75390 Federal Register / Vol. 77, No. 245 / Thursday, December 20, 2012 / Rules and Regulations 

VII. Statutory and Executive Order 

Reviews 

Under the Clean Air Act, the 

Administrator is required to approve a 

SIP submission that complies with the 

provisions of the Act 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 Clean Air Act. 

Accordingly, this action merely 

approves state law as meeting Federal 

requirements and does not impose 

additional requirements beyond those 

imposed by state law. For that reason, 

this 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 Clean Air Act; 

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 rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by February 19, 

2013. Filing a petition for 

reconsideration by the Administrator of 

this final rule does not affect the finality 

of this action for the purposes of judicial 

review nor does it extend the time 

within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Nitrogen 

dioxide, Ozone, Reporting and 

recordkeeping requirements, and 

Volatile organic compounds. 

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

Dated: April 30, 2012. 

James B. Martin, 

Regional Administrator, Region 8. 

40 CFR part 52 is amended as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

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

Subpart G—Colorado 

■ 2. Section 52.320 is amended by 

adding two sentences to the end of 

paragraph (c)(107)(i)(C) to read as 

follows: 

§ 52.320 Identification of plan. 

* * * * * 

(c) * * * 

(107) * * * 

(i) * * * 

(C) * * * On August 8, 2006, 

Colorado submitted revisions to 

Colorado’s Regulation Number 11— 

Motor Vehicle Emissions Inspection 

Program, part F, section III.A.2, that 

EPA approved and that superseded the 

version of section III.A.2 that EPA 

incorporated by reference in this 

paragraph. See § 52.329(f). 

* * * * * 

■ 3. Add paragraph (f) to § 52.329 to 

read as follows: 

§ 52.329 Rules and regulations. 

* * * * * 

(f) On August 8, 2006, Dennis E. Ellis, 

Executive Director of the Colorado 

Department of Public Health and 

Environment, and on behalf of the 

Governor, submitted revisions to 5 CCR 

1001–13, Colorado’s Regulation Number 

11—Motor Vehicle Emissions 

Inspection Program, part F, section 

III.A.2. These revisions removed from 

Colorado’s Regulation Number 11 the 

light duty vehicle emission testing 

limits that went into effect on January 

1, 2006 for 1996 and newer model year 

vehicles. These revisions were adopted 

on November 17, 2005, and became 

state-effective on January 30, 2006. The 

revised version of section III.A.2, as 

approved by EPA, reads as follows: 

(1) The following emissions standards 

shall apply to those tests performed on 

model year 1996 and newer vehicles, on 

and after January 1, of the dates 

specified: 

Calendar year HC CO NOX

2002 .............................. 1.2 20 3.0 

2003 .............................. 1.2 20 3.0 

[FR Doc. 2012–30442 Filed 12–19–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2012–0842; FRL–9372–8] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is promulgating 

significant new use rules (SNURs) under 


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the Toxic Substances Control Act 

(TSCA) for 9 chemical substances which 

were the subject of premanufacture 

notices (PMNs). This action requires 

persons who intend to manufacture, 

import, or process any of these 9 

chemical substances for an activity that 

is designated as a significant new use by 

this rule to notify EPA at least 90 days 

before commencing that activity. The 

required notification will provide EPA 

with the opportunity to evaluate the 

intended use and, if necessary, to 

prohibit or limit that activity before it 

occurs. 

DATES: This rule is effective on February 

19, 2013. For purposes of judicial 

review, this rule shall be promulgated at 

1 p.m. (e.s.t.) on January 3, 2013. 

Written adverse or critical comments, 

or notice of intent to submit adverse or 

critical comments, on one or more of 

these SNURs must be received on or 

before January 22, 2013 (see Unit VI. of 

the SUPPLEMENTARY INFORMATION). If 

adverse comment is received, EPA will 

publish a timely withdrawal of the rule 

in the Federal Register. 

For additional information on related 

reporting requirement dates, see Units 

I.A., VI., and VII. of the SUPPLEMENTARY

INFORMATION. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2012–0842, 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–2012–0842. 

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– 

2012–0842. 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: 

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 rule. The following list 

of North American Industrial 

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 and 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 these SNURs 

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 this rule on or after 

January 22, 2013 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 


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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 promulgating these SNURs 

using direct final procedures. These 

SNURs will require persons to notify 

EPA at least 90 days before commencing 

the manufacture, import, or processing 

of a chemical substance for any activity 

designated by these SNURs 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. 

Additional rationale and background to 

these rules are more fully set out in the 

preamble to EPA’s first direct final 

SNUR published in the Federal Register 

issue of April 24, 1990 (55 FR 17376) 

(April 24, 1990 SNUR). Consult that 

preamble for further information on the 

objectives, rationale, and procedures for 

SNURs and on the basis for significant 

new use designations, including 

provisions for developing test data. 

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 

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 

SNUN 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 9 chemical 

substances that are the subject of these 

SNURs, 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 Rule 

EPA is establishing significant new 

use and recordkeeping requirements for 

9 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 SNUR. 

• Toxicity concerns. 

• 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 rule. 

The regulatory text section of this 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 rule, may be claimed 

as CBI. Unit IX. discusses a procedure 

companies may use to ascertain whether 

a proposed use constitutes a significant 

new use. 

This rule includes SNURs on 9 PMN 

substances that are not subject to 

consent orders under TSCA section 5(e). 

In these cases, for a variety of reasons, 

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.’’ 

These so-called ‘‘non-5(e) SNURs’’ are 

promulgated pursuant to § 721.170. EPA 

has determined that every activity 

designated as a ‘‘significant new use’’ in 

all non-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 


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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–09–107 

Chemical name: Fatty acids, tall-oil, 

reaction products with modified fatty 

acids and polyalkanolamines (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as an asphalt emulsifier. 

Based on test data on the PMN 

substance, and ecological structural 

activity relationships (EcoSAR) analysis 

of test data on analogous aliphatic 

amines, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 110 parts per billion (ppb) 

of the PMN substance in surface waters. 

As described in the PMN, releases of the 

PMN substance are not expected to 

result in surface water concentrations 

that exceed 110 ppb. 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 resulting in 

surface water concentrations exceeding 

110 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400) and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10629. 

PMN Numbers P–11–619 and P–11–620 

Chemical name: Amino acid, 

carboxyalkyl, alkylsulfonate, alkali salts 

(generic). 

CAS number: Not available. 

Basis for action: The consolidated 

PMN states that the generic (nonconfidential) use of the substances will 

be as an industrial cleaning solution 

component. Based on test data on the 

PMN substances and EcoSAR analysis 

of test data on analogous polyanionic 

monomers, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 770 ppb for 

the aggregate of the PMN substances in 

surface waters. As described in the 

PMN, releases to surface waters are not 

expected to exceed 770 ppb for the 

aggregate of the PMN substances. 

Therefore, EPA has not determined that 

the proposed manufacturing or use of 

the substances may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substances 

resulting in surface water 

concentrations exceeding 770 ppb for 

the aggregate of the PMN substances 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substances meet 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substances. 

CFR citation: 40 CFR 721.10630. 

PMN Number P–12–64 

Chemical name: Mixed metal borate 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an illuminating 

phosphor. Based on test data on 

analogous respirable, poorly soluble 

particulates, EPA identified concerns for 

lung overload and oncogenicity to 

workers exposed to the PMN substance. 

At the production volume described in 

the PMN, and because the uses 

described in the PMN do not use an 

application method that generates a 

vapor, mist, aerosol, or dust significant 

worker exposure is minimal. 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 

exceeding the confidential annual 

manufacture and import volume stated 

in the PMN or any use of the substance 

using an application method that 

generates a vapor, mist, aerosol, or dust 

may cause serious health effects. Based 

on this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(1)(i)(C) and (b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS 

Guidelines 870.3465) with a 60-day 

holding period; dry particle size 

distribution/counting by transmission 

electron microscope (TEM) or scanning 

electron microscopy (SEM) methods; 

and images of the powder for 

morphology would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10631. 

PMN Number P–12–181 

Chemical name: Benzamide, N- 

[(cyclohexylamino)thioxomethyl]-. 

CAS number: 4921–92–0. 

Basis for action: The PMN states that 

the use of the substance is as a cure 

initiator in adhesive formulations. 

Based on analysis of test data on 

analogous thioureas, EPA identified 

concerns for thyroid toxicity, 

developmental toxicity, and 

developmental neurotoxicity to the 

general population exposed to the PMN 

substance. Based on EcoSAR analysis of 

test data on analogous imides and 

thioureas, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 2 ppb of the 

PMN substance in surface waters. For 

the uses described in the PMN, 

significant general population exposure 

is unlikely, as use in consumer product 

is not expected and releases of the PMN 

substance are not expected to result in 

surface water concentrations that exceed 

2 ppb. 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 in consumer 

products or use of the substance 

resulting in surface water 

concentrations exceeding 2 ppb may 

cause serious health effects or 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii), 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); fish acute toxicity 

test, freshwater and marine (OPPTS Test 

Guideline 850.1075); algal toxicity test 

(OCSPP Test Guideline 850.4500); and a 

combined repeated dose toxicity with 

the reproduction/developmental 

toxicity screening test (OPPTS Test 

Guideline 870.3650) would help 

characterize the environmental and 

health effects of the PMN substance. 

CFR citation: 40 CFR 721.10632. 

PMN Number P–12–276 

Chemical name: Aromatic sulfonic 

acid amino azo dye salts (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic use of the PMN substance 

will be in exhaust dyeing of cellulosic 

fabrics. Based on the alkylation 

potential of the PMN substance, there 

are concerns for skin and lung 

sensitization; mutagenicity; 

oncogenicity; and developmental, liver, 


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and kidney toxicities. In addition, there 

are concerns for mutagenicity and 

oncogenicity, based on the betaaromatic azo reduction product, as this 

PMN substance is expected to undergo 

azo reduction in the GI tract with good 

absorption potential of the reduction 

products. As described in the PMN, EPA 

does not expect significant exposure to 

workers. 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 the use 

of a NIOSH-certified M100 respirator 

with an APF of 10 or any increase in the 

annual manufacture and import volume 

of 10,000 kilograms (kgs) of the 

substance, could change the potential 

for exposure correspondingly, and may 

result in serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(1)(i)(c) and (b)(3)(ii). 

Recommended testing: EPA has 

determined that results of an Ames test 

with the Prival modification (OPPTS 

Test Guideline 870.5100), and an 

unscheduled DNA synthesis test in 

mammalian cells in culture (OPPTS 

Test Guideline 870.5550) would help 

characterize the health effects of the 

PMN substance. The test material for the 

unscheduled DNA synthesis test must 

be the specific sulfonated beta-aromatic 

amine that would result from the azo 

reduction of the PMN substance, rather 

than the intact PMN compound. It is 

necessary that the specific sulfonatedaromatic amine in question be isolated 

prior to testing. For both tests, the betaaromatic amine is to serve as an 

additional positive control. 

CFR citation: 40 CFR 721.10633. 

PMN Number P–12–464 

Chemical name: Iodonium, 

diphenyl-, 4,4′-di-C10-13-alkyl derivs., 

(OC-6-11)-hexafluoroantimonates(1-). 

CAS number: 1370442–66–2. 

Basis for action: The PMN states that 

the substance will be used as a 

photoinitiator used for ultraviolet 

release coatings. Based on the EcoSAR 

analysis of test data on analogous 

cationic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 8 ppb of 

the PMN substance in surface waters for 

greater than 20 days per year. This 20- 

day criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early-life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the PMN 

substance to surface water exceed 

releases from the use described in the 

PMN. For the use described in the PMN, 

environmental releases did not exceed 8 

ppb for more than 20 days per year. 

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 use of the 

substance other than as described in the 

PMN could result in exposures which 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that a fish early-life stage 

toxicity test (OPPTS Test Guideline 

850.1400); a daphnid chronic toxicity 

test (OPPTS Test Guideline 850.1300); 

and an algal toxicity test (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. When testing the 

PMN substance, if difficulty is 

encountered in dissolving the chemical 

in the test media, the submitter may 

wish to consult the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000). 

CFR citation: 40 CFR 721.10634. 

PMN Number P–12–480 

Chemical name: Alkyl maleimide 

substituted bicyclic olefin (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

substance will be used as a monomer in 

the manufacture of a specialty polymer. 

Based on EcoSAR analysis of test data 

on analogous imides, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

PMN substance are not expected to 

result in surface water concentrations 

that exceed 1 ppb. 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 resulting in 

surface water concentrations exceeding 

1 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substance. When 

testing the PMN substance, if difficulty 

is encountered in dissolving the 

chemical in the test media, the 

submitter may wish to consult the 

special considerations for conducting 

aquatic laboratory studies (OPPTS Test 

Guideline 850.1000). 

CFR citation: 40 CFR 721.10635. 

PMN Number P–12–501 

Chemical name: Slimes and sludges, 

automotive coating, wastewater 

treatment, solid waste. 

CAS number: 1392095–50–9. 

Chemical substance definition: The 

waste solids produced from the 

treatment of wastewaters from 

automotive pretreatment processes, 

electro-deposition coating processes, 

surface coating processes and topcoat 

coating processes. It may contain oxides 

of iron, calcium, aluminum, zinc, 

nickel, and magnesium. 

Basis for action: The PMN substance 

will be used as a feedstock replacement 

in cement kiln production. Based on 

analogous crystalline chemical 

substances, EPA identified concerns for 

potential oncogenicity. These concerns 

are for effects to workers from 

inhalation exposure to the PMN 

substance in powder form. For the uses 

described in the PMN, significant 

worker exposure is unlikely, as 

inhalation exposure is not expected. 

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 the 

manufacture, processing, or use of the 

substance in powder form may cause 

serious health effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(1)(i)(C). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) would help 

characterize the human health effects of 

the PMN substance. Test should be 

conducted with special attention to 

histopathology (inflammation and cell 

proliferation) of the lung tissues and to 

various parameters of the 

bronchoalveolar lavage fluid (BALF), 

e.g., marker enzyme activities, total 

protein content, total cell count, cell 

differential, and cell viability. It is not 

necessary to look at internal organs. A 

recovery period of 60 days should be 

included to assess the progression or 

regression of any lesions. If the results 

of the 90-day inhalation toxicity test 

indicate that the PMN particles have 

carcinogenic potential, a 2-year 


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inhalation bioassay in rats may be 

warranted. 

CFR citation: 40 CFR 721.10636. 

V. Rationale and Objectives of the Rule 

A. Rationale 

In these 9 cases, EPA determined that 

one or more of the criteria of concern 

established at § 721.170 were met, as 

discussed in Unit IV. 

B. Objectives 

EPA is issuing these SNURs for 

specific chemical substances which 

have undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this 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 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. Direct Final Procedures 

EPA is issuing these SNURs as a 

direct final rule, as described in 

§ 721.160(c)(3) and § 721.170(d)(4). In 

accordance with § 721.160(c)(3)(ii) and 

§ 721.170(d)(4)(i)(B), the effective date 

of this rule is February 19, 2013 without 

further notice, unless EPA receives 

written adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments before January 22, 

2013. 

If EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments, on 

one or more of these SNURs before 

January 22, 2013, EPA will withdraw 

the relevant sections of this direct final 

rule before its effective date. EPA will 

then issue a proposed SNUR for the 

chemical substance(s) on which adverse 

or critical comments were received, 

providing a 30-day period for public 

comment. 

This rule establishes SNURs for a 

number of chemical substances. Any 

person who submits adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments, must 

identify the chemical substance and the 

new use to which it applies. EPA will 

not withdraw a SNUR for a chemical 

substance not identified in the 

comment. 

VII. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Rule 

Significant new use designations for a 

chemical substance are legally 

established as of the date of publication 

of this direct final rule, December 20, 

2012. 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule have undergone 

premanufacture review. 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 rule, when 

chemical substances identified in this 

SNUR are added to the TSCA Inventory, 

other persons may engage in a 

significant new use as defined in this 

rule before the effective date of the rule. 

However, 6 of the 9 chemical substances 

contained in this rule have CBI 

chemical identities, and since EPA has 

received a limited number of post-PMN 

bona fide submissions (per §§ 720.25 

and 721.11), the Agency believes that it 

is highly unlikely that any of the 

significant new uses described in the 

regulatory text of this rule are ongoing. 

As discussed in the April 24, 1990 

SNUR, 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 this 

direct final rule rather than as of the 

effective date of the rule. If uses begun 

after publication were considered 

ongoing rather than new, it would be 

difficult for EPA to establish SNUR 

notification requirements because a 

person could defeat the SNUR by 

initiating the significant new use before 

the rule became effective, and then 

argue that the use was ongoing before 

the effective date of the rule. Thus, 

persons who begin commercial 

manufacture, import, or processing of 

the chemical substances regulated 

through this SNUR will have to cease 

any such activity before the effective 

date of this 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 this 

SNUR before the effective date. If a 

person meets the conditions of advance 

compliance under § 721.45(h), the 

person is 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. 

Unit IV. lists recommended testing for 

non-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.’’ 

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. 


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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. Procedural Determinations 

By this rule, EPA is establishing 

certain significant new uses which have 

been claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 

under 40 CFR part 2 procedures, EPA is 

required to keep this information 

confidential. EPA promulgated a 

procedure to deal with the situation 

where a specific significant new use is 

CBI, at 40 CFR 721.1725(b)(1). 

Under these procedures a 

manufacturer, importer, or processor 

may request EPA to determine whether 

a proposed use would be a significant 

new use under the rule. The 

manufacturer, importer, or processor 

must show that it has a bona fide intent 

to manufacture, import, or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture, import, or process the 

chemical substance. If EPA concludes 

that the person has shown a bona fide 

intent to manufacture, import, or 

process the chemical substance, EPA 

will tell the person whether the use 

identified in the bona fide submission 

would be a significant new use under 

the rule. Since most of the chemical 

identities of the chemical substances 

subject to these SNURs are also CBI, 

manufacturers, importers, and 

processors can combine the bona fide 

submission under the procedure in 

§ 721.1725(b)(1) with that under 

§ 721.11 into a single step. 

If EPA determines that the use 

identified in the bona fide submission 

would not be a significant new use, i.e., 

the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture, 

import, or process the chemical 

substance so long as the significant new 

use trigger is not met. In the case of a 

production volume trigger, this means 

that the aggregate annual production 

volume does not exceed that identified 

in the bona fide submission to EPA. 

Because of confidentiality concerns, 

EPA does not typically disclose the 

actual production volume that 

constitutes the use trigger. Thus, if the 

person later intends to exceed that 

volume, a new bona fide submission 

would be necessary to determine 

whether that higher volume would be a 

significant new use. 

X. SNUN Submissions 

According to § 721.1(c), persons 

submitting a SNUN must comply with 

the same notification 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, generated using 

e-PMN software, and submitted to the 

Agency 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. 

XI. 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 rule. EPA’s complete 

economic analysis is available in the 

docket under docket ID number EPA– 

HQ–OPPT–2012–0842. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This rule establishes SNURs for 

several new chemical substances that 

were the subject of PMNs. 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 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 is amending the table in 

40 CFR part 9 to list the OMB approval 

number for the information collection 

requirements contained in this 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 (RAF) 

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 rule. 

This rule is within the scope of the 

February 18, 2012 certification. Based 

on the Economic Analysis discussed in 

Unit XI. 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. 


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• Submission of the SNUN would not 

cost any small entity significantly more 

than $8,300. 

Therefore, the promulgation of the 

SNUR 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 will be impacted by this 

rule. As such, EPA has determined that 

this rule does 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 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 rule does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This rule does not 

significantly nor 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 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, 

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 does not 

involve any technical standards, 

NTTAA 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). 

XIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 action 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: December 13, 2012. 

Maria J. Doa, 

Director, Chemical Control Division, 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. In § 9.1, add the following sections 

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 

* * * * * 

721.10629 ................................. 2070–0012 

721.10630 ................................. 2070–0012 

721.10631 ................................. 2070–0012 

721.10632 ................................. 2070–0012 

721.10633 ................................. 2070–0012 

721.10634 ................................. 2070–0012 

721.10635 ................................. 2070–0012 

721.10636 ................................. 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 § 721.10629 to subpart E to 

read as follows: 

§ 721.10629 Fatty acids, tall-oil, reaction 

products with modified fatty acids and 

polyalkanolamines (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acids, tall-oil, 

reaction products with modified fatty 

acids and polyalkanolamines (PMN P– 

09–107) 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) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4) (N=110). 

(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 (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 


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(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 5. Add § 721.10630 to subpart E to 

read as follows: 

§ 721.10630 Amino acid, carboxyalkyl, 

alkylsulfonate, alkali salt (generic). 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as amino acid, carboxyalkyl, 

alkylsulfonate, alkali salts (PMNs P–11– 

619 and P–11–620) are 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) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4) (where N = 770 parts per billion 

(ppb) for the aggregate of the PMN 

substances, P–11–619 and P–11–620). 

When calculating the surface water 

concentrations according to the 

instructions in § 721.90(a)(4), (b)(4), and 

(c)(4), the statement that the amount of 

the substances that will be released will 

be calculated before the substances 

enter control technology does not apply. 

Instead, if the waste stream containing 

the substances will be treated before 

release, then the amount of the 

substances reasonably likely to be 

removed from the waste stream by such 

treatment may be subtracted in 

calculating the number of kilograms 

released. No more than 90 percent 

removal efficiency may be attributed to 

such treatment. 

(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 (k) 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. 

■ 6. Add § 721.10631 to subpart E to 

read as follows: 

§ 721.10631 Mixed metal borate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as mixed metal borate (PMN 

P–12–64) 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(s), (y)(1), and 

(y)(2). 

(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 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 this section. 

■ 7. Add § 721.10632 to subpart E to 

read as follows: 

§ 721.10632 Benzamide, N- 

[(cyclohexylamino)thioxomethyl]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzamide, N- 

[(cyclohexylamino)thioxomethyl]- (PMN 

P–12–181; CAS No. 4921–92–0) 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) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(ii) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4) (N= 2). 

(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), (i), and (k) 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. 

■ 8. Add § 721.10633 to subpart E to 

read as follows: 

§ 721.10633 Aromatic sulfonic acid amino 

azo dye salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic sulfonic acid 

amino azo dye salts (PMN P–12–276) 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)(4) (National Institute for 

Occupational Safety and Health 

(NIOSH)-certified M100 respirator with 

an assigned protection factor of at least 

10), (a)(6), (b) (concentration set at 0.1 

percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(s) (10,000 

kilograms). 

(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 (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. 

■ 9. Add § 721.10634 to subpart E to 

read as follows: 

§ 721.10634 Iodonium, diphenyl-, 4,4′-diC10-13-alkyl derivs., (OC-6-11)- 

hexafluoroantimonates(1-). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

iodonium, diphenyl-, 4,4′-di-C10-13- 

alkyl derivs., (OC-6-11)- 

hexafluoroantimonates(1-) (PMN P–12– 

464; CAS No. 1370442–66–2) 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) (photoinitiator 

used for ultraviolet release coatings). 

(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 substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 10. Add § 721.10635 to subpart E to 

read as follows: 

§ 721.10635 Alkyl maleimide substituted 

bicyclic olefin (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkyl maleimide 


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Federal Register / Vol. 77, No. 245 / Thursday, December 20, 2012 / Rules and Regulations 75399 

substituted bicyclic olefin (PMN P–12– 

480) 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) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4) (N=1). 

(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 (k) 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. 

■ 11. Add § 721.10636 to subpart E to 

read as follows: 

§ 721.10636 Slimes and sludges, 

automotive coating, wastewater treatment, 

solid waste. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

slimes and sludges, automotive coating, 

wastewater treatment, solid waste (PMN 

P–12–501; CAS No. 1392095–50–9) 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(v)(1), (w)(1), and 

(x)(1). 

(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 substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2012–30695 Filed 12–19–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 111207737–2141–02] 

RIN 0648–XC405 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Big Skate in the 

Central Regulatory Area of the Gulf of 

Alaska 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS is prohibiting retention 

of big skate in the Central Regulatory 

Area of the Gulf of Alaska (GOA). This 

action is necessary because the 2012 

total allowable catch of big skate in the 

Central Regulatory Area of the GOA has 

been reached. 

DATES: Effective 1200 hrs, Alaska local 

time (A.l.t.), December 17, 2012, 

through 2400 hrs, A.l.t., December 31, 

2012. 

FOR FURTHER INFORMATION CONTACT: Josh 

Keaton, 907–586–7228. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

GOA exclusive economic zone 

according to the Fishery Management 

Plan for Groundfish of the Gulf of 

Alaska (FMP) prepared by the North 

Pacific Fishery Management Council 

under authority of the MagnusonStevens Fishery Conservation and 

Management Act. Regulations governing 

fishing by U.S. vessels in accordance 

with the FMP appear at subpart H of 50 

CFR part 600 and 50 CFR part 679. 

The 2012 total allowable catch (TAC) 

of big skate in the Central Regulatory 

Area of the GOA is 1,793 metric tons 

(mt) as established by the final 2012 and 

2013 harvest specifications for 

groundfish of the GOA (77 FR 15194, 

March 14, 2012). 

In accordance with § 679.20(d)(2), the 

Administrator, Alaska Region, NMFS 

(Regional Administrator), has 

determined that the 2012 TAC of big 

skate in the Central Regulatory Area of 

the GOA has been reached. Therefore, 

NMFS is requiring that big skate caught 

in the Central Regulatory Area of the 

GOA be treated as prohibited species in 

accordance with § 679.21(b). 

Classification 

This action responds to the best 

available information recently obtained 

from the fishery. The Acting Assistant 

Administrator for Fisheries, NOAA 

(AA), finds good cause to waive the 

requirement to provide prior notice and 

opportunity for public comment 

pursuant to the authority set forth at 5 

U.S.C. 553(b)(B) as such requirement is 

impracticable and contrary to the public 

interest. This requirement is 

impracticable and contrary to the public 

interest as it would prevent NMFS from 

responding to the most recent fisheries 

data in a timely fashion and would 

delay prohibiting the retention of big 

skate in the Central Regulatory Area of 

the GOA. NMFS was unable to publish 

a notice providing time for public 

comment because the most recent, 

relevant data only became available as 

of December 14, 2012. 

The AA also finds good cause to 

waive the 30-day delay in the effective 

date of this action under 5 U.S.C. 

553(d)(3). This finding is based upon 

the reasons provided above for waiver of 

prior notice and opportunity for public 

comment. 

This action is required by § 679.20 

and § 679.21 and is exempt from review 

under Executive Order 12866. 

Authority: 16 U.S.C. 1801 et seq. 

Dated: December 17, 2012. 

Emily H. Menashes, 

Deputy Director, Office of Sustainable 

Fisheries, National Marine Fisheries Service. 

[FR Doc. 2012–30693 Filed 12–17–12; 4:15 pm] 

BILLING CODE 3510–22–P 


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