[Federal Register Volume 85, Number 115 (Monday, June 15, 2020)]
[Proposed Rules]
[Pages 36175-36182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12614]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2020-0251; FRL-10010-40]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (20-6.B)

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 chemical substances which are 
the subject of premanufacture notices (PMNs). This action would require 
persons to notify EPA at least 90 days before commencing manufacture 
(defined by statute to include import) or processing of any of these 
chemical substances for an activity that is designated as a significant 
new use by this proposed rule. This action would further require that 
persons not commence manufacture or processing for the significant new 
use until they have submitted a Significant New Use Notice, and EPA has 
conducted a review of the notice, made an appropriate determination on 
the notice under TSCA, and has taken any risk management actions as are 
required as a result of that determination.

DATES: Comments must be received on or before July 15, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2020-0251, 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.
    Please note that due to the public health emergency the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://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: 
[email protected].

[[Page 36176]]

    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this proposed 
rule. The following list of North American Industrial Classification 
System (NAICS) codes is not intended to be exhaustive, but rather 
provides a guide to help readers determine whether this document 
applies to them. Potentially affected entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
provisions. This action may also affect certain entities through pre-
existing import certification and export notification rules under TSCA, 
which would include the SNUR requirements should these proposed rules 
be finalized. The EPA policy in support of import certification appears 
at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20, 
any persons who export or intend to export a chemical substance that is 
the subject of this proposed rule on or after July 15, 2020 are subject 
to the export notification provisions of TSCA section 12(b) (15 U.S.C. 
2611(b)) 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 CBI 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 which are the subjects of PMNs P-18-151, P-18-271, 
P-19-19, P-19-88, P-19-109, P-20-36, P- and 20-37. These proposed SNURs 
would require persons who intend to manufacture or process any of these 
chemical substances for an activity that is designated as a significant 
new use to notify EPA at least 90 days before commencing that activity.
    The record for these proposed SNURs, identified as docket ID number 
EPA-HQ-OPPT-2020-0251, includes information considered by the Agency in 
developing these proposed SNURs.

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

    TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four TSCA section 5(a)(2) factors 
listed in Unit III.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 
40 CFR 721.1(c), persons subject to these SNURs must comply with the 
same significant new use notice (SNUN) requirements and EPA regulatory 
procedures as submitters of PMNs under TSCA section 5(a)(1)(A) (15 
U.S.C. 2604(a)(1)(A)). In particular, these requirements include the 
information submission requirements of TSCA sections 5(b) and 5(d)(1) 
(15 U.S.C. 2604(b) and 2604(d)(1)), the exemptions authorized by TSCA 
sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 
40 CFR part 720. Once EPA receives a SNUN, EPA must either determine 
that the use is not likely to present an unreasonable risk of injury 
under the conditions of use for the chemical substance or take such 
regulatory action as is associated with an alternative determination 
before the manufacture or processing for the significant new use can 
commence. If EPA determines that the use is not likely to present an 
unreasonable risk, EPA is required under TSCA section 5(g) to make 
public, and submit for publication in the Federal Register, a statement 
of EPA's findings.

III. Significant New Use Determination

    TSCA section 5(a)(2) states that EPA's determination that a use of 
a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In determining what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, and 
potential human exposures and environmental releases that may be 
associated with the substances, in the context of the four bulleted 
TSCA section 5(a)(2) factors listed in this unit. During its review of 
these chemicals, EPA identified certain conditions of use that are not 
intended by the submitters, but reasonably foreseen to occur. EPA is 
proposing to designate those reasonably foreseen conditions of use as 
well as certain other circumstances of use as significant new uses.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for 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 SNUR.

[[Page 36177]]

     Potentially Useful Information.
     CFR citation assigned in the regulatory text section of 
these proposed rules.
    The regulatory text section of this document specifies the 
activities designated as significant new uses. Certain new uses, 
including production volume limits and other uses designated in the 
proposed rules, may be claimed as CBI.
    The chemical substances that are the subject of these proposed 
SNURs are undergoing premanufacture review. In addition to those 
conditions of use intended by the submitter, EPA has identified certain 
other reasonably foreseen conditions of use. EPA has preliminarily 
determined that the chemicals under their intended conditions of use 
are not likely to present an unreasonable risk. However, EPA has not 
assessed risks associated with the reasonably foreseen conditions of 
use for these chemicals. EPA is proposing to designate these reasonably 
foreseen conditions of use and other circumstances of use as 
significant new uses. As a result, those significant new uses cannot 
occur without first going through a separate, subsequent EPA review and 
determination process associated with a SNUN.
    The substances subject to these proposed rules are as follows:
PMN Number: P-18-151
    Chemical name: Formaldehyde, reaction products with 1,3-
benzenedimethanamine and p-tert-butylphenol.
    CAS number: 158800-93-2.
    Basis for action: The PMN states that the use of the substance will 
be as a curing agent for epoxy systems. Based on the physical/chemical 
properties of the PMN substance and Structure Activity Relationships 
(SAR) analysis of test data on analogous substances, EPA has identified 
concerns for aquatic toxicity, reproductive/developmental toxicity, 
respiratory sensitization, skin corrosion, skin irritation, skin 
sensitization, and systemic effects if the chemical substance is used 
in ways other than as intended by the PMN submitter. This proposed SNUR 
designates the following as ``significant new uses'' requiring further 
review by EPA:
     Manufacture, processing, or use in a manner that results 
in inhalation exposure.
     Release of a manufacturing, processing, or use stream 
associated with any use of the PMN substance exceeding a surface water 
concentration of 1 ppb.
    Potentially Useful Information: EPA has determined that certain 
information about the environmental and health effects of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance 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 determined that the results of aquatic toxicity, 
eye damage, reproductive toxicity, skin corrosion, skin sensitization, 
and specific target organ toxicity testing would help characterize the 
potential environmental and health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11498.
PMN Number: P-18-271
    Chemical Name: 2-Propanol, 1-butoxy-, 2,2'-ester (generic).
    CAS Number: Not available.
    Basis for Action: The PMN states that the use of the substance will 
be as a film-forming coalescent for architectural coatings; for 
automotive OEM coatings; for can and coil coatings; for industrial wood 
coatings; for floor polishes, for industrial maintenance coatings; for 
marine and wood coatings; for transportation coatings; for use in 
printing inks; and as a chemical intermediate to prepare ester 
plasticizers. Based on the physical/chemical properties of the PMN 
substance and Structure Activity Relationships (SAR) analysis of test 
data on analogous substances, EPA has identified concerns for 
irritation and specific target organ toxicity as hazards based on the 
expected metabolite (propylene glycol n-butyl ether) if the chemical 
substance is used in ways other than as intended by the PMN submitter. 
The proposed SNUR designates the following as ``significant new uses'' 
requiring further EPA review:t.:
     Use other than as a film-forming coalescent for 
architectural coatings; for automotive OEM coatings; for can and coil 
coatings; for industrial wood coatings; for floor polishes, for 
industrial maintenance coatings; for marine and wood coatings; for 
transportation coatings; for use in printing inks; and as a chemical 
intermediate to prepare ester plasticizers, consistent with the 
manufacturing, processing, use, distribution, and disposal information 
described in the PMN.
     Processing the PMN substance to a weight fraction greater 
than 8% in the final formulation.
    Potentially Useful Information: EPA has determined that certain 
information about the environmental and health effects of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance 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 determined that the results of toxicokinetics, 
skin irritation, eye damage, specific target organ toxicity, and 
aquatic toxicity testing would help characterize the potential 
environmental and health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11499.
PMN Number: P-19-19
    Chemical Name: Haloalkane (generic).
    CAS Number: Not available.
    Basis for Action: The PMN states that the generic use of the 
substance will be as a chemical intermediate. Based on the physical/
chemical properties of the PMN substance and Structure Activity 
Relationships (SAR) analysis of test data on analogous substances, EPA 
has identified concerns for skin irritation, specific target organ 
toxicity, and aquatic toxicity if the chemical substance is used in 
ways other than as intended by the PMN submitter. This proposed SNUR 
designates the following as ``significant new uses'' requiring further 
review by EPA:
     Release of a manufacturing, processing, or use stream 
associated with any use of the PMN substance exceeding a surface water 
concentration of 23 ppb.
     Use of the PMN substance without a National Institute for 
Occupational Safety and Health (NIOSH) certified respirator with an 
assigned protection factor of at least 1000.
    Potentially Useful Information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health and environmental effects of the PMN 
substance 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 determined that the results of skin irritation, 
specific target organ toxicity, and aquatic toxicity testing would help 
characterize the potential health and environmental effects of the PMN 
substance.
    CFR Citation: 40 CFR 721.11500.
PMN Number: P-19-88
    Chemical Name: Ethanamine, N-ethyl-, 2-hydroxy-1,2,3-
propanetricarboxylate (1:?).
    CAS Number: 23251-73-2.
    Basis for Action: The PMN states that the generic use of the 
substance will be as feedstock for amine recovery. Based on the 
physical/chemical properties of

[[Page 36178]]

the PMN substance and Structure Activity Relationships (SAR) analysis 
of test data on analogous substances, EPA has identified concerns for 
acute toxicity, reproductive toxicity, serious eye damage, skin 
corrosion, and specific target organ toxicity if the chemical substance 
is used in ways other than as intended by the PMN submitter. This 
proposed SNUR designates the following as ``significant new uses'' 
requiring further review by EPA:
     Manufacture, processing, or use in a manner that results 
in inhalation exposure.
     Release of a manufacturing, processing, or use stream 
associated with any use of the PMN substance exceeding a surface water 
concentration of 46 ppb.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful 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 determined that the results of skin 
corrosion, eye damage, reproductive/developmental effects, and specific 
target organ toxicity testing would help characterize the potential 
health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11501.
PMN Number: P-19-109
    Chemical Names: Copper, [[2,2',2''-
(nitrilo-.kappa.N)tris[ethanolato-.kappa.O]](2-)]- (P-19-109, chemical 
A) and copper, bis[2-(amino-.kappa.N)ethanolato-.kappa.O]- (P-19-109, 
chemical B).
    CAS Numbers: 21545-60-8 (P-19-109, chemical A) and 14215-52-2 (P-
19-109, chemical B).
    Basis for Action: The PMN states that the use of the substances 
will be as components of a cleaning formulation to improve the 
wettability of the overall cleaning solution on the substrate. Based on 
the physical/chemical properties of the PMN substance and Structure 
Activity Relationships (SAR) analysis of test data on analogous 
substances, EPA has identified concerns for acute toxicity, aquatic 
toxicity, eye irritation, reproductive toxicity, skin irritation, and 
specific target organ toxicity if the chemical substance is used in 
ways other than as intended by the PMN submitter. This proposed SNUR 
designates the following as ``significant new uses'' requiring further 
review by EPA:
     Use of the PMN substances in consumer products.
     Manufacture, processing, or use in a manner that results 
in inhalation exposure.
     Release of a manufacturing, processing, or use stream 
associated with any use of the PMN substance exceeding a surface water 
concentration of 3 ppb.
    Potentially Useful Information: EPA has determined that certain 
information about the environmental and health effects of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances 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 determined that the results of aquatic toxicity, 
developmental toxicity, neurotoxicity, pulmonary effects, reproductive 
toxicity, and specific target organ toxicity testing would help 
characterize the potential environmental and health effects of the PMN 
substances.
    CFR Citations: 40 CFR 721.11502 (P-19-109, chemical A); 40 CFR 
721.11503 (P-19-109, chemical B).
PMN Number: P-20-36
    Chemical Name: Carbonic acid, di(lithium-6Li) salt.
    CAS Number: 25890-20-4.
    Basis for Action: The PMN states that the generic use of these 
substance will be as a chemical intermediate for the manufacture of 
Lithium-6 Chloride. Based on the physical/chemical properties of the 
PMN substance and Structure Activity Relationships (SAR) analysis of 
test data on analogous substances, EPA has identified concerns for 
acute toxicity, aquatic toxicity, eye irritation, reproductive 
toxicity, skin irritation, and specific target organ toxicity if the 
chemical substance is used in ways other than as intended by the PMN 
submitter. This proposed SNUR designates the following as ``significant 
new uses'' requiring further review by EPA:
     Use other than for the confidential use specified in the 
PMN.
     Release of a manufacturing, processing, or use stream 
associated with any use of the PMN substance exceeding a surface water 
concentration of 35 ppb.
    Potentially Useful Information: No toxicity data are necessary as 
the moiety of concern for the new chemical substance (lithium) is well 
studied and has a rich toxicity database. EPA has determined that the 
results of workplace exposure or environmental release information 
would help characterize the potential effects of the PMN substance.
    CFR Citation: 40 CFR 721.11504.
PMN Number: P-20-37
    Chemical Name: Lithium Chloride (6LiCl).
    CAS Number: 20227-31-0.
    Basis for Action: The PMN states that the generic use of the 
substance will be as a material used in the manufacture of devices for 
gamma and neutron radiation detection. Based on the physical/chemical 
properties of the PMN substance and Structure Activity Relationships 
(SAR) analysis of test data on analogous substances, EPA has identified 
concerns for acute toxicity, eye irritation, reproductive toxicity, 
skin irritation, and specific target organ toxicity if the chemical 
substance is used in ways other than as intended by the PMN submitter. 
This proposed SNUR designates the following as ``significant new uses'' 
requiring further review by EPA:
     Use other than for the confidential use specified in the 
PMN.
    Potentially Useful Information: No toxicity data are necessary as 
the moiety of concern for the new chemical substance (lithium) is well 
studied and has a rich toxicity database. EPA has determined that the 
results of workplace exposure or environmental release information 
would help characterize the potential effects of the PMN substance.
    CFR Citation: 40 CFR 721.11505.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are the subject of these proposed SNURs and as further discussed 
in Unit IV, EPA identified certain other reasonably foreseen conditions 
of use, in addition to those conditions of use intended by the 
submitter. EPA has preliminarily determined that the chemical under the 
intended conditions of use is not likely to present an unreasonable 
risk. However, EPA has not assessed risks associated with the 
reasonably foreseen conditions of use. EPA is proposing to designate 
these conditions of use as well as certain other circumstances of use 
as significant new uses to ensure that they are no longer reasonably 
foreseen to occur without first going through a separate, subsequent 
EPA review and determination process associated with a SNUN.

B. Objectives

    EPA is proposing these SNURs because the Agency wants:
     To have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed

[[Page 36179]]

chemical substance for the described significant new use.
     To be obligated to make a determination under TSCA section 
5(a)(3) regarding the use described in the SNUN, under the conditions 
of use. The Agency will either determine under TSCA section 5(a)(3)(C) 
that the significant new use is not likely to present an unreasonable 
risk, including an unreasonable risk to a potentially exposed or 
susceptible subpopulation identified as relevant by the Administrator 
under the conditions of use, or make a determination under TSCA section 
5(a)(3)(A) or (B) and take the required regulatory action associated 
with the determination, before manufacture or processing for the 
significant new use of the chemical substance can occur.
     To be able to complete its review and determination on 
each of the PMN substances, while deferring analysis on the significant 
new uses proposed in these rules unless and until the Agency receives a 
SNUN.
    Issuance of a proposed SNUR for a chemical substance does not 
signify that the chemical substance is listed on the TSCA Inventory. 
Guidance on how to determine if a chemical substance is on the TSCA 
Inventory is available on the internet at https://www.epa.gov/tsca-inventory.

VI. Applicability of the Proposed Rules to Uses Occurring Before the 
Effective Date of the Final Rule

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this proposed rule 
were undergoing premanufacture review at the time of signature of this 
proposed rule and were not on the TSCA Inventory. 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 
the chemical substances subject to these proposed SNURs, EPA concludes 
that the proposed significant new uses are not ongoing.
    EPA designates June 2, 2020 (date of web posting of this proposed 
rule) 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.
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified on or after 
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 
EPA would have to take action under TSCA section 5 allowing manufacture 
or processing to proceed. 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.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require development of 
any particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: If a person is required to 
submit information for a chemical substance pursuant to a rule, Order 
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA 
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information 
to be submitted to EPA at the time of submission of the SNUN.
    In the absence of a rule, Order, or consent agreement under TSCA 
section 4 covering the chemical substance, persons are required only to 
submit information in their possession or control and to describe any 
other information known to or reasonably ascertainable by them (see 40 
CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. Unit IV. lists potentially 
useful information for all SNURs listed here. Descriptions are provided 
for informational purposes. The potentially useful information 
identified in Unit IV. will be useful to EPA's evaluation in the event 
that someone submits a SNUN for the significant new use. Companies who 
are considering submitting a SNUN are encouraged, but not required, to 
develop the information on the substance, which may assist with EPA's 
analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency pertaining to protocol selection. Furthermore, 
pursuant to TSCA section 4(h), which pertains to reduction of testing 
in vertebrate animals, EPA encourages consultation with the Agency on 
the use of alternative test methods and strategies (also called New 
Approach Methodologies, or NAMs), if available, to generate the 
recommended test data. EPA encourages dialog with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h).
    The potentially useful information described in Unit IV. may not be 
the only means of providing information to evaluate the chemical 
substance associated with the significant new uses. However, submitting 
a SNUN without any test data may increase the likelihood that EPA will 
take action under TSCA sections 5(e) or 5(f). EPA recommends that 
potential SNUN submitters contact EPA early enough so that they will be 
able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 40 CFR 720.50. SNUNs 
must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available 
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this proposed rule. EPA's complete economic 
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2020-0251.

X. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulations and Regulatory Review

    This action proposes to establish SNURs for new chemical substances 
that were the subject of PMNs. The Office of Management and Budget

[[Page 36180]]

(OMB) has exempted these types of actions from review under Executive 
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, 
January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to the PRA, 44 U.S.C. 3501 et seq., an Agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA and assigned 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, 
Regulatory Support Division, Office of Mission Support (2822T), 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001. Please remember to include the OMB control number in any 
correspondence, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., the 
Agency hereby certifies that promulgation of this action will not have 
a significant 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, EPA has concluded 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 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, EPA 
received 7 SNUNs in Federal fiscal year (FY) 2013, 13 in FY2014, 6 in 
FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018, only a fraction 
of these SNUNs 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 cost of submitting a SNUN to about 
$10,116 for qualifying small firms.
    Therefore, the potential economic impacts of complying with this 
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 action does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1531-1538 et seq.).

E. Executive Order 13132: Federalism

    This action will not have a substantial direct effect on States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government, as specified in Executive Order 13132 (64 FR 43255, 
August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action will not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes; will not 
significantly or uniquely affect the communities of Indian Tribal 
governments; nor does it involve or impose any requirements that affect 
Indian Tribes. Accordingly, the requirements of Executive Order 13175 
(65 FR 67249, November 9, 2000), do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because this is not an economically significant 
regulatory action as defined by Executive Order 12866, and this action 
does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355, 
May 22, 2001), because this action is not expected to affect energy 
supply, distribution, or use and because this action is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

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

    Dated: May 29, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
    Therefore, it is proposed that 40 CFR part 721 is amended as 
follows:

[[Page 36181]]

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. Sec.  721.11498 through 721.11506 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11498 Formaldehyde, reaction products with 1,3-
benzenedimethanamine and p-tert-butylphenol.
721.11499 2-Propanol, 1-butoxy-, 2,2'-ester (generic).
721.11500 Haloalkane (generic).
721.11501 Ethanamine, N-ethyl-, 2-hydroxy-1,2,3-
propanetricarboxylate (1:?).
721.11502 Copper, [[2,2',2''-
(nitrilo-.kappa.N)tris[ethanolato-.kappa.O]](2-)]- (P-19-109, 
chemical A).
721.11503 Copper, bis[2-(amino-.kappa.N)ethanolato-.kappa.O]- (P-19-
109, chemical B).
721.11504 Carbonic acid, di(lithium-6Li) salt.
721.11505 Lithium chloride (6LiCl).
721.11506 [Reserved].
* * * * *


Sec.  721.11498   Formaldehyde, reaction products with 1,3-
benzenedimethanamine and p-tert-butylphenol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as formaldehyde, 
reaction products with 1,3-benzenedimethanamine and p-tert-butylphenol 
(PMN P-18-151; CASRN 158800-93-2) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the PMN substance 
in a manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11499   2-Propanol, 1-butoxy-, 2,2'-ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 2-
propanol, 1-butoxy-, 2,2'-ester (PMN P-18-271) 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 use the PMN substance other than as a film-
forming coalescent for architectural coatings; for automotive OEM 
coatings; for can and coil coatings; for industrial wood coatings; for 
floor polishes, for industrial maintenance coatings; for marine and 
wood coatings; for transportation coatings; for use in printing inks; 
or as a chemical intermediate to prepare ester plasticizers. It is a 
significant new use to process the PMN substance to a weight fraction 
greater than 8% in the final formulation.
    (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 (c), and (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.


Sec.  721.11500   Haloalkane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
haloalkane (PMN P-19-19) 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) Workplace protection. Requirements as specified in Sec.  
721.63(a)(4) through (6), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 1000. For purposes of Sec.  721.63(a)(6), particulate 
(including solids or liquid droplets).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 23.
    (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 (d), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11501   Ethanamine, N-ethyl-, 2-hydroxy-1,2,3-
propanetricarboxylate (1:?).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as ethanamine, N-
ethyl-, 2-hydroxy-1,2,3-propanetricarboxylate (1:?) (PMN P-19-88; CASRN 
23251-73-2) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the PMN substance 
in a manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 46.
    (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), (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11502   Copper, [[2,2',2''-
(nitrilo-.kappa.N)tris[ethanolato-.kappa.O]](2-)]-(P-19-109, chemical 
A).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as copper, [[2,2',2''-
(nitrilo-.kappa.N)tris[ethanolato-.kappa.O]](2-)]- (PMN P-19-109, 
chemical A; CASRN 21545-60-8) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the PMN substance in any manner that 
results in inhalation exposure.

[[Page 36182]]

    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 3.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11503   Copper, bis[2-(amino-.kappa.N)ethanolato-.kappa.O]- 
(P-19-109, chemical B).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as copper, bis[2-
(amino-.kappa.N)ethanolato-.kappa.O]- (PMN P-19-109, chemical B; CASRN 
14215-52-2) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the PMN substance in any matter that 
results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 3.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11504   Carbonic acid, di(lithium-6Li) salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as carbonic acid, 
di(lithium-6Li) salt (PMN P-20-36; CASRN 25890-20-4) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 35.
    (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), (i), and (k).
    (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)(ii) of 
this section.


Sec.  721.11505   Lithium chloride (6LiCl).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as lithium chloride 
(6LiCl) (PMN P-20-37; CASRN 20227-31-0) 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(j).
    (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 (c), and (i).
    (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)(ii) of 
this section.


Sec.  721.11506   [Reserved].

[FR Doc. 2020-12614 Filed 6-12-20; 8:45 am]
BILLING CODE 6560-50-P