Document ID: EPA-HQ-OPPT-2008-0918-0092
Agency: epa
Document Type: Rule
Title: Significant New Use Rule: 1-Propene, 2,3,3,3-tetrafluoro
Posted Date: 2010-10-27T04:00Z

[Federal Register: October 27, 2010 (Volume 75, Number 207)]
[Rules and Regulations]               
[Page 65987-65994]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc10-8]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2008-0918; FRL-8846-8]
RIN 2070-AB27

 
1-Propene, 2,3,3,3-tetrafluoro-; Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing 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 the subject of premanufacture notice (PMN) P-07-601. 
This action requires persons who intend to manufacture, import, or 
process the chemical substance for a use that is designated as a 
significant new use by this final rule to notify EPA at least 90 days 
before commencing that activity. EPA believes that this action is 
necessary because the chemical substance may be hazardous to human 
health. The required notification would provide EPA with the 
opportunity to evaluate the intended use and, if necessary, to prohibit 
or limit that activity before it occurs.

DATES: This final rule is effective November 26, 2010.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2008-0918. 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., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket 
Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., 
NW., Washington, DC. The EPA/DC Public Reading Room hours of operation 
are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number of the EPA/DC Public Reading Room is 
(202) 566-1744, and the telephone number for the OPPT Docket is (202) 
566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
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.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422

[[Page 65988]]

South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-
1404; e-mail address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. 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 final 
rule: 1-Propene, 2,3,3,3-tetrafluoro- (PMN P-07-601; CAS No. 754-12-1). 
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; 
see also 19 CFR 127.28. Chemical importers must certify that the 
shipment of the chemical substance complies with all applicable rules 
and orders under TSCA. For importers of the chemical substance subject 
to this SNUR those requirements include the SNUR. The EPA policy in 
support of import certification appears at 40 CFR part 707, subpart B. 
In addition, any persons who export or intend to export the chemical 
substance that is the subject of this final rule on or after November 
26, 2010 are subject to the export notification provisions of TSCA 
section 12(b) (15 U.S.C. 2611(b)) (see Sec.  [emsp14]721.20) and must 
comply with the export notification requirements in 40 CFR part 707, 
subpart D.

II. Background

A. What action is the agency taking?

    EPA is finalizing a SNUR under TSCA section 5(a)(2) for the 
chemical substance identified as 1-Propene, 2,3,3,3-tetrafluoro- (PMN 
P-07-601; CAS No. 754-12-1; aka HFO-1234yf). This action requires 
persons who intend to manufacture, import, or process the chemical 
substance for an activity that is designated as a significant new use 
by this final rule to notify EPA at least 90 days before commencing 
that activity.
    Previously, in the Federal Register of February 1, 2010 (75 FR 
4983) (FRL-8438-4), EPA issued a direct final SNUR for the chemical 
substance. However, EPA received notices of intent to submit adverse 
comments on this SNUR. Therefore, as required by Sec.  
721.170(d)(4)(i), in the Federal Register of April 2, 2010 (75 FR 
16670) (FRL-8816-9), EPA withdrew the direct final SNUR on this 
chemical substance and subsequently proposed a SNUR using notice and 
comment procedures in the Federal Register of April 2, 2010 (75 FR 
16706) (FRL-8818-2). More information on the chemical substance subject 
to this final rule can be found in the direct final or proposed SNUR. 
The record for the direct final and proposed SNUR on this chemical 
substance was established in the docket under docket ID number EPA-HQ-
OPPT-2008-0918. That docket includes information considered by the 
Agency in developing the direct final rule and this final rule, 
including comments on the proposed rule. The chemical substance 
addressed under this final SNUR is also being reviewed under the Clean 
Air Act (CAA) to determine whether it may be listed as an acceptable 
substitute for CFC-12 in motor vehicle air conditioning systems. See 
``Protection of Stratospheric Ozone: New Substitute in the Motor 
Vehicle Air Conditioning Sector under the Significant New Alternatives 
Policy (SNAP) Program'' (74 FR 53445, October 19, 2009) (FRL-8969-7).
    EPA received six comments on the proposed SNUR and two comments on 
the original direct final SNUR. A full discussion of EPA's response to 
these comments is included in Unit V. of this document. After 
consideration of these comments, EPA is issuing a modified final rule 
on the chemical substance that:
    1. Clarifies the significant new use provisions by organizing them 
under the following paragraphs of Sec.  721.80:
     Section 721.80(j) (use other than as a refrigerant in 
motor vehicle air conditioning systems in new passenger cars and 
vehicles).
     Section 721.80(m) (commercial use other than in new 
passenger cars and vehicles in which the charging of motor vehicle air 
conditioning systems with the PMN substance was done by the motor 
vehicle original equipment manufacturer (OEM)).
     Section 721.80(o) (distribution in commerce of products 
intended for use by a consumer for the purpose of servicing, 
maintenance, and disposal involving the PMN substance).
    2. Removes the following significant new use provisions:
     All servicing, maintenance, and disposal involving the PMN 
substance will be done only by CAA section 609 certified technicians 
using CAA section 609 certified refrigerant handling equipment.
     Uses in which the chemical substance will be sold or 
distributed in other than 20-pound (net weight) containers or larger 
(this significant new use is now encompassed by Sec.  721.80(o)).
    Furthermore, EPA has provided in the docket to this rule additional 
human health information to supplement EPA's findings under Sec.  
721.170(d)(3)(i) and EPA's findings in the proposed rule. See Unit IV. 
of the proposed rule in the Federal Register of April 2, 2010 (75 FR 
16706) for a discussion of EPA's findings.

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. Persons who 
must report are described in 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

[[Page 65989]]

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 in Customs and 
Border Patrol regulations at 19 CFR 12.118 through 12.127; see also 19 
CFR 127.28. Chemical importers must certify that the shipment of the 
chemical substance complies with all applicable rules and orders under 
TSCA. For importers of the chemical substance subject to this final 
SNUR those requirements include the SNUR. The EPA policy in support of 
import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export the chemical 
substance identified in this 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. Rationale and Objectives of the Rule

A. Rationale

    During the review of the chemical substance PMN P-07-601--as 
discussed in the proposed rule--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. EPA determined 
that one or more of the criteria of concern established at Sec.  
721.170 were met. 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.

B. Objectives

    EPA is issuing this final 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 final rule:
     EPA will receive notice of any person's intent to 
manufacture, import, or process a listed chemical substance for the 
described significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing, 
importing, or processing a listed chemical substance for the described 
significant new use.
     EPA will be able to regulate prospective manufacturers, 
importers, or processors of a listed chemical substance before the 
described significant new use of that chemical substance occurs, 
provided that regulation is warranted pursuant to TSCA sections 5(e), 
5(f), 6, or 7.
    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.

IV. 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 authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for HFO-
1234yf, EPA considered relevant information--in the docket and 
discussed further in Unit V. of this document--about the toxicity of 
the chemical substance, likely human exposures and environmental 
releases associated with possible uses, taking into consideration the 
four bulleted TSCA section 5(a)(2) factors listed in this unit, and the 
regulations at Sec.  721.170 for issuing a SNUR after receipt of a PMN.

V. Response to Comments on Proposed SNUR on 1-Propene, 2,3,3,3-
tetrafluoro-

    EPA received comments from a number of submitters on the proposed 
rule for the chemical substance identified as 1-Propene, 2,3,3,3-
tetrafluoro- (PMN P-07-601; CAS No. 754-12-1; aka HFO-1234yf). These 
comments, many of which covered similar issues, have been grouped under 
general headings. Many of the comments stated that EPA's risk 
assessment for the PMN substance overstates both the potential hazards 
of the chemical substance and the potential exposures from ``do-it-
yourself'' (DIY) consumer use, and uses a health effects endpoint from 
a toxicity study that is inappropriate given the duration of exposure 
that could result from DIY consumer use. These commenters evaluated 
EPA's risk assessment and conducted their own quantitative risk 
assessments for single, short-term exposure scenarios, using where 
possible the same information and approach used in EPA's Risk 
Assessment for the PMN Substance (Ref. 4). A discussion of the comments 
received and the Agency's responses follows.

A. Risk Assessment: Toxicity

    Commenters stated that adverse health impacts from use of HFO-
1234yf under the conditions specified would not be expected for car 
occupants, servicing personnel, or DIY consumers. The comments relate 
to the choice of the point of departure (POD) for the Agency's risk 
assessment of single-exposure (DIY consumers) use scenarios and to the 
Agency's use of a Margin of Exposure (MOE), as opposed to Hazard Index 
(HI), approach to evaluate the chemical substance.
    Comment: Why didn't the Agency use the 200,000 parts per million 
(ppm) effect level from a 4-hour rat study on HFO-1234yf to select the 
POD for the risk assessment?
    Response: This acute 4-hour exposure study in rats showed some lung 
effects at approximately 200,000 ppm, the lowest exposure level in the 
study.

[[Page 65990]]

Thus, EPA considers 200,000 ppm to be a LOAEL (low observed adverse 
effect level). If a LOAEL were used in the risk assessment instead of a 
NOAEL (no observed adverse effect level), EPA would use an uncertainty 
factor to estimate a NOAEL, which would result in a lower POD than what 
was used. Instead, EPA used the NOAEL for a subacute 14-day study on 
the chemical substance as the endpoint, because the LOAEL from the 
acute 4-hour study is an effect endpoint which is inappropriate for 
developing safe exposure levels for humans. Some of the animals in the 
4-hour acute study had grey, discolored lungs at both exposure levels 
in the study, and EPA considered this an adverse effect. Therefore, EPA 
could not determine a NOAEL from the acute 4-hour study. It is Agency 
policy to use the NOAEL where available, because of greater assurance 
of a ``safe'' level. Where only the LOAEL is available, that will be 
used along with any necessary additional uncertainty factors. For 
example, if EPA had started with the LOAEL of 200,000 ppm, it would 
have required an additional MOE of 10 to estimate a NOAEL from a LOAEL, 
for a total MOE of 300 instead of 30. This would have resulted in a 
more conservative risk assessment than using the NOAEL from the 14-day 
subacute study.
    Comment: Why didn't the Agency use the cardiac sensitization study 
in dogs as the POD?
    Response: Cardiac sensitization studies are for very short 
durations--on the order of 10 minutes--and they only address cardiac 
sensitization. The PMN chemical does not induce cardiac sensitization. 
EPA selected the acute POD from a multiple-exposure, two-week rat 
inhalation study on the PMN substance, reasoning that if no effects 
were seen in the duration of the study, then no effects would be seen 
from a single exposure.
    Comment: Why did EPA use the MOE rather than HI approach for risk 
assessment of HFO-1234yf?
    Response: Where available, it is EPA policy to use a NOAEL for the 
POD. This is the highest exposure level that did not cause an adverse 
health effect in a study. In this case, EPA selected the POD from an 
animal (rat 2-week inhalation) study. Because animals may respond to 
different exposure levels than humans, there is some uncertainty when 
extrapolating from animals to humans. For this reason, an Uncertainty 
Factor (UF) is applied when extrapolating from animals to humans--
typically a factor of 10 is used but, in this case, since there was a 
reasonable estimate of the pharmacokinetic component of the 
uncertainty, this UF was reduced to 3. An additional UF is applied to 
account for variation in the human population response to a chemical 
exposure--in this case, a UF of 10 was used. The two UFs give a 
resultant UF of 30 to yield an acceptable level of health risk. EPA's 
policy for review of new chemicals under TSCA is to divide the POD by 
the exposure level to obtain the MOE. For this PMN substance, the 
``acceptable level of health risk'' would be an MOE of 30 or greater.
    One commenter proposed dividing the estimated exposure to the PMN 
chemical by the POD levels to obtain a HI. If the exposure is less than 
the POD, the HI is <1 and this would be considered an ``acceptable 
level of health risk.'' This HI approach, however, does not factor in 
uncertainties about extrapolating from animal to human responses, nor 
does it address variability within the human population with regard to 
thresholds of response to chemical exposures. EPA has consistently 
applied the MOE approach to PMN evaluations (and for other risk 
assessments) in order to account for these uncertainties. This is the 
rationale for EPA continuing to use the MOE approach for this chemical 
substance.
    Perhaps most important to EPA's position on this final SNUR is that 
EPA has uncertainties about using available single-exposure studies on 
HFO-1234yf to determine the MOEs for different exposure scenarios. As a 
result of concerns with these studies, EPA calculated single exposure 
MOEs from the NOAEL in the 2-week inhalation toxicity study of the PMN 
chemical in rats. There are some additional uncertainties in the single 
exposure (acute) assessments because of the observation of lethality in 
rabbit dams after multiple exposures in a developmental study to the 
PMN substance. For these reasons, as mentioned in Unit IV. of the 
proposed SNUR, EPA recommends a rabbit acute inhalation toxicity study 
to address the question of whether pregnant rabbits would die from a 
single exposure. Rabbits should be exposed for one hour, using the 
Organisation for Economic Co-operation and Development (OECD) 403 test 
guideline. Pregnant rabbits should be exposed on gestational day 12 
(this is within the time-frame that pregnant rabbits started dieing in 
the developmental study).

B. Risk Assessment: Exposure

    Comment: Commenter stated that EPA's assessment, using the Gradient 
Report (Ref. 6), overstates the potential exposures from consumer DIY 
use of HFO-1234yf to refill MVAC systems. The commenter asserted that 
EPA's methodology to estimate the exposure levels associated with the 
DIY use greatly exaggerates the exposure that could be experienced in 
actual use conditions. The specific exposure parameters that the 
commenters questioned were assumptions regarding:
     Garage volume.
     Time the user spent under the hood during recharging 
operations.
     The size of the space where any leaking gas would 
disperse.
     The air exchange rate in a service area that should be 
well-ventilated when the engine is running.
     Use of the refrigerant in a closed garage with no 
ventilation.
     The amount of refrigerant used during recharge operations.
    During the comment period for the proposed SNUR, the PMN submitter 
conducted a simulated vehicle service leak testing, using HFC-134a as a 
surrogate, indicating that exposures from use of a 12-oz can during 
consumer DIY use are below the Agency's level of concern for HFO-1234yf 
(Ref. 7).
    Response: After reviewing the submitted consumer DIY use exposure 
study, EPA responded with a list of clarifying questions (Ref. 5), to 
which the PMN submitter subsequently responded (Ref. 8). Although the 
PMN submitter's responses were helpful, EPA still has concerns about 
potential exposures to consumers during DIY use and the inherent 
toxicity of HFO-1234yf. Therefore, the Agency has decided to retain 
requirements in the final rule for notification to the Agency prior to 
distribution in commerce of products intended for use by DIY consumers, 
while waiting for data from the acute inhalation toxicity study in 
rabbits described in Unit V.A. With regards to exposure, the peak 
concentration values from the submitted study are as high as 3% by 
volume, equivalent to 30,000 ppm. These peaks appeared to occur in the 
first one or two minutes of each emission. Accordingly, EPA would need 
exposure data presented and averaged out over shorter Time Weighted 
Averages (TWAs) than the 30 minutes currently in the study, because it 
would appear that a number of these early exposure peaks could result 
in TWA values that would result in MOEs less than the acceptable Agency 
level of 30 (see Unit V.A.). This is important because the data on HFO-
1234yf are insufficient to differentiate whether the toxicity is due to 
blood level alone from an acute exposure, is due to accumulated 
exposure over time (area under the curve), or is due to some

[[Page 65991]]

combination of both. Since blood equilibrium levels are reached within 
minutes, a high level of exposure in a short duration could result in 
blood levels exceeding a threshold if the mode of action is due to 
blood levels. Additional TWAs of 3, 5, and 10 minutes are recommended.
    The Agency's chief concern during its analysis of the submitted 
exposure study, and generally when estimating potential consumer 
exposure to HFO-1234yf, is that even if there is a low likelihood of 
the types of exposure scenarios assessed in this study occurring, there 
are estimates of 11 million DIY consumer recharging events per year in 
the United States (Ref. 1) (this is not necessarily 11 million people 
as some individuals recharge more than once). The Clodic survey 
commissioned by the California Air Resources Board (Ref. 3) indicated 
that 10% of DIY consumers released 100 g or more of refrigerant during 
servicing, including 2% releasing more than 500 g, and another 15% of 
DIY consumers released 50 to 100 g during servicing, due to faulty 
recharging equipment and poor technique. Both these percentages and the 
overall number of DIY consumer recharging events indicate that a 
substantial number of events could have significant leaks. The Agency 
recognizes that commenters have suggested, as an alternative to the 
container size limitation contained in the proposed SNUR, that the 
reductions in emissions and exposures can be accomplished by 
restricting sales and use of all refrigerants to qualified technicians, 
or by using DIY consumer containers and charging equipment that 
minimize the potential for releases (e.g., having a resealable/leak 
control device on all containers and using charging connection 
equipment that has a quick coupler with a moving rod to open the low 
pressure refrigerant valve on the vehicle). For example, CARB's 
``Certification Procedures for Small Containers of Automotive 
Refrigerant,'' effective March 10, 2010 (Ref. 2), mandates a self-
sealing valve with leakage rate in storage of <=3.0 g/yr, container 
labeling requirements, and education materials requirements. However, 
commenters provided insufficient information on these approaches for 
EPA to assess whether, for HFO-1234yf, they would reduce exposures 
during DIY consumer use and thus eliminate the potential toxicity risk. 
Consequently, the Agency has removed the specific container size 
limitation proposed as a significant new use, and replaced it with a 
description that directly addresses the issue of potential exposure to 
DIY consumers by clarifying that significant new use, found at 40 CFR 
721.80(o) (``use in a consumer product''), as ``distribution in 
commerce of products intended for use by a consumer for the purpose of 
servicing, maintenance, and disposal involving the PMN substance.''
    Information on such techniques or equipment to minimize potential 
exposures to DIY consumers should accompany any SNUN submitted in 
response to this final SNUR that requests use of HFO-1234yf in DIY 
consumer products. Other information submitted with such a SNUN should 
include data that quantifies exposures for durations shorter than the 
30-minute TWA presented in the exposure study submitted by the PMN 
submitter, in particular, TWAs for 3 minutes, 5 minutes, and 10 
minutes, in addition to 30 minutes.

C. CAA Section 609 Certification

    Comment: One commenter stated that the training and equipment 
requirements currently in CAA section 609 relative to other 
refrigerants would not be necessary for environmentally safe usage of 
HFO-1234yf during initial charging in an automobile assembly plant. The 
commenter stated that a CAA section 609 certification is not currently 
required for automobile assembly plants workers or equipment; 
manufacturers perform their own training programs; and Occupational 
Safety and Health Administration (OSHA) requirements for handling 
flammable substances already fully address the flammability-related 
HFO-1234yf worker safety issues in automobile assembly facilities.
    Response: EPA recognizes that the requirements for certification 
contained in CAA section 609 are reserved only for the MVAC servicing 
sector, i.e., ``service for consideration,'' which includes technicians 
or mechanics being paid either with cash, credit, goods, or services 
when they perform a service in a vehicle involving a refrigerant in an 
air conditioning system (40 CFR 82.32 (g)).
    The following scenarios are not covered under CAA section 609:
     Initial charge of an MVAC by OEMs.
     The action of disposing or disassembling an MVAC in a 
disposal facility in accordance with 40 CFR 82.152 and 40 CFR 82.156 
(f). The action of extracting or recovering refrigerant from an MVAC at 
a disposal facility does not require CAA section 608 or 609 
certification (40 CFR 82.34 (d)); however, such processing does require 
the use of an approved refrigerant handling equipment meeting the 
requirements of 40 CFR 82.36 (i.e., CAA section 609 equipment).
     Servicing on gratitude (service done for free). For 
example, a DIY individual if not being paid with cash, credits, goods, 
or service would not be covered under CAA section 609 requirements.
    Furthermore, intentionally venting any refrigerant is prohibited 
under section 608 of the CAA and under 40 CFR 82.154 (a)(1).
    EPA expects, in accordance with 40 CFR 82.34, that all servicing 
and maintenance of the MVAC involving the PMN substance will be done 
only by CAA section 609-certified technicians using CAA section 609-
certified refrigerant handling equipment, and that extraction or 
recovery of the PMN substance from MVAC bound for disposal and located 
at a motor vehicle disposal facility will be done with CAA section 609-
approved refrigerant recovery equipment. In 2011, EPA expects to 
propose regulations under CAA section 609 that specifically address 
requirements for servicing using HFO-1234yf (e.g., certification of 
refrigerant handling equipment). EPA also expects that during initial 
charging by OEM, general industry requirements under OSHA 29 CFR 1910 
for personal protective equipment, training and other measures for 
working with chemicals that may pose risks to their health and safety, 
are already applicable and any further restrictions under this final 
SNUR would be redundant and unnecessary.
    Therefore, EPA agrees with the commenter and has modified the 
relevant language in the regulatory text of the proposed rule to remove 
specific references to the CAA section 609 certification.

D. Use of HFO-1234yf as a Delivery Agent

    Comment: One commenter expressed concern that HFC-134a refrigerant 
has been used to deliver chemicals into MVAC systems for the advertised 
purpose of increasing system-cooling performance and/or injecting oil, 
trace dyes, sealants to stop refrigerant system leakage, etc. The 
commenter requests that EPA not allow use of HFO-1234yf as transfer/
delivery agent for such purposes. Another commenter requested that HFO-
1234yf not be allowed for this use due to health concerns.
    Response: Prior to marketing HFO-1234yf as a delivery agent, a 
person would need to submit notices to EPA under both the CAA SNAP 
program and under TSCA. If a person plans to market HFO-1234yf as a 
``delivery agent'' in cans, rather than as a refrigerant for MVAC, then 
they must submit a SNAP

[[Page 65992]]

information notice to EPA for use of HFO-1234yf as an aerosol 
propellant. Under the SNAP program, the person would be allowed to 
market HFO-1234yf as an aerosol propellant 90 days after submission of 
a complete notice. Similarly, under the SNUR, that person would also 
need to submit a SNUN 90 days before engaging in a use other than as a 
refrigerant in MVAC, such as a delivery agent. In many cases, EPA 
responds to a SNUN by amending the SNUR to allow companies other than 
the SNUN submitter (such as the submitter's processor customers) to 
engage in the newly approved use(s).

VI. Applicability of Rule to Uses Occurring Before Effective Date of 
the Final Rule

    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 SNUR rather than as of the 
effective date of the final rule. If uses begun after publication were 
considered ongoing, rather than new, it would be difficult for EPA to 
establish SNUR notice requirements because a person could defeat the 
SNUR by initiating the proposed significant new use before the rule 
became effective, and then argue that the use was ongoing as of the 
effective date of the final rule.
    Any person who began commercial manufacture, import, or processing 
of 1-Propene, 2,3,3,3-tetrafluoro- (PMN P-07-601; CAS No. 754-12-1; aka 
HFO-1234yf) for any of the significant new uses designated in the 
proposed SNUR after the date of publication of the proposed SNUR must 
stop that activity before the effective date of this final rule. 
Persons who ceased those activities will have to meet all SNUR notice 
requirements and wait until the end of the notification review period, 
including all extensions, before engaging in any activities designated 
as significant new uses. If, however, persons who began manufacture, 
import, or processing of the chemical substance between the date of 
publication of the proposed SNUR and the effective date of this final 
SNUR meet the conditions of advance compliance as codified at Sec.  
721.45(h), those persons would be considered to have met the final SNUR 
requirements for those activities.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require the development 
of any particular test data before submission of a SNUN. There are two 
exceptions:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).
    In the absence of a section 4 test rule or a section 5(b)(4) 
listing covering the chemical substance, 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 40 CFR 
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. In this case, EPA recommends 
a rabbit acute inhalation toxicity study to address human health 
concerns. EPA strongly encourages persons, before performing any 
testing, to consult with the Agency pertaining to protocol selection. 
The OECD test guidelines are available from the OECD Bookshop at http:/
/www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
    The recommended tests may not be the only means of addressing the 
potential risks of the chemical substance. However, SNUNs submitted 
without any test data may increase the likelihood that EPA will respond 
by taking action under TSCA section 5(e), particularly if satisfactory 
test results have not been obtained from a prior PMN or SNUN submitter. 
EPA recommends that potential SNUN submitters contact EPA early enough 
so that they will be able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical 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. of this document, according to Sec.  
[emsp14]721.1(c), persons submitting a SNUN must comply with the same 
notice requirements and EPA regulatory procedures as persons submitting 
a PMN, including submission of test data on health and environmental 
effects as described in 40 CFR 720.50. SNUNs must be submitted to EPA 
on EPA Form No. 7710-25 in accordance with the procedures set forth in 
Sec.  [emsp14]721.25 and Sec.  [emsp14]720.40. This form is available 
from the Environmental Assistance Division (7408M), 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001. Forms and information are also 
available on-line at http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

    EPA evaluated the potential costs of establishing SNUN requirements 
for potential manufacturers, importers, and processors of the chemical 
substance during the development of the direct final rule. The Agency's 
complete Economic Analysis is available in the docket under docket ID 
number EPA-HQ-OPPT-2008-0918.

X. References

    The following is a listing of those documents used to prepare the 
preamble to this final rule. Additional information for this final rule 
can be located under docket ID number EPA-HQ-OPPT-2008-0918, which is 
available for inspection as specified under ADDRESSES.
    1. CARB 2008. Technical Support Document Staff Analysis on 
Emissions and Economic Impact of Proposed Regulation for Small 
Containers of Automotive Refrigerant. Appendix G to CARB, 2010 (Ref. 
2).
    2. CARB 2010. Certification Procedures for Small Containers of 
Automotive Refrigerant. California Air Resources Board, effective March 
10, 2010. Document incorporated by reference in California Code of 
Regulations (CCR), title 17, sections 95360 through 9537. Available on-
line at http://www.arb.ca.gov/regact/2009/hfc09/hfc09.htm.
    3. Clodic et al. 2008. Clodic, D, Tremoulet, A, Riachi, Y, et al. 
Evaluation of the Potential Impact of Emissions of HFC-134a from Non 
Professional Servicing of Motor Vehicle Air Conditioning Systems. 
Prepared under CARB Agreement No. 06-341. December 2008.
    4. EPA 2009. Risk Assessment: PMN 07-0601; Reflecting Deliberations 
and Decisions From the 03/04/09 RAD Dispo. Docket ID number: EPA-HQ-
OPPT-2008-0918-0034.
    5. EPA 2010. EPA Questions to Honeywell on Submitted Exposure 
Study. Docket ID number: EPA-HQ-OPPT-2008-0918.
    6. Gradient 2009. Risk Assessment for Alternative Refrigerant HFO-
1234yf. Gradient Corporation, Seattle, Washington. April 3, 2009. 
Prepared for SAE International, Cooperative Research Program 1234.

[[Page 65993]]

    7. Honeywell 2010a. Comment on EPA Proposed Rule. Simulated Vehicle 
Service Leak Testing and Exposure Study. Docket ID number: EPA-HQ-OPPT-
2008-0918-0088.
    8. Honeywell 2010b. Honeywell Response to EPA Questions on 
Submitted Exposure Study. Docket ID number: EPA-HQ-OPPT-2008-0918.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

    This final rule establishes 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 is amending the table 
in 40 CFR part 9 to list the OMB approval number for the information 
collection requirements contained in this final rule. This listing of 
the OMB control numbers and their subsequent codification in the CFR 
satisfies the display requirements of PRA and OMB's implementing 
regulations at 5 CFR part 1320. This Information Collection Request 
(ICR) was previously subject to public notice and comment prior to OMB 
approval, and given the technical nature of the table, EPA finds that 
further notice and comment to amend it is unnecessary. As a result, EPA 
finds that there is ``good cause'' under section 553(b)(3)(B) of the 
Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this 
table without further notice and comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this SNUR will not have a significant adverse economic impact on a 
substantial number of small entities. The rationale supporting this 
conclusion is discussed in this unit. The requirement to submit a SNUN 
applies to any person (including small or large entities) who intends 
to engage in any activity described in the final rule as a 
``significant new use.'' Because these uses are ``new,'' based on all 
information currently available to EPA, it appears that no small or 
large entities presently engage in such activities. A SNUR requires 
that any person who intends to engage in such activity in the future 
must first notify EPA by submitting a SNUN. Although some small 
entities may decide to pursue a significant new use in the future, EPA 
cannot presently determine how many, if any, there may be. However, 
EPA's experience to date is that, in response to the promulgation of 
over 1,400 SNURs, the Agency receives on average only 5 notices per 
year. Of those SNUNs submitted from 2006-2008, only one appears to be 
from a small entity. In addition, the estimated reporting cost for 
submission of a SNUN (see Unit IX.) is minimal regardless of the size 
of the firm. Therefore, EPA believes that the potential economic 
impacts of complying with these SNURs are not expected to be 
significant or adversely impact a substantial number of small entities. 
In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 
29684) (FRL-5597-1), the Agency presented its general determination 
that final SNURs are not expected to have a significant economic impact 
on a substantial number of small entities, which was provided to the 
Chief Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this final rule. 
As such, EPA has determined that this rule does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
affect on small governments subject to the requirements of sections 
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4).

E. Executive Order 13132

    This action will not have a substantial direct effect on States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government, as specified in Executive Order 13132, entitled 
Federalism (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This final rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This does 
not significantly or uniquely affect the communities of Indian Tribal 
governments, nor does it involve or impose any requirements that affect 
Indian Tribes. Accordingly, the requirements of Executive Order 13175, 
entitled Consultation and Coordination with Indian Tribal Governments 
(65 FR 67249, November 9, 2000), do not apply to this final rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), because this action 
is not expected to affect energy supply,

[[Page 65994]]

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).

XII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of the rule in the Federal Register. 
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: October 14, 2010.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

0
Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.

0
2. The table in Sec.  [emsp14]9.1 is amended by adding the following 
section in numerical order under the undesignated center heading 
``Significant New Uses of Chemical Substances'' to read as follows:

Sec.  [emsp14]9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                   40 CFR Citation                      OMB Control No.
------------------------------------------------------------------------

                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------

                                * * * * *
721.10182............................................          2070-0012

                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
4. Add Sec.  [emsp14]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 other than as a refrigerant in 
motor vehicle air conditioning systems in new passenger cars and 
vehicles (i.e., as defined in 40 CFR 82.32 (c) and (d)); Sec.  721.80 
(m) (commercial use other than in new passenger cars and vehicles in 
which the charging of motor vehicle air conditioning systems with the 
PMN substance was done by the motor vehicle original equipment 
manufacturer (OEM)); and Sec.  721.80(o) (distribution in commerce of 
products intended for use by a consumer for the purpose of servicing, 
maintenance, and disposal involving the PMN substance).
    (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 chemical substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2010-27166 Filed 10-26-10; 8:45 am]
BILLING CODE 6560-50-P