[Federal Register Volume 78, Number 105 (Friday, May 31, 2013)]
[Proposed Rules]
[Pages 32617-32621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12779]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2008-0918; FRL-9387-7]
RIN 2070-AB27
Proposed Modification of Significant New Uses of 1-Propene,
2,3,3,3-tetrafluoro-
AGENCY: Environmental Protection Agency (EPA).
[[Page 32618]]
ACTION: Proposed rule.
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SUMMARY: Under section 5(a)(2) of the Toxic Substances Control Act
(TSCA), EPA is proposing to amend the significant new use rule (SNUR)
for the chemical substance identified as 1-Propene, 2,3,3,3-
tetrafluoro-, which was the subject of premanufacture notice (PMN) P-
07-601. This action would amend the SNUR to allow the manufacture and
processing for certain uses without requiring a significant new use
notice (SNUN). EPA is proposing this amendment based on review of newly
submitted exposure and toxicity data.
DATES: Comments must be received on or before July 1, 2013.
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 online instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN:
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-
2008-918. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (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 technical information contact: Jim
Alwood, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8974; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email 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 substance identified as 1-Propene,
2,3,3,3-tetrafluoro- (PMN P-07-601). Potentially affected entities may
include, but are not limited to:
Manufacturers, importers, or processors of the subject
chemical substance (NAICS codes 325 and 324110), e.g., chemical
manufacturers 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.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
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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?
In the Federal Register of October 27, 2010 (75 FR 65987) (FRL-
8846-8), EPA published a final SNUR (codified at Sec. 721.10182) for
the chemical substance identified as 1-Propene, 2,3,3,3-tetrafluoro-,
(PMN P-07-601; CAS No. 754-12-1; which is also identified by the trade
name HFO-1234yf), in accordance with the procedures at Sec. 721.170. A
SNUR requires persons who intend to manufacture, import, or process the
chemical substance for an activity designated as a significant new use
to notify EPA at least 90 days before commencing that activity.
EPA is proposing to amend the scope of the SNUR as detailed in this
unit. In addition, EPA is proposing to clarify the language in the
regulatory text to more clearly communicate that the manufacture and
processing for use as a refrigerant in motor vehicle air conditioning
systems in new passenger cars and vehicles as reported in the original
PMN is not subject to the notification requirement. The docket includes
information considered by the Agency in developing the final rule and
the new information considered when proposing the modification to this
rule.
PMN Number P-07-601
Chemical name: 1-Propene, 2,3,3,3-tetrafluoro-.
CAS number: 754-12-1.
Federal Register publication date and reference: October 27, 2010
(75 FR 65987).
Basis for modification of the SNUR: In the final SNUR, EPA
explained that it sought additional information to review use by
consumers attempting to recharge air conditioning systems in vehicles
originally charged with the refrigerant. Specifically, EPA sought an
acute rabbit inhalation toxicity study to better characterize health
effects from a single exposure and sought additional information on
techniques or equipment to minimize exposure to consumers and data that
quantifies exposures for durations shorter than the 30-minute time-
weighted average (TWA) presented in the exposure study conducted by the
PMN submitter. In response, the PMN submitter conducted an acute
inhalation toxicity study with rabbits on the PMN substance. The
submitted results demonstrated no toxicity in the one-hour exposure of
rabbits to 0, 50,000, and 100,000 parts per million (ppm) of the PMN
substance. The human equivalent concentration of the 100,000 ppm
exposure in rabbits is 190,000 ppm and was utilized for a risk
assessment. In addition, potential after-market manufacturers and the
PMN submitter also provided additional information on the previously
submitted exposure study that was conducted quantifying the exposures
for durations shorter than 30 minutes and data on exposures from use of
certain specified fittings. The test conditions demonstrated a highest
30-minute TWA exposure of 1,789 ppm. Based on the newly submitted data,
EPA calculated the ratio of the level of exposure in rabbits that did
not cause any effects with the highest measured TWA exposure. The
calculated ratio is 106, which EPA considers protective of human
health. The detailed risk assessment is contained in the public docket.
Based on this new assessment, EPA proposes to find that use of the PMN
substance by consumers to recharge air conditioning systems in vehicles
originally charged with the refrigerant by the motor vehicle original
equipment manufacturer (OEM) no longer meets the concern criteria at
Sec. 721.170(b). Based on this proposed finding, EPA is proposing to
modify the SNUR by eliminating the requirement to submit a notice prior
to the manufacture and processing for the specified consumer use of the
PMN substance.
In addition, EPA is proposing to clarify the language in the
regulatory text to more clearly communicate that manufacture and
processing for use as a refrigerant in motor vehicle air conditioning
systems in new passenger cars and vehicles as reported in the original
PMN is not a significant new use. The current regulatory text
identifies the significant new use by reference to 40 CFR 721.80(j),
which refers to any ``use other than'' a use described in the
premanufacture notice and then uses a parenthetical to more
specifically identify the significant new use, beginning with ``use
other than.'' However, using the language ``use other than'' when
referring to a regulatory provision which begins with ``use other
than'' can be confusing. As a result, EPA is proposing to clarify the
regulatory text by simply identifying the significant new use as use
other than as a refrigerant in motor vehicle air conditioning systems
in new passenger cars and vehicles (i.e., as defined in 40 CFR 82.32
(c) and (d). The docket established for this proposed amendment to the
SNUR is available under docket ID number EPA-HQ-OPPT-2008-0918.
CFR citation: 40 CFR 721.10182.
B. What is the Agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the TSCA section 5(a)(2) factors, listed in
Unit III. of this document. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
and 40 CFR part 721 requires persons to submit a significant new use
notice (SNUN) to EPA at least 90 days before they manufacture
(including import) or process the chemical substance for that use.
Persons who must report are described in Sec. [emsp14]721.5.
EPA may respond to SNUNs by, among other things, issuing or
modifying a TSCA section 5(e) consent order and/or amending the SNUR
promulgated under TSCA section 5(a)(2). Amendment of the SNUR will
often be necessary to allow persons other than the SNUN submitter to
engage in the newly authorized use(s), because even after a person
submits a SNUN and the review period expires, other persons still must
submit a SNUN before engaging in the significant new use.
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 to 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.
[[Page 32620]]
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
To determine that consumer use in the recharge of motor vehicle air
conditioning systems originally charged with the PMN substance by the
motor vehicle OEM is not a significant new use of the chemical
substance identified as 1-Propene, 2,3,3,3-tetrafluoro-(PMN P-07-601),
EPA considered relevant information about the toxicity of the chemical
substance, likely human exposures and environmental releases associated
with this chemical use, taking into consideration the four bulleted
TSCA section 5(a)(2) factors listed in this unit.
IV. Rationale for the Proposed Rule
During review of PMN P-07-601, the chemical substance identified as
1-Propene, 2,3,3,3-tetrafluoro-, EPA determined that one or more of the
criteria of concern established at Sec. 721.170 were met and
regulation under section 5(a)(2) of TSCA was warranted. The basis for
such findings is outlined in Unit II. of this document and in the
Federal Register document of June 26, 1990 (55 FR 26102). Based on
these findings, a SNUR was promulgated pursuant to Sec.
[emsp14]721.170.
After the review of new test data and information subsequent to
issuance of the SNUR (see Unit II.), and consideration of the factors
included in TSCA section 5(a)(2) (see Unit III.), EPA proposes to find
that the concern criteria in Sec. 721.170(b), are no longer met for
the consumer use in the recharge of motor vehicle air conditioning
systems originally charged with the PMN substance by the motor vehicle
OEM.
V. Economic Analysis
EPA evaluated the potential costs of establishing SNUN requirements
for potential manufacturers, importers, and processors of the chemical
substances during the development of the direct final rule. The
Agency's complete Economic Analysis is available in the docket under
docket ID number EPA-HQ-OPPT-2008-0918. This proposal will not add to
the costs identified in that analysis as it would, if finalized,
relieve an existing notification requirement for certain manufacturers
and processors.
VI. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would modify a SNUR for a chemical substance
that is the subject of a PMN. 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. 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 proposed rule would, if finalized, relieve an existing
notification requirement for certain manufacturers and processors. 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 would not impose any burden requiring
additional OMB approval. If an entity were to submit a SNUN to the
Agency under the existing SNUR, 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
On February 18, 2012, EPA certified pursuant to section 605(b) of
the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that
promulgation of a SNUR does not have a significant economic impact on a
substantial number of small entities where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUN submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
rule.
This rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit V. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR amendment.
Submission of the SNUN would not cost any small entity
significantly more than $8,300. Therefore, the promulgation of the SNUR
amendment would not have a significant economic impact on a substantial
number of small entities.
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 reason to believe that any
State, local, or Tribal government would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any effect on small governments subject to the requirements of
sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of
1995 (UMRA) (Pub. L. 104-4).
E. Executive Order 13132
This action would 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 proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor would it involve or
impose any requirements that
[[Page 32621]]
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
proposed 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 proposed rule 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 FR7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: May 22, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. In Sec. [emsp14]721.10182, revise paragraphs (a)(1) and (a)(2)(i)
to read as follows:
Sec. 721.10182 1-Propene, 2,3,3,3-tetrafluoro-.
(a) * * * (1) The chemical substance identified as 1-propene,
2,3,3,3-tetrafluoro- (PMN P- 07-601; CAS No. 754-12-1) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) * * *
(i) Industrial, commercial, and consumer activities. A significant
new use is use other than as a refrigerant in motor vehicle air
conditioning systems in new passenger cars and vehicles (i.e., as
defined in 40 CFR 82.32 (c) and (d)); Sec. [emsp14]721.80(m)
(commercial use other than in passenger cars and vehicles in which the
charging of motor vehicle air conditioning systems with the PMN
substance was done by the motor vehicle original equipment manufacturer
(OEM); Sec. [emsp14]721.80(o) (use in consumer products other than
products used to recharge the motor vehicle air conditioning systems in
passenger cars and vehicles in which the charging of motor vehicle air
conditioning systems with the PMN substance was done by the motor
vehicle OEM).
* * * * *
[FR Doc. 2013-12779 Filed 5-30-13; 8:45 am]
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