[Federal Register Volume 73, Number 143 (Thursday, July 24, 2008)]
[Proposed Rules]
[Pages 43314-43342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16992]



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Part III





Environmental Protection Agency





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40 CFR Part 799



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

  Federal Register / Vol. 73, No. 143 / Thursday, July 24, 2008 / 
Proposed Rules  

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[EPA-HQ-OPPT-2007-0531; FRL-8373-9]
RIN 2070-AD16


Testing of Certain High Production Volume Chemicals; Second 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) to require manufacturers, 
importers, and processors of certain high production volume (HPV) 
chemical substances to conduct testing to obtain screening level data 
for health and environmental effects and chemical fate. EPA has 
preliminarily determined that: Each of the 19 chemical substances 
included in this proposed rule is produced in substantial quantities 
and that there is or may be substantial human exposure to each of them; 
there are insufficient data to reasonably determine or predict the 
effects on health or the environment of the manufacture, distribution 
in commerce, processing, use, or disposal of the chemicals, or of any 
combination of these activities; and the testing program proposed here 
is necessary to develop such data. Data developed under this proposed 
rule will provide critical information about the environmental fate and 
potential hazards associated with these chemicals which, when combined 
with information about exposure and uses, will allow the Agency and 
others to evaluate potential health and environmental risks and to take 
appropriate follow-up action. Persons who export or intend to export 
any chemical substance included in the final rule would be subject to 
the export notification requirements in TSCA section 12(b)(1) and at 40 
CFR part 707, subpart D. EPA has also taken steps, as described in this 
document, to consider animal welfare and to provide instructions on 
ways to reduce or in some cases eliminate animal testing, while at the 
same time ensuring that the public health is protected.

DATES: Comments must be received on or before October 22, 2008.
    Written requests to present oral comments must be received on or 
before October 22, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2007-0531, 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-2007-0531. 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 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-0531. 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. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Follow the on-line 
instructions to view the docket index or access available documents. 
Although listed in the index, some information is not publicly 
available, e.g., Confidential Business Information (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 
Federal 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 numbers: 
(202) 564-8091 or (202) 564-8173; e-mail addresses: 
[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.  799.5087(j) of the proposed 
regulatory text. Any use of the term ``manufacture'' in this document 
will encompass ``import,'' unless otherwise stated. In addition, as 
described in Unit

[[Page 43315]]

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 TSCA 
section 12(b)(1) and at 40 CFR part 707, subpart D. Potentially 
affected entities may include, but are not limited to:
     Manufacturers (defined by statute to include importers) of 
one or more of the 19 subject chemical substances (NAIC codes 325 and 
324110), e.g., chemical manufacturing and petroleum refineries.
     Processors of one or more of the 19 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.  799.5087(b) of the proposed regulatory text. If you have 
any questions regarding the applicability of this action to a 
particular entity, consult either of the technical persons listed under 
FOR FURTHER INFORMATION CONTACT.

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 
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. If such a request is 
received on or before October 22, 2008, 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 19 chemical substances 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), repeat dose toxicity, and developmental and 
reproductive toxicity. The chemicals are HPV chemicals, i.e., chemicals 
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).
    The tests are screening level tests which are part of the Screening 
Information Data Set (SIDS) (see Unit II.D.). Some or all of these 
tests are being proposed as required tests for a particular chemical 
substance, depending upon what data are already available for that 
substance.
    This action also follows an earlier testing action for certain HPV 
chemicals (see ``Testing of Certain High Production Volume Chemicals; 
Proposed Rule'' (Ref. 2) and ``Testing of Certain High Production 
Volume Chemicals; Final Rule'' (Ref. 3).
    At a future date, EPA plans to propose testing for additional HPV 
chemicals as the Agency learns more about the chemicals with respect to 
human exposure, release, and sufficiency of data and experience 
available on the potential hazards.

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

    EPA is proposing this test rule under section 4(a)(1)(B) of TSCA 
(15 U.S.C. 2603(a)(1)(B)).
    Section 2(b)(1) of TSCA (15 U.S.C. 2601(b)(1)) states that it is 
the policy of the United States that ``adequate data should be 
developed with respect to the effect of chemical substances and 
mixtures on health and the environment and that the development of such 
data should be the responsibility of those who manufacture [which is 
defined by statute to include import] and those who process such 
chemical substances and mixtures[.]'' To implement this policy, TSCA 
section 4(a)(1) mandates that EPA require by rule that manufacturers 
and/or processors of chemical substances and mixtures conduct testing 
if the Administrator finds that:

    (1)(A)(i) the manufacture, distribution in commerce, processing, 
use, or disposal of a chemical substance or mixture, or that any 
combination of such activities, may present an unreasonable risk of 
injury to health or the environment,
    (ii) there are insufficient data and experience upon which the 
effects of such 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; or

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    (B)(i) a chemical substance or mixture is or will be produced in 
substantial quantities, and (I) it enters or may reasonably be 
anticipated to enter the environment in substantial quantities or 
(II) there is or may be significant or substantial human exposure to 
such substance or mixture,
    (ii) there are insufficient data and experience upon which the 
effects of the manufacture, distribution in commerce, processing, 
use, or disposal of such substance or mixture or of any combination 
of such activities on health or the environment can reasonably be 
determined or predicted, and
    (iii) testing of such substance or mixture with respect to such 
effects is necessary to develop such data [.]

    If EPA makes these findings for a chemical substance or mixture, 
the Administrator shall require by rule that testing be conducted on 
that chemical substance or mixture to develop data about health or 
environmental effects for which there is an insufficiency of data and 
experience, and which are relevant to a determination that the 
manufacture, distribution in commerce, processing, use, or disposal of 
the chemical substance or mixture, or any combination of such 
activities, does or does not present an unreasonable risk of injury to 
health or the environment. TSCA section 4(a)(1).
    Once the Administrator has made a finding under TSCA section 
4(a)(1)(A) or 4(a)(1)(B), EPA may require any type of health or 
environmental effects testing necessary to address unanswered questions 
about the effects of the chemical substance or mixture that are 
relevant to whether the manufacture, distribution in commerce, 
processing, use, or disposal of the chemical substance or mixture, or 
any combination of such activities, presents an unreasonable risk of 
injury to health or the environment. EPA need not limit the scope of 
testing required to the factual basis for the TSCA section 
4(a)(1)(A)(i) or (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 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 chemical substances specified in Table 2 in Sec.  
799.5087(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?

    On April 21, 1998, EPA initiated a national effort to empower 
citizens by providing them with knowledge about the most widespread 
chemicals in commerce. A major objective of this effort is to make 
certain basic information about the environmental fate and potential 
health and environmental hazards associated with HPV chemicals 
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, and TSCA section 4 
rules.
    1. Voluntary HPV Challenge Program. The voluntary HPV Challenge 
Program, officially launched in late 1998, 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 this program through data reported under the 
TSCA Inventory Update Rule (IUR) during 1990.
    The data set sought by the voluntary HPV Challenge Program is known 
as the Screening Information Data Set (SIDS) that was developed by the 
Organization for Economic Cooperation and Development (OECD), of which 
the United States is a member. SIDS provides an internationally agreed 
upon set of test data for screening high production volume chemicals 
for human and environmental hazards, and will assist the Agency and 
others to make an informed, preliminary judgment about the hazards of 
HPV chemicals.
    Since the Program's inception in 1998, industry chemical 
manufacturers and importers have participated in the Challenge by 
sponsoring 2,250 chemicals. More than 350 companies and 100 consortia 
have sponsored chemicals directly in the Program while additional 
companies/consortia have sponsored chemicals indirectly in an 
international counterpart to the voluntary HPV Challenge Program, the 
International Council of Chemical Associations (ICCA) HPV Initiative. 
HPV chemicals that are not sponsored in the Program may be subject to a 
test rule under TSCA section 4 where, among other things, these 
chemicals lack needed testing. The voluntary HPV Challenge Program is 
further described in a Federal Register document which published on 
December 26, 2000 (Ref. 1) and on the voluntary HPV Challenge Program 
website (http://www.epa.gov/chemrtk).
    Under the voluntary HPV Challenge Program, alternatives to the 
testing proposed under this proposed rule were available. For example, 
under the OECD HPV SIDS Program, some instances have been identified 
where, using chemical category approaches, less than a full set of SIDS 
tests for every chemical in the category has been judged sufficient for 
screening purposes. In addition, the OECD HPV SIDS Program allows some 
use of structure activity relationship (SAR) analysis for individual 
chemicals. These strategies have the potential to reduce the time 
required to complete the program, the number of tests actually 
conducted, and the number of test animals needed.
    EPA advocated the use of categories or SAR approaches in the 
voluntary HPV Challenge Program and provided support for their use by 
developing guidance documents to assist industry and others in 
constructing scientifically defensible categories (Ref. 45) and SAR 
(Ref. 48). While EPA encouraged the use of scientifically appropriate 
categories of related chemicals and SAR under the voluntary HPV 
Challenge Program, these approaches are not included in this proposed 
rule. EPA has not identified any chemicals in this proposal for which 
category and SAR approaches would be appropriate. In addition, EPA 
believes that the incorporation of such elements in a test rule would 
require complex, time consuming, and intensive procedural steps, such 
as multi-phase rulemaking, without a corresponding benefit.
    In the proposed test rule (Ref. 2) for the final HPV SIDS test rule 
(Ref. 3), EPA specifically solicited comments and suggestions on 
procedures that would allow inclusion of such approaches in TSCA 
section 4 HPV SIDS rulemaking. The procedures suggested by commenters 
on that proposed rule would have required complex, time consuming, and 
resource-intensive procedural steps, such as multi-phase rulemaking. As 
a result, EPA did not incorporate these suggestions into the final 
rule. In addition, EPA did not identify, nor did the commenters bring 
to EPA's attention, any possibilities that would have allowed inclusion 
of a category or SAR approach within the final test rule for any 
specific chemicals included in the final test rule (Ref. 19).
    Although the Agency believes that none of the chemicals included in 
this proposed rule appear to be candidates for category or SAR 
approaches, persons who believe that a chemical under this

[[Page 43317]]

proposed rule can be dealt with using a category or 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 determines that a chemical is 
appropriate for consideration under a category or SAR approach, and 
that practicable measures are available at the time to modify the 
proposed testing requirement, EPA will take such measures as are 
necessary to avoid unnecessary testing in the final rule.
    2. Certain international efforts. The voluntary HPV Challenge 
Program is designed to make maximum use of scientifically adequate 
existing test data and to avoid unnecessary and duplicative testing of 
U.S. HPV chemicals. Therefore, EPA is continuing to participate in the 
voluntary international efforts, complementary to the voluntary HPV 
Challenge Program, that are being coordinated by the OECD to secure 
basic hazard information on HPV chemicals in use worldwide, including 
some of those on the U.S. (1990) 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).
    The OECD HPV SIDS Program seeks the development of test data, if 
such data are not already available, related to 6 health and 
environmental effects endpoints for international HPV chemicals (see 
Unit II.D.). The SIDS data set has been internationally agreed upon by 
the 29 member countries of the OECD as providing the minimum data set 
required to make an informed preliminary judgment about the hazards of 
a given HPV chemical.
    The ICCA consists of representatives of chemical industry trade 
associations from the United States, Europe, Japan, Australia, Canada, 
Mexico, Brazil, New Zealand, and Argentina. The intended goal of the 
ICCA HPV Initiative was to complete screening-level hazard assessments 
on 1,000 ``high priority'' chemicals. Most of the chemicals on the ICCA 
working list (Ref. 7) are also U.S. HPV chemicals. The ICCA testing/
assessment work is tied directly to that under the OECD HPV SIDS 
Program.
    Any U.S. HPV chemicals that are handled under the OECD HPV SIDS 
Program or the ICCA HPV Initiative are considered by EPA to be 
``sponsored'' and are not anticipated to be addressed in the voluntary 
HPV Challenge Program unless the international commitments are not met. 
Nor does EPA intend to evaluate these chemicals for possible TSCA 
section 4 HPV SIDS rulemaking unless the international commitments are 
not met.
    The OECD HPV SIDS Program and the ICCA HPV Initiative are further 
described in the Federal Register document announcing the voluntary HPV 
Challenge Program (Ref. 1) and on the OECD website (Ref. 6) and ICCA 
website (Ref. 7).
    3. TSCA rulemaking. U.S. data needs which remain unmet in the 
voluntary HPV Challenge Program or through international efforts may be 
addressed through TSCA section 4 rulemakings, such as the final test 
rule promulgated by EPA on March 16, 2006 (Ref. 3). This proposed rule 
is the second TSCA section 4 HPV SIDS rule, and addresses the unmet 
data needs of 19 chemicals.
    Data collected and/or developed under a final rule based on this 
proposal and the voluntary HPV Challenge Program, when combined with 
information about exposure and uses, will allow the Agency and others 
to better assess the potential risk to health and the environment from 
these chemicals. EPA intends to make the information collected under 
the final rule available to the public, other Federal agencies, and any 
other interested parties on its website (http://www.epa.gov/chemrtk) 
and in the public docket for the final rule. As appropriate, this 
information will be used to ensure a scientifically sound basis for 
risk assessment/management actions. This effort will serve to further 
the Agency's goal of identifying and controlling human and 
environmental risks as well as providing greater protection and 
knowledge to the public. By using the same approach to testing as that 
of the OECD HPV SIDS Program, EPA is assuring that the data developed 
under this proposed rulemaking activity and the voluntary HPV Challenge 
Program will be comparable to the data being developed in other 
countries, thereby enabling an international sharing of data and the 
prevention of unnecessary and duplicative testing. See Refs.1 and 2, 
pp. 81662-81664, for further information about the voluntary HPV 
Challenge Program and international efforts.

D. Why is this Proposal Focusing on HPV Chemicals and SIDS Testing?

    This proposal pertains to HPV chemicals, which are manufactured or 
imported in amounts equal to or greater than 1 million lbs. per year. 
Although those chemicals cover only about 11% of the chemical 
substances on the TSCA Inventory (see TSCA sections 8(a) and 8(b)), 
using TSCA Inventory information available in 1988 (Ref. 8, p. 32296), 
that small percentage of the TSCA Inventory accounted for 95% of total 
chemical production in the United States.
    Testing under this proposal pertains to SIDS testing because SIDS 
is a battery of tests agreed upon by the international community 
through OECD, of which the United States is a member country, as 
appropriate for screening HPV chemical substances for toxicity and 
produces information relevant to understanding the basic health and 
environmental hazards and fate of HPV chemicals. The content of SIDS 
was agreed upon at the 13\th\ Joint Meeting of the OECD Chemicals Group 
and Management Committee of the Special Programme on the Control of 
Chemicals (Refs. 9 and 10). The United States believes these are the 
right tests for basic screening of U.S. HPV chemicals for health and 
environmental effects and environmental fate.
     SIDS testing evaluates the following six testing endpoints 
(Ref. 6):
     Acute toxicity.
     Repeat dose toxicity.
     Developmental and reproductive toxicity.
     Genetic toxicity (gene mutations and chromosomal 
aberrations).
     Ecotoxicity (studies in fish, Daphnia, and algae).
     Environmental fate (including physical/chemical properties 
(melting point, boiling point, vapor pressure, n-octanol/water 
partition coefficient, and water solubility), photolysis, hydrolysis, 
transport/distribution, and biodegradation).
While data on the six SIDS endpoints do not fully characterize a 
chemical's toxicity and fate, they 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 Does EPA's HPV Work Relate to that of OECD?

    As noted in Unit II.C.2., the OECD HPV SIDS Program is 
complementary to the voluntary HPV Challenge Program. However, EPA's 
definition of an HPV chemical differs from that of the OECD. EPA 
defines an HPV chemical as having an annual production or importation 
volume of 1 million lbs. or more. OECD defines an HPV chemical as 
having an annual production volume of 2.2 million lbs. (equivalent to 1 
million kilograms (kg)) reported in any member country.
    The presence of a chemical on the OECD's list of HPV chemicals was 
and

[[Page 43318]]

continues to be accepted by OECD member countries as providing a 
sufficient indicator of potential exposure to warrant testing at the 
SIDS level (Ref. 11). EPA, however, does not believe that a production 
volume threshold which is chosen for an international program on 
existing chemicals and which is the only trigger for entry into that 
program should be determinative of the threshold chosen for 
``substantial production'' under TSCA section 4(a)(1)(B)(i). See EPA's 
``B'' policy (Ref. 4). Among the reasons is that the TSCA section 
4(a)(1)(B)(i) finding of substantial production is not the sole finding 
EPA must make to require testing based on TSCA section 4(a)(1)(B). EPA 
must also find that there is substantial release, or substantial or 
significant human exposure under TSCA sections 4(a)(1)(B)(i)(I) and 
(II). In addition, EPA must find that data are insufficient and testing 
is necessary under TSCA sections 4(a)(1)(B)(ii) and (iii). Accordingly, 
a finding that a chemical is produced in substantial quantities alone 
is not a sufficient basis to require testing under TSCA section 4.
    In response to EPA's proposed ``B'' policy (Ref. 8), both the 
American Chemistry Council (ACC), formerly the Chemical Manufacturers 
Association (CMA) and the Society of the Plastics Industry, Inc., 
commented that EPA's proposed annual production-volume threshold of 1 
million lbs. is a reasonable interpretation of ``substantial 
production'' under TSCA (Refs. 12 and 13). Additionally, they indicated 
that the OECD's 2.2 million lb. threshold would be preferable to 
achieve consistency between EPA's activities under TSCA section 4 and 
the OECD HPV SIDS Program. Although the United States and OECD differ 
in their definition of an HPV chemical and what should trigger basic 
screening tests of an HPV chemical, both the U.S. and OECD HPV SIDS 
Programs are alike in their information needs for an HPV chemical. Both 
the U.S. and OECD HPV SIDS Programs have identified the SIDS battery of 
tests as the basic screening tests needed to provide enough information 
to support a screening level assessment of the health and environmental 
effects of a chemical.

F. Why is EPA Pursuing Hazard Information on HPV Chemicals?

    In 1998 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. 14). Of the over 2,800 
U.S. HPV chemicals based on 1990 IUR data, 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.

G. What is the Role of this Proposed Rule and Any Future TSCA Section 4 
HPV SIDS Rulemaking with Regard to the Voluntary HPV Challenge Program?

    As indicated in the December 26, 2000 Federal Register document 
describing the voluntary HPV Challenge Program (Ref. 1), EPA intends to 
use rulemaking under TSCA, where appropriate, to help fill data gaps 
not addressed as part of the voluntary HPV Challenge Program or 
international efforts. EPA does not intend at this time to evaluate 
U.S. HPV chemicals that have been or are being handled through the OECD 
HPV SIDS Program or under a complementary program being coordinated by 
the ICCA (Ref. 7) for screening level testing under TSCA section 4 HPV 
SIDS rulemaking, although the Agency may revisit this question if 
commitments under those international programs are not met. See Unit 
III.G. of Ref. 1 for more information on these programs. EPA is 
evaluating the extent to which additional non-sponsored HPV chemicals 
meet the threshold criteria for rulemaking under TSCA section 4.

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

    Hazard data are used in risk assessment and risk management, and 
ultimately to inform the public and promote the pollution prevention 
ethic. Activities to ensure the availability of basic hazard 
information on HPV chemicals support EPA's objectives.
    EPA would use the data obtained from this proposed rule to support 
development of preliminary hazard and risk assessments for the 19 
chemical substances 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 chemical substances 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. In the past, EPA has used data from test 
rules to support such activities as the development of water quality 
criteria, Toxic Release Inventory (TRI) listings, chemical advisories, 
and reduction of workplace exposures.
    Under the Security and Prosperity Partnership of North America 
(SPP), a trilateral effort to encourage greater cooperation and 
information sharing among the United States, Canada, and Mexico (http://www.spp.gov), the United States committed in August 2007 to assess and 
initiate needed action by the end of 2012 on the approximately 6,750 
chemicals produced above 25,000 lbs. per year in the United States. 
(http://www.spp.gov/pdf/spp_reg_coop_chemicals.pdf). To fulfill 
these SPP commitments, EPA established the Chemical Assessment and 
Management Program (ChAMP). Under ChAMP, EPA is developing screening-
level documents that summarize basic hazard and exposure information on 
HPV chemicals, identify potential risks, note scientific issues and 
uncertainties, and indicate the initial priority being assigned by the 
Agency for potential future appropriate action. These screening-level 
documents are based primarily on hazard, use, and exposure data 
available to the Agency through the voluntary HPV Challenge Program and 
on EPA's examination of chemical use and exposure information collected 
from the 2006 IUR as well as data from readily available sources of 
hazard and exposure information. Information on ChAMP and the risk-
based prioritization process for HPV chemicals is available on the 
EPA's ChAMP website (http://www.epa.gov/champ) and on the related risk-
based prioritization page (http://www.epa.gov/hpv/hpvis/aboutrbd.htm).
    The data obtained from a final test rule based on this proposal 
would furnish the basic hazard information integral to this ChAMP 
process for the 19 chemical substances subject to the rule.
    Finally, because the SIDS data would be comparable to the type of 
data agreed to as being appropriate and being developed by the OECD HPV 
SIDS Program, the development of these data would enable an 
international sharing of data. As conceived by the OECD, the SIDS 
battery of tests can be used by governments and others worldwide to 
conduct an initial assessment of the

[[Page 43319]]

hazards and risks posed by HPV chemicals and prioritize HPV chemicals 
to identify those in need of additional, more in-depth testing and 
assessment, as well as those of lesser concern. Not only could the data 
contribute to the international effort, but also international SIDS 
testing and assessments can be used to fill the data gaps identified as 
part of the voluntary HPV Challenge Program. Additional detailed 
information is available on the SIDS website (http://cs3-hq.oecd.org/scripts/hpv) and EPA's voluntary HPV Challenge Program website (http://www.epa.gov/chemrtk).
    Data collected or developed for each sponsored chemical in the 
voluntary HPV Challenge Program are provided in the format of a 
``robust'' (i.e., detailed) summary. A robust summary contains 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 either be an experiment or in some 
cases an estimation or prediction method. (See Ref. 15; also at http://www.epa.gov/HPV/pubs/general/robsumgd.htm). A robust summary provides 
information that would assist a technically qualified person in making 
an independent assessment of a given study, and thereby facilitates the 
evaluation of existing data and the identification of additional data 
needs. EPA requests that existing data relevant to the testing in this 
proposed rule be submitted to the Agency in robust summary format. For 
any data developed under that final rule, EPA will request that a 
robust summary of the final report for each specific test be submitted 
in addition to the required final report itself (see Sec.  799.5087(i) 
of the proposed regulatory text). Persons who respond to 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.''

I. 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 SIDS 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.
    The governmental and non-governmental scientific community is 
working to design, validate, and employ new methods of toxicity testing 
that are more accurate, less costly, and that reduce the need to use 
live animals. Over the years, significant research has been pursued to 
develop and validate non-animal test methods. U.S. scientists in 
academia, government, and industry have participated in both domestic 
and international efforts to develop alternative, non-animal tests. As 
part of the enterprise, the National Institute of Environmental Health 
Sciences (NIEHS) established a Federal Interagency Committee, the 
Interagency Coordinating Committee on Validation of Alternative Methods 
(ICCVAM), to review the status and validation of toxicological test 
methods including those that are performed in vitro. EPA scientists 
have contributed significantly to this body of knowledge and are 
continuing to play an important role in the development of alternative 
test methods for consideration.
    In addition, as part of the voluntary HPV Challenge Program, EPA 
asked participants in that program to observe certain testing 
principles, which are laid out in an October 14, 1999 letter (Ref. 16). 
In this same letter, the Agency also indicated its intention that 
related TSCA rulemaking proceed in a manner consistent with these 
principles. This letter is available in the public docket for this 
proposed rulemaking, as well as on EPA's ChemRTK website. In the 
letter, EPA requested that participants conduct a thoughtful, 
qualitative analysis of existing data before testing. This proposed 
rule reflects many of the principles presented in the referenced 
voluntary HPV Challenge Program letter. Certain components of these 
principles, however, are not pertinent to this proposed rule. For 
example, this proposed rule does not require any dermal toxicity 
testing or any terrestrial toxicity testing.

III. EPA Proposed Findings

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

    As indicated in Unit II.B., in order to develop a rulemaking 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 chemicals. EPA is proposing to require testing of 
the chemical substances included in this proposed test rule based on 
its preliminary findings under TSCA section 4(a)(1)(B)(i) relating to 
``substantial'' production and ``substantial human exposure,'' 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 this proposed rule are listed in Table 2 in Sec.  
799.5087(j) of the proposed regulatory text along with their Chemical 
Abstract Service (CAS) registry numbers.
    In EPA's ``B'' policy (see Unit II.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). The ``B'' policy also provides guidelines that are generally 
considered by EPA in evaluating whether there is ``substantial human 
exposure'' of workers, consumers, and the general population to a 
chemical substance or mixture. Refer to EPA's ``B'' policy for further 
discussion on how EPA generally evaluates chemicals or mixtures under 
TSCA section 4(a)(1)(B)(i). For the reasons set out in the ``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 the guidelines with respect to the 
chemicals included in this proposed rule.
    EPA has found preliminarily that, under TSCA section 4(a)(1)(B)(i), 
each of the 19 chemical substances included in this proposed rule is 
produced in ``substantial'' quantities (see Unit III.B.) and that there 
is or may be ``substantial human exposure'' to each chemical substance 
(see Units III.C. and III.D.). Also, for one substance, EPA has found

[[Page 43320]]

preliminarily that, under TSCA section 4(a)(1)(B)(i), the 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 19 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 policy.
    The chemical substances included in this proposed rule are listed 
in Sec.  799.5087(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 proposal is produced and/or imported in an 
amount equal to or greater than 1 million lbs. per year (Ref. 18), 
based on information gathered pursuant to the 2006 IUR which is the 
most recently available compilation of TSCA Inventory data. EPA 
believes that these annual production and/or importation volumes are 
``substantial'' as that term is used with reference to production in 
TSCA section 4(a)(1)(B)(i). (See 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. 18).

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

    EPA has made preliminary findings that the manufacture, processing, 
and use of the 19 chemical substances (Table 1.-Exposure Based 
Findings-Substantial Human Exposure, 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. 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); see Ref. 4). Therefore, 
EPA's preliminary finding is that there is or may be substantial human 
exposure (workers) to these 19 chemical substances.
    In addition to the 2006 IUR data, EPA also reviewed National 
Occupational Exposure Survey (NOES) data developed by the National 
Institute for Occupational Safety and Health (NIOSH). Based on the NOES 
data, EPA found that more than 1,000 workers were exposed to each of 
the 19 chemical substances that are the subject of this proposed 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. 20, 57, and 58). EPA also compared production volumes from the 
1986 IUR data collection to the production volumes for the 2006 IUR 
data collection. Of the 19 chemical substances in this proposed rule, 
only one chemical's production volume decreased from 1986 to 2006. The 
2006 IUR production volume data are consistent with NOES results, as 
the production volumes for the remaining chemical substances either 
stayed the same or increased since 1986, thereby indicating that the 
usage of these chemical substances is no less than when NOES data were 
gathered.
    EPA has performed a chemical-by-chemical analysis for all 19 
chemical substances and carefully considered the industrial process and 
use information along with the commercial and consumer use information 
from the 2006 IUR submissions. Commercial uses are defined as ``The use 
of a chemical substance or mixture in a commercial enterprise providing 
saleable goods or services (e.g., dry cleaning establishment, painting 
contractor)''; 40 CFR 710.43. Detailed information from the IUR 
submissions can be found in ``Testing of Certain High Production Volume 
Chemicals; Second Group of Chemicals (Exposure Findings Supporting 
Information)'' (Ref. 18). Based on the nature of the IUR uses, EPA 
considers that chemicals with reported commercial uses 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.
    In 2003, EPA partially exempted certain petroleum process streams 
(including ``Hydrocarbons, C>4'' (CAS No. 68647-60-9) and ``Oils, 
reclaimed'' (CAS No. 69029-75-0)) from reporting certain processing and 
use data under the TSCA section 8(a) IUR. The exemption was not based 
on an assessment of the toxicity of the process streams but on the fact 
that the chemicals are frequently processed, transported, and stored in 
vessels that minimize the potential for releases and exposure to 
workers. (Federal Register issue of January 7, 2003 (68 FR 848) (FRL-
6767-4) and Federal Register issue of December 19, 2005 (71 FR 75059) 
(FRL-7743-9); available on-line at: http://www.epa.gov/fedrgstr). 
Despite the fact that the degree of exposure is expected to be 
diminished to particular workers because of the chemical processing and 
handling practices used, available data indicate that more than 1,000 
workers are potentially exposed to these chemicals, supporting the 
preliminary finding of substantial human exposure (Ref. 18).

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 13 of the chemical substances included in this action result or 
may result in exposure to a substantial number of consumers (Ref. 18). 
EPA reviewed the consumer use information reported for the 2006 IUR and 
carefully

[[Page 43321]]

considered the nature of those uses. Upon completion of the review, EPA 
concluded that the reported consumer uses for the chemicals in this 
action may result in at least 10,000 potentially exposed consumers, 
thus meeting the exposure based finding for consumers.
    In addition to findings made based on the 2006 IUR data, EPA has 
also made consumer exposure based findings based on the National 
Library of Medicine (NLM) Household Products Database (Ref. 18). The 
chemical substances reported in the National Library of Medicine (NLM) 
Household Products Database are present in multiple household products 
subject to TSCA including hobby/craft products, personal care products, 
home cleaning products, home maintenance products, and automotive 
products. The NLM Household Products Database provides information on 
the chemical ingredients and their percentage in specific brands of 
household products. Information in the database is from a variety of 
publicly available sources including brand-specific labels and Material 
Safety Data Sheets when available from manufacturers and manufacturers' 
websites. Publicly available information from the database is available 
on-line at: http://householdproducts.nlm.nih.gov.
    EPA believes that use of the consumer products identified in the 
NLM Household Products Database may expose a substantial number of 
consumers (i.e., greater than 10,000) to these chemical substances. EPA 
believes that an exposure of over 10,000 consumers to a chemical 
substance is ``substantial'' as that term is used with reference to 
``human exposure'' in TSCA section 4(a)(1)(B)(i). EPA believes, based 
on experience gained through case-by-case analysis of existing 
chemicals, that an exposure of 10,000 consumers or more to a chemical 
substance is a reasonable interpretation of the phrase ``substantial 
human exposure'' in TSCA section 4(a)(1)(B)(i). (See Ref. 4.) 
Therefore, EPA's preliminary finding is that there is or may be 
substantial human exposure (consumers) to these chemical substances.
    A discussion of EPA's preliminary ``substantial exposure'' finding 
for consumers is contained in a separate document (see Ref. 18). The 
Agency solicits comment regarding additional information pertaining to 
numbers of consumers potentially exposed to the chemical substances 
identified in this proposed rule.

                                              Table 1.--Exposure Based Findings--Substantial Human Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Meet Exposure                                                              Meet
                                   2006 IUR            Based                           Meet Exposure    Meet Exposure    Substantial or   NLM Household
           CAS No.                Production      CriteriaFor Mfg   NOES (number of   Based Criteria    Based Criteria    Significant       Chemicals
                                    Volume         & Industrial        workers)       for Commercial    for Consumers       Release          Database
                                                      Workers                             Workers                           Criteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
75-07-0                        > 100 million     X                 216,533                             X                X                X
                                (M)-500 M
--------------------------------------------------------------------------------------------------------------------------------------------------------
78-11-5                        > 1 M-10 M        X                 2,650                               X                                 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
84-65-1                        > 10 M-50 M       X                 6,187             X                 X                                 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
89-32-7                        > 1 M-10 M        X                 1,926                                                                 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
110-44-1                       > 1 M-10 M        X                 69,243            X                 X                                 X
--------------------------------------------------------------------------------------------------------------------------------------------------------
118-82-1                       > 1 M-10 M        X                 120,009           X                 X                                 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
119-61-9                       > 1 M-10 M        X                 41,516            X                 X                                 X
--------------------------------------------------------------------------------------------------------------------------------------------------------
144-62-7                       > 1 M-10 M        X                 142,000           X                 X                X                X
--------------------------------------------------------------------------------------------------------------------------------------------------------
149-44-0                       > 1 M-10 M        X                 239,465           X                 X                                 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
2524-04-1                      > 10 M-50 M       X                 1,088                                                                 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
4719-04-4                      > 10 M-50 M       X                 225,251           X                 X                X                X
--------------------------------------------------------------------------------------------------------------------------------------------------------
6381-77-7                      > 1 M-10 M        X                 19,468                                                                ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
31138-65-5                     > 1 M-10 M        X                 74,165            X                 X                                 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
66241-11-0                     > 1 M-10 M        X                 38,555            X                 X                                 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
68187-76-8                     > 1 M-10 M        X                 11,164            X                 X                                 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
68187-84-8                     > 1 M-10 M        X                 36,381            X                 X                                 X
--------------------------------------------------------------------------------------------------------------------------------------------------------
68479-98-1                     > 10 M-50 M       X                 4,121                                                                 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
68527-02-6                     > 1 M-10 M        X                 84,192                                                                ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
68647-60-9                     > 1 Billion lbs.  X                 1,257                                                                 ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 43322]]

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

    EPA does not have readily available data on environmental releases 
for most of the 19 chemical substances in this proposed rule. However, 
one substance, acetaldehyde (CAS No. 75-07-0) is included in TRI and 
has estimated environmental release in 2005 of 13,567,452 lbs. (Ref. 
18). TRI contains information about releases of certain chemicals and 
management of wastes at a wide variety of sources, including 
manufacturing operations, certain service businesses, and Federal 
facilities. Publicly available information from the 2005 TRI reporting 
cycle is available on-line at: http://www.epa.gov/triexplorer. Two 
additional chemicals (ethanedioic acid and 1,3,5-triazine-
1,3,5(2H,4H,6H)-triethanol) also meet the substantial release criteria 
based on the environmental releases from their reported IUR uses.
    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).
    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), Toxicology Literature 
Online (TOXLINE), and the National Technical Information Service 
(NTIS). EPA also searched for available data as summarized in its HPV 
Information System (Ref. 56). For one HPV chemical, data available from 
an EPA reassessment of its use as an inert in pesticides formulations 
were examined (Ref. 21). 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 voluntary HPV Challenge Program 
website (http://www.epa.gov/chemrtk/pubs/general/guidocs.htm): 
``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).
    It is worth noting that additional testing is being proposed for 
five chemicals that had been included in the final TSCA section 4 HPV 
SIDS rulemaking issued on March 16, 2006 (Ref. 3). EPA noted in the 
proposed (Ref. 2) and final rule (Ref. 3) for that first HPV SIDS 
rulemaking that, for chemicals for which some data were available on 
one or more SIDS endpoints, EPA was not requiring testing at that time 
for those endpoints. However, EPA stated at that time that no 
definitive determination had been made as to the adequacy of those 
existing data for an initial assessment of a chemical's hazards or 
risks to health or the environment. Consequently, in that final rule, 
EPA stated that if EPA determines that it needs additional data 
regarding any of the chemical substances included in the final rule, 
the Agency might seek further health and/or environmental effects 
testing for those chemical substances. EPA has now completed its 
assessment of the adequacy of the available data for those endpoints 
that were not included for these chemicals in the first HPV SIDS 
rulemaking. In some instances, EPA has made a preliminary finding that, 
for some of the SIDS endpoints, the existing data and experience are 
not sufficient to enable the effects of these substances on health or 
the environment to reasonably be determined or predicted. Therefore, 
EPA has also proposed testing for those endpoints in this proposed 
rule.
    Section 799.5087(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 chemical substances 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); repeat dose toxicity; and developmental and reproductive 
toxicity) are insufficient to enable EPA to reasonably determine or 
predict the human health and environmental effects resulting from 
manufacture, processing, and use of these chemical substances.
    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. 
15) for each such study to facilitate EPA's review of the full study 
report or publication. Persons who respond to 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.''
    As noted in Unit II.C.1., persons who believe that adequate 
information regarding a chemical subject to this proposed rule can be 
developed using a category or 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.

G. Is Testing Necessary for These Chemical Substances?

    EPA would use the data obtained from this proposed testing to 
support development of preliminary hazard and risk characterizations 
for these HPV chemicals as part of the ChAMP process

[[Page 43323]]

fulfilling the U.S. commitments under the SPP to set initial priorities 
for potential future appropriate action, including possible further 
testing that would produce more definitive hazard information where 
needed on such chemical substances. Such additional information is 
needed by EPA, other Federal agencies, the public, industry, and others 
to ensure that adequate hazard and risk assessments can be conducted on 
these chemical substances. EPA has used data from test rules to support 
such activities as the development of water quality criteria, TRI 
listings, chemical advisories, and input for actions resulting in 
reduction of workplace exposures.
    EPA preliminarily believes that conducting the needed SIDS testing 
identified for the 19 subject chemical substances is necessary to 
provide data relevant to a determination of whether the manufacture, 
processing, and use of the chemical substances does or does not present 
an unreasonable risk of injury to human health and the environment.

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.  799.5087(j) of the proposed 
regulatory text.
    All of the proposed testing requirements are listed in Table 2 in 
Sec.  799.5087(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, however, requires that the American Society 
for Testing and Materials (ASTM) or the TSCA test guidelines at 40 CFR 
part 799 (TSCA 799 guidelines) be used because the language in the TSCA 
799 guidelines makes clear which steps are mandatory and which steps 
are only recommended. EPA's TSCA 799 guidelines, however, have been 
harmonized with the OECD guidelines. Accordingly, in order to comply 
with this test rule, testing must be conducted in accordance with the 
specified mandatory and enforceable requirements in the ASTM or TSCA 
799 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: American Society for Testing and Materials (ASTM) E 
324-99 (Capillary tube) (Ref. 22).
     Boiling Point: ASTM E 1719-05 (Ebulliometry) (Ref. 23).
     Vapor Pressure: ASTM E 1782-03 (Thermal analysis) (Ref. 24).
     n-Octanol/Water Partition Coefficient:
     Method A (40 CFR 799.6755--shake flask)
     Method B (ASTM E 1147-92(2005)--liquid chromatography) (Ref. 25).
     Method C (40 CFR 799.6756--generator column).
     Water Solubility:
     Method A: (ASTM E 1148-02--shake flask) (Ref. 26).
     Method B (40 CFR 799.6784--shake flask).
     Method C (40 CFR 799.6784--column elution).
     Method D (40 CFR 799.6786--generator column).
    EPA is proposing, for those chemicals for which melting points 
determinations are needed, that melting points be determined according 
to the method ASTM E 324-99. Although ASTM 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 has explained that ASTM E 324-99 was withdrawn because:

    The standard utilizes old, well-developed technology; it is 
highly unlikely that any additional [changes] and/or modifications 
will ever be pursued by the E15 [committee]. The time and effort 
needed to maintain these documents detract from the time available 
to develop new standards which use modern technology.
 (Ref. 27)

Withdrawal of the method by ASTM means only that ASTM no longer 
continues to develop and improve the method. It does not mean that ASTM 
no longer considers the method to be valid. ASTM still makes the method 
available for informational purposes and it can still be purchased from 
ASTM at the address listed in Sec.  799.5087(h) of the proposed 
regulatory text. EPA concludes that ASTM's withdrawal of E 324-99 does 
not have negative implications on the validity of the method; 
therefore, EPA is proposing, for those chemicals for which melting 
points determinations are needed, that melting points be determined 
according to the method ASTM E 324-99.
    For the n-octanol/water partition coefficient 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.  799.5087(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 substance's n-octanol/water partition coefficient. Prior 
to determining the appropriate standard to use, if any, to measure the 
n-octanol/water partition coefficient, EPA is recommending that the log 
Kow be quantitatively estimated. EPA recommends that the 
method described in ``Atom/Fragment Contribution Method for Estimating 
Octanol-Water Partition Coefficients'' (Ref. 28) be used in making such 
estimation. EPA is 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 in 
recognition of the fact that depending on the chemical substance's log 
Kow, one or more test methods may provide adequate 
information for determining the log Kow, but that in some 
instances one particular test method may be more appropriate In 
general, EPA believes that the more hydrophobic a subject chemical is, 
the less well Method A (Sec.  799.6755--shake flask) will work and 
Method B (ASTM E 1147-92(2005)) and Method C (Sec.  799.6756--generator 
column) become more suitable, especially Method C. 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 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.

[[Page 43324]]



      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. 29). 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 E1720-01 (Sealed vessel CO2 production 
test) (Ref. 30).
     Method B: ISO 14593 (CO2 headspace test) (Ref. 31).
     Method C: ISO 7827 (Method by analysis of dissolved organic carbon 
(DOC)) (Ref. 32).
     Method D: ISO 9408 (Determination of oxygen demand in a closed 
respirometer) (Ref. 33).
     Method E: ISO 9439 (Carbon dioxide evolution test) (Ref. 34).
     Method F: ISO 10707 (Closed bottle test) (Ref 35).
     Method G: ISO 10708 (Two-phase closed bottle test) (Ref. 36).
    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 E1720-01) 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. 37), 
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. 38).
     Acute toxicity to Daphnia (ASTM E 729-96(2002)) (Ref. 38).
     Toxicity to plants (algae) (ASTM E 1218-04e1) (Ref. 39).
     Test Group 2:
     Chronic toxicity to Daphnia (ASTM E 1193-97(2004)) (Ref. 40).
     Toxicity to plants (algae) (ASTM E 1218-04e1) (Ref. 39).
    For the ``Aquatic Toxicity'' endpoint, the OECD HPV SIDS Program 
recognizes that, for certain chemicals, acute toxicity studies are of 
limited value in assessing the substances' aquatic toxicity. This issue 
arises when considering chemical substances with high log 
Kow values. In such cases, toxicity is unlikely to be 
observed over the duration of acute toxicity studies because of reduced 
uptake and the extended amount of time required for such substances to 
reach steady state or toxic concentrations in the test organism. For 
such situations, the OECD HPV SIDS Program recommends use of chronic 
toxicity testing in Daphnia in place of acute toxicity testing in fish 
and Daphnia. EPA is proposing that the aquatic toxicity testing 
requirement be

[[Page 43325]]

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.  
799.5087(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.  799.5087(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.  799.5087(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.  799.5087(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. 29, 41, and 42). A 
chemical substance with a fish BCF value of 1,000 or more is 
characterized as having a tendency to accumulate in living organisms 
relative to the concentration of the chemical in the surrounding 
environment (Ref. 42). For the purposes of this proposed rulemaking, 
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. 43). EPA has also used a measured BCF 
that is equal to or greater than 1,000 or, in the absence of 
bioconcentration data, a log P [same as log Kow] value equal 
to or greater than 4.3 to help define the potential of a new chemical 
substance to cause significant adverse environmental effects 
(Significant New Use Rules; General Provisions For New Chemical Follow-
Up (Ref. 44) (See also 40 CFR 721.3.)). EPA considers the difference 
between the log Kow of 4.3 cited in the 1989 Federal 
Register document and the log Kow value of 4.2 cited in this 
proposed rule to be negligible.
    EPA recognizes that in some circumstances, acute aquatic toxicity 
testing (Test Group 1) may be relevant for certain chemical substances 
having a log Kow equal to or greater than 4.2. chemical 
substances that are dispersible in water (e.g., surfactants, 
detergents, aliphatic amines, and cationic dyes) may have log 
Kow values greater than 4.2 and may still be acutely toxic 
to aquatic organisms. For any chemical substance listed in Table 3 in 
Sec.  799.5087(j) of the 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 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. 
59) 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.  
799.5087(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.  799.5087(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.  799.5087(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. This test is included as a special condition in Table 3 
of the proposed regulatory text. A document developed by NIH/NIEHS 
provides guidance on how to use the NRU assay to estimate a starting 
dose for an acute oral toxicity test (Ref. 50). Recent versions of the 
standardized protocols for the NRU assay are available at the NIEHS/
ICCVAM website, http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm (Refs. 51-53).
    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 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/

[[Page 43326]]

Developmental Toxicity Screening Test: 40 CFR 799.9365.
     Reproduction/Developmental Toxicity Screening Test: 40 CFR 
799.9355.
     Repeated Dose 28-Day Oral Toxicity Study: 40 CFR 799.9305.
    For the ``Mammalian Toxicity--Repeated Dose/Reproduction/
Developmental'' endpoint, EPA recommends the use of the Combined 
Repeated Dose Toxicity Study with the Reproduction/Developmental 
Toxicity Screening Test (40 CFR 799.9365) as the test of choice. EPA 
recognizes, however, that there may be reasons to test a particular 
chemical substance using both the Reproduction/Developmental Toxicity 
Screening Test (40 CFR 799.9355) and the Repeated Dose 28-Day Oral 
Toxicity Study (40 CFR 799.9305) instead of the Combined Repeated Dose 
Toxicity Study with the Reproduction/Developmental Toxicity Screening 
Test (40 CFR 799.9365). With regard to such cases, EPA is 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 chemical substances 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. 46). As described in that guidance, such chemical substances may 
be eligible for a reduced testing battery which substitutes a 
developmental toxicity study for the SIDS requirement to address 
repeated dose (e.g., subchronic), reproductive, and developmental 
toxicity. In other words, since only the developmental toxicity study 
would be conducted for those chemical substances 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 chemical substances that are listed in 
the proposed regulatory text are solely closed system intermediates as 
defined in the voluntary HPV Challenge Program guidance document (Ref. 
46). Persons who believe that a chemical substance 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 
substance 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 rulemaking. In 
those cases in which the Agency can determine that chemicals are solely 
closed system intermediates, it plans to handle them in accordance with 
the existing OECD procedures.

B. When Would Any Testing Imposed by this Proposed Rulemaking 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.  
799.5087(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, and with the TSCA Good Laboratory Practice Standards (GLPS) (40 
CFR part 792).

D. What Form 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'' substance. First 
introduced when EPA compiled the TSCA Chemical Substance Inventory, the 
term Class 1 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 substance refers to a chemical 
substance having a composition that cannot be represented by a 
specific, complete chemical structure diagram, because such a substance 
generally contains two or more different chemical species (not 
including impurities). Table 2 in Sec.  799.5087(j) of the proposed 
regulatory text identifies the listed chemical substances as either 
Class 1 or Class 2 substances.
    EPA is proposing that, for the Class 1 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 substances in the past under TSCA section 4(a) 
testing actions, except for 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 substances listed in this proposed rule. For the Class 2 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).
    In proposing a different approach for identifying the substance to 
be tested with regard to Class 2 substances, EPA recognizes two 
characteristics which further distinguish Class 1 from Class 2 
substances. First, unlike for Class 1 substances, knowledge of the 
composition of commercial Class 2 substances can vary in quality and 
specificity from substance to substance.
    The composition of the chemical species which comprise a Class 2 
substance may be:
     Well-characterized in terms of molecular formulae, 
structural diagrams, and compositional percentages of all species 
present (for example, methyl phenol);
     Less well-characterized, for example, characterized only 
by molecular formulae, non-specific structural diagrams, and/or by 
incomplete or unknown compositional percentages of the species present 
(for example, C12-C14 tert-alkyl amines); or
     Poorly characterized because all that is known is the 
identity of only some of the chemical species present and their 
percentages of composition, or of only the feedstocks and method of 
manufacture used to manufacture the substance (for example, nut shell 
liquor of cashew).
    Secondly, the composition of some Class 2 substances may vary from 
one manufacturer to another, or, for a single manufacturer, from 
production run to production run, because of small variations in 
feedstocks, manufacturing methods, or other production variables. A 
``Class 2'' designation most frequently represents a group of chemical 
substances comprising substances that have similar combinations of 
different

[[Page 43327]]

chemical species and/or that were prepared from similar feedstocks 
using similar production methods. By contrast, Class 1 substances 
generally represent a much narrower group of substances for which the 
only variables are their impurities. EPA believes that, for purposes of 
this proposed rule, the testing of any representative form of a subject 
Class 2 substance would provide the data necessary to support the 
development of preliminary or screening level hazard and risk 
characterizations for the subject Class 2 substance. However, EPA would 
encourage the selection of representative forms of test substances that 
meet industry or consensus standards, where they exist. In accordance 
with TSCA GLPS at 40 CFR part 792, the final study report would be 
required to include test substance identification information, 
including name, CAS number, strength, purity, and composition, or other 
appropriate characteristics. (See 40 CFR 792.185).
    As an alternative to requiring the testing of a representative form 
of a Class 2 substance designated by a person subject to the final 
rule, EPA is considering whether the Agency should specify the 
particular form of each chemical substance that must be tested, and, if 
so, what criteria EPA should use to identify the particular 
representative form that would be tested. EPA might specify, for 
example, a form of a substance that meets an industry or consensus 
specification, if one exists, or the form with the highest production 
volume, which could potentially be identified via information reported 
under a TSCA section 8(a) rule, or by other means.
    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 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 
testing of Class 2 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 rulemaking. 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 chemical substances 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 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 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 this proposed 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.

[[Page 43328]]



   Table 4.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
 Tier 1 (Persons initially required to    Tier 2 (Persons not initially
                comply)                        required to comply)
------------------------------------------------------------------------
Persons who manufacture (as defined at   A. Persons who manufacture (as
 TSCA section 3(7)), or intend to         defined at TSCA section 3(7))
 manufacture, a test rule substance,      or intend to manufacture a
 and who are not listed under Tier 2      test rule substance solely as
                                          one or more of the following:
                                         --As a byproduct (as defined at
                                          40 CFR 791.3(c));
                                         --As an impurity (as defined at
                                          40 CFR 790.3);
                                         --As a naturally occurring
                                          chemical substance (as defined
                                          at 40 CFR 710.4(b));--As a non-
                                          isolated intermediate (as
                                          defined at 40 CFR 704.3);
                                         --As a component of a Class 2
                                          substance (as described at 40
                                          CFR 720.45(a)(1)(i));
                                         --In amounts of less than 500
                                          kg (1,100 lbs.) annually (as
                                          described at 40 CFR
                                          790.42(a)(4)); or
                                         --In small quantities solely
                                          for 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 reconfigured the tiers in 40 
CFR 790.42. 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 substances, manufacturers of non-isolated 
intermediates, and manufacturers of components of Class 2 substances. 
The Agency took administrative burden and complexity into account in 
determining who was to be in Tier 1 in this proposed rule. EPA believes 
that those persons in Tier 1 who would conduct testing under this 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 substances, 
manufacturers of non-isolated intermediates, and manufacturers of 
components of Class 2 substances historically have not themselves 
participated in testing or contributed to reimbursement of those 
persons who have conducted testing. EPA understands that these 
manufacturers may include persons for whom the marginal transaction 
costs involved in negotiating and administering testing arrangements 
are deemed likely to raise the expense and burden of testing to a level 
that is disproportional to the additional benefits of including these 
persons in Tier 1. Therefore, EPA does not believe that the likelihood 
of the persons 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.  799.5087(b)(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. Tier 2 manufacturers, i.e., those who manufacture, or 
intend to manufacture, a test rule substance solely as one or more of 
the following: A byproduct, an impurity, a naturally occurring 
substance, a non-isolated intermediate, a component of a Class 2 
substance, in amounts less than 1,100 lbs. annually, or in small 
quantities solely for research and development.
    ii. Tier 2B. Tier 2 processors, i.e., those who process, or intend 
to process, a test rule 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. 54). 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. 55).
    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.  799.5087(c)(2), (c)(5), (c)(7), and 
(c)(11) of the proposed regulatory text. In this rule, EPA would not 
require the submission of equivalence data (i.e., data demonstrating 
that your substance is equivalent to the substance actually being 
tested) as a condition for approval

[[Page 43329]]

of your exemption. Therefore, 40 CFR 790.82(e)(1) and 40 CFR 790.85 
would not apply to this test 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.  799.5087(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.  799.5087(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 rule; 
thus, persons subject to this rule are not required to comply with 40 
CFR 790.48 itself (see Sec.  799.5087(c)(4)-(c)(7) and Sec.  
799.5087(d)(3) of the proposed regulatory text). Note that persons who 
obtain exemptions or receive them automatically would nonetheless be 
subject to providing reimbursement to persons who do actually conduct 
the testing, as described in Unit 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. 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.
    If a problem occurs with the initiation, conduct, or completion of 
the required testing, or with the submission of the required data to 
EPA, the Agency may require you to submit a notice of intent to test or 
an exemption application. See 40 CFR 790.93 and Sec.  799.5087(c)(10) 
of the 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; and
     EPA has published a Federal Register document directing 
persons in Tier 2 to submit to EPA letters of intent to conduct testing 
or exemption applications. See Sec.  799.5087(c)(4), (c)(5), (c)(6), 
and (c)(7) of the 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 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 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 rule with respect to that chemical substance who are not already 
in violation of the rule would be in violation of the rule.
    4. How do the reimbursement procedures work? In the past, persons 
subject to test rules have independently worked out among themselves 
their respective financial contributions to those persons who have 
actually conducted the testing. However, if persons are unable to agree 
privately on reimbursement, they may take advantage of EPA's 
reimbursement procedures at 40 CFR part 791, promulgated under the 
authority of TSCA section 4(c). These procedures include: The 
opportunity for a hearing with the American Arbitration Association; 
publication by EPA of a document in the Federal Register concerning the 
request for a hearing; and the appointment of a hearing officer to 
propose an order for fair and equitable reimbursement. The hearing 
officer may base his or her proposed order on the production volume 
formula set out at 40 CFR 791.48, but is not obligated to do so. Under 
this 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.  799.5087(j) of 
the proposed regulatory text. A robust summary of the final report for 
each specific test should be submitted in addition to and at the same 
time as the final report. The term ``robust summary'' is used to 
describe the technical information necessary to adequately describe an 
experiment or study and includes the objectives, methods, results, and 
conclusions of the full study report which can be either an experiment 
or in some cases an estimation or prediction method. Guidance for the 
compilation of robust summaries is described in a document entitled 
Draft Guidance on Developing Robust Summaries (Ref. 15) which is 
available at: http://www.epa.gov/HPV/pubs/general/robsumgd.htm. Persons 
who respond to 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.''

[[Page 43330]]

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. 47) 
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 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 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 
section 4 must notify the EPA Administrator of such export or intent to 
export. The 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

    In addition, EPA has prepared an economic assessment entitled 
Economic Analysis for the Proposed Section 4 Test Rule for High 
Production Volume Chemicals; Final Report (Ref. 17), a copy of which 
has been placed in the public docket for this proposed rulemaking. This 
economic assessment evaluates the potential for significant economic 
impacts as a result of the testing that would be required by this 
proposal. The analysis covers 19 chemical substances. The total social 
cost of providing test data on the 19 chemical substances that were 
evaluated in this economic analysis is estimated to be $4.4 million 
(Ref. 17).
    While legally subject to this test rule, processors of a subject 
chemical would be required to comply with the requirements of the rule 
only if they are directed to do so by EPA as described in Sec.  
799.5087(c)(5) and (c)(6) of the 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 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, 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 a screening approach that estimated the impact of testing 
requirements as a percentage of each chemical substance's sale price. 
This measure compares annual revenues from the sale of a chemical 
substance to the annualized compliance cost for that chemical to assess 
the percentage of testing costs that can be accommodated by the revenue 
stream generated by that chemical over a number of years. Compliance 
costs include costs of testing and administering the testing, as well 
as reporting costs. Annualized compliance costs divide testing 
expenditures into an equivalent, constant yearly expenditure over a 
longer period of time. To calculate the percent price impact, testing 
costs (including laboratory and administrative expenditures) are 
annualized over 15 years using a 7% discount rate. Annualized testing 
costs are then divided by the estimated annual revenue of the chemical 
substance to derive the cost-to-sales ratio. EPA estimates the total 
annualized compliance cost of testing for the 19 chemical substances 
evaluated in the economic analysis to be $1.68 million under the 
average cost scenario. In addition, the TSCA section 12(b) export 
notification requirements (included in the total and annualized cost 
estimates) that would be triggered by the final rule are expected to 
have a negligible impact on exporters. The estimated cost of the TSCA 
section 12(b) export notification requirements, which, under the final 
rule, would be required for the first export to a particular country of 
a chemical subject to the rule, is estimated to range from $25.56 per 
notice to $80.22 per notice (Ref.17). The Agency's estimated total 
costs of testing (including both laboratory and administrative costs) 
annualized testing cost, and public reporting burden hours for this 
proposed rule are presented in the economic assessment.
    Under a least cost scenario, 16 out of the 19 chemical substances 
(84%) would have a price impact at less than the 1% level. Similarly, 
15 out of the 19 chemical substances (79%) would be impacted at less 
than the 1% level under an average cost scenario. Thus, the potential 
for adverse economic impact due to the proposed test rule is low for at 
least 79% of the chemical substances in this proposed rule. 
Approximately 4 chemicals (21%) of the 19 chemical substances for which 
price data are available would have a price impact at a level greater 
than or equal to 1% under the least (average) cost scenario.
    EPA believes, on the basis of these calculations, that the proposed 
testing of the chemical substances presents a low potential for adverse 
economic impact for the majority of the 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 of the chemicals. There are, 
however, some chemical substances for which the price impact is 
expected to exceed 1% of the revenue from that chemical. The potential 
for adverse economic impact is expected to be higher for these chemical 
substances. In these cases, companies may choose to use revenue sources 
other than the profits from the individual chemicals to pay for 
testing. Smaller businesses are less likely to have additional revenue 
sources to cover the compliance costs in this situation. Therefore, the 
Agency also compared the costs of compliance to company sales for small 
businesses.

[[Page 43331]]

    EPA does not provide quantitative estimates of the benefits from 
these tests. Ideally, a discussion of benefits would focus on the 
additional benefits to be gained from new information relative to 
information that already exists. Such an approach could examine the 
value of new information provided as a result of the test rule where 
such information has not been publicly available. Because of 
constraints on information on the value of information, our evaluation 
of benefits is qualitative and does not address incremental benefits. 
We believe, however, that the net benefits of the new information are 
positive.

VII. Public Comment

    As discussed in Units III.D. and III.E., 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 
Units III.F., 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.F., 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. 15). 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 also solicits public comment on the test methods proposed and 
the analysis detailing the burdens and costs for the regulatory impacts 
resulting from this rule.
    In addition, EPA solicits comment on the proposed and alternative 
approaches to the testing of Class 2 substances, whether the proposed 
approach for testing Class 1 substances (i.e., that each Class 1 
substance be tested at a purity of 99% or more) should be applied to 
any Class 2 substances, and whether the proposed or alternative 
approaches for the testing of Class 2 substances (i.e., that a 
representative sample of each Class 2 substance be tested) should be 
applied to any Class 1 substances.

VIII. Materials in the Docket

    As indicated under ADDRESSES, a docket has been established for 
this proposed rulemaking under docket ID number EPA-HQ-OPPT-2007-0531. 
The following is a listing of the documents that have been placed in 
the public 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 public docket, regardless of whether these referenced documents are 
physically located in the public docket. For assistance in locating 
documents that are referenced in documents that EPA has placed in the 
public docket, but that are not physically located in the docket, 
please consult the technical contact listed under FOR FURTHER 
INFORMATION CONTACT. The public 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. Proposed Test Rule for the Testing of Certain High 
Production Volume Chemicals. Proposed Rule. Federal Register (65 FR 
81658, December 26, 2000) (FRL-6758-4).
    3. EPA. Final Test Rule for the Testing of Certain High Production 
Volume Chemicals. Final Rule. 40 CFR part 799. Federal Register (71 FR 
13708, March 16, 2006) (FRL-7335-2).
    4. EPA. TSCA Section 4(a)(1)(B) Final Statement of Policy. Notice. 
Federal Register (58 FR 28736, May 14, 1993).
    5. EPA, OPPT. HPV Challenge Program Chemical List. This list is 
updated periodically, and 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. International Council of Chemical Associations (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. OECD Secretariat. Summary Record of the 13th Joint Meeting of 
the OECD Chemicals Group and Management Committee of the Special 
Programme on the Control of Chemicals, November 8-10, 1989. ENV/CHEM/
CM/89.2. February 1990.
    10. OECD Secretariat. Proposal for Further Work on the 
Investigation of High Production Volume Chemicals. OECD Chemicals Group 
and Management Committee of the Special Programme on the Control of 
Chemicals. ENV/CHEM/CM/89.14. October 1989.
    11. OECD. Decision-Recommendation on the Co-Operative Investigation 
and Risk Reduction of Existing Chemicals-C(90)163/FINAL. January 31, 
1991.
    12. CMA (ACC). Comments on EPA's TSCA section 4(a)(1)(B) Proposed 
Statement of Policy submitted to the TSCA Public Docket Office, EPA. 
September 13, 1991.
    13. Epoxy Resin Systems Task Group of the Society of the Plastics 
Industry, Inc. Comments on EPA's TSCA section 4(a)(1)(B) Proposed 
Statement of Policy submitted to the TSCA Public Docket Office, EPA. 
September 13, 1991.
    14. 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.
    15. EPA, OPPT. Draft Guidance on Developing Robust Summaries. 
October, 22, 1999. Available on-line at: http://www.epa.gov/HPV/pubs/general/robsumgd.htm.
    16. EPA, Office of Prevention, Pesticides and Toxic Substances 
(OPPTS). Letter from Susan H. Wayland, Deputy Assistant Administrator, 
to participants in the voluntary HPV Challenge Program. October 14, 
1999. Available on-line at http://www.epa.gov/chemrtk/pubs/general/ceoltr2.htm.
    17. EPA, OPPT, Economics, Exposure and Technology Division (EETD), 
Economic and Policy Analysis Branch (EPAB). Economic Analysis for the 
Proposed Section 4 Test Rule for High Production Volume Chemicals; 
Final Report. February 2008.
    18. EPA, OPPT, EETD. Testing of Certain High Production Volume 
Chemicals; Second Group of Chemicals (Exposure Findings Supporting 
Information). July 2008.

[[Page 43332]]

    19. EPA. OPPT. Chemical Information and Testing Branch (CITB). 
Response to public comments regarding testing of certain high 
production volume chemicals. May 31, 2005.
    20. 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. 1988. Available on-line at: http://www.cdc.gov/niosh/88-106.html.
    21. EPA. Inert Reassessment--Oxalic Acid (CAS Reg. No. 144-62-7). 
Action Memorandum. From: Pauline Wagner, Chief, Inert Ingredient 
Assessment Branch, To: Lois A. Rossi, Director, Registration Division. 
September 6, 2005.
    22. American Society for Testing and Materials International (ASTM 
International). Standard Test Method for Relative Initial and Final 
Melting Points and the Melting Range of Organic Chemicals. ASTM. E 324-
99. 1999.
    23. ASTM International. Standard Test Method for Vapor Pressure of 
Liquids by Ebulliometry. ASTM. E 1719-05. 2005.
    24. ASTM International. Standard Test Method for Determining Vapor 
Pressure by Thermal Analysis. ASTM. E 1782-03. 2003.
    25. ASTM International. Standard Test Method for Partition 
Coefficient (n-Octanol/Water) Estimation by Liquid Chromatography. 
ASTM. E 1147-92(2005). 2005.
    26. ASTM International. Standard Test Method for Measurements of 
Aqueous Solubility. ASTM. E 1148-02. 2002.
    27. 49. ASTM International. Question about ASTM E 324. E-mail from 
Diane Rehiel, ASTM, to Greg Schweer, CITB, CCD, OPPT, EPA. September 
15, 2004.
    28. Meylan, W.M. and Howard, P.H. Atom/Fragment Contribution Method 
for Estimating Octanol-Water Partition Coefficients. Journal of 
Pharmaceutical Sciences. 84(1):83-92. 1995.
    29. Meylan, W.M., Howard, P.H., and Boethling, R.S. Improved Method 
for Estimating Water Solubility From Octanol/Water Partition 
Coefficient. Environmental Toxicology and Chemistry. 15(2):100-106. 
1996.
    30. ASTM International. Standard Test Method for Determining Ready, 
Ultimate, Biodegradability of Organic Chemicals in a Sealed Vessel 
CO2 Production Test, ASTM E 1720-01. 2001.
    31. International Organization for Standardization (ISO). Water 
quality--Evaluation of ultimate aerobic biodegradability of organic 
compounds in aqueous medium--Method by analysis of inorganic carbon in 
sealed vessels (CO2 headspace test). ISO 14593. 1999.
    32. ISO. Water quality--Evaluation in an aqueous medium of the 
``ultimate'' aerobic biodegradability of organic compounds--Method by 
analysis of dissolved organic carbon (DOC). ISO 7827. 1994.
    33. ISO. Water quality--Evaluation of ultimate aerobic 
biodegradability of organic compounds in aqueous medium by 
determination of oxygen demand in a closed respirometer. ISO 9408. 
1999.
    34. ISO. Water quality--Evaluation of ultimate aerobic 
biodegradability of organic compounds in aqueous medium--Carbon dioxide 
evolution test. ISO 9439. 1999.
    35. ISO. Water quality--Evaluation in an aqueous medium of the 
``ultimate'' aerobic biodegradability of organic compounds--Method by 
analysis of biochemical oxygen demand (closed bottle test). ISO 10707. 
1994.
    36. ISO. Water quality--Evaluation in an aqueous medium of the 
ultimate aerobic biodegradability of organic compounds--Determination 
of biochemical oxygen demand in a two-phase closed bottle test 
(available in English only). ISO 10708. 1997.
    37. ISO. Water quality--Guidance for the preparation and treatment 
of poorly water-soluble organic compounds for the subsequent evaluation 
of their biodegradability in an aqueous medium. ISO 10634. 1995.
    38. ASTM International. Standard Guide for Conducting Acute 
Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and 
Amphibians. ASTM. E 729-96(2002). 2002.
    39. ASTM International. Standard Guide for Conducting Static 
Toxicity Tests with Microalgae. ASTM. E 1218-04e1. 2004.
    40. ASTM International. Standard Guide for Conducting Daphnia magna 
Life-Cycle Toxicity Tests. ASTM. E 1193-97(2004). 2004.
    41. 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.
    42. Bintein, S.; DeVillers, J.; and Karcher, W. Nonlinear 
dependence of fish bioconcentration on n-octanol/water partition 
coefficient. SAR and QSAR in Environmental Research, 1:29-39. 1993.
    43. EPA. Document containing EPA's Policy Statement under TSCA 
section 5 entitled Category for Persistent, Bioaccumulative, and Toxic 
New Chemical Substances. Notice. Federal Register (64 FR 60194, 
November 4, 1999) (FRL-6097-7). Available on-line at: http://www.epa.gov/oppt/newchems/pubs/pbtpolcy.htm.
    44. EPA. Significant New Use Rules; General Provisions for New 
Chemical Follow-Up. Final Rule. Federal Register (54 FR 31307, July 27, 
1989).
    45. EPA, OPPT. Development of Chemical Categories in the HPV 
Challenge Program (Draft). August 25, 1999. Available on-line at: 
http://www.epa.gov/chemrtk/pubs/general/categuid.htm.
    46. 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.
    47. EPA, OPPT, EETD, EPAB. Analysis of Laboratory Capacity to 
Support U.S. EPA Chemical Testing Program Initiatives. August 2004.
    48. 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.
    49. EPA, OPPT, EETD, EPAB. Economic Analysis in Support of the TSCA 
12(b) Information Collection Request. October 30, 1998.
    50. 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.
    51. 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.
    52. 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. National Toxicology Program (NTP) 
Interagency Center for the Evaluation of Alternative Toxicological 
Methods (NICEATM). November 4, 2003. Available on-line at: http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm.
    53. NIEHS 2003c. Test Method Protocol for the NHK Neutral Red 
Uptake Cytotoxicity Test, a Test for

[[Page 43333]]

Basal Cytotoxicity for an in vitro Validation Study--Phase III. 
National Toxicology Program (NTP) Interagency Center for the Evaluation 
of Alternative Toxicological Methods (NICEATM). November 4, 2003. 
Available on-line at: http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm.
    54. EPA. Toxic Substances; Test Rule Development and Exemption 
Procedures. Interim Final Rule. 40 CFR part 790. Federal Register (50 
FR 20652, May 17, 1985).
    55. EPA. Toxic Substances Control Act; Data Reimbursement. Final 
Rule. 40 CFR part 791. Federal Register (48 FR 31786, July 11, 1983).
    56. EPA. OPPT. High Production Volume Chemical Data Information 
System (HPVIS). Data from HVPIS on 18 HPV chemicals. May 2008.
    57. NIOSH. National occupational exposure survey analysis of 
management interview responses. Vol. III. Pedersen DH, Sieber WK, 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. 1989. Available on-line 
at: http://www.cdc.gov/niosh/89-103.html.
    58. NIOSH. National occupational exposure survey sampling 
methodology. Vol. II. Sieber WK, 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. 1989. Available on-line at: http://www.cdc.gov/niosh/89-102.html.
    59. 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, because it 
does not raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
section 3(f)(4) of the Executive Order. Accordingly, EPA did not submit 
this proposed rulemaking to OMB for review under Executive Order 12866.
    EPA has prepared an economic analysis of this proposed action, 
which is contained in a document entitled Economic Analysis for the 
Proposed Section 4 Test Rule for High Production Volume Chemicals; 
Final Report (Ref. 17). 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 test rule is provided 
in the economic analysis (Ref. 17).
    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 rulemaking 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 
title 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 19 chemicals is 9,008 hours, with an estimated burden 
per chemical of 474 hours (Ref. 17). 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. 17). In estimating the total burden hours 
approved for the information collection activities related to export 
notification, the Agency has included sufficient burden hours to 
accommodate any export notifications that may be required by the 
Agency's issuance of final 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 action 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 proposal.

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

[[Page 43334]]

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. 17), which is summarized in Unit 
VI., and a copy of which is available in the docket for this proposed 
rulemaking. 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 the 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 rulemaking (Ref. 17), 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. 17) in order to characterize the potential small entity impacts 
of this proposed rule on small business:
    1. The size of the adverse economic impact (measured as the ratio 
of the cost to sales or revenue).
    2. 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 rulemaking, 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 codes 325 and 
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 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.
    The SBA has developed 6 digit NAICS code-specific size standards 
based on employment thresholds. These size standards range from 500 to 
1,500 employees for the various 6 digit NAICS codes that are 
potentially impacted (Ref. 17). For a conservative estimate of the 
number of small businesses affected by this proposed rule, the Agency 
chose an employment threshold of less than 1,500 employees for all 
businesses regardless of the NAICS-specific threshold to determine 
small business status.
    For each manufacturer of the 19 chemicals covered by this 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 48 affected UCEs. Sales and employment data could be found for 45 
and 46 of these UCEs (88%), respectively.
    Parent company sales data were collected to identify companies that 
qualified as a ``small business'' for purposes of the RFA analysis. 
Based on the SBA size standard applied (1,500 employees or less), 20 
companies were identified as small.
    The potential significance of this 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 20 small businesses analyzed for small business impacts, one 
company had no sales data available. Another two companies could not be 
classified as small or large because there were no employment data 
available, but were still included in the small business impact 
analysis. Of the 19 designated as small businesses, none had cost-to-
sales ratios of greater than 1% under both the least and average cost 
scenarios. For the chemicals where sales data were unavailable, EPA 
used the median sales value sales of all other small businesses equal 
to $15.4 million. The costs for the three companies were estimated to 
be well below 0.01% of this sales level. Given these results, the 
Agency has determined that there is not a significant economic impact 
on a substantial number of small entities as a result of this proposed 
rule, if finalized.
    The estimated cost of the TSCA section 12(b)(1) export 
notification, which, as a result of the final rule,

[[Page 43335]]

would be required for the first export to a particular country of a 
chemical subject to the rule, is estimated to be $80.22 for the first 
time that an exporter must comply with TSCA section 12(b)(1) export 
notification requirements, and $25.56 for each subsequent export 
notification submitted by that exporter (Refs. 17, 48, and 49). EPA has 
concluded that the costs of TSCA section 12(b)(1) export notification 
would have a negligible impact on exporters of the chemicals 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 
rulemaking 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, 
which are summarized in Unit VI., would be $4.4 million. The total 
annualized costs of this proposed rule are estimated to be $1.68 
million. In addition, since EPA does not have any information to 
indicate that any State, local, or tribal government manufactures or 
processes the chemicals covered by this action such that this 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 chemicals. 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 chemicals, and would result in the 
development of data about those chemicals that can subsequently be used 
to assist the Agency and others in determining whether the chemicals 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 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 this 
rule, EPA is proposing the use of voluntary consensus standards issued 
by ASTM and ISO which evaluate the same type of toxicity as the TSCA 
and OECD test guidelines, where applicable. Copies of the 17 ASTM and 
ISO standards referenced in the proposed regulatory text at Sec.  
799.5087(h) have been placed in the docket for this proposed 
rulemaking. You may obtain copies of the ASTM standards from the 
American Society for Testing and Materials, 100 Bar Harbor Dr., West 
Conshohocken, PA 19428-2959, and copies of the ISO standards from the 
International Organization for Standardization, Case Postale, 56 CH-
1211 Gen[egrave]ve 20 Switzerland. In the final rule, EPA intends to 
seek approval from the Director of the Federal Register for the 
incorporation by reference of the ASTM 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,

[[Page 43336]]

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 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 rulemaking, 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 chemicals covered by the rule. Although not 
directly impacting environmental justice-related concerns, this 
information will better enable the Agency to better protect human 
health and the environment, including in low-income and minority 
communities.

List of Subjects in 40 CFR Part 799

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


    Dated: July 17, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:
    1. The authority citation for part 799 would continue to read as 
follows:

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

    2. By adding Sec.  799.5087 to subpart D of part 799 that would 
read as follows:


Sec.  799.5087  Chemical testing requirements for certain high 
production volume chemicals; second 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'' substances in Table 2 in paragraph (j) of 
this section, the purity of each substance must be 99% or greater, 
unless otherwise specified in this section. For the chemical substances 
identified as ``Class 2'' substances in Table 2 in paragraph (j), a 
representative form of each substance must be tested. The 
representative form selected for a given Class 2 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.

   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

[[Page 43337]]

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 [date 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 document described in paragraph (c)(4) 
of this section.
    (6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its 
intentto 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 [date 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 document described in paragraph (c)(6) 
of this section, either submit to EPA a letter of intent to test or 
apply to EPA for an exemption from testing. The letter of intent to 
test or the exemption application must be received by EPA no later than 
30 days after publication of the document described in paragraph (c)(6) 
of this section.
    (8) If no manufacturer or processor has notified EPA of its intent 
to conduct one or more of the tests required by this section for any of 
the chemical substances listed in Table 2 in paragraph (j) of this 
section within 30 days after the publication of the Federal Register 
document described in paragraph (c)(6) of this section, EPA will notify 
all manufacturers and processors of those chemical substances of this 
fact by certified letter or by publishing a Federal Register document 
specifying the test(s) for which no letter of intent has been 
submitted. This letter or Federal Register document will additionally 
notify all manufacturers and processors that all exemption applications 
concerning the test(s) have been denied, and will give the 
manufacturers and processors of the chemical substance(s) an 
opportunity to take corrective action.
    (9) If no manufacturer or processor has notified EPA of its intent 
to conduct one or more of the tests required by this section for any of 
the chemical substances listed in Table 2 in paragraph (j) of this 
section within 30 days after receipt of the certified letter or 
publication of the Federal Register document described in paragraph 
(c)(8) of this section, all manufacturers and processors subject to 
this section with respect to that chemical substance who are not 
already in violation of this section will be in violation of this 
section.
    (10) If a problem occurs with the initiation, conduct, or 
completion of the required testing or the submission of the required 
data with respect to a chemical substance listed in Table 2 in 
paragraph (j) of this section, under the procedures in 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 to comply with this section? (1) To comply with 
this section you must either submit to EPA a letter of intent to test, 
or apply to and obtain from EPA an exemption from testing.
    (2) For each test with respect to which you submit to EPA a letter 
of intent to test, you must conduct the testing specified in paragraph 
(h) of this section and submit the test data to EPA.
    (3) You must also comply with the procedures governing test rule 
requirements in part 790 of this chapter, as modified by this section, 
including the submission of letters of intent to test or exemption 
applications, 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; 
paragraph (a)(2) and paragraph (b) of Sec. Sec.  790.80, 790.82(e)(1), 
790.85, and 790.48.
    (e) If I do not comply with this section, when will I be considered 
in violation of it? You will be considered in violation of this section 
as of one 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? (1) The tests that are required 
for each chemical substance are indicated in

[[Page 43338]]

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 [date 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 should be submitted in addition 
to and at the same time as the final report. The term ``robust 
summary'' is used to describe the technical information necessary to 
adequately describe an experiment or study and includes the objectives, 
methods, results, and conclusions of the full study report which can be 
either an experiment or in some cases an estimation or prediction 
method. Guidance for the compilation of robust summaries is described 
in a document entitled Draft Guidance on Developing Robust Summaries 
which is available at: http://www.epa.gov/HPV/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
                                                                                                paragraph)
----------------------------------------------------------------------------------------------------------------
75-07-0                                Acetaldehyde              1                       C2, F2
----------------------------------------------------------------------------------------------------------------
78-11-5                                1,3-Propanediol, 2,2-     1                       C4
                                        bis[(nitrooxy)methyl]-
                                        , dinitrate (ester)
----------------------------------------------------------------------------------------------------------------
84-65-1                                9,10-Anthracenedione      1                       C6
----------------------------------------------------------------------------------------------------------------
89-32-7                                1H,3H-Benzo[1,2-c:4,5-    1                       A3, A4, A5, B, C1, D,
                                        c']difuran-1,3,5,7-                               E1, F1
                                        tetrone
----------------------------------------------------------------------------------------------------------------
110-44-1                               2,4-Hexadienoic acid,     1                       C6, F2
                                        (E,E)-
----------------------------------------------------------------------------------------------------------------
118-82-1                               Phenol, 4,4'-             1                       C1
                                        methylenebis[2,6-
                                        bis(1,1-dimethylethyl)-
 
----------------------------------------------------------------------------------------------------------------
119-61-9                               Methanone, diphenyl-      1                       B, C2
----------------------------------------------------------------------------------------------------------------
144-62-7                               Ethanedioic acid          1                       A1, A2, A3, A5, B, C1,
                                                                                          E2, F2
----------------------------------------------------------------------------------------------------------------
149-44-0                               Methanesulfinic acid,     1                       E1
                                        hydroxy-, monosodium
                                        salt
----------------------------------------------------------------------------------------------------------------
2524-04-1                              Phosphorochloridothioic   1                       A1, A2, A3, A4, A5, B,
                                        acid, O,O-diethyl                                 C1, E1, E2, F2
                                        ester
----------------------------------------------------------------------------------------------------------------
4719-04-4                              1,3,5-Triazine-           1                       C6
                                        1,3,5(2H,4H,6H)-
                                        triethanol
----------------------------------------------------------------------------------------------------------------
6381-77-7                              D-erythro-Hex-2-enonic    1                       A4, B, C1
                                        acid, [gamma]-lactone,
                                        monosodium salt
----------------------------------------------------------------------------------------------------------------
31138-65-5                             D-gluco-Heptonic acid,    1                       A1, A2, A4, A5, B, C1,
                                        monosodium salt,                                  D, E1, E2, F1
                                        (2.xi.)-
----------------------------------------------------------------------------------------------------------------
66241-11-0                             C.I. Leuco Sulphur        2                       A1, A2, A3, A4, A5, B,
                                        Black 1                                           C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68187-76-8                             Castor oil, sulfated,     2                       A1, A2, A4, A5, C1, D,
                                        sodium salt                                       E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68187-84-8                             Castor oil, oxidized      2                       A1, A2, A3, A4, A5, B,
                                                                                          C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68479-98-1                             Benzenediamine, ar,ar-    1                       A1, A2, A3, A4, A5, C1,
                                        diethyl-ar-methyl-                                E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68527-02-6                             Alkenes, C12-24, chloro   2                       A1, A2, A3, A4, A5, B,
                                                                                          C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68647-60-9                             Hydrocarbons, C > 4       2                       A2, A3, A5, B, C1, D,
                                                                                          E1, E2, F1
----------------------------------------------------------------------------------------------------------------


[[Page 43339]]


       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 43340]]

 
                                      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 43341]]

 
                                      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 43342]]

 
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 chemicals
  may request a modification to the test standard as described in 40 CFR 790.55. Based upon the supporting
  rationale provided by the test sponsor, EPA may allow an alternative threshold or method be used for
  determining whether acute or chronic aquatic toxicity testing be performed for a specific substance.
iv. The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available 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 [date 30 days 
after date of publication of the final rule in the Federal Register].
[FR Doc. E8-16992 Filed 7-23-08; 8:45am]
BILLING CODE 6560-50-S