[Federal Register Volume 76, Number 204 (Friday, October 21, 2011)]
[Proposed Rules]
[Pages 65580-65608]
[FR Doc No: 2011-26894]

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

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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<PHONE_NUMBER>. 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<PHONE_NUMBER>, 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:<PHONE_NUMBER> or (202)
564-9823; e-mail address<EMAIL_ADDRESS>or
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. 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

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

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

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.

            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 <= 10.............  1,000+..............  Yes.................  Other; CBI.........  Yes.
67-72-1..............  Ethane, 1,1,1,2,2,2-  1 <= 10.............  1,000+..............  Yes.................  None...............  No.
                        hexachloro-.
78-00-2..............  Plumbane, tetraethyl- 1 <= 10.............  100-999.............  No..................  Lubricants, greases  Yes.
                        .                                                                                and fuel additives.
95-14-7..............  1H-Benzotriazole....  1 <= 10.............  100-999.............  No..................  Lubricants, greases  Yes.
                                                                                and fuel
                                                                                additives; metal
                                                                                products; other.
118-48-9.............  2H-3,1-Benzoxazine-   10 <= 50............  100-999.............  No..................  Agricultural         Yes.
                        2,4(1H)-dione.                                                                          products (non-
                                                                                pesticidal); other.
128-44-9.............  1,2-Benzisothiazol-   1 <= 10.............  100-999.............  No..................  Other..............  Yes.
                        3(2H)-one, 1,1-
                        dioxide, sodium
                        salt (1:1).
928-72-3.............  Glycine, N-           500 <= 1,000........  1,000+..............  Yes.................  None...............  No.
                        (carboxymethyl)-,
                        sodium salt (1:2).
1809-19-4............  Phosphonic acid,      1 <= 10.............  1,000+..............  Yes.................  CBI................  Yes.
                        dibutyl ester.
25377-73-5...........  2,5-Furandione, 3-    1 <= 10.............  1-99................  No..................  Other..............  Yes.
                        (dodecen-1-
                        yl)dihydro-.
26544-38-7...........  2,5-Furandione,       1 <= 10.............  100-999.............  No..................  Lubricants, greases  Yes.
                        dihydro-3-                                                                              and fuel
                        (tetrapropenyl)-.                                                                       additives; paints
                                                                                and coatings; not
                                                                                readily obtainable
                                                                                (NRO).
27859-58-1...........  Butanedioic acid,2-   1 <= 10.............  1,000+..............  Yes.................  Lubricants, greases  Yes.
                        (tetrapropenyl)-.                                                                       and fuel
                                                                                additives; CBI.
28777-98-2...........  2,5-Furandione,       10 <= 50............  100-999.............  No..................  Paper products.....  Yes.
                        dihydro-3-
                        (octadecen-1-yl)-.
29385-43-1...........  1H-Benzotriazole,     1 <= 10.............  100-999.............  No..................  Lubricants, greases  Yes.
                        6(or75)-methyl-.                                                                        and fuel additives.
32072-96-1...........  2,5-Furandione, 3-    50 <= 100...........  1,000+..............  Yes.................  Paper products.....  Yes.
                        (hexadecen-1-
                        yl)dihydro-.
61789-73-9...........  Quaternary ammonium   1 <= 10.............  100-999.............  No..................  CBI................  Yes.
                        compounds,
                        benzylbis(hydrogena
                        ted tallow
                        alkyl)methyl,
                        chlorides.
64665-57-2...........  1H-Benzotriazole,     1 <= 10.............  100-999.............  No..................  Other..............  Yes.
                        6(or7)-methyl-,
                        sodium salt.
68131-13-5...........  Naphthenic acids,     1 <= 10.............  1,000+..............  Yes.................  None...............  No.
                        reaction products
                        with
                        diethylenetriamine.
68153-60-6...........  Fatty acids, tall-    1 <= 10.............  1,000+..............  Yes.................  None...............  No.
                        oil, reaction
                        products with
                        diethylenetriamine,
                        acetates.
68424-85-1...........  Quaternary ammonium   1 <= 10.............  1,000+..............  Yes.................  Other; CBI.........  Yes.
                        compounds, benzyl-
                        C12-16-
                        alkyldimethyl,
                        chlorides.
68442-77-3...........  2-Butenediamide,      1 <= 10.............  1,000+..............  Yes.................  None...............  No.
                        (2E)-, N1,N4-bis[2-
                        (4,5-dihydro-2-
                        nortall-oil alkyl-
                        1H-imidazol-1-
                        yl)ethyl] derivs.
68607-28-3...........  Quaternary ammonium   1 <= 10.............  1,000+..............  Yes.................  Other..............  Yes.
                        compounds, (oxydi-
                        2,1-
                        ethanediyl)bis[coco
                        alkyldimethyl,
                        dichlorides.
68909-18-2...........  Pyridinium, 1-        1 <= 10.............  1,000+..............  Yes.................  Other..............  Yes.
                        (phenylmethyl)-, Et
                        Me derivs.,
                        chlorides.
69834-17-9...........  Benzene,              1 <= 10.............  100-999.............  No..................  Soaps and            Yes.
                        decylphenoxy-.                                                                          detergents.
--------------------------------------------------------------------------------------------------------------------------------------------------------

        Table B--List of Chemical Substances for Which a SNUR Is Proposed and for Which a Test Rule Is Being Considered as an Alternative Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Chemical substance                         Chemical substance
                                                       2006 IUR                              meets the ``B     Commercial/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 <= 10...........  1-99..............  No................  None................  No.
                        (trifluoromethyl)-.
100-53-8.............  Benzenemethanethiol......  1 <= 10...........  1-99..............  No................  None................  No.
104-91-6.............  Phenol, 4-nitroso-.......  1 <= 10...........  1-99..............  No................  None................  No.
110-03-2.............  2,5-Hexanediol, 2,5-       1 <= 10...........  100-999...........  No................  None................  No.
                        dimethyl-.
124-63-0.............  Methanesulfonyl chloride.  1 <= 10...........  100-999...........  No................  None................  No.
142-30-3.............  3-Hexyne-2,5-diol, 2,5-    1 <= 10...........  100-999...........  No................  None................  No.
                        dimethyl-.
460-00-4.............  Benzene, 1-bromo-4-fluoro- 1 <= 10...........  100-999...........  No................  Not readily           No.
                        .                                                                                obtainable (NRO).
542-92-7.............  1,3-Cyclopentadiene......  1 <= 10...........  1-99..............  No................  None................  No.
553-26-4.............  4,4'-Bipyridine..........  10 <= 50..........  100-999...........  No................  None................  No
8007-45-2............  Tar, coal................  1 <= 10...........  1-99..............  No................  None................  No.
28106-30-1...........  Benzene, ethenylethyl-...  1 <= 10...........  100-999...........  No................  None................  No.
35203-06-6...........  Benzenamine, 2-ethyl-6-    10 <= 50..........  1-99..............  No................  None................  No.
                        methyl-N-methylene-.
35203-08-8...........  Benzenamine, 2,6-diethyl-  10 <= 50..........  1-99..............  No................  None................  No.
                        N-methylene-.
37734-45-5...........  Carbonochloridothioic      1 <= 10...........  100-999...........  No................  None................  No.
                        acid, S-(phenylmethyl)
                        ester.
37764-25-3...........  Acetamide, 2,2-dichloro-   1 <= 10...........  1-99..............  No................  None................  No.
                        N,N-di-2-propen-1-yl-.
61789-72-8...........  Quaternary ammonium        1 <= 10...........  100-999...........  No................  None................  No.
                        compounds,
                        benzyl(hydrogenated
                        tallow alkyl)dimethyl,
                        chlorides.
61790-13-4...........  Naphthenic acids, sodium   1 <= 10...........  100-999...........  No................  None................  No.
                        salts.
65996-91-0...........  Distillates (coal tar),    1 <= 10...........  100-999...........  No................  None................  No.
                        upper.
68308-01-0...........  Tail gas (petroleum),      10 <= 50..........  100-999...........  No................  None................  No.
                        cracked distillate
                        hydrotreater stripper.
68478-20-6...........  Residues (petroleum),      10 <= 50..........  1-99..............  No................  None................  No.
                        steam-cracked petroleum
                        distillates
                        cyclopentadiene conc.,
                        C4-cyclopentadiene-free.
68526-82-9...........  Alkenes, C6-10,            1 <= 10...........  100-999...........  No................  NRO.................  No.
                        hydroformylation
                        products, high-boiling.
68909-77-3...........  Ethanol, 2,2'-oxybis-,     1 <= 10...........  100-999...........  No................  None................  No.
                        reaction products with
                        ammonia, morpholine
                        derivs. residues.
--------------------------------------------------------------------------------------------------------------------------------------------------------

IV. Proposed Section 4(a)(1)(B) Test Rule and Basis to Also Consider
Table B. Chemical Substances for a Section 4(a)(1)(B) Test Rule

A. What are the proposed findings?

    1. Exposure findings. EPA is proposing to require testing of the
chemical substances listed in Table A. based on its preliminary
findings under TSCA section 4(a)(1)(B)(i) relating to ``substantial''
production and ``substantial human exposure,'' as well as findings
under TSCA sections 4(a)(1)(B)(ii) and (a)(1)(B)(iii) relating to
insufficient data and the need for testing. The chemical substances in
Table A. are also listed in Table 2. of Sec.  799.5090(j) of the
proposed regulatory text along with their CASRNs.
    i. Are these chemical substances produced in substantial
quantities? EPA has made preliminary findings that each of the chemical
substances included in this proposed test rule are produced in
substantial quantities. In accordance with the ``B policy'' (discussed
in Unit II.D.), each of these substances is manufactured (which, as
noted in Unit I.A., includes 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 the most recently available
compilation of IUR (now CDR) data.
    ii. Are a substantial number of workers exposed to these chemical
substances? EPA has made preliminary findings that the manufacture,
processing, and use of 12 of the 23 chemical substances listed in Table
A. result or may result in exposure of a substantial number of workers
to the chemical substances (Ref. 5).
    For chemical substances whose total production volume (manufactured
and imported) exceeded 300,000 lbs. at a site during calendar year
2005, manufacturers (which as noted in Unit I.A., includes importers)
were required through the 2006 IUR to report the number of potentially
exposed workers during industrial processing and use to the extent the
information was readily obtainable. Manufacturers of 12 of the 23
chemical substances listed in Table A. reported that more than 1,000
workers or more were potentially exposed to these chemical substances.
Based on the threshold values stated in EPA's ``B Policy,'' EPA
believes that an exposure of 1,000 workers or more on a routine or
episodic basis to a chemical substance or mixture is ``substantial'' as
that term is used with reference to ``human exposure'' in TSCA section
4(a)(1)(B)(i). Therefore, EPA's preliminary finding is that there is or
may be substantial human exposure (workers) to 12 of these 23 chemical
substances.
    iii. Are a substantial number of consumers exposed to these
chemical substances? EPA has made preliminary findings that the
manufacture, processing, and use of 18 of the 23 chemical substances
listed in Table A. result or may result in exposure of a substantial
number of consumers to the chemical substances (Ref. 5).

    In addition to worker exposure information, manufacturers of more
than 300,000 lbs. of a given chemical substance at a site during
calendar year 2005 were required to provide information regarding the
commercial and consumer uses of the chemical substance. EPA reviewed
the consumer use information reported for the 2006 IUR and carefully
considered the nature of those uses. These 18 chemical substances were
found to be used in such products as tires, footwear, flooring,
bottles, sporting equipment, games, soaps and detergents, and paper
products. Based on this review, EPA has preliminarily concluded that
the reported consumer uses may result in exposures to at least 10,000
consumers. Based on the threshold values stated in EPA's ``B Policy,''
EPA believes that an exposure of 10,000 consumers or more to a chemical
substance is ``substantial'' as that term is used with reference to
``human exposure'' in TSCA section 4(a)(1)(B)(i). Therefore, EPA's
preliminary finding is that there is or may be substantial human
exposure (consumers) to 18 of these 23 chemical substances.
    2. Are sufficient data available to evaluate these chemical
substances? Under TSCA section 4(a)(1)(B)(ii), EPA has preliminarily
determined for the chemical substances in Table A. that there are
insufficient data and experience to reasonably determine or predict the
effects of the manufacture, distribution in commerce, processing, use,
or disposal of these chemical substances, or of any combination of such
activities, on human health or the environment.
    In developing the testing requirements for chemical substances
contained in Table A., EPA searched for available information on
chemical/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

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.

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 < 0: no
                               799.6755 (shake       testing required.
                               flask).              log Kow range 0-1:
                              Method B: ASTM E       Method A or B.
                               1147-92 (2005)       log Kow range > 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.
                                                    <= 0.001 mg/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

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).

    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

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

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

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.

    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

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

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