Proposed Significant New Use Rule for 1-Propene, 2,3,3,3-tetrafluoro-, 16706-16711 [2010-7191]
Download as PDF
16706
Federal Register / Vol. 75, No. 63 / Friday, April 2, 2010 / Proposed Rules
(e) Enforcement period. This section
will be enforced from 6 a.m. to 5 p.m.
on June 9, 2010 unless cancelled earlier
by the Captain of the Port.
Dated: March 22, 2010.
A. Popiel,
Captain, U.S. Coast Guard, Captain of the
Port North Carolina.
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R06–OAR–2008–0089; FRL–9132–2]
Approval and Promulgation of
Implementation Plans; Texas;
Revisions to Voiding of Permits and
Extension of Permits
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA is proposing to approve
severable portions of a submittal from
the State of Texas, through the Texas
Commission on Environmental Quality
(TCEQ), on September 25, 2003, to
revise the Texas Major and Minor New
Source Review (NSR) State
Implementation Plan (SIP). Within this
SIP submittal, the State repealed a
paragraph of the SIP rule pertaining to
the Texas Major and Minor NSR SIP and
renumbered the SIP rule’s paragraphs.
We are proposing to approve the new
replacement rule as meeting the Major
and Minor NSR SIP requirements for
voiding of permits.
We are also proposing to approve the
portion of the revision that addresses
the recodification of the provision
relating to the granting of one 18-month
extension of a permit as meeting the
Major and Minor NSR SIP requirement
for extensions of permits. The revision
imposes requirements on permitees,
requiring a review of the permit’s
underlying permit determinations
before this SIP-approved extension can
be granted. Finally, the revision
provides for a second permit extension
if certain conditions are met, including
a health effects review. EPA is
proposing to approve the new
replacement rule for this second permit
extension as meeting the Major and
Minor NSR and NNSR SIP
requirements.
EPA finds that these changes to the
Texas SIP comply with the Federal
Clean Air Act (the Act or CAA) and EPA
regulations, are consistent with EPA
policies, and will improve air quality.
14:33 Apr 01, 2010
Jkt 220001
ENVIRONMENTAL PROTECTION
AGENCY
Comments must be received on
or before May 3, 2010.
[EPA–HQ–OPPT–2008–0918; FRL–8818–2]
DATES:
Comments may be mailed to
Mr. Jeff Robinson, Chief, Air Permits
Section (6PD–R), Environmental
Protection Agency, 1445 Ross Avenue,
Suite 1200, Dallas, Texas 75202–2733.
Comments may also be submitted
electronically or through hand delivery/
courier by following the detailed
instructions in the ADDRESSES section of
the direct final rule located in the rules
section of the Federal Register.
ADDRESSES:
[FR Doc. 2010–7427 Filed 4–1–10; 8:45 am]
VerDate Nov<24>2008
This action is being proposed under
section 110 and parts C and D of the
Act.
FOR FURTHER INFORMATION CONTACT: If
you have questions concerning today’s
proposal, please contact Ms. Melanie
Magee (6PD–R), Air Permits Section,
Environmental Protection Agency,
Region 6, 1445 Ross Avenue (6PD–R),
Suite 1200, Dallas, TX 75202–2733. The
telephone number is (214) 665–7161.
Ms. Magee can also be reached via
electronic mail at
magee.melanie@epa.gov.
In the
final rules section of this Federal
Register, EPA is approving the State’s
SIP submittal as a direct final rule
without prior proposal because the
Agency views this as a noncontroversial
submittal and anticipates no relevant
adverse comments. A detailed rationale
for the approval is set forth in the direct
final rule. If no adverse comments are
received in response to this action, no
further activity is contemplated. If EPA
receives relevant adverse comments, the
direct final rule will be withdrawn and
all public comments received will be
addressed in a subsequent final rule
based on this proposed rule. EPA will
not institute a second comment period.
Any parties interested in commenting
on this action should do so at this time.
Please note that if EPA receives adverse
comment on an amendment, paragraph,
or section of the rule, and if that
provision may be severed from the
remainder of the rule, EPA may adopt
as final those provisions of the rule that
are not the subject of an adverse
comment.
For additional information, see the
direct final rule which is located in the
rules section of this Federal Register.
SUPPLEMENTARY INFORMATION:
Dated: March 24, 2010.
Lawrence E. Starfield,
Acting Regional Administrator, Region 6.
[FR Doc. 2010–7212 Filed 4–1–10; 8:45 am]
BILLING CODE 6560–50–P
PO 00000
Frm 00031
Fmt 4702
Sfmt 4702
40 CFR Parts 721
RIN 2070–AB27
Proposed Significant New Use Rule for
1-Propene, 2,3,3,3-tetrafluoroAGENCY: Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA is proposing a significant
new use rule (SNUR) under section
5(a)(2) of the Toxic Substances Control
Act (TSCA) for the chemical substance
identified as 1-Propene, 2,3,3,3tetrafluoro- (CAS No. 754–12–1) which
was subject to premanufacture notice
(PMN) P–07–601. This proposed rule
would require persons who intend to
manufacture, import, or process the
substance for an activity that is
designated as a significant new use to
notify EPA at least 90 days before
commencing that activity. The required
notification would provide EPA with
the opportunity to evaluate the intended
use and, if necessary, to prohibit or limit
the activity before it occurs.
DATES: Comments must be received on
or before May 3, 2010.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2008–0918, by
one of the following methods:
• Federal eRulemaking Portal: https://
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 Bldg.,
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 https://
www.regulations.gov, including any
personal information provided, unless
E:\FR\FM\02APP1.SGM
02APP1
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
Federal Register / Vol. 75, No. 63 / Friday, April 2, 2010 / Proposed Rules
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 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 https://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
https://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
VerDate Nov<24>2008
14:33 Apr 01, 2010
Jkt 220001
(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:
TSCA-Hotline@epa.gov.
For technical information contact:
Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (202) 564–
9232; e-mail address:
moss.kenneth@epa.gov.
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
contained in this proposed rule.
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 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
§ 721.5. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements promulgated at 19 CFR
12.118 through 12.127 and 19 CFR
127.28 (the corresponding EPA policy
appears at 40 CFR part 707, subpart B).
Chemical importers must certify that the
shipment of the chemical substance
complies with all applicable rules and
orders under TSCA. Importers of
chemicals subject to a final SNUR 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
PO 00000
Frm 00032
Fmt 4702
Sfmt 4702
16707
this proposed rule on or after May 3,
2010 are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see § 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 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 proposing a significant new
use rule (SNUR) under section 5(a)(2) of
TSCA for the chemical substance
E:\FR\FM\02APP1.SGM
02APP1
16708
Federal Register / Vol. 75, No. 63 / Friday, April 2, 2010 / Proposed Rules
identified as 1-Propene, 2,3,3,3tetrafluoro- (PMN P–07–601; CAS No.
754–12–1). This SNUR would require
persons who intend to manufacture,
import, or process the chemical
substance for any activity designated as
a significant new use to notify EPA at
least 90 days before commencing the
activity.
In the Federal Register of February 1,
2010 (75 FR 4983) (FRL–8438–4), EPA
issued a direct final SNUR for the
substance in accordance with the
procedures at § 721.170(d)(4)(i). EPA
received notice of intent to submit
adverse comments on this SNUR.
Therefore, as required by at
§ 721.170(d)(4)(i), EPA is withdrawing
the direct final SNUR, which is
published elsewhere in this Federal
Register and is now issuing this
proposed SNUR on this substance. The
record for the direct final SNUR on this
substance was established as docket
EPA–HQ–OPPT–2009–0918. That
record includes information considered
by the Agency in developing the direct
final rule and the notice of intent to
submit adverse comments.
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
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 § 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
final rule. Provisions relating to user
fees appear at 40 CFR part 700.
According to § 721.1(c), persons subject
to this SNUR 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
VerDate Nov<24>2008
14:33 Apr 01, 2010
Jkt 220001
TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR
part 720. Once EPA receives a SNUN,
EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control
the activities for which it has received
the SNUN. If EPA does not take action,
EPA is required under TSCA section
5(g) to explain in the Federal Register
its reasons for not taking action.
Chemical importers are subject to the
TSCA section 13 (15 U.S.C. 2612)
import certification requirements
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. 2611 (b)) (see § 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 chemical
substance that is the subject of this
proposed SNUR, EPA considered
relevant information about the toxicity
of the chemical substance, likely human
exposures and environmental releases
associated with possible uses, and the
four bulleted TSCA section 5(a)(2)
factors listed in this Unit.
PO 00000
Frm 00033
Fmt 4702
Sfmt 4702
For the chemical substance 1Propene, 2,3,3,3-tetrafluoro- (PMN P–
07–601; CAS No. 754–12–1), EPA did
not find that the use scenarios described
in the PMN triggered the determination
set forth under section 5(e) of TSCA.
EPA did, however, determine that
certain changes from the use scenario
described in the PMN could result in
increased exposures, thereby
constituting a ‘‘significant new use.’’
EPA has determined that activities
proposed as a ‘‘significant new use’’
satisfy the two requirements stipulated
in § 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.
IV. Substance Subject to this Proposed
Rule and Basis for the Action
EPA is proposing to establish
significant new use and recordkeeping
requirements for the chemical substance
identified as 1-Propene, 2,3,3,3tetrafluoro- (PMN P–07–601; CAS No.
754–12–1). The specific activities
proposed as significant new uses and
other requirements are listed in 40 CFR
721.10182 of the proposed regulatory
text.
PMN Number P–07–601
Chemical name: 1-Propene, 2,3,3,3tetrafluoro-.
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
E:\FR\FM\02APP1.SGM
02APP1
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
Federal Register / Vol. 75, No. 63 / Friday, April 2, 2010 / Proposed Rules
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
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 proposed 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
VerDate Nov<24>2008
14:33 Apr 01, 2010
Jkt 220001
proposed use conditions include
incorporation of engineering strategies
and/or devices to mitigate flammability
risks for this substance (see Unit V. of
the proposed SNAP 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 SNAP 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 SNAP 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
Organisation for Economic Co-operation
and Development (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
Proposed Rule
A. Rationale
During the review of the chemical
substance P–07–601, EPA determined
that one or more of the criteria of
concern established at § 721.170 were
met, as discussed in Unit IV.
B. Objectives
EPA is proposing this SNUR for a
chemical substance that has undergone
premanufacture review because the
Agency wants to achieve the following
objectives with regard to the significant
new uses designated in this proposed
rule:
• EPA would 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 would 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 would be able to regulate
prospective manufacturers, importers,
or processors of a listed chemical
PO 00000
Frm 00034
Fmt 4702
Sfmt 4702
16709
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.
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 https://www.epa.gov/opptintr/
newchems/pubs/invntory.htm.
VI. Applicability of the Proposed Rule
to Uses Occurring Before Effective Date
of the Final Rule
To establish a significant ‘‘new’’ use,
EPA must determine that the use is not
ongoing. EPA solicits comments on
whether any of the uses proposed as
significant new uses are ongoing.
As discussed in the Federal Register
of April 24, 1990 (55 FR 17376), EPA
has decided that the intent of TSCA
section 5(a)(1)(B) is best served by
designating a use as a significant new
use as of the date of publication of the
proposed rule rather than as of the
effective date of the final rule. If uses
begun after publication of the proposed
rule 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 final, and then
argue that the use was ongoing before
the effective date of the final rule. Thus,
persons who begin commercial
manufacture, import, or processing with
the chemical substances that would be
regulated as a ‘‘significant new use’’
through this proposed rule, must cease
any such activity before the effective
date of the rule if and when finalized.
To resume their activities, these persons
would have to comply with all
applicable SNUR notice requirements
and wait until the notice review period,
including all extensions, expires.
EPA has promulgated provisions to
allow persons to comply with this
proposed SNUR before the effective
date. If a person were to meet the
conditions of advance compliance
under § 721.45(h), the person would be
considered to have met the
requirements of the final SNUR, for
those activities.
VII. 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)).
E:\FR\FM\02APP1.SGM
02APP1
16710
Federal Register / Vol. 75, No. 63 / Friday, April 2, 2010 / Proposed Rules
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
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
§ 720.50). However, upon review of
PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
EPA recommended certain testing listed
in Unit IV. Descriptions of tests are
provided for informational purposes.
EPA strongly encourages persons, before
performing any testing, to consult with
the Agency pertaining to protocol
selection. To access the OPPTS
harmonized test guidelines referenced
in this document electronically, please
go to https://www.epa.gov/oppts and
select ‘‘Test Methods and Guidelines.’’
The Organisation for Economic Cooperation and Development (OECD) test
guidelines are available from the OECD
Bookshop at https://
www.oecdbookshop.org or SourceOECD
at https://www.sourceoecd.org.
The recommended test(s) 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 test(s).
SNUN submitters should be aware
that EPA would 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 substance.
• Potential benefits of the chemical
substance.
• Information on risks posed by the
chemical substance compared to risks
posed by potential substitutes.
VIII. SNUN Submissions
As stated in Unit II.C., according to
§ 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 § 720.50. SNUNs must be
submitted to the Environmental
Protection Agency on EPA Form No.
7710–25 in accordance with the
procedures set forth in §§ 721.25 and
720.40. This form is available from the
Environmental Assistance Division
(7408M), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001 (see
VerDate Nov<24>2008
14:33 Apr 01, 2010
Jkt 220001
§§ 721.25 and 720.40). Forms and
information are also available
electronically at https://www.epa.gov/
opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers, importers, and
processors of the chemical substance at
the time of the direct final rule. The
Agency’s complete economic analysis is
available in the public docket for the
direct final rule (EPA–HQ–OPPT–2008–
0918).
X. References
The official record for this proposed
rule has been established. The following
is a listing of the documents that have
been placed in the proposed rule phase
of the docket under docket ID number
EPA–HQ–OPPT–2008–0918, which is
available for inspection as specified
under ADDRESSES. These documents
serve as supplementary information
specific to P–07–601 (aka HFO–1234yf)
for consideration when submitting
comments.
1. Letter Confirming Release of CBI
Claims for HFO–1234yf Gradient
Report.
2. Gradient Corporation. 2008. Risk
Assessment for Alternative Refrigerant
HFO–1234yf.
3. WIL Research Laboratories, LLC.
2008. An Inhalation Prenatal
Developmental Toxicity Study of HFO–
1234yf (2,3,3,3-tetrafluoropropene) in
Rabbits.
4. United States Environmental
Protection Agency (EPA). 2009.
Addendum to Risk Assessment: PMN P–
07–601.
XI. Statutory and Executive Order
Reviews
A. Executive Order 12866
This proposed rule would establish a
SNUR for a chemical substance that was
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
PO 00000
Frm 00035
Fmt 4702
Sfmt 4702
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable. EPA would amend the table
in 40 CFR part 9 to list the OMB
approval number for the information
collection requirements contained in
this proposed 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 would not impose any
burden requiring additional OMB
approval. If an entity were to submit a
SNUN to the Agency, the annual burden
is estimated to average between 30 and
170 hours per response. This burden
estimate includes the time needed to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques, to the Director, Collection
Strategies Division, Office of
Environmental Information (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency hereby
certifies that promulgation of this SNUR
would 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
E:\FR\FM\02APP1.SGM
02APP1
Federal Register / Vol. 75, No. 63 / Friday, April 2, 2010 / Proposed Rules
new use.’’ Because these uses are ‘‘new,’’
based on all information currently
available to EPA, it appears that no
small or large entities presently engage
in such activities. A SNUR requires that
any person who intends to engage in
such activity in the future must first
notify EPA by submitting a SNUN.
Although some small entities may
decide to pursue a significant new use
in the future, EPA cannot presently
determine how many, if any, there may
be. However, EPA’s experience to date
is that, in response to the promulgation
of over 1,400 SNURs, the Agency
receives on average only 5 notices per
year. Of those SNUNs submitted from
2006–2008, only one appears to be from
a small entity. In addition, the estimated
reporting cost for submission of a SNUN
(see Unit IX.) is minimal regardless of
the size of the firm. Therefore, the
potential economic impacts of
complying with this SNUR are not
expected to be significant or adversely
impact a substantial number of small
entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR
29684) (FRL–5597–1), the Agency
presented its general determination that
final SNURs are not expected to have a
significant economic impact on a
substantial number of small entities,
which was provided to the Chief
Counsel for Advocacy of the Small
Business Administration.
D. Unfunded Mandates Reform Act
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government 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 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).
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
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).
VerDate Nov<24>2008
14:33 Apr 01, 2010
Jkt 220001
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 or uniquely
affect the communities of Indian Tribal
governments, nor would 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 proposed rule.
16711
Dated: March 25, 2010.
Barbara A. Cunningham,
Acting Director, Office of Pollution Prevention
and Toxics.
Therefore, it is proposed that 40 CFR
part 721 be amended as follows:
PART 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add § 721.10182 to subpart E to
read as follows:
G. Executive Order 13045
§ 721.10182
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.
(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 § 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 § 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 § 721.185 apply to this
section.
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 FR 7629,
February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
PO 00000
Frm 00036
Fmt 4702
Sfmt 9990
1-Propene, 2,3,3,3-tetrafluoro-.
[FR Doc. 2010–7191 Filed 4–1–10; 8:45 am]
BILLING CODE 6560–50–S
E:\FR\FM\02APP1.SGM
02APP1
Agencies
[Federal Register Volume 75, Number 63 (Friday, April 2, 2010)]
[Proposed Rules]
[Pages 16706-16711]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7191]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 721
[EPA-HQ-OPPT-2008-0918; FRL-8818-2]
RIN 2070-AB27
Proposed Significant New Use Rule for 1-Propene, 2,3,3,3-
tetrafluoro-
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the
chemical substance identified as 1-Propene, 2,3,3,3-tetrafluoro- (CAS
No. 754-12-1) which was subject to premanufacture notice (PMN) P-07-
601. This proposed rule would require persons who intend to
manufacture, import, or process the substance for an activity that is
designated as a significant new use to notify EPA at least 90 days
before commencing that activity. The required notification would
provide EPA with the opportunity to evaluate the intended use and, if
necessary, to prohibit or limit the activity before it occurs.
DATES: Comments must be received on or before May 3, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2008-0918, by one of the following methods:
Federal eRulemaking Portal: https://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 Bldg., 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
https://www.regulations.gov, including any personal information
provided, unless
[[Page 16707]]
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 https://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 https://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: TSCA-Hotline@epa.gov.
For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-9232; e-mail
address: moss.kenneth@epa.gov.
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 contained in this
proposed rule. 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
manufacturing and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec. 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28 (the corresponding EPA policy appears at 40 CFR part
707, subpart B). Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to a final SNUR 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 proposed rule on or after May 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
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 proposing a significant new use rule (SNUR) under section
5(a)(2) of TSCA for the chemical substance
[[Page 16708]]
identified as 1-Propene, 2,3,3,3-tetrafluoro- (PMN P-07-601; CAS No.
754-12-1). This SNUR would require persons who intend to manufacture,
import, or process the chemical substance for any activity designated
as a significant new use to notify EPA at least 90 days before
commencing the activity.
In the Federal Register of February 1, 2010 (75 FR 4983) (FRL-8438-
4), EPA issued a direct final SNUR for the substance in accordance with
the procedures at Sec. 721.170(d)(4)(i). EPA received notice of intent
to submit adverse comments on this SNUR. Therefore, as required by at
Sec. 721.170(d)(4)(i), EPA is withdrawing the direct final SNUR, which
is published elsewhere in this Federal Register and is now issuing this
proposed SNUR on this substance. The record for the direct final SNUR
on this substance was established as docket EPA-HQ-OPPT-2009-0918. That
record includes information considered by the Agency in developing the
direct final rule and the notice of intent to submit adverse comments.
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 final
rule. Provisions relating to user fees appear at 40 CFR part 700.
According to Sec. 721.1(c), persons subject to this SNUR must comply
with the same notice requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these
requirements include the information submission requirements of TSCA
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it
has received the SNUN. If EPA does not take action, EPA is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.
Chemical importers are subject to the TSCA section 13 (15 U.S.C.
2612) import certification requirements 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. 2611 (b)) (see
Sec. 721.20) and must comply with the export notification requirements
in 40 CFR part 707, subpart D.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the
chemical substance that is the subject of this proposed SNUR, EPA
considered relevant information about the toxicity of the chemical
substance, likely human exposures and environmental releases associated
with possible uses, and the four bulleted TSCA section 5(a)(2) factors
listed in this Unit.
For the chemical substance 1-Propene, 2,3,3,3-tetrafluoro- (PMN P-
07-601; CAS No. 754-12-1), EPA did not find that the use scenarios
described in the PMN triggered the determination set forth under
section 5(e) of TSCA. EPA did, however, determine that certain changes
from the use scenario described in the PMN could result in increased
exposures, thereby constituting a ``significant new use.'' EPA has
determined that activities proposed as a ``significant new use''
satisfy 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.
IV. Substance Subject to this Proposed Rule and Basis for the Action
EPA is proposing to establish significant new use and recordkeeping
requirements for the chemical substance identified as 1-Propene,
2,3,3,3-tetrafluoro- (PMN P-07-601; CAS No. 754-12-1). The specific
activities proposed as significant new uses and other requirements are
listed in 40 CFR 721.10182 of the proposed regulatory text.
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
[[Page 16709]]
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 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 proposed 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 SNAP 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 SNAP
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 SNAP 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
Organisation for Economic Co-operation and Development (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 Proposed Rule
A. Rationale
During the review of the chemical substance P-07-601, 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 proposing this SNUR for a chemical substance that has
undergone premanufacture review because the Agency wants to achieve the
following objectives with regard to the significant new uses designated
in this proposed rule:
EPA would 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 would 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 would 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.
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 https://www.epa.gov/opptintr/newchems/pubs/invntory.htm.
VI. Applicability of the Proposed Rule to Uses Occurring Before
Effective Date of the Final Rule
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. EPA solicits comments on whether any of the uses
proposed as significant new uses are ongoing.
As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. If uses begun after publication of
the proposed rule 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 final, and then argue that the use was ongoing
before the effective date of the final rule. Thus, persons who begin
commercial manufacture, import, or processing with the chemical
substances that would be regulated as a ``significant new use'' through
this proposed rule, must cease any such activity before the effective
date of the rule if and when finalized. To resume their activities,
these persons would have to comply with all applicable SNUR notice
requirements and wait until the notice review period, including all
extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
proposed SNUR before the effective date. If a person were to meet the
conditions of advance compliance under Sec. 721.45(h), the person
would be considered to have met the requirements of the final SNUR, for
those activities.
VII. 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)).
[[Page 16710]]
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.
EPA recommended certain testing listed in Unit IV. Descriptions of
tests are provided for informational purposes. EPA strongly encourages
persons, before performing any testing, to consult with the Agency
pertaining to protocol selection. To access the OPPTS harmonized test
guidelines referenced in this document electronically, please go to
https://www.epa.gov/oppts and select ``Test Methods and Guidelines.''
The Organisation for Economic Co-operation and Development (OECD) test
guidelines are available from the OECD Bookshop at https://www.oecdbookshop.org or SourceOECD at https://www.sourceoecd.org.
The recommended test(s) 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
test(s).
SNUN submitters should be aware that EPA would 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 substance.
Potential benefits of the chemical substance.
Information on risks posed by the chemical substance
compared to risks posed by potential substitutes.
VIII. SNUN Submissions
As stated in Unit II.C., according to Sec. 721.1(c), persons
submitting a SNUN must comply with the same notice requirements and EPA
regulatory procedures as persons submitting a PMN, including submission
of test data on health and environmental effects as described in Sec.
720.50. SNUNs must be submitted to the Environmental Protection Agency
on EPA Form No. 7710-25 in accordance with the procedures set forth in
Sec. Sec. 721.25 and 720.40. This form is available from the
Environmental Assistance Division (7408M), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001 (see Sec. Sec. 721.25 and 720.40). Forms and
information are also available electronically at https://www.epa.gov/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substance at the time of the direct final rule. The
Agency's complete economic analysis is available in the public docket
for the direct final rule (EPA-HQ-OPPT-2008-0918).
X. References
The official record for this proposed rule has been established.
The following is a listing of the documents that have been placed in
the proposed rule phase of the docket under docket ID number EPA-HQ-
OPPT-2008-0918, which is available for inspection as specified under
ADDRESSES. These documents serve as supplementary information specific
to P-07-601 (aka HFO-1234yf) for consideration when submitting
comments.
1. Letter Confirming Release of CBI Claims for HFO-1234yf Gradient
Report.
2. Gradient Corporation. 2008. Risk Assessment for Alternative
Refrigerant HFO-1234yf.
3. WIL Research Laboratories, LLC. 2008. An Inhalation Prenatal
Developmental Toxicity Study of HFO-1234yf (2,3,3,3-tetrafluoropropene)
in Rabbits.
4. United States Environmental Protection Agency (EPA). 2009.
Addendum to Risk Assessment: PMN P-07-601.
XI. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish a SNUR for a chemical substance
that was 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. EPA would amend the table
in 40 CFR part 9 to list the OMB approval number for the information
collection requirements contained in this proposed 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 would not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR would 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
[[Page 16711]]
new use.'' Because these uses are ``new,'' based on all information
currently available to EPA, it appears that no small or large entities
presently engage in such activities. A SNUR requires that any person
who intends to engage in such activity in the future must first notify
EPA by submitting a SNUN. Although some small entities may decide to
pursue a significant new use in the future, EPA cannot presently
determine how many, if any, there may be. However, EPA's experience to
date is that, in response to the promulgation of over 1,400 SNURs, the
Agency receives on average only 5 notices per year. Of those SNUNs
submitted from 2006-2008, only one appears to be from a small entity.
In addition, the estimated reporting cost for submission of a SNUN (see
Unit IX.) is minimal regardless of the size of the firm. Therefore, the
potential economic impacts of complying with this SNUR are not expected
to be significant or adversely impact a substantial number of small
entities. In a SNUR that published in the Federal Register of June 2,
1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general
determination that final SNURs are not expected to have a significant
economic impact on a substantial number of small entities, which was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
D. Unfunded Mandates Reform Act
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government 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 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 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 or uniquely affect the
communities of Indian Tribal governments, nor would 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 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 FR 7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: March 25, 2010.
Barbara A. Cunningham,
Acting Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. 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. 2010-7191 Filed 4-1-10; 8:45 am]
BILLING CODE 6560-50-S