[Federal Register: June 24, 2010 (Volume 75, Number 121)]
[Rules and Regulations]
[Page 35977-35989]
[DOCID:fr24jn10-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2008-0920; FRL-8824-6]
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 17
chemical substances which were the subject of premanufacture notices
(PMNs). Two 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 17 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 August 23, 2010. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
July 8, 2010.
    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 July 26, 2010 (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-2008-0920, 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-2008-0920. 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-
2008-0920. 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 website 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:
Tracey Klosterman, Chemical Control Division (7405M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-2209; 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
and 19 CFR 127.28 (the corresponding EPA policy appears at 40 CFR part
707, subpart B). 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. In addition, any persons
who export or intend to export a chemical substance that is the subject
of this rule on or after July 26, 2010 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 those listed in TSCA section 5(a)(2) (see
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.
The mechanism for reporting under this requirement is established under
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.
    Chemical importers are subject to the TSCA section 13 (15 U.S.C.
2612) import certification requirements codified at 19 CFR 12.118
through 12.127, and 19 CFR 127.28 (the corresponding EPA policy appears
at 40 CFR part 707, subpart B). Chemical importers must certify that
the shipment of the chemical substance complies with all applicable
rules and orders under TSCA. Importers of chemical substances subject
to a final SNUR must certify their compliance with the SNUR
requirements. In addition, any persons who export or intend to export a
chemical substance identified in a final SNUR 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.

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 17
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, and the four bulleted TSCA section 5(a)(2) factors
listed in this unit.

IV. Substances Subject to this Rule

    EPA is establishing significant new use and recordkeeping
requirements for 17 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).
     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 2 PMN substances that are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA
determined that activities associated with the PMN substances may
present unreasonable risk to human health or the environment. Those
consent orders require protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``5(e) SNURs'' on these PMN substances are promulgated pursuant to
Sec.  721.160, and are based on and consistent with the provisions in
the

underlying consent orders. The 5(e) SNURs designate as a ``significant
new use'' the absence of the protective measures required in the
corresponding consent orders.
    Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) consent order usually requires, among
other things, that potentially exposed employees wear specified
respirators unless actual measurements of the workplace air show that
air-borne concentrations of the PMN substance are below a New Chemical
Exposure Limit (NCEL) that is established by EPA to provide adequate
protection to human health. In addition to the actual NCEL
concentration, the comprehensive NCELs provisions in TSCA section 5(e)
consent orders, which are modeled after Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limits (PELs) provisions,
include requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. However, no comparable NCEL provisions currently exist
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases,
the individual SNURs in 40 CFR part 721, subpart E, will state that
persons subject to the SNUR who wish to pursue NCELs as an alternative
to the Sec.  721.63 respirator requirements may request to do so under
Sec.  721.30. EPA expects that persons whose Sec.  721.30 requests to
use the NCELs approach for SNURs are approved by EPA will be required
to comply with NCELs provisions that are comparable to those contained
in the corresponding TSCA section 5(e) consent order for the same
chemical substance.
    This rule also includes SNURs on 15 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 Number P-02-996
Chemical name: Aliphatic triamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the chemical substance will be
used as a monomer for polymers with amide or imide links; a crosslinker
for epoxy type coatings, adhesives and sealants; a crosslinker for
epoxy type composites; a monomer for urea and urethane urea polymers
used in coatings; a chemical intermediate for functional chemicals:
amides, imides; a chemical intermediate for functional chemicals:
isocyanates, salts; and a chemical intermediate for functional
chemicals: cyclic amines, etc. Based on test data on the PMN substance
and analogous substances, EPA identified concerns for corrosion of the
skin, eyes, mucous membranes and lungs; respiratory tract irritation;
immunotoxicity; developmental toxicity; and reproductive toxicity from
exposure to the PMN substance. In addition, based on test data on the
PMN substance, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 48 parts per billion (ppb) of the PMN
substance in surface waters. For the use described in the PMN, worker
inhalation and dermal exposures are not expected and releases to water
are not expected. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance involving an application method which generates a vapor,
mist, or aerosol may cause serious health effects and 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)(3)(i),
(b)(3)(ii), and (b)(4)(i).
Recommended testing: EPA has determined that the results of the
following testing would help characterize the human health and
environmental effects of the PMN substance: Either a 90-day inhalation
toxicity test (OCSPP Harmonized Test Guideline 870.3465) in rodents,
modified for a 28-day exposure, or a repeated dose inhalation toxicity
study (Organization for Co-Operation and Development (OECD) 412 test
guideline); a prenatal developmental toxicity study (OCSPP Harmonized
Test Guideline 870.3700) via the oral route; a reproduction and
fertility study (OCSPP Harmonized Test Guideline 870.3800) via the oral
route; an immunotoxicity test (OCSPP Harmonized Test Guideline
870.7800) via the oral route; a fish chronic toxicity test (OCSPP
Harmonized Test Guideline 850.1400); and a daphnid chronic toxicity
test (OCSPP Harmonized Test Guideline 850.1300). All recommended tests
should be performed on the PMN substance neutralized with HCl to a pH
of 7.0. Further, a certificate of analysis should be included for the
test substance.
CFR citation: 40 CFR 721.10184.
PMN Number P-03-106
Chemical name: 1,2-Propanediol, 3-(diethylamino)-, polymers with 5-
isocyanato-1- (isocyanatomethyl)-1,3,3-trimethylcyclohexane, propylene
glycol and reduced Me esters of reduced polymd. oxidized
tetrafluoroethylene, 2-ethyl-1-hexanol-blocked, acetates (salts).
CAS number: 328389-90-8.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a surface treatment agent. Based on
test data on analogous substances, EPA believes this substance could
cause lung toxicity to workers if inhaled, via irritation to mucous
membranes and cationic binding with membranes. For the use described in
the PMN, significant worker dermal or inhalation exposure is not
expected. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that use of the
substance involving an application method which generates a vapor,
mist, or aerosol may result in serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day
inhalation toxicity study (OCSPP Harmonized Test Guideline 870.3465)
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10185.

PMN Number P-04-132
Chemical name: Ethylhexyl oxetane (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: March 7, 2007.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance

will be as an additive for industrial applications. The order was
issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based
on findings that this substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the consent order requires use of dermal personal protective
equipment, including gloves demonstrated by testing to be impervious
(Polyvinyl Alcohol gloves with a thickness of no less than 31.3 mils or
Silvershield/4H sleeves with a thickness of no less than 2.7 mils have
been shown to satisfy this requirement for up to 8 hours), requires the
establishment of a hazard communication program, and limits uses to
those listed in the consent order. The SNUR designates as a
``significant new use'' the absence of these protective measures.
Toxicity concern: Based on test data on the PMN substance, EPA
identified concerns for liver toxicity, thyroid toxicity, and systemic
toxicity. Further, based on test data on the PMN substance, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 20 ppb of the PMN substance in surface waters.
Recommended testing: EPA has determined that the following tests would
help characterize the human health and environmental effects of the PMN
substance: A 90-day oral toxicity test (OCSPP Harmonized Test Guideline
870.3100) in rodents; a fish early-life stage toxicity test (OCSPP
Harmonized Test Guideline 850.1400) with rainbow trout; and a daphnid
chronic toxicity test (OCSPP Harmonized Test Guideline 850.1300). 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 substance will remain in effect
until the order is modified or revoked by EPA based on submission of
that or other relevant information.

CFR citation: 40 CFR 721.10186.
PMN Number P-05-186
Chemical names: (Chemical A) 4-Morpholinepropanamine, N-(1,3-
dimethylbutylidene)-; (Chemical B) Fatty acids, tall-oil, reaction
products with 4-methyl-2-pentanone and aliphatic polyamine (generic);
(Chemical C) Fatty acids, tall-oil, reaction products with
(butoxymethyl) oxirane formaldehyde-phenol polymer glycidyl ether,
morpholinepropanamine, propylene glycol diamine and aliphatic
polyamine, N-(1,3 -dimethylbutylidene) derivs (generic); and (Chemical
D) Formaldehyde, polymer with aliphatic diamine and phenol, reaction
products with 4-methyl-2-pentanone (generic).
CAS numbers: (Chemical A) 1003863-30-6; (Chemical B) not available;
(Chemical C) not available; and (Chemical D) not available.
Basis for action: The PMN states that the substances will be used as
curing agents for epoxy coating systems. Based on test data on
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 10 ppb of the PMN in surface
waters. For the uses described in the PMN, releases of the substances
are not expected to result in surface waters concentrations that exceed
10 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that any use of the
substances resulting in surface water concentrations exceeding 10 ppb
may cause significant adverse environmental effects. Based on this
information, the PMN substances meet the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the
following tests would help characterize the environmental effects of
the PMN substances: A fish acute toxicity test, freshwater and marine
(OCSPP Harmonized Test Guideline 850.1075) using the static method with
24-hour renewal intervals; a fish acute toxicity test mitigated by
humic acid (OCSPP Harmonized Test Guideline 850.1085) using the static
method with 24-hour renewal intervals; an aquatic invertebrate acute
toxicity test, freshwater daphnids (OCSPP Harmonized Test Guideline
850.1010) using the static method with 24-hour renewal intervals; and
an algal toxicity test, tiers I and II (OCSPP Harmonized Test Guideline
850.5400) using the static method. For all fish and daphnid testing,
the dilution water must have a water hardness of less than 180 mg/L
calcium carbonate and a total organic carbon (TOC) level of less than
2.0 mg/L. Further, the stock solution should be adjusted to a pH of 7
at study initiation prior to the introduction of test organisms. Study
reports must include chemical names, CAS numbers, and composition of
the test substance.

CFR citations: 40 CFR 721.10187 (P-05-186, Chemical A); 40 CFR
721.10188 (P-05-186, Chemical B); 40 CFR 721.10189 (P-05-186, Chemical
C); and 40 CFR 721.10190 (P-05-186, Chemical D).
PMN Numbers P-06-262, P-06-263, and P-06-264
Chemical names: (P-06-262) Amides, coco, N-[3-(dibutylamino)propyl];
(P-06-263, Chemical A) Amides, coco, N-[3-(dibutylamino)propyl],
acrylates; (P-06-263, Chemical B) 1-Butanaminium, N-(3-aminopropyl)-N-
butyl-N-(2-carboxyethyl)-, N-coco acyl derivs., inner salts; and (P-06-
264) Dialkylcocoamidoalkylpropionate (generic).
CAS numbers: (P-06-262) 851544-20-2; (P-06-263, Chemical A) 851545-09-
0; (P-06-263, Chemical B) 851545-17-0; and (P-06-264) not available.
Basis for action: The consolidated PMN states that the substances will
be used as intermediates for hydrate inhibitors for oil and gas wells,
production pipelines and flowlines (P-06-262); and hydrate inhibitors
for oil and gas wells, production pipelines and flowlines (P-06-263 and
P-06-264). Based on test data on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 20 ppb of the PMN substances in surface waters. For the uses
described in the PMNs, these 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 the
following tests would help characterize the environmental effects of
the PMN substance: A fish acute toxicity test, freshwater and marine
(OCSPP Harmonized Test Guideline 850.1075); an aquatic invertebrate
acute toxicity test, freshwater daphnids (OCSPP Harmonized Test
Guideline 850.1010); an algal toxicity test, tiers I and II (OCSPP
Harmonized Test Guideline 850.5400); a ready biodegradability test
(OCSPP Harmonized Test Guideline 835.3110); and an activated sludge
sorption isotherm (OCSPP Harmonized Test Guideline 835.1110) would help
characterize the environmental effects of the PMN substances. Testing
should be performed on P-06-264. Further, a certificate of analysis
should be included for the test substances.

CFR citations: 40 CFR 721.10191 (P-06-262); 40 CFR 721.10192 (P-06-263,
Chemical A); 40 CFR 721.10193 (P-06-263, Chemical B); and 40 CFR
721.10194 (P-06-264).
PMN Numbers P-06-265, P-06-266, and P-06-267

Chemical names: (P-06-265) Dialkylcornoilamidoalkylamine (generic); (P-
06-266, Chemical A) Dialkylcornoilamidoacrylate (generic); (P-06-266,
Chemical B) Dialkycornoilamidoalkylbetaine (generic); and (P-06-267)
Dialkylcornoilamidopropionate (generic).
CAS numbers: (P-06-265) Not available; (P-06-266, Chemical A) not
available; (P-06-266, Chemical B) not available; and (P-06-267) not
available.
Basis for action: The consolidated PMN states that the substances will
be used as intermediates for hydrate inhibitors for oil and gas wells,
production pipelines and flowlines (P-06-265); and hydrate inhibitors
for oil and gas wells, production pipelines and flowlines (P-06-266 and
P-06-267). Based on test data on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 20 ppb of the PMN substances in surface waters. For the uses
described in the PMNs, these 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 the
following tests would help characterize the environmental effects of
the PMN substance: A fish acute toxicity test, freshwater and marine
(OCSPP Harmonized Test Guideline 850.1075); an aquatic invertebrate
acute toxicity test, freshwater daphnids (OCSPP Harmonized Test
Guideline 850.1010); an algal toxicity test, tiers I and II (OCSPP
Harmonized Test Guideline 850.5400); a ready biodegradability test
(OCSPP Harmonized Test Guideline 835.3110); and an activated sludge
sorption isotherm (OCSPP Harmonized Test Guideline 835.1110) would help
characterize the environmental effects of the PMN substances. Testing
should be performed on P-06-267. Further, a certificate of analysis
should be included for the test substances.

CFR citations: 40 CFR 721.10195 (P-06-265); 40 CFR 721.10196 (P-06-266,
Chemical A); 40 CFR 721.10197 (P-06-266, Chemical B); and 40 CFR
721.10198 (P-06-267).
PMN Number P-06-702
Chemical name: Substituted aliphatic amine (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: May 26, 2009.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a polymer
curative. The order was issued under sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) of TSCA based on findings that this substance may
present an unreasonable risk of injury to the environment and human
health. To protect against these risks, the consent order requires use
of dermal personal protective equipment, including gloves demonstrated
by testing to be impervious (Ansell NEOX style 9-912 gloves have been
shown to satisfy this requirement for up to 110 minutes), use of
respiratory personal protective equipment, including a National
Institute of Occupational Safety and Health (NIOSH)-approved
respiratory protection with an APF of at least 50 or compliance with a
New Chemical Exposure Limit (NCEL) of 0.14 mg/m\3\ as an 8-hour time-
weighted average, establishment of a hazard communication program, and
restricts releases to water. The SNUR designates as a ``significant new
use'' the absence of these protective measures.
Toxicity concern: Based on test data on analogous substances, EPA
identified concerns for chronic liver toxicity, acute oral toxicity and
corrosion to membranes, dermal toxicity, inhalation toxicity, dermal
and eye irritation to workers exposed to the PMN substance. EPA set the
NCEL at 0.14 mg/m\3\ as an 8-hour time-weighted average. In addition,
based on test data on the PMN substance, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb of the
PMN substance in surface waters.
Recommended testing: EPA has determined that the results of the
following tests would help characterize the health and environmental
effects of the PMN substance: A primary skin irritation test (OECD 404
test guideline); a primary eye irritation test (OECD 405 test
guideline); a 28-day repeated dose (OECD 407 test guideline) gavage in
rats, a fish early life stage toxicity test (OCSPP Harmonized Test
Guideline 850.1400); and a daphnid chronic toxicity test (OCSPP
Harmonized Test Guideline 850.1300). The PMN submitter has agreed not
to exceed the production volume limit without performing the primary
skin irritation test (OECD 404 test guideline); primary eye irritation
test (OECD 405 test guideline); and 28-day repeated dose test (OECD 407
test guideline) gavage in rats. The order does not require submission
of the fish early life-stage toxicity test and the daphnid chronic
toxicity test 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 substance will remain in
effect until the order is modified or revoked by EPA based on
submission of that or other relevant information.
CFR citation: 40 CFR 721.10199.
PMN Number P-09-75
Chemical name: Benzenacetonitrile, cyclohexylidene-alkyl substituted
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the PMN substance will be as a component of odorant compositions
for highly-dispersive applications. Based on test data on the PMN
substance, EPA predicts chronic toxicity to aquatic organisms at
concentrations that exceed 123 ppb of the PMN substance in surface
waters. For the processing and use scenario and production volume in
the amended PMN, releases of the substance are not expected to result
in surface water concentrations that exceed 123 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 that exceed 123 ppb, or exceedance of the annual maximum
manufacturing and importation limit of 10,000 kg, 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 the
following tests would help characterize the environmental effects of
the PMN substance: A fish early life stage toxicity test (OCSPP
Harmonized Test Guideline 850.1400) and a field testing for aquatic
organisms test (OCSPP Harmonized Test Guideline 850.1950). The fish
early-life stage test should be performed using the flow-through method
with measured concentrations. Further, a certificate of analysis should
be provided for the test substance. EPA recommends conducting the early
life stage fish test first, as the results of this test may affect the
choice of species for subsequent field testing.
CFR citation: 40 CFR 721.10200.

V. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances
that are the subjects of these SNURs, EPA

concluded that for 2 of the 17 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.
    In the other 15 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 August 23, 2010 without further notice, unless EPA
receives written adverse or critical comments, or notice of intent to
submit adverse or critical comments before July 26, 2010.
    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 July 26, 2010, 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 June 24, 2010.
    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 2 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, 12 of the 17
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, 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 (see Unit III.).
    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, except where the
chemical substance subject to the SNUR is also subject to a test rule
under TSCA section 4 (see TSCA section 5(b)). 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.
    In the TSCA section 5(e) consent orders for several of the chemical
substances regulated under this rule, EPA has established production
volume limits 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 limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Under recent TSCA section 5(e)
consent orders, each PMN submitter is required to submit each study at
least 14 weeks (earlier TSCA section 5(e) consent orders required
submissions at least 12 weeks) before reaching the specified production
limit. Listings of the tests specified in the TSCA section 5(e) consent
orders are included in Unit IV. The SNURs contain the same production
volume limits as the TSCA section 5(e) consent orders. Exceeding these
production limits is defined as a significant new use. Persons who
intend to exceed the production limit must notify the Agency by
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture, import, or processing.
    The recommended tests may not be the only means of addressing the
potential risks of the chemical substance. However, SNUN submitting for
significant new use 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. This rule cross-
references Sec.  721.1725(b)(1) and is similar to that in Sec.  721.11
for situations where the chemical identity of the chemical substance
subject to a SNUR is CBI. This procedure is cross-referenced in each
SNUR that includes specific significant new uses that are CBI.
    Under these procedures a manufacturer, importer, or processor may
request EPA to 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

    As stated in Unit II.C., 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 to EPA, on EPA Form No. 7710-25 in
accordance with the procedures set forth in Sec. Sec.  721.25 and
720.40. This form is available from the Environmental Assistance
Division (7408M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. Forms and information are also 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.

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, or TSCA section 5(e) consent orders. 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 the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable. 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 these SNURs will not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is discussed in this unit. 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 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 over 1,400 SNURs, the
Agency receives on average only 5 notices per year. Of those SNUNs
submitted from 2006-2008, only one appears to be from a small entity.
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 these
SNURs 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 affect on
small governments subject to the requirements of sections 202, 203,
204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public
Law 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 does
not significantly or 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 to 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: June 17, 2010.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

0
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.

* * * * *

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

------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
                                * * * * *
721.10184............................................          2070-0012
721.10185............................................          2070-0012
721.10186............................................          2070-0012
721.10187............................................          2070-0012
721.10188............................................          2070-0012
721.10189............................................          2070-0012
721.10190............................................          2070-0012
721.10191............................................          2070-0012
721.10192............................................          2070-0012
721.10193............................................          2070-0012
721.10194............................................          2070-0012
721.10195............................................          2070-0012
721.10196............................................          2070-0012
721.10197............................................          2070-0012
721.10198............................................          2070-0012
721.10199............................................          2070-0012
721.10200............................................          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.  721.10184 to subpart E to read as follows:

Sec.  721.10184  Aliphatic triamine (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aliphatic triamine (PMN P-02-996) 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(y)(1).
    (ii) Release to water. Requirements as specified in Sec.  721.90
(a)(1), (b)(1), and (c)(1).
    (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), (i), 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
5. Add Sec.  721.10185 to subpart E to read as follows:

Sec.  721.10185  1,2-Propanediol, 3-(diethylamino)-, polymers with 5-
isocyanato-1- (isocyanatomethyl)-1,3,3-trimethylcyclohexane, propylene
glycol and reduced Me esters of reduced polymd. oxidized
tetrafluoroethylene, 2-ethyl-1-hexanol-blocked, acetates (salts).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-propanediol, 3-
(diethylamino)-, polymers with 5-isocyanato-1- (isocyanatomethyl)-
1,3,3-trimethylcyclohexane, propylene glycol and reduced Me esters of
reduced polymd. oxidized tetrafluoroethylene, 2-ethyl-1-hexanol-
blocked, acetates (salts) (PMN P-03-106; CAS No. 328389-90-8) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(y)(l).
    (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
6. Add Sec.  721.10186 to subpart E to read as follows:

Sec.  721.10186  Ethylhexyl oxetane (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethylhexyl oxetane (PMN P-04-132) 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 after it has been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(3)(i), (b) (concentration
set at 1.0 percent), and (c). Polyvinyl Alcohol gloves with a thickness
of no less than 31.3 mils or Silvershield/4H sleeves with a thickness
of no less than 2.7 mils have been shown to satisfy the requirements of
Sec.  721.63(a)(3)(i) for up to 8 hours.
    (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)(iii), (g)(1)(iv), (g)(2)(i), (g)(2)(v),
(g)(3)(ii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k).
    (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), (e), (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.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.

0
7. Add Sec.  721.10187 to subpart E to read as follows:

Sec.  721.10187  4-Morpholinepropanamine, N-(1,3-dimethylbutylidene)-.

    (a) Chemical substance and significant new uses subject to
reporting.

(1) The chemical substance identified as 4-morpholinepropanamine, N-
(1,3-dimethylbutylidene)- (PMN P-05-186, Chemical A; CAS No. 1003863-
30-6) 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=10). However, when this chemical
substance is released in combination with any of the substances in
Sec.  721.10188, Sec.  721.10189, or Sec.  721.10190, then the value of
N shall instead be adjusted according to the following formula:
    [(N1 x Release1) + (N2 x Release2) + (N3 x Release3) + (N4 x
Release4)] / (Release1 + Release2 + Release3 + Release4) = Adjusted N
    Where the ``N'' variables are the N values for each of the four
substances as specified in this section and Sec.  721.10188, Sec.
721.10189, Sec.  721.10190 and the ``Release'' variables are the number
of kilograms released of the respective four substances (in units of
kg/site/day) per Sec.  721.91(a).
    (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.  721.10188 to subpart E to read as follows:

Sec.  721.10188  Fatty acids, tall-oil, reaction products with 4-
methyl-2-pentanone and aliphatic polyamine (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, tall-oil, reaction products with 4-methyl-2-pentanone and
aliphatic polyamine (PMN P-05-186, Chemical B) 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=10). However, when this chemical
substance is released in combination with any of the substances in
Sec.  721.10187, Sec.  721.10189, or Sec.  721.10190, then the value of
N shall instead be adjusted according to the following formula:
    [(N1 x Release1) + (N2 x Release2) + (N3 x Release3) + (N4 x
Release4)] / (Release1 + Release2 + Release3 + Release4) = Adjusted N
    Where the ``N'' variables are the N values for each of the four
substances as specified in this section and Sec.  721.10187, Sec.
721.10189, Sec.  721.10190 and the ``Release'' variables are the number
of kilograms released of the respective four substances (in units of
kg/site/day) per Sec.  721.91(a).
    (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.  721.10189 to subpart E to read as follows:

Sec.  721.10189  Fatty acids, tall-oil, reaction products with
(butoxymethyl) oxirane formaldehyde-phenol polymer glycidyl ether,
morpholinepropanamine, propylene glycol diamine and aliphatic
polyamine, N-(1,3 -dimethylbutylidene) derivs (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, tall-oil, reaction products with (butoxymethyl) oxirane
formaldehyde-phenol polymer glycidyl ether, morpholinepropanamine,
propylene glycol diamine and aliphatic polyamine, N-(1,3 -
dimethylbutylidene) derivs (PMN P-05-186, Chemical C) 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=10). However, when this chemical
substance is released in combination with any of the substances in
Sec.  721.10187, Sec.  721.10188, or Sec.  721.10190, then the value of
N shall instead be adjusted according to the following formula:
    [(N1 x Release1) + (N2 x Release2) + (N3 x Release3) + (N4 x
Release4)] / (Release1 + Release2 + Release3 + Release4) = Adjusted N
    Where the ``N'' variables are the N values for each of the four
substances as specified in this section and Sec.  721.10187, Sec.
721.10188, Sec.  721.10190 and the ``Release'' variables are the number
of kilograms released of the respective four substances (in units of
kg/site/day) per Sec.  721.91(a).
    (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.  721.10190 to subpart E to read as follows:

Sec.  721.10190  Formaldehyde, polymer with aliphatic diamine and
phenol, reaction products with 4-methyl-2-pentanone (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
formaldehyde, polymer with aliphatic diamine and phenol, reaction
products with 4-methyl-2-pentanone (PMN P-05-186; Chemical D) 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=10). However, when this chemical
substance is released in combination with any of the substances in
Sec.  721.10187, Sec.  721.10188, or Sec.  721.10189, then the value of
N shall instead be adjusted according to the following formula:
    [(N1 x Release1) + (N2 x Release2) + (N3 x Release3) + (N4 x
Release4)] / (Release1 + Release2 + Release3 + Release4) = Adjusted N
    Where the ``N'' variables are the N values for each of the four
substances as specified in this section and Sec.  721.10187, Sec.
721.10188, Sec.  721.10189 and the ``Release'' variables are the number
of kilograms released of the respective four substances (in units of
kg/site/day) per Sec.  721.91(a).
    (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
11. Add Sec.  721.10191 to subpart E to read as follows:

Sec.  721.10191  Amides, coco, N-[3-(dibutylamino)propyl].

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amides, coco, N-[3-
(dibutylamino)propyl] (PMN P-06-262; CAS No. 851544-20-2) 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
12. Add Sec.  721.10192 to subpart E to read as follows[U1]:

Sec.  721.10192  Amides, coco, N-[3-(dibutylamino)propyl], acrylates.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amides, coco, N-[3-
(dibutylamino)propyl], acrylates (PMN P-06-263, Chemical A; CAS No.
851545-09-0) 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
13. Add Sec.  721.10193 to subpart E to read as follows:

Sec.  721.10193  1-Butanaminium, N-(3-aminopropyl)-N-butyl-N-(2-
carboxyethyl)-, N-coco acyl derivs., inner salts.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-butanaminium, N-
(3-aminopropyl)-N-butyl-N-(2-carboxyethyl)-, N-coco acyl derivs., inner
salts (PMN P-06-263, Chemical B; CAS No. 851545-17-0) 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
14. Add Sec.  721.10194 to subpart E to read as follows:

Sec.  721.10194  Dialkylcocoamidoalkylpropionate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dialkylcocoamidoalkylpropionate (PMN P-06-264) 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.  721.10195 to subpart E to read as follows:

Sec.  721.10195  Dialkylcornoilamidoalkylamine (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dialkylcornoilamidoalkylamine (PMN P-06-265) 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.  721.10196 to subpart E to read as follows:

Sec.  721.10196  Dialkylcornoilamidoacrylate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dialkylcornoilamidoacrylate (PMN P-06-266, Chemical A) 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.  721.10197 to subpart E to read as follows:

Sec.  721.10197  Dialkycornoilamidoalkylbetaine (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dialkycornoilamidoalkylbetaine (PMN P-06-266, Chemical B) 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
18. Add Sec.  721.10198 to subpart E to read as follows:

Sec.  721.10198  Dialkylcornoilamidopropionate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dialkylcornoilamidopropionate (PMN P-06-267) 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
19. Add Sec.  721.10199 to subpart E to read as follows:

Sec.  721.10199  Substituted aliphatic amine (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted aliphatic amine (PMN P-06-702) 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 after it has been completely reacted
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2), (a)(3)(i), (a)(4), (a)(5), (a)(6), (b)
(concentration set at 1.0 percent), and (c). Ansell NEOX style 9-912
gloves have been shown to satisfy the requirements of Sec.
721.63(a)(3)(i) for up to 110 minutes. Respirators must provide a
National Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 50. The following NIOSH-approved
respirators meet the requirements for Sec.  721.63(a)(4): Air
purifying, tight-fitting full-face respirator equipped with the
appropriate combination cartridges, cartridges should be tested and
approved for the gas/vapor substance (i.e., organic vapor, acid gas, or
substance-specific cartridge) and should include a particulate filter
(N100 if oil aerosols are absent, R100, or P100); powered air-purifying
respirator equipped with a tight-fitting facepiece (full-face) and the
appropriate combination cartridges, cartridges should be tested and
approved for the gas/vapor substance (i.e., organic vapor, acid gas, or
substance-specific cartridges) and should include High Efficiency
Particulate Air (HEPA) filters; supplied-air respirator operated in
pressure demand or continuous flow mode and equipped with a tight-
fitting face piece (full-face). As an alternative to the respiratory
requirements listed here, a manufacturer, importer, or processor may
choose to follow the new chemical exposure limit (NCEL) provisions
listed in the Toxic Substances Control Act (TSCA) section 5(e) consent
order for this substance. The NCEL is 0.14 mg/m\3\ as an 8-hour time-
weighted average. 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.
    (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)(i), (g)(1)(ii), (g)(1)(iv), (g)(2)(i),
(g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii),
(g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(r).
    (iv) Release to water. Requirements as specified in Sec.  721.90
(a)(1), (b)(1), and (c)(1).
    (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), (e), (f), (g), (h), (i), 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.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.

0
20. Add Sec.  721.10200 to subpart E to read as follows:

Sec.  721.10200  Benzenacetonitrile, cyclohexylidene-alkyl substituted
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzenacetonitrile, cyclohexylidene-alkyl substituted (PMN P-09-75) 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(s) (10,000 kg).
    (ii) Release to water. Requirements as specified in Sec.  721.90
(a)(4), (b)(4), and (c)(4) (N=123).
    (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), (i), 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.

[FR Doc. 2010-15334 Filed 6-23-10; 8:45 am]
BILLING CODE 6560-50-S