Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations 43527 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Directive 023–01 and Commandant 

Instruction M16475.1D, which guide the 

Coast Guard in complying with the 

National Environmental Policy Act of 

1969 (42 U.S.C. 4321–4370f), and have 

determined that this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves safety 

zone that impacts a less than a one-mile 

stretch of the Upper Mississippi River 

for approximately three hours on one 

day. It is categorically excluded from 

further review under paragraph L60(a) 

of Appendix A, Table 1 of DHS 

Instruction Manual 023–01–001–01, 

Rev. 01. A Record of Environmental 

Consideration supporting this 

determination is available in the docket 

where indicated under ADDRESSES. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to contact the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

and Department of Homeland Security 

Delegation No. 0170.1. 

■ 2. Add § 165.T08–0724 to read as 

follows: 

§ 165. T08–0742 Safety Zone; Mile Markers 

751.2 to 751.8, Upper Mississippi River, 

Alma, WI. 

(a) Location. The following area is a 

safety zone: All navigable waters of the 

Mississippi River between mile marker 

(MM) 751.2 and MM 751.8, Alma, WI. 

(b) Effective period. This section will 

be enforced from September 28, 2018 

through October 15, 2018. 

(c) Enforcement period. This section 

will be enforced for three hours on one 

day, two hours prior to, thirty minutes 

during, and thirty minutes after the 

completion of demolition at the 

Dairyland Power Cooperative Station in 

Alma, WI. The Captain of the Port 

Sector Upper Mississippi River (COTP) 

or a designated representative will 

inform the public of the enforcement 

through Broadcast Notices to Mariners 

(BNMs), Local Notices to Mariners 

(LNMs) and/or Safety Marine 

Information Broadcasts (SMIBs) or other 

means of public notice at least three 

hours in advance of the enforcement of 

this safety zone. 

(d) Regulations. (1) In accordance 

with the general regulations in § 165.23 

of this part, persons and vessels are 

prohibited from entering the safety zone 

unless authorized by the COTP or a 

designated representative. A designated 

representative is a commissioned, 

warrant, or petty officer of the U.S. 

Coast Guard assigned to units under the 

operational control of USCG Sector 

Upper Mississippi River. A designated 

representative may be a Patrol 

Commander (PATCOM). The PATCOM 

may be aboard either a Coast Guard or 

Coast Guard Auxiliary vessel. The Patrol 

Commander may be contacted on 

Channel 16 VHF–FM (156.8 MHz) by 

the call sign ‘‘PATCOM’’. 

(2) Persons or vessels desiring to enter 

into or pass through the zone must 

request permission from the COTP or a 

designated representative. They may be 

contacted on VHF–FM channel 16 or by 

telephone at 314–269–2332. 

(3) If permission is granted, all 

persons and vessels shall comply with 

the instructions of the COTP or 

designated representative. 

(e) Informational broadcasts. The 

COTP or a designated representative 

will inform the public through 

Broadcast Notices to Mariners (BNMs), 

Local Notices to Mariners (LNMs) and/ 

or Safety Marine Information Broadcasts 

(SMIBs) or other means of public notice 

of the enforcement period for the 

temporary safety zone as well as any 

changes in the dates and times of 

enforcement. 

Dated: August 21, 2018. 

Stormer, Scott A., 

Captain, U.S. Coast Guard, Captain of the 

Port Sector Upper Mississippi River. 

[FR Doc. 2018–18453 Filed 8–24–18; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2017–0560; FRL–9982–77] 

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 10 chemical substances 

which were the subject of 

premanufacture notices (PMNs). The 

chemical substances are subject to 

Orders issued by EPA pursuant to 

section 5(e) of TSCA. This action 

requires persons who intend to 

manufacture (defined by statute to 

include import) or process any of these 

10 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 

initiates EPA’s evaluation of the 

intended use within the applicable 

review period. Persons may not 

commence manufacture or processing 

for the significant new use until EPA 

has conducted a review of the notice, 

made an appropriate determination on 

the notice, and has taken such actions 

as are required with that determination. 

DATES: This rule is effective on October 

26, 2018. For purposes of judicial 

review, this rule shall be promulgated at 

1 p.m. (e.s.t.) on September 10, 2018. 

Written adverse comments on one or 

more of these SNURs must be received 

on or before September 26, 2018 (see 

Unit VI. of the SUPPLEMENTARY

INFORMATION). If EPA receives written 

adverse commentsts, on one or more of 

these SNURs before September 26, 2018, 

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–2017–0560, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 


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or other information whose disclosure is 

restricted by statute. 

• 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: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

For technical information contact: 

Kenneth Moss, Chemical Control 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

telephone number: (202) 564–9232; 

email address: moss.kenneth@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: 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 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 

September 26, 2018 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 preparing and submitting your 

comments, see the commenting tips at 

http://www.epa.gov/dockets/ 

comments.html. 

II. Background 

A. What action is the Agency taking? 

1. Direct Final Rule. EPA is 

promulgating these SNURs using direct 

final rule 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 obligates EPA to 

assess risks that may be associated with 

the significant new uses under the 

conditions of use and, if appropriate, to 

regulate the proposed uses before they 

occur. 

2. Proposed Rule. In addition to this 

direct final rule, elsewhere in this issue 

of the Federal Register, EPA is issuing 

a notice of proposed rulemaking for this 

rule. If EPA receives no adverse 

comment, the Agency will not take 

further action on the proposed rule and 

the direct final rule will become 

effective as provided in this action. If 

EPA receives adverse comment on one 

or more of SNURs in this action by 

September 11, 2018 (see Unit VI. of the 

SUPPLEMENTARY INFORMATION), the 

Agency will publish in the Federal 

Register a timely withdrawal of the 

specific SNURs that the adverse 

comments pertain to, informing the 

public that the actions will not take 

effect. EPA would then address all 

adverse public comments in a response 

to comments document in a subsequent 

final rule, based on the proposed rule. 

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 (15 

U.S.C. 2604(a)(1)(B)(i)). TSCA 

furthermore prohibits such 

manufacturing or processing from 

commencing until EPA has conducted a 

review of the notice, made an 

appropriate determination on the notice, 

and taken such actions as are required 

in association with that determination 

(15 U.S.C. 2604(a)(1)(B)(ii)). As 

described in Unit V., the general SNUR 

provisions are found at 40 CFR part 721, 

subpart A. 

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 must either 

determine that the significant new use 

is not likely to present an unreasonable 

risk of injury or take such regulatory 

action as is associated with an 

alternative determination before the 

manufacture or processing for the 

significant new use can commence. If 


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EPA determines that the significant new 

use is not likely to present an 

unreasonable risk, EPA is required 

under TSCA section 5(g) to make public, 

and submit for publication in the 

Federal Register, a statement of EPA’s 

findings. 

III. Significant New Use Determination 

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

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

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

statute authorizes EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 10 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 

10 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) 

Order. 

• Information identified by EPA that 

would help characterize the potential 

health and/or environmental effects of 

the chemical substance in support of a 

request by the PMN submitter to modify 

the Order, or if a manufacturer or 

processor is considering submitting a 

SNUN for a significant new use 

designated by the SNUR. 

This information may include testing 

required in a TSCA section 5(e) Order 

to be conducted by the PMN submitter, 

as well as testing not required to be 

conducted but which would also help 

characterize the potential health and/or 

environmental effects of the PMN 

substance. Any recommendation for 

information identified by EPA was 

made based on EPA’s consideration of 

available screening-level data, if any, as 

well as other available information on 

appropriate testing for the chemical 

substance. Further, any such testing 

identified by EPA that includes testing 

on vertebrates was made after 

consideration of available toxicity 

information, computational toxicology 

and bioinformatics, and highthroughput screening methods and their 

prediction models. EPA also recognizes 

that whether testing/further information 

is needed will depend on the specific 

exposure and use scenario in the SNUN. 

EPA encourages all SNUN submitters to 

contact EPA to discuss any potential 

future testing. See Unit VIII. for more 

information. 

• CFR citation assigned in the 

regulatory text section of this rule. 

The regulatory text sections of these 

rules specify the activities designated as 

significant new uses. Certain new uses, 

including exceedance of 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. 

These rules include 10 PMN 

substances that are subject to Orders 

under TSCA section 5(e)(1)(A). Each 

Order is based on one or more of the 

findings in TSCA section 5(a)(3)(B): 

There is insufficient information to 

permit a reasoned evaluation; in the 

absence of sufficient information to 

permit a reasoned evaluation, the 

activities associated with the PMN 

substances may present unreasonable 

risk to human health or the 

environment; the substance is or will be 

produced in substantial quantities, and 

enters or may reasonably be anticipated 

to enter the environment in substantial 

quantities or there is or may be 

significant (substantial) human 

exposure to the substance. Those Orders 

require protective measures to limit 

exposures or otherwise mitigate the 

potential unreasonable risk. The SNURs 

identify as significant new uses any 

manufacturing, processing, use, 

distribution in commerce, or disposal 

that does not conform to the restrictions 

imposed by the underlying Orders, 

consistent with TSCA section 5(f)(4). 

Where EPA determines that the PMN 

substance may present an unreasonable 

risk of injury to human health via 

inhalation exposure, the underlying 

TSCA section 5(e) Order requires, 

among other things, that potentially 

exposed employees wear specified 

respirators unless actual measurements 

of the workplace air show that air-borne 

concentrations of the PMN substance 

are below a New Chemical Exposure 

Limit (NCEL) that is established by EPA 

to provide adequate protection to 

human health. In addition to the actual 

NCEL concentration, the comprehensive 

NCELs provisions in TSCA section 5(e) 

Orders, which are modeled after 

Occupational Safety and Health 

Administration (OSHA) Permissible 

Exposure Limits (PELs) provisions, 

include requirements addressing 

performance criteria for sampling and 

analytical methods, periodic 

monitoring, respiratory protection, and 

recordkeeping. However, no comparable 

NCEL provisions currently exist in 40 

CFR part 721, subpart B, for SNURs. 

Therefore, for these cases, the 

individual SNURs in 40 CFR part 721, 

subpart E, will state that persons subject 

to the SNUR who wish to pursue NCELs 

as an alternative to the § 721.63 

respirator requirements may request to 

do so under § 721.30. EPA expects that 

persons whose § 721.30 requests to use 

the NCELs approach for SNURs that are 

approved by EPA will be required to 

comply with NCELs provisions that are 

comparable to those contained in the 

corresponding TSCA section 5(e) Order 

for the same chemical substance. 

PMN Number: P–13–307 

Chemical name: Substituted 

carbocycle, N-[[[4-[[(4-substituted 

carbocyclic)amino]sulfonyl]carbocyclic]

amino]carbonyl]-4-methyl-(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: July 31, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as a component of manufactured 

consumer article—contained use. Based 

on SAR analysis of test data on 

analogous substances, EPA has 

identified concerns for systemic toxicity 

on the spleen, liver and thymus, blood 

effects, developmental toxicity and 

immunotoxicity. Based on SAR analysis 

for amides, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 5 parts per 

billion (ppb) in surface waters. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 


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health and the environment. To protect 

against these risks, the Order requires: 

1. Submission of certain toxicity 

testing prior to exceeding the 

confidential production volume limit 

specified in the Order; 

2. Use of personal protective 

equipment, including impervious 

gloves, to prevent dermal exposure; 

3. Use of NIOSH certified respirators 

with Assigned Protection Factor (APF) 

of 10 to prevent inhalation exposures or 

compliance with a NCEL of 4 mg/m3 as 

an 8-hour time-weighted average to 

prevent inhalation exposure; 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the Safety Data 

Sheet (SDS); 

5. Refraining from manufacturing the 

PMN substance in the United States 

(i.e., import only); 

6. Use of the PMN substance only for 

the confidential use specified in the 

Order; and 

7. No release of the PMN substances 

resulting in surface water 

concentrations that exceed 30 ppb. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN substances may be potentially 

useful to characterize the effects of the 

PMN substances in support of a request 

by the PMN submitter to modify the 

Order, or if a manufacturer or processor 

is considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. The submitter 

has agreed not to exceed a certain 

production volume limit without 

performing specific organ toxicity 

testing. 

CFR citation: 40 CFR 721.11116. 

PMN Numbers: P–16–316 and P–16–317 

Chemical name: Aliphatic polyester 

(generic). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: July 27, 2017. 

Basis for TSCA section 5(e) Order: 

The PMNs state that the generic (nonconfidential) use of the substances will 

be as drilling chemicals. Based on SAR 

analysis of test data on analogous 

substances, EPA has identified concerns 

for kidney toxicity. The Order was 

issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substances may 

present an unreasonable risk of injury to 

health and the environment. To protect 

against these risks, the Order requires: 

1. Use of the PMN substances only for 

the confidential use specified in the 

Order; and 

2. Manufacture (which under TSCA 

includes import) the PMN substances 

with a average molecular weight no 

lower than 22,000 for P–16–0316 and no 

lower than 14,000 for P–16–0317 and 

species with a molecular weight less 

than 500 present at a maximum of 2% 

by weight. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the fate, environmental toxicity 

and human health toxicity of the PMN 

substances may be potentially useful to 

characterize the effects of the PMN 

substances in support of a request by the 

PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. EPA has 

determined that the results of water 

solubility and log Kow testing, acute 

and chronic aquatic toxicity testing and 

developmental toxicity testing may be 

potentially useful in characterizing the 

health and environmental effects of the 

PMN substances. Although the Order 

does not require these tests, the Order’s 

restrictions will remain in effect until 

the Order is modified or revoked by 

EPA based on submission of this or 

other relevant information. 

CFR citations: 40 CFR 721.11117. 

PMN Number: P–16–342 

Chemical name: Modified acrylic 

polymer (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: August 7, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as a dispersant for deflocculation of 

pigments in industrial paints and 

coatings. Based on SAR analysis of test 

data on analogous substances, EPA has 

identified concerns for lung toxicity. 

The Order was issued under TSCA 

sections 5(a)(3)(B)(ii)(I) and 

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to health and the 

environment. To protect against these 

risks, the Order requires: 

1. Refrain from manufacturing the 

PMN substance in the United States 

(i.e., import only); 

2. Use of the PMN substance only as 

a dispersant for deflocculation of 

pigments in industrial paints and 

coatings; 

3. Use the PMN substance in the 

paint/coating formulation at a 

concentration not greater than 1 percent 

by weight or volume; 

4. No modification of the processing 

method or use activities of the PMN 

substance that would allow inhalation 

exposure to the PMN substance by 

vapor, dust, mist or aerosols at 

concentrations greater than 1 percent by 

weight or volume; and 

5. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the (SDS). 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN substances may be potentially 

useful to characterize the effects of the 

PMN substances in support of a request 

by the PMN submitter to modify the 

Order, or if a manufacturer or processor 

is considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. EPA has 

determined that the results of 

pulmonary toxicity testing may be 

potentially useful in characterizing the 

health effects of the PMN substance. 

Although the Order does not require 

these tests, the Order’s restrictions will 

remain in effect until the Order is 

modified or revoked by EPA based on 

submission of this or other relevant 

information. 

CFR citation: 40 CFR 721.11118. 

PMN Numbers: P–16–406 and P–16–407 

Chemical names: Functionalized 

polyimide (generic). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: July 27, 2017. 

Basis for TSCA section 5(e) Order: 

The PMNs state that the generic (nonconfidential) use of the substances will 

be as coating for solid substrates. Based 

on SAR analysis of test data on 

analogous substances, EPA has 

identified concerns for lung toxicity. 

The Order was issued under TSCA 

sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), 

based on a finding that the information 

available to the Agency is insufficient to 

permit a reasoned evaluation of the 

human health effects. To protect against 

any potential risks the Order requires: 

1. Use of the PMN substances only as 

a coating for solid substrates; 

2. No use of the PMN substances 

involving application methods that 


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generate inhalation exposures to the 

PMN substance by vapor, dust, mist or 

aerosols; and 

3. No modification of manufacturing 

process of the PMN substances such that 

workers would be exposed through 

inhalation. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN substances may be potentially 

useful to characterize the effects of the 

PMN substances in support of a request 

by the PMN submitter to modify the 

Order, or if a manufacturer or processor 

is considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. EPA has 

determined that the results of 

pulmonary toxicity testing may be 

potentially useful in characterizing the 

health effects of the PMN substances. 

Although the Order does not require 

these tests, the Order’s restrictions will 

remain in effect until the Order is 

modified or revoked by EPA based on 

submission of this or other relevant 

information. 

CFR citation: 40 CFR 721.11119. 

PMN Number: P–16–413 

Chemical name: Siloxanes and 

Silicones, di-Me, 3-hydroxypropyl Me, 

Me 3,3,4,4,5,5,6,6,6-nonafluorohexyl. 

CAS number: 1610862–54–8. 

Effective date of TSCA section 5(e) 

Order: July 13, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the use of the PMN 

substance is as an anti-fingerprint 

material for a metal coating application. 

Based on SAR analysis of test data on 

analogous substances, EPA has 

identified concerns for lung toxicity 

based on waterproofing of the lung if 

inhaled. The Order was issued under 

TSCA sections 5(a)(3)(B)(ii)(I) and 

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to health and the 

environment. To protect against these 

risks, the Order requires: 

1. Submission of certain fate testing 

on the PMN substance prior to 

exceeding the production volume limits 

specified in the Order; 

2. No processing or use of the PMN 

substance in a manner that results in 

inhalation exposure due to spray, mist 

or aerosol; 

3. Refraining from manufacturing the 

PMN substance in the United States 

(i.e., import only); and 

4. No release of the PMN substance 

into the waters of the United States. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the fate and human health toxicity 

of the PMN substance may be 

potentially useful to characterize the 

effects of the PMN substance in support 

of a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. The 

submitter has agreed not to exceed the 

confidential production limit without 

performing a UV/visible absorption test, 

a direct and indirect photolysis test, 

aerobic and anaerobic transformation in 

soil test and aerobic and anaerobic 

transformation in sediment test. In 

addition, EPA has determined that the 

results of pulmonary toxicity testing 

may be potentially useful in 

characterizing the human health effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions will remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11120. 

PMN Number: P–16–455 

Chemical name: Sodium Tungsten 

Oxide. 

CAS number: 11120–01–7. 

Effective date of TSCA section 5(e) 

Order: November 2, 2016. 

Basis for TSCA section 5(e) Order: 

The PMN states that the use of the PMN 

substance will be as a component of 

infrared absorption material. Based on 

test data on an analog, EPA has 

identified concerns for lung toxicity and 

carcinogenicity. The Order was issued 

under TSCA sections 5(a)(3)(B)(ii)(I) and 

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to health and the 

environment. EPA assessed risks based 

on the disposal processes and 

engineering controls described in the 

PMN. To protect against these risks, the 

Order requires: 

1. Submission of certain toxicity 

testing on the PMN substance prior to 

exceeding the confidential production 

volume limit specified in the Order; 

2. Use of personal protective 

equipment, including impervious 

gloves, to prevent dermal exposure; 

3. Use of NIOSH certified respirators 

with a minimum (APF) of 1000 to 

prevent inhalation exposure or 

compliance with a NCEL of 0.3 mg/m3

as an 8-hour time-weighted average to 

prevent inhalation exposure; 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the (SDS); 

5. Use of the PMN substance only as 

a component of infrared absorption 

material; 

6. No use of the PMN substance 

involving application methods that 

generate dust, mist or aerosol unless 

such application method occurs within 

an enclosed process; 

7. No release of the PMN substance 

into the waters of the United States; and 

8. The PMN substance and any waste 

streams from manufacture, processing, 

and use containing the PMN substance 

must be disposed of only by 

incineration or landfill. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and 

environmental toxicity of the PMN 

substance may be potentially useful to 

characterize the effects of the PMN 

substance in support of a request by the 

PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. The submitter 

has agreed not to exceed the 

confidential production limit without 

performing specific pulmonary toxicity 

and carcinogenicity testing. In addition, 

EPA has determined that the results of 

certain chronic aquatic toxicity testing 

may be potentially useful in 

characterizing the environmental effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions will remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11121. 

PMN Number: P–16–503 

Chemical name: Fatty acids, tall-oil, 

polymers with alkanoic acid, 

substituted carbomonocycle, alkyl 

peroxide-initiated (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: January 11, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the nonconfidential use of the PMN substance 

will be as a site-limited polymer 

intermediate for production of a deck 

stain coating resin additive. Based on 

physical-chemical properties of the 

PMN substance, EPA identified low 


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concerns for human health and 

environmental effects. However if the 

PMN substance were manufactured 

differently, EPA identified concerns for 

developmental toxicity and aquatic 

toxicity. The Order was issued under 

TSCA sections 5(a)(3)(B)(ii)(I) and 

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to health and the 

environment. To protect against these 

risks, the Order requires: 

1. Manufacture (including import) the 

PMN substance with a number average 

molecular weight no lower than 1500, 

and no more than 24% by weight of acid 

monomer in the polymer; and 

2. Use of the PMN substance only as 

an intermediate 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the fate, human health and 

environmental toxicity of the PMN 

substance may be potentially useful to 

characterize the effects of the PMN 

substance in support of a request by the 

PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. EPA has 

determined that the results of physicalchemical property testing, chronic 

aquatic toxicity testing, and 

developmental toxicity testing may be 

potentially useful in characterizing the 

health and environmental effects of the 

PMN substance. Although the Order 

does not require these tests, the Order’s 

restrictions will remain in effect until 

the Order is modified or revoked by 

EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11122. 

PMN Number: P–16–570 

Chemical name: Carboxylic acids, C6– 

18 and C8–15-di, polymers with 

diethylene glycol, glycerol, oleic acid, 

phthalic acid and sorbitol. 

CAS number: 1877295–51–6. 

Effective date of TSCA section 5(e) 

Order: August 5, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the use of the PMN 

substance will be as an aromatic 

polyester polyol for manufacturing rigid 

foam. Based on test data on an analog, 

EPA has identified concerns for 

reproductive and developmental 

toxicity. Based on SAR analysis for 

esters, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 610 parts per billion (ppb). 

The Order was issued under TSCA 

sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), 

based on a determination that ‘‘the 

information available is insufficient to 

permit a reasoned evaluation of the 

human health effects and the PMN 

substance, ‘‘stating that ‘‘because of the 

absence of sufficient information to 

permit EPA to make such a 

determination and in light of the 

potential risk of human health effects 

posed by the uncontrolled manufacture 

(which includes import), processing, 

distribution in commerce, use and 

disposal of the PMN substance. EPA has 

concluded that uncontrolled 

manufacture, processing, distribution in 

commerce use, and disposal of the PMN 

substance may present an unreasonable 

risk of injury to human health.’’ To 

protect against these risks, the Order 

requires: 

1. Submission of certain toxicity 

testing prior to exceeding the 

confidential production volume limit 

specified in the Order; 

2. Use of personal protective 

equipment to prevent dermal exposures; 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the (SDS); 

4. Manufacture (including import) the 

PMN substance with residual phthalate 

not greater than 0.1% by weight; 

5. Use of the PMN substance only as 

an aromatic polyester polyol for rigid 

foam; 

6. No modification of manufacturing, 

processing or use activities of the PMN 

substance to result in the generation of 

a vapor, mist or aerosol; and 

7. No release of the PMN substance 

into the waters of the United States. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the environmental and human 

health toxicity of the PMN substance 

may be potentially useful to characterize 

the effects of the PMN substance in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. The submitter 

has agreed not to exceed the 

confidential production limit without 

performing specific reproductive/ 

developmental toxicity testing. In 

addition, EPA has determined that the 

results of acute aquatic toxicity testing 

may be potentially useful in 

characterizing the environmental effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions will remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11123. 

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 all 10 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) Orders 

requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. 

The SNURs identify as significant 

new uses any manufacturing, 

processing, use, distribution in 

commerce, or disposal that does not 

conform to the restrictions imposed by 

the underlying Orders, consistent with 

TSCA section 5(f)(4). 

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 either determine 

that the prospective manufacture or 

processing is not likely to present an 

unreasonable risk, or to take necessary 

regulatory action associated with any 

other determination, before the 

described significant new use of the 

chemical substance occurs. 

• EPA will identify as significant new 

uses any manufacturing, processing, 

distribution in commerce, use, or 

disposal that does not conform to the 

restrictions imposed by the underlying 

Orders, consistent with TSCA section 

5(f)(4). 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 


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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. The effective date of 

this rule is October 26, 2018 without 

further notice, unless EPA receives 

written adverse comments before 

September 26, 2018. 

If EPA receives written adverse 

comments on one or more of these 

SNURs before September 26, 2018, EPA 

will withdraw the relevant sections of 

this direct final rule before its effective 

date. 

This rule establishes SNURs for a 

number of chemical substances. Any 

person who submits adverse comments 

must identify the chemical substance 

and the new use to which it applies. 

EPA will not withdraw a SNUR for a 

chemical substance not identified in the 

comment. 

VII. Applicability of the Significant 

New Use Designation 

To establish a significant new use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule have undergone 

premanufacture review. In cases where 

EPA has not received a notice of 

commencement (NOC) and the chemical 

substance has not been added to the 

TSCA Inventory, no person may 

commence such activities without first 

submitting a PMN. Therefore, for 

chemical substances for which an NOC 

has not been submitted EPA concludes 

that the designated significant new uses 

are not ongoing. 

When chemical substances identified 

in this rule are added to the TSCA 

Inventory, EPA recognizes that, before 

the rule is effective, other persons might 

engage in a use that has been identified 

as a significant new use. However, 

TSCA section 5(e) Orders have been 

issued for all of the chemical 

substances, and the PMN submitters are 

prohibited by the TSCA section 5(e) 

Orders from undertaking activities 

which will be designated as significant 

new uses. The identities of 7 of the 10 

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) for a chemical substance 

covered by this action. 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 August 27, 

2018 as the cutoff date for determining 

whether the new use is ongoing. The 

objective of EPA’s approach has been to 

ensure that a person could not defeat a 

SNUR by initiating a significant new use 

before the effective date of the direct 

final rule. 

Persons who begin commercial 

manufacture or processing of the 

chemical substances for a significant 

new use identified as of that date will 

have to cease any such activity upon the 

effective date of the final rule. To 

resume their activities, these persons 

will have to first comply with all 

applicable SNUR notification 

requirements and wait until EPA has 

conducted a review of the notice, made 

an appropriate determination on the 

notice, and has taken such actions as are 

required with that determination. 

VIII. Development and Submission of 

Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular new information (e.g., 

generating test data) before submission 

of a SNUN. There is an exception: 

development of test data is required 

where the chemical substance subject to 

the SNUR is also subject to a rule, order 

or consent agreement under TSCA 

section 4 (see TSCA section 5(b)(1)). 

In the absence of a TSCA section 4 

test rule covering the chemical 

substance, persons are required only to 

submit information in their possession 

or control and to describe any other 

information known to or reasonably 

ascertainable by them (see 40 CFR 

720.50). However, upon review of PMNs 

and SNUNs, the Agency has the 

authority to require appropriate testing. 

Unit IV. lists required or recommended 

testing for all of the listed SNURs. 

Descriptions of this information are 

provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. Furthermore, pursuant to 

TSCA section 4(h), which pertains to 

reduction of testing in vertebrate 

animals, EPA encourages consultation 

with the Agency on the use of 

alternative test methods and strategies 

(also called New Approach 

Methodologies, or NAMs), if available, 

to generate the recommended test data. 

EPA encourages dialog with Agency 

representatives to help determine how 

best the submitter can meet both the 

data needs and the objective of TSCA 

section 4(h). 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 certain of the TSCA section 5(e) 

Orders for 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. Under recent 

TSCA section 5(e) Orders, each PMN 

submitter is required to submit each 

study at least 14 weeks (earlier TSCA 

section 5(e) Orders required 

submissions at least 12 weeks) before 

reaching the specified production limit. 

Listings of the tests specified in the 

TSCA section 5(e) Orders are included 

in Unit IV. The SNURs contain the same 

production volume limits as the TSCA 

section 5(e) 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. 

Any request by EPA for the triggered 

and pended testing described in the 

Orders was made based on EPA’s 

consideration of available screeninglevel data, if any, as well as other 

available information on appropriate 

testing for the PMN substances. Further, 

any such testing request on the part of 

EPA that includes testing on vertebrates 

was made after consideration of 

available toxicity information, 

computational toxicology and 

bioinformatics, and high-throughput 

screening methods and their prediction 

models. 

The potentially useful information 

identified 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 


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early enough so that they will be able 

to generate useful information. 

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. 

• 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 § 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., 

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– 

2017–0560. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This action establishes SNURs for 

several new chemical substances that 

were the subject of PMNs and TSCA 

section 5(e) 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 action. 

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 action. 

This action is within the scope of the 

February 18, 2012 certification. Based 

on the Economic Analysis discussed in 

Unit XI. and EPA’s experience 

promulgating SNURs (discussed in the 

certification), EPA believes that the 

following are true: 

• A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 


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• Submission of the SNUN would not 

cost any small entity significantly more 

than $8,300. 

Therefore, the promulgation of the 

SNUR would not have a significant 

economic impact on a substantial 

number of small entities. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government will be impacted by this 

action. As such, EPA has determined 

that this action 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 action does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This action 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 action. 

G. Executive Order 13045 

This action is not subject to Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This action is not subject to Executive 

Order 13211, entitled ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

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

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

In addition, since this action does not 

involve any technical standards, 

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

note), does not apply to this action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

XIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects 

40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: August 20, 2018. 

Jeffery T. Morris, 

Director, Office of Pollution Prevention and 

Toxics. 

Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971–1975 Comp. p. 973; 42 U.S.C. 241, 

242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 

300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048. 

■ 2. In § 9.1, add the following sections 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB 

control No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.11116 ............................. 2070–0012 

721.11117 ............................. 2070–0012 

721.11118 ............................. 2070–0012 

721.11119 ............................. 2070–0012 

721.11120 ............................. 2070–0012 

721.11121 ............................. 2070–0012 

721.11122 ............................. 2070–0012 

721.11123 ............................. 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 § 721.11116 to subpart E to 

read as follows: 

§ 721.11116 Substituted carbocycle, N-[[[4- 

[[(4-substituted carbocyclic)amino]sulfonyl]

carbocyclic]amino]carbonyl]-4-methyl- 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

substituted carbocycle, N-[[[4-[[(4-

substituted carbocyclic)amino]sulfonyl]

carbocyclic]amino]carbonyl]-4-methyl- 

(PMN P–13–307) 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) 

(when determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (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 


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prevent exposure, where feasible), 

(a)(5)(respirators must provide a 

National Institute for Occupational 

Safety and Health (NIOSH) assigned 

protection factor of at least 10 or 

maintain workplace airborne 

concentrations), (a)(6)(particulate), 

(b)(concentrations set at 1.0%) and (c). 

(A) As an alternative to the respirator 

requirements in paragraph (a)(2)(i) of 

this section, a manufacturer or processor 

may choose to follow the new chemical 

exposure limit (NCEL) provision listed 

in the TSCA section 5(e) Order for this 

substance. The NCEL is 4 mg/m3 as an 

8-hour time weighted average. Persons 

who wish to pursue NCELs as an 

alternative to § 721.63 respirator 

requirements may request to do so 

under § 721.30. Persons whose § 721.30 

requests to use the NCELs approach are 

approved by EPA will be required to 

follow NCELs provisions comparable to 

those contained in the corresponding 

TSCA section 5(e) Order. 

(B) [Reserved] 

(ii) Hazard communication. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e)(concentration 

set at 1.0%), (f), (g)(1)(iv), (viii), (ix), 

(g)(2)(ii), (iii), (use respiratory protection 

or maintain workplace airborne 

concentrations below an 8-hour timeweighted average of 4 mg/m3), (g)(2)(v), 

(g)(4)(i), (ii) and (g)(5). Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System (GHS) and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

(iv) Release to water. Requirements as 

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

(c)(4) where N = 30 ppb. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (i) and (k). 

(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. 

■ 5. Add § 721.11117 to subpart E to 

read as follows: 

§ 721.11117 Aliphatic polyester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as aliphatic polyester (PMNs 

P–16–316 and P–16–317) 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) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). It is a 

significant new use to manufacture the 

PMN substances with an average 

molecular weight lower than 22,000 

daltons for P16–316 and lower than 

14,000 daltons for P–16–317 and 

containing more than 2% by weight of 

molecular weight species less than 500 

daltons. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) 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)(i) of this section. 

■ 6. Add § 721.11118 to subpart E to 

read as follows: 

§ 721.11118 Modified acrylic polymer 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as modified acrylic polymer 

(PMN P–16–342) 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. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e)(concentration 

set at 1.0%), (f), (g)(1)(ii), (g)(2)(ii), and 

(g)(5). Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System (GHS) and 

OSHA Hazard Communication Standard 

may be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f). It is a significant 

new use for any use other than as a 

dispersant for deflocculation of 

pigments in industrial paints and 

coatings, any use in the paint/coating 

formulation at concentration greater 

than 1 percent by weight or volume, and 

any use of the substance that would 

allow inhalation exposure to the 

substance by vapor, dust, mist or 

aerosols at concentrations greater than 1 

percent by weight or volume. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (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. 

■ 7. Add § 721.11119 to subpart E to 

read as follows: 

§ 721.11119 Functionalized polyimide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

as functionalized polyimide (PMN P– 

16–406 and P–16–407) 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) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(y)(1) and (2). It is 

a significant new use to use the 

substances other than as a coating for 

solid substrates. Any manufacturing 

process that results in inhalation 

exposure to the substances is a 

significant new use. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) 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. 

■ 8. Add § 721.11120 to subpart E to 

read as follows: 

§ 721.11120 Siloxanes and Silicones, diMe, 3-hydroxypropyl Me, Me 

3,3,4,4,5,5,6,6,6-nonafluorohexyl. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

siloxanes and silicones, di-Me, 3- 

hydroxypropyl Me, Me 3,3,4,4,5,5,6,6,6- 

nonafluorohexyl (CAS: 1610862–54–8) 

(PMN P–16–413) 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: 


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(i) Industrial, commercial, and 

consumer activities. Requirements are 

described in § 721.80(f) and (p)(40,000 

kilograms and 151,300 kilograms). It is 

a significant new use to process or use 

the PMN substance in a manner that 

results in inhalation exposure to spray, 

mist or aerosol. 

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (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. 

■ 9. Add § 721.11121 to subpart E to 

read as follows: 

§ 721.11121 Sodium tungsten oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

sodium tungsten oxide (CAS No. 11120– 

01–7) (PMN P–16–455) is 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 

substance after they have been 

incorporated into a polymer matrix. 

(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)(when determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (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), 

(a)(5)(respirators must provide a 

National Institute for Occupational 

Safety and Health (NIOSH) assigned 

protection factor of at least 1000, 

(a)(6)(particulate), (b)(concentrations set 

at 0.1%) and (c). 

(A) As an alternative to the respirator 

requirements in paragraph (a)(2)(i) of 

this section, a manufacturer or processor 

may choose to follow the new chemical 

exposure limit (NCEL) provision listed 

in the TSCA section 5(e) Order for this 

substance. The NCEL is 0.3 mg/m3 as an 

8-hour time weighted average. Persons 

who wish to pursue NCELs as an 

alternative to § 721.63 respirator 

requirements may request to do so 

under § 721.30. Persons whose § 721.30 

requests to use the NCELs approach are 

approved by EPA will be required to 

follow NCELs provisions comparable to 

those contained in the corresponding 

TSCA section 5(e) Order. 

(B) [Reserved] 

(ii) Hazard communication. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e)(concentration 

set at 0.1%), (f), (g)(1)(lung effects), 

(g)(1)(vii), (g)(2)(ii), (iii), (g)(2)(use 

respiratory protection or maintain 

workplace airborne concentrations 

below an 8-hour time-weighted average 

of 0.3 mg/m3), (g)(3)(ii), (g)(4)(i), (iii) 

and (g)(5). Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System (GHS) and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q). It is a 

significant new to use the substance 

other than as a component of infrared 

absorption material. It is a significant 

new use to use involving an application 

method that generates a dust, mist, or 

aerosol, unless the application method 

occurs within an enclosed process. 

(iv) Disposal. Requirements as 

specified in § 721.85(a)(1), (2), (b)(1), (2), 

(c)(1), and (2). 

(v) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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)(iii) of this section. 

■ 10. Add § 721.11122 to subpart E to 

read as follows: 

§ 721.11122 Fatty acids, tall-oil, polymers 

with alkanoic acid, substituted 

carbomonocycle, alkyl peroxide-initiated 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acids, tall-oil, 

polymers with alkanoic acid, 

substituted carbomonocycle, alkyl 

peroxide-initiated (PMN P–16–503) 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(g). It is a 

significant new use to manufacture the 

substance with an average molecular 

weight lower than 1,500 dalton or more 

than 24% by weight of acid monomer in 

the polymer. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

■ 11. Add § 721.11123 to subpart E to 

read as follows: 

§ 721.11123 Carboxilic acids, C6–18 and 

C8–15-di, polymers with diethylene glycol, 

glycerol, oleic acid, phthalic, acid and 

sorbitol. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

Carboxilic acids, C6–18 and C8–15-di, 

polymers with diethylene glycol, 

glycerol, oleic acid, phthalic, acid and 

sorbitol (CAS: 1877295–51–6) (PMN P– 

16–570) is 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 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

when determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) 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, 

(b)(concentrations set at 0.1%) and (c). 

(ii) Hazard communication. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e)(concentration 

set at 1.0%), (f), (g)(1)(vi), (ix), (g)(2)(i), 

(ii), (iii), (v), (g)(3)(i), (g)(4)(iii) and 

(g)(5). Alternative hazard and warning 


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statements that meet the criteria of the 

Globally Harmonized System (GHS) and 

OSHA Hazard Communication Standard 

may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q). It is a 

significant new use to use the substance 

other than as an aromatic polyester 

polyol for manufacturing rigid foam. It 

is a significant new use to manufacture 

the substance with residual phthalate 

greater than 0.1% by weight. It is a 

significant new use to modify the 

manufacturing, processing or use 

activities of the PMN substance to result 

in the generation of a vapor, mist or 

aerosol. 

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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)(iii) of this section. 

[FR Doc. 2018–18534 Filed 8–24–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2017–0464; FRL–9982–24] 

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 19 chemical substances 

which were the subject of 

premanufacture notices (PMNs). The 

chemical substances are subject to 

Orders issued by EPA pursuant to 

section 5(e) of TSCA. This action 

requires persons who intend to 

manufacture (defined by statute to 

include import) or process any of these 

19 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 

initiates EPA’s evaluation of the 

intended use within the applicable 

review period. Persons may not 

commence manufacture or processing 

for the significant new use until EPA 

has conducted a review of the notice, 

made an appropriate determination on 

the notice, and has taken such actions 

as are required with that determination. 

DATES: This rule is effective on October 

26, 2018. For purposes of judicial 

review, this rule shall be promulgated at 

1 p.m. (e.s.t.) on September 10, 2018. 

Written adverse comments on one or 

more of these SNURs must be received 

on or before September 26, 2018 (see 

Unit VI. of the SUPPLEMENTARY

INFORMATION). If EPA receives written 

adverse comments on one or more of 

these SNURs before September 26, 2018, 

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–2017–0464, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• 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: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT:

For technical information contact: 

Kenneth Moss, Chemical Control 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

telephone number: (202) 564–9232; 

email address: moss.kenneth@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: 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 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 

September 26, 2018 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 


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