
[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Rules and Regulations]
[Pages 1067-1093]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-33313]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 799

[EPA-HQ-OPPT-2007-0531; FRL-8846-9]
RIN 2070-AD16


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is promulgating a final rule under section 4(a)(1)(B) of 
the Toxic Substances Control Act (TSCA) to require manufacturers, 
importers, and processors of certain high production volume (HPV) 
chemical substances to conduct testing to obtain screening level data 
for health and environmental effects and chemical fate.

[[Page 1068]]


DATES: This final rule is effective February 7, 2011. The incorporation 
by reference of certain publications listed in the rule is approved by 
the Director of the Federal Register as of February 7, 2011. For 
purposes of judicial review, this final rule shall be promulgated at 1 
p.m. eastern daylight/standard time on January 24, 2011.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2007-0531. 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 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.

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.  799.5087(j) of the regulatory text. 
Any use of the term ``manufacture'' in this document will encompass 
``import,'' unless otherwise stated. In addition, as described in Unit 
VI., once the Agency issues a final rule, any person who exports, or 
intends to export, any of the chemical substances included in the final 
rule will be subject to the export notification requirements in 40 CFR 
part 707, subpart D. Potentially affected entities may include, but are 
not limited to:
     Manufacturers (defined by statute to include importers) of 
one or more of the 19 subject chemical substances (NAICS codes 325 and 
324110), e.g., chemical manufacturing and petroleum refineries.
     Processors of one or more of the 19 subject 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.  799.5087(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 a final test rule under TSCA section 4(a)(1)(B) 
(15 U.S.C. 2603(a)(1)(B)) that requires manufacturers and processors of 
19 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 (lbs) per year). A detailed discussion regarding efforts 
to enhance the availability of screening level hazard and environmental 
fate information about HPV chemicals can be found in a Federal Register 
notice which published on December 26, 2000 (Ref. 1).
    In the proposed rule for this final rule, published in the Federal 
Register of July 24, 2008, EPA proposed Screening Information Data Set 
(SIDS) testing for 19 HPV chemicals (Ref. 2). Comments were received on 
the proposed rule. In consideration of those comments, EPA changed some 
testing requirements for certain HPV chemicals, as explained in Unit 
III. However, none of these changes resulted in dropping all testing 
proposed for any of the chemical substances, and EPA is still requiring 
testing for each of the 19 HPV chemicals originally proposed for 
testing in 2008.
    This action also follows an earlier testing action for certain HPV 
chemicals (see the proposed and final rules entitled ``Testing of 
Certain High Production Volume Chemicals; Proposed Rule'' (Ref. 3) and 
``Testing of Certain High Production Volume Chemicals; Final Rule'' 
(Ref. 4)).
    EPA has also proposed testing for a third group of HPV chemicals 
(Ref. 5), and plans to propose testing for additional HPV chemicals as 
the Agency learns more about these chemical substances with respect to 
human exposure, release, and sufficiency of data and experience 
available on their potential hazards.

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. Section 
2(b)(1) of TSCA (15 U.S.C. 2603(b)(1)) states that it is the policy of 
the United States that:

    * * * adequate data should be developed with respect to the 
effect of chemical substances and mixtures on health and the 
environment and that the development of such data should be the 
responsibility of those who manufacture [which is defined by statute 
to include import] and those who process such chemical substances 
and mixtures[.]

    To implement this policy, EPA is promulgating this test 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

[[Page 1069]]

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. 6, pp. 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 certain HPV chemicals specified in Table 2 in Sec.  799.5087(j) of 
the regulatory text. Following consideration of the public comments 
received by EPA on the proposed rule (Ref. 2) and production volume 
information (i.e., 2006 Inventory Update Rule (IUR) data), EPA is 
making the following findings for the 19 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 certain 
basic information about the environmental fate and potential health and 
environmental hazards associated with the most widespread chemical 
substances in commerce available to the public. Mechanisms to collect 
or, where necessary, develop needed data on U.S. HPV chemicals include 
the voluntary HPV Challenge Program, certain international efforts (the 
Organization for Economic Cooperation and Development (OECD) HPV SIDS 
Program, and the International Council of Chemical Associations (ICCA) 
HPV Initiative), and TSCA section 4 test rules. The voluntary HPV 
Challenge Program was created to ensure that a baseline set of data on 
approximately 2,800 HPV chemicals would be made available to EPA and 
the public. HPV chemicals are manufactured or imported in amounts equal 
to or greater than 1 million lbs per year and were first identified for 
this program through data reported under the 1990 IUR. 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 chemicals for human and 
environmental hazards, and assists the Agency and others in making an 
informed, preliminary judgment about the hazards of HPV chemicals.
    The voluntary HPV Challenge Program was designed to make maximum 
use of scientifically adequate existing test data and to avoid 
unnecessary and duplicative testing of U.S. HPV chemicals. Therefore, 
EPA is continuing to participate in the voluntary international 
efforts, complementary to the voluntary HPV Challenge Program, that are 
being coordinated by OECD to secure basic hazard information on HPV 
chemicals in use worldwide, including some of those on the 1990 U.S. 
HPV chemicals list (Ref. 7). This includes agreements to sponsor a U.S. 
HPV chemical under either the OECD HPV SIDS Program (Ref. 8), including 
sponsorship by OECD member countries beyond the United States, or the 
international HPV Initiative that is being organized by the ICCA (Ref. 
9).
    Additional details regarding the voluntary HPV Challenge Program 
and these international efforts were provided in the prior HPV TSCA 
section 4 rules (Refs. 2-4).
    As EPA stated in the first HPV test rule, U.S. data needs that 
remained unmet in the voluntary HPV Challenge Program or through 
international efforts could be addressed through TSCA section 4 
rulemakings, such as the final test rule promulgated by EPA on March 
16, 2006 (Ref. 4). This second final TSCA section 4 HPV SIDS rule 
addresses the unmet data needs for 19 chemical substances.
    EPA intends to make the information collected under the final rule 
available to the public, other Federal agencies, and any other 
interested parties on its website (http://www.epa.gov/chemrtk) and in 
the docket for the final rule identified under ADDRESSES. As 
appropriate, this information will be used to ensure a scientifically 
sound basis for risk assessment/management actions.

D. Why is EPA focusing on HPV chemicals and SIDS testing?

    This final rule pertains to HPV chemicals, which EPA determined 
account for 95% of total chemical production in the United States (Ref. 
10, p. 32296). EPA found that, of those HPV non-polymeric organic 
substances based on 1990 IUR reporting, only 7% had a full set of 
publicly available and internationally recognized basic screening test 
data for health and environmental effects (Ref. 11). Of the over 2,800 
U.S. HPV chemicals, 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 chemicals pose potential 
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. 
8):
     Acute toxicity.
     Repeat dose toxicity.
     Developmental and reproductive toxicity.
     Genetic toxicity (gene mutations and chromosomal 
aberrations).
     Ecotoxicity (studies in fish, Daphnia, and algae).

[[Page 1070]]

     Environmental fate (including physical/chemical properties 
(melting point, boiling point, vapor pressure, n-octanol/water 
partition coefficient, and water solubility), photolysis, hydrolysis, 
transport/distribution, and biodegradation).
    Data on the six SIDS endpoints provide a consistent minimum set of 
information that can be used to help assess the relative risks of 
chemical substances and whether additional testing or assessment is 
necessary.

E. How would 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 19 HPV 
chemicals subject to the rule. The data will also be used by EPA to set 
priorities for further testing that may produce hazard information on 
these chemicals that may be needed by EPA, other Federal agencies, the 
public, industry, and others, to support adequate risk assessments. As 
appropriate, this information will be used to ensure a scientifically 
sound basis for risk characterizations 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. EPA uses data 
from test rules to support such actions as the risk management 
decisions and activities under TSCA, development of water quality 
criteria, Toxic Release Inventory (TRI) listings, and reduction of 
workplace exposures.
    In addition, a key goal of the HPV Challenge Program was making 
basic health and environmental effects data for HPV chemicals available 
to the public as part of EPA's ``Right to Know'' Initiative. A basic 
premise of the 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, among others--can use the data provided through the HPV 
Challenge Program, and also data collected on HPV chemicals through 
other means, including TSCA section 4 testing, to make informed 
decisions related to the human and the environmental hazards of 
chemical substances that they encounter in their daily lives.

III. Response to Public Comments

    EPA received a number of comments 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'' (Ref. 12). The comments and EPA's ``Response to Public 
Comments'' document are available in the docket. The comments on the 
proposed rule were submitted by the Acetaldehyde Working Group (AWG) of 
the Vinyl Acetate Council; Albemarle Corporation (Albemarle); American 
Chemistry Council (ACC); Chlorinated Paraffins Industry Association 
(CPIA); Dyno Nobel, Inc. (Dyno Nobel); and Vertellus Specialties, Inc. 
(Vertellus). Comments were also submitted by People for the Ethical 
Treatment of Animals (PETA), the Physicians Committee for Responsible 
Medicine (PCRM), the Alternatives Research Development Foundation 
(ARDF), and the American Anti-Vivisection Society (AAVS). Additional 
comments submitted by PCRM were also on behalf of the Doris Day Animal 
League (DDAL) and the Humane Society of the United States (HSUS). EPA 
also received comments from numerous private citizens. In response to 
these comments, EPA made the following changes to the regulatory text 
in the final rule:
    1. The screening test for reproduction/developmental toxicity is 
not required for 2,4-hexadienoic acid, (E,E)- (Chemical Abstract 
Service Registry Number (CASRN) 110-44-1), also known as sorbic acid. 
This change is further discussed in Unit VII.A. and in the ``Response 
to Public Comments'' document (Ref. 12).
    2. Screening testing for reproductive/developmental toxicity is not 
required for ethanedioic acid (CASRN 144-62-7). This change is further 
discussed in Unit VII.B. and in the ``Response to Public Comments'' 
document (Ref. 12).
    3. Vapor pressure, water solubility, n-Octanol/Water Partition 
Coefficient (log 10 basis) or ``log Kow,'' and aquatic 
toxicity testing are not required for castor oil, oxidized (CASRN 
68187-84-8). EPA is also not requiring water solubility or log 
Kow testing for castor oil, sulfated, sodium salt (CASRN 
68187-76-8). These changes are further discussed in Unit VII.C. and in 
the ``Response to Public Comments'' document (Ref. 12). In addition, 
for castor oil, oxidized (CASRN 68187-84-8), the acute mammalian 
toxicity test is not required. This change is further discussed in Unit 
VII.D. and in the ``Response to Public Comments'' document (Ref. 12).
    4. Boiling point is not required for benzenediamine, ar,ar-diethyl-
ar-methyl--(CASRN 68479-98-1). This change is further discussed in Unit 
VII.E. and in the ``Response to Public Comments'' document (Ref. 12).
    5. Acute mammalian toxicity, repeated-dose toxicity, and in vitro 
mutagenicity tests are not required for alkenes, C12-24, 
chloro. These changes are further discussed in Unit VII.F. and in the 
``Response to Public Comments'' document (Ref. 12).

IV. Findings

A. What is the basis for EPA's final rule to test these chemical 
substances?

    As indicated 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, among other things, make certain findings regarding 
either risk (TSCA section 4(a)(1)(A)(i)) or production combined with 
either chemical release or human exposure (TSCA section 4(a)(1)(B)(i)), 
with regard to those chemical substances. EPA is requiring testing of 
the chemical substances included in this final test 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.  799.5087(j) of the regulatory 
text along with their CASRN.
    ``Substantial production'' of a chemical substance or mixture under 
TSCA section 4(a)(1)(B)(i) is generally considered to be aggregate 
production (including import) volume equaling or exceeding 1 million 
lbs per year of that chemical substance or mixture and exposure of 
1,000 workers or more on a routine or episodic basis to a chemical 
substance or mixture is considered to be ``substantial exposure.'' See 
EPA's ``B'' policy (Ref. 6) 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 19 
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. 13). Also, for three 
substances, EPA finds that, under TSCA section 4(a)(1)(B)(i), the 
substance enters or may reasonably be anticipated to enter the 
environment in substantial quantities (Ref. 13). 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

[[Page 1071]]

substances, or of any combination of such activities, on human health 
or the environment. EPA also finds that testing the 19 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. 6) 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.  799.5087(j) of the regulatory text along with their CASRN. For a 
chemical-by-chemical summary of each of the findings, see Table 1 of 
this unit.

                                                            Table 1--Exposure-Based Findings
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Meet exposure                                                           Meet
                                      2006 IUR        based criteria                   Meet exposure-   Meet exposure-   substantial or   NLM  household
             CASRN                production volume     for Mfg &      NOES  (number   based criteria   based criteria    significant       chemicals
                                        (lbs)           industrial     of  workers)    for commercial   for consumers       release          database
                                                         workers                          workers                           criteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
75-07-0........................  > 100 M-500 M.....               X          216,533  ...............               X                X                X
78-11-5........................  > 1 M-10 M........               X            2,650  ...............               X   ...............  ...............
84-65-1........................  > 10 M-50 M.......               X            6,187               X                X   ...............  ...............
89-32-7........................  > 1 M-10 M........               X            1,926  ...............  ...............  ...............  ...............
110-44-1.......................  > 1 M-10 M........               X           69,243               X                X   ...............               X
118-82-1.......................  > 1 M-10 M........               X          120,009               X                X   ...............  ...............
119-61-9.......................  > 1 M-10 M........               X           41,516               X                X   ...............               X
144-62-7.......................  > 1 M-10 M........               X          142,000               X                X                X                X
149-44-0.......................  > 1 M-10 M........               X          239,465               X                X   ...............  ...............
2524-04-1......................  > 10 M-50 M.......               X            1,088  ...............  ...............  ...............  ...............
4719-04-4......................  > 10 M-50 M.......               X          225,251               X                X                X                X
6381-77-7......................  > 1 M-10 M........               X           19,468  ...............  ...............  ...............  ...............
31138-65-5.....................  > 1 M-10 M........               X           74,165               X                X   ...............  ...............
66241-11-0.....................  > 1 M-10 M........               X           38,555               X                X   ...............  ...............
68187-76-8.....................  > 1 M-10 M........               X           11,164               X                X
68187-84-8.....................  > 1 M-10 M........               X           36,381               X                X   ...............               X
68479-98-1.....................  > 10 M-50 M.......               X            4,121  ...............  ...............  ...............  ...............
68527-02-6.....................  > 1 M-10 M........               X           84,192  ...............  ...............  ...............  ...............
68647-60-9.....................  > 1 Billion.......               X            1,257
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: CASRN--Chemical Abstract Service Registry Number, IUR--Inventory Update Rule, M--Million, Mfg--Manufacturing, NOES--National Occupational
  Exposure Survey, NLM--National Library of Medicine.

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 and/or imported in an amount equal to or greater 
than 1 million lbs per year (Ref. 13), based on information gathered 
pursuant to the 2006 IUR (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. 6, 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. 
13).

C. Are a substantial number of workers exposed to these chemical 
substances?

    EPA finds that the manufacture, processing, and use of the 19 
chemical substances included in this action result 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 document for this final rule (Ref. 
13).
    This finding is based, in large part, on information submitted in 
accordance with the 2006 IUR. For chemicals whose total production 
volume (manufactured and imported) exceeded 300,000 lbs at a site 
during calendar year 2005, manufacturers and importers were required to 
report the number of potentially exposed workers during industrial 
processing and use to the extent the information was readily 
obtainable. In addition, the submitters were required to provide 
information regarding the commercial and consumer uses of the chemical 
substance.
    In accordance with the Agency's ``B'' policy (Ref. 6), EPA 
believes, as a general matter, that an exposure of over 1,000 workers 
to a chemical substance is ``substantial'' as that term is used with 
reference to ``human exposure'' in TSCA section 4(a)(1)(B)(i). EPA 
further believes, based on experience gained through case-by-case 
analysis of existing chemicals, that an exposure of 1,000 workers or 
more to a chemical substance is a reasonable interpretation of the 
phrase ``substantial human exposure'' in TSCA section 4(a)(1)(B)(i) 
(see Ref. 6). EPA is not aware of any facts in this case that warrant 
departure from this policy, and finds that there is or may be 
substantial human exposure (workers) to these 19 chemical substances.
    Besides the 2006 IUR data, EPA also reviewed National Occupational 
Exposure Survey (NOES) data developed by the National Institute for 
Occupational Safety and Health (NIOSH). The NOES data additionally 
support EPA's finding that more than 1,000 workers are exposed to each 
of the 19 chemical substances that are the subject of this final rule. 
The NOES was a nationwide data gathering project conducted by NIOSH, 
which was designed to develop national estimates for the number of 
workers potentially exposed to various chemical, physical, and 
biological agents and describe the distribution of these potential 
exposures. Begun in 1980 and completed in 1983, the survey involved a 
walk-through investigation by trained surveyors of 4,490 facilities in 
523 different types of industries. Surveyors recorded potential 
exposures when a chemical agent was likely to enter or contact the 
worker's body for a minimum duration. These potential

[[Page 1072]]

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. 14-16). EPA also compared production volumes 
from the 1986 IUR data collection to the production volumes for the 
2006 IUR data collection. Of the 19 chemical substances in this final 
rule, only one chemical's (acetaldehyde, CASRN 75-07-0) production 
volume decreased from 1986 to 2006 (Ref. 13). The 2006 IUR production 
volume data are consistent with NOES results, as the production volumes 
for the remaining chemical substances either stayed the same or 
increased since 1986, thereby indicating that the usage of these 
chemical substances is no less than when NOES data were gathered.
    EPA has performed a chemical-by-chemical analysis for all 19 
chemical substances and carefully considered the industrial process and 
use information along with the commercial and consumer use information 
from the 2006 IUR submissions. Commercial uses are defined as ``The use 
of a chemical substance or mixture in a commercial enterprise providing 
saleable goods or services (e.g., dry cleaning establishment, painting 
contractor)'' (40 CFR 710.43). Detailed information from the 2006 IUR 
submissions can be found in ``Testing of Certain High Production Volume 
Chemicals; Second Group of Chemicals (Exposure Findings Supporting 
Information)'' (Ref. 13). Based on the nature of the 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 is the sum of information on 
both industrial workers plus commercial use workers.
    In 2003, EPA partially exempted certain petroleum process streams 
(including ``Hydrocarbons, C>4'' (CASRN 68647-60-9) and ``Oils, 
reclaimed'' (CASRN 69029-75-0)) from reporting certain processing and 
use data under the TSCA section 8(a) 2006 IUR. The exemption was not 
based on an assessment of the toxicity of the process streams but on 
the fact that the chemical substances are frequently processed, 
transported, and stored in vessels that minimize the potential for 
releases and exposure to workers (Refs. 17 and 18). Despite the fact 
that the degree of exposure is expected to be diminished to particular 
workers because of the chemical processing and handling practices used, 
available data indicate that more than 1,000 workers are potentially 
exposed to these chemical substances, supporting the finding of 
substantial human exposure (Ref. 13).

D. Are a substantial number of consumers exposed to these chemical 
substances?

    Based on 2006 IUR data, EPA finds that the uses of 13 of the 
chemical substances included in this action result or may result in 
exposure to a substantial number of consumers (Ref. 13). EPA reviewed 
the consumer use information reported for the 2006 IUR and carefully 
considered the nature of those uses. Upon completion of the review, EPA 
concluded that the reported consumer uses for these 13 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 based on the National 
Library of Medicine (NLM) Household Products Database (see Ref. 13). 
The chemical substances reported in the NLM Household Products Database 
are present in multiple household products subject to TSCA including 
hobby/craft products, personal care products, home cleaning products, 
home maintenance products, and automotive products. The NLM Household 
Products Database provides information on the chemical ingredients and 
their percentage in specific brands of household products. Information 
in the NLM Household Products Database 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 believes that use of the consumer products identified in the 
NLM Household Products Database may expose a substantial number of 
consumers (i.e., greater than 10,000) to these chemical substances. EPA 
believes that an exposure of over 10,000 consumers to a chemical 
substance is ``substantial'' as that term is used with reference to 
``human exposure'' in TSCA section 4(a)(1)(B)(i). EPA further believes, 
based on experience gained through case-by-case analysis of existing 
chemical substances, that an exposure of 10,000 consumers or more to a 
chemical substance is a reasonable interpretation of the phrase 
``substantial human exposure'' in TSCA section 4(a)(1)(B)(i) (see Ref. 
6). Therefore, EPA finds that there is or may be substantial human 
exposure (consumers) to these chemical substances.
    A discussion of EPA's ``substantial exposure'' finding for 
consumers is contained in a separate document (see Ref. 13).

E. Are substantial quantities of these chemical substances released to 
the environment?

    EPA finds for three chemical substances in this final rule that 
there are substantial releases to the environment. One substance, 
acetaldehyde (CASRN 75-07-0) is included in TRI and has estimated 
environmental release in 2005 of 13,567,452 lbs (see Ref. 13). TRI 
contains information about releases of certain chemical substances and 
management of wastes at a wide variety of sources, including 
manufacturing operations, certain service businesses, and Federal 
facilities. Two additional chemical substances (ethanedioic acid (CASRN 
144-62-7) and 1,3,5-triazine-1,3,5(2H,4H,6H)-triethanol (CASRN 4719-04-
4)) also meet the substantial release criteria based on the 
environmental releases from their reported 2006 IUR uses.
    EPA believes that in general an environmental release of a chemical 
substance in an amount equal to or greater than 1 million lbs per year 
or greater than 10% of the reported production volume is 
``substantial'' as that term is used with reference to ``enter the 
environment in substantial quantities'' in TSCA section 4(a)(1)(B)(i) 
(see Ref. 6).
    A discussion of EPA's ``substantial release to the environment'' 
finding is contained in a separate document (see Ref. 13).

F. Do sufficient data exist for these chemical substances?

    EPA has determined that for the 19 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 to the chemical substances 
included in this final rule during the manufacturing, processing, or 
use of the subject chemical substances.
    The finding for 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. 2, 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 proposal or identified by EPA after the publication of the proposal 
to this

[[Page 1073]]

final rule. The studies and data submitted or identified subsequent to 
the proposal 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.).
    EPA encouraged the submission of existing data on SIDS testing 
endpoints which are 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 rule. However, if persons required 
to test under this final rule become aware of additional relevant 
scientifically adequate existing data (including structure-activity 
relationships (SAR) information or a scientifically defensible category 
approach) and submit this information to EPA at any time before testing 
is initiated, the Agency would consider such data to determine if they 
satisfy the testing requirement and would take appropriate necessary 
action to ensure that the testing in this rule is no longer required. 
In fact, they may submit such information as a requested modification 
to the testing requirements under 40 CFR 790.55 at anytime as long as 
the request is made at least 60 days before the reporting deadline for 
the test in question.
    Section 799.5087(j) of the regulatory text lists each chemical 
substance and the SIDS tests for which adequate data are not currently 
available to the Agency. The Agency finds that the existing data for 
one or more of the SIDS testing endpoints for each of the chemical 
substances listed in Table 2 in Sec.  799.5087(j) of the regulatory 
text (including environmental fate (comprising five tests for physical/
chemical properties [melting point, boiling point, vapor pressure, n-
octanol/water partition coefficient, and water solubility] and 
biodegradation); ecotoxicity (tests in fish, Daphnia, and algae); acute 
toxicity; genetic toxicity (gene mutations and chromosomal 
aberrations); repeat dose toxicity; and developmental and reproductive 
toxicity) are insufficient to enable EPA to reasonably determine or 
predict the human health and environmental effects resulting from 
manufacture, processing, and use of these chemical substances.

G. 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 in ascertaining the health and environmental effects of the 
19 chemical substances in this final rule. EPA knows of no other means 
to generate the SIDS data other than the testing described in this 
rule, and therefore believes that conducting the needed SIDS testing 
identified for the 19 subject chemical substances is necessary to 
provide data relevant to a determination of whether the manufacture, 
processing, and use of the chemical substances does or does not present 
an unreasonable risk of injury to human health and the environment. 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 being required in this action?

    EPA is requiring specific testing and reporting requirements for 
the chemical substances specified in Sec.  799.5087(j) of the 
regulatory text. The testing requirements for each chemical are denoted 
by alphanumeric symbols in Table 2 in Sec.  799.5087(j) of the 
regulatory text. Table 3 in Sec.  799.5087(j) of the regulatory text 
provides the key to identify the tests denoted by the alphanumeric 
symbols and lists special conditions which might apply when conducting 
some of those tests. The test methods listed in Table 3 in Sec.  
799.5087(j) of the regulatory text are grouped according to the 
endpoint that they address. The following endpoints and test standards 
are required under this final rule; 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
    Melting Point: American Society for Testing and Materials (ASTM) 
E 324-99 (capillary tube) (Ref. 21). (If a Freezing Point: OECD102 
(melting point/melting range) (Ref. 25)).
    Boiling Point: ASTM E 1719-05 (ebulliometry) (Ref. 22).
    Vapor Pressure: ASTM E 1782-08 (thermal analysis) (Ref. 23).
    n-Octanol/Water Partition Coefficient: Method A (40 CFR 
799.6755--shake flask).
    Method B (ASTM E 1147-92 (Reapproved 2005)--liquid 
chromatography) (Ref. 24).
    Method C (40 CFR 799.6756--generator column).
    Water Solubility: Method A (ASTM E 1148-02 (Reapproved 2008)--
shake flask) (Ref. 26).
    Method B (40 CFR 799.6784--shake flask).
    Method C (40 CFR 799.6784--column elution).
    Method D (40 CFR 799.6786--generator column).

    EPA is 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. 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).

    However, ASTM still makes the method available for informational 
purposes and it can still be purchased from ASTM at the address listed 
in Sec.  799.5087(h) of the regulatory text.
    EPA concludes that ASTM's withdrawal of ASTM E 324-99 does not have 
negative implications on the validity of the method; therefore, 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.
    However, EPA received public comment about testing a substance that 
is a liquid at room temperature (Ref. 12). In its response, EPA notes 
that the melting point ideally is identical with the solidification or 
freezing point. Therefore, a measured freezing point would in this case 
meet the obligation to report the melting point. Since ASTM E 324-99 
(capillary tube) does not specifically include instructions for 
determining freezing point, EPA is instead requiring, for substances 
which are liquid at room temperature, OECD 102 (melting point/melting 
range), which includes guidance for determining freezing point.
    For the vapor pressure endpoint, ASTM has updated and revised its 
test method for vapor pressure (ASTM E 1782-08--thermal analysis) since 
the time of the proposed rule. 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) is listed as 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., E1719);

[[Page 1074]]

``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. 22).
    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.  
799.5087(j) of the regulatory text.
    For the log Kow endpoint, EPA is requiring that an 
appropriate selection be made from among three alternative methods for 
measuring the chemical substance's log Kow. Prior to 
determining the appropriate standard to use, if any, to measure the n-
octanol/water partition coefficient, EPA is recommending that the log 
Kow be quantitatively estimated. EPA recommends that the 
method described in ``Atom/Fragment Contribution Method for Estimating 
Octanol-Water Partition Coefficients'' (Ref. 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, Method B (ASTM E 1147-92 (Reapproved 2005)) and 
especially Method C (40 CFR 799.6756--generator column) become more 
suitable than Method A (40 CFR 799.6755--shake flask). 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:
                              The appropriate log   Which method is
                               Kow test, if any,     required, if any,
                               would be selected     is determined by
                               from those listed     the test
                               in this column--see   substance's
                               Special Conditions    estimated log Kow
                               in the adjacent       as follows:
                               column
                              Method A: 40 CFR      log Kow <0: No
                               799.6755 (shake       testing required.
                               flask).              log Kow range 0-1:
                              Method B: ASTM E       Method A or B.
                               1147-92 (Reapproved  log Kow range > 1-4:
                               2005) (liquid         Method A, B, or C.
                               chromatography)      log Kow range > 4-6:
                              Method C: 40 CFR       Method B or C.
                               799.6756 (generator  log Kow >6: Method
                               column).              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--American Society for Testing and Materials.

    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, if any, would be 
determined by first quantitatively estimating the test substance's 
water solubility. One recommended method for estimating water 
solubility is described in ``Improved Method for Estimating Water 
Solubility from Octanol/Water Partition Coefficient'' (Ref. 29). EPA is 
also requiring that test sponsors submit in the final study report the 
underlying rationale for the test standard selected for this endpoint. 
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 water 
solubility tests be conducted starting at pH 7 to ensure environmental 
relevance. The estimated water solubility ranges that EPA is requiring 
for use in this final rule to select the appropriate test standard are 
shown in Table 3 of this unit.

                          Table 3--Test Requirements for the Water Solubility Endpoint
----------------------------------------------------------------------------------------------------------------
         Testing category             Test requirements and references               Special conditions
----------------------------------------------------------------------------------------------------------------
Physical/chemical properties.....  Water solubility:                       Water solubility:

[[Page 1075]]

 
                                   The appropriate method to use, if any,  Which method is required, if any,
                                    to test for water solubility would be   would be determined by the test
                                    selected from those listed in this      substance's estimated water
                                    column--see Special Conditions in the   solubility. Test sponsors must
                                    adjacent column.                        provide in the final study report
                                   Method A: ASTM E 1148-02 (Reapproved     the underlying rationale for the
                                    2008) (shake flask).                    method and pH selected. In order to
                                   Method B: 40 CFR 799.6784 (shake         ensure environmental relevance, EPA
                                    flask).                                 highly recommends that the selected
                                   Method C: 40 CFR 799.6784 (column        study be conducted starting at pH 7.
                                    elution).
                                   Method D: 40 CFR 799.6786 (generator
                                    column).
                                   ......................................  > 5,000 mg/L: Method A or B.
                                                                           > 10 mg/L--5,000 mg/L: Method A, B,
                                                                            C, or D.
                                                                           > 0.001 mg/L-10 mg/L: Method C or D.
                                                                           <= 0.001 mg/L: No testing required.
----------------------------------------------------------------------------------------------------------------
Note: ASTM--American Society for Testing and Materials, mg/L--milligrams/liters.

2. Environmental Fate and Pathways
    Ready Biodegradation: Method A: ASTM E 1720-01 (Reapproved 2008) 
(Sealed vessel CO2 production test) (Ref. 30).
    Method B: International Organization for Standardization (ISO) 
14593:1999(E) (CO2 headspace test) (Ref. 31).
    Method C: ISO 7827:1994(E) (Method by analysis of dissolved 
organic carbon (DOC)) (Ref. 32).
    Method D: ISO 9408:1999(E) (Determination of oxygen demand in a 
closed respirometer) (Ref. 33).
    Method E: ISO 9439:1999(E) (Carbon dioxide evolution test) (Ref. 
34).
    Method F: ISO 10707:1994(E) (Closed bottle test) (Ref. 35).
    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 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, if any, 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 substances 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
    Test Group 1: Acute toxicity to fish (ASTM E 729-96 (Reapproved 
2007)) (Ref. 38), Acute toxicity to Daphnia (ASTM E 729-96 
(Reapproved 2007)) (Ref. 38), and Toxicity to plants (algae) (ASTM E 
1218-04\e1\) (Ref. 39).
    Test Group 2: Chronic toxicity to Daphnia (ASTM E 1193-97 
(Reapproved 2004)) (Ref. 40) and Toxicity to plants (algae) (ASTM E 
1218-04\e1\) (Ref. 39).

    ASTM has updated its test method for Conducting Acute Toxicity 
Tests on Test Materials with Fishes, Macroinvertebrates, and Amphibians 
(ASTM E 729-96 (Reapproved 2002)). The test method was reapproved in 
2007. There were minor changes, for example, reference to ASTM Web site 
in place of Annual Book of ASTM Standards minor changes in references 
and dates, titles of ASTM documents changed to correspond to new 
titles, etc., however the test method itself is unchanged. When 
required, 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 substances' aquatic 
toxicity. This issue arises when considering chemical substances with 
high log Kow values. In such cases, toxicity is unlikely to 
be observed over the duration of acute toxicity studies because of 
reduced uptake and the extended amount of time required for such 
substances to reach steady state or toxic concentrations in the test 
organism. For such situations, the OECD HPV SIDS Program recommends use 
of chronic toxicity testing in Daphnia in place of acute toxicity 
testing in fish and Daphnia. EPA is 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.  799.5087(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.  799.5087(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\e1\). For test substances 
determined to have a log Kow that is greater than or equal 
to 4.2, one or both of the following tests (described as ``Test Group 
2'' in Table 3 in Sec.  799.5087(j) of the regulatory text) are 
required: Chronic toxicity to Daphnia (ASTM E 1193-97 (Reapproved 
2004)) and Toxicity to plants (algae) (ASTM E 1218-04\e1\). As outlined 
in Table 3 in Sec.  799.5087(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.
    Using SAR, a log Kow of 4.2 corresponds with a fish 
bioconcentration factor (BCF) of about 1,000 (Refs. 29, 41, and 42). A 
chemical substance with a fish BCF value of 1,000 or more is 
characterized as having a tendency to accumulate in living organisms 
relative to the concentration of the chemical substance in the 
surrounding environment (Ref. 42). For the purposes of this final rule, 
EPA's use

[[Page 1076]]

of a log Kow equal to or greater than 4.2 (which corresponds 
with a fish BCF value of 1,000) is consistent with the approach taken 
in the Agency's Final Policy Statement under TSCA section 5 (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. 44) 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.  799.5087(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 the final rule as described in 40 CFR 790.55. Based upon 
the supporting rationale provided by the test sponsor, EPA may allow an 
alternative threshold or method to be used for determining whether 
acute or chronic aquatic toxicity testing must be performed for a 
specific substance.
4. Mammalian Toxicity--Acute

    Acute Inhalation Toxicity (rat): Method A (40 CFR 799.9130).
    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'' in the form of the chemical 
substance's physical/chemical properties or physical state be 
considered in determining the appropriate test method that would be 
used from among those included for this endpoint in Table 3 in Sec.  
799.5087(j) of the regulatory text. The OECD HPV SIDS Program 
recognizes that, for most chemical substances, the oral route of 
administration will suffice for this endpoint. However, consistent with 
the approach taken under the voluntary HPV Challenge Program, EPA is 
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.  799.5087(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 the 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.  799.5087(j) of the regulatory 
text). Consistent with the voluntary 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.  
799.5087(j) of the regulatory text. A document developed by 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 NTU assay are available at the NIEHS/Interagency 
Coordination Committee on the Validation of Alternative Methods 
(ICCVAM) website (Refs. 47-49).
5. Mammalian Toxicity--Genotoxicity
    Gene Mutations: Bacterial Reverse Mutation Test (in vitro): 40 
CFR 799.9510.
    Chromosomal Damage: In Vitro Mammalian Chromosome Aberration 
Test (40 CFR 799.9537), or the In Vivo Mammalian Bone Marrow 
Chromosomal Aberration Test (rodents: Mouse (preferred species), 
rat, or Chinese hamster) (40 CFR 799.9538), or the In Vivo Mammalian 
Erythrocyte Micronucleus Test (sampled in bone marrow) (rodents: 
Mouse (preferred species), rat, or Chinese hamster) (40 CFR 
799.9539).

    Persons 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 subject person who uses one of the in 
vivo methods instead of the in vitro method to address this end-point 
would be required to submit to EPA a rationale for conducting that 
alternate test in the final study report.
6. Mammalian Toxicity--Repeated Dose/Reproduction/Developmental
    Combined Repeated Dose Toxicity Study with the Reproduction/
Developmental Toxicity Screening Test: 40 CFR 799.9365.
    Reproduction/Developmental Toxicity Screening Test: 40 CFR 
799.9355.
    Repeated Dose 28-Day Oral Toxicity Study: 40 CFR 799.9305.

    For the ``Mammalian Toxicity--Repeated Dose/Reproduction/
Developmental'' endpoint, EPA recommends the use of the Combined 
Repeated Dose Toxicity Study with the Reproduction/Developmental 
Toxicity Screening Test (40 CFR 799.9365) as the test of choice. EPA 
recognizes, however, that there may be reasons to test a particular 
chemical 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 subject person who uses the combination of the Reproduction/
Developmental Toxicity Screening Test and the Repeated Dose 28-Day Oral 
Toxicity Study in place of the Combined Repeated Dose Toxicity Study 
with Reproduction/Developmental Toxicity Screen submit to EPA a 
rationale for conducting these alternate tests in the final study 
reports.
    In the proposal (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,'' and if that were 
the case, such chemical substances may be eligible for a reduced 
testing battery which substitutes a developmental toxicity study for 
the SIDS requirement to address repeated dose, reproduction, and 
developmental toxicity. EPA requested persons who believe that their 
chemical substance is used solely as a closed system intermediate to 
submit appropriate information along with their comments which 
substantiate this belief. If EPA agreed that the chemical substance is 
used solely as a closed system intermediate, EPA would defer repeated 
dose, reproduction, and developmental toxicity testing and address any 
needed developmental toxicity testing in subsequent rulemaking. In its 
comments on the proposal to this final rule, PETA (Ref. 50) claimed 
that the chemical substance phosphorochloridothioic acid, O,O-diethyl 
ester (CASRN 2524-

[[Page 1077]]

04-1) is a closed system intermediate; Albemarle further claimed that 
this chemical substance is no longer being manufactured (Ref. 51). EPA 
has not found, at this time, that these claims result in a change of 
the testing requirements for this substance. Albemarle is not the only 
producer of this chemical and existing production data indicate that 
this chemical is still an HPV chemical. Furthermore, EPA has not 
received any claims from a chemical manufacturer that this substance is 
used solely as a closed system intermediate. EPA's response to these 
claims is discussed in Unit E.12. of the ``Response to Public 
Comments'' document (Ref. 12).

B. When will the testing imposed by this final rule begin?

    Once this final rule is effective, which is 30 days after its 
publication in the Federal Register, the required testing must be 
initiated at a time sufficient to allow the required final report to be 
submitted by the deadline indicated in Sec.  799.5087(i) of the 
regulatory text.

C. How must the studies required under this test 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.  799.5087(j) of the regulatory text, the 
reporting requirements described in Sec.  799.5087(i) of the regulatory 
text, and with 40 CFR Part 792--TSCA Good Laboratory Practice 
Standards.

D. What form of test substances will be tested under this rule?

    EPA is specifying two distinct approaches for identifying the 
specific substances that would be tested under this rule, the 
application of which would depend on whether the substance is 
considered to be a ``Class 1'' or a ``Class 2'' chemical substance. 
First introduced when EPA compiled the TSCA Chemical Substance 
Inventory, the term Class 1 chemical substance refers to a chemical 
substance having a chemical composition that consists of a single 
chemical species (not including impurities) that can be represented by 
a specific, complete structure diagram. By contrast, the term Class 2 
chemical substance refers to a chemical substance having a composition 
that cannot be represented by a specific, complete chemical structure 
diagram, because such a substance generally contains two or more 
different chemical species (not including impurities). Table 2 in Sec.  
799.5087(j) of the regulatory text identifies the listed substances as 
either Class 1 or Class 2 substances.
    The ``Class 1'' chemical substances listed in Table 2 in Sec.  
799.5087(j) of the regulatory text (i.e., 14 of the 19 chemical 
substances included in this final rule) must be tested at a purity of 
at least 99%. In those 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.  
799.5087(j) of the regulatory text (i.e., 5 of the 19 chemical 
substances included in this final rule), EPA is requiring that the 
substance to be 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 for 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. A 
``Class 2'' designation most frequently represents a group of 
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 substances generally represent 
a much narrower group of substances for which the only variables are 
their impurities. EPA believes that, for purposes of this final rule, 
the testing of any representative form of a subject Class 2 substance 
would provide the data necessary to support the development of 
preliminary or screening level hazard and risk characterizations for 
the subject Class 2 substance. However, EPA would encourage the 
selection of representative forms of test substances that meet industry 
or consensus standards, where they exist. In accordance with TSCA Good 
Laboratory Practice Standards (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). In future 
TSCA section 4 test rules involving Class 2 substances, testing 
requirements relative to the number and specificity of the 
representative form of the substance may differ from the testing 
requirement in this final rule (i.e., testing of any representative 
form of the subject Class 2 substances). For example, EPA may require 
testing of more than one representative form of a Class 2 chemical 
substance or may specify the representative form to be tested and/or 
may specify equivalence data that must be submitted by exemption 
applicants (see 40 CFR 790.82).

E. Am I required to test under this rule?

    1. Am I subject to this rule? You are subject to this final rule 
and may be required to test if you manufacture (which is defined by 
statute to include import) or process, or intend to manufacture or 
process, one or more chemical substances listed in this final rule 
during the time period discussed 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 substance.
    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.  799.5087(j) of 
the regulatory text at any time from the effective date of the

[[Page 1078]]

final test 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 TSCA section 4(a) test rule, which, unless 
otherwise noted in the regulatory text, incorporates EPA's generic 
procedures applicable to TSCA section 4(a) test rules (contained within 
40 CFR part 790), fall into one of two groups, designated here as Tier 
1 and Tier 2. Persons in Tier 1 (those who would have to initially 
comply with the final rule) 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.
    Persons in Tier 2 (those who do not have to initially comply with 
the final rule) need not take any action unless they are notified by 
EPA that they are required to do so (because, for example, no person in 
Tier 1 had submitted a letter of intent to conduct testing), as 
described in Unit V.E.3.f. Note that both persons in Tier 1 who obtain 
exemptions and persons in Tier 2 would nonetheless be subject to 
providing reimbursement to persons who actually conduct the testing, as 
described in Unit V.E.4.
    a. Who is in Tier 1 and Tier 2? Table 4 of this unit describes who 
is in Tier 1 and Tier 2.

   Table 4--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
 Tier 1 (Persons initially required to    Tier 2 (Persons not initially
                comply)                        required to comply)
------------------------------------------------------------------------
Persons who manufacture (as defined at   A. Persons who manufacture (as
 TSCA section 3(7)), or intend to         defined at TSCA section 3(7))
 manufacture, a test rule substance,      or intend to manufacture a
 and who are not listed under Tier 2.     test rule substance solely as
                                          one or more of the following:
                                         --As a byproduct (as defined at
                                          40 CFR 791.3(c));
                                         --As an impurity (as defined at
                                          40 CFR 790.3);
                                         --As a naturally occurring
                                          chemical substance (as defined
                                          at 40 CFR 710.4(b));
                                         --As a non-isolated
                                          intermediate (as defined at 40
                                          CFR 704.3);
                                         --As a component of a Class 2
                                          substance (as described at 40
                                          CFR 720.45(a)(1)(i));
                                         --In amounts of less than 500
                                          kg (1,100 lbs) annually (as
                                          described at 40 CFR
                                          790.42(a)(4)); or
                                         --In small quantities solely
                                          for R&D (as described at 40
                                          CFR 790.42(a)(5)).
                                         B. Persons who process (as
                                          defined at TSCA section 3(10))
                                          or intend to process a test
                                          rule substance (see 40 CFR
                                          790.42(a)(2)).
------------------------------------------------------------------------
Note: kg--kilogram, R&D--research and development, TSCA--Toxic
  Substances Control Act.

    Under 40 CFR 790.2, EPA may establish procedures applying to 
specific test rules that differ from the generic procedures governing 
TSCA section 4(a) test rules in 40 CFR part 790. For purposes of this 
final rule, EPA has established certain requirements that differ from 
those under 40 CFR part 790.
    In this final test rule, EPA has reconfigured the tiers in 40 CFR 
790.42. In addition to processors, manufacturers of less than 500 
kilograms (kgs) (1,100 lbs) per year (small-volume manufacturers), and 
manufacturers of small quantities for research and development (R&D 
manufacturers), EPA has added the following persons to Tier 2:
    Byproduct manufacturers, impurity manufacturers, manufacturers of 
naturally occurring substances, manufacturers of non-isolated 
intermediates, and manufacturers of components of Class 2 substances. 
The Agency took administrative burden and complexity into account in 
determining who was to be in Tier 1 in this final rule. EPA believes 
that those persons in Tier 1 who are required to conduct testing under 
this final rule are generally large chemical manufacturers who, in the 
experience of the Agency, have traditionally conducted testing or 
participated in testing consortia under previous TSCA section 4(a) test 
rules.
    The Agency also believes that byproduct manufacturers, impurity 
manufacturers, manufacturers of naturally occurring substances, 
manufacturers of non-isolated intermediates, and manufacturers of 
components of Class 2 substances historically have not themselves 
participated in testing or contributed to reimbursement of those 
persons who have conducted testing. EPA understands that these 
manufacturers may include persons for whom the marginal transaction 
costs involved in negotiating and administering testing arrangements 
are deemed likely to raise the expense and burden of testing to a level 
that is disproportional to the additional benefits of including these 
persons in Tier 1. Therefore, EPA does not believe that the likelihood 
of the persons added to Tier 2 actually conducting the testing is 
sufficiently high to justify burdening these persons with Tier 1 
requirements (e.g., submitting requests for exemptions). Nevertheless, 
these persons, along with all other persons in Tier 2, would be subject 
to reimbursement obligations to persons who actually conduct the 
testing, as described in Unit V.E.4.
    TSCA section 4(b)(3)(B) requires all manufacturers and/or 
processors of a chemical substance to test that chemical substance if 
EPA has made findings under TSCA section 4(a)(1)(A)(ii) or TSCA section 
4(a)(1)(B)(ii) for that chemical substance, and issued a TSCA section 
4(a) test rule requiring testing. However, practicality must be a 
factor in determining who is subject to a particular test rule. Thus, 
persons who do not know or cannot reasonably ascertain that they are 
manufacturing or processing a substance subject to this final rule, 
(e.g., manufacturers or processors of a substance as a trace 
contaminant who are not aware of and cannot reasonably ascertain these 
activities) are not be subject to the rule. See Unit V.E.1. and Sec.  
799.5087(b)(2) of the regulatory text.
    b. Subdivision of Tier 2 entities. In this final rule the Agency 
has prioritized which persons in Tier 2 would be required to perform 
testing, if needed. Specifically, the Agency subdivided Tier 2 entities 
into:
    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

[[Page 1079]]

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 lbs annually, or in small quantities solely 
for research and development.
    ii. Tier 2B. Tier 2 processors, i.e. those who process, or intend 
to process, a test rule 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 Tier 2B. It is 
appropriate to require manufacturers in Tier 2A to submit letters of 
intent to test or exemption applications before processors are called 
upon because the Agency believes that testing costs are traditionally 
passed by manufacturers along to processors, enabling them to share in 
the costs of testing (Ref. 52). 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. 53).
    c. When is it appropriate for a person required to comply with the 
rule to apply for an exemption rather than to submit a letter of intent 
to conduct testing? You may apply for an exemption if you believe that 
the required testing will be performed by another person (or a 
consortium of persons formed under TSCA section 4(b)(3)(A)). You can 
find procedures relating to exemptions in 40 CFR 790.80 through 790.99, 
and Sec.  799.5087(c)(2), (c)(5), (c)(7), and (c)(11) of the regulatory 
text. In this final rule, EPA will not require the submission of 
equivalence data (i.e., data demonstrating that your substance is 
equivalent to the substance actually being tested) as a condition for 
approval 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 received a letter of 
intent to test from another source or has received (or expects to 
receive) the test data that would be required under this rule, the 
Agency would conditionally approve your exemption application under 40 
CFR 790.87.
    The Agency would terminate conditional exemptions if a problem 
occurs with the initiation, conduct, or completion of the required 
testing, or with the submission of the required data to EPA. EPA may 
then require you to submit a notice of intent to test or an exemption 
application. See 40 CFR 790.93 and Sec.  799.5087(c)(8) of the 
regulatory text. In addition, the Agency would terminate a conditional 
exemption if no letter of intent to test has been received by persons 
required to comply with the rule. See, e.g., Sec.  799.5087(c)(6) of 
the regulatory text. Note that the provisions at 40 CFR 790.48(b) have 
been incorporated into the regulatory text of this final rule; thus, 
persons subject to this final rule are not required to comply with 40 
CFR 790.48 itself (see Sec.  799.5087(c)(4)-(c)(7) and Sec.  
799.5087(d)(3) of the 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 would be subject to the rule and you would be 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.
    If a problem occurs with the initiation, conduct, or completion of 
the required testing, or with the submission of the required data to 
EPA, the Agency may require you to submit a notice of intent to test or 
an exemption application. See 40 CFR 790.93 and Sec.  799.5087(c)(10) 
of the regulatory text.
    In addition, you will need to submit a notice of intent to test or 
an exemption application if:
     No manufacturer in Tier 1 has notified EPA of its intent 
to conduct testing; and
     EPA has published a Federal Register document directing 
persons in Tier 2 to submit to EPA letters of intent to conduct testing 
or exemption applications.
    See Sec.  799.5087(c)(4), (c)(5), (c)(6), and (c)(7) of the 
regulatory text. The Agency will conditionally approve an exemption 
application under 40 CFR 790.87, if EPA has received a letter of intent 
to test or has received (or expects to receive) the test data required 
under this rule. EPA is not aware of any circumstances in which test 
rule Tier 1 entities have sought reimbursement from Tier 2 entities 
either through private agreements or by soliciting the involvement of 
the Agency under the reimbursement regulations at 40 CFR part 791.
    f. What will happen if no one submits a letter of intent to conduct 
testing? EPA anticipates that it will receive letters of intent to 
conduct testing for all of the tests specified and chemical substances 
included in this final rule. However, in the event it does not receive 
a letter of intent for one or more of the tests required for any of the 
chemical substances in this rule within 30 days after the publication 
of a Federal Register document notifying Tier 2 manufacturers and 
processors 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 the rule with respect to that chemical substance who are not already 
in violation of the rule would be in violation of the rule.
    4. How do the reimbursement procedures work? In the past, persons 
subject to test rules have independently worked out among themselves 
their respective financial contributions to those persons who have 
actually conducted the testing. However, if persons are unable to agree 
privately on reimbursement, they may take advantage of EPA's 
reimbursement procedures at 40 CFR part 791, promulgated under the 
authority of TSCA section 4(c). These procedures include: The 
opportunity for a hearing with the American Arbitration Association; 
publication by EPA of a document in the Federal Register concerning the 
request for a hearing; and the appointment of a hearing officer to 
propose an order for fair and equitable reimbursement. The hearing 
officer may base his or her proposed order on the production volume 
formula set out at 40 CFR 791.48, but is not obligated to do so. Under 
this 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

[[Page 1080]]

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?

    A final report must be submitted for each test for each chemical 
substance 13 months after the effective date of the final rule, i.e., 
by the deadline indicated in Sec.  799.5087(i) of the regulatory text. 
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 
robust summaries are also encouraged to submit the robust summary 
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 
the final rule?

    A company that submits a letter of intent to test under the 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 test rule?

    EPA's most recent analysis of laboratory capacity (Ref. 54) 
indicates that available test facilities and personnel would adequately 
accommodate the testing specified in this rule.

I. Might EPA seek further testing of the chemical substances in this 
final test 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 this 
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 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 substance.

VII. Decision Not To Require Testing for Certain Endpoints

    For certain testing endpoints for certain chemicals 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.  799.5087(j) of 
the regulatory text, which lists the chemical substances and testing 
requirements, has been revised to reflect this. Further discussion 
follows in Units VII.A. through VII.F.

A. Screening Reproduction/Developmental Toxicity of 2,4-Hexadienoic 
Acid, (E,E)-

    As discussed in Unit E.3. of the ``Response to Public Comments'' 
document (Ref. 12), EPA reviewed additional data, including studies 
submitted by the PETA (PETA submitted on behalf of themselves and other 
Animal Welfare Organizations (AWOs)) for 2,4-hexadienoic acid, (E,E)- 
(CASRN 110-44-1), also known as sorbic acid. After reviewing these 
data, EPA finds existing studies are adequate to evaluate reproduction/
developmental toxicity and is not finalizing the proposed testing for 
reproduction/developmental toxicity for sorbic acid.

B. Screening Reproduction/Developmental Toxicity of Ethanedioic Acid

    As discussed in Unit E.4. of the ``Response to Public Comments'' 
document (Ref. 12), EPA reviewed additional data, including studies 
submitted by PETA (PETA submitted on behalf of themselves and other 
AWOs) for ethanedioic acid (CASRN 144-62-7). After reviewing these 
data, EPA finds existing studies are adequate to evaluate reproduction/
developmental toxicity and is not finalizing the proposed testing for 
reproduction/developmental toxicity for ethanedioic acid. However, as 
further discussed in the ``Response to Public Comments'' document, EPA 
finds studies submitted for other endpoints inadequate and is still 
requiring the testing of ethanedioic acid for chromosomal damage, 
aquatic toxicity and chemical/physical endpoints as described in Table 
2 in Sec.  799.5087(j) of the regulatory text.

C. Physical Chemical Properties and Aquatic Toxicity of Castor Oil, 
Oxidized, and Physical Chemical Properties of Castor Oil, Sulfated, 
Sodium Salt

    As discussed in Unit E.7. of the ``Response to Public Comments'' 
document (Ref. 12), EPA reviewed data submitted by Vertellus on vapor 
pressure, water solubility, and Log Kow. Based on 
information provided by Vertellus, indicating the extremely low water 
solubility and vapor pressure, and extremely high Log Kow of 
this substance, EPA is not finalizing the proposed testing for these 
endpoints for castor oil, oxidized (CASRN 68187-84-8). In addition, EPA 
agrees with Vertellus that the extreme insolubility of this substance 
makes aquatic toxicity testing for this chemical substance not 
feasible. Therefore, EPA is not finalizing the proposed testing for 
aquatic toxicity testing for castor oil, oxidized. However, EPA is 
still requiring a ``melting point'' test be conducted for this 
substance. EPA acknowledges Vertellus' comment that the substance is a 
liquid at room temperature. In these cases the melting point 
determination would actually involve determination of a freezing point. 
Since ASTM E 324-99 (capillary tube) does not specifically include 
instructions for determining a freezing point, for that particular 
endpoint EPA

[[Page 1081]]

is requiring OECD Guideline 102 (melting point/melting range) be used 
instead of ASTM E 324-99 for that test. Furthermore, as discussed in 
Unit E.7. of the ``Response to Public Comments'' document, because of 
its structural similarity with castor oil, oxidized, EPA is also not 
requiring water solubility and log Kow for castor oil, 
sulfated, sodium salt (CASRN 68187-76-8). However, because of its 
surfactant properties, EPA is still requiring aquatic toxicity testing 
for castor oil, sulfated, sodium salt.

D. Mammalian Toxicity--Acute, of Castor Oil, Oxidized

    As discussed in Unit E.7. of the ``Response to Public Comments'' 
document (Ref. 12), EPA reviewed data submitted by Vertellus on acute 
toxicity of oxidized castor oil (CASRN 68187-84-8) and has concluded 
that these data are adequate. However, while EPA believes that data for 
certain endpoints, as just discussed, are adequate for castor oil, 
sulfated; and castor oil, oxidized; data are still needed on the other 
end-points listed for these chemical substances in Table 2 in Sec.  
799.5087(j) of the regulatory text, including, for castor oil, 
sulfated, mammalian acute toxicity testing, for which EPA received no 
data contraindicating this testing need.

E. Boiling Point of Benzenediamine, Ar,Ar-Diethyl-Ar-Methyl-

    Boiling point is not required for benzenediamine, ar,ar-diethyl-ar-
methyl- (CASRN 68479-98-1), as discussed in Unit E.8. of the ``Response 
to Public Comments'' document (Ref. 12). Albemarle provided EPA with 
data which are adequate for this endpoint.

F. Acute Mammalian Toxicity, Repeated-Dose Toxicity, and Mutagenicity 
Endpoints of Alkenes, C12	24, Chloro

    As discussed in Unit E.9. of the ``Response to Public Comments'' 
document (Ref. 12), EPA reviewed additional data including studies 
submitted by AWOs and CPIA. In addition to data on this group of 
chemicals, comments focused on the potential acceptability of using 
analog data available for other similar classes of chlorinated 
paraffins. For certain proposed tests, EPA has accepted certain of 
these data, including analog data on similar substances. However, for 
other testing endpoints, EPA does not agree that the surrogate 
chemicals are acceptable analogs, or has found some of the submitted 
studies inadequate. Specifically, EPA finds that data are acceptable 
for the acute mammalian, repeated-dose, and mutagenicity endpoints. EPA 
continues to require testing on physical/chemical properties (all), 
biodegradation, aquatic toxicity testing (C1, Test Group 2), in vitro 
chromosomal aberrations, and reproductive and developmental toxicity.

VIII. Economic Impacts

    EPA has prepared an economic assessment entitled ``Economic Impact 
Analysis for the Final Section 4 Test Rule for High Production Volume 
Chemicals'' (Ref. 55), a copy of which has been placed in the docket 
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 19 chemical substances. The total 
social cost of providing test data on the 19 chemical substances that 
were evaluated in this economic analysis is estimated to be $4.19 
million. (Ref. 55).
    While legally subject to this test rule, processors of a subject 
chemical substance would be required to comply with the requirements of 
the rule only if they are directed to do so by EPA as described in 
Sec.  799.5087(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 the 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 
19 chemical substances evaluated in the economic analysis to be $1.48 
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 the rule, is 
estimated to range from $25.56 per notice to $80.22 per notice (Ref. 
55). 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, 16 out of the 19 chemical substances 
(84%) would have a price impact at less than the 1% level. Similarly, 
15 out of the 19 chemical substances (79%) 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 test rule is low for at 
least 79% of the chemical substances in this rule. Approximately 4 
chemical substances (21%) of the 19 chemical substances for which price 
data are available would have a price impact at a level greater than or 
equal to 1% under the least (average) cost scenario.
    EPA believes, on the basis of these calculations, that the testing 
of the chemical substances in this final rule presents a low potential 
for adverse economic impact for the majority of chemical substances. 
Because the subject chemical substances have relatively large 
production volumes, the annualized costs of testing, expressed as a 
percentage of annual revenue, are very small for most chemical 
substances. There are, however, some chemical substances for which the 
price impact is expected to exceed 1% of the revenue from that chemical 
substance. The potential for adverse economic impact is

[[Page 1082]]

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.
    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 the test rule where 
such information has not been publicly available. Because of 
constraints on information on the value of information, our evaluation 
of benefits is qualitative and does not address incremental benefits. 
We believe, 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-2007-0531. 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, 
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; Second 
Group of Chemicals. Proposed Rule. Federal Register (73 FR 43314, July 
24, 2008) (FRL-8373-9).
    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 13707, March 16, 2006) (FRL-7335-2).
    5. 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).
    6. 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).
    7. EPA, Office of Pollution Prevention and Toxics (OPPT). HPV 
Challenge Program Chemical List. Available on-line at: http://www.epa.gov/oppt/chemrtk/pubs/update/hpvchmlt.htm.
    8. OECD Secretariat. Manual for the Investigation of HPV Chemicals. 
OECD Programme on the Co-Operative Investigation of High Production 
Volume Chemicals. Paris, France. September 2004. Available on-line at: 
http://www.oecd.org/document/7/0,2340,en_2649_34379_1947463_1_1_1_1,00.htm.
    9. ICCA. ICCA HPV Working List of Chemicals. October 2005. 
Available on-line at: http://www.cefic.org/activities/hse/mgt/hpv/hpvinit.htm and http://www.iccahpv.com/hpvchallenge/about.cfm.
    10. EPA. TSCA Section 4(a)(1)(B) Proposed Statement of Policy. 
Notice. Federal Register (56 FR 32294, July 15, 1991).
    11. Chemical Manufacturing Association (CMA) now American Chemistry 
Council (ACC). Comments on EPA's TSCA section 4(a)(1)(B) Proposed 
Statement of Policy submitted to the TSCA Public Docket Office, EPA. 
September 13, 1991.
    12. EPA, OPPT, Chemical Information and Testing Branch (CITB). 
Response to public comments regarding testing of certain high 
production volume chemicals. August 2010.
    13. EPA, OPPT, Economics, Exposure and Technology Division (EETD). 
Testing of Certain High Production Volume Chemicals-2 (Exposure 
Findings Supporting Information). July 2010.
    14. 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. Available on-
line at: http://www.cdc.gov/niosh/88-106.html. 1988.
    15. 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. Available on-line at: http://www.cdc.gov/niosh/89-103.html. 1989.
    16. DHHS, CDC, NIOSH. National occupational exposure survey 
sampling methodology. Vol. II. Sieber, W.K., ed. Cincinnati, OH. DHHS 
(NIOSH) Publication No. 89-102. Available on-line at: http://www.cdc.gov/niosh/89-102.html. 1989.
    17. EPA. TSCA Inventory Update Rule Amendments. Final Rule. Federal 
Register (68 FR 848, January 7, 2003) (FRL-6767-4).
    18. EPA. TSCA Inventory Update Reporting Revisions. Final Rule. 
Federal Register (70 FR 75059, December 19, 2005) (FRL-7743-9).
    19. EPA, OPPT. Draft Guidance on Developing Robust Summaries. 
October 22, 1999. Available on-line at: http://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. ASTM International. Standard Test Method for Vapor Pressure of 
Liquids by Ebulliometry. ASTM E 1719-05. 2005.
    23. ASTM International. Standard Test Method for Determining Vapor 
Pressure by Thermal Analysis. ASTM E 1782-08. 2008.
    24. ASTM International. Standard Test Method for Partition 
Coefficient (n-Octanol/Water) Estimation by Liquid Chromatography. ASTM 
E 1147-92 (Reapproved 2005).
    25. OECD. Guideline for the Testing of Chemicals: Melting Point/
Melting Range. OECD 102. July 27, 1995.
    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.

[[Page 1083]]

    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).
    41. 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.
    42. 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.
    43. 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 on-line at: http://www.epa.gov/oppt/newchems/pubs/pbtpolcy.htm.
    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 on-line 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 on-line 
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 on-line 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 
on-line at: http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm.
    50. PETA. Comments on EPA's Proposed Test Rule for Testing of 
Certain High Production Volume Chemicals; Second Group of Chemicals 
submitted to the TSCA Public Docket Office, EPA. October 22, 2008.
    51. Albemarle. Comments on EPA's Proposed Test Rule for Testing of 
Certain High Production Volume Chemicals; Second Group of Chemicals 
submitted to the TSCA Public Docket Office, EPA. October 21, 2008.
    52. EPA. Toxic Substances; Test Rule Development and Exemption 
Procedures. Interim Final Rule. Federal Register (50 FR 20652, 20654, 
May 17, 1985).
    53. EPA. Toxic Substances Control Act; Data Reimbursement. Final 
Rule. Federal Register (48 FR 31786, 31789, July 11, 1983).
    54. EPA, Economics and Policy Analysis Branch (EPAB). Analysis of 
Laboratory Capacity to Support U.S. EPA Chemical Testing Program 
Initiatives. Washington, DC. August 2004.
    55. EPA, OPPT. Economic Impact Analysis for the Final Section 4 
Test Rule for High Production Volume Chemicals-2. Prepared by the OPPT 
Economic and Policy Analysis Branch. July 2010.
    56. EPA, OPPT. The Use of Structure-Activity Relationships (SAR) in 
the High Production Volume Chemicals Challenge Program. August 26, 
1999. Available on-line at: http://www.epa.gov/chemrtk/pubs/general/sarfinl1.htm.
    57. EPA, OPPT, EETD, EPAB. Economic Analysis in Support of the TSCA 
12(b) Information Collection Request. Washington, DC. October 30, 1998.

X. 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 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-2 (Ref. 55). A 
copy of the economic analysis is available in the docket for this final 
rule and is summarized in Unit VIII.

[[Page 1084]]

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 test rule is provided in the economic analysis (Ref. 55).
    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 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. EPA is 
amending the table in 40 CFR part 9 to list the OMB approval number for 
the information collection requirements contained in this final rule. 
This listing of the OMB control numbers and their subsequent 
codification in the CFR satisfies the display requirements of PRA and 
OMB's implementing regulations at 5 CFR part 1320. This ICR was 
previously subject to public notice and comment prior to OMB approval, 
and given the technical nature of the table, EPA finds that further 
notice and comment to amend it is unnecessary. In addition, EPA is 
correcting typographical errors in several listings which were 
introduced into the table by a final rule published in the Federal 
Register issue of June 30, 2010 (75 FR 37722) (FRL-8833-7).
    As a result, EPA finds that there is ``good cause'' under section 
553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 
553(b)(3)(B), to amend this table without further notice and comment.
    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 19 chemical substances is 9,008 hours, with an estimated burden 
per chemical substance of 474 hours (Ref. 55). 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. 55). 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 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 
would not have a significant adverse economic impact on a substantial 
number of small entities. The factual basis for the Agency's 
determination is presented in the small entity impact analysis prepared 
as part of the economic analysis for this final rule (Ref. 55), which 
is summarized in Unit VIII., 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. 55), 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. 55) 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

[[Page 1085]]

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 either 750; 1,000; or 1,500 
employees. When assessing the potential impacts of test rules on 
chemical manufacturers, EPA believes that a standard based on total 
annual sales may provide a more appropriate means to judge the ability 
of a chemical manufacturing firm to support chemical testing without 
significant costs or burdens.
    EPA is currently determining what level of annual sales would 
provide the most appropriate size cutoff with regard to various 
segments of the chemical industry usually impacted by TSCA section 4(a) 
test rules, but has not yet reached a determination. As stated above, 
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. 55). For a conservative estimate of the 
number of small businesses affected by the HPV 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 19 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 48 affected UCEs. Sales and employment data could be found for 45 
and 46 of these UCEs (88%), respectively.
    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), 20 
companies 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 20 small businesses analyzed for small business impacts, one 
company had no sales data available. Another two companies could not be 
classified as small or large because there were no employment data 
available, but were still included in the small business impact 
analysis. Of the 19 designated as small businesses, none had cost-to-
sales ratios of greater than 1% under both the least- and average-cost 
scenarios. For the chemical substances where sales data were 
unavailable, EPA used the median sales value sales of all other small 
businesses equal to $15.4 million. The costs for the three companies 
were estimated to be well below 0.01% 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.
    The estimated cost of the TSCA section 12(b)(1) export 
notification, which, as a result of the final rule, would be required 
for the first export to a particular country of a chemical substance 
subject to the rule, is estimated to be $80.22 for the first time that 
an exporter must comply with TSCA section 12(b)(1) export notification 
requirements, and $25.56 for each subsequent export notification 
submitted by that exporter (Refs. 55-57). EPA has concluded that the 
costs of TSCA section 12(b)(1) export notification would have a 
negligible impact on exporters of the chemical substances in the final 
rule, regardless of the size of the exporter.

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 VIII., would be $4.19 million. The total annualized costs of this 
final rule are estimated to be $1.48 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 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 would establish testing and 
recordkeeping requirements that apply to manufacturers (including 
importers) and processors of certain chemical substances. Because EPA 
has no information to indicate that any State or local government 
manufactures or processes the chemical substances covered by this 
action, this 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 affect on tribal governments, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian

[[Page 1086]]

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 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 would establish testing and recordkeeping requirements that 
apply to manufacturers (including importers) and processors of certain 
chemical substances, and would result in the development of data about 
those chemical substances that can subsequently be used to assist the 
Agency and others in determining whether the chemical substances in 
this 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 rule, EPA is requiring the 
use of voluntary consensus standards issued by ASTM and ISO which 
evaluate the same type of toxicity as the TSCA and OECD test methods, 
where applicable. Copies of the 18 ASTM, ISO, and OECD test methods 
referenced in Sec.  799.5087(h) of the regulatory text have been placed 
in the docket for this final rule. You may obtain copies of the ASTM 
standards from the American Society for Testing and Materials, 100 Bar 
Harbor Dr., West Conshohocken, PA 19428-2959, and copies of the ISO 
standards from the International Organization for Standardization, Case 
Postale, 56 CH-1211 Gen[egrave]ve 20 Switzerland. EPA received the 
required approval from the Director of the Federal Register for the 
incorporation by reference of the ASTM and ISO standards 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 the TSCA test methods, 40 
CFR 799.6756, 799.6784, 799.6786, 799.9130, 799.9510, 799.9538, 
799.9365, 799.9305, and 799.9355, respectively, upon which the test 
standards in this final rule are based.

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 the 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.

XI. 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

40 CFR Part 9

    Environmental protection, Administrative practice and procedure, 
Reporting and recordkeeping requirements.

40 CFR Part 799

    Environmental protection, Chemicals, Hazardous substances, 
Incorporation by reference, Laboratories, Reporting and recordkeeping 
requirements.

    Dated: December 21, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority:  7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 
2003, 2005, 2006, 2601-2671, 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 
1330, 1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 
CFR 1971-1975, Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 
7542, 9601-9657, 11023, 11048.


0
2. In Sec.  [emsp14]9.1, in the table, revise the entries ``Part 725, 
Part 749, Part 761, Part 790, and Part 799'' under the appropriate 
undesignated center heading indicated below to read as follows:

[[Page 10873]]

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
     Reporting Requirements and Review Processes for Microorganisms
------------------------------------------------------------------------
Part 725................................................       2070-0012
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
                        Water Treatment Chemicals
------------------------------------------------------------------------
Part 749................................................       2070-0193
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution
                    in Commerce, and Use Prohibitions
------------------------------------------------------------------------
Part 761................................................       2070-0012
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
     Procedures Governing Testing Consent Agreements and Test Rules
------------------------------------------------------------------------
Part 790................................................       2070-0033
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
    Identification of Specific Chemical Substance and Mixture Testing
                              Requirements
------------------------------------------------------------------------
Part 799................................................       2070-0033
------------------------------------------------------------------------

* * * * *

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 Sec.  799.5087 to subpart D to read as follows:


Sec.  799.5087  Chemical testing requirements for second group of high 
production volume chemicals (HPV2).

    (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 February 7, 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 comply with this   Persons not initially required to comply with this section
 section (Tier 1).                                (Tier 2).
Persons not otherwise specified in column 2 of   Tier 2A. Persons who manufacture (as defined at TSCA section
 this table that manufacture (as defined at       3(7)) or intend to manufacture a chemical substance included
 TSCA section 3(7)) or intend to manufacture a    in this section solely as one or more of the following:
 chemical substance included in this section.    --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 lbs) annually (as
                                                  described at 40 CFR 790.42(a)(4)); or
                                                 --For research and development (as described at 40 CFR
                                                  790.42(a)(5)).
                                                 B. Persons who process (as defined at TSCA section 3(10)) or
                                                  intend to process a chemical substance included in this
                                                  section (see 40 CFR 790.42(a)(2)).
----------------------------------------------------------------------------------------------------------------
Note: kg--kilogram, 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 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 February 7, 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.

[[Page 1088]]

    (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 February 7, 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 February 7, 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 February 7, 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 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, 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; paragraph (a)(2) and paragraph 
(b) of Sec.  790.80; Sec.  790.82(e)(1); Sec.  790.85; and Sec.  
790.48.
    (e) If I do not comply with this section, when will I be considered 
in violation of it? You will be considered in violation of this section 
as of 1 day after the date by which you are required to comply with 
this section.
    (f) How are EPA's data reimbursement procedures affected for 
purposes of this section? If persons subject to this section are unable 
to agree on the amount or method of reimbursement for test data 
development for one or more chemical substances included in this 
section, any person may request a hearing as described in 40 CFR part 
791. In the determination of fair reimbursement shares under this 
section, if the hearing officer chooses to use a formula based on 
production volume, the total production volume amount will include 
amounts of a chemical substance produced as an impurity.
    (g) Who must comply with the export notification requirements? Any 
person who exports, or intends to export, a chemical substance listed 
in Table 2 in paragraph (j) of this section is subject to 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

[[Page 1089]]

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 test methods from the 
American Society for Testing and Materials, 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 test 
methods from the International Organization for Standardization, 1, ch. 
de la Voie-Creuse, Case postale, 56 CH-1211 Geneve 20 Switzerland, 
telephone number: +41 22 749 01 11, web address: http://www.iso.org; 
and a copy 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 test method and guideline at 
the EPA Docket Center, EPA West, Rm. B102, 1301 Constitution Ave., NW., 
Washington, DC 20004, telephone number: (202) 566-1744, or 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 final report for each specific test 
for each subject chemical substance must be received by EPA by March 7, 
2012, unless an extension is granted in writing pursuant to 40 CFR 
790.55. A robust summary of the final report for each specific test 
should be submitted in addition to and at the same time as the final 
report. The term ``robust summary'' is used to describe the technical 
information necessary to adequately describe an experiment or study and 
includes the objectives, methods, results, and conclusions of the full 
study report which can be either an experiment or in some cases an 
estimation or prediction method. Guidance for the compilation of robust 
summaries is described in a document entitled ``Draft Guidance on 
Developing Robust Summaries'' which is available on-line: 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/
         CASRN            Chemical name       Class      (See table 3 of
                                                          this section)
------------------------------------------------------------------------
75-07-0...............  Acetaldehyde.....            1   C2, F2.
78-11-5...............  1,3-Propanediol,             1   C4.
                         2,2-
                         bis[(nitrooxy)me
                         thyl]-,
                         dinitrate
                         (ester).
84-65-1...............  9,10-                        1   C6.
                         Anthracenedione.
89-32-7...............  1H,3H-Benzo[1,2-             1   A3, A4, A5, B,
                         c:4,5-c']difuran-               C1, D, E1, F1.
                         1,3,5,7-tetrone.
110-44-1..............  2,4-Hexadienoic              1   C6.
                         acid, (E,E)-.
118-82-1..............  Phenol, 4,4'-                1   C1.
                         methylenebis[2,6-
                         bis(1,1-
                         dimethylethyl)-.
119-61-9..............  Methanone,                   1   B, C2.
                         diphenyl-.

[[Page 1090]]

 
144-62-7..............  Ethanedioic acid.            1  A1, A2, A3, A5,
                                                         B, C1, E2.
149-44-0..............  Methanesulfinic              1   E1.
                         acid,.
                        hydroxy-,
                         monosodium salt.
2524-04-1.............  Phosphorochlorido            1   A1, A2, A3, A4,
                         thioic acid, O,O-               A5, B, C1, E1,
                         diethyl ester.                  E2, F2.
4719-04-4.............  1,3,5-Triazine-              1   C6.
                         1,3,5(2H,4H,6H)-
                         triethanol.
6381-77-7.............  D-erythro-hex-2-             1   A4, B, C1.
                         enonic acid,
                         gamma.-lactone,
                         monosodium salt.
31138-65-5............  D-gluco-heptonic             1   A1, A2, A4, A5,
                         acid, monosodium                B, C1, D, E1,
                         salt, (2.xi.)-.                 E2, F1.
66241-11-0............  C.I. Leuco                   2   A1, A2, A3, A4,
                         Sulphur Black 1.                A5, B, C1, D,
                                                         E1, E2, F1.
68187-76-8............  Castor oil,                  2   A1, A2, C1, D,
                         sulfated, sodium                E1, E2, F1.
                         salt.
68187-84-8............  Castor oil,                  2   A1, A2, B, E1,
                         oxidized.                       E2, F1.
68479-98-1............  Benzenediamine,              1   A1, A3, A4, A5,
                         ar,ar-diethyl-ar-               C1, E1, E2, F1.
                         methyl-.
68527-02-6............  Alkenes, C12	24,             2   A1, A2, A3, A4,
                         chloro.                         A5, B, C1, E2,
                                                         F2.
68647-60-9............  Hydrocarbons, C >            2   A2, A3, A5, B,
                         4.                              C1, D, E1, E2,
                                                         F1.
------------------------------------------------------------------------
Note: CASRN = Chemical Abstract Service Registry Number.


       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 requirements and
          Testing category              Test symbol              references               Special conditions
----------------------------------------------------------------------------------------------------------------
Physical/chemical properties.......  A                  1. Melting Point: American   n-Octanol/water Partition
                                                         Society for Testing and      Coefficient (log 10 basis)
                                                         Materials (ASTM) E 324-99    or log KOW:
                                                         (capillary tube), if a      Which method is required,
                                                         Freezing Point:              if any, is determined by
                                                         Organization for Economic    the test substance's
                                                         Cooperation and              estimated \i\ log KOW as
                                                         Development (OECD) 102       follows:
                                                         (melting point/melting      log KOW < 0: No testing
                                                         range).                      required.
                                                        2. Boiling Point: ASTM E     log KOW range 0-1: Method A
                                                         1719-05 (ebulliometry).      or B.
                                                        3. Vapor Pressure: ASTM E    log KOW range > 1-4: Method
                                                         1782-08 (thermal analysis).  A, B, or C.
                                                        4. n-Octanol/Water           log KOW range > 4-6: Method
                                                         Partition Coefficient (log   B or C.
                                                         10 basis) or log KOW: (See  log KOW > 6: Method C.
                                                         Special Conditions for the  Test sponsors must provide
                                                         log KOW test requirement     in the final study report
                                                         and select the appropriate   the underlying rationale
                                                         method to use, if any,       for the method and pH
                                                         from those listed in this    selected. In order to
                                                         column.).                    ensure environmental
                                                         Method A: 40 CFR 799.6755    relevance, EPA highly
                                                         (shake flask).               recommends that the
                                                         Method B: ASTM E 1147-92     selected study be
                                                         (Reapproved 2005) (liquid    conducted at pH 7.
                                                         chromatography).            Water Solubility:
                                                         Method C: 40 CFR 799.6756   Which method is required,
                                                         (generator column).          if any, is determined by
                                                        5. Water Solubility: (See     the test substance's
                                                         Special Conditions for the   estimated \ii\ water
                                                         water solubility test        solubility. Test sponsors
                                                         requirement and select the   must provide in the final
                                                         appropriate method to use,   study report the
                                                         if any, from those listed    underlying rationale for
                                                         in this column.).            the method and pH
                                                         Method A: ASTM E 1148-02     selected. In order to
                                                         (Reapproved 2008) (shake     ensure environmental
                                                         flask).                      relevance, EPA highly
                                                         Method B: 40 CFR 799.6784    recommends that the
                                                         (shake flask).               selected study be
                                                         Method C: 40 CFR 799.6784    conducted starting at pH
                                                         (column elution).            7.
                                                         Method D: 40 CFR 799.6786   > 5,000 milligram/Liter (mg/
                                                         (generator column).          L): Method A or B.
                                                                                     > 10 mg/L-5,000 mg/L:
                                                                                      Method A, B, C, or D.
                                                                                     > 0.001 mg/L-10 mg/L:
                                                                                      Method C or D.
                                                                                     <= 0.001 mg/L: No testing
                                                                                      required.
Environmental fate and pathways--    B                  For B, consult               Which method is required,
 ready biodegradation.                                   International Organization   if any, is determined by
                                                         for Standardization (ISO)    the test substance's
                                                         10634:1995(E) for            physical and chemical
                                                         guidance, and choose one     properties, including its
                                                         of the methods listed in     water solubility. ISO
                                                         this column:.                10634:1995(E) provides
                                                        1. ASTM E 1720-01             guidance for selection of
                                                         (Reapproved 2008) (sealed    an appropriate test method
                                                         vessel CO2 production        for a given test
                                                         test) OR.                    substance. Test sponsors
                                                        2. ISO 14593:1999(E) (CO2     must provide in the final
                                                         headspace test) OR.          study report the
                                                        3. ISO 7827:1994(E)           underlying rationale for
                                                         (analysis of DOC) OR.        the method selected.
                                                        4. ISO 9408:1999(E)
                                                         (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).

[[Page 1091]]

 
Aquatic toxicity...................  C1                 For C1, Test Group 1 or      The following are the
                                                         Test Group 2 listed in       special conditions for C1,
                                                         this column must be used     C2, C3, C4, C5, and C7
                                                         to fulfill the testing       testing; there are no
                                                         requirements--See Special    special conditions for C6.
                                                         Conditions..                Which test group is
                                                        Test Group 1 for C1:.......   required is determined by
                                                        1. Acute Toxicity to Fish:    the test substance's
                                                         ASTM E 729-96 (Reapproved    measured log KOW as
                                                         2007).                       obtained under Test
                                                        2. Acute Toxicity to          Category A, or using an
                                                         Daphnia: ASTM E 729-96       existing measured log KOW.
                                                         (Reapproved 2007).           \iii\
                                                        3. Toxicity to Plants        If log KOW < 4.2: Test
                                                         (Algae): ASTM E 1218-04      Group 1 is required.
                                                         \e1\.                       If log KOW =
                                                        Test Group 2 for C1:.......   4.2: Test Group 2 is
                                                        1. Chronic Toxicity to        required
                                                         Daphnia: ASTM E 1193-97
                                                         (Reapproved 2004).
                                                        2. Toxicity to Plants
                                                         (Algae): ASTM E 1218--04
                                                         \e1\.
                                     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
                                                         \e1\.
                                     .................  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
                                                         \e1\.
                                     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
                                                         \e1\.
                                     .................  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
                                                         \e1\.
                                     C4                 For C4, Test Group 1 or
                                                         Test Group 2 listed in
                                                         this column must be used
                                                         to fulfill the testing
                                                         requirements--See Special
                                                         Conditions..
                                     .................  Test Group 1 for C4:.......
                                     .................  1. Acute Toxicity to Fish:
                                                         ASTM E 729-96 (Reapproved
                                                         2007).
                                     .................  2. Acute Toxicity to
                                                         Daphnia: ASTM E 729-96
                                                         (Reapproved 2007).
                                     .................  Test Group 2 for C4:.......
                                     .................  1. Chronic Toxicity to
                                                         Daphnia: ASTM E 1193-97
                                                         (Reapproved 2004).
                                     C5                 For C5, Test Group 1 or
                                                         Test Group 2 listed in
                                                         this column must be used
                                                         to fulfill the testing
                                                         requirements--See Special
                                                         Conditions..
                                     .................  Test Group 1 for C5:.......
                                     .................  1. Acute Toxicity to
                                                         Daphnia: ASTM E 729-96
                                                         (Reapproved 2007).
                                     .................  Test Group 2 for C5:.......
                                     .................  1. Chronic Toxicity to
                                                         Daphnia: ASTM E 1193-97
                                                         (Reapproved 2004).
                                     C6                 Toxicity to Plants (Algae):
                                                         ASTM E 1218-04 \e1\.
                                     C7                 For C7, Test Group 1 or
                                                         Test Group 2 listed in
                                                         this column must be used
                                                         to fulfill the testing
                                                         requirements--See Special
                                                         Conditions..
                                     .................  Test Group 1 for C7:.......
                                     .................  1. Acute Toxicity to Fish:
                                                         ASTM E 729-96 (Reapproved
                                                         2007).
                                     .................  Test Group 2 for C7:.......
                                     .................  1. Chronic Toxicity to
                                                         Daphnia: ASTM E 1193-97
                                                         (Reapproved 2004).

[[Page 1092]]

 
Mammalian toxicity--acute..........  D                  See special conditions for   Which testing method is
                                                         this test requirement and    required is determined by
                                                         select the method that       the test substance's
                                                         must be used from those      physical state at room
                                                         listed in this column..      temperature (25 [deg]C).
                                                        Method A: Acute Inhalation    For those test substances
                                                         Toxicity (rat): 40 CFR       that are gases at room
                                                         799.9130.                    temperature, Method A is
                                                        Method B: EITHER:..........   required; otherwise, use
                                                         1. Acute (Up/Down) Oral      either of the two methods
                                                         Toxicity (rat): ASTM E       listed under Method B.
                                                         1163-98 (Reapproved 2002).  In Method B, 40 CFR
                                                         OR........................   799.9110(d)(1)(i)(A)
                                                         2. Acute (Up/Down) Oral      refers to the OECD 425 Up/
                                                         Toxicity (rat): 40 CFR       Down Procedure.\iv\
                                                         799.9110(d)(1)(i)(A).       Estimating starting dose
                                                                                      for Method B: Data from
                                                                                      the neutral red uptake
                                                                                      basal cytotoxicity assay
                                                                                      \v\ using normal human
                                                                                      keratinocytes or mouse
                                                                                      BALB/c 3T3 cells may be
                                                                                      used to estimate the
                                                                                      starting dose.
Mammalian toxicity--genotoxicity...  E1                 Bacterial Reverse 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: In       damage are encouraged to
                                                         vitro Mammalian Chromosome   use the in vitro Mammalian
                                                         Aberration Test: 40 CFR      Chromosome Aberration Test
                                                         799.9537.                    (40 CFR 799.9537) to
                                                         OR........................   generate the needed data
                                                        Mammalian Bone Marrow         unless known chemical
                                                         Chromosomal Aberration       properties (e.g., physical/
                                                         Test (in vivo in rodents:    chemical properties,
                                                         mouse (preferred species),   chemical class
                                                         rat, or Chinese hamster):    characteristics) preclude
                                                         40 CFR 799.9538.             its use. A subject person
                                                         OR........................   who uses one of the in
                                                        Mammalian Erythrocyte         vivo methods instead of
                                                         Micronucleus Test [sampled   the in vitro method to
                                                         in bone marrow] (in vivo     address a chromosomal
                                                         in rodents: Mouse            damage test requirement
                                                         (preferred species), rat,    must submit to EPA a
                                                         or Chinese hamster): 40      rationale for conducting
                                                         CFR 799.9539.                that alternate 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:     Toxicity Study with the
                                                         40 CFR 799.9365.             Reproduction/Developmental
                                                         OR........................   Toxicity Screening Test
                                                        Reproduction/Developmental    (40 CFR 799.9365).
                                                         Toxicity Screening Test:     However, there may be
                                                         40 CFR 799.9355.             valid reasons to test a
                                                         AND.......................   particular chemical using
                                                        Repeated Dose 28-Day Oral     both 40 CFR 799.9355 and
                                                         Toxicity Study in rodents:   40 CFR 799.9305 to fill
                                                         40 CFR 799.9305.             Mammalian Toxicity--
                                                                                      Repeated Dose/Reproduction/
                                                                                      Developmental data needs.
                                                                                      A subject person who uses
                                                                                      the combination of 40 CFR
                                                                                      799.9355 and 40 CFR
                                                                                      799.9305 in place of 40
                                                                                      CFR 799.9365 must submit
                                                                                      to EPA a rationale for
                                                                                      conducting these alternate
                                                                                      tests in the final study
                                                                                      reports. Where F2 or F3 is
                                                                                      required, no rationale for
                                                                                      conducting the required
                                                                                      test need be provided in
                                                                                      the final study report.
                                     F2                 Reproduction/Developmental
                                                         Toxicity Screening Test:
                                                         40 CFR 799.9355.
                                     F3                 Repeated Dose 28-Day Oral
                                                         Toxicity Study in rodents:
                                                         40 CFR 799.9305.
----------------------------------------------------------------------------------------------------------------
\i\ EPA recommends, but does not require, that log KOW be quantitatively estimated prior to initiating this
  study. One method, among many similar methods, for estimating log KOW is described in the article entitled
  ``Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients'' by W.M. Meylan and
  P.H. Howard in the Journal of Pharmaceutical Sciences. 84(1):83-92. January 1992. This reference is available
  in docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm. 3334, EPA West Bldg., 1301
  Constitution Ave., NW., Washington, DC 20004, telephone number: (202) 566-1744, from 8:30 a.m. to 4:30 p.m.,
  Monday through Friday, excluding legal holidays.
\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-2007-0531 at the EPA Docket Center, Rm.
  3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC 20004, telephone number: (202) 566-1744,
  from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
\iii\ Chemical substances that are dispersible in water may have log KOW values greater than 4.2 and may still
  be acutely toxic to aquatic organisms. Test sponsors who wish to conduct Test Group 1 studies on such
  chemicals may request a modification to the test standard as described in 40 CFR 790.55. Based upon the
  supporting rationale provided by the test sponsor, EPA may allow an alternative threshold or method be used
  for determining whether acute or chronic aquatic toxicity testing be performed for a specific substance.
\iv\ The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available in docket ID number EPA-HQ-
  OPPT-2007-0531 at the EPA Docket Center, Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC
  20004, telephone number: (202) 566-1744, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
  holidays.

[[Page 1093]]

 
\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-2007-0531 at the EPA Docket
  Center, Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC 20004, telephone number: (202)
  566-1744, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.

[FR Doc. 2010-33313 Filed 1-6-11; 8:45 am]
BILLING CODE 6560-50-P


