Certain High Production Volume Chemicals; Test Rule and Significant New Use Rule; Fourth Group of Chemicals, 65580-65608 [2011-26894]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

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



[[Page 65579]]

Vol. 76

Friday,

No. 204

October 21, 2011

Part III





Environmental Protection Agency





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40 CFR Parts 721 and 799





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

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

[[Page 65580]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 721 and 799

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


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

DATES: Comments must be received on or before January 19, 2012.
    You may submit a request for an opportunity to present oral 
comments. This request must be made in writing. If such a request is 
received on or before January 19, 2012, EPA will hold a public meeting 
on this proposed rule in Washington, DC.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2010-0520, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID Number EPA-HQ-OPPT-2010-0520. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2010-0520. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://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 https://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 https://www.regulations.gov, or, if only available in 
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA 
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution 
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of 
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the EPA/DC Public Reading Room 
is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.
    Submission of requests: You may submit a request for an opportunity 
to present oral comments. This request must be made in writing and 
submitted to the mailing or hand delivery addresses provided in this 
unit. If such a request is received, EPA will announce the scheduling 
of the public meeting in a subsequent document in the Federal Register.

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

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

[[Page 65581]]

entities not listed in this unit could also be affected. The North 
American Industrial Classification System (NAICS) codes have been 
provided to assist you and others in determining whether this action 
might apply to certain entities. If you have any questions regarding 
the applicability of this action to a particular entity, consult either 
technical person listed under FOR FURTHER INFORMATION CONTACT.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. See Unit 
VI. for export notification requirements.

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

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

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

    You may submit a request for an opportunity to present oral 
comments. This request must be made in writing. If such a request is 
received on or before January 19, 2012, EPA will hold a public meeting 
on this proposed rule in Washington, DC. This written request must be 
submitted to the mailing or hand delivery addresses provided under 
ADDRESSES. If such a request is received, EPA will announce the 
scheduling of the public meeting in a subsequent document in the 
Federal Register. If a public meeting is announced, and if you are 
interested in attending or presenting oral and/or written comments at 
the public meeting, you should follow the instructions provided in the 
subsequent Federal Register document announcing the public meeting.

II. Background

A. What action is the agency taking and why?

    Congress gave EPA (also referred to as ``Agency'') broad authority 
to require testing of chemical substances when EPA can establish a 
minimum level of risk concern for a chemical substance (hazard and 
exposure are considered), and/or when EPA can establish that there is 
or may be substantial production and release or exposure of a chemical 
substance (production volume and exposure are considered). HPV chemical 
substances often have either significant release or human exposure 
scenarios that would stimulate EPA interest and support an EPA decision 
to require testing or to require notification before additional 
exposures occur. EPA is proposing to regulate 45 HPV chemical 
substances with either a test rule or a SNUR. EPA is proposing a test 
rule under TSCA section 4(a)(1)(B) for 23 of these 45 HPV chemical 
substances and a SNUR under TSCA section 5(a)(2) for the other 22 HPV 
chemical substances (see Tables A. and B. in Unit III.).
    These 45 HPV chemical substances are among the chemical substances 
that were included in EPA's HPV Challenge Program (hereafter HPV 
Challenge) initiated in 1998. Of the 2,782 chemical substances 
originally included in the HPV Challenge, 1,858 were officially 
sponsored either directly in the HPV Challenge or indirectly through 
international efforts, although 5 were later withdrawn. Another 416 of 
the 2,782 chemical substances were removed from the scope of the HPV 
Challenge for a variety of reasons (e.g., polymers, inorganics, etc.). 
The remaining 508 of the 2,782 chemical substances were termed 
``orphans'' because they were not sponsored and there were no other 
factors that removed the chemical substances from the scope of the HPV 
Challenge. Of the 508 orphans, 405 are no longer produced at HPV 
levels. Of the remaining 103 chemical substances, 63 have been included 
in one of three test rules, or EPA has otherwise received data adequate 
to meet its needs. The remaining 40, plus the 5 chemical substances 
whose HPV Challenge sponsorships were withdrawn, are the subject of 
this proposed test rule and SNUR. For more information on the HPV 
Challenge go to https://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

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

C. Applicability of General Provisions

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

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

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

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

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

[[Page 65583]]

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

F. What are some future considerations?

    One of EPA's top priorities is to assure the safety of chemical 
substances in commerce. Under TSCA, EPA has a primary mission to 
identify and, where appropriate, control unreasonable risks of 
manufacturing, processing, distribution in commerce, use, and disposal 
of chemical substances. It is essential that chemical substance review 
be supported by information sufficient to allow informed decision 
making and that information and decisions are of high quality and are 
widely understandable. As such, EPA continues to collect information 
from existing sources, to request new and better information where it 
is determined to be needed, and to make all supporting information 
publicly available, to the extent permitted under TSCA section 14 and 
40 CFR part 2. Open access to information allows individuals, 
communities, businesses, and governments to make informed decisions and 
policies that incorporate environmental and health considerations and 
minimize external and/or unintended harmful impacts. Therefore, EPA 
intends to continue to focus on filling data needs on priority chemical 
substances, including high production volume chemical substances. EPA 
is interested in stakeholder input on a number of issues described in 
this section. Some specific issues EPA has identified to date follow.
    1. Coordination of simultaneous test rule and SNUR proposals. In 
this action, EPA is simultaneously proposing a test rule and SNUR to 
regulate two sets of chemical substances. EPA believes that this is an 
efficient way to require submission of test data on chemical substances 
that meet all of the necessary test rule criteria and (for the latter 
group of chemical substances) to require submission of advance 
notification to EPA of use in a consumer product or of any use, or 
combination of uses, that is reasonably likely to expose 1,000 or more 
workers. With respect to chemical substances that meet some, but 
potentially not all test rule criteria, the SNUR also facilitates 
efficiency by mitigating the need for EPA to continually reevaluate 
each HPV chemical substance to determine whether exposure potential has 
changed. EPA is considering issuing further coordinated proposals of 
test rules and SNURs. This would occur in conjunction with future 
Inventory Update Reporting (IUR) rule data releases, covering all 
newly-HPV chemical substances. EPA requests comment on this approach. 
In September 2011, the IUR was renamed Chemical Data Reporting (CDR) 
and moved from 40 CFR part 710 subpart C to 40 CFR part 711 (76 FR 
50816, August 16, 2011) (FRL-8872-9). For more information on this 
change go to https://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 https://www.epa.gov/comptox/toxcast) (Ref. 4) be used to prioritize chemical 
substances and support hazard findings for testing?

III. Chemical Substances Subject to This Action

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

[[Page 65584]]



            Table A--Chemical Substances for Which a Test Rule Is Proposed and for Which a SNUR Is Being Considered as an Alternative Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Chemical  substance                        Chemical substance
                                              2006 IUR production                           meets the  ``B     Commercial/Consumer     meets the  ``B
        CASRN              CA Index name       volume  (million     2006 IUR number of    finding'' criteria    uses indicated in    finding''  criteria
                                                     lbs.)            workers exposed     of >=1,000 workers         2006 IUR            of >=10,000
                                                                                                exposed                               consumers exposed
--------------------------------------------------------------------------------------------------------------------------------------------------------
56-40-6..............  Glycine.............  1 <= 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.
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 65585]]


        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).

[[Page 65586]]

    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 (https://www.epa.gov/hpv): ``Guidance for 
Meeting the SIDS Requirements (the SIDS Guide)'' and ``Guidance for 
Assessing the Adequacy of Existing Data.'' Furthermore, data adequacy 
and reliability were evaluated using the OECD guidelines which can be 
found in section 3.1 of the OECD ``Manual for the Investigation of HPV 
Chemicals'' (Ref. 1). The results of EPA's data adequacy analysis can 
be found in the HPV4 Data Adequacy Evaluations document (Ref. 7).
    Section 799.5090(j) of the proposed regulatory text lists each 
chemical substance and the SIDS tests for which adequate data are not 
currently available to the Agency. The Agency preliminarily finds that 
the existing data for one or more of the SIDS testing endpoints for 
each of the chemical substances listed in Table 2. in Sec.  799.5090(j) 
of the proposed regulatory text (i.e., chemical substances in Table A.) 
are insufficient to enable EPA to reasonably determine or predict the 
human health and environmental effects resulting from manufacture, 
distribution in commerce, processing, use, and disposal of these 
chemical substances.
    To the extent that additional studies relevant to the testing 
proposed in this rulemaking are known to exist, EPA strongly encourages 
the submission of this information as comments to the proposed rule, 
including full citations for publications and full copies of 
unpublished studies. If EPA judges such data to be sufficient, 
corresponding testing will not be included in the final rule. 
Commenters may prepare a robust summary (Ref. 8) for each such study to 
facilitate EPA's review of the full study report or publication.
    Persons who believe that adequate information regarding a chemical 
substance subject to this proposed rule can be developed using a 
category or the Structure-Activity Relationships (SAR) approach are 
encouraged to submit appropriate information, along with their 
rationale substantiating this belief, during the comment period on this 
proposed rule. If, based on submitted information and other information 
available to EPA, the Agency agrees, EPA will take such measures as are 
needed to avoid unnecessary testing in the final rule.
    3. Is testing necessary for these chemical substances? EPA has also 
found preliminarily that testing the 23 chemical substances identified 
in Table A. is necessary to develop the needed data (TSCA section 
4(a)(1)(B)(iii)). EPA has not identified any ``additional factors'' as 
discussed in the ``B Policy'' (Ref. 2, p. 28743) to cause the Agency to 
use decision making criteria other than those described in the ``B 
Policy.'' EPA knows of no other means to generate the SIDS data other 
than the testing proposed in this document, and therefore has 
preliminarily found that conducting the needed SIDS testing identified 
for the 23 chemical substances in Table A. is necessary to provide data 
relevant to a determination of whether the manufacture, processing, and 
use of the chemical substances does or does not present an unreasonable 
risk of injury to human health and the environment.

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

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

[[Page 65587]]

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

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

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

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

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

[[Page 65588]]



Table C--Test Requirements for the n-Octanol/Water Partition Coefficient
                                Endpoint
------------------------------------------------------------------------
                                Test requirements
      Testing category           and references      Special conditions
------------------------------------------------------------------------
Physical/chemical properties  n-Octanol/water       n-Octanol/water
                               partition             partition
                               coefficient (log 10   coefficient or log
                               basis) or log Kow:    Kow:
                              The appropriate log      Which method is
                               Kow test, if any,        required, if
                               would be selected        any, is
                               from those listed        determined by
                               in this column--see      the test
                               special conditions       substance's
                               in the adjacent          estimated log
                               column.                  Kow as follows:
                              Method A: 40 CFR      log Kow < 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 th