (Reapproved
2007)..
2. Acute Toxicity to Daphnia:
ASTM E 729-96 (Reapproved
2007)..
Test Group 2 for C4: Chronic
Toxicity to Daphnia: ASTM E
1193-97 (Reapproved 2004)..
[[Page 65409]]
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: Acute
Toxicity to Daphnia: ASTM E
729-96 (Reapproved 2007)..
Test Group 2 for C5: Chronic
Toxicity to Daphnia: ASTM E
1193-97 (Reapproved 2004)..
C6 Toxicity to Plants (Algae):
ASTM E 1218-04 e\1\.
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: Acute
Toxicity to Fish: ASTM E 729-
96 (Reapproved 2007)..
Test Group 2 for C7: Chronic
Toxicity to Daphnia: ASTM E
1193-97 (Reapproved 2004)..
Mammalian toxicity--acute............. D See special conditions for Which testing method is
this test requirement and required is determined by the
select the method that must test substance's physical
be used from those listed in state at room temperature (25
this column. [deg]C). For those test
Method A: Acute Inhalation substances that are gases at
Toxicity (rat): 40 CFR room temperature, Method A is
799.9130. required; otherwise, use
Method B: EITHER:............. either of the two methods
1. Acute (Up/Down) Oral listed under Method B.
Toxicity (rat): ASTM E 1163- In Method B, 40 CFR
98 (Reapproved 2002). 799.9110(d)(1)(i)(A) refers
OR........................... to the OECD 425 Up/Down
2. Acute (Up/Down) Oral Procedure.\iv\
Toxicity (rat): 40 CFR Estimating starting dose for
799.9110(d)(1)(i)(A).. Method B: Data from the
neutral red uptake basal
cytotoxicity assay \v\ using
normal human keratinocytes or
mouse BALB/c 3T3 cells may be
used to estimate the starting
dose.
Mammalian toxicity--genotoxicity...... E1 Bacterial Reverse Mutation None.
Test (in vitro): 40 CFR
799.9510.
E2 Conduct any one of the Persons required to conduct
following three tests for testing for chromosomal
chromosomal damage: damage are encouraged to use
In vitro Mammalian Chromosome the in vitro Mammalian
Aberration Test: 40 CFR Chromosome Aberration Test
799.9537.. (40 CFR 799.9537) to generate
OR............................ the needed data unless known
Mammalian Bone Marrow chemical properties (e.g.,
Chromosomal Aberration Test physical/chemical properties,
(in vivo in rodents: mouse chemical class
(preferred species), rat, or characteristics) preclude its
Chinese hamster): 40 CFR use. A subject person who
799.9538. uses one of the in vivo
OR........................... methods instead of the in
Mammalian Erythrocyte vitro method to address a
Micronucleus Test [sampled in chromosomal damage test
bone marrow] (in vivo in requirement must submit to
rodents: Mouse (preferred EPA a rationale for
species), rat, or Chinese conducting that alternate
hamster): 40 CFR 799.9539.. test in the final study
report.
Mammalian toxicity--repeated dose/ F1 Combined Repeated Dose Where F1 is required, EPA
reproduction/developmental. Toxicity Study with the recommends use of the
Reproduction/Developmental Combined Repeated Dose
Toxicity Screening Test: 40 Toxicity Study with the
CFR 799.9365 Reproduction/Developmental
OR........................... Toxicity Screening Test (40
Reproduction/Developmental CFR 799.9365). However, there
Toxicity Screening Test: 40 may be valid reasons to test
CFR 799.9355. a particular chemical using
AND.......................... both 40 CFR 799.9355 and 40
Repeated Dose 28-Day Oral CFR 799.9305 to fill
Toxicity Study in rodents: 40 Mammalian Toxicity--Repeated
CFR 799.9305.. 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.
[[Page 65410]]
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. 1995. This reference is available in
docket ID number EPA-HQ-OPPT-2009-0112 at the EPA Docket Center (EPA/DC), Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC, from 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.
\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 in docket ID number EPA-HQ-OPPT-2009-0112 at the EPA Docket Center (EPA/DC),
Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC, from 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.
\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 chemical
substance.
\iv\ The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available in docket ID number EPA-HQ-
OPPT-2007-0531 at the EPA Docket Center (EPA/DC), Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW.,
Washington, DC, from 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.
\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 in docket ID number EPA-HQ-OPPT-2009-0112 at the EPA Docket
Center (EPA/DC), Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC, from 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.
[FR Doc. 2011-27227 Filed 10-20-11; 8:45 am]
BILLING CODE 6560-50-P