Document ID: EPA-HQ-OPPT-2018-0697-0001
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rules on Certain Chemical Substances
Posted Date: 2019-03-19T04:00Z

[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Proposed Rules]
[Pages 9999-10019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04457]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2018-0697; FRL-9986-83]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for 28 chemical substances which 
were the subject of premanufacture notices (PMNs). The chemical 
substances are subject to Orders issued by EPA pursuant to section 5(e) 
of TSCA. This action would require persons who intend to manufacture 
(defined by statute to include import) or process any of these 28 
chemical substances for an activity that is proposed as a significant 
new use to notify EPA at least 90 days before commencing that activity. 
The required notification initiates EPA's evaluation of the intended 
use within the applicable review period. Persons may not commence 
manufacture or processing for the significant new use until EPA has 
conducted a review of the notice, made an appropriate determination on 
the notice, and has taken such actions as are required with that 
determination.

DATES: Comments must be received on or before May 3, 2019.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0697, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-9232; email address: 
moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this 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 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28. Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to final SNURs must certify 
their compliance with the SNUR requirements. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this proposed rule on or after April 
18, 2019 are subject to the export notification provisions of TSCA 
section 12(b) (15 U.S.C. 2611(b)) (see Sec.  721.20), and must comply 
with the export notification requirements in 40 CFR part 707, subpart 
D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for 
chemical substances that were the subject of PMNs and are subject to 
Orders issued by EPA pursuant to section 5(e) of TSCA. These proposed 
SNURs would require persons to notify EPA at least 90 days before 
commencing the manufacture or processing of a chemical substance for 
any activity proposed as a significant new use. Receipt of such notices 
would allow EPA to assess risks that may be presented by the intended 
uses and, if appropriate, to regulate the proposed use before it 
occurs. Additional rationale and background to these proposed rules are 
more fully set out in the preamble to EPA's first direct final SNUR 
published in the Federal Register issue of April 24, 1990 (55 FR 
17376). Consult that preamble for

[[Page 10000]]

further information on the objectives, rationale, and procedures for 
SNURs and on the basis for significant new use designations, including 
provisions for developing test data.

B. What is the Agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
requires persons to submit a significant new use notice (SNUN) to EPA 
at least 90 days before they manufacture or process the chemical 
substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore 
prohibits such manufacturing or processing from commencing until EPA 
has conducted a review of the notice, made an appropriate determination 
on the notice, and taken such actions as are required in association 
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)).

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, and exemptions to reporting requirements. Provisions 
relating to user fees appear at 40 CFR part 700. According to Sec.  
721.1(c), persons subject to SNURs must comply with the same SNUN 
requirements and EPA regulatory procedures as submitters of PMNs under 
TSCA section 5(a)(1)(A). In particular, these requirements include the 
information submission requirements of TSCA section 5(b) and 5(d)(1), 
the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and 
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a 
SNUN, EPA must either determine that the significant new use is not 
likely to present an unreasonable risk of injury or take such 
regulatory action as is associated with an alternative determination 
before the manufacture or processing for the significant new use can 
commence. If EPA determines that the significant new use is not likely 
to present an unreasonable risk, EPA is required under TSCA section 
5(g) to make public, and submit for publication in the Federal 
Register, a statement of EPA's findings.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 28 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances and 
potential human exposures and environmental releases that may be 
associated with the conditions of use of the substances, in the context 
of the four bulleted TSCA section 5(a)(2) factors listed in this unit.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for 28 chemical substances in 40 CFR part 721, subpart E. In this unit, 
EPA provides the following information for each chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) Order.
     Information identified by EPA that would help characterize 
the potential health and/or environmental effects of the chemical 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use designated by the SNUR. This information 
may include testing required in a TSCA section 5(e) Order to be 
conducted by the PMN submitter, as well as testing not required to be 
conducted but which would also help characterize the potential health 
and/or environmental effects of the PMN substance. Any recommendation 
for information identified by EPA was made based on EPA's consideration 
of available screening-level data, if any, as well as other available 
information on appropriate testing for the chemical substance. Further, 
any such testing identified by EPA that includes testing on vertebrates 
was made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models. EPA also recognizes that 
whether testing/further information is needed will depend on the 
specific exposure and use scenario in the SNUN. EPA encourages all SNUN 
submitters to contact EPA to discuss any potential future testing. See 
Unit VII. for more information.
     CFR citation assigned in the regulatory text section of 
the proposed rule. The regulatory text section of each proposed rule 
specifies the activities that would be designated as significant new 
uses. Certain new uses, including exceedance of production volume 
limits (i.e., limits on manufacture volume) and other uses designated 
in this proposed rule, may be claimed as CBI. These proposed rules 
include 28 PMN substances that are subject to Orders issued under TSCA 
section 5(e)(1)(A). Each Order is based on one or more of the findings 
in TSCA section 5(a)(3)(B): There is insufficient information to permit 
a reasoned evaluation; in the absence of sufficient information to 
permit a reasoned evaluation, the activities associated with the PMN 
substances may present unreasonable risk to health or the environment; 
the substance is or will be produced in substantial quantities, and 
enters or may reasonably be anticipated to enter the environment in 
substantial quantities or there is or may be significant (substantial) 
human exposure to the substance. Those Orders require protective 
measures to limit exposures or otherwise mitigate the potential 
unreasonable risk. The proposed SNURs would identify as significant new 
uses any manufacturing, processing, use, distribution in commerce, or 
disposal that does not conform to the restrictions imposed by the 
underlying Orders, consistent with TSCA section 5(f)(4).
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) Order usually requires, among other 
things, that potentially exposed employees wear specified respirators 
unless actual measurements of the workplace air

[[Page 10001]]

show that air-borne concentrations of the PMN substance are below a New 
Chemical Exposure Limit (NCEL) that is established by EPA to provide 
adequate protection to human health. In addition to the actual NCEL 
concentration, the comprehensive NCELs provisions in TSCA section 5(e) 
Orders, which are modeled after Occupational Safety and Health 
Administration (OSHA) Permissible Exposure Limits (PELs) provisions, 
include requirements addressing performance criteria for sampling and 
analytical methods, periodic monitoring, respiratory protection, and 
recordkeeping. However, no comparable NCEL provisions currently exist 
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, 
the individual SNURs in 40 CFR part 721, subpart E, will state that 
persons subject to the SNUR who wish to pursue NCELs as an alternative 
to the Sec.  721.63 respirator requirements may request to do so under 
Sec.  721.30. EPA expects that persons whose Sec.  721.30 requests to 
use the NCELs approach for SNURs that are approved by EPA will be 
required to comply with NCELs provisions that are comparable to those 
contained in the corresponding TSCA section 5(e) Order for the same 
chemical substance.

PMN Numbers: P-15-353 and P-15-433

    Chemical Names: Fatty acids, C16 and C18-unsaturated, methyl 
esters, chlorinated (P-15-353) and chlorinated complex esters (generic) 
(P-15-433).
    CAS Numbers: 1642303-17-0 (P-15-353) and not available (P-15-433).
    Effective date of TSCA section 5(e) Order: July 25, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the PMN substances will be as lubricant 
additives. Based on submitted analogue data, EPA has identified concern 
for irritation. Based on the physical/chemical properties of the PMN 
substances (as described in the New Chemical Program's PBT category at 
64 FR 60194; November 4, 1999) and test data on structurally similar 
substances, the PMN substances are potentially persistent, 
bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN 
substances will persist in the environment for more than two months and 
estimates a bioaccumulation factor of greater than or equal to 1,000. 
The Order was issued under TSCA section 5(a)(3)(B)(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 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 significant (or substantial) human exposure to the substances.
    To protect against these risks, the Order requires:
    1. Submission to EPA of certain testing before exceeding the three-
year time limit specified in the Order; and
    2. Use of the PMN substances only for the confidential uses 
specified in 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 fate and environmental effects of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that would be designated by this 
proposed SNUR. The submitter has agreed not to manufacture the PMN 
substances beyond three years without performing a specific 
biodegradation study and an ecotoxicity testing scheme for P-15-353 to 
determine the rate of loss of the parent PMN substances and formation 
and identification of degradation products, and to assess their 
toxicity.
    CFR citation: 40 CFR 721.11221 (P-15-353) and 40 CFR 721.11222 (P-
15-433).

PMN Number: P-16-186

    Chemical Name: Sodium branched chain alkyl hydroxyl and branched 
chain alkenyl sulfonates (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: June 26, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a surfactant. EPA 
identified concern for lung effects based on surfactant activity if 
respirable particles are inhaled and concern for irritation based on 
potential surfactant activity to all exposed tissues. EPA also 
identified concern for developmental toxicity based on data provided 
for an analogue. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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:
    1. Use of personal protective equipment to prevent dermal exposure 
where there is a potential for dermal exposure;
    2. Refraining from modifying the manufacture, processing or use of 
the PMN substance in a manner that results in inhalation exposure to 
vapor, dust, spray, mist or aerosol;
    3. Use of the PMN substance only for the confidential use specified 
in the Order; and
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and 
Safety Data Sheet (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 about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this proposed SNUR. EPA 
has also determined that the results of specific pulmonary toxicity 
testing would help characterize the potential health effects of the PMN 
substance. Although the Order does not require this test, the Order's 
restrictions on manufacture, processing, distribution in commerce, and 
use of the PMN substance will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
relevant information.
    CFR citation: 40 CFR 721.11223.

PMN Number: P-16-207

    Chemical Name: Spiro tetrafluoroborate (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: August 6, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as an additive for an electrolyte solution. Based 
on physical/chemical properties and analysis of test data on the PMN 
substance, EPA has identified concern for developmental neurotoxicity, 
effects to the bladder, liver, kidney, thymus, stomach, thyroid, and 
blood. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(I)(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

[[Page 10002]]

risk of injury to human health or the environment. To protect against 
these risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding 
the aggregate volumes specified in the Order;
    2. Use of personal protective equipment where there is potential 
for dermal exposure;
    3. Use of a National Institute of Occupational Safety and Health 
(NIOSH)-certified respirator with an assigned protection factor (APF) 
of at least 1000 (where there is potential for inhalation exposure) or 
compliance with a NCEL of 0.2 mg/m\3\ as an 8-hour time-weighted 
average;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    5. Refraining from domestic manufacture in the United States (i.e., 
import only); and
    6. Use of the PMN substance only for the confidential use specified 
in 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 environmental and 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 would be designated by 
this SNUR. The submitter has agreed not to exceed a certain production 
volume limit without performing specific reproductive toxicity testing 
and acute aquatic toxicity testing.
    CFR citation: 40 CFR 721.11224.

PMN Numbers: P-16-246 and P-16-516

    Chemical Names: 2-pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-
methoxyphenyl)-4,5-difluoro-, phenylmethyl ester (P-16-246) and 2-
pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-fluoro-3-methoxyphenyl)-
5-fluoro-, phenylmethyl ester, hydrochloride (1:1) (P-16-516).
    CAS Numbers: 1391033-38-7 (P-16-246) and not available (P-16-516).
    Effective date of TSCA section 5(e) Order: May 21, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as chemical 
intermediates. Based on analysis of test data on analogous esters, EPA 
has identified concerns for carcinogenicity, developmental/reproductive 
effects, systemic toxicity, sensitization, and aquatic/terrestrial 
toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of 
sufficient information to permit a reasoned evaluation, the substances 
may present an unreasonable risk of injury human health and the 
environment. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances 
prior to exceeding the time limits specified in the Order;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Use of a NIOSH-certified respirator with an APF of at least 50 
where there is a potential for inhalation exposure;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    5. Use of the PMN substances only for the confidential uses 
specified in the Order; and
    6. No release of the PMN substances to surface waters.
    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 health effects of the PMN substances 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 proposed SNUR. The submitter has agreed not to exceed certain time 
limits without performing sensitization, mutagenicity, reproductive/
developmental, and carcinogenicity effects testing. EPA has also 
determined that the results of acute aquatic toxicity testing would 
help characterize the potential environmental effects of the PMN 
substances. Although the Order does not require these tests, the 
Order's restrictions on manufacture, processing, distribution in 
commerce, and disposal will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or relevant 
information.
    CFR citations: 40 CFR 721.11225 (P-16-246) and 40 CFR 721.11226 (P-
16-516).

PMN Numbers: P-16-271 and P-16-450

    Chemical Name: 1,2,4-Benzenetricarboxylic acid, 1,2,4-trinonyl 
ester.
    CAS Number: 1817723-10-6.
    Effective date of TSCA section 5(e) Orders: June 22, 2018.
    Basis for TSCA section 5(e) Orders: The PMNs state that the use of 
the substance will be used as a plasticizer for wire and cable 
insulation. EPA identified concerns for the PMN substance as a mild 
skin irritant as well as for blood, developmental, systemic, maternal, 
and male reproductive toxicity based on analysis of test data on 
analogous trimellitate esters. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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. 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 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 
significant (or substantial) human exposure to the substance. To 
protect against these risks, the Orders require:
    1. Submit to EPA certain toxicity testing before manufacturing 
(including import) a total of 1,750,000 kilograms (in each Order) of 
the PMN substance;
    2. Submit to EPA additional toxicity testing which will be 
determined upon EPA review of the initial toxicity testing results;
    3. Use of personal protective equipment to prevent dermal exposure 
where there is a potential for dermal exposure;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS and worker training in accordance with the Hazard Communication 
section of the Orders;
    5. Refraining from domestic manufacture in the United States (i.e., 
import only); and
    6. Use of the PMN substance only as plasticizer for wire and cable 
insulation.
    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 health and environmental effects of the PMN 
substance may be potentially useful in support of a request by the PMN 
submitters 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 proposed SNUR. The submitters have agreed not to 
exceed certain production volume limits without performing 
reproductive/

[[Page 10003]]

developmental toxicity tests and aquatic sediment toxicity tests.
    CFR citation: 40 CFR 721.11227.

PMN Number: P-16-388

    Chemical Name: Aliphatic polyamines, polymers with bisphenol A and 
epichlorohydrin (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: July 23, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a hardener for epoxy 
coating. Based on the high percentage of amines and a high pH when in 
liquid formulation, EPA has identified concern for irritation to the 
eyes, skin, mucous membranes, and lungs. The Order was issued under 
TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that 
the available information is insufficient to permit a reasoned 
evaluation of the human health effects of the PMN substances. To 
protect against these risks, the Order requires:
    1. Use of the PMN substance only for the confidential use specified 
in the Order;
    2. Use of personal protective equipment to prevent dermal exposure 
where there is potential for dermal exposure;
    3. No use of the PMN substance in a consumer product; and
    4. Establishment and use 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 about the 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 would be designated by 
this proposed SNUR. EPA has also determined that the results of skin 
irritation and skin sensitization toxicity testing would help 
characterize the potential health effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions on manufacture, distribution in commerce, and use of the 
PMN substance will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11228.

PMN Numbers: P-16-489, P-16-490, and P-16-491

    Chemical Name: Epoxy-amine adduct, methanesulfonates (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: June 11, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be open, non-dispersive. 
Based on physical/chemical properties of the PMN substances, EPA has 
identified concern for lung toxicity. Ecotoxicity hazards were 
identified based on structural analysis relationship (``SAR'') 
predictions for polycationic polymers. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substances may present an unreasonable risk of injury 
to human health and the environment. To protect against these risks, 
the Order requires:
    1. Refrain from manufacture, processing, or use of the PMN 
substances that result in inhalation exposure to vapor, mist, or 
aerosols;
    2. Refrain from manufacture, processing, or use of the PMN 
substances for consumer use;
    3. No release of the PMN substances from manufacturing, processing, 
or use resulting in surface water concentrations that exceed 208 parts 
per billion (ppb); and
    4. Establishment and use 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 about the physical/chemical properties, environmental and 
health effects of the PMN substances may be potentially useful to 
characterize the effects of the PMN substances in support of a request 
by the PMN submitter to modify the Order, or if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that would be designated by this proposed SNUR. EPA has also determined 
that the results of certain physical/chemical properties, acute aquatic 
toxicity testing, and pulmonary effects testing would help characterize 
the potential health effects of the PMN substances. Although the Order 
does not require these tests, the Order's restrictions on manufacture, 
distribution in commerce, and use of these PMN substances will remain 
in effect until the Order is modified or revoked by EPA based on 
submission of this or relevant information.
    CFR citation: 40 CFR 721.11229.

PMN Number: P-16-509

    Chemical Name: Modified ethylene-vinyl alcohol copolymer (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: July 23, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the PMN substance will be for packaging 
applications. EPA identified concerns for lung effects if respirable 
particles are inhaled based on physical/chemical properties. The Order 
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that 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 refraining from manufacturing (which 
includes import), processing or using the PMN substance with particle 
size less than 50 microns.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about 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 would be designated by 
this proposed SNUR. EPA has also determined that the results of 
specific pulmonary toxicity testing would help characterize the 
potential 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 721.11230.

PMN Number: P-16-546

    Chemical Name: Cashew, nutshell liq., polymer with acid and 
halohydrin (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: July 20, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as an adhesion application. Based on the presence 
of cashew, nutshell liquid in the PMN substance, EPA has identified 
concerns for sensitization from dermal exposure. The Order was issued 
under TSCA

[[Page 10004]]

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 and the environment. To protect against these risks, 
the Order requires:
    1. Use of personal protective equipment including chemically 
impervious gloves and eye goggles where there is a potential for dermal 
exposure;
    2. Use of a NIOSH-certified respirator with an APF of at least 50 
to mitigate inhalation exposure and 1000 where the PMN substance has a 
use involving an application that generates vapor, mist, dust or 
aerosol;
    3. No use of the PMN substance use in a consumer product; and
    4. Establishment and use 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 about the 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 would be designated by 
this proposed SNUR. EPA has also determined that the results of 
sensitization testing would help characterize the potential health 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions on manufacture, distribution in 
commerce, and use of the PMN substance will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
relevant information.
    CFR citation: 40 CFR 721.11231.

PMN Number: P-16-589

    Chemical Name: Pentaerythritol ester of mixed linear and branched 
carboxylic acids (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: October 4, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a synthetic aircraft 
engine lubricant for contained use industrial lubricant. EPA identified 
concern for developmental, kidney, liver, and specific organ effects 
based on test data on the potential branch acid moiety hydrolysis 
product of the PMN substance. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
health and the environment. To protect against these risks, the Order 
requires:
    1. Use of personal protective equipment to prevent dermal exposure 
where there is a potential for dermal exposure;
    2. Refraining from modifying the manufacture or processing of the 
PMN substance in a manner that results in inhalation exposure to the 
substance;
    3. Use of the PMN substance only for the confidential use specified 
in the Order;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS; and
    5. No release of the PMN substance resulting in exceedance of a 
surface water concentration of 330 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 the environmental fate and health effects of the PMN 
substance would 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 also determined that the results of 
hydrolysis testing and reproductive/developmental toxicity testing 
would help characterize the potential health effects of the PMN 
substance. Although the Order does not require this test, the Order's 
restrictions on manufacture, processing, distribution in commerce, and 
use of the PMN substance will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or relevant 
information.
    CFR citation: 40 CFR 721.11232.

PMN number: P-17-116

    Chemical Name: Cashew nut shell liquid, branched polyester-
polyether polyol (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: September 6, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the PMN substance will be as a polyurethane foam to raise concrete 
slabs. Based on the presence of cashew nut shell liquid, there is 
concern for sensitization. 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.
    To protect against this risk, the Order requires:
    1. Submit to EPA certain toxicity testing before manufacturing 
(including import) a total of 65,000 kilograms of the PMN substance;
    2. Provide personal protective equipment to its workers to prevent 
dermal exposure, including impervious gloves where there is potential 
for dermal exposure;
    3. Refraining from domestic manufacture in the United States (i.e., 
import only);
    4. Manufacture (including import) the PMN substance with no greater 
than 0.1% weight cashew nut oil;
    5. Not use the PMN substance involving an application method that 
results in the generation of vapor, mist, or aerosol; and
    6. Establishment and use 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 about the health effects of the PMN substance may be 
potentially useful in support of a request by the PMN submitters 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 proposed SNUR. The submitter has agreed not to exceed certain 
production volume limit without performing sensitization testing.
    CFR citation: 40 CFR 721.11233.

PMN Number: P-17-121

    Chemical Name: Methylene diphenyl diisocyanate terminated 
polyurethane resin (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: July 17, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a polyurethane used in an adhesive. Based on 
the isocyanate moiety, EPA has identified concerns for respiratory and 
dermal sensitization and lung and mucous membrane irritation. The Order 
was issued under TSCA section 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

[[Page 10005]]

human health and 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 that the substance 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 significant (or substantial) human 
exposure to the substance.
    To protect against these risks, the Order requires:
    1. Submitting to EPA the results of annual medical surveillance 
monitoring;
    2. Use of personal protective equipment to prevent dermal exposure 
where there is potential for dermal exposure;
    3. Use of NIOSH-certified respirators with an APF of at least 50 
where there is potential for inhalation exposure;
    4. No application methods of the PMN substance that generate a 
vapor, mist, aerosol, spray, or dust;
    5. Refrain from manufacturing, processing, or using the PMN 
substance for consumer use or for commercial uses that could introduce 
the substance into a consumer setting; and
    6. Establishment and use 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 about the health effects of the PMN substance may be 
potentially useful in support of a request by the PMN submitters 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 proposed SNUR. The submitter has agreed to perform annual medical 
surveillance monitoring as specified in the Order.
    CFR citation: 40 CFR 721.11234.

PMN Number: P-17-328

    Chemical Name: 2-Furancarboxylic acid, tetrahydro-.
    CAS Number: 16874-33-2.
    Effective date of TSCA section 5(e) Order: July 26, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a selective polishing agent for chemical 
mechanical planarization slurry for semiconductor wafer processing. 
Based on analysis of test data on an analogous chemical, EPA has 
identified concern for severe eye irritation, blood effects, 
reproductive effects, and immunotoxicity. Based on physical/chemical 
properties the substance is also expected to be corrosive, cause skin 
and eye burns, systemic effects, respiratory and digestive tract 
irritation with possible burns, pulmonary edema, solvent neurotoxicity, 
and solvent irritation. 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:
    1. Use of personal protective equipment involving impervious gloves 
and chemical safety goggles where there is potential for dermal 
exposure;
    2. Use of a NIOSH-certified respirator with an APF of at least 50 
where there is a potential for inhalation exposure;
    3. Refraining from domestic manufacture in the United States (i.e., 
import only); and
    4. Establishment and use 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 about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this proposed SNUR. EPA 
has also determined that the results of reproductive/developmental 
toxicity testing would help characterize the potential health effects 
of the PMN substance. Although the Order does not require these tests, 
the Order's restrictions on manufacture, processing, distribution in 
commerce, and use of the PMN substance will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
relevant information.
    CFR citation: 40 CFR 721.11235.

PMN Numbers: P-17-373 and P-17-374

    Chemical Names: Substituted heteromonocycle, homopolymer, alkyl 
substituted carbamate, substituted alkyl ester, substituted 
heteromonocycle, homopolymer, alkyl substituted carbamate, substituted 
alkyl ester (generic) (P-17-373) and polysiloxanes, di alkyl, 
substituted alkyl group terminated, alkoxylated, reaction products with 
alkanoic acid, isocyanate substituted-alkyl carbomonocycle and polyol 
(generic) (P-17-374).
    CAS Numbers: Not available.
    Effective date of TSCA section 5(e) Order: June 7, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the use of 
P-17-373 will be as an ultraviolet curable resin-overprint varnish and 
P-17-374 will be as an ultraviolet curable resin. Based on test data 
for structurally similar acrylates, EPA has identified concerns for eye 
and skin irritation, sensitization, mutagenicity, oncogenicity, liver 
and kidney toxicities. EPA also identified concern for developmental 
toxicity based on analogy to triethanolamines. Based on analogy to 
acrylates and carbamate esters, P-17-374 could cause environmental 
effects at concentrations of 110 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 health and the environment. To protect against these risks, the 
Order requires:
    1. Use of personal protective equipment to prevent dermal exposure 
where there is potential for dermal exposure;
    2. Use of NIOSH-certified respirators with an APF of at least 50 
where there is potential for inhalation exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    4. Refraining from domestic manufacture in the United States (i.e., 
import only);
    5. Import of P-17-374 with no more than 0.1% residual isocyanate;
    6. Import of the PMN substances to have a number average molecular 
weight of greater than or equal to 1000 daltons;
    7. Refraining from using the PMN substances other than as an 
ultraviolet curable resin for coatings; and
    8. No release of P-17-374 resulting in surface water concentrations 
that exceed 110 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 the health effects of the PMN substances 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 proposed SNUR. EPA

[[Page 10006]]

has also determined that the results of sensitization testing would 
help characterize the potential health effects of the PMN substances. 
Although the Order does not require this test, the Order's restrictions 
on manufacture, processing, distribution in commerce, and use of the 
PMN substances will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11236 (P-17-373) and 40 CFR 721.11239 (P-
17-374).

PMN Number: P-18-17

    Chemical Name: Substituted carbomonocycle, polymer with substituted 
heteromonocycle and substituted polyalkylene glycol (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: June 21, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be for corrosion protection. Based on the physical/
chemical properties of the PMN substance, analysis of test data, and 
structurally analogous epoxides, EPA identified concerns for 
mutagenicity, oncogenicity, developmental toxicity, male reproductive 
effects, liver and kidney toxicity, and dermal and respiratory 
sensitization. The Order was issued under TSCA section 
5(a)(3)(B)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to health and the environment. To 
protect against these risks, the Order requires:
    1. Refraining from domestic manufacture in the United States (i.e., 
import only);
    2. Refrain from using the PMN substance other than for primer 
coating for corrosion protection;
    3. Import the PMN substance with an average molecular weight 
greater than 1000 daltons with no more than 10% less than 500 daltons 
and no more than 25% less than 1000 daltons;
    4. Use of personal protective equipment to prevent dermal exposure 
where there is potential for dermal exposure;
    5. Use of NIOSH-certified respirators with an APF of at least 1000 
where there is potential for inhalation exposure; and
    6. Establishment and use 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 about the environmental and 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 would be 
designated by this proposed SNUR. EPA has also determined that the 
results of water solubility, acute and chronic aquatic toxicity, 
systemic toxicity, sensitization, and carcinogenicity testing would 
help characterize the potential health and environmental effects of the 
PMN substance. Although the Order does not require this information, 
the Order's restrictions on manufacture, processing, distribution in 
commerce, and use of the PMN substance will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
relevant information.
    CFR citation: 40 CFR 721.11240.

PMN Number: P-18-40

    Chemical Name: Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, substituted alkanedioc acid, 
substituted alkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl 
substituted carbomonocycle and alkyl substituted alkanediol (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: July 26, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a binder for ultraviolet curable coating 
resin. Based on physical/chemical properties, data on the PMN 
substance, and analysis of test data on an analogous chemical, EPA has 
identified concerns for developmental toxicity, oncogenicity, liver and 
kidney toxicity, ocular irritation, sensitization, irritation/
corrosion, and eye damage. The Order was issued under TSCA section 
5(a)(3)(B)(ii)(I) based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to health or the environment. To protect 
against these risks, the Order requires:
    1. Refraining from domestic manufacture in the United States (i.e., 
import only);
    2. Only use the PMN substance as a binder for ultraviolet curable 
coating resins;
    3. Import the PMN substance with a number average molecular weight 
of greater than 1000 daltons;
    4. Import the PMN substance with no greater than 20% of the acid 
moiety;
    5. Use of personal protective equipment where there is potential 
for dermal exposure;
    6. Use of a NIOSH-certified respirator with an APF of at least 1000 
where there is a potential for inhalation exposure; and
    7. Establishment and use 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 about the health and environmental 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 would be 
designated by this proposed SNUR. EPA has also determined that the 
results of water solubility, acute and chronic aquatic toxicity, 
systemic toxicity, sensitization, and carcinogenicity testing would 
help characterize the potential health and environmental effects of the 
PMN substance. Although the Order does not require these tests, the 
Order's restrictions on manufacture, processing, distribution in 
commerce, and use of the PMN substance will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
relevant information.
    CFR citation: 40 CFR 721.11241.

PMN Number: P-18-46

    Chemical Name: Substituted carbomonocycle, polymer with 
diisocyanatoalkane, substituted alkylacrylate blocked (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: June 21, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as an ultraviolet curable resin. Based on 
physical/chemical properties, analysis of test data on the PMN 
substance, and structurally analogous acrylates, EPA has identified 
concerns for mutagenicity, oncogenicity, developmental toxicity, liver 
and kidney toxicity, dermal and respiratory sensitization. The Order 
was issued under TSCA section 5(a)(3)(B)(ii)(I) based on a finding that 
in the absence of sufficient information to permit a reasoned 
evaluation, the substance may

[[Page 10007]]

present an unreasonable risk of injury to health and the environment. 
To protect against these risks, the Order requires:
    1. Refraining from domestic manufacture in the United States (i.e., 
import only);
    2. Refrain from using the PMN substance other than as an 
ultraviolet curable resin;
    3. Import the PMN substance with an average molecular weight 
greater than 1390 daltons with no more than 11% less than 500 daltons 
and no more than 30% less than 1000 daltons;
    4. Use of personal protective equipment to prevent dermal exposure 
where there is potential for dermal exposure;
    5. Use of NIOSH-certified respirators with an APF of at least 1000 
where there is potential for inhalation exposure; and
    6. Establishment and use 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 about the health and environmental 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 would be 
designated by this proposed SNUR. EPA has also determined that the 
results of water solubility, acute and chronic aquatic toxicity, 
pulmonary toxicity, and sensitization, testing would help characterize 
the potential health and environmental effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions on manufacture, processing, distribution in commerce, and 
use of the PMN substance will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or relevant 
information.
    CFR citation: 40 CFR 721.11242.

PMN Number: P-18-47

    Chemical Name: 1,2-Ethanediol, 1,2-dibenzoate.
    CAS Number: 94-49-5.
    Effective date of TSCA section 5(e) Order: July 31, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a phlegmatizer (stabilizer for compounds 
susceptible to detonation) for peroxides for use with polyester and 
vinyl ester resins as well as with curable unsaturated polyester and 
methacrylic resins. Based on test data on the PMN substance, and 
analysis of test data on analogous chemicals, EPA has identified 
concerns for blood, liver, and kidney toxicity, neurotoxicity, 
immunotoxicity, and reproductive and developmental toxicity, and 
ecotoxicity. The Order was issued under TSCA sections 5(a)(3)(B)(i) and 
5(e)(1)(A)(i), based on a finding that the available information is 
insufficient to permit a reasoned evaluation of the health effects of 
the PMN substance. The Order was also issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to health and the 
environment. Additionally, the Order was issued under 
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the 
substance is or will be produced in substantial quantities and that the 
substance either enters or may reasonable be anticipated to enter the 
environment in substantial quantities, or there is or may be 
significant (or substantial) human exposure to the substance. To 
protect against these risks, the Order requires:
    1. Use of personal protective equipment where there is potential 
for dermal exposure;
    2. Use of a NIOSH-certified respirator with an APF of at least 25 
where there is a potential for inhalation exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    4. Refraining from domestic manufacture in the United States (i.e., 
import only);
    5. Only use the PMN substance as a phlegmatizer (stabilizer for 
compounds susceptible to detonation) for peroxides for use with 
polyester and vinyl ester resins as well as with curable unsaturated 
polyester and methacrylic resins; and
    6. No release of the PMN substance resulting in surface water 
concentrations that exceed 10 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 the health and environmental 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 would be 
designated by this proposed SNUR. EPA has also determined that the 
results of acute aquatic toxicity and neurotoxicity/developmental 
neurotoxicity/prenatal development testing would help characterize the 
potential health and environmental effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions on manufacture, processing, distribution in commerce, and 
use of the PMN substance will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or relevant 
information.
    CFR citation: 40 CFR 721.11243.

PMN Number: P-18-51

    Chemical Name: Alkenoic acid, reaction products with polymers with 
isocyanatoalkane and substituted alkanoic acid, substituted 
monoacrylate alkanoate-blocked (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: July 30, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a waterborne ultraviolet curable coating resin 
binder for inkjet, ink, or overprint varnish. Based on physical/
chemical properties, available data on the PMN substance and comparison 
to structurally analogous acrylates, EPA has identified concern for 
developmental toxicity, sensitization, irritation, corrosion, and eye 
damage. The Order was issued under TSCA section 5(a)(3)(B)(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:
    1. Refraining from domestic manufacture in the United States (i.e., 
import only);
    2. Only use the PMN substance as a waterborne ultraviolet curable 
coating resin binder for inkjet, ink, or overprint varnish;
    3. Import the PMN substance with no greater than 24% branched alkyl 
acid moiety content;
    4. Import the PMN substance with no greater than 0.1% isocyanate 
content;
    5. Use of personal protective equipment where there is potential 
for dermal exposure;
    6. Use of a NIOSH-certified respirator with an APF of at least 1000 
where there is a potential for inhalation exposure;
    7. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS; and
    8. No release of the PMN substance resulting in surface water 
concentrations that exceed 660 ppb.

[[Page 10008]]

    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 health and environmental 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 would be 
designated by this proposed SNUR. EPA has also determined that the 
results of water solubility, acute and chronic aquatic toxicity, 
developmental toxicity, and sensitization testing would help 
characterize the potential health and environmental effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions on manufacture, processing, distribution in commerce, and 
use of the PMN substance will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or relevant 
information.
    CFR citation: 40 CFR 721.11244.

PMN Numbers: P-18-71 and P-18-79

    Chemical Names: Aromatic dicarboxylic acid, compd. with alkane 
diamines, polymer with alkane diamine and alkane dicarboxylic acid 
(generic) (P-18-71) and Aromatic dicarboxylic acid, compd. with alkyl 
diamines, homopolymer (generic) (P-18-79).
    CAS Numbers: Not available.
    Effective date of TSCA section 5(e) Order: July 6, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as engineering 
thermoplastic. EPA identified concern for lung effects if the PMN 
substances are made with a particle size less than 10 microns based on 
analogy to similar poorly soluble particles. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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 and the environment. To protect against this 
risk, the Order requires manufacture of the PMN substances with a 
particle size greater than 10 microns. The proposed SNUR would 
designate as a ``significant new use'' the absence of this protective 
measure.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substances would 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 proposed SNUR. EPA has also determined that the results of 
pulmonary effects testing would help characterize the potential health 
effects of the PMN substance. Although the Order does not require this 
test, the Order's restrictions on manufacture, processing, distribution 
in commerce, and use of the PMN substances will remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
relevant information.
    CFR citations: 40 CFR 721.11245 (P-18-71) and 40 CFR 721.11246 (P-
18-79).

PMN Number: P-18-82

    Chemical Name: Aspartic acid, tallow modified diester (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: July 3, 2018.
    Basis for TSCA section 5(e) order: The PMN states that the use of 
the substance will be as an intermediate used in the manufacture of a 
surface-active agent. Based on test data available for an analogue, EPA 
has identified concerns for irritation, blood effects, neurotoxicity 
and surfactant effects in the lungs based on analogue data. Based on 
SAR analysis of 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 substances may present an 
unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Manufacture, process and use of the PMN substance only as stated 
in the PMN submission;
    2. Use only as an intermediate;
    3. Refraining from modifying the manufacture, processing or use in 
a manner resulting in inhalation exposure;
    4. Use of personal protective equipment to prevent dermal exposure 
(where there is potential for dermal exposure);
    5. Establishment and use of a hazard communication program, 
including human health precautionary statement on each label and in the 
SDS;
    6. That PMN residuals will be recycled back into the process as 
stated in the PMN; and
    7. 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 about the environmental and 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 would be 
designated by this proposed SNUR. EPA has also determined that the 
results of acute aquatic toxicity, pulmonary effects, and specific 
target organ toxicity testing would help characterize the potential 
environmental and health effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions on 
manufacture, processing, distribution in commerce, use, and disposal of 
the PMN substance will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11247.

PMN Number: P-18-130

    Chemical Name: Substituted alkanediol, polymer with 
heteromonocycles, alkenoate, metal complexes (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: July 26, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as an adhesion promoter for industrial 
application. Based on analysis of analogous acrylates, and physical/
chemical properties, EPA has identified concerns for mutagenicity, 
oncogenicity, developmental toxicity, sensitization, irritation, and 
liver and kidney toxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to health and the 
environment. To protect against these risks, the Order requires:
    1. Use of personal protective equipment where there is a potential 
for dermal exposure;
    2. Use of a NIOSH-certified respirator with an APF of at least 50 
to mitigate inhalation and 1000 where the PMN substance has a use 
involving spray application;
    3. Refraining from domestic manufacture in the United States (i.e., 
import only);

[[Page 10009]]

    4. Use of the PMN substance only as an adhesion promoter for 
industrial applications; and
    5. Establishment and use 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 about the 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 would be designated by 
this proposed SNUR. EPA has also determined that the results of 
absorption, distribution, metabolism, elimination, genotoxicity, and 
sensitization testing would help characterize the potential health 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions on manufacture, distribution in 
commerce, and use of the PMN substance will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
relevant information.
    CFR citation: 40 CFR 721.11248.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these proposed SNURs, EPA concluded that for all 28 
chemical substances regulation was warranted under TSCA section 5(e), 
pending the development of information sufficient to make reasoned 
evaluations of the health or environmental effects of the chemical 
substances. The basis for such findings is outlined in Unit IV. Based 
on these findings, TSCA section 5(e) Orders requiring the use of 
appropriate exposure controls were negotiated with the PMN submitters. 
The SNURs would identify as significant new uses any manufacturing, 
processing, use, distribution in commerce, or disposal that does not 
conform to the restrictions imposed by the underlying Orders, 
consistent with TSCA section 5(f)(4).

B. Objectives

    EPA is proposing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives about the significant new uses 
designated in this rule:
     EPA would receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA would be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
     EPA would identify as significant new uses any 
manufacturing, processing, use, distribution in commerce, or disposal 
that does not conform to the restrictions imposed by the underlying 
Orders, consistent with TSCA section 5(f)(4).
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the internet at 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. 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. 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 section 5(e) Orders have been 
issued for all of the chemical substances, and the PMN submitters are 
prohibited by the TSCA section 5(e) Orders from undertaking activities 
which would be designated as significant new uses. The identities of 23 
of the 28 chemical substances subject to this proposed rule have been 
claimed as confidential (per Sec. Sec.  720.25) for a chemical 
substance covered by this action. Based on this, the Agency believes 
that it is highly unlikely that any of the significant new uses 
described in the regulatory text of this proposed rule are ongoing.
    Therefore, EPA designates March 19, 2019 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 
developing this proposed rule, EPA has recognized that, given EPA's 
general practice of posting proposed rules on its website a week or 
more in advance of Federal Register publication, this objective could 
be thwarted even before Federal Register publication of the proposed 
rule.
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified as of that 
date would have to cease any such activity upon the effective date of 
the final rule. To resume their activities, these persons would have to 
first comply with all applicable SNUR notification requirements and 
wait until EPA has conducted a review of the notice, made an 
appropriate determination on the notice, and has taken such actions as 
are required with that determination.

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: Development of test data 
is required where the chemical substance subject to the SNUR is also 
subject to a rule, order or consent agreement under TSCA section 4 (see 
TSCA section 5(b)(1)). In the absence of a TSCA section 4 test rule 
covering the chemical substance, persons are required only to submit 
information in their possession or control and to describe any other 
information known to or reasonably ascertainable by them (see 40 CFR 
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. Unit IV. lists potentially 
useful information identified by EPA that would help characterize the 
potential health and/or environmental effects of the PMN/SNUN substance 
for all of the listed SNURs. EPA recognizes that the 2016 Lautenberg 
Amendments have led to modifications in our approach to testing 
requirements, including an

[[Page 10010]]

increased consideration of alternatives to vertebrate testing. 
Descriptions of tests/information needs are provided for informational 
purposes only and EPA strongly encourages persons, before performing 
any testing, to consult with the Agency pertaining to protocol 
selection. 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 potentially useful information. EPA encourages dialogue with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h). To access the 
OCSPP test guidelines referenced in this document electronically, 
please go to http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.'' The Organisation for Economic Co-operation and 
Development test guidelines are available from the OECD Bookshop at 
http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
    In certain of the TSCA section 5(e) Orders for the chemical 
substances that would be regulated under this proposed rule, EPA has 
established production 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. Listings of 
the tests specified in the TSCA section 5(e) Orders are included in 
Unit IV. The proposed SNURs contain the same production limits as the 
TSCA section 5(e) Orders. Exceeding these production limits is defined 
as a significant new use. Persons who intend to exceed the production 
limit must notify the Agency by submitting a SNUN at least 90 days in 
advance of commencement of non-exempt commercial manufacture or 
processing and wait until EPA has conducted a review of the notice, 
made an appropriate determination on the notice, and has taken such 
actions as are required with that determination.
    Any request by EPA for the testing described in the Orders was made 
based on EPA's consideration of available screening-level data, if any, 
as well as other available information on appropriate testing for the 
PMN substances. Further, any such testing/information 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. 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 Sec.  721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 40 CFR 720.50. SNUNs 
must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40 and Sec.  721.25. E-PMN software is 
available electronically at http://www.epa.gov/opptintr/newchems.

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 under docket ID number EPA-HQ-OPPT-
2018-0650.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNURs for several new chemical 
substances that were the subject of PMNs and TSCA section 5(e) Orders. 
The Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable.
    The information collection requirements related to this proposed 
rule have already been approved by OMB pursuant to PRA under OMB 
control number 2070-0012 (EPA ICR No. 574). This action does not impose 
any burden requiring additional OMB approval. If an entity were to 
submit a SNUN to the Agency, the annual burden is estimated to average 
between 30 and 170 hours per response. This burden estimate includes 
the time needed to review instructions, search existing data sources, 
gather and maintain the data needed, and complete, review, and submit 
the required SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this proposed SNUR 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. Although some small 
entities may decide to pursue a

[[Page 10011]]

significant new use in the future, EPA cannot presently determine how 
many, if any, there may be. However, 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, and 14 in FY2017, 
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

    This proposed rule 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, 
entitled ``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This proposed rule would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule 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, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000), do not apply to this action.

G. Executive Order 13045

    This proposed rule is not subject to Executive Order 13045, 
entitled ``Protection of Children from Environmental Health Risks and 
Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an 
economically significant regulatory action as defined by Executive 
Order 12866, and this action does not address environmental health or 
safety risks disproportionately affecting children.

H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211, 
entitled ``Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), 
because this proposed rule is not expected to affect energy supply, 
distribution, or use and because this proposed rule is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this proposed rule would not involve any 
technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not 
apply to this action.

J. Executive Order 12898

    This proposed rule does not entail special considerations of 
environmental justice related issues as delineated by Executive Order 
12898, entitled ``Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations'' (59 FR 7629, February 
16, 1994).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: February 27, 2019.
Jeffery Morris,
Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 721--[AMENDED]

0
 1. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
2. Add Sec.  721.11221 to subpart E to read as follows:

Sec.  721.11221   Fatty acids, C16 and C18-unsaturated, methyl esters, 
chlorinated.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified as fatty acids, C16 
and C18-unsaturated, methyl esters, chlorinated (PMN P-15-353, CAS No. 
1642303-17-0) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture the substance beyond three years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of the substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.
0
3. Add Sec.  721.11222 to subpart E to read as follows:

Sec.  721.11222  Chlorinated complex esters (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
chlorinated complex esters (PMN P-15-433) 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 Sec.  721.80(k). It is a significant new use to 
manufacture the substance beyond three years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in

[[Page 10012]]

Sec.  721.125(a) through (i) are applicable to manufacturers and 
processors of the substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.
0
4. Add Sec.  721.11223 to subpart E to read as follows:

Sec.  721.11223  Sodium branched chain alkyl hydroxyl and branched 
chain alkenyl sulfonates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as sodium 
branched chain alkyl hydroxyl and branched chain alkenyl sulfonates (P-
16-186) 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 Sec.  
721.63(a)(1), (2)(i), (iv), (3), (When determining which persons are 
reasonable likely to be exposed as required for Sec.  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 exposures, where feasible), (6)(v), (vi), 
(particulate), (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72 (a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (ix), (eye irritation), (2)(i), (v), (eye protection), (4)(i), 
(ii), (iii), and (5). 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 Sec.  721.80(k). It is a significant new use to 
manufacture, process or use of the substance in a manner that results 
in inhalation exposure to vapor, dust, spray, mist, or aerosol.
    (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 Sec.  
721.125 (a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.
0
5. Add Sec.  721.11224 to subpart E to read as follows:

Sec.  721.11224  Spiro tetrafluoroborate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as spiro 
tetrafluoroborate (PMN P-16-207) 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 Sec.  
721.63(a)(1), (2), (3), (4), (When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63 (a)(1) and 
(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible), 
(a)(5)(respirators must provide a NIOSH assigned protection factor of 
at least 1000), (a)(6)(particulate), (b)(concentration set at 1.0%), 
and (c).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL is 0.2 mg/m\3\ as 
an 8-hour time-weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(iv), 
(ix), (2)(i), (ii), (iii), (iv)(use respiratory protection, or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.2 mg/m\3\, (v), (g)(5), 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 Sec.  721.80(f), (k), and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.
0
6. Add Sec.  721.11225 to subpart E to read as follows:

Sec.  721.11225   2-Pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-
methoxyphenyl)-4,5-difluoro-, phenylmethyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-
pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-methoxyphenyl)-4,5-
difluoro-, phenylmethyl ester (PMN P-16-246, CAS No. 1391033-38-7) 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 Sec.  
721.63(a)(1), (2)(i), (iv), (3), (4), (When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible), 
(a)(5)(respirators must provide a National Institute for Occupational 
Safety and Health assigned protection factor of at least 50), 
(a)(6)(i), (ii), (v), (vi), (b)(concentration set at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i), 
(ii), (iv), (vi), (vii), (ix), (2)(i), (ii), (iii), (iv), (v), (3)(i), 
(ii), (4)(iii), and (5). 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 Sec.  721.80(k). It is a

[[Page 10013]]

significant new use to manufacture the substance beyond nine months.
    (iv) Release to water. Requirements as specified in Sec.  
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 Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.
0
7. Add Sec.  721.11226 to subpart E to read as follows:

Sec.  721.11226  2-Pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-
fluoro-3-methoxyphenyl)-5-fluoro-, phenylmethyl ester, hydrochloride 
(1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-
pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-fluoro-3-methoxyphenyl)-
5-fluoro-, phenylmethyl ester, hydrochloride (1:1) (PMN P-16-516) 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 Sec.  
721.63(a)(1), (2)(i), (iv), (3), (4), (When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible), 
(a)(5)(respirators must provide a National Institute for Occupational 
Safety and Health assigned protection factor of at least 50), (6)(i), 
(ii), (v), (vi), (b)(concentration set at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set 0.1%), (f), (g)(1)(i), (ii), 
(iv), (vi), (vii), (ix), (2)(i), (ii), (iii), (iv), (v), (3)(i), (ii), 
(4)(iii), and (5). 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 Sec.  721.80(k). It is a significant new use to 
manufacture the substance beyond nine months.
    (iv) Release to water. Requirements as specified in Sec.  
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 Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.
0
8. Add Sec.  721.11227 to subpart E to read as follows:

Sec.  721.11227  1,2,4-Benzenetricarboxylic acid, 1,2,4-trinonyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,2,4-
benzenetricarboxylic acid, 1,2,4-trinonyl ester (P-16-271 and P-16-450, 
CAS No. 1817723-10-6) 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 incorporated into a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2), (3), (When determining which persons are reasonable 
likely to be exposed as required for Sec.  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 exposures, where feasible), (a)(6)(particulate), 
(b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (iv), 
(vi), (ix), (2)(i), (v), (4)(i), (ii), (iii), and (v). 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 Sec.  721.80(f) and (p)(1,750,000 kilograms). It is a 
significant new use to use the substance other than as a plasticizer in 
wire and cable insulation.
    (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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
9. Add Sec.  721.11228 to subpart E to read as follows:

Sec.  721.11228  Aliphatic polyamines, polymers with bisphenol A and 
epichlorohydrin (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
aliphatic polyamines, polymers with bisphenol A and epichlorohydrin 
(PMN P-16-388) 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 Sec.  
721.63(a)(1), (2)(i), (iii), (3), (When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible), (a)(6)(v), (vi), 
(particulate), (b)(concentration set at 1.0%) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), 
(mucous membrane irritation), (lung irritation), (eye irritation), 
(g)(2)(i), (use gloves and eye protection), and (g)(5), 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 Sec.  721.80(k) and (o).
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 10014]]

apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.
0
10. Add Sec.  721.11229 to subpart E to read as follows:

Sec.  721.11229  Epoxy-amine adduct, methanesulfonates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances generically identified as epoxy-
amine adduct, methanesulfonates (PMN P-16-489, PMN P-16-490, PMN P-16-
491), are 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 Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii), 
(2)(ii), (3)(i), (ii), (5), alternative hazard and warning statement 
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 Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substances resulting in inhalation 
exposure to vapor, mist, or aerosols.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 208 ppb.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (f), (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
11. Add Sec.  721.11230 to subpart E to read as follows:

Sec.  721.11230  Modified ethylene-vinyl alcohol copolymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (2) The chemical substance generically identified as 
modified ethylene-vinyl alcohol copolymer (P-16-509) 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 substance after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance with 
particle size less than 50 microns.
    (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 Sec.  
721.125(a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
12. Add Sec.  721.11231 to subpart E to read as follows:

Sec.  721.11231  Cashew, nutshell liq., polymer with acid and 
halohydrin (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as cashew, 
nutshell liq., polymer with acid and halohydrin (PMN P-16-546) 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 Sec.  
721.63(a)(1), (2)(i), (iv), (3), (4), (When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63 
(a)(1), (4) engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), (a)(5)(respirators must provide a National Institute 
for Occupational Safety and Health assigned protection factor (APF) of 
at least 50, or an APF of 1000 where the PMN substance has a use 
involving an application method that generates vapor, mist or aerosol), 
(6)(v), (vi), (particulate), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(skin sensitization),(respiratory 
sensitization), (g)(2)(i), (ii), (iii), (iv), (v), (5), 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 Sec.  721.80(o).
    (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 Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
13. Add Sec.  721.11232 to subpart E to read as follows:

Sec.  721.11232  Pentaerythritol ester of mixed linear and branched 
carboxylic acids (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
pentaerythritol ester of mixed linear and branched carboxylic acids (P-
16-589) 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 Sec.  
721.63(a)(1), (3), (When determining which persons are reasonable 
likely to be exposed as required for Sec.  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 exposures, where feasible), (a)(6)(particulate), 
(b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(iv), (v), 
(vi), (ix), (2)(i), (ii), (iii), (v), (4)(minimize release to water), 
and (g)(5). 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 Sec.  721.80(k). It is a

[[Page 10015]]

significant new use to manufacture or process this substance in any 
manner that results in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4) and (b)(4), where N = 330 ppb.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.
0
14. Add Sec.  721.11233 to subpart E to read as follows:

Sec.  721.11233  Cashew nut shell liquid, branched polyester-polyether 
polyol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as cashew 
nut shell liquid, branched polyester-polyether polyol (PMN P-17-116) 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 Sec.  
721.63(a)(1), (2)(i), (3), (When determining which persons are 
reasonably likely to be exposed as required for Sec.  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), (6)(particulate), 
(b)(concentration set at 0.1%) and (c).
    (ii) Hazard communication: Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), 
(g)(1)(sensitization), (g)(2)(i), (v), and (g)(5). 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 Sec.  721.80(f), (p)(65,000 kg), and (y)(1). It is a 
significant new use to manufacture the PMN substance with greater than 
0.1% weight residual cashew nut oil.
    (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 Sec.  
721.125(a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
15. Add Sec.  721.11234 to subpart E to read as follows:

Sec.  721.11234  Methylene diphenyl diisocyanate terminated 
polyurethane resin (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
methylene diphenyl diisocyanate terminated polyurethane resin (PMN P-
17-121) 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 Sec.  
721.63(a)(1), (2)(i), (iii), (iv), (3), (4), (When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), (a)(5)(respirators must provide NIOSH assigned 
protection factor of at least 50), (a)(6)(v), (vi), (particulate), 
(b)(concentration set at 1.0%) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), 
(asthma), (g)(2)(i), (ii), (iii), (iv), (v), and (g)(5), 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. It is a 
significant new use to manufacture, process, or use the substance for 
consumer use or for commercial uses that could introduce the substance 
into a consumer setting. It is a significant new use to manufacture the 
substance without conducting medical surveillance as specified in the 
Order. It is a significant new use to use the substance in a spray 
application that results in inhalation exposure to a vapor, dust, mist, 
spray, or aerosol.
    (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 Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
16. Add Sec.  721.11235 to subpart E to read as follows:

Sec.  721.11235  2-Furancarboxylic acid, tetrahydro-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-furancarboxylic 
acid, tetrahydro- (PMN P-17-328, CAS No. 16874-33-2) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iii), (iv), (3), (4), (When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), (a)(5)(respirators must provide a National Institute 
for Occupational Safety and Health assigned protection factor of at 
least 50), (a)(6)(v), (vi), (particulate), (b)(concentration set at 
1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(vi), 
(severe eye irritation), (blood effects), (immunotoxicity), (g)(2)(i), 
(ii), (iii), (v), (eye protection), (g)(5). 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 Sec.  721.80(f).
    (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 Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The

[[Page 10016]]

provisions of Sec.  721.185 apply to this section.
0
17. Add Sec.  721.11236 to subpart E to read as follows:

Sec.  721.11236  Substituted heteromonocycle, homopolymer, alkyl 
substituted carbamate, substituted alkyl ester, substituted 
heteromonocycle, homopolymer, alkyl substituted carbamate, substituted 
alkyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
substituted heteromonocycle, homopolymer, alkyl substituted carbamate, 
substituted alkyl ester, substituted heteromonocycle, homopolymer, 
alkyl substituted carbamate, substituted alkyl ester (PMN P-17-373) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of the 
Order 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 Sec.  
721.63(a)(1), (2)(i), (3), (4), (When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(a)(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible), 
(a)(5)(respirators must provide a National Institute for Occupational 
Safety and Health assigned protection factor of at least 50), 
(a)(6)(v), (vi), (particulate), (b)(concentration set at 0.1%) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), 
(vii), (ix), (sensitization), (systemic effects), (a)(2)(i), (ii), 
(iii), (v), (a)(5), 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 Sec.  721.80(f). It is a significant new use to 
manufacture the substance unless the number average molecular weight is 
greater than or equal to 1000 daltons. It is a significant new use to 
use the substance other than as an ultraviolet curable coating resin.
    (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 Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
18. Add Sec.  721.11237 to subpart E to read as follows:

Sec.  721.11237  Polysiloxanes, di alkyl, substituted alkyl group 
terminated, alkoxylated, reaction products with alkanoic acid, 
isocyanate substituted-alkyl carbomonocycle and polyol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
polysiloxanes, di alkyl, substituted alkyl group terminated, 
alkoxylated, reaction products with alkanoic acid, isocyanate 
substituted-alkyl carbomonocycle and polyol (PMN P-17-374) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section. The requirements of the Order 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 Sec.  
721.63(a)(1), (2)(i), (3), (4), (When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(a)(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures.) shall be considered 
and implemented to prevent exposure, where feasible), 
(a)(5)(respirators must provide a NIOSH assigned protection factor of 
at least 50), (a)(6)(v), (vi), (particulate), (b)(concentration set at 
0.1%) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), 
(vii), (ix), (sensitization), (systemic effects), (g)(2)(i), (ii), 
(iii), (v), (g)(5). 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 Sec.  721.80(f). It is a significant new use to import 
the substance with more than 0.1% residual isocyanate. It is a 
significant new use to import the substance at a number average 
molecular weight less than 1000 daltons. It is a significant new use to 
use the substance other than as an ultraviolet curable coating resin.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 110.
    (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 Sec.  
721.125(a) through (k) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
19. Add Sec.  721.11238 to subpart E to read as follows:

Sec.  721.11238  Substituted carbomonocycle, polymer with substituted 
heteromonocycle and substituted polyalkylene glycol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
substituted carbomonocycle, polymer with substituted heteromonocycle 
and substituted polyalkylene glycol (PMN P-18-17) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iii), (iv), (3), (4), (When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), (a)(5)(respirators must provide a National Institute 
for Occupational Safety and Health assigned protection factor of at 
least 1000), (a)(6)(particulate), (b)(concentration set at 0.1%) and 
(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), (ii), 
(iii), (iv), (v), (vi), (vii), (ix), (irritation to eyes, lungs, and 
mucus membranes), (g)(2)(i), (ii), (iii), (iv), (v), (avoid eye 
contact), (g)(5), alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.

[[Page 10017]]

    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), It is a significant new use to import 
the substance if the average molecular weight is less than or equal to 
1000 daltons, more than 10% is less than 500 daltons, or more than 25% 
is less than 1000 daltons. It is a significant new use to use the 
substance other than for primer coating for corrosion 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 Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
20. Add Sec.  721.11239 to subpart E to read as follows:

Sec.  721.11239  Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, substituted alkanedioc acid, 
substituted alkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl 
substituted carbomonocycle and alkyl substituted alkanediol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkanedioic acid, polymers with alkanoic acid-dipentaerythritol 
reaction products, substituted alkanedioc acid, substituted alkanoic 
acid, isocyanato-(isocyanatoalkyl)-alkyl substituted carbomonocycle and 
alkyl substituted alkanediol (PMN P-18-40) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iii), (iv), (3), (4), (When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), (a)(5)(respirators must provide a National Institute 
for Occupational Safety and Health assigned protection factor of at 
least 1000), (a)(6)(particulate), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(i), (vii), (ix), (irritation to 
eyes, lungs, and mucous membranes), (dermal sensitization), 
(respiratory sensitization), (g)(2)(i), (ii), (iii), (iv), (v), (g)(5). 
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 Sec.  721.80(f). It is a significant new use to import 
the substance if the number average molecular weight is less than or 
equal to 1000 daltons or greater than 20% of the acid moiety. It is a 
significant new use to use the substance other than as a binder for 
ultraviolet curable coating resins.
    (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 Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
21. Add Sec.  721.11240 to subpart E to read as follows:

Sec.  721.11240  Substituted carbomonocycle, polymer with 
diisocyanatoalkane, substituted alkylacrylate blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
substituted carbomonocycle, polymer with diisocyanatoalkane, 
substituted alkylacrylate blocked (PMN P-18-46) 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 Sec.  
721.63(a)(1), (2)(i), (iii), (iv), (3), (4), (When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), (a)(5)(respirators must provide a National Institute 
for Occupational Safety and Health assigned protection factor of at 
least 1000), (a)(6)(particulate), (b)(concentration set at 0.1%) and 
(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), (iv), 
(v), (vii), (ix), (irritation to eyes, lungs, and mucus membranes), 
(dermal and respiratory sensitization), (g)(2)(i), (ii), (iii), (iv), 
(v), (avoid eye contact), (g)(5). 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 Sec.  721.80(f). It is a significant new use to import 
the substance if the average molecular weight is less than or equal to 
1390 daltons, more than 11% is less than 500 daltons, or more than 30% 
is less than 1000 daltons. It is a significant new use to use the 
substance other than as an ultraviolet curable resin.
    (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 Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
22. Add Sec.  721.11241 to subpart E to read as follows:

Sec.  721.11241  1,2-Ethanediol, 1,2-dibenzoate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,2-ethanediol, 
1,2-dibenzoate (PMN P-18-47, CAS No. 94-49-5) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely 
entrained in cured resin.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2), (3), (4), (When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible),

[[Page 10018]]

(a)(5)(respirators must provide a National Institute for Occupational 
Safety and Health assigned protection factor of at least 25), (a)(6), 
(v), (vi), (particulate), (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(iii), 
(iv), (vi), (viii), (ix), (blood effects), (g)(2)(i), (ii), (iv), (v), 
(3)(i), (ii), (g)(5). 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 Sec.  721.80(f). It is a significant new use to use the 
substance other than as a phlegmatizer (stabilizer for compounds 
susceptible to detonation) for peroxides for use with polyester and 
vinyl ester resins as well as with curable unsaturated polyester and 
methacrylic resins.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 10.
    (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 Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
23. Add Sec.  721.11242 to subpart E to read as follows:

Sec.  721.11242  Alkenoic acid, reaction products with polymers with 
isocyanatoalkane and substituted alkanoic acid, substituted 
monoacrylate alkanoate-blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkenoic acid, reaction products with polymers with isocyanatoalkane 
and substituted alkanoic acid, substituted monoacrylate alkanoate-
blocked (PMN P-18-51) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the 
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iii), (iv), (3), (4), (When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), (a)(5)(respirators must provide a National Institute 
for Occupational Safety and Health assigned protection factor of at 
least 1000), (a)(6)(particulate), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(i), (ix), (irritation to eyes, 
lungs, and mucous membranes), (dermal sensitization), (respiratory 
sensitization), (g)(2)(i), (ii), (iii), (iv), (v), (avoid eye contact), 
(g)(5). 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 Sec.  721.80(f). It is a significant new use to use the 
substance other than as a waterborne ultraviolet curable coating resin 
binder for inkjet, ink, or overprint varnish. It is a significant new 
use to import the substance with greater than 24% of the branched alkyl 
acid moiety content. It is a significant new use to import the 
substance with greater than 0.1% isocyanate content.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 660.
    (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 Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
24. Add Sec.  721.11243 to subpart E to read as follows:

Sec.  721.11243  Aromatic dicarboxylic acid, compd. with alkane 
diamines, polymer with alkane diamine and alkane dicarboxylic acid 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
aromatic dicarboxylic acid, compd. with alkane diamines, polymer with 
alkane diamine and alkane dicarboxylic acid (P-18-71) 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. It is a 
significant new use to manufacture the substance with particle size 
less than 10 microns.
    (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 Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this significant new use rule.
0
25. Add Sec.  721.11244 to subpart E to read as follows:

Sec.  721.11244  Aromatic dicarboxylic acid, compd. with alkyl 
diamines, homopolymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
aromatic dicarboxylic acid, compd. with alkyl diamines, homopolymer (P-
18-79) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new use is:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the substance with particle size 
less than 10 microns.
    (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 Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this significant new use rule.
0
26. Add Sec.  721.11245 to subpart E to read as follows:

Sec.  721.11245  Aspartic acid, tallow modified diester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
aspartic acid, tallow modified diester (PMN P-18-82) 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

[[Page 10019]]

Sec.  721.63(a)(1), (2)(i), (iii), (3), (When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible), (b)(concentration 
set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), 
(iv), (2)(i), (ii), (v), (3)(i), (ii), (4)(iii)(above concentration of 
1 part per billion (ppb), (g)(5). 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 Sec.  721.80(g). It is a significant new use to 
manufacture, process, or use the substance that results in inhalation 
exposure. It is a significant new use to manufacture, process and use 
the substance other than as stated in the PMN.
    (iv) Disposal. Residuals must be recycled back into the process as 
stated in the PMN.
    (v) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), (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 Sec.  
721.125(a) through (k) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraphs (a)(2)(iii) 
and (iv) of this section.
0
27. Add Sec.  721.11246 to subpart E to read as follows:

Sec.  721.11246  Substituted alkanediol, polymer with heteromonocycles, 
alkenoate, metal complexes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
substituted alkanediol, polymer with heteromonocycles, alkenoate, metal 
complexes (PMN P-18-130) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the 
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iii), (3), (4), (When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
(4) engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible), 
(a)(5)(respirators must provide a National Institute for Occupational 
Safety and Health assigned protection factor (APF) of at least 50, or 
if spray applied an APF of 1000), (a)(6)(v), (vi), (particulate), and 
(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(i), (sensitization), (mutagenicity), 
(g)(2)(i), (ii), (iii), (iv), (v), (g)(5). 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 Sec.  721.80(f). It is a significant new use to use the 
substance other than as an adhesion promoter for industrial 
applications.
    (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 Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
[FR Doc. 2019-04457 Filed 3-18-19; 8:45 am]
 BILLING CODE 6560-50-P