[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Rules and Regulations]
[Pages 61566-61587]
[FR Doc No: 2011-25497]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2010-1075; FRL-8880-2]
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
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 36
chemical substances which were the subject of premanufacture notices
(PMNs). Four 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 36 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 5, 2011. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (E.S.T.) on
October 19, 2011.
    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 4, 2011 (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-2010-1075, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention:
Docket ID Number EPA-HQ-OPPT-2010-1075. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is<PHONE_NUMBER>. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2010-1075. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

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:
(202) 564-9232; e-mail address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this rule.
Potentially affected entities may include, but are not limited to:
     Manufacturers, importers, or processors of one or more
subject chemical substances (NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also

be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. To
determine whether you or your business may be affected by this action,
you should carefully examine the applicability provisions in Sec.
721.5. If you have any questions regarding the applicability of this
action to a particular entity, consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. 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;
see also 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 on or after
November 4, 2011 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 e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

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 of April 24, 1990
(55 FR 17376). 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 notice 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 section 5(b)
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2),
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA
receives a SNUN, EPA may take regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities 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 36
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, taking into consideration 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 36 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) 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).
     Toxicity concerns.
     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 4 PMN substances (P-06-36, P-06-37, P-09-146 and
P-09-147) for which EPA determined, pursuant to TSCA section 5(e), that
uncontrolled manufacture, import, processing, distribution in commerce,
use, and disposal may present an unreasonable risk of injury to human
health or the environment. Accordingly, these substances are subject to
``risk-based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I).
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 32 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-
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-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 Numbers P-06-36 and P-06-37
    Chemical names: (P-06-36) Rutile, tin zinc, calcium-doped and (P-
06-37) Rutile, tin zinc, sodium-doped.
    CAS numbers: (P-06-36) 389623-01-2 and (P-06-37) 389623-07-8.
    Effective date of TSCA section 5(e) consent order: February 17,
2009.
    Basis for TSCA section 5(e) consent order: The PMN states that the
substances will be used as colorants for polymers and industrial
coatings. The order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that the substances may present an
unreasonable risk of injury to human health. To protect against these
risks, the consent order requires: Use of personal respiratory
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 an 8-
hour time weighted average; establishment of a hazard communication
program; and restricts the company from manufacturing the PMN
substances with a d10 particle size less than 100 nanometers, where d10
particle size presents the particle size, as determined by laser light
scattering, at which 10 percent by weight of the substance measured is
smaller; and corresponding recordkeeping. The SNUR designates as a
``significant new use'' the absence of these protective measures.
    Toxicity concern: Based on structural activity relationship
analysis derived from test data on structurally similar respirable,
poorly soluble particulates, the PMN substances may cause lung overload
and fibrosis in workers exposed to the PMN substances by the inhalation
route.
    Recommended testing: EPA has determined that the following test
would help characterize the human health effects of the PMN substances:
A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in
rats. The testing should include a 60-day recovery period to assess the
progression or regression of any lesions; and include special attention
to histopathology (inflammation and cell proliferation) of the lung
tissues and to various parameters of the bronchoalveolar lavage fluid
(BALF), e.g., marker enzyme activities, total protein content, total
cell count, cell differential, and cell viability. The order does not
require submission of the aforementioned information at any specified
time or production volume. However, the order's restrictions on
manufacturing, import, processing, distribution in

commerce, use, and disposal of the PMN substances will remain in effect
until the order is modified or revoked by EPA based on submission of
that or other relevant information.
    CFR citations: 40 CFR 721.10230 (P-06-36) and 40 CFR 721.10231 (P-
06-37).
PMN Number P-08-694
    Chemical name: N-arylamino-phenol-formaldehyde condensate
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) uses of the substance will be as a curative to be used
with epoxy resin; a curative to be used with isocyanates in urethane
systems; and an intermediate for synthesis of epoxy resins. Based on
ecological structure-activity relationship (EcoSAR) analysis of test
data on analogous phenols, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 1 part per billion (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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance. Fish and daphnid
testing should be performed using the flow-through method with measured
concentrations. Algal testing should be performed using the static
method with measured concentrations. EPA recommends that the special
considerations for conducting laboratory studies (OPPTS Test Guideline
850.1000) be followed to facilitate solubility in the test media,
because of the PMN's low water solubility. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
    CFR citation: 40 CFR 721.10232.
PMN Number P-08-704
    Chemical name: Linear alkyl epoxide (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) uses of the substance will be as site-limited
intermediates for personal care ingredients and foam control agents.
Based on EcoSAR analysis of test data on analogous epoxides, 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 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance. Fish and daphnid
testing should be performed using the flow-through method with measured
concentrations. Algal testing should be performed using the static
method with measured concentrations. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
    CFR citation: 40 CFR 721.10233.
PMN Number P-09-61
    Chemical name: Hydroxy-chloro-cyclopropyl-heteromonocyclic
carboxylic acid (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
an industrial intermediate. 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 6
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 6 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 6 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 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.
Testing should be performed using the flow-through method with measured
concentrations. Test reports should include protocols approved by EPA,
certificate of analysis for the test substance, raw data, and results.
    CFR citation: 40 CFR 721.10234.
PMN Number P-09-72
    Chemical name: Phenol, 2-ethoxy-4-(ethoxymethyl)-.
    CAS number: 71119-07-8.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a perfumery ingredient.
Based on EcoSAR analysis of test data on analogous phenols, EPA
predicts that 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
PMN 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance. Fish and daphnid
testing should be performed using the flow-through method with

measured concentrations. Algal testing should be performed using the
static method with measured concentrations. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
    CFR citation: 40 CFR 721.10235.
PMN Number P-09-139
    Chemical name: 1-Propanamine, 3-[2-(2-methoxyethoxy)ethoxy]-.
    CAS number: 91933-40-3.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a dispersant. Based on
test data on an analogous substance submitted under TSCA section 8(e),
EPA identified the following toxicity concerns from exposure to the PMN
substance: Irritation to eyes; sensitization and corrosion to skin; and
irritation to mucous membranes, lungs, and the gastrointestinal tract.
For the uses described in the PMN, worker exposure and general
population exposure are limited. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance may
present an unreasonable risk. However, EPA has determined that use of
the substance other than as described in the PMN, or use of the
substance in a consumer product, may result in significant human
exposures. 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 an
acute oral toxicity test (OPPTS Test Guideline 870.1100 or Organisation
for Economic Co-operation and Development (OECD) Test Guideline 425); a
bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a
mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395)
via the intraperitoneal route; and a repeated dose 28-day oral toxicity
study in rodents (OPPTS Test Guideline 870.3050 or OECD Test Guideline
407) would help characterize the human health effects of the PMN
substance. Testing should be performed on the neutralized PMN
substance. Test reports should include protocols approved by EPA,
certificate of analysis for the test substance, raw data, and results.
    CFR citation: 40 CFR 721.10236.
PMN Numbers P-09-146 and P-09-147
    Chemical names: (P-09-146) Formaldehyde, polymers with acetone-
phenol reaction products and phenol, sodium salts and (P-09-147)
Formaldehyde, polymers with acetone-phenol reaction products and
phenol, potassium sodium salts.
    CAS numbers: (P-09-146) 1065544-88-8 and (P-09-147) 1072227-60-1.
    Effective date of TSCA section 5(e) consent order: May 26, 2010.
    Basis for TSCA section 5(e) consent order: The PMNs state that the
generic (non-confidential) use of the substances will be as adhesives.
The order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that the substances may present an
unreasonable risk of injury to human health. To protect against these
risks, the consent order requires: Restrictions on formaldehyde
residuals and polymer composition in the PMN substances; testing of
representative samples at new manufacturing facilities; development and
implementation of a written control plan for analysis and compliance
with specified chemical composition limits; use only as listed in the
consent order; no processing or distribution of the PMNs except when
processed under specified conditions, where the PMNs are irreversibly
cured into a thermoset polymer matrix; and maintaining certain records.
The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Toxicity concern: Based on physical-chemical properties, the PMN
substances are expected to be absorbed from the lung and low molecular
weight fractions are expected to be poorly absorbed from the
gastrointestinal tract. Further, the PMN substances are not expected to
be absorbed through the skin. EPA identified concerns for respiratory
tract irritation, coughing; skin irritation and redness; eye
irritation, watering, and redness; sensitization and severe allergic
reactions. Further, based on test data on formaldehyde, a component of
the PMN substances and regarded by EPA and International Agency for
Research on Cancer (IARC) to be a carcinogen, EPA predicts human
carcinogenicity.
    Recommended testing: EPA has determined that the following test
would help characterize the human health effects of the PMN substances:
Determining formaldehyde concentration in air from wood products, using
a large scale chamber (American Society for Testing and Materials
International (ASTM) Test Guideline E1333-10 or its equivalent) to
demonstrate that formaldehyde emissions are equal to or less than 0.04
parts per million (ppm). The order does not require submission of the
aforementioned information at any specified time or production volume.
However, the order's restrictions on manufacturing, import, processing,
distribution in commerce, use, and disposal of the PMN substances will
remain in effect until the order is modified or revoked by EPA based on
submission of that or other relevant information.
    CFR citations: 40 CFR 721.10237 (P-09-146) and 40 CFR 721.10238 (P-
09-147).
PMN Numbers P-09-152 and P-09-153
    Chemical names: Trivalent chromium complexes of a substituted beta-
naphthol amine azo dye (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the use of the substances
will be as acid dyes for coloring anodized aluminum. Based on test data
on analogous substances including Beta-naphthylamine and chromium, EPA
determined that the PMN substances may cause blood toxicity
(methemoglobinemia), male reproductive toxicity, developmental
toxicity, mutagenicity, and oncogenicity to workers and the general
public exposed to the PMN substances via the lung or gastrointestinal
tract. For the use described in the PMNs, worker inhalation exposure is
unlikely, as the substances are imported, processed, and used as a wet
press cake (greater than 30 percent water). Significant general
population exposure is unlikely, as significant inhalation and drinking
water exposures are not expected. Therefore, EPA has not determined
that the proposed import, processing, or use of the substances may
present an unreasonable risk. EPA has determined, however, that
domestic manufacture, use of the substances other than as described in
the PMNs, or the import, processing, or use of the substances in a
powder or solid form (other than as a wet press cake that is comprised
of greater than 30 percent water), may cause serious health effects.
Based on this information, the PMN substances meet 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
bacterial reverse mutation test (OPPTS Test Guideline 870.5100) with
the prival modification with a concurrent positive control; and an
unscheduled DNA synthesis in mammalian cells in culture (OPPTS Test
Guideline 870.5550) in rat hepatocytes on the Beta-naphthylamine
reduction product would help characterize the human health effects of
the PMN substances. Test reports should include protocols approved by
EPA, certificate of analysis for the test substance, raw data, and
results.
    CFR citation: 40 CFR 721.10239.

PMN Numbers P-09-154, P-09-155, and P-09-156
    Chemical names: (P-09-154) Olefinic carbocycle, reaction products
with alkoxysilane (generic); (P-09-155) olefinic carbocycle, reaction
products with alkoxysilane, sulfurized (generic); and (P-09-156)
olefinic carbocycle, reaction products with alkoxysilane,
polysulfurized (generic).
    CAS numbers: (P-09-154) Not available; (P-09-155) not available;
and (P-09-156) not available.
    Basis for action: The PMNs state that the generic (non-
confidential) uses of the substances will be as a processing additive
intermediate (P-09-154 and P-09-155) and as a processing additive (P-
09-156). Based on EcoSAR analysis of test data on analogous
alkoxysilanes, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the PMN substance (P-09-154) and 6
ppb of the PMN substance (P-09-156) in surface waters. Based on test
data on analogous alkoxysilanes and thiols, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb of the
PMN substance (P-09-155) in surface waters. As described in the PMNs,
the substances will not be 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 release to surface
waters 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 ready
biodegradability--CO2 in sealed vessels test (OPPTS Test
Guideline 835.3140); 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, tiers I and II (OPPTS Test Guideline 850.5400) would
help characterize the environmental effects of the PMN substance. Fish
and daphnid testing should be performed using the flow-through method
with measured concentrations. Algal testing should be performed using
the static method with measured concentrations. EPA recommends that the
fate testing be performed first as the results may mitigate the need
for further toxicity testing or change the testing recommendations.
Testing should be performed on P-09-155. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
    CFR citations: 40 CFR 721.10240 (P-09-154); 40 CFR 721.10241 (P-09-
155); and 40 CFR 721.10242 (P-09-156).
PMN Numbers P-09-193 and P-09-195
    Chemical names: (P-09-193) Phosphonic acid, P-[2-[bis(2-
hydroxyethyl)amino]ethyl]-, bis(2-chloroethyl) ester and (P-09-195)
Phosphonic acid, P-[2-[bis(2-hydroxyethyl)amino]ethyl]-, 2-[bis(2-
chloroethoxy)phosphinyl]ethyl 2-chloroethyl ester.
    CAS numbers: (P-09-193) 55088-28-3 and (P-09-195) 1094213-37-2.
    Basis for action: The PMNs state that the substances will be used
as intermediates in the manufacture of a polyurethane flame retardant.
Based on the alkylating activity of the PMN substances, EPA has
concerns for oncogenicity, mutagenicity, developmental toxicity, dermal
and respiratory sensitization, and irritation to all tissues.
Additionally, the Agency has concern for liver toxicity, kidney
toxicity, heart toxicity, developmental toxicity, and neurotoxicity
based on test data for analog substances submitted to the Agency under
TSCA section 8(e). Based on EcoSAR analysis of test data on
structurally similar aliphatic amines, EPA predicts toxicity to aquatic
organisms at concentrations that exceed 8 ppb in surface waters. As
described in the PMN, significant worker dermal and inhalation exposure
is unlikely for the use described in the PMN due to the use of personal
protective equipment and engineering controls. Further, significant
general population and environmental exposure is unlikely as the
substances are not released to water. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of these substances
may present an unreasonable risk. EPA has determined, however, that use
of the substances other than as intermediates in the manufacture of a
polyurethane flame retardant, use of the substances without the use of
impervious gloves where there is potential for dermal exposure, or any
use of the substances resulting in release to surface waters may cause
significant adverse health or environmental effects. Based on this
information, the PMN substances meet 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 90-
day 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the human health and environmental effects of the PMN substances. Fish
and daphnid testing should be performed using the flow-through method
with measured concentrations. Algal testing should be performed using
the static method with measured concentration. Testing should be
performed on P-09-193. Test reports should include protocols approved
by EPA, certificate of analysis for the test substance, raw data, and
results.
    CFR citations: 40 CFR 721.10243 (P-09-193) and 40 CFR 721.10244 (P-
09-195).
PMN Number P-09-207
    Chemical name: Branched and linear fatty alcohol ethoxylate
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
an intermediate in the manufacture of nonionic surfactants. Based on
EcoSAR analysis of test data on analogous nonionic surfactants, 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, releases of the PMN substance are not expected to
result in surface water concentrations that exceed 14 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 use of the substance other than as an
intermediate in the manufacture of nonionic surfactants 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance. Fish and daphnid
testing should be performed using the flow-through method with measured
concentrations. Algal testing should be performed using the static
method with measured concentrations. EPA recommends that the special
considerations for conducting laboratory

studies (OPPTS Test Guideline 850.1000) be followed to facilitate
solubility in the test media, because of the PMN's low water
solubility. Test reports should include protocols approved by EPA,
certificate of analysis for the test substance, raw data, and results.
    CFR citation: 40 CFR 721.10245.
PMN Number P-09-234
    Chemical name: Alkylpolyhydroxy polymer (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a drilling fluid
additive. Based on EcoSAR analysis of test data on analogous alkyl
ethoxylate nonionic surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 56 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 release to surface waters 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance. Fish and daphnid
testing should be performed using the flow-through method with measured
concentrations. Algal testing should be performed using the static
method with measured concentrations. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
    CFR citation: 40 CFR 721.10246.
PMN Number P-09-258
    Chemical name: Bis-phenoxyethanol fluorene diacrylate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
a raw material in ultra violet (UV) curable inks and coatings. EPA
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). EPA estimates that the PMN substance will persist in the
environment for more than two months and estimates a bioaccumulation
factor of greater than or equal to 5,000. Also, based on test data on
analogous acrylates, EPA believes exposure to the PMN substance may
cause systemic human health effects and predicts toxicity to aquatic
organisms. As described in the PMN, significant worker exposure is
unlikely 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 any predictable or purposeful release
containing the PMN substance into the waters of the United States may
cause serious health effects and significant environmental effects,
since the PMN substance has been characterized by EPA as a PBT. Based
on this information, the PMN substance meets the concern criteria at
Sec.  721.170(b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
    Recommended testing: EPA has determined that the results of the
tiered testing described in the New Chemicals Program's PBT Category
would help characterize the PBT attributes of the PMN substance. Test
reports should include protocols approved by EPA, certificate of
analysis for the test substance, raw data, and results.
    CFR citation: 40 CFR 721.10247.
PMN Number P-09-259
    Chemical name: Aromatic bromide (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
a synthetic intermediate. EPA 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 (64 FR 60194; November 4, 1999).
EPA estimates that the PMN substance will persist in the environment
more than six months and estimates a bioaccumulation factor of greater
than or equal to 5,000. Also, based on test data on analogous
brominated aromatics and neutral organics (aryl halides), EPA believes
exposure to the PMN substance may cause systemic human health effects
and predicts toxicity to aquatic organisms. As described in the PMN,
significant worker exposure is unlikely 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 or any predictable or
purposeful release containing the PMN substance into the waters of the
United States may cause serious health effects and significant
environmental effects, since the PMN substance has been characterized
by EPA as a PBT. Based on this information, the PMN substance meets the
concern criteria at Sec.  721.170(b)(3)(ii), (b)(4)(ii), and
(b)(4)(iii).
    Recommended testing: EPA has determined that the results of the
tiered testing described in the New Chemicals Program's PBT Category
would help characterize the PBT attributes of the PMN substance. Test
reports should include protocols approved by EPA, certificate of
analysis for the test substance, raw data, and results.
    CFR citation: 40 CFR 721.10248.
PMN Number P-09-316
    Chemical name: Disubstituted phenol (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 test data on analogous anilines and phenols, as well as on
test data submitted to the Agency under TSCA section 8(e), EPA
identified concerns for liver toxicity, mutagenicity, carcinogenicity,
developmental toxicity, neurotoxicity, and male reproductive system
toxicity to workers from inhalation exposure to the PMN substance.
Additionally, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 6 ppb of the PMN substance in surface
waters. For the use described in the PMN, significant worker exposure
is unlikely due to the use of personal protective equipment.
Furthermore, significant environmental exposure is unlikely as the
substance is not released to surface water resulting in surface water
concentrations that exceed 6 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 use
other than as a chemical intermediate, or exceedance of the manufacture
and import limit of 100 kg per year 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
combined chronic toxicity/carcinogenicity test (OPPTS Test Guideline
870.4300); a bacterial reverse mutation test (OPPTS Test Guideline
870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test
Guideline 870.5395); a daphnid chronic toxicity test (OPPTS Test
Guideline 850.1300) prolonged exposure; a fish early-life stage
toxicity test (OPPTS Test Guideline 850.1400) using rainbow trout and a
60-day minimum duration; and an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would help characterize the human
health and environmental effects of the PMN substance. Fish and daphnid
testing should be performed using the flow-through method with measured
concentrations. Algal testing should be performed using the static
method with measured concentrations. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
    CFR citation: 40 CFR 721.10249.
PMN Number P-09-356
    Chemical name: Zirconium lysine complex (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesion promoter and
corrosion inhibitor. Based on EcoSAR analysis of test data on analogous
inorganic zirconium compounds, EPA predicts toxicity to aquatic
organisms at concentrations that exceed 120 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 120
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 120 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance. Fish and daphnid
testing should be performed using the flow-through method with measured
concentrations. Algal testing should be performed using the static
method with measured concentrations. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
    CFR citation: 40 CFR 721.10250.
PMN Number P-09-366
    Chemical name: Fatty acids, reaction products with alkanolamine
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
an intermediate for a product used as a component of a multipurpose
additive in gasoline. Based on test data on the PMN substance, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 400 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 400 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 use of the substance other than as an intermediate could
result in exposures which may cause significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(4)(i).
    Recommended testing: EPA has determined that the results of an
aerobic and anaerobic transformation in aquatic sediment systems (OECD
Test Guideline 308); 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. Fish and daphnid testing should be performed
using the flow-through method with measured concentrations. EPA
recommends that the special considerations for conducting laboratory
studies (OPPTS Test Guideline 850.1000) be followed to facilitate
solubility in the test media, because of the PMN's low water
solubility. EPA also recommends performing the fate testing first as
the results may mitigate the need for further toxicity testing or
change the testing requirements. Test reports should include protocols
approved by EPA, certificate of analysis for the test substance, raw
data, and results.
    CFR citation: 40 CFR 721.10251.
PMN Number P-09-373
    Chemical name: Thiosulfuric acid
(H2S2O3), manganese(2+) salt (1:1).
    CAS number: 1033050-53-1.
    Basis for action: The PMN states that the substance will be used as
a micronutrient manganese source for selected agricultural crops. Based
on EcoSAR analysis of test data on analogous manganese salts, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 400 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 400 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 400 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance. Fish and daphnid
testing should be performed using the flow-through method with mean
measured concentrations. Algal testing should be performed using the
static method with mean measured concentrations. Test reports should
include protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
    CFR citation: 40 CFR 721.10252.
PMN Number P-09-388
    Chemical name: Butanedioic acid, 2-methylene-, polymer with 2,5
furanedione, copper(2+) manganese(2+) sodium zinc salt, hydrogen
peroxide-initiated.
    CAS number: 1134078-27-5.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a seed coating to provide
micronutrients. Based on EcoSAR analysis of test data on analogous
soluble complexes of zinc, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 34 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 34 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 34 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-CO2 in sealed vessels (headspace test)
(OECD Test Guideline 310); 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, tiers I and II (OPPTS Test Guideline 850.5400)
would help characterize the environmental effects of the PMN substance.
Fish and daphnid testing should be performed using the flow-through
method with measured concentrations. Algal testing should be performed
using the static method with measured concentrations. EPA recommends
performing the fate testing first as the results may mitigate the need
for further toxicity testing or change the testing requirements. Test
reports should include protocols approved by EPA, certificate of
analysis for the test substance, raw data, and results.
    CFR citation: 40 CFR 721.10253.
PMN Number P-09-390
    Chemical name: Substituted acrylamide (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material. Based on
test data on the PMN substance and EcoSAR analysis of test data on
analogous amides and acrylamides, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 21 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 21 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 21 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 fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075) using the flow-through method with measured concentrations,
and an algal toxicity test, tiers I and II (OPPTS Test Guideline
850.5400) using the static method with measured concentrations would
help characterize the environmental effects of the PMN substance. Test
reports should include protocols approved by EPA, certificate of
analysis for the test substance, raw data, and results.
    CFR citation: 40 CFR 721.10254.
PMN Number P-09-400
    Chemical name: Vinyl carboxylic acid 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 test
data on the PMN substance and analogous vinyl esters, EPA identified
concerns for dermal sensitization; dermal irritation; mutagenicity;
neurotoxicity; and blood, liver, kidney, spleen, brain, testes,
developmental, and reproductive toxicity to the general population if
exposed 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 15 ppb of the PMN substance in surface
waters. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(3)(ii) and (b)(4)(i). At the production
volume stated in the PMN, general population exposure is limited.
Further, as described in the PMN, releases of the PMN substance are not
expected to result in surface water concentrations that exceed 15 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk
under TSCA section 5(e). However, EPA has determined that annual
manufacture (including importation) of this PMN substance at volumes
greater than 100,000 kilograms per year may result in significant human
exposures. Further, EPA has determined that any use of the substance
resulting in surface water concentrations exceeding 15 ppb may cause
significant adverse environmental effects.
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity 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. Aquatic toxicity testing should be performed using the flow-
through method with measured concentrations. Test reports should
include protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
    CFR citation: 40 CFR 721.10255.
PMN Number P-09-479
    Chemical name: Benzoic acid, 4-(dimethylamino)-, 1,1'-
[(methylimino)di-2,I-ethanediyl] ester.
    CAS number: 925246-00-0.
    Basis for action: The PMN states that the substance will be used as
a co-photoinitiator for UV-curable pigmentation inks; co-photoinitiator
for photoresists, optical fibers, and printed plates; co-photoinitiator
for UV-curable coatings; and co-photoinitiator for UV-curable adhesives
and other coatings. Based on test data on the PMN substance and EcoSAR
analysis of test data on analogous aliphatic amines and esters, 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 release
to surface waters 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 835.3100); 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. Testing
should be performed using the flow-through method with mean measured
concentrations. EPA recommends that the special considerations for
conducting laboratory studies (OPPTS Test Guideline 850.1000) be
followed to facilitate solubility in the test media, because of the
PMN's low water solubility. EPA also recommends that the fate testing
be performed first as the results may mitigate the need for further
toxicity testing or change the testing recommendations. Test reports
should

include protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
    CFR citation: 40 CFR 721.10256.
PMN Number P-09-532
    Chemical name: Butyl aromatic bisurea (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a sealant. Based on
EcoSAR analysis of test data on analogous substituted urea, 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 will not be 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
release to surface waters 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance. Fish and daphnid
testing should be performed using the flow-through method with measured
concentrations. Algal testing should be performed using the static
method with measured concentrations. EPA recommends that the special
considerations for conducting laboratory studies (OPPTS Test Guideline
850.1000) be followed to facilitate solubility in the test media,
because of the PMN's low water solubility. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
    CFR citation: 40 CFR 721.10257.
PMN Numbers P-09-535 and P-09-540
    Chemical names: (P-09-535) Aromatic hydrocarbon (generic) and (P-
09-540) Halogenated aromatic hydrocarbon (generic).
    CAS numbers: (P-09-535) Not available and (P-09-540) not available.
    Basis for action: The PMNs state that the substances will be used
as synthetic intermediates. EPA has identified health and environmental
concerns because the substances may be PBT chemicals, based on
physical/chemical properties of the PMN substances, as described in the
New Chemicals Program's PBT Category (64 FR 60194; November 4, 1999).
EPA estimates that the PMN substances will persist in the environment
more than two months and estimates bioaccumulation factors that are
greater than or equal to 5,000. Also, based on test data on analogous
poly-aromatic hydrocarbons, EPA predicts chronic adverse human health
effects. As described in the PMNs, significant worker exposure is
unlikely and 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 predictable or purposeful release
containing the PMN substances into the waters of the United States may
cause serious health effects and significant adverse environmental
effects, since the PMN substances have been characterized by EPA as
PBT. Based on this information, the PMN substances meet the concern
criteria at Sec.  721.170(b)(3)(ii) and (b)(4)(iii).
    Recommended testing: EPA has determined that the results of the
tiered testing described in the New Chemicals Program's PBT Category
would help characterize the PBT attributes of the PMN substances. Test
reports should include protocols approved by EPA, certificate of
analysis for the test substance, raw data, and results.
    CFR citations: 40 CFR 721.10258 (P-09-535) and 40 CFR 721.10259 (P-
09-540).
PMN Number P-09-552
    Chemical name: Benzene, 1,3-bis(1-chloro-1-methylethyl)-.
    CAS number: 37133-18-9.
    Basis for action: The PMN states that the substance will be used as
a site-limited starting material in novel polymer synthesis reactions.
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 (64 FR 60194; November 4, 1999). 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 1,000.
In addition, based on the potential for the PMN to be an alkylating
agent, EPA identified concerns for oncogenicity, developmental
toxicity, sensitivity, and corrosion to all tissues from dermal and
respiratory exposure. Further, based on EcoSAR analysis of test data on
analogous benzyl halides, EPA predicts toxicity to aquatic organisms at
concentrations that exceed 1 ppb of the PMN substance in surface
waters. As described in the PMN, significant worker exposure is
unlikely due to the use of adequate dermal and respiratory protection
and the substance is not expected to be 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 predictable or purposeful release
containing the PMN substance into the waters of the United States may
cause serious health effects and significant adverse environmental
effects, since the PMN substance has been characterized by EPA as a
PBT. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(1)(i)(C), (b)(3)(ii), (b)(4)(ii), and
(b)(4)(iii).
    Recommended testing: EPA has determined that the results of the
tiered testing described in the New Chemicals Program's PBT Category
(64 FR 60914; November 4, 1999) should help characterize the PBT
attributes of the PMN substance. Test reports should include protocols
approved by EPA, certificate of analysis for the test substance, raw
data, and results.
    CFR citation: 40 CFR 721.10260.
PMN Numbers P-09-589 and P-09-590
    Chemical names: (P-09-589) Oxime, di-Me silane (generic) and (P-09-
590) Oxime, Me vinyl silane (generic).
    CAS numbers: (P-09-589) Not available and (P-09-590) not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as chain extenders. Based
on test data on the PMN substances and the expected hydrolysis product,
EPA identified concerns for carcinogenicity, dermal sensitization,
blood effects, reproductive toxicity, and neurotoxicity to workers and
the general population exposed dermally or by inhalation to the PMN
substances. In addition, based on EcoSAR analysis of test data on
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 2 ppb of the PMN substances in
surface waters. As described in the PMNs, worker exposure will be
minimal due to the use of adequate personal protective equipment,
general population inhalation and dermal exposure is not expected, and
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 without the use of
impervious gloves where there is potential for dermal exposure, annual
manufacture (including importation) of each of the PMN substances at
volumes greater than 20,000 kilograms, or any use of the substances
resulting in release to surface waters may cause serious health effects
and/or significant adverse environmental effects. Based on this
information, the PMN substances meet the concern criteria at Sec.
721.170(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a two-
generation reproduction toxicity test (OECD Test Guideline 416); a
ready biodegradability test (OPPTS Test Guideline 835.3110); a porous
pot test (OPPTS Test Guideline 835.3220); a fish acute toxicity test,
freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute
toxicity mitigated by humic acid test (OPPTS Test Guideline 850.1085);
an aquatic invertebrate acute toxicity test; freshwater daphnids (OPPTS
Test Guideline 850.1010); and an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would help characterize the human
health and environmental effects of the PMN substances. Fish and
daphnid testing should be performed using the flow-through method with
measured concentrations. Algal testing should be performed using the
static method with measured concentrations. Testing should be performed
on P-09-589. EPA recommends that the fate testing be performed first as
the results may mitigate the need for further testing or change the
testing requirements. Test reports should include protocols approved by
EPA, certificate of analysis for the test substance, raw data, and
results.
    CFR citations: 40 CFR 721.10261 (P-09-589) and 40 CFR 721.10262 (P-
09-590).
PMN Number P-09-634
    Chemical name: Phenol, 4-(1,1-dimethylethyl)-2-nitro-.
    CAS number: 3279-07-0.
    Basis for action: The PMN states that the substance will be used as
a raw material (reactant) for production of intermediate for a
photographic chemical. Based on test data on the PMN substance, and
test data submitted under TSCA section 8(e) on analogous aminophenols,
EPA identified concerns for irritation to the eye and skin,
mutagenicity, neurotoxicity, developmental, liver, blood, and
reproductive toxicities to workers and members of the general
population if exposed to the PMN substance. In addition, 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. For the uses described in
the PMN, significant worker exposure is unlikely, as dermal/inhalation
exposure is not expected; the substance is not released to surface
waters; and the substance is not expected to result in significant
exposure to the general population. 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 or any use of the
substance resulting in release to surface waters 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), 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 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, tiers I and II
(OPPTS Test Guideline 850.5400) would help characterize the human
health and environmental effects of the PMN substance. Fish and daphnid
testing should be performed using the flow-through method with measured
concentrations. Algal testing should be performed using the static
method with measured concentrations. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
    CFR citation: 40 CFR 721.10263.
PMN Number P-10-343
    Chemical name: Polycarbocyclic methacrylate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a polymeric component.
Based on EcoSAR analysis of test data on analogous methacrylates, 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, 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 release
to surface waters 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 fish acute
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075);
an aquatic invertebrate acute toxicity test (OPPTS Test Guideline
850.1010); and an algal toxicity test, tiers I and II (OPPTS Test
Guideline 850.5400) would help characterize the environmental effects
of the PMN substance. Fish and daphnid testing should be performed
using the flow-through method with measured concentrations. Algal
testing should be performed using the static method with measured
concentrations. EPA recommends that the special considerations for
conducting laboratory studies (OPPTS Test Guideline 850.1000) be
followed to facilitate solubility in the test media, because of the
PMN's low water solubility. Test reports should include protocols
approved by EPA, certificate of analysis for the test substance, raw
data, and results.
    CFR citation: 40 CFR 721.10264.

V. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA concluded that for 4 of the 36
chemical substances, regulation was warranted under TSCA section 5(e),
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) consent orders requiring the use
of appropriate exposure controls were negotiated with the PMN
submitters. The SNUR provisions for these chemical substances are
consistent with the provisions of the TSCA section 5(e) consent orders.
These SNURs are promulgated pursuant to Sec.  721.160 (see Unit II.).
    In the other 32 cases, where the uses are not regulated under a
TSCA section

5(e) consent order, EPA determined that one or more of the criteria of
concern established at Sec.  721.170 were met, as discussed in Unit IV.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
     EPA will receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
     EPA will be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
     EPA will ensure that all manufacturers, importers, and
processors of the same chemical substance that is subject to a TSCA
section 5(e) consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Inventory. Guidance on how
to determine if a chemical substance is on the TSCA Inventory is
available on the Internet at http://www.epa.gov/opptintr/newchems/pubs/invntory.htm.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in
Sec.  721.160(c)(3) and Sec.  721.170(d)(4). In accordance with Sec.
721.160(c)(3)(ii) and Sec.  721.170(d)(4)(i)(B), the effective date of
this rule is December 5, 2011 without further notice, unless EPA
receives written adverse or critical comments, or notice of intent to
submit adverse or critical comments before November 4, 2011.
    If EPA receives written adverse or critical comments, or notice of
intent to submit adverse or critical comments, on one or more of these
SNURs before November 4, 2011, EPA will withdraw the relevant sections
of this direct final rule before its effective date. EPA will then
issue a proposed SNUR for the chemical substance(s) on which adverse or
critical comments were received, providing a 30-day period for public
comment.
    This rule establishes SNURs for a number of chemical substances.
Any person who submits adverse or critical comments, or notice of
intent to submit adverse or critical comments, must identify the
chemical substance and the new use to which it applies. EPA will not
withdraw a SNUR for a chemical substance not identified in the comment.

VII. Applicability of Rule to Uses Occurring Before Effective Date of
the Rule

    Significant new use designations for a chemical substance are
legally established as of the date of publication of this direct final
rule, October 5, 2011.
    To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. TSCA section 5(e) consent orders have
been issued for 4 chemical substances and the PMN submitters are
prohibited by the TSCA section 5(e) consent orders from undertaking
activities which EPA is designating as significant new uses. In cases
where EPA has not received a notice of commencement (NOC) and the
chemical substance has not been added to the TSCA Inventory, no other
person may commence such activities without first submitting a PMN. For
chemical substances for which an NOC has not been submitted at this
time, EPA concludes that the uses are not ongoing. However, EPA
recognizes that prior to the effective date of the rule, when chemical
substances identified in this SNUR are added to the TSCA Inventory,
other persons may engage in a significant new use as defined in this
rule before the effective date of the rule. However, 23 of the 36
chemical substances contained in this rule have CBI chemical
identities, and since EPA has received a limited number of post-PMN
bona fide submissions (per Sec. Sec.  720.25 and 721.11), the Agency
believes that it is highly unlikely that any of the significant new
uses described in the regulatory text of this rule are ongoing.
    As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of this direct final rule rather than as of the
effective date of the rule. If uses begun after publication were
considered ongoing rather than new, it would be difficult for EPA to
establish SNUR notice requirements because a person could defeat the
SNUR by initiating the significant new use before the rule became
effective, and then argue that the use was ongoing before the effective
date of the rule. Thus, persons who begin commercial manufacture,
import, or processing of the chemical substances regulated through this
SNUR will have to cease any such activity before the effective date of
this rule. To resume their activities, these persons would have to
comply with all applicable SNUR notice requirements and wait until the
notice review period, including all extensions, expires.
    EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person meets the conditions of
advance compliance under Sec.  721.45(h), the person is considered
exempt from the requirements of the SNUR.

VIII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
    1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
    In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. lists those tests. Unit IV. also lists recommended
testing for non-5(e) SNURs. Descriptions of tests are provided for
informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. To access the harmonized test guidelines referenced
in this document electronically, please go to http://www.epa.gov/ocspp
and select ``Test Methods and Guidelines.'' The Organisation for
Economic Co-operation and Development (OECD) test guidelines are
available from the OECD Bookshop at http://www.oecdbookshop.org or
SourceOECD at http://www.sourceoecd.org. The American Society for
Testing and

Materials International (ASTM) standards are available at http://www.astm.org/Standard/index.shtml.
    In the TSCA section 5(e) consent orders for four of the chemical
substances regulated under this rule, EPA has established restrictions
in view of the lack of data on the potential health and environmental
risks that may be posed by the significant new uses or increased
exposure to the chemical substances. These restrictions will not be
removed until EPA determines that the unrestricted use will not present
an unreasonable risk of injury or result in significant or substantial
exposure or environmental release. This determination is usually made
based on the results of the required or recommended toxicity tests.
    The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1). Today's rules cross-reference Sec.  721.1725(b)(1)
(which is similar to the procedure in Sec.  721.11, for situations
where the chemical identity of the chemical substance subject to a SNUR
is CBI) in each SNUR that includes specific significant new uses that
are CBI.
    Under these procedures a manufacturer, importer, or processor may
request that EPA determine whether a proposed use would be a
significant new use under the rule. The manufacturer, importer, or
processor must show that it has a bona fide intent to manufacture,
import, or process the chemical substance and must identify the
specific use for which it intends to manufacture, import, or process
the chemical substance. If EPA concludes that the person has shown a
bona fide intent to manufacture, import, or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers, importers, and
processors can combine the bona fide submission under the procedure in
Sec.  721.1725(b)(1) with that under Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture, import, or process the chemical substance so
long as the significant new use trigger is not met. In the case of a
production volume trigger, this means that the aggregate annual
production volume does not exceed that identified in the bona fide
submission to EPA. Because of confidentiality concerns, EPA does not
typically disclose the actual production volume that constitutes the
use trigger. Thus, if the person later intends to exceed that volume, a
new bona fide submission would be necessary to determine whether that
higher volume would be a significant new use.

X. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply
with the same notice requirements and EPA regulatory procedures as
persons submitting a PMN, including submission of test data on health
and environmental effects as described in Sec.  720.50. SNUNs must be
submitted on EPA Form No. 7710-25, generated using e-PMN software, and
submitted to the Agency in accordance with the procedures set forth in
Sec. Sec.  721.25 and 720.40. E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substances subject to this rule. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2010-1075.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This rule establishes SNURs for several new chemical substances
that were the subject of PMNs. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993).

B. Paperwork Reduction Act

    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under PRA, unless it has been approved by OMB and displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable. EPA is amending the table
in 40 CFR part 9 to list the OMB approval number for the information
collection requirements contained in this rule. This listing of the OMB
control numbers and their subsequent codification in the CFR satisfies
the display requirements of PRA and OMB's implementing regulations at 5
CFR part 1320. This Information Collection Request (ICR) was previously
subject to public notice and comment prior to OMB approval, and given
the technical nature of the table, EPA finds that further notice and
comment to amend it is unnecessary. As a result, EPA finds that there
is ``good cause'' under section 553(b)(3)(B) of the Administrative
Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without
further notice and comment.
    The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data

needed, and complete, review, and submit the required SNUN.
    Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR will not have a significant adverse economic impact on a
substantial number of small entities. The requirement to submit a SNUN
applies to any person (including small or large entities) who intends
to engage in any activity described in the final rule as a
``significant new use.'' Because these uses are ``new,'' based on all
information currently available to EPA, it appears that no small or
large entities presently engage in such activities. A SNUR requires
that any person who intends to engage in such activity in the future
must first notify EPA by submitting a SNUN. Although some small
entities may decide to pursue a significant new use in the future, EPA
cannot presently determine how many, if any, there may be. However,
EPA's experience to date is that, in response to the promulgation of
SNURs covering over 1,000 chemicals, the Agency receives only a handful
of notices per year. For example, the number of SNUNs was four in
Federal fiscal year 2005, eight in FY2006, six in FY2007, eight in
FY2008, and seven in FY2009. During this five-year period, three small
entities submitted a SNUN. In addition, the estimated reporting cost
for submission of a SNUN (see Unit XI.) is minimal regardless of the
size of the firm. Therefore, EPA believes that the potential economic
impacts of complying with this SNUR are not expected to be significant
or adversely impact a substantial number of small entities. In a SNUR
that published in the Federal Register of June 2, 1997 (62 FR 29684)
(FRL-5597-1), the Agency presented its general determination that final
SNURs are not expected to have a significant economic impact on a
substantial number of small entities, which was provided to the Chief
Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this rule. As
such, EPA has determined that this rule does not impose any enforceable
duty, contain any unfunded mandate, or otherwise have any effect on
small governments subject to the requirements of sections 202, 203,
204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4).

E. Executive Order 13132

    This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This rule
does not significantly nor uniquely affect the communities of Indian
Tribal governments, nor does it involve or impose any requirements that
affect Indian Tribes. Accordingly, the requirements of Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 9, 2000), do not apply to this rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866, and
this action does not address environmental health or safety risks
disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001), because this action
is not expected to affect energy supply, distribution, or use and
because this action is not a significant regulatory action under
Executive Order 12866.

I. National Technology Transfer and Advancement Act

    In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions To Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

XIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: September 23, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241,

242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5,
300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-
6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

0
2. The table in Sec.  9.1 is amended by adding the following sections
in numerical order under the undesignated center heading ``Significant
New Uses of Chemical Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                          OMB  control
                     40 CFR citation                           No.
-----------------------------------------------------------------------

                                * * * * *
              Significant New Uses of Chemical Substances

                                * * * * *
721.10230...............................................     2070-0012
721.10231...............................................     2070-0012
721.10232...............................................     2070-0012
721.10233...............................................     2070-0012
721.10234...............................................     2070-0012
721.10235...............................................     2070-0012
721.10236...............................................     2070-0012
721.10237...............................................     2070-0012
721.10238...............................................     2070-0012
721.10239...............................................     2070-0012
721.10240...............................................     2070-0012
721.10241...............................................     2070-0012
721.10242...............................................     2070-0012
721.10243...............................................     2070-0012
721.10244...............................................     2070-0012
721.10245...............................................     2070-0012
721.10246...............................................     2070-0012
721.10247...............................................     2070-0012
721.10248...............................................     2070-0012
721.10249...............................................     2070-0012
721.10250...............................................     2070-0012
721.10251...............................................     2070-0012
721.10252...............................................     2070-0012
721.10253...............................................     2070-0012
721.10254...............................................     2070-0012
721.10255...............................................     2070-0012
721.10256...............................................     2070-0012
721.10257...............................................     2070-0012
721.10258...............................................     2070-0012
721.10259...............................................     2070-0012
721.10260...............................................     2070-0012
721.10261...............................................     2070-0012
721.10262...............................................     2070-0012
721.10263...............................................     2070-0012
721.10264...............................................     2070-0012

                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

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

0
4. Add Sec.  721.10230 to subpart E to read as follows:

Sec.  721.10230  Rutile, tin zinc, calcium-doped.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as rutile, tin zinc,
calcium-doped (PMN P-06-36; CAS No. 389623-01-2) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this rule do not
apply to quantities of the PMN substance that have been incorporated
into a polymer, glass, dispersion, cementitious matrix, or a similar
incorporation.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(5), (a)(6)(i), (b) (concentration set at 1.0
percent), and (c). The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirators with an assigned
protection factor (APF) of 10 meet the minimum requirements for Sec.
721.63(a)(5):
    (A) NIOSH-certified air-purifying, tight-fitting half-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with
a loose- fitting hood or helmet and high efficiency particulate air
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with
a tight-fitting facepiece (either half-face or full-face) and HEPA
filters; or
    (E) NIOSH-certified supplied-air respirator operated in pressure
demand or continuous flow mode and equipped with a hood or helmet, or
tight-fitting facepiece (either half-face or full-face).
    (1) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose
to follow the new chemical exposure limit (NCEL) provisions listed in
the TSCA section 5(e) consent order for these substances. The NCEL is
1.5 mg/m\3\ as an 8-hour time-weighted-average for both chemical
substances combined. Persons who wish to pursue NCELs as an alternative
to the Sec.  721.63 respirator requirements may request to do so under
Sec.  721.30. Persons whose Sec.  721.30 requests to use the NCELs
approach are approved by EPA will receive NCELs provisions comparable
to those contained in the corresponding section 5(e) consent order.
    (2) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory protection or
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 1.5 mg/m\3\), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (manufacture of the substances with a
particle size less than 100 nanometers, where d10 particle size
presents the particle size, as determined by laser light scattering, at
which 10 perecent by weight of the substance measured is smaller).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (f), (g), (h), and (i) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
5. Add Sec.  721.10231 to subpart E to read as follows:

Sec.  721.10231  Rutile, tin zinc, sodium-doped.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as rutile, tin zinc,
sodium-doped (PMN P-06-37; CAS No. 389623-07-8) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this rule do not apply to
quantities of the PMN substance that have been incorporated into a
polymer, glass, dispersion, cementitious matrix, or a similar
incorporation.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(5), (a)(6)(i), (b) (concentration set at 1.0
percent), and (c). The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirators with an assigned
protection factor (APF) of 10 meet the minimum requirements for Sec.
721.63(a)(5):
    (A) NIOSH-certified air-purifying, tight-fitting half-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with
a

loose-fitting hood or helmet and high efficiency particulate air (HEPA)
filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with
a tight-fitting facepiece (either half-face or full-face) and HEPA
filters; or
    (E) NIOSH-certified supplied-air respirator operated in pressure
demand or continuous flow mode and equipped with a hood or helmet, or
tight-fitting facepiece (either half-face or full-face).
    (1) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose
to follow the new chemical exposure limit (NCEL) provisions listed in
the TSCA section 5(e) consent order for these substances. The NCEL is
1.5 mg/m\3\ as an 8-hour time-weighted-average for both chemical
substances combined. Persons who wish to pursue NCELs as an alternative
to the Sec.  721.63 respirator requirements may request to do so under
Sec.  721.30. Persons whose Sec.  721.30 requests to use the NCELs
approach are approved by EPA will receive NCELs provisions comparable
to those contained in the corresponding section 5(e) consent order.
    (2) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory protection or
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 1.5 mg/m\3\), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (manufacture of the substances with a
particle size less than 100 nanometers, where d10 particle size
presents the particle size, as determined by laser light scattering, at
which 10 percent by weight of the substance measured is smaller).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (f), (g), (h), and (i) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
6. Add Sec.  721.10232 to subpart E to read as follows:

Sec.  721.10232  N-arylamino-phenol-formaldehyde condensate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as n-
arylamino-phenol-formaldehyde condensate (PMN P-08-694) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
7. Add Sec.  721.10233 to subpart E to read as follows:

Sec.  721.10233  Linear alkyl epoxide (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as linear
alkyl epoxide (PMN P-08-704) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
8. Add Sec.  721.10234 to subpart E to read as follows:

Sec.  721.10234  Hydroxy-chloro-cyclopropyl-heteromonocyclic carboxylic
acid (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydroxy-chloro-cyclopropyl-heteromonocyclic carboxylic acid (PMN P-09-
61) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 6).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
9. Add Sec.  721.10235 to subpart E to read as follows:

Sec.  721.10235  Phenol, 2-ethoxy-4-(ethoxymethyl)-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, 2-ethoxy-4-
(ethoxymethyl)- (PMN P-09-72; CAS No. 71119-07-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
10. Add Sec.  721.10236 to subpart E to read as follows:

Sec.  721.10236  1-Propanamine, 3-[2-(2-methoxyethoxy)ethoxy]-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propanamine, 3-
[2-(2-methoxyethoxy)ethoxy]- (PMN P-09-139; CAS No. 91933-40-3) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.

    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j) and (o).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.

0
11. Add Sec.  721.10237 to subpart E to read as follows:

Sec.  721.10237  Formaldehyde, polymers with acetone-phenol reaction
products and phenol, sodium salts.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as formaldehyde,
polymers with acetone-phenol reaction products and phenol, sodium salts
(PMN P-09-146; CAS No. 1065544-88-8) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this rule do not apply to quantities
of the PMN substance that have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) including:
    (A) Manufacture or import of the PMN substance only where the
maximum unbound formaldehyde residual levels and typical polymer weight
to weight composition ratios are as specified in the TSCA section 5(e)
consent order.
    (B) Upon start-up of manufacture of the PMN at any new facility,
conduct the American Society for Testing and Materials International
(ASTM) E1333-10 test or its equivalent on a representative sample of
the finished cured resin product, demonstrating that formaldehyde
emissions are less than or equal to 0.04 ppm.
    (C) Development and implementation of a written control plan that
includes analysis of representative samples to ensure compliance with
(a)(2)(i)(A) and (a)(2)(i)(B) of this section.
    (D) Manufacturing, processing, distribution, or use of the PMN
substance only as described in the TSCA section 5(e) consent order.
    (E) Processing or distribution for processing only under the
conditions described in the TSCA section 5(e) consent order and which
are capable of irreversibly curing the PMN substance into a thermoset
polymer matrix.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.

0
12. Add Sec.  721.10238 to subpart E to read as follows:

Sec.  721.10238  Formaldehyde, polymers with acetone-phenol reaction
products and phenol, potassium sodium salts.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as formaldehyde,
polymers with acetone-phenol reaction products and phenol, potassium
sodium salts (PMN P-09-147; CAS No. 1072227-60-1) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this rule do not
apply to quantities of the PMN substance that have been completely
reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) including:
    (A) Manufacture or import of the PMN substance only where the
maximum unbound formaldehyde residual levels and typical polymer weight
to weight composition ratios are as specified in the TSCA section 5(e)
consent order.
    (B) Upon start-up of manufacture of the PMN at any new facility,
conduct the American Society for Testing and Materials International
(ASTM) E1333-10 test or its equivalent on a representative sample of
the finished cured resin product, demonstrating that formaldehyde
emissions are less than or equal to 0.04 ppm.
    (C) Development and implementation of a written control plan that
includes analysis of representative samples to ensure compliance with
(a)(2)(i)(A) and (a)(2)(i)(B) of this section.
    (D) Manufacturing, processing, distribution, or use of the PMN
substance only as described in the TSCA section 5(e) consent order.
    (E) Processing or distribution for processing only under the
conditions described in the TSCA section 5(e) consent order and which
are capable of irreversibly curing the PMN substance into a thermoset
polymer matrix.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.

0
13. Add Sec.  721.10239 to subpart E to read as follows:

Sec.  721.10239  Trivalent chromium complexes of a substituted beta-
naphthol amine azo dye (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
trivalent chromium complexes of a substituted beta-naphthol amine azo
dye (PMNs P-09-152 and P-09-153) are subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f) and (j) (acid dye for coloring anodized
aluminum). Also, requirements as specified in Sec.  721.80(v)(1),
(v)(2), (w)(1), (w)(2), (x)(1), and (x)(2), except that importing,
processing, and use of the PMN substance in the form of a wet press
cake containing greater than 30 percent water does not require
submission of a SNUN.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
14. Add Sec.  721.10240 to subpart E to read as follows:

Sec.  721.10240  Olefinic carbocycle, reaction products with
alkoxysilane (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
olefinic carbocycle, reaction products with alkoxysilane (PMN P-09-154)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
15. Add Sec.  721.10241 to subpart E to read as follows:

Sec.  721.10241  Olefinic carbocycle, reaction products with
alkoxysilane, sulfurized (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
olefinic carbocycle, reaction products with alkoxysilane, sulfurized
(PMN P-09-155) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
16. Add Sec.  721.10242 to subpart E to read as follows:

Sec.  721.10242  Olefinic carbocycle, reaction products with
alkoxysilane, polysulfurized (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
olefinic carbocycle, reaction products with alkoxysilane,
polysulfurized (PMN P-09-156) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
17. Add Sec.  721.10243 to subpart E to read as follows:

Sec.  721.10243  Phosphonic acid, P-[2-[bis(2-
hydroxyethyl)amino]ethyl]-, bis(2-chloroethyl) ester.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphonic acid, P-
[2-[bis(2-hydroxyethyl)amino]ethyl]-, bis(2-chloroethyl) ester (PMN P-
09-193; CAS No. 55088-28-3) is subject to reporting under this section