[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Rules and Regulations]
[Pages 1067-1093]
[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.

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<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER> or<PHONE_NUMBER>; e-mail addresses:
<EMAIL_ADDRESS>or<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address<EMAIL_ADDRESS>
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

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).

     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

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
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                                                      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
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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

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

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);

``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:

                                   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

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-

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

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

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

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

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

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.

    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.

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