Significant New Use Rules on Certain Chemical Substances (20-10.B), 66506-66512 [2020-22645]
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Federal Register / Vol. 85, No. 203 / Tuesday, October 20, 2020 / Proposed Rules
threshold of showing that at least one
claim of the patent is unpatentable.
The Office has also received input
from stakeholders proposing that the
Office adopt a bright-line rule that
precludes institution of an AIA trial
against challenged claims if the patent
owner opposes institution and any of
the challenged claims are or have been
asserted against the petitioner, the
petitioner’s real party in interest, or a
privy of the petitioner in a district court
or ITC action that is unlikely to be
stayed.
By contrast, the Office also has
received input from other stakeholders
proposing that the Office adopt a brightline rule to eliminate any consideration
of the state of any district court or ITC
actions involving the challenged patent,
so long as the petition complies with
statutory timing requirements and meets
the particular institution threshold of
showing that at least one claim of the
patent is unpatentable.
In light of the various contrasting
views from some stakeholders, the
Office solicits further public input on
what should be considered as part of a
balanced assessment of the relevant
circumstances when exercising its
discretion to institute an AIA trial.
Issues for Comment
The USPTO seeks comments on
considerations for instituting AIA trials
as it relates to serial and parallel AIA
petitions, as well as proceedings in
other tribunals. The questions
enumerated below are a preliminary
guide to aid the USPTO in collecting
relevant information to assist in
modifications, if any, to its current
practices, and in the development of
any possible rulemaking on this subject.
The questions should not be taken as an
indication that the USPTO has taken a
position or is predisposed to any
particular views. The USPTO welcomes
comments from the public on any issues
believed to be relevant to these topics,
and is particularly interested in answers
to the following questions:
Serial Petitions
1. Should the Office promulgate a rule
with a case-specific analysis, such as
generally outlined in General Plastic,
Valve I, Valve II and their progeny, for
deciding whether to institute a petition
on claims that have previously been
challenged in another petition?
2. Alternatively, in deciding whether
to institute a petition, should the Office
(a) altogether disregard whether the
claims have previously been challenged
in another petition, or (b) altogether
decline to institute if the claims have
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previously been challenged in another
petition?
ENVIRONMENTAL PROTECTION
AGENCY
Parallel Petitions
40 CFR Part 721
3. Should the Office promulgate a rule
with a case-specific analysis, such as
generally outlined in the Consolidated
Trial Practice Guide, for deciding
whether to institute more than one
petition filed at or about the same time
on the same patent?
4. Alternatively, in deciding whether
to institute more than one petition filed
at or about the same time on the same
patent, should the Office (a) altogether
disregard the number of petitions filed,
or (b) altogether decline to institute on
more than one petition?
Proceedings in Other Tribunals
5. Should the Office promulgate a rule
with a case-specific analysis, such as
generally outlined in Fintiv and its
progeny, for deciding whether to
institute a petition on a patent that is or
has been subject to other proceedings in
a U.S. district court or the ITC?
6. Alternatively, in deciding whether
to institute a petition on a patent that is
or has been subject to other proceedings
in district court or the ITC, should the
Office (a) altogether disregard such
other proceedings, or (b) altogether
decline to institute if the patent that is
or has been subject to such other
proceedings, unless the district court or
the ITC has indicated that it will stay
the action?
Other Considerations
7. Whether or not the Office
promulgates rules on these issues, are
there any other modifications the Office
should make in its approach to serial
and parallel AIA petitions, proceedings
in other tribunals, or other use of
discretion in deciding whether to
institute an AIA trial?
Andrei Iancu,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.
[FR Doc. 2020–22946 Filed 10–19–20; 8:45 am]
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[EPA–HQ–OPPT–2020–0497; FRL–10015–
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RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances (20–10.B)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
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,
and has taken any risk management
actions as are required as a result of that
determination.
DATES: Comments must be received on
or before November 19, 2020.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2020–0497,
using the Federal eRulemaking Portal at
https://www.regulations.gov. Follow the
online instructions for submitting
comments. Do not submit electronically
any information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
Due to the public health emergency,
the EPA Docket Center (EPA/DC) and
Reading Room is closed to visitors with
limited exceptions. The staff continues
to provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
William Wysong, Chemical Control
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
SUMMARY:
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telephone number: (202) 564–4163;
email address: wysong.william@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or use the chemical substances
contained in this proposed rule. The
following list of North American
Industrial Classification System
(NAICS) codes is not intended to be
exhaustive, but rather provides a guide
to help readers determine whether this
document applies to them. Potentially
affected entities may include:
• Manufacturers or processors of one
or more subject chemical substances
(NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import provisions. 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
November 19, 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
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that does not contain the information
claimed as CBI must be submitted for
inclusion in the public docket.
Information so marked will not be
disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
commenting-epa-dockets.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under
TSCA section 5(a)(2) for chemical
substances which are the subjects of
PMNs P–18–289, P–18–330, P–18–334,
P–18–335, and P–18–337. 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–2020–0497, 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. Do the SNUR general provisions
apply?
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 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,
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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 chemical
substance 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 be
added to 40 CFR part 721, subpart E for
the chemical substances identified in
this unit. For each chemical substance,
EPA provides the following information
in this unit:
• PMN number.
• Chemical name (generic name, if
the specific name is claimed as CBI).
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• Chemical Abstracts Service (CAS)
Registry number (if assigned for nonconfidential 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 these
proposed rules 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–18–289
Chemical name: 2(2(Methylcaboxymonocyclic)amino)
ethoxy)-alcohol (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic use of the substance will be
as a gas scrubber and wastewater
deodorizer. 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 eye irritation,
skin irritation, 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:
1. Manufacture beyond an annual
production volume of 80,000 kg.
2. Use other than for the confidential
uses specified in the PMN.
Potentially useful information: EPA
has determined that certain information
about the effects of the PMN substance
may be potentially useful if a
manufacturer or processor is
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considering submitting a SNUN for a
significant new use that would be
designated by this proposed SNUR. EPA
has determined that the results of eye
irritation/corrosion and specific target
organ toxicity testing would help
characterize the potential health effects
of the PMN substance.
CFR citation: 40 CFR 721.11561.
PMN Number: P–18–330
Chemical name: Formaldehyde,
polymer with alkyl aryl ketone
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic use of the substance will be
as an initiator. Based on the physical/
chemical properties of the PMN
substance and SAR analysis of test data
on analogous substances, EPA has
identified concerns for nephrotoxicity,
skin sensitization, specific target organ
toxicity, and systemic 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:
1. Use of the PMN substance in a
consumer product.
2. Release of the PMN substance
resulting in surface water
concentrations that exceed 770 ppb.
Potentially useful information: EPA
has determined that certain information
about the 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
sensitization and specific target organ
toxicity testing would help characterize
the potential health effects of the PMN
substance.
CFR citation: 40 CFR 721.11562.
PMN Number: P–18–334
Chemical name: Propanedioic acid,
1,3-dihexyl ester.
CAS number: 1431–37–4.
Basis for action: The PMN states that
the use of the substance will be as a
chemical intermediate. 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,
eye irritation, 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:
1. Use other than as a chemical
intermediate.
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2. Release of the PMN substance
resulting in surface water
concentrations that exceed 3 ppb.
Potentially useful information: EPA
has determined that certain information
about the 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
aquatic toxicity, eye irritation/corrosion,
and specific target organ toxicity testing
would help characterize the potential
environmental and health effects of the
PMN substance.
CFR citation: 40 CFR 721.11563.
PMN Number: P–18–335
Chemical name: Propanedioic acid,
1,3-dicyclohexyl ester.
CAS number: 1152–57–4.
Basis for action: The PMN states that
the use of the substance will be as a
chemical intermediate. 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,
eye irritation, skin irritation, 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:
1. Use other than as a chemical
intermediate.
2. Release of the PMN substance
resulting in surface water
concentrations that exceed 6 ppb.
Potentially useful information: EPA
has determined that certain information
about the 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
aquatic toxicity, eye irritation/corrosion,
skin irritation/corrosion, and specific
target organ toxicity testing would help
characterize the potential environmental
and health effects of the PMN substance.
CFR citation: 40 CFR 721.11564.
PMN Number: P–18–337
Chemical name: Propanedioic acid,
2,2-bis(hydroxymethyl)-, 1,3dicyclohexyl ester.
CAS number: 2222732–46–7.
Basis for action: The PMN states that
the 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
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on analogous substances, EPA has
identified concerns for aquatic toxicity,
eye irritation, skin irritation, 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 95 ppb.
Potentially useful information: EPA
has determined that certain information
about the 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
aquatic toxicity, eye irritation/corrosion,
skin irritation/corrosion, and specific
target organ toxicity testing would help
characterize the potential environmental
and health effects of the PMN substance.
CFR citation: 40 CFR 721.11565.
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
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TSCA section 5(a)(3)(C) that the
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/tscainventory.
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 October 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 section 5 allowing
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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
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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-chemicalsunder-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 for this rulemaking.
X. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive orders can be
found at https://www.epa.gov/lawsregulations-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulations
and Regulatory Review
This action proposes to establish
SNURs for 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).
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16:48 Oct 19, 2020
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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 under OMB control
number 2070–0012 (EPA ICR No. 574).
This action does not impose any burden
requiring additional OMB approval. If
an entity were to submit a SNUN to the
Agency, the annual burden is estimated
to average between 30 and 170 hours
per response. This burden estimate
includes the time needed to review
instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques, to the Director, 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., I hereby certify that
promulgation of this proposed SNUR
would not have a significant adverse
economic impact on a substantial
number of small entities. The
requirement to submit a SNUN applies
to any person (including small or large
entities) who intends to engage in any
activity described in the final rule as a
‘‘significant new use.’’ Because these
uses are ‘‘new,’’ based on all
information currently available to EPA,
it appears that no small or large entities
presently engage in such activities.
A SNUR requires that any person who
intends to engage in such activity in the
future must first notify EPA by
submitting a SNUN. Although some
small entities may decide to pursue a
significant new use in the future, EPA
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Fmt 4702
Sfmt 4702
cannot presently determine how many,
if any, there may be. However, EPA’s
experience to date is that, in response to
the promulgation of SNURs covering
over 1,000 chemicals, the Agency
receives only a small number of notices
per year. For example, the number of
SNUNs received was seven in Federal
fiscal year (FY) 2013, 13 in FY2014, six
in FY2015, 12 in FY2016, 13 in FY2017,
and 11 in FY2018, only a fraction of
these were from small businesses. In
addition, the Agency currently offers
relief to qualifying small businesses by
reducing the SNUN submission fee from
$16,000 to $2,800. This lower fee
reduces the total reporting and
recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying
small firms. Therefore, the potential
economic impacts of complying with
this proposed SNUR are not expected to
be significant or adversely impact a
substantial number of small entities. In
a SNUR that published in the Federal
Register of June 2, 1997 (62 FR 29684)
(FRL–5597–1), the Agency presented its
general determination that final SNURs
are not expected to have a significant
economic impact on a substantial
number of small entities, which was
provided to the Chief Counsel for
Advocacy of the Small Business
Administration.
D. Unfunded Mandates Reform Act
(UMRA)
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government will be impacted by this
proposed rule. As such, EPA has
determined that this proposed rule 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 federalism
implications because it is not expected
to 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).
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Federal Register / Vol. 85, No. 203 / Tuesday, October 20, 2020 / Proposed Rules
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, significantly or uniquely
affect the communities of Indian Tribal
governments, and does not involve or
impose any requirements that affect
Indian Tribes, as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000).
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
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: September 30, 2020.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Therefore, for the reasons stated in the
preamble, EPA proposes to amend 40
CFR part 721 as follows:
16:48 Oct 19, 2020
Jkt 253001
1. The authority citation for part 721
continues to read as follows:
■
Authority 15 U.S.C. 2604, 2607, and
2625(c).
2. Add §§ 721.11561 through
721.11565 to subpart E to read as
follows:
■
Subpart E—Significant New Uses for
Specific Chemical Substances
Sec.
*
*
*
*
*
721.11561 2(2(Methylcaboxymonocyclic)amino)
ethoxy)-alcohol (generic).
721.11562 Formaldehyde, polymer with
alkyl aryl ketone (generic).
721.11563 Propanedioic acid, 1,3-dihexyl
ester.
721.11564 Propanedioic acid, 1,3dicyclohexyl ester.
721.11565 Propanedioic acid, 2,2bis(hydroxymethyl)-, 1,3-dicyclohexyl
ester
*
This proposed rule 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.
VerDate Sep<11>2014
PART 721—SIGNIFICANT NEW USES
OF CHEMICAL SUBSTANCES
*
*
*
*
§ 721.11561 2(2(Methylcaboxymonocyclic)amino)ethoxy)alcohol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as 2(2(Methylcaboxymonocyclic)amino)
ethoxy)-alcohol (PMN P–18–289) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) and (s) (80,000
kilograms).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11562 Formaldehyde, polymer with
alkyl aryl ketone (generic).
(a) Chemical substance and
significant new uses subject to reporting.
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Frm 00021
Fmt 4702
Sfmt 4702
66511
(1) The chemical substance generically
identified as formaldehyde, polymer
with alkyl aryl ketone (PMN P–18–330)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 770.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11563
ester.
Propanedioic acid, 1,3-dihexyl
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
propanedioic acid, 1,3-dihexyl ester
(PMN P–18–334, CAS No. 1431–37–4) 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 § 721.80(g).
(ii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), (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
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11564 Propanedioic acid, 1,3dicyclohexyl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
propanedioic acid, 1,3-dicyclohexyl
ester (PMN P–18–335, CAS No. 1152–
57–4) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
E:\FR\FM\20OCP1.SGM
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66512
Federal Register / Vol. 85, No. 203 / Tuesday, October 20, 2020 / Proposed Rules
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4), where N = 6.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11565 Propanedioic acid, 2,2bis(hydroxymethyl)-, 1,3-dicyclohexyl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
propanedioic acid, 2,2bis(hydroxymethyl)-, 1,3-dicyclohexyl
ester (PMN P–18–337, CAS No.
2222732–46–7) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4), where N = 95.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
[FR Doc. 2020–22645 Filed 10–19–20; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 64
[WC Docket No. 12–375; DA 20–1128, FRS
17113]
Rates for Interstate Inmate Calling
Services
Federal Communications
Commission.
ACTION: Proposed rule; availability of
supplemental information.
AGENCY:
VerDate Sep<11>2014
16:48 Oct 19, 2020
Jkt 253001
In this document, the Federal
Communications Commission
(Commission) announces the
availability, under the terms of the
Protective Order in the ICS proceeding,
of the inmate calling services database
(the ICS Database) that the Commission
staff developed for use in its Rates for
Interstate Inmate Calling Services (ICS)
proceeding, FCC 20–111, released
August 7, 2020, Fourth Further Notice
of Proposed Rulemaking (Fourth
FNPRM). This document also sets forth
the requirements individuals must meet
in order to obtain a copy of the ICS
database.
SUMMARY:
The public notice was effective
on September 24, 2020.
ADDRESSES: You may submit comments,
identified by WC Docket No. 12–375, by
any of the following methods:
• Federal Communications
Commission’s Website: https://
apps.fcc.gov/ecfs/. Follow the
instructions for submitting comments.
• Paper Filers: Parties who choose to
file by paper must file an original and
one copy of each filing. If more than one
docket or rulemaking number appears in
the caption of this proceeding, filers
must submit two additional copies for
each additional docket or rulemaking
number.
Filings can be sent by commercial
overnight courier, or by first-class or
overnight U.S. Postal Service mail. All
filings must be addressed to the
Commission’s Secretary, Office of the
Secretary, Federal Communications
Commission.
• Commercial overnight mail (other
than U.S. Postal Service Express Mail
and Priority Mail) must be sent to 9050
Junction Drive, Annapolis Junction, MD
20701. U.S. Postal Service first-class,
Express, and Priority mail must be
addressed to 445 12th Street SW,
Washington, DC 20554.
• Effective March 19, 2020, and until
further notice, the Commission no
longer accepts any hand or messenger
delivered filings. This is a temporary
measure taken to help protect the health
and safety of individuals, and to
mitigate the transmission of COVID–19.
See FCC Announces Closure of FCC
Headquarters Open Window and
Change in Hand-Delivery Policy, Public
Notice, DA 20–304 (March 19, 2020).
https://www.fcc.gov/document/fcccloses-headquarters-open-window-andchanges-hand-delivery-policy.
People with Disabilities: Contact the
FCC to request reasonable
accommodations (accessible format
documents, sign language interpreters,
CART, etc.) by email: FCC504@fcc.gov
DATES:
PO 00000
Frm 00022
Fmt 4702
Sfmt 4702
or phone: 202–418–0530 or TTY: 202–
418–0432.
FOR FURTHER INFORMATION CONTACT: Erik
Raven-Hansen, Pricing Policy Division
of the Wireline Competition Bureau, at
(202) 418–1532 or via email at
Erik.Raven-Hansen@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s
document (Public Notice), DA 20–1128,
released on September 24, 2020. The
full text of this document is available for
public inspection and can be
downloaded at https://docs.fcc.gov/
public/attachments/DA-20-1128A1.pdf.
The full text of this document can also
be obtained at the following internet
address: https://www.fcc.gov/document/
wcb-and-oea-announce-availability-icsdatabase.
By the Public Notice, the Wireline
Competition Bureau (Bureau) and Office
of Economics and Analytics (OEA)
announce the availability of the
database developed by Commission staff
for use in the Rates for Interstate Inmate
Calling Services proceeding (the ICS
Database) under the terms of the
Protective Order in this proceeding (28
FCC Rcd 16954). The Commission used
this ICS Database in developing its rate
cap proposals in the recent 2020 ICS
Notice.
The ICS Database contains
confidential information submitted to
the Commission by providers of calling
services for incarcerated individuals,
including cost and revenue information
that each provider submitted in
response to the Commission’s Second
Mandatory Data Collection. The
database also includes geocoding
information related to facility locations
added by the Commission staff that
outside parties might find difficult to
replicate. Making this database available
will allow interested parties to rely on
a common dataset in evaluating and
responding to the Commission’s rate cap
proposals in this proceeding, while
ensuring providers remain protected
against the unwarranted disclosure of
their confidential information.
To request access to the ICS Database,
interested individuals must first satisfy
the requirements of the Protective
Order. Under the terms of the Protective
Order, access to information submitted
under a claim of confidentiality is
limited to counsel and outside
consultants who are not involved in
competitive decision-making, who have
executed the Acknowledgement of
Confidentiality appended to that Order,
and who meet the other requirements of
that Order. Individuals who qualify
thereunder should contact the Bureau’s
staff, as set forth below. Before making
E:\FR\FM\20OCP1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 203 (Tuesday, October 20, 2020)]
[Proposed Rules]
[Pages 66506-66512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22645]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2020-0497; FRL-10015-28]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (20-
10.B)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances 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, and has taken any risk management actions
as are required as a result of that determination.
DATES: Comments must be received on or before November 19, 2020.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0497, using the Federal eRulemaking Portal
at https://www.regulations.gov. Follow the online instructions for
submitting comments. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
Due to the public health emergency, the EPA Docket Center (EPA/DC)
and Reading Room is closed to visitors with limited exceptions. The
staff continues to provide remote customer service via email, phone,
and webform. For the latest status information on EPA/DC services and
docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: William Wysong, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001;
[[Page 66507]]
telephone number: (202) 564-4163; email address:
[email protected].
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 November 19, 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 https://www.epa.gov/dockets/commenting-epa-dockets.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) for
chemical substances which are the subjects of PMNs P-18-289, P-18-330,
P-18-334, P-18-335, and P-18-337. 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-2020-0497, 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. Do the SNUR general provisions apply?
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 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 chemical substance 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
be added to 40 CFR part 721, subpart E for the chemical substances
identified in this unit. For each chemical substance, EPA provides the
following information in this unit:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
[[Page 66508]]
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 these proposed rules 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-18-289
Chemical name: 2-(2(Methylcaboxymonocyclic)amino)ethoxy)-alcohol
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic use of the
substance will be as a gas scrubber and wastewater deodorizer. 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 eye irritation, skin
irritation, 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:
1. Manufacture beyond an annual production volume of 80,000 kg.
2. Use other than for the confidential uses specified in the PMN.
Potentially useful information: EPA has determined that certain
information about the 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 eye irritation/corrosion
and specific target organ toxicity testing would help characterize the
potential health effects of the PMN substance.
CFR citation: 40 CFR 721.11561.
PMN Number: P-18-330
Chemical name: Formaldehyde, polymer with alkyl aryl ketone
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic use of the
substance will be as an initiator. Based on the physical/chemical
properties of the PMN substance and SAR analysis of test data on
analogous substances, EPA has identified concerns for nephrotoxicity,
skin sensitization, specific target organ toxicity, and systemic
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:
1. Use of the PMN substance in a consumer product.
2. Release of the PMN substance resulting in surface water
concentrations that exceed 770 ppb.
Potentially useful information: EPA has determined that certain
information about the 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 sensitization and
specific target organ toxicity testing would help characterize the
potential health effects of the PMN substance.
CFR citation: 40 CFR 721.11562.
PMN Number: P-18-334
Chemical name: Propanedioic acid, 1,3-dihexyl ester.
CAS number: 1431-37-4.
Basis for action: The PMN states that the use of the substance will
be as a chemical intermediate. 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,
eye irritation, 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:
1. Use other than as a chemical intermediate.
2. Release of the PMN substance resulting in surface water
concentrations that exceed 3 ppb.
Potentially useful information: EPA has determined that certain
information about the 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 aquatic toxicity, eye
irritation/corrosion, and specific target organ toxicity testing would
help characterize the potential environmental and health effects of the
PMN substance.
CFR citation: 40 CFR 721.11563.
PMN Number: P-18-335
Chemical name: Propanedioic acid, 1,3-dicyclohexyl ester.
CAS number: 1152-57-4.
Basis for action: The PMN states that the use of the substance will
be as a chemical intermediate. 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,
eye irritation, skin irritation, 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:
1. Use other than as a chemical intermediate.
2. Release of the PMN substance resulting in surface water
concentrations that exceed 6 ppb.
Potentially useful information: EPA has determined that certain
information about the 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 aquatic toxicity, eye
irritation/corrosion, skin irritation/corrosion, and specific target
organ toxicity testing would help characterize the potential
environmental and health effects of the PMN substance.
CFR citation: 40 CFR 721.11564.
PMN Number: P-18-337
Chemical name: Propanedioic acid, 2,2-bis(hydroxymethyl)-, 1,3-
dicyclohexyl ester.
CAS number: 2222732-46-7.
Basis for action: The PMN states that the 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
[[Page 66509]]
on analogous substances, EPA has identified concerns for aquatic
toxicity, eye irritation, skin irritation, 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 95 ppb.
Potentially useful information: EPA has determined that certain
information about the 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 aquatic toxicity, eye
irritation/corrosion, skin irritation/corrosion, and specific target
organ toxicity testing would help characterize the potential
environmental and health effects of the PMN substance.
CFR citation: 40 CFR 721.11565.
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 the 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 October 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 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
[[Page 66510]]
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 for this rulemaking.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/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 under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
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., I
hereby certify that promulgation of this proposed SNUR would not have a
significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities.
A SNUR requires that any person who intends to engage in such
activity in the future must first notify EPA by submitting a SNUN.
Although some small entities may decide to pursue a significant new use
in the future, EPA cannot presently determine how many, if any, there
may be. However, EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13
in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018,
only a fraction of these were from small businesses. In addition, the
Agency currently offers relief to qualifying small businesses by
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee
reduces the total reporting and recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying small firms. Therefore, the
potential economic impacts of complying with this proposed SNUR are not
expected to be significant or adversely impact a substantial number of
small entities. In a SNUR that published in the Federal Register of
June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its
general determination that final SNURs are not expected to have a
significant economic impact on a substantial number of small entities,
which was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this proposed
rule. As such, EPA has determined that this proposed rule 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 federalism implications because it is not
expected to 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).
[[Page 66511]]
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,
significantly or uniquely affect the communities of Indian Tribal
governments, and does not involve or impose any requirements that
affect Indian Tribes, as specified in Executive Order 13175 (65 FR
67249, November 9, 2000).
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 proposed rule 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: September 30, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR part 721 as follows:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
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. 721.11561 through 721.11565 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11561 2-(2(Methylcaboxymonocyclic)amino)ethoxy)-alcohol
(generic).
721.11562 Formaldehyde, polymer with alkyl aryl ketone (generic).
721.11563 Propanedioic acid, 1,3-dihexyl ester.
721.11564 Propanedioic acid, 1,3-dicyclohexyl ester.
721.11565 Propanedioic acid, 2,2-bis(hydroxymethyl)-, 1,3-
dicyclohexyl ester
* * * * *
Sec. 721.11561 2-(2(Methylcaboxymonocyclic)amino)ethoxy)-alcohol
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as 2-
(2(Methylcaboxymonocyclic)amino)ethoxy)-alcohol (PMN P-18-289) 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) and (s) (80,000 kilograms).
(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)(i) of
this section.
Sec. 721.11562 Formaldehyde, polymer with alkyl aryl ketone
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
formaldehyde, polymer with alkyl aryl ketone (PMN P-18-330) 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).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 770.
(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) 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. 721.11563 Propanedioic acid, 1,3-dihexyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propanedioic acid,
1,3-dihexyl ester (PMN P-18-334, CAS No. 1431-37-4) 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(g).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), (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) 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. 721.11564 Propanedioic acid, 1,3-dicyclohexyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propanedioic acid,
1,3-dicyclohexyl ester (PMN P-18-335, CAS No. 1152-57-4) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
[[Page 66512]]
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N = 6.
(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) 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. 721.11565 Propanedioic acid, 2,2-bis(hydroxymethyl)-, 1,3-
dicyclohexyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propanedioic acid,
2,2-bis(hydroxymethyl)-, 1,3-dicyclohexyl ester (PMN P-18-337, CAS No.
2222732-46-7) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N = 95.
(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. 2020-22645 Filed 10-19-20; 8:45 am]
BILLING CODE 6560-50-P
