Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Rules and Regulations 8273 

promulgates the operating regulations or 

procedures for drawbridges. This rule is 

categorically excluded, under figure 2– 

1, paragraph (32)(e), of the Instruction. 

Under figure 2–1, paragraph (32)(e), of 

the Instruction, an environmental 

analysis checklist and a categorical 

exclusion determination are not 

required for this rule. 

List of Subjects in 33 CFR Part 117 

Bridges. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 117 as follows: 

PART 117—DRAWBRIDGE 

OPERATION REGULATIONS 

■ 1. The authority citation for part 117 

continues to read as follows: 

Authority: 33 U.S.C. 499; 33 CFR 1.05–1; 

Department of Homeland Security Delegation 

No. 0170.1. 

■ 2. In § 117.505, paragraphs (b), (c), 

and (d) are redesignated as (c), (d), and 

(e) and a new paragraph (b) is added to 

read as follows: 

§ 117.505 Terrebonne Bayou. 

* * * * * 

(b) The draw of the St. Ann bridge, 

mile 28.8 at Bourg, shall open on signal 

if at least 24 hours notice is given. 

* * * * * 

Dated: January 24, 2014. 

Todd A. Sokalzuk, 

Captain, U.S. Coast Guard, Commander, 

Eighth Coast Guard District, Acting. 

[FR Doc. 2014–03088 Filed 2–11–14; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2013–0739; FRL–9903–70] 

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 35 chemical substances 

which were the subject of 

premanufacture notices (PMNs). 

Fourteen of these chemical substances 

are subject to TSCA section 5(e) consent 

orders issued by EPA. This action 

requires persons who intend to 

manufacture (including import) or 

process any of these 35 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 April 14, 

2014. For purposes of judicial review, 

this rule shall be promulgated at 1 p.m. 

(e.s.t.) on February 26, 2014. 

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 March 14, 2014 (see Unit VI. of 

the SUPPLEMENTARY INFORMATION). 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 March 14, 

2014, EPA will withdraw the relevant 

sections of this direct final rule before 

its effective date. 

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–2013–0739, 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–2013–0739. 

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– 

2013–0739. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available 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; 


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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: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, 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 (including 

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 

March 14, 2014 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, 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 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, 


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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 35 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 

35 chemical substances in 40 CFR part 

721, subpart E. In this unit, EPA 

provides the following information for 

each chemical substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• Chemical Abstracts Service (CAS) 

Registry number (if assigned for nonconfidential chemical identities). 

• Basis for the TSCA section 5(e) 

consent order or, for non-section 5(e) 

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

SNURs without TSCA section 5(e) 

consent orders). 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VIII. for more information). 

• CFR citation assigned in the 

regulatory text section of this 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 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 14 PMN substances 

that are subject to ‘‘risk-based’’ consent 

orders under TSCA section 

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

that activities associated with the PMN 

substances may present unreasonable 

risk to human health or the 

environment. Those consent orders 

require protective measures to limit 

exposures or otherwise mitigate the 

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

PMN substances are promulgated 

pursuant to § 721.160, and are based on 

and consistent with the provisions in 

the underlying consent orders. The 

section 5(e) SNURs designate as a 

‘‘significant new use’’ the absence of the 

protective measures required in the 

corresponding consent orders. 

This rule also includes SNURs on 21 

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-section 5(e) 

SNURs’’ are promulgated pursuant to 

§ 721.170. EPA has determined that 

every activity designated as a 

‘‘significant new use’’ in all non-section 

5(e) SNURs issued under § 721.170 

satisfies the two requirements stipulated 

in § 721.170(c)(2), i.e., these significant 

new use activities, ‘‘(i) are different from 

those described in the premanufacture 

notice for the substance, including any 

amendments, deletions, and additions 

of activities to the premanufacture 

notice, and (ii) may be accompanied by 

changes in exposure or release levels 

that are significant in relation to the 

health or environmental concerns 

identified’’ for the PMN substance. 

PMN Number P-08-179 

Chemical name: 1,2,3- 

Propanetricarboxamide, N1,N2,N3- 

tris(2-methylcyclohexyl)-. 

CAS number: 160535–46–6. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a nucleator for polymers. 

Based on ecological structure activity 

relationship (EcoSAR) analysis of test 

data on analogous amides, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 12 parts 

per billion (ppb) of the PMN substance 

in surface waters. As described in the 

PMN, releases of the substance are not 

expected to result in surface water 

concentrations that exceed 12 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 12 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 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. EPA also 

recommends that the guidance 

document on aquatic toxicity testing of 

difficult substances and mixtures 

(Organisation for Economic CoOperation (OECD) Test Guideline 23) be 

followed. 

CFR citation: 40 CFR 721.10695. 

PMN Numbers P-11-483, P-11-487, 

P-11-527, P-11-528, P-11-529, P-11-530, 

P-11-532, P-11-533, and P-11-534 

Chemical names: Polyfluorinated 

alkyl thiol (generic) (P-11-483 and P-11- 

528); Polyfluorinated alkyl polyamide 

(generic) (P-11-487); Polyfluorinated 

alkyl halide (generic) (P-11-527); 

Polyfluorinated alkyl thio acrylamide 

(generic) (P-11-529); Polyfluorinated 

alkyl thio polyacrylamide (generic) (P11-530 and P-11-533); Polyfluorinated 

alkyl amine (generic) (P-11-532); and 

Polyfluorinated alkyl thio polyacrylic 

acid-acrylamide (generic) (P-11-534). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

consent order: April 12, 2013. 

Basis for TSCA section 5(e) consent 

order: The PMNs P-11-487, P-11-530, P11-533, and P-11-534 state that the 

generic (non-confidential) use of these 

substances is as surfactants. The PMNs 

P-11-483, P-11-527, P-11-528, P-11-529, 

and P-11-532 state that the generic (nonconfidential) use of these substances is 

as chemical intermediates. Based on 

analogy to other perfluorinated 

chemicals including perfluorooctanoic 

acid (PFOA), perfluorooctanesufonate 

(PFOS), and perfluorohexane sulfonate 

(PFHS), EPA has concerns that the PMN 

substances and/or degradation products 

will persist in the environment, could 

bioaccumulate or biomagnify, and be 

toxic (PBT) to people, wild mammals 

and birds. Some perfluorinated 

chemicals, PFOA and PFOS, are 

expected to persist for years in the 

environment. Biodegradation and 

photolysis tests of analogous substances 

to PFOA and PFOS indicate little or no 

biodegradation or photolysis of 

perfluoroalkyl compounds. 

Bioaccumulation concerns are based on 

concerns raised by the measured 

presence of certain perfluoroalkyl 

compounds with longer carbon chain 

length, including PFOA, PFOS, and 

PFHS in wildlife and in human blood 

samples. EPA has human health 

concerns for irritation to skin, eyes, 

lungs, mucous membranes, and lung 

toxicity if inhaled based on surfactant 

properties of the PMN substances. 

Toxicity studies on PFOA and PFOS 

indicate liver toxicity, blood toxicity, 

male reproductive toxicity, 

immunosuppression, and oncogenicity. 

These factors, taken together, raise 


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concerns for potential adverse chronic 

effects of P-11-483, P-11-487, P-11-527, 

P-11-528, P-11-529, P-11-530, P-11-532, 

P-11-533, P-11-534 and/or degradation 

products. The consent order was issued 

under TSCA section 5(e)(1)(A) based on 

a finding that these substances may 

present an unreasonable risk of injury to 

human health and the environment, 

these substances may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substances and their potential 

degradation products. To protect against 

these risks, the consent order requires: 

1. Risk notification. If as a result of 

the test data required, the company 

becomes aware that the PMN substance 

may present a risk of injury to human 

health or the environment, the company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into a 

Material Safety Data Sheet (MSDS), 

within 90 days. 

2. Manufacture of the PMN 

substances: (a) According to the 

chemical composition section of the 

consent order, including analyzing and 

reporting certain starting raw material 

impurities to EPA; and (b) within the 

maximum established limits of certain 

fluorinated impurities of the PMN 

substances as stated in the consent 

order. 

3. Use of the substances only as 

described in the consent order. 

4. No use of the PMN substances in 

consumer products with spray 

applications. 

5. Submission of certain 

environmental fate testing prior to 

exceeding the confidential production 

volume limit of the aggregate amount of 

the PMN substances, P-11-487, P-11- 

530, P-11-533, and P-11-534 specified in 

the consent order. 

6. The individual annual manufacture 

volume for P-11-487, P-11-530, P-11- 

533, and P-11-534 must not reach the 

confidential annual production volume 

specified in the consent order. 

7. Incinerate all waste containing any 

of the PMN substances from 

manufacturing and processing in an 

incinerator with a combustion 

temperature of a minimum of 1,000 

degrees Celsius (C) and a residence time 

of a minimum of 2 seconds. 

8. No use of the substances resulting 

in releases to surface water. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the test data from 

certain human health, environmental 

fate, and ecotoxicity testing identified in 

the consent order would help 

characterize possible effects of the 

substances and their degradation 

products. The company has agreed not 

to exceed the first production limit 

without performing a metabolism and 

pharmacokinetics test (OPPTS Test 

Guideline 870.7485), and a combined 

repeated dose toxicity with the 

reproduction/development toxicity 

screening test (OPPTS Test Guideline 

870.3650 modified or OECD Test 

Guideline 422 modified) on a species to 

be determined by the results of the 

pharmacokinetics studies with 

modifications, for the P-11-483 chemical 

substance. The PMN submitter has also 

agreed not to exceed the second 

production limit without performing the 

aerobic and anaerobic transformation in 

soil test (OECD Test Guideline 307) for 

the P-11-530 chemical substance. The 

company has agreed not to exceed the 

third production limit without 

performing the fish acute toxicity test, 

freshwater and marine test (OPPTS Test 

Guideline 850.1075), an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010), and an algal 

toxicity test (Office of Chemical Safety 

and Pollution Prevention (OCSPP) Test 

Guideline 850.4500) for the P-11-483 

chemical substance. The company also 

has agreed to not to exceed the fourth 

production limit without performing the 

avian reproduction test (OPPTS Test 

Guideline 850.2300) for the P-11-483 

chemical substance, and hydrolysis as a 

function of pH and temperature (OPPTS 

Test Guideline 835.2130), ultraviolet 

(UV)/visible absorption (OPPTS Test 

Guideline 830.7050), direct photolysis 

rate in water by sunlight test (OPPTS 

Test Guideline 835.2210), if 

wavelengths greater than 290 

nanometers (nm) are absorbed in the 

previous test, indirect photolysis 

screening test: Sunlight photolysis in 

waters containing dissolved humic 

substances (OPPTS Test Guideline 

835.5270), anaerobic biodegradability of 

organic compounds in digested sludge: 

By measurement of gas production 

(OPPTS Test Guideline 835.3420), and 

modified semi continuous activated 

sludge (SCAS) test for insoluble and 

volatile chemicals (OPPTS Guideline 

835.5045), or inherent biodegradability: 

Zahn-Wellens/EVPA Test (OECD Test 

Guideline 302B), modified with analysis 

for degradation products for P-11-530 

chemical substance. Further testing 

details are available in the consent order 

located in the docket under docket 

EPA–HQ–OPPT–2013–0739. EPA has 

also determined that the results of 

certain other human health, ecotoxicity, 

and environmental fate testing would 

help characterize the PMN substance. 

The consent order does not require 

submission of the pended testing 

detailed in the consent order at any 

specified time or production volume. 

However, the consent order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal of the PMNs will remain in 

effect until the consent order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citations: 40 CFR 721.10696 

(P-11-483 and P-11-528); 40 CFR 

721.10697 (P-11-487); 40 CFR 721.10698 

(P-11-527); 40 CFR 721.10699 (P-11- 

529); 40 CFR 721.10700 (P-11-530 and 

P-11-533); 40 CFR 721.10701 (P-11-532); 

and 40 CFR 721.10702 (P-11-534). 

PMN Numbers P-12-416, P-12-417, 

P-12-418, and P-12-419 

Chemical names: Multi-walled carbon 

nanotubes (generic). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

consent order: December 3, 2012. 

Basis for TSCA section 5(e) consent 

order: The PMNs state that the use of 

the substances will be as: An additive 

for electro-static discharge (ESD) in 

semiconductor packaging and electronic 

devices; additive for weight-reduction 

in vehicles and windmill blades; 

additive to reinforce building frames 

and machine components; additive to 

improve conductivity in batteries and 

solar cells; additive in seat-heaters (heat 

generating element in heating devices 

and materials); electron emitter for 

lighting and x-ray sources; additive for 

heat transfer and thermal emission in 

electronic devices; additive for 

electromagnetic interface (EMI) 

shielding; catalyst support in chemical 

manufacturing; and filter additive to 

remove nanoscale materials. Based on 

test data on analogous respirable, poorly 

soluble particulates and other carbon 

nanotubes (CNTs), EPA identified 

concerns for pulmonary toxicity, 

fibrosis, carcinogenicity, mutagenicity, 

and immunotoxicity. Further, available 

data suggest that pulmonary deposition 

of some nanoparticles, including CNTs, 

may induce cardiovascular toxicity if 

inhaled. Although there are no 

environmental toxicity studies on CNTs 

available, EPA expects that some 

fraction of the CNTs, if released into the 

environment, will eventually be 

suspended in water. There have been 

sublethal effects observed for analogue 

single wall CNTs in rainbow trout at 

levels as low as 100 ppb. The order was 


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issued under TSCA sections 5(e)(1)(A)(i) 

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

that these substances may present an 

unreasonable risk of injury to human 

health and the environment. To protect 

against these risks, the consent order 

requires: 

1. Use of personal protective 

equipment including gloves and 

protective clothing impervious to the 

substances when there is a potential 

dermal exposure and a National 

Institute of Occupational Safety and 

Health (NIOSH)-certified air-purifying, 

tight-fitting full-face respirator equipped 

with N-100, or P-100, or R-100 filters or 

power air-purifying particulate 

respirator with an assigned protection 

factor (APF) of at least 50 when there is 

potential inhalation exposure. 

2. No domestic manufacture. 

3. Use of the substances only as 

described in the consent order. 

4. Import of the substances at a 

cumulative, aggregate volume not to 

exceed a confidential volume specified 

in the consent order unless the company 

has submitted the results of certain 

health studies. 

5. No use of the substances resulting 

in surface water releases. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the following tests 

would help characterize the human 

health effects of the PMN substances. 

The PMN submitter has agreed not to 

exceed the confidential production 

volume stated in the consent order 

without performing the 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) on P-12-416 with a 

post-exposure observation period of up 

to 3 months; bronchoalveolar lavage 

fluid (BALF) analysis; aggregation/

agglomeration state, shape, particle size 

distribution and surface properties of 

material as-manufactured (dry) and asadministered; aggregation/

agglomeration state, shape, particle size 

distribution and surface properties of 

materials of the delivered materials after 

administration; determination of 

cardiovascular toxicity, heart 

histopathology, and data on pulmonary 

deposition. In addition, in the consent 

order, the PMN submitter agreed to 

provide physical/chemical properties 

data within a specified time limit. 

CFR citation: 40 CFR 721.10703. 

PMN Number P-12-548 

Chemical name: Aryl-substituted 

alkane (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: April 30, 2013. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a dielectric fluid. EPA has 

identified health and environmental 

concerns because the substance may be 

a persistent, bio-accumulative, 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 PMN 

substance will persist in the 

environment more than two months and 

estimates a bioaccumulation factor of 

greater than or equal to 1,000. Also, 

based on submitted test data on the 

PMN substance, EPA identified 

concerns for developmental and liver 

toxicity to dermally exposed workers. 

Based on EcoSAR analysis of test data 

on neutral organic chemicals, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

8 ppb of the PMN substance in surface 

waters. The consent order was issued 

under TSCA sections 5(e)(1)(A)(i) and 

5(e)(1)(A)(ii)(I) based on a finding that 

uncontrolled manufacture, processing, 

distribution in commerce, use, and 

disposal of this substance may present 

an unreasonable risk of injury to human 

health or the environment. To protect 

against these risks, the consent order 

requires: 

1. Use of personal protective 

equipment including gloves impervious 

to the substance when there is a 

potential dermal exposure. 

2. Establishment and use of a hazard 

communication program. 

3. Use of the substance only as 

described in the consent order. 

4. Manufacture of the substance at a 

cumulative volume not to exceed a 

confidential volume specified in the 

consent order unless the company has 

submitted the results of certain health 

studies. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the following tests 

would help characterize the 

environmental and human health effects 

of the PMN substance. The consent 

order contains three confidential 

production volume limits. The PMN 

submitter has agreed not to exceed the 

first production volume limit without 

performing a 14-day dermal toxicity test 

(OPPTS Test Guideline 870.3200 or 

OECD Test Guideline 410). The PMN 

submitter has also agreed not to exceed 

the second (higher) production volume 

limit without performing a 

bioaccumulation in sediment-dwelling 

benthic oligochaetes test (OECD Test 

Guideline 315). The PMN submitter has 

also agreed not to exceed the third 

(higher) production volume limit 

without performing a sediment and soil 

adsorption/desorption isotherm test 

(OPPTS Test Guideline 835.1220). The 

PMN submitter has also agreed to 

submit to EPA the results of any other 

testing conducted to comply with 

REACH (Regulation, Evaluation, 

Authorization, and Restriction of 

Chemicals in the European Union) no 

later than 90 days after submission of 

the testing to the European Union. 

CFR citation: 40 CFR 721.10704. 

PMN Number P-12-572 

Chemical name: Aromatic amine with 

cyclo amino carbonyls (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a reactive amine for 

enhancing pigment dispersions. Based 

on test data on the PMN substance as 

well as on analogous aromatic amines, 

EPA identified human health concerns 

regarding oncogenicity and 

mutagenicity from exposure to the PMN 

substance via inhalation, dermal, and 

drinking water exposures. Further, 

based on EcoSAR analysis of test data 

on analogous anilines, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 11 ppb of 

the PMN substance in surface waters. 

This concentration is also expected by 

the Agency to be protective of human 

health concerns via drinking water 

exposure. As described in the PMN, 

occupational exposures are expected to 

be minimal due to the use of impervious 

gloves and a NIOSH-certified particulate 

respirator. Releases of the substance are 

not expected to result in surface water 

concentrations that exceed 11 ppb 

which then effectively limits drinking 

water exposures. 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 impervious gloves, where there is a 

potential for dermal exposure; use of the 

substance without a NIOSH-certified 

particulate respirator with an APF of at 

least 10, where there is a potential for 

inhalation exposures; use of the 

substance other than as an intermediate; 

or use of the substance resulting in 

surface water concentrations exceeding 

11 ppb 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)(i), 

(b)(3)(ii), and (b)(4)(ii). 


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Recommended testing: EPA has 

determined that the results of an algal 

toxicity test (OCSPP Test Guideline 

850.4500), an aquatic invertebrate acute 

toxicity test (OPPTS Test Guideline 

850.1010), a fish acute toxicity test 

(OPPTS Test Guideline 850.1075), and a 

combined repeated dose toxicity with 

the reproduction/developmental 

toxicity test (OPPTS Test Guideline 

870.3650) would help characterize the 

human health and environmental effects 

of the PMN substance. 

CFR citation: 40 CFR 721.10705. 

PMN Number P-12-576 

Chemical name: Infused carbon 

nanostructures (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as an additive to provide 

conductive properties to reinforcements 

used in composites. Based on available 

information on analogous carbon 

structures, EPA identified concerns for 

lung effects. No significant inhalation 

exposures are expected when the PMN 

substance is manufactured according to 

the process identified in the PMN, to 

incorporate the PMN substance into 

pellets. 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 

a manufacturing process other than as 

described in the PMN (the 

manufacturing process described in the 

PMN includes incorporation of the PMN 

substance into pellets), 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 following analysis 

of the PMN substance would help 

characterize the effects of the PMN 

substance: The dimensions, the 

structure, branching characteristics, 

presence of the catalyst in the PMN 

substance, and physical-chemical 

properties of the carbon nanostructures. 

These properties should be determined 

and reported to EPA once a year for 

three consecutive years. 

CFR citation: 40 CFR 721.10706. 

PMN Number P-13-127 

Chemical name: Substituted benzyl 

acrylate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the use of the substance is as a resin for 

industrial coatings. Based on test data 

on the PMN substance, 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 

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 

releases to surface waters exceeding 1 

ppb may result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

Recommended testing: EPA has 

determined that the results of a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) and a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10707. 

PMN Number P-13-152 

Chemical name: Zirconium 

substituted heteropolycyclic (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is a contained use in 

electronic equipment. Based on EcoSAR 

analysis of test data on analogous 

zirconium compounds, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 10 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 10 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 

releases to surface water concentrations 

exceeding 10 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 algal 

toxicity test (OCSPP Test Guideline 

850.4500), a daphnid chronic toxicity 

test (OPPTS Test Guideline 850.1300), 

and a fish early-life stage toxicity test 

(OPPTS Test Guideline 850.1400) would 

help characterize the environmental 

effects of the PMN substance. EPA also 

recommends that the guidance 

document on aquatic toxicity testing of 

difficult substance and mixtures (OECD 

Test Guideline 23) be followed. 

CFR citation: 40 CFR 721.10708. 

PMN Number P-13-168 

Chemical name: Alkylphenol 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the use of the substance is as a reactant 

for a lubricant additive. Based on 

EcoSAR analysis of test data on 

analogous phenols, 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 

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 the results of a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300), a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400), and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. EPA also recommends that 

the guidance document on aquatic 

toxicity testing of difficult substances 

and mixtures (OECD Test Guideline 23) 

be followed. 

CFR citation: 40 CFR 721.10709. 

PMN Number P-13-192 

Chemical name: 4,7-Methano-1Hindene, 3a,4,7,7a-tetrahydro-, polymer 

with 2-methyl-1,3-butadiene and 5-(1- 

methylethenyl)bicyclo[2.2.1]hept-2-ene. 

CAS number: 1412159–51–3. 

Basis for action: The PMN states that 

the substance is used as a rubber 

additive. Based on EcoSAR analysis of 

test data on analogous neutral organics, 

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 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 

result in significant adverse 


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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 daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300), a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400), and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. EPA also recommends that 

the guidance document on aquatic 

toxicity testing of difficult substances 

and mixtures (OECD Test Guideline 23) 

be followed. 

CFR citation: 40 CFR 721.10710. 

PMN Number P-13-197 

Chemical name: Alkyl substituted 

catechol (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a raw material for 

organic synthesis. Based on test data on 

an analog, EPA identified potential 

human health concerns regarding 

oncogenicity, skin and eye irritation and 

corrosion, dermal sensitization, 

mutagenicity, and developmental 

toxicity from exposure to the PMN 

substance via inhalation, dermal, and 

drinking water exposures. Further, 

based on EcoSAR analysis of test data 

on analogous polyphenols, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 20 ppb of 

the PMN substance in surface waters. 

This concentration is also expected by 

the Agency to be protective of human 

health concerns via drinking water 

exposures. As described in the PMN, 

occupational exposure is expected to be 

minimal due to the use of impervious 

gloves and a NIOSH-certified particulate 

respirator with an APF of 1,000; and 

releases to surface waters are not 

expected which then effectively limits 

drinking water exposures. 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 impervious gloves, 

where there is a potential for dermal 

exposure; use of the substance without 

a NIOSH-certified particulate respirator 

with an APF of 1,000, where there is a 

potential for inhalation exposures; use 

of the substance other than as an 

intermediate; or use of the substance 

resulting in surface water 

concentrations exceeding 20 ppb 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), 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of an algal 

toxicity test (OCSPP Test Guideline 

850.4500); 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), as well as either the in vitro 

skin corrosion: transcutaneous electrical 

resistance test (TER) (OECD Test 

Guideline 430) or the in vitro skin 

corrosion: human skin model test 

(OECD Test Guideline 431) or the in 

vitro membrane barrier test method for 

skin corrosion (OECD Test Guideline 

435) would help characterize the human 

health and environmental effects of the 

PMN substance. 

CFR citation: 40 CFR 721.10711. 

PMN Number P-13-217 

Chemical name: Antimony 

tris(dialkyldithiocarbamate) (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the use of the substance is as an extreme 

pressure, anti-wear additive for greases 

and oils. Based on EcoSAR analysis of 

test data on analogous dithiocarbamates, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 4 ppb of the PMN substance 

in surface waters. As described in the 

PMN, releases of the substance are not 

expected to result in surface water 

concentrations that exceed 4 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 4 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 a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) and a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10712. 

PMN Number P-13-259 

Chemical name: Antimony 

tris(dialkyldithiocarbamate) (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the use of the substance is as an extreme 

pressure, anti-wear additive for greases 

and oils containing the PMN substance 

and sulfurized isobutylene. Based on 

EcoSAR analysis of test data on 

analogous organic antimony 

dithiocarbamate, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 4 ppb of the 

PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

4 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 

4 ppb may result in 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 ready 

biodegradability test (OECD Test 

Guideline 301), a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300), and a fish early-life stage 

toxicity test (OPPTS Test Guideline 

850.1400) would help characterize the 

environmental effects of the PMN 

substance. EPA also recommends that 

the guidance document on aquatic 

toxicity testing of difficult substances 

and mixtures (OECD Test Guideline 23) 

be followed. 

CFR citation: 40 CFR 721.10713. 

PMN Number P-13-260 

Chemical name: Zinc 

bis(dialkyldithiocarbamate) (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the use of the substance is as an extreme 

pressure, anti-wear additive for greases 

and oils containing the PMN substance 

and process oil as well as an extreme 

pressure, anti-wear additive for greases 

and oils containing the PMN substance 

and sulfurized isobutylene. Based on 

EcoSAR analysis of test data on 

analogous zinc salts, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 7 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

7 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 

7 ppb may result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 


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the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OECD Test 

Guideline 301), a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300), and a fish early-life stage 

toxicity test (OPPTS Test Guideline 

850.1400) would help characterize the 

environmental effects of the PMN 

substance. EPA also recommends that 

the guidance document on aquatic 

toxicity testing of difficult substances 

and mixtures (OECD Test Guideline 23) 

be followed. 

CFR citation: 40 CFR 721.10714. 

PMN Number P-13-346 

Chemical name: Carbonic acid, 

dialkyl ester (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

PMN substance will be as an 

encapsulated part in a polymer matrix 

used as part of a fragrance slurry in 

consumer fabric care and cleaning 

products. Based on test data on the PMN 

substance and EcoSAR analysis of test 

data on analogous esters, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 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 importing 100,000 

kilograms of the PMN substance per 

year. For the use described in the PMN 

and at the importation volume 

described in the PMN, environmental 

releases did not exceed 1 ppb for more 

than 20 days per year. Therefore, EPA 

has not determined that the proposed 

importing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any domestic manufacture of the PMN 

substance, use of the substance other 

than as described in the PMN, or 

importing the PMN substance at 

volumes greater than 100,000 kilograms 

per year, 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 

Guideline 850.1400) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10715. 

PMN Number P-13-355 

Chemical name: Phenol, 2,6- 

dimethyl-, homopolymer, ether with 

2,2′,3,3′,5,5′-hexamethyl[1,1′-biphenyl]- 

4,4′-diol 

(2:1),bis[(ethenylphenyl)methyl] ether. 

CAS number: 558452–77–0. 

Basis for action: The PMN states that 

the use of the substance is as a 

polymeric coating. Based on test data on 

the PMN substance, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 2 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

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 resulting in 

surface water concentrations exceeding 

2 ppb may result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

Recommended testing: EPA has 

determined that the results of a 

chironomid sediment toxicity test 

(OPPTS Test Guideline 850.1790); a 

whole sediment acute toxicity 

invertebrates, freshwater or marine 

(OPPTS Test Guideline 850.1735 or 

850.1740); a sediment-water chironomid 

toxicity using spiked water test (OECD 

Test Guideline 219); a sediment-water 

chironomid toxicity test using spiked 

sediment (OECD Test Guideline 218); a 

sediment-water lumbriculus toxicity test 

using spiked sediment (OECD Test 

Guideline 225); a sediment-water 

chironomid life-cycle toxicity test using 

spiked water or spiked sediment (OECD 

Test Guideline 233); methods for 

measuring the toxicity and 

bioaccumulation of sediment-associated 

contaminants with freshwater 

invertebrates (EPA 600/R–99/064 March 

2000; see http://nepis.epa.gov/Exe/

ZyPDF.cgi/Docket=30003SBA.PDF), and 

environmental monitoring of the PMN 

substance would help characterize the 

environmental effects of the PMN 

substance. EPA also recommends that 

the guidance document on aquatic 

toxicity testing of difficult substances 

and mixtures (OECD Test Guideline 23) 

be followed. 

CFR citation: 40 CFR 721.10716. 

PMN Number P-13-365 

Chemical name: MDI modified 

polyalkene glycols (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an adhesive 

component. Based on test data on 

analogous diisocyanates, EPA identified 

concerns for dermal and respiratory 

sensitization, and lung and mucous 

membrane irritation effects. For the use 

described in the PMN, EPA does not 

expect significant occupational or 

consumer inhalation exposure due to 

the use of adequate personal protective 

equipment and because the substance is 

not applied using a method that 

generates a vapor, mist, or aerosol nor 

is it used in a consumer product. 

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 a NIOSH-certified 

particulate respirator with an APF of at 

least 10, where there is a potential for 

inhalation exposures; any use of the 

substance in consumer products; or any 

use of the substance involving an 

application method that generates a 

vapor, mist, or aerosol, 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 skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10717. 

PMN Number P-13-374 

Chemical name: Substituted picolinic 

acid (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the specific use of the substance will be 

as a pesticide intermediate. Based on 

test data of the PMN substance and 

close analogs, the Agency identified 

human health concerns for systemic and 

developmental toxicities, neurotoxicity, 

and oncogenicity from dermal, drinking 

water, and inhalation exposures. 

Further, based on test data on the PMN 

substance, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 180 ppb of 

the PMN substance in surface water. 

This concentration is also expected by 

the Agency to be protective of human 

health concerns via drinking water 

exposure. For the use described in the 

PMN, EPA does not expect significant 

occupational exposures and releases of 

the PMN substance are not expected to 


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result in surface water concentrations 

that exceed 180 ppb which then 

effectively limits drinking water 

exposures. 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 

a pesticide intermediate could result in 

exposures which may cause serious 

health or ecological effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

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

(b)(4)(i). 

Recommended testing: EPA has 

determined that the results of industrial 

workplace monitoring and 

environmental release information 

would help characterize the health and 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10718. 

PMN Number P-13-392 

Chemical name: Acrylic acid esters 

polymers, reaction products with 

polyisocyanate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be for wood, plastic, and 

automotive paint material. Based on test 

data on analogous diisocyanates, EPA 

identified concerns for dermal and 

respiratory sensitization, irritation to all 

moist tissues, and lung effects if inhaled 

based on the low molecular weight 

isocyanates, to workers exposed to the 

PMN substance. As described in the 

PMN, worker inhalation exposure is not 

expected and dermal exposure will be 

minimal due to the use of adequate 

personal protective equipment. 

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 a NIOSH-certified 

respirator with an APF of at least 10, 

where there is potential inhalation 

exposure; or any use of the PMN 

substance in a consumer product, 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 skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10719. 

PMN Number P-13-393 

Chemical name: 1,3- 

Benzenedicarboxylic acid, polymer with 

1,4-benzenedicarboxylic acid, 1,4- 

dimethyl 1,4-benzenedicarboxylate, 2,2- 

dimethyl-1,3- 

propanediol,dodecanedioic acid, 1,2- 

ethanediol, hexanedioic acid, 1,6- 

hexanediol, alkyldiol ester and aromatic 

isocyanate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an industrial 

adhesive. Based on test data on 

analogous diisocyanates, the Agency 

identified concerns for dermal and 

respiratory sensitization, irritation to all 

moist tissues, and lung effects if inhaled 

based on the low molecular weight 

isocyanates. For the use described in the 

PMN, EPA does not expect significant 

occupational or consumer inhalation 

exposure due to the use of adequate 

personal protective equipment and 

because the substance is not applied 

using a method that generates a vapor, 

mist, or aerosol nor is the substance 

used in a consumer product. 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 a NIOSH-certified particulate 

respirator with an APF of at least 10, 

where there is a potential for inhalation 

exposures; any use of the substance in 

consumer products; or any use of the 

substance involving an application 

method that generates a vapor, mist, or 

aerosol, 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 skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10720. 

PMN Number P-13-455 

Chemical name: Poly(oxy-1,2- 

ethanediyl), .alpha.,.alpha.′-[(1- 

methylethylidene)di-4,1- 

phenylene]bis[.omega.-[[6-(2,5-dihydro2,5-dioxo-1H-pyrrol-1-yl)-1- 

oxohexyl]oxy]-. 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a conductive 

adhesive in the electronics industry. 

Based on EcoSAR analysis of test data 

on analogous imides and esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb of the PMN substance in surface 

waters. For the specific use described in 

the PMN, environmental releases 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 PMN substance resulting in surface 

water concentrations exceeding 1 ppb 

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 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 721.10721. 

PMN Number P-13-468 

Chemical name: Oxirane,2-[(1- 

propen-1-yloxy)methyl]-. 

CAS number: 1607–23–4. 

Basis for action: The PMN states that 

the substance will be used as a sitelimited chemical intermediate to make a 

curable monomer. Based on test data on 

analogous epoxides, EPA identified 

concerns for skin and lung sensitization, 

mutagenicity, oncogenicity, 

developmental toxicity, male 

reproductive, liver, and kidney toxicity 

to workers exposed to the PMN 

substance. As described in the PMN, 

worker inhalation exposure is not 

expected and dermal exposure will be 

minimal due to the use as an 

intermediate and use of adequate 

personal protective equipment. 

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 a NIOSH-certified 

respirator with an APF of at least 10, 

where there is potential inhalation 

exposure; the use of the substance 

without impervious gloves, where there 

is potential for dermal exposure; or use 

other than as an intermediate may cause 

serious health effects. Based on this 

information, the PMN substances meet 

the concern criteria at 

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

Recommended testing: EPA has 

determined that the results of a 

carcinogenicity test (OPPTS Test 


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Guideline 870.4200) and 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 721.10722. 

PMN Number P-13-471 

Chemical name: Methylene 

diisocyanate polymer with 

polypropylene glycol and diols 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an industrial 

adhesive. Based on test data on 

analogous diisocyanates, EPA identified 

concerns for oncogenicity, mutagenicity, 

respiratory and dermal sensitization, 

and lung and mucous membrane 

irritation to workers exposed to the 

PMN substance. As described in the 

PMN, worker inhalation exposure is not 

expected and dermal exposure will be 

minimal due to the use as an 

intermediate and use of adequate 

personal protective equipment. 

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 a NIOSH-certified 

particulate respirator with an APF of at 

least 10, where there is potential 

inhalation exposure, or the use of the 

substance in a consumer product, 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 skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10723. 

PMN Number P-13-472 

Chemical name: Oxirane,[[2-(2- 

ethenyloxy)ethoxy]methyl]-. 

CAS number: 16801–19–7. 

Basis for action: The PMN states that 

the substance will be used as a sitelimited intermediate to manufacture a 

curable monomer. Based on test data on 

analogous epoxides, EPA identified 

concerns for skin and lung sensitization, 

mutagenicity, oncogenicity, 

developmental toxicity, male 

reproductive, liver, and kidney toxicity 

to workers exposed to the PMN 

substance. In addition, based on 

analogous vinyl ethers, there were 

concerns for oncogenicity, reproductive 

toxicity, and blood toxicity. As 

described in the PMN, worker 

inhalation exposure is not expected and 

dermal exposure will be minimal due to 

the use as an intermediate and use of 

adequate personal protective 

equipment. 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 a 

NIOSH-certified respirator with an APF 

of at least 10, where there is potential 

inhalation exposure; the use of the 

substance without impervious gloves, 

where there is potential for dermal 

exposure; or use other than as an 

intermediate may cause serious health 

effects. Based on this information, the 

PMN substances meet the concern 

criteria at § 721.170(b)(1)(i)(C) and 

(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 

carcinogenicity test (OPPTS Test 

Guideline 870.4200) and 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 721.10724. 

V. Rationale and Objectives of the Rule 

A. Rationale 

During review of the PMNs submitted 

for the chemical substances that are 

subject to these SNURs, EPA concluded 

that for 14 of the 35 chemical 

substances, regulation was warranted 

under TSCA section 5(e), pending the 

development of information sufficient to 

make reasoned evaluations of the health 

or environmental effects of the chemical 

substances. The basis for such findings 

is outlined in Unit IV. Based on these 

findings, TSCA section 5(e) consent 

orders requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. The SNUR 

provisions for these chemical 

substances are consistent with the 

provisions of the TSCA section 5(e) 

consent orders. These SNURs are 

promulgated pursuant to § 721.160 (see 

Unit VI.). 

In the other 21 cases, where the uses 

are not regulated under a TSCA section 

5(e) consent order, EPA determined that 

one or more of the criteria of concern 

established at § 721.170 were met, 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 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 or processing a 

listed chemical substance for the 

described significant new use. 

• EPA will be able to regulate 

prospective manufacturers or processors 

of a listed chemical substance before the 

described significant new use of that 

chemical substance occurs, provided 

that regulation is warranted pursuant to 

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

• EPA will ensure that all 

manufacturers and processors of the 

same chemical substance that is subject 

to a TSCA section 5(e) consent order are 

subject to similar requirements. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Chemical Substance Inventory 

(TSCA Inventory). Guidance on how to 

determine if a chemical substance is on 

the TSCA Inventory is available on the 

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

existingchemicals/pubs/tscainventory/

index.html. 

VI. 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 April 14, 2014 without 

further notice, unless EPA receives 

written adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments before March 14, 

2014. 

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 

March 14, 2014, 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 


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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. However, 

TSCA section 5(e) consent orders have 

been issued for 14 of the 35 chemical 

substances, and the PMN submitters are 

prohibited by the TSCA section 5(e) 

consent orders from undertaking 

activities which would be designated as 

significant new uses. The identities of 

29 of the 35 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 February 

12, 2014 as the cutoff date for 

determining whether the new use is 

ongoing. Persons who begin commercial 

manufacture 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 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 

subject to the SNUR is also subject to a 

test rule under TSCA section 4 (see 

TSCA section 5(b)(1)). 

2. Development of test data may be 

necessary where the chemical substance 

has been listed under TSCA section 

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

In the absence of a TSCA section 4 

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

listing covering the chemical substance, 

persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 40 

CFR 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

lists those tests. Unit IV. also lists 

recommended testing for non-section 

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 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http://

www.oecdbookshop.org or SourceOECD 

at http://www.sourceoecd.org. 

In the TSCA section 5(e) consent 

orders for several of the chemical 

substances regulated under this rule, 

EPA has established production volume 

limits in view of the lack of data on the 

potential health and environmental 

risks that may be posed by the 

significant new uses or increased 

exposure to the chemical substances. 

These limits cannot be exceeded unless 

the PMN submitter first submits the 

results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by these chemical 

substances. Listings of the tests 

specified in the TSCA section 5(e) 

consent orders are included in Unit IV. 

The SNURs contain the same 

production volume limits as the TSCA 

section 5(e) consent orders. Exceeding 

these production limits is defined as a 

significant new use. Persons who intend 

to exceed the production limit must 

notify the Agency by submitting a 

SNUN at least 90 days in advance of 

commencement of non-exempt 

commercial manufacture or processing. 

The recommended tests specified in 

Unit IV. may not be the only means of 

addressing the potential risks of the 

chemical substance. However, 

submitting a SNUN without any test 

data may increase the likelihood that 

EPA will take action under TSCA 

section 5(e), particularly if satisfactory 

test results have not been obtained from 

a prior PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

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 or processor may request 

EPA to determine whether a proposed 

use would be a significant new use 

under the rule. The manufacturer or 

processor must show that it has a bona 

fide intent to manufacture or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture or process the chemical 

substance. If EPA concludes that the 

person has shown a bona fide intent to 

manufacture 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 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., 


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the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture 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 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– 

2013–0739. 

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, or TSCA 

section 5(e) consent orders. 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 (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 


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Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Rules and Regulations 8285 

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: February 3, 2014. 

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 § 14;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 

* * * * * 

721.10695 ............................. 2070–0012 

721.10696 ............................. 2070–0012 

721.10697 ............................. 2070–0012 

721.10698 ............................. 2070–0012 

721.10699 ............................. 2070–0012 

721.10700 ............................. 2070–0012 

721.10701 ............................. 2070–0012 

721.10702 ............................. 2070–0012 

721.10703 ............................. 2070–0012 

721.10704 ............................. 2070–0012 

721.10705 ............................. 2070–0012 

721.10706 ............................. 2070–0012 

721.10707 ............................. 2070–0012 

721.10708 ............................. 2070–0012 

721.10709 ............................. 2070–0012 

721.10710 ............................. 2070–0012 

721.10711 ............................. 2070–0012 

721.10712 ............................. 2070–0012 

721.10713 ............................. 2070–0012 

721.10714 ............................. 2070–0012 

721.10715 ............................. 2070–0012 

721.10716 ............................. 2070–0012 

721.10717 ............................. 2070–0012 

721.10718 ............................. 2070–0012 

721.10719 ............................. 2070–0012 

721.10720 ............................. 2070–0012 

721.10721 ............................. 2070–0012 

721.10722 ............................. 2070–0012 

721.10723 ............................. 2070–0012 

721.10724 ............................. 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 § 721.10695 to subpart E to 

read as follows: 

§ 721.10695 1,2,3-Propanetricarboxamide, 

N1,N2,N3-tris(2-methylcyclohexyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,2,3-Propanetricarboxamide, 

N1,N2,N3-tris(2-methylcyclohexyl)- 

(PMN P-08-179; CAS No. 160535-46-6) 

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 = 12). 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 5. Add § 721.10696 to subpart E to 

read as follows: 

§ 721.10696 Polyfluorinated alkyl thiol 

(generic). 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as polyfluorinated alkyl 

thiol (PMNs P-11-483 and P-11-528) 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) Hazard communication program. A 

significant new use of the substances is 

any manner or method of manufacture 

or processing associated with any use of 

the substances without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for the substances, the 

employer becomes aware that the 

substances may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If the substance(s) are not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance(s) are 

reintroduced into the workplace. 


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(B) The employer must ensure that 

persons who will receive the PMN 

substance(s) from the employer, or who 

have received the PMN substance(s) 

from the employer within 5 years from 

the date the employer becomes aware of 

the new information described in 

paragraph (a)(2)(i)(A) of this section, are 

provided an MSDS containing the 

information required under paragraph 

(a)(2)(i)(A) of this section within 90 days 

from the time the employer becomes 

aware of the new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (a significant 

new use is any use other than as 

allowed by the section 5(e) consent 

order which includes analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), and (o) (use in a consumer 

product that could be spray applied). 

(iii) Disposal. Requirements as 

specified in § 721.85(a)(1) and (b)(1) (at 

a temperature of at least 1,000 degrees 

C with a minimum residence time of 2 

seconds). 

(iv) Release to water. Requirements as 

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

(c)(1), except for releases allowed by the 

section 5(e) the consent order . 

(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), (f), (h), (j) and 

(k) are applicable to manufacturers and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 6. Add § 721.10697 to subpart E to 

read as follows: 

§ 721.10697 Polyfluorinated alkyl 

polyamide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyfluorinated alkyl 

polyamide (PMN P-11-487) 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) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture 

or processing associated with any use of 

this substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If this substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

(a)(2)(i)(A) of this section, are provided 

an MSDS containing the information 

required under paragraph (a)(2)(i)(A) of 

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (a significant 

new use is any use other than as 

allowed by the section 5(e) consent 

order which includes analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), (o) (use in a consumer 

product that could be spray applied), 

(q), and (t). 

(iii) Disposal. Requirements as 

specified in § 721.85(a)(1) and (b)(1) (at 

a temperature of at least 1,000 degrees 

C with a minimum residence time of 2 

seconds). 

(iv) Release to water. Requirements as 

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

(c)(1), except for releases allowed by the 

section 5(e) the consent order. 

(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), (f), (h), (i), (j), and 

(k) are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 7. Add § 721.10698 to subpart E to 

read as follows: 

§ 721.10698 Polyfluorinated alkyl halide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyfluorinated alkyl 

halide (PMN P-11-527) 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) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture 

or processing associated with any use of 

this substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If this substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

(a)(2)(i)(A) of this section, are provided 

an MSDS containing the information 

required under paragraph (a)(2)(i)(A) of 

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (a significant 

new use is any use other than as 

allowed by the section 5(e) consent 

order which includes analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), and (o) (use in a consumer 

product that could be spray applied). 

(iii) Disposal. Requirements as 

specified in § 721.85(a)(1) and (b)(1) (at 

a temperature of at least 1,000 degrees 

C with a minimum residence time of 2 

seconds). 

(iv) Release to water. Requirements as 

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


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(c)(1), except for releases allowed by the 

section 5(e) the consent order. 

(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), (f), (h), (j), and 

(k) are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 8. Add § 721.10699 to subpart E to 

read as follows: 

§ 721.10699 Polyfluorinated alkyl thio 

acrylamide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyfluorinated alkyl thio 

acrylamide (PMN P–11–529) 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) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture 

or processing associated with any use of 

this substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If this substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

(a)(2)(i)(A) of this section, are provided 

an MSDS containing the information 

required under paragraph (a)(2)(i)(A) of 

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (a significant 

new use is any use other than as 

allowed by the section 5(e) consent 

order which includes analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), and (o) (use in a consumer 

product that could be spray applied). 

(iii) Disposal. Requirements as 

specified in § 721.85(a)(1) and (b)(1) (at 

a temperature of at least 1,000 degrees 

C with a minimum residence time of 2 

seconds). 

(iv) Release to water. Requirements as 

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

(c)(1), except for releases allowed by the 

section 5(e) the consent order. 

(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), (f), (h), (j), and 

(k) are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 9. Add § 721.10700 to subpart E to 

read as follows: 

§ 721.10700 Polyfluorinated alkyl thio 

polyacrylamide (generic). 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as polyfluorinated alkyl thio 

polyacrylamide (PMNs P–11–530 and 

P–11–533) 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) Hazard communication program. A 

significant new use of the substances is 

any manner or method of manufacture, 

or processing associated with any use of 

the substances without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for the substances, the 

employer becomes aware that the 

substances may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If the substance(s) is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance(s) is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance(s) from the employer, or who 

have received the PMN substance(s) 

from the employer within 5 years from 

the date the employer becomes aware of 

the new information described in 

paragraph (a)(2)(i)(A) of this section, are 

provided an MSDS containing the 

information required under paragraph 

(a)(2)(i)(A) of this section within 90 days 

from the time the employer becomes 

aware of the new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (a significant 

new use is any use other than as 

allowed by the section 5(e) consent 

order which includes analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), (o) (use in a consumer 

product that could be spray applied), 

(q), and (t). 

(iii) Disposal. Requirements as 

specified in § 721.85(a)(1) and (b)(1) (at 

a temperature of at least 1,000 degrees 

C with a minimum residence time of 2 

seconds). 

(iv) Release to water. Requirements as 

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

(c)(1), except for releases allowed by the 

section 5(e) the consent order. 

(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), (f), (h), (j), and 

(k) are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to 

paragraph (a)(2)(ii) of 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 § 721.10701 to subpart E to 

read as follows: 

§ 721.10701 Polyfluorinated alkyl amine 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyfluorinated alkyl 

amine (PMN P–11–532) is subject to 

reporting under this section for the 


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significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture 

or processing associated with any use of 

this substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If this substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

(a)(2)(i)(A) of this section, are provided 

an MSDS containing the information 

required under paragraph (a)(2)(i)(A) of 

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (a significant 

new use is any use other than as 

allowed by the section 5(e) consent 

order which includes analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), and (o) (use in a consumer 

product that could be spray applied). 

(iii) Disposal. Requirements as 

specified in § 721.85(a)(1) and (b)(1) (at 

a temperature of at least 1,000 degrees 

C with a minimum residence time of 2 

seconds). 

(iv) Release to water. Requirements as 

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

(c)(1), except for releases allowed by the 

section 5(e) the consent order. 

(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), (f), (h), (i), (j), and 

(k) are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 11. Add § 721.10702 to subpart E to 

read as follows: 

§ 721.10702 Polyfluorinated alkyl thio 

polyacrylic acid-acrylamide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyfluorinated alkyl thio 

polyacrylic acid-acrylamide (PMN P– 

11–534) 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) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture, 

or processing associated with any use of 

this substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If this substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

(a)(2)(i)(A) of this section, are provided 

an MSDS containing the information 

required under paragraph (a)(2)(i)(A) of 

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (a significant 

new use is any use other than as 

allowed by the section 5(e) consent 

order which includes analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), (o) (use in a consumer 

product that could be spray applied), 

(q), and (t). 

(iii) Disposal. Requirements as 

specified in § 721.85(a)(1) and (b)(1) (at 

a temperature of at least 1,000 degrees 

C with a minimum residence time of 2 

seconds). 

(iv) Release to water. Requirements as 

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

(c)(1), except for releases allowed by the 

section 5(e) the consent order . 

(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), (f), (h), (i), (j), and 

(k) are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 12. Add § 721.10703 to subpart E to 

read as follows: 

§ 721.10703 Multi-walled carbon 

nanotubes (generic). 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as multi-walled carbon 

nanotubes (PMNs P–12–416, P–12–417, 

P–12–418, and P–12–419) are subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this section do not 

apply to quantities of the PMN 

substances that have been completely 

reacted (cured); incorporated or 

embedded into a polymer matrix that 

itself has been completely reacted 

(cured); imbedded into a permanent 

polymer form that is not intended to 

undergo further processing; or 

incorporated into an article as defined at 

40 CFR 721.3(c). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(4), (National Institute of 

Occupational Safety and Health 

(NIOSH)-certified air-purifying, tightfitting full-face respirator equipped with 

N–100, or P–100, or R–100 filters or 

power air-purifying particulate 

respirator), (a)(6)(i), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 


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operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k) and (q). 

(iii) Release to water. Requirements as 

specified in § 721.90(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), (e), (i), and (k) 

are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 13. Add § 721.10704 to subpart E to 

read as follows: 

§ 721.10704 Aryl-substituted alkane. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as an aryl-substituted alkane 

(PMN P–12–548) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(concentration set at 1.0 percent), and 

(c). 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e) 

(concentration set at 1.0 percent), (f), 

(g)(1)(iv), (g)(1)(ix), (g)(2)(i), (g)(2)(v), 

and (g)(3)(ii) and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). It is a 

significant new use to conduct testing 

on the chemical substance to comply 

with REACH (Regulation, Evaluation, 

Authorization, and Restriction of 

Chemicals in the European Union) 

without submitting all final reports and 

the underlying data of the testing to EPA 

no later than 90 days after submission 

of the testing to the European Union. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (f), (g), (h), 

and (i) are applicable to manufacturers 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 14. Add § 721.10705 to subpart E to 

read as follows: 

§ 721.10705 Aromatic amine with cyclo 

amino carbonyls (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic amine with 

cyclo amino carbonyls (PMN P–12–572) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), 

(NIOSH-certified particulate respirator 

with an APF of at least 10), (a)(6)(i), 

(a)(6)(ii), (b) (concentration set 0.1 

percent), and (c). When determining 

which persons are reasonably likely to 

be exposed as required for 

§ 721.63(a)(4), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

NIOSH-certified respirators with an APF 

of at least 10 meet the requirements of 

§ 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

high efficiency particulate absorption 

(HEPA) filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting face piece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full face piece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(iii) 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), (d), (e), (i), and (k) 

are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 15. Add § 721.10706 to subpart E to 

read as follows: 

§ 721.10706 Infused carbon 

nanostructures (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as infused carbon 

nanostructures (PMN P–12–576) 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. A significant new 

use is any manufacturing process other 

than that described in the 

premanufacture notice (PMN) which 

includes the incorporation of the PMN 

substance into pellets. 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 16. Add § 721.10707 to subpart E to 

read as follows: 

§ 721.10707 Substituted benzyl acrylate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

substituted benzyl acrylate (PMN P–13– 

127) 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 


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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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 17. Add § 721.10708 to subpart E to 

read as follows: 

§ 721.10708 Zirconium substituted 

heteropolycyclic (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as zirconium substituted 

heteropolycyclic (PMN P–13–152) 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=10). 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 18. Add § 721.10709 to subpart E to 

read as follows: 

§ 721.10709 Alkylphenol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkylphenol (PMN P–13– 

168) 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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 19. Add § 721.10710 to subpart E to 

read as follows: 

§ 721.10710 4, 7-Methano-1H-indene, 3a, 

4, 7, 7a-tetrahydro-, polymer with 2-methyl1, 3-butadiene and 5-(1- 

methylethenyl)bicyclo[2.2.1]hept-2-ene. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

4, 7-methano-1H-indene, 3a, 4, 7, 7atetrahydro-, polymer with 2-methyl-1, 3- 

butadiene and 5-(1- 

methylethenyl)bicyclo[2.2.1]hept-2-ene 

(PMN P–13–192; CAS No. 1412159–51– 

3) 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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 20. Add § 721.10711 to subpart E to 

read as follows: 

§ 721.10711 Alkyl substituted catechol 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkyl substituted catechol 

(PMN P–13–197) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4) 

(NIOSH-certified particulate respirator 

with an APF of at least 1,000), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., place policies 

and procedures) shall be considered and 

implemented to prevent exposure, 

where feasible. The following NIOSHcertified respirators with an APF of at 

least 1,000 meet the requirements of 

§ 721.63(a)(4); 

(A) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

full face piece. 

(B) NIOSH-certified pressure-demand 

supplied-air respirator equipped with a 

full face piece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(iii) Release to water. Requirements as 

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

(c)(4) (N=20). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 21. Add § 721.10712 to subpart E to 

read as follows: 

§ 721.10712 Antimony 

tris(dialkyldithiocarbamate) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as antimony 

tris(dialkyldithiocarbamate) (PMN P– 

13–217) 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=4). 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 22. Add § 721.10713 to subpart E to 

read as follows: 

§ 721.10713 Antimony 

tris(dialkyldithiocarbamate) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as antimony 

tris(dialkyldithiocarbamate) (PMN P– 


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13–259) 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=4). 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 23. Add § 721.10714 to subpart E to 

read as follows: 

§ 721.10714 Zinc 

bis(dialkyldithiocarbamate) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as zinc 

bis(dialkyldithiocarbamate) (PMN P– 

13–260) 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=7). 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 24. Add § 721.10715 to subpart E to 

read as follows: 

§ 721.10715 Carbonic acid, dialkyl ester 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbonic acid, dialkyl 

ester (PMN P–13–346) 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(f), (j), and (s) 

(100,000 kilograms). 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 25. Add § 721.10716 to subpart E to 

read as follows: 

§ 721.10716 Phenol, 2,6-dimethyl-, 

homopolymer, ether with 2,2’,3,3’,5,5’- 

hexamethyl[1,1’-biphenyl]-4,4’-diol 

(2:1),bis[(ethenylphenyl)methyl] ether. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phenol, 2,6-dimethyl-, homopolymer, 

ether with 2,2’,3,3’,5,5’-hexamethyl[1,1’- 

biphenyl]-4,4’-diol 

(2:1),bis[(ethenylphenyl)methyl] ether 

(PMN P–13–355, CAS No. 558452–77–0) 

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) Release to water. Requirements as 

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

(c)(4) (N=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 (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 26. Add § 721.10717 to subpart E to 

read as follows: 

§ 721.10717 MDI modified polyalkene 

glycols (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as MDI modified polyalkene 

glycols (PMN P–13–365) 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), (a)(6)(ii) and (a)(6)(v), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(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), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 27. Add § 721.10718 to subpart E to 

read as follows: 

§ 721.10718 Substituted picolinic acid 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted picolinic acid 

(PMN P–13–374) 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. A significant new 

use is any use other than as a pesticide 

intermediate. 

(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 


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§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 28. Add § 721.10719 to subpart E to 

read as follows: 

§ 721.10719 Acrylic acid esters polymers, 

reaction products with polyisocyanate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as acrylic acid esters 

polymers, reaction products with 

polyisocyanate (PMN P–13–392) 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), (a)(6)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

NIOSH-certified respirators with an APF 

of at least 10 meet the requirements of 

§ 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting face piece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full face piece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 29. Add § 721.10720 to subpart E to 

read as follows: 

§ 721.10720 1,3-Benzenedicarboxylic acid, 

polymer with 1,4-benzenedicarboxylic acid, 

1,4-dimethyl 1,4-benzenedicarboxylate, 2,2- 

dimethyl-1,3-propanediol,dodecanedioic 

acid, 1,2-ethanediol, hexanedioic acid, 1,6- 

hexanediol, alkyldiol ester and aromatic 

isocyanate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 1,3-Benzenedicarboxylic 

acid, polymer with 1,4- 

benzenedicarboxylic acid, 1,4-dimethyl 

1,4-benzenedicarboxylate, 2,2-dimethyl1,3-propanediol,dodecanedioic acid, 

1,2-ethanediol, hexanedioic acid, 1,6- 

hexanediol, alkyldiol ester and aromatic 

isocyanate (PMN P–13–393) 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), (a)(6)(ii) and (a)(6)(v), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(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), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 30. Add § 721.10721 to subpart E to 

read as follows: 

§ 721.10721 Poly(oxy-1,2-ethanediyl), 

.alpha.,.alpha.′-[(1-methylethylidene)di-4,1- 

phenylene]bis[.omega.-[[6-(2,5-dihydro-2,5- 

dioxo-1H-pyrrol-1-yl)-1-oxohexyl]oxy]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

poly(oxy-1,2-ethanediyl), 

.alpha.,.alpha.′-[(1-methylethylidene)di4,1-phenylene]bis[.omega.-[[6-(2,5- 

dihydro-2,5-dioxo-1H-pyrrol-1-yl)-1- 

oxohexyl]oxy]- (PMN P–13–455) 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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 31. Add § 721.10722 to subpart E to 

read as follows: 

§ 721.10722 Oxirane,2-[(1-propen-1- 

yloxy)methyl]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

oxirane,2-[(1-propen-1-yloxy)methyl]- 

(PMN P–13–468; CAS No. 1607–23–4) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), 

(a)(6)(ii), (a)(6)(v), (b)(1) (concentration 

set at 0.1 percent), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following NIOSH-certified respirators 

with an APF of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 


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Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Rules and Regulations 8293 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting face piece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full face piece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(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) through (e) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 32. Add § 721.10723 to subpart E to 

read as follows: 

§ 721.10723 Methylene diisocyanate 

polymer with polypropylene glycol and 

diols (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as methylene diisocyanate 

polymer with polypropylene glycol and 

diols (PMN P–13–471) 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), (a)(6)(i), (a)(6)(ii), 

(a)(6)(v), and (c). When determining 

which persons are reasonably likely to 

be exposed as required for 

§ 721.63(a)(4), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

NIOSH-certified respirators with an APF 

of at least 10 meet the requirements of 

§ 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting face piece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full face piece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(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 and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 33. Add § 721.10724 to subpart E to 

read as follows: 

§ 721.10724 Oxirane, [[2-(2- 

ethenyloxy)ethoxy]methyl]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

oxirane, [[2-(2- 

ethenyloxy)ethoxy]methyl]- (PMN P– 

13–472; CAS No. 16801–19–7) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), 

(a)(6)(ii), (a)(6)(v), (b)(concentration set 

at 0.1 percent), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following NIOSH-certified respirators 

with an APF of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting face piece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full face piece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(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) through (e) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2014–03079 Filed 2–11–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2013–0704; FRL–9905–59] 

Bacillus thuringiensis Cry1F Protein in 

Soybean; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the plantincorporated protectant (PIP), Bacillus 

thuringiensis Cry1F protein, in or on the 

food commodity soybean. Dow 

AgroSciences LLC submitted a petition 

to EPA under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), requesting 

an exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of Bacillus 

thuringiensis Cry1F protein in soybean 

under the FFDCA. 

DATES: This regulation is effective 

February 12, 2014. Objections and 

requests for hearings must be received 

on or before April 14, 2014, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0704, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 


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