Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Proposed Rules 31239 

Because this rule proposed to authorize 

pre-existing State rules which are at 

least equivalent to, and no less stringent 

than existing federal requirements, and 

imposes no additional requirements 

beyond those imposed by State law, and 

there are no anticipated significant 

adverse human health or environmental 

effects, the proposed rule is not subject 

to Executive Order 12898. 

List of Subjects in 40 CFR Parts 271 

Environmental protection, 

Administrative practice and procedure, 

Confidential business information, 

Hazardous waste, Hazardous waste 

transportation, Indian lands, 

Intergovernmental relations, Penalties, 

Reporting and recordkeeping 

requirements. 

Authority: This action is issued under the 

authority of sections 2002(a), 3006, and 

7004(b) of the Solid Waste Disposal Act as 

amended 42 U.S.C. 6912(a), 6926, 6974(b). 

Dated: June 4, 2021. 

David Gray, 

Acting Regional Administrator, Region 6. 

[FR Doc. 2021–12238 Filed 6–10–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 721 and 725 

[EPA–HQ–OPPT–2020–0588; FRL–10022– 

56] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances (21–1.5e) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing significant 

new use rules (SNURs) under the Toxic 

Substances Control Act (TSCA) for 

chemical substances that were the 

subject of premanufacture notices 

(PMNs) and a Microbial Commercial 

Activity Notice (MCAN), and are also 

subject to Orders issued by EPA 

pursuant to TSCA. The SNURs require 

persons who intend to manufacture 

(defined by statute to include import) or 

process any of these chemical 

substances for an activity that is 

proposed 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 use, under the 

conditions of use for that chemical 

substance, within the applicable review 

period. Persons may not commence 

manufacture or processing for the 

significant new use until EPA has 

conducted a review of the notice, made 

an appropriate determination on the 

notice, and has taken such actions as are 

required by that determination. 

DATES: Comments must be received on 

or before July 12, 2021. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2020–0588, 

through the Federal eRulemaking Portal 

at https://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. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: William 

Wysong, New Chemicals Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; telephone 

number: (202) 564–4163; email address: 

wysong.william@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 proposed 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 provisions 

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, which would include the SNUR 

requirements should these proposed 

rules be finalized. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, pursuant to 40 CFR 721.20 or 

40 CFR 725.920 (for the microorganism), 

any persons who export or intend to 

export a chemical substance that is the 

subject of this proposed rule on or after 

July 12, 2021 are subject to the export 

notification provisions of TSCA section 

12(b) (15 U.S.C. 2611(b)) (see 40 CFR 

721.20), and must comply with the 

export notification requirements in 40 

CFR part 707, subpart D. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 

https://www.epa.gov/dockets/ 

commenting-epa-dockets. 

II. Background 

A. What action is the Agency taking? 

EPA is proposing these SNURs under 

TSCA section 5(a)(2) (15 U.S.C. 

2604(a)(2)) for chemical substances that 

were the subject of PMNs and an 

MCAN. These proposed SNURs would 

require persons to notify EPA at least 90 

days before commencing the 

manufacture or processing of any of 

these chemical substances for an 

activity proposed as a significant new 

use. Receipt of such notices would 

allow EPA to assess risks and, if 

appropriate, to regulate the significant 

new use before it may occur. 


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The docket for these proposed 

SNURs, identified as docket ID number 

EPA–HQ–OPPT–2020–0588, includes 

information considered by the Agency 

in developing these proposed SNURs. 

B. What is the Agency’s authority for 

taking this action? 

TSCA section 5(a)(2) (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 TSCA section 5(a)(2) 

factors listed in Unit III. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A and (for 

microorganisms) 40 CFR part 725, 

subpart L. 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. Pursuant to 

40 CFR 721.1(c), persons subject to 

these SNURs must comply with the 

same significant new use notice (SNUN) 

requirements and EPA regulatory 

procedures as submitters of PMNs under 

TSCA section 5(a)(1)(A). These 

requirements include the information 

submission requirements of TSCA 

sections 5(b) and 5(d)(1), the 

exemptions authorized by TSCA 

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

and the regulations at 40 CFR part 720. 

Once EPA receives a SNUN and before 

the manufacture or processing for the 

significant new use can commence, EPA 

must either determine that the use is not 

likely to present an unreasonable risk of 

injury under the conditions of use for 

the chemical substance or take such 

regulatory action as is associated with 

an alternative determination. If EPA 

determines that the 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 

TSCA section 5(a)(2) 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 determining what would constitute 

a significant new use for the chemical 

substances that are the subject of these 

SNURs, EPA considered relevant 

information about the toxicity of the 

chemical substances, potential human 

exposures and environmental releases 

that may be associated with possible 

uses of these chemical substances, in 

the context of the four TSCA section 

5(a)(2) factors listed in this unit. 

The proposed rules include PMN and 

MCAN substances that are subject to 

Orders issued under TSCA section 

5(e)(1)(A), as required by the 

determinations made under TSCA 

section 5(a)(3)(B). The TSCA Orders 

require protective measures to limit 

exposures or otherwise mitigate the 

potential unreasonable risk. The 

proposed SNURs identify significant 

new uses as any manufacturing, 

processing, use, distribution in 

commerce, or disposal that does not 

conform to the restrictions imposed by 

the underlying TSCA Orders, consistent 

with TSCA section 5(f)(4). 

Where EPA determined that the PMN 

substance may present an unreasonable 

risk of injury to human health via 

inhalation exposure, the underlying 

TSCA Order usually requires 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), and 

includes requirements addressing 

performance criteria for sampling and 

analytical methods, periodic 

monitoring, respiratory protection, and 

recordkeeping. 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 40 CFR 721.63 

respirator requirements may request to 

do so under 40 CFR 721.30. EPA expects 

that persons whose 40 CFR 721.30 

requests to use the NCELs approach for 

SNURs that are approved by EPA will 

be required to comply with NCELs 

provisions that are comparable to those 

contained in the corresponding TSCA 

Order for the same chemical substance. 

IV. Substances Subject to This Proposed 

Rule 

EPA is proposing significant new use 

and recordkeeping requirements for 

certain chemical substances in 40 CFR 

part 721, subpart E and in 40 CFR part 

725, subpart M (for the microorganism). 

In this unit, EPA provides the following 

information for each chemical substance 

that is identified in this unit as subject 

to this proposed rule: 

• PMN or MCAN 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). 

• Effective date of and basis for the 

TSCA Order. 

• Potentially Useful Information. 

• CFR citation assigned in the 

regulatory text section of the proposed 

rule. 

The chemicals subject to these 

proposed SNURs are as follows: 

PMN Number: P–16–167 

Chemical Name: Hindered amine 

alkyl ester compounds (generic). 

CAS Number: Not available. 

Effective Date of TSCA Order: April 

24, 2020. 

Basis for TSCA Order: The PMN states 

that the use will be as a light stabilizer 

for plastic articles. Based on submitted 

test data, EPA has identified concerns 

for dermal irritation and sensitization. 

Based on comparison to analogous 

aliphatic amines, EPA predicts that 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against these risks, the Order 

requires: 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

Assigned Protection Factor (APF) of at 

least 50 where there is a potential for 

inhalation exposure; 

• Establishment of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 1 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 


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Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of chronic 

aquatic toxicity and reproduction/ 

developmental toxicity screening testing 

may be potentially useful to characterize 

the human health and environmental 

effects of the PMN substance. Although 

the Order does not require these tests, 

the Order’s restrictions 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 721.11571. 

PMN Numbers: P–16–419, P–16–423, 

and P–16–424 

Chemical Names: N-alkyl-dialkyl 

piperidine (generic) (P–16–419), 

Tetraalkylpiperidinium halide (generic) 

(P–16–423), and Tetraalkylpiperidinium 

hydroxide (generic) (P–16–424). 

CAS Numbers: Not available. 

Effective Date of TSCA Order: April 

15, 2020. 

Basis for TSCA Order: The PMNs state 

that the generic (non-confidential) uses 

will be as an intermediate (P–16–419 

and P–16–423) and as a directing agent 

(P–16–424). Based on comparison to 

analogous chemical substances, EPA has 

identified concerns for acute toxicity, 

corrosion, systemic and respiratory 

effects (P–16–419). Based on 

comparison to analogous chemical 

substances and the high pH, EPA has 

identified concerns for acute oral 

toxicity, developmental/reproductive 

toxicity, neurotoxicity, renal effects, and 

corrosion to all tissues (P–16–423 and 

P–16–424). Based on comparison to 

analogous chemical substances, EPA 

predicts that toxicity to aquatic 

organisms may occur at concentrations 

that exceed 286 ppb for P–16–419 and 

20 ppb for P–16–423 and P–16–424. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substances may 

present an unreasonable risk of injury to 

human health or the environment. The 

Order was also issued under TSCA 

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

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

the substance which was the subject of 

P–16–424 is or will be produced in 

substantial quantities and that the 

substance either enters or may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

or there is or may be a significant (or 

substantial) human exposure to the 

substance. To protect against these risks, 

the Order requires: 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a NIOSH-certified respirator 

with an APF of at least 10 where there 

is a potential for inhalation exposure 

(P–16–419); 

• Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

• Use of P–16–419 only as a sitelimited intermediate; 

• Use of P–16–423 only as an 

intermediate; 

• Use of P–16–424 only for the 

confidential use allowed in the Order; 

and 

• No release of the PMN substances 

resulting in surface water 

concentrations that exceed 286 ppb (P– 

16–419) or 20 ppb (P–16–423 and P–16– 

424). 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

as determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of aquatic 

toxicity and specific target organ 

toxicity testing may be potentially 

useful to characterize the human health 

and environmental effects of the PMN 

substances. Additionally, the results of 

reproductive toxicity testing may be 

potentially useful to characterize the 

human health effects of PMNs P–16–423 

and P–16–424. Although the Order does 

not require these tests, the Order’s 

restrictions remain in effect until the 

Order is modified or revoked by EPA 

based on submission of this or other 

relevant information. 

CFR Citations: 40 CFR 721.11572 (P– 

16–419), 40 CFR 721.11573 (P–16–423), 

and 40 CFR 721.11574 (P–16–424). 

PMN Numbers: P–17–235 and P–18–226 

Chemical Names: Amidoamino 

quaternary ammonium salt (generic) (P– 

17–235), and Tri alkyl, mono alkoxy, 

fatty acid ester, ammonium salt 

(generic) (P–18–226). 

CAS Numbers: Not available. 

Effective Date of TSCA Order: April 

22, 2020. 

Basis for TSCA Order: The PMNs state 

that the generic (non-confidential) use 

of the PMN substances will be as an 

anti-agglomerant. Based on the 

surfactant properties of the compounds 

and comparison to analogous 

substances, EPA has identified concerns 

for surfactant effects on the lungs, 

irritation and possible corrosion to the 

eyes, skin, and respiratory tract. Based 

on comparison to analogous substances, 

EPA has also identified concerns for 

developmental toxicity. Based on 

comparison to analogous polycationic 

polymers, EPA predicts that toxicity to 

aquatic organisms may occur at 

concentrations that exceed 60 ppb for 

P–17–235 and 44 ppb for P–18–226. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substances may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against these risks, the Order 

requires: 

• Use of the PMN substances only for 

the uses allowed in the Order; and 

• No release of the PMN substances 

resulting in surface water 

concentrations that exceed 44 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of chronic 

aquatic toxicity, reproductive toxicity, 

and pulmonary effects testing may be 

potentially useful to characterize the 

human health and environmental effects 

of the PMN substances. Although the 

Order does not require these tests, the 

Order’s restrictions remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other relevant information. 

CFR Citations: 40 CFR 721.11575 (P– 

17–235) and 40 CFR 721.11576 (P–18– 

226). 

PMN Number: P–17–259 

Chemical Name: Halogenated 

aromatic amine (generic). 

CAS Number: Not available. 

Effective Date of TSCA Order: August 

31, 2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

of the substance will be as a curative for 

thermosetting resins. Based on 

comparison to structurally analogous 

chemical substances, EPA has identified 

concerns for skin sensitization and 

systemic effects (liver, blood, and 

spleen). Based on comparison to 


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analogous anilines, EPA predicts that 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against these risks, the Order 

requires: 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 1 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of skin 

sensitization, specific target organ 

toxicity, and aquatic toxicity testing 

may be potentially useful to characterize 

the human health and environmental 

effects of the PMN substance. Although 

the Order does not require these tests, 

the Order’s restrictions 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 721.11577. 

PMN Number: P–18–43 

Chemical Name: 1,4- 

Benzenedicarboxylic acid, 1,4-dipentyl 

ester, branched and linear. 

CAS Number: 2097734–13–7. 

Effective Date of TSCA Order: 

September 16, 2020. 

Basis for TSCA Order: The PMN states 

that the use will be as a plasticizer or 

fast fuser in PVC-plastisols for flooring, 

wall paper, coated fabrics, underbody 

coating; processing aid or fast fuser in 

PVC dry blends for flooring, coated 

fabrics, films & sheets, tubes & hoses; 

flexibilizing additive for paints and 

lacquers; use in formulation or repacking; and as a laboratory agent. 

Based on the potential metabolite 

terephthalic acid, EPA has identified 

concerns for systemic toxicity. Based on 

comparison to analogous esters, EPA 

predicts that toxicity to aquatic 

organisms may occur at concentrations 

that exceed 2 ppb. The Order was issued 

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

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health or the 

environment. The Order was also issued 

under TSCA sections 5(a)(3)(B)(ii)(II) 

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

that the substance is expected to be 

produced in substantial quantities, and 

that there may be a significant or 

substantial human exposure to the 

substance, and that the substance may 

enter the environment in substantial 

quantities. To protect against these 

risks, the Order requires: 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 2 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of chronic 

aquatic toxicity testing may be 

potentially useful to characterize the 

environmental effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions 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 721.11578. 

PMN Numbers: P–18–178, P–18–217, 

and P–18–218 

Chemical Names: Dialkyltin 

dialkylcarboxylate (generic) (P–18–178), 

Alkyltin dodecylthioester (generic) (P– 

18–217), and Alkyltin 

tetradecylthioester (generic) (P–18–218). 

CAS Numbers: Not available. 

Effective Date of TSCA Order: May 20, 

2020. 

Basis for TSCA Order: The PMNs state 

that the use of the substances will be as 

stabilizers for PVC compounds. Based 

on the physical/chemical properties of 

the PMN substances and test data on 

structurally similar substances, the PMN 

substances are potentially persistent, 

bioaccumulative, and toxic (PBT) 

chemicals (as described in the New 

Chemical Program’s PBT category at 64 

FR 60194; November 4, 1999; FRL– 

6097–7). EPA estimates that the PMN 

substances will persist in the 

environment for more than 2 months 

and estimates a bioaccumulation factor 

of greater than or equal to 1,000. Based 

on comparison to analogous chemical 

substances, EPA has identified concerns 

for immune, reproductive, 

developmental, and systemic effects. 

Based on comparison to analogous 

organotins, EPA predicts that toxicity to 

aquatic organisms may occur at 

concentrations that exceed 2 ppb. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substances may 

present an unreasonable risk of injury to 

human health or the environment. The 

Order was also issued under TSCA 

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

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

the substances are or will be produced 

in substantial quantities and that the 

substances either enter or may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

or there is or may be a significant (or 

substantial) human exposure to the 

substances. To protect against these 

risks, the Order requires: 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a NIOSH-certified respirator 

with an APF of at least 10 where there 

is a potential for inhalation exposure for 

P–18–178; 

• No use of the PMN substances other 

than as stabilizers for PVC compounds; 

and 

• No release of the PMN substances 

into the waters of the United States. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of 

persistence, bioaccumulation, aquatic 

toxicity, reproductive toxicity and 

specific target organ toxicity testing may 

be potentially useful to characterize the 

human health and environmental effects 

of the PMN substances. Although the 

Order does not require these tests, the 

Order’s restrictions remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other relevant information. 

CFR Citations: 40 CFR 721.11579 (P– 

18–178), 40 CFR 721.11580 (P–18–217), 

and 40 CFR 721.11581 (P–18–218). 

PMN Number: P–18–256 

Chemical Name: Undecanol, 

branched. 

CAS Number: 203473–00–4. 

Effective Date of TSCA Order: August 

18, 2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a chemical intermediate and 


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a solvent. Based on submitted test data 

on the new chemical substance, EPA 

has identified concerns for skin and eye 

irritation and systemic toxicity. Based 

on test data for structurally analogous 

chemical substance, EPA has also 

identified concerns for developmental 

and systemic toxicity. Based on 

comparison to analogous neutral 

organics, EPA predicts that toxicity to 

aquatic organisms may occur at 

concentrations that exceed 4 ppb. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health or the environment. The 

Order was also issued under TSCA 

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

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

the substance is expected to be 

produced in substantial quantities, and 

that there may be significant or 

substantial human exposure to the 

substance, and that the substance may 

enter the environment in substantial 

quantities. To protect against these 

risks, the Order requires: 

• No use of the PMN substance other 

than as a chemical intermediate; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 4 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of specific 

organ toxicity, developmental toxicity, 

and aquatic toxicity testing may be 

potentially useful to characterize the 

human health and environmental effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions 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 721.11582. 

PMN Number: P–18–283 

Chemical Name: Hydroxy alkanoic 

acid, compds. with 

aminoalkoxyalcohol-epoxy polymeralkanolamine reaction products 

(generic). 

CAS Number: Not available. 

Effective Date of TSCA Order: March 

31, 2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

of the substance will be for open, nondispersive use. Based on comparison to 

structurally analogous chemical 

substances for the low molecular weight 

(LMW) fractions of the PMN substance, 

EPA has identified concerns for 

irritation and sensitization. Based on 

comparison to structurally analogous 

chemical substances, EPA has also 

identified concerns for reproductive 

toxicity and systemic effects. Based on 

comparison to analogous aliphatic 

amines and polycationic polymers, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

4 ppb. The Order was issued under 

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

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Establishment of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; and 

• No release of the PMN substance 

into the waters of the United States. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of aquatic 

toxicity, skin and eye irritation, skin 

sensitization, reproductive toxicity, and 

specific target organ toxicity testing may 

be potentially useful to characterize the 

human health and environmental effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions remain in effect 

until the Order is modified or revoked 

by EPA based on a submission of this 

or other relevant information. 

CFR Citation: 40 CFR 721.11583. 

PMN Number: P–18–298 

Chemical Name: 1,3-Propanediol, 2- 

ethyl-2-(hydroxymethyl)-, polymer with 

ethyleneamine, 2- 

(chloromethyl)oxirane, 2-[[4-(1,1- 

dimethylethyl)phenoxy]methyl]oxirane, 

2,2′-[1,6-hexanediylbis(oxymethylene)]

bis[oxirane], 4,4′-(1-methylethylidene)

bis[phenol], alkyl ether amine, and 2- 

[(2-methylphenoxymethyl]oxirane 

(generic). 

CAS Number: Not available. 

Effective Date of TSCA Order: August 

4, 2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as an epoxy curing agent. Based 

on comparison to structurally analogous 

amines and the LMW fractions, EPA has 

identified concerns for skin and eye 

irritation, dermal and respiratory 

sensitization, and lung effects. Based on 

the comparison to structurally 

analogous epoxide residuals, EPA has 

also identified concerns for 

reproductive toxicity and systemic 

effects. Based on comparison to 

analogous aliphatic amines and 

polycationic polymers, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 50 ppb. 

The Order was issued under TSCA 

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

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health or the 

environment. To protect against these 

risks, the Order requires: 

• No manufacturing, processing, or 

use of the PMN substance in an 

application method that results in 

inhalation exposure; 

• No use of the PMN substance in a 

consumer product; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 50 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of 

absorption, eye damage, skin irritation, 

specific target organ toxicity, and 

aquatic toxicity testing may be 

potentially useful to characterize the 

human health and environmental effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions 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 721.11584. 

PMN Number: P–18–310 

Chemical Name: Benzenepropanoic 

acid, 3-(2H-benzotriazol-2-yl)-5-(1,1- 


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dimethylethyl)-4-hydroxy-2,2- 

bis(hydroxymethyl)butyl ester. 

CAS Number: 2101609–93–0. 

Effective Date of TSCA Order: August 

14, 2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a polymer additive. Based on 

test data on structurally analogous 

chemical substances, EPA has identified 

concerns for blood, liver, thyroid and 

kidney effects, reproductive toxicity, 

and developmental toxicity. Based on 

comparison to analogous phenols and 

benzotriazoles, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against these risks, the Order 

requires: 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a NIOSH-certified respirator 

with an APF of at least 1,000 where 

there is a potential for inhalation 

exposure; 

• Establishment of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 1 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if the manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of 

developmental neurotoxicity and 

aquatic toxicity testing may be 

potentially useful to characterize the 

human health and environmental effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions 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 721.11585. 

PMN Number: P–18–318 

Chemical Name: 1- 

Octadecanaminium, N,N-dimethyl-N- 

[3-(triethoxysilyl)propyl]-, chloride 

(1:1). 

CAS Number: 62117–57–1. 

Effective Date of TSCA Order: 

September 25, 2020. 

Basis for TSCA Order: The PMN states 

that the use will be as a surface 

treatment for added lubricity and antistatic purposes. Based on comparison to 

structurally analogous chemical 

substances, EPA has identified concerns 

for irritation to the eyes, skin, and 

respiratory tract and liver effects. Based 

on comparison to structurally analogous 

chemical substances and structural 

alerts for cationic surfactants, EPA has 

also identified concerns for lung effects. 

Based on comparison to analogous 

polycationic polymers, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against these risks, the Order 

requires: 

• Establishment of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

• Use of the PMN substance only as 

a surface treatment for added lubricity 

and anti-static properties; 

• No use of the PMN substance in an 

application method that results in 

inhalation exposure; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 1 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of skin 

irritation, eye irritation, pulmonary 

effects, and aquatic toxicity testing may 

be potentially useful to characterize the 

human health and environmental effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions 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 721.11586. 

PMN Number: P–18–323 

Chemical Name: 2-Propenoic acid, 2- 

methyl-, 3-methyl-3-buten-1-yl ester. 

CAS Number: 156291–88–2. 

Effective Date of TSCA Order: March 

13, 2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

of the PMN substance will be as a raw 

material for polymer manufacturing. 

Based on submitted test data on the 

PMN substance and structural alerts, 

EPA has identified concerns for skin 

irritation and skin/respiratory 

sensitization. Based on comparison to 

structurally analogous chemical 

substances, EPA has also identified 

concerns for systemic, respiratory, and 

developmental effects. Based on 

comparison to analogous methacrylates, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 98 ppb. The Order was 

issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against these risks, the Order 

requires: 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a NIOSH-certified respirator 

with an APF of at least 50 to prevent 

inhalation exposure where there is a 

potential for inhalation exposure; 

• Establishment of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

• Use of the PMN substance only for 

the confidential use allowed in the 

Order; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 98 ppb. 

The proposed SNUR designates as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that 

would be designated by this SNUR. EPA 

has determined that the results of 

chronic aquatic toxicity and specific 

target organ toxicity testing may be 

potentially useful to characterize the 

environmental and human health effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions 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 721.11587. 


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PMN Number: P–18–327 

Chemical Name: Mixed metal oxide 

(generic). 

CAS Number: Not available. 

Effective Date of TSCA Order: August 

21, 2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a filler for non-dispersive 

resins. Based on comparison to 

structurally analogous chemical 

substances, EPA has identified concerns 

for dermal and respiratory sensitization. 

EPA has also identified concerns for 

lung effects (lung overload) if the 

particulate is respirable, based on 

information for other poorly soluble 

particulates, and carcinogenicity if the 

PMN substance is crystalline and 

respirable. The Order was issued under 

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

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health or the 

environment. To protect against these 

risks, the Order requires: 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a NIOSH-certified respirator 

with an APF of at least 1,000 where 

there is a potential for inhalation 

exposure, or compliance with a NCEL of 

0.1 mg/m3 as an 8-hour time-weighted 

average (TWA) to prevent inhalation 

exposure; and 

• Establishment of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of 

pulmonary toxicity, skin sensitization, 

and carcinogenicity testing may be 

potentially useful to characterize the 

human health effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions 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 721.11588. 

PMN Number: P–18–347 

Chemical Name: Amines, 

polyethylenepoly-, triethylenetetramine 

fraction, polymers with guanidine 

hydrochloride (1:1). 

CAS Number: 1902936–67–7. 

Effective Date of TSCA Order: March 

17, 2020. 

Basis for TSCA Order: The PMN states 

that the use of the substance will be as 

an aldehyde scavenger for the 

manufacture of polyurethane foams. 

Based on comparison to structurally 

analogous chemical substances, EPA has 

identified concerns for skin 

sensitization. Based on available test 

data on the PMN substance, EPA has 

also identified concerns for acute 

toxicity. Based on structural alerts for 

polycationic binding, EPA has also 

identified concerns for lung effects. 

Based on comparison to structurally 

analogous polycationic polymers, EPA 

predicts that toxicity to aquatic 

organisms may occur at concentrations 

that exceed 2 ppb. The Order was issued 

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

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Establishment of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 2 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

about may be potentially useful in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. EPA has 

determined that the results of aquatic 

toxicity, pulmonary effects and skin 

sensitization testing may be potentially 

useful to characterize the human health 

and environmental effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions 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 721.11589. 

PMN Number: P–18–405 

Chemical Name: Phenol, 4,4′-(1- 

methylethylidene)bis-, polymer with 

3,6,9,12-tetraoxatetradeca-1, 13-diene, 

glycidyl ether. 

CAS Number: 647028–24–8. 

Effective Date of TSCA Order: August 

7, 2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as an adhesive. Based on the 

epoxide moiety for the LMW fraction, 

EPA has identified concerns for skin 

and lung sensitization, carcinogenicity, 

developmental toxicity, male 

reproductive toxicity, liver, and kidney 

toxicity. Based on submitted test data, 

information in the SDS, and analogous 

epoxides, EPA has also identified 

concerns for skin irritation and 

genotoxicity. Based on comparison to 

analogous epoxides, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against such risks, the Order 

requires: 

• No manufacturing, processing, or 

use of the PMN substance in a manner 

that results in inhalation exposure; 

• No use of the PMN substance in a 

consumer product; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 1 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of 

pulmonary toxicity, skin sensitization, 

carcinogenicity, reproductive/ 

developmental toxicity, skin and eye 

irritation, specific target organ toxicity 

and aquatic toxicity testing may be 

potentially useful to characterize the 

human health and environmental effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions 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 721.11590. 

PMN Number: P–19–36 

Chemical Name: 1,4- 

Benzenedicarboxylic acid, 1,4-bis(2- 

phenoxyethyl) ester. 


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CAS Number: 25900–07–6. 

Effective Date of TSCA Order: July 24, 

2020. 

Basis for TSCA Order: The PMN states 

that the use will be as an additive to 

polymers for improvement in gas barrier 

performance. Based on comparison to 

structurally analogous chemical 

substances, EPA has identified concerns 

for irritation to the skin, eyes, and 

respiratory tract. Based on test data for 

terephthalic acid, EPA has also 

identified concerns for bladder effects 

and developmental effects. Based on test 

data for 2-phenoxyethanol, EPA has also 

identified concerns for blood effects, 

kidney effects, bladder effects, and 

respiratory tract effects. Based on 

comparison to analogous esters, EPA 

predicts that toxicity to aquatic 

organisms may occur at concentrations 

that exceed 3 ppb. The Order was issued 

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

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health or the 

environment. To protect against these 

risks, the Order requires: 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a NIOSH-certified respirator 

with an APF of at least 1,000 where 

there is a potential for inhalation 

exposure; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 3 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of skin 

irritation, reproductive/developmental 

toxicity, specific target organ toxicity, 

and aquatic toxicity testing may be 

potentially useful to characterize the 

human health and environmental effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions 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 721.11591. 

PMN Number: P–19–52 

Chemical Name: Poly(oxy-1,2- 

ethanediyl), .alpha.-nonyl-.omega.- 

hydroxy-, branched and linear. 

CAS Number: 2242406–13–7. 

Effective Date of TSCA Order: 

February 14, 2020. 

Basis for TSCA Order: The PMN states 

that the use of the PMN substance will 

be as a hard surface cleaner and as a 

component of laundry detergent. Based 

on repeating polyether units, EPA has 

identified concerns for surfactant effects 

on the lungs. Based on comparison to 

structurally analogous chemical 

substances, EPA has also identified 

concerns for eye corrosion and mild 

skin irritation. Based on alcohol 

ethoxylates, EPA has also identified 

liver, cardiac, and systemic effects. 

Based on comparison to analogous 

nonionic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 34 ppb. 

The Order was issued under TSCA 

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

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health or the 

environment. To protect against these 

risks, the Order requires: 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a NIOSH-certified respirator 

with an APF of at least 1,000 where 

there is potential for inhalation 

exposure; 

• Establishment of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

• No use of the PMN substance where 

the concentration of the PMN substance 

in the product formulation intended for 

distribution in commerce exceeds 1% 

by weight; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 34 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of acute 

aquatic toxicity, chronic aquatic 

toxicity, pulmonary effects, specific 

target organ toxicity, eye damage, and 

skin irritation testing may be potentially 

useful to characterize the human health 

and environmental effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions still 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 721.11592. 

PMN Number: P–19–53 

Chemical Name: 1-Butanamine, Nbutyl-N-[(triethoxysilyl)methyl]-. 

CAS Number: 35501–23–6. 

Effective Date of TSCA Order: August 

5, 2020. 

Basis for TSCA Order: The PMN states 

that the use of the substance will be as 

a surface treatment, sealant, caulk, and 

coating for mineral building materials 

such as concrete, brick, limestone, and 

plaster, as well as on wood, metal, and 

other substrates. Based on the 

alkoxysilanes category and reactivity of 

the new chemical substance, EPA has 

identified concerns for lung effects. 

Based on submitted test data, EPA has 

also identified concerns for skin 

sensitization and developmental effects. 

Based on comparison to analogous 

aliphatic amines, EPA predicts toxicity 

to aquatic organisms may occur in 

concentrations that exceed 150 ppb. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against these risks, the Order 

requires: 

• Use of dermal protective equipment 

where there is a potential for dermal 

exposure; 

• No import, processing, or use of the 

PMN substance other than in liquid 

form; 

• No domestic manufacture (i.e., 

import only); and 

• No use of the PMN substance in a 

consumer product. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of 

pulmonary effects and skin sensitization 

testing may be potentially useful to 

characterize the human health effects of 

the PMN substance. Although the Order 

does not require these tests, the Order’s 

restrictions 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 721.11593. 


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PMN Number: P–19–77 

Chemical Name: Alkenylamide 

(generic). 

CAS Number: Not available. 

Effective Date of TSCA Order: March 

31, 2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

of the substance will be for agricultural 

use. Based on available test data on a 

structurally analogous chemical 

substance, EPA has identified concerns 

for skin irritation, eye irritation, 

reproductive toxicity, and systemic 

toxicity. Based on information in the 

SDS, EPA has also identified concerns 

for respiratory tract irritation. Based on 

comparison to analogous amides, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

4 ppb. The Order was issued under 

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

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

the absence of sufficient information to 

permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

• Use of the PMN substance only for 

the confidential use allowed in the 

Order; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 4 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that 

would be designated by this SNUR. EPA 

has determined that the results of eye 

damage, skin irritation, specific target 

organ toxicity, and aquatic toxicity 

testing may be potentially useful to 

characterize the human health and 

environmental effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions 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 721.11594. 

PMN Number: P–19–131 

Chemical Name: Isoalkylaminium, Nisoalkyl, -N, N-dimethyl chloride 

(generic). 

CAS Number: Not available. 

Effective Date of TSCA Order: July 24, 

2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as an additive for horizontal oil 

drilling. Based on comparison to 

structurally analogous chemical 

substances, EPA has identified concerns 

for irritation to the eyes and skin, 

systemic effects, lung effects, and 

developmental effects. Based on 

comparison to analogous chemical 

substances, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against these risks, the Order 

requires: 

• Establishment of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

• No manufacturing, processing, or 

use of the PMN substance in a manner 

that results in inhalation exposure; 

• No use of the PMN substance in 

consumer products; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 1 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of skin 

irritation, eye irritation, specific target 

organ toxicity, and aquatic toxicity 

testing may be potentially useful to 

characterize the human health and 

environmental effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions 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 721.11595. 

PMN Numbers: P–19–143 and P–19–144 

Chemical Names: Aldehyde, polymer 

with mixed alkane polyamines, 2,2′- 

[1,4- 

alkanediylbis(oxyalkylene)]bis[oxirane], 

2-(alkoxyalkyloxirane, 4,4′-(1- 

alkylidene)bis[phenol], 2,2′-[(1- 

alkylidene)bis(4,1- 

alkyleneoxyalkylene)]bis[oxirane] and 

2-(aryloxyalkyl)oxirane, acetate (salt) 

(generic) (P–19–143) and Alkanedioic 

acid, compds. with substituted 

arylalkylamine-arylalcohol 

disubstituted alkane-the diglycidyl ether 

of a arylalcohol disubstituted alkaneepichlorohydrin-aldehyde-2,2′[(1- 

alkylidene)bis[4,1-aryleneoxy(alkyl-2,1- 

alkanediyl)oxyalkylene]]bis[oxirane]- 

alkanepolyamine polymer-1-[[2-[(2- 

aminoalkyl)amino]alkyl]amino]-3- 

aryloxy-2-alcohol reaction products 

(generic) (P–19–144). 

CAS Numbers: Not available. 

Effective Date of TSCA Order: 

February 18, 2020. 

Basis for TSCA Order: The PMNs state 

that the use of the substances will be as 

a crosslinking agent for use in epoxy 

resin for water-based coating for a 

variety of substrates and civil 

applications in commercial uses (P–19– 

143) and a crosslinking agent in epoxy 

based self-leveling floor coatings (P–19– 

144). EPA has identified concerns for 

lung effects (cationic binding) if 

respirable particles are inhaled. Based 

on structural alerts for polyamines, EPA 

has identified dermal and respiratory 

sensitization. Based on comparison to 

analogous chemical substances, EPA has 

identified concerns for skin and eye 

irritation. Based on the LMW species, 

EPA has also identified concerns for 

systemic, reproductive, and 

developmental effects. Based on 

comparison to analogous polycationic 

polymers, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substances may 

present an unreasonable risk of injury to 

human health or the environment. The 

Order was also issued under TSCA 

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

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

the substance which was the subject of 

PMN P–19–143 is expected to be 

produced in substantial quantities, and 

that there may be significant or 

substantial human exposure to the 

substance, and that the substance may 

enter the environment in substantial 

quantities. To protect against these 

risks, the Order requires: 

• No manufacture, processing, or use 

of the PMN substances in a manner that 

results in inhalation exposure to either 

the PMN substances or to formaldehyde; 

• No use of the PMN substances in 

consumer products; and 

• No release of the PMN substances 

resulting in surface water 

concentrations that exceed 1 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 


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Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of 

pulmonary effects, eye irritation, skin 

irritation, skin sensitization, specific 

target organ toxicity, reproductive and 

developmental toxicity, and aquatic 

toxicity testing may be potentially 

useful to characterize the human health 

and environmental effects of the PMN 

substances. Although the Order does not 

require these tests, the Order’s 

restrictions remain in effect until the 

Order is modified or revoked by EPA 

based on submission of this or other 

relevant information. 

CFR Citations: 40 CFR 721.11596 (P– 

19–143) and 40 CFR 721.11597 (P–19– 

144). 

PMN Number: P–19–145 

Chemical Name: Polyazaalkane with 

oxirane and methyloxirane, haloalkane 

(generic). 

CAS Number: Not available. 

Effective Date of TSCA Order: July 6, 

2020. 

Basis for TSCA Order: The PMN states 

that the use of the substance will be as 

an oil field drilling fluid additive. Based 

on structure, EPA has identified 

concerns for lung effects (surfactancy). 

Based on comparison to structurally 

analogous chemical substances, EPA has 

also identified concerns for 

neurological, systemic, and 

reproductive/developmental effects. 

Based on comparison to analogous 

cationic polymers, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 26 ppb. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against these risks, the Order 

requires: 

• Establishment of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

• No manufacture, processing, or use 

of the PMN substance in a manner that 

results in inhalation exposure; and 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 26 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of 

neurotoxicity, specific target organ 

toxicity, pulmonary effects, 

reproductive/developmental effects, and 

aquatic toxicity testing may be 

potentially useful to characterize the 

health and environmental effects of the 

PMN substance. Although the Order 

does not require these tests, the Order’s 

restrictions 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 721.11598. 

PMN Number: P–19–153 

Chemical Name: Dibromoalkyl ether 

tetrabromobisphenol A (generic). 

CAS Number: None available. 

Effective Date of TSCA Order: July 20, 

2020. 

Basis for TSCA Order: The PMN states 

that the use of the substance will be as 

a raw material in flame retardant 

products. Based on the physical/ 

chemical properties of the PMN 

substance and of the photolysis product, 

the PMN substance and the photolysis 

product are potentially persistent, 

bioaccumulative, and toxic (PBT) 

chemicals (as described in the New 

Chemical Program’s PBT category at 64 

FR 60194; November 4, 1999; FRL– 

6097–7). EPA estimates that the PMN 

substance will persist in the 

environment for more than 6 months 

and estimates a bioaccumulation factor 

of greater than or equal to 1,000. EPA 

estimates that the photolysis product 

will persist in the environment for more 

than 2 months and estimates a 

bioaccumulation factor of greater than 

or equal to 1,000. Based on available 

data on the PMN substance, EPA has 

identified concerns for eye irritation, 

systemic effects, and reproductive/ 

developmental effects. Based on data for 

the photolysis product, EPA has also 

identified concerns for systemic effects 

and carcinogenicity. Based on 

comparison to analogous anionic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb. The 

Order was issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health or the environment. To 

protect against these risks, the Order 

requires: 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Establishment of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; and 

• No release of the PMN substance 

into surface waters of the United States. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ in the 

absence of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of 

environmental fate, bioaccumulation, 

specific target organ toxicity and 

carcinogenicity testing may be 

potentially useful to characterize the 

human health effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions 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 721.11599. 

PMN Number: P–20–29 

Chemical Name: Octonal, 7(or 8)- 

formyl-. 

CAS Number: 1607842–40–9. 

Effective Date of TSCA Order: August 

5, 2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as an oil soluble additive. Based 

on submitted test data on the new 

chemical substance, EPA has identified 

concerns for skin and eye irritation, 

dermal sensitization, systemic toxicity, 

and neurotoxicity. Based on OECD 

Toolbox results, EPA has identified 

concerns for respiratory sensitization. 

Based on comparison to structurally 

analogous chemical substances, EPA has 

also identified concerns for respiratory 

effects. Based on comparison to 

analogous neutral organics, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

17 ppb. The Order was issued under 

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

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health or the 

environment. To protect against these 

risks, the Order requires: 


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• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 17 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of aquatic 

toxicity testing may be potentially 

useful to characterize the environmental 

effects of the PMN substance. Although 

the Order does not require these tests, 

the Order’s restrictions 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 721.115600. 

PMN Number: P–20–42 

Chemical Name: Sulfonium, trisaryl-, 

7,7-dialkyl-2-heteropolycyclic-1- 

alkanesulfonate (1:1) (generic). 

CAS Number: Not available. 

Effective Date of TSCA Order: April 

29, 2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

of the PMN substance will be as a 

photoacid generator. Based on the 

physical/chemical properties of the 

PMN substances and test data on 

structurally similar substances, the PMN 

substances are potentially persistent, 

bioaccumulative, and toxic (PBT) 

chemicals (as described in the New 

Chemical Program’s PBT category at 64 

FR 60194; November 4, 1999; FRL– 

6097–7). EPA estimates that the PMN 

substances will persist in the 

environment for more than 2 months 

and estimates a bioaccumulation factor 

of greater than or equal to 1,000. Based 

on the photoreactivity of the PMN 

substance, EPA has identified concerns 

for photosensitization. Based on 

comparison to analogous substances, 

EPA has identified concerns for eye 

corrosion, irritation, acute toxicity, liver 

toxicity, neurotoxicity, and reproductive 

(developmental) toxicity. EPA has also 

identified concerns for lung overload by 

insoluble polymers for photoacid 

generators with polymeric anions that 

have a molecular weight over 10,000 g/ 

mol. The Order was issued under TSCA 

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

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health or the 

environment. To protect against these 

risks, the Order requires: 

• No manufacture of the PMN 

substance beyond the time limits 

specified in the Order without submittal 

to EPA the results of certain testing 

described in the Testing section of the 

Order. 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Establishment of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

• No modification of the processing 

of the PMN substance in any way that 

generates a vapor, dust, mist, or aerosol 

in a non-enclosed process; 

• Use of the PMN substance only as 

described in the PMN; 

• No domestic manufacture of the 

PMN substance (i.e., import only); 

• Import of the PMN substance only 

in solution, or in any form in sealed 

containers weighing 5 kilograms or less; 

and 

• No exceedance of the confidential 

annual importation volume listed the 

Order. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

about the physical/chemical properties, 

fate, bioaccumulation, environmental 

hazard, and human health effects of the 

PMN substance may be potentially 

useful in support of a request by the 

PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. The submitter 

has agreed not to exceed the time limits 

specified in the Order without 

performing the required Tier I and Tier 

II testing outlined in the Testing section 

of the Order. 

CFR Citation: 40 CFR 721.11601. 

PMN Number: P–20–104 

Chemical Name: Alkenoic acid, 

polymer with (alkyl alkenyl) polyether 

(generic). 

CAS Number: None available. 

Effective Date of TSCA Order: August 

25, 2020. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as an additive. Based on 

structural alerts and comparison to 

structurally analogous chemical 

substances, EPA has identified concerns 

for lung effects (surfactancy) and 

irritation to the skin, eyes, and 

respiratory tract. Based on comparison 

to structurally analogous chemical 

substances, EPA has also identified 

concerns for systemic effects (i.e., 

neurotoxicity and cardiotoxicity) and 

aquatic toxicity. Based on a residual 

which is present in the substance, EPA 

has also identified concerns for 

irritation/corrosion to the skin and eyes, 

skin sensitization, systemic effects, and 

developmental effects. The Order was 

issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health. The Order was also 

issued under TSCA sections 

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

based on a finding that the substance is 

expected to be produced in substantial 

quantities, and that there may be 

significant or substantial human 

exposure to the substance, and that the 

substance may enter the environment in 

substantial quantities. To protect against 

these risks, the Order requires: 

• No manufacture, processing, or use 

of the PMN substance in a manner that 

results in inhalation exposure; 

• No use of the PMN substance in a 

consumer product; 

• No release of the PMN substance 

resulting in surface water 

concentrations that exceed 75 ppb. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of aquatic 

toxicity testing may be potentially 

useful to characterize the environmental 

effects of the PMN substance. Although 

the Order does not require these tests, 

the Order’s restrictions 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 721.11602. 

MCAN Number: J–16–26 

Microorganism name: Trichoderma 

reesei modified (generic). 

CAS number: Not applicable. 

Effective Date of TSCA Order: April 

10, 2017. 

Basis for TSCA Order: The MCAN 

states that the generic (non-confidential) 

use of the microorganism will be for 

enzyme production. EPA determined 

that certain fermentation conditions, 

other than the typical submerged 

standard industrial fermentation process 


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for enzyme production, could result in 

increased exposures. Specifically, EPA 

is concerned that where growth on plant 

material or on solid substrates occurs, T. 

reesei has been shown to produce a 

secondary metabolite known as 

paracelsin, which is associated with a 

variety of toxic effects to mammalian 

and bacterial cells. The Order was 

issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the microorganism 

may present an unreasonable risk of 

injury to human health or the 

environment. To protect against these 

risks, the Order requires: 

• No manufacture, processing, or use 

of the microorganism other than in a 

fermentation system that meets all of the 

following conditions: 

(A) Enzyme production occurs by 

submerged fermentation (i.e., for 

enzyme production, growth of the 

microorganism occurs beneath the 

surface of the liquid growth medium); 

and 

(B) Any fermentation of solid plant 

material or insoluble substrate, to which 

Trichoderma reesei fermentation broth 

is added after the standard industrial 

fermentation is completed, is initiated 

only after the inactivation of the 

microorganism as delineated in 40 CFR 

725.422(d). 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially useful information: EPA 

has determined that the results of the 

following studies would help 

characterize any potential human health 

and environmental effects of the MCAN 

substance if a manufacturer or processor 

is considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR: 

• Investigation of whether paracelsin 

will be produced, and at what levels if 

the genetically-modified T. reesei is 

grown on various plant biomass 

materials for different durations under 

various fermentation conditions in 

cellulosic biomass facilities. 

• If paracelsin is produced, a study of 

whether paracelsin would be denatured/ 

inactivated during production and 

processing. 

• If paracelsin is released from the 

facility, a study of whether paracelsin 

would be degraded/inactivated during 

wastewater treatment. 

• If released to the environment, 

studies on the persistence, stability, 

dissemination, accumulation, and the 

potential resulting biological activity of 

paracelsin with exposure to aquatic and 

terrestrial organisms in the 

environment. 

• Studies to determine the ability of 

the MCAN microorganism to survive in 

the environment relative to the survival 

of the unmodified parent or recipient 

strain, and to assess its competitiveness 

with other fungi in the environment. 

This study may require some 

supplementation with one or more 

carbon sources and the use of various 

soil types. 

• A study to determine survival of the 

fungus during an anaerobic 

fermentation for production of ethanol 

by an ethanologen, and survival of the 

fungus during ethanol distillation or at 

the distillation temperature for ethanol. 

Although the Order does not require 

these tests, the Order’s restrictions 

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 725.1081. 

V. Rationale and Objectives of the 

Proposed Rule 

A. Rationale 

During review of the PMNs and 

MCAN submitted for the chemical 

substances that are the subject to these 

proposed SNURs, EPA concluded that 

regulation was warranted under TSCA 

section 5(e), pending the development 

of information sufficient to make 

reasoned evaluations of the health or 

environmental effects of the chemical 

substances. The basis for such findings 

is outlined in Unit IV. Based on these 

findings, TSCA section 5(e) Orders 

requiring the use of appropriate 

exposure controls were negotiated with 

the PMN and MCAN submitters. As a 

general matter, EPA believes it is 

necessary to follow the TSCA Orders 

with a SNUR that identifies the absence 

of those protective measures as 

significant new uses to ensure that all 

manufacturers and processors—not just 

the original submitter—are held to the 

same standard. 

B. Objectives 

EPA is proposing these SNURs for 

specific chemical substances which 

have undergone premanufacture review 

because the Agency wants: 

• To identify as significant new uses 

any manufacturing, processing, use, 

distribution in commerce, or disposal 

that does not conform to the restrictions 

imposed by the underlying TSCA 

Orders, consistent with TSCA section 

5(f)(4). 

• To 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. 

• To 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. 

VI. Applicability of the Proposed 

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 proposed 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 (or MCAN, as 

applicable). 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 proposed 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 Orders have been 

issued for these chemical substances 

and the PMN and MCAN submitters are 

prohibited by the TSCA Orders from 

undertaking activities which would be 

designated as significant new uses. The 

identities of many of the chemical 

substances subject to this proposed rule 

have been claimed as confidential per 

40 CFR 720.85 or 40 CFR 725.85 (for the 

microorganism). 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 proposed rule are ongoing. 

Therefore, EPA designates June 11, 

2021 as the cutoff date for determining 

whether the new use is ongoing. The 

objective of EPA’s approach is to ensure 

that a person cannot defeat a SNUR by 

initiating a significant new use before 

the effective date of the final rule. 

In the unlikely event that a person 

began 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 

EPA has conducted a review of the 


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notice, made an appropriate 

determination on the notice, and has 

taken such actions as are required with 

that determination. 

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 https://www.epa.gov/tscainventory. 

VII. 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: If a 

person is required to submit information 

for a chemical substance pursuant to a 

rule, TSCA Order or consent agreement 

under TSCA section 4, then TSCA 

section 5(b)(1)(A) requires such 

information to be submitted to EPA at 

the time of submission of the SNUN. 

In the absence of a rule, TSCA Order, 

or consent agreement under TSCA 

section 4 covering the chemical 

substance, persons are required only to 

submit information in their possession 

or control and to describe any other 

information known or reasonably 

ascertainable (see 40 CFR 720.50 or 40 

CFR 725.160 [for the microorganism]). 

However, upon review of PMNs and 

SNUNs, the Agency has the authority to 

require appropriate testing. Unit IV. lists 

potentially useful information for the 

SNURs listed in this document. 

Descriptions of this information is 

provided for informational purposes. 

The potentially useful information 

identified in Unit IV. will be useful to 

EPA’s evaluation in the event that 

someone submits a SNUN for the 

significant new use. 

EPA strongly encourages persons, 

before performing any testing, to consult 

with the Agency. Furthermore, pursuant 

to TSCA section 4(h), which pertains to 

reduction of testing in vertebrate 

animals, EPA encourages consultation 

with the Agency on the use of 

alternative test methods and strategies 

(also called New Approach 

Methodologies, or NAMs), if available, 

to generate the recommended test data. 

EPA encourages dialog with Agency 

representatives to help determine how 

best the submitter can meet both the 

data needs and the objective of TSCA 

section 4(h). For more information on 

alternative test methods and strategies 

to reduce vertebrate animal testing, visit 

https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/ 

alternative-test-methods-and-strategiesreduce. 

In some of the TSCA Orders for the 

chemical substances identified in this 

rule, EPA has established time limits in 

view of the lack of data on the potential 

health and environmental risks that may 

be posed by the significant new uses or 

increased exposure to the chemical 

substances. These limits cannot be 

exceeded unless the PMN submitter first 

submits the results of specified tests that 

would permit a reasoned evaluation of 

the potential risks posed by these 

chemical substances. The SNURs 

contain the same time limits as the 

TSCA Orders. Exceeding these 

production limits is defined as a 

significant new use. Persons who intend 

to exceed the time limit must notify the 

Agency by submitting a SNUN at least 

90 days in advance of commencement of 

non-exempt commercial manufacture or 

processing. 

Any request by EPA for the triggered 

and pended testing described in the 

TSCA Orders was made based on EPA’s 

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

available information on appropriate 

testing for the PMN substances. Further, 

any such testing request on the part of 

EPA that includes testing on vertebrates 

was made after consideration of 

available toxicity information, 

computational toxicology and 

bioinformatics, and high-throughput 

screening methods and their prediction 

models. 

The potentially useful information 

listed in Unit IV. may not be the only 

means of addressing the potential risks 

of the chemical substance. However, 

submitting a SNUN without any test 

data or other information may increase 

the likelihood that EPA will take action 

under TSCA section 5(e) or 5(f). 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. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

VIII. SNUN Submissions 

According to 40 CFR 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. 

According to 40 CFR 725.900, persons 

submitting an MCAN for a significant 

new use of a microorganism must 

comply with the same notification 

requirements and EPA regulatory 

procedures as persons submitting an 

MCAN for a new microorganism, 

including submission of test data on 

health and environmental effects as 

described in 40 CFR 725.160. E–PMN 

software is available electronically at 

https://www.epa.gov/reviewing-newchemicals-under-toxic-substancescontrol-act-tsca. 

IX. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers and processors 

of the chemical substances subject to 

this proposed rule. EPA’s complete 

economic analysis is available in the 

docket for this rulemaking. 

X. Statutory and Executive Order 

Reviews 

Additional information about these 

statutes and Executive orders can be 

found at https://www.epa.gov/lawsregulations-and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulations 

and Regulatory Review 

This action proposes to establish 

SNURs for several new chemical 

substances that were the subject of 

PMNs and an MCAN. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Orders 12866 

(58 FR 51735, October 4, 1993) and 

13563 (76 FR 3821, January 21, 2011). 

B. Paperwork Reduction Act (PRA) 

According to the 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. 

The information collection activities 

associated with SNURs have already 


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been approved by OMB under the PRA 

and assigned OMB control number 

2070–0012 (EPA ICR No. 574). This 

proposed rule does not contain 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 using 

automated collection techniques, to the 

Director, Regulatory Support Division, 

Office of Mission Support (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) 

Pursuant to the RFA section 605(b) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that promulgation of these 

SNURs would not have a significant 

adverse economic impact on a 

substantial number of small entities. 

The requirement to submit a SNUN 

applies to any person (including small 

or large entities) who intends to engage 

in any activity described in the final 

rule as a ‘‘significant new use.’’ Because 

these uses are ‘‘new,’’ based on all 

information currently available to EPA, 

it appears that no small or large entities 

presently engage in such activities. A 

SNUR requires that any person who 

intends to engage in such activity in the 

future must first notify EPA by 

submitting a SNUN. EPA’s experience to 

date is that, in response to the 

promulgation of SNURs covering over 

1,000 chemicals, the Agency receives 

only a small number of notices per year. 

For example, the number of SNUNs 

received was seven in Federal fiscal 

year (FY) 2013, 13 in FY2014, six in 

FY2015, 10 in FY2016, 14 in FY2017, 

and 18 in FY2018 and only a fraction of 

these were from small businesses. In 

addition, the Agency currently offers 

relief to qualifying small businesses by 

reducing the SNUN submission fee from 

$16,000 to $2,800. This lower fee 

reduces the total reporting and 

recordkeeping of cost of submitting a 

SNUN to about $10,116 for qualifying 

small firms. Therefore, the potential 

economic impacts of complying with 

this proposed SNUR are not expected to 

be significant or adversely impact a 

substantial number of small entities. In 

a SNUR that published in the Federal 

Register of June 2, 1997 (62 FR 29684) 

(FRL–5597–1), the Agency presented its 

general determination that final SNURs 

are not expected to have a significant 

economic impact on a substantial 

number of small entities, which was 

provided to the Chief Counsel for 

Advocacy of the Small Business 

Administration. 

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 proposed rule would 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: Federalism 

This action would 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 (64 FR 43255, 

August 10, 1999). 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action would not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This action would not 

significantly nor uniquely affect the 

communities of Indian Tribal 

governments, nor would it involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175 

(65 FR 67249, November 9, 2000), do 

not apply to this action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

This action is not subject to Executive 

Order 13045 (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: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211 (66 FR 28355, May 22, 

2001), because this proposed rule is not 

expected to affect energy supply, 

distribution, or use. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

This action does not involve any 

technical standards subject to NTTAA 

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

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898 (59 FR 7629, 

February 16, 1994). 

List of Subjects in 40 CFR Parts 721 and 

725 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: June 4, 2021. 

Tala Henry, 

Deputy Director, Office of Pollution 

Prevention and Toxics. 

Therefore, for the reasons stated in the 

preamble, it is proposed that 40 CFR 

chapter I be amended as follows: 

PARTS 721—SIGNIFICANT NEW USES 

OF CHEMICAL SUBSTANCES 

■ 1. The authority citation for part 721 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, 2613, and 

2625(c). 

■ 2. Add §§ 721.11571 through 

721.11603 to subpart E to read as 

follows: 

Subpart E—Significant New Uses for 

Specific Chemical Substances 

* * * * * 

Sec. 

* * * * * 

721.11571 Hindered amine alkyl ester 

compounds (generic). 

721.11572 N-alkyl-dialkyl piperidine 

(generic). 

721.11573 Tetraalkylpiperidinium halide 

(generic). 

721.11574 Tetraalkylpiperidinium 

hydroxide (generic). 

721.11575 Amidoamino quaternary 

ammonium salt (generic). 

721.11576 Tri alkyl, mono alkoxy, fatty acid 

ester, ammonium salt (generic). 

721.11577 Halogenated aromatic amine 

(generic). 


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721.11578 1,4-Benzenedicarboxylic acid, 

1,4-dipentyl ester, branched and linear. 

721.11579 Dialkyltin dialkylcarboxylate 

(generic). 

721.11580 Alkyltin dodecylthioester 

(generic). 

721.11581 Alkyltin tetradecylthioester 

(generic). 

721.11582 Undecanol, branched. 

721.11583 Hydroxy alkanoic acid, compds. 

with aminoalkoxyalcohol-epoxy 

polymer-alkanolamine reaction products 

(generic). 

721.11584 1,3-Propanediol, 2-ethyl-2- 

(hydroxymethyl)-, polymer with 

ethyleneamine, 2-(chloromethyl)oxirane, 

2-[[4-(1,1-dimethylethyl)phenoxy]

methyl]oxirane, 2,2′-[1,6-hexanediylbis

(oxymethylene)]bis[oxirane], 4,4′-(1- 

methylethylidene)bis[phenol], alkyl 

ether amine, and 2-[(2- 

methylphenoxymethyl]oxirane (generic). 

721.11585 Benzenepropanoic acid, 3-(2Hbenzotriazol-2-yl)-5-(1,1-dimethylethyl)- 

4-hydroxy-2,2-bis(hydroxymethyl)butyl 

ester. 

721.11586 1-Octadecanaminium, N,Ndimethyl-N- [3-(triethoxysilyl)propyl]-, 

chloride (1:1). 

721.11587 2-Propenoic acid, 2-methyl-, 3- 

methyl-3-buten-1-yl ester. 

721.11588 Mixed metal oxide (generic). 

721.11589 Amines, polyethylenepoly-, 

triethylenetetramine fraction, polymers 

with guanidine hydrochloride (1:1). 

721.11590 Phenol, 4,4′-(1- 

methylethylidene)bis-, polymer with 

3,6,9,12-tetraoxatetradeca-1, 13-diene, 

glycidyl ether. 

721.11591 1,4-Benzenedicarboxylic acid, 

1,4-bis(2-phenoxyethyl) ester. 

721.11592 Poly(oxy-1,2-ethanediyl), 

.alpha.-nonyl-.omega.-hydroxy-, 

branched and linear. 

721.11593 1-Butanamine, N-butyl-N- 

[(triethoxysilyl)methyl]-. 

721.11594 Alkenylamide (generic). 

721.11595 Isoalkylaminium, N-isoalkyl, -N, 

N-dimethyl chloride (generic). 

721.11596 Aldehyde, polymer with mixed 

alkane polyamines, 2,2′-[1,4- 

alkanediylbis(oxyalkylene)]bis[oxirane], 

2-(alkoxyalkyloxirane, 4,4′-(1-alkylidene)

bis[phenol], 2,2′-[(1-alkylidene)bis(4,1- 

alkyleneoxyalkylene)]bis[oxirane] and 2- 

(aryloxyalkyl)oxirane, acetate (salt) 

(generic). 

721.11597 Alkanedioic acid, compds. with 

substituted arylalkylamine-arylalcohol 

disubstituted alkane-the diglycidyl ether 

of a arylalcohol disubstituted alkaneepichlorohydrin-aldehyde-2,2′(1- 

alkylidene)bis[4,1-aryleneoxy(alkyl-2,1- 

alkanediyl)oxyalkylene]]bis[oxirane]- 

alkanepolyamine polymer-1-[[2-[(2- 

aminoalkyl)amino]alkyl]amino]-3- 

aryloxy-2-alcohol reaction products 

(generic). 

721.11598 Polyazaalkane with oxirane and 

methyloxirane, haloalkane (generic). 

721.11599 Dibromoalkyl ether 

tetrabromobisphenol A (generic). 

721.11600 Octonal, 7(or 8)-formyl-. 

721.11601 Sulfonium, trisaryl-, 7,7-dialkyl2-heteropolycyclic-1-alkanesulfonate 

(1:1) (generic). 

721.11602 Alkenoic acid, polymer with 

(alkyl alkenyl) polyether (generic). 

* * * * * 

§ 721.11571 Hindered amine alkyl ester 

compounds (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

The chemical substance generically 

identified as hindered amine alkyl ester 

compounds (PMN P–16–167) is subject 

to reporting under this section for the 

significant new use 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) through (iv), 

(a)(3) through (6), 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 of 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). For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 50. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate 

(including solids or liquid droplets), 

gas/vapor (all substances in gas form), 

and combination gas/vapor and 

particulate (gas and liquid/solid 

physical states are present). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), (g)(1), (g)(2)(i) through 

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

(iii), and (g)(5). For purposes of 

§ 721.72(g)(1), this substance may cause: 

Skin irritation; respiratory 

complications; central nervous system 

effects; blood effects. Alternative hazard 

and warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (h), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11572 N-alkyl-dialkyl piperidine 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as N-alkyl-dialkyl piperidine 

(PMN P–16–419) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i) through (iii), 

(a)(3) through (6), (b), and (c). When 

determining which persons are 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. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 10. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include gas/vapor (all 

substances in the gas form). For 

purposes of § 721.63(b), the 

concentration is set at 1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(2)(i) through (v), 

(g)(3)(ii), (g)(4), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

corrosion; serious eye damage; acute 

toxicity; specific target organ toxicity. 

For purposes of § 721.72(g)(4), notice to 

users: Water release restrictions apply. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(h). 

(iv) Release to water. Requirements as 

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

(c)(4), where N=286. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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


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applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11573 Tetraalkylpiperidinium halide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as tetraalkylpiperidinium 

halide (PMN P–16–423) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been completely reacted 

(cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(c). When determining which persons 

are likely to be exposed as required for 

§ 721.63(a)(1), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general, 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. For purposes 

of § 721.63(b), the concentration is set at 

1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(2)(i) through (iii) 

and (v), (g)(3)(ii), (g)(4), and (g)(5). For 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), the substance 

may cause: Acute toxicity; specific 

target organ toxicity; reproductive 

toxicity. For purposes of § 721.72(g)(4), 

notice to users: Water release 

restrictions apply. Alternative hazard 

and warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(iv) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11574 Tetraalkylpiperidinium 

hydroxide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as tetraalkylpiperidinium 

hydroxide (PMN P–16–424) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been completely reacted 

(cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i) through (iii), 

(a)(3), (b), and (c). When determining 

which persons are likely to be exposed 

as required for § 721.63(a)(1), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general, and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(b), the 

concentration is set at 1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(2)(i) through (v), 

(g)(3)(ii), (g)(4), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

corrosion; serious eye damage; acute 

toxicity; specific target organ toxicity; 

reproductive toxicity. For purposes of 

§ 721.72(g)(4), notice to users: Water 

release restrictions apply. Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). 

(iv) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification 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). 

§ 721.11575 Amidoamino quaternary 

ammonium salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as amidoamino quaternary 

ammonium salt (PMN P–17–235) is 

subject to reporting under this section 

for the significant new use described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). 

(ii) Release to water. Requirements as 

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

(c)(4), where N=44. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification 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. 

§ 721.11576 Tri alkyl, mono alkoxy, fatty 

acid ester, ammonium salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as tri alkyl, mono alkoxy, 

fatty acid ester, ammonium salt (PMN 

P–18–226) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). 

(ii) Release to water. Requirements as 

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

(c)(4), where N=44. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 


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(2) Limitation or revocation of certain 

modification 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. 

§ 721.11577 Halogenated aromatic amine 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as halogenated aromatic 

amine (PMN P–17–259) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4), where 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11578 1,4-Benzenedicarboxylic acid, 

1,4-dipentyl ester, branched and linear. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,4-benzenedicarboxylic acid, 1,4- 

dipentyl ester, branched and linear 

(PMN P–18–43; CAS No. 2097734–13–7) 

is subject to reporting under this section 

for the significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved] 

(b) Specific requirements. The 

provision of subpart A of this part apply 

to this section except as modified by 

this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11579 Dialkyltin dialkylcarboxylate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as dialkyltin 

dialkylcarboxylate (PMN P–18–178) is 

subject to reporting under this section 

for the significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been completely reacted 

(cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3) through (6), and (c). 

When determining which persons are 

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. For purposes 

of § 721.63(a)(5), respirators must 

provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 10. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate 

(including solids or liquid droplets). 

(ii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to use the substance other than 

as a stabilizer for PVC compounds. 

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(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) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11580 Alkyltin dodecylthioester 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as alkyltin dodecylthioester 

(PMN P–18–217) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), and (c). When 

determining which persons are likely to 

be exposed as required for 

§ 721.63(a)(1), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general, 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. 

(ii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to use the substance other than 

as a stabilizer for PVC compounds. 

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(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) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section 

§ 721.11581 Alkyltin tetradecylthioester 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as alkyltin tetradecylthioester 

(PMN P–18–218) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), and (c). When 

determining which persons are likely to 

be exposed as required for 

§ 721.63(a)(1), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general, 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 


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considered and implemented to prevent 

exposure, where feasible. 

(ii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to use the substance other than 

as a stabilizer for PVC compounds. 

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(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) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section 

§ 721.11582 Undecanol, branched. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

undecanol, branched (PMN P–18–256) 

is subject to reporting under this section 

for the significant new use described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) 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), where N=4. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11583 Hydroxy alkanoic acid, 

compds. with aminoalkoxyalcohol-epoxy 

polymer-alkanolamine reaction products 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as hydroxy alkanoic acid, 

compds. with aminoalkoxyalcoholepoxy polymer-alkanolamine reaction 

products (PMN P–18–283) 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) through (iii), 

(a)(3), (b), and (c). When determining 

which persons are reasonably likely to 

be exposed as required for 

§ 721.63(a)(1), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. For purposes 

of § 721.63(b), the concentration is set at 

1%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72 

(a) through (f), (g)(1), (g)(2)(i) and (v), 

(g)(3)(ii), (g)(4)(iii), and (g)(5). For 

purposes of § 721.72(e), the 

concentration is set at 1%. For purposes 

of § 721.72(g)(1), this substance may 

cause: Skin irritation; skin sensitization; 

eye irritation; specific target organ 

toxicity; reproductive toxicity. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (h), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11584 1,3-Propanediol, 2-ethyl-2- 

(hydroxymethyl)-, polymer with 

ethyleneamine, 2-(chloromethyl)oxirane, 2- 

[[4-(1,1-dimethylethyl)

phenoxy]methyl]oxirane, 2,2′-[1,6- 

hexanediylbis(oxymethylene)]bis[oxirane], 

4,4′-(1-methylethylidene)bis[phenol], alkyl 

ether amine, and 2-[(2- 

methylphenoxymethyl]oxirane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as 1,3-propanediol, 2-ethyl-2- 

(hydroxymethyl)-, polymer with 

ethyleneamine, 2- 

(chloromethyl)oxirane, 2-[[4-(1,1- 

dimethylethyl)phenoxy]methyl]oxirane, 

2,2′-[1,6-hexanediylbis(oxymethylene)]

bis[oxirane], 4,4′-(1-methylethylidene)

bis[phenol], alkyl ether amine, and 2- 

[(2-methylphenoxymethyl]oxirane 

(PMN P–18–298) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

PMN substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the PMN substance for 

an application method that results in 

inhalation exposure. 

(ii) Release to water. Requirements as 

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

(c)(4), where N=50. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11585 Benzenepropanoic acid, 3- 

(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)- 

4-hydroxy-2,2-bis(hydroxymethyl)butyl 

ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzenepropanoic acid, 3-(2Hbenzotriazol-2-yl)-5-(1,1-dimethylethyl)- 

4-hydroxy-2,2-bis(hydroxymethyl)butyl 

ester (PMN P–18–310; CAS No. 

2101609–93–0) is subject to reporting 

under this section for the significant 

new use described in paragraph (a)(2) of 

this section. The requirements of this 

section do not apply to quantities of the 

PMN substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i) through (iii), 

(a)(3) through (6), 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. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 


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(APF) of at least 1,000. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include gas/vapor and 

particulate. 

(A) As an alternative to the respirator 

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

this section, a manufacturer or processor 

may choose to follow the new chemical 

exposure limit (NCEL) provision listed 

in the TSCA section 5(e) consent order 

for this substance. The NCEL is 0.16 mg/ 

m3 as an 8-hour time-weighted average. 

Persons who wish to pursue NCELs as 

an alternative to § 721.63 respirator 

requirements may request to do so 

under § 721.30. Persons whose § 721.30 

requests to use the NCELs approach are 

approved by EPA will be required to 

follow NCELs provisions comparable to 

those contained in the corresponding 

TSCA section 5(e) consent order. 

(B) [Reserved] 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(3)(ii), and (g)(5). 

For purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: Specific target 

organ toxicity; reproductive toxicity. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (h), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11586 1-Octadecanaminium, N,Ndimethyl-N- [3-(triethoxysilyl)propyl]-, 

chloride (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-octadecanaminium, N,N-dimethyl-N- 

[3-(triethoxysilyl)propyl]-, chloride (1:1) 

(PMN P–18–318; CAS No. 62117–57–1) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(3)(ii), and (g)(5). 

For purposes of § 721.72(g)(1), this 

substance may cause: Skin irritation; 

eye irritation; specific target organ 

toxicity. For purposes of § 721.72(e), the 

concentration is set at 1.0%. Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(ii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to use the substance other than 

as a surface treatment for added 

lubricity and anti-static properties. It is 

a significant new use to use the 

substance in an application method that 

results in inhalation exposure to 

workers. 

(iii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11587 2-Propenoic acid, 2-methyl-, 3- 

methyl-3-buten-1-yl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-propenoic acid, 2-methyl-, 3-methyl-3- 

buten-1-yl ester (PMN P–18–323; CAS 

No. 156291–88–2) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

PMN substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i) through (iii), 

(a)(3) through (6), 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. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 50. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate 

(including solids or liquid droplets) and 

gas/vapor (all substances in the gas 

form). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), (g)(1), (g)(2)(i) through 

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

(iii), and (g)(5). For purposes of 

§ 721.72(g)(1), this substance may cause: 

skin irritation; developmental effects; 

systemic effects; respiratory effects; skin 

sensitization; respiratory sensitization. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer use. Requirements as 

specified in § 721.80(k). 

(iv) Release to water. Requirements as 

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

(c)(4), where N=98. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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. 

§ 721.11588 Mixed metal oxide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as mixed metal oxide (PMN 

P–18–327) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3) through (6), 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. For 

purposes of § 721.63(a)(5), respirators 


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must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 1,000. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate 

(including solids or liquid droplets). 

(A) As an alternative to the respirator 

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

this section, a manufacturer or processor 

may choose to follow the new chemical 

exposure limit (NCEL) provision listed 

in the TSCA section 5(e) consent order 

for this substance. The NCEL is 0.1 mg/ 

m3 as an 8-hour time-weighted average. 

Persons who wish to pursue NCELs as 

an alternative to § 721.63 respirator 

requirements may request to do so 

under § 721.30. Persons whose § 721.30 

requests to use 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. 

(B) [Reserved] 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), (g)(1), (g)(2), and (g)(5). 

For purposes of § 721.72(g)(1), this 

substance may cause: cancer; skin 

sensitization; respiratory sensitization; 

specific target organ toxicity. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. For purposes of § 721.72(g)(2), 

when using this substance: avoid skin 

contact, avoid breathing substance, 

avoid ingestion, use respiratory 

protection or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 0.1 mg/ 

m3, and use skin protection. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (h) are applicable 

to manufacturers and processors of this 

substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11589 Amines, polyethylenepoly-, 

triethylenetetramine fraction, polymers with 

guanidine hydrochloride (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

amines, polyethylenepoly-, 

triethylenetetramine fraction, polymers 

with guanidine hydrochloride (1:1) 

(PMN P–18–347; CAS No. 1902936–67– 

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) and (3), (b), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. For purposes 

of § 721.63(b), the concentration is set at 

1%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(2)(i) and (v), 

(g)(3)(i) and (ii), (g)(4)(i), and (g)(5). For 

purposes of § 721.72(e), the 

concentration is set at 1%. For purposes 

of § 721.72(g)(1), this substance may 

cause: acute toxicity; skin sensitization; 

specific target organ toxicity. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (h), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11590 Phenol, 4,4′-(1- 

methylethylidene)bis-, polymer with 

3,6,9,12-tetraoxatetradeca-1, 13-diene, 

glycidyl ether. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phenol, 4,4′-(1-methylethylidene)bis-, 

polymer with 3,6,9,12-tetraoxatetradeca1, 13-diene, glycidyl ether (PMN P–18– 

405; CAS No. 647028–24–8) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the PMN substance in a 

manner that results in inhalation 

exposure. 

(ii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11591 1,4-Benzenedicarboxylic acid, 

1,4-bis(2-phenoxyethyl) ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,4-benzenedicarboxylic acid, 1,4-bis(2- 

phenoxyethyl) ester (PMN P–19–36; 

CAS No. 25900–07–6) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(6), 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 of 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. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 1,000. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate 

(including solids or liquid droplets). 

(ii) Release to water. Requirements as 

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

(c)(4), where N=3. 

(b) Specific requirements. The 

provisions of subpart A of this part may 

apply to this section except as modified 

by this paragraph (b). 


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(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11592 Poly(oxy-1,2-ethanediyl), 

.alpha.-nonyl-.omega.-hydroxy-, branched 

and linear. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

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

.omega.-hydroxy-, branched and linear 

(PMN P–19–52; CAS No. 2242406–13–7) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i) through (iii), 

(a)(3) through (6), (b), 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. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 1,000. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate 

(including solids or liquid droplets). For 

purposes of § 721.63(b), the 

concentration is set at 1%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(2)(i) through (v), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1%. For purposes of § 721.72(g)(1), this 

substance may cause: Skin irritation; 

respiratory complications; internal 

organ effects; eye corrosion. Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer use. It is a significant new use 

to use the substance where the 

concentration of the substance in the 

product formulation intended for 

distribution in commerce exceeds 1% 

by weight. 

(iv) Release to water. Requirements as 

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

(c)(4), where N=34. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11593 1-Butanamine, N-butyl-N- 

[(triethoxysilyl)methyl]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-Butanamine, N-butyl-N- 

[(triethoxysilyl)methyl]- (PMN P–19–53; 

CAS No. 35501–23–6) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been completely reacted 

(cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1) and (3), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general, 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to process and use 

the substance other than in a liquid 

formulation. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11594 Alkenylamide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as alkenylamide (PMN P–19– 

77) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). 

(ii) Release to water. Requirements as 

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

(c)(4), where N=4. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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. 

§ 721.11595 Isoalkylaminium, N-isoalkyl, 

-N, N-dimethyl chloride (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as isoalkylaminium, Nisoalkyl, -N, N-dimethyl chloride (PMN 

P–19–131) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(3)(ii), and (g)(5). 

For purposes of § 721.72(e), the 

concentration is set at 1%. For purposes 

of § 721.72(g)(1), this substance may 

cause: Skin irritation; eye irritation; 

specific target organ toxicity. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). It is significant 

new use to manufacture, process, or use 

the PMN substance in a manner that 

results in inhalation exposure. 

(iii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 


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(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11596 Aldehyde, polymer with mixed 

alkane polyamines, 2,2′-[1,4- 

alkanediylbis(oxyalkylene)]bis[oxirane], 2- 

(alkoxyalkyloxirane, 4,4′-(1- 

alkylidene)bis[phenol], 2,2′-[(1- 

alkylidene)bis(4,1- 

alkyleneoxyalkylene)]bis[oxirane] and 2- 

(aryloxyalkyl)oxirane, acetate (salt) 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as aldehyde, polymer with 

mixed alkane polyamines, 2,2′-[1,4- 

alkanediylbis(oxyalkylene)]bis[oxirane], 

2-(alkoxyalkyloxirane, 4,4′-(1- 

alkylidene)bis[phenol], 2,2′-[(1- 

alkylidene)bis(4,1- 

alkyleneoxyalkylene)]bis[oxirane] and 

2-(aryloxyalkyl)oxirane, acetate (salt) 

(PMN P–19–143) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

PMN substance after they have been 

completely reacted (cured) or destroyed. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the PMN substance in a 

manner that results in inhalation 

exposure to either the PMN substance or 

to formaldehyde. 

(ii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11597 Alkanedioic acid, compds. 

with substituted arylalkylamine-arylalcohol 

disubstituted alkane-the diglycidyl ether of 

a arylalcohol disubstituted alkaneepichlorohydrin-aldehyde-2,2′[(1- 

alkylidene)bis[4,1-aryleneoxy(alkyl-2,1- 

alkanediyl)oxyalkylene]]bis[oxirane]- 

alkanepolyamine polymer-1-[[2-[(2- 

aminoalkyl)amino]alkyl]amino]-3-aryloxy-2- 

alcohol reaction products (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as alkanedioic acid, compds. 

with substituted arylalkylaminearylalcohol disubstituted alkane-the 

diglycidyl ether of a arylalcohol 

disubstituted alkane-epichlorohydrinaldehyde-2,2′[(1-alkylidene)bis[4,1- 

aryleneoxy(alkyl-2,1- 

alkanediyl)oxyalkylene]]bis[oxirane]- 

alkanepolyamine polymer-1-[[2-[(2- 

aminoalkyl)amino]alkyl]amino]-3- 

aryloxy-2-alcohol reaction products 

(PMN P–19–144) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

substance after they have been 

completely reacted (cured) or destroyed. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the PMN substance in a 

manner that results in inhalation 

exposure to either the PMN substance or 

to formaldehyde. 

(ii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11598 Polyazaalkane with oxirane 

and methyloxirane, haloalkane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as polyazaalkane with oxirane 

and methyloxirane, haloalkane (PMN P– 

19–145) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), and (g)(5). For 

purposes of § 721.72(e), the 

concentration is set at 1%. For purposes 

of § 721.72(g)(1), this substance may 

cause: reproductive toxicity; specific 

target organ toxicity. Alternative hazard 

and warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(ii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to manufacture, process, or use 

the PMN substance in a manner that 

results in inhalation exposure. 

(iii) Release to water. Requirements as 

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

(c)(4), where N=26. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (h), 

(i) and (k) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11599 Dibromoalkyl ether 

tetrabromobisphenol A (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as dibromoalkyl ether 

tetrabromobisphenol A (PMN P–19–153) 

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) and (iii), (a)(3), 

and (c). When determining which 

persons are reasonably likely to be 

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

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(3)(ii), and (g)(5). 

For purposes of § 721.72(e), the 

concentration is set at 1%. For purposes 

of § 721.72(g)(1), this substance may 

cause: eye irritation; carcinogenicity; 


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reproductive toxicity; specific target 

organ toxicity. Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (h), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11600 Octonal, 7(or 8)-formyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

Octonal, 7(or 8)-formyl- (PMN P–20–29; 

CAS No. 1607842–40–9) 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) Release to water. Requirements as 

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

(c)(4), where N=17. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11601 Sulfonium, trisaryl-, 7,7- 

dialkyl-2-heteropolycyclic-1- 

alkanesulfonate (1:1) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as sulfonium, trisaryl-, 7,7- 

dialkyl-2-heteropolycyclic-1- 

alkanesulfonate (1:1) (PMN P–20–42) is 

subject to reporting under this section 

for the significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been completely reacted or 

adhered (during the photolithographic 

process) onto a semiconductor wafer 

surface or similar manufactured article 

used in the production of 

semiconductor technologies. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

and (c). When determining which 

persons are reasonably likely to be 

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

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e), (g)(1), (g)(2)(i) through (v), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1%. For purposes of § 721.72(g)(1), this 

substance may cause: Skin irritation; 

acute toxicity; skin sensitization; serious 

eye damage; specific target organ 

toxicity; neurotoxicity; genetic toxicity; 

reproductive toxicity. Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

a significant new use to import the PMN 

substance other than in solution, unless 

in sealed containers weighing 5 

kilograms or less. It is a significant new 

use to process the PMN substance in 

any way that generates a dust, mist, or 

aerosol in a non-enclosed process. It is 

a significant new use to manufacture the 

PMN substance longer than 18 months. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

manufacturers and processors of this 

substance. 

(2) Limitation or revocation of certain 

modification 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. 

§ 721.11602 Alkenoic acid, polymer with 

(alkyl alkenyl) polyether (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as alkenoic acid, polymer 

with (alkyl alkenyl) polyether (PMN P– 

20–104) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the substance in a 

manner that results in inhalation 

exposure. 

(ii) Release to water. Requirements as 

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

(c)(4), where N=75. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

modification requirements. The 

provisions of § 721.185 apply to this 

section. 

* * * * * 

PART 725— REPORTING 

REQUIREMENTS AND REVIEW 

PROCESSES FOR MICROORGANISMS 

■ 3. The authority citation for part 725 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, 2613, and 

2625. 

■ 4. Add § 725.1081 to read as follows: 

§ 725.1081 Trichoderma reesei (generic). 

(a) Microorganism and significant new 

uses subject to reporting. (1) The 

genetically-modified microorganism 

generically identified as Trichoderma 

reesei modified (MCAN J–16–26) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2)(i) It is a significant new use to 

manufacture, process, or use the 

microorganism other than in a 

fermentation system that meets all of the 

following conditions: 

(A) Enzyme production occurs by 

submerged fermentation (i.e., for 

enzyme production, growth of the 

microorganism occurs beneath the 

surface of the liquid growth medium); 

and 

(B) Any fermentation of solid plant 

material or insoluble substrate to which 

Trichoderma reesei fermentation broth 

is added after the standard industrial 

fermentation is completed is initiated 

only after the inactivation of the 


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microorganism as delineated in 

§ 725.422(d). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart L of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 725.950(b)(2) through (4) are 

applicable to manufacturers and 

processors of this microorganism. 

(2) Modification or revocation of 

certain notification requirements. The 

provisions of § 725.984 apply to this 

section. 

* * * * * 

[FR Doc. 2021–12147 Filed 6–10–21; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 210607–0122] 

RIN 0648–BK55 

Fisheries of the Northeastern United 

States; Northeast Multispecies 

Fishery; 2021–2023 Small-Mesh 

Multispecies Specifications 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Proposed rule; request for 

comments. 

SUMMARY: NMFS proposes small-mesh 

multispecies specifications for the 2021 

fishing year, and projected 

specifications for fishing years 2022 and 

2023, as recommended by the New 

England Fishery Management Council. 

This action also proposes changes to 

whiting possession limits on certain 

trips and would restore the in-season 

adjustment trigger for northern red hake. 

This action is necessary to establish 

allowable harvest levels and other 

management measures consistent with 

the most recent scientific information. 

This rule also informs the public of the 

proposed fishery specifications and 

provides an opportunity for comment. 

DATES: Comments must be received by 

June 28, 2021. 

ADDRESSES: You may submit comments 

on this document, identified by NOAA– 

NMFS–2021–0043, by the following 

method: 

Electronic Submission: Submit all 

electronic public comments via the 

Federal e-Rulemaking Portal. 

1. Go to https://www.regulations.gov, 

and enter ‘‘NOAA–NMFS–2021–0043’’ 

in the Search box; 

2. Click the ‘‘Comment’’ icon, 

complete the required fields; and 

3. Enter or attach your comments. 

Instructions: Comments sent by any 

other method, to any other address or 

individual, or received after the end of 

the comment period, may not be 

considered by NMFS. All comments 

received are a part of the public record 

and will generally be posted for public 

viewing on www.regulations.gov 

without change. All personal identifying 

information (e.g., name, address, etc.), 

confidential business information, or 

otherwise sensitive information 

submitted voluntarily by the sender will 

be publicly accessible. NMFS will 

accept anonymous comments (enter 

‘‘N/A’’ in the required fields if you wish 

to remain anonymous). 

The New England Fishery 

Management Council prepared a draft 

environmental assessment (EA) for this 

action that describes the proposed 

measures and other considered 

alternatives. The EA also provides an 

economic analysis, as well as an 

analysis of the biological, economic, and 

social impacts of the proposed measures 

and other considered alternatives. 

Copies of the specifications document, 

including the EA and information on 

the economic impacts of the proposed 

measures, are available upon request 

from Thomas A. Nies, Executive 

Director, New England Fishery 

Management Council, 50 Water Street, 

Newburyport, MA 01950. This 

document is also accessible via the 

internet at https://www.nefmc.org/ 

library/2021-2023-whitingspecifications. 

FOR FURTHER INFORMATION CONTACT: 

Cynthia Ferrio, Fishery Policy Analyst, 

(978) 281–9180. 

SUPPLEMENTARY INFORMATION: 

Background 

The small-mesh multispecies fishery 

comprises three species of hakes that are 

managed as five stocks: Northern and 

southern silver hake; northern and 

southern red hake; and offshore hake. 

Southern silver hake and offshore hake 

are often grouped together for 

management purposes and collectively 

referred to as ‘‘southern whiting.’’ The 

New England Fishery Management 

Council manages the small-mesh 

multispecies fishery within the 

Northeast Multispecies Fishery 

Management Plan (FMP). This action 

proposes catch limit specifications for 

the 2021 small-mesh multispecies 

fishery, and projects specifications for 

fishing years 2022 and 2023, based on 

the Council’s recommendations. 

This action would also increase 

whiting (silver hake and offshore hake) 

possession limits on trips using gear 

with less than 3-in (7.62-cm) mesh from 

3,500 pounds (lb) (1,588 kilograms (kg)) 

or 7,500 lb (3,402 kg) to 15,000 lb (6,804 

kg), and restore the in-season 

adjustment trigger for northern red hake 

to 90 percent from 37.9 percent. These 

recommended changes reflect the most 

recent stock assessment information 

(September 2020), and are intended to 

increase fishing flexibility, decrease 

regulatory discards, and promote 

rebuilding of the southern red hake 

stock. 

Proposed Specifications 

This action proposes the Council’s 

recommendations for 2021 and 

projected 2022–2023 small-mesh 

multispecies catch specifications, as 

well as revised management measures 

reduce regulatory discards. These 

proposed catch limits would increase 

annual quotas for southern whiting and 

both red hake stocks, and decrease the 

quota for northern silver hake (Table 1). 

Specifications for fishing years 2022 and 

2023 are projected to be the same as the 

proposed 2021 limits. 

TABLE 1—PROPOSED SMALL-MESH MULTISPECIES SPECIFICATIONS FOR FISHING YEARS 2021–2023 (METRIC TONS), 

WITH THE PERCENT CHANGE IN THE TOTAL ALLOWABLE LANDINGS (TAL) FROM FISHING YEAR 2020 

Overfishing 

limit 

Acceptable 

biological 

catch 

Annual 

catch limit TAL Percent change 

Northern Red Hake .............................................................. N/A 3,452 3,278 1,405 +413 

Northern Silver Hake ........................................................... 39,930 20,410 19,387 17,457 ¥34 

Southern Red Hake ............................................................. N/A 1,505 1,429 422 +89 


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