27048 Federal Register / Vol. 78, No. 90 / Thursday, May 9, 2013 / Rules and Regulations 

state and local government agencies, 

and nongovernment entities for: 

(i) All matters relating to the 

promotion of economy and efficiency in 

the administration of, or the prevention 

and detection of fraud and abuse in, 

programs and operations administered 

or financed by the Commission; or 

(ii) The identification and prosecution 

of participants in such fraud and abuse; 

(6) Keep the Commission and 

Congress fully and currently informed 

through reports concerning fraud and 

other serious problems, abuses, and 

deficiencies relating to programs and 

operations administered or financed by 

the Commission; recommend corrective 

action concerning such problems, 

abuses, and deficiencies; and report on 

the progress made in implementing 

such corrective action. 

(b) [Reserved] 

[FR Doc. 2013–10696 Filed 5–8–13; 8:45 am] 

BILLING CODE 7710–FW–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2013–0100 FRL–9384–8] 

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 

the Toxic Substances Control Act 

(TSCA) for 15 chemical substances 

which were the subject of 

premanufacture notices (PMNs). This 

action requires persons who intend to 

manufacture, import, or process any of 

these 15 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 July 8, 

2013. For purposes of judicial review, 

this rule shall be promulgated at 1 p.m. 

(e.s.t.) on May 23, 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 June 10, 2013 (see Unit VI. of the 

SUPPLEMENTARY INFORMATION). 

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–2013–0100, 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–2013–0100. 

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– 

2013–0100. 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. 


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Federal Register / Vol. 78, No. 90 / Thursday, May 9, 2013 / Rules and Regulations 27049 

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 

June 10, 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 

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). 

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 sections 5(b) and 5(d)(1), the 

exemptions authorized by TSCA 

sections 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 

sections 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 15 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 

15 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) 

number (if assigned for non-confidential 

chemical identities). 


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• 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. 

This rule includes a PMN substance 

whose reported chemical name includes 

the term ‘‘carbon nanotube’’ or ‘‘CNT’’. 

Because of a lack of established 

nomenclature for carbon nanotubes, the 

TSCA Inventory names for carbon 

nanotubes are currently in generic form, 

e.g., carbon nanotube (CNT), multiwalled carbon nanotube (MWCNT), 

double-walled carbon nanotube 

(DWCNT), or single-walled carbon 

nanotube (SWCNT). EPA uses the 

specific structural characteristics 

provided by the PMN submitter to more 

specifically characterize the Inventory 

listing for an individual CNT. All 

submitters of new chemical notices for 

CNTs have claimed those specific 

structural characteristics as CBI. EPA is 

publishing the generic chemical name 

along with the PMN number to identify 

that a distinct chemical substance was 

the subject of the PMN without 

revealing the confidential chemical 

identity of the PMN substance. 

Confidentiality claims preclude a more 

detailed description of the identity of 

these CNTs. If an intended 

manufacturer, importer, or processor of 

CNTs is unsure of whether its CNTs are 

subject to this SNUR or any other 

SNUR, the company can either contact 

EPA or obtain a written determination 

from EPA pursuant to the bona fide 

procedures at § 721.11. EPA is using the 

specific structural characteristics, for all 

CNTs submitted as new chemical 

substances under TSCA, to help develop 

standard nomenclature for placing these 

chemical substances on the TSCA 

Inventory. EPA has compiled a generic 

list of those structural characteristics 

entitled ‘‘Material Characterization of 

Carbon Nanotubes for Molecular 

Identity (MI) Determination & 

Nomenclature.’’ A copy of this list is 

available in the docket for these SNURs 

under docket ID number EPA–HQ– 

OPPT–2013–0100. If EPA develops a 

more specific generic chemical name for 

these materials, that name will be made 

publicly available. 

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. 

None of the 15 PMN substances 

included in this rule are 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 

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–11–60 

Chemical name: 

Methylenebis[isocyanatobenzene], 

polymer with alkanedoic acid, alkylene 

glycols, alkoxylated alkanepolyol and 

substituted trialkoxysilane (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as an adhesive system 

component. Based on structural activity 

relationship (SAR) analysis of test data 

on analogous diisocyanates, EPA 

identified concerns for dermal and 

respiratory sensitization and for 

pulmonary toxicity to workers exposed 

to free isocyanates. Also, based on 

ecological structural activity 

relationship (EcoSAR) analysis on 

analogous polycationic polymers, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

61 parts per billion (ppb) of the PMN 

substance in surface waters. As 

described in the PMN, significant 

worker exposure or releases of the PMN 

substance to surface waters are 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 

any use of the substance other than as 

described in the PMN (manufacture 

with all isocyanate groups reacted 

within the polymer), or any use of the 

substance resulting in surface water 

concentrations exceeding 61 ppb could 

result in exposures which 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)(3)(ii) and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a water 

solubility: Column elution method; 

shake flask method test (OPPTS 

830.7840), an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010), a fish 

acute toxicity test, freshwater and 

marine test (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. 

CFR citation: 40 CFR 721.10661. 

PMN Number P–11–204 

Chemical name: Acetaldehyde, 

substituted-, reaction products with 2- 

butyne-1, 4-diol (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the use of the substance is as a 

brightener for nickel electroplating. 

Based on EcoSAR analysis of test data 

on analogous halo alcohols, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

7 ppb of the 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 7 

ppb for more than 20 days per year. 

Therefore, EPA has not determined that 

the proposed 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 the results of 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. 


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CFR citation: 40 CFR 721.10662. 

PMN Number P–12–44 

Chemical name: Functionalized 

multi-walled carbon nanotubes 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as an additive for rubber 

and batteries. Based on available 

information on analogous chemical 

substances, EPA identified concerns for 

lung effects to workers exposed to the 

PMN substance. As described in the 

PMN, no significant inhalation 

exposures are expected to workers due 

to the manufacturing, processing, and 

use processes described in the PMN and 

the use of adequate personal protective 

equipment. EPA expects that some 

fraction of the carbon nanotubes, if 

released into the environment, will 

eventually become suspended in water. 

Sublethal effects have been observed for 

carbon nanotubes in fish at levels as low 

as 100 ppb. Observed effects included 

respiratory stress, ventilation rate, gill 

mucus secretion, gill damage, and 

aggressive behavior. As described in the 

PMN, no environmental exposures are 

expected, because the PMN substance is 

not released to surface water. 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; 

manufacturing, processing, or use in a 

powder form; or any use of the 

substance resulting in surface water 

releases 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)(3)(ii) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the health and environmental effects of 

the PMN substance: (1) A 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) with a postexposure observation period of up to 3 

months, bronchoalveolar lavage fluid 

(BALF) analysis, particle size 

distribution information and other 

toxicologically relevant properties, data 

on histopathology of pulmonary and expulmonary organs/tissues 

(cardiovascular, central nervous system, 

liver, kidney, etc.), pulmonary 

deposition (lung burden), clearance 

half-life (biopersistence) and 

translocation of the test material, and a 

determination of cardiovascular 

toxicity; (2) analysis by Scanning 

Transmission Electron Microscopy 

(STEM), Transmission Electron 

Microscopy (TEM), or Scanning 

Electron Microscopy (SEM) of number 

of walls (range and average), tube ends 

(open, capped, circular, other), tube 

width/diameter (measure inner and 

outer diameters or range), tube length 

(range) including a description of any 

deformities found in the tubes (bumps, 

branching, gaps, etc.); (3) percent (range) 

of functional groups found on the tubes 

(include the method of determination); 

and (4) particle size determined by 

count not by weight or volume 

(preferably using STEM). 

CFR citation: 40 CFR 721.10663. 

PMN Numbers P–12–408, P–12–409, P– 

12–410, P–12–411, P–12–412, and P–12– 

413 

Chemical name: Alkenedioic acid 

dialkyl ester, reaction products with 

alkenoic acid alkyl esters and diamine 

(generic). 

CAS numbers: Not available. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of 

these substances are as binders. Based 

on EcoSAR analysis of test data on 

analogous aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb for the aggregate of the PMN 

substances in surface waters. As 

described in the PMNs, releases to 

surface waters are not expected. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, 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 1 ppb for the 

aggregate of the PMN substances 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 the results of an aquatic 

invertebrate acute toxicity test (OPPTS 

Test Guideline 850.1010), 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. The tests should be 

conducted on either the P–12–411 or P– 

12–413 substance. 

CFR citation: 40 CFR 721.10664. 

PMN Number P–12–414 

Chemical name: 2-Propenoic acid, (2- 

ethyl-2-methyl-1,3-dioxolan-4-yl)methyl 

ester. 

CAS number: 69701–99–1. 

Basis for action: The PMN states that 

the use of the substance is as a reactive 

intermediate for use in ultraviolet (UV), 

electron beam (EB) and conventionally 

cured coating and ink formulations. 

Based on test data submitted on the 

PMN substance and EcoSAR analysis of 

test data on analogous acrylates, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

26 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 26 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 or any increase of the annual 

production volume of 50,000 kilograms 

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)(i) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early life-stage toxicity test (OPPTS Test 

Guidelines 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 721.10665. 

PMN Number P–12–437 

Chemical name: Quaternary 

ammonium compounds, bis(fattyalkyl) 

dimethyl, salts with tannins (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a component in drilling 

fluid. Based on EcoSAR analysis of test 

data on analogous cationic surfactants, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 11 ppb of the PMN 

substance in surface waters. As 

described in the PMN, releases of the 

PMN substance to surface waters are 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 any use of 


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the substance other than as described in 

the PMN or resulting in surface water 

concentrations exceeding 11 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 the results of an 

activated sludge sorption isotherm test 

(OPPTS Test Guideline 835.1110), a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075), a fish acute toxicity test 

mitigated by humic acid (OPPTS Test 

Guidelines 850.1085), an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010), and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

fate and environmental effects of the 

PMN substance. 

CFR citation: 40 CFR 721.10666. 

PMN Number P–12–560 

Chemical name: Slimes and sludges, 

aluminum and iron casting, wastewater 

treatment, solid waste. 

CAS number: 1391739–82–4. 

Chemical substance definition: The 

waste solids produced from the 

treatment of wastewaters during 

aluminum and iron casting, machining 

and finishing operations. It may contain 

aluminum, barium, chromium, copper, 

iron, lead, manganese, nickel, and zinc. 

Basis for action: The PMN states that 

the use of the substance is as a feedstock 

to provide mineral content for cement 

manufacturing. Based on test data on 

analogous respirable, poorly soluble 

particulates, EPA identified concerns for 

lung effects from lung overload 

associated with inhalation of the PMN 

substance when in powder form. EPA 

also identified concerns for 

neurotoxicity, immunotoxicity, and 

blood effects from any lead that is 

bioavailable; respiratory sensitization 

and immunotoxicity from any nickel, 

lead, aluminum, copper, and iron that is 

bioavailable; and digestive system 

effects from any copper that reaches the 

gastrointestinal tract. These concerns 

are for effects to workers from 

inhalation exposure to the PMN 

substance. For the uses described in the 

PMN, significant inhalation worker 

exposure is not expected as the PMN 

substance is not manufactured, 

processed, or used in powder form. 

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)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) with 60-day 

holding period would help characterize 

the human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10667. 

PMN Number P–13–18 

Chemical name: Trisodium 

diethylene triaminepolycarboxylate 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a stabilizing agent for 

polymers. Based on the PMN 

substance’s chelating potential of 

calcium, magnesium, iron, and other 

divalent cations and test data on 

analogous chemical substances such as 

pentacarboxylic acid chelators (TSCA 

section 8(e) submission # 10980, CAS 

No. 140–01–2), ethylenediamine 

tetramethylene phosphonic acid, 

ethylene diamine tetramethylene 

phosphonic acid (EDTMPA), 

ethylenediaminetetraacetic acid (EDTA), 

and nitrilotriacetic acid (NTA), EPA 

identified concerns for blood toxicity, 

effects on the heart, inhibited muscle 

functioning, bone toxicity, bone cancer, 

developmental toxicity, and kidney 

toxicity. These concerns are for effects 

to workers from inhalation exposure to 

the PMN. EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substances may 

present an unreasonable risk. EPA has 

determined, however, use of the 

substance other than as described in the 

PMN may cause serious health effects. 

Based on this information, the PMN 

substance meets the concern criteria at 

§ 721.170(b)(1)(i)(c), (b)(3)(i), and 

(b)(3)(ii). 

Recommended testing: EPA has 

determined that a 90-day oral toxicity in 

rodents test (OPPTS Test Guideline 

870.3100) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10668. 

PMN Number P–13–78 

Chemical name: Tertiary amine alkyl 

ether (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a catalyst 

for producing polyurethane foam. Based 

on test data on analogous chemical 

substances, EPA identified concerns for 

acute toxicity, irritation/corrosion to all 

exposed tissues, kidney toxicity, liver 

toxicity, effects to the adrenal system, 

and male reproductive toxicity to 

workers and the general population 

exposed to the PMN substance. For the 

use described in the PMN, significant 

worker and general population 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 use of the 

PMN substance other than for the use 

described in the PMN may result in 

serious health effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 

combined repeated dose toxicity with 

the reproduction/development toxicity 

screening test (OPPTS Test Guideline 

870.3650) would help characterize the 

health effects of the PMN substance. 

CFR citation: 40 CFR 721.10669. 

PMN Number P–13–108 

Chemical name: Bromine, 

manufacture of, by-products from, 

distillation residues. 

CAS number: Not available. 

Chemical substance definition: The 

complex residuum obtained during the 

production of bromine using brine and 

waste streams from the production of 

halogenated hydrocarbons. It consists 

predominantly of halogenated 

hydrocarbons and ketones, having 

carbon numbers predominantly in the 

range of C3–C17. The boiling point is 

approximately 98°C to 350°C (208 °F to 

662 °F). 

Basis for action: The PMN states that 

the use of the substance is as feed for 

bromine recovery. EPA identified health 

and environmental concerns because 

the substance may be a persistent, bioaccumulative, and toxic (PBT) chemical, 

based on physical/chemical properties 

of the PMN substance, as described in 

the New Chemical Program’s PBT 

category (64 FR 60194; November 4, 

1999) (FRL–6097–7). EPA estimates that 

the substance will persist in the 

environment for more than 2 months 

and estimates a bioaccumulation factor 

of greater than or equal to 1,000. Also, 

based on test data on analogous 

bromobenzene and derivatives and 

brominated organic compounds, EPA 

identified concerns for liver toxicity, 

reproductive toxicity, developmental 

toxicity, mutagenicity, neurotoxicity, 

oncogenicity, and endocrine disruption. 

Further, based on EcoSAR analysis of 

test data on analogous neutral organic 

substances, EPA predicts toxicity to 


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aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

substance in surface waters. As 

described in the PMN, significant 

worker exposures are not expected and 

the substance is not released to surface 

waters. 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 releases may cause serious 

health effects and 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), (b)(4)(ii), and 

(b)(4)(iii). 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the health and environmental effects of 

the PMN substance: 

(1) Modified semi-continuous 

activated sludge (SCAS) with analysis 

for degradation products (OPPTS Test 

Guideline 835.5045, or Organisation for 

Economic Co-operation and 

Development (OECD) Test Guideline 

302A); (2) direct photolysis (OPPTS Test 

Guideline 835.2210), if wavelengths 

greater than 290 nano meters (nm) are 

absorbed, determined using OPPTS Test 

Guideline 830.7050; (3) indirect 

photolysis (OPPTS Test Guideline 

835.5270); (4) hydrolysis as a function 

of pH and temperature (OPPTS Test 

Guideline 835.2130 or OECD Test 

Guideline 111); (5) aerobic and 

anaerobic transformation in soil (OECD 

Test Guideline 307); (6) 

phototransformation on soil surfaces 

(Draft OECD Jan. 2002); (7) aerobic and 

anaerobic transformation in aquatic 

sediment systems (OECD Test Guideline 

308); (8) fish BCF (OECD Test Guideline 

305) or earthworm bioaccumulation 

(OECD Test Guideline 317); (9) 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test (OECD Test 

Guideline 422); (10) fish early life-stage 

toxicity test (OPPTS Test Guideline 

850.1400); (11) daphnid chronic toxicity 

test (OPPTS Test Guideline 850.1300); 

and (12) algal toxicity test (OCSPP Test 

Guideline 850.4500). EPA also 

recommends that the special 

considerations for conducting aquatic 

laboratory studies (OPPTS Test 

Guideline 850.1000) be followed. 

CFR citation: 40 CFR 721.10670. 

V. Rationale and Objectives of the Rule 

A. Rationale 

In these 15 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 July 8, 2013 without 

further notice, unless EPA receives 

written adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments before June 10, 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 June 

10, 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 the Significant 

New Use Designation 

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 person may 

commence such activities without first 

submitting a PMN. Therefore, for 

chemical substances for which an NOC 

has not been submitted EPA concludes 

that the designated significant new uses 

are not ongoing. 

When chemical substances identified 

in this rule are added to the TSCA 

Inventory, EPA recognizes that, before 

the rule is effective, other persons might 

engage in a use that has been identified 

as a significant new use. The identities 

of 13 of the 15 chemical substances 

subject to this rule have been claimed as 

confidential and EPA has received no 

post-PMN bona fide submissions (per 

§ 720.25 and § 721.11). Based on this, 

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. 

Therefore EPA designates May 9, 2013 

as the cutoff date for determining 

whether the new use is ongoing. Persons 

who begin commercial manufacture, 

import, or processing of the chemical 

substances for a significant new use 

identified as of that date would have to 

cease any such activity upon the 

effective date of the final rule. To 

resume their activities, these persons 

would have to first comply with all 

applicable SNUR notification 

requirements and wait until the notice 

review period, including any 

extensions, expires. If such a person met 

the conditions of advance compliance 

under § 721.45(h), the person would be 

considered exempt from the 

requirements of the SNUR. Consult the 

Federal Register document of April 24, 

1990 (55 FR 17376) for a more detailed 

discussion of the cutoff date for ongoing 

uses. 

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 


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subject to the SNUR is also subject to a 

test rule under TSCA section 4 (see 

TSCA section 5(b)(1)). 

2. Development of test data may be 

necessary where the chemical substance 

has been listed under TSCA section 

5(b)(4) (see TSCA section 5(b)(2)). 

In the absence of a TSCA section 4 

test rule or a TSCA section 5(b)(4) 

listing covering the chemical substance, 

persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 40 

CFR 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

Unit IV. lists recommended testing for 

these 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 

OECD test guidelines are available from 

the OECD Bookshop at http:// 

www.oecdbookshop.org or SourceOECD 

at http://www.sourceoecd.org. 

When physical/chemical properties of 

test material and/or material 

characterization tests are recommended 

for nanoscale substances that are the 

subject of this rule, you should take into 

consideration the characterizations 

identified in the Guidance Manual for 

the Testing of Manufactured 

Nanomaterials: OECD’s Sponsorship 

Programme, which is available at 

http://www.oecd.org/officialdocuments/ 

displaydocumentpdf/?cote=env/jm/ 

mono(2009)20/rev&doclanguage=en. 

The recommended tests specified in 

Unit IV. may not be the only means of 

addressing the potential risks of the 

chemical substance. However, 

submitting a SNUN without any test 

data may increase the likelihood that 

EPA will take action under TSCA 

section 5(e), particularly if satisfactory 

test results have not been obtained from 

a prior PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

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 40 

CFR 720.50. SNUNs must be submitted 

on EPA Form No. 7710–25, generated 

using e-PMN software, and submitted to 

the Agency in accordance with the 

procedures set forth in 40 CFR 720.40 

and § 721.25. E–PMN software is 

available electronically at http:// 

www.epa.gov/opptintr/newchems. 

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–2013–0100. 

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 


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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 (RFA) 

On February 18, 2012, EPA certified 

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

601 et seq.), that promulgation of a 

SNUR does not have a significant 

economic impact on a substantial 

number of small entities where the 

following are true: 

1. A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

2. The SNUR submitted by any small 

entity would not cost significantly more 

than $8,300. 

A copy of that certification is 

available in the docket for this 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. 

• 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: May 2, 2013. 

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: 


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27056 Federal Register / Vol. 78, No. 90 / Thursday, May 9, 2013 / Rules and Regulations 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR Citation OMB Control 

no. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.10661 ............................. 2070–0012. 

721.10662 ............................. 2070–0012. 

721.10663 ............................. 2070–0012. 

721.10664 ............................. 2070–0012. 

721.10665 ............................. 2070–0012. 

721.10666 ............................. 2070–0012. 

721.10667 ............................. 2070–0012. 

721.10668 ............................. 2070–0012. 

721.10669 ............................. 2070–0012. 

721.10670 ............................. 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 § 721.10661 to subpart E to 

read as follows: 

§ 721.10661 

Methylenebis[isocyanatobenzene], polymer 

with alkanedoic acid, alkylene glycols, 

alkoxylated alkanepolyol and substituted 

trialkoxysilane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 

methylenebis[isocyanatobenzene], 

polymer with alkanedoic acid, alkylene 

glycols, alkoxylated alkanepolyol and 

substituted trialkoxysilane (PMN P–11– 

60) 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) (manufacture 

with all isocyanate groups reacted 

within the polymer). (ii) Release to water. Requirements as 

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

(c)(4) (N = 61). 

(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. 

■ 5. Add § 721.10662 to subpart E to 

read as follows: 

§ 721.10662 Acetaldehyde, substituted-, 

reaction products with 2-butyne-1, 4-diol 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as acetaldehyde, substituted- 

, reaction products with 2-butyne-1, 4- 

diol (PMN P–11–204) 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) (brightener for 

nickel electroplating). (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. 

■ 6. Add § 721.10663 to subpart E to 

read as follows: 

§ 721.10663 Functionalized multi-walled 

carbon nanotubes (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as functionalized multiwalled carbon nanotubes (PMN P–12– 

44) 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), (v)(1), (w)(1), 

and (x)(1). 

(ii) Release to water. Requirements as 

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

(c)(1). 

(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), (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. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

■ 7. Add § 721.10664 to subpart E to 

read as follows: 

§ 721.10664 Alkenedioic acid dialkyl ester, 

reaction products with alkenoic acid alkyl 

esters and diamine (generic). 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as alkenedioic acid dialkyl 

ester, reaction products with alkenoic 

acid alkyl esters and diamine (PMNs P– 

12–408, P–12–409, P–12–410, P–12– 

411, P–12–412, and P–12–413) 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 = 1 parts per billion 

(ppb) for the aggregate of the PMN 

substances, P–12–408, P–12–409, P–12– 

410, P–12–411, P–12–412, and P–12– 

413). 

(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. 

■ 8. Add § 721.10665 to subpart E to 

read as follows: 

§ 721.10665 2-Propenoic acid, (2-ethyl-2- 

methyl-1,3-dioxolan-4-yl)methyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 2-propenoic acid, (2- 

ethyl-2-methyl-1,3-dioxolan-4-yl)methyl 

ester (PMN P–12–414; CAS No. 69701– 

99–1) 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) (reactive 

intermediate for use in ultraviolet (UV), 

electron beam (EB), and conventionally 

cured coating and ink formulations) and 

(s) (50,000 kilograms). 


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Federal Register / Vol. 78, No. 90 / Thursday, May 9, 2013 / Rules and Regulations 27057 

(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. 

■ 9. Add § 721.10666 to subpart E to 

read as follows: 

§ 721.10666 Quaternary ammonium 

compounds, bis(fattyalkyl) dimethyl, salts 

with tannins (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as quaternary ammonium 

compounds, bis(fattyalkyl) dimethyl, 

salts with tannins (PMN P–12–437) 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). 

(ii) Release to water. Requirements as 

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

(c)(4) (N = 11). 

(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. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

■ 10. Add § 721.10667 to subpart E to 

read as follows: 

§ 721.10667 Slimes and sludges, 

aluminum and iron casting, wastewater 

treatment, solid waste. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as slimes and sludges, 

aluminum and iron casting, wastewater 

treatment, solid waste (PMN P–12–560; 

CAS No. 1391739–82–4; chemical 

substance definition: The waste solids 

produced from the treatment of 

wastewaters during aluminum and iron 

casting, machining and finishing 

operations. It may contain aluminum, 

barium, chromium, copper, iron, lead, 

manganese, nickel, and zinc.) 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. 

■ 11. Add § 721.10668 to subpart E to 

read as follows: 

§ 721.10668 Trisodium diethylene 

triaminepolycarboxylate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as trisodium diethylene 

triaminepolycarboxylate (PMN P–13– 

18) 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). 

(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. 

■ 12. Add § 721.10669 to subpart E to 

read as follows: 

§ 721.10669 Tertiary amine alkyl ether 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tertiary amine alkyl ether 

(PMN P–13–78) 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) (a catalyst for 

producing polyurethane foam). 

(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. 

■ 13. Add § 721.10670 to subpart E to 

read as follows: 

§ 721.10670 Bromine, manufacture of, byproducts from, distillation residues. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as bromine, manufacture of, 

by-products from, distillation residues 

(PMN P–13–108; chemical substance 

definition: The complex residuum 

obtained during the production of 

bromine using brine and waste streams 

from the production of halogenated 

hydrocarbons. It consists predominantly 

of halogenated hydrocarbons and 

ketones, having carbon numbers 

predominantly in the range of C3–C17. 

The boiling point is approximately 98°C 

to 350°C (208°F to 662°F).) 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)(1), (b)(1), and 

(c)(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. 

[FR Doc. 2013–11061 Filed 5–8–13; 8:45 am] 

BILLING CODE 6560–50–P 


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