Testing of Certain High Production Volume Chemicals; Second Group of Chemicals, 1067-1093 [2010-33313]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[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 https://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 (https://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 temp