[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