[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Rules and Regulations]
[Pages 61117-61155]
[FR Doc No: 2012-23993]

Vol. 77

Friday,

No. 194

October 5, 2012

Part IV

Environmental Protection Agency

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40 CFR Part 9 and 721

Significant New Use Rules on Certain Chemical Substances; Final Rule

Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Rules
and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2012-0277; FRL-9364-5]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under
the Toxic Substances Control Act (TSCA) for 78 chemical substances
which were the subject of premanufacture notices (PMNs). Seven of these
chemical substances are subject to TSCA section 5(e) consent orders
issued by EPA. This action requires persons who intend to manufacture,
import, or process any of these 78 chemical substances for an activity
that is designated as a significant new use by this rule to notify EPA
at least 90 days before commencing that activity. The required
notification will provide EPA with the opportunity to evaluate the
intended use and, if necessary, to prohibit or limit that activity
before it occurs.

DATES: This rule is effective on December 4, 2012. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
October 19, 2012.
    Written adverse or critical comments, or notice of intent to submit
adverse or critical comments, on one or more of these SNURs must be
received on or before November 5, 2012 (see Unit VI. of the
SUPPLEMENTARY INFORMATION).
    For additional information on related reporting requirement dates,
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2012-0277, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online 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, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN:
Docket ID Number EPA-HQ-OPPT-2012-0277. 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-
2012-0277. EPA's policy is that all comments received will be included
in the docket without change and may be made available online 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 email. 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 email comment
directly to EPA without going through regulations.gov, your email
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.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Kenneth Moss, 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>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this rule.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Manufacturers, importers, or processors of one or more
subject chemical substances (NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
Sec.  721.20), and must comply with

the export notification requirements in 40 CFR part 707, subpart D.

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 email. 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.

II. Background

A. What action is the Agency taking?

    EPA is promulgating these SNURs using direct final procedures.
These SNURs will require persons to notify EPA at least 90 days before
commencing the manufacture, import, or processing of a chemical
substance for any activity designated by these SNURs as a significant
new use. Receipt of such notices allows EPA to assess risks that may be
presented by the intended uses and, if appropriate, to regulate the
proposed use before it occurs. Additional rationale and background to
these rules are more fully set out in the preamble to EPA's first
direct final SNUR published in the Federal Register issue of April 24,
1990 (55 FR 17376) (April 24, 1990 SNUR). Consult that preamble for
further information on the objectives, rationale, and procedures for
SNURs and on the basis for significant new use designations, including
provisions for developing test data.

B. What is the Agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) 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 the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. 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 significant new use notice (SNUN) to EPA
at least 90 days before they manufacture, import, or process the
chemical substance for that use. Persons who must report are described
in Sec.  721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 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 rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec.  721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA sections 5(b)
and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(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 for 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.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a
chemical substance.
     The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
     The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 78
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, and the four bulleted TSCA section 5(a)(2) factors
listed in this unit.

IV. Substances Subject to this Rule

    EPA is establishing significant new use and recordkeeping
requirements for 84 chemical substances in 40 CFR part 721, subpart E.
In this unit, EPA provides the following information for each chemical
substance:
     PMN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order or, for non-
section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA
section 5(e) consent orders).
     Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VIII. for more
information).
     CFR citation assigned in the regulatory text section of
this rule.
    The regulatory text section of this rule specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits (i.e., limits on manufacture and importation
volume) and other uses designated in this rule, may be claimed as CBI.
Unit IX. discusses a procedure companies may use to ascertain whether a
proposed use constitutes a significant new use.
    This rule includes 7 PMN substances (P-04-80, P-06-149, P-06-153,
P-07-

327, P-09-48, P-09-636, and P-10-367) that are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA
determined that activities associated with the PMN substances may
present unreasonable risk to human health or the environment. Those
consent orders require protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``5(e) SNURs'' on these PMN substances are promulgated pursuant to
Sec.  721.160, and are based on and consistent with the provisions in
the underlying consent orders. The 5(e) SNURs designate as a
``significant new use'' the absence of the protective measures required
in the corresponding consent orders.
    Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) consent order usually requires, among
other things, that potentially exposed employees wear specified
respirators unless actual measurements of the workplace air show that
air-borne concentrations of the PMN substance are below a New Chemical
Exposure Limit (NCEL) that is established by EPA to provide adequate
protection to human health. In addition to the actual NCEL
concentration, the comprehensive NCELs provisions in TSCA section 5(e)
consent orders, which are modeled after Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limits (PELs) provisions,
include requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. However, no comparable NCEL provisions currently exist
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases,
the individual SNURs in 40 CFR part 721, subpart E, will state that
persons subject to the SNUR who wish to pursue NCELs as an alternative
to the Sec.  721.63 respirator requirements may request to do so under
Sec.  721.30. EPA expects that persons whose Sec.  721.30 requests to
use the NCELs approach for SNURs are approved by EPA will be required
to comply with NCELs provisions that are comparable to those contained
in the corresponding TSCA section 5(e) consent order for the same
chemical substance.
    This rule also includes SNURs on 71 PMN substances that are not
subject to consent orders under TSCA section 5(e). In these cases, for
a variety of reasons, EPA did not find that the use scenario described
in the PMN triggered the determinations set forth under TSCA section
5(e). However, EPA does believe that certain changes from the use
scenario described in the PMN could result in increased exposures,
thereby constituting a ``significant new use.'' These so-called ``non-
section 5(e) SNURs'' are promulgated pursuant to Sec.  721.170. EPA has
determined that every activity designated as a ``significant new use''
in all non-section 5(e) SNURs issued under Sec.  721.170 satisfies the
two requirements stipulated in Sec.  721.170(c)(2), i.e., these
significant new use activities, ``(i) are different from those
described in the premanufacture notice for the substance, including any
amendments, deletions, and additions of activities to the
premanufacture notice, and (ii) may be accompanied by changes in
exposure or release levels that are significant in relation to the
health or environmental concerns identified'' for the PMN substance.
PMN Number P-00-535
    Chemical name: 1-Octadecanol, manuf. of, distn. lights,
fractionation heavies, distn. lights.
    CAS number: 243640-46-2.
    Basis for action: The PMN states that the substance will be used as
a feedstock for esterification. Based on ecological structure activity
relationship (EcoSAR) analysis of test data on analogous neutral
organic chemicals, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 1 part per billion (ppb) of the PMN
substance in surface waters for greater than 20 days per year. This 20-
day criterion is derived from partial life cycle tests (daphnid chronic
and fish early-life stage tests) that typically range from 21 to 28
days in duration. EPA predicts toxicity to aquatic organisms may occur
if releases of the PMN substance to surface water exceed releases from
the use described in the PMN. For the use described in the PMN,
environmental releases did not exceed 1 ppb for more than 20 days per
year. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance other than as a feedstock for esterification may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (Office of Pollution Prevention and
Toxics (OPPTS) Test Guideline 850.1400); a daphnid chronic toxicity
test (OPPTS Test Guideline 850.1300); and an algal toxicity test
(Office for Chemical Safety and Pollution Prevention (OCSPP) Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substance.
    CFR citation: 40 CFR 721.10426.
PMN Number P-01-579
    Chemical name: Acrylate ester (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a monomer. Based on
EcoSAR analysis of test data on analogous acrylates, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
50 ppb of the PMN substance in surface waters. As described in the PMN,
releases of the PMN substance are not expected to result in surface
water concentrations that exceed 50 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 50 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help to characterize the
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10537
PMN Number P-02-161
    Chemical name: Phosphonium, tetrakis (hydroxymethyl)-, chloride
(1:1), reaction products with 1-tetradecanamine and urea.
    CAS number: 359406-89-6.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a flame retardant. Based
on test data on the PMN substance and EcoSAR analysis of test data on
analogous cationic surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 2 ppb of the PMN
substance in surface waters. As described in the PMN, the substance is
not released to surface waters. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance may
present an unreasonable

risk. EPA has determined, however, that any use of the substance
resulting in surface water concentrations exceeding 2 ppb may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.  721.170 (b)(4)(i)
and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); a fish acute
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075);
and an aquatic invertebrate acute toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010) would help characterize the
environmental and fate effects of the PMN substance.
    CFR citation: 40 CFR 721.10538.
PMN Number P-02-653
    Chemical name: Bis[phenyl-2H-1,3-benzoxazine]derivative (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
a resin for electronic laminates, adhesives, encapsulants, and
composites. Based on EcoSAR analysis of test data on analogous neutral
organic chemicals, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb of the PMN substance in surface
waters. As described in the PMN, the substance is not released to
surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance presents an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 1 ppb may
cause significant adverse environmental effects. Based on this
information the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
bioconcentration factor (BCF) test (OPPTS Test Guideline 850.1730); a
fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10539.
PMN Number P-02-984
    Chemical name: 1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.
    CAS number: 404362-22-7.
    Basis for action: The PMN states that the substance will be used as
an epoxy curing agent. Based on EcoSAR analysis of test data on
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 5 ppb of the PMN substance in
surface waters. As described in the PMN, the substance is not released
to surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 5 ppb may
cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10540.
PMN Number P-03-481
    Chemical name: 5,2,6-(Iminomethenimino)-1H-imidazo[4,5-b]pyrazine,
octahydro-1,3,4,7,8,10-hexanitro-.
    CAS number: 135285-90-4.
    Basis for action: The PMN substance will be used as an explosive
and propellant. Based on structure activity relationship (SAR) analysis
of test data on analogous octahydro-1,3,5,7-tetranitro-1,3,5,7-
tetrazocine (also called HMX or octogen); CAS No. 2691-41-0, as well as
test data for hexahydro-1,3,5-trinitro-1,3,5-triazine (also called RDX,
cyclonite, hexogen, or cyclotrimethylenetrinitramine); CAS No. 121-82-
4, EPA identified concerns for neurotoxicity, including severe
convulsions or seizures, systemic effects, reproductive and
developmental effects, immunotoxicity and oncogenicity from exposure to
the PMN substance. In addition, based on EcoSAR analysis of test data
on analogous polynitro organic analogues, EPA predicts toxicity to
aquatic organisms from the degradation product of the PMN substance at
surface water concentrations that exceed 50 ppb of the degradation
product. For the use described in the PMN, dermal and inhalation
exposures are not expected, and releases to surface waters are not
expected to result in surface water concentrations exceeding 50 ppb for
the PMN degradation product. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that use of the
substance without respiratory protection, impervious gloves, or release
to surface waters without chemical destruction or conversion may cause
serious health effects and significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec.  721.170 (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity study with reproductive/developmental
toxicity screening test, including neurotoxicity assessment and
functional observations (OPPTS Test Guideline 870.3650); a combined
chronic toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300);
a hydroysis as a function of pH and temperature test (OPPTS Test
Guideline 835.2130); and a ready biodegradability test (OPPTS Test
Guideline 835.3110) would help to characterize the human health and
environmental fate of the PMN substance.
    CFR citation: 40 CFR 721.10541.
PMN Number P-03-624
    Chemical name: Dodecanedioic acid, 1,12-dimethyl ester.
    CAS number: 1731-79-9.
    Basis for action: The PMN states that the substance will be used as
a chemical intermediate. Based on EcoSAR analysis of test data on
analogous esters, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 30 ppb of the PMN substance in surface
waters. As described in the PMN, releases of the PMN substance are not
expected to result in surface water concentrations that exceed 30 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, and use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance resulting in
surface water concentrations exceeding 30 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help

characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10542.
PMN Number P-04-79
    Chemical name: Oxetane, 3-methyl-3-[(2,2,3,3,3-
pentafluoropropoxy)methyl]-.
    CAS number: 449177-94-0.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a monomer in the
production of reactive polymers for surface coatings and other polymer
intermediates. Based on SAR analysis of test data on analogous
oxetanes, EPA identified concerns for male reproductive toxicity, liver
toxicity, and thyroid effects from exposure to the PMN substance. As
described in the PMN, significant inhalation exposures are not expected
and dermal exposures are not expected due to the use of protective
gloves. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance presents an
unreasonable risk. EPA has determined, however, that any use of the
substance without dermal protection where there is a potential for
dermal exposures may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a
combined repeated dose test with a reproductive/developmental toxicity
screening (Organisation for Economic Co-operation and Development
(OECD) Test Guideline 422) via gavage in rats would help characterize
the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10543.
PMN Number P-04-80
    Chemical name: Oxetane, 3-methyl-3-[[(3,3,4,4,5,5,6,6,6-
nonafluorohexyl)oxy]methyl]-.
    CAS number: 475678-78-5.
    Effective date of TSCA section 5(e) consent order: December 28,
2004.
    Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used as a monomer in the production of reactive
polymers for surface coating materials and other polymer intermediates.
EPA has identified health and environmental concerns because the
substance may be a persistent, bio-accumulative, and toxic (PBT)
chemical, based on physical/chemical properties of the PMN substance,
as described in the New Chemical Program's PBT category (64 FR 60194;
November 4, 1999) (FRL-6097-7). Also, based on SAR analysis of test
data on analogous oxetanes, EPA identified concerns for male
reproductive toxicity and systemic effects from exposures to the PMN
substance. Further, based on EcoSAR analysis of analogous oxetanes, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 5 ppb of the PMN substance in surface waters. The consent order
was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and
5(e)(1)(A)(ii)(II), based on a finding that this substance may present
an unreasonable risk of injury to human health and the environment, the
substance may be produced in substantial quantities and may reasonably
be anticipated to enter the environment in substantial quantities, and
there may be significant (or substantial) human exposure to the
substance and its potential degradation products. To protect against
these risks, the consent order requires:
    1. Use of personal protective equipment including dermal protection
(where there is a potential for dermal exposure).
    2. Establishment and use of a hazard communication program.
    3. No release of the PMN substance into the waters of the United
States.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity test with a reproductive/developmental
toxicity screening test (OPPTS Test Guideline 870.3650 or OECD Test
Guideline 422) in rats by gavage would help characterize possible human
health effects of the PMN substance. The PMN submitter has agreed not
to exceed the confidential production limit specified in the consent
order without performing this test. In addition, EPA has determined the
results of a log Kow test (OECD Test Guideline 117), and (depending
upon the results of the log Kow test) a fish BCF test (OPPTS Test
Guideline 850.1730); a fish acute toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity
test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline 850.4500), would help characterize
the persistence, bioaccumulation, and environmental effects of the PMN
substance. The consent order does not require submission of this
additional recommended testing at any specified time or production
volume. However, the consent order's restrictions on manufacture,
import, processing, distribution in commerce, use, and disposal of the
PMN substance will remain in effect until the Order is modified or
revoked by EPA based on submission of that or other relevant
information.
    CFR citation: 40 CFR 721.10544.
PMN Number P-04-313
    Chemical name: Aminotriazine modified cresol novolec resin
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a glass epoxy laminate.
Based on EcoSAR analysis of test data on analogous phenols, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 10 ppb of the PMN substance in surface waters. As described in
the PMN, releases of the PMN substance are not expected to result in
surface water concentrations that exceed 10 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance presents an unreasonable risk. EPA has determined, however,
that any use of the substance resulting in surface water concentrations
exceeding 10 ppb may cause significant adverse environmental effects.
Based on this information the PMN substance meets the concern criteria
at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
BCF test (OPPTS Test Guideline 850.1730), and either an aerobic and
anaerobic transformation in aquatic sediment systems test (OECD Test
Guideline 308) or a shake flask die-away test (OPPTS Test Guideline
835.3170) would help to characterize the environmental effects of the
PMN substance.
    CFR citation: 40 CFR 721.10545.
PMN Number P-04-340
    Chemical name: Pentenylated polyethylene glycol sulfate salt
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a polymerization
additive. Based on EcoSAR analysis of test data on analogous anionic
surfactants, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the PMN substance in surface
waters. As described in the PMN, releases of the substance are not
expected to result in surface water concentrations that exceed 1 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance resulting in
surface water concentrations exceeding 1 ppb may cause significant
adverse

environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help to characterize the
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10546.
PMN Number P-04-587
    Chemical name: Dialkyl dimethyl ammonium methylcarbonate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
a chemical intermediate. Based on EcoSAR analysis of test data on
analogous cationic surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 5 ppb of the PMN
substance in surface waters for greater than 20 days per year. This 20-
day criterion is derived from partial life cycle tests (daphnid chronic
and fish early-life stage tests) that typically range from 21 to 28
days in duration. EPA predicts toxicity to aquatic organisms may occur
if releases of the PMN substance to surface water exceed releases from
the use described in the PMN. For the chemical intermediate use
described in the PMN, environmental releases did not exceed 5 ppb for
more than 20 days per year. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance presents an
unreasonable risk. EPA has determined, however, that any use of the
substance other than as a chemical intermediate may cause significant
adverse environmental effects. Based on this information the PMN
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) would
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10547.
PMN Number P-04-624
    Chemical name: Mixed alkyl phosphate esters alkoxylated (generic).
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a component in
a lubricant blend. Based on EcoSAR analysis of test data on analogous
nonionic surfactants, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 40 ppb of the PMN substance in
surface waters. As described in the PMN, releases of the substance are
not expected to result in surface water concentrations that exceed 40
ppb. Therefore, EPA has not determined that manufacturing, processing,
and use of the substance may present an unreasonable risk. EPA has
determined, however, that any use of the substance resulting in surface
water concentrations exceeding 40 ppb may cause significant adverse
environmental effects. Based on this information the PMN substance
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help to characterize the
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10548.
PMN Number P-04-635
    Chemical name: Ethane, 1,1,2,2-tetrafluoro-1-(2,2,2-
trifluoroethoxy)-.
    CAS number: 406-78-0.
    Basis for action: The PMN states that the substance will be used
for cleaning electronic components, precision cleaning, dewatering of
electronic components and other parts following aqueous cleaning, and
as a carrier/lubricant coating for hard disk drives and other precision
parts. Based on test data on the PMN substance, EPA identified concerns
for neurotoxicity. For the industrial use described in the PMN, the
substance is imported and no significant worker exposures are expected.
Therefore, EPA has not determined that the proposed processing or use
of the substance presents an unreasonable risk. EPA has determined,
however, that domestic manufacture, use in non-industrial products, or
use other than as described in the PMN may cause serious chronic health
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(3)(i).
    Recommended testing: EPA has determined that inhalation monitoring
data, collected according to the EPA draft Inhalation Monitoring Data
Collection Guidelines (located in the docket under docket ID number
EPA-HQ-OPPT-2012-0277) would help characterize the human health effects
of the PMN substance.
    CFR citation: 40 CFR 721.10549.
PMN Number P-05-324
    Chemical name: Rare earth salt of a carboxylic acid (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a paint component. Based
on SAR analysis of test data on analogous lanthanides, EPA identified
concerns for developmental toxicity, kidney toxicity, and blood
toxicity (specifically, anticoagulant activity). In addition, based on
EcoSAR analysis of test data on analogous organic and inorganic salts,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 5 ppb of the PMN substance in surface waters. For the use
described in the PMN, significant worker and general population
exposures are not expected, and releases of the substance are not
expected to result in surface water concentrations that exceed 5 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance presents an unreasonable risk. EPA
has determined, however, that any use of the substance other than as
described in the PMN, or any use resulting in surface water
concentrations exceeding 5 ppb may cause serious health effects and
significant adverse environmental effects. Based on this information
the PMN substance meets the concern criteria at Sec.  721.170
(b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of an
acute oral toxicity test (OPPTS Test Guideline 870.1100); a bacterial
reverse mutation test (OPPTS Test Guideline 870.5100); a mammalian
erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) via the
intraperitoneal route; a repeated dose 28-day oral toxicity test in
rodents (OPPTS Test Guideline 870.3050), including a neurotoxicity
functional observational battery, as described in the neurotoxicity
screening battery (OPPTS Test Guideline 870.6200); a prenatal
developmental toxicity test (OPPTS Test Guideline 870.3700) in one
species, via the oral route; either a porous pot test (OPPTS Test
Guideline 835.3220) or an aerobic sewage treatment simulation test
(OECD Test Guideline 303A); a fish acute toxicity test, freshwater and
marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute
toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the human health and environmental effects of the PMN
substance.

    CFR citation: 40 CFR 721.10550.
PMN Number P-05-613
    Chemical name: Bisphenol S mono ether (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a color developer. Based
on SAR analysis of test data on analogous epoxides, EPA identified
concerns for respiratory sensitization, mutagenicity, oncogenicity,
developmental toxicity, male reproductive toxicity, liver toxicity, and
kidney toxicity. In addition, based on test data on the PMN substance
and EcoSAR analysis of test data on analogous phenols, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb of the PMN substance in surface water. For the use described in the
PMN, occupational exposures during manufacture are not expected as the
PMN substance is imported. Occupational exposures during processing and
use are not expected to be significant due to expected use of
appropriate personal protective equipment, and the substance is not
released to surface waters during processing or use. Therefore, EPA has
not determined that the proposed processing or use of the substance
presents an unreasonable risk. EPA has determined, however, that
domestic manufacture, any use of the substance other than as described
in the PMN, or any use of the substance resulting in surface water
concentrations exceeding 1 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec.  721.170 (b)(1)(i)(C), (b)(3)(ii),
(b)(4)(i), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity with the reproduction/development
toxicity screening test (OPPTS Test Guideline 870.3650); a
carcinogenicity test (OPPTS Test Guideline 870.4200); a fish early-life
stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid
chronic toxicity test (OPPTS Test Guideline 850.1300) would help
characterize the human health and environmental effects of the PMN
substance.
    CFR citation: 40 CFR 721.10551.
PMN Number P-05-774
    Chemical name: Oxirane, 2-(1-chlorocyclopropyl)-2-[(2-
chlorophenyl)methyl]-.
    CAS number: 134818-68-1.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate.
Based on test data on the PMN substance, EPA identified concerns for
dermal sensitization. In addition, based on SAR analysis of test data
on analogous epoxides and chlorobenzenes, EPA identified concerns for
carcinogenicity, mutagenicity, systemic toxicity, neurotoxicity, and
reproductive toxicity from worker exposures. Further, based on test
data on the PMN substance and EcoSAR analysis of test data on analogous
monoepoxides, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 2 ppb of the PMN substance in surface
waters. For the site-limited intermediate use described in the PMN,
significant worker dermal exposure is unlikely due to the use of
impervious personal protective equipment and releases of the substance
are not expected to result in surface water concentrations that exceed
2 ppb. Therefore, EPA has not determined that manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that use of the substance without workers
wearing impervious gloves, where there is a potential for dermal
exposures; use of the substance other than as a site-limited chemical
intermediate, or any use of the substance resulting in surface water
concentrations exceeding 2 ppb may cause serious health effects and
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.  721.170
(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), (b)(4)(i), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a
porous pot test (OPPTS Test Guideline 835.3220); a mammalian
erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) by the
intraperitoneal route; a combined repeated dose toxicity test (OPPTS
Test Guideline 870.3650) with the reproduction/development toxicity
screening test and neurotoxicity endpoints; a carcinogenicity test
(OPPTS Test Guideline 870.4200); a fish early-life stage toxicity test
(OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS
Test Guideline 850.1300); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the human health and
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10552.
PMN Number P-06-149
    Chemical name: Potassium titanium oxide.
    CAS number: 12673-69-7.
    Effective date of TSCA section 5(e) consent order: March 18, 2008.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance is as a physical
characteristics modifier for industrial use in certain solid composite
articles. Based on test data on the PMN substance and SAR analysis of
test data on analogous respirable, poorly soluble particulates
(subcategory titanium dioxide), EPA identified concerns for lung
toxicity and fibrosis in workers exposed to the PMN substance by the
inhalation route. The Order was issued under sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) of TSCA based on a finding that the substance may
present an unreasonable risk of injury to human health. To protect
against this risk, the consent order requires:
    1. Use of personal protective equipment including a National
Institute for Occupational Safety and Health (NIOSH)-certified
respirator with an assigned protection factor (APF) of at least 10, or
compliance with a NCEL of 1.5 mg/m\3\ as a time weighted average (when
there is a potential for inhalation exposures).
    2. Establishment and use of a hazard communication program.
    3. No manufacture of the PMN substance with a particle size less
than 100 nanometers.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Recommended testing: EPA determined that the results of the
following study would help characterize the human health effects of the
PMN substance: A 90-day inhalation toxicity test with special attention
to histopathology (inflammation and cell proliferation) of the lung
tissues and to various parameters of the broncoalveolar lavage fluid
(BALF), e.g., marker enzyme activities, total protein content, total
cell count, cell differential, and cell viability (OPPTS Test Guideline
870.3465).
    CFR citation: 40 CFR 721.10553.
PMN Number P-06-153
    Chemical name: Iso-tridecanol (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: October 13,
2006.
    Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used as a reactant. Based on test data on the PMN

substance, and EcoSAR analysis of test data on analogous neutral
organic compounds, EPA predicts toxicity to aquatic organisms at
concentrations that exceed 8 ppb of the PMN substance in surface
waters. Further, aquatic toxicity, persistence, and bioaccumulation
potential vary depending on the isoindex (i.e., the average number of
branches per alkyl unit) of the PMN substance. EPA has determined that
as the isoindex increases, persistence and bioaccumulation values
increase. At the isoindex value of 2.32 for the intended PMN substance,
the substance is not considered a PBT chemical and aquatic toxicity
risk is mitigated by the decrease in persistence. However, as the
isoindex increases above 3, EPA estimates that the PMN substance will
persist in the environment more than two months and EPA estimates a
bioaccumulation factor of greater than or equal to 1000. If the
isoindex is less than three, the PMN is not expected to persist. The
consent order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I), based on a finding that this substance may present
an unreasonable risk of injury to the environment. To protect against
these risks, the consent order requires manufacture of the PMN
substance according to the chemical composition section of the consent
order, with no greater than an average of three branches per alkyl unit
and routine analysis of the PMN substance to verify compliance with the
average number of alkyl units restriction. The SNUR designates as a
``significant new use'' the absence of these protective measures.
    Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); a fish early-
life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid
chronic toxicity test (OPPTS Test Guideline 850.1300) would help
characterize the environmental effects of the PMN substance. The
consent order does not require the submission of this testing at any
specified time or production volume. However, the consent order's
restrictions on manufacture, import, processing, distribution in
commerce, use, and disposal of the PMN substances will remain in effect
until the consent order is modified or revoked by EPA based on
submission of that or other relevant information.
    CFR citation: 40 CFR 721.10554.
PMN Number P-06-370
    Chemical name: Benzoic acid nonyl ester, branched and linear.
    CAS number: 670241-72-2.
    Basis for action: The PMN states that the substance will be used as
a softener for polyvinyl chloride. Based on test data on the PMN
substance, EPA identified concerns for developmental toxicity from
exposure to the PMN substance. In addition, based on test data on the
PMN substance and EcoSAR analysis of test data on analogous esters, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 6 ppb of the PMN substance in surface waters. As described in
the PMN, dermal exposures are not expected due to the use of impervious
gloves and no domestic manufacture, and releases of the PMN substance
are not expected to result in surface water concentrations that exceed
6 ppb. Therefore, EPA has not determined that the proposed processing
or use of the substance presents an unreasonable risk. EPA has
determined, however, that any use of the substance without impervious
gloves, where there is a potential for dermal exposures; any domestic
manufacture; or any use of the substance resulting in surface water
concentrations exceeding 6 ppb may cause serious health effects and
significant adverse environmental effects. Based on this information
the PMN substance meets the concern criteria at Sec.  721.170
(b)(3)(i), (b)(4)(i), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day subchronic dermal toxicity test in rats (OPPTS Test Guideline
870.3250) and a daphnid chronic toxicity test (OPPTS Test Guideline
850.1300) would help characterize the human health and environmental
effects of the PMN substance. EPA also recommends that the special
considerations for conducting aquatic laboratory studies (OPPTS Test
Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10555.
PMN Numbers P-06-450, P-06-451, and P-06-452
    Chemical names: (P-06-450) Poly(oxy-1,2-ethanediyl), .alpha.- (2-
methyl-2-propen-1-yl) -.omega.-hydroxy-,C12-15-alkyl ethers;
(P-06-451) Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl)
-.omega.-hydroxy-,C10-16-alkyl ethers; and (P-06-452)
Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-
hydroxy-,C12-16-alkyl ethers.
    CAS numbers: (P-06-450) 675869-02-0; (P-06-451) 620610-66-4; and
(P-06-452) 675869-05-3.
    Basis for action: The consolidated PMN states that the substances
will be used as wetting agents for low foam spray metal cleaning. Based
on EcoSAR analysis of test data on analogous neutral organic chemicals,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 10 ppb of the PMN substances in surface waters. At the
combined production volume stated in the notice, releases of the PMN
substances are not expected to result in surface water concentrations
that exceed 10 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that any increase in
the combined annual manufacture and import volume of 45,000 kilograms
(kgs) of the substances could result in exposures which may cause
significant adverse environmental effects. Based on this information,
the PMN substances meet the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075) on any of the three PMN substances would help characterize
the environmental effects of the PMN substances.
    CFR citations: 40 CFR 721.10556 (P-06-450); 40 CFR 721.10557 (P-06-
451); and 40 CFR 721.10558 (P-06-452).
PMN Number P-06-793
    Chemical name: Morpholine, 4-C6-12 acyl derivs.
    CAS number: 887947-29-7.
    Basis for action: The PMN states that the substance will be used as
a pesticide dispersant/solvent. Based on test data on the PMN
substance, EPA identified concerns for systemic effects from dermal
exposures. As described in the PMN, worker dermal exposures are not
expected due to the use of impervious skin protection and hazard
communication warnings for systemic effects. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without impervious dermal
protection, where there is a potential for dermal exposures, or any use
of the substance without hazard communication warnings for systemic
effects may cause serious health effects. Based on this information,
the PMN meets the concern criteria at Sec.  721.170(b)(3)(i).
    Recommended testing: EPA has determined that the results of 90-day
subchronic dermal toxicity test (OPPTS Test Guideline 870.3250) would
help characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10559.

PMN Numbers P-07-143 and P-07-144
    Chemical names: Alkanoldioic dialkyl esters (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as lubricant additives.
Based on EcoSAR analysis of test data on analogous esters, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 3
ppb of the PMN substances in surface waters for greater than 20 days
per year. This 20-day criterion is derived from partial life cycle
tests (daphnid chronic and fish early-life stage tests) that typically
range from 21 to 28 days in duration. EPA predicts toxicity to aquatic
organisms may occur if releases of the PMN substances to surface water
exceed releases from the use described in the PMNs. For the use
described in the PMNs, environmental releases did not exceed 3 ppb for
more than 20 days per year. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substances presents
an unreasonable risk. EPA has determined, however, that any use of the
substances other than as described in the PMNs may cause significant
adverse environmental effects. Based on this information the PMN
substances meet the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) would
help characterize the environmental effects of the PMN substances. EPA
also recommends that the special considerations for conducting aquatic
laboratory studies (OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10560.
PMN Number P-07-327
    Chemical name: Substituted phenol (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: September 17,
2008.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as an
antioxidant. Based on EcoSAR analysis of test data on analogous
phenols, EPA predicts toxicity to aquatic organisms at concentrations
that exceed 1 ppb of the PMN substance in surface waters. The consent
order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I),
and 5(e)(1)(A)(ii)(II), based on a finding that the substance may
present an unreasonable risk of injury to the environment, may be
produced in substantial quantities, and may reasonably be anticipated
to enter the environment in substantial quantities. To protect against
these risks, the consent order requires:
    1. Establishment and use of a hazard communication program.
    2. No release of the PMN substance into the waters of the United
States.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Recommended testing: EPA has determined that the results of certain
human health toxicity testing specified in the consent order would help
characterize the human health effects of the substance. The PMN
submitter has agreed not to exceed the confidential production volume
limit without performing an in vitro mouse lymphoma assay (mammalian
cell mutation test) (OPPTS Test Guideline 870.5300) and a repeated dose
28-day oral toxicity test (OPPTS Test Guideline 870.3050) to include a
neurotoxicity battery (OPPTS Test Guideline 870.6200).
    In addition, EPA has determined that the results of a fish early-
life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid
chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal
toxicity test (OCSPP Test Guideline 850.4500) would help characterize
the environmental effects of the PMN substance. The consent order does
not require submission of this aquatic toxicity testing by any
specified time or production volume. However, the consent order's
restrictions on manufacture, import, processing, distribution in
commerce, use and disposal of the PMN will remain in effect until the
consent order is modified or revoked by EPA based on submission of that
or other relevant information.
    CFR citation: 40 CFR 721.10561.
PMN Number P-07-375
    Chemical name: Aluminum trihydrate and silane homopolymer
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance will
be as a flame retardant. Based on test data on an analogous insoluble
high molecular weight polymer, EPA identified concerns for lung
toxicity if the PMN substance is inhaled. At an annual production
volume of 100,000 kgs, worker exposure is limited and consumer exposure
is not expected. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any increase of
the annual 100,000 kg production volume may result in increased
exposure to the PMN substance which may cause significant adverse human
health effects. Based on this information, the PMN substance meets the
concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-
day holding period would help characterize the health effects of the
PMN substance.
    CFR citation: 40 CFR 721.10562.
PMN Number P-07-496
    Chemical name: 2-Oxiranemethanamine, N-[3-(2-
oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-.
    CAS number: 71604-74-5.
    Basis for action: The PMN substance will be used as a preparation
of pre-impregnated cloth/fiber tapes for aerospace composite articles.
Based on SAR analysis of test data on analogous epoxides, EPA
identified concerns for oncogenicity, mutagenicity, developmental
toxicity, reproductive toxicity, and liver toxicity from exposure to
the PMN substance. As described in the PMN, worker dermal exposure to
the PMN substance will be minimal due to the use of impervious gloves,
and no significant inhalation exposure is expected. Therefore, EPA has
not determined that the proposed manufacturing, processing, or use of
the substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without the use of impervious
gloves, where there is potential for dermal exposure, or any use of the
substance other than as a preparation of pre-impregnated cloth/fiber
tapes for aerospace composite articles may cause serious health
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(1)(i)(C) and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day subchronic dermal toxicity test in rats (OPPTS Test Guideline
870.3250) and a dermal carcinogenicity test (OPPTS Test Guideline
870.4200) would help characterize the human health effects of the PMN
substance.
    CFR citation: 40 CFR 721.10563.
PMN Number P-08-39
    Chemical name: Mixed amino diaryl sulfone isomers (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a hardening agent. Based
on SAR analysis of test data on analogous dianilines, EPA identified

concerns for immunotoxicity, oncogenicity, blood effects, liver
effects, and hypersensitivity from exposures to the PMN substance. In
addition, based on EcoSAR analysis of analogous dianilines, EPA
predicts toxicity to aquatic organisms at concentrations that exceed 8
ppb of the PMN substance in surface waters. For the non-consumer use
described in the PMN, significant worker exposures are not expected as
the PMN is used in liquid form, and releases of the substance to
surface waters are not expected. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance
presents an unreasonable risk. EPA has determined, however, that any
use of the substance in consumer products, any use of the substance in
the form of a powder, or any use of the substance resulting in surface
water concentrations exceeding 8 ppb may cause serious health effects
and significant adverse environmental effects. Based on this
information the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a rat
acute oral retinopathy screening test; a pigmented rat 90-day
subchronic toxicity test (OPPTS Test Guidelines 870.3100 or 870.3465)
by either the oral or inhalation route, including histopathological
examination of the eyes (by both light and electron microscopy) and
reproductive organs; a fish acute toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity
test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline 850.4500) would help characterize
the human health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10564.
PMN Number P-08-263
    Chemical name: Ethanol, 2,2'-[[3-[(2-
hydroxyethyl)amino]propyl]imino]bis-, N-(hydrogenated tallow alkyl)
derivs.
    CAS number: 90367-25-2.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material to
manufacture a surfactant blend. Based on EcoSAR analysis of test data
on analogous aliphatic amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 1 ppb of the PMN
substance in surface waters. As described in the PMN, releases of the
PMN substance are not expected to result in surface water
concentrations that exceed 1 ppb. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that any
use of the substance resulting in surface water concentrations
exceeding 1 ppb may cause significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a
simulation test--aerobic sewage treatment: activated sludge units
(OPPTS Test Guideline 835.3240); a fish acute toxicity test, freshwater
and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity
mitigated by humic acid (OPPTS Test Guideline 850.1085); an aquatic
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline
850.4500) would help characterize the environmental effects of the PMN
substance.
    CFR citation: 40 CFR 721.10565.
PMN Number P-08-292
    Chemical name: 1-Propanamine, N- (1-methylethyl) -,3-
(C12-15-alkyloxy) derivs.
    CAS number: 944835-56-7.
    Basis for action: The PMN states that the substance will be used as
a lubricant additive intermediate. Based on EcoSAR analysis of test
data on analogous aliphatic amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 1 ppb of the
substance in surface waters. As described in the PMN, the substance is
not released to surface waters. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance
presents an unreasonable risk. EPA has determined, however, that any
use of the substance resulting in surface water concentrations
exceeding 1 ppb may cause significant adverse environmental effects.
Based on this information the PMN substance meets the concern criteria
at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); a fish acute
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075);
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline 850.1010); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substance.
    CFR citation: 40 CFR 721.10566.
PMN Number P-08-300
    Chemical name: Amidoamine salt (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a laundry product
additive. Based on EcoSAR analysis of test data on analogous aliphatic
amines, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the substance in surface waters. As
described in the PMN, releases of the substance are not expected to
result in surface water concentrations that exceed 1 ppb. Therefore,
EPA has not determined that the proposed manufacturing, processing, or
use of the substance presents an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 1 ppb may cause significant adverse
environmental effects. Based on this information the PMN substance
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); a fish acute
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075);
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline 850.1010); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substance.
    CFR citation: 40 CFR 721.10567.
PMN Number P-08-464
    Chemical name: Diethanolamine salt of polymeric acid (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
a pigment dispersant in latex paints. Based on EcoSAR analysis of test
data on analogous inorganic phosphates, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 4 ppb of the
substance in surface waters. As described in the PMN, releases of the
substance are not expected to result in surface water concentrations
that exceed 4 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance presents an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 4 ppb may
cause significant adverse environmental effects. Based on this
information the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).

    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10568.
PMN Number P-08-471
    Chemical name: Tricyclic quaternary amine salt (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate.
Based on EcoSAR analysis of test data on analogous cationic
surfactants, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 100 ppb of the substance in surface waters.
As described in the PMN, the substance is not released to surface
waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance presents an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 100 ppb
may cause significant adverse environmental effects. Based on this
information the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10569.
PMN Number P-08-537
    Chemical name: Cyclic amine reaction product with acetophenone and
formaldehyde acid salt (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an acid inhibitor. Based
on test data on the PMN substance and EcoSAR analysis of test data on
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 8 ppb of the PMN substance in
surface waters. As described in the PMN, releases of the PMN substance
are not expected to result in surface water concentrations that exceed
8 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance presents an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 8 ppb may
cause significant adverse environmental effects. Based on this
information the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10570.
PMN Number P-08-611
    Chemical name: 1,3-Benzenediol, polymer with 1,1'-
methylenebis[isocyanatobenzene].
    CAS number: 1008753-84-1.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a rubber additive. Based
on SAR analysis of test data on analogous diisocyanates, EPA identified
concerns for dermal and respiratory sensitization and for pulmonary
toxicity to workers exposed to free isocyanates. Also, based on EcoSAR
analysis of test data on analogous esters and phenols, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb of the PMN substance in surface waters. For the use scenarios
described in the PMN, which were supported by product composition tests
and simulated use condition tests, significant worker exposure is not
expected, and the substance is not released to surface waters.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that use of the substance other than as
described in the PMN (manufacture with all isocyanate groups reacted
within the polymer), or any use of the substance resulting in surface
water concentrations exceeding 1 ppb could result in exposures which
may cause serious health effects or significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170 (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a
dermal sensitization test (OPPTS Test Guideline 870.2600); a 90-day
subchronic inhalation toxicity test (OPPTS Test Guideline 870.3465); a
fish acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the human
health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10571.
PMN Number P-08-680
    Chemical name: Benzamide, N-[[4-
[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxy-.
    CAS number: 221667-31-8.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adjuvant for
agricultural products. Based on test data on the PMN substance, EPA
identified concerns for urinary tract toxicity from exposure to the PMN
substance. As described in the PMN, worker dermal and inhalation
exposures will be minimal due to the use of impervious gloves, a NIOSH-
certified respirator with an APF of at least 10, and establishment of a
hazard communication program. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance may
present an unreasonable risk. EPA has determined, however, that any use
of the substance without impervious gloves, where there is a potential
for dermal exposures; any use of the substance without a NIOSH-
certified respirator with an APF of at least 10, where there is a
potential for inhalation exposures; or without establishing the hazard
communication program may result in serious health effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(i).
    Recommended testing: EPA has determined that inhalation monitoring
data would help characterize the health effects of the PMN substance.
EPA's draft Inhalation Monitoring Data Collection Guidelines are
available in the docket for this rule under docket ID number EPA-HQ-
OPPT-2012-0277.
    CFR citation: 40 CFR 721.10572.
PMN Number P-08-737
    Chemical name: Magnesium hydroxide surface treated with substituted
alkoxy silanes (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
a flame retardant. Based on test data on analogous respirable, poorly
soluble particulates, EPA identified concerns for

lung toxicity and immunotoxicity if the PMN substance is inhaled. For
the use described in the PMN, and at the annual 100,000 kg production
volume stated in the PMN, worker inhalation exposure will be minimal
due to adequate personal protective equipment. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any increase of the annual 100,000 kg production volume,
or use without workers wearing a NIOSH-certified respirator with an APF
of at least 10, or use without an appropriate hazard communication
program may result in serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-
day holding period would help characterize the health effects of the
PMN substance.
    CFR citation: 40 CFR 721.10573.
PMN Number P-09-48
    Chemical name: Alkylcarboxy polyester acrylate reaction products
with mixed metal oxides (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: August 31, 2009.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a film
coating additive. Based on particle size data on the PMN substance, and
SAR analysis of test data on analogous respirable, poorly soluble
particulates, EPA identified concerns for inflammation of the lungs,
lung fibrosis and lung cancer, as well as internal organ effects. In
addition, based on EcoSAR analysis of test data on analogous acrylate
substances, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 55 ppb of the PMN substance in surface
waters. The consent order was issued under TSCA sections 5(e)(1)(A)(i)
and 5(e)(1)(A)(ii)(I), based on a finding that this substance may
present an unreasonable risk of injury to human health and the
environment. To protect against these risks, the consent order
requires:
    1. Use of impervious gloves (when there is a potential for dermal
exposure).
    2. Establishment and use of a hazard communication program.
    3. No manufacturing, processing, or use of the PMN substance in
non-enclosed processes when the PMN substance is in the powder form.
    4. No use involving an application method that generates a vapor,
mist, aerosol, or a dust.
    5. Transport of the PMN substance to processors using only reusable
tote tanks cleaned not more than once per year.
    6. Use of the PMN substance only for the confidential use specified
in the consent order.
    7. Disposal of the PMN substance, any waste streams from
manufacture of the PMN substance, and any waste streams from processing
of the PMN substance only by incineration in a Resource Conservation
and Recovery Act (RCRA)-approved hazardous waste incinerator.
    8. Waste streams from use of the PMN substance must either be
disposed of by incineration in a RCRA-approved hazardous waste
incinerator, or be recycled via polymer reclamation.
    9. No release of the PMN substance into the waters of the United
States.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test in rats with a post-exposure observation
period of up to 60 days, including bronchoalveolar lavage fluid
analysis (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413);
determination of incineration removal efficiency, full dissolution test
using transformed PMN substance following incineration (OECD ENV/JM/
MONO(2001)); and particle size distribution, aspect ratio, and
crystalline structure of transformed PMN substance following
incineration (OPPTS Test Guideline 830.7520) would help characterize
the human health effects, environmental fate, and physical chemical
properties of the PMN substance. The consent order does not require
submission of this testing at any specified time or production volume.
However, the consent order's restrictions on manufacture, import,
processing, distribution in commerce, use, and disposal of the PMN will
remain in effect until the consent order is modified or revoked by EPA
based on submission of that or other relevant information.
    CFR citation: 40 CFR 721.10574.
PMN Number P-09-480
    Chemical name: 1-Propanone, 1,1'-(oxydi-4,1-phenylene)bis[2-
hydroxy-2-methyl-.
    CAS number: 71868-15-0.
    Basis for action: The PMN states that the use of the substance will
be used as a co-photoinitiator for ultra-violet (UV)-curable pigmented
inks, co-photo initiator for photoresists, optical fibers and printed
plates, and co-photoinitiator for UV-curable coatings and a co-
photoinitiator for UV-curable adhesives and other coatings. Based on
test data on the PMN substance, EPA identified concerns for
reproductive toxicity effects from exposure to the PMN substance. In
addition, based on test data on the PMN substance, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
14 ppb of the PMN substance in surface waters. For the use described in
the PMN, worker exposure will be minimal due to the use of a NIOSH-
certified respirator with an APF of at least 50, adequate hazard
communication, and no domestic manufacture of the PMN substance, and
environmental effects will be minimal as releases of the substance to
surface waters are not expected. Therefore, EPA has not determined that
the proposed processing or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance without a NIOSH-certified respirator with an APF of at least
50, where there is potential inhalation exposure; any domestic
manufacture; without adequate hazard communication; or any use of the
substance resulting in surface water concentrations exceeding 14 ppb
may cause serious health effects and significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(3)(i) and (b)(4)(i).
    Recommended testing: EPA has determined that the results of a two-
generation reproductive toxicity (OECD Test Guideline 416); a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the human health and environmental effects of the PMN
substance. EPA also recommends that the special considerations for
conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000)
be followed.
    CFR citation: 40 CFR 721.10575.
PMN Number P-09-486
    Chemical name: Polyalkenyl, N,N'-bistriazole (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non
confidential) use of the substance will be as a lubricant additive.
Based on EcoSAR analysis of analogous polycationic polymers, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 140 ppb of the PMN substance in surface waters for greater than
20 days

per year. This 20-day criterion is derived from partial life cycle
tests (daphnid chronic and fish early-life stage tests) that typically
range from 21 to 28 days in duration. EPA predicts toxicity to aquatic
organisms may occur if releases of the PMN substance to surface water
exceed releases from the use described in the PMN. For the use
described in the PMN, environmental releases did not exceed 140 ppb for
more than 20 days per year. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that any use of the
substance other than as described in the PMN may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10576.
PMN Number P-09-636
    Chemical name: Benzenamine, 5-(1,1-dimethylethyl)-2-[(2-
ethylhexyl)thio]-,4-methylbenzenesulfonate (1:1).
    CAS number: 852360-51-1.
    Effective date of TSCA section 5(e) consent order: June 4, 2010.
    Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used as a chemical intermediate. EPA has identified
health and environmental concerns because the substance may be a PBT
chemical, based on physical/chemical properties of the PMN substance,
as described in the New Chemical Program's PBT category. EPA estimates
that the PMN substance will persist in the environment more than two
months and estimates a bioaccumulation factor of greater than or equal
to 5,000. Also, based on test data on the PMN substance and SAR
analysis for anilines, EPA predict toxicity to aquatic organisms at
concentrations that exceed 1 ppb and developmental toxicity to workers
from exposures during uses other than as a site-limited chemical
intermediate. The consent order was issued under TSCA section
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the consent order
requires:
    1. Establishment and use of a hazard communication program.
    2. Use of the PMN substance only as a site-limited intermediate.
    3. No release of the PMN substance into the waters of the United
States.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Recommended testing: EPA has determined that the results of human
health, aquatic toxicity, and environmental fate testing would help
characterize the effects of the PMN substance. The PMN submitter has
agreed not to exceed the first production volume limit of 15,000 kgs
prior to submitting testing to determine the log Kow value (by either
the liquid chromatography test (OPPTS Test Guideline 830.7575) or the
generator column method (OPPTS Test Guideline 830.7560)); and the ready
biodegradability test (OPPTS Test Guideline 835.3110) by any of six
methods described in the consent order: Depending on the results of the
first tier testing, the PMN submitter has agreed not to exceed the
second production volume limit of 170,000 kgs prior to submitting
testing to determine biodegradation and bioaccumulation potential.
Further, depending upon the results of the second tier testing, the PMN
submitter has agreed not to exceed the third production volume limit of
496,000 kgs prior to submitting: a combined repeated dose toxicity test
with a reproductive/developmental toxicity screening test (OECD Test
Guideline 422) in rats; a mammalian erythrocyte micronucleus test
(OPPTS Test Guideline 870.5395) via the intraperitoneal route; a
sediment/water microcosm biodegradation test (OPPTS Test Guideline
835.3180); fish early-life stage toxicity test (OPPTS Test Guideline
850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline
850.1300).
    CFR citation: 40 CFR 721.10577.
PMN Number P-10-231
    Chemical name: Unsaturated polyester imide (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance will
be as electrical insulating varnish for motors, generators and
transformers. Based on EcoSAR analysis of aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 52 ppb of the PMN substance in surface waters. As described in
the PMN, the substance is not released to surface waters. Therefore,
EPA has not determined that the proposed manufacturing, processing, or
use of the substance may present an unreasonable risk. EPA has
determined, however, that any use of the substance resulting in surface
water concentrations exceeding 52 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline:
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline: 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance. EPA also recommends that
the special considerations for conducting aquatic laboratory studies
(OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10578.
PMN Number P-10-367
    Chemical name: Carbon black derived from the pyrolysis of rubber
tire shreds (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: May 16, 2011.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as carbon black
for general industrial use. Based on test data on carbon black and SAR
analysis of test data on analogous respirable, poorly soluble
particulates, EPA identified concerns for immunotoxicity, pulmonary
toxicity, and carcinogenicity. In addition, based on aquatic toxicity
data on carbon black, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 1,000 ppb of the PMN substance in
surface waters. The consent order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that this
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the consent order
requires:
    1. Manufacture of the PMN substance using only the process
described in the PMN.
    2. Manufacturing, processing, or use of the PMN substance in
compliance with the Occupational Safety and Health Administration
(OSHA) Permissible Exposure Limit (PEL) for carbon black of 3.5 mg/
m\3\.
    3. Manufacture of the PMN substance to meet the NIOSH recommended
time weighted average (TWA) for polyaromatic hydrocarbons (PAH) in
carbon black of 0.1 mg/m\3\ as described in the NIOSH Pocket Guide to
Chemical

Hazards Appendix C (see http://www.cdc.gov/niosh/npg/nengapdza.html).
    4. Submission of data demonstrating compliance with the NIOSH TWA
for PAH as described in the testing section of the consent order.
    5. No release of the PMN substance into the waters of the United
States.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Recommended testing: EPA has determined that the results of certain
human health testing would help characterize the human health effects
of the PMN substance. The PMN submitter has agreed not to exceed the
confidential production volume specified in the consent order prior to
performing a 90-day inhalation toxicity test (OPPTS Test Guideline
870.3465) with (1) a post-exposure observation period of up to 3
months; (2) bronchoalveolar lavage fluid (BALF) analysis, aggregate/
agglomeration state, shape, size/size particle distribution and surface
properties of materials as administered; (3) aggregation/agglomeration
state, shape, size/size particle distribution; and surface properties
of materials of the delivered materials after administration; and (4)
determination of cardiovascular toxicity, heart histopathology, and
data on pulmonary deposition. Further, the PMN submitter must submit
additional worker exposure monitoring data to determine whether worker
exposures exceed the NIOSH REL for PAH. In addition, EPA has determined
that the results of a 2-year carcinogenicity test (OPPTS Test Guideline
870.4300) would help characterize the human health effects of the PMN
substance. The consent order does not require submission of this test
at any specified time or production volume. However, the consent
order's restrictions on manufacture, import, processing, distribution
in commerce, use, and disposal of the PMN will remain in effect until
the consent order is modified or revoked by EPA based on submission of
that or other relevant information.
    CFR citation: 40 CFR 721.10579.
PMN Number P-10-452
    Chemical name: Poly[oxy(methyl-1,2-ethanediyl)], alpha, alpha'-
[1,4-cyclohexanediylbis(methylene)]bis[omega-(2-aminomethylethoxy)-.
    CAS number: 1220986-58-2.
    Basis for action: The PMN states that the use for this substance
will be as an epoxy curing agent. Based on EcoSAR on analogous
aliphatic amines, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 98 ppb of the PMN substance in surface
waters. As described in the PMN notice, releases of the PMN substance
are not expected to result in surface water concentrations that exceed
98 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 98 ppb,
may cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a
porous pot test (OPPTS Test Guideline 835.3220); a fish acute toxicity
test, freshwater and marine (OPPTS Test Guideline: 850.1075); an
aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline: 850.1010); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substance.
    CFR citation: 40 CFR 721.10580.
PMN Numbers P-10-524 and P-10-525
    Chemical names: Brominated polyurethane prepolymers of methylene
diphenyl diisocyanate (MDI) (generic).
    CAS numbers: Not available.
    Basis for action: The consolidated PMN states that the generic
(non-confidential) use of the substances will be as components of
polyurethane coatings for non-consumer use. Based on test data on
analogous isocyanates, EPA identified concerns for dermal
sensitization, respiratory sensitization, and irritation. For the non-
consumer use described in the PMNs, worker inhalation exposures will be
minimal due to the use of a NIOSH-certified respirator with an APF of
at least 10. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that any use of the
substances without a NIOSH-certified respirator with an APF of at least
10, where there is a potential of inhalation exposures, or any consumer
use of the substances may result in human exposures which may cause
serious health effects. Based on this information, the PMN substances
meet the concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a
dermal sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS 870.3465) in rodents would help
characterize the human health effects of the PMN substances.
    CFR citation: 40 CFR 721.10581.
PMN Number P-10-571
    Chemical name: Quaternary ammonium compound (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an inhibitor for oil
field applications. Based on EcoSAR on analogous cationic surfactants,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 47 ppb of the PMN substance in surface waters. As described
in the PMN, releases of the PMN substance are not expected to result in
surface water concentrations that exceed 47 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 47 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); a fish acute
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075);
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline 850.1010); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the environmental and fate
effects of the PMN substance. EPA also recommends that the special
considerations for conducting aquatic laboratory studies (OPPTS Test
Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10582.
PMN Number P-10-588
    Chemical name: Benzenamine, 4,4'-[1,3-phenylenebis(1-
methylethylidene)]bis-.
    CAS number: 2687-27-6.
    Basis for action: The PMN states that the use will be as a
precursor to a polyimide resin. Based on SAR analysis of test data on
analogous aromatic amines, EPA identified concerns for chronic organ
effects, developmental toxicity and reproductive toxicity from
exposures to the PMN substance. In addition, based on EcoSAR analysis
of test data on analogous aromatic amines, EPA predicts toxicity to
aquatic organisms at concentrations that exceed

1 ppb of the PMN substance in surface waters. As described in the PMN,
inhalation exposures are expected to be minimal due to the use of a
NIOSH-certified particulate respirator with an APF of at least 1,000
and releases to surface waters are not expected. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without a NIOSH-certified
particulate respirator with an APF of at least 1,000, where there is
potential for inhalation exposures, or any use of the substance
resulting in surface water concentrations exceeding 1 ppb may cause
serious health effects and significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec.  721.170 (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a log
Kow test (OPPTS Test Guideline 830.7550, 830.7560 or 830.7570; or OECD
Test Guideline 123); a ready biodegradability test (OPPTS Test
Guideline 835.3110); and a combined repeated dose toxicity with the
reproduction/development toxicity screening test (OPPTS Test Guideline
835.3650) would help characterize the human health and environmental
effects of the PMN substance.
    CFR citation: 40 CFR 721.10583.
PMN Number P-11-29
    Chemical name: Cyclopentene, 1,3,3,4,4,5,5-heptafluoro-.
    CAS number: 1892-03-1.
    Basis for action: The PMN states that the substance will be used as
a dry etching agent for production of semiconductors. Based on test
data on the PMN substance and SAR analysis of test data on analogous
halogenated hydrocarbons, EPA identified concerns for chronic toxicity
from exposure to the PMN substance. In addition, based on EcoSAR
analysis of analogous neutral organic compounds, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 2 ppb of
the PMN substance in surface waters for greater than 20 days per year.
This 20-day criterion is derived from partial life cycle tests (daphnid
chronic and fish early-life stage tests) that typically range from 21
to 28 days in duration. EPA predicts toxicity to aquatic organisms may
occur if releases of the PMN substance to surface water exceed releases
from the use described in the PMN. Significant exposures are not
expected at a production volume of less than 10,000 kg per year. In
addition, there is no consumer use or domestic manufacture for the PMN
substance. Further, for the use described in the PMN, environmental
releases did not exceed 2 ppb for more than 20 days per year.
Therefore, EPA has not determined that the proposed processing or use
of the substance may present an unreasonable risk. EPA has determined,
however, that any domestic manufacture; any use of the substance other
than as a dry etching agent for production of semiconductors; any use
in a consumer product; or exceedance of the annual import limit of
10,000 kg per year could change exposure potential and may cause
serious health effects and significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec.  721.170 (b)(3)(i), (b)(3)(ii), (b)(4)(i), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day repeated dose inhalation test (OPPTS Test Guideline 870.3465); a
fish early-life stage toxicity test (OPPTS Test Guideline 850.1400);
and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300)
would help characterize the human health and environmental effects of
the PMN substance. EPA also recommends that the special considerations
for conducting aquatic laboratory studies (OPPTS Test Guideline
850.1000) be followed.
    CFR citation: 40 CFR 721.10584.
PMN Numbers P-11-43 and P-11-44
    Chemical names: (P-11-43) Disiloxane, 1-butyl-1,1,3,3-tetramethyl-
and (P-11-44) Disiloxane, 1,3-dibutyl-1,1,3,3-tetramethyl-.
    CAS numbers: (P-11-43) 121263-51-2 and (P-11-44) 4619-08-3.
    Basis for action: The PMN states that the use of the substances
will be as reducing agents for organic substrates and as chemical
intermediates. Based on EcoSAR analysis of test data on analogous
neutral organic compounds, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 1 ppb of the PMN substances in
surface waters. As described in the PMNs, the substances are not
released to surface waters. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substances may
present an unreasonable risk. EPA has determined, however, that any use
of the substances resulting in surface water concentrations exceeding 1
ppb may cause significant adverse environmental effects. Based on this
information, the PMN substances meet the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substances. EPA also
recommends that the special considerations for conducting aquatic
laboratory studies (OPPTS Test Guideline 850.1000) be followed.
    CFR citations: 40 CFR 721.10585 (P-11-43) and 40 CFR 721.18586 (P-
11-44).
PMN Number P-11-81
    Chemical name: 1H-Pyrazole, 3,4-dimethyl-.
    CAS number: 2820-37-3.
    Basis for action: The PMN states that the use of the substance will
be as an intermediate. Based on EcoSAR analysis of test data on
analogous pyrazoles, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 19 ppb of the PMN substance in
surface waters. As described in the PMN, the substance is not released
to surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 19 ppb
may cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of: either
a ready biodegradability test (OPPTS Test Guideline 835.3110) or a
porous pot test (OPPTS Test Guideline 835.3220); a fish acute toxicity
test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline
850.4500) would help characterize the environmental and fate effects of
the PMN substance.
    CFR citation: 40 CFR 721.10587.
PMN Number P-11-98
    Chemical name: Phenol, 2-[1-[[3-(1H-imidazol-1-
yl)propyl]imino]ethyl]-.
    CAS number: 1253404-90-8.
    Basis for action: The PMN states that the generic (non-
confidential) use will be as an epoxy catalyst. Based on EcoSAR
analysis of test data on analogous phenols, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb of

the PMN substance in surface waters. As described in the PMN, the
substance is not released to surface waters. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 1 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guidelines 835.3110); a hydrolysis as
a function of pH test (OPPTS Test Guideline 835.2110); an aerobic
treatment simulation test (OECD Test Guideline 303A); a fish acute
toxicity test, freshwater and marine (OPPTS Test Guidelines 850.1075);
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline 850.1010); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the environmental and fate
effects of the PMN substance. EPA also recommends that the special
considerations for conducting aquatic laboratory studies (OPPTS Test
Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10588.
PMN Numbers P-11-106 and P-11-107
    Chemical names: (P-11-106) Unsaturated fatty acids, amides with
polyethylenepolyamine (generic) and (P-11-107) Fatty acids, amides with
triethylentetramine (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that substances will be used as a
surfactant in asphalt emulsion (P-11-106) and an anti-stripping agent
in asphalt (P-11-107). Based on EcoSAR analysis of test data on
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 1 ppb of the PMN substances in
surface waters. As described in the PMN, the substances are not
released to surface waters. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substances may
present an unreasonable risk. EPA has determined, however, that any use
of the substances resulting in surface water concentrations exceeding 1
ppb may cause significant adverse environmental effects. Based on this
information, the PMN substances meet the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substances. EPA also recommends that
the special considerations for conducting aquatic laboratory studies
(OPPTS Test Guideline 850.1000) be followed.
    CFR citations: 40 CFR 721.10589 (P-11-106) and 40 CFR 721.10590 (P-
11-107).
PMN Number P-11-110
    Chemical name: Tertiary ammonium compound (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an inhibitor for oil
field applications. Based on EcoSAR analysis of test data on analogous
aliphatic amines, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb of the PMN substance in surface
waters. As described in the PMN, the substance is not released to
surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 1 ppb may
cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage test, freshwater and marine (OPPTS Test Guideline
850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline
850.1300); and a mysid chronic toxicity test (OPPTS Test Guideline
850.1350) in salt water would help characterize the environmental
effects of the PMN substance. EPA also recommends that the special
considerations for conducting aquatic laboratory studies (OPPTS Test
Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10591.
PMN Number P-11-130
    Chemical name: 1-Butanol, 4-amino-.
    CAS number: 13325-10-5.
    Basis for action: The PMN states that the PMN substance will be
used as an intermediate. Based on SAR analysis of test data on
analogous aliphatic amines, EPA identified concerns for neurotoxicity,
liver toxicity, and kidney toxicity from exposures to the PMN
substance. For the intermediate use described in the PMN, significant
worker exposures are not expected. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, use of
the substance other than as an intermediate may cause serious health
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); an acute oral
toxicity test (OPPTS Test Guideline 870.1100); a repeated dose 28-day
oral toxicity in rodents (OPPTS Test Guideline 870.3050) including a
neurotoxicity functional observational battery, as described in the
neurotoxicity screening battery (OPPTS Test Guideline 870.6200); a
bacterial reverse mutation test (OPPTS Test Guideline 870.5100); and a
mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395)
via the intraperitoneal route would help characterize the human health
and fate effects of the PMN substance.
    CFR citation: 40 CFR 721.10592.
PMN Number P-11-162
    Chemical name: 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-
dioxo-, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester.
    CAS number: 70293-55-9.
    Basis for action: The PMN states that the substance will be uses as
an adhesive monomer. Based on EcoSAR analysis of test data on analogous
esters and methacrylates, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 20 ppb of the PMN substance in
surface waters. As described in the PMN, releases of the substance are
not expected to result in surface water concentrations that exceed 20
ppb. Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance resulting in
surface water concentrations exceeding 20 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute

toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance. EPA also
recommends that the special considerations for conducting aquatic
laboratory studies (OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10593.
PMN Number P-11-173
    Chemical name: Hexanedioic acid, polymer with 2,2-dimethyl-1,3-
propanediol, 1,6-hexanediol, hydrazine, 3-hydroxy-2-(hydroxymethyl)-2-
methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane and 1,1'-[(1-methylethylidene)bis(4,1-
phenyleneoxy)]bis[2-propanol], iso-Bu alc.-blocked, compds. with
triethylamine.
    CAS number: 1138156-39-4.
    Basis for action: The PMN states that the generic (non-
confidential) use for the substance will be as a coating for wooden
floors. Based on EcoSAR analysis of test data on analogous amphoteric
polymers, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 150 ppb for the PMN substance in surface
waters. As described in the PMN, releases of the substance to surface
waters are not expected to result in surface water concentrations that
exceed 150 ppb, due to pretreatment by primary, secondary, and tertiary
waste treatment, or treatment in a lined, self-contained solar
evaporation pond. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 150 ppb
may cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance. EPA also recommends that
the special considerations for conducting aquatic laboratory studies
(OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10594.
PMN Number P-11-230
    Chemical name: Octadecen-1-aminium, N-ethyl-N,N-dimethy-, ethyl
sulfate (1:1).
    CAS number: 1256282-88-8.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an antistatic agent for
acrylic yarn. Based on EcoSAR analysis of test data on cationic
surfactants, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 4 ppb of the PMN substance in surface
waters. As described in the PMN, the substance is not released to
surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 4 ppb may
cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075) in clean dilution water; a fish acute toxicity test mitigated
by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate
acute toxicity test, freshwater daphnids (OPPTS Test Guideline
850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500)
would help characterize the environmental effects of the PMN substance.
EPA also recommends that the special considerations for conducting
aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10595.
PMN Number P-11-234
    Chemical name: Oligomeric phenolic ether (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate.
Based on EcoSAR analysis of test data on analogous neutral organic
chemicals, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the PMN substance in surface
waters. As described in the PMN, the substance is not released to
surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 1 ppb may
cause significant adverse environmental effects and result in
substantial human exposure via drinking water or fish ingestion. Based
on this information, the PMN substance meets the concern criteria at
Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); an acute
toxicity test (OPPTS Test Guideline 870.1000); a mammalian erythrocyte
micronucleus test (OPPTS Test Guideline 870.5395); a repeated dose 28-
day oral toxicity test in rodents (OPPTS Test Guideline 870.3050); a
bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a fish
BCF test (OPPTS Test Guideline 850.1730); a fish early-life stage
toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity
test (OCSPP Test Guideline 850.4500) would help characterize the human
health and environmental effects of the PMN substance. EPA also
recommends that the special considerations for conducting aquatic
laboratory studies (OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10596.
PMN Number P-11-252
    Chemical name: Benzeneacetonitrile, alkoxy-
[[(alkylsulfonyl)oxy]imino]- (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a photographic chemical.
Based on EcoSAR analysis of test data on analogous vinyl/allyl
nitriles, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the PMN substance in surface
waters. As described in the PMN, the substance is not released to
surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 1 ppb may
cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300): and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance. EPA also

recommends that the special considerations for conducting aquatic
laboratory studies (OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10597.
PMN Numbers P-11-270, P-11-271, P-11-272, P-11-273, and P-11-274
    Chemical names: (P-11-270) Lead strontium titanium zirconium oxide;
(P-11-271) Calcium cobalt lead titanium tungsten oxide; (P-11-272)
Calcium cobalt lead strontium titanium tungsten oxide; (P-11-273)
Lanthanum lead titanium zirconium oxide; and (P-11-274) Lead niobium
titanium zirconium oxide.
    CAS numbers: (P-11-270) 61461-40-3; (P-11-271) 1262279-31-1; (P-11-
272) 1262279-30-0; (P-11-273) 1227908-26-0; and (P-11-274) 56572-83-9.
    Basis for action: The PMNs state that the substances will be used
as piezoelectric ceramics for active and passive underwater acoustic
systems. Based on test data on lead and SAR analysis of test data on
analogous respirable, poorly soluble particulates, EPA identified
concerns for neurobehavioral and other neurological effects,
cerebrovascular disease, high blood pressure, renal effects, cardiac
effects, lung effects, neurological effects, hematological effects,
reproductive toxicity, and immunotoxicity. In addition, based on EcoSAR
analysis of test data on analogous inorganic lead compounds, EPA
expects toxicity to aquatic organisms to occur at concentrations that
exceed an aggregate of 8 ppb of the PMN substances in surface waters.
For the uses described in the PMNs, worker inhalation exposures are
expected to be minimal due to use of a NIOSH-certified respirator with
an APF of at least 50, and releases of the PMN substances are not
expected to result in an aggregate surface water concentration that
exceeds 8 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that any use of the
substances without the use of a NIOSH-certified respirator with an APF
of at least 50, where there is a potential for inhalation exposures;
any use of the substances other than as piezoelectric ceramics for
active and passive underwater acoustic systems; or any use of the
substances resulting in an aggregate surface water concentration
exceeding 8 ppb may cause serious health effects and significant
adverse environmental effects. Based on this information the PMN
substances meet the concern criteria at Sec.  721.170 (b)(3)(i) and
(b)(4)(ii).
    Recommended testing: EPA has determined that inhalation monitoring
data, collected according to the EPA draft Inhalation Monitoring Data
Collection Guidelines (located in the docket under docket ID number
EPA-HQ-OPPT-2012-0277) would help characterize the human health effects
of the PMN substances.
    CFR citations: 40 CFR 721.10598 (P-11-270); 40 CFR 721.10599 (P-11-
271); 40 CFR 721.10600 (P-11-272); 40 CFR 721.10601 (P-11-273); and 40
CFR 721.10602 (P-11-274).
PMN Number P-11-280
    Chemical name: Epoxy modified alkyd resin, partially neutralized
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a coating resin. Based on
EcoSAR analysis of test data on analogous phosphates, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb of the PMN substance in surface waters. As described in the PMN,
the substance is not released to surface waters. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 1 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of an
algal toxicity test (OCSPP Test Guideline 850.4500) without adding
phosphate would help characterize the environmental effects of the PMN