Document ID: EPA-HQ-OPPT-2008-0918-0076
Agency: epa
Document Type: Proposed Rule
Title: Proposed Significant New Use Rule: 1-Propene, 2,3,3,3-tetrafluoro-
Posted Date: 2010-04-02T04:00Z

[Federal Register: April 2, 2010 (Volume 75, Number 63)]
[Proposed Rules]               
[Page 16706-16711]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ap10-27]                         

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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.

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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: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East 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 
http://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 http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically at http://www.regulations.gov, or, if only available in 
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA 
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution 
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of 
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the EPA/DC Public Reading Room 
is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: 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 http://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 
http://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 http://
www.oecdbookshop.org or SourceOECD at http://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 http://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