
[Federal Register Volume 76, Number 204 (Friday, October 21, 2011)]
[Rules and Regulations]
[Pages 65385-65410]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27227]


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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.

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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: 
campanella.paul@epa.gov or schaeffer.john@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: TSCA-Hotline@epa.gov.

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


