Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Rules and Regulations 44079 

Sector New Orleans (COTP) or 

designated representative. 

(2) Vessels requiring entry into this 

safety zone must request permission 

from the COTP or a designated 

representative. They may be contacted 

on VHF–FM Channel 16 or 67. 

(3) Persons and vessels permitted to 

enter this safety zone must transit at 

their slowest safe speed and comply 

with all lawful directions issued by the 

COTP or the designated representative. 

(e) Information broadcasts. The COTP 

or a designated representative will 

inform the public through Broadcast 

Notices to Mariners of any changes in 

the planned schedule. 

Dated: September 15, 2017. 

Wayne R. Arguin, 

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

Port New Orleans. 

[FR Doc. 2017–20109 Filed 9–20–17; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2016–0331; FRL–9959–81] 

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 37 chemical substances 

which were the subject of 

premanufacture notices (PMNs). The 

applicable review periods for the PMNs 

submitted for these 37 chemical 

substances all ended prior to June 22, 

2016 (i.e., the date on which President 

Obama signed into law the Frank R. 

Lautenberg Chemical Safety for the 21st 

Century Act which amends TSCA). Six 

of these chemical substances are subject 

to TSCA section 5(e) consent orders 

issued by EPA. This action requires 

persons who intend to manufacture 

(defined by statute to include import) or 

process any of these 37 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. 

Manufacture and processing for the 

significant new use is unable to 

commence until EPA has conducted a 

review of the notice, made an 

appropriate determination on the notice, 

and take such actions as are required 

with that determination. 

DATES: This rule is effective on 

November 20, 2017. For purposes of 

judicial review, this rule shall be 

promulgated at 1 p.m. (e.s.t.) on October 

5, 2017. 

Written adverse or critical comments, 

or notice of intent to submit adverse or 

critical comments, on one or more of 

these SNURs must be received on or 

before October 23, 2017 (see Unit VI. of 

the SUPPLEMENTARY INFORMATION). If EPA 

receives written adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments, on one or 

more of these SNURs before October 23, 

2017, EPA will withdraw the relevant 

sections of this direct final rule before 

its effective date. 

For additional information on related 

reporting requirement dates, see Units 

I.A., VI., and VII. of the SUPPLEMENTARY

INFORMATION. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2016–0331, 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 

October 23, 2017 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 


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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? 

EPA is promulgating these SNURs 

using direct final procedures. These 

SNURs will require persons to notify 

EPA at least 90 days before commencing 

the manufacture or processing of a 

chemical substance for any activity 

designated by these SNURs as a 

significant new use. Receipt of such 

notices allows EPA to assess risks that 

may be presented by the intended uses 

and, if appropriate, to regulate the 

proposed use before it occurs. 

Additional rationale and background to 

these rules are more fully set out in the 

preamble to EPA’s first direct final 

SNUR published in the Federal Register 

issue of April 24, 1990 (55 FR 17376). 

Consult that preamble for further 

information on the objectives, rationale, 

and procedures for SNURs and on the 

basis for significant new use 

designations, including provisions for 

developing test data. 

B. What is the agency’s authority for 

taking this action? 

Section 5(a)(2) of TSCA (15 U.S.C. 

2604(a)(2)) authorizes EPA to determine 

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including the four bulleted TSCA 

section 5(a)(2) factors listed in Unit III. 

Once EPA determines that a use of a 

chemical substance is a significant new 

use, TSCA section 5(a)(1)(B) requires 

persons to submit a significant new use 

notice (SNUN) to EPA at least 90 days 

before they manufacture or process the 

chemical substance for that use (15 

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

furthermore prohibits such 

manufacturing or processing from 

commencing until EPA has conducted a 

review of the notice, made an 

appropriate determination on the notice, 

and taken such actions as are required 

in association with that determination 

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

described in Unit V., the general SNUR 

provisions are found at 40 CFR part 721, 

subpart A. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the rule, recordkeeping requirements, 

exemptions to reporting requirements, 

and applicability of the rule to uses 

occurring before the effective date of the 

rule. Provisions relating to user fees 

appear at 40 CFR part 700. According to 

§ 721.1(c), persons subject to these 

SNURs must comply with the same 

SNUN requirements and EPA regulatory 

procedures as submitters of PMNs under 

TSCA section 5(a)(1)(A). In particular, 

these requirements include the 

information submission requirements of 

TSCA section 5(b) and 5(d)(1), the 

exemptions authorized by TSCA section 

5(h)(1), (h)(2), (h)(3), and (h)(5), and the 

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA must either 

determine that the significant new use 

is not likely to present an unreasonable 

risk of injury or take such regulatory 

action as is associated with an 

alternative determination before the 

manufacture or processing for the 

significant new use can commence. If 

EPA determines that the significant new 

use is not likely to present an 

unreasonable risk, EPA is required 

under TSCA section 5(g) to make public, 

and submit for publication in the 

Federal Register, a statement of EPA’s 

findings. 

III. Significant New Use Determination 

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

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

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

statute authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 37 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 

37 chemical substances in 40 CFR part 

721, subpart E. In this unit, EPA 

provides the following information for 

each chemical substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• Chemical Abstracts Service (CAS) 

Registry number (if assigned for nonconfidential chemical identities). 

• Basis for the TSCA section 5(e) 

consent order or, for non-TSCA section 

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

SNURs without TSCA section 5(e) 

consent orders). 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VIII. for more information). 

• CFR citation assigned in the 

regulatory text section of this rule. 

The regulatory text section of this rule 

specifies the activities designated as 

significant new uses. Certain new uses, 

including production volume limits 

(i.e., limits on manufacture volume) and 

other uses designated in this rule, may 

be claimed as CBI. Unit IX. discusses a 

procedure companies may use to 

ascertain whether a proposed use 

constitutes a significant new use. 

This rule includes 6 PMN substances 

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

orders under TSCA section 

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

that activities associated with the PMN 

substances may present unreasonable 

risk to human health or the 

environment. Those consent orders 

require protective measures to limit 

exposures or otherwise mitigate the 

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

these PMN substances are promulgated 

pursuant to § 721.160, and are based on 

and consistent with the provisions in 

the underlying consent orders. The 

TSCA section 5(e) SNURs designate as 

a ‘‘significant new use’’ the absence of 

the protective measures required in the 

corresponding consent orders. 

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) consent 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 


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to the actual NCEL concentration, the 

comprehensive NCELs provisions in 

TSCA section 5(e) consent 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 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) 

consent order for the same chemical 

substance. 

This rule also includes SNURs on 31 

PMN substances that are not subject to 

consent orders under TSCA section 5(e). 

These cases completed Agency review 

prior to June 22, 2016. Under TSCA, 

prior to the enactment of the Frank R. 

Lautenberg Chemical Safety for the 21st 

Century Act on June 22, 2016, EPA did 

not find that the use scenario described 

in the PMN triggered the determinations 

set forth under TSCA section 5(e). 

However, EPA does believe that certain 

changes from the use scenario described 

in the PMN could result in increased 

exposures, thereby constituting a 

‘‘significant new use.’’ These so-called 

‘‘non-TSCA section 5(e) SNURs’’ are 

promulgated pursuant to § 721.170. EPA 

has determined that every activity 

designated as a ‘‘significant new use’’ in 

all non-TSCA section-5(e) SNURs issued 

under § 721.170 satisfies the two 

requirements stipulated in 

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

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

those described in the premanufacture 

notice for the substance, including any 

amendments, deletions, and additions 

of activities to the premanufacture 

notice, and (ii) may be accompanied by 

changes in exposure or release levels 

that are significant in relation to the 

health or environmental concerns 

identified’’ for the PMN substance. 

PMN Number P–05–436 

Chemical name: Ethylene glycol ester 

of an aromatic substituted propenoic 

acid (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a modifier for 

polyester polymer. Based on structure 

activity relationship (SAR) analysis of 

test data on structurally similar 

substances, EPA predicts toxicity to 

aquatic organisms at concentrations that 

exceed 10 parts per billion (ppb) of the 

PMN substance in surface waters. As 

described in the PMN, releases to 

surface waters of the PMN substance are 

not expected to exceed 10 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in surface water 

concentrations exceeding 10 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (Office of Pollution Prevention 

and Toxics (OPPTS) Test Guideline 

850.1075); an acute invertebrate toxicity 

test, freshwater daphnids (Office of 

Chemical Safety and Pollution 

Prevention (OCSPP) Test Guideline 

850.1010); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10961. 

PMN Number P–10–504 

Chemical name: Phosphoric acid, 

metal salt (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a flame 

retardant for textiles. Based on SAR 

analysis of test data on analogous 

substances, EPA identified eye and 

dermal irritation as well as 

immunotoxicity concerns to workers 

from exposure to the PMN substance via 

the inhalation route. Additionally, 

based on SAR analysis of test data on 

analogous inorganic phosphates, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

5 ppb of the PMN substance in surface 

waters. For the use described in the 

PMN, significant releases of the 

substance are not expected, and worker 

dermal and inhalation will be minimal. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that substantial 

production volume increases, or use of 

the PMN substance other than as 

described in the PMN, could change 

exposure potential, which may cause 

significant adverse health and 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170(b)(3)(ii) 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

oral toxicity test (OPPTS Test Guideline 

870.3100); a fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075); an acute 

invertebrate toxicity test, freshwater 

daphnids (OCSPP Test Guideline 

850.1010); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the human health and 

environmental effects of the PMN 

substance. EPA also recommends that 

the guidance document on aquatic 

toxicity testing of difficult substances 

and mixtures (Organisation for 

Economic Co-operation and 

Development (OECD) Test Guideline 23) 

be followed to facilitate solubility in the 

test media. 

CFR citation: 40 CFR 721.10962. 

PMN Number P–13–289 

Chemical name: Alkanoic acid, 

tetramethylheteromonocycle ester 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as an additive component 

to engine lubricants. Based on test data 

on the PMN substance, as well as SAR 

analysis of test data on analogous 

aliphatic amines and esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

2 ppb of the PMN substance in surface 

waters. As described in the PMN, 

releases of the substance are not 

expected to result in surface water 

concentrations that exceed 2 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in surface water 

concentrations exceeding 2 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(i) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OCSPP Test 

Guideline 850.1400) and a daphnid 

chronic toxicity test (OCSPP Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10963. 


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PMN Number P–13–908 

Chemical name: Polyether polyester 

urethane phosphate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as an additive. Based on 

SAR analysis of test data on analogous 

inorganic phosphates, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 5 ppb of 

the substance in surface waters for 

greater than 20 days per year. This 20- 

day criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the substance to 

surface water exceed releases from 

manufacturing, processing, and use 

levels described in the PMN. For the 

manufacturing, processing, and use 

operations described in the PMN, 

environmental releases did not exceed 5 

ppb for more than 20 days per year. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. However, 

EPA has determined that, if in the future 

there is domestic manufacture, the use 

changes from that described in the 

PMN, or if the production volume 

increases substantially, the potential for 

release to the environment may change 

correspondingly and can result in 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of an algal 

toxicity test (OCSPP Test Guideline 

850.4500), with the PMN substance 

substituted for the phosphate nutrient in 

the algal growth medium, would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10964. 

PMN Number P–14–129 

Chemical name: Propanamide, 2- 

hydroxy-N,N-dimethyl-. 

CAS number: 35123–06–9. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a solvent in pesticide 

formulations and solvent for fertilizers. 

Based on test data on the PMN 

substance, EPA identified concerns for 

solvent neurotoxicity, blood and liver 

toxicity, kidney effects, and 

developmental toxicity. For the uses 

described in the PMN, EPA does not 

expect significant dermal or inhalation 

occupational exposures, nor does it 

expect consumer exposures. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however that any use of the substance 

other than as described in the PMN, any 

use of the PMN substance without the 

use of dermal protection, where there is 

a potential for dermal exposures; or any 

use of the PMN substance in consumer 

products may cause serious human 

health effects. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170(b)(3)(i). 

Recommended testing: EPA has 

determined that the results of a dermal 

penetration test (OPPTS Test Guideline 

870.7600) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10965. 

PMN Number P–14–260 

Chemical name: 1-Propene, 2-bromo3,3,3-trifluoro-. 

CAS number: 1514–82–5. 

Effective date of TSCA section 5(e) 

consent order: March 7, 2016. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the PMN 

substance will be used as a fire 

extinguishing agent for: Portable 

extinguishers (onboard aviation and all 

nonresidential); niche systems (aircraft, 

normally unoccupied systems, selfcontained automatic fire extinguishing 

systems); and streaming systems for 

aircraft rescue fire fighting vehicles. 

Based on test data on the PMN 

substance, EPA predicts reproductive 

effects to unprotected workers from 

repeated inhalation exposures. The 

Order was issued under TSCA sections 

5(e)(1)(A)(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 consent order requires: 

1. Use of personal protective 

equipment including a NIOSH–certified 

respirator with an APF of at least 10 or 

compliance with a NCEL of 1.0 parts per 

million (ppm) as an 8-hour timeweighted average, when there is a 

potential for inhalation exposures. 

2. Hazard communication. 

Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the Safety Data 

Sheet (SDS). 

3. No domestic manufacture of the 

PMN substance. 

4. Processing (including filling of 

hand-held fire extinguishers or fire 

extinguishing systems) of the PMN 

substance in an enclosed process. 

5. Use only as either (1) total flooding 

agent in unoccupied spaces, specifically 

engine nacelles and auxiliary power 

units (APUs) in aircraft; or (2) streaming 

fire extinguishing agent for use only in 

handheld extinguishers in aircraft. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Recommended testing: EPA has 

determined that inhalation monitoring 

data, collected according to the EPA 

draft Inhalation Monitoring Data 

Collection Guidelines (located in the 

docket under docket ID number EPA– 

HQ–OPPT–2016–0331 would help 

characterize the human health effects of 

the PMN substance. The Order’s 

restrictions on manufacture, processing, 

distribution in commerce, and disposal 

will remain in effect until the Order is 

modified or revoked by EPA based on 

submission of this or other relevant 

information. 

CFR citation: 40 CFR 721.10966. 

PMN Number P–14–759 

Chemical name: Pyrolysis oil product 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: May 4, 2016. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

is as an on-site coolant and petroleum 

feed-stock. Based on SAR analysis of 

test data on analogous benzene and 

alkyl benzenes, EPA identified concerns 

for oncogenicity, neurological effect, 

and blood toxicity to unprotected 

workers from repeated inhalation 

exposures. Further, based on SAR 

analysis of test data on analogous 

neutral organic chemicals, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 20 ppb of 

the PMN substance in surface waters. 

The Order was issued under TSCA 

sections 5(e)(1)(A)(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 and the 

environment. To protect against these 

risks, the consent order requires: 

1. Use of personal protective 

equipment including impervious gloves 

(where there is a potential for dermal 

exposures) and a NIOSH–certified 

respirator with an APF of at least 10 

(where there is a potential for dermal or 

inhalation exposures) or compliance 

with a NCEL of 0.5 ppm as an 8-hour 

time-weighted average. 

2. Manufacture, processing, or use of 

the PMN substance only for the use 

specified in the consent order. 

3. No use of the PMN substance 

resulting in releases to surface waters 

concentrations that exceed 20 ppb. 


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The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Recommended testing: EPA has 

determined that the results of a 

developmental neurotoxicity test 

(OPPTS Test Guideline 870.6300) with 

a complete blood count and differential 

for white blood cells; inhalation 

monitoring data, collected according to 

the EPA draft Inhalation Monitoring 

Data Collection Guidelines (located in 

the docket under docket ID number 

EPA–HQ–OPPT–2016–0331; a fish acute 

toxicity test, freshwater and marine 

(OPPTS Test Guideline 850.1075); an 

acute invertebrate toxicity test, 

freshwater daphnids (OCSPP Test 

Guideline 850.1010) and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

human health and environmental effects 

of the PMN substance. The Order’s 

restrictions on manufacture, processing, 

distribution in commerce, and disposal 

will remain in effect until the Order is 

modified or revoked by EPA based on 

submission of this or other relevant 

information. 

CFR citation: 40 CFR 721.10967. 

PMN Number P–15–279 

Chemical name: 1-Octanamine, 7 (or 

8)-(aminomethyl)-. 

CAS number: 1613320–81–2. 

Basis for action: The PMN states that 

the substance is used as a raw material 

for highly heat resistant plastic. Based 

on test data on the PMN substance, as 

well as SAR analysis of test data on 

analogous aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

123 parts per billion of the PMN 

substance in surface waters. As 

described in the PMN, releases of the 

substance during the use described in 

the PMN are not expected to result in 

surface water concentrations that exceed 

123 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance for the use described in the 

PMN may present an unreasonable risk. 

EPA has determined, however, that any 

use of the substance resulting in surface 

water concentrations exceeding 123 ppb 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OCSPP Test 

Guideline 850.1400) and a daphnid 

chronic toxicity test (OCSPP Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10968. 

PMN Number P–15–409 

Chemical name: Substituted 

alkanolamine ether (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: March 3, 2016. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substance will be used as a hydrogen 

sulfide scavenger. The Order was issued 

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

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

the substance may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substance. Based on this finding, the 

consent order requires: 

1. Risk notification. If as a result of 

the test data required, the company 

becomes aware that the PMN substances 

may present a risk of injury to human 

health or the environment, the company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into an SDS, 

within 90 days. 

2. Submission of certain toxicity, 

physical-chemical property, and 

environmental fate testing on the PMN 

substance prior to exceeding the 

confidential production volume limits 

as specified in the consent order. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these measures. 

Recommended testing: EPA has 

determined that the results of certain 

toxicity and environmental fate testing 

would help characterize the PMN 

substance. The submitter has agreed to 

complete the testing identified in the 

testing section of the consent order by 

the confidential limits specified. 

CFR citation: 40 CFR 721.10969. 

PMN Number P–15–583 

Chemical name: Butanedioic acid, 

alkyl amine, dimethylbutyl ester 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: February 8, 2016. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substance will be used as an additive to 

engine motor oil. Based on physicalchemical properties data, EPA predicts 

that the PMN substance will persist in 

the environment, could bioaccumulate 

or biomagnify, and could be toxic (PBT) 

to people, wild mammals, and birds. 

Further, based on test data on the PMN, 

as well as SAR analysis of analogous 

aliphatic amines, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters. The 

Order was issued under TSCA sections 

5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 

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

the substance may present an 

unreasonable risk of injury to the 

environment and human health, the 

substance may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substance. To protect against these 

exposures and risks, the consent order 

requires: 

1. Risk notification. If as a result of 

the test data required, the company 

becomes aware that the PMN substances 

may present a risk of injury to human 

health or the environment, the company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into an SDS, 

within 90 days. 

2. Submission of certain toxicity, 

physical-chemical property, and 

environmental fate testing on the PMN 

substance prior to exceeding the 

confidential production volume limits 

as specified in the consent order. 

3. No releases of the PMN substance 

into the waters of the United States. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Recommended testing: EPA has 

determined that the results of certain 

toxicity and environmental fate testing 

would help characterize the PMN 

substance. The submitter has agreed to 

complete the testing identified in the 

testing section of the consent order by 

the confidential limits specified. In 

addition, EPA has determined that the 

results of a fish early-life stage toxicity 

test (OCSPP Test Guideline 850.1400) 

and a daphnid chronic toxicity test 

(OCSPP Test Guideline 850.1300) would 

help characterize the environmental 

effects of the PMN substance. The 

Order’s restrictions on manufacture, 

processing, distribution in commerce, 

and disposal will remain in effect until 

the Order is modified or revoked by 

EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.10970. 

PMN Number P–15–672 

Chemical name: Carbon nanotube 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: January 15, 2016. 


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Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the PMN 

substance will be in filtration media. 

Based on test data on analogous 

respirable, poorly soluble particulates 

and carbon nanotubes, EPA identified 

concerns for pulmonary toxicity and 

oncogenicity. Based on test data for 

other carbon nanotubes EPA identified 

concerns for environmental toxicity. 

The Order was issued under TSCA 

sections 5(e)(1)(A)(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 and the 

environment. To protect against these 

risks, the consent order requires: 

1. Use of personal protective 

equipment involving impervious gloves 

and protective clothing (where there is 

a potential for dermal exposure) and a 

NIOSH-certified respirator with N–100, 

P–100, or R–100 cartridges (where there 

is a potential for inhalation exposure). 

2. Processing and use of the PMN 

substance only for the use specified in 

the consent order. 

3. Processing and use of the PMN 

substance only as an aqueous slurry, 

wet form, or a contained dry form as 

described in the PMN. 

4. No use of the PMN substance 

resulting in releases to surface waters 

and disposal of the PMN substance only 

by landfill or incineration. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Recommended testing: EPA has 

determined that a two-year inhalation 

bioassay (OPPTS 870.4200); a fish earlylife stage toxicity test (OCSPP Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OCSPP Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize possible health and 

environmental effects of the substance. 

Although the Order does not require 

these tests, the Order’s restrictions on 

manufacture, processing, distribution in 

commerce, and disposal will remain in 

effect until the Order is modified or 

revoked by EPA based on submission of 

this or other relevant information. 

CFR citation: 40 CFR 721.10971. 

PMN Number P–15–678 

Chemical name: Metal salt of mineral 

acid, reaction products with alumina, 

aluminum hydroxide, aluminum 

hydroxide oxide (Al(OH)O), silica, 

titanium oxide (TiO2) and 3- 

(triethoxysilyl)-1-propanamine 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as an industrial paper 

additive. Based on SAR analysis of test 

data on analogous respirable, poorly 

soluble particulates, EPA identified 

concerns for lung toxicity if inhaled 

based on lung overload. As described in 

the PMN, inhalation is expected to be 

minimal for this use. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance other than as 

identified in the PMN may result in 

serious health effects. Based on this 

information, the PMN meets the concern 

criteria at § 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10972. 

PMN Numbers P–15–766 and P–15–767 

Chemical names: Halogenated 

bisphenol A, polymer with 

epichlorohydrin, alkenoate (generic) (P– 

15–766) and Halogenated bisphenol A, 

polymer with bisphenol A diglycidyl 

ether and epoxidized phenolformaldehyde resin, alkenoate (generic) 

(P–15–767). 

CAS numbers: Not available. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substances will be as resins for flame 

retardant polyester. Based on test data 

on the confidential impurity of the PMN 

substance, EPA identified concerns for 

chronic toxicity effects to workers and 

the general population exposed to the 

PMN substances. Further, based on the 

confidential impurity, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 20 ppb of 

the impurity in surface waters. As 

described in the PMNs, EPA does not 

expect significant occupational 

exposures, general population 

exposures, nor releases of the substance 

to result in surface water concentrations 

that exceed 20 ppb of the impurity in 

surface waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any consumer use, any use other than as 

described in the PMNs, or any increase 

in production volume over 10,000 kg/yr 

may result in serious human health and 

significant adverse environmental 

effects. Based on this information, the 

PMN substances meet the concern 

criteria at § 721.170(b)(5)(ii). 

Recommended testing: EPA has 

determined that the results of a 

combined repeated dose toxicity test 

(OECD Test Guideline 422) with the 

reproduction/developmental toxicity 

screening test; a fish early-life stage 

toxicity test (OCSPP Test Guideline 

850.1400); a daphnid chronic toxicity 

test (OCSPP Test Guideline 850.1300); 

and an algal toxicity test (OCSPP Test 

Guideline 850.4500) would help 

characterize the human health and 

environmental effects of the PMN 

substances. 

CFR citations: 40 CFR 721.10973 (P– 

15–766) and 40 CFR 721.10974 (P–15– 

767). 

PMN Number P–16–14 

Chemical name: Silicon, tris[dialkyl 

phenyl]-dialkyl-dioxoalkanenaphthalene disulfonate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as an ink additive. Based 

on test data on the PMN substance, as 

well as SAR analysis of test data on 

analogous diketones, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 6 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance during the use described in 

the PMN are not expected to result in 

surface water concentrations that exceed 

6 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance for the use described in the 

PMN may present an unreasonable risk. 

EPA has determined, however, that any 

use of the substance resulting in surface 

water concentrations exceeding 6 ppb 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OECD Test 

Guideline 301); a fish early-life state 

toxicity test (OCSPP Test Guideline 

850.1400); and a daphnid chronic 

toxicity test (OCSPP Test Guideline 

850.1300) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10975. 

PMN Number P–16–40 

Chemical name: Tar acids fraction 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a polymer. Based on test 

data on the PMN substance, as well as 

SAR analysis of test data on analogous 

phenols, EPA predicts toxicity to 


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aquatic organisms may occur at 

concentrations that exceed 45 ppb of the 

PMN substance in surface waters. As 

described in the PMN, releases of the 

substance during the use described in 

the PMN are not expected to result in 

surface water concentrations that exceed 

45 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance for the use described in the 

PMN may present an unreasonable risk. 

EPA has determined, however, that any 

use of the substance resulting in surface 

water concentrations exceeding 45 ppb 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life state toxicity test (OCSPP Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OCSPP Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10976. 

PMN Numbers P–16–59 and P–16–60 

Chemical names: Dialkyl 

fattyalkylamino propanamide 

alkylamine (generic) (P–16–59) and 

Fattyalkylaminopropanoate ester 

(generic) (P–16–60). 

CAS numbers: Not available. 

Basis for action: The PMNs state that 

the substances will be used as chemical 

intermediates. Based on data on the 

PMN substances, as well as SAR 

analysis of test data on analogous 

aliphatic amines, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substances in surface waters. As 

described in the PMNs, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

1 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substances resulting in 

surface water concentrations exceeding 

1 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substances meets 

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

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OCSPP Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OCSPP Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substances. 

CFR citations: 40 CFR 721.10977 (P– 

16–59) and 40 CFR 721.10978 (P–16– 

60). 

PMN Number P–16–70 

Chemical Name: Boron sodium oxide 

(B5NaO8), labeled with boron-10. 

CAS Number: 200443–98–7. 

Basis for Action: The PMN states that 

this substance is to be used as an 

emergency shutdown coolant in boiling 

water reactors. Based on test data for 

boron compounds, the EPA identified 

potential human health concerns 

regarding reproductive effects, 

developmental toxicity, neurotoxicity, 

and blood effects from exposure to the 

PMN substance via inhalation exposure. 

Further, based on SAR analysis of test 

data on boron compounds, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1,240 ppb 

of the PMN substance in surface waters 

for greater than 20 days per year. This 

20-day criterion is derived from partial 

life cycle tests (daphnid chronic and 

fish early life stage tests) that typically 

range from 21 to 28 days in duration. 

EPA predicts toxicity to aquatic 

organisms may occur if releases of the 

substance to surface water, from uses 

other than as described in the PMN, 

exceed releases from the use described 

in the PMN. For the use described in the 

PMN, inhalation and dermal exposures 

are expected to be minimal and 

environmental releases did not exceed 

1,240 ppb for more than 20 days per 

year. Therefore, EPA has not determined 

that the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance other than as listed in the 

PMN may result in serious human 

health and significant adverse 

environmental effects. Based on this 

information, the PMN substance meet 

the concern criteria at § 721.170(b)(3)(ii) 

and (b)(4)(ii). 

Recommended Testing: EPA has 

determined that the results of a 

reproductive/developmental toxicity 

screening test (OPPTS 870.3550/OECD 

Test Guideline 421); a fish acute toxicity 

test, freshwater and marine (OPPTS Test 

Guideline 850.1075); an acute 

invertebrate toxicity test, freshwater 

daphnids (OPPTS Test Guideline 

850.1010); and algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the human health and 

environmental effects of the PMN 

substance. 

CFR Citation: 40 CFR 721.10979. 

PMN Number P–16–94 

Chemical name: Perfluoropolyether 

modified organosilane (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a stainproof coating agent for touch panel. 

Based on physical-chemical properties 

data on the PMN substance, as well as 

SAR analysis of test data on analogous 

perfluorinated chemicals and potential 

perfluorinated degradation products, 

EPA identified concerns for irritation to 

skin, eyes, lungs, mucous membranes, 

lung toxicity, liver toxicity, blood 

toxicity, male reproductive toxicity, 

immunosupression, and oncogenicity. 

EPA has concerns that these degradation 

products will persist in the 

environment, could bioaccumulate or 

biomagnify, and could be toxic (PBT) to 

people, wild mammals, and birds. EPA 

predicts adverse effects to human health 

and the environment may occur if 

releases of the PMN substance to surface 

water at production volumes higher 

than described in the PMN exceed the 

releases expected from the production 

volume described in the PMN. For the 

described production volume in the 

PMN, significant environmental releases 

are not expected. 

Therefore, EPA has not determined 

that the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any 

substantial combined production 

volume increase could result in 

exposures which may cause serious 

human health and significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(1)(i)(D), (b)(3)(iii), and 

(b)(4)(iv). 

Recommended testing: EPA has 

determined that the results of an 

indirect photolysis screening test: 

Sunlight photolysis in waters containing 

dissolved humic substances (OPPTS 

Test Guideline 835.5270), and 

simulation tests to assess the primary 

and ultimate biodegradability of 

chemicals discharged to wastewater 

(OPPTS Test Guideline 835.3280/OECD 

Test Guideline 314) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10980. 

PMN Number P–16–95 

Chemical name: Modified phenolformaldehyde resin (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a flame retardant 


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additive. Based on SAR analysis of test 

data on analogous neutral organics, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

96 ppb of the PMN substance in surface 

waters. Further, based on the alcohol 

groups, EPA has concern for irritation to 

eyes, lungs, and mucous membranes. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

96 ppb and exposures to workers and 

general population are minimal due to 

the use as a flame retardant additive. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substance other than as stated in the 

PMN or any use of the substance 

resulting in surface water 

concentrations exceeding 96 ppb may 

result in serious human health and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(ii) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of an acute 

toxicity test (OPPTS Test Guideline 

870.1000); a repeated dose 28-day oral 

toxicity study (OPPTS Test Guideline 

870.3050) in rodents; a bacterial reverse 

mutation test (OPPTS Test Guideline 

870.5100); a mammalian erythrocyte 

micronucleus test (OPPTS Test 

Guideline 870.5395); a fish early-life 

stage toxicity test (OCSPP Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OCSPP Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the human health and 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10981. 

PMN Number P–16–101 

Chemical name: Disubstituted 

benzene alkanal (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a component for 

household products, including cleaning, 

fabric and air care. Based on SAR 

analysis of test data on analogous 

structurally similar substances, EPA 

identified concerns for developmental 

toxicity from dermal exposures of the 

PMN substance to workers and 

consumers. For the use described in the 

PMN, dermal exposures are not 

expected based on the use of impervious 

gloves, and consumer dermal exposures 

are expected to be minimal. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substances may present an 

unreasonable risk. EPA has determined, 

however, that any use of the PMN 

substance without the use of dermal 

protection, where there is a potential for 

dermal exposures, or any use of the 

PMN substance other than for the use 

specified in the PMN may result in 

serious human health effects. Based on 

this information, the PMN substance 

meet the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that results of a 90-day oral 

toxicity test (OPPTS Test Guideline 

870.3100) in rats via the gavage route, 

and a developmental toxicity test 

OPPTS Test Guideline 870.3650) in rats 

via the gavage route would help 

characterize the effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10982. 

PMN Number P–16–102 

Chemical name: Phthalic anhydride, 

polymer with alkylene glycol and 

alkanepolyol, acrylate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a coating component. 

Based on SAR analysis of test data on 

analogous acrylates, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance during the use described in 

the PMN are not expected to result in 

surface water concentrations that exceed 

1 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance for the use described in the 

PMN may present an unreasonable risk. 

EPA has determined, however, that any 

use of the substance resulting in surface 

water concentrations exceeding 1 ppb 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a water 

solubility test (OPPTS Test Guideline 

830.7840, a fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075); an acute 

invertebrate toxicity test, freshwater 

daphnids (OCSPP Test Guideline 

850.1010); and algal toxicity test 

(OCSPP Test Guideline 850.4500); 

would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10983. 

PMN Number P–16–104 

Chemical name: 2-Pyridinecarboxylic 

acid, 4,5-dichloro-6-(4-chloro-2-fluoro3-methoxyphenyl)-. 

CAS number: 1546765–39–2. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a feed stock for an 

intermediate. Based on SAR analysis of 

test data on analogous halopyridines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 8 ppb of the PMN substance 

in surface waters. Further, based on the 

acid moiety, EPA has concern for 

irritation to eyes, lungs, and mucous 

membranes. As described in the PMN, 

releases of the substance are not 

expected to result in surface water 

concentrations that exceed 8 ppb and 

exposures to workers and general 

population are minimal due to the use 

as an intermediate. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance other than as an 

intermediate or any use of the substance 

resulting in surface water 

concentrations exceeding 8 ppb may 

result in serious human health and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(ii) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of an acute 

toxicity test (OPPTS Test Guideline 

870.1000); a repeated dose 28-day oral 

toxicity study (OPPTS Test Guideline 

870.3050) in rodents; a bacterial reverse 

mutation test (OPPTS Test Guideline 

870.5100); a mammalian erythrocyte 

micronucleus test (OPPTS Test 

Guideline 870.5395); a fish acute 

toxicity test, freshwater and marine 

(OPPTS Test Guideline 850.1075); an 

acute invertebrate toxicity test, 

freshwater daphnids (OCSPP Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

human health and environmental effects 

of the PMN substance. 

CFR citation: 40 CFR 721.10984. 

PMN Numbers P–16–136, P–16–139, and 

P–16–140 

Chemical names: Dialkylamino 

alkylamide inner salt (generic). 

CAS numbers: Not available. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of 

these substances is in oil production. 

Based on SAR analysis of test data on 

analogous aliphatic amines, EPA 


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predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb of the PMN substances in surface 

waters. As described in the PMNs, 

releases of these substances are not 

expected to result in surface water 

concentrations that exceed 1 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substances may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substances resulting in surface water 

concentrations exceeding 1 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substances meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OCSPP Test 

Guideline 850.1400); a mysid chronic 

toxicity test (OCSPP Test Guideline 

850.1350); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substances. Testing 

should be conducted on PMN substance 

P–16–139. 

CFR citation: 40 CFR 721.10985. 

PMN Number P–16–170 

Chemical name: Nanocarbon 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: June 21, 2016. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substance will be used as an additive to 

composite materials. Based on test data 

on analogous respirable, poorly soluble 

particulates and nanocarbon materials, 

EPA identified concerns for pulmonary 

toxicity and oncogenicity. Based on test 

data for other nanocarbon materials EPA 

identified concerns for environmental 

toxicity. The Order was issued under 

TSCA sections 5(e)(1)(A)(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 and the environment. To protect 

against these risks, the consent order 

requires: 

1. Use of personal protective 

equipment involving impervious gloves 

and protective clothing (where there is 

a potential for dermal exposure) and a 

NIOSH-certified respirator with N–100, 

P–100, or R–100 cartridges (where there 

is a potential for inhalation exposure). 

2. Submission of a dustiness test 

within six months of notice of 

commencement. 

3. Submission of a 90-day chronic 

inhalation study prior to exceeding the 

confidential production volume limit 

specified in the consent order. 

4. Processing and use of the PMN 

substance only for the use specified in 

the consent order including no 

application method that generates a 

vapor, mist or aerosol unless the 

application method occurs in an 

enclosed process. 

5. No use of the PMN substance 

resulting in releases to surface waters 

and disposal of the PMN substance only 

by landfill or incineration. 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Recommended testing: EPA has 

determined that the development of 

data on certain physical-chemical 

properties, as well as certain human 

health and environmental toxicity 

testing would help characterize possible 

effects of the substance. The submitter 

has agreed to provide a dustiness test 

(European Standard EU 15051) by six 

months from commencement of 

manufacture. In addition, the submitter 

has agreed not to exceed the 

confidential production limit without 

performing a 90-day inhalation toxicity 

test (OPPTS Test Guideline 870.3465 or 

OECD Test Guideline 413) in rats with 

a post-exposure observation period of 

up to 9 months (including BALF 

analysis, a determination of 

cardiovascular toxicity (clinically-based 

blood/plasma protein analyses), and 

histopathology of the heart). Although 

the order does not require a two-year 

inhalation bioassay (OPPTS Test 

Guideline 870.4200), a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300), a fish early-life stage toxicity 

test (OCSPP Test Guideline 850.1400), 

or an algal toxicity test (OCSPP Test 

Guideline 850.4500), the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, and disposal 

will remain in effect until the Order is 

modified or revoked by EPA based on 

submission of this or other relevant 

information. 

CFR citation: 40 CFR 721.10986. 

PMN Number P–16–177 

Chemical name: Barium molybdenum 

niobium tantalum tellurium vanadium 

zinc oxide. 

CAS number: 1440529–21–4. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a glass coating. Based on 

SAR analysis of test data on the 

analogous respirable, poorly soluble 

particulates, EPA identified concerns for 

lung effects to workers exposed to the 

PMN substance. As described in the 

PMN, worker exposure will be minimal 

due to the use of adequate respiratory 

protection. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance without a National 

Institute for Occupational Safety and 

Health (NIOSH)-certified respirators 

with an assigned protection factor (APF) 

of at least 10, where there is potential 

respiratory exposure, any use other than 

in the PMN, or domestic manufacture 

may result in serious human health 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

subchronic toxicity test (OPPTS Test 

Guideline 870.3465) via the inhalation 

route with a 60-day holding period 

would help characterize the human 

health effects of the PMN substance. 

CFR citation: 40 CFR 721.10987. 

PMN Number P–16–179 

Chemical name: Alkanoic acids, 

esters with alkanetriol (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a grease. Based on SAR 

analysis of test data on analogous esters, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the PMN substance 

in surface waters. As described in the 

PMN, releases of the substance are not 

expected to result in surface water 

concentrations that exceed 1 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in surface water 

concentrations exceeding 1 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OCSPP Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OCSPP Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10988. 

PMN Number P–16–182 

Chemical names: Manganese, 

tris[.mu.-(2-ethylhexanoato- 

.kappa.O:.kappa.O’)]bis(octahydro-1,4,7- 

trimethyl-1H-1,4,7-triazonine- 

.kappa.N1,.kappa.N4,.kappa.N7)di- (P– 

16–182, chemical A); Manganese, [.mu.- 

(acetato-.kappa.O:.kappa.O’)]bis[.mu.-(2- 

ethylhexanoatoVerDate Sep<11>2014 16:39 Sep 20, 2017 Jkt 241001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\FR\FM\21SER1.SGM 21SER1

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.kappa.O:.kappa.O’)]bis(octahydro-1,4,7- 

trimethyl-1H-1,4,7-triazonine- 

.kappa.N1,.kappa.N4,.kappa.N7)di- (P– 

16–182, chemical B); Manganese, 

bis[.mu.-(acetato- 

.kappa.O:.kappa.O’)][.mu.-(2- 

ethylhexanoato- 

.kappa.O:.kappa.O’)]bis(octahydro-1,4,7- 

trimethyl-1H-1,4,7-triazonine- 

.kappa.N1,.kappa.N4,.kappa.N7)di- (P– 

16–182, chemical C); and Manganese, 

tris[.mu.-(acetato- 

.kappa.O:.kappa.O’)]bis(octahydro-1,4,7- 

trimethyl-1H-1,4,7-triazonine- 

.kappa.N1,.kappa.N4,.kappa.N7)di- (P– 

16–182, chemical D). 

CAS numbers: 2020407–62–7 (P–16– 

182, chemical A); 2020407–63–8 (P–16– 

182, chemical B); 2020407–64–9 (P–16– 

182, chemical C); and 2020407–65–0 (P– 

16–182, chemical D). 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substances will be as resins. Based on 

SAR analysis of test data on analogous 

compounds, EPA identified concerns for 

systemic effects to the thyroid and 

pituitary gland, liver toxicity, 

developmental and reproductive 

toxicity, and mutagenicity. There are 

also concerns for immunotoxicity, 

reproductive and developmental 

toxicity, neurotoxicity, blood effects, 

and kidney toxicity, and uncertain 

concerns for asthma and oncogenicity, 

based on manganese, and concerns for 

developmental toxicity for branched 

acid hydrolysis products, by analogy to 

valproic acid and other acids that are 

branched on the carbon adjacent to the 

acid group, all based on exposure to the 

PMN substances via inhalation or 

dermal exposure. As described in the 

PMN, exposure is expected to be 

minimal due to negligible inhalation 

exposures and use of adequate dermal 

personal protection equipment. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substances may 

present an unreasonable risk. EPA has 

determined, however, that any domestic 

manufacture; any manufacture of the 

PMN substances at a concentration 

greater than 10% in any formulation; or 

any use of the PMN substances without 

the use of chemical impervious gloves, 

where there is a potential for dermal 

exposures may result in serious human 

health effects. Based on this 

information, the PMN substances meet 

the concern criteria at 40 CFR 

721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 

combined repeated dose toxicity 

reproduction/development toxicity 

screening test (OECD Test Guideline 

422) would help characterize the human 

health effects of the PMN substances. 

CFR citations: 40 CFR 721.10989 (P– 

16–182, chemical A), 40 CFR 721.10990 

(P–16–182, chemical B), 40 CFR 

721.10991 (P–16–182, chemical C), and 

40 CFR 721.10992 (P–16–182, chemical 

D). 

PMN Number P–16–190 

Chemical name: Aryl polyolefin 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a lubricant. Based 

on analogy to C10–13 alkyl derivatives 

of benzene, EPA identified concerns for 

reproductive and developmental 

toxicity to workers exposed to the PMN 

substance based on exposure to the 

PMN substance via dermal exposure. As 

described in the PMN, exposure is 

expected to be minimal due to use of 

adequate dermal personal protection 

equipment. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance other than as 

described in the PMN, or any use 

without the use of dermal protection 

where there is a potential for dermal 

exposures may cause serious human 

health effects. Based on this 

information, the PMN substance meets 

the concern criteria at 40 CFR 

721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a twogeneration reproduction toxicity test 

(OECD Test Guideline 416) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10993. 

PMN Number P–16–260 

Chemical name: Melamine nitrate 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a gas generant for 

automobile air bag inflators. Based on 

test data on the PMN substance, as well 

as SAR analysis of test data on 

analogous melamines, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 14 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance during the use described in 

the PMN are not expected to result in 

surface water concentrations that exceed 

14 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance for the use described in the 

PMN may present an unreasonable risk. 

EPA has determined, however, that any 

use of the substance resulting in surface 

water concentrations exceeding 14 ppb 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OCSPP Test 

Guideline 850.1400) and a daphnid 

chronic toxicity test (OCSPP Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10994. 

PMN Number P–16–272 

Chemical name: Lecithins, soya, 

hydrogenated. 

CAS number: 308068–11–3. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is an ingredient in a 

formulated product. Based on SAR 

analysis of test data on analogous 

amphoteric surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance during the use described in 

the PMN are not expected to result in 

surface water concentrations that exceed 

1 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance for the use described in the 

PMN may present an unreasonable risk. 

EPA has determined, however, that any 

use of the substance resulting in surface 

water concentrations exceeding 1 ppb 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OCSPP Test Guideline 850.1010); an 

algal toxicity test (OCSPP Test 

Guideline 850.4500); a fish early-life 

stage toxicity test (OCSPP Test 

Guideline 850.1400); and a daphnid 

chronic toxicity test (OCSPP Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10995. 


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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 6 of the 37 chemical substances, 

regulation was warranted under TSCA 

section 5(e), pending the development 

of information sufficient to make 

reasoned evaluations of the health or 

environmental effects of the chemical 

substances. The basis for such findings 

is outlined in Unit IV. Based on these 

findings, TSCA section 5(e) consent 

orders requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. The SNUR 

provisions for these chemical 

substances are consistent with the 

provisions of the TSCA section 5(e) 

consent orders. These SNURs are 

promulgated pursuant to § 14;721.160 

(see Unit VI.). 

In the other 31 cases, where the uses 

are not regulated under a TSCA section 

5(e) consent order, EPA determined that 

one or more of the criteria of concern 

established at § 14;721.170 were met, as 

discussed in Unit IV. 

B. Objectives 

EPA is issuing these SNURs for 

specific chemical substances which 

have undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this rule: 

• EPA will receive notice of any 

person’s intent to manufacture or 

process a listed chemical substance for 

the described significant new use before 

that activity begins. 

• EPA will have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing or processing a 

listed chemical substance for the 

described significant new use. 

• EPA will be able to 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 ensure that all 

manufacturers and processors of the 

same chemical substance that is subject 

to a TSCA section 5(e) consent order are 

subject to similar requirements. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Chemical Substance Inventory 

(TSCA Inventory). Guidance on how to 

determine if a chemical substance is on 

the TSCA Inventory is available on the 

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

existingchemicals/pubs/tscainventory/ 

index.html. 

VI. Direct Final Procedures 

EPA is issuing these SNURs as a 

direct final rule, as described in 

§ 14;721.160(c)(3) and 

§ 14;721.170(d)(4). In accordance with 

§ 14;721.160(c)(3)(ii) and 

§ 14;721.170(d)(4)(i)(B), the effective 

date of this rule is November 20, 2017 

without further notice, unless EPA 

receives written adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments before 

October 23, 2017. 

If EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments, on 

one or more of these SNURs before 

October 23, 2017, EPA will withdraw 

the relevant sections of this direct final 

rule before its effective date. EPA will 

then issue a proposed SNUR for the 

chemical substance(s) on which adverse 

or critical comments were received, 

providing a 30-day period for public 

comment. 

This rule establishes SNURs for a 

number of chemical substances. Any 

person who submits adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments, must 

identify the chemical substance and the 

new use to which it applies. EPA will 

not withdraw a SNUR for a chemical 

substance not identified in the 

comment. 

VII. Applicability of the Significant 

New Use Designation 

To establish a significant new use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule have undergone 

premanufacture review. In cases where 

EPA has not received a notice of 

commencement (NOC) and the chemical 

substance has not been added to the 

TSCA Inventory, no person may 

commence such activities without first 

submitting a PMN. Therefore, for 

chemical substances for which an NOC 

has not been submitted EPA concludes 

that the designated significant new uses 

are not ongoing. 

When chemical substances identified 

in this rule are added to the TSCA 

Inventory, EPA recognizes that, before 

the rule is effective, other persons might 

engage in a use that has been identified 

as a significant new use. However, 

TSCA section 5(e) consent orders have 

been issued for 6 chemical substances, 

and the PMN submitters are prohibited 

by the TSCA section 5(e) consent orders 

from undertaking activities which 

would be designated as significant new 

uses. The identities of 26 of the 37 

chemical substances subject to this rule 

have been claimed as confidential and 

EPA has received no post-PMN bona 

fide submissions (per §§ 720.25 and 

721.11). Based on this, the Agency 

believes that it is highly unlikely that 

any of the significant new uses 

described in the regulatory text of this 

rule are ongoing. 

Therefore, EPA designates June 1, 

2017 which is the date of public release 

by posting on EPA’s Web site, as the 

cutoff date for determining whether the 

new use is ongoing. This designation 

varies slightly from EPA’s past practice 

of designating the date of Federal 

Register publication as the date for 

making this determination. The 

objective of EPA’s approach has been to 

ensure that a person could not defeat a 

SNUR by initiating a significant new use 

before the effective date of the direct 

final rule. In developing this rule, EPA 

has recognized that, given EPA’s 

practice of now posting rules on its Web 

site a week or more in advance of 

Federal Register publication, this 

objective could be thwarted even before 

that publication. Thus, EPA has slightly 

modified its approach in this 

rulemaking and plans to follow this 

modified approach in future significant 

new use rulemakings. 

Persons who begin commercial 

manufacture or processing of the 

chemical substances for a significant 

new use identified as of that date would 

have to cease any such activity upon the 

effective date of the final rule. To 

resume their activities, these persons 

would have to first comply with all 

applicable SNUR notification 

requirements and wait until the notice 

review period, including any 

extensions, expires. If such a person met 

the conditions of advance compliance 

under § 721.45(h), the person would be 

considered exempt from the 

requirements of the SNUR. Consult the 

Federal Register document of April 24, 

1990 for a more detailed discussion of 

the cutoff date for ongoing uses. 

VIII. 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 


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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. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

lists those tests. Unit IV. also lists 

recommended testing for non-TSCA 

section 5(e) SNURs. Descriptions of tests 

are provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http://

www.oecdbookshop.org or SourceOECD 

at http://www.sourceoecd.org. 

In the TSCA section 5(e) consent 

orders for several of the chemical 

substances regulated under this rule, 

EPA has established production volume 

limits in view of the lack of data on the 

potential health and environmental 

risks that may be posed by the 

significant new uses or increased 

exposure to the chemical substances. 

These limits cannot be exceeded unless 

the PMN submitter first submits the 

results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by these chemical 

substances. Under recent TSCA section 

5(e) consent orders, each PMN submitter 

is required to submit each study at least 

14 weeks (earlier TSCA section 5(e) 

consent orders required submissions at 

least 12 weeks) before reaching the 

specified production limit. Listings of 

the tests specified in the TSCA section 

5(e) consent orders are included in Unit 

IV. The SNURs contain the same 

production volume limits as the TSCA 

section 5(e) consent orders. Exceeding 

these production limits is defined as a 

significant new use. Persons who intend 

to exceed the production limit must 

notify the Agency by submitting a 

SNUN at least 90 days in advance of 

commencement of non-exempt 

commercial manufacture or processing. 

The recommended tests specified in 

Unit IV. may not be the only means of 

addressing the potential risks of the 

chemical substance. However, 

submitting a SNUN without any test 

data may increase the likelihood that 

EPA will take action under TSCA 

section 5(e), particularly if satisfactory 

test results have not been obtained from 

a prior PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

IX. Procedural Determinations 

By this rule, EPA is establishing 

certain significant new uses which have 

been claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 

under 40 CFR part 2 procedures, EPA is 

required to keep this information 

confidential. EPA promulgated a 

procedure to deal with the situation 

where a specific significant new use is 

CBI, at § 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 

§ 14;721.1725(b)(1) with that under 

§ 14;721.11 into a single step. 

If EPA determines that the use 

identified in the bona fide submission 

would not be a significant new use, i.e., 

the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture or 

process the chemical substance so long 

as the significant new use trigger is not 

met. In the case of a production volume 

trigger, this means that the aggregate 

annual production volume does not 

exceed that identified in the bona fide 

submission to EPA. Because of 

confidentiality concerns, EPA does not 

typically disclose the actual production 

volume that constitutes the use trigger. 

Thus, if the person later intends to 

exceed that volume, a new bona fide 

submission would be necessary to 

determine whether that higher volume 

would be a significant new use. 

X. SNUN Submissions 

According to § 14;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– 

2016–0331. 

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, or TSCA 

section 5(e) consent orders. The Office 

of Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

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

B. Paperwork Reduction Act (PRA) 

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

seq.), an agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under PRA, 

unless it has been approved by OMB 

and displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. EPA is amending the table in 

40 CFR part 9 to list the OMB approval 

number for the information collection 


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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 

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: April 5, 2017. 

Maria J. Doa, 

Director, Chemical Control Division, Office 

of Pollution Prevention and Toxics. 

Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

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

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

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

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

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

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


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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 

*****

721.10961 ............................. 2070–0012 

721.10962 ............................. 2070–0012 

721.10963 ............................. 2070–0012 

721.10964 ............................. 2070–0012 

721.10965 ............................. 2070–0012 

721.10966 ............................. 2070–0012 

721.10967 ............................. 2070–0012 

721.10968 ............................. 2070–0012 

721.10969 ............................. 2070–0012 

721.10970 ............................. 2070–0012 

721.10971 ............................. 2070–0012 

721.10972 ............................. 2070–0012 

721.10973 ............................. 2070–0012 

721.10974 ............................. 2070–0012 

721.10975 ............................. 2070–0012 

721.10976 ............................. 2070–0012 

721.10977 ............................. 2070–0012 

721.10978 ............................. 2070–0012 

721.10979 ............................. 2070–0012 

721.10980 ............................. 2070–0012 

721.10981 ............................. 2070–0012 

721.10982 ............................. 2070–0012 

721.10983 ............................. 2070–0012 

721.10984 ............................. 2070–0012 

721.10985 ............................. 2070–0012 

721.10986 ............................. 2070–0012 

721.10987 ............................. 2070–0012 

721.10988 ............................. 2070–0012 

721.10989 ............................. 2070–0012 

721.10990 ............................. 2070–0012 

721.10991 ............................. 2070–0012 

721.10992 ............................. 2070–0012 

721.10993 ............................. 2070–0012 

721.10994 ............................. 2070–0012 

721.10995 ............................. 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 § 721.10961 to subpart E to 

read as follows: 

§ 721.10961 Ethylene glycol ester of an 

aromatic substituted propenoic acid 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as ethylene glycol ester of an 

aromatic substituted propenoic acid 

(PMN P–05–436) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=10). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 5. Add § 721.10962 to subpart E to 

read as follows: 

§ 721.10962 Phosphoric acid, metal salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as phosphoric acid, metal 

salt (PMN P–10–504) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) and (s) (100,000 

kilograms). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) 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. 

■ 6. Add § 721.10963 to subpart E to 

read as follows: 

§ 721.10963 Alkanoic acid, 

tetramethylheteromonocycle ester 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanoic acid, 

tetramethylheteromonocycle ester (PMN 

P–13–289) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=2). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 7. Add § 721.10964 to subpart E to 

read as follows: 

§ 721.10964 Polyether polyester urethane 

phosphate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyether polyester 

urethane phosphate (PMN P–13–908) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (j) and (s) (1,000 

kilograms). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) 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)(ii) of this section. 


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■ 8. Add § 14;721.10965 to subpart E to 

read as follows: 

§ 721.10965 Propanamide, 2-hydroxy-N,Ndimethyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

propanamide, 2-hydroxy-N,N-dimethyl- 

(PMN P–14–129, CAS No. 35123–06–9) 

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) Protection in the workplace. 

Requirements as specified in 

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

(concentration set at 1.0 percent). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) and (o). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 9. Add § 14;721.10966 to subpart E to 

read as follows: 

§ 721.10966 1-Propene, 2-bromo-3,3,3- 

trifluoro-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-propene, 2-bromo-3,3,3-trifluoro- 

(PMN P–14–260, CAS No. 1514–82–5) is 

subject to reporting under this section 

for the significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance after 

they have been charged into a fire 

extinguisher or fire extinguishing 

system. 

(2) The significant new uses are: 

(i) Protection in the workplace. (A) 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), (a)(4), (a)(6)(v), 

(a)(6)(vi), (b) (concentration set at 1.0 

percent), and (c). When determining 

which persons are reasonably likely to 

be exposed as required for § 721.63(a)(1) 

and (a)(4), engineering control measures 

(e.g., enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

Applied Protection Factor (APF) of at 

least 10 meet the requirements of 

§ 721.63(a)(4): 

(1) NIOSH-certified air-purifying half 

mask respirator equipped with a gas/ 

vapor (organic vapor) cartridge. 

(2) NIOSH-certified powered airpurifying respirator with a hood or 

helmet and with a gas/vapor (organic 

vapor) cartridge. 

(3) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

half-mask. 

(4) NIOSH-certified continuous flow 

supplied-air respirator with a loose 

fitting facepiece, hood, or helmet. 

(5) NIOSH-certified negative pressure 

(demand) self-contained breathing 

apparatus (SCBA) with a half-mask. 

(B) 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) consent order 

for this substance. The NCEL is 1.0 parts 

per million (ppm) 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) consent order. 

(ii) Hazard communication program. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 1.0 

percent), (f), (g)(1) (cardiac sensitization 

and reproductive effects), (g)(2)(i), 

(g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(c), (f), and (k) (A 

significant new use is any use other 

than as either a total flooding agent in 

unoccupied spaces, specifically engine 

nacelles and auxiliary power units 

(APUs) in aircraft; or as a streaming fire 

extinguishing agent for use only in 

handheld extinguishers in aircraft). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 10. Add § 14;721.10967 to subpart E to 

read as follows: 

§ 721.10967 Pyrolysis oil product 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as pyrolysis oil product 

(PMN P–14–759) 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. (A) 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), (a)(4), (a)(6) 

(particulate and gas/vapor), (b) 

(concentration set at 0.1 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

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

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

Applied Protection Factor (APF) of at 

least 10 meet the requirements of 

§ 721.63(a)(4): 

(1) NIOSH-certified air-purifying half 

mask respirator equipped with an 

organic vapor cartridge. 

(2) NIOSH-certified powered airpurifying respirator with a hood or 

helmet and with an organic vapor 

cartridge. 

(3) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

half-mask. 

(4) NIOSH-certified continuous flow 

supplied-air respirator with a loose 

fitting facepiece, hood, or helmet. 

(5) NIOSH-certified negative pressure 

(demand) self-contained breathing 

apparatus (SCBA) with a half-mask. 

(B) 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) consent order 

for this substance. The NCEL is 0.5 parts 

per million (ppm) 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 


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44094 Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Rules and Regulations 

contained in the corresponding TSCA 

section 5(e) consent order. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). 

(iii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e), (i) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 11. Add § 14;721.10968 to subpart E to 

read as follows: 

§ 721.10968 1-Octanamine, 7 (or 8)- 

(aminomethyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-octanamine, 7 (or 8)-(aminomethyl)- 

(PMN P–15–279, CAS No. 1613320–81– 

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) Release to water. Requirements as 

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

(c)(4) (N=123). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 12. Add § 721.10969 to subpart E to 

read as follows: 

§ 721.10969 Substituted alkanolamine 

ether (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted alkanolamine 

ether (PMN P–15–409) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of the substance is 

any manner or method of manufacture 

or processing associated with any use of 

the substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under TSCA section 5(e) 

consent order for the substance, the 

employer becomes aware that the 

substances may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into an SDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If the substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to an SDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

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

an SDS containing the information 

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

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (h) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 13. Add § 721.10970 to subpart E to 

read as follows: 

§ 721.10970 Butanedioic acid, alkyl amine, 

dimethylbutyl ester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as butanedioic acid, alkyl 

amine, dimethylbutyl ester (PMN P–15– 

583) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this rule do 

not apply to quantities of the PMN 

substance after they have been added to 

engine oil. 

(i) Hazard communication program. A 

significant new use of the substance is 

any manner or method of manufacture 

or processing associated with any use of 

the substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under TSCA section 5(e) 

consent order for the substance, the 

employer becomes aware that the 

substances may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into an SDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If the substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to an SDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

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

an SDS containing the information 

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

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q). 

(iii) Release to water. Requirements as 

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

(c)(1). 

(2) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (h), (i) and (k) 

are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 14. Add § 721.10971 to subpart E to 

read as follows: 


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§ 721.10971 Carbon nanotube (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbon nanotube (PMN 

P–15–672) 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)(2)(ii), (a)(3), 

(a)(4), (a)(6) (particulate), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

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

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. A 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an N–100, P–100, or 

R–100 cartridge meet the requirements 

of § 721.63(a)(4). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. It is a significant 

new use to process or use the chemical 

substance other than as an aqueous 

slurry, wet form, or a contained dry 

form as described in the PMN. 

(iii) Disposal. Requirements as 

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

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

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) through 

(k) are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 15. Add § 721.10972 to subpart E to 

read as follows: 

§ 721.10972 Metal salt of mineral acid, 

reaction products with alumina, aluminum 

hydroxide, aluminum hydroxide oxide 

(Al(OH)O), silica, titanium oxide (TiO2) and 

3-(triethoxysilyl)-1-propanamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as metal salt of mineral acid, 

reaction products with alumina, 

aluminum hydroxide, aluminum 

hydroxide oxide (Al(OH)O), silica, 

titanium oxide (TiO2) and 3- 

(triethoxysilyl)-1-propanamine (PMN 

P–15–678) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) 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. 

■ 16. Add § 721.10973 to subpart E to 

read as follows: 

§ 721.10973 Halogenated bisphenol A, 

polymer with epichlorohydrin, alkenoate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated bisphenol A, 

polymer with epichlorohydrin, 

alkenoate (PMN P–15–766) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j), (o) and (s) 

(10,000 kilograms). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) 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 § 721.10974 to subpart E to 

read as follows: 

§ 721.10974 Halogenated bisphenol A, 

polymer with bisphenol A diglycidyl ether 

and epoxidized phenol-formaldehyde resin, 

alkenoate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as halogenated bisphenol A, 

polymer with bisphenol A diglycidyl 

ether and epoxidized phenolformaldehyde resin, alkenoate (PMN 

P–15–767) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j), (o) and (s) 

(10,000 kilograms). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) 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. 

■ 18. Add § 721.10975 to subpart E to 

read as follows: 

§ 721.10975 Silicon, tris[dialkyl phenyl]- 

dialkyl-dioxoalkane-naphthalene 

disulfonate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as silicon, tris[dialkyl 

phenyl]-dialkyl-dioxoalkanenaphthalene disulfonate (PMN P–16–14) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). The significant 

new use is use other than as described 

in PMN–16–14 where the surface water 

concentrations described in paragraph 

(a)(3)(i) are exceeded. 

(ii) [Reserved] 

(3) The significant new uses for any 

use other than as described in PMN–16– 

14: 


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(i) Release to water. Requirements as 

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

(c)(4) (N=6). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (i), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 19. Add § 721.10976 to subpart E to 

read as follows: 

§ 721.10976 Tar acids fraction (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tar acids fraction (PMN 

P–16–40) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=45). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 20. Add § 721.10977 to subpart E to 

read as follows: 

§ 721.10977 Dialkyl fattyalkylamino 

propanamide alkylamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as dialkyl fattyalkylamino 

propanamide alkylamine (PMN P–16– 

59) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 21. Add § 721.10978 to subpart E to 

read as follows: 

§ 721.10978 Fattyalkylaminopropanoate 

ester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 

fattyalkylaminopropanoate ester (PMN 

P–16–60) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 22. Add § 721.10979 to subpart E to 

read as follows: 

§ 721.10979 Boron sodium oxide 

(B5NaO8), labeled with boron-10. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

boron sodium oxide (B5NaO8), labeled 

with boron-10 (PMN P–16–70, CAS No. 

200443–98–7) 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. A significant new 

use is any use of the substance other 

than as an emergency shutdown coolant 

in boiler water reactors. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

■ 23. Add § 721.10980 to subpart E to 

read as follows: 

§ 721.10980 Perfluoropolyether modified 

organosilane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as perfluoropolyether 

modified organosilane (PMN P–16–94) 

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(s) (500 kilograms). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) 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. 

■ 24. Add § 721.10981 to subpart E to 

read as follows: 

§ 721.10981 Modified phenol-formaldehyde 

resin (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as modified phenolformaldehyde resin (PMN P–16–95) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=96). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (i), and (k) are 


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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. 

■ 25. Add § 721.10982 to subpart E to 

read as follows: 

§ 721.10982 Disubstituted benzene alkanal 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as disubstituted benzene 

alkanal (PMN P–16–101) 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)(2)(i), (a)(3), (b) 

(concentration set at 1.0 percent), and 

(c). 

(ii) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 26. Add § 721.10983 to subpart E to 

read as follows: 

§ 721.10983 Phthalic anhydride, polymer 

with alkylene glycol and alkanepolyol, 

acrylate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as phthalic anhydride, 

polymer with alkylene glycol and 

alkanepolyol, acrylate (PMN P–16–102) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 27. Add § 721.10984 to subpart E to 

read as follows: 

§ 721.10984 2-Pyridinecarboxylic acid, 4,5- 

dichloro-6-(4-chloro-2-fluoro-3- 

methoxyphenyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-pyridinecarboxylic acid, 4,5-dichloro6-(4-chloro-2-fluoro-3-methoxyphenyl)- 

(PMN P–16–104, CAS No. 1546765–39– 

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(g). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=8). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (i), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 28. Add § 721.10985 to subpart E to 

read as follows: 

§ 721.10985 Dialkylamino alkylamide inner 

salt (generic). 

(a) Chemical substance and significant 

new uses subject to reporting. (1) The 

chemical substances identified 

generically as dialkylamino alkylamide 

inner salt (PMNs P–16–136, P–16–139 

and P–16–140) are subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (k) are 

applicable to manufacturers and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 29. Add § 721.10986 to subpart E to 

read as follows: 

§ 721.10986 Nanocarbon (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as nanocarbon (PMN P–16– 

170) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this rule do 

not apply when the PMN substance is 

incorporated into the composite 

material allowed by the section 5(e) 

consent order. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(4), (a)(6) (particulate), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

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

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. A 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an N–100, P–100, or 

R–100 cartridge meet the requirements 

of § 721.63(a)(4). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). A 

significant new use is any use involving 

an application method that generates a 

vapor, mist or aerosol. 

(iii) Disposal. Requirements as 

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

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

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) through 

(k) are applicable to manufacturers and 

processors of this substance. 


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(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 § 721.10987 to subpart E to 

read as follows: 

§ 721.10987 Barium molybdenum niobium 

tantalum tellurium vanadium zinc oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

barium molybdenum niobium tantalum 

tellurium vanadium zinc oxide (PMN 

P–16–177, CAS No. 1440529–21–4) 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)(4), (a)(6)(i), (a)(6)(ii), (b) 

(concentration set at 1.0 percent) and 

(c). When determining which persons 

are reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in 721.80(f) and (j). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (d) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(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. 

■ 31. Add § 721.10988 to subpart E to 

read as follows: 

§ 721.10988 Alkanoic acids, esters with 

alkanetriol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanoic acids, esters with 

alkanetriol (PMN P–16–179) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 32. Add § 721.10989 to subpart E to 

read as follows: 

§ 721.10989 Manganese, tris[.mu.-(2- 

ethylhexanoato- 

.kappa.O:.kappa.O’)]bis(octahydro-1,4,7- 

trimethyl-1H-1,4,7-triazonine- 

.kappa.N1,.kappa.N4,.kappa.N7)di- (P–16– 

182, chemical A). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

manganese, tris[.mu.-(2-ethylhexanoato- 

.kappa.O:.kappa.O’)]bis(octahydro-1,4,7- 

trimethyl-1H-1,4,7-triazonine- 

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

(PMN P–16–182, chemical A; CAS No. 

2020407–62–7) 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)(3), and (b) 

(concentration set at 1.0 percent). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (j) (a 

significant new use is any manufacture 

at a concentration of greater than 10% 

of the PMN substance in any 

formulation). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 33. Add § 721.10990 to subpart E to 

read as follows: 

§ 721.10990 Manganese, [.mu.-(acetato- 

.kappa.O:.kappa.O’)]bis[.mu.-(2- 

ethylhexanoato- 

.kappa.O:.kappa.O’)]bis(octahydro-1,4,7- 

trimethyl-1H-1,4,7-triazonine- 

.kappa.N1,.kappa.N4,.kappa.N7)di- (P–16– 

182, chemical B). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

manganese, [.mu.-(acetato- 

.kappa.O:.kappa.O’)]bis[.mu.-(2- 

ethylhexanoato- 

.kappa.O:.kappa.O’)]bis(octahydro-1,4,7- 

trimethyl-1H-1,4,7-triazonine- 

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

(PMN P–16–182, chemical B; CAS No. 

2020407–63–8) 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) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), and (b) 

(concentration set at 1.0 percent). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (j) (a 

significant new use is any manufacture 

at a concentration of greater than 10% 

of the PMN substance in any 

formulation). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 34. Add § 721.10991 to subpart E to 

read as follows: 

§ 721.10991 Manganese, bis[.mu.-(acetato- 

.kappa.O:.kappa.O’)][.mu.-(2- 

ethylhexanoato- 

.kappa.O:.kappa.O’)]bis(octahydro-1,4,7- 

trimethyl-1H-1,4,7-triazonine- 

.kappa.N1,.kappa.N4,.kappa.N7)di- (P–16– 

182, chemical C). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

manganese, bis[.mu.-(acetato- 

.kappa.O:.kappa.O’)][.mu.-(2- 

ethylhexanoato- 

.kappa.O:.kappa.O’)]bis(octahydro-1,4,7- 

trimethyl-1H-1,4,7-triazonine- 

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

(PMN P–16–182, chemical C; CAS No. 

2020407–64–9) is subject to reporting 


asabaliauskas on DSKBBXCHB2PROD with RULES
Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Rules and Regulations 44099 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), and (b) 

(concentration set at 1.0 percent). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (j) (a 

significant new use is any manufacture 

at a concentration of greater than 10% 

of the PMN substance in any 

formulation). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 35. Add § 721.10992 to subpart E to 

read as follows: 

§ 721.10992 Manganese, tris[.mu.-(acetato- 

.kappa.O:.kappa.O’)]bis(octahydro-1,4,7- 

trimethyl-1H-1,4,7-triazonine- 

.kappa.N1,.kappa.N4,.kappa.N7)di- (P–16– 

182, chemical D). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

manganese, tris[.mu.-(acetato- 

.kappa.O:.kappa.O’)]bis(octahydro-1,4,7- 

trimethyl-1H-1,4,7-triazonine- 

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

(PMN P–16–182, chemical D; CAS No. 

2020407–65–0) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), and (b) 

(concentration set at 1.0 percent). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (j) (a 

significant new use is any manufacture 

at a concentration of greater than 10% 

of the PMN substance in any 

formulation). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 36. Add § 721.10993 to subpart E to 

read as follows: 

§ 721.10993 Aryl polyolefin (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aryl polyolefin (PMN P– 

16–190) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), and (b) 

(concentration set at 1.0 percent). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (d) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 37. Add § 721.10994 to subpart E to 

read as follows: 

§ 721.10994 Melamine nitrate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as melamine nitrate (PMN 

P–16–260) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=14). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 38. Add § 721.10995 to subpart E to 

read as follows: 

§ 721.10995 Lecithins, soya, 

hydrogenated. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

lecithins, soya, hydrogenated (PMN P– 

16–272, CAS No. 308068–11–3) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2017–20158 Filed 9–20–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R02–OAR–2017–0044; FRL–9968–05– 

Region 2] 

Approval of Air Quality Implementation 

Plans; New Jersey, 2011 Periodic 

Emission Inventory SIP for the Ozone 

Nonattainment and PM2.5/Regional 

Haze Areas 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving a State 

Implementation Plan (SIP) revision 

submitted by the New Jersey 

Department of Environmental 

Protection. The SIP revision consists of 

the following: 2011 calendar year ozone 

precursor emission inventories for 

volatile organic compounds (VOC), 

oxides of nitrogen (NOX) and carbon 

monoxide (CO) for the New YorkNorthern New Jersey-Long Island area 

classified as Moderate ozone 

nonattainment for the 2008 8-hour 

ozone standard, and the PhiladelphiaVerDate Sep<11>2014 16:39 Sep 20, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\FR\FM\21SER1.SGM 21SER1

asabaliauskas on DSKBBXCHB2PROD with RULES