[Federal Register Volume 75, Number 37 (Thursday, February 25, 2010)]
[Proposed Rules]
[Pages 8575-8601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3734]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[EPA-HQ-OPPT-2009-0112; FRL-8805-8]
RIN 2070-AD16


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

DATES: Comments must be received on or before May 26, 2010.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2009-0112, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID Number EPA-HQ-OPPT-2009-0112. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special

[[Page 8576]]

arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2009-0112. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically 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) at Rm. 3334, EPA West Bldg., 1301 Constitution 
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of 
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the EPA/DC Public Reading Room 
is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: [email protected].
     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 number: 
(202) 564-8091 or (202) 564-8173; e-mail address: 
[email protected] or [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture 
(defined by statute to include import) or process any of the chemical 
substances that are listed in Sec.  799.5089(j) of the proposed 
regulatory text. Any use of the term ``manufacture'' in this proposed 
rule will encompass ``import,'' unless otherwise stated. In addition, 
as described in Unit V., 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 29 subject chemical substances (NAIC codes 325 and 
324110), e.g., chemical manufacturing and petroleum refineries.
     Processors of one or more of the 29 subject chemical 
substances (NAIC 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 IV.E. and 
consult Sec.  799.5089(b) of the proposed regulatory text. If you have 
any questions regarding the applicability of this action to a 
particular entity, consult either technical person listed under FOR 
FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

C. Can I Request an Opportunity to Present Oral Comments to the Agency?

    You may submit a request for an opportunity to present oral 
comments. This request must be made in writing.

[[Page 8577]]

If such a request is received on or before May 26, 2010, EPA will hold 
a public meeting on this proposed rule in Washington, DC. This written 
request must be submitted to the mailing or hand delivery addresses 
provided under ADDRESSES. If such a request is received, EPA will 
announce the scheduling of the public meeting in a subsequent document 
in the Federal Register. If a public meeting is announced, and if you 
are interested in attending or presenting oral and/or written comments 
at the public meeting, you should follow the instructions provided in 
the subsequent Federal Register document announcing the public meeting.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing to issue a test rule under TSCA section 4(a)(1)(B) 
(15 U.S.C. 2603(a)(1)(B)) that would require manufacturers and 
processors of the 29 chemical substances listed in this proposed rule 
to conduct testing for environmental fate (including five tests for 
physical/chemical properties and biodegradation), ecotoxicity (in fish, 
Daphnia, and algae), acute toxicity, genetic toxicity (gene mutations 
and chromosomal aberrations), repeated 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).
    This proposed rule follows earlier testing actions for certain HPV 
chemicals (see Refs. 2, 3, and 11).
    This proposed TSCA section 4(a) test rule addresses some of the 207 
remaining ``orphan'' HPV chemicals that were placed on the Priority 
Testing List by the Interagency Testing Committee (ITC). For a summary, 
see: ``Sixty-Third Report of the TSCA Interagency Testing Committee to 
the Administrator of the Environmental Protection Agency; Receipt of 
Report and Request for Comments; Notice'' (Ref. 9). ``Orphan'' chemical 
substances are those HPV chemicals that were not sponsored for testing 
under the voluntary HPV Challenge Program or under certain 
international efforts (see Unit II.C.).
    Of the 207 chemical substances, 159 no longer meet the HPV 
criterion; 3 already have data that meets needs identified in this 
proposed rule; and 16, while meeting the production volume criterion 
for HPV, appear to lack the exposure data necessary to support TSCA 
section 4(a)(1)(B) findings. Therefore, these 178 chemical substances 
are not being considered for testing by EPA at this time. The remaining 
29 chemical substances are addressed in this proposed TSCA section 4(a) 
test rule. These conclusions are based primarily on information 
reported in the 2006 TSCA Inventory Update Rule (IUR) (40 CFR part 710) 
and a 2006 TSCA Preliminary Assessment Information Reporting (PAIR) 
rule issued for the HPV orphan chemicals (Ref. 10). EPA also sought and 
considered, when available, information from other data sources (e.g., 
the Toxics Release Inventory (TRI), the National Occupational Exposure 
Survey (NOES)).

B. What is the Agency's Authority for Taking this Action?

    EPA is proposing this test rule under TSCA section 4(a)(1)(B) (15 
U.S.C. 2603(a)(1)(B)), which directs EPA to 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 [.]

    Once the EPA Administrator has made a finding under 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)(B)(i) findings. This 
approach is explained in more detail in EPA's TSCA section 4(a)(1)(B) 
Final Statement of Policy (B Policy) (Ref. 4, pp. 28738-28739).
    In this proposed test rule, EPA would use 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.  799.5089(j) of 
the proposed regulatory text. EPA has made preliminary findings for 
these chemical substances under TSCA section 4(a)(1)(B) that: 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 chemicals 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 
Screening Information Data Sets (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 identified for the voluntary HPV 
Challenge Program through data reported under the IUR during 1990. The 
SIDS data set sought by the voluntary 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

[[Page 8578]]

coordinated by the 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. 5). This includes agreements to sponsor a U.S. 
HPV chemical under either the OECD HPV SIDS Program (Ref. 6), including 
sponsorship by OECD member countries beyond the United States, or the 
international HPV Initiative that is being organized by the ICCA (Ref. 
7).
    Additional details regarding the voluntary HPV Challenge Program 
and these international efforts were provided in the prior HPV TSCA 
section 4 rules (Refs. 2, 3, and 11). It was EPA's position that 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 published by EPA on 
March 16, 2006 (Ref. 3). This proposed rule is the third TSCA section 4 
HPV SIDS rule, and addresses the unmet data needs of 29 chemical 
substances.
    After EPA publishes the final rule based on the proposed rule, EPA 
intends to make the information collected under the final rule 
available to the public, other Federal agencies, and any other 
interested parties. This information will be 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 this Proposed Rule Focusing on HPV Chemicals and SIDS 
Testing?

    This proposed rule pertains to HPV chemicals, which are 
manufactured or imported in amounts equal to or greater than 1 million 
lbs. per year, which EPA determined account for 95% of total chemical 
production in the United States (Ref. 8, p. 32296). EPA found that, of 
those non-polymeric organic substances produced or imported in amounts 
equal to or greater than 1 million lbs. per year 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. 12). Of the over 2,800 U.S. HPV chemicals 
43% had no publicly available basic hazard data. For the remaining 
chemicals, 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 chemicals 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. 
6):
     Acute toxicity.
     Repeated 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 
chemicals and whether additional testing or assessment is necessary.

E. How Would the Data Developed Under this Test Rule Be Used?

    EPA would use the data obtained from the rule proposed in this 
document to support development of preliminary hazard and risk 
assessments for the 29 HPV chemicals subject to the rule. The data 
would also be used by EPA to set priorities for further testing that 
may produce hazard information on these HPV chemicals that may be 
needed by EPA, other Federal agencies, the public, industry, and 
others, to support adequate risk assessments. As appropriate, this 
information would be used to ensure a scientifically sound basis for 
risk characterizations and risk management actions. As such, this 
effort would 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 activities as the development of water quality 
criteria, TRI listings, chemical advisories, and reduction of workplace 
exposures.
    In addition, a key goal of the voluntary 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 voluntary HPV Challenge Program is that the 
public has a right to know about the hazards associated with chemicals 
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 
chemicals that they encounter in their daily lives.

F. How are Animal Welfare Issues Being Considered in the HPV 
Initiative?

    EPA recognizes the concerns that have been expressed about the use 
of test procedures that require the use of animals. As discussed in 
Unit II.E. of Ref. 1, EPA is making every effort to ensure that as the 
HPV Initiative is implemented (including TSCA section 4 HPV test 
rules), unnecessary or duplicative testing is avoided and the use of 
animals is minimized. As a general matter, EPA does not require that 
tests on animals be conducted if an alternative scientifically 
validated method is found acceptable and practically available for use. 
Where testing must be conducted to develop adequate data, the Agency is 
committed to reducing the number of animals used for testing, to 
replacing test methods requiring animals with alternative test methods 
when acceptable alternative methods are available, and to refining 
existing test methods to optimize animal use when there is no 
substitute for animal testing. EPA believes that these reduction, 
replacement, and refinement objectives are all important elements in 
the overall consideration of alternative testing methods.

III. EPA Proposed Findings

A. What is the Basis for EPA's Proposed Rule to Test These Chemical 
Substances?

    As indicated in Unit II.B., in order to promulgate a final 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 proposing to require 
testing of the chemical substances included in this proposed rule based 
on its preliminary findings under TSCA section 4(a)(1)(B)(i) relating 
to ``substantial'' production and ``substantial human exposure,'' and/
or ``substantial release to the environment,'' as well as findings 
under TSCA sections 4(a)(1)(B)(ii) and (iii) relating to sufficient 
data and the need for testing. The chemical substances included in

[[Page 8579]]

this proposed rule are listed in Table 2 in Sec.  799.5089(j) of the 
proposed regulatory text along with their Chemical Abstract Service 
(CAS) Registry numbers.
    In EPA's B Policy (see Unit III.E.), ``substantial production'' of 
a chemical substance or mixture is generally considered to be aggregate 
production (including import) volume equaling or exceeding 1 million 
lbs. per year of that chemical substance or mixture (Ref. 4, p. 28747). 
EPA's B Policy also provides guidelines that are generally considered 
by EPA in evaluating whether there is or may be ``substantial human 
exposure'' of workers, consumers, and the general population to a 
chemical substance or mixture or whether a chemical substance enters or 
may reasonably be anticipated to enter the environment in substantial 
quantities. Refer to EPA's B Policy for further discussion on how EPA 
generally evaluates chemical substances or mixtures under TSCA section 
4(a)(1)(B)(i). For the reasons set out in EPA's B Policy, EPA believes 
that the guidance included in the B Policy is appropriate for 
consideration in this proposed rule and EPA sees no reason not to act 
consistently with that guidance with respect to the chemical substances 
included in this proposed rule.
    EPA has found preliminarily that, under TSCA section 4(a)(1)(B)(i), 
each of the 29 chemical substances included in this proposed rule is 
produced in ``substantial'' quantities (see Unit III.B.) and, for 27 
chemical substances, that there is or may be ``substantial human 
exposure'' to each chemical substance (see Units III.C. and III.D.). 
Also, for 3 chemical substances (including the 2 for which EPA is not 
able to make a preliminary finding regarding substantial human 
exposure), EPA has found preliminarily that, under TSCA section 
4(a)(1)(B)(i), the chemical substance enters or may reasonably be 
anticipated to enter the environment in substantial quantities (see 
Unit III.E.). In addition, under TSCA section 4(a)(1)(B)(ii), EPA has 
preliminarily determined 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 (see 
Unit III.F.). EPA has also found preliminarily that testing the 29 
chemical substances identified in this proposed rule is necessary to 
develop such data (TSCA section 4(a)(1)(B)(iii)) (see Unit III.F.). EPA 
has not identified any ``additional factors'' as discussed in the B 
Policy (Ref. 4, p. 28746) to cause the Agency to use decisionmaking 
criteria other than those described in the B Policy.
    The chemical substances included in this proposed rule are listed 
in Sec.  799.5089(j) of the proposed regulatory text along with their 
CAS numbers.

B. Are These Chemical Substances Produced and/or Imported in 
Substantial Quantities?

    EPA has made preliminary findings that each of the chemical 
substances included in this proposed rule is produced and/or imported 
in an amount equal to or greater than 1 million lbs. per year (Ref. 
15). These findings are based on:
    1. Information gathered in the 2006 IUR (40 CFR part 710), which is 
the most recently available compilation of TSCA Inventory data.
    2. A TSCA section 8(a) PAIR rule (Ref. 10), issued for those HPV 
orphan chemicals which had been added to the ITC Priority Testing List 
(Ref. 9). 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 also Ref. 4, p. 28746). 
A discussion of EPA's preliminary ``substantial production'' finding 
for each chemical substance included in this proposed rule is contained 
in a separate document (see Ref. 15).

C. Are a Substantial Number of Workers Exposed to These Chemicals?

    EPA has made preliminary findings that the manufacture, processing, 
and use of 27 of the 29 chemical substances (Table 1. of Unit III.D.) 
included in this action result or may result in exposure of a 
substantial number of workers to the chemical substances.
    This finding is based, in large part, on information submitted in 
accordance with the 2006 IUR (40 CFR part 710) and the 2006 PAIR rule 
(Ref. 10). 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 are required to provide information regarding the commercial 
and consumer uses of the chemical substance.
    EPA believes 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 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) (Ref. 4). Therefore, 
EPA's preliminary finding is that there is or may be substantial human 
exposure (workers) to 27 of these 29 chemical substances.
    In addition to the 2006 IUR and the 2006 PAIR data collected on the 
HPV orphan chemicals, EPA also reviewed NOES data developed by the 
National Institute for Occupational Safety and Health (NIOSH) (Ref. 
16). The NOES data indicates that more than 1,000 workers were exposed 
to 7 of the 29 chemical substances that are the subject of this 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 chemicals 
(Refs. 16, 51, and 52). For the 29 chemical substances in this proposed 
rule, EPA compared production volumes from the 1986 IUR data collection 
to the production volumes for the 2006 IUR and PAIR data collections. 
For the 29 chemical substances in this proposed rule, there was no 
decrease in production volume from 1986 to 2006. For the 7 chemical 
substances for which EPA has NOES data indicating substantial worker 
exposure, the 2006 IUR and 2006 PAIR production volume data are 
consistent with the 1980's NOES results, in that production volumes for 
these chemical substances either stayed the same or increased since 
1986, thereby suggesting 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 29 
chemical substances and carefully considered the industrial process and 
use information along with the commercial and consumer use information 
from the 2006 IUR and PAIR submissions. Commercial uses are defined as: 
``The

[[Page 8580]]

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 
IUR submissions can be found in the ``Testing of Certain High 
Production Volume Chemicals-3 (Exposure Findings Supporting 
Information)'' (Ref. 15). Based on the descriptions provided for the 
IUR uses, EPA has preliminarily concluded that chemical substances with 
certain reported commercial uses, such as painting contractor, etc., 
may result in potential exposure to 1,000 workers or more. The total 
number of workers reported under the IUR is the sum of information on 
both industrial workers plus commercial use workers. EPA's exposure 
findings document (Ref. 15) discusses the basis of EPA's preliminary 
``substantial exposure'' finding for workers. The Agency also solicits 
comment regarding the number of workers potentially exposed to the 
chemical substances identified in this proposed rule.

D. Are a Substantial Number of Consumers Exposed to These Chemicals?

    Based on 2006 IUR data, EPA has made preliminary findings that the 
uses of 20 of the chemical substances included in this action result or 
may result in exposure to a substantial number of consumers (Ref. 15). 
EPA reviewed the consumer use information reported for the 2006 IUR and 
carefully considered the nature of those uses. As stated in EPA's B 
Policy, the Agency believes, based on experience gained through case-
by-case analysis of other chemical substances, that an exposure of 
10,000 or more consumers to a chemical substance is a reasonable 
interpretation of the phrase ``substantial human exposure'' in TSCA 
section 4(a)(1)(B)(i) (Ref. 4). Upon completion of the review, EPA has 
preliminarily concluded that the reported consumer uses for certain of 
the chemical substances in this action may result in exposures to at 
least 10,000 consumers, so there is substantial human exposure to these 
chemical substances.
    A discussion of the basis for EPA's preliminary ``substantial 
exposure'' finding for consumers is contained in a separate document 
(Ref. 15). The Agency solicits comment regarding the number of 
consumers potentially exposed to the chemical substances identified in 
this proposed rule, particularly on assumptions that are based on EPA's 
experience with other chemical substances that there is or may be 
``substantial human exposure'' to a chemical substance when that 
chemical substance is used in certain consumer-use products, and is 
produced at high production volume.

                                                                  Table 1.--Exposure Based Findings--Substantial Human Exposure
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Production Volume               Meet Exposure                                                                 Meet Substantial
                                 ---------------------------------------- Based Criteria For   NOES  (number of      Meet Exposure       Meet Exposure      or Significant     2006 IUR or PAIR
             CAS No.                                                        Manufacturing &        workers)       Based Criteria for  Based Criteria for   Release Criteria       commercial/
                                       2006 IUR              PAIR         Industrial Workers                      Commercial Workers       Consumers            (PAIR)           consumer use
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
83-41-0                           < 1 million (M)     > 10M-50M                                                                                           X                   ..................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96-22-0                           > 10M-50M           > 10M-50M                                                                       X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
98-09-9                           > 1M-10M            > 1M-10M            X                   851                 X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
98-56-6                           > 1M-10M            > 1M-10M            X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
111-44-4                          > 1M-10M            < 1M                X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
127-68-4                          > 1M-10M            < 1M                X                   9,386               X                                                           ..................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
506-51-4                          < 1M                > 1M-10M            X                   1,281               X                                                           ..................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
506-52-5                          < 1M                > 1M-10M            X                   1,565               X                                                           ..................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
515-40-2                          > 1M-10M            > 1M-10M            X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2494-89-5                         > 1M-10M            > 1M-10M            X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
5026-74-4                         > 1M-10M            > 1M-10M            X                   952                 X                                                           ..................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
22527-63-5                        > 1M-10M            > 1M-10M            X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
24615-84-7                        > 1M-10M            < 1M                X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
25321-41-9                        > 1M-10M            < 1M                X                   2,843               X                                                           ..................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
25646-71-3                        > 1M-10M            < 1M                X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
52556-42-0                        > 1M-10M            > 1M-10M            X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
61788-76-9                        > 10M-50M           > 1M-10M            X                   176,314             X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
65996-79-4                        > 10M-50M           > 1M-10M            X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
65996-82-9                        > 100M-1 billion    > 100M-1B           X                                       X                   X                                       X
                                   (B)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 8581]]

 
65996-89-6                        > 1B                > 1B                X                   761                 X                   X                   X                   X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
65996-92-1                        > 100M-1B           > 100M-1B           X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
68082-78-0                        > 1M-10M            > 1M-10M            X                   41,153              X                                                           ..................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
68187-57-5                        > 100M-1B           > 100M-1B           X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
68442-60-4                        > 1M-10M            > 1M-10M            X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
68610-90-2                        > 1M-10M            > 1M-10M                                                                        X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
68988-22-7                        > 10M-50M           > 10M-50M                                                                                           X                   ..................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
70693-50-4                        > 1M-10M            > 1M-10M            X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
72162-15-3                        > 1M-10M            < 1M                X                   64,227              X                                                           ..................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
73665-18-6                        > 50M-100M          > 100M-1B           X                                       X                   X                                       X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

E. Are Substantial Quantities of These Chemicals Released to the 
Environment?

    EPA has made preliminary findings that three chemical substances, 
benzene, 1,2-dimethyl-3-nitro-acetaldehyde (CAS No. 83-41-0); tar oils, 
coal (CAS No. 65996-89-6); and 1,4-benzenedicarboxylic acid, 1,4-
dimethyl ester, manuf. of, by-products from (CAS No. 68988-22-7) enter 
or may reasonably be anticipated to enter the environment in 
substantial quantities. These findings are based upon their reported 
PAIR data.
    EPA believes that 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. 4, 
pp. 28736, 28746).
    The Agency solicits comment regarding additional information 
pertaining to the amount of environmental release of the chemical 
substances identified in this proposed rule.

F. Do Sufficient Data Exist for These Chemical Substances?

    In developing the testing requirements for chemicals contained in 
this proposed rule, available information on chemical/physical 
properties, environmental fate, ecotoxicity and human health effects 
was searched using the data sources outlined in the OECD guidelines 
found in section 3.1 (Reliability, Relevance and Adequacy) of the 
``Manual for the Investigation of HPV Chemicals'' (Ref. 6) such as: 
Beilstein Database, CRC Handbook of Chemistry and Physics, Hawley's 
Condensed Chemical Dictionary, Illustrated Handbooks of Physical-
Chemical Properties and Environmental Fate for Organic Chemicals, Merck 
Index, Hazardous Substances Data Bank (HSDB), TOXLINE, and National 
Technical Information Service (NTIS). EPA also searched for available 
data as summarized in its HPV Information System (Ref. 50). When 
appropriate, the Federal Research In Progress (FEDRIP) database was 
also searched. Any information that was obtained from these searches 
was evaluated for data acceptability using the guidelines described on 
EPA's HPV Challenge Program website (http://www.epa.gov/chemrtk): 
``Guidance for Meeting the SIDS Requirements (the SIDS Guide)'' and 
``Guidance for Assessing the Adequacy of Existing Data.'' Furthermore, 
data adequacy and reliability were evaluated using the OECD guidelines 
which can be found in section 3.1 of the OECD ``Manual for the 
Investigation of HPV Chemicals'' (Ref. 6).
    Section 799.5089(j) of the proposed regulatory text lists each 
chemical and the SIDS tests for which adequate data are not currently 
available to the Agency. The Agency preliminarily finds that the 
existing data for one or more of the SIDS testing endpoints for each of 
the chemicals listed in Table 2 of the proposed 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); repeated 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. Can Other Data Meet the Requirements for the Testing Proposed in 
this Action?

    EPA solicits comment concerning the availability of existing 
studies on the SIDS endpoints proposed in this document on these 
chemical substances. To the extent that additional studies relevant to 
the testing proposed in this rulemaking are known to exist, EPA 
strongly encourages the submission of this information as comments to 
the proposed rule, including full citations for publications and full 
copies of unpublished studies. If EPA judges such data to be 
sufficient, corresponding testing will not be included in the final 
rule. Commenters are also encouraged to prepare a robust summary (Ref. 
13) for each such study to facilitate EPA's review of the full study 
report or publication. Persons who respond to

[[Page 8582]]

this request to submit robust summaries are also encouraged to submit 
the robust summary electronically via the High Production Volume 
Information System (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.''
    Persons who believe that adequate information regarding a chemical 
subject to this proposed rule can be developed using a category or the 
Structure-Activity Relationships (SAR) approach are encouraged to 
submit appropriate information, along with their rationale which 
substantiates this belief, during the comment period on this proposed 
rule. If, based on submitted information and other information 
available to EPA, the Agency agrees EPA will take such measures as are 
needed to avoid unnecessary testing in the final rule.

H. Is Testing Necessary for These Chemical Substances?

    EPA knows of no other means to generate the SIDS data other than 
the testing proposed in this document, and therefore believes that 
conducting the needed SIDS testing identified for the 29 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's 
important to make these data available to satisfy the ``Right-to-Know'' 
principles included in the HPV Challenge Program goals.

IV. Proposed Testing

A. What Testing is Being Proposed in this Action?

    EPA is proposing specific testing and reporting requirements for 
the chemical substances specified in Sec.  799.5089(j) of the proposed 
regulatory text.
    All of the proposed testing requirements are listed in Table 2 in 
Sec.  799.5089(j) of the proposed regulatory text and consist of a 
series of test methods covering many of the endpoints in the OECD HPV 
SIDS testing battery. EPA's TSCA 799 test guidelines (40 CFR part 799, 
subparts E and H) have been harmonized with the OECD test guidelines. 
However, EPA is specifying that the American Society for Testing and 
Materials International (ASTM International) or the TSCA 799 test 
guidelines be used rather than OECD test guidelines because the 
language in the ASTM International standards and the TSCA 799 test 
guidelines makes clear which steps are mandatory and which steps are 
only recommended. Accordingly, in order to comply with the testing 
proposed, EPA is proposing that testing must be conducted in accordance 
with ASTM International or TSCA 799 test guidelines. Most of the 
proposed testing requirements for a particular endpoint are specified 
in one test standard. In the case of certain endpoints, however, any of 
multiple listed methods could be used. For several of the proposed test 
standards, EPA has identified and is proposing certain ``Special 
Conditions'' as discussed in this unit. The following endpoints and 
proposed test standards would be required under this proposed rule.
    1. Physical/Chemical Properties.
    Melting Point: ASTM E 324-99 (capillary tube) (Ref. 17).
    Boiling Point: ASTM E 1719-05 (ebulliometry) (Ref. 18).
    Vapor Pressure: ASTM E 1782-03 (thermal analysis) (Ref. 19).
    n-Octanol/Water Partition Coefficient:
    Method A (40 CFR 799.6755--shake flask).
    Method B (ASTM E 1147-92(2005)--liquid chromatography) (Ref. 20).
    Method C (40 CFR 799.6756--generator column).
    Water Solubility:
    Method A: (ASTM E 1148-02--shake flask) (Ref. 21).
    Method B (40 CFR 799.6784--shake flask).
    Method C (40 CFR 799.6784--column elution).
    Method D (40 CFR 799.6786--generator column).
    For those chemical substances needing melting points 
determinations, EPA is proposing that melting points be determined 
according to ASTM method E 324-99. Although ASTM International 
indicates on its website, http://www.astm.org/cgi-bin/SoftCart.exe/STORE/filtrexx40.cgi?U+mystore+lien2117+-L+E324+/usr6/htdocs/astm.org/DATABASE.CART/WITHDRAWN/E324.htm that ASTM E 324-99 has been withdrawn, 
ASTM International's withdrawal of the method means only that ASTM 
International no longer continues to develop and improve the method. It 
does not mean that ASTM International no longer considers the method to 
be valid. ASTM International 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. 22)

    ASTM International still makes the method available for 
informational purposes and it can still be purchased from ASTM 
International at the address listed in Sec.  799.5089(h) of the 
proposed regulatory text.
    EPA concludes that ASTM International's withdrawal of ASTM E 324-99 
does not have negative implications on the validity of the method, and 
EPA is proposing that melting points be determined according to ASTM E 
324-99.
    For the ``n-Octanol/Water Partition Coefficient (log 10 basis)'' 
and water solubility endpoints, EPA is proposing that certain ``Special 
Conditions'' be considered by test sponsors in determining the 
appropriate test method that would be used from among those included 
for these endpoints in Table 3 in Sec.  799.5089(j) of the proposed 
regulatory text.
    For the ``n-Octanol/Water Partition Coefficient (log 10 basis)'' 
endpoint, also known as log Kow, EPA proposes that an 
appropriate selection be made from among three alternative methods for 
measuring the chemical substance's n-Octanol/Water Partition 
Coefficient (log 10 basis; ``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. 23) be used in making such 
estimation. EPA is proposing that test sponsors must submit with the 
final study report the underlying rationale for the test standard 
selected for this endpoint. EPA is proposing this approach recognizing 
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 is, the less well Method A (40 CFR 
799.6755--shake flask) will work and Method B (ASTM E 1147-92(2005)) 
and Method C (40 CFR 799.6756--generator column) become more suitable, 
especially Method C. The proposed test methodologies have been 
developed to meet a wide variety of

[[Page 8583]]

needs; and, as such, are silent on experimental conditions related to 
pH. Therefore, EPA proposes that all required n-Octanol/Water Partition 
Coefficient tests be conducted at pH 7 to ensure environmental 
relevance. The proposed 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 n-Octanol/Water Partition
                          Coefficient Endpoint
------------------------------------------------------------------------
                                  Test Requirements
        Testing Category           and References     Special Conditions
------------------------------------------------------------------------
Physical/chemical properties     n-Octanol/Water     n-Octanol/Water
                                  Partition           Partition
                                  Coefficient (log    Coefficient or log
                                  10 basis) or log    Kow:
                                  Kow:               Which method is
                                 The appropriate      required, if any,
                                  log Kow test, if    is determined by
                                  any, would be       the test
                                  selected from       substance's
                                  those listed in     estimated log Kow
                                  this column--see    as follows:
                                  Special            log Kow < 0: no
                                  Conditions in the   testing required.
                                  adjacent column..  log Kow range 0-1:
                                 Method A: 40 CFR     Method A or B.
                                  799.6755 (shake    log Kow range > 1-
                                  flask).             4: Method A or B
                                 Method B: ASTM E     or C.
                                  1147-92(2005)      log Kow range > 4-
                                  (liquid             6: Method B or C.
                                  chromatography).   log Kow > 6: Method
                                 Method C: 40 CFR     C.
                                  799.6756           Test sponsors must
                                  (generator          provide in the
                                  column).            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.
------------------------------------------------------------------------

    For the ``Water Solubility'' endpoint, EPA proposes an 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. 24). EPA is also proposing that test 
sponsors be required to submit in the final study report the underlying 
rationale for the test standard selected for this endpoint. The 
proposed 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 proposes that all required water solubility tests be 
conducted starting at pH 7 to ensure environmental relevance. The 
estimated water solubility ranges that EPA is proposing for use in 
selecting an appropriate proposed test standard are shown in Table 3 of 
this unit.

      Table 3.--Test Requirements for the Water Solubility Endpoint
------------------------------------------------------------------------
                                  Test Requirements
        Testing Category           and References     Special Conditions
------------------------------------------------------------------------
Physical/chemical properties     Water solubility:   Water solubility:
                                 The appropriate     Which method is
                                  method to use, if   required, if any,
                                  any, to test for    would be
                                  water solubility    determined by the
                                  would be selected   test substance's
                                  from those listed   estimated water
                                  in this column--    solubility. Test
                                  see Special         sponsors must
                                  Conditions in the   provide in the
                                  adjacent column..   final study report
                                 Method A: ASTM E     the underlying
                                  1148-02 (shake      rationale for the
                                  flask).             method and pH
                                 Method B: 40 CFR     selected. In order
                                  799.6784 (shake     to ensure
                                  flask).             environmental
                                 Method C: 40 CFR     relevance, EPA
                                  799.6784 (column    highly recommends
                                  elution).           that the selected
                                 Method D: 40 CFR     study be conducted
                                  799.6786            starting at pH 7.
                                  (generator         > 5,000 milligram/
                                  column).            Liter (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.
------------------------------------------------------------------------

    2. Environmental Fate and Pathways.
    Ready Biodegradation:
    Method A: ASTM E 1720-01 (Sealed vessel CO2 production 
test) (Ref. 25).
    Method B: International Organization for Standardization (ISO) 
14593 (CO2 headspace test) (Ref. 26).
    Method C: ISO 7827 (Method by analysis of dissolved organic carbon 
(DOC)) (Ref. 27).
    Method D: ISO 9408 (Determination of oxygen demand in a closed 
respirometer) (Ref. 28).
    Method E: ISO 9439 (Carbon dioxide evolution test) (Ref. 29).
    Method F: ISO 10707 (Closed bottle test) (Ref. 30).
    Method G: ISO 10708 (Two-phase closed bottle test) (Ref. 31).
    For the ``Ready Biodegradation'' endpoint, EPA proposes an 
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) and Method B (ISO 
14593) 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 (Ref. 32), 
provides guidance for selection of an appropriate test method for a 
given test substance considering the substances physical and chemical 
properties. EPA is also proposing that test sponsors be required to 
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(2002)) (Ref. 33),
    Acute toxicity to Daphnia (ASTM E 729-96(2002)) (Ref. 33), and
    Toxicity to plants (algae) (ASTM E 1218-04e1) (Ref. 34).
    Test Group 2:
    Chronic toxicity to Daphnia (ASTM E 1193-97(2004)) (Ref. 35) and
    Toxicity to plants (algae) (ASTM E 1218-04e1) (Ref. 34).
    For the ``Aquatic Toxicity'' endpoint, the OECD HPV SIDS Program 
recognizes that, for certain chemical substances, acute toxicity 
studies are of limited

[[Page 8584]]

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 proposing 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 
IV.A.1., in the discussion of ``n-Octanol/Water Coefficient,'' and in 
Table 3 in Sec.  799.5089(j) of the proposed regulatory text. For test 
substances determined to have a log Kow of less than 4.2, 
one or more of the following tests (described as ``Test Group 1'' in 
Table 3 in Sec.  799.5089(j) of the proposed regulatory text) are 
proposed: Acute toxicity to fish (ASTM E 729-96(2002)); Acute toxicity 
to Daphnia (ASTM E 729-96(2002)); and Toxicity to plants (algae) (ASTM 
E 1218-04e1). For test substances determined to have a log 
Kow that is greater than or equal to 4.2, one or both of the 
following tests (described as ``Test Group 2'' in Table 3 in Sec.  
799.5089(j) of the proposed regulatory text) are proposed: Chronic 
toxicity to Daphnia (ASTM E 1193-97(2004)) and Toxicity to plants 
(algae) (ASTM E 1218-04e1). As outlined in Table 3 in Sec.  799.5089(j) 
of the proposed regulatory text, depending on the testing proposed 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. 24, 36, and 37). A 
chemical 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. 37). For the purposes of this proposed 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 entitled 
``Category for Persistent, Bioaccumulative, and Toxic New Chemical 
Substances'' (Ref. 38). 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 (``Significant New Use Rules; 
General Provisions For New Chemical Follow-Up'' under TSCA sections 5 
and 26(c) (Ref. 39; see also 40 CFR 721.3)). EPA considers the 
difference between the log Kow of 4.3 cited in the 1989 
Federal Register document (Ref. 39) and the log Kow value of 
4.2 cited in this proposed TSCA section 4 test rule to be negligible.
    EPA recognizes that in some circumstances, acute aquatic toxicity 
testing (Test Group 1) may be relevant for certain chemical substances 
having a log Kow equal to or greater than 4.2. Chemical 
substances that are dispersible in water (e.g., surfactants, 
detergents, aliphatic amines, and cationic dyes) may have log 
Kow values greater than 4.2 and may still be acutely toxic 
to aquatic organisms. For any chemical substance listed in Table 3 in 
Sec.  799.5089(j) of the proposed 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 test substance. EPA is soliciting public 
comment on this approach as well as other alternative approaches in 
this area.
    4. Mammalian Toxicity--Acute.
    Acute Inhalation Toxicity (rat): Method A (40 CFR 799.9130)
    Acute Oral Toxicity (rat): Method B (ASTM E 1163-98(2002) (Ref. 53) 
or 40 CFR 799.9110(d)(1)(i)(A))
    For the ``Mammalian Toxicity--Acute'' endpoint, EPA is proposing 
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.  
799.5089(j) of the proposed 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 
proposing that, for test substances that are gases at room temperature 
(25[deg] C), the acute mammalian toxicity study be conducted using 
inhalation as the exposure route (described as Method A (40 CFR 
799.9130) in Table 3 in Sec.  799.5089(j) of the proposed 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 chemicals (i.e., those that are either liquids or solids at room 
temperature), EPA is proposing that the acute toxicity testing be 
conducted via oral administration using an ``Up/Down'' test method 
(described as Method B (ASTM E 1163-98 (2002) or 40 CFR 
799.9110(d)(1)(i)(A)) in Table 3 in Sec.  799.5089(j) of the proposed 
regulatory text). Consistent with the voluntary HPV Challenge Program, 
EPA is proposing to allow the use of the Neutral Red Uptake (NRU) basal 
cytotoxicity assay to select the starting dose for the acute oral 
toxicity test (Ref. 52). This test is included as a Special Condition 
in Table 3 of the proposed regulatory text. A document developed by 
National Institutes of Health/National Insitute of Environmental Health 
Sciences (NIH/NIEHS) provides guidance on how to use the NRU assay to 
estimate a starting dose for an acute oral toxicity test (Ref. 44). 
Recent versions of the standardized protocols for the NRU assay are 
available at the NIEHS/Interagency Coordinating Committee on the 
Validation of Alternative Methods (ICCVAM) website, http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm 
(Refs. 45-47).
    Dermal toxicity testing is not proposed in this rulemaking, and the 
Agency does not intend to include any dermal toxicity testing in any 
TSCA section 4 HPV SIDS rulemakings.
    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 who would be 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

[[Page 8585]]

chemical properties preclude its use. These could include, for example, 
physical chemical properties or chemical class characteristics. A 
primary focus of both the voluntary HPV Challenge Program and this 
proposed rule is to implement this program in a manner consistent with 
the OECD HPV SIDS Program and as part of a larger international 
activity with global involvement. This proposed approach provides the 
same degree of flexibility as that which currently exists under the 
OECD HPV SIDS testing program (Ref. 6). 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 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 proposing 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 would be required to submit 
to EPA a rationale for conducting these alternate tests in the final 
study reports.
    Certain of the chemicals for which Mammalian Toxicity--Repeated 
Dose/Reproduction/Developmental testing is proposed may be used solely 
as ``closed system intermediates,'' as described in the EPA guidance 
document developed for the voluntary HPV Challenge Program (Ref. 40). 
As described in that guidance, such chemicals may be eligible for a 
reduced testing battery which substitutes a developmental toxicity 
study for the SIDS requirement to address repeated dose (e.g., 
subchronic), reproductive, and developmental toxicity. In other words, 
since only the developmental toxicity study would be conducted for 
those chemicals that qualify for a reduced testing battery, repeated 
dose (e.g., subchronic) and reproductive studies would not be 
conducted. At the present time, EPA does not have sufficient 
information to know with any degree of certainty which if any of the 
chemicals that are listed in the proposed regulatory text are solely 
closed system intermediates as defined in the voluntary HPV Challenge 
Program guidance document (Ref. 40). Persons who believe that a 
chemical fully satisfies the terms outlined in the guidance document 
are encouraged to submit appropriate information along with their 
comments on this proposed rule which substantiate this belief. If, 
based on submitted information and other information available to EPA, 
the Agency believes that a chemical is considered likely to meet the 
requirements for use solely as a closed system intermediate; EPA would 
not address any developmental toxicity testing needs in this proposed 
rule.

B. When Would any Testing Imposed by this Proposed Rule Begin?

    The testing requirements contained in this proposed rule are not 
effective until and unless the Agency issues a final rule. Based on the 
effective date of the final rule, which is typically 30 days after the 
publication of a final rule in the Federal Register, the test sponsor 
may plan the initiation of any required testing as appropriate to 
submit the required final report by the deadline indicated as the 
number of months after the effective date that would be shown in Sec.  
799.5089(j) of the proposed regulatory text.

C. How Would the Studies Proposed under this Test Rule be Conducted?

    Persons required to comply with the final rule would have to 
conduct the necessary testing in accordance with the testing and 
reporting requirements established in the regulatory text of the final 
rule, with 40 CFR Part 790--Procedures Governing Testing Consent 
Agreements and Test Rules (except for paragraphs (a), (d), (e), and (f) 
of Sec.  790.45; Sec.  790.48; paragraph (a)(2) and paragraph (b) of 
Sec.  790.80; paragraph (e)(1) of Sec.  790.82; and Sec.  790.85), and 
with 40 CFR Part 792--Good Laboratory Practice Standards.

D. What Forms of Test Substances Would be Tested Under this Rule?

    EPA is proposing two distinct approaches for identifying the 
specific substances that would be tested under this proposed 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.  
799.5089(j) of the proposed regulatory text identifies the listed 
substances as either Class 1 or Class 2 chemical substances.
    EPA is proposing that, for the Class 1 chemical substances that are 
listed in the proposed rule, the test substance have a purity of 99% or 
greater. EPA has generally applied this standard of purity to the 
testing of Class 1 chemical substances in the past under TSCA section 
4(a) testing actions, except for chemical substances where it has been 
shown that such purity is unattainable. EPA is soliciting comment on 
whether a purity level of 99% or greater cannot be attained for any of 
the Class 1 chemical substances listed in this proposed rule. For the 
Class 2 chemical substances that are listed in the proposed rule, EPA 
is proposing that the test substance be any representative form of the 
chemical substance, to be defined by the test sponsor(s).
    Under both of the approaches described in this unit, manufacturers 
and processors of each chemical substance listed in this proposed rule 
would be jointly responsible for the testing of a representative form 
of each Class 2 chemical substance.
    To facilitate EPA's review of exemption applications under this 
alternative, the Agency would require the submission of certain 
chemical substance-identifying data, including characteristics and 
properties of the exemption applicant's substance, such as boiling 
point, melting point, chemical analysis, additives (if any), and 
spectral data information.
    EPA solicits comment on the proposed alternative approaches to the

[[Page 8586]]

testing of Class 2 chemical substances included in this proposed rule.

E. Would I Be Required to Test Under this Rule?

    Under TSCA section 4(a)(1)(B)(ii), EPA has made preliminary 
findings that there are insufficient data and experience to reasonably 
determine or predict health and environmental effects resulting from 
the manufacture, processing, or use of the chemical substances listed 
in this proposed rule. As a result, under TSCA section 4(b)(3)(B), 
manufacturers and processors of these chemical substances, and those 
who intend to manufacture or process them, would be subject to the rule 
with regard to those listed chemicals which they manufacture or 
process.
    1. Would I be subject to this rule? You would be subject to this 
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 proposed rule 
during the time period discussed in Unit IV.E.2. However, if you do not 
know or cannot reasonably ascertain that you manufacture or process a 
listed test rule chemical substance (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 would not be 
subject to the rule for that listed chemical substance.
    2. When would my manufacture or processing (or my intent to do so) 
cause me to be subject to this rule? You would be subject to this rule 
if you manufacture or process, or intend to manufacture or process, a 
chemical substance listed in the rule at any time from the effective 
date of the final test rule to the end of the test data reimbursement 
period. The term ``reimbursement period'' is defined at 40 CFR 791.3(h) 
and may vary in length for each substance to be tested under a final 
TSCA section 4(a) test rule, depending on what testing is required and 
when testing is completed. See Unit IV.E.4.
    3. Would I be required to test if I were subject to the rule? It 
depends on the nature of your activities. All persons who would be 
subject to this 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), would 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) would 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 would not have to initially comply 
with the final rule) would not need to 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 IV.E.3.d. 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 IV.E.4.
    a. Who would be in Tier 1 and Tier 2? All persons who would be 
subject to the final rule are considered to be in Tier 1 unless they 
fall within 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
                                          kilograms (kg) (1,100 lbs.)
                                          annually (as described at 40
                                          CFR 790.42(a)(4)); or
                                         --In small quantities solely
                                          for research and development
                                          (R and 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)).
------------------------------------------------------------------------

    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 
proposed rule, EPA is proposing to establish certain requirements that 
differ from those under 40 CFR part 790.
    In this proposed test rule, EPA has configured the tiers in 40 CFR 
790.42 as in previous HPV test rules (Refs. 3 and 7). In addition to 
processors, manufacturers of less than 500 kg (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 chemical 
substances, manufacturers of non-isolated intermediates, and 
manufacturers of components of Class 2 chemical substances. The Agency 
took administrative burden and complexity into account in determining 
who was to be in Tier 1 in this proposed rule. EPA believes that those 
persons in Tier 1 who would conduct testing under this proposed rule, 
when finalized, would generally be 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 chemical 
substances, manufacturers of non-isolated intermediates, and 
manufacturers of components of Class 2 chemical 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

[[Page 8587]]

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 proposed to be 
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 IV.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 sections 4(a)(1)(A)(ii) or 
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 chemical substance subject to this 
proposed rule, e.g., manufacturers or processors of a chemical 
substance as a trace contaminant who are not aware of and cannot 
reasonably ascertain these activities, would not be subject to the 
rule. See Unit IV.E.1. and Sec.  799.5089b)(2) of the proposed 
regulatory text.
    b. Subdivision of Tier 2 entities. The Agency is proposing to 
prioritize which persons in Tier 2 would be required to perform 
testing, if needed. Specifically, the Agency is proposing that Tier 2 
entities be subdivided into:
    i. Tier 2A-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 chemical 
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-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 sections 3(10) and 
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. 48). In addition, ``[t]here are [typically] 
so many processors [of a given test rule chemical] 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. 49).
    c. When would it be appropriate for a person who would be 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.  799.5089(c)(2), (c)(5), (c)(7), and 
(c)(11) of the proposed regulatory text. In this proposed rule, EPA 
would not require the submission of equivalence data (i.e., data 
demonstrating that your chemical substance is equivalent to the 
chemical substance actually being tested) as a condition for approval 
of your exemption. Therefore, 40 CFR 790.82(e)(1) and 40 CFR 790.85 
would not apply to this proposed rule.
    d. What would happen if I submitted 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.  799.5089(c)(8) of the proposed 
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.  799.5089(c)(6) of 
the proposed regulatory text. Note that the provisions at 40 CFR 
790.48(b) have been incorporated into the regulatory text of this 
proposed rule; thus, persons subject to this rule are not required to 
comply with 40 CFR 790.48 itself (see Sec.  799.5089(c)(4)-(c)(7) and 
Sec.  799.5089(d)(3) of the proposed regulatory text). 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 IV.E.4.
    e. What would my obligations be if I were 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 
IV.E.4. There is no difference whether you are in Tier 2A or Tier 2B as 
regards reimbursement. Concerning testing, if you are in Tier 2, you 
are considered to have an automatic conditional exemption. You would 
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. As previously noted, Tier 2A manufacturers would be notified to 
test before Tier 2B processors (Unit IV.E.3.ii.).
    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.  799.5089(c)(10) 
of the proposed regulatory text.
    In addition, you would 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.
     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.  799.5089(c)(4), (c)(5), (c)(6), 
and (c)(7) of the proposed regulatory text. The Agency would 
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 would happen if no one submitted 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 the

[[Page 8588]]

final rule. However, in the event it does not receive a letter of 
intent for one or more of the tests required by the final rule for any 
of the chemical substances in the final rule within 30 days after the 
publication of a Federal Register document notifying Tier 2 processors 
of the obligation to submit a letter of intent to conduct testing or to 
apply for an exemption from testing, EPA would 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 would additionally notify all 
manufacturers and processors that all exemption applications concerning 
the test(s) have been denied, and would 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 
final rule with respect to that chemical substance who are not already 
in violation of the final rule would be in violation of the final 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(a). 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 proposed 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 Reporting Requirements are Proposed Under this Test Rule?

    You would be required to submit a final report for a specific test 
by the deadline indicated as the number of months after the effective 
date of the final rule, which would be shown in Sec.  799.5089(j) of 
the proposed regulatory text. EPA is also proposing that a robust 
summary of the final report for each specific test would be required to 
be submitted electronically 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. 13). Persons who 
respond to this request to submit robust summaries are also encouraged 
to submit the robust summary electronically via the 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.'' EPA is soliciting 
comment on this proposed reporting requirement.

G. What Would I Need to Do if I Cannot Complete the Testing Required by 
the Final Rule?

    A company who submits a letter of intent to test under the final 
rule and who 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. Would There be Sufficient Test Facilities and Personnel to Undertake 
the Testing Proposed Under this Test Rule?

    EPA's most recent analysis of laboratory capacity (Ref. 41) 
indicates that available test facilities and personnel would adequately 
accommodate the testing proposed in this rule.

I. Might EPA Seek Further Testing of the Chemicals in this Proposed 
Test Rule?

    If EPA determines that it needs additional data regarding any of 
the chemical substances included in this proposed 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.

V. Export Notification

    Any person who exports, or intends to export, one of the chemical 
substances contained in this proposed rule in any form (e.g., as 
byproducts, impurities, components of Class 2 chemical substances, 
etc.) will be subject to the export notification requirements in TSCA 
section 12(b)(1) and at 40 CFR part 707, subpart D, but only after the 
final rule is issued and only if the chemical substance is contained in 
the final rule. Export notification is generally not required for 
articles, as provided by 40 CFR 707.60(b). Section 12(b) of TSCA 
states, in part, that any person who exports or intends to export to a 
foreign country a chemical substance or mixture for which the 
submission of data is required under TSCA section 4 must notify the EPA 
Administrator of such export or intent to export. The EPA Administrator 
in turn will notify the government of the importing country of EPA's 
regulatory action with respect to the chemical substance.

VI. Economic Impacts

    EPA has prepared an economic assessment entitled ``Economic Impact 
Analysis for the Proposed Section 4 Test Rule for High Production 
Volume Chemicals-3'' (Ref. 14), a copy of which has been placed in the 
docket for this proposed rule. This economic assessment evaluates the 
potential for significant economic impacts as a result of the testing 
that would be required by this proposed rule. The analysis covers 29 
chemical substances. The total social cost of providing test data on 
the 29 chemical substances that were evaluated in this economic 
analysis is estimated to be $10.30 million assuming an average cost 
scenario. Total costs of compliance to industry are estimated at $10.21 
million (Ref. 14).
    While legally subject to this test rule, processors of a subject 
chemical would be required to comply with the requirements of the final 
rule only if they are directed to do so by EPA as described in Sec.  
799.5089(c)(5) and (c)(6) of the proposed 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

[[Page 8589]]

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 proposed 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 processors would not need to comply with the proposed 
rule initially, 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 proposed rule, EPA 
employed an initial 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. In addition, 
they include the estimated cost of the TSCA section 12(b) export 
notification requirements, which, under the final rule, would be 
required for the first export to a particular country of a chemical 
substance subject to the final rule, estimated to range from $26.86 per 
notice to $85.70 per notice (Ref.14). These export notification 
requirements (included in the total and annualized cost estimates) that 
would be triggered by the final rule are expected to have a negligible 
impact on exporters.
    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.
    These annualized testing costs are then divided by the estimated 
annual revenue of the chemical substance to derive a cost-to-sales 
ratio.
    The screening results suggest that under a least cost scenario, 17 
out of the 29 chemical substances (59%) would have a price impact at 
less than the 1% level. Similarly, 16 out of the 29 chemical substances 
(55%) would be impacted at less than the 1% level under an average cost 
scenario.
    EPA believes, on the basis of these calculations, that the proposed 
testing of the chemical substances 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. EPA, therefore, compared the annualized 
costs of testing to company revenue for those chemical substances 
because in these cases, companies may choose to use revenue sources 
other than the profits from the individual chemical substances to pay 
for testing. EPA estimates that the costs of testing will exceed 1% of 
company revenue for one of the affected companies. 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.
    The benefits resulting from this proposed test rule are discussed 
qualitatively in ``Economic Impact Analysis for the Proposed Section 4 
Test rule for High Production Volume Chemicals-3'' (Ref. 14). EPA 
believes that the net benefits of this proposed rule are positive, but 
quantification of the benefits of the proposed rule would require more 
specific information about use patterns and preferences than is 
available.

VII. Public Comment

    As discussed in Units III.C. and III.D., the Agency solicits 
comment regarding additional information pertaining to potential 
exposure of workers and consumers, respectively, to the chemical 
substances identified in this proposed rule. Also, as discussed in Unit 
III.E., the Agency solicits comment regarding additional information 
pertaining to environmental releases of the chemical substances 
identified in this proposed rule.
    As discussed in Unit III.G., EPA is soliciting comments which 
identify existing data that may meet the requirements of studies under 
this proposed rule. To the extent that data relevant to the testing 
specified in this proposed rule are known to exist, EPA strongly 
encourages the submission of this information as comments to the 
proposed rule. Data submitted to EPA to meet the requirements of 
testing under this proposed rule must be in the form of full copies of 
unpublished studies or full citations of published studies, and may be 
accompanied by a robust summary (Ref. 13). To the extent that studies 
required under this proposed rule are currently available, and the data 
are judged sufficient by EPA, testing for the endpoint/chemical 
combination will not be required in the final rule based on this 
proposed rule.
    EPA is also soliciting public comment on the proposed requirement 
for submission of robust summaries, the test methods proposed, and the 
analysis detailing the burdens and costs for the regulatory impacts 
resulting from this proposed rule.
    In addition, EPA solicits comment on the proposed and alternative 
approaches to the testing of Class 2 chemical substances, whether the 
proposed approach for testing Class 1 chemical substances (i.e., that 
each Class 1 chemical substance be tested at a purity of 99% or more) 
should be applied to any Class 2 chemical substances, and whether the 
proposed or alternative approaches for the testing of Class 2 chemical 
substances (i.e., that a representative sample of each Class 2 
substance be tested) should be applied to any Class 1 chemical 
substances.

VIII. Materials in the Docket

    As indicated under ADDRESSES, a docket has been established for 
this proposed rule under docket ID number EPA-HQ-OPPT-2009-0112. The 
following is a listing of the documents that have been placed in the 
docket for this proposed rule. The docket includes information 
considered by EPA in developing this proposed 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, please consult either technical 
person 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; 
Proposed Rule. Federal Register (65 FR 81658, December 26, 2000) (FRL-
6758-4).

[[Page 8590]]

    3. EPA. Testing of Certain High Production Volume Chemicals; Final 
Rule. Federal Register (71 FR 13708, March 16, 2006) (FRL-7335-2).
    4. EPA. TSCA Section 4(a)(1)(B) Final Statement of Policy; Criteria 
for Evaluating Substantial Production, Substantial Release, and 
Substantial or Significant Human Exposure; Notice. Federal Register (58 
FR 28736, May 14, 1993).
    5. EPA. OPPT. HPV Challenge Program Chemical List. This list is 
available on-line at: http://www.epa.gov/oppt/chemrtk/pubs/update/hpvchmlt.htm.
    6. 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.
    7. ICCA. ICCA HPV Working List of Chemicals. October 2005. This 
list is updated periodically, and is available on-line at: http://www.cefic.org/activities/hse/mgt/hpv/hpvinit.htm.
    8. EPA. TSCA Section 4(a)(1)(B) Proposed Statement of Policy; 
Notice. Federal Register (56 FR 32294, July 15, 1991).
    9. EPA. Sixty-Third Report of the TSCA Interagency Testing 
Committee to the Administrator of the Environmental Protection Agency; 
Receipt of Report and Request for Comments; Notice. Federal Register 
(73 FR 65486, November 3, 2008) (FRL-8387-6).
    10. EPA. Preliminary Assessment Information Reporting; Addition of 
Certain Chemicals. Final Rule and Technical Corrections. Federal 
Register (71 FR 47122, August 16, 2006) (FRL-7764-9).
    11. 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).
    12. EPA. Office of Pollution Prevention and Toxics (OPPT). Chemical 
Hazard Data Availability Study: What Do We Really Know About the Safety 
of High Production Volume Chemicals? April 1998. Available on-line at: 
http://www.epa.gov/chemrtk/pubs/general/hazchem.htm.
    13. EPA. OPPT. Draft Guidance on Developing Robust Summaries. 
October, 22, 1999. Available on-line at: http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
    14. EPA. OPPT. Economic Impact Analysis for the Proposed Section 4 
Test Rule for High Production Volume Chemicals-3. Prepared by the OPPT 
Economic and Policy Analysis Branch. December 2009.
    15. EPA. OPPT. Testing of Certain High Production Volume Chemicals-
3 (Exposure Findings Supporting Information). Prepared by OPPT 
Economics, Exposure and Technology Division. September 2009.
    16. NIOSH. National occupational exposure survey field guidelines. 
Vol. I. Seta JA, Sundin DS, Pedersen DH, eds. Cincinnati, OH: U.S. 
Department of Health and Human Services, Centers for Disease Control, 
National Institute for Occupational Safety and Health, DHHS (NIOSH) 
Publication No. 88-106. Available on-line at: http://www.cdc.gov/niosh/88-106.html. 1988.
    17. ASTM International. Standard Test Method for Relative Initial 
and Final Melting Points and the Melting Range of Organic Chemicals. 
ASTM E 324-99. 1999.
    18. ASTM International. Standard Test Method for Vapor Pressure of 
Liquids by Ebulliometry. ASTM E 1719-05. 2005.
    19. ASTM International. Standard Test Method for Determining Vapor 
Pressure by Thermal Analysis. ASTM. E 1782-03. 2003.
    20. ASTM International. Standard Test Method for Partition 
Coefficient (n-Octanol/Water) Estimation by Liquid Chromatography. ASTM 
E 1147-92(2005). 2005.
    21. ASTM International. Standard Test Method for Measurements of 
Aqueous Solubility. ASTM E 1148-02. 2002.
    22. ASTM International. Question about ASTM E 324. E-mail from 
Diane Rehiel, ASTM, to Greg Schweer, CITB, CCD, OPPT, EPA. September 
15, 2004.
    23. Meylan, W.M. and Howard, P.H. Atom/Fragment Contribution Method 
for Estimating Octanol-Water Partition Coefficients. Journal of 
Pharmaceutical Sciences. Vol. 84(1):83-92. 1995.
    24. 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. Vol. 15(2):100-
106. 1996.
    25. ASTM International. Standard Test Method for Determining Ready, 
Ultimate, Biodegradability of Organic Chemicals in a Sealed Vessel 
CO2 Production Test. ASTM E 1720-01. 2001.
    26. 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.
    27. 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.
    28. 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.
    29. ISO. Water quality -- Evaluation of ultimate aerobic 
biodegradability of organic compounds in aqueous medium -- Carbon 
dioxide evolution test. ISO 9439. 1999.
    30. 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.
    31. 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.
    32. 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.
    33. ASTM International. Standard Guide for Conducting Acute 
Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and 
Amphibians. ASTM E 729-96(2002). 2002.
    34. ASTM International. Standard Guide for Conducting Static 
Toxicity Tests with Microalgae. ASTM E 1218-04e1. 2004.
    35. ASTM International. Standard Guide for Conducting Daphnia magna 
Life-Cycle Toxicity Tests. ASTM E 1193-97(2004). 2004.
    36. Veith, G.D. and Kosian, P. Estimating bioconcentration 
potential from Octanol/Water Partition Coefficients, in Physical 
Behavior of PCB's in the Great Lakes (MacKay, Paterson, Eisenreich, and 
Simmons, eds.), Ann Arbor Science, Ann Arbor, MI. 1982.
    37. 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.
    38. EPA. 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.
    39. EPA. Significant New Use Rules; General Provisions for New 
Chemical

[[Page 8591]]

Follow-Up; Final Rule. Federal Register (54 FR 31298, July 27, 1989).
    40. EPA. OPPT. Guidance for Testing Closed System Intermediates for 
the HPV Challenge Program (Draft) (March 17, 1999). Available on-line 
at: http://www.epa.gov/oppt/chemrtk/pubs/general/closed9.htm.
    41. EPA. Analysis of Laboratory Capacity to Support U.S. EPA 
Chemical Testing Program Initiatives. Economic and Policy Analysis 
Branch. Washington, DC. August 2004.
    42. 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.
    43. EPA. Economic Analysis in Support of the TSCA 12(b) Information 
Collection Request, OPPT/EETD/EPAB. Washington, DC. October 30, 1998.
    44. 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.
    45. 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.
    46. 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.
    47. 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.
    48. EPA. Toxic Substances; Test Rule Development and Exemption 
Procedures; Interim Final Rule. Federal Register (50 FR 20652, May 17, 
1985).
    49. EPA. Toxic Substances Control Act; Data Reimbursement; Final 
Rule. Federal Register (48 FR 31786, July 11, 1983).
    50. EPA. OPPT. High Production Volume Chemical Data Information 
System (HPVIS). Data from HVPIS on 29 HPV chemicals. December 2009.
    51. NIOSH. National occupational exposure survey analysis of 
management interview responses. Vol. III. Pedersen, D.H. and Sieber, 
W.K., eds. Cincinnati, OH. U.S. Department of Health and Human 
Services, Centers for Disease Control, National Institute for 
Occupational Safety and Health, DHHS (NIOSH) Publication No. 89-103. 
Available on-line at: http://www.cdc.gov/niosh/89-103.html. 1989.
    52. NIOSH. National occupational exposure survey sampling 
methodology. Vol. II. Sieber, W.K., ed. Cincinnati, OH. U.S. Department 
of Health and Human Services, Centers for Disease Control, National 
Institute for Occupational Safety and Health, DHHS (NIOSH) Publication 
No. 89-102. Available on-line at: http://www.cdc.gov/niosh/89-102.html. 
1989.
    53. ASTM International. Standard Test Method for estimating Acute 
Oral Toxicity in Rats. ASTM E 1163-98(2002). 2002.

IX. 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 proposed rule is not a 
``significant regulatory action'' subject to review by the Office of 
Management and Budget (OMB) under Executive Order 12866.
    EPA has prepared an economic analysis of this proposed action, 
which is contained in a document entitled ``Economic Impact Analysis 
for the Proposed Section 4 Test Rule for High Production Volume 
Chemicals-3'' (Ref. 14). A copy of the economic analysis is available 
in the docket for this proposed rule and is summarized in Unit VI.

B. Paperwork Reduction Act

    This proposed 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. Although the activities are approved, OMB has specified that 
the additional burden associated with a new test rule is not covered by 
the ICR until the final rule is effective. 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 OMB 
inventory. The Agency's estimated burden for this proposed test rule is 
provided in the economic analysis (Ref. 14).
    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 proposed rule does 
not propose 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, a collection of information that is subject 
to approval under PRA, unless it displays a currently valid OMB control 
number. The OMB control numbers for the EPA regulations codified in 
chapter 40 of the CFR, after appearing in the preamble of the final 
rule, are listed in 40 CFR part 9, displayed either by publication in 
the Federal Register or by other appropriate means, such as on the 
related collection instrument or form, if applicable. The display of 
OMB control numbers in certain EPA regulations is consolidated in 40 
CFR part 9.
    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 proposed rule, EPA estimates the public reporting 
burden for all 29 chemical substances is 52,184 hours (average cost 
scenario). EPA assumes that industry will form a ``task force'' or 
panel to coordinate testing where appropriate. A panel may often 
represent groups of chemical substances. EPA estimates 16 panels for 
the proposed rule; with an estimated burden per panel of 3,262 hours 
(average cost scenario) (Ref.14).
    The estimated burden of the information collection activities 
related to export notification is estimated to average 1 burden hour 
for each chemical/country combination for an initial notification and 
0.5 hours for each subsequent notification (Ref. 14). In estimating the 
total burden hours approved for the information collection activities 
related to export notification, the Agency has included sufficient

[[Page 8592]]

burden hours to accommodate any export notifications that may be 
required by the Agency's issuance of final chemical test rules. 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.
    Comments are requested on the Agency's need for this information, 
the accuracy of the provided burden estimates, and any suggested 
methods for minimizing respondent burden, including through the use of 
automated collection techniques. Send comments to EPA as part of your 
overall comments on this proposed rule in the manner specified under 
ADDRESSES. In developing the final rule, the Agency will address any 
comments received regarding the information collection requirements 
contained in this proposed rule.

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 
of this proposed rule on small entities, the Agency hereby certifies 
that this proposed 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 proposed 
rule (Ref. 14), which is summarized in Unit VI., and a copy of which is 
available in the docket for this proposed 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 proposed 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 proposed rule (Ref. 14), EPA has determined that this 
proposed 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. 14) in order to characterize the potential small entity impacts 
of this proposed 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 proposed rule, EPA has 
analyzed the potential small business impacts using the size standards 
established under this default definition. The SBA size standards, 
which are primarily intended to determine whether a business entity is 
eligible for government programs and preferences reserved for small 
businesses (13 CFR 121.101), ``seek to ensure that a concern that meets 
a specific size standard is not dominant in its field of operation.'' 
(13 CFR 121.102(b)). See section 632(a)(1) of the Small Business Act. 
In analyzing potential impacts, RFA recognizes that it may be 
appropriate at times to use an alternate definition of small business. 
As such, section 601(3) of RFA provides that an agency may establish a 
different definition of small business after consultation with the SBA 
Office of Advocacy and after notice and an opportunity for public 
comment. Even though the Agency has used the default SBA definition of 
small business to conduct its analysis of potential small business 
impacts for this proposed rule, EPA does not believe that the SBA size 
standards are generally the best size standards to use in assessing 
potential small entity impacts with regard to TSCA section 4(a) test 
rules.
    The SBA size standard is generally based on the number of employees 
an entity in a particular industrial sector may have. For example, in 
the chemical manufacturing industrial sector (i.e., NAICS code 325 and 
NAICS code 324110), approximately 98% of the firms would be classified 
as small businesses under the default SBA definition. The SBA size 
standard for 75% of this industry sector is 500 employees, and the size 
standard for 23% of this industry sector is either 750, 1,000, or 1,500 
employees. When assessing the potential impacts of test rules on 
chemical manufacturers, EPA believes that a standard based on total 
annual sales may provide a more appropriate means to judge the ability 
of a chemical manufacturing firm to support chemical testing without 
significant costs or burdens.
    EPA is currently determining what level of annual sales would 
provide the most appropriate size cutoff with regard to various 
segments of the chemical industry usually impacted by TSCA section 4(a) 
test rules, but has not yet reached a determination. As stated in this 
unit, therefore, the factual basis for the RFA determination for this 
proposed rule is based on an analysis using the default SBA size 
standards. Although EPA is not currently proposing to establish an 
alternate definition for use in the analysis conducted for this 
proposed rule, the analysis for this proposed rule also presents the 
results of calculations using a standard based on total annual sales 
(40 CFR 704.3). EPA is interested in receiving comments on whether the 
Agency should consider establishing an alternate definition for small 
business to use in the small entity impact analyses for future TSCA 
section 4(a) test rules, and what size cutoff may be appropriate.
    SBA has developed 6-digit NAICS code-specific size standards based 
on employment thresholds. These size standards range from 500 to 1,500 
employees for the various 6-digit NAICS codes that are potentially 
affected (Ref. 14). For a conservative estimate of the number of small 
businesses affected by the HPV rules, the Agency uses an employment 
threshold of less than 1,500 employees for all businesses regardless of 
the NAIC-specific threshold to determine small business status.
    For each manufacturer of the 29 chemical substances covered by this

[[Page 8593]]

proposed rule, the parent company (ultimate corporate entity or UCE) 
was identified and sales and employment data were obtained for 
companies where data was publicly available. The search determined that 
there were 54 affected UCEs. Sales and employment data could be found 
for 52 of these UCEs (96%). Two companies could not be classified as 
small or large because there were no employment data available, but 
were still included in the small business impact analysis.
    Parent company sales data were collected to identify companies that 
qualified as a ``small business'' for purposes of RFA analysis. Based 
on the SBA size standard applied (1,500 employees or less), 21 
companies (39%) were identified as small.
    The potential significance of this proposed rule's impact on small 
businesses was analyzed by examining the number of small entities that 
experienced different levels of costs as a percentage of their sales. 
Small businesses were placed in the following categories on the basis 
of cost-to sales ratios: Less than 1%, greater than 1%, and greater 
than 3%. This analysis was conducted under both a least and average 
cost scenario.
    Of the 21 businesses designated as small business, none had cost-
to-sales ratios of greater than 1% and 3% under both the least and 
average cost scenarios. For the chemical substances where sales data 
were unavailable, EPA used the median sales value sales of all other 
small businesses equal to $24.7 million. The costs for the two 
companies were estimated to be well below 1% of this sales level. Given 
these results, the Agency has determined that there is not a 
significant economic impact on a substantial number of small entities 
as a result of this proposed rule, if finalized.
    The estimated cost of the TSCA section 12(b)(1) export 
notification, which, as a result of the final rule, would be required 
for the first export to a particular country of a chemical substance 
subject to the final rule, is estimated to be $85.70 for the first time 
that an exporter must comply with TSCA section 12(b)(1) export 
notification requirements, and $26.86 for each subsequent export 
notification submitted by that exporter (Refs. 14, 42, and 43). EPA has 
concluded that the costs of TSCA section 12(b)(1) export notification 
would have a negligible impact on exporters of the chemical substances 
in the final rule, regardless of the size of the exporter.
    Any comments regarding the impacts that this action may impose on 
small entities, or regarding whether the Agency should consider 
establishing an alternate definition of small business to be used for 
analytical purposes for future test rules and what size cutoff may be 
appropriate, should be submitted to the Agency in the manner specified 
under ADDRESSES.

D. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA), Public Law 104-4, EPA has determined that this proposed rule 
does not contain a Federal mandate that may result in expenditures of 
$100 million or more for State, local, and tribal governments, in the 
aggregate, or the private sector in any 1 year. It is estimated that 
the total aggregate costs of this proposed rule to the private sector, 
which are summarized in Unit VI., would be $10.21 million. The total 
annualized costs of this proposed rule to the private sector are 
estimated to be $3.61 and 3.89 million using a 3% and 7% discount rate 
over 3 years (average cost scenario). In addition, since EPA does not 
have any information to indicate that any State, local, or tribal 
government manufactures or processes the chemical substances covered by 
this action such that the final rule would apply directly to State, 
local, or tribal governments, EPA has determined that this proposed 
rule would not significantly or uniquely affect small governments. 
Accordingly, this proposed rule is not subject to the requirements of 
sections 202, 203, 204, and 205 of UMRA.

E. Executive Order 13132

    Under Executive Order 13132, entitled Federalism (64 FR 43255, 
August 10, 1999), EPA has determined that this proposed rule does not 
have ``federalism implications'' because it will not have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in the Executive Order. This proposed rule would establish testing and 
recordkeeping requirements that apply to manufacturers (including 
importers) and processors of certain chemical substances. Because EPA 
has no information to indicate that any State or local government 
manufactures or processes the chemical substances covered by this 
action, this proposed rule does not apply directly to States and 
localities and will not affect State and local governments. Thus, 
Executive Order 13132 does not apply to this proposed rule.

F. Executive Order 13175

    Under Executive Order 13175, entitled Consultation and Coordination 
with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has 
determined that this proposed rule does not have tribal implications 
because it will not have any affect on tribal governments, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in the Executive Order. As 
indicated previously, EPA has no information to indicate that any 
tribal government manufactures or processes the chemical substances 
covered by this action. Thus, Executive Order 13175 does not apply to 
this proposed rule.

G. Executive Order 13045

    This proposed rule is not subject to Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997), because it does not 
establish an environmental standard intended to mitigate health or 
safety risks, will not have an annual effect on the economy of $100 
million or more, nor does it otherwise have a disproportionate effect 
on children. This proposed rule would establish testing and 
recordkeeping requirements that apply to manufacturers (including 
importers) and processors of certain chemical substances, and would 
result in the development of data about those chemical substances that 
can subsequently be used to assist the Agency and others in determining 
whether the chemical substances in this proposed rule present potential 
risks, allowing the Agency and others to take appropriate action to 
investigate and mitigate those risks.

H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211, 
entitled Actions Concerning Regulations that Significantly Affect 
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), 
because it is unlikely to have any significant adverse effect on the 
supply, distribution, or use of energy.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note), directs EPA to use voluntary consensus standards in its 
regulatory activities unless to do so would be inconsistent

[[Page 8594]]

with applicable law or otherwise impractical. Voluntary consensus 
standards are technical standards (e.g., materials specifications, test 
methods, sampling procedures, and business practices) that are 
developed or adopted by voluntary consensus standards bodies. The NTTAA 
directs EPA to provide Congress, through OMB, explanations when the 
Agency decides not to use available and applicable voluntary consensus 
standards.
    This proposed rule involves technical standards because it proposes 
to require the use of particular test methods. If the Agency makes 
findings under TSCA section 4(a), EPA is required by TSCA section 4(b) 
to include specific standards or test methods that are to be used for 
the development of the data required in the test rules issued under 
TSCA section 4. For some of the testing that would be required by the 
final rule, EPA is proposing the use of voluntary consensus standards 
issued by ASTM International and ISO which evaluate the same type of 
toxicity as the TSCA 799 test guidelines and OECD test guidelines, 
where applicable. Copies of the 17 ASTM International and ISO standards 
referenced in the proposed regulatory text at Sec.  799.5089(h) have 
been placed in the docket for this proposed rule. You may obtain copies 
of the ASTM International standards from the American Society for 
Testing and Materials International, 100 Bar Harbor Dr., West 
Conshohocken, PA 19428-2959, and copies of the ISO standards from the 
International Organization for Standardization, Case Postale, 56 CH-
1211 Gen[egrave]ve 20 Switzerland. In the final rule, EPA intends to 
seek approval from the Director of the Federal Register for the 
incorporation by reference of the ASTM International and ISO standards 
used in the final rule in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51.
    EPA is not aware of any potentially applicable voluntary consensus 
standards which evaluate partition coefficient (n-octanol/water) 
generator column, water solubility (column elution and generator 
column), acute inhalation toxicity, bacterial reverse mutations, in 
vivo mammalian bone marrow chromosomal aberrations, combined repeated 
dose with reproductive/developmental toxicity screen, repeated dose 28-
day oral toxicity screen, or the reproductive developmental toxicity 
screen which could be considered in lieu of the TSCA 799 test 
guidelines, 40 CFR 799.6756, 799.6784, 799.6786, 799.9130, 799.9510, 
799.9538, 799.9365, 799.9305, and 799.9355, respectively, upon which 
the test standards in this proposed rule are based. The Agency invites 
comment on the potential use of voluntary consensus standards in this 
proposed rule, and, specifically, invites the public to identify 
potentially applicable consensus standard(s) and to explain why such 
standard(s) should be used here.

J. Executive Order 12898

    This proposed rule does not have an adverse impact on the 
environmental and health conditions in low-income and minority 
communities that require special consideration by the Agency under 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994). The Agency believes that 
the information collected under this proposed rule, if finalized, will 
assist EPA and others in determining the potential hazards and risks 
associated with the chemical substances covered by this proposed rule. 
Although not directly impacting environmental justice-related concerns, 
this information will enable the Agency to better protect human health 
and the environment, including in low-income and minority communities.

List of Subjects in 40 CFR Part 799

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


    Dated: February 17, 2010.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 799-- IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND 
MIXTURE TESTING REQUIREMENTS

    1. The authority citation for part 799 continues to read as 
follows:

    Authority:  15 U.S.C. 2603, 2611, 2625.

    2. Add Sec.  799.5089 to subpart D of part 799 to read as follows:


Sec.  799.5089  Chemical testing requirements for certain high 
production volume chemicals; third group of chemicals.

    (a) What substances will be tested under this section? Table 2 in 
paragraph (j) of this section identifies the chemical substances that 
must be tested under this section. For the chemical substances 
identified as ``Class 1'' chemical substances in Table 2 in paragraph 
(j) of this section, the purity of each chemical substance must be 99% 
or greater, unless otherwise specified in this section. For the 
chemical substances identified as ``Class 2'' chemical substances in 
Table 2 in paragraph (j), a representative form of each chemical 
substance must be tested. The representative form selected for a given 
Class 2 chemical substance should meet industry or consensus standards 
where they exist.
    (b) Am I subject to this section? (1) If you manufacture (including 
import) or intend to manufacture, or process or intend to process, any 
chemical substance listed in Table 2 in paragraph (j) of this section 
at any time from the effective date of the final rule to the end of the 
test data reimbursement period as defined in 40 CFR 791.3(h), you are 
subject to this section with respect to that chemical substance.
    (2) If you do not know or cannot reasonably ascertain that you 
manufacture or process a chemical substance listed in Table 2 in 
paragraph (j) of this section during the time period described in 
paragraph (b)(1) of this section (based on all information in your 
possession or control, as well as all information that a reasonable 
person similarly situated might be expected to possess, control, or 
know, or could obtain without unreasonable burden), you are not subject 
to this section with respect to that chemical substance.
    (c) If I am subject to this section, when must I comply with it? 
(1) (i) Persons subject to this section are divided into two groups, as 
set forth in Table 1 of this paragraph: Tier 1 (persons initially 
required to comply) and Tier 2 (persons not initially required to 
comply). If you are subject to this section, you must determine if you 
fall within Tier 1 or Tier 2, based on Table 1 of this paragraph.

[[Page 8595]]



   Table 1.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
                                          Tier 2 (Persons not initially
 Tier 1 (Persons initially required to     required to comply with this
       comply with this section)                     section)
------------------------------------------------------------------------
Persons not otherwise specified in       Tier 2A. Persons who
 column 2 of this table that              manufacture (as defined at
 manufacture (as defined at TSCA          TSCA section 3(7)) or intend
 section 3(7)) or intend to manufacture   to manufacture a chemical
 a chemical substance included in this    substance included in this
 section.                                 section 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
                                          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
                                          kilogram (kg) (1,100 lbs.)
                                          annually (as described at 40
                                          CFR 790.42(a)(4)); or
                                         --For research and development
                                          (as described at 40 CFR
                                          790.42(a)(5)).
                                         B. Persons who process (as
                                          defined at TSCA section 3(10))
                                          or intend to process a
                                          chemical substance included in
                                          this section (see 40 CFR
                                          790.42(a)(2)).
------------------------------------------------------------------------

    (ii) Table 1 of paragraph (c)(1)(i) of this section expands the 
list of persons in Tier 2, that is those persons specified in Sec.  
790.42(a)(2), (a)(4) and (a)(5) of this chapter, who, while legally 
subject to this section, must comply with the requirements of this 
section only if directed to do so by EPA under the circumstances set 
forth in paragraphs (c)(4), (c)(5), (c)(6), (c)(7), and (c)(10) of this 
section.
    (2) If you are in Tier 1 with respect to a chemical substance 
listed in Table 2 in paragraph (j) of this section, you must, for each 
test required under this section for that chemical substance, either 
submit to EPA a letter of intent to test or apply to EPA for an 
exemption from testing. The letter of intent to test or the exemption 
application must be received by EPA no later than 30 days after the 
effective date of the final rule.
    (3) If you are in Tier 2 with respect to a chemical substance 
listed in Table 2 in paragraph (j) of this section, you are considered 
to have an automatic conditional exemption and you will be required to 
comply with this section with regard to that chemical substance only if 
directed to do so by EPA under paragraphs (c)(5), (c)(7), or (c)(10) of 
this section.
    (4) If no person in Tier 1 has notified EPA of its intent to 
conduct one or more of the tests required by this section on any 
chemical substance listed in Table 2 in paragraph (j) of this section 
within 30 days after the effective date of the final rule, EPA will 
publish a Federal Register document that would specify the test(s) and 
the chemical substance(s) for which no letter of intent has been 
submitted and notify manufacturers in Tier 2A of their obligation to 
submit a letter of intent to test or to apply for an exemption from 
testing.
    (5) If you are in Tier 2A (as specified in Table 1 in paragraph (c) 
of this section) with respect to a chemical substance listed in Table 2 
in paragraph (j) of this section, and if you manufacture, or intend to 
manufacture, this chemical substance as of [30 days after date of 
publication of the final rule in the Federal Register], or within 30 
days after publication of the Federal Register document described in 
paragraph (c)(4) of this section, you must, for each test specified for 
that chemical substance in the document described in paragraph (c)(4) 
of this section, either submit to EPA a letter of intent to test or 
apply to EPA for an exemption from testing. The letter of intent to 
test or the exemption application must be received by EPA no later than 
30 days after publication of the Federal Register document described in 
paragraph (c)(4) of this section.
    (6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its 
intent to conduct one or more of the tests required by this section on 
any chemical substance listed in Table 2 in paragraph (j) of this 
section within 30 days after the publication of the Federal Register 
document described in paragraph (c)(4) of this section, EPA will 
publish another Federal Register document that would specify the 
test(s) and the chemical substance(s) for which no letter of intent has 
been submitted, and notify processors in Tier 2B of their obligation to 
submit a letter of intent to test or to apply for an exemption from 
testing.
    (7) If you are in Tier 2B (as specified in Table 1 in paragraph (c) 
of this section) with respect to a chemical substance listed in Table 2 
in paragraph (j) of this section, and if you process, or intend to 
process, this chemical substance as of [30 days after date of 
publication of the final rule in the Federal Register], or within 30 
days after publication of the Federal Register document described in 
paragraph (c)(6) of this section, you must, for each test specified for 
that chemical substance in the Federal Register document described in 
paragraph (c)(6) of this section, either submit to EPA a letter of 
intent to test or apply to EPA for an exemption from testing. The 
letter of intent to test or the exemption application must be received 
by EPA no later than 30 days after publication of the Federal Register 
document described in paragraph (c)(6) of this section.
    (8) If no manufacturer or processor has notified EPA of its intent 
to conduct one or more of the tests required by this section for any of 
the chemical substances listed in Table 2 in paragraph (j) of this 
section within 30 days after the publication of the Federal Register 
document described in paragraph (c)(6) of this section, EPA will notify 
all manufacturers and processors of those chemical substances of this 
fact by certified letter or by publishing a Federal Register document 
specifying the test(s) for which no letter of intent has been 
submitted. This letter or Federal Register document will additionally 
notify all manufacturers and processors that all exemption applications 
concerning the test(s) have been denied, and will give the 
manufacturers and processors of the chemical substance(s) an 
opportunity to take corrective action.
    (9) If no manufacturer or processor has notified EPA of its intent 
to conduct one or more of the tests required by this section for any of 
the chemical substances listed in Table 2 in paragraph (j) of this 
section within 30 days after receipt of the certified letter or 
publication of the Federal Register document described in paragraph 
(c)(8) of this section, all manufacturers and processors subject to 
this section with respect to that chemical substance who are not 
already in violation of this

[[Page 8596]]

section will be in violation of this section.
    (10) If a problem occurs with the initiation, conduct, or 
completion of the required testing or the submission of the required 
data with respect to a chemical substance listed in Table 2 in 
paragraph (j) of this section, under the procedures in Sec. Sec.  
790.93 and 790.97 of this chapter, EPA may initiate termination 
proceedings for all testing exemptions with respect to that chemical 
substance and may notify persons in Tier 1 and Tier 2 that they are 
required to submit letters of intent to test or exemption applications 
within a specified period of time.
    (11) If you are required to comply with this section, but your 
manufacture or processing of, or intent to manufacture or process, a 
chemical substance listed in Table 2 in paragraph (j) of this section 
begins after the applicable compliance date referred to in paragraphs 
(c)(2), (c)(5), or (c)(6) of this section, you must either submit a 
letter of intent to test or apply to EPA for an exemption. The letter 
of intent to test or the exemption application must be received by EPA 
no later than the day you begin manufacture or processing.
    (d)  What must I do comply with this section? (1) To comply with 
this section you must either submit to EPA a letter of intent to test, 
or apply to and obtain from EPA an exemption from testing.
    (2) For each test with respect to which you submit to EPA a letter 
of intent to test, you must conduct the testing specified in paragraph 
(h) of this section and submit the test data to EPA.
    (3) You must also comply with the procedures governing test rule 
requirements in part 790 of this chapter, as modified by this section, 
including the submission of letters of intent to test or exemption 
applications, the submission of study plans prior to testing, the 
conduct of testing, and the submission of data; Part 792--Good 
Laboratory Practice Standards of this chapter; and this section. The 
following provisions of 40 CFR part 790 do not apply to this section: 
Paragraphs (a), (d), (e), and (f) of Sec.  790.45; Sec.  790.48; 
paragraph (a)(2) and paragraph (b) of Sec.  790.80; paragraph (e)(1) of 
Sec.  790.82; and Sec.  790.85.
    (e)  If I do not comply with this section, when will I be 
considered in violation of it? You will be considered in violation of 
this section as of 1 day after the date by which you are required to 
comply with this section.
    (f)  How are EPA's data reimbursement procedures affected for 
purposes of this section? If persons subject to this section are unable 
to agree on the amount or method of reimbursement for test data 
development for one or more chemical substances included in this 
section, any person may request a hearing as described in 40 CFR part 
791. In the determination of fair reimbursement shares under this 
section, if the hearing officer chooses to use a formula based on 
production volume, the total production volume amount will include 
amounts of a chemical substance produced as an impurity.
    (g)  Who must comply with the export notification requirements? Any 
person who exports, or intends to export, a chemical substance listed 
in Table 2 in paragraph (j) of this section is subject to part 707, 
subpart D, of this chapter.
    (h)  How must I conduct my testing? The tests that are required for 
each chemical substance are indicated in Table 2 in paragraph (j) of 
this section. The test methods that must be followed are provided in 
Table 3 in paragraph (j) of this section. You must proceed in 
accordance with these test methods as required according to Table 3 in 
paragraph (j) of this section, or as appropriate if more than one 
alternative is allowed according to Table 3 in paragraph (j) of this 
section.
    (i)  Reporting requirements. A final report for each specific test 
for each subject chemical substance must be received by EPA by [13 
months after the effective date of the final rule] unless an extension 
is granted in writing pursuant to 40 CFR 790.55. A robust summary of 
the final report for each specific test shall be submitted 
electronically in addition to and at the same time as the final report. 
The term ``robust summary'' is used to describe the technical 
information necessary to adequately describe an experiment or study and 
includes the objectives, methods, results, and conclusions of the full 
study report which can be either an experiment or in some cases an 
estimation or prediction method. Guidance for the compilation of robust 
summaries is described in a document entitled ``Draft Guidance on 
Developing Robust Summaries'' which is available on-line at: http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
    (j)  Designation of specific chemical substances and testing 
requirements. The chemical substances identified by chemical name, 
Chemical Abstract Service Registry number (CAS No.), and class in Table 
2 of this paragraph must be tested in accordance with the requirements 
designated in Tables 2 and 3 of this paragraph, and the requirements 
described in 40 CFR Part 792-Good Laboratory Practice Standards:

                             Table 2.--Chemical Substances and Testing Requirements
----------------------------------------------------------------------------------------------------------------
                                                                                           Required Tests  (See
               CAS No.                      Chemical Name                Class               Table 3 of this
                                                                                                 section)
----------------------------------------------------------------------------------------------------------------
83-41-0                                Benzene, 1,2-dimethyl-3- 1                         A1, A2, A3, A4, A5, D,
                                        nitro-                                            E2, F1
----------------------------------------------------------------------------------------------------------------
96-22-0                                3-Pentanone              1                         E1, F2
----------------------------------------------------------------------------------------------------------------
98-09-9                                Benzenesulfonyl          1                         C2, E1, E2, F1
                                        chloride
----------------------------------------------------------------------------------------------------------------
98-56-6                                Benzene, 1-chloro-4-     1                         A4, B, C1, F2
                                        (trifluoromethyl)-
----------------------------------------------------------------------------------------------------------------
111-44-4                               'Ethane, 1,1'-oxybis[2-  1                         C6, F1
                                        chloro-
----------------------------------------------------------------------------------------------------------------
127-68-4                               Benzenesulfonic acid, 3- 1                        A3, F2
                                        nitro-, sodium salt
                                        (1:1)
----------------------------------------------------------------------------------------------------------------
506-51-4                               1-Tetracosanol           1                         A2, A3, A4, A5, B, C1,
                                                                                          D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
506-52-5                               1-Hexacosanol            1                         A2, A3, A4, A5, C1, D,
                                                                                          E1, E2, F1
----------------------------------------------------------------------------------------------------------------
515-40-2                               Benzene, (2-chloro-1,1-  1                         A1, A3, A4, A5, B, C1,
                                        dimethylethyl)-                                   D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------

[[Page 8597]]

 
2494-89-5                              Ethanol, 2-[(4-          1                         A1, A2, A3, A4, A5, B,
                                        aminophenyl)sulfonyl]-                            C1, D, E1, E2, F1
                                        , 1-(hydrogen sulfate)
----------------------------------------------------------------------------------------------------------------
5026-74-4                              2-Oxiranemethanamine, N- 1                        A1, A2, A3, A4, A5, B,
                                        [4-(2-                                            C2, F1
                                        oxiranylmethoxy)phenyl
                                        ]-N-(2-oxiranylmethyl)-
 
----------------------------------------------------------------------------------------------------------------
22527-63-5                             Propanoic acid, 2-       1                        A1, A2, A3, A4, A5, B,
                                        methyl-, 3-                                       C1, D, E1, E2, F1
                                        (benzoyloxy)-2,2,4-
                                        trimethylpentyl ester
----------------------------------------------------------------------------------------------------------------
24615-84-7                             2-Propenoic acid, 2-     1                         A1, A2, A3, A4, A5, B,
                                        carboxyethyl ester                                C1, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
25321-41-9                             Benzenesulfonic acid,    1                        A2, A3, A4, A5, B, C1,
                                        dimethyl-                                         D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
25646-71-3                             Methanesulfonamide, N-   1                        A1, A2, A3, A4, A5, B,
                                        [2-[(4-amino-3-                                   C1, F1
                                        methylphenyl)ethylamin
                                        o]ethyl]-, sulfate
                                        (2:3)
----------------------------------------------------------------------------------------------------------------
52556-42-0                             1-Propanesulfonic acid,  1                         A1, A2, A3, A4, A5, B,
                                        2-hydroxy-3-(2-                                   C1, D, E1, E2, F1
                                        propenyloxy)-, sodium
                                        salt (1:1)
----------------------------------------------------------------------------------------------------------------
61788-76-9                             Alkanes, chloro          2                        A2, A3, A4, A5, B,
----------------------------------------------------------------------------------------------------------------
65996-79-4                             Solvent naphtha (coal)   2                        A3, A4, A5, B, C1, D,
                                                                                          E1, E2, F1
----------------------------------------------------------------------------------------------------------------
65996-82-9                             Tar oils, coal           2                        A3, A4, A5, B, C1, D,
                                                                                          E1, E2, F1
----------------------------------------------------------------------------------------------------------------
65996-89-6                             Tar, coal, high-         2                        A4, A5, B, C1, D, E1,
                                        temperature                                       E2, F1
----------------------------------------------------------------------------------------------------------------
65996-92-1                             Distillates (coal tar)   2                        A3, A4, A5, B, C1, D,
                                                                                          E1, E2, F2
----------------------------------------------------------------------------------------------------------------
68082-78-0                             Lard, oil, Me esters     2                        A1, A2, A3, A4, A5, B,
                                                                                          C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68187-57-5                             Pitch, coal tar-         2                        A4, A5, B, C6, D, E1,
                                        petroleum                                         E2, F1
----------------------------------------------------------------------------------------------------------------
68442-60-4                             Acetaldehyde, reaction   2                        A1, A2, A3, A4, A5, B,
                                        products with                                     C1, D, E1, E2, F1
                                        formaldehyde, by-
                                        products from
----------------------------------------------------------------------------------------------------------------
68610-90-2                             2-Butenedioic acid (2E)- 2                        A1, A2, A3, A4, A5, B,
                                        , di-C8-18-alkyl                                  C1, D, E1, E2, F1
                                        esters
----------------------------------------------------------------------------------------------------------------
68988-22-7                             1,4-Benzenedicarboxylic  2                        A1, A2, A3, A4, A5, B,
                                        acid, 1,4-dimethyl                                C1, D, E1, E2, F1
                                        ester, manuf. of, by-
                                        products from
----------------------------------------------------------------------------------------------------------------
70693-50-4                             Phenol, 2,4-bis(1-       1                        A1, A2, A3, A4, A5, B,
                                        methyl-1-phenylethyl)-                            C1, D, E1, E2, F1
                                        6-[2-(2-
                                        nitrophenyl)diazenyl]-
----------------------------------------------------------------------------------------------------------------
72162-15-3                             1-Decene, sulfurized     2                         A2, A3, A4, A5, B, C1,
                                                                                          D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
73665-18-6                             Extract residues         2                         A2, A3, A4, A5, B, C1,
                                        (coal), tar oil alk.,                             D, E1, E2, F1
                                        naphthalene distn.
                                        residues
----------------------------------------------------------------------------------------------------------------



[[Page 8598]]


       Table 3.--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2 of This Paragraph
----------------------------------------------------------------------------------------------------------------
                                                                Test Requirements and
          Testing Category                      Test                  References           Special Conditions
----------------------------------------------------------------------------------------------------------------
Physical/Chemical Properties          A                        1. Melting Point: ASTM   n-Octanol/Water
                                                                E 324-99 (capillary      Partition Coefficient
                                                                tube)                    or log Kow:
                                                               2. Boiling Point: ASTM   Which method is
                                                                E 1719-05                required, if any, is
                                                                (ebulliometry).          determined by the test
                                                               3. Vapor Pressure: ASTM   substance's estimated
                                                                E 1782-03 (thermal       \i\ log Kow as follows:
                                                                analysis).              log Kow < 0: no testing
                                                               4. n-Octanol/Water        required.
                                                                Partition Coefficient   log Kow range 0-1:
                                                                (log 10 basis) or log    Method A or B.
                                                                Kow: (See Special       log Kow range > 1-4:
                                                                Conditions for the log   Method A or B or C.
                                                                Kow test requirement    log Kow range > 4-6:
                                                                and select the           Method B or C.
                                                                appropriate method to   log Kow > 6: Method C.
                                                                use, if any, from       Test sponsors must
                                                                those listed in this     provide in the final
                                                                column.).                study report the
                                                                Method A: 40 CFR         underlying rationale
                                                                799.6755 (shake flask).  for the method and pH
                                                                Method B: ASTM E 1147-   selected. In order to
                                                                92(2005) (liquid         ensure environmental
                                                                chromatography).         relevance, EPA highly
                                                                Method C: 40 CFR         recommends that the
                                                                799.6756 (generator      selected study be
                                                                column).                 conducted at pH 7.
                                                               5. Water Solubility:     Water Solubility:
                                                                (See Special            Which method is
                                                                Conditions for the       required, if any, is
                                                                water solubility test    determined by the test
                                                                requirement and select   substance's estimated
                                                                the appropriate method   \ii\ water solubility.
                                                                to use, if any, from     Test sponsors must
                                                                those listed in this     provide in the final
                                                                column.).                study report the
                                                                Method A: ASTM E 1148-   underlying rationale
                                                                02 (shake flask).        for the method and pH
                                                                Method B: 40 CFR         selected. In order to
                                                                799.6784 (shake flask).  ensure environmental
                                                                Method C: 40 CFR         relevance, EPA highly
                                                                799.6784 (column         recommends that the
                                                                elution).                selected study be
                                                                Method D: 40 CFR         conducted starting at
                                                                799.6786 (generator      pH 7.
                                                                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.
----------------------------------------------------------------------------------------------------------------
Environmental Fate and Pathways--     B                        For B, consult ISO       Which method is
 Ready Biodegradation                                           10634 for guidance,      required, if any, is
                                                                and choose one of the    determined by the test
                                                                methods listed in this   substance's physical
                                                                column:                  and chemical
                                                               1. ASTM 1720-01 (sealed   properties, including
                                                                vessel CO2 production    its water solubility.
                                                                test).                   ISO 10634 provides
                                                                OR....................   guidance for selection
                                                               2. ISO 14593 (CO2         of an appropriate test
                                                                headspace test).         method for a given test
                                                                OR....................   substance. Test
                                                               3. ISO 7827 (analysis     sponsors must provide
                                                                of DOC).                 in the final study
                                                                OR....................   report the underlying
                                                               4. ISO 9408               rationale for the
                                                                (determination of        method selected.
                                                                oxygen demand in a
                                                                closed respirometer).
                                                                OR....................
                                                               5. ISO 9439 (CO2
                                                                evolution test).
                                                                OR....................
                                                               6. ISO 10707 (closed
                                                                bottle test).
                                                                OR....................
                                                               7. ISO 10708 (two-phase
                                                                closed bottle test).
----------------------------------------------------------------------------------------------------------------
Aquatic Toxicity                      C1                       For C1, Test Group 1 or  The following are the
                                                                Test Group 2 listed in   Special Conditions for
                                                                this column must be      C1, C2, C3, C4, C5, and
                                                                used to fulfill the      C7 testing; there are
                                                                testing requirements--   no Special Conditions
                                                                see Special              for C6. Which test
                                                                Conditions.              group is required is
                                                               Test Group 1 for C1:...   determined by the test
                                                               1. Acute Toxicity To      substance's measured
                                                                Fish: ASTM E 729-        log KOW as obtained
                                                                96(2002).                under Test Category A,
                                                               2. Acute Toxicity To      or using an existing
                                                                Daphnia: ASTM E 729-     measured log KOW. \iii\
                                                                96(2002).               If log Kow < 4.2: Test
                                                               3. Toxicity To Plants     Group 1 is required.
                                                                (Algae): ASTM E 1218-   If log Kow >= 4.2: Test
                                                                04e1.                    Group 2 is required.
                                                               Test Group 2 for C1:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                     --------------------------------------------------

[[Page 8599]]

 
                                      C2                       For C2, Test Group 1 or  ........................
                                                                Test Group 2 listed in
                                                                this column must be
                                                                used to fulfill the
                                                                testing requirements--
                                                                see Special
                                                                Conditions..
                                                               Test Group 1 for C2:...
                                                               1. Acute Toxicity To
                                                                Daphnia: ASTM E 729-
                                                                96(2002).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                                               Test Group 2 for C2:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                     --------------------------------------------------
                                      C3                       For C3, Test Group 1 or  ........................
                                                                Test Group 2 listed in
                                                                this column must be
                                                                used to fulfill the
                                                                testing requirements--
                                                                see Special
                                                                Conditions.
                                                               Test Group 1 for C3:...
                                                               1. Acute Toxicity To
                                                                Fish: ASTM E 729-
                                                                96(2002).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                                               Test Group 2 for C3:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                     --------------------------------------------------
                                      C4                       For C4, Test Group 1 or  ........................
                                                                Test Group 2 listed in
                                                                this column must be
                                                                used to fulfill the
                                                                testing requirements--
                                                                see Special
                                                                Conditions.
                                                               Test Group 1 for C4:...
                                                               1. Acute Toxicity To
                                                                Fish: ASTM E 729-
                                                                96(2002).
                                                               2. Acute Toxicity To
                                                                Daphnia: ASTM E 729-
                                                                96(2002).
                                                               Test Group 2 for C4:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. [Reserved]..........
                                     --------------------------------------------------
                                      C5                       For C5, Test Group 1 or  ........................
                                                                Test Group 2 listed in
                                                                this column must be
                                                                used to fulfill the
                                                                testing requirements--
                                                                see Special
                                                                Conditions.
                                                               Test Group 1 for C5:...
                                                               1. Acute Toxicity To
                                                                Daphnia: ASTM E 729-
                                                                96(2002).
                                                               2. [Reserved]..........
                                                               Test Group 2 for C5:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. [Reserved]..........
                                     --------------------------------------------------
                                      C6                       Toxicity To Plants       ........................
                                                                (Algae): ASTM E 1218-
                                                                04e1
                                     --------------------------------------------------

[[Page 8600]]

 
                                      C7                       For C7, Test Group 1 or  ........................
                                                                Test Group 2 listed in
                                                                this column must be
                                                                used to fulfill the
                                                                testing requirements--
                                                                see Special
                                                                Conditions.
                                                               Test Group 1 for C7:...
                                                               1. Acute Toxicity To
                                                                Fish: ASTM E 729-
                                                                96(2002).
                                                               2. [Reserved]..........
                                                               Test Group 2 for C7:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. [Reserved]..........
----------------------------------------------------------------------------------------------------------------
Mammalian Toxicity--Acute             D                        See Special Conditions   Which testing method is
                                                                for this test            required is determined
                                                                requirement and select   by the test substance's
                                                                the method that must     physical state at room
                                                                be used from those       temperature (25[deg]C).
                                                                listed in this column.   For those test
                                                               Method A: Acute           substances that are
                                                                Inhalation Toxicity      gases at room
                                                                (rat): 40 CFR 799.9130.  temperature, Method A
                                                               Method B: EITHER:......   is required; otherwise,
                                                               1. Acute (Up/Down) Oral   use either of the two
                                                                Toxicity (rat): ASTM E   methods listed under
                                                                1163-98(2002).           Method B.
                                                                OR....................  In Method B, 40 CFR
                                                               2. Acute (Up/Down) Oral   799.9110(d)(1)(i)(A)
                                                                Toxicity (rat): 40 CFR   refers to the OECD 425
                                                                799.9110(d)(1)(i)(A).    Up/Down Procedure. \iv\
                                                                                        Estimating starting dose
                                                                                         for Method B: Data from
                                                                                         the neutral red uptake
                                                                                         basal cytotoxicity
                                                                                         assay \v\ using normal
                                                                                         human keratinocytes or
                                                                                         mouse BALB/c 3T3 cells
                                                                                         may be used to estimate
                                                                                         the starting dose.
----------------------------------------------------------------------------------------------------------------
Mammalian Toxicity--Genotoxicity      E1                       Bacterial Reverse        None
                                                                Mutation Test (in
                                                                vitro): 40 CFR
                                                                799.9510
                                     ---------------------------------------------------------------------------
                                      E2                       Conduct any one of the   Persons required to
                                                                following three tests    conduct testing for
                                                                for chromosomal          chromosomal damage are
                                                                damage:                  encouraged to use the
                                                               In vitro Mammalian        in vitro Mammalian
                                                                Chromosome Aberration    Chromosome Aberration
                                                                Test: 40 CFR 799.9537.   Test (40 CFR 799.9537)
                                                                OR....................   to generate the needed
                                                               Mammalian Bone Marrow     data unless known
                                                                Chromosomal Aberration   chemical properties
                                                                Test (in vivo in         (e.g., physical/
                                                                rodents: mouse           chemical properties,
                                                                (preferred species),     chemical class
                                                                rat, or Chinese          characteristics)
                                                                hamster): 40 CFR         preclude its use. A
                                                                799.9538.                subject person who uses
                                                                OR....................   one of the in vivo
                                                               Mammalian Erythrocyte     methods instead of the
                                                                Micronucleus Test        in vitro method to
                                                                [sampled in bone         address a chromosomal
                                                                marrow] (in vivo in      damage test requirement
                                                                rodents: mouse           must submit to EPA a
                                                                (preferred species),     rationale for
                                                                rat, or Chinese          conducting that
                                                                hamster): 40 CFR         alternate test in the
                                                                799.9539.                final study report.
----------------------------------------------------------------------------------------------------------------
Mammalian Toxicity--Repeated Dose/    F1                       Combined Repeated Dose   Where F1 is required,
 Reproduction/Developmental                                     Toxicity Study with      EPA recommends use of
                                                                the Reproduction/        the Combined Repeated
                                                                Developmental Toxicity   Dose Toxicity Study
                                                                Screening Test: 40 CFR   with the Reproduction/
                                                                799.9365                 Developmental Toxicity
                                                                OR....................   Screening Test (40 CFR
                                                               Reproduction/             799.9365). However,
                                                                Developmental Toxicity   there may be valid
                                                                Screening Test: 40 CFR   reasons to test a
                                                                799.9355.                particular chemical
                                                                AND...................   using both 40 CFR
                                                               Repeated Dose 28-Day      799.9355 and 40 CFR
                                                                Oral Toxicity Study in   799.9305 to fill
                                                                rodents: 40 CFR          Mammalian Toxicity--
                                                                799.9305.                Repeated Dose/
                                                                                         Reproduction/
                                                                                         Developmental data
                                                                                         needs. A subject person
                                                                                         who uses the
                                                                                         combination of 40 CFR
                                                                                         799.9355 and 40 CFR
                                                                                         799.9305 in place of 40
                                                                                         CFR 799.9365 must
                                                                                         submit to EPA a
                                                                                         rationale for
                                                                                         conducting these
                                                                                         alternate tests in the
                                                                                         final study reports.
                                                                                         Where F2 or F3 is
                                                                                         required, no rationale
                                                                                         for conducting the
                                                                                         required test need be
                                                                                         provided in the final
                                                                                         study report.
                                     --------------------------------------------------
                                      F2                       Reproduction/            ........................
                                                                Developmental Toxicity
                                                                Screening Test: 40 CFR
                                                                799.9355
                                     --------------------------------------------------
                                      F3                       Repeated Dose 28-Day     ........................
                                                                Oral Toxicity Study in
                                                                rodents: 40 CFR
                                                                799.9305
----------------------------------------------------------------------------------------------------------------
i. EPA recommends, but does not require, that log KOW be quantitatively estimated prior to initiating this
  study. One method, among many similar methods, for estimating log KOW is described in the article entitled
  ``Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients'' by W.M. Meylan and
  P.H. Howard in the Journal of Pharmaceutical Sciences. 84(1):83-92. January 1992. This reference is available
  under docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located
  at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
  legal holidays.

[[Page 8601]]

 
ii. EPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating
  this study. One method, among many similar methods, for estimating water solubility is described in the
  article entitled ``Improved Method for Estimating Water Solubility From Octanol/Water Partition Coefficient''
  by W.M. Meylan, P.H. Howard, and R.S. Boethling in Environmental Toxicology and Chemistry. 15(2):100-106.
  1996. This reference is available under docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm.
  3334 in the EPA West Bldg. located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30
  p.m., Monday through Friday, excluding legal holidays.
iii. Chemical substances that are dispersible in water may have log Kow values greater than 4.2 and may still be
  acutely toxic to aquatic organisms. Test sponsors who wish to conduct Test Group 1 studies on such chemical
  substances may request a modification to the test standard as described in 40 CFR 790.55. Based upon the
  supporting rationale provided by the test sponsor, EPA may allow an alternative threshold or method be used
  for determining whether acute or chronic aquatic toxicity testing be performed for a specific substance.
iv. The OECD 425 Up/Down Procedure, revised by OECD test guidelines in December 2001, is available under docket
  ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located at 1301
  Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
  holidays.
v. The neutral red uptake basal cytotoxicity assay, which may be used to estimate the starting dose for the
  mammalian toxicity-acute endpoint, is available under docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket
  Center, Rm. 3334 in the EPA West Bldg. located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m.
  to 4:30 p.m., Monday through Friday, excluding legal holidays.

    (k) Effective date. This section is effective on [30 days after 
date of publication of the final rule in the Federal Register].

[FR Doc. 2010-3734 Filed 2-24-10; 8:45 am]
BILLING CODE 6560-50-S