Testing of Certain High Production Volume Chemicals; Third Group of Chemicals, 65385-65410 [2011-27227]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[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]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Part 799

[EPA-HQ-OPPT-2009-0112; FRL-8885-5]
RIN 2070-AJ86


Testing of Certain High Production Volume Chemicals; Third Group 
of Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is promulgating this final rule under section 4(a)(1)(B) 
of the Toxic Substances Control Act (TSCA) to require manufacturers, 
importers, and processors to conduct testing to obtain screening level 
data for health and environmental effects and chemical fate for 15 high 
production volume (HPV) chemical substances listed in this final rule. 
This test data is needed in order to help EPA to determine whether 
these 15 HPV chemical substances pose a risk to human health and/or 
environmental safety. Based on comments received by EPA on the proposed 
rule for this final rule, EPA has determined that only 15 of the 29 HPV 
chemical substances proposed for testing meet the criteria for testing 
at this time.

DATES: This final rule is effective November 21, 2011.
    The incorporation by reference of certain publications listed in 
this final rule is approved by the Director of the Federal Register as 
of November 21, 2011.
    For purposes of judicial review, this final rule shall be 
promulgated at 1 p.m. eastern daylight/standard time on November 7, 
2011.

[[Page 65386]]


ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2009-0112. All documents in the 
docket are listed on the regulations.gov Web site. Although listed in 
the index, some information is not publicly available; i.e., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available in the electronic docket at https://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 (https://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 req