40986 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 

the deviation period from 11 a.m. to 2 

p.m. on September 3, 2018. The bridge 

shall operate in accordance with 33 CFR 

117.869 at all other times. Waterway 

usage on this part of the Columbia River 

includes vessels ranging from large 

commercial ships, tug and tow vessels 

to recreational pleasure craft. 

Vessels able to pass under the bridges 

in the closed-to-navigation positions 

may do so at any time. Both bridges will 

be able to open for emergencies, and 

there is no immediate alternate route for 

vessels to pass. The Coast Guard will 

also inform the users of the waterways 

through our Local and Broadcast 

Notices to Mariners of the change in 

operating schedule for the bridge so that 

vessels can arrange their transits to 

minimize any impact caused by the 

temporary deviation. 

In accordance with 33 CFR 117.35(e), 

the drawbridges must return to their 

regular operating schedule immediately 

at the end of the effective period of this 

temporary deviation. This deviation 

from the operating regulations is 

authorized under 33 CFR 117.35. 

Dated: August 9, 2018. 

Steven M. Fischer, 

Bridge Administrator, Thirteenth Coast Guard 

District. 

[FR Doc. 2018–17801 Filed 8–16–18; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2018–0676] 

Drawbridge Operation Regulation; 

Willamette River at Portland, OR 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of deviation from 

drawbridge regulation; modification. 

SUMMARY: The Coast Guard has modified 

a temporary deviation from the 

operating schedule that governs the 

Hawthorne Bridge crosses the 

Willamette River, mile 13.1, at Portland, 

OR. The deviation is necessary to 

accommodate a filming event for a 

movie. This modified deviation changes 

the period the bridge is authorized to 

remain in the closed-to-navigation 

position. 

DATES: This modified deviation is 

effective from 6 p.m. on September 8, 

2018, to 12:01 a.m. on September 9, 

2018. 

ADDRESSES: The docket for this 

deviation, USCG–2018–0676 is available 

at http://www.regulations.gov. Type the 

docket number in the ‘‘SEARCH’’ box 

and click ‘‘SEARCH.’’ Click on Open 

Docket Folder on the line associated 

with this deviation. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this 

modification, call or email Mr. Steven 

Fischer, Bridge Administrator, 

Thirteenth Coast Guard District; 

telephone 206–220–7282, email d13-pfd13bridges@uscg.mil. 

SUPPLEMENTARY INFORMATION: On July 

19, 2018, we published a temporary 

deviation entitled ‘‘Drawbridge 

Operation Regulation; Willamette River 

at Portland, OR’’ in the Federal Register 

(83 FR 34041). That temporary deviation 

allowed the subject bridge to not open 

to marine vessels from 6 p.m. on 

September 1, 2018 to 12:01 a.m. on 

September 2, 2018. Multnomah County, 

the bridge owner, requested a 

modification of the current published 

deviation to the following times: 6 p.m. 

on September 8, 2018, to 12:01 a.m. on 

September 9, 2018. This change is due 

to scheduling issues with the filming 

crew for a movie. 

The Hawthorne Bridge provides a 

vertical clearance of 49 feet in the 

closed-to-navigation position referenced 

to the vertical clearance above Columbia 

River Datum 0.0. The subject bridge 

operates per 33 CFR 117.897(c)(3)(v). 

Waterway usage on this part of the 

Willamette River includes vessels 

ranging from commercial tug and barge 

to small pleasure craft. The Coast Guard 

requested objections to this 

modification from local mariners via 

email. No objections were submitted to 

us. Waterway usage on this part of the 

Willamette River includes vessels 

ranging from commercial tug and barge 

to small pleasure craft. 

Vessels able to pass through the 

bridge in the closed-to-navigation 

position may do so at any time. The 

bridge will be able to open for 

emergencies, and there is no immediate 

alternate route for vessels to pass. The 

Coast Guard will inform the users of the 

waterway, through our Local and 

Broadcast Notices to Mariners, of the 

change in operating schedule for the 

bridge so that vessel operators can 

arrange their transits to minimize any 

impact caused by the temporary 

deviation. 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the effective period of this 

temporary deviation. This deviation 

from the operating regulations is 

authorized under 33 CFR 117.35. 

Dated: August 9, 2018. 

Steven M. Fischer, 

Bridge Administrator, Thirteenth Coast Guard 

District. 

[FR Doc. 2018–17800 Filed 8–16–18; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2017–0414; FRL–9971–37] 

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 27 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 

27 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 

16, 2018. For purposes of judicial 

review, this rule shall be promulgated at 

1 p.m. (e.s.t.) on August 31, 2018. 

Written adverse comments on one or 

more of these SNURs must be received 

on or before September 17, 2018 (see 

Unit VI. of the SUPPLEMENTARY

INFORMATION). If EPA receives written 

adverse comments on one or more of 

these SNURs before September 17, 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) 


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Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 40987 

number EPA–HQ–OPPT–2017–0414, 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 17, 2018 are subject to the 

export notification provisions of TSCA 

section 12(b) (15 U.S.C. 2611(b)) (see 

§ 721.20), and must comply with the 

export notification requirements in 40 

CFR part 707, subpart D. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 

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

comments.html. 

II. Background 

A. What action is the Agency taking? 

1. Direct Final Rule. EPA is 

promulgating these SNURs using direct 

final 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 17, 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 


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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 

27 chemical substances in 40 CFR part 

721, subpart E. In this unit, EPA 

provides the following information for 

each chemical substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• Chemical Abstracts Service (CAS) 

Registry number (if assigned for nonconfidential chemical identities). 

• Basis for the TSCA section 5(e) 

Order. 

• Information identified by EPA that 

would help characterize the potential 

health and/or environmental effects of 

the chemical substance in support of a 

request by the PMN submitter to modify 

the Order, or if a manufacturer or 

processor is considering submitting a 

SNUN for a significant new use 

designated by the SNUR. 

This information may include testing 

required in a TSCA section 5(e) Order 

to be conducted by the PMN submitter, 

as well as testing not required to be 

conducted but which would also help 

characterize the potential health and/or 

environmental effects of the PMN 

substance. Any recommendation for 

information identified by EPA was 

made based on EPA’s consideration of 

available screening-level data, if any, as 

well as other available information on 

appropriate testing for the chemical 

substance. Further, any such testing 

identified by EPA that includes testing 

on vertebrates was made after 

consideration of available toxicity 

information, computational toxicology 

and bioinformatics, and highthroughput screening methods and their 

prediction models. EPA also recognizes 

that whether testing/further information 

is needed will depend on the specific 

exposure and use scenario in the SNUN. 

EPA encourages all SNUN submitters to 

contact EPA to discuss any potential 

future testing. See Unit VIII. for more 

information. 

• CFR citation assigned in the 

regulatory text section of this rule. 

The regulatory text section of each 

rule specifies 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 27 PMN 

substances that are subject to Orders 

issued 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 Numbers: P–12–277, P–12–278, P– 

12–280, P–12–281, P–12–282, P–12–283, 

and P–12–284 

Chemical names: Alkanes, C20–28, 

chloro (P–12–277), Slack waxes 

(petroleum), chloro (P–12–278), 

Hexacosane, chloro derivs. and 

octacosane, chloro derivs. (P–12–280), 

Alkanes, C20–24, chloro (P–12–281), 

Alkanes, C14–16, chloro (P–12–282), 

Tetradecane, chloro derivs. (P–12–283), 

and Octadecane, chloro derivs. (P–12– 

284). 

CAS numbers: 2097144–43–7 (P–12– 

277), 2097144–44–8 (P–12–278), 

2097144–46–0 and 2097144–47–1 (P– 

12–280), 2097144–45–9 (P–12–281), 

1372804–76–6 (P–12–282), 198840–65– 

2 (P–12–283), 2097144–48–2 (P–12– 

284). 

Effective date of TSCA section 5(e) 

Order: June 5, 2017. 

Basis for TSCA section 5(e) Order: 

The PMNs state that the PMN 

substances will be used as flame 

retardants and plasticizers in polyvinyl 

chloride (PVC), polymers, and rubber; 

flame retardants, plasticizers, and 


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lubricants in adhesives, caulk, sealants, 

and coatings; additives in lubricants 

including metalworking fluids; and 

flame retardants and waterproofers in 

textiles. Based on the physical/chemical 

properties of the PMN substances (as 

described in the New Chemical 

Program’s PBT category at 64 FR 60194; 

November 4, 1999; FRL–6097–7) and 

test data on structurally similar 

medium-chain chlorinated paraffins 

(MCCP), the PMN substances are a 

potentially persistent, bioaccumulative, 

and toxic (PBT) chemicals. EPA 

estimates that the PMN substances will 

persist in the environment more than 2 

months and estimates a 

bioaccumulation factor of greater than 

or equal to 1,000. Based on data on 

MCCP, EPA has identified concerns for 

systemic toxicity as well as aquatic and 

terrestrial toxicity. The Order was 

issued under TSCA sections 

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

based on a finding that the substances 

may present an unreasonable risk of 

injury to health or the environment. To 

protect against these risks, the Order 

requires: 

1. Submission of certain toxicity 

testing on the representative congener 

groups prior to exceeding a certain time 

period specified in the Order. 

2. Use of the PMN substances only for 

the uses specified in the Order: Flame 

retardants and plasticizers in PVC, 

polymers, and rubber; flame retardants, 

plasticizers, and lubricants in adhesives, 

caulk, sealants, and coatings; additives 

in lubricants including metalworking 

fluids; and flame retardants and 

waterproofers in textiles. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the fate, and terrestrial and 

aquatic toxicity of the PMN substances 

may be potentially useful to characterize 

the effects of the PMN substances in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. The submitter 

has agreed not to exceed a certain time 

limit without performing chronic 

aquatic and terrestrial toxicity and 

biodegradation testing. 

CFR citations: 40 CFR 721.11068 (P– 

12–277), 40 CFR 721.11069 (P–12–278), 

40 CFR 721.11070 (P–12–280), 40 CFR 

721.11071 (P–12–281), 40 CFR 

721.11072 (P–12–282 and P–14–684), 40 

CFR 721.11073 (P–12–283 and P–14– 

683), and 40 CFR 721.11074 (P–12–284). 

PMN Numbers: P–12–433, P–12–453, 

and P–12–505 

Chemical names: Alkanes, C18–20, 

chloro (P–12–433), Alkanes, C14–17, 

chloro (P–12–453) and Alkanes, C22–30, 

chloro (P–12–505). 

CAS numbers: 106262–85–3 (P–12– 

433), 85535–85–9 (P–12–453) and 

288260–42–4 (P–12–505). 

Effective date of TSCA section 5(e) 

Order: June 5, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the PMN 

substances will be used as flame 

retardants and plasticizers in PVC, 

polymers, and rubber; flame retardants, 

plasticizers, and lubricants in adhesives, 

caulk, sealants, and coatings; additives 

in lubricants including metalworking 

fluids; and flame retardants and 

waterproofers in textiles. Based on the 

physical/chemical properties of the 

PMN substances (as described in the 

New Chemical Program’s PBT category 

at 64 FR 60194; November 4, 1999; 

FRL–6097–7) and test data on 

structurally similar medium-chain 

chlorinated paraffins (MCCP), the PMN 

substances are potentially persistent, 

bioaccumulative, and toxic (PBT) 

chemicals. EPA estimates that the PMN 

substances will persist in the 

environment more than 2 months and 

estimates a bioaccumulation factor of 

greater than or equal to 1,000. Based on 

test data on MCCP EPA has identified 

concerns for systemic toxicity as well as 

aquatic and terrestrial toxicity. The 

Order was issued under TSCA sections 

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

based on a finding that the substances 

may present an unreasonable risk of 

injury to health or the environment. To 

protect against these risks, the Order 

requires: 

1. Submission of certain toxicity 

testing on the representative congener 

groups prior to exceeding a certain time 

period specified in the Order. 

2. Use of the PMN substances only for 

the uses specified in the Order: Flame 

retardants and plasticizers in PVC, 

polymers, and rubber; flame retardants, 

plasticizers, and lubricants in adhesives, 

caulk, sealants, and coatings; additives 

in lubricants including metalworking 

fluids; and flame retardants and 

waterproofers in textiles. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the fate, and terrestrial and 

aquatic toxicity of the PMN substances 

may be potentially useful to characterize 

the effects of the PMN substances in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. The submitter 

has agreed not to exceed a certain time 

limit without performing chronic 

aquatic and terrestrial toxicity and 

biodegradation testing. 

CFR citations: 40 CFR 721.11075 (P– 

12–433), 40 CFR 721.11076 (P–12–453), 

40 CFR 721.11077 (P–12–505). 

PMN Numbers: P–14–683 and P–14–684 

Chemical names: Tetradecane, chloro 

derivs. (P–14–683) and Alkanes, C14–16, 

chloro (P–14–684). 

CAS numbers: 198840–65–2 (P–14– 

683) and 1372804–76–6 (P–14–684). 

Effective date of TSCA section 5(e) 

Order: May 17, 2017. 

Basis for TSCA section 5(e) Order: 

The PMNs state that the substances will 

be used as flame retardants and 

plasticizers in PVC, polymers, and 

rubber; flame retardants, plasticizers, 

and lubricants in adhesives, caulk, 

sealants, and coatings; additives in 

lubricants including metalworking 

fluids; and flame retardants and 

waterproofers in textiles. Based on the 

physical/chemical properties of the 

PMN substances (as described in the 

New Chemical Program’s PBT category 

at 64 FR 60194; November 4, 1999; 

FRL–6097–7) and test data on 

structurally similar medium-chain 

chlorinated paraffins (MCCP), the PMN 

substances are potentially persistent, 

bioaccumulative, and toxic (PBT) 

chemicals. EPA estimates that the PMN 

substances will persist in the 

environment more than 2 months and 

estimates a bioaccumulation factor of 

greater than or equal to 1,000. Further, 

EPA has identified concerns for 

systemic toxicity, as well as aquatic and 

terrestrial toxicity. The Order was 

issued under TSCA sections 

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

based on a finding that the substances 

may present an unreasonable risk of 

injury to health or the environment. To 

protect against these risks, the Order 

requires: 

1. Submission of certain toxicity 

testing on the representative congener 

groups prior to exceeding a certain time 

period specified in the Order. 

2. Use of the PMN substances only for 

the uses specified in the Order: Flame 

retardants and plasticizers in PVC, 

polymers, and rubber; flame retardants, 

plasticizers, and lubricants in adhesives, 

caulk, sealants, and coatings; additives 

in lubricants including metalworking 

fluids; and flame retardants and 

waterproofers in textiles. 


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The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the fate, and terrestrial and 

aquatic toxicity of the PMN substances 

may be potentially useful to characterize 

the effects of the PMN substances in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. The submitter 

has agreed not to exceed a certain time 

limit without performing chronic 

aquatic and terrestrial toxicity and 

biodegradation testing. 

CFR citations: 40 CFR 721.11072 (P– 

12–282 and P–14–684), 40 CFR 

721.11073 (P–12–283 and P–14–683). 

PMN Number: P–16–150 

Chemical name: Chloroflurocarbon 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: May 31, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as an intermediate. Based on test data 

on the PMN substance, EPA identified 

concerns for acute human toxicity. 

Based on analogue data EPA identified 

concerns for toxicity to aquatic and 

terrestrial organisms. The Order was 

issued under TSCA sections 

5(a)(3)(B)(ii)(I), 5(a)(3)(B)(ii)(II) 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 and that the substance 

will be produced in substantial 

quantities and may be reasonably 

anticipated to enter the environment in 

substantial quantities. To protect against 

these risks, the Order requires: 

1. Submission of certain toxicity 

testing on the substance prior to 

exceeding the production limits 

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 of 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

assigned protection factor (APF) of at 

least 1000 (where there is a potential for 

inhalation exposure) in conjunction 

with a minimum set of engineering 

controls described in the PMN, or 

compliance with a new chemical 

exposure limit (NCEL) of 170 parts per 

billion (ppb) as an 8-hour time-weighted 

average to prevent inhalation exposure. 

4. Use of engineering controls to limit 

worker exposure and air release of the 

PMN substance to the environment. 

5. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the Safety Data 

Sheet (SDS). 

6. Manufacture, processing, and use 

in an enclosed process. 

7. Use only as a chemical 

intermediate. 

8. No release of the substance 

resulting in surface water 

concentrations that exceed 240 ppb. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and aquatic 

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 target organ toxicity 

testing, reproductive and developmental 

toxicity testing, and acute and chronic 

aquatic toxicity testing. 

CFR citation: 40 CFR 721.11078. 

PMN Number: P–16–379 

Chemical name: Silane, 1,1′-(1,2- 

ethanediyl)bis[1,1-dichloro-1-methyl]-, 

hydrolysis products with 

chloroethenyldimethylsilane. 

CAS number: 1485477–78–8. 

Effective date of TSCA section 5(e) 

Order: June 8, 2017. 

Basis for TSCA section 5(e) Order: 

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

a chemical intermediate for polymer 

synthesis. Based on SAR analysis of test 

data on analogous substances, EPA has 

identified concerns for liver toxicity and 

mutagenicity. 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 

these risks, the Order requires: 

1. Submission of certain toxicity 

testing on the substance prior to 

exceeding the confidential production 

volume limit specified in the Order. 

2. Use of personal protective 

equipment including impervious gloves 

and clothing which covers any other 

exposed areas of the arms, legs and torso 

(where there is a potential for dermal 

exposure). 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

4. No domestic manufacture of the 

substance. 

5. Use of the substance only for the 

confidential uses specified in the Order. 

6. No use involving application 

methods that generate a dust, mist, 

vapor, or aerosol. 

7. Disposal of the substance only by 

water or landfill. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN 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 target organ toxicity 

and mutagenicity testing. In addition, 

EPA has determined that the results of 

other specific target organ toxicity 

testing 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 721.11079. 

PMN Number: P–16–410 

Chemical name: Silicophosphonate— 

sodium silicate (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: May 4, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as an automotive engine fluid 

additive. Based on test data on the PMN 

substance, EPA has identified concerns 

for skin and eye irritation, corrosion, 

and systemic toxicity. The Order was 

issued under TSCA sections 

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

based on a finding that the substance 

may present an unreasonable risk of 

injury to human health. To protect 

against these risks, the Order requires: 


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1. No domestic manufacture of the 

substance. 

2. Use of the substance in 

formulations containing no greater than 

0.2% of the chemical substance and for 

the confidential uses specified in the 

Order. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN substance may be potentially 

useful to characterize the effects of the 

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 irritation 

testing may be potentially useful in 

characterizing the health effects of the 

PMN substance. Although the Order 

does not require these tests, the Order’s 

restrictions 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 721.11080. 

PMN Number: P–16–438 

Chemical name: 3-Butenenitrile, 2- 

(acetyloxy)-. 

CAS number: 15667–63–7. 

Effective date of TSCA section 5(e) 

Order: June 23, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states the substance will be 

used as a chemical intermediate for a 

pesticide inert. Based on test data on the 

PMN substance, EPA identified 

concerns for acute toxicity, irritation to 

all tissues, developmental toxicity, and 

neurotoxicity. EPA identified concerns 

for aquatic organism toxicity based on 

submitted data. 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. Further, based on SAR 

analysis of test data on analogous vinyl/ 

allyl esters vinyl/allyl esters nitriles and 

test data on the PMN substance, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

8 ppb in surface waters. To protect 

against these risks, the Order requires: 

1. Submission of monitoring data on 

the substance. 

2. Use of personal protective 

equipment including impervious gloves 

and protective clothing (where there is 

a potential for dermal exposures) and a 

NIOSH-certified powered air purifying 

particulate respirator with an Assigned 

Protection Factor (APF) of at least 1000 

(where there is a potential for inhalation 

exposures). 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

4. Manufacture, process, and use of 

the substance in a closed system as 

specified in the PMN. 

5. Use of the substance only as a 

chemical intermediate. 

6. No release of the substance into the 

surface waters of the United States. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the aquatic toxicity of the PMN 

substance may be potentially useful to 

characterize the effects of the PMN 

substance in support of a request by the 

PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. EPA has 

determined that the results of chronic 

aquatic toxicity testing of the PMN 

substance may be potentially useful in 

characterizing the environmental effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions on manufacture, 

processing, distribution in commerce, 

and use 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 721.11081. 

PMN Number: P–16–543 

Chemical name: Halogenophosphoric 

acid metal salt (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: May 24, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use will be as a battery 

ingredient. Based on test data on the 

PMN substance and an analogue, EPA 

has identified concerns for irritation, 

corrosion, acute toxicity, 

immunotoxicity, developmental 

toxicity, neurotoxicity, and cancer. 

Further, based on test data on the PMN 

substance, EPA identified concerns for 

aquatic organism toxicity at surface 

water concentrations that exceed 3 ppb. 

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 

these risks, the Order requires: 

1. Submission of monitoring data as 

specified in the Order. 

2. Use of personal protective 

equipment as specified in the Order 

(where there is a potential for dermal 

exposure). 

3. Use of a NIOSH-certified respirator 

with an APF of at least 1000 (where 

there is a potential for inhalation 

exposure). 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

5. No domestic manufacture of the 

substance. 

6. Use of the substance only in an 

enclosed process. 

7. Use of the substance only for the 

confidential uses specified in the Order. 

8. Manufacture, process, or use of the 

substance without the engineering 

controls required by the Order to control 

dermal and inhalation exposure. 

9. Disposal of the substance by 

hazardous waste incineration except 

when in wastewater. 

10. No release of the substance 

resulting in surface water 

concentrations that exceed 3 ppb. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity, human 

exposure, aquatic toxicity, and fate 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 to conduct an exposure 

monitoring program for employees who 

are reasonably likely to be exposed to 

the PMN substance and a hydrolysis 

product of the PMN substance. In 

addition, EPA has determined that the 

results of specific target organ toxicity, 

acute aquatic toxicity, and 

biodegradation testing of the PMN 

substance 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 


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is relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11082. 

PMN Number: P–16–596 

Chemical names: Alkenoic acid, 

reaction products with polyethylene 

glycol ether with hydroxyalkyl 

substituted alkane (generic). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: June 5, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the substance will 

be used as a site-limited intermediate 

used for production of ultraviolet (UV) 

curable coating resin. Based on SAR 

analysis on structurally similar 

substances, EPA has identified concerns 

for irritation, sensitization, 

developmental toxicity, liver and 

kidney effects, and oncogenicity. 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. 

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. To protect against these risks, 

the Order requires: 

1. Submission of test data on the 

substance prior to exceeding the 

confidential production volume limit 

specified in the Order. 

2. Use of personal protective 

equipment including impervious gloves 

(where there is a potential for dermal 

exposure). 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

4. No domestic manufacture of the 

substance. 

5. Use of the substance only as a sitelimited intermediate for the production 

of UV curable coating resin. 

6. No release of the substance to 

surface waters of the United States. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN substance may be potentially 

useful to characterize the effects of the 

PMN substances in support of a request 

by the PMN submitter to modify the 

Order, or if a manufacturer or processor 

is considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. EPA has 

determined that the results of a 

reproductive/developmental toxicity 

testing may be potentially useful in 

characterizing the health effects of the 

PMN substance. The submitter has 

agreed not to manufacture beyond a 

certain production volume limit without 

performing reproductive/developmental 

toxicity testing. 

CFR citation: 40 CFR 721.11083. 

PMN Number: P–17–10 

Chemical name: Alkyl substituted 

alkenoic acid, alkyl ester, polymer with 

alkyl substituted alkenoate and alkenoic 

acid, hydroxy 

substituted[(oxoalkyl)oxy]alkyl ester, 

reaction products with alkanoic acid, 

dipentaerythritil and isocyanate 

substituted carbomonocycle, compds. 

with alkylamine (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: June 31, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the substance will 

be used as a UV curable coating resin. 

Based on test data on structurally 

similar substances, EPA has identified 

concerns for irritation, sensitization, 

developmental effects, internal organ 

effects (liver and kidney), and cancer. 

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 

these risks, the Order requires: 

1. Use of personal protective 

equipment including impervious gloves 

to prevent dermal exposure (where there 

is a potential for dermal exposure). 

2. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

3. No domestic manufacture of the 

substance. 

4. No manufacture, process, or use of 

the substance that results in generation 

of a vapor, mist, or aerosol. 

5. No manufacture of the substance 

where there is more than 0.1% residual 

isocyanate by weight. 

6. Use of the substance only as a UV 

curable coating resin. 

7. Only import the substance in totes. 

8. Manufacture of the substance to 

have an average molecular weight of 

greater than 2,000 daltons. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN substance may be potentially 

useful to characterize the effects of the 

PMN substances in support of a request 

by the PMN submitter to modify the 

Order, or if a manufacturer or processor 

is considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. EPA has 

determined that the results of 

reproductive/developmental toxicity 

testing may be potentially useful in 

characterizing the health effects of the 

PMN substance. Although the Order 

does not require these tests, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, and use 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 721.11084. 

PMN Number: P–17–15 

Chemical name: Heteromonocycle 

ester with alkanediol (generic). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: June 13, 2017. 

Basis for TSCA section 5(e) Order: 

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

is a precursor for a photochromatic 

substance. Based on SAR analysis of test 

data on analogous esters, EPA has 

identified concerns for irritation to skin, 

eye, and mucous membrane, and 

systemic toxicity. Further, based on 

SAR analysis of test data on analogous 

nonionic esters, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 3 ppb of the 

PMN substance 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. 

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. To protect against these risks, 

the Order requires: 

1. Submission of certain toxicity 

testing on the substance prior to 

exceeding the confidential production 

volume limit specified in the Order. 

2. Use of personal protective 

equipment including impervious gloves 

to prevent dermal exposure (where there 

is a potential for dermal exposure). 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

4. No domestic manufacture of the 

substance. 

5. No use of the substance other than 

other than for the confidential uses 

identified in the Order. 


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6. No release of the substance 

resulting in surface water 

concentrations that exceed 3 ppb. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and aquatic 

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 reproductive/developmental 

toxicity and acute aquatic toxicity 

testing. 

CFR citation: 40 CFR 721.11085. 

PMN Number: P–17–29 

Chemical name: Substituted 

carbomonocycle, polymer with 

(aminoalkyl)-alkanediamine, 

(haloalkyl)oxirane, dialkylalkanediamine and alkyl-alkanamine, 

reaction products with dialkanolamine 

and [[(alkyl)oxy]alkyl]oxirane (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: May 10, 2017. 

Basis for TSCA section 5(e) Order: 

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

intermediate prepolymer. Based on the 

physical/chemical properties of the 

substance and SAR analysis of test data 

on analogous aliphatic amines, EPA has 

identified concerns for irritation, lung 

effects, and aquatic toxicity. The Order 

was issued under TSCA sections 

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

based on a finding that the substance 

may present an unreasonable risk of 

injury to health and the environment. 

To protect against these risks, the Order 

requires: 

1. Submission of certain toxicity 

testing on the substance prior to 

exceeding the confidential production 

volume limit specified in the Order. 

2. Use of personal protective 

equipment including impervious gloves 

to prevent dermal exposure (where there 

is a potential for dermal exposure). 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

4. No use other than for the 

confidential uses identified in the 

Order. 

5. No use involving an application 

method that generates a vapor, mist, or 

aerosol. 

6. No domestic manufacture of the 

substance. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and aquatic 

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 irritation and acute aquatic 

toxicity testing. In addition, EPA has 

determined that the results of a 

pulmonary effects testing 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 721.11086. 

PMN Numbers: P–17–154, P–17–155, 

and P–17–156 

Chemical names: Carboxylic acid 

amine (1:1) (generic) (P–17–154), Mix 

fatty acids compd. with amine (1:1) 

(generic) (P–17–155), and Mix fatty 

acids compd. with amine (1:1) (generic) 

(P–17–156). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: June 15, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substances is as 

a coating. Based on physical/chemical 

properties of the substances and SAR 

analysis of test data on amines, EPA 

identified concerns for irritation, 

corrosion, developmental toxicity, 

reproductive toxicity, neurotoxicity, and 

thyroid toxicity. Further, based on test 

data on analogous anionic surfactants 

and aliphatic amines, EPA identified 

concern for toxicity to aquatic 

organisms at surface water 

concentrations that exceed 240 ppb. 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. 

EPA’s estimates indicate that variations 

of the parameters (including batch size, 

number of processing sites, days per 

year of operation) of the uses for the 

chemical substance would not result in 

increased inhalation exposure. To 

protect against these risks, the Order 

requires: 

1. Submission of certain toxicity 

testing on the substances prior to 

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 

exposure). 

3. Establishment and use of a hazard 

communication program, including 

human health and environmental 

precautionary statements on each label 

and in the SDS. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN substances may be potentially 

useful to characterize the effects of the 

PMN substances in support of a request 

by the PMN submitter to modify the 

Order, or if a manufacturer or processor 

is considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. The submitter 

has agreed to not exceed a confidential 

production volume without performing 

reproductive/developmental toxicity 

testing. 

CFR citation: 40 CFR 721.11087 (P– 

17–154), 40 CFR 721.11088 (P–17–155), 

40 CFR 721.11089 (P–17–156). 

PMN Number: P–17–218 

Chemical name: 

Bicyclo[2.2.1]heptane-1- 

methanesulfonic acid, 7,7-dimethyl-2- 

oxo-, compd. with N,Ndiethylethanamine (1:1). 

CAS number: 67019–84–5. 

Effective date of TSCA section 5(e) 

Order: May 19, 2017. 

Basis for TSCA section 5(e) Order: 

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

processing aid for membrane 

production. Based on SAR analysis of 

test data on structurally similar 

respirable particles, EPA identified 

concerns for corrosivity, irritation, 

sensitization, developmental toxicity, 

specific target organ toxicity, and 

neurotoxicity. 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 

these risks, the Order requires: 

1. Submission of certain toxicity 

testing on the substance prior to 


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exceeding the confidential production 

volume limit specified in the Order. 

2. Use of personal protective 

equipment including impervious gloves 

to prevent dermal exposure (where there 

is a potential for dermal exposure). 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

4. No manufacture, processing, or use 

involving an application method that 

generates a vapor, mist, aerosol, or dust. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN substance may be potentially 

useful to characterize the effects of the 

PMN substance in support of a request 

by the PMN submitter to modify the 

Order, or if a manufacturer or processor 

is considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. The submitter 

has agreed not to exceed the 

confidential production limit without 

performing a skin sensitization study. In 

addition, EPA has determined that the 

results of reproductive/developmental 

toxicity testing 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, 

and use 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 721.11090. 

PMN Number: P–17–226 

Chemical name: Manganese(2+), 

bisoctahydro-1,4,7-trimethyl-1H-1,4,7- 

triazonine- 

.kappa.N1,.kappa.N4,.kappa.N7)tri- 

.mu.-oxidi-, hexafluorophosphate(1-) 

(1:2). 

CAS number: 116633–52–4. 

Effective date of TSCA section 5(e) 

Order: June 15, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a detergent additive. Based on test 

data on the substance and analogue test 

data, EPA has identified concerns for 

eye irritation, thyroid, blood, and liver 

toxicity, male reproductive toxicity, 

neurotoxicity, immunosuppression, 

respiratory sensitization, and 

mutagenicity. Based on test data on the 

substance and test data on analogous 

neutral organics, EPA identified concern 

for toxicity to aquatic organisms at 

surface water concentrations that exceed 

240 ppb. 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 

these risks, the Order requires: 

1. Use of personal protective 

equipment to prevent dermal exposure 

(where there is a potential for dermal 

exposure). 

2. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

3. No use other than the confidential 

use allowed in the Order. 

4. No domestic manufacture of the 

substance. 

5. No processing without appropriate 

engineering controls to prevent 

inhalation exposure, including dust 

removal with 99.9% efficiency when 

loading or unloading the substance in 

powder form. 

6. No release of the substance 

resulting in surface water 

concentrations that exceed 240 ppb. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN substance may be potentially 

useful to characterize the effects of the 

PMN substance in support of a request 

by the PMN submitter to modify the 

Order, or if a manufacturer or processor 

is considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. EPA has 

determined that the results of specific 

target organ toxicity testing 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, 

and use 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 721.11091. 

PMN Numbers: P–17–228 and P–17–229 

Chemical names: 2′-Fluoro-4′′-alkyl-4- 

propyl-1,1′:4′1′′-terphenyl (generic) (P– 

17–228) and 4-ethyl-2′-fluoro-4′′-alkyl1,1′:4′1′′-terphenyl (generic) (P–17–229). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: May 18, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substances is a 

coating for displays. Based on the 

physical/chemical properties of the 

substances (as described in the New 

Chemical Program’s PBT category at 64 

FR 60194; November 4, 1999; FRL– 

6097–7) and test data on structurally 

similar substances, the substances are 

potentially persistent, bioaccumulative, 

and toxic (PBT) chemicals. EPA 

estimates that the substances will 

persist in the environment more than 2 

months and estimates a 

bioaccumulation factor of greater than 

or equal to 1,000. Further, based on test 

data on structurally similar chemicals, 

EPA has identified concerns for 

reproductive effects, adrenal and liver 

toxicity. The Order was issued under 

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

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

the substances may present an 

unreasonable risk of injury to health and 

the environment. To protect against 

these risks, the Order requires: 

1. Use of personal protective 

equipment including impervious gloves 

to prevent dermal exposure (where there 

is a potential for dermal exposure). 

2. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

3. No manufacture beyond the 

confidential annual production volume 

limit specified in the Order. 

4. No processing or use of the 

substances in an application method 

that generates a dust, mist, or aerosol. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the fate and human health toxicity 

of the PMN substances may be 

potentially useful to characterize the 

effects of the PMN substances in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. EPA has 

determined that the results of 

biodegradation and reproductive/ 

developmental toxicity testing of the 

PMN substances may be potentially 

useful in characterizing the 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 


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information that EPA determines is 

relevant and needed to evaluate a 

modification request. 

CFR citations: 40 CFR 721.11092 (P– 

17–228) and 40 CFR 721.11093 (P–17– 

229). 

PMN Number: P–17–261 

Chemical name: Poly(oxy-1,2- 

ethanediyl),-.alpha.-(2-benzoylbenzoyl)- 

.omega.-[(2-benzoylbenzoyl)oxy]-. 

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 substance will 

be used as a difunctional type II 

photoinitiator for use in inks and 

coatings. Based on physical/chemical 

properties, SAR analysis and test data 

on analogous esters with branched 

polyols, EPA has identified concerns for 

corrosion of the skin, eyes, and mucous 

membranes, developmental toxicity, 

systemic toxicity, and blood effects. 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. 

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 

for the chemical substance would not 

result in increased inhalation exposure. 

To protect against these risks, the Order 

requires: 

1. Submission of certain toxicity 

testing on the substance prior to 

exceeding the confidential production 

volume limit specified in the Order. 

2. Use of personal protective 

equipment including impervious gloves 

(where there is a potential for dermal 

exposure). 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

4. No domestic manufacture of the 

substance. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN 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 in the 

Order without performing irritation 

testing. 

CFR citation: 40 CFR 721.11094. 

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 27 chemical substances 

regulation was warranted under TSCA 

section 5(e), pending the development 

of information sufficient to make 

reasoned evaluations of the health or 

environmental effects of the chemical 

substances. The basis for such findings 

is outlined in Unit IV. Based on these 

findings, TSCA section 5(e) Orders 

requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. 

The SNURs identify as significant 

new uses any manufacturing, 

processing, use, distribution in 

commerce, or disposal that does not 

conform to the restrictions imposed by 

the underlying Orders, consistent with 

TSCA section 5(f)(4). 

B. Objectives 

EPA is issuing these SNURs for 

specific chemical substances which 

have undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this rule: 

• EPA will receive notice of any 

person’s intent to manufacture or 

process a listed chemical substance for 

the described significant new use before 

that activity begins. 

• EPA will have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing or processing a 

listed chemical substance for the 

described significant new use. 

• EPA will be able to either determine 

that the prospective manufacture or 

processing is not likely to present an 

unreasonable risk, or to take necessary 

regulatory action associated with any 

other determination, before the 

described significant new use of the 

chemical substance occurs. 

• EPA will identify as significant new 

uses any manufacturing, processing, 

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 direct 

final rules. The effective date of these 

rules is September 17, 2018 without 

further notice, unless EPA receives 

written adverse comments before 

September 17, 2018. 

If EPA receives written adverse 

comments on one or more of these 

SNURs before September 17, 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 13 of the 27 

chemical substances subject to this rule 

have been claimed as confidential and 

EPA has received no post-PMN bona 

fide submissions (per §§ 720.25 and 

721.11) for a chemical substance 

covered by this action. Based on this, 

the Agency believes that it is highly 

unlikely that any of the significant new 

uses described in the regulatory text of 

this rule are ongoing. 


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Therefore, EPA designates August 17, 

2018 as the cutoff date for determining 

whether the new use is ongoing. The 

objective of EPA’s approach has been to 

ensure that a person could not defeat a 

SNUR by initiating a significant new use 

before the effective date of the direct 

final rule. 

Persons who begin commercial 

manufacture or processing of the 

chemical substances for a significant 

new use identified as of that date will 

have to cease any such activity upon the 

effective date of the final rule. To 

resume their activities, these persons 

will have to first comply with all 

applicable SNUR notification 

requirements and wait until EPA has 

conducted a review of the notice, made 

an appropriate determination on the 

notice, and has taken such actions as are 

required with that determination. 

VIII. Development and Submission of 

Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular new information (e.g., 

generating test data) before submission 

of a SNUN. There is an exception: 

Development of test data is required 

where the chemical substance subject to 

the SNUR is also subject to a rule, order 

or consent agreement under TSCA 

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

In the absence of a TSCA section 4 

test rule covering the chemical 

substance, persons are required only to 

submit information in their possession 

or control and to describe any other 

information known to or reasonably 

ascertainable by them (see 40 CFR 

720.50). However, upon review of PMNs 

and SNUNs, the Agency has the 

authority to require appropriate testing. 

Unit IV. lists potentially useful 

information for all of the listed SNURs. 

Descriptions of this information are 

provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. Furthermore, pursuant to 

TSCA section 4(h), which pertains to 

reduction of testing in vertebrate 

animals, EPA encourages consultation 

with the Agency on the use of 

alternative test methods and strategies 

(also called New Approach 

Methodologies, or NAMs), if available, 

to generate the recommended test data. 

EPA encourages dialog with Agency 

representatives to help determine how 

best the submitter can meet both the 

data needs and the objective of TSCA 

section 4(h). To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http://www.oecdbook

shop.org or SourceOECD at http://

www.sourceoecd.org. 

In certain of the TSCA section 5(e) 

Orders for the chemical substances 

regulated under this rule, EPA has 

established production volume limits in 

view of the lack of data on the potential 

health and environmental risks that may 

be posed by the significant new uses or 

increased exposure to the chemical 

substances. These limits cannot be 

exceeded unless the PMN submitter first 

submits the results of 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. 

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. 


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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– 

2017–0414. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This action establishes SNURs for 

several new chemical substances that 

were the subject of PMNs and TSCA 

section 5(e) Orders. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

Review’’ (58 FR 51735, October 4, 1993). 

B. Paperwork Reduction Act (PRA) 

According to PRA (44 U.S.C. 3501 et 

seq.), an agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under PRA, 

unless it has been approved by OMB 

and displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. EPA is amending the table in 

40 CFR part 9 to list the OMB approval 

number for the information collection 

requirements contained in this action. 

This listing of the OMB control numbers 

and their subsequent codification in the 

CFR satisfies the display requirements 

of PRA and OMB’s implementing 

regulations at 5 CFR part 1320. This 

Information Collection Request (ICR) 

was previously subject to public notice 

and comment prior to OMB approval, 

and given the technical nature of the 

table, EPA finds that further notice and 

comment to amend it is unnecessary. As 

a result, EPA finds that there is ‘‘good 

cause’’ under section 553(b)(3)(B) of the 

Administrative Procedure Act (5 U.S.C. 

553(b)(3)(B)) to amend this table 

without further notice and comment. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per response. This burden estimate 

includes the time needed to review 

instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act (RFA) 

On February 18, 2012, EPA certified 

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

601 et seq.), that promulgation of a 

SNUR does not have a significant 

economic impact on a substantial 

number of small entities where the 

following are true: 

1. A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

2. The SNUR submitted by any small 

entity would not cost significantly more 

than $8,300. 

A copy of that certification is 

available in the docket for this action. 

This action is within the scope of the 

February 18, 2012 certification. Based 

on the Economic Analysis discussed in 

Unit XI. and EPA’s experience 

promulgating SNURs (discussed in the 

certification), EPA believes that the 

following are true: 

• A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

• 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 


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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 3, 2018. 

Mark A. Hartman, 

Acting Director, Office of Pollution Prevention 

and Toxics. 

Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

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

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

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

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

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

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

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

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

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

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

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

11023, 11048. 

■ 2. In § 9.1, add the following sections 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB 

control No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.11068 ................................... 2070–0012 

721.11069 ................................... 2070–0012 

721.11070 ................................... 2070–0012 

721.11071 ................................... 2070–0012 

721.11072 ................................... 2070–0012 

721.11073 ................................... 2070–0012 

721.11074 ................................... 2070–0012 

721.11075 ................................... 2070–0012 

721.11076 ................................... 2070–0012 

721.11077 ................................... 2070–0012 

721.11078 ................................... 2070–0012 

721.11079 ................................... 2070–0012 

721.11080 ................................... 2070–0012 

721.11081 ................................... 2070–0012 

721.11082 ................................... 2070–0012 

721.11083 ................................... 2070–0012 

721.11084 ................................... 2070–0012 

721.11085 ................................... 2070–0012 

721.11086 ................................... 2070–0012 

721.11087 ................................... 2070–0012 

721.11088 ................................... 2070–0012 

721.11089 ................................... 2070–0012 

721.11090 ................................... 2070–0012 

721.11091 ................................... 2070–0012 

721.11092 ................................... 2070–0012 

721.11093 ................................... 2070–0012 

721.11094 ................................... 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 § 721.11068 to subpart E to 

read as follows: 

§ 721.11068 Alkanes, C20–28, chloro. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

alkanes, C20–28, chloro (PMN P–12–277, 

CAS No. 2097144–43–7) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (flame 

retardants and plasticizers in polyvinyl 

chloride, polymers, and rubber; flame 

retardant, plasticizer, and lubricant in 

adhesives, caulk, sealants, and coatings; 

additive in lubricants including 

metalworking fluids; and flame 

retardant and waterproofer in textiles). 

It is a significant new use to 

manufacture the chemical substance 

more than 5 years. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 5. Add § 721.11069 to subpart E to 

read as follows: 

§ 721.11069 Slack waxes (petroleum), 

chloro. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

slack waxes (petroleum), chloro (PMN 

P–12–278, CAS No. 2097144–44–8) 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) (flame 

retardants and plasticizers in polyvinyl 

chloride, polymers, and rubber; flame 

retardant, plasticizer, and lubricant in 

adhesives, caulk, sealants, and coatings; 

additive in lubricants including 

metalworking fluids; and flame 

retardant and waterproofer in textiles). 

It is a significant new use to 

manufacture the chemical substance 

more than 5 years. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 6. Add § 721.11070 to subpart E to 

read as follows: 


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§ 721.11070 Hexacosane, chloro derivs. 

and octacosane, chloro derivs. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

hexacosane, chloro derivs. and 

octacosane, chloro derivs. (PMN P–12– 

280, CAS Nos. 2097144–46–0 and 

2097144–47–1) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (flame 

retardants and plasticizers in polyvinyl 

chloride, polymers, and rubber; flame 

retardant, plasticizer, and lubricant in 

adhesives, caulk, sealants, and coatings; 

additive in lubricants including 

metalworking fluids; and flame 

retardant and waterproofer in textiles). 

It is a significant new use to 

manufacture the chemical substance 

more than 5 years. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 7. Add § 721.11071 to subpart E to 

read as follows: 

§ 721.11071 Alkanes, C20–24, chloro. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

alkanes, C20–24, chloro (PMN P–12–281, 

CAS No. 2097144–45–9) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (flame 

retardants and plasticizers in polyvinyl 

chloride, polymers, and rubber; flame 

retardant, plasticizer, and lubricant in 

adhesives, caulk, sealants, and coatings; 

additive in lubricants including 

metalworking fluids; and flame 

retardant and waterproofer in textiles). 

It is a significant new use to 

manufacture the chemical substance 

more than 5 years. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 8. Add § 721.11072 to subpart E to 

read as follows: 

§ 721.11072 Alkanes, C14–16, chloro. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

alkanes, C14–16, chloro (PMNs P–12–282 

and P–14–684, CAS No. 1372804–76–6) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (flame 

retardants and plasticizers in polyvinyl 

chloride, polymers, and rubber; flame 

retardant, plasticizer, and lubricant in 

adhesives, caulk, sealants, and coatings; 

additive in lubricants including 

metalworking fluids; and flame 

retardant and waterproofer in textiles). 

It is a significant new use to 

manufacture the chemical substance 

more than 5 years. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 9. Add § 721.11073 to subpart E to 

read as follows: 

§ 721.11073 Tetradecane, chloro derivs. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

tetradecane, chloro derivs. (PMNs P–12– 

283 and P–14–683, CAS No. 198840– 

65–2) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (flame 

retardants and plasticizers in polyvinyl 

chloride, polymers, and rubber; flame 

retardant, plasticizer, and lubricant in 

adhesives, caulk, sealants, and coatings; 

additive in lubricants including 

metalworking fluids; and flame 

retardant and waterproofer in textiles). 

It is a significant new use to 

manufacture the chemical substance 

more than 5 years. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 10. Add § 721.11074 to subpart E to 

read as follows: 

§ 721.11074 Octadecane, chloro derivs. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

octadecane, chloro derivs. (PMN P–12– 

284, CAS No. 2097144–48–2) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (flame 

retardants and plasticizers in polyvinyl 

chloride, polymers, and rubber; flame 

retardant, plasticizer, and lubricant in 

adhesives, caulk, sealants, and coatings; 

additive in lubricants including 

metalworking fluids; and flame 

retardant and waterproofer in textiles). 

It is a significant new use to 

manufacture the chemical substance 

more than 5 years. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 11. Add § 721.11075 to subpart E to 

read as follows: 

§ 721.11075 Alkanes, C18–20, chloro. 

(a) Chemical substance and 

significant new uses subject to reporting. 


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(1) The chemical substance identified as 

alkanes, C18–20, chloro (PMN P–12–433, 

CAS No. 106262–85–3) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (flame 

retardants and plasticizers in polyvinyl 

chloride, polymers, and rubber; flame 

retardant, plasticizer, and lubricant in 

adhesives, caulk, sealants, and coatings; 

additive in lubricants including 

metalworking fluids; and flame 

retardant and waterproofer in textiles). 

It is a significant new use to 

manufacture the chemical substance 

more than 5 years. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 12. Add § 721.11076 to subpart E to 

read as follows: 

§ 721.11076 Alkanes, C14–17, chloro. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

alkanes, C14–17, chloro (PMN P–12–453, 

CAS No. 85535–85–9) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (flame 

retardants and plasticizers in polyvinyl 

chloride polymers, and rubber; flame 

retardant, plasticizer, and lubricant in 

adhesives, caulk, sealants, and coatings; 

additive in lubricants including 

metalworking fluids; and flame 

retardant and waterproofer in textiles). 

It is a significant new use to 

manufacture the chemical substance 

more than 5 years. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 13. Add § 721.11077 to subpart E to 

read as follows: 

§ 721.11077 Alkanes, C22–30, chloro. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

alkanes, C22–30, chloro (PMN P–12–505, 

CAS No. 288260–42–4) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (flame 

retardants and plasticizers in polyvinyl 

chloride, polymers, and rubber; flame 

retardant, plasticizer, and lubricant in 

adhesives, caulk, sealants, and coatings; 

additive in lubricants including 

metalworking fluids; and flame 

retardant and waterproofer in textiles). 

It is a significant new use to 

manufacture the chemical substance 

more than 5 years. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 14. Add § 721.11078 to subpart E to 

read as follows: 

§ 721.11078 Chloroflurocarbon (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as chloroflurocarbon (PMN 

P–16–150) 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), (3), and (4), when 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor (APF) of at least 1,000), (a)(6) 

(liquid), 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 170 ppb 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 (d), (f), (g)(1) (fatal if inhaled), 

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

or maintain workplace airborne 

concentrations at or below an 8-hour 

time-weighted average of 170 ppb), 

(g)(2)(v), (g)(3)(i), (ii), (g)(4) (release to 

water 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(a) through (c), (g), 

and (q). It is a significant new use to 

manufacture, process, or use the PMN 

substance without the engineering 

controls described in the corresponding 

TSCA section 5(e) Order to prevent 

worker and environmental exposures. It 

is a significant new use to manufacture 

the chemical substance more than one 

year. 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 240. 

(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. 


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(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 § 721.11079 to subpart E to 

read as follows: 

§ 721.11079 Silane, 1,1′-(1,2- 

ethanediyl)bis[1,1-dichloro-1-methyl]-, 

hydrolysis products with 

chloroethenyldimethylsilane. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

Silane, 1,1′-(1,2-ethanediyl)bis[1,1- 

dichloro-1-methyl]-, hydrolysis 

products with 

chloroethenyldimethylsilane (PMN P– 

16–379, CAS No. 1485477–78–8) 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 at 1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1) (liver toxicity), (mutagenicity), 

(g)(2)(i), (ii), (iii), (v), (g)(4)(i), (do not 

incinerate), 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), (q), (y)(1) 

and (2). 

(iv) Disposal. Requirements as 

specified in § 721.85(a) (water), (a)(2), 

(b) (water), (b)(2), (c) (water), and (c)(2). 

(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 (j) 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 § 721.11080 to subpart E to 

read as follows: 

§ 721.11080 Silicophosphonate—sodium 

silicate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as silicophosphonate— 

sodium silicate (PMN P–16–410) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (k). A 

significant new use is any use in 

formulations containing greater than 

0.2% of the chemical substance. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(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. 

■ 17. Add § 721.11081 to subpart E to 

read as follows: 

§ 721.11081 3-Butenenitrile, 2-(acetyloxy). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

3-butenenitrile, 2-(acetyloxy) (PMN P– 

16–438, CAS No. 15667–63–7) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(4), when determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor (APF) of at least 1000), 

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

(b)(concentration set at 1.0%), and (c). It 

is a significant new use to manufacture, 

process or use the substance without 

following the monitoring procedure as 

specified in the worker protection 

section of the corresponding TSCA 

section 5(e) Order. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1) (fatal if swallowed), (fatal if in 

contact with skin), (toxic if inhaled), 

(g)(2)(i), (ii), (iii), (iv), (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(g). It is a 

significant new use to manufacture or 

use the substance other than in an 

enclosed system as described in the 

PMN. 

(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. 

■ 18. Add § 721.11082 to subpart E to 

read as follows: 

§ 721.11082 Halogenophosphoric acid 

metal salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenophosphoric acid 

metal salt (PMN P–16–543) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 


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(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(the confidential 

dermal protection described in the 

corresponding TSCA section 5(e) Order 

‘‘the Order’’), (a)(2)(ii), (iii), (iv), (a)(3), 

(a)(4), when determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor of at least 1,000), (a)(6) 

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

(b)(concentration set at 0.1%), and (c). It 

is a significant new use to manufacture, 

process or use the substance without 

following the monitoring procedure as 

specified in the worker protection 

section of the Order. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 0.1%), 

(f), (g)(1)(i), (ii), (iii), (iv), (v), (vii), (viii), 

(ix), (g)(2)(i), (ii), (iii), (use protective 

engineering controls or equipment for 

dermal and inhalation protection, 

(g)(3)(i), (ii), (g)(4)(i), (ii), (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(c), (f), and (k). It is 

a significant new use to vary or alter, the 

manufacturing, processing, and use, 

distribution/transportation, treatment 

and disposal processes, process 

equipment, engineering controls, and 

handling practices (including worker 

activities and cleaning procedures) 

described in the PMN in such a way as 

to increase the magnitude of inhalation 

exposure. 

(iv) Disposal. Requirements as 

specified in § 721.85. It is a significant 

new use to dispose of the substance 

other than by hazardous waste 

incineration according to 40 CFR parts 

260 through 299 unless the substance is 

in waste water. When the substance is 

in wastewater it may be disposed of as 

required in paragraph (a)(2)(v) of this 

section. 

(v) Release to water. Requirements as 

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

(c)(4) where N=3. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (k) are applicable 

to manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 19. Add § 721.11083 to subpart E to 

read as follows: 

§ 721.11083 Alkenoic acid, reaction 

products with polyethylene glycol ether 

with hydroxyalkyl substituted alkane 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkenoic acid, reaction 

products with polyethylene glycol ether 

with hydroxyalkyl substituted alkane 

(PMN P–16–596) 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), (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 at 0.1%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72 

(a) through (e)(concentration set at 

0.1%), (f), (g)(1)(i), (dermal 

sensitization), (g)(1)(iv), (cancer, if 

inhaled), (g)(1)(ix), (g)(2)(i), (ii), (iii), (v), 

(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), (k), and (q). 

(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. 

■ 20. Add § 721.11084 to subpart E to 

read as follows: 

§ 721.11084 Alkyl substituted alkenoic 

acid, alkyl ester, polymer with alkyl 

substituted alkenoate and alkenoic acid, 

hydroxy substituted[(oxoalkyl)oxy]alkyl 

ester, reaction products with alkanoic acid, 

dipentaerythritil and isocyanate substituted 

carbomonocycle, compds. with alkylamine 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkyl substituted alkenoic 

acid, alkyl ester, polymer with alkyl 

substituted alkenoate and alkenoic acid, 

hydroxy substituted[(oxoalkyl)oxy]alkyl 

ester, reaction products with alkanoic 

acid, dipentaerythritil and isocyanate 

substituted carbomonocycle, compds. 

with alkylamine (PMN P–17–10) 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), (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 at 0.1%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 0.1%), 

(f), (g)(1)(i), (sensitization), (g)(1)(vii), 

(systemic effects), (g)(1)(ix), (g)(2)(i), (ii), 

(iii), (v), 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. 


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(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k) (ultraviolet 

curable coating resin), and (y)(1). It is a 

significant new use to manufacture the 

chemical substance with an average 

molecular weight below 2,000 daltons 

or containing greater than 0.1% residual 

isocyanate. It is a significant new use to 

import the substance other than in totes. 

(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) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 21. Add § 721.11085 to subpart E to 

read as follows: 

§ 721.11085 Heteromonocycle ester with 

alkanediol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as heteromonocycle ester 

with alkanediol (PMN P–17–15) 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), (iii), (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, (b) 

(concentration set at 1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 1.0%), 

(f), (g)(1)(i), (g)(2)(i), (ii), (iii), (v), 

(g)(3)(i), (ii), (g)(4) (release to water 

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). 

(iv) Release to water. Requirements as 

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

(c)(4) where N=3. 

(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. 

■ 22. Add § 721.11086 to subpart E to 

read as follows: 

§ 721.11086 Substituted carbomonocycle, 

polymer with (aminoalkyl)-alkanediamine, 

(haloalkyl)oxirane, dialkyl-alkanediamine 

and alkyl-alkanamine, reaction products 

with dialkanolamine and 

[[(alkyl)oxy]alkyl]oxirane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted 

carbomonocycle, polymer with 

(aminoalkyl)-alkanediamine, 

(haloalkyl)oxirane, dialkylalkanediamine and alkyl-alkanamine, 

reaction products with dialkanolamine 

and [[(alkyl)oxy]alkyl]oxirane (PMN P– 

17–29) 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 at 1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 1.0%), 

(f), (g)(1)(i), (eye irritation), (g)(1)(ii), 

(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), (k), (q), and 

(y)(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) 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. 

■ 23. Add § 721.11087 to subpart E to 

read as follows: 

§ 721.11087 Carboxylic acid amine (1:1) 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carboxylic acid amine 

(1:1) (PMN P–17–154) 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), (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 at 1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 1.0%), 

(f), (g)(1)(i), (ii), (iii), (thyroid effects), 

(g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), (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(q). 


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(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) 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. 

■ 24. Add § 721.11088 to subpart E to 

read as follows: 

§ 721.11088 Mix fatty acids compd with 

amine (1:1) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as mix fatty acids compd 

with amine (1:1) (PMN P–17–155) 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), (ii), (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 at 1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1)(i), (ii), (iii), (thyroid effects), 

(g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), (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(q). 

(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) 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. 

■ 25. Add § 721.11089 to subpart E to 

read as follows: 

§ 721.11089 Mix fatty acids compd with 

amine (1:1) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as mix fatty acids compd 

with amine (1:1) (PMN P–17–156) 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), (iii), (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 a 1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1)(i), (ii), (iii), (thyroid effects), 

(g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), (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(q). 

(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) 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. 

■ 26. Add § 721.11090 to subpart E to 

read as follows: 

§ 721.11090 Bicyclo[2.2.1]heptane-1- 

methanesulfonic acid, 7,7-dimethyl-2-oxo-, 

compd. with N,N-diethylethanamine (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

bicyclo[2.2.1]heptane-1- 

methanesulfonic acid, 7,7-dimethyl-2- 

oxo-, compd. with N,Ndiethylethanamine (1:1) (PMN P–17– 

218. CAS No. 67019–84–5) 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, (a)(6) 

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

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

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 1.0%), 

(f), (g)(1)(i), (corrosivity), (sensitization), 

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

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), (y)(1) and (2). 

(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) 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 


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

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

■ 27. Add § 721.11091 to subpart E to 

read as follows: 

§ 721.11091 Manganese (2+), 

bisoctahydro-1,4,7-trimethyl-1H–1,4,7- 

triazonine-.kappa.N1,.kappa.N4,.kappa.N7) 

tri-.mu.-oxidi-, hexafluorophosphate(1-) 

(1:2). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

manganese (2+), bisoctahydro-1,4,7- 

trimethyl-1H–1,4,7-triazonine- 

.kappa.N1,.kappa.N4,.kappa.N7) tri- 

.mu.-oxidi-, hexafluorophosphate(1-) 

(1:2) (1:1) (PMN P–17–226, CAS No. 

116633–52–4) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (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, (a)(6) 

(particulate), (b) (concentration set at 

0.1%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 0.1%), 

(f), (g)(1) (eye irritation), (respiratory 

sensitization), (g)(1)(iii), (iv), (vi), (vii), 

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

(g)(4) (release to water provisions 

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) and (k). It is a 

significant new use to process or use the 

substance without engineering controls 

to prevent exposure, including dust 

removal with 99.9% efficiency when 

loading or unloading the substance in 

powder form. 

(iv) Release to water. Requirements as 

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

(c)(4) where N=240. 

(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. 

■ 28. Add § 721.11092 subpart E to read 

as follows: 

§ 721.11092 2′-Fluoro-4′′-alkyl-4-propyl1,1′:4′1′′-terphenyl (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 2′-fluoro-4′′-alkyl-4- 

propyl-1,1′:4′1′′-terphenyl (PMN P–17– 

228) 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 at 1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1)(vi), (adrenal effects), (liver 

effects), (g)(2)(i), (ii), (iii), (v), 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(t) and (y)(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) 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. 

■ 29. Add § 721.11093 to subpart E to 

read as follows: 

§ 721.11093 4-ethyl-2′-fluoro-4′′-alkyl1,1′:4′,1′′-terphenyl (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 4-ethyl-2′-fluoro-4′′-alkyl1,1′:4′,1′′-terphenyl (PMN P–17–229) 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%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set 1.0%), (f), 

(g)(1)(vi), (adrenal effects), (liver effects), 

(g)(2)(i), (ii), (iii), (v), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(t) and (y)(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) 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. 

■ 30. Add § 721.11094 to subpart E to 

read as follows: 

§ 721.11094 Poly(oxy-1,2- 

ethanediyl),alpha-(2-benzoyl)-omega-[(2- 

benzoylbenzoyl)oxy]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

poly(oxy-1,2-ethanediyl),alpha-(2- 

benzoyl)-omega-[(2- 

benzoylbenzoyl)oxy]- (PMN P–17–261) 

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 


daltland on DSKBBV9HB2PROD with RULES
41006 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 

1The SJVUAPCD adopted its 2014 RACT SIP on 

June 19, 2014. 

2CARB’s May 4, 2018 transmittal letter contained 

a public draft version of the Supplement to the 2014 

RACT SIP along with a request that the EPA provide 

parallel processing of the documents concurrently 

with the state’s public process. See footnote 1 in our 

May 17, 2018 proposed rule. 

3See Supplement to the 2014 RACT SIP, 

Appendix B. 

4On June 21, 2018, the SJVUAPCD Governing 

Board adopted ‘‘Revision to the State 

Implementation Plan (SIP) to Address Federal Clean 

Air Act Requirements for Reasonably Available 

Control Technology (RACT)’’. Appendix A: ‘‘J.R. 

Simplot Permit Conditions’’ and Appendix B: 

‘‘Negative Declarations’’, as contained in the 

adopted document, are substantially similar to the 

versions contained in the District’s parallel 

processing request which the EPA proposed to 

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), (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 at 1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 1.0%), 

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

(photosensitization), (g)(2)(i), (ii), (iii), 

(v), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (q). 

(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) 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. 2018–17348 Filed 8–16–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2018–0272; FRL–9981–09– 

Region 9] 

Air Plan Approval; California; San 

Joaquin Valley Unified Air Pollution 

Control District; Reasonably Available 

Control Technology Demonstration 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is taking final action to 

approve revisions to the San Joaquin 

Valley Unified Air Pollution Control 

District (SJVUAPCD or ‘‘District’’) 

portion of the California State 

Implementation Plan (SIP). These 

revisions concern the District’s 2014 

demonstration regarding Reasonably 

Available Control Technology (RACT) 

requirements for the 2008 8-hour ozone 

National Ambient Air Quality Standard 

(NAAQS). We are also taking final 

action to approve into the California SIP 

the following documents that help 

support the District’s RACT 

demonstration: SJVUAPCD’s 

supplement to its 2014 RACT SIP 

demonstration, which contains 

SJVUAPCD’s negative declarations 

where the District concludes it has no 

sources subject to certain Control 

Techniques Guidelines (CTG) 

documents and relevant permit 

conditions to implement RACT level 

requirements for J.R. Simplot’s Nitric 

Acid plant in Helm, California (CA); and 

SJVUAPCD’s 2016 Ozone Plan for the 

2008 8-Hour Ozone Standard—Chapter 

3.4 and Appendix C only. We are 

approving local SIP revisions to 

demonstrate that RACT is implemented 

as required under the Clean Air Act 

(CAA or the ‘‘the Act’’). 

DATES: This rule will be effective on 

September 17, 2018. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–R09–OAR–2018–0272. All 

documents in the docket are listed on 

the https://www.regulations.gov 

website. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 

Information or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available through https://

www.regulations.gov, or please contact 

the person identified in the FOR FURTHER

INFORMATION CONTACT section for 

additional availability information. 

FOR FURTHER INFORMATION CONTACT: 

Stanley Tong, EPA Region IX, (415) 

947–4122, tong.stanley@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, ‘‘we,’’ ‘‘us’’ 

and ‘‘our’’ refer to the EPA. 

Table of Contents 

I. Proposed Action 

II. Public Comments and EPA Responses 

III. EPA Action 

IV. Incorporation by Reference 

V. Statutory and Executive Order Reviews 

I. Proposed Action 

On May 17, 2018 (83 FR 22908), the 

EPA proposed to approve SJVUACPD’s 

‘‘2014 Reasonably Available Control 

Technology (RACT) Demonstration for 

the 8-Hour Ozone State Implementation 

Plan (SIP)’’ (2014 RACT SIP), submitted 

to the EPA by the California Air 

Resources Board (CARB) on July 18, 

2014,1 for approval as a revision to the 

California SIP. 

In addition to the 2014 RACT SIP, our 

May 17, 2018 proposed rule was also 

based on our evaluation of the public 

draft version of SJVUAPCD’s 

‘‘Supplement to the 2014 Reasonably 

Available Control Technology (RACT) 

State Implementation Plan (SIP) for the 

2008 8-hour Ozone Standard’’ 

(Supplement to the 2014 RACT SIP) that 

was transmitted by CARB on May 4, 

2018, along with a request for parallel 

processing.2 The District’s Supplement 

to the 2014 RACT SIP contained 

relevant RACT permit conditions in a 

permit to operate for J.R. Simplot’s 

Nitric Acid plant in Helm, CA, and 

negative declarations where the District 

concluded it had no sources subject to 

the following CTG source categories: 

Surface coating of insulation of 

magnetic wire; manufacture of 

synthesized pharmaceutical products; 

manufacture of pneumatic rubber tires; 

leaks from synthetic organic chemical 

polymer and resin manufacturing 

equipment; volatile organic compound 

(VOC) emissions from manufacture of 

high-density polyethylene, 

polypropylene and polyester resins; 

VOC emissions from air oxidation 

processes in synthetic organic chemical 

manufacturing industry (SOCMI); VOC 

emissions from reactor processes and 

distillation operations in SOCMI; and 

surface coating operations at 

shipbuilding and ship repair facilities.3

We indicated that we would not take 

final action on the Supplement to the 

2014 RACT SIP until CARB submitted 

the final adopted version to the EPA as 

a SIP revision. On June 21, 2018, the 

SJVUAPCD held a public hearing and 

adopted the Supplement to the 2014 

RACT SIP.4 On June 29, 2018, CARB 


daltland on DSKBBV9HB2PROD with RULES