[Federal Register Volume 75, Number 20 (Monday, February 1, 2010)]
[Rules and Regulations]
[Pages 4983-4996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1936]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2008-0918; FRL-8438-4]
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 15
chemical substances which were the subject of premanufacture notices
(PMNs). Three of these chemical substances are subject to TSCA section
5(e) consent orders issued by EPA. This action requires persons who
intend to manufacture,
[[Page 4984]]
import, or process any of these 15 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: The effective date of this rule is April 2, 2010 without further
notice, unless EPA receives written adverse or critical comments, or
notice of intent to submit adverse or critical comments before March 3,
2010. This rule shall be promulgated for purposes of judicial review at
1 p.m. (e.s.t.) on February 16, 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 March 3, 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.
Significant new use designations for a chemical substance are
legally established as of the date of publication of this direct final
rule February 1, 2010. See the discussion in Unit VII. for more
specific details.
Any persons intending to import or export a chemical substance that
is the subject of this rule on or after March 3, 2010 are subject to
the TSCA section 13 import certification requirements and the export
notification provisions of TSCA section 12(b). See the discussion in
Unit I.A. and Unit II.C. for more specific details.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2008-0918, 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-2008-0918. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is (202) 564-8930. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2008-0918. 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 (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: [email protected].
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 protected].
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
[[Page 4985]]
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 March 3, 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). 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.
1612) 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 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. 2612 (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 15
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 factors listed in TSCA section 5(a)(2) and
this unit.
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IV. Substances Subject to this Rule
EPA is establishing significant new use and recordkeeping
requirements for 15 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 3 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.
This rule also includes SNURs on 12 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). EPA, however, 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-03-141
Chemical name: Cyclopentane, methoxy-.
CAS number: 5614-37-9.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as an industrial solvent. Based on test
data on the PMN substance, EPA has identified concerns for systemic
toxicity and neurotoxicity. For the use described in the PMN,
significant worker exposure is not expected. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance other than as described in the
PMN may cause serious health effects. Based on this information, the
PMN substance meets the concern criteria at Sec. 721.170(b)(3)(i).
Recommended testing: EPA has determined that the results of the
following tests would help characterize the human health effects of the
PMN substance: A 90-day oral toxicity test in rodents (OPPTS Harmonized
Test Guideline 870.3100); a flammability test (OPPTS Harmonized Test
Guideline 830.6315); a sediment and soil adsorption/desorption isotherm
test (OPPTS Harmonized Test Guideline 835.1220); and a standard
practice for determination of odor and taste threshold by a forced-
choice ascending concentration series method of limits (American
Society for Testing and Materials (ASTM) E679-04 test guideline).
CFR citation: 40 CFR 721.10169.
PMN Number P-03-197
Chemical name: Polyoxyethylene polyalkylarylphenylether sulfate
ammonium salt (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a surface active agent for emulsion
polymerization. Based on test data on analogous anionic surfactants,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 5 parts per billion (ppb) of the PMN substance in surface
waters. For the use described in the PMN, releases of the substance are
not expected to result in surface waters concentrations that exceed 5
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 other than
as described in the PMN may cause significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Harmonized Test
Guideline 850.1075); an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an
algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline
850.5400) would help characterize the environmental effects of the PMN
substance. All aquatic toxicity testing should be performed using the
flow-through method with measured concentrations. Further, a
certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10170.
PMN Number P-03-285
Chemical name: 1H-benz(e)indolium, 1,1,2,3-tetramethyl-, 4-
methylbenzenesulfonic acid (1:1).
CAS number: 141914-99-0.
Basis for action: The PMN states that the substance will be used as a
chemical intermediate for the manufacture of a dye in imaging media/
products. Based on test data on the PMN substance, EPA identified
concerns for acute lethality from inhalation of the PMN substance. As
described in the PMN, worker inhalation exposure will be minimal due to
the use of adequate personal protective equipment. Therefore, EPA has
not determined that the proposed manufacturing, processing, or use of
the substance may present an unreasonable risk. EPA has determined,
however, that use of the substance without the use of a National
Institute for Occupational Safety and Health (NIOSH)-approved
respirator with an assigned protection factor (APF) of at least 10
where there is a potential for inhalation exposure, or exceedance of
the 11,000 kilogram annual manufacture and import volume may cause
serious health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(3)(i).
[[Page 4987]]
Recommended testing: EPA has determined that the results of a repeated
dose 28-day oral toxicity in rodents (OPPTS Harmonized Test Guideline
870.3050 or Organisation for Economic Co-operation and Development
(OECD) 407 test guideline) would help characterize the human health
effects of the PMN substance.
CFR citation: 40 CFR 721.10171.
PMN Number P-03-633
Chemical name: Alkylamide derivative (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 for the manufacture of
photosensitive materials. Based on test data on analogous substances,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 1 ppb of the PMN substance in surface waters. As described
in the PMN, releases of the substance are not expected to result in
surface water concentrations that exceed 1 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 1 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Harmonized Test Guideline
850.1400); a daphnid chronic toxicity test (OPPTS Harmonized Test
Guideline 850.1300); and an algal toxicity test, tiers I and II (OPPTS
Harmonized Test Guideline 850.5400) would help characterize the
environmental effects of the PMN substance. Fish and daphnia testing
should be performed using the flow-through method with measured
concentrations. Algal testing should be performed using the static
method with measured concentrations. Further, a certificate of analysis
should be provided for the test substance.
CFR citation: 40 CFR 721.10172.
PMN Number P-03-793
Chemical name: Silanamine,1,1,1-triethoxy-N,N-diethyl-.
CAS number: 35077-00-0.
Basis for action: The PMN states that the substance will be used as an
external donor for olefin polymerization. Based on submitted test data,
EPA has identified health concerns for corrosion. Also, based on test
data on analogous alkoxysilanes and aliphatic amines, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
10 ppb of the PMN substance in surface waters. As described in the PMN,
significant worker exposure is unlikely and releases to surface waters
are not expected. Therefore, EPA has not determined that the proposed
import, processing, or use of the substance may present an unreasonable
risk. EPA has determined, however, that domestic manufacture of the
substance could result in exposures which may cause serious health
effects and significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170 (b)(3)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Harmonized Test
Guideline 850.1075); an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an
algal toxicity test, tiers I and II (OPPTS Harmonized 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 toxicity testing
should be performed using the static method with measured
concentrations. No human health testing is recommended at this time.
Further, a certificate of analysis should be provided for the test
substance.
CFR citation: 40 CFR 721.10173.
PMN Number P-04-139
Chemical name: 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-
, N-peanut-oil acyl derivs., inner salts.
CAS number: 691401-28-2.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as an oil well additive. Based on test
data on analogous substances, EPA identified concerns for irritation,
possible corrosion, and developmental toxicity. For the use described
in the PMN, worker inhalation exposure is not expected and worker
dermal exposures will be minimal due to the use of adequate personal
protective equipment. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that use of the
substance without the use of impervious gloves where there is a
potential for dermal exposure, or use of the substance other than as
described in the PMN may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a prenatal
developmental toxicity test (OPPTS Harmonized Test Guideline 870.3700)
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10174.
PMN Number P-04-141
Chemical name: 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-
dimethyl-3-sulfo-, N-(C12-18 and C18-unsatd. acyl) derivs., inner
salts.
CAS number: 691400-36-9.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be used as an additive for various cleaners.
Based on test data on analogous amphoteric surfactants, 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 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)(ii).
Recommended testing: EPA has determined that the results of a porous
pot test (OPPTS Harmonized Test Guideline 835.3220); an aquatic
invertebrate acute toxicity test, freshwater daphnids (OPPTS Harmonized
Test Guideline 850.1010); and an algal toxicity test, tiers I and II
(OPPTS Harmonized Test Guideline 850.5400) would help characterize the
environmental effects of the PMN substance. 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. Further, a certificate of analysis should be provided
for the test material.
CFR citation: 40 CFR 721.10175.
PMN Number P-04-144
Chemical name: Amides, peanut-oil, N-[3-(dimethylamino)propyl].
CAS number: 691400-76-7.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be used as a chemical intermediate. Based on
test data on analogous aliphatic amines, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed
[[Page 4988]]
1 ppb of the PMN substance in surface waters. As described in the PMN,
the substance is not released to surface waters. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in 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 the
following tests would help characterize the environmental effects of
the PMN substance: A fish acute toxicity test, freshwater and marine
(OPPTS Harmonized Test Guideline 850.1075); a fish acute toxicity test
mitigated by humic acid (OPPTS Harmonized Test Guideline 850.1085) with
the chloride salt adjusted to a pH of 7; an aquatic invertebrate acute
toxicity test, freshwater daphnids (OPPTS Harmonized Test Guideline
850.1010); and an algal toxicity test, tiers I and II (OPPTS Harmonized
Test Guideline 850.5400). All aquatic toxicity testing should be
performed using the static method with measured concentrations.
Further, a certificate of analysis should be provided for the test
substance.
CFR citation: 40 CFR 721.10176.
PMN Number P-04-153
Chemical name: Phosphoric acid, yttrium(3+) salt (1:1).
CAS number: 13990-54-0.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a phosphor. Based on test data on
analogous inorganic phosphates and soluble yttrium compounds, 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 substance are not expected to result in
surface water concentrations that exceed 6 ppb. Therefore, EPA has not
determined that the proposed import, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that domestic manufacture or 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)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Harmonized Test
Guideline 850.1075); an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an
algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline
850.5400) would help characterize the environmental effects of the PMN
substance. All aquatic toxicity testing should be performed using the
static method with measured concentrations of yttrium. Further, a
certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10177.
PMN Number P-04-319
Chemical name: Distillates (Fischer-Tropsch), hydroisomerized middle,
C10-13-branched alkane fraction.
CAS number: 642928-30-1.
Basis for action: The PMN states that the substance will be used as
industrial/commercial paint and ink formulations; indoor industrial
heating oil; and solvent blend for industrial cleaning. Based on test
data on structurally similar chemicals with a carbon chain range of C5
to C21, EPA has identified health concerns for liver toxicity, kidney
toxicity, developmental toxicity, mutagenicity, cancer, neurotoxicity,
skin sensitization, hydrocarbon pneumonia, and irritation to mucous
membranes. Also, based on test data on analogous neutral organic
compounds, 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, worker dermal and inhalation exposure
will be minimal due to the use of adequate personal protective
equipment, and releases to water are not expected. Therefore, EPA has
not determined that the proposed import, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that use of the substance without the use of impervious gloves
where there is the potential for dermal exposure, use of the substance
without the use of a NIOSH-approved respirator with an APF of at least
100 where there is potential for inhalation exposure, domestic
manufacturing, 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)(1)(i)(C),
(b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of the
following tests would help characterize the human health and
environmental effects of the PMN substance: A prenatal developmental
toxicity test (OPPTS Harmonized Test Guideline 870.3700), using one
species via the oral route; a fish early-life stage toxicity test
(OPPTS Harmonized Test Guideline 850.1400) with fathead minnows, a
daphnid chronic toxicity test (OPPTS Harmonized Test Guideline
850.1300); and an algal toxicity test, tiers I and II (OPPTS Harmonized
Test Guideline 850.5400). Fish and daphnid testing should be performed
using the flow-through method with measured concentrations. Dilution
water total organic carbon (TOC) concentration should be less than 2.0
mg TOC per liter. Algal testing should be performed using the static
method with measured concentrations. Further, a certificate of analysis
should be provided for the test substance.
CFR citation: 40 CFR 721.10178.
PMN Numbers P-04-346 and P-04-347
Chemical name: Copolymers of phenol and aromatic hydocarbon (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: November 15, 2004.
Basis for TSCA section 5(e) consent order: The consolidated PMN states
that the generic (non-confidential) use of the substances will be as
binder components. The order was issued under sections 5(e)(1)(A)(i)
and 5(e)(1)(A)(ii)(I) of TSCA, based on a finding that these substances
may present an unreasonable risk of injury to the environment. To
protect against this risk, the consent order requires the company to
not manufacture or import the PMN substances unless the average
molecular weight is greater than 500 daltons. To ensure compliance, the
consent order also requires that the substances be analyzed both at the
time of initial commencement and annually thereafter. The SNUR
designates as a ``significant new use'' the absence of these protective
measures.
Toxicity concern: Based on test data on analogous phenols, EPA predicts
toxicity to aquatic organisms varies with the average number molecular
weight of the PMN substances. As the average number molecular weight
decreases, the aquatic toxicity of the substances increases. When the
average molecular weight is 366 daltons, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb of the
PMN substances in surface waters. The PMN substances with a molecular
weight greater than 500 daltons are of lower concern for toxicity
because the expected water solubility is estimated to be less than 1
ppb.
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Harmonized Test Guideline
850.1400), a daphnid chronic toxicity test (OPPTS Harmonized Test
Guideline 850.1300);
[[Page 4989]]
and an algal toxicity test, tiers I and II (OPPTS Harmonized Test
Guideline 850.5400) would help characterize possible 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. EPA should be consulted to determine what form of the
chemical substances should be tested. The order does not require
submission of the testing at any specified time or production volume.
However, the order's restrictions on manufacture, import, processing,
distribution in commerce, use and disposal of the chemical substances
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 721.10179.
PMN Number P-04-692
Chemical name: Trifunctional acrylic ester (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: December 6, 2004.
Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used in lacquer/dry film manufacture. The order was
issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based
on a finding that this substance may present an unreasonable risk of
injury to the environment. To protect against this risk, the consent
order requires the company to not manufacture or import the PMN
substance unless the mean number of moles of the ethoxy group is
greater than or equal to 8. To ensure compliance, the consent order
also requires that the substance be analyzed both at the time of
initial commencement and annually thereafter. The SNUR designates as a
``significant new use'' the absence of these protective measures.
Toxicity concern: Based on test data on analogous esters, EPA predicts
toxicity to aquatic organisms varies with the average number of moles
of the ethoxy group. As the number of moles of ethoxy group decreases,
the aquatic toxicity of the substance increases. For the PMN substance
with an average of 3 moles of ethoxy, EPA predicts toxicity to aquatic
organisms at concentrations that exceed 40 ppb of the PMN substance in
surface waters.
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Harmonized Test
Guideline 850.1075); an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an
algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline
850.5400) would help characterize the environmental effects of the PMN
substance. Fish and daphnid testing should be performed using flow-
through method with measured concentrations. Algal testing should be
performed using the static method with measured concentrations. EPA
should be consulted to determine what form of the chemical substance
should be tested. The order does not require submission of the testing
at any specified time or production volume. However, the order's
restrictions on manufacture, import, processing, distribution in
commerce, use and disposal of the chemical 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 721.10180.
PMN Number P-07-453
Chemical name: Halide salt of an alkylamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a solder adjuvant, an open, non-
dispersive use. Based on test data on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms at concentrations that exceed 20
ppb of the PMN substance in surface waters. For the use described in
the PMN, releases of the substance are not expected to result in
surface water concentrations that exceed 20 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance other than as described in the
PMN could result in release to surface waters which 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 Harmonized Test
Guideline 850.1075); an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an
algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline
850.5400) would help characterize the environmental effects of the PMN
substance. All aquatic toxicity testing should be performed using the
static method with nominal concentrations. Further, a certificate of
analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10181.
PMN Number P-07-601
Chemical name: 1-Propene, 2,3,3,3-tetrafluoro-.
CAS number: 754-12-1.
Basis for action: The PMN states that the substance will be used as a
motor vehicle air conditioning (MVAC) refrigerant in new passenger cars
and vehicles (i.e., as defined in 40 CFR 82.32 (c) and (d)). Initial
charging of MVAC units with the PMN substance will be done by the motor
vehicle original equipment manufacturer. All servicing, maintenance,
and disposal involving the PMN substance will be done only by Clean Air
Act (CAA) section 609 certified technicians using CAA section 609
certified refrigerant handling equipment. Based on test data on the PMN
substance, EPA identified health concerns for developmental toxicity
and lethality to workers and consumers if they were exposed to a
significant amount of the PMN substance via inhalation. The PMN
substance has an ozone depletion potential of zero, and based on test
data, has a low global warming potential (GWP100 of about
4). For the use scenario described in the PMN, significant industrial
or commercial worker exposure is unlikely due to the use of CAA section
609 certified refrigerant handling equipment and other protective
measures. Potential consumer (vehicle passenger) exposure from
refrigerant leaks into the passenger compartment of a vehicle is not
expected to present significant risk of serious health effects.
Flammability concerns with the PMN substance are being addressed
through regulatory actions by EPA's Office of Air and Radiation (see
the following paragraph). Further, ``do-it-yourself'' consumer
exposures are not expected because the PMN substance only will be sold
or distributed in 20-pound containers or larger. Therefore, EPA has not
determined that the manufacturing, processing, or use of the substance
as described in the PMN may present an unreasonable risk. EPA has
determined, however, that (1) use of the substance other than as a MVAC
refrigerant in new passenger cars and vehicles as defined in 40 CFR
82.32 (c) and (d), (2) initial charging of MVAC units with the PMN
substance by any person other than CAA section 609 certified
technicians without using CAA section 609 certified refrigerant
handling equipment, (3) servicing, maintenance, and disposal involving
the PMN substance by persons other than CAA section 609 certified
technicians without using CAA section 609 certified refrigerant
[[Page 4990]]
handling equipment, or (4) sale or distribution of the PMN substance in
containers smaller than 20-pounds (net weight) may cause serious health
effects in accordance with 40 CFR 721.170(b)(3)(i).
This SNUR is intended to complement recently proposed and
forthcoming regulations on the PMN substance under the CAA in that this
SNUR addresses health risk issues of the subject refrigerant. On
October 19, 2009, EPA published a proposed rule on the PMN substance
entitled ``Protection of Stratospheric Ozone: New Substitute in the
Motor Vehicle Air Conditioning Sector under the Significant New
Alternatives Policy (SNAP) Program'' (74 FR 53445) (FRL-8969-7). The
SNAP Program, mandated under section 612 of the CAA, requires EPA to
develop a program for evaluating alternatives to ozone-depleting
substances and to create lists of substitutes for specific uses that do
not present greater overall risk to human health and the environment
than other alternatives that are available. In the October 19, 2009,
action, EPA proposed to find HFO-1234yf acceptable, subject to certain
use conditions, as a substitute for CFC-12 in new motor vehicle air
conditioning systems (passenger cars and trucks). The proposed use
conditions include incorporation of engineering strategies and/or
devices to mitigate flammability risks for this substance (see Unit V.
of the proposed rule). Use of most flammable refrigerants, including
the PMN substance, in existing MVAC systems as a retrofit has
previously been determined by EPA to be unacceptable. The proposed rule
would require a petition and a new SNAP submission specifically for the
use of the PMN substance in existing MVAC equipment as a retrofit
before EPA would consider allowing such use (see Unit VI. of the
proposed rule). EPA also intends to promulgate a follow-on rulemaking
under section 609 of the CAA to address service equipment, technician
certification, and end-of-life disposal specifications.
Recommended testing: EPA has determined that the results of an acute
inhalation toxicity study (OPPTS Harmonized Test Guideline 870.1300 or
OECD 403 test guideline) with rabbits would help characterize the human
health effects of the PMN substance. Exposure concentrations of 10,000,
50,000, and 100,000 parts per million (ppm) should be used. Further,
rabbits should be exposed for 1 hour, and pregnant rabbits should be
exposed on Gravid Day 12.
CFR citation: 40 CFR 721.10182.
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 3 of the 15
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 12 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 April 2, 2010 without further notice, unless EPA receives
written adverse or critical comments, or notice of intent to submit
adverse or critical comments before March 3, 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 March 3, 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
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 3 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, 6 of the 15
chemical substances contained in this rule have
[[Page 4991]]
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. Many OPPTS Harmonized Test Guidelines are now
available on the Internet. Please go to http://www.epa.gov/oppts and
select ``Test Methods and Guidelines'' on the left-side navigation
menu. 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 (ASTM) test guidelines are
available at http://www.astm.org/standard/index.shtml.
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, SNUNs submitted for
significant new uses 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 many 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,
[[Page 4992]]
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 40 CFR
720.50. SNUNs must be mailed to the Environmental Protection Agency,
OPPT Document Control Office (7407M), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Information must be submitted in the form
and manner set forth in EPA Form No. 7710-25. This form is available
from the Environmental Assistance Division (7408M), 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001 (see Sec. Sec. 721.25 and
720.40). Forms and information are also available electronically at
http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm.
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 1,000 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
[[Page 4993]]
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: January 13, 2010.
Wendy C. Hamnett,
Acting 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
------------------------------------------------------------------------
* * * * *
721.10169............................................ 2070-0012
721.10170............................................ 2070-0012
721.10171............................................ 2070-0012
721.10172............................................ 2070-0012
721.10173............................................ 2070-0012
721.10174............................................ 2070-0012
721.10175............................................ 2070-0012
721.10176............................................ 2070-0012
721.10177............................................ 2070-0012
721.10178............................................ 2070-0012
721.10179............................................ 2070-0012
721.10180............................................ 2070-0012
721.10181............................................ 2070-0012
721.10182............................................ 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. 721.10169 to subpart E to read as follows:
Sec. 721. 10169 Cyclopentane, methoxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cyclopentane,
methoxy- (PMN P-03-141; CAS No. 5614-37-9) 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 721.80(j).
(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
5. Add Sec. 721.10170 to subpart E to read as follows:
Sec. 721.10170 Polyoxyethylene polyalkylarylphenylether sulfate
ammonium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyoxyethylene polyalkylarylphenylether sulfate ammonium salt (PMN P-
03-197) 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).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
[[Page 4994]]
(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
6. Add Sec. 721.10171 to subpart E to read as follows:
Sec. 721.10171 1H-benz(e)indolium, 1,1,2,3-tetramethyl-, 4-
methylbenzenesulfonic acid (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1H-benz(e)indolium,
1,1,2,3-tetramethyl-, 4-methylbenzenesulfonic acid (1:1) (PMN P-03-285;
CAS No. 141914-99-0) 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) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4), (a)(5), (b) (concentration set at 1 percent), and (c).
Respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 10. The
following NIOSH-approved respirators with an APF of 10-25 meet the
minimum requirements for Sec. 721.63(a)(4): Air-purifying, tight-
fitting respirator equipped with N100 (if oil aerosols absent), R100,
or P100 filters (either half- or full-face); powered air-purifying
respirator equipped with a loose-fitting hood or helmet and High
Efficiency Particulate Air (HEPA) filters; powered air-purifying
respirator equipped with a tight-fitting facepiece (either half- or
full-face) and HEPA filters; supplied-air respirator operated in
pressure demand or continuous flow mode and equipped with a hood or
helmet, or tight-fitting facepiece (either half- or full-face).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(s) (11,000 kilograms).
(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), 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
7. Add Sec. 721.10172 to subpart E to read as follows:
Sec. 721.10172 Alkylamide derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylamide derivative (PMN P-03-633) 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. 721.10173 to subpart E to read as follows:
Sec. 721.10173 Silanamine,1,1,1-triethoxy-N,N-diethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as silanamine,1,1,1-
triethoxy-N,N-diethyl- (PMN P-03-793; CAS No. 35077-00-0) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(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
9. Add Sec. 721.10174 to subpart E to read as follows:
Sec. 721.10174 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-
dimethyl-, N-peanut-oil acyl derivs., inner salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-Propanaminium, 3-
amino-N-(carboxymethyl)-N,N-dimethyl-, N-peanut-oil acyl derivs., inner
salts (PMN P-04-139; CAS No. 691401-28-2) 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) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(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), 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
10. Add Sec. 721.10175 to subpart E to read as follows:
Sec. 721.10175 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-
dimethyl-3-sulfo-, N-(C12-18 and C18-unsatd. acyl) derivs., inner
salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-Propanaminium, N-
(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-18 and C18-
unsatd. acyl) derivs., inner salts (PMN P-04-141; CAS No. 691400-36-9)
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.
[[Page 4995]]
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
11. Add Sec. 721.10176 to subpart E to read as follows:
Sec. 721.10176 Amides, peanut-oil, N-[3-(dimethylamino)propyl].
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amides, peanut-oil,
N-[3-(dimethylamino)propyl] (PMN P-04-144; CAS No. 691400-76-7) 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. 721.10177 to subpart E to read as follows:
Sec. 721.10177 Phosphoric acid, yttrium(3+) salt (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphoric acid,
yttrium(3+) salt (1:1) (PMN P-04-153; CAS No. 13990-54-0) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(ii) Release to water. Requirements as specified in Sec. 721.90
(b)(4) and (c)(4) (N=6).
(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
13. Add Sec. 721.10178 to subpart E to read as follows:
Sec. 721.10178 Distillates (Fischer-Tropsch), hydroisomerized middle,
C10-13-branched alkane fraction.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as distillates
(Fischer-Tropsch), hydroisomerized middle, C10-13-branched alkane
fraction (PMN P-04-319; CAS No. 642928-30-1) 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) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5), (b) (concentration
set at 0.1 percent), and (c). Respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 100. The following NIOSH-approved
respirator meets the minimum requirements for Sec. 721.63(a)(4):
Supplied-air respirator operated in pressure demand or continuous flow
mode and equipped with a tight-fitting full facepiece.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(iii) Release to water. Requirements as specified in Sec. 721.90
(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), (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
14. Add Sec. 721.10179 to subpart E to read as follows:
Sec. 721.10179 Copolymers of phenol and aromatic hydocarbon
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
copolymers of phenol and aromatic hydocarbon (PMNs P-04-346 and P-04-
347) 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(k) (no manufacture or import of the PMN
substances unless the average molecular weight is greater than 500
daltons). Representative samples of the PMN substances must be analyzed
and determined to comply with these requirements both at the time of
initial commencement and annually thereafter.
(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 these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
15. Add Sec. 721.10180 to subpart E to read as follows:
Sec. 721.10180 Trifunctional acrylic ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
trifunctional acrylic ester (PMN P-04-692) 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. Requirement as
specified in Sec. 721.80(k) (no manufacture or import of the PMN
substance unless the mean number of moles of the ethoxy group is
greater than or equal to 8). Representative samples of the PMN
substance must be analyzed and determined to comply with these
requirements both at the time of initial commencement and annually
thereafter.
(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
16. Add Sec. 721.10181 to subpart E to read as follows:
Sec. 721.10181 Halide salt of an alkylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as halide
salt of an alkylamine (PMN P-07-453) is subject
[[Page 4996]]
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).
(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
17. Add Sec. 721.10182 to subpart E to read as follows:
Sec. 721.10182 1-Propene, 2,3,3,3-tetrafluoro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propene, 2,3,3,3-
tetrafluoro- (PMN P-07-601; CAS No. 754-12-1; also known as HFO-1234yf)
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) (use as a motor vehicle air
conditioning (MVAC) refrigerant in new passenger cars and vehicles as
defined in 40 CFR 82.32 (c) and (d). The initial charging of MVAC units
with the PMN substance will be done by the motor vehicle original
equipment manufacturer. All servicing, maintenance, and disposal
involving the PMN substance will be done only by Clean Air Act (CAA)
section 609 certified technicians using CAA section 609 certified
refrigerant handling equipment. The PMN substance only will be sold or
distributed in 20-pound (net weight) containers or larger).
(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.
[FR Doc. 2010-1936 Filed 1-29-10; 8:45 am]
BILLING CODE 6560-50-S