4806 Federal Register / Vol. 78, No. 15 / Wednesday, January 23, 2013 / Proposed Rules 

III. Proposed Action 

EPA is proposing to approve 

Washington’s SIP revision dated 

November 28, 2012, specifically 

Appendix A, ‘‘2008 Baseline Emissions 

Inventory and Documentation’’ and 

Appendix B, ‘‘SIP Strengthening Rules.’’ 

We have made the determination that 

this action is consistent with section 

110 of the CAA. EPA is soliciting public 

comments which will be considered 

before taking final action. 

IV. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

CAA and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this action 

merely proposes to approve state law as 

meeting Federal requirements and does 

not impose additional requirements 

beyond those imposed by state law. For 

that reason, this proposed action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this proposed approval 

does not impose substantial direct costs 

on tribal governments or preempt tribal 

law as specified by Executive Order 

13175 (65 FR 67249, November 9, 2000). 

Consistent with EPA policy, EPA 

nonetheless provided a consultation 

opportunity to the Puyallup Tribe in a 

letter dated December 11, 2012. EPA did 

not receive a request for consultation. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Nitrogen dioxide, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: January 7, 2013. 

Dennis J. McLerran, 

Regional Administrator, Region 10. 

[FR Doc. 2013–01339 Filed 1–22–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2011–0941; FRL–6369–9] 

RIN 2070–AB27 

Proposed Significant New Use Rule on 

Certain Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing significant 

new use rules (SNURs) under the Toxic 

Substances Control Act (TSCA) for four 

chemical substances which were the 

subject of premanufacture notices 

(PMNs). This action would require 

persons who intend to manufacture, 

import, or process any of the chemical 

substances for an activity that is 

designated as a significant new use by 

this proposed rule to notify EPA at least 

90 days before commencing that 

activity. The required notification 

would provide EPA with the 

opportunity to evaluate the intended 

use and, if necessary, to prohibit or limit 

the activity before it occurs. 

DATES: Comments must be received on 

or before February 22, 2013. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2011–0941, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East Bldg., 

Rm. 6428, 1201 Constitution Ave. NW., 

Washington, DC. ATTN: Docket ID 

Number EPA–HQ–OPPT–2011–0941. 

The DCO is open from 8 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2011–0941. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or 

email. The regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through 

regulations.gov, your email address will 

be automatically captured and included 

as part of the comment that is placed in 

the docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

at http://www.regulations.gov. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 


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copy. Publicly available docket 

materials are available electronically at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave. NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: 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; email address: 

moss.kenneth@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, import, 

process, or use the chemical substances 

contained in this proposed rule. The 

following list of North American 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Manufacturers, importers, or 

processors of one or more subject 

chemical substances (NAICS codes 325 

and 324110), e.g., chemical 

manufacturing and petroleum refineries. 

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. Importers 

of chemical substances subject to a final 

SNUR must certify their compliance 

with the SNUR requirements. 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 a chemical substance 

that is the subject of a proposed or 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. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What action is the agency taking? 

EPA is proposing these SNURs under 

TSCA section 5(a)(2) for four chemical 

substances which were the subject of 

PMNs P–07–204, P–10–58, P–10–59, 

and P–10–60. These SNURs would 

require persons who intend to 

manufacture, import, or process any of 

these chemical substances for an 

activity that is designated as a 

significant new use to notify EPA at 

least 90 days before commencing that 

activity. 

In the Federal Register issue of 

September 21, 2012 (77 FR 58666) 

(FRL–9357–2), EPA issued direct final 

SNURs on these four chemical 

substances in accordance with the 

procedures at § 721.160(c)(3)(i). EPA 

received notice of intent to submit 

adverse comments on these SNURs. 

Therefore, as required by 

§ 721.160(c)(3)(ii), EPA has removed the 

direct final SNURs in a separate final 

rule published in the Federal Register, 

and is now issuing this proposed rule 

on the four chemical substances. The 

record for the direct final SNURs on 

these chemical substances was 

established as docket EPA–HQ–OPPT– 

2011–0941. That docket includes 

information considered by the Agency 

in developing the direct final rule and 

the notice of intent to submit adverse 

comments. 

B. What is the agency’s authority for 

taking this action? 

Section 5(a)(2) of TSCA (15 U.S.C. 

2604(a)(2)) authorizes EPA to determine 

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including the four bulleted TSCA 

section 5(a)(2) factors listed in Unit III. 

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 


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occurring before the effective date of the 

rule. Provisions relating to user fees 

appear at 40 CFR part 700. According to 

§ 721.1(c), persons subject to these 

SNURs must comply with the same 

notice requirements and EPA regulatory 

procedures as submitters of PMNs under 

TSCA section 5(a)(1)(A). In particular, 

these requirements include the 

information submission requirements of 

TSCA section 5(b) and 5(d)(1), the 

exemptions authorized by TSCA section 

5(h)(1), (h)(2), (h)(3), and (h)(5), and the 

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

5(e), 5(f), 6, or 7 to control the activities 

for which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

III. Significant New Use Determination 

Section 5(a)(2) of TSCA states that 

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

enumerated in TSCA section 5(a)(2), the 

statute authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the four 

chemical substances that are the subject 

of this proposed rule, EPA considered 

relevant information about the toxicity 

of the chemical substances, likely 

human exposures and environmental 

releases associated with possible uses, 

and the four bulleted TSCA section 

5(a)(2) factors listed in this unit. 

IV. Substances Subject to This Proposed 

Rule 

EPA is proposing significant new use 

and recordkeeping requirements for four 

chemical substances in 40 CFR part 721, 

subpart E. In this unit, EPA provides the 

following information for each chemical 

substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• Chemical Abstracts Service (CAS) 

Registry number (if assigned for nonconfidential chemical identities). 

• Basis for the TSCA section 5(e) 

consent order or, for TSCA non-section 

5(e) SNURs, the basis for the SNUR (i.e., 

SNURs without TSCA section 5(e) 

consent orders). 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VIII. for more information). 

• CFR citation assigned in the 

regulatory text section of this proposed 

rule. 

The regulatory text section of this 

proposed rule specifies the activities 

designated as significant new uses. 

Certain new uses, including production 

volume limits (i.e., limits on 

manufacture and importation volume) 

and other uses designated in this 

proposed rule, may be claimed as CBI. 

See Unit IX. 

This proposed rule includes PMN 

substances P–10–58, P–10–59, and P– 

10–50 that are subject to ‘‘risk-based’’ 

consent orders under TSCA section 

5(e)(1)(A)(ii)(I) where EPA determined 

that activities associated with the PMN 

substances may present unreasonable 

risk to human health or the 

environment. These consent orders 

require protective measures to limit 

exposures or otherwise mitigate the 

potential unreasonable risk. The socalled ‘‘TSCA section 5(e) SNURs’’ on 

these PMN substances are proposed 

pursuant to § 721.160, and are based on 

and consistent with the provisions in 

the underlying consent orders. The 

TSCA section 5(e) SNURs designate as 

a ‘‘significant new use’’ the absence of 

the protective measures required in the 

corresponding consent orders. 

This proposed rule also includes a 

SNUR on PMN substance P–07–204 that 

was not subject to a consent order under 

TSCA section 5(e). In this case, EPA did 

not find that the use scenario described 

in the PMN triggered the determinations 

set forth under TSCA section 5(e). 

However, EPA does believe that certain 

changes from the use scenario described 

in the PMN could result in increased 

exposures, thereby constituting a 

‘‘significant new use.’’ This so-called 

‘‘TSCA non-section 5(e) SNUR’’ is 

proposed pursuant to § 721.170. EPA 

has determined that every activity 

designated as a ‘‘significant new use’’ in 

all TSCA non-section 5(e) SNURs issued 

under § 721.170 satisfies 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. 

PMN Number P–07–204 

Chemical name: Pentane, 1,1,1,2,3,3- 

hexafluoro-4-(1,1,2,3,3,3- 

hexafluoropropoxy)-. 

CAS number: 870778–34–0. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a heat transfer 

fluid. Based on test data on the PMN 

substance and structure activity 

relationship (SAR) analysis of test data 

on analogous perfluorinated substances, 

EPA identified concerns for 

neurotoxicity and liver effects from 

exposures to the PMN substance. For 

the uses described in the amended 

PMN, EPA does not expect significant 

worker exposures due to the use of 

impervious gloves. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance without 

impervious gloves, where there is a 

potential for dermal exposure; or any 

use of the substance other than as 

described in the amended PMN may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at § 721.170 

(b)(3)(i) and (ii). 

Recommended testing: EPA has 

determined that the results of a 28-day 

dermal toxicity test (OPPTS Test 

Guideline 870.3200) in rats, a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465), and a test using 

the ‘‘Standard Test Method for 

Permeation of Liquids and Gases 

through Protective Clothing Materials 

under Conditions of Continuous 

Contact’’ (American Society for Testing 

and Materials (ASTM) International 

Standard F739–12) as reported in the 

‘‘Standard Guide for Documenting the 

Results of Chemical Permeation Testing 

of Materials Used in Protective 

Clothing’’ (ASTM International 

Standard F1194–99 (2010)) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10509. 

PMN Numbers P–10–58, P–10–59, and 

P–10–60 

Chemical names: Partially fluorinated 

alcohol substituted glycols (generic). 

CAS numbers: Not available. 


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Effective date of TSCA section 5(e) 

consent order: October 8, 2010. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) uses of the PMN 

substances will be as intermediates (P– 

10–58 and P–10–59) and a surface active 

agent (P–10–60). EPA has concerns for 

potential incineration or other 

decomposition products of the PMN 

substances. These perfluorinated 

decomposition products may be 

released to the environment from 

incomplete incineration of the PMN 

substances at low temperatures. EPA 

has preliminary evidence, including 

data on some fluorinated polymers, 

which suggests that, under some 

conditions, the PMN substances could 

degrade in the environment. EPA has 

concerns that these degradation 

products will persist in the 

environment, could bioaccumulate or 

biomagnify, and could be toxic to 

people, wild mammals, and birds. These 

concerns are based on data on analogous 

chemical substances, including 

perfluorooctanoic acid (PFOA) and 

other perfluorinated alkyls, including 

the presumed environmental degradant. 

The order was issued under TSCA 

sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), 

and 5(e)(1)(A)(ii)(II), based on a finding 

that these substances may present an 

unreasonable risk of injury to the 

environment and human health, the 

substances may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substances and their potential 

degradation products. To protect against 

these exposures and risks, the consent 

order requires submission of testing on 

the PMN substance P–10–60 at five 

identified aggregate manufacture and 

importation volumes; requires analysis 

of raw materials; and restricts the use of 

P–10–58 and P–10–59 as intermediates 

to make P–10–60. The SNUR designates 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Recommended testing: EPA has 

determined that the results of certain 

fate and physical/chemical property 

testing identified in the TSCA section 

5(e) consent order would help 

characterize possible effects of the PMN 

substances and their degradation 

products. The TSCA section 5(e) 

consent order contains five production 

volume limits. The PMN submitter has 

agreed not to exceed the confidential 

production volume limits without 

performing the specified testing on PMN 

substance P–10–60. Additional testing is 

included in the preamble to the TSCA 

section 5(e) consent order, but this 

testing is not required at any specified 

time or production volume. However, 

the TSCA section 5(e) consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMN substance 

will remain in effect until the TSCA 

section 5(e) consent order is modified or 

revoked by EPA based on submission of 

that or other relevant information. 

CFR citation: 40 CFR 721.10515. 

V. Rationale and Objectives of the 

Proposed Rule 

A. Rationale 

During review of the PMNs submitted 

for the four chemical substances that are 

subject to these proposed SNURs, EPA 

concluded that for three of the 

substances, regulation was warranted 

under TSCA section 5(e), pending the 

development of information sufficient to 

make reasoned evaluations of the health 

and environmental effects of the 

chemical substances. For one of the four 

substances, where the uses are not 

regulated under a TSCA section 5(e) 

consent order, EPA determined that one 

or more of the criteria of concern 

established at § 721.170 were met. The 

basis for these findings is outlined in 

Unit IV. 

Based upon comments received from 

the September 21, 2012 direct final rule, 

the proposed SNUR for P–10–58, P–10– 

59, and P–10–60 has been amended to 

be consistent with the provisions of the 

TSCA section 5(e) consent order and the 

proposed SNUR for P–07–0204 has been 

amended to clarify the restriction at 

721.80(j). This proposed rule includes 

the following changes: 

1. Revision of paragraph (a)(2)(i) for 

the proposed SNUR on P–10–58, P–10– 

69, and P–10–60. 

2. Revision of paragraph (a)(2)(ii) for 

the proposed SNUR for P–07–0204. 

B. Objectives 

EPA is proposing these SNURs for 

specific chemical substances that have 

undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this proposed rule: 

• EPA would receive notice of any 

person’s intent to manufacture, import, 

or process a listed chemical substance 

for the described significant new use 

before that activity begins. 

• EPA would have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing, importing, or 

processing a listed chemical substance 

for the described significant new use. 

• EPA would be able to regulate 

prospective manufacturers, importers, 

or processors of a listed chemical 

substance before the described 

significant new use of that chemical 

substance occurs, provided that 

regulation is warranted pursuant to 

TSCA sections 5(e), 5(f), 6, or 7. 

• EPA would ensure that all 

manufacturers, importers, and 

processors of the same chemical 

substance that is subject to a TSCA 

section 5(e) consent order are subject to 

similar requirements. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Chemical Substance Inventory 

(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/ 

existingchemicals/pubs/tscainventory/ 

index.html. 

VI. Applicability of the Proposed Rule 

to Uses Occurring Before Effective Date 

of the Final Rule 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this proposed rule have 

undergone premanufacture review. 

TSCA section 5(e) consent orders have 

been issued for three chemical 

substances and the PMN submitters are 

prohibited by the TSCA section 5(e) 

consent orders from undertaking 

activities which EPA is designating as 

significant new uses. In cases where 

EPA has not received a notice of 

commencement (NOC) and the chemical 

substance has not been added to the 

TSCA Inventory, no other person may 

commence such activities without first 

submitting a PMN. For chemical 

substances for which an NOC has not 

been submitted at this time, EPA 

concludes that the uses are not ongoing. 

However, EPA recognizes that prior to 

the effective date of the final rule, when 

chemical substances identified in these 

SNURs are added to the TSCA 

Inventory, other persons may engage in 

a significant new use as defined in this 

proposed rule before the effective date 

of the final rule. 

As discussed in the SNURs published 

in the Federal Register issue 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 September 21, 

2012 direct final rule rather than as of 

the effective date of the final rule for 

this proposed rule. If uses begun after 

publication were considered ongoing 

rather than new, it would be difficult for 


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4810 Federal Register / Vol. 78, No. 15 / Wednesday, January 23, 2013 / Proposed Rules 

EPA to establish SNUR notification 

requirements because a person could 

defeat the SNUR by initiating the 

significant new use before the proposed 

rule became an effective final rule, and 

then argue that the use was ongoing 

before the effective date of the final rule 

based on this proposed rule. Thus, 

persons who begin commercial 

manufacture, import, or processing of 

the chemical substances regulated 

through these SNURs will have to cease 

any such activity before the effective 

date of the final rule based upon this 

proposed rule. To resume their 

activities, these persons would have to 

comply with all applicable SNUR 

notification requirements and wait until 

the notice review period, including any 

extensions expires. 

EPA has promulgated provisions to 

allow persons to comply with these 

SNURs before the effective date of the 

final rule. If a person meets the 

conditions of advance compliance 

under § 721.45(h), the person is 

considered exempt from the 

requirements of the SNUR. 

VII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN. The two exceptions are: 

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 TSCA section 4 

test rule or a TSCA 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 cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

lists those tests. Unit IV. also lists 

recommended testing for TSCA nonsection 5(e) SNURs. Descriptions of tests 

are provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ ASTM 

International standards are available at 

http://www.astm.org/Standard/ 

index.shtml. 

In the TSCA section 5(e) consent 

orders for three of the chemical 

substances in this proposed rule, EPA 

has established production volume 

limits in view of the lack of data on the 

potential health and environmental 

risks that may be posed by the 

significant new uses or increased 

exposure to the chemical substances. 

These limits cannot be exceeded unless 

the PMN submitter first submits the 

results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by these chemical 

substances. Under recent TSCA section 

5(e) consent orders, each PMN submitter 

is required to submit each study before 

reaching the specified production limit. 

The SNURs contain the same 

production volume limits as the TSCA 

section 5(e) consent order. Exceeding 

these production limits is defined as a 

significant new use. Persons who intend 

to exceed the production limit must 

notify the Agency by submitting a 

SNUN at least 90 days in advance of 

commencement of non-exempt 

commercial manufacture, import, or 

processing. 

The recommended tests specified in 

Unit IV. may not be the only means of 

addressing the potential risks of the 

chemical substance. However, 

submitting a SNUN without any test 

data may increase the likelihood that 

EPA will take action under TSCA 

section 5(e), particularly if satisfactory 

test results have not been obtained from 

a prior PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate 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 substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

VIII. SNUN Submissions 

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 

on EPA Form No. 7710–25, generated 

using e-PMN software, and submitted to 

the Agency in accordance with the 

procedures set forth in 40 CFR 720.40 

and § 721.25. E–PMN software is 

available electronically at http:// 

www.epa.gov/opptintr/newchems. 

IX. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers, importers, and 

processors of the chemical substances 

during the development of the direct 

final rule. EPA’s complete economic 

analysis is available in the docket under 

docket ID number EPA–HQ–OPPT– 

2011–0941. 

X. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This proposed rule would establish 

SNURs for four chemical substances 

that were the subject of PMNs, and in 

three cases, a TSCA section 5(e) consent 

order. 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 (PRA) 

According to the 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 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. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action would not impose any 

burden requiring additional OMB 

approval. If an entity were to submit a 

SNUN to the Agency, the annual burden 

is estimated to average between 30 and 

170 hours per response. This burden 

estimate includes the time needed to 

review instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 


wreier-aviles on DSK5TPTVN1PROD with 
Federal Register / Vol. 78, No. 15 / Wednesday, January 23, 2013 / Proposed Rules 4811 

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 (RFA) 

On February 18, 2012, EPA certified 

pursuant to RFA section 605(b) (5 U.S.C. 

601 et seq.), that promulgation of a 

SNUR does not have a significant 

economic impact on a substantial 

number of small entities where the 

following are true: 

1. A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

2. The SNUR submitted by any small 

entity would not cost significantly more 

than $8,300. 

A copy of that certification is 

available in the docket for this proposed 

rule. 

This proposed rule is within the 

scope of the February 18, 2012 

certification. Based on the Economic 

Analysis discussed in Unit IX. and 

EPA’s experience promulgating SNURs 

(discussed in the certification), EPA 

believes that the following are true: 

• A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

• Submission of the SNUN would not 

cost any small entity significantly more 

than $8,300. 

Therefore, the promulgation of these 

SNURs would not have a significant 

economic impact on a substantial 

number of small entities. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government would be impacted by this 

proposed rule. As such, EPA has 

determined that this proposed rule 

would not impose any enforceable duty, 

contain any unfunded mandate, or 

otherwise have any effect on small 

governments subject to the requirements 

of UMRA sections 202, 203, 204, or 205 

(2 U.S.C. 1501 et seq.). 

E. Executive Order 13132 

This action would not have a 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999). 

F. Executive Order 13175 

This proposed rule would not have 

Tribal implications because it is not 

expected to have substantial direct 

effects on Indian Tribes. This proposed 

rule would not significantly nor 

uniquely affect the communities of 

Indian Tribal governments, nor would it 

involve or impose any requirements that 

affect Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), do not apply 

to this proposed rule. 

G. Executive Order 13045 

This action is not subject to Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This proposed rule is not subject to 

Executive Order 13211, entitled 

‘‘Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

In addition, since this action would 

not involve any technical standards, 

NTTAA section 12(d) (15 U.S.C. 272 

note), would not apply to this action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

List of Subjects in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: January 14, 2013. 

Maria J. Doa, 

Director, Chemical Control Division, Office 

of Pollution, Prevention and Toxics. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 721—[AMENDED] 

■ 1. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 2. Add § 721.10509 to subpart E to 

read as follows: 

§ 721.10509 Pentane, 1,1,1,2,3,3- 

hexafluoro-4-(1,1,2,3,3,3- 

hexafluoropropoxy)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

pentane, 1,1,1,2,3,3-hexafluoro-4- 

(1,1,2,3,3,3-hexafluoropropoxy)-(PMN 

P–07–204; CAS No. 870778–34–0) 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) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3), (b) 

(concentration set at 1.0%), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (applies 

specifically to the confidential uses 

identified in the amended 

premanufacture notice (PMN)). 

(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), (d), (e), 

and (i) are applicable to manufacturers, 

importers, and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 3. Add § 721.10515 to subpart E to 

read as follows: 

§ 721.10515 Partially fluorinated alcohol 

substituted glycols (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as partially fluorinated 

alcohol substituted glycols (PMN P–10– 

58, P–10–59, and P–10–60) are subject 

to reporting under this section for the 


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4812 Federal Register / Vol. 78, No. 15 / Wednesday, January 23, 2013 / Proposed Rules 

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(k) (manufacture 

and import of the PMN substances 

according to the chemical synthesis and 

composition section of the TSCA 

section 5(e) consent order, including 

analysis, reporting, and limitations of 

maximum impurity levels of certain 

fluorinated impurities; manufacture and 

import of P–10–58 and P–10–59 only as 

intermediates for the manufacture of P– 

10–60), and (q). 

(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 these substances, 

except the recordkeeping requirements 

for § 721.125(b) and (c) do not apply to 

importers or processors when any one of 

the substances are contained in a 

formulation at less than 3 weight 

percent. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(i) of this section. 

[FR Doc. 2013–01194 Filed 1–22–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R8–ES–2011–0063: 

FXES11130900000–134–FF09E32000] 

RIN 1018–AV29 

Endangered and Threatened Wildlife 

and Plants; Removal of the Valley 

Elderberry Longhorn Beetle From the 

Federal List of Endangered and 

Threatened Wildlife 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Proposed rule; reopening of 

public comment. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), announce the 

reopening of the public comment period 

on our October 2, 2012, 12-month 

petition finding and proposed rule to 

remove the valley elderberry longhorn 

beetle (Desmocerus californicus 

dimorphus) from the List of Endangered 

and Threatened Wildlife. The 60-day 

comment period for our proposed rule 

ended on December 3, 2012. This notice 

announces a 30-day reopening of the 

comment period to allow all interested 

parties an additional opportunity to 

comment on the proposed rule and to 

submit information on the status of the 

species. If you submitted comments 

previously, you do not need to resubmit 

them because we have already 

incorporated them into the public 

record and will fully consider them in 

preparation of the final rule. 

DATES: We will consider all comments 

received or postmarked on or before 

February 22, 2013. Comments submitted 

electronically using the Federal 

eRulemaking Portal (see ADDRESSES

section, below) must be received by 

11:59 p.m. Eastern Time on the closing 

date. 

ADDRESSES: Document availability: You 

may obtain copies of the proposed rule 

and related documents on the Internet at 

http://www.regulations.gov under 

Docket Number FWS–R8–ES–2011– 

0063, or by mail from the Sacramento 

Fish and Wildlife Office (see FOR

FURTHER INFORMATION CONTACT). 

Comment submission: You may 

submit written comments by one of the 

following methods: 

(1) Electronically: Go to the Federal 

eRulemaking Portal: http:// 

www.regulations.gov. In the Search box, 

enter FWS–R8–ES–2011–0063, which is 

the docket number for this rulemaking. 

On the search results page, under the 

Comment Period heading in the menu 

on the left side of your screen, check the 

box next to ‘‘Open’’ to locate this 

document. Please ensure you have 

found the correct document before 

submitting your comments. If your 

comments will fit in the provided 

comment box, please use this feature of 

http://www.regulations.gov, as it is most 

compatible with our comment review 

procedures. If you attach your 

comments as a separate document, our 

preferred file format is Microsoft Word. 

If you attach multiple comments (such 

as form letters), our preferred format is 

a Microsoft Excel spreadsheet. 

(2) By Hard Copy: Submit by U.S. 

mail or hand-delivery to: Public 

Comments Processing, Attn: FWS–R8– 

ES–2011–0063; Division of Policy and 

Directives Management; U.S. Fish and 

Wildlife Service; 4401 N. Fairfax Drive, 

MS 2042–PDM; Arlington, VA 22203. 

We request that you send comments 

only by the methods described above. 

We will post all information received on 

http://www.regulations.gov. This 

generally means that we will post any 

personal information you provide us 

(see Public Comments in 

SUPPLEMENTARY INFORMATION for more 

information). 

FOR FURTHER INFORMATION CONTACT: Jan 

Knight, Deputy Field Supervisor, 

Sacramento Fish and Wildlife Office, 

2800 Cottage Way, Suite W–2605, 

Sacramento, CA 95825; telephone 916– 

414–6600; facsimile 916–414–6712. If 

you use a telecommunications device 

for the deaf (TDD), call the Federal 

Information Relay Service (FIRS) at 

800–877–8339. 

SUPPLEMENTARY INFORMATION: 

Public Comments 

We will accept written comments and 

information during this reopened 

comment period on our October 2, 2012, 

12-month finding and proposed rule to 

remove the valley elderberry longhorn 

beetle from the List of Endangered and 

Threatened Wildlife, and to remove the 

designation of critical habitat (77 FR 

60237). For more information on the 

specific information we are seeking, 

please see the October 2, 2012, proposed 

rule. You may obtain copies of the 

proposed rule and related documents on 

the Internet at http:// 

www.regulations.gov under Docket 

Number FWS–R8–ES–2011–0063, or by 

mail from the Sacramento Fish and 

Wildlife Office (see FOR FURTHER

INFORMATION CONTACT). 

You may submit your comments and 

materials concerning the proposed rule 

by one of the methods listed in 

ADDRESSES. We will not accept 

comments sent by email or fax, or to an 

address not listed in ADDRESSES. If you 

submit a comment via http:// 

www.regulations.gov, your entire 

comment—including your personal 

identifying information—will be posted 

on the Web site. If you submit a 

hardcopy comment that includes 

personal identifying information, you 

may request at the top of your document 

that we withhold this information from 

public review. However, we cannot 

guarantee that we will be able to do so. 

We will post all hardcopy comments on 

http://www.regulations.gov. 

All comments for this reopening of 

the public comment period must be 

received or postmarked on or before the 

date shown in DATES. Comments 

previously submitted need not be 

resubmitted, as they will be fully 

considered in preparation of the final 

rule. We intend that any final action 

resulting from this proposal be as 

accurate as possible and based on the 


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