Document ID: EPA-HQ-OPPT-2020-0303-0001
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rules on Certain Chemical Substances (20-7.B)
Posted Date: 2020-07-21T04:00Z

[Federal Register Volume 85, Number 140 (Tuesday, July 21, 2020)]
[Proposed Rules]
[Pages 44032-44038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15017]

[[Page 44032]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2020-0303; FRL-10011-81]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (20-7.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 (SNUN), 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 August 20, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2020-0303, 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: 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 
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 August 20, 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-16-313, P-17-333, 
P-18-320, P-18-363, P-20-15, P-20-38, and P-20-40. 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-2020-0303, 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

[[Page 44033]]

40 CFR 721.1(c), persons subject to these SNURs must comply with the 
same SNUN requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A) (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 certain 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.
     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-16-313

    Chemical name: Tar acids (shale oil), C6-9 fraction, alkyl phenols, 
low boiling.
    CAS number: 1887000-93-2.
    Basis for action: The PMN states that the use of the substance will 
be as a raw material in the production of resins. Based on the 
physical/chemical properties of the PMN substance, test data on the PMN 
substance, and Structure Activity Relationships (SAR) analysis of 
analogous substances, EPA has identified concerns for acute toxicity, 
aquatic toxicity, reproductive toxicity, skin corrosion, skin 
sensitization, and specific target organ toxicity if the chemical is 
not used following the limitations noted. This proposed SNUR designates 
the following as ``significant new uses'' requiring further review by 
EPA:
     Release of the PMN substance resulting in surface water 
concentrations that exceed 14 ppb.
    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 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 specific target organ toxicity 
testing would help characterize the potential health effects of the PMN 
substance.
    CFR citation: 40 CFR 721.11507.

PMN Number: P-17-333

    Chemical name: 2-Propenoic acid, mixed esters with heterocyclic 
dimethanol and heterocyclic methanol (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance will 
be as a reactive diluent for optical film coating. Based on test data 
on the PMN substance and SAR analysis of analogous substances, EPA has 
identified concerns for aquatic toxicity, reproductive toxicity, 
respiratory sensitization, skin sensitization, and specific target 
organ toxicity if the chemical is not used following the limitations 
noted. This proposed SNUR designates the following as ``significant new 
uses'' requiring further review by EPA:
     Release of the PMN substance resulting in surface water 
concentrations that exceed 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, 
developmental toxicity, reproductive toxicity, and specific target 
organ toxicity testing would help characterize the potential 
environmental and health effects of the PMN substance.
    CFR citation: 40 CFR 721.11508

PMN Number: P-18-320

    Chemical name: Alkane, diisocyanato-(isocyanatoalkyl)-(generic).
    CAS number: Not available.

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    Basis for action: The PMN states that the generic use of the 
substance will be as a hardener. Based on the physical/chemical 
properties of the PMN substance and data on the PMN substance and 
structurally analogous chemical substances, EPA has identified concerns 
for respiratory sensitization, serious eye damage, skin irritation, 
skin sensitization, and specific target organ toxicity if the chemical 
is not used following the limitations noted. This proposed SNUR 
designates the following as ``significant new uses'' requiring further 
review by EPA:
     Use without personal protective equipment to prevent 
dermal exposure where there is a potential for dermal exposure and a 
National Institute for Occupational Safety and Health certified 
respirator with an Assigned Protection Factor of at least 1,000 where 
there is a potential for inhalation exposures.
     Use of the PMN substance in a consumer product.
    Potentially useful information: EPA has determined that certain 
information about the fate properties 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 fate data and information that would inform the 
understanding of the hydrolysis at different concentrations would help 
characterize the health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.11509.

PMN Number: P-18-363

    Chemical name: Phenol, polymer with formaldehyde, 5-methyl-1,3-
benzenediol-terminated, sodium salts (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic use of the 
substance will be as an adhesive. Based on SAR analysis of test data on 
analogous substances, EPA has identified concerns for aquatic toxicity, 
eye irritation, serious eye damage, and skin irritation/corrosion if 
the chemical is not used following the limitations noted. This proposed 
SNUR designates the following as ``significant new uses'' requiring 
further review by EPA:
     Release of the PMN substance resulting in surface water 
concentrations that exceed 4 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, 
skin irritation/corrosion, and eye damage testing would help 
characterize the potential environmental and health effects of the PMN 
substance.
    CFR citation: 40 CFR 721.11510.

PMN Number: P-20-15

    Chemical name: N-Alkyl heteromonocyclic diphenolamide, polymer with 
bisphenol A, haloaryl-substituted sulfone, compd. with cyclic sulfonate 
ester, polyaryl alcohol terminated (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance will 
be as a polymer in the manufacture of hollow fiber products. Based on 
the physical/chemical properties of the PMN substance and SAR analysis 
of test data on analogous substances, EPA has identified concerns for 
specific target organ toxicity if the chemical is not used following 
the limitations noted. This proposed SNUR designates the following as 
``significant new uses'' requiring further review by EPA:
     Manufacture beyond the confidential annual production 
volume specified in the PMN.
     Use other than as a polymer in the manufacture of hollow 
fiber membrane products.
    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 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 pulmonary effects (polymer lung 
overload) testing would help characterize the potential health effects 
of the PMN substance.
    CFR citation: 40 CFR 721.11511.

PMN Number: P-20-38

    Chemical name: 1,3,5-Triazine-2,4,6(1H,3H,5H)-trione, 1,3,5-tris[3-
(2-oxiranyl)propyl]-.
    CAS number: 91403-64-4.
    Basis for action: The PMN states that the use of the substance will 
be as a resist compound for semiconductor manufacture. Based on the 
physical/chemical properties of the PMN substance and SAR analysis of 
test data on analogous substances, EPA has identified concerns for 
acute toxicity, aquatic toxicity, eye irritation, gene cell 
mutagenicity, reproductive toxicity, respiratory sensitization, skin 
irritation, skin sensitization, and specific target organ toxicity if 
the chemical is not used following the limitations noted. This proposed 
SNUR designates the following as ``significant new uses'' requiring 
further review by EPA:
     Manufacture, process, or use the PMN substance in any 
manner that results in inhalation exposure.
     Release of the PMN substance resulting in surface water 
concentrations that exceed 5 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, 
developmental toxicity, neurotoxicity, and reproductive toxicity 
testing would help characterize the potential environmental and health 
effects of the PMN substance.
    CFR citation: 40 CFR 721.11512.

PMN Number: P-20-40

    Chemical name: 2-Propenoic acid, cycloalkyl ester (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic use of the 
substance will be as an additive for use in inks, coatings, adhesives 
and sealants. Based on the physical/chemical properties of the PMN 
substance and SAR analysis of test data on analogous substances, EPA 
has identified concerns for aquatic toxicity, aspiration hazard, 
reproductive toxicity, skin sensitization, and specific target organ 
toxicity if the chemical is not used following the limitations noted. 
This proposed SNUR designates the following as ``significant new uses'' 
requiring further review by EPA:
     Release of the PMN substance resulting in surface water 
concentrations that exceed 7 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, 
developmental toxicity, reproductive toxicity, skin sensitization,

[[Page 44035]]

and specific target organ toxicity testing would help characterize the 
potential environmental and health effects of the PMN substance.
    CFR citation: 40 CFR 721.11513.

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. As a result, those significant new uses cannot 
occur without 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 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 chemical, under the conditions of 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 July 6, 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

[[Page 44036]]

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 40 CFR 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-
2020-0303.

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 
(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 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, 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 of 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.

[[Page 44037]]

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: June 30, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR part 721 is 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. Sec.  721.11507 through 721.11513 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11507 Tar acids (shale oil), C6-9 fraction, alkyl phenols, low 
boiling.
721.11508 2-Propenoic acid, mixed esters with heterocyclic 
dimethanol and heterocyclic methanol (generic).
721.11509 Alkane, diisocyanato-(isocyanatoalkyl)- (generic).
721.11510 Phenol, polymer with formaldehyde, 5-methyl-1,3-
benzenediol-terminated, sodium salts (generic).
721.11511 N-Alkyl heteromonocyclic diphenolamide, polymer with 
bisphenol A, haloaryl-substituted sulfone, compd. with cyclic 
sulfonate ester, polyaryl alcohol terminated (generic).
721.11512 1,3,5-Triazine-2,4,6(1H,3H,5H)-trione, 1,3,5-tris[3-(2-
oxiranyl)propyl]-.
721.11513 2-Propenoic acid, cycloalkyl ester (generic).
* * * * *

Sec.  721.11507   Tar acids (shale oil), C6-9 fraction, alkyl phenols, 
low boiling.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as tar acids (shale 
oil), C6-9 fraction, alkyl phenols, low boiling (PMN P-16-313, CAS No. 
1887000-93-2) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 14.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11508   2-Propenoic acid, mixed esters with heterocyclic 
dimethanol and heterocyclic methanol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 2-
propenoic acid, mixed esters with heterocyclic dimethanol and 
heterocyclic methanol (PMN P-17-333) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 1.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11509   Alkane, diisocyanato-(isocyanatoalkyl)- (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as alkane, 
diisocyanato-(isocyanatoalkyl)- (PMN P-18-320) 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)(1) and (3) through (6), and (c). 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. 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) 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 (e), (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.

Sec.  721.11510  Phenol, polymer with formaldehyde, 5-methyl-1,3-
benzenediol-terminated, sodium salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as phenol, 
polymer with formaldehyde, 5-methyl-1,3-benzenediol-terminated, sodium 
salts (generic) (PMN P-18-363) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 4.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).

[[Page 44038]]

    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11511  N-Alkyl heteromonocyclic diphenolamide, polymer with 
bisphenol A, haloaryl-substituted sulfone, compd. with cyclic sulfonate 
ester, polyaryl alcohol terminated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as N-Alkyl 
heteromonocyclic diphenolamide, polymer with bisphenol A, haloaryl-
substituted sulfone, compd. with cyclic sulfonate ester, polyaryl 
alcohol terminated (PMN P-20-15) 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(s). It is a significant new use to use the 
PMN substance for other than as a polymer in the manufacture of hollow 
fiber membrane products.
    (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.
    (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.  721.11512  1,3,5-Triazine-2,4,6(1H,3H,5H)-trione, 1,3,5-tris[3-
(2-oxiranyl)propyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,3,5-triazine-
2,4,6(1H,3H,5H)-trione, 1,3,5-tris[3-(2-oxiranyl)propyl]- (PMN P-20-38, 
CAS No. 91403-64-4) 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. It is a 
significant new use to manufacture, process, or use the PMN substance 
in any 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 = 5.
    (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.  721.11513  2-Propenoic acid, cycloalkyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 2-
Propenoic acid, cycloalkyl ester (PMN P-20-40) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) where N = 7.
    (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 (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.

[FR Doc. 2020-15017 Filed 7-20-20; 8:45 am]
BILLING CODE 6560-50-P