```

[Federal Register Volume 76, Number 204 (Friday, October 21, 2011)]
[Proposed Rules]
[Pages 65580-65608]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26894]

[[Page 65579]]

Vol. 76

Friday,

No. 204

October 21, 2011

Part III

Environmental Protection Agency

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40 CFR Parts 721 and 799

Certain High Production Volume Chemicals; Test Rule and Significant New 
Use Rule; Fourth Group of Chemicals; Proposed Rule

Federal Register / Vol. 76 , No. 204 / Friday, October 21, 2011 / 
Proposed Rules

[[Page 65580]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 721 and 799

[EPA-HQ-OPPT-2010-0520; FRL-8876-6]
RIN 2070-AJ66

Certain High Production Volume Chemicals; Test Rule and 
Significant New Use Rule; Fourth Group of Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to issue a test rule under Toxic Substances 
Control Act (TSCA) section 4(a)(1)(B) to require manufacturers and 
processors of 23 high production volume (HPV) chemical substances to 
develop screening-level health, environmental, and fate data based on 
the potential for substantial exposures of workers and consumers to 
these chemicals. EPA is also proposing to issue simultaneously a 
significant new use rule (SNUR) for another 22 HPV chemical substances 
under TSCA section 5(a)(2). The SNUR would require persons to file a 
significant new use notice (SNUN) with EPA prior to manufacturing, 
importing, or processing any of these chemical substances for use in a 
consumer product or for any use, or combination of uses, that is 
reasonably likely to expose 1,000 or more workers at a single corporate 
entity. The required notification would provide EPA with the 
opportunity to evaluate the intended use and, if necessary, to prohibit 
or limit that activity before it occurs. EPA is also soliciting comment 
on a number of issues with regard to both the test rule and the SNUR.

DATES: Comments must be received on or before January 19, 2012.
    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 January 19, 2012, EPA will hold a public meeting 
on this proposed rule in Washington, DC.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2010-0520, 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-2010-0520. 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-
2010-0520. 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 Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically at http://www.regulations.gov, or, if only available in 
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA 
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution 
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of 
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the EPA/DC Public Reading Room 
is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.
    Submission of requests: You may submit a request for an opportunity 
to present oral comments. This request must be made in writing and 
submitted to the mailing or hand delivery addresses provided in this 
unit. If such a request is received, EPA will announce the scheduling 
of the public meeting in a subsequent document in the Federal Register.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Robert Jones (test rule) or Amy Breedlove (SNUR), Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8161 or (202) 
564-9823; e-mail address: jones.robert@epa.gov or 
breedlove.amy@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by these actions if you manufacture 
(defined by statute to include import) or process any of the chemical 
substances that are listed in Tables A. or B. in Unit III. Potentially 
affected entities may include, but are not limited to:
     Manufacturers (defined by statute to include importers) of 
one or more of the subject chemical substances (NAICS codes 325 and 
324110), e.g., chemical manufacturing and petroleum refineries.
     Processors of one or more of the subject chemical 
substances (NAICS codes 325 and 324110), e.g., chemical manufacturing 
and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of

[[Page 65581]]

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. If you have any questions regarding 
the applicability of this action to a particular entity, consult either 
technical person listed under FOR FURTHER INFORMATION CONTACT.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. See Unit 
VI. for export notification requirements.

B. What should I consider as I prepare my comments for EPA?

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

C. Can I request an opportunity to present oral comments to the agency?

    You may submit a request for an opportunity to present oral 
comments. This request must be made in writing. If such a request is 
received on or before January 19, 2012, 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 and why?

    Congress gave EPA (also referred to as ``Agency'') broad authority 
to require testing of chemical substances when EPA can establish a 
minimum level of risk concern for a chemical substance (hazard and 
exposure are considered), and/or when EPA can establish that there is 
or may be substantial production and release or exposure of a chemical 
substance (production volume and exposure are considered). HPV chemical 
substances often have either significant release or human exposure 
scenarios that would stimulate EPA interest and support an EPA decision 
to require testing or to require notification before additional 
exposures occur. EPA is proposing to regulate 45 HPV chemical 
substances with either a test rule or a SNUR. EPA is proposing a test 
rule under TSCA section 4(a)(1)(B) for 23 of these 45 HPV chemical 
substances and a SNUR under TSCA section 5(a)(2) for the other 22 HPV 
chemical substances (see Tables A. and B. in Unit III.).
    These 45 HPV chemical substances are among the chemical substances 
that were included in EPA's HPV Challenge Program (hereafter HPV 
Challenge) initiated in 1998. Of the 2,782 chemical substances 
originally included in the HPV Challenge, 1,858 were officially 
sponsored either directly in the HPV Challenge or indirectly through 
international efforts, although 5 were later withdrawn. Another 416 of 
the 2,782 chemical substances were removed from the scope of the HPV 
Challenge for a variety of reasons (e.g., polymers, inorganics, etc.). 
The remaining 508 of the 2,782 chemical substances were termed 
``orphans'' because they were not sponsored and there were no other 
factors that removed the chemical substances from the scope of the HPV 
Challenge. Of the 508 orphans, 405 are no longer produced at HPV 
levels. Of the remaining 103 chemical substances, 63 have been included 
in one of three test rules, or EPA has otherwise received data adequate 
to meet its needs. The remaining 40, plus the 5 chemical substances 
whose HPV Challenge sponsorships were withdrawn, are the subject of 
this proposed test rule and SNUR. For more information on the HPV 
Challenge go to http://www.epa.gov/hpv/ or see the Federal Register of 
March 16, 2008 (71 FR 13708) (FRL-7335-2). This action contains the 
fourth and final test rule in the series and includes the last 
unsponsored/orphan chemical substances in the HPV Challenge.
    The data that EPA seeks through the HPV Challenge is the Screening 
Information Data Set (SIDS) developed by the Organisation for Economic 
Co-operation and Development (OECD), of which the United States is a 
member. SIDS consists of tests for six endpoints (Ref. 1), including 
acute toxicity, repeated dose toxicity, developmental and reproductive 
toxicity, genetic toxicity, ecotoxicity, and environmental fate. The 
six SIDS endpoints provide a minimum, internationally-agreed-upon set 
of test data for screening HPV chemical substances for human and 
environmental hazards, and assist EPA and others in making an informed, 
preliminary judgment about the hazards of HPV chemical substances.

B. What is the agency's authority for taking these actions?

    1. Test rule. EPA is proposing this test rule under TSCA section 
4(a)(1)(B) which directs EPA to require by rule that manufacturers and/
or processors of chemical substances and mixtures conduct testing, if 
the EPA Administrator finds that:
    i. A chemical substance or mixture is or will be produced in 
substantial quantities, and (1) it enters or may reasonably be 
anticipated to enter the environment in substantial quantities or (2) 
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

[[Page 65582]]

substance or mixture or of any combination of such activities on health 
or the environment can reasonably be determined or predicted.
    iii. Testing of such substance or mixture with respect to such 
effects is necessary to develop such data.
    2. SNUR. Section 5(a)(2) of TSCA authorizes EPA to determine that a 
use of a chemical substance is a ``significant new use.'' EPA must make 
this determination by rule after considering all relevant factors, 
including those listed in TSCA section 5(a)(2). Once EPA determines 
that a use of a chemical substance is a significant new use, TSCA 
section 5(a)(1)(B) requires persons to submit a SNUN to EPA at least 90 
days before they manufacture, import, or process the chemical substance 
for that use.

C. Applicability of General Provisions

    1. Test rule. General provisions for test rules appear under 40 CFR 
part 790 (subparts A, B, C, and E), 40 CFR part 791, 40 CFR part 792, 
and 40 CFR part 799 (subpart A). 40 CFR part 790, subpart A, describes 
the scope, purpose, and authority for test rules and consent 
agreements, provisions for submitting information to the Agency, and 
the treatment of confidential business information. 40 CFR part 790, 
subpart B covers the procedures for developing consent agreements and 
test rules. 40 CFR part 790, subpart C covers the implementation, 
enforcement, and modification of test rules. This subpart includes 
information about persons subject to testing and required to submit 
letters-of-intent to conduct testing and persons who must submit 
testing exemption applications, and includes information about the 
submission of study plans and how to modify test standards and 
schedules if necessary. Subpart E of 40 CFR part 790 provides detailed 
information about exemptions from test rules. 40 CFR parts 791 and 792 
respectively cover provisions for data reimbursement and required good 
laboratory practice standards. 40 CFR part 799, subpart A, provides 
additional information on the scope and purpose of the rule, the 
applicability of the rule, submitting information, test standards, the 
availability of test guidelines, distinguishing positive and negative 
results, the effects of non-compliance, chemicals for which the testing 
reimbursement period has passed, and imports and exports.
    Persons who export or intend to export a chemical substance 
identified in a final test rule are subject to the export notification 
provisions of TSCA section 12(b). Regulations that interpret TSCA 
section 12(b) appear at 40 CFR part 707, subpart D, notices of export 
under section 12(b).
    2. SNUR. General provisions for SNURs appear under 40 CFR part 721, 
subpart A. These provisions describe persons subject to the rule, 
recordkeeping requirements, exemptions to reporting requirements, and 
applicability of the rule to uses occurring before the effective date 
of the final rule. Provisions relating to user fees appear at 40 CFR 
part 700. According to 40 CFR 721.1(c), persons subject to SNURs must 
comply with the same notice requirements and EPA regulatory procedures 
as submitters of Premanufacture Notices (PMNs) under TSCA section 
5(a)(1)(A). In particular, these requirements include the information 
submission requirements of TSCA section 5(b) and 5(d)(1), the 
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and 
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a 
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6 
or 7 to control the activities on which it has received the SNUN. If 
EPA does not take action, EPA is required under TSCA section 5(g) to 
explain in the Federal Register its reasons for not taking action.

D. What is the agency's ``B Policy''?

    TSCA section 2(b) states that it is the policy of the United States 
that: (1) 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 and those who process such chemical substances and 
mixtures; (2) adequate authority should exist to regulate chemical 
substances and mixtures which present an unreasonable risk of injury to 
health or the environment and to take action with respect to chemical 
substances and mixtures which are imminent hazards; and (3) authority 
over chemical substances and mixtures should be exercised in such a 
manner as not to impede unduly or create unnecessary economic barriers 
to technological innovation while fulfilling the primary purpose of 
this Act to assure that such innovation and commerce in such chemical 
substances and mixtures do not present an unreasonable risk of injury 
to health or the environment (15 U.S.C. 2601(b)(1)).
    TSCA section 4(a)(1)(B) authorizes and requires EPA to issue a test 
rule for a chemical substance if EPA finds, among other things, that 
the chemical substance ``is or will be produced in substantial 
quantities'' and either ``enters or may reasonably be anticipated to 
enter the environment in substantial quantities'' or ``there is or may 
be significant or substantial human exposure.''
    TSCA, however, does not say what is ``significant'' or 
``substantial'' under TSCA section (4)(a)(1)(B). EPA, therefore, 
published a policy, known as the ``B Policy,'' in 1993 (Ref. 2) for 
aiding in the determination of when production or environmental release 
is substantial or when human exposure is either significant or 
substantial for the purpose of issuing a test rule under TSCA section 
(4)(a)(1)(B). Under the ``B Policy,'' ``produced in substantial 
quantities'' generally means manufactured or imported in one million 
pounds or more per year; a ``substantial environmental release'' is 
generally either one million pounds per year or ten percent of total 
manufactured and imported volume, whichever is less; and ``substantial 
human exposure'' is generally 100,000 or more people in the general 
population, or 10,000 or more consumers, or 1,000 or more workers.

E. Why is the agency proposing both a test rule and a SNUR?

    EPA is proposing these two actions together because the Agency 
believes the actions are complementary and will best ensure these HPV 
chemicals are adequately evaluated by the Agency. For example, if EPA 
receives comments on this proposal sufficient to establish that one of 
the 23 chemical substances proposed to be regulated under the test rule 
is not used in a way that meets the substantial exposure criteria, but 
information received indicates that the chemical substance meets the 
criteria for the SNUR, EPA intends to include the chemical substance in 
the final SNUR rather than the test rule, without further public notice 
and comment. Simply removing such a chemical substance from the test 
rule in such circumstances, without including it in the SNUR, would not 
provide a regulatory mechanism for timely notification to EPA in the 
event of changed circumstances that would likely justify the issuance 
of a test rule for the chemical substance. Further, if public comment 
on these proposed actions is sufficient to establish that any of the 
uses to be covered for the 22 chemical substances proposed in the SNUR 
are, in fact, on-going, yet such comments also establish that there is 
already substantial exposure to the chemical substance, EPA intends to 
review the status of the chemical substance and, as warranted, take 
appropriate steps to promulgate a test rule rather than a SNUR for the

[[Page 65583]]

chemical substance. Unit IV. of this document details the proposed 
findings to issue a test rule for the 23 chemical substances listed in 
Table A. and provides additional discussion pertaining to whether the 
promulgation of a test rule for 22 chemical substances listed in Table 
B. may be warranted. Unit V. of this document details the proposed 
findings to issue a SNUR for the 22 chemical substances listed in Table 
B. and the basis to issue a SNUR for the 23 chemical substances listed 
in Table A. in the event that public comments provide additional data 
establishing that, for one or more of such chemical substances, there 
is no ongoing use in a consumer product and no ongoing use reasonably 
likely to expose 1,000 or more workers.

F. What are some future considerations?

    One of EPA's top priorities is to assure the safety of chemical 
substances in commerce. Under TSCA, EPA has a primary mission to 
identify and, where appropriate, control unreasonable risks of 
manufacturing, processing, distribution in commerce, use, and disposal 
of chemical substances. It is essential that chemical substance review 
be supported by information sufficient to allow informed decision 
making and that information and decisions are of high quality and are 
widely understandable. As such, EPA continues to collect information 
from existing sources, to request new and better information where it 
is determined to be needed, and to make all supporting information 
publicly available, to the extent permitted under TSCA section 14 and 
40 CFR part 2. Open access to information allows individuals, 
communities, businesses, and governments to make informed decisions and 
policies that incorporate environmental and health considerations and 
minimize external and/or unintended harmful impacts. Therefore, EPA 
intends to continue to focus on filling data needs on priority chemical 
substances, including high production volume chemical substances. EPA 
is interested in stakeholder input on a number of issues described in 
this section. Some specific issues EPA has identified to date follow.
    1. Coordination of simultaneous test rule and SNUR proposals. In 
this action, EPA is simultaneously proposing a test rule and SNUR to 
regulate two sets of chemical substances. EPA believes that this is an 
efficient way to require submission of test data on chemical substances 
that meet all of the necessary test rule criteria and (for the latter 
group of chemical substances) to require submission of advance 
notification to EPA of use in a consumer product or of any use, or 
combination of uses, that is reasonably likely to expose 1,000 or more 
workers. With respect to chemical substances that meet some, but 
potentially not all test rule criteria, the SNUR also facilitates 
efficiency by mitigating the need for EPA to continually reevaluate 
each HPV chemical substance to determine whether exposure potential has 
changed. EPA is considering issuing further coordinated proposals of 
test rules and SNURs. This would occur in conjunction with future 
Inventory Update Reporting (IUR) rule data releases, covering all 
newly-HPV chemical substances. EPA requests comment on this approach. 
In September 2011, the IUR was renamed Chemical Data Reporting (CDR) 
and moved from 40 CFR part 710 subpart C to 40 CFR part 711 (76 FR 
50816, August 16, 2011) (FRL-8872-9). For more information on this 
change go to http://www.epa.gov/cdr.
    2. Minimum data set. For more than 15 years, EPA has used OECD's 
SIDS to facilitate and standardize the screening of the relatively 
large number of HPV chemical substances on the TSCA Inventory. EPA 
requests comment on whether SIDS continues to be the most appropriate 
data set to screen chemical substances for potential environmental and 
health hazards. Are additional or different tests also appropriate? 
Should EPA consider having more than one screening data set depending 
on the nature of exposures (e.g., a different set of tests for 
children's exposures or environmental releases)?
    3. Computational toxicology. The U.S. National Academy of Sciences 
National Research Council in their 2007 report ``Toxicity Testing in 
the 21st Century: A Vision and a Strategy'' (Ref. 3) encouraged 
``work[ing] towards a transition to new integrative and predictive 
molecular and computational techniques to enhance efficiency and 
accuracy and to reduce reliance on animal testing.'' EPA requests 
suggestions on practical, implementable ways to work toward this goal 
in its actions under TSCA. Should tools such as ToxCast (at http://www.epa.gov/comptox/toxcast) (Ref. 4) be used to prioritize chemical 
substances and support hazard findings for testing?

III. Chemical Substances Subject to This Action

    The 45 chemical substances included in this action are the 
remaining unsponsored/orphan chemical substances, which have not 
previously been subject to test rules or other HPV Challenge-related 
follow-up actions. EPA is proposing to issue a test rule under TSCA 
section 4(a)(1)(B) for the 23 chemical substances listed in Table A. in 
this unit and proposing to establish a SNUR under TSCA section 5(a)(2) 
for the other 22 chemical substances (see Table B. in this unit). 
Respecting the 23 chemical substances proposed for a section 4(a)(1)(B) 
test rule (i.e., those in Table A.), in the event that public comments 
provide additional data respecting any of these chemical substances, 
establishing that there is no ongoing use in a consumer product and no 
ongoing use reasonably likely to expose 1,000 or more workers for any 
such substance, EPA intends to finalize a SNUR for each such chemical 
substance. Finally, with respect to the 22 chemical substances proposed 
for a SNUR (i.e., those in Table B.), in the event that public comments 
provide additional data establishing that there is already substantial 
exposure to the chemical substance, EPA intends to review the status of 
the chemical substance and, as warranted, take appropriate steps to 
promulgate a section 4(a)(1)(B) test rule for the chemical substance. 
For each of these chemical substances, Tables A. and B. provide the 
Chemical Abstract (CA) Index Name, Chemical Abstract Service (CAS) 
Registry Number (CASRN), and 2006 IUR information on production volume, 
number of workers exposed, and commercial/consumer uses. Substantial 
worker exposure is deduced from the number of workers reported. 
Substantial consumer exposure is deduced from production volume and 
consumer uses if production volume exceeds one million pounds per year 
and consumer uses are indicated, it is likely that consumer exposure 
exceeds ten thousand people.
    For each of the test rule candidate chemical substances, EPA has 
used the 2006 IUR information to preliminarily determine that the 
chemical substance is produced in substantial quantities and that there 
is substantial human exposure. For each of the significant new use 
(SNU) candidates, EPA has considered the 2006 IUR information in 
determining the proposed SNU designations. These findings are discussed 
further in Unit IV.A.1., Unit V.A., and Ref. 5.

[[Page 65584]]

            Table A--Chemical Substances for Which a Test Rule Is Proposed and for Which a SNUR Is Being Considered as an Alternative Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Chemical  substance                        Chemical substance
                                              2006 IUR production                           meets the  ``B     Commercial/Consumer     meets the  ``B
        CASRN              CA Index name       volume  (million     2006 IUR number of    finding'' criteria    uses indicated in    finding''  criteria
                                                     lbs.)            workers exposed     of >=1,000 workers         2006 IUR            of >=10,000
                                                                                                exposed                               consumers exposed
--------------------------------------------------------------------------------------------------------------------------------------------------------
56-40-6..............  Glycine.............  1 consumer      meets the ``B
        CASRN                CA Index name         production volume  2006 IUR number of  finding'' criteria    uses indicated in    finding'' criteria
                                                    (million lbs.)      workers exposed       of >= 1,000           2006 IUR            of >= 10,000
                                                                                            workers exposed                           consumers exposed
--------------------------------------------------------------------------------------------------------------------------------------------------------
98-16-8..............  Benzenamine, 3-            1 physical properties, environmental fate, ecotoxicity and human 
health effects, 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. 1) such as: The 
Beilstein Database, Chemical Rubber Company's 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 (HPVIS) (Ref. 6). When 
appropriate, the Federal Research In Progress (FEDRIP) database was 
also searched. Any information that was obtained from these searches 
was evaluated for data acceptability using the guidelines described on 
EPA's HPV Challenge Web site (http://www.epa.gov/hpv): ``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. 1). The results of EPA's data adequacy analysis can 
be found in the HPV4 Data Adequacy Evaluations document (Ref. 7).
    Section 799.5090(j) of the proposed regulatory text lists each 
chemical substance 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. in Sec.  799.5090(j) 
of the proposed regulatory text (i.e., chemical substances in Table A.) 
are insufficient to enable EPA to reasonably determine or predict the 
human health and environmental effects resulting from manufacture, 
distribution in commerce, processing, use, and disposal of 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 may prepare a robust summary (Ref. 8) for each such study to 
facilitate EPA's review of the full study report or publication.
    Persons who believe that adequate information regarding a chemical 
substance subject to this proposed rule can be developed using a 
category or the Structure-Activity Relationships (SAR) approach are 
encouraged to submit appropriate information, along with their 
rationale substantiating 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.
    3. Is testing necessary for these chemical substances? EPA has also 
found preliminarily that testing the 23 chemical substances identified 
in Table A. is necessary to develop the needed data (TSCA section 
4(a)(1)(B)(iii)). EPA has not identified any ``additional factors'' as 
discussed in the ``B Policy'' (Ref. 2, p. 28743) to cause the Agency to 
use decision making criteria other than those described in the ``B 
Policy.'' EPA knows of no other means to generate the SIDS data other 
than the testing proposed in this document, and therefore has 
preliminarily found that conducting the needed SIDS testing identified 
for the 23 chemical substances in Table A. 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.

B. What is the basis to also consider chemical substances from Table B. 
for testing under section 4(a)(1)(B)?

    As an alternative to issuing a SNUR, EPA is considering requiring 
testing of one or more of the chemical substances listed in Table B. 
EPA will consider this approach based on its preliminary findings under 
TSCA section 4(a)(1)(B)(i) relating to ``substantial'' production, its 
further analysis of the factors listed under TSCA sections 4 
(a)(1)(B)(ii) and (a)(1)(B)(iii) relating to insufficient data and the 
need for testing and additional data received in public comments. If 
information received in public comments establishes that consumer uses, 
or uses that could affect 1,000 workers or more, are already ongoing, 
then that information may indicate that a SNUR is inappropriate for the 
particular chemical substance listed in Table B. The same information, 
however, may prompt EPA to conclude that a test rule is appropriate for 
such a substance, since evidence of ongoing use may also be evidence of 
substantial human exposure. If public comments provide the basis to 
conclude that there is already or may be substantial human exposure to 
one of the chemical substances in Table B., and there is a basis to 
make the other findings required under TSCA sections 4 (a)(1)(B)(ii) 
and (a)(1)(B)(iii), then EPA intends to review the status of the 
chemical substance and, as warranted, take appropriate steps to 
promulgate a test rule rather than a SNUR for the chemical substance.
    EPA has made preliminary findings that each of the chemical 
substances listed in Table B. are produced in substantial quantities 
(manufactured, including imported, in an amount equal to or greater 
than 1 million lbs. per year (Ref. 5)). These findings are based on 
information gathered in the 2006 IUR

[[Page 65587]]

rule. The 2006 data are the most recently available compilation of IUR 
(now CDR) data.

C. What testing is being proposed in this action and is also being 
considered for chemical substances in Table B.?

    EPA is proposing specific testing and reporting requirements for 
the chemical substances from Table A. (specified in Sec.  
[emsp14]799.5090(j) of the proposed regulatory text) and is also 
considering the same requirements with respect to the chemical 
substances listed in Table B. All of the proposed testing requirements 
are listed in Table 2. in Sec.  799.5090(j) of the proposed regulatory 
text and consist of a series of test methods covering many of the 
endpoints in the OECD HPV SIDS testing battery.
    EPA's TSCA 799 test guidelines (40 CFR part 799, subparts E and H) 
have been harmonized with the OECD test guidelines. However, EPA is 
specifying that the American Society for Testing and Materials 
International (ASTM International) or the TSCA 799 test guidelines be 
used rather than OECD test guidelines because the language in the ASTM 
International standards and the TSCA 799 test guidelines makes clear 
which steps are mandatory and which steps are only recommended. 
Accordingly, to comply with the testing being proposed, EPA is 
proposing that testing must be conducted in accordance with ASTM 
International or TSCA 799 test guidelines. Note: ASTM issues its test 
methods under a fixed designation (e.g., E1719); the number immediately 
following the designation indicates the year of original adoption or, 
in the case of revision, the year of last revision. A number in 
parentheses indicates the year of last re-approval. A superscript 
epsilon (e) indicates an editorial change since the last revision or 
re-approval. 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 test standards are included in this proposed 
test rule.
    1. Physical/chemical properties. Melting Point: ASTM E 324-99 
(capillary tube) (Refs. 9 and 10).
    Boiling Point: ASTM E 1719-05 (ebulliometry) (Ref. 11). Vapor 
Pressure: ASTM E 1782-08 (thermal analysis) (Ref. 12). n-Octanol/Water 
Partition Coefficient: Method A (40 CFR 799.6755--shake flask); Method 
B (ASTM E 1147-92(2005)--liquid chromatography) (Ref. 13); Method C (40 
CFR 799.6756--generator column).
    Water Solubility: Method A (ASTM E 1148-02--shake flask) (Ref. 14); 
Method B (40 CFR 799.6784--shake flask); Method C (40 CFR 799.6784--
column elution); Method D (40 CFR 799.6786--generator column).
    For those chemical substances needing melting points 
determinations, EPA is proposing that melting points be determined 
according to ASTM method E 324-99. Although ASTM International 
indicates on its Web site, http://www.astm.org/DATABASE.CART/WITHDRAWN/E324.htm, that ASTM E 324-99 has been withdrawn, ASTM International's 
withdrawal of the method means only that ASTM International no longer 
continues to develop and improve the method. It does not mean that ASTM 
International no longer considers the method to be valid. ASTM 
International has explained that ASTM E 324-99 was withdrawn because:

    The standard utilizes old, well-developed technology; it is 
highly unlikely that any additional [changes] and/or modifications 
will ever be pursued by the E15 [committee]. The time and effort 
needed to maintain these documents detract from the time available 
to develop new standards which use modern technology (Ref. 15).

    ASTM International still makes the method available for 
informational purposes and it can still be purchased from ASTM 
International at the address listed in Sec.  799.5090(h) of the 
proposed regulatory text.
    EPA concludes that ASTM International's withdrawal of ASTM E 324-99 
does not have negative implications on the validity of the method, and 
EPA is proposing that melting points be determined according to ASTM E 
324-99.
    For those chemical substances that are liquid at room temperature, 
EPA is proposing a measured freezing point to meet the obligation to 
report the melting point. Since ASTM E 324-99 (capillary tube) does not 
specifically include instructions for determining freezing point, EPA 
is instead proposing to require, for substances which are liquid at 
room temperature, OECD 102 (melting point/melting range), which 
includes guidance for determining freezing point (Ref. 10).
    For the ``n-Octanol/Water Partition Coefficient (log 10 basis)'' 
and water solubility endpoints, EPA is proposing that certain ``special 
conditions'' be considered by test sponsors in determining the 
appropriate test method that would be used from among those included 
for these endpoints in Table C. of this unit and in Table 3. in Sec.  
799.5090(j) of the proposed regulatory text.
    For the ``n-Octanol/Water Partition Coefficient (log 10 basis)'' 
endpoint, also known as log Kow, EPA proposes that an 
appropriate selection be made from among three alternative methods for 
measuring the chemical substance's n-Octanol/Water Partition 
Coefficient (log 10 basis; ``log Kow''). Prior to 
determining the appropriate standard to use, if any, to measure the n-
Octanol/Water Partition Coefficient, EPA is recommending that the log 
Kow be quantitatively estimated. EPA recommends that the 
method described in ``Atom/Fragment Contribution Method for Estimating 
Octanol-Water Partition Coefficients'' (Ref. 16) be used in making such 
estimation. EPA is proposing that test sponsors must submit with the 
final study report the underlying rationale for the test standard 
selected for this endpoint. EPA is proposing this approach recognizing 
that, depending on the chemical substance's log Kow, one or 
more test methods may provide adequate information for determining the 
log Kow, but that in some instances one particular test 
method may be more appropriate. In general, EPA believes that the more 
hydrophobic a subject chemical substance is, the less well Method A (40 
CFR 799.6755--shake flask) will work and Method B (ASTM E 1147-
92(2005)) and Method C (40 CFR 799.6756--generator column) become more 
suitable, especially Method C. The proposed test methodologies have 
been developed to meet a wide variety of needs and, as such, are silent 
on experimental conditions related to pH. Therefore, EPA highly 
recommends that all required n-Octanol/Water Partition Coefficient 
tests be conducted at pH 7 to ensure environmental relevance.'' Table 
C. of this unit shows the proposed test standards and log 
Kow ranges that would determine which tests must be 
conducted for this endpoint.

[[Page 65588]]

Table C--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 10   coefficient or log
                               basis) or log Kow:    Kow:
                              The appropriate log      Which method is
                               Kow test, if any,        required, if
                               would be selected        any, is
                               from those listed        determined by
                               in this column--see      the test
                               special conditions       substance's
                               in the adjacent          estimated log
                               column.                  Kow as follows:
                              Method A: 40 CFR      log Kow  1-4:
                               (liquid               Method A or B or C.
                               chromatography).     log Kow range > 4-6:
                              Method C: 40 CFR       Method B or C.
                               799.6756 (generator  log Kow > 6: Method
                               column).              C.
                                                    Test sponsors must
                                                     provide in the
                                                     final study report
                                                     the underlying
                                                     rationale for the
                                                     method and pH
                                                     selected. In order
                                                     to ensure
                                                     environmental
                                                     relevance, EPA
                                                     highly recommends
                                                     that the selected
                                                     study be conducted
                                                     at pH 7.
------------------------------------------------------------------------

    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. 17). 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 D. 
of this unit.

      Table D--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 determined
                               water solubility      by the test
                               would be selected     substance's
                               from those listed     estimated water
                               in this column--see   solubility. Test
                               special conditions    sponsors must
                               in the adjacent       provide in the
                               column                final study report
                              Method A: ASTM E       the underlying
                               1148-02 (Re-          rationale for the
                               approved 2008)        method and pH
                               (shake flask).        selected. In order
                              Method B: 40 CFR       to ensure
                               799.6784 (shake       environmental
                               flask).               relevance, EPA
                              Method C: 40 CFR       highly recommends
                               799.6784 (column      that the selected
                               elution).             study be conducted
                              Method D: 40 CFR       starting at pH 7.
                               799.6786 (generator  > 5,000 milligrams/
                               column).              liters (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.
                                                    L: No
                                                     testing required.
------------------------------------------------------------------------

    2. Environmental fate and pathways. Ready Biodegradation: Method 
A--ASTM E 1720-01(Reapproved 2008) (Sealed vessel CO2 
production test) (Ref. 18); Method B--International Organization for 
Standardization (ISO) 14593 (CO2 headspace test) (Ref. 19); 
Method C-- ISO 7827 (Method by analysis of dissolved organic carbon 
(DOC)) (Ref. 20); Method D--ISO 9408 (Determination of oxygen demand in 
a closed respirometer) (Ref. 21); Method E--ISO 9439 (Carbon dioxide 
evolution test) (Ref. 22); Method F--ISO 10707 (Closed bottle test) 
(Ref. 23); Method G--ISO 10708 (Two-phase closed bottle test) (Ref. 
24).
    For the ``Ready Biodegradation'' endpoint, EPA proposes an 
appropriate selection be made from among seven alternative methods for 
measuring the chemical substance's ready biodegradability. For most 
test substances, EPA considers Method A (ASTM E 1720-01) and Method B 
(ISO 14593) to be generally applicable, cost effective, and widely 
accepted internationally. However, any test method used will depend on 
the physical and chemical properties of the test substance, including 
its water solubility. An additional document, ISO 10631 (Ref. 25), 
provides guidance for selection of an appropriate test method for a 
given test substance considering the substance's 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 (2007)) (Ref. 26); Acute toxicity to Daphnia (ASTM E 729-
96(2007)) (Ref. 26); and Toxicity to plants (algae) (ASTM E 1218-04e1) 
(Ref. 27). Test

[[Page 65589]]

Group 2: Chronic toxicity to Daphnia (ASTM E 1193-97 (2004)) (Ref. 28); 
and Toxicity to plants (algae) (ASTM E 1218-04e1) (Ref. 27).
    For the ``Aquatic Toxicity'' endpoint, the OECD HPV SIDS Program 
recognizes that, for certain chemical substances, acute toxicity 
studies are of limited value in assessing the chemical substance's 
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 chemical substances to reach steady state or toxic concentrations 
in the test organism. For such situations, the OECD HPV SIDS Program 
recommends use of chronic toxicity testing in Daphnia in place of acute 
toxicity testing in fish and Daphnia. EPA is proposing that the aquatic 
toxicity testing requirement be determined based on the test chemical 
substance's measured log Kow as determined by using the 
approach outlined in this unit in the discussion of ``n-Octanol/Water 
Coefficient,'' and in Table 3. in Sec.  799.5090(j) of the proposed 
regulatory text. For test chemical 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.  [emsp14]799.5090(j) 
of the proposed regulatory text) are proposed: Acute toxicity to fish 
(ASTM E 729-96 (2007)); Acute toxicity to Daphnia (ASTM E 729-96 
(2007)); and Toxicity to plants (algae) (ASTM E 1218-04e1). For test 
chemical 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.  [emsp14]799.5090(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 Unit IV.C.3. and in Sec.  
[emsp14]799.5090(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. 17, 29, and 30). A 
chemical substance with a fish BCF value of 1,000 or more is 
characterized as having a tendency to accumulate in living organisms 
relative to the concentration of the chemical substance in the 
surrounding environment (Ref. 30). For the purposes of this proposed 
rule, EPA's use of a log Kow equal to or greater than 4.2 
(which corresponds with a fish BCF value of 1,000) is consistent with 
the approach taken in the Agency's Final Policy Statement under TSCA 
section 5 entitled ``Category for Persistent, Bioaccumulative, and 
Toxic New Chemical Substances'' (Ref. 31). EPA has also used a measured 
BCF that is equal to or greater than 1,000 or, in the absence of 
bioconcentration data, a log P [same as log Kow] value equal 
to or greater than 4.3 to help define the potential of a new chemical 
substance to cause significant adverse environmental effects 
(``Significant New Use Rules; General Provisions For New Chemical 
Follow-Up'' under TSCA sections 5 and 26(c) (Ref. 32; see also 40 CFR 
721.3)). EPA considers the difference between the log Kow of 
4.3 cited in the 1989 Federal Register document (Ref. 32) and the log 
Kow value of 4.2 cited in this proposed TSCA section 4 test 
rule to be negligible.
    EPA recognizes that in some circumstances, acute aquatic toxicity 
testing (Test Group 1) may be relevant for certain chemical substances 
having a log Kow equal to or greater than 4.2. Chemical 
substances that are dispersible in water (e.g., surfactants, 
detergents, aliphatic amines, and cationic dyes) may have log 
Kow values greater than 4.2 and may still be acutely toxic 
to aquatic organisms. For any chemical substance listed in Table 3. in 
Sec.  799.5090(j) of the proposed regulatory text for which a test 
sponsor believes that an alternative to the log Kow 
threshold of 4.2 is appropriate, the test sponsor may request a 
modification of the test standard in the final rule as described in 40 
CFR 790.55. Based upon the supporting rationale provided by the test 
sponsor, EPA may allow an alternative threshold or method to be used 
for determining whether acute or chronic aquatic toxicity testing must 
be performed for a specific test substance. EPA is soliciting public 
comment on this approach as well as other alternative approaches in 
this area.
    4. Mammalian toxicity--acute. Acute Inhalation Toxicity (rat): 
Method A (40 CFR 799.9130). Acute Oral Toxicity (rat): Method B (ASTM E 
1163-98(2002) (Ref. 33) or 40 CFR 799.9110(d)(1)(i)(A)).
    For the ``Mammalian Toxicity--Acute'' endpoint, EPA is proposing 
that certain special conditions such as the chemical substance's 
physical/chemical properties or physical state be considered in 
determining the appropriate test method from among those included for 
this endpoint in Table 3. in Sec.  [emsp14]799.5090(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, EPA is proposing that, for test chemical 
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.  
799.5090(j) of the proposed regulatory text). In the case of a 
potentially explosive test chemical substance, care must be taken to 
avoid the generation of explosive concentrations. For all other 
chemical substances (i.e., those that are either liquids or solids at 
room temperature), EPA is proposing that 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.  799.5090(j) of the proposed 
regulatory text). Consistent with the voluntary HPV Challenge, 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 (Refs. 34 and 35). This test is included as a Special 
Condition in Table 3. in Sec.  [emsp14]799.5090(j) of the proposed 
regulatory text. A document developed by National Institutes of Health/
National Institute of Environmental Health Sciences (NIH/NIEHS) 
provides guidance on how to use the NRU assay to estimate a starting 
dose for an acute oral toxicity test (Ref. 36). Recent versions of the 
standardized protocols for the NRU assay are available at the NIEHS/
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM) Web site, http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm (Refs. 34, 35, and 37).
    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).

[[Page 65590]]

    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 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. 1). A 
person subject to this rule 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 in the final report a rationale for conducting that 
alternate test.
    6. Mammalian toxicity--repeated dose/reproduction/developmental. 
Combined Repeated Dose Toxicity Study with the Reproduction/
Developmental Toxicity Screening Test: 40 CFR 799.9365. Reproduction/
Developmental Toxicity Screening Test: 40 CFR 799.9355. Repeated Dose 
28-Day Oral Toxicity Study: 40 CFR 799.9305.
    For the ``Mammalian Toxicity--Repeated Dose/Reproduction/
Developmental'' endpoint, EPA recommends the use of the Combined 
Repeated Dose Toxicity Study with the Reproduction/Developmental 
Toxicity Screening Test (40 CFR 799.9365) as the test of choice. EPA 
recognizes, however, that there may be reasons to test a particular 
chemical substance using both the Reproduction/Developmental Toxicity 
Screening Test (40 CFR 799.9355) and the Repeated Dose 28-Day Oral 
Toxicity Study (40 CFR 799.9305) instead of the Combined Repeated Dose 
Toxicity Study with the Reproduction/Developmental Toxicity Screening 
Test (40 CFR 799.9365). With regard to such cases, EPA is proposing 
that a person subject to this rule, 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 in the final study reports a rationale for 
conducting these alternate tests.
    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 (Ref. 38). 
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 guidance document (Ref. 38). 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 rule.

D. When would any testing imposed by this proposed rule begin?

    The testing requirements contained in this proposed rule are not 
effective until and unless the Agency issues a final test rule. Based 
on the effective date of the final test 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 in Sec.  799.5090(i) of the proposed regulatory text.

E. How would the studies proposed under this test rule be conducted?

    Persons required to comply with the final rule would have to 
conduct the necessary testing in accordance with the testing and 
reporting requirements established in the regulatory text of the final 
rule, with 40 CFR part 790--Procedures Governing Testing Consent 
Agreements and Test Rules (except for paragraphs (a), (d), (e), and (f) 
of Sec.  [emsp14]790.45; Sec.  790.48; paragraph (a)(2) and paragraph 
(b) of Sec.  [emsp14]790.80; paragraph (e)(1) of Sec.  790.82; and 
Sec.  790.85), and with 40 CFR part 792--Good Laboratory Practice 
Standards.

F. What forms of chemical substances would be tested under this rule?

    EPA is proposing two distinct approaches for identifying the 
specific chemical substances that would be tested under a final rule 
originating from this proposed rule, the application of which would 
depend on whether the chemical substance is considered to be a ``Class 
1'' or a ``Class 2'' chemical substance. First introduced when EPA 
compiled the TSCA Chemical Substance Inventory, the term Class 1 
chemical substance refers to a chemical substance having a chemical 
composition that consists of a single chemical species (not including 
impurities) that can be represented by a specific, complete structure 
diagram. By contrast, a Class 2 chemical substance has 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.  [emsp14]799.5090(j) of the proposed regulatory text identifies 
the listed chemical substances as either Class 1 or Class 2 chemical 
substances.
    EPA is proposing that, for the Class 1 chemical substances that are 
listed in this proposed rule, the test chemical substance have a purity 
of 99% or greater. EPA has generally applied this standard of purity to 
the testing of Class 1 chemical substances in the past under TSCA 
section 4(a) testing actions, except for chemical substances where it 
has been shown that such purity is unattainable. EPA is soliciting 
comment on whether a purity level of 99% or greater cannot be attained 
for any of the Class 1 chemical substances listed in this proposed 
rule. For the Class 2 chemical substances that are listed in this 
proposed rule, EPA is proposing that the test chemical substance be any 
representative form of the chemical substance, to be defined by the 
test sponsor(s).
    EPA solicits comment on the proposed alternative approach to the 
testing of Class 2 chemical substances included in this proposed rule.

G. Who would be required to test under this rule?

    1. Would I be subject to this rule? If this proposed rule becomes 
final, you would be subject to the final rule and may be required to 
test if you manufacture (which is defined by statute to include import) 
or process, or intend to manufacture or process, one or more chemical 
substances listed in this

[[Page 65591]]

proposed rule during the time period described in this unit. However, 
if you do not know or cannot reasonably ascertain that you manufacture 
or process a listed test rule chemical substance (based on all 
information in your possession or control, as well as all information 
that a reasonable person similarly situated might be expected to 
possess, control, or know, or could obtain without unreasonable 
burden), you would not be subject to the rule for that listed chemical 
substance.
    2. When would my manufacture or processing (or my intent to do so) 
cause me to be subject to this rule? You would be subject to this rule 
if you manufacture or process, or intend to manufacture or process, a 
chemical substance listed in the rule at any time from the effective 
date of the final test rule to the end of the test data reimbursement 
period. The term ``reimbursement period'' is defined at 40 CFR 791.3(h) 
and may vary in length for each substance to be tested under a final 
TSCA section 4(a) test rule, depending on what testing is required and 
when testing is completed.
    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. Addresses of 
the EPA Document Control Office where this information should be sent 
are found in this document under ADDRESSES.
    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). 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.
    4. 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 E. of this unit describes who is in Tier 1 
and Tier 2.

         Table E--Persons Subject to the Rule: 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 chemical        or intend to manufacture a
 substance, and who are not listed        test rule chemical substance
 under Tier 2.                            solely as one or more of the
                                          following:
                                            --As a byproduct (as defined
                                             at 40 CFR 791.3(c));
                                            --As an impurity (as defined
                                             at 40 CFR 790.3);
                                            --As a naturally occurring
                                             chemical substance (as
                                             defined at 40 CFR
                                             710.4(b));
                                            --As a non-isolated
                                             intermediate (as defined at
                                             40 CFR 704.3);
                                            --As a component of a Class
                                             2 substance (as described
                                             at 40 CFR 720.45(a)(1)(i));
                                            --In amounts of less than
                                             500 kilograms (kg) (1,100
                                             lbs.) annually (as
                                             described at 40 CFR
                                             790.42(a)(4)); or
                                            --In small quantities solely
                                             for research and
                                             development (R & 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 for specific test 
rules that differ from the generic procedures governing TSCA section 
4(a) test rules in 40 CFR part 790. For purposes of this proposed rule, 
EPA is proposing to establish certain requirements that differ from 
those under 40 CFR part 790.
    In this proposed test rule, EPA has configured the tiers in 40 CFR 
790.42 as in previous HPV test rules (Refs. 39, 40, and 41). In 
addition to processors, manufacturers of less than 500 kg (1,100 lbs.) 
per year (``small-volume manufacturers''), and manufacturers of small 
quantities for research and development (``R&D manufacturers''), EPA 
has added the following persons to Tier 2: Byproduct manufacturers, 
impurity manufacturers, manufacturers of naturally occurring chemical 
substances, manufacturers of non-isolated intermediates, and 
manufacturers of components of Class 2 chemical substances. The Agency 
took administrative burden and complexity into account in determining 
who was to be in Tier 1 in this proposed rule. EPA believes that those 
persons in Tier 1 who would conduct testing under this proposed rule, 
when finalized, would generally be large manufacturers of chemical 
substances who, in the experience of the Agency, have traditionally 
conducted testing or participated in testing consortia under previous 
TSCA section 4(a) test rules.
    The Agency also believes that byproduct manufacturers, impurity 
manufacturers, manufacturers of naturally occurring chemical 
substances, manufacturers of non-isolated intermediates, and 
manufacturers of components of Class 2 chemical substances historically 
have not themselves participated in testing or contributed to 
reimbursement of those persons who have conducted testing. EPA 
understands that these manufacturers may include persons for 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.
    TSCA section 4(b)(3)(B) requires all manufacturers and/or 
processors of a

[[Page 65592]]

chemical substance to test that chemical substance if EPA has made 
findings under TSCA sections 4(a)(1)(A)(ii) or (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 Sec.  [emsp14]799.5090(b)(2) of the 
proposed regulatory text.
    5. Who is in the Tier 2 subdivisions? The Agency is proposing to 
prioritize which persons in Tier 2 would be required to perform 
testing, if needed. Specifically, the Agency is proposing that Tier 2 
entities be subdivided into:
    i. Tier 2A--manufacturers, i.e., those who manufacture, or intend 
to manufacture, a test rule chemical substance solely as one or more of 
the following: A byproduct, an impurity, a naturally occurring chemical 
substance, a non-isolated intermediate, a component of a Class 2 
chemical substance, in amounts less than 1,100 lbs. annually, or in 
small quantities solely for research and development.
    ii. Tier 2B--processors, i.e., those who process, or intend to 
process, a test rule chemical substance (in any form). The terms 
``process'' and ``processor'' are defined by TSCA sections 3(10) and 
3(11), respectively.
    If the Agency needs testing from persons in Tier 2, EPA would seek 
testing from persons in Tier 2A before proceeding to Tier 2B. It is 
appropriate to require manufacturers in Tier 2A to submit letters of 
intent to test or exemption applications before processors are called 
upon because the Agency believes that testing costs are traditionally 
passed by manufacturers along to processors, enabling them to share in 
the costs of testing (Ref. 42). In addition, as stated by EPA in the 
Data Reimbursement rule, ``[t]here are [typically] so many processors 
[of a given test rule chemical substance] that it would be difficult to 
include them all in the technical decisions about the tests and in the 
financial decisions about how to allocate the costs'' (Ref. 43).
    6. 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)). Procedures relating to exemptions are in 40 CFR 790.80 
through 790.99, and Sec.  [emsp14]799.5090(c)(2), (c)(5), (c)(7), and 
(c)(11) of the proposed regulatory text. In this proposed rule, EPA 
would not require the submission of equivalence data (i.e., data 
demonstrating that your chemical substance is equivalent to the 
chemical substance actually being tested) as a condition for approval 
of your exemption. Therefore, 40 CFR 790.82(e)(1) and 40 CFR 790.85 
would not apply to this proposed rule.
    7. What would happen if I submitted an exemption application? 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 may 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.  799.5090(c)(8) of the proposed 
regulatory text for details on submitting this notice. In addition, the 
Agency would terminate a conditional exemption if no letter of intent 
to test has been received from persons required to comply with the 
rule. See, e.g., Sec.  799.5090(c)(6) of the proposed regulatory text. 
Note that the provisions at 40 CFR 790.48(b) have been incorporated 
into the regulatory text of this proposed rule; thus, persons subject 
to the final rule are not required to comply with 40 CFR 790.48 itself 
(see Sec.  799.5090(c)(4)-(c)(7) and Sec.  799.5090(d)(3) of the 
proposed regulatory text). Persons who obtain exemptions or receive 
them automatically would nonetheless be subject to providing 
reimbursement to persons who do actually conduct the testing, as 
described in Unit IV.G.4.
    8. 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. The obligation to 
provide reimbursement is not affected by placement in Tier 2A or Tier 
2B. Concerning testing, if you are in Tier 2, you are considered to 
have an automatic conditional exemption. You would not need to submit a 
letter of intent to test or an exemption application unless you are 
notified by EPA that you are required to do so. As previously noted, 
Tier 2A manufacturers would be notified to test before Tier 2B 
processors.
    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.  799.5090(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: i. no manufacturer in Tier 1 has notified 
EPA of its intent to conduct testing; and ii. 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.  799.5090(c)(4), (c)(5), (c)(6), and (c)(7) of the proposed 
regulatory text. 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.
    9. 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 final rule 
within 30 days after the publication of a Federal Register document 
notifying Tier 2 processors of the obligation to submit a letter of 
intent to conduct testing or to apply for an exemption from testing, 
EPA would notify all manufacturers and processors of the chemical 
substance of this fact by certified letter or by publishing a Federal 
Register document specifying the test(s) for which no letter of intent 
has been submitted. This letter or Federal Register document would 
additionally notify all manufacturers and processors that all exemption 
applications concerning the test(s) have been denied, and would give 
them an opportunity to take corrective action. If no one has notified 
EPA of its intent to conduct the required testing of the chemical 
substance within 30 days after receipt of the certified letter or 
publication of the Federal Register document, all manufacturers and 
processors subject to the final rule with respect to that chemical 
substance who are not already in violation of the final

[[Page 65593]]

rule would be in violation of the final rule.
    10. What are the reimbursement procedures? In the past, persons 
subject to test rules have independently worked out among themselves 
their respective financial contributions to those persons who have 
actually conducted the testing. However, if persons are unable to agree 
privately on reimbursement, they may take advantage of EPA's 
reimbursement procedures at 40 CFR part 791, promulgated under the 
authority of TSCA section 4(a). These procedures include: The 
opportunity for a hearing with the American Arbitration Association; 
publication by EPA of a document in the Federal Register concerning the 
request for a hearing; and the appointment of a hearing officer to 
propose an order for fair and equitable reimbursement. The hearing 
officer may base his or her proposed order on the production volume 
formula set out at 40 CFR 791.48, but is not obligated to do so. Under 
this proposed rule, amounts manufactured as impurities would be 
included in production volume (40 CFR 791.48(b)), subject to the 
discretion of the hearing officer (40 CFR 791.40(a)). The hearing 
officer's proposed order may become the Agency's final order, which is 
reviewable in Federal court (40 CFR 791.60).

H. What reporting requirements would be required under this test rule?

    For each test for each chemical substance, you would be required to 
submit a study plan 90 days after the effective date of the final rule 
and 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.  799.5090(i) of the regulatory text. Addresses 
of the EPA Document Control Office where this information should be 
sent are found in this document under ADDRESSES.

I. 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.

J. 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. 44) 
indicates that available test facilities and personnel would adequately 
accommodate the testing proposed in this rule.

K. Might EPA seek further testing of the chemical substances 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. Proposed TSCA Section 5(a)(2) SNUR and Basis To Potentially Add One 
or More Chemical Substances From Table A. to the SNUR

    EPA has preliminarily determined that each of the 45 substances 
listed in Tables A. and B. in Unit III. is produced in substantial 
quantities (>=1 million lbs./yr) and made preliminary findings that 
there may be substantial human exposure to 23 of these substances. 
However, for 22 of the 45 chemical substances, the Agency does not 
currently have exposure information that would adequately support such 
findings under TSCA section 4(a)(1)(B). For those remaining 22 chemical 
substances (i.e., Table B.), EPA is proposing to establish significant 
new use reporting and recordkeeping requirements under TSCA section 
5(a)(2) that would require EPA notification prior to worker or consumer 
exposures rising to substantial levels.

A. What are the rationale and objectives for taking this action?

    1. Rationale. Each of the chemical substances included in Table B. 
is produced in substantial quantities. EPA considered the factors set 
out in TSCA section 5(a)(2) and the longstanding use of the exposure 
thresholds in the ``B Policy'' (see Unit V.B.) to determine that 
manufacturers and processors of any of these chemical substances should 
be required to notify EPA if exposure to any of these chemical 
substances is expected to increase significantly. Accordingly, the 
significant new uses are: Any use in a consumer product, and any use or 
combination of uses that is reasonably likely to expose 1,000 or more 
workers at a single corporate entity (defined as the aggregate of all 
of the domestic facilities owned or operated by an individual 
corporation). The SNUR facilitates efficiency by mitigating the need 
for EPA to continually reevaluate each HPV chemical substance to 
determine whether exposure potential has increased so that there is or 
may be substantial human exposure. EPA recognizes, however, that the 
proposed SNU designation would not encompass every new use that could 
potentially give rise to significant or substantial human exposure.
    Consistent with EPA's past practice for issuing SNURs under TSCA 
Section 5(a)(2), EPA's decision to propose a SNUR for a particular 
chemical use need not be based on an extensive evaluation of the 
hazard, exposure, or potential risk associated with that use. Rather, 
the Agency's action is based on EPA's determination that if the use 
begins or resumes, it may present a risk that EPA should evaluate 
before the manufacturing or processing for that use begins. Since the 
new use does not currently exist, deferring a detailed consideration of 
potential risks or hazards related to that use is an effective use of 
resources. If a person decides to begin manufacturing or processing the 
chemical for the use, the notice to EPA allows EPA to evaluate the use 
according to the specific parameters and circumstances surrounding that 
intended use.
    2. Objectives. Under TSCA section 5(a)(1)(B), any person intending 
to manufacture, import, or process any of these chemical substances for 
one or more of the designated SNUs would be required to notify EPA with 
a SNUN before that activity begins. EPA would then have an opportunity 
to review and evaluate data submitted in a SNUN and, if warranted 
pursuant to TSCA sections 5(e), 5(f), 6 or 7, EPA would be able to 
regulate prospective manufacturers (which, as noted in Unit I.A., 
includes importers) or processors of the chemical substances before the 
designated SNUs of the chemical substance occurs.

B. How were the significant new uses determined?

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a SNU must be made after consideration of 
all relevant factors including:
    1. The projected volume of manufacturing and processing of a 
chemical substance.
    2. The extent to which a use changes the type or form of exposure 
of human beings or the environment to a chemical substance.

[[Page 65594]]

    3. The extent to which a use increases the magnitude and duration 
of exposure of human beings or the environment to a chemical substance.
    4. The reasonably anticipated manner and methods of manufacturing, 
processing, distribution in commerce, and disposal of a chemical 
substance.
    In addition to these factors, the statute authorizes EPA to 
consider any other relevant factors. To determine what would constitute 
a SNU of the chemical substances listed in Table B. and of the chemical 
substances listed in Table A., EPA considered the section 5(a)(2) 
factors, as well as EPA's 1993 ``B Policy'' (Ref. 2), discussed in Unit 
II.D.
    For the first section 5(a)(2) factor, production volume, EPA 
considered the fact that all 22 of the chemical substances in Table B., 
and all 23 of the chemical substances in Table A., have been produced 
in substantial amounts, i.e., volumes above one million lbs./year. EPA 
would expect that increased or expanded use of these chemical 
substances could correspond to a further increase in annual production 
volume and thereby increase exposures.
    Next, EPA considered the extent to which a use changes the type or 
form of exposure of human beings or the environment to a chemical 
substance. Current IUR information available to EPA indicates that all 
but 2 of the 22 chemical substances in Table B. are used solely for 
industrial purposes. For the remaining two chemical substances in Table 
B., EPA could find no evidence of any ongoing consumer uses. With 
respect to these 22 chemical substances (i.e., Table B.), any use in 
consumer products would likely result in new consumer exposures to 
these chemical substances. These potential new users could be exposed 
via pathways different from industrial users, and consumers may be less 
likely to use, or have access to, appropriate protective equipment 
(e.g. gloves or respirators) than industrial users. An expansion into 
use in consumer products may also include new environmental releases, 
deliberate or accidental (e.g., consumers may dispose of a chemical 
substance by pouring it down a storm drain or household sink).
    With respect to the chemical substances listed in Table A., EPA has 
information indicating that ongoing use of certain of these chemical 
substances already involves the exposure of 10,000 or more consumers. 
If public comment on this proposal is accompanied by additional 
information that contradicts the information upon which EPA has based 
its preliminary conclusions (i.e., less than 10,000 consumers are 
exposed), that information could potentially also establish that there 
are no ongoing uses of the chemical substance in consumer products. If 
EPA concludes, on the basis of public comments, that there is an 
inadequate basis to issue a test rule for the chemical substance, it 
would also conclude, as a general matter, that there is an adequate 
basis to issue a SNUR for the chemical substance. In such a case, EPA 
intends to incorporate the chemical substance into the final SNUR 
without further opportunity for public notice and comment. EPA believes 
that the commencement of consumer uses of the chemical substances in 
Table A. (if such uses are not currently ongoing) would be a SNU of the 
chemical substances. This is because potential new users could be 
exposed via pathways different from industrial users, and may be less 
likely to use appropriate protective equipment (e.g. gloves or 
respirators) than industrial users. An expansion into use in consumer 
products may also include new environmental releases (e.g., consumers 
may dispose of a chemical substance by pouring it down a storm drain or 
household sink).
    EPA also considered the extent to which a use increases the 
magnitude and duration of human or environmental exposure to a chemical 
substance. Commencement of a chemical substance's use in a consumer 
product would increase the amount and time that consumers were exposed 
to the chemical substance. In determining substantial consumer 
exposure, EPA considered the production volume and consumer uses. If 
production volume exceeds one million pounds per year and consumer uses 
are indicated, it is likely that consumer exposure exceeds the 
substantial threshold of ten thousand people as defined by the ``B 
Policy.'' EPA has reached this conclusion with respect to the chemical 
substances in Table B. and the chemical substances in Table A. (to the 
extent that use of the chemical substances in Table A. in consumer 
products is not already ongoing).
    EPA also considered how the number of workers exposed (as reported 
under the IUR rule) might change if use of a chemical substance changed 
or expanded. For example, the commencement of additional new uses may 
increase the total production volume of a chemical substance, thereby 
increasing the magnitude and duration of exposure for industrial 
workers. None of the 22 chemical substances listed in Table B. are 
known to meet the ``B Policy'' threshold for substantial worker 
exposure (>= 1,000 workers) at this time. However, if exposure were to 
increase such that 1,000 or more workers at a single corporate entity 
were reasonably likely to be exposed, EPA believes that the increased 
exposure would be a significant change. In this context, ``single 
corporate entity'' refers to the aggregate of all of the domestic 
facilities owned or operated by an individual corporation. Therefore, 
the SNUR notification requirements would be triggered 90 days before 
the sum of all potentially exposed workers at domestic facilities 
comprising the single corporate entity was expected to reach 1,000 
workers or more.
    With respect to the chemical substances listed in Table A., EPA has 
information that ongoing use of certain of these chemical substances 
already involves the exposure of 1,000 or more workers. If EPA 
concludes, on the basis of public comments, that there is no basis to 
issue a test rule for such chemical substance then it would also 
conclude, as a general matter, that there is an adequate basis to issue 
a SNUR for the chemical substance. In such a case, EPA intends to 
incorporate the chemical substance into the final SNUR without further 
opportunity for public notice and comment. Chemical substances from 
Table A., like the chemical substances from Table B., are high 
production volume chemical substances. If exposure to a Table A. 
chemical substance were to increase such that 1,000 or more workers at 
a single corporate entity were to become reasonably likely to be 
exposed, EPA believes that the increased exposure would be a 
significant change.
    With respect to the chemical substances in Tables A. and B., EPA 
also considered the reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of 
these chemical substances in determining what would be a SNU. Given the 
production volume of these chemical substances, any change in these 
methods or practices could affect human or environmental exposures, but 
the lack of available toxicity data, and of more detailed information 
about existing methods and practices, hampers EPA's ability to more 
fully consider this fourth factor.
    Finally, EPA considered the ``B Policy.'' Since 1993, EPA has used 
the production, exposure, and release benchmarks in the ``B Policy'' 
for making TSCA section 4 test rule findings. EPA has also considered 
and incorporated the production, worker, and consumer exposure 
benchmarks in the selection of chemical substances to be included and 
development of the SNUs included in today's proposed action. These 
chemical substances have already been in production at high

[[Page 65595]]

volumes, and at least some workers are exposed. EPA is proposing to 
incorporate certain ``B Policy'' exposure thresholds into its rationale 
for the proposed SNUs because they are clear numeric criteria that have 
been used to determine substantial human exposure since 1993. They have 
provided a clear threshold--well understood by EPA, industry, and other 
stakeholders--of levels of worker or consumer exposure that are 
important under TSCA. EPA is interested in receiving comment concerning 
use of the ``B Policy'' in this context.

C. What were the alternatives to proposing this SNUR?

    Before proposing this SNUR, EPA considered promulgating a TSCA 
section 8(a) reporting rule. Under a TSCA section 8(a) rule, EPA could, 
among other things, generally require persons to report information to 
the Agency when they intend to manufacture, import, or process a listed 
chemical substance for a specific use or any use. However, if EPA were 
to require reporting under TSCA section 8(a) instead of TSCA section 
5(a), EPA would not have the opportunity to assess the risk of the new 
use prior to commencement of that activity, or, if warranted, to take 
immediate follow-up regulatory action under TSCA sections 5(e) or 5(f) 
to prohibit or limit the activity before it begins.

D. What would be the applicability of the final rule to uses occurring 
before the effective date of the final rule?

    As discussed in the Federal Register of April 24, 1990 (55 FR 
17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA 
is best served by designating a use as a SNU as of the date of 
publication of the proposed rule rather than as of the effective date 
of the final rule. If uses begun after publication of the proposed rule 
were considered ongoing rather than new, it would be difficult for EPA 
to establish SNUR notice requirements, because a person could defeat 
the SNUR by initiating the proposed SNU before the rule became final, 
and then argue that the use was ongoing as of the effective date of the 
final rule. Thus, persons who, after publication of the proposed SNUR, 
begin commercial manufacture, import, or processing of the chemical 
substance(s) listed in Table B. for a use proposed in this action for a 
SNU would have to cease any such activity before the effective date of 
the rule if and when finalized. To resume their activities, these 
persons would have to comply with all applicable SNUR notice 
requirements and wait until the notice review period, including all 
extensions, expires. EPA has promulgated provisions to allow persons to 
comply with SNURs before the effective date. If a person were to meet 
the conditions of advance compliance under Sec.  721.45(h), that person 
would be considered to have met the requirements of the final SNUR for 
those activities.

E. Do test data and other information have to be submitted?

    TSCA section 5 does not require developing any particular test data 
before submission of a SNUN, except where the chemical substance is 
also subject to a test rule under TSCA section 4 (see TSCA section 
5(b)), or when a chemical substance is included on the list described 
under section 5(b)(4). Unless submission of data is required under 
section 4 or 5(b)(4), persons are required only to submit test data in 
their possession or control and to describe any other data known to or 
reasonably ascertainable by them (40 CFR 721.25). However, as a general 
matter, EPA recommends that SNUN submitters include data that would 
permit a reasoned evaluation of risks posed by the chemical substance 
during its manufacture, import, processing, use, distribution in 
commerce, or disposal. EPA encourages persons to consult with the 
Agency before submitting a SNUN. As part of this optional pre-notice 
consultation, EPA would discuss specific data it believes may be useful 
in evaluating a significant new use. SNUNs submitted for significant 
new uses without any test data may increase the likelihood that EPA 
will take action under TSCA section 5(e) to prohibit or limit 
activities associated with this chemical substance.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs that provide detailed information on:
    1. Human exposure and environmental releases that may result from 
the significant new uses of the chemical substances.
    2. Potential benefits of the chemical substances.
    3. Information on risks posed by the chemical substances compared 
to risks posed by potential substitutes.

F. How do I submit a SNUN?

    EPA recommends that submitters consult with the Agency prior to 
submitting a SNUN to discuss what data may be useful in evaluating a 
SNU. Discussions with the Agency prior to submission can afford ample 
time to conduct any tests that might be helpful in evaluating risks 
posed by the substance. According to 40 CFR 721.1(c), persons 
submitting a SNUN must comply with the same notice requirements and EPA 
regulatory procedures as persons submitting a PMN, including submission 
of test data on health and environmental effects as described in 40 CFR 
720.50. SNUNs must be submitted to EPA, on EPA Form No. 7710-25 in 
accordance with the procedures set forth in 40 CFR 721.25 and 40 CFR 
720.40.
    EPA published a final rule on January 6, 2010 (75 FR 773) (FRL-
8794-5), that established standards and requirements for the use of the 
electronic-PMN (e-PMN) software and EPA's Central Data Exchange (CDX) 
to electronically submit these notices. The Agency is introducing 
electronic reporting via CDX using the e-PMN in three phases over a 
two-year period. The effective date of the rule was April 6, 2010. 
Until April 6, 2011, submissions were permitted via CDX, optical disc, 
or paper. After April 6, 2011, paper submissions are no longer being 
accepted. After April 6, 2012, all submissions will be required to be 
submitted electronically via CDX. Regardless of the delivery method, 
EPA requires that all submissions be generated using the new e-PMN 
software. For additional information and instructions go to: http://www.epa.gov/opptintr/newchems/epmn/epmn-index.htm. Until April 6, 2012, 
SNUNs may still be mailed to the Environmental Protection Agency, OPPT 
Document Control Office (7407M), 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460-0001.

G. What are the recordkeeping requirements?

    EPA is proposing that persons subject to this proposed SNUR be 
required to maintain several records in addition to those required by 
40 CFR 721.40 (persons required to submit a SNUN must retain 
documentation of information contained in that SNUN). EPA is proposing 
to require manufacturers and processors to maintain the records 
described in 40 CFR 721.125 (a), (b), and (c) in this SNUR. Section 
721.125(a) requires records documenting manufacture and importation 
volume and dates; Sec.  721.125(b) documents volumes purchased in the 
U.S. by processors, the names and addresses of suppliers, and the dates 
of purchase; and Sec.  721.125(c) requires records documenting the 
names and addresses (including shipment destination address, if 
different) of all persons outside the site of manufacture, importation, 
or processing to whom the manufacturer, importer, or processor directly 
sells or transfers the chemical

[[Page 65596]]

substance, the date, and the quantity of each sale or transfer. These 
records would help EPA to determine compliance with the SNUR.

VI. Export Notification Requirements

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

VII. Economic Impacts

A. What would be the economic impacts of the proposed test rule?

    EPA has prepared an economic assessment entitled ``Economic 
Analysis for the Proposed High Production Volume Challenge Chemicals 
Test Rule--Fourth Group of Chemicals'' (Ref. 45), a copy of which has 
been placed in the docket for this proposed rule. This economic 
assessment evaluates the potential for significant economic impacts as 
a result of the testing that would be required by this proposed rule. 
The analysis covers 23 chemical substances. The total social cost of 
providing test data on the 23 chemical substances that were evaluated 
in this economic analysis is estimated to be $7.72 million assuming an 
average cost scenario. Total costs of compliance to industry are 
estimated at $7.65 million (Ref. 45).
    While legally subject to this test rule, processors of a subject 
chemical substance would be required to comply with the requirements of 
the final rule only if they are directed to do so by EPA as described 
in Sec.  799.5090(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 substance, the Agency assumes that, for each chemical 
substance in this proposed rule, at least one such person will submit a 
letter of intent to conduct the required testing and that person will 
conduct such testing and will submit the test data to EPA. Because 
processors would not need to comply with the proposed rule initially, 
the economic assessment does not address processors.
    Compliance costs include costs of testing and administering the 
testing, as well as reporting costs. In addition, they include the 
estimated cost of the TSCA section 12(b) export notification 
requirements, which, under the final rule, would be required for the 
first export to a particular country of a chemical substance subject to 
the final rule, estimated to range from $27.50 per notice to $86.99 per 
notice (Ref. 45). These export notification requirements (included in 
the total and annualized cost estimates) that would be triggered by the 
final rule are expected to have a negligible impact on exporters.
    The potential for adverse economic impact as a result of the rule 
is expected to be higher for smaller businesses. Smaller businesses are 
less likely to have additional revenue sources to cover the compliance 
costs. Therefore, the Agency compared the costs of compliance to 
company sales for small businesses. EPA estimates that there are 25 
small entities that would be affected by this proposed rule. Of these, 
EPA estimates that there is no small business for which the cost impact 
of the testing exceeds 1 percent of the company's revenue. EPA 
believes, on the basis of these calculations, that the proposed testing 
of the chemical substances presents a low potential for adverse 
economic impact for the majority of chemical substances.
    The benefits resulting from this proposed test rule are discussed 
qualitatively in the ``Economic Analysis for the Proposed High 
Production Volume Challenge Chemicals Test Rule-Fourth Group of 
Chemicals'' (Ref. 45). EPA believes that the net benefits of this 
proposed rule are positive, but quantification of the benefits of the 
proposed rule would require more specific information about use 
patterns and preferences than is available.

B. What would be the economic impacts of the proposed SNUR?

    1. SNUNs. EPA has evaluated the potential costs of establishing 
SNUR reporting and recordkeeping requirements for potential 
manufacturers, importers, and processors of the chemical substance 
included in this proposed rule. While most businesses are subject to a 
$2,500 user fee required by 40 CFR 700.45(b)(2)(iii), small businesses 
with an annual sales of less than $40 million when combined with those 
of the parent company (if any) are subject to a reduced user fee of 
$100 (40 CFR 700.45(b)(1)). The costs of submission of SNUNs will not 
be incurred by any company unless a company decides to pursue a SNU as 
defined in this proposed SNUR. However there are limited costs 
associated with the recordkeeping requirements required by this SNUR, 
whether or not a SNUN is submitted. Furthermore, while the expense of a 
notice and the uncertainties of possible EPA regulation may discourage 
certain innovations, that impact would be limited because such factors 
are unlikely to discourage an innovation that has high potential value. 
EPA's complete economic analysis is available in the public docket for 
this proposed rule (Ref. 46).
    2. Export notification. Under section 12(b) of TSCA and the 
implementing regulations at 40 CFR part 707, subpart D, exporters must 
notify EPA if they export or intend to export a chemical substance or 
mixture for which, among other things, a rule has been proposed or 
promulgated under TSCA section 5. For persons exporting a chemical 
substance the subject of a proposed or final SNUR, a one-time notice 
must be provided for the first export or intended export to a 
particular country. The total costs of export notification will vary by 
chemical substance, depending on the number of required notifications 
(i.e., the number of countries to which the chemical substance is 
exported). Although EPA estimates that an exporting company making 
notifications may need to prepare 12 notifications per year at a cost 
of $78.56 each, EPA is unable to make any estimate of the likely number 
of export notifications for the chemical substances covered in this 
proposed SNUR (Ref. 46).

VIII. Request for Public Comment

    EPA is interested in stakeholder input on a number of issues in 
this action as well as future actions on high production volume 
chemical substances.
    1. In this document, EPA is proposing either a test rule or SNUR to 
regulate a given set of chemical substances. EPA believes that this is 
an efficient way to require submission of test data on chemical 
substances that meet all of the necessary exposure criteria and require 
submission of a notification to EPA if

[[Page 65597]]

and when additional exposure criteria are met. The SNUR also 
facilitates efficiency by mitigating the need for EPA to continually 
reevaluate each HPV chemical substance to determine whether conditions 
have changed so as to increase potential exposure. EPA is considering 
proposing further combined test rules/SNURs in conjunction with future 
CDR data releases, covering all newly-HPV chemical substances. EPA 
requests comment on this approach.
    2. EPA is proposing to incorporate the ``B Policy'' worker exposure 
threshold into the proposed SNU designations because it is a clear, 
numeric criterion that has been used to determine substantial human 
exposure since 1993. EPA is interested in receiving comment concerning 
use of the ``B Policy'' in this context.
    3. EPA solicits comment on whether any of the chemical substances 
proposed for the SNUR are already being manufactured or processed for 
one of the significant new uses listed in Unit V., and should 
consequently be included in the test rule. Analogously, EPA solicits 
comment on whether any of the chemical substances proposed for the test 
rule are no longer used in applications that meet the substantial human 
exposure finding described in the ``B Policy'' and should consequently 
be included in the SNUR.
    4. EPA solicits comment on whether any of the chemical substances 
proposed for the test rule or the SNUR should be subject to neither a 
test rule nor a SNUR. EPA requests comment on this topic so as to 
confirm or refute the Agency's general expectation that either a SNUR 
or a test rule is warranted for each chemical substance listed in 
Tables A. and B. of Unit III. EPA's general expectation is as follows: 
If additional information indicates that a test rule is not warranted 
for a particular chemical substance listed in Table A. because 
particular uses are not ongoing, EPA generally anticipates that such 
information would indicate that a SNUR is warranted instead. 
Conversely, if additional information indicates that a SNUR is not 
warranted for a particular chemical substance listed in Table B. 
because particular uses are already ongoing, EPA generally anticipates 
that such information would indicate that a test rule is warranted 
instead.
    5. EPA solicits comment on whether there is a better alternative to 
proposing the SNUR trigger of >=1000 workers exposed at a single 
corporate entity. The test rule findings are based on >=1000 workers 
exposed at the national level. EPA asks for comment on whether there is 
an approach that would reduce the discrepancy between the corporate 
level for the SNUR and national level for the test rule.
    6. EPA solicits comment respecting relevant trends in production 
volume for the chemical substances proposed to be subject to either a 
test rule or a SNUR. EPA is especially interested in such trend 
information in the case that a commenter believes that neither a test 
rule nor a SNUR is warranted for a chemical substance because the 
chemical substance currently has an overall production volume of less 
than 1 million lbs. per year. Because production volume may vary from 
year to year, EPA does not believe that the mere fact that the most 
recent annual production volume is less than 1 million pounds would 
necessarily establish that a test rule is not warranted (and such 
information would not by itself suggest that a SNUR is unwarranted, 
since substantial production is not a required finding for SNURs). More 
detailed comments, distinguishing a long-term decline in production 
volume from a short-term dip, would be especially helpful to the Agency 
in evaluating any comments that current production volumes are too low 
to warrant the regulatory action proposed.
    7. As described in Unit IV.B., to the extent that EPA learns that 
consumer uses, or uses that could affect 1,000 workers or more, are 
already ongoing for a chemical substance listed in Table B., it intends 
to evaluate whether taking steps to promulgate a test rule for the 
chemical substance is warranted. To assist the Agency in such 
circumstances, EPA solicits comment respecting the sufficiency of the 
available data and the need for additional testing on the chemical 
substances in Table B., consistent with the standards set forth in TSCA 
sections 4 (a)(1)(B)(ii) and (a)(1)(B)(iii).
    8. The U.S. National Academy of Sciences National Research Council 
in their 2007 report ``Toxicity Testing in 21st Century: A Vision and a 
Strategy'' encouraged ``work[ing] towards a transition to new 
integrative and predictive molecular and computational techniques to 
enhance efficiency and accuracy and to reduce reliance on animal 
testing.'' EPA requests suggestions on practical, implementable ways to 
work toward this goal in its actions under TSCA. Should tools such as 
ToxCast (http://www.epa.gov/ncct/toxcast/) be used to prioritize 
chemical substances and support hazard findings for testing in the 
future?
    9. EPA solicits comments which identify existing data that may meet 
the requirements of studies under the proposed test rule. To the extent 
that data relevant to the testing specified in the 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 the 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. 8). 
To the extent that studies required under the proposed rule are 
currently available, and the data are judged sufficient by EPA, testing 
for the endpoint/chemical substance combination will not be required in 
the final test rule based on this proposed rule.
    10. Persons who believe that adequate information regarding a 
chemical substance subject to the proposed test rule can be developed 
using a category or the SAR approach are encouraged to submit 
appropriate information, along with their rationale substantiating this 
belief, during the comment period on the proposed rule.
    11. EPA solicits comment on the proposed test rule approaches for 
Class 1 and Class 2 chemical substances. Should each Class 1 chemical 
substance be tested at a purity of 99% or more? Should the proposed 
test substance purity for Class 1 chemical substances be applied to any 
Class 2 chemical substances? Should the proposed approach for testing 
Class 2 chemical substances (i.e., that a representative sample of each 
Class 2 chemical substance be tested) be applied to any Class 1 
chemical substances?
    12. For more than 15 years, EPA has used OECD's SIDS to facilitate 
and standardize the screening of the relatively large number of 
chemical substances on the TSCA Inventory. EPA requests comment on 
whether SIDS continues to be the most appropriate data set to screen 
chemical substances for potential environmental and health hazards and 
whether EPA should consider other data sets in the event of any future 
test rule on new HPV chemical substances. Are additional or different 
tests also appropriate? Should EPA consider having more than one 
screening data set depending on the nature of exposures, e.g., a 
different set of tests for children's exposures or environmental 
releases?
    13. 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 
guidance document (Ref. 38). Persons who believe that a chemical 
substance

[[Page 65598]]

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.

IX. Materials in the Docket

    As indicated under ADDRESSES, a docket has been established for 
this proposed rule under docket ID number EPA-HQ-OPPT-2010-0520. The 
following is a listing of the documents that have been placed in the 
docket for this proposed rule. The docket includes information 
considered by EPA in developing this proposed rule, including the 
documents listed in this unit, which are physically located in the 
docket. In addition, interested parties should consult documents that 
are referenced in the documents that EPA has placed in the docket, 
regardless of whether these referenced documents are physically located 
in the docket. For assistance in locating documents that are referenced 
in documents that EPA has placed in the docket, but that are not 
physically located in the docket, please consult either technical 
person listed under FOR FURTHER INFORMATION CONTACT. The docket is 
available for review as specified under ADDRESSES.

1. OECD Secretariat. Manual for the Investigation of HPV Chemicals. 
OECD Programme on the Co-Operative Investigation of High Production 
Volume Chemicals. Paris, France. December, 2009. Available on-line 
at: http://www.oecd.org/document/7/0,3746,en_2649_34379_1947463_1_1_1_1,00.html.
2. EPA. TSCA section 4(a)(1)(B) Final Statement of Policy; Criteria 
for Evaluating Substantial Production, Substantial Release, and 
Substantial or Significant Human Exposure; Notice. Federal Register 
(58 FR 28736, May 14, 1993).
3. U.S. National Academy of Sciences, National Research Council. 
``Toxicity Testing in the 21st Century: A Vision and a Strategy.'' 
2007. Available on-line at: http://dels.nas.edu/resources/static-assets/materials-based-on-reports/reports-in-brief/Toxicity_Testing_final.pdf.
4. EPA. National Center for Computational Toxicology. 
ToxCastTM. 2007. http://www.epa.gov/ncct/toxcast/.
5. EPA. OPPT. Testing of Certain High Production Volume Chemicals-4 
(Exposure Findings Supporting Information). Prepared by OPPT, 
Economics, Exposure and Technology Division. March, 2011.
6. EPA. OPPT. High Production Volume Chemical Data Information 
System (HPVIS). Data from HPVIS on 23 HPV chemicals. June 2011.
7. EPA. OPPT. Risk Assessment Division. HPV4 Data Adequacy 
Evaluations. 2010.
8. EPA. OPPT. Draft Guidance on Developing Robust Summaries. October 
22, 1999. Available on-line at: http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
9. ASTM International. Standard Test Method for Relative Initial and 
Final Melting Points and the Melting Range of Organic Chemicals. 
ASTM E 324-99. 1999.
10. OECD. Guideline for the Testing of Chemicals: Melting Point/
Melting Range. OECD 102. July 27, 1995.
11. ASTM International. Standard Test Method for Vapor Pressure of 
Liquids by Ebulliometry. ASTM E 1719-05. 2005.
12. ASTM International. Standard Test Method for Determining Vapor 
Pressure by Thermal Analysis. ASTM E 1782-03 (2008).
13. ASTM International. Standard Test Method for Partition 
Coefficient (n-Octanol/Water) Estimation by Liquid Chromatography. 
ASTM E 1147-92 (2005).
14. ASTM International. Standard Test Method for Measurements of 
Aqueous Solubility. ASTM E 1148-02 (2008).
15. ASTM International. Question about ASTM E 324. E-mail from Diane 
Rehiel, ASTM, to Greg Schweer, CITB, CCD, OPPT, EPA. September 15, 
2004.
16. Meylan, W.M. and Howard, P.H. Atom/Fragment Contribution Method 
for Estimating Octanol-Water Partition Coefficients. Journal of 
Pharmaceutical Sciences. Vol. 84(1):83-92. 1995.
17. Meylan, W.M., Howard, P.H., and Boethling, R.S. Improved Method 
for Estimating Water Solubility From Octanol/Water Partition 
Coefficient. Environmental Toxicology and Chemistry. Vol. 15(2):100-
106. 1996.
18. ASTM International. Standard Test Method for Determining Ready, 
Ultimate, Biodegradability of Organic Chemicals in a Sealed Vessel 
CO2 Production Test. ASTM E 1720-01. (Reapproved 2008).
19. 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.
20. 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.
21. 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.
22. ISO. Water quality--Evaluation of ultimate aerobic 
biodegradability of organic compounds in aqueous medium--Carbon 
dioxide evolution test. ISO 9439. 1999.
23. 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.
24. 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.
25. 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 
10631. 1995.
26. ASTM International. Standard Guide for Conducting Acute Toxicity 
Tests on Test Materials with Fishes, Macroinvertebrates, and 
Amphibians. ASTM E 729-96 (2007).
27. ASTM International. Standard Guide for Conducting Static 
Toxicity Tests with Microalgae. ASTM E 1218-04e1. 2004.
28. ASTM International. Standard Guide for Conducting Daphnia magna 
Life-Cycle Toxicity Tests. ASTM E 1193-97 (2004).
29. Veith, G.D. and Kosian, P. Estimating bioconcentration potential 
from Octanol/Water Partition Coefficients, in Physical Behavior of 
PCBs in the Great Lakes (MacKay, Paterson, Eisenreich, and Simmons, 
eds.), Ann Arbor Science, Ann Arbor, MI. 1982.
30. Bintein, S.; DeVillers, J.; and Karcher, W. Nonlinear dependence 
of fish bioconcentration on n-Octanol/Water Partition Coefficient. 
SAR and QSAR in Environmental Research. Vol. 1, pp. 29-39. 1993.
31. EPA. Category for Persistent, Bioaccumulative, and Toxic New 
Chemical Substances; Notice. Federal Register (64 FR 60194, November 
4, 1999) (FRL-6097-7). Available online at: http://www.epa.gov/oppt/newchems/pubs/pbtpolcy.htm.
32. EPA. Significant New Use Rules; General Provisions for New 
Chemical Follow-Up; Final Rule. Federal Register (54 FR 31298, July 
27, 1989).
33. ASTM International. Standard Test Method for Estimating Acute 
Oral Toxicity in Rats. ASTM E 1163-98 (2002).
34. NIEHS 2003b. Test Method Protocol for the BALB/c 3T3 Neutral Red 
Uptake Cytotoxicity Test, a Test for Basal Cytotoxicity for an in 
vitro Validation Study--Phase III. NTP/NICEATM. November 4, 2003. 
Available online at: http://iccvam.niehs.nih.gov/methods/acutetox/invidocs/phIIIprot/3t3phIII.pdf.
35. NIEHS 2003c. Test Method Protocol for the NHK Neutral Red Uptake 
Cytotoxicity Test, a Test for Basal Cytotoxicity for an in vitro 
Validation Study--Phase III. NTP/NICEATM. November 4, 2003. 
Available online at: http://iccvam.niehs.nih.gov/methods/acutetox/invidocs/phIIIprot/nhkphIII.pdf.
36. 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 online at: http://iccvam.niehs.nih.gov/methods/acutetox/inv_cyto_guide.htm.
37. NIEHS 2003a. Test Method Protocol for Solubility Determination, 
in vitro

[[Page 65599]]

Cytotoxicity Validation Study--Phase III. National Toxicology 
Program (NTP) Interagency Center for the Evaluation of Alternative 
Toxicological Methods (NICEATM). September 24, 2003. Available 
online at: http://iccvam.niehs.nih.gov/methods/acutetox/invidocs/phIIIprot/solphIII.pdf.
38. EPA. OPPT. Guidance for Testing Closed System Intermediates for 
the HPV Challenge Program (Draft) (March 17, 1999). Available online 
at: http://www.epa.gov/oppt/chemrtk/pubs/general/closed9.htm.
39. EPA. Testing of Certain High Production Volume Chemicals; Final 
Rule. Federal Register (71 FR 13708, March 16, 2006) (FRL-7335-2).
40. EPA. Testing of Certain High Production Volume Chemicals; Second 
Group of Chemicals; Proposed Rule. Federal Register (73 FR 43314, 
July 24, 2008) (FRL-8373-9).
41. EPA. Proposed Test Rule for the Testing of Certain High 
Production Volume Chemicals; Third Group of Chemicals. Federal 
Register (75 FR, February 25, 2010) (FRL-9116-2).
42. EPA. Toxic Substances; Test Rule Development and Exemption 
Procedures; Interim Final Rule. Federal Register (50 FR 20652, May 
17, 1985).
43. EPA. Toxic Substances Control Act; Data Reimbursement; Final 
Rule. Federal Register (48 FR 31786, July 11, 1983).
44. EPA. Analysis of Laboratory Capacity to Support U.S. EPA 
Chemical Testing Program Initiatives. Economic and Policy Analysis 
Branch. Washington, DC. October 28, 2010.
45. EPA. OPPT. Economic Analysis for the Proposed High Production 
Volume Challenge Chemicals Test Rule--Fourth Group of Chemicals. 
Prepared by the Economic and Policy Analysis Branch, Economics, 
Exposure and Technology Division. August 15, 2011.
46. EPA. OPPT. Economic Analysis of the Significant New Use Rule for 
High Production Volume Chemical Substances. Prepared by the Economic 
and Policy Analysis Branch, Economics, Exposure and Technology 
Division. May 26, 2011.

X. Statutory and Executive Order Reviews

A. Regulatory Planning and Review

    This proposed rule is not a ``significant regulatory action'' under 
Executive Order 12866, entitled Regulatory Planning and Review (58 FR 
51735, October 4, 1993) and 13563, entitled (76 FR 3821, January 21, 
2011).

B. Paperwork Activities

    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., an Agency may not conduct or sponsor, and a person is not 
required to respond to a collection of information that requires 
approval by the Office of Management and Budget (OMB) under the PRA, 
unless it has been approved by OMB and displays a currently valid OMB 
control number. The OMB control numbers for EPA's regulations in title 
40 of the CFR, after appearing in the Federal Register, are listed in 
40 CFR part 9, and included on the related collection instrument, or 
form, if applicable.
    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.
    For this rulemaking, the paperwork activities are addressed in 3 
parts, based on the separate activities.
    1. Paperwork activities related to testing. The proposed testing in 
this rulemaking does not impose any new or amended paperwork collection 
requirements that would require additional review and/or approval by 
OMB under the PRA. Although the activities are approved, OMB has 
specified that the additional burden associated with a new test rule is 
not covered by the ICR until the final rule is effective. The 
information collection requirements contained in TSCA section 4 test 
rules have already been approved by OMB under PRA, and have been 
assigned OMB control number 2070-0033 (EPA ICR No. 1139). In the 
context of developing a new test rule, the Agency must determine 
whether the total annual burden covered by the approved ICR needs to be 
amended to accommodate the burden associated with the new test rule. If 
so, the Agency must submit an Information Correction Worksheet (ICW) to 
OMB and obtain OMB approval of an increase in the total approved annual 
burden in the OMB inventory. The Agency's estimated burden for this 
proposed test rule is provided in the economic analysis (Ref. 45).
    The standard chemical substance 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 23 chemical substances is 38,000 hours 
(average cost scenario). EPA assumes that industry will form a ``task 
force'' or panel to coordinate testing where appropriate. A consortium 
represents all the manufacturers of a chemical substance. EPA estimates 
23 consortia for the proposed rule; with an estimated burden per 
consortium of 2,000 hours (rounded) (Ref. 45).
    2. Paperwork activities related to SNUNs. The information 
collection requirements related to the proposed SNUR have already been 
approved by OMB pursuant to the PRA under OMB control number 2070-0038 
(EPA ICR No. 1188). This action does not impose any burden requiring 
additional OMB approval.
    If an entity were to submit a SNUN to the Agency, the annual burden 
is estimated to average 91.68 hours per response. This burden estimate 
includes the time needed to review instructions, search existing data 
sources, gather and maintain the data needed, and complete, review, and 
submit the required SNUN. In addition, depending on whether or not an 
entity submits a SNUN, EPA has estimated the burden of the associated 
recordkeeping requirements (Ref. 46).
    3. Paperwork activities related to export notifications. The 
information collection activities related to export notification under 
TSCA section 12(b)(1) are already approved under OMB control number 
2070-0030 (EPA ICR No. 0795). This proposed rule does not propose any 
new or changes to the export notification requirements, and is not 
expected to result in any substantive changes in the burden estimates 
for EPA ICR No. 0795 that would require additional review and/or 
approval by OMB.
    The estimated burden of the information collection activities 
related to export notification is estimated to average 1 burden hour 
for each chemical substance/country combination for an initial 
notification and 0.5 hours for each subsequent notification (Ref. 46). 
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 substance 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.
    Comments are requested on the Agency's need for this information, 
the

[[Page 65600]]

accuracy of the provided burden estimates, and any suggested methods 
for minimizing respondent burden, including through the use of 
automated collection techniques. Send comments to EPA as part of your 
overall comments on this proposed rule in the manner specified under 
ADDRESSES. In developing the final rule, the Agency will address any 
comments received regarding the information collection requirements 
contained in this proposed rule.

C. Small Entity Impacts

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 
5 U.S.C. 601 et seq., after considering the potential economic impacts 
of this proposed rule on small entities, the Agency hereby certifies 
that this proposed rule would not have a significant adverse economic 
impact on a substantial number of small entities. The factual basis for 
the Agency's determination is presented in the small entity impact 
analysis prepared as part of each of the economic analyses for this 
proposed rule (Refs. 45 and 46), which are summarized in Unit VII., and 
copies of which are available in the docket for this proposed rule. The 
following is a brief summary of the factual basis for this 
certification.
    Under RFA, small entities include small businesses, small 
organizations, and small governmental jurisdictions. For purposes of 
assessing the impacts of this proposed rule on small entities, small 
entity is defined in accordance with RFA as:
     A small business as defined by the Small Business 
Administration's (SBA) regulations at 13 CFR 121.201.
     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.
     A small organization that is any not-for-profit enterprise 
which is independently owned and operated and is not dominant in its 
field.
    Based on the industry profile that EPA prepared as part of the 
economic analysis for this proposed rule (Ref. 45), 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.
    For this rulemaking, EPA considered the potential impact on small 
entities associated with the proposed testing, SNU notifications, and 
export notifications.
    1. Potential small entity impacts related to the proposed testing. 
Two factors are examined in EPA's small entity impact analysis (Ref. 
45) in order to characterize the potential small entity impacts of the 
proposed testing on small business:
     The size of the adverse economic impact (measured as the 
ratio of the cost to sales or revenue).
     The total number of small entities that experience the 
adverse economic impact.
    Section 601(3) of RFA establishes as the default definition of 
``small business'' the definition used in section 3 of the Small 
Business Act, 15 U.S.C. 632, under which SBA establishes small business 
size standards (13 CFR 121.201). For this proposed rule, EPA has 
analyzed the potential small business impacts using the size standards 
established under this default definition. The SBA size standards, 
which are primarily intended to determine whether a business entity is 
eligible for government programs and preferences reserved for small 
businesses (13 CFR 121.101), ``seek to ensure that a concern that meets 
a specific size standard is not dominant in its field of operation.'' 
(13 CFR 121.102(b)). See section 632(a)(1) of the Small Business Act. 
In analyzing potential impacts, RFA recognizes that it may be 
appropriate at times to use an alternate definition of small business. 
As such, section 601(3) of RFA provides that an agency may establish a 
different definition of small business after consultation with the SBA 
Office of Advocacy and after notice and an opportunity for public 
comment. Even though the Agency has used the default SBA definition of 
small business to conduct its analysis of potential small business 
impacts for this proposed rule, EPA does not believe that the SBA size 
standards are generally the best size standards to use in assessing 
potential small entity impacts with regard to TSCA section 4(a) test 
rules.
    The SBA size standard is generally based on the number of employees 
an entity in a particular industrial sector may have. For example, in 
the chemical substance manufacturing industrial sector (i.e., NAICS 
code 325 and NAICS code 324110), approximately 98% of the firms would 
be classified as small businesses under the default SBA definition. The 
SBA size standard for 75% of this industry sector is 500 employees, and 
the size standard for 23% of this industry sector is either 750, 1,000, 
or 1,500 employees. When assessing the potential impacts of test rules 
on chemical substance manufacturers, EPA believes that a standard based 
on total annual sales may provide a more appropriate means to judge the 
ability of a chemical substance manufacturing firm to support chemical 
substance 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 substance industry usually impacted by TSCA 
section 4(a) test rules, but has not yet reached a determination. As 
stated in this unit, therefore, the factual basis for the RFA 
determination for this proposed rule is based on an analysis using the 
default SBA size standards. Although EPA is not currently proposing to 
establish an alternate definition for use in the analysis conducted for 
this proposed rule, the analysis for this proposed rule also presents 
the results of calculations using a standard based on total annual 
sales (40 CFR 704.3). EPA is interested in receiving comments on 
whether the Agency should consider establishing an alternate definition 
for small business to use in the small entity impact analyses for 
future TSCA section 4(a) test rules and what size cutoff may be 
appropriate.
    SBA has developed 6-digit NAICS code-specific size standards based 
on employment thresholds. These size standards range from 500 to 1,500 
employees for the various 6-digit NAICS codes that are potentially 
affected (Ref. 45). For a conservative estimate of the number of small 
businesses affected by the HPV rules, the Agency uses an employment 
threshold of less than 1,500 employees for all businesses regardless of 
the NAIC-specific threshold to determine small business status (Ref. 
45).
    For each manufacturer of the 23 chemical substances covered by the 
proposed testing, 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 59 affected UCEs. Sales data could be found for 52 of these 
UCE's and employment data could be found for 57 of these UCEs. Two 
companies could not be classified as small or large because there were 
no employment data available (Ref. 45).
    Parent company sales data were collected to identify companies that 
qualified as a ``small business'' for purposes of RFA analysis. Based 
on the SBA size standard applied (1,500 employees or less), 25 
companies (42.4%) were identified as small (Ref. 45).
    The potential significance of the proposed testing's impact on 
small businesses was analyzed by examining

[[Page 65601]]

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 (Ref. 45).
    Of the 25 businesses designated as small business, none had cost-
to-sales ratios of greater than 1% and 3% under both the least and 
average cost scenarios. For the chemical substances where sales data 
were unavailable, EPA used the median revenue of all other small 
businesses equal to $2.56 million. The costs for these companies were 
estimated to be well below 1% of this sales level. Given these results, 
the Agency has determined that there is not a significant economic 
impact on a substantial number of small entities as a result of the 
proposed testing, if finalized (Ref. 45).
    2. Potential small entity impacts related to the SNUR. A SNUR 
applies to any person (including small or large entities) who intends 
to engage in any activity described in the rule as a ``significant new 
use.'' By definition of the word ``new'' and based on all information 
currently available to EPA, it appears that no small or large entities 
presently engage in such activity. Since a SNUR only requires that any 
person who intends to engage in such activity in the future must first 
notify EPA by submitting a SNUN, there are no costs associated with the 
SNUN until it is submitted. However there are limited costs associated 
with the recordkeeping requirements required by this SNUR, whether or 
not a SNUN is submitted. Although some small entities may decide to 
conduct such activities in the future, EPA cannot presently determine 
how many, if any, there may be.
    EPA's experience to date is that, in response to the promulgation 
of over 1,000 SNURs, the Agency receives on average less than 10 
notices per year. Of those SNUNs submitted, none appear to be from 
small entities in response to any SNUR. In addition, the estimated 
reporting cost for submission of a SNUN (see Unit VII.), are minimal 
regardless of the size of the firm. Therefore, EPA believes that the 
potential economic impact of complying with this SNUR is not expected 
to be significant or adversely impact a substantial number of small 
entities. In a SNUR that published on June 2, 1997 (62 FR 29684) (FRL-
5597-1), the Agency presented its general determination that proposed 
and final SNURs are not expected to have a significant economic impact 
on a substantial number of small entities, which was also provided to 
the Chief Counsel for Advocacy of the Small Business Administration 
(Ref. 46).
    3. Potential small entity impacts related to export notifications. 
The estimated cost of the TSCA section 12(b)(1) export notification, 
which, as a result of the final rule, would be required for the first 
export to a particular country of a chemical substance subject to the 
final rule, is estimated to be $85.70 for the first time that an 
exporter must comply with TSCA section 12(b)(1) export notification 
requirements, and $26.86 for each subsequent export notification 
submitted by that exporter (Refs. 45 and 46). EPA has concluded that 
the costs of TSCA section 12(b)(1) export notification would have a 
negligible impact on exporters of the chemical substances in the final 
rule, regardless of the size of the exporter.
    Any comments regarding the potential adverse economic 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

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA), 2 U.S.C. 1531-1538, EPA has determined that this proposed rule 
does not contain a Federal mandate that may result in expenditures of 
$100 million or more for State, local, and Tribal governments, in the 
aggregate, or the private sector in any one year. It is estimated that 
the total aggregate costs of this proposed rule to the private sector, 
which are summarized in Unit VII., would be $7.65 million. The total 
annualized costs of this proposed rule to the private sector are 
estimated to be $2.71 and $2.92 million using a 3% and 7% discount rate 
over 3 years (average cost scenario).
    In addition, since EPA does not have any information to indicate 
that any State, local, or Tribal government manufactures or processes 
the chemical substances covered by this action such that the final rule 
would apply directly to State, local, or Tribal governments, EPA has 
determined that this proposed test rule and SNUR 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. Federalism

    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 they will not have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in the executive order. This proposed rule would establish testing and 
recordkeeping requirements that apply to manufacturers (including 
importers) and processors of certain chemical substances. Because EPA 
has no information to indicate that any State or local government 
manufactures or processes the chemical substances covered by these 
actions, this proposed test rule and SNUR is not expected to affect any 
State or local governments. Thus, Executive Order 13132 does not apply 
to this proposed rule.

F. Indian Tribal Government Implications

    Under Executive Order 13175, entitled Consultation and Coordination 
with Indian Tribal Governments (59 FR 22951, November 9, 2000), EPA has 
determined that this proposed rule does not have Tribal implications 
because it will not have substantial direct effects 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. Thus, Executive Order 13175 does not apply to this 
proposed rule.

G. Protection of Children

    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 the rulemaking 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, notification 
and recordkeeping requirements that apply to manufacturers (including 
importers) and processors of certain chemical substances. The 
development of data about those chemical substances can subsequently be 
used to assist the Agency and others in determining

[[Page 65602]]

whether the chemical substances in this proposed rule present potential 
risks, allowing the Agency and others to take appropriate action to 
investigate and mitigate those risks.

H. Effect on Energy Supply, Distribution, or Use

    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 not a significant regulatory action under Executive Order 
12866.

I. Technical Standards

    Section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA), 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.
    The proposed test rule involves technical standards because it 
proposes to require the use of particular test methods. If the Agency 
makes findings under TSCA section 4(a), EPA is required by TSCA section 
4(b) to include specific standards or test methods that are to be used 
for the development of the data required in the test rules issued under 
TSCA section 4. For some of the testing that would be required by the 
final rule, EPA is proposing the use of voluntary consensus standards 
issued by ASTM International and ISO which evaluate the same type of 
toxicity as the TSCA 799 test guidelines and OECD test guidelines, 
where applicable. Copies of the 17 ASTM International and ISO standards 
referenced in the proposed regulatory text at Sec.  799.5090(h) have 
been placed in the docket for this proposed rule. You may obtain copies 
of the ASTM International standards from the American Society for 
Testing and Materials International, 100 Bar Harbor Dr., West 
Conshohocken, PA 19428-2959, and copies of the ISO standards from the 
International Organization for Standardization, Case Postale, 56 CH-
1211 Geneve 20 Switzerland. In the final rule, EPA intends to seek 
approval from the Director of the Federal Register for the 
incorporation by reference of the ASTM International and ISO standards 
used in the final rule in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51.
    EPA is not aware of any potentially applicable voluntary consensus 
standards which evaluate partition coefficient (n-octanol/water) 
generator column, water solubility (column elution and generator 
column), acute inhalation toxicity, bacterial reverse mutations, in 
vivo mammalian bone marrow chromosomal aberrations, combined repeated 
dose with reproductive/developmental toxicity screen, repeated dose 28-
day oral toxicity screen, or the reproductive developmental toxicity 
screen which could be considered in lieu of the TSCA 799 test 
guidelines, 40 CFR 799.6756, 799.6784, 799.6786, 799.9130, 799.9510, 
799.9538, 799.9365, 799.9305, and 799.9355, respectively, upon which 
the test standards in this proposed rule are based.
    The Agency invites comment on the potential use of voluntary 
consensus standards in this proposed rule, and, specifically, invites 
the public to identify potentially applicable consensus standard(s) and 
to explain why such standard(s) should be used here.

J. Environmental Justice

    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 test rule, if finalized, 
will assist EPA and others in determining the potential hazards and 
risks associated with the chemical substances covered by this proposed 
test rule. Although not directly impacting environmental justice-
related concerns, this information will enable the Agency to better 
protect human health and the environment, including in low-income and 
minority communities.

List of Subjects

40 CFR Part 721

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

40 CFR Part 799

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

    Dated: September 28, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 721--[AMENDED]

    1. The authority citation for part 721 continues to read as 
follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

    2. Add Sec.  721.10228 to subpart E to read as follows:

Sec.  721.10228  High production volume challenge program chemical 
substances.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified in Table 1. are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.

        Table 1--List of Chemical Substances Included in the SNUR
------------------------------------------------------------------------
 Chemical abstract service registry number  Chemical abstract (CA) index
                  (CASRN)                               name
------------------------------------------------------------------------
98-16-8...................................  Benzenamine, 3-
                                             (trifluoromethyl)-.
100-53-8..................................  Benzenemethanethiol.
104-91-6..................................  Phenol, 4-nitroso-.
110-03-2..................................  2,5-Hexanediol, 2,5-dimethyl-
                                             .
124-63-0..................................  Methanesulfonyl chloride.
142-30-3..................................  3-Hexyne-2,5-diol, 2,5-
                                             dimethyl-.
460-00-4..................................  Benzene, 1-bromo-4-fluoro-.
542-92-7..................................  1,3-Cyclopentadiene.

[[Page 65603]]

 
553-26-4..................................  4,4'-Bipyridine.
8007-45-2.................................  Tar, coal.
28106-30-1................................  Benzene, ethenylethyl-.
35203-06-6................................  Benzenamine, 2-ethyl-6-
                                             methyl-N-methylene-.
35203-08-8................................  Benzenamine, 2,6-diethyl-N-
                                             methylene-.
37734-45-5................................  Carbonochloridothioic acid,
                                             S-(phenylmethyl) ester.
37764-25-3................................  Acetamide, 2,2-dichloro-N,N-
                                             di-2-propen-1-yl-.
61789-72-8................................  Quaternary ammonium
                                             compounds,
                                             benzyl(hydrogenated tallow
                                             alkyl)dimethyl, chlorides.
61790-13-4................................  Naphthenic acids, sodium
                                             salts.
65996-91-0................................  Distillates (coal tar),
                                             upper.
68308-01-0................................  Tail gas (petroleum),
                                             cracked distillate
                                             hydrotreater stripper.
68478-20-6................................  Residues (petroleum), steam-
                                             cracked petroleum
                                             distillates cyclopentadiene
                                             conc., C4-cyclopentadiene-
                                             free.
68526-82-9................................  Alkenes, C6-10,
                                             hydroformylation products,
                                             high-boiling.
68909-77-3................................  Ethanol, 2,2'-oxybis-,
                                             reaction products with
                                             ammonia, morpholine derivs.
                                             residues.
------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Use in a consumer product.
    (ii) Any use, or combination of uses, that is reasonably likely to 
expose 1,000 or more workers at a single corporate entity (defined as 
the aggregate of all of the domestic facilities owned or operated by an 
individual corporation).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), and (c) are applicable to manufacturers, importers, 
and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

PART 799--[AMENDED]

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

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

    4. Add Sec.  799.5090 to subpart D to read as follows:

Sec.  [emsp14]799.5090  Chemical testing requirements for certain high 
production volume chemicals; fourth group of chemicals.

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

   Table 1--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
                                          Persons not initially required
  Persons initially required to comply     to comply with this section
       with this section (Tier 1)                    (Tier 2)
------------------------------------------------------------------------
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 chemical substance (as
                                             described at 40 CFR
                                             720.45(a)(1)(i));
                                            --In amounts of less than
                                             500 kg (1,100 lbs.)
                                             annually (as described at
                                             40 CFR 790.42(a)(4)); or
                                            --For research and
                                             development (as described
                                             at 40 CFR 790.42(a)(5)).

[[Page 65604]]

 
                                         Tier 2B. 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 40 CFR 
790.42(a)(2), (a)(4) and (a)(5), who, while legally subject to this 
section, must comply with the requirements of this section only if 
directed to do so by EPA under the circumstances set forth in 
paragraphs (c)(4), (c)(5), (c)(6), (c)(7), and (c)(10) of this section.
    (2) If you are in Tier 1 with respect to a chemical substance 
listed in Table 2. in paragraph (j) of this section, you must, for each 
test required under this section for that chemical substance, either 
submit to EPA a letter of intent to test or apply to EPA for an 
exemption from testing. The letter of intent to test or the exemption 
application must be received by EPA no later than 30 days after the 
effective date of the final rule.
    (3) If you are in Tier 2 with respect to a chemical substance 
listed in Table 2. in paragraph (j) of this section, you are considered 
to have an automatic conditional exemption and you will be required to 
comply with this section with regard to that chemical substance only if 
directed to do so by EPA under paragraphs (c)(5), (c)(7), or (c)(10) of 
this section.
    (4) If no person in Tier 1 has notified EPA of its intent to 
conduct one or more of the tests required by this section on any 
chemical substance listed in Table 2. in paragraph (j) of this section 
within 30 days after the effective date of the final rule, EPA will 
publish a Federal Register document that would specify the test(s) and 
the chemical substance(s) for which no letter of intent has been 
submitted and notify manufacturers in Tier 2A of their obligation to 
submit a letter of intent to test or to apply for an exemption from 
testing.
    (5) If you are in Tier 2A (as specified in Table 1. in paragraph 
(c) of this section) with respect to a chemical substance listed in 
Table 2. in paragraph (j) of this section, and if you manufacture, or 
intend to manufacture, this chemical substance as of [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 Federal Register 
document described in paragraph (c)(4) of this section.
    (6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its 
intent to conduct one or more of the tests required by this section on 
any chemical substance listed in Table 2. in paragraph (j) of this 
section within 30 days after the publication of the Federal Register 
document described in paragraph (c)(4) of this section, EPA will 
publish another Federal Register document that would specify the 
test(s) and the chemical substance(s) for which no letter of intent has 
been submitted, and notify processors in Tier 2B of their obligation to 
submit a letter of intent to test or to apply for an exemption from 
testing.
    (7) If you are in Tier 2B (as specified in Table 1. in paragraph 
(c) of this section) with respect to a chemical substance listed in 
Table 2. in paragraph (j) of this section, and if you process, or 
intend to process, this chemical substance as of [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 Federal Register document 
described in paragraph (c)(6) of this section, either submit to EPA a 
letter of intent to test or apply to EPA for an exemption from testing. 
The letter of intent to test or the exemption application must be 
received by EPA no later than 30 days after publication of the Federal 
Register document described in paragraph (c)(6) of this section.
    (8) If no manufacturer or processor has notified EPA of its intent 
to conduct one or more of the tests required by this section for any of 
the chemical substances listed in Table 2. in paragraph (j) of this 
section within 30 days after the publication of the Federal Register 
document described in paragraph (c)(6) of this section, EPA will notify 
all manufacturers and processors of those chemical substances of this 
fact by certified letter or by publishing a Federal Register document 
specifying the test(s) for which no letter of intent has been 
submitted. This letter or Federal Register document will additionally 
notify all manufacturers and processors that all exemption applications 
concerning the test(s) have been denied, and will give the 
manufacturers and processors of the chemical substance(s) an 
opportunity to take corrective action.
    (9) If no manufacturer or processor has notified EPA of its intent 
to conduct one or more of the tests required by this section for any of 
the chemical substances listed in Table 2. in paragraph (j) of this 
section within 30 days after receipt of the certified letter or 
publication of the Federal Register document described in paragraph 
(c)(8) of this section, all manufacturers and processors subject to 
this section with respect to that chemical substance who are not 
already in violation of this section will be in violation of this 
section.
    (10) If a problem occurs with the initiation, conduct, or 
completion of the required testing or the submission of the required 
data with respect to a chemical substance listed in Table 2. in 
paragraph (j) of this section, under the procedures in 40 CFR 790.93 
and 790.97, EPA may initiate termination proceedings for all testing 
exemptions with respect to that chemical substance and may notify 
persons in Tier 1 and Tier 2 that they are required to submit letters 
of intent to test or exemption applications within a specified period 
of time.
    (11) If you are required to comply with this section, but your 
manufacture or processing of, or intent to manufacture or process, a 
chemical substance listed in Table 2. in paragraph (j) of this section 
begins after the applicable compliance date referred to in paragraphs 
(c)(2), (c)(5), or (c)(6) of this section, you must either submit a 
letter of intent to test or apply to EPA for an exemption. The letter 
of intent to test or the exemption application must be received by EPA 
no later than the day you begin manufacture or processing.
    (d) What must I do to comply with this section? (1) To comply with 
this section you must either submit to EPA a letter of intent to test, 
or apply to and

[[Page 65605]]

obtain from EPA an exemption from testing.
    (2) For each test with respect to which you submit to EPA a letter 
of intent to test, you must conduct the testing specified in paragraph 
(h) of this section and submit the test data to EPA.
    (3) You must also comply with the procedures governing test rule 
requirements in part 790 of this chapter, as modified by this section, 
including the submission of letters of intent to test or exemption 
applications, the submission of study plans prior to testing, the 
conduct of testing, and the submission of data; 40 CFR part 792--Good 
Laboratory Practice Standards; and this section. The following 
provisions of 40 CFR part 790 do not apply to this section: Paragraphs 
(a), (d), (e), and (f) of Sec.  790.45; Sec.  790.48; paragraph (a)(2) 
and paragraph (b) of Sec.  790.80; paragraph (e)(1) of Sec.  790.82; 
and Sec.  790.85.
    (e) If I do not comply with this section, when will I be considered 
in violation of it? You will be considered in violation of this section 
as of 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 40 CFR part 
707, subpart D.
    (h) How must I conduct my testing? The tests that are required for 
each chemical substance are indicated in Table 2. in paragraph (j) of 
this section. The test methods that must be followed are provided in 
Table 3. in paragraph (j) of this section. You must proceed in 
accordance with these test methods as required according to Table 3. in 
paragraph (j) of this section, or as appropriate if more than one 
alternative is allowed according to Table 3. in paragraph (j) of this 
section.
    (i) Reporting requirements. A final report for each specific test 
for each subject chemical substance must be received by EPA by [date 13 
months after the effective date of publication of the final rule in the 
Federal Register] unless an extension is granted in writing pursuant to 
40 CFR 790.55. A robust summary of the final report for each specific 
test may be submitted electronically in addition to and at the same 
time as the final report. The term ``robust summary'' is used to 
describe the technical information necessary to adequately describe an 
experiment or study and includes the objectives, methods, results, and 
conclusions of the full study report which can be either an experiment 
or in some cases an estimation or prediction method. Guidance for the 
compilation of robust summaries is described in a document entitled 
``Draft Guidance on Developing Robust Summaries'' which is available 
on-line at: http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
    (j) Designation of specific chemical substances and testing 
requirements. The chemical substances identified by chemical substance 
name, Chemical Abstract Service Registry Number (CASRN), and class in 
Table 2. of this paragraph must be tested in accordance with the 
requirements designated in Tables 2. and 3. of this paragraph, and the 
requirements described in 40 CFR part 792--Good Laboratory Practice 
Standards.

                              Table 2--Chemical Substances and Testing Requirements
----------------------------------------------------------------------------------------------------------------
  Chemical abstract service registry      Chemical abstract (CA) index                Required tests (see Table
            number (CASRN)                            name                  Class        3. of this section)
----------------------------------------------------------------------------------------------------------------
56-40-6...............................  Glycine.........................          1  A3
67-72-1...............................  Ethane, 1,1,1,2,2,2-hexachloro-.          1  C6
78-00-2...............................  Plumbane, tetraethyl-...........          1  A4, A5, C6, E2
95-14-7...............................  1H-Benzotriazole................          1  A3, C6, F1
118-48-9..............................  2H-3,1-Benzoxazine-2,4(1H)-dione          1  A3, A4, A5, C3, E1, E2, F1
128-44-9..............................  1,2-Benzisothiazol-3(2H)-one,             1  A2, A3, A4, A5, C1, F1
                                         1,1-dioxide, sodium salt (1:1).
928-72-3..............................  Glycine, N-(carboxymethyl)-,              1  A1, A3, A4, A5, B
                                         sodium salt (1:2).
1809-19-4.............................  Phosphonic acid, dibutyl ester..          1  A1, A4, C1, E1, E2, F1
25377-73-5............................  2,5-Furandione, 3-(dodecen-1-             1  A1, A2, A3, A4, A5, B, C1,
                                         yl)dihydro-.                                 D, E2, F1
26544-38-7............................  2,5-Furandione, dihydro-3-                1  A1, A2, A3, A4, A5, B, C1,
                                         (tetrapropenyl)-.                            D, E1, E2, F1
27859-58-1............................  Butanedioic acid, 2-                      1  A1, A2, A3, A4, A5, C1, D,
                                         (tetrapropenyl)-.                            E1, E2, F1
28777-98-2............................  2,5-Furandione, dihydro-3-                1  A2, A3, A4, A5, C1, D, E1,
                                         (octadecen-1-yl)-.                           E2, F1
29385-43-1............................  1H-Benzotriazole, 6(or 7)-methyl-         1  A3, A4, A5, E2, F1
                                         .
32072-96-1............................  2,5-Furandione, 3-(hexadecen-1-           1  A1, A2, A3, A4, A5, B, C1,
                                         yl)dihydro-.                                 D, E1, E2, F1
61789-73-9............................  Quaternary ammonium compounds,            2  A3
                                         benzylbis(hydrogenated tallow
                                         alkyl)methyl, chlorides.
64665-57-2............................  1H-Benzotriazole, 6(or 7)-methyl-         1  A1, A3, A4, A5, E1, E2, F1,
                                         , sodium salt.
68131-13-5............................  Naphthenic acids, reaction                2  C1, D, E1, E2, F1
                                         products with
                                         diethylenetriamine.
68153-60-6............................  Fatty acids, tall-oil, reaction           2  A1, A2, A3, A4, A5, B, C1,
                                         products with                                D, E1, E2, F1
                                         diethylenetriamine, acetates.
68424-85-1............................  Quaternary ammonium compounds,            1  A1, A2, A3
                                         benzyl-C12-16-
                                         alkyldimethyl,chlorides.
68442-77-3............................  2-Butenediamide, (2E)-, N1,N4-            2  A1, A2, A3, A4, A5, B,
                                         bis[2-(4,5-dihydro-2-nortall-               C1, D, E1, E2, F1
                                         oil alkyl-1H-imidazol-1-
                                         yl)ethyl] derivs.
68607-28-3............................  Quaternary ammonium compounds,            2  A1, A2, A3, A4, A5,
                                         (oxydi-2,1-ethanediyl)bis[coco
                                         alkyldimethyl, dichlorides.

[[Page 65606]]

 
68909-18-2............................  Pyridinium, 1-(phenylmethyl)-,            2  A1, A2, A3, A4, A5, C1, D,
                                         Et Me derivs., chlorides.                    E1, E2, F1
69834-17-9............................  Benzene, decylphenoxy-..........          1  A1, A2, A3, A4, A5, B, C1,
                                                                                      D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------

                Table 3--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2
----------------------------------------------------------------------------------------------------------------
                                          Test         Test requirements and
           Testing category              symbol             references                  Special conditions
----------------------------------------------------------------------------------------------------------------
Physical/chemical properties..........        A   1. Melting Point: ASTM E 324-
                                                   99 (capillary tube), if a
                                                   Freezing Point: Organisation
                                                   for Economic Co-operation and
                                                   Development (OECD) 102
                                                   (melting point/melting
                                                   range).
                                        ........  2. Boiling Point: ASTM E 1719-
                                                   05 (ebulliometry).
                                        ........  3. Vapor Pressure: ASTM E 1782- ..............................
                                                   03 (thermal analysis).
Physical/chemical properties                  A   4. n-Octanol/Water Partition    n-Octanol/Water Partition
 (continued).                                      Coefficient (log 10 basis) or   Coefficient or log Kow: Which
                                                   log Kow: (see special           method is required, if any,
                                                   conditions for the log Kow      is determined by the test
                                                   test requirement and select     substance's estimated \1\ log
                                                   the appropriate method to       Kow as follows:
                                                   use, if any, from those        log Kow  1-4: Method A
                                                   (liquid chromatography)..       or B or C.
                                                  Method C: 40 CFR 799.6756       log Kow range > 4-6: Method B
                                                   (generator column).             or C.
                                                                                  log Kow > 6: Method C.
                                                                                  Test sponsors must provide in
                                                                                   the final study report the
                                                                                   underlying rationale for the
                                                                                   method and pH selected. In
                                                                                   order to ensure environmental
                                                                                   relevance, EPA highly
                                                                                   recommends that the selected
                                                                                   study be conducted at pH 7.
                                                  5. Water Solubility: (See       Water Solubility:
                                                   special conditions for the     Which method is required, if
                                                   water solubility test           any, is determined by the
                                                   requirement and select the      test substance's estimated
                                                   appropriate method to use, if   \2\ water solubility. Test
                                                   any, from those listed in       sponsors must provide in the
                                                   this column).                   final study report the
                                                  Method A: ASTM E 1148-02         underlying rationale for the
                                                   (shake flask).                  method and pH selected. In
                                                  Method B: 40 CFR 799.6784        order to ensure environmental
                                                   (shake flask).                  relevance, EPA highly
                                                  Method C: 40 CFR 799.6784        recommends that the selected
                                                   (column elution).               study be conducted starting
                                                  Method D: 40 CFR 799.6786        at pH 7.
                                                   (generator column).
                                        ........                                  > 5,000 mg/L: Method A or B.
                                        ........                                  > 10 mg/L-5,000 mg/L: Method
                                                                                   A, B, C, or D.
                                        ........                                  > 0.001 mg/L-10 mg/L: Method C
                                                                                   or D.
                                        ........                                  L: No testing
                                                                                   required.
Environmental fate and pathways--ready        B   For B, consult ISO 10631 for    Which method is required, if
 biodegradation.                                   guidance, and choose one of     any, is determined by the
                                                   the methods listed in this      test substance's physical and
                                                   column:                         chemical properties,
                                                  1. ASTM 1720-01 (sealed vessel   including its water
                                                   CO2 production test) or.        solubility. ISO 10631
                                                  2. ISO 14593 (CO2 headspace      provides guidance for
                                                   test) or.                       selection of an appropriate
                                                  3. ISO 7827 (analysis of DOC)    test method for a given test
                                                   or.                             substance. Test sponsors must
                                                  4. ISO 9408 (determination of    provide in the final study
                                                   oxygen demand in a closed       report the underlying
                                                   respirometer) or.               rationale for the method
                                                                                   selected.
                                        ........  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 Test    The following are the special
                                                   Group 2 listed in this column   conditions for C1, C2, C3,
                                                   must be used to fulfill the     C4, C5, and C7 testing; there
                                                   testing requirements--see       are no special conditions for
                                                   special conditions.             C6.
                                                  Test Group 1 for C1:..........  Which test group is required
                                                  1. Acute Toxicity To Fish:       is determined by the test
                                                   ASTM E 729-96 (2007)..          substance's measured log Kow
                                                  2. Acute Toxicity To Daphnia:    as obtained under Test
                                                   ASTM E 729-96 (2007)..          Category A, or using an
                                                  3. Toxicity To Plants (Algae):   existing measured log Kow.\3\
                                                   ASTM E 1218-04\e1\..           If log Kow = 4.2:
                                                   Daphnia: ASTM E 1193-97         Test Group 2 is required.
                                                   (2004).
                                                  2. Toxicity To Plants (Algae):
                                                   ASTM E 1218-04\e1\..

[[Page 65607]]

 
                                               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 (2007)..
                                                  2. Toxicity To Plants (Algae):
                                                   ASTM E 1218-04\e1\.
                                        ........  Test Group 2 for C2:            ..............................
                                                  1. Chronic Toxicity To
                                                   Daphnia: ASTM E 1193-97
                                                   (2004)..
                                                  2. Toxicity To Plants (Algae):
                                                   ASTM E 1218-04\e1\..
                                               C3 For C3, Test Group 1 or Test
                                                   Group 2 listed in this column
                                                   must be used to fulfill the
                                                   testing requirements--see
                                                   special conditions.
                                        ........  Test Group 1 for C3:
                                        ........     1. Acute Toxicity To Fish:
                                                      ASTM E 729-96 (2007).
                                        ........     2. Toxicity To Plants
                                                      (Algae): ASTM E 1218-
                                                      04\e1\.
                                        ........  Test Group 2 for C3:
                                        ........     1. Chronic Toxicity To
                                                      Daphnia: ASTM E 1193-97
                                                      (2004).
                                        ........     2. Toxicity To Plants
                                                      (Algae): ASTM E 1218-
                                                      04\e1\.
                                               C4 For C4, Test Group 1 or Test
                                                   Group 2 listed in this column
                                                   must be used to fulfill the
                                                   testing requirements--see
                                                   special conditions.
                                        ........  Test Group 1 for C4:
                                        ........     1. Acute Toxicity To Fish:
                                                      ASTM E 729-96 (2007).
                                        ........     2. Acute Toxicity To
                                                      Daphnia: ASTM E 729-96
                                                      (2007).
                                        ........  Test Group 2 for C4:
                                        ........     1. Chronic Toxicity To
                                                      Daphnia: ASTM E 1193-97
                                                      (2004).
                                               C5 For C5, Test Group 1 or Test
                                                   Group 2 listed in this column
                                                   must be used to fulfill the
                                                   testing requirements--see
                                                   special conditions.
                                        ........  Test Group 1 for C5:
                                        ........     1. Acute Toxicity To
                                                      Daphnia: ASTM E 729-96
                                                      (2007).
                                        ........  Test Group 2 for C5:
                                        ........     1. Chronic Toxicity To       ..............................
                                                      Daphnia: ASTM E 1193-97
                                                      (2004).
                                               C6 Toxicity To Plants (Algae):
                                                   ASTM E 1218-04e1.
                                               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 (2007).
                                        ........  Test Group 2 for C7:
                                           .....  1. Chronic Toxicity To
                                                   Daphnia: ASTM E 1193-97
                                                   (2004).
Mammalian toxicity--acute.............        D   See special conditions for      Which testing method is
                                                   this test requirement and       required is determined by the
                                                   select the method that must     test substance's physical
                                                   be used from those listed in    state at room temperature (25
                                                   this column.                    [deg]C). For those test
                                                  Method A: Acute Inhalation       substances that are gases at
                                                   Toxicity (rat): 40 CFR          room temperature, Method A is
                                                   799.9130..                      required; otherwise, use
                                                  Method B: either:.............   either of the two methods
                                                  1. Acute (Up/Down) Oral          listed under Method B.
                                                   Toxicity (rat): ASTM E 1163-   In Method B, 40 CFR
                                                   98 (2002).                      799.9110(d)(1)(i)(A) refers
                                                  or............................   to the OECD 425 Up/Down
                                                  2. Acute (Up/Down) Oral          Procedure.\4\
                                                   Toxicity (rat): 40 CFR         Estimating starting dose for
                                                   799.9110(d)(1)(i)(A).           Method B: Data from the
                                                                                   neutral red uptake basal
                                                                                   cytotoxicity assay \5\ using
                                                                                   normal human keratinocytes or
                                                                                   mouse BALB/c 3T3 cells may be
                                                                                   used to estimate the starting
                                                                                   dose.
Mammalian toxicity--genotox-icity.....       E1   Bacterial Reverse Mutation      None.
                                                   Test (in vitro): 40 CFR
                                                   799.9510.

[[Page 65608]]

 
                                             E2   Conduct any one of the          Persons required to conduct
                                                   following three tests for       testing for chromosomal
                                                   chromosomal damage:             damage are encouraged to use
                                                  In vitro Mammalian Chromosome    the in vitro Mammalian
                                                   Aberration Test: 40 CFR         Chromosome Aberration Test
                                                   799.9537.                       (40 CFR 799.9537) to generate
                                                  or............................   the needed data unless known
                                                  Mammalian Bone Marrow            chemical properties (e.g.,
                                                   Chromosomal Aberration Test     physical/chemical properties,
                                                   (in vivo in rodents: Mouse      chemical class
                                                   (preferred species), rat, or    characteristics) preclude its
                                                   Chinese hamster): 40 CFR        use. A subject person who
                                                   799.9538.                       uses one of the in vivo
                                                  or............................   methods instead of the in
                                                  Mammalian Erythrocyte            vitro method to address a
                                                   Micronucleus Test [sampled in   chromosomal damage test
                                                   bone marrow] (in vivo in        requirement must submit to
                                                   rodents: mouse (preferred       EPA a rationale for
                                                   species), rat, or Chinese       conducting that alternate
                                                   hamster): 40 CFR 799.9539..     test in the final study
                                                                                   report.
Mammalian toxicity--repeated dose/           F1   Combined Repeated Dose          Where F1 is required, EPA
 repro-duction/developmental.                      Toxicity Study with the         recommends use of the
                                                   Reproduction/Developmental      Combined Repeated Dose
                                                   Toxicity Screening Test: 40     Toxicity Study with the
                                                   CFR 799.9365.                   Reproduction/Developmental
                                                  or............................   Toxicity Screening Test (40
                                                  Reproduction/Developmental       CFR 799.9365). However, there
                                                   Toxicity Screening Test: 40     may be valid reasons to test
                                                   CFR 799.9355.                   a particular chemical
                                                  and...........................   substance using both 40 CFR
                                                  Repeated Dose 28-Day Oral        799.9355 and 40 CFR 799.9305
                                                   Toxicity Study in rodents: 40   to fill Mammalian Toxicity--
                                                   CFR 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.
----------------------------------------------------------------------------------------------------------------
\1\ 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-2010-0520 at the EPA Docket Center, Rm. 3331 in the EPA West Building located at
  1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
  legal holidays.
\2\ 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-2010-0520 at the EPA Docket Center, Rm. 3331 in
  the EPA West Building located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m.,
  Monday through Friday, excluding legal holidays.
\3\ Chemical substances that are dispersible in water may have log Kow values greater than 4.2 and may still be
  acutely toxic to aquatic organisms. Test sponsors who wish to conduct Test Group 1 studies on such chemical
  substances may request a modification to the test standard as described in 40 CFR 790.55. Based upon the
  supporting rationale provided by the test sponsor, EPA may allow an alternative threshold or method be used
  for determining whether acute or chronic aquatic toxicity testing be performed for a specific substance.
\4\ The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available under docket ID number EPA-HQ-
  OPPT-2010-0520 at the EPA Docket Center, Rm. 3331 in the EPA West Building located at 1301 Constitution Ave.,
  NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
\5\ 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-2010-0520 at the EPA Docket
  Center, Rm. 3331 in the EPA West Building 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. 2011-26894 Filed 10-20-11; 8:45 am]
BILLING CODE 6560-50-P
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