43538 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations 

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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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 26, 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 

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 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 

19 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 


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future testing. See Unit VIII. for more 

information. 

• CFR citation assigned in the 

regulatory text section of this rule. 

The regulatory text section 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 19 PMN 

substances that are subject to Orders 

under TSCA section 5(e)(1)(A)(ii)(I) 

where EPA determined that it has 

insufficient information to conduct a 

reasoned evaluation and the activities 

associated with the PMN substances 

may present unreasonable risk to human 

health or the environment. 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 determined that the PMN 

substance may present an unreasonable 

risk of injury to human health via 

inhalation exposure, the underlying 

TSCA section 5(e) Order usually 

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–15–719 

Chemical name: Benzene, 1,4- 

bis(alkyl)-, homopolymer (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: July 24, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a flame retardant synergist and 

radical source. Based on test data and 

analog data EPA estimates that the PMN 

substances will persist in the 

environment for more than two months 

and estimates a bioaccumulation factor 

of greater than or equal to 1,000. 

Because the PMN substance is expected 

to be persistent and bioaccumulative, 

EPA is unable to assess the potential 

risks to sediment dwelling organisms. 

The Order was issued under TSCA 

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

5(e)(1)(A)(ii)(I), as well as 5(a)(3)(B)(i) 

and 5(e)(1)(A)(i) based on findings that 

the substance may present an 

unreasonable risk of injury to health and 

the environment, and that the 

information available to the Agency is 

insufficient to permit a reasoned 

evaluation of the environmental effects 

of the PMN substance. To protect 

against potential risks, the Order 

requires: 

1. Submit to EPA certain toxicity 

testing prior to exceeding the 

confidential production volume limits 

specified in the Order; 

2. Label containers of the substance 

and provide Safety Data Sheets (SDS) or 

Material Safety Data Sheets (MSDS) and 

worker training in accordance with the 

provisions of the Hazard 

Communication Program section; 

3. Not use the substance other than for 

the confidential uses allowed in the 

Order; 

4. Dispose of the substance only by 

incineration or landfill; and 

5. Comply with the release to water 

provisions. 

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 fate, 

bioaccumulation, 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 aquatic toxicity, 

bioaccumulation and environmental fate 

testing. 

CFR citation: 40 CFR 721.11097. 

PMN Number P–16–99 

Chemical name: Polyethylene glycol 

polymer with aliphatic 

polycarbodiimide Bis(alkoxysilylpropyl) 

amine blocked (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: June 30, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as an additive for industrial coatings. 

EPA identified concerns for irritation to 

all issues and lung toxicity based on 

SAR analysis of test data on analogous 

alkoxysilanes and concerns for acute 

toxicity, neurotoxicity (especially to the 

eye), and liver, kidney, and cardiac 

toxicity based on the release of 

methanol. 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 

the substance may present an 

unreasonable risk of injury to health and 

the environment. To protect against 

potential risks, the Order requires: 

1. Submission to EPA of certain 

toxicity testing prior to exceeding the 

confidential aggregate production 

volume limit specified in the Order; 

2. Use of personal protective 

equipment to prevent dermal exposure 

(where there is a potential for dermal 

exposure); 

3. Use of a National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

Applied Protection Factor (APF) of at 

least 10 (where there is a potential for 

inhalation exposure) or compliance 

with a New Chemicals Exposure Limit 

(NCEL) of 0.9 milligrams per cubic 

meter as an 8-hour time-weighted 

average to prevent inhalation exposure. 

(EPA’s estimates indicate that variations 

of the parameters (including batch size, 

number of processing sites, days per 

year of operation) of the uses identified 

below would not result in inhalation 

exposure that would indicate a different 

respirator.) 

4. Establishment and use of a hazard 

communication program, including 

precautionary statements on each label 

and in the SDS. 

5. Not use the substance other than for 

the use allowed in the Order in 

commercial use (as that term is defined 

in 40 CFR 721.3) but without any use in 


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a consumer setting (as that term is 

defined in 40 CFR 721.3); 

6. Not exceed the confidential annual 

production volume limit in the Order; 

and 

7. No manufacture of the substance 

where there is more than 0.2% residual 

isocyanate. 

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 toxicity of the PMN substance 

may be potentially useful to characterize 

the health 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 and 

internal organ toxicity testing. 

CFR citation: 40 CFR 721.11098. 

PMN Number P–16–221 

Chemical name: Fluorinated 

organopolysilazane (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: June 20, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the substance will 

be used as a coating agent for optical 

lenses. EPA identified human health 

and environmental concerns because 

the potential degradation products of 

the PMN substance may be persistent, 

bioaccumulative, and toxic (PBT) 

chemicals. EPA estimates that the PMN 

substance degradation products will 

persist in the environment for more than 

two months and estimates a 

bioaccumulation factor of greater than 

or equal to 1,000. EPA also identified 

concerns for liver toxicity, blood 

toxicity, male reproductive toxicity, and 

toxicity to aquatic organisms, terrestrial 

mammals and birds based on data for 

the PMN substance degradation 

product. 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 

the substance may present an 

unreasonable risk of injury to health and 

the environment. To protect against 

potential risks, the Order requires: 

1. Submission to EPA of certain 

toxicity testing before exceeding a total 

production volume of 204 kilograms, as 

specified in the Order; 

2. Use of personal protective 

equipment to prevent dermal exposure 

(where there is a potential for dermal 

exposures); 

3. No use of the substance other than 

allowed by the Order which is the 

confidential coating system described in 

the PMN; 

4. Manufacture not to exceed an 

annual manufacture volume of 100 

kilograms; 

5. Refrain from domestic manufacture 

in the United States (i.e., import only); 

and 

6. No release of the PMN substance to 

surface waters. 

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 toxicity of the PMN substance 

may be potentially useful to characterize 

the health 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 production 

limit in the Order without performing 

specific internal organ toxicity testing 

on the degradation product of the PMN 

substance. In addition, EPA has 

determined that the results of specific 

organ toxicity on degradations products 

of the PMN substance may be 

potentially useful in characterizing the 

health effects of the PMN substance. 

Although the Order does not require 

this additional testing, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal will remain in effect until the 

Order is modified or revoked by EPA 

based on submission of this or other 

information that EPA determines is 

relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11099. 

PMN Number P–16–359 

Chemical name: Carbopolycyclebis(diazonium), dihalo-, chloride (1:2), 

reaction products with metal hydroxide, 

4-[(dioxoalkyl)amino]substituted 

benzene, 2- 

[(dioxoalkyl)amino]substituted benzene, 

5-[(dioxoalkyl)amino]-2-hydroxysubstituted benzene and oxo-nphenylalkanamide (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: June 20, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a pigment additive for industrial 

coatings. EPA identified concerns for 

oncogenicity and mutagenicity for the 

PMN substance degradation product. 

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 

the substance may present an 

unreasonable risk of injury to health and 

the environment. To protect against 

potential risks, the Order requires: 

1. Submission to EPA of certain 

toxicity testing before exceeding the 

confidential production volume limit 

specified in the Order; 

2. Use of personal protective 

equipment to prevent dermal exposure 

(where there is a potential for inhalation 

exposures); 

3. Establishment and use of a hazard 

communication program, including 

precautionary statements on each label 

and in SDS; 

4. No processing or use of the 

substance at temperatures greater than 

200 degrees Celsius; and 

5. No domestic manufacture of the 

substance. 

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 biodegradability of 

the PMN substance may be potentially 

useful to characterize the health 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 

production limit in the Order without 

performing specific biodegradability 

and photolysis tests. 

CFR citation: 40 CFR 721.11100. 

PMN Number P–16–363 

Chemical name: Blocked polyester 

polyurethane, neutralized (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: June 20, 2017. 

Basis for TSCA section 5(e) Order: 

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

be an open non-dispersive use. EPA 

identified concerns for irritation, 

sensitization, and lung toxicity based on 

analogy to diisocyanates and cationic 

binding to lung tissue. 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 the substance 

may present an unreasonable risk of 

injury to human health. To protect 

against potential risks, the Order 

requires: 

1. Use personal protective equipment 

to prevent dermal exposure (where there 

is a potential for dermal exposures); 

2. Establishment and use of a hazard 

communication program, including 


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precautionary statements on each label 

and in the SDS; 

3. Manufacture (including import) the 

substance with a residual of free 

isocyanate monomers no greater than 

0.1% by weight; 

4. Refraining from manufacture, 

processing, or use activities if it results 

in inhalation exposure to vapor, dust, 

mist or aerosols; 

5. Refraining from manufacture, 

processing, or use for consumer use or 

in commercial use (as that term is 

defined in 40 CFR 721.3) where there is 

use in a consumer setting (as that term 

is defined in 40 CFR 721.3); and 

6. Manufacture, process, or use the 

substance only in an aqueous 

formulation. 

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 toxicity of the PMN substance 

may be potentially useful to characterize 

the health 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 specific 

target organ toxicity testing and a 

sensitization test of the PMN substance 

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 on manufacture, processing, 

use, distribution in commerce, and 

disposal will remain in effect until the 

Order is modified or revoked by EPA 

based on submission of this or other 

information that EPA determines is 

relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11101. 

PMN Number P–16–370 

Chemical name: Methoxy-terminated 

polysiloxane (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: July 18, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a crosslinker for adhesives and 

coatings. EPA identified concerns for 

irritation to the skin, eyes, lung, and 

mucous membranes and other lung 

effects on analogy to alkoxysilanes. 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 the substance 

may present an unreasonable risk of 

injury to human health. To protect 

against potential risks, the Order 

requires: 

1. Submission to EPA of certain 

toxicity testing before exceeding the 

confidential production volume limit 

specified in the Order; 

2. Use of personal protective 

equipment to prevent dermal exposure 

(where there is a potential for dermal 

exposures); 

3. Establishment and use of a hazard 

communication program, including 

precautionary statements on each label 

and in the SDS; 

4. Use of a NIOSH-certified respirator 

with an APF of at least 10 (where there 

is a potential for inhalation exposures) 

or compliance with a NCEL of 8.4 

milligrams per cubic meter as an 8-hour 

time-weighted average to prevent 

inhalation exposure. (EPA’s estimates 

indicate that variations of the 

parameters (including batch size, 

number of processing sites, days per 

year of operation) of the uses identified 

below would not result in inhalation 

exposure that would indicate a different 

respirator.) 

5. Refraining from modifying the 

manufacture, processing, or use 

activities if it results in inhalation 

exposure to vapor, dust, mist or 

aerosols; and 

6. Refraining from manufacture, 

processing, or use for consumer use or 

in commercial use (as that term is 

defined in 40 CFR 721.3) where there is 

use in a consumer setting (as that term 

is defined in 40 CFR 721.3). 

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 toxicity of the PMN substance 

may be potentially useful to characterize 

the health 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 production 

limit in the Order without performing 

specific pulmonary toxicity testing. 

CFR citation: 40 CFR 721.11103. 

PMN Number P–16–376 

Chemical name: Hydroxystyrene resin 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: June 16, 2017. 

Basis for TSCA section 5(e) Order: 

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

be for photolithography. EPA identified 

potential health and environmental 

toxicity if the PMN substance is 

manufactured at a lower molecular 

weight. 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 

the substance may present an 

unreasonable risk of injury to health and 

the environment. To protect against 

potential risks, the Order requires 

manufacture of the substance at an 

average molecular weight greater than 

2906 daltons and with 0.5 percent low 

weight molecular species less than 500 

daltons and 1.0 percent low weight 

molecular species less than 1,000 

daltons. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of this protective 

measure. 

Potentially useful information: EPA 

has determined that certain information 

about the physical-chemical properties 

and toxicity of the PMN substance may 

be potentially useful to characterize the 

health and environmental 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 tests, internal organ 

effects testing, and aquatic toxicity tests 

may be potentially useful in 

characterizing the health and 

environmental effects of the PMN 

substance. Although the Order does not 

require this testing, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal will remain in effect until the 

Order is modified or revoked by EPA 

based on submission of this or other 

information that EPA determines is 

relevant and needed to evaluate a 

modification request 

CFR citation: 40 CFR 721.11104. 

PMN Number P–16–487 

Chemical name: Benzenesulfonic acid 

1,2-diazenediylbis[6-ethenyl]-3- 

sulfophenyl diazenyl-2-sulfophenyl 

ethenyl salt (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: June 27, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the substance will 

be used as a yellow dye for paper. EPA 

identified concerns for developmental, 

reproductive, liver, kidney, and blood 

toxicity based for the azo reduction 

products of the substance based on 

analogue data. Based on SAR analysis 

for acid dyes, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 55 parts per 

billion (ppb) in surface waters. The 


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Order was issued under TSCA sections 

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

well as 5(a)(3)(B)(ii)(II) and 

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

the substance may present an 

unreasonable risk of injury to health and 

the environment and that the substance 

is or will be produced in substantial 

quantities and there is or may be 

significant (substantial) human 

exposure to the substance. To protect 

against potential risks, the Order 

requires: 

1. Submission to EPA of certain 

toxicity testing before exceeding the 

confidential production volume limits 

specified in the Order; 

2. Use of personal protective 

equipment to prevent dermal exposure 

(where there is a potential for dermal 

exposures); 

3. Establishment and use of a hazard 

communication program, including 

precautionary statements on each label 

and in the SDS; 

4. No manufacture of the substance in 

the United States (i.e. import only); 

5. Import the substance only as a 

solution; 

6. No use of the substance other than 

for the confidential uses allowed in the 

Order; and 

7. Not release the substance in surface 

waters resulting in concentrations that 

exceed 55 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 fate and toxicity of the PMN 

substance may be potentially useful to 

characterize the health and 

environmental 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 production 

limit in the Order without performing 

specific photolysis, internal organ 

effects, reproductive/developmental 

toxicity, and aquatic toxicity tests. 

CFR citation: 40 CFR 721.11105. 

PMN Number P–16–533 

Chemical name: Ethanaminium, 

alkyl-, salt with triazole (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: July 24, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a cleaning agent for electronics 

manufacture. EPA identified concerns 

for neurotoxicity, developmental and 

reproductive toxicity, irritation, 

corrosion, sensitization, and 

carcinogenicity based on analogy to 

benzotriazole and quaternary amines. 

Based on SAR analysis of test data on 

analogous benzotriazoles, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 570 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 

the substance may present an 

unreasonable risk of injury to health and 

the environment. To protect against 

potential risks, the Order requires: 

1. Submission to EPA of certain 

toxicity testing before exceeding the 

confidential production volume limits 

specified in the Order; 

2. Use of personal protective 

equipment to prevent dermal exposure 

(where there is a potential for dermal 

exposure); 

3. Establishment and use of a hazard 

communication program, including 

precautionary statements on each label 

and in the SDS; 

4. Refrain from manufacture, process 

or use activities that result in inhalation 

exposure to vapor, dust, mist or 

aerosols; 

5. No use other than confidential use 

allowed by the Order; and 

6. No release of the substance to 

surface waters. 

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 toxicity of the PMN substance 

may be potentially useful to characterize 

the health and environmental 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 

production limit in the Order without 

performing specific internal organ 

effects testing of the PMN substance. In 

addition, EPA has determined that the 

results of acute and chronic aquatic 

toxicity testing may be potentially 

useful in characterizing the 

environmental effects of the PMN 

substance. Although the Order does not 

require this additional testing, the 

Order’s restrictions on manufacture, 

processing, distribution in commerce, 

use, and disposal will remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other information that EPA determines 

is relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11105. 

PMN Number P–16–595 

Chemical name: Substituted- 

(hydroxyalkyl)-alkyl-alkanoic acid, 

hydroxy-(substitutedalkyl)-alkyl-, 

polymer with alpha-hydro-omegahydroxypoly[oxy (alkylethanediyl)] and 

isocyanato-(isocyanatoalkyl)- 

multialkylcycloalkane, salt, alkanolblocked, compds. (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: June 27, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a polymer. EPA identified 

concerns for irritation to skin, eyes, and 

lung, kidney and developmental effects 

based on functional groups present as 

part of the PMN structure. Based on 

SAR analysis of test data on analogous 

polyanionic polymers, EPA identified 

potential environmental toxicity if the 

substance is produced with a different 

average molecular weight or proportion 

of repeating units. 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 

the substance may present an 

unreasonable risk of injury to health and 

the environment. To protect against 

potential risks, the Order requires: 

1. No manufacture of the substance in 

the United States (i.e. import only); 

2. Import of the substance under the 

confidential conditions required by the 

Order; 

3. No use of the substance other than 

as the confidential use allowed 

described in the Order; and 

4. No release of the substance to 

surface waters. 

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 physical-chemical properties 

and toxicity of the PMN substance may 

be potentially useful to characterize the 

health and environmental 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 measurements, acute 

toxicity tests, and acute and chronic 

aquatic toxicity tests may be potentially 

useful in characterizing the health and 

environmental effects of the PMN 

substance. Although the Order does not 

require this additional testing, the 

Order’s restrictions on manufacture, 

processing, distribution in commerce, 

use, and disposal will remain in effect 


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until the Order is modified or revoked 

by EPA based on submission of this or 

other information that EPA determines 

is relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11106. 

PMN Number P–17–170 

Chemical name: Alkanediol, 2,2-bis 

(substituted alkyl)- polymer with 

substituted alkane, heteromonocycles, 

alkenoate (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: July 12, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the substance will 

be used as an ultraviolet curable coating 

resin for three-dimensional printing 

applications. EPA identified concerns 

for oncogenicity, developmental 

toxicity, liver and kidney effects, 

sensitization, and irritation based on 

analogy to acrylates. EPA also identified 

additional human health concerns and 

environmental toxicity concerns if the 

polymer is made differently than 

described in the PMN. 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 the substance 

may present an unreasonable risk of 

injury to health and the environment. 

To protect against potential risks, the 

Order requires: 

1. Submission to EPA of certain 

toxicity testing before exceeding the 

aggregate production volume limit of 

105,000 kilograms specified in the 

Order; 

2. Use of personal protective 

equipment to prevent dermal exposure 

including gloves (where there is a 

potential for dermal exposures); 

3. Establishment and use of a hazard 

communication program, including 

precautionary statements on each label 

and in the SDS; 

4. Refrain from manufacture, process 

or use activities that result in inhalation 

exposure to vapor, dust, mist or 

aerosols; 

5. No use other than as an ultraviolet 

curable coating resin for threedimensional printing applications; 

6. Manufacture of the substance with 

no greater than 0.1% residual 

isocyanate; and 

7. Manufacture of the substance with 

an average molecular weight greater 

than 1,000 daltons. 

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 physical-chemical properties 

and toxicity of the PMN substance may 

be potentially useful to characterize the 

health and environmental 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 production 

limit in the Order without performing 

specific mutagenicity and sensitization 

testing of the PMN substance. In 

addition, EPA has determined that the 

results of physical-chemical property 

measurements, internal organ toxicity 

tests, and acute and chronic aquatic 

toxicity tests may be potentially useful 

in characterizing the environmental 

effects of the PMN substance. Although 

the Order does not require this 

additional testing, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal will remain in effect until the 

Order is modified or revoked by EPA 

based on submission of this or other 

information that EPA determines is 

relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11107. 

PMN Number P–17–172 

Chemical name: Sulfurized 

alkylphenol, calcium salts (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: June 19, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a lubricating oil additive. EPA 

identified concerns for lung toxicity 

based on submitted test data and data 

for analogous chemicals. The Order was 

issued under TSCA sections 

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

well as 5(a)(3)(B)(ii)(II) and 

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

the substance may present an 

unreasonable risk of injury to human 

health and the environment, and the 

substance is or will be produced in 

substantial quantities and there is or 

may be significant (substantial) human 

exposure to the substance. To protect 

against potential risks, the Order 

requires: 

1. Refrain from manufacture, process 

or use activities that result in inhalation 

exposure to vapor, dust, mist or 

aerosols; and 

2. No use other than the confidential 

use allowed by the Order; 

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 toxicity of the PMN substance 

may be potentially useful to characterize 

the health 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 

pulmonary effects testing may be 

potentially useful in characterizing the 

health effects of the PMN substance. 

Although the Order does not require 

this additional testing, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal will remain in effect until the 

Order is modified or revoked by EPA 

based on submission of this or other 

information that EPA determines is 

relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11108. 

PMN Number P–17–177 

Chemical name: 

Monoheteropentacycloalkane-4- 

carboxylic acid, substituted cyclo-alkyl 

ester (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: July 28, 2017. 

Basis for TSCA section 5(e) Order: 

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

be for microlithography for electronic 

device manufacturing. EPA identified 

human health and environmental 

concerns because the substance may be 

persistent, bioaccumulative, and toxic 

(PBT) chemicals. EPA estimates that the 

substance will persist in the 

environment for more than two months 

and estimates a bioaccumulation factor 

of greater than or equal to 1,000. EPA 

identified concerns for oncogenicity, 

developmental toxicity, liver and 

kidney effects, sensitization, and 

irritation based on data for analogous 

chemicals. Based on SAR estimates for 

esters and other analogous chemicals. 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 2 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 the substance 

may present an unreasonable risk of 

injury to health and the environment. 

To protect against potential risks, the 

Order requires: 

1. Use of personal protective 

equipment to prevent dermal exposure 

(where there is a potential for dermal 

exposures); 

2. Establishment and use of a hazard 

communication program, including 

precautionary statements on each label 

and in the SDS; 


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3. No manufacture of the substance in 

the United States (i.e. import only); 

4. No use other than the confidential 

use allowed by the Order; 

5. No exceedance of the confidential 

annual production volume limit in the 

Order; and 

6. No release of the substance to 

surface waters. 

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 toxicity of the PMN 

substance may be potentially useful to 

characterize the health and 

environmental 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 acute 

toxicity, mutagenicity, sensitization, 

internal organ toxicity, reproductive/ 

developmental toxicity, biodegradation, 

bioconcentration, and acute and chronic 

aquatic toxicity testing may be 

potentially useful in characterizing the 

health and environmental effects of the 

PMN substance. Although the Order 

does not require this additional testing, 

the Order’s restrictions on manufacture, 

processing, distribution in commerce, 

use, and disposal will remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other information that EPA determines 

is relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11109. 

PMN Number P–17–179 

Chemical name: Modified 

carboxypolyamine salt (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 substance will 

be used as a dispersive additive for 

pigments in industrial paints and 

coatings. EPA identified concerns for 

skin irritation and lung toxicity based 

on cationic binding properties. 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 the substance 

may present an unreasonable risk of 

injury to health and the environment. 

To protect against potential risks, the 

Order requires: 

1. Submission to EPA of certain 

toxicity testing before excceding the 

confidential production volume limit 

specified in the Order; 

2. Use of personal protective 

equipment to prevent dermal exposure 

(where there is a potential for dermal 

exposures); 

3. Establishment and use of a hazard 

communication program, including 

precautionary statements on each label 

and in the SDS; 

4. Refrain from manufacture, process 

or use activities that result in inhalation 

exposure to vapor, dust, mist or 

aerosols; 

5. No use other than a dispersive 

additive for pigments in industrial 

paints and coatings; 

6. No processing or use of the 

substance in a paint or coating 

formulation greater than 1% by weight 

or volume; and 

7. No manufacture of the substance in 

the United States (i.e. import only). 

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 toxicity of the PMN substance 

may be potentially useful to characterize 

the health 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 production 

limit in the Order without performing 

specific pulmonary effects testing of the 

PMN substance. 

CFR citation: 40 CFR 721.11110. 

PMN Number P–17–222 

Chemical name: 1, 3,5-Triazine-2,4- 

diamine, 6-phenyl-, reaction products 

with polyalkylene glycol mono- alkyl 

ether and 2,4-toluene diisocyanate 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: July 28, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as an additive open non-dispersive 

use. EPA identified concerns for dermal 

sensitization, respiratory sensitization, 

lung effects, neurotoxicity, and 

developmental toxicity based on the 

potential for residual diisocyanates. 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 the substance 

may present an unreasonable risk of 

injury to health and the environment. 

To protect against potential risks, the 

Order requires: 

1. Refrain from manufacture, process 

or use activities that result in inhalation 

exposure to vapor, dust, mist or 

aerosols; 

2. Not sell the substance for 

‘‘consumer use’’ or for ‘‘commercial 

uses’’ (as the term is defined at 40 CFR 

721.3) when the ‘‘saleable goods or 

service’’ could introduce the material 

into a ‘‘consumer’’ setting (as that term 

is defined in 40 CFR 721.3); 

3. Use the substance only in a 

formulation for the use allowed in the 

Order with isocyanate residuals not 

greater than 0.1 percent by weight or 

volume; and 

4. Import the substance where there is 

no more than 0.15% residual toluene 

isocyanate. 

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 toxicity of the PMN substance 

may be potentially useful to characterize 

the health 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 a 

sensitization test and pulmonary effects 

test may be potentially useful in 

characterizing the health effects of the 

PMN substance. Although the Order 

does not require this additional testing, 

the Order’s restrictions on manufacture, 

processing, distribution in commerce, 

use, and disposal will remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other information that EPA determines 

is relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11111. 

PMN Number P–17–231 

Chemical name: Fatty acids, polymers 

with benzoic acid, 

cyclohexanedicarboxylic acid 

anhydride, aliphatic diisocyanate, alkyl 

diol, alkyl triol, pentaerythritol, 

phthalic anhydride, polyalkylene glycol 

amine, and aromatic dicarboxylate 

sulfonic acid sodium salt (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: July 20, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a paint, stain, or primer coating. 

EPA identified concerns for dermal 

sensitization, respiratory sensitization, 

lung effects, neurotoxicity, and 

developmental toxicity based on the 

potential for residual diisocyanates. The 

Order was issued under TSCA sections 


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

based on a finding that the substance 

may present an unreasonable risk of 

injury to health and the environment. 

To protect against potential risks, the 

Order requires: 

1. Manufacture of the substance 

where there is no more than 0.1% 

residual isocyanate. 

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 toxicity of the PMN substance 

may be potentially useful to characterize 

the health 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 a 

sensitization test and a pulmonary 

effects test may be potentially useful in 

characterizing the health effects of the 

PMN substance. Although the Order 

does not require this additional testing, 

the Order’s restrictions on manufacture, 

processing, distribution in commerce, 

use, and disposal will remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other information that EPA determines 

is relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11112. 

PMN Numbers P–17–247 and P–17–248 

Chemical names: Branched alkyl 

(C=17) carboxylic acid (generic) (P–17– 

247) and branched alkyl (C=18) alcohol 

(generic) (P–17–248). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: June 29, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as chemical raw materials. EPA 

identified human health and 

environmental concerns because the 

substances may be persistent, 

bioaccumulative, and toxic (PBT) 

chemicals. EPA estimates that the 

substances will persist in the 

environment for more than two months 

and estimates a bioaccumulation factor 

of greater than or equal to 1,000. Based 

on analogue data EPA identified 

concerns for developmental toxicity, 

liver, kidney, and thyroid effects, 

dermal sensitization, and irritation. 

Based on SAR estimates for neutral 

organic chemicals, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 1 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 

the substances may present an 

unreasonable risk of injury to health and 

the environment. To protect against 

potential risks, the Order requires: 

1. Submission to EPA of certain 

toxicity testing before exceeding the 

confidential production volume limit 

specified in the Order; 

2. Use of personal protective 

equipment to prevent dermal exposure 

(where there is a potential for dermal 

exposures); 

3. Establishment and use of a hazard 

communication program, including 

precautionary statements on each label 

and in the SDS; 

4. Refrain from manufacture, process 

or use activities that result in inhalation 

exposure to vapor, dust, mist or 

aerosols; 

5. No use other than as a chemical 

intermediate; 

6. No manufacture of the substances 

in the United States (i.e. import only); 

and 

7. No release of the substances to 

surface waters. 

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 bioaccumulation and toxicity 

of the PMN substance may be 

potentially useful to characterize the 

health and environmental 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 production 

limit in the Order without performing 

specific sensitization, internal organ 

effect, and reproductive/developmental 

testing of the PMN substances. In 

addition, EPA has determined that the 

results of acute aquatic toxicity and 

bioaccumulation testing may be 

potentially useful in characterizing the 

environmental and health effects of the 

PMN substances. Although the Order 

does not require this additional testing, 

the Order’s restrictions on manufacture, 

processing, distribution in commerce, 

use, and disposal will remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other information that EPA determines 

is relevant and needed to evaluate a 

modification request. 

CFR citations: 40 CFR 721.11113 P– 

17–247 and 40 CFR 721.11114 P–17– 

248. 

PMN Number P–17–260 

Chemical name: Alkoxy silane 

modified butadiene styrene copolymer 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: July 10, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a resin modifier. EPA identified 

concerns for lung effects based on test 

data for the substance and data for 

analogous alkoxysilane non-ionic 

polymers. 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 

the substance may present an 

unreasonable risk of injury to human 

health. To protect against potential 

risks, the Order requires: 

1. Refrain from manufacture, process 

or use activities that result in inhalation 

exposure to vapor, dust, mist or 

aerosols; and 

2. No use other than the confidential 

use allowed by the Order; 

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 toxicity of the PMN substance 

may be potentially useful to characterize 

the health 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 

pulmonary effects test may be 

potentially useful in characterizing the 

health effects of the PMN substance. 

Although the Order does not require 

this additional testing, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal will remain in effect until the 

Order is modified or revoked by EPA 

based on submission of this or other 

information that EPA determines is 

relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11115. 

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 19 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 


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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, 

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). 

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. 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 the 19 

chemical substances subject to these 

rules have been claimed as confidential 

and EPA has received no post-PMN 

bona fide submission (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. In developing this rule, EPA 

has recognized that, given EPA’s 

practice of on occasion posting rules on 

its website a week or more in advance 

of Federal Register publication, this 

objective could be thwarted even before 

that publication. 

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 potentially useful 

information for all of the listed SNURs. 

Descriptions of this information is 

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 


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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 specified 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. 

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 or other information 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 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– 

2017–0464. 

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 


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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. 

• 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 17, 2018. 

Jeffery T. Morris, 

Director, Chemical Control Division, Office 

of Pollution Prevention and Toxics. 

Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

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

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

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

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

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

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

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

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

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

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

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

11023, 11048. 

■ 2. In § 9.1, add the following sections 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 


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§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB 

control No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.11097 ............................. 2070–0012 

721.11098 ............................. 2070–0012 

721.11099 ............................. 2070–0012 

721.11100 ............................. 2070–0012 

721.11101 ............................. 2070–0012 

721.11102 ............................. 2070–0012 

721.11103 ............................. 2070–0012 

721.11104 ............................. 2070–0012 

721.11105 ............................. 2070–0012 

721.11106 ............................. 2070–0012 

721.11107 ............................. 2070–0012 

721.11108 ............................. 2070–0012 

721.11109 ............................. 2070–0012 

721.11110 ............................. 2070–0012 

721.11111 ............................. 2070–0012 

721.11112 ............................. 2070–0012 

721.11113 ............................. 2070–0012 

721.11114 ............................. 2070–0012 

721.11115 ............................. 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 § 721.11097 to subpart E to 

read as follows: 

§ 721.11097 Benzene, 1,4-bis(alkyl)-, 

homopolymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically benzene, 1,4-bis(alkyl)-, 

homopolymer (PMN P–15–719) 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) 

through (e)(concentrations set at 1.0 

percent), (f), (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. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). 

(iii) Disposal. Requirements as 

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

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

(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. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (f) 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. 

■ 5. Add § 721.11098 to subpart E to 

read as follows: 

§ 721.11098 Polyethylene glycol polymer 

with aliphatic polycarbodiimide 

bis(alkoxysilylpropyl) amine blocked 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyethylene glycol 

polymer with aliphatic 

polycarbodiimide bis(alkoxysilylpropyl) 

amine blocked (PMN P–16–99) 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 (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, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) with an assigned 

protection factor (APF) of at least 10), 

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

at 1.0 percent) 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 0.9 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) 

through (e)(concentration set 1.0 

percent), (f), (g)(1)(ii), (g)(2)(ii), (iii), (use 

respiratory protection or maintain 

workplace airborne concentrations at or 

below an 8-hour time-weighted average 

of 0.9 mg/m3), 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(k), (q) and (t). It is 

a significant new use to process or use 

the chemical substance other than for 

commercial use but without any use in 

a consumer setting. It is a significant 

new use to manufacture the chemical 

substance containing greater than 0.2% 

residual isocyanate. 

(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 (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. 

■ 6. Add § 721.11099 to subpart E to 

read as follows: 

§ 721.11099 Fluorinated 

organopolysilazane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as a fluorinated 

organopolysilazane (PMN P–16–221) 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)(3), (a)(4), when 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) engineering 


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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)(6)(particulate), (a)(6)(v), (vi), 

(b)(concentrations set at 1.0 percent), 

and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (p) (204 

kilograms) and (s)(100 kilograms). It is 

a significant new use to use the 

substance other than in confidential 

coating system allowed in the Order. 

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

■ 7. Add § 721.11100 to subpart E to 

read as follows: 

§ 721.11100 Carbopolycyclebis(diazonium), dihalo-, chloride (1:2), 

reaction products with metal hydroxide, 4- 

[(dioxoalkyl)amino]substituted benzene, 2- 

[(dioxoalkyl)amino]substituted benzene, 5- 

[(dioxoalkyl)amino]-2-hydroxy-substituted 

benzene and oxo-n-phenylalkanamide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbopolycyclebis(diazonium), dihalo-, chloride (1:2), 

reaction products with metal hydroxide, 

4-[(dioxoalkyl)amino] substituted 

benzene, 2- 

[(dioxoalkyl)amino]substituted benzene, 

5-[(dioxoalkyl) amino] 2-hydroxysubstituted benzene and oxo-nphenylalkanamide (PMN P–16–359) 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)(3), (a)(4), 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, 

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

at 0.1 percent) and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set 0.1 

percent), (f), (g)(1)(iv), (vii), (g)(2)(i), (ii), 

(do not process or use at greater than 

200 degrees Celsius), 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) and (q). It is a 

significant new use to process or use the 

PMN substance at a temperature greater 

than 200 degrees C. 

(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 (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. 

■ 8. Add § 721.11101 to subpart E to 

read as follows: 

§ 721.11101 Blocked polyester 

polyurethane, neutralized (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as blocked polyester 

polyurethane, neutralized (PMN P–16– 

363) 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 

substance after they have been reacted 

(cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), 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, 

(a)(2)(i), (ii), (iii), (a)(3), 

(a)(6)(particulate), (a)(6)(v), (vi) 

(b)(concentrations set at 0.1 percent) 

and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72 

(a) through (e)(concentration set 0.1 

percent), (f), (g)(1)(i), (ii), (g)(2)(i), (ii), 

(iii), (iv), 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 It is a significant 

new use to manufacture, process, or use 

the substance with a residual of free 

isocyanate monomers greater than 0.1 

percent by weight. It is a significant new 

use to modify manufacture, process or 

use activities if it results in inhalation 

exposure to vapor, dust, mist or aerosols 

to the substance. It is a significant new 

use to manufacture, process, or use the 

substance for consumer use, or for 

commercial uses when the saleable 

goods or service could introduce the 

substance into a consumer setting. It is 

a significant new use to manufacture, 

process, or use the substance other than 

in an aqueous formulation. 

(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 (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. 

■ 9. Add § 721.11102 to subpart E to 

read as follows: 

§ 721.11102 Methoxy-terminated 

polysiloxane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as methoxy-terminated 

polysiloxane (PMN P–16–370) 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 substance after 

they have been reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 


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

(a)(4), 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, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor (APF) of at least 25), 

(a)(6)(particulate), (a)(6)(v), (vi), 

(b)(concentrations set at 1.0 percent), 

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 8.4 milligrams 

per cubic meter 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) 

through (e)(concentration set 1.0 

percent), (f), (g)(1)(i), (ii), (g)(2)(i), (ii), 

(iii), (use respiratory protection or 

maintain workplace airborne 

concentrations at or below an 8-hour 

time-weighted average of 8.4 mg/m3), 

(g)(2)(v), (do not use for spray 

application), 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), and (y)(1). It is 

a significant new use to manufacture, 

process, or use the substance for 

consumer use, or for commercial uses 

when the saleable goods or service 

could introduce the substance into a 

consumer setting. 

(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 (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. 

■ 10. Add § 721.11103 to subpart E to 

read as follows: 

§ 721.11103 Hydroxystyrene resin 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as hydroxystyrene resin 

(PMN P–16–376) 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 It is a significant 

new use to manufacture the PMN 

substance with an average molecular 

weight less than 2906 daltons and to 

have greater than 0.5 percent low weight 

molecular species less than 500 daltons 

and 1.0 percent low weight molecular 

species less than 1000 daltons. 

(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) through (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 § 721.11104 to subpart E to 

read as follows: 

§ 721.11104 Benzenesulfonic acid 1,2- 

diazenediylbis[6-ethenyl]-3-sulfophenyl 

diazenyl-2-sulfophenyl ethenyl salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as benzenesulfonic acid 1,2- 

diazenediylbis[6-ethenyl]-3-sulfophenyl 

diazenyl-2-sulfophenyl ethenyl salt 

(PMN P–16–487) 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) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (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) 

(concentration set 1.0 percent), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set 1.0 

percent), (f), (g)(1)(iv), (vi), (ix), (blood 

effects), (g)(2)(i), (v), (g)(3)(i), (ii), 

(g)(4)(water release restrictions apply), 

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). It is 

a significant new use to import the 

substance other than in solution. 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 55. 

(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 (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. 

■ 12. Add § 721.11105 to subpart E to 

read as follows: 

§ 721.11105 Ethanaminium, alkyl-, salt 

with triazole (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as ethanaminium, alkyl-, salt 

with triazole (PMN P–16–533) 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 substance after 

they have been 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 


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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, 

(a)(6)(particulate), (a)(6)(v), (vi), (b) 

(concentration set 0.1 percent), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set 0.1 

percent), (f), (g)(1)(i), (iii), (v), (vii), (ix), 

(g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), 

(g)(4)(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(k) and (q). It is a 

significant new use to modify the 

manufacture, process or use activities if 

it results in inhalation exposure to 

vapor, dust, mist or aerosols to the 

substance. 

(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. 

(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. 

■ 13. Add § 721.11106 to subpart E to 

read as follows: 

§ 721.11106 Substituted-(hydroxyalkyl)- 

alkyl-alkanoic acid, hydroxy- 

(substitutedalkyl)-alkyl-, polymer with 

alpha-hydro-omega-hydroxypoly[oxy 

(alkylethanediyl)] and isocyanato- 

(isocyanatoalkyl)-multialkylcycloalkane, 

salt, alkanol-blocked, compds. (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted- 

(hydroxyalkyl)-alkyl-alkanoic acid, 

hydroxy-(substitutedalkyl)-alkyl-, 

polymer with alpha-hydro-omegahydroxypoly [oxy(alkylethanediyl)] and 

isocyanato-(isocyanatoalkyl)- 

multialkylcycloalkane, salt, alkanolblocked, compds. (PMN P–16–595) 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 substance after 

they have been reacted (cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to import the 

substance other than as required in the 

Order. 

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) (b), (c), (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. 

■ 14. Add § 721.11107 to subpart E to 

read as follows: 

§ 721.11107 Alkanediol, 2,2-bis 

(substituted alkyl)- polymer with substituted 

alkane, heteromonocycles, alkenoate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanediol, 2,2-bis 

(substituted alkyl)- polymer with 

substituted alkane, heteromonocycles, 

alkenoate (PMN P–17–170) 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 reacted 

(cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (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)(concentration set 0.1 percent), and 

(c) 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set 0.1 

percent), (f), (g)(1)(i), (ii), (v), (vii), (ix), 

(g)(2)(i), (v), (g)(4) 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 (k)(ultraviolet 

curable coating resin for three 

dimensional printing applications) and 

(p)(105,000 kilograms). It is a significant 

new use to modify the manufacture, 

process or use activities if it results in 

inhalation exposure to vapor, dust, mist 

or aerosols to the substance. It is a 

significant new use to manufacture the 

chemical substance containing greater 

than 0.1 percent residual isocyanate or 

an average molecular weight below 

1,000 daltons. 

(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 (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. 

■ 15. Add § 721.11108 to subpart E to 

read as follows: 

§ 721.11108 Sulfurized alkylphenol, 

calcium salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sulfurized alkylphenol, 

calcium salts (PMN P–17–172) 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(k). It is a 

significant new use to modify the 

manufacture, process or use activities if 

it results in inhalation exposure to 

vapor, dust, mist or aerosols to the 

substance. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 


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43554 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations 

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)(iii) of this section. 

■ 16. Add § 721.11109 to subpart E to 

read as follows: 

§ 721.11109 

Monoheteropentacycloalkane-4-carboxylic 

acid, substituted cyclo-alkyl ester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 

monoheteropentacycloalkane-4- 

carboxylic acid, substituted cyclo-alkyl 

ester (PMN P–17–177) 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 substance after 

they have been reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (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)(concentration set 0.1 percent), and 

(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set 0.1 

percent), (f), (g)(1)(i), (ii), (iv), (vi), (vii), 

(ix), (skin, eye, and mucous membrane 

irritation), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), 

(ii), (g)(4)(i), (ii), (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(f), (k), and (t). 

(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. 

(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. 

■ 17. Add § 721.11110 to subpart E to 

read as follows: 

§ 721.11110 Modified carboxypolyamine 

salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as modified 

carboxypolyamine salt (PMN P–17–179) 

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 substance after 

they have been reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (iv), (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, 

(a)(6)(particulate), (a)(6)(v), (vi), 

(b)(concentration set 0.1 percent), and 

(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set 0.1 

percent), (f), (g)(1)(i), (ii), (g)(2)(i), (ii), 

(v), (g)(3)(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)(dispersive 

additive for pigments in industrial 

paints and coatings) and (q). It is a 

significant new use to process or use the 

substance in a paint or coating 

formulation greater than 1 percent by 

weight or volume. It is a significant new 

use to process or use the substance 

resulting in inhalation exposure to a 

vapor, dust, mist or aerosol at 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. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

■ 18. Add § 721.11111 to subpart E to 

read as follows: 

§ 721.11111 1,3,5-Triazine-2,4-diamine, 6- 

phenyl-, reaction products with 

polyalkylene glycol mono- alkyl ether and 

2,4-toluene diisocyanate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 1,3,5-triazine-2,4- 

diamine, 6-phenyl-, reaction products 

with polyalkylene glycol mono-alkyl 

ether and 2,4-toluene diisocyanate 

(PMN P–17–222) 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 

reacted (cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k)(use of the 

substance in the formulation for the use 

allowed in the Order with isocyanate 

residuals not greater than 0.1 percent by 

weight or volume). It is a significant 

new use to process or use the chemical 

substance other than for commercial use 

but without any use in a consumer 

setting. It is a significant new use to 

modify the manufacture, process or use 

activities if it results in inhalation 

exposure to vapor, dust, mist or aerosols 

to the substance. It is a significant new 

use to import the chemical substance 

containing greater than 0.15 percent 

residual isocyanate. 

(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. 


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Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations 43555 

(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. 

■ 19. Add § 721.11112 to subpart E to 

read as follows: 

§ 721.11112 Fatty acids, polymers with 

benzoic acid, cyclohexanedicarboxylic acid 

anhydride, aliphatic diisocyanate, alkyl diol, 

alkyl triol, pentaerythritol, phthalic 

anhydride, polyalkylene glycol amine, and 

aromatic dicarboxylate sulfonic acid 

sodium salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acids, polymers with 

benzoic acid, cyclohexanedicarboxylic 

acid anhydride, aliphatic diisocyanate, 

alkyl diol, alkyl triol, pentaerythritol, 

phthalic anhydride, polyalkylene glycol 

amine, and aromatic dicarboxylate 

sulfonic acid sodium salt (PMN P–17– 

231) 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 

substance after they have been reacted 

(cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. It is a significant 

new use to manufacture the chemical 

substance containing greater than 0.1 

percent residual isocyanate. 

(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. 

■ 20. Add § 721.11113 to subpart E to 

read as follows: 

§ 721.11113 Branched alkyl (C = 17) 

carboxylic acid (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as branched alkyl (C = 17) 

carboxylic acid (PMN P–17–247) 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 substance after 

they have been 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)(concentration set 1.0 percent), and 

(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set 1.0 

percent), (f), (g)(1)(irritation), 

(sensitization), (g)(1)(iv), (vi), (ix), 

(g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), 

(g)(4)(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(f), (g) and (q). It is 

a significant new use to modify the 

manufacture, process or use activities if 

it results in inhalation exposure to 

vapor, dust, mist or aerosols to the 

substance. 

(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. 

(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. 

■ 21. Add § 721.11114 to subpart E to 

read as follows: 

§ 721.11114 Branched alkyl (C = 18) 

alcohol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as branched alkyl (C = 18) 

alcohol (PMN P–17–248) 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 substance after 

they have been 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)(concentration set 1.0 percent), and 

(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set 1.0 

percent), (f), (g)(1)(irritation), 

(sensitization), (g)(1)(iv), (vi), (ix), 

(g)(2)(i), (ii),)(iii), (v), (g)(3)(i), (ii), 

(g)(4)(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(f), (g) and (q). It is 

a significant new use to modify the 

manufacture, process or use activities if 

it results in inhalation exposure to 

vapor, dust, mist or aerosols to the 

substance. 

(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. 

(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. 

■ 22. Add § 721.11115 to subpart E to 

read as follows: 

§ 721.11115 Alkoxy silane modified 

butadiene styrene copolymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkoxy silane modified 


amozie on DSK3GDR082PROD with RULES
43556 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations 

1See Expanding the Economic and Innovation 

Opportunities of Spectrum Through Incentive 

Auctions, Report and Order, 29 FCC Rcd 6567, 

6820, paras. 618–19 (2014), 79 FR 48442 (Aug. 15, 

2014), (Incentive Auction R&O). 

2See Consolidated Appropriations Act, 2018, 

Public Law 115–141, at Division E, Title V, sec. 511, 

132 Stat. 348 (2018) (codified at 47 U.S.C. 1452(j)– 

(n)). 

3See 47 U.S.C. 1452(j)(3)(B). Section 511(j)(3)(C) 

provides that, if all reimbursements pursuant to the 

Spectrum Act and the Reimbursement Expansion 

Act have been made before July 3, 2023, ‘‘the 

Commission shall submit to the Secretary of the 

Treasury a certification that all such 

reimbursements have been made.’’ Id. sec. 

1452(j)(3)(C). In addition, the Reimbursement 

Expansion Act provides that reimbursement 

payments to LPTV/translator and FM stations may 

not be made after April 13, 2020 unless the 

Commission ‘‘submits to Congress a certification 

that such payments are necessary to reimburse costs 

reasonably incurred’’ by such stations. See id. sec. 

1452(j)(2)(C)(ii), (iii). 

butadiene styrene copolymer (PMN P– 

17–260) 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 

substance after they have been reacted 

(cured). 

(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 modify the 

manufacture, process or use activities if 

it results in inhalation exposure to 

vapor, dust, mist or aerosols to the 

substance. 

(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. 

[FR Doc. 2018–18403 Filed 8–24–18; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[MB Docket Nos. 18–214, 12–268; FCC 18– 

113] 

LPTV, TV Translator, and FM 

Broadcast Station Reimbursement; 

Expanding the Economic and 

Innovation Opportunities of Spectrum 

Through Incentive Auctions 

AGENCY: Federal Communications 

Commission. 

ACTION: Final action. 

SUMMARY: In this document, the 

Commission directs the Media Bureau 

to engage a contractor to assist in the 

reimbursement process and 

administration of the Reimbursement 

Fund for LPTV, TV translator, and FM 

stations, and also directs the Bureau to 

make determinations regarding eligible 

costs and the reimbursement process, 

such as calculating the amount of 

allocations to eligible entities and 

seeking comment on a revised Catalog of 

Eligible Expenses. The Commission also 

determines that the Media Bureau will 

announce, pursuant to the requirements 

in the Reimbursement Expansion Act, 

when the reimbursement program for all 

entities eligible for reimbursement 

pursuant to the Spectrum Act and the 

Reimbursement Expansion Act will end. 

Finally, the Commission interprets the 

Reimbursement Expansion Act as 

providing at least $50 million for use by 

the Commission to fund its efforts to 

educate consumers about the 

reorganization of broadcast television 

spectrum under the United States Code. 

DATES: This action is effective August 

27, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Maria Mullarkey, Maria.Mullarkey@

fcc.gov, of the Media Bureau, Policy 

Division, (202) 418–2120. For additional 

information concerning the Paperwork 

Reduction Act information collection 

requirements contained in this 

document, contact Cathy Williams at 

(202) 418–2918 or send an email to 

PRA@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Order, 

FCC 18–113, adopted on August 2, 

2018, and released on August 3, 2018. 

The full text of this document is 

available electronically via the FCC’s 

Electronic Document Management 

System (EDOCS) website at http://

fjallfoss.fcc.gov/edocs_public/ or via the 

FCC’s Electronic Comment Filing 

System (ECFS) website at http://

fjallfoss.fcc.gov/ecfs2/. Documents will 

be available electronically in ASCII, 

Microsoft Word, and/or Adobe Acrobat. 

This document is also available for 

public inspection and copying during 

regular business hours in the FCC 

Reference Information Center, Federal 

Communications Commission, 445 12th 

Street SW, CY–A257, Washington, DC 

20554. Alternative formats are available 

for people with disabilities (Braille, 

large print, electronic files, audio 

format), by sending an email to fcc504@

fcc.gov or calling the Commission’s 

Consumer and Governmental Affairs 

Bureau at (202) 418–0530 (voice), (202) 

418–0432 (TTY). 

The Order does not contain new or 

modified information collection 

requirements subject to the Paperwork 

Reduction Act of 1995. In addition, 

therefore, it does not contain any new 

or modified information collection 

burdens for small business concerns 

with fewer than 25 employees, pursuant 

to the Small Business Paperwork Relief 

Act of 2002. 

I. Order 

1. Reimbursement Contractor. Similar 

to the approach the Commission took 

with respect to full power, Class A, and 

MVPD entities,1 we direct the Media 

Bureau to engage a contractor to assist 

in the reimbursement process and 

administration of the Reimbursement 

Fund for LPTV/translator and FM 

stations. We direct the Media Bureau to 

engage a third-party contractor to assist 

in the reimbursement process, which 

will be overseen by the Bureau. 

2. Reimbursement Process. We direct 

the Media Bureau to revise the forms to 

be used by eligible LPTV/translator and 

FM stations to claim reimbursement 

from the Reimbursement Fund and for 

any other Reimbursement Fund-related 

purposes. We also direct the Media 

Bureau to calculate the amount of the 

allocations to eligible entities from the 

Reimbursement Fund, develop a revised 

Catalog of Eligible Expenses, and make 

other determinations regarding eligible 

costs and the reimbursement process. 

Finally, we direct the Media Bureau to 

implement the necessary policies and 

procedures relating to eligibility 

certifications, allocations, draw downs, 

payments, obligations, and expenditures 

of money from the Reimbursement Fund 

in order to protect against waste, fraud, 

and abuse and in the event of 

bankruptcy. Given the importance of 

maintaining the integrity of the Fund, 

the Media Bureau will consult with the 

Office of General Counsel and the Office 

of the Managing Director in acting 

pursuant to this direction. 

3. Reimbursement Period. The 

Reimbursement Expansion Act 2

provides that the Commission must 

make all reimbursements using the 

additional funds appropriated by the 

Reimbursement Expansion Act to the 

Reimbursement Fund by July 3, 2023.3

With respect to LPTV/translators and 

FM stations, we authorize the Media 

Bureau to announce, in one or more 

public notices to be issued following the 


amozie on DSK3GDR082PROD with RULES