Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 81437 

Board of Patent Appeals and 

Interferences was filed under 35 U.S.C. 

134 and § 41.31 of this title and ending 

on the date an appeal brief in 

compliance with 41.37 or a request for 

continued examination in compliance 

with § 1.114 was filed; 

* * * * * 

Dated: December 15, 2011. 

David J. Kappos, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2011–33150 Filed 12–27–11; 8:45 am] 

BILLING CODE 3510–16–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2011–0633; FRL–9325–9] 

RIN 2070–AB27 

Proposed Significant New Use Rule for 

Phenol, 2,4-dimethyl-6-(1- 

methylpentadecyl)- 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing a significant 

new use rule (SNUR) under section 

5(a)(2) of the Toxic Substances Control 

Act (TSCA) for the chemical substance 

identified as phenol, 2,4-dimethyl-6-(1- 

methylpentadecyl)- (PMN P–94–209; 

CAS No. 134701–20–5). This action 

would require persons who intend to 

manufacture, import, or process the 

substance 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 

that activity before it occurs. 

DATES: Comments must be received on 

or before January 27, 2012. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2011–0633, 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. Attention: Docket ID 

Number EPA–HQ–OPPT–2011–0633. 

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– 

2011–0633. 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 

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: Abeer 

Hashem, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–1117; email address: 

hashem.abeer@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: TSCA– 

Hotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, import, 

process, or use the chemical substance 

contained in this proposed rule. 

Potentially affected entities may 

include, but are not limited to: 

• Manufacturers, importers, or 

processors of the subject chemical 

substance (NAICS codes 325 and 

324110), e.g., chemical manufacturing 

and petroleum refineries. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

§ 721.5. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

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81438 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 

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 chemicals 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? 

Under section 5(a)(2) of TSCA, EPA is 

re-proposing a SNUR previously 

proposed for phenol, 2,4-dimethyl-6-(1- 

methylpentadecyl)- (PMN P–94–209; 

CAS No. 134701–20–5) in the Federal 

Register of September 9, 1998 (63 FR 

48157) (FRL–6020–8) but which was not 

finalized. In the 1998 proposed SNUR, 

based on submitted test data, EPA 

expressed concerns for liver toxicity, 

kidney toxicity, adrenal toxicity, and 

blood toxicity. Additionally, based on 

submitted test data and analogy to 

phenols, EPA was also concerned that 

toxicity to aquatic organisms would 

occur at concentrations as low as 1 part 

per billion (ppb). EPA determined that 

use of the substance as described in the 

Premanufacture Notice (PMN) did not 

present an unreasonable risk because 

workers would not be subject to 

significant dermal exposures and there 

were no significant environmental 

releases. EPA also determined that other 

potential uses of the substance may 

result in significant dermal exposures to 

workers and significant environmental 

releases. Based on this information, the 

PMN substance met the concern criteria 

at § 721.170 (b)(3)(i) and (b)(4)(i). In the 

1998 proposed SNUR, EPA proposed 

worker protection requirements as 

specified in § 721.63 (a)(2)(i) and (a)(3), 

release to water restrictions as specified 

in § 721.90 (a)(1), (b)(1), and (c)(1) and 

associated recordkeeping requirements. 

Recently, EPA re-evaluated the 

information now available on phenol, 

2,4-dimethyl-6-(1-methylpentadecyl)-. 

Since the PMN was initially reviewed, 

the Agency’s Ecological Structure 

Activity Relationships (EcoSAR) dataset 

for phenols has been significantly 

updated to include 203 chemicals, up 

from 78 chemicals. The additional 

number of data points has increased the 

robustness of the category, which has 

changed the underlying Quantitative 

Structure Activity Relationships 

(QSAR). As a result, when the most 

recent version of EcoSAR was run for 

phenol, 2,4-dimethyl-6-(1- 

methylpentadecyl)- in 2011, the 

program predicted no adverse 

ecotoxicological effects at saturation for 

this substance. Additionally, measured 

water solubility data submitted to the 

Agency subsequent to the 1998 proposal 

support the new EcoSAR prediction of 

no expected acute or chronic adverse 

ecological effects. 

Therefore, based upon the new 

EcoSAR predictions and the measured 

water solubility data, EPA now 

concludes that the ecological hazard 

and risk of this substance are low. EPA 

no longer determines that this substance 

may present an unreasonable risk to the 

aquatic environment. As a result EPA, 

based on the new data received and the 

Agency’s predictive tools, no longer 

finds that the PMN substance meets the 

concern criteria at § 721.170 (b)(4)(i). 

Therefore, EPA is re-proposing this 

SNUR, retaining the previously 

proposed worker protection 

requirements specified in § 721.63 

(a)(2)(i) and (a)(3), while removing the 

proposed release to water restrictions 

specified § 721.90 (a)(1), (b)(1), and 

(c)(1). 

This proposed SNUR would require 

persons to notify EPA at least 90 days 

before commencing the manufacture, 

import, or processing of the chemical 

substance identified as phenol, 2,4- 

dimethyl-6-(1-methyl pentadecyl)-, 

(PMN P–94–209; CAS No.134701–20–5), 

for any activity preliminarily designated 

by this proposed SNUR as a significant 

new use. Receipt of such notices allows 

EPA to assess risks that may be 

presented by the intended uses and, if 

appropriate, to regulate the proposed 

use before it occurs. The record 

established for this proposed SNUR is 

available in the docket under Docket ID 

number EPA–HQ–OPPT–2011–0633. 

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 

rule. Provisions relating to user fees 

appear at 40 CFR part 700. According to 

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Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 81439 

§ 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 chemical 

substance that is the subject of this 

proposed SNUR, EPA considered 

relevant information about the toxicity 

of the chemical substance, likely human 

exposures and environmental releases 

associated with possible uses, taking 

into consideration the four bulleted 

TSCA section 5(a)(2) factors listed in 

this unit. 

IV. Substance Subject to This Proposed 

Rule 

EPA is proposing to establish 

significant new use and recordkeeping 

requirements for the chemical substance 

identified as phenol, 2,4-dimethyl-6-(1- 

methylpentadecyl)- (P–94–209). In this 

unit, EPA provides the following 

information for this chemical substance: 

PMN Number P–94–209 

Chemical name: Phenol 2,4-dimethyl6-(1-methylpentadecyl)-. 

Chemical Abstracts Service (CAS) 

number: 134701–20–5. 

Basis for action: The PMN states that 

the substance will be used as an 

antioxidant. EPA is not aware of 

additional uses of this PMN chemical 

substance. Based on submitted test data, 

there is concern for liver toxicity, 

kidney toxicity, adrenal toxicity, and 

blood toxicity. However, after review of 

the PMN EPA determined that use of the 

substance as described in the PMN did 

not present an unreasonable risk 

because workers would not be subject to 

significant dermal exposures. EPA has 

determined that other potential uses of 

the substance may result in significant 

dermal exposures to workers. Based on 

this information the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(i). 

Recommended testing: EPA has 

determined that a dermal absorption 

study (OPPTS Test Guideline 870.3250) 

would help characterize the health 

effects of the PMN substance. Test 

reports should include protocols 

approved by the EPA, certificate of 

analysis for the test substance, raw data, 

and results. 

CFR citation: 40 CFR 721.5725. 

V. Rationale and Objectives of the 

Proposed Rule 

A. Rationale 

During review of phenol, 2,4- 

dimethyl-6-(1-methylpentadecyl)-, EPA 

preliminarily determined that one or 

more of the criteria of concern 

established at § 721.170 were met, as 

discussed in Units II and IV. 

B. Objectives 

EPA is proposing this SNUR for a 

chemical substance that has undergone 

premanufacture review because the 

Agency wants to achieve the following 

objectives with regard to the significant 

new uses designated in this proposed 

rule: 

• EPA would receive notice of any 

person’s intent to manufacture, import, 

or process a listed chemical substance 

for the described significant new use 

before that activity begins. 

• EPA would have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing, importing, or 

processing a listed chemical substance 

for the described significant new use. 

• EPA would be able to regulate 

prospective manufacturers, importers, 

or processors of a listed chemical 

substance before the described 

significant new use of that chemical 

substance occurs, provided that 

regulation is warranted pursuant to 

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

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Inventory. Guidance on how to 

determine if a chemical substance is on 

the TSCA Inventory is available on the 

Internet at http://www.epa.gov/opptintr/ 

existingchemicals/pubs/tscainventory/ 

index.html. 

VI. Notice and Comment Procedures 

EPA is issuing this SNUR by notice 

and comment procedure, as described in 

§ 721.170(d)(4). In accordance with 

§ 721.170(d)(4)(ii)(A), persons are given 

the opportunity to submit comments on 

or before January 27, 2012 on whether 

EPA should establish notification 

requirements. 

VII. Applicability of the Proposed Rule 

to Uses Occurring Before Effective Date 

of the Final Rule 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. EPA solicits comments on 

whether any of the uses proposed as 

significant new uses are ongoing. 

As discussed in the Federal Register 

of April 24, 1990 (55 FR 17376), EPA 

has decided that the intent of TSCA 

section 5(a)(1)(B) is best served by 

designating a use as a significant new 

use as of the date of publication of the 

proposed rule rather than as of the 

effective date of the final rule. If uses 

begun after publication of the proposed 

rule were considered ongoing rather 

than new, it would be difficult for EPA 

to establish SNUR notice requirements 

because a person could defeat the SNUR 

by initiating the significant new use 

before the rule became final, and then 

argue that the use was ongoing before 

the effective date of the final rule. Thus, 

persons who begin commercial 

manufacture, import, or processing 

activities with the chemical substances 

that would be regulated as a ‘‘significant 

new use’’ through this proposed rule, 

must cease any such activity before the 

effective date of the rule if and when 

finalized. To resume their activities, 

these persons would have to comply 

with all applicable SNUR notice 

requirements and wait until the notice 

review period, including all extensions, 

expires. 

EPA has promulgated provisions to 

allow persons to comply with this 

proposed SNUR before the effective 

date. If a person were to meet the 

conditions of advance compliance 

under § 721.45(h), the person would be 

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81440 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 

considered exempt from the 

requirements of the SNUR. 

VIII. 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 

§ 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

EPA recommended certain testing in 

Unit IV. Descriptions of tests are 

provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. To access the OPPTS Test 

Guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

The recommended tests 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. 

IX. 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 

§ 720.50. SNUNs must be submitted on 

EPA Form No. 7710–25 in accordance 

with the procedures set forth in 

§§ 721.25 and 720.40. E–PMN software 

is available electronically at http:// 

www.epa.gov/opptintr/newchems. 

X. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers, importers, and 

processors of the chemical substances 

subject to this proposed rule. EPA’s 

complete economic analysis is available 

in the docket under docket ID number 

EPA–HQ–OPPT–2011–0633. 

XI. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This proposed rule would establish a 

SNUR for a chemical substance that was 

the subject of a PMN. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

B. Paperwork Reduction Act 

According to the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., an Agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under PRA, 

unless it has been approved by OMB 

and displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. EPA would amend the table 

in 40 CFR part 9 to list the OMB 

approval number for the information 

collection requirements contained in 

this proposed rule, if the SNUR is 

subsequently issued as a 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 would not impose any 

burden requiring additional OMB 

approval. If an entity were to submit a 

SNUN to the Agency, the annual burden 

is estimated to average between 30 and 

170 hours per response. This burden 

estimate includes the time needed to 

review instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that promulgation of this SNUR 

would not have a significant adverse 

economic impact on a substantial 

number of small entities. The rationale 

supporting this conclusion is discussed 

in this unit. The requirement to submit 

a SNUN applies to any person 

(including small or large entities) who 

intends to engage in any activity 

described in the rule as a ‘‘significant 

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 1,000 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 

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believes that the potential economic 

impacts of complying with this SNUR 

are not expected to be significant or 

adversely impact a substantial number 

of small entities. In a SNUR that 

published in the Federal Register of 

June 2, 1997 (62 FR 29684) (FRL–5597– 

1), the Agency presented its general 

determination that final SNURs are not 

expected to have a significant economic 

impact on a substantial number of small 

entities, which was provided to the 

Chief Counsel for Advocacy of the Small 

Business Administration. 

D. Unfunded Mandates Reform Act 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government would be impacted by this 

proposed rule. As such, EPA has 

determined that this proposed rule 

would not impose any enforceable duty, 

contain any unfunded mandate, or 

otherwise have any effect 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 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 

In addition, since this action does not 

involve any technical standards, section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note), does not 

apply to this action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994). 

List of Subjects in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: December 16, 2011. 

Wendy C. Hamnett, 

Director, Office of Pollution Prevention and 

Toxics. 

Therefore, it is proposed that 40 CFR 

part 721 be amended as follows: 

PART 721—[AMENDED] 

1. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

2. Add § 721.5725 to subpart E to read 

as follows: 

§ 721.5725 Phenol, 2,4-dimethyl-6-(1- 

methylpentadecyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phenol, 2,4-dimethyl-6-(1- 

methylpentadecyl)- (PMN P–94–209; 

CAS No. 134701–20–5) 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)(2)(i) and (a)(3). 

(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), (d), and (e) 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. 

[FR Doc. 2011–33256 Filed 12–27–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2010–1075; FRL–9329–4] 

RIN 2070–AB27 

Proposed Significant New Use Rules 

on Certain Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing significant 

new use rules (SNURs) under section 

5(a)(2) of the Toxic Substances Control 

Act (TSCA) for the chemical substances 

rutile, tin zinc, calcium-doped (CAS No. 

389623–01–2) and rutile, tin zinc, 

sodium-doped (CAS No. 389623–07–8) 

which were the subject of 

premanufacture notices (PMNs P–06–36 

and P–06–37) and TSCA section 5(e) 

consent orders issued by EPA. The 

proposed SNURs on these substances, 

which are based on and consistent with 

the provisions of the underlying consent 

orders, would designate as a significant 

new use the absence of the protective 

measures required in the consent orders. 

This action would require persons who 

intend to manufacture, import, or 

process either 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 January 27, 2012. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

mstockstill on DSK4VPTVN1PROD with PROPOSALS