Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Rules and Regulations 65987 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(g), of the Instruction. This rule 

involves establishing, disestablishing, or 

changing Regulated Navigation Areas 

and security or safety zones. An 

environmental analysis checklist and a 

categorical exclusion determination are 

available in the docket where indicated 

under ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, and 

Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. 

Chapter 701; 50 U.S.C. 191, 195; 33 CFR 

1.05–1(g), 6.04–1, 6.04–6, and 160.5; Pub. L. 

107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1. 

■ 2. Add temporary § 165.T11–367 to 

read as follows: 

§ 165.T11–367 Safety zone; Epic 

Roasthouse Private Party, San Francisco, 

CA. 

(a) Location. This temporary safety 

zone is established for the waters of San 

Francisco Bay 1,000 yards off Epic 

Roasthouse Restaurant, San Francisco, 

CA. The fireworks launch site will be 

located in position 37° 46′35.30′′ N, 122° 

23′13.33′′ W (NAD 83). 

From 10:45 a.m. until 8:45 p.m. on 

November 5, 2010, the temporary safety 

zone applies to the navigable waters 

around the fireworks site within a 

radius of 100 feet. From 8:45 p.m. until 

9:30 p.m. on November 5, 2010, the area 

to which the temporary safety zone 

applies will increase in size to 

encompass the navigable waters around 

the fireworks site within a radius of 

1,000 feet. 

(b) Definitions. As used in this 

section, ‘‘designated representative’’ 

means a Coast Guard Patrol 

Commander, including a Coast Guard 

coxswain, petty officer, or other officer 

on a Coast Guard vessel or a Federal, 

State, or local officer designated by or 

assisting the Captain of the Port San 

Francisco (COTP) in the enforcement of 

the safety zone. 

(c) Regulations. 

(1) Under the general regulations in 

§ 165.23 of this title, entry into, 

transiting, or anchoring within this 

safety zone is prohibited unless 

authorized by the COTP or the COTP’s 

designated representative. 

(2) The safety zone is closed to all 

vessel traffic, except as may be 

permitted by the COTP or a designated 

representative. 

(3) Vessel operators desiring to enter 

or operate within the safety zone must 

contact the COTP or a designated 

representative to obtain permission to 

do so. Vessel operators given permission 

to enter or operate in the safety zone 

must comply with all directions given to 

them by the COTP or the designated 

representative. Persons and vessels may 

request permission to enter the safety 

zone on VHF–16 or through the 24-hour 

Command Center at telephone 415–399– 

3547. 

(d) Effective period. This section is 

effective from 10:45 a.m. through 9:30 

p.m. on November 5, 2010. 

Dated: October 15, 2010. 

C.L. Stowe, 

Captain, U.S. Coast Guard, Captain of the 

Port San Francisco. 

[FR Doc. 2010–27114 Filed 10–26–10; 8:45 am] 

BILLING CODE 9110–04–P 

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. 

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 


jdjones on DSK8KYBLC1PROD with RULES
65988 Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Rules and Regulations 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; e-mail address: TSCAHotline@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 

§ 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 § 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 

§ 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 § 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 § 721.80(o)). 

Furthermore, EPA has provided in the 

docket to this rule additional human 

health information to supplement EPA’s 

findings under § 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 § 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 


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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 § 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 

§ 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 

§ 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 § 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-tetrafluoroEPA 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-ityourself’’ (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 singleexposure (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. 


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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, twoweek 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 Cooperation 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 


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Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Rules and Regulations 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 flammabilityrelated 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 


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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 § 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 § 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 § 721.25 and 

§ 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 online 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. 


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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, 


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65994 Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Rules and Regulations 

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. 

■ Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 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. 

■ 2. The table in § 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: 

§ 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] 

■ 3. The authority citation for part 721 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, and 

2625(c). 

■ 4. Add § 721.10182 to subpart E to 

read as follows: 

§ 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 § 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)); § 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 § 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 § 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 § 721.185 apply to this 

section. 

[FR Doc. 2010–27166 Filed 10–26–10; 8:45 am] 

BILLING CODE 6560–50–P 


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