Significant New Use Rules on Certain Chemical Substances (20-3.B), 22870-22875 [2021-08880]
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Federal Register / Vol. 86, No. 82 / Friday, April 30, 2021 / Rules and Regulations
intermittently enforced over the course
of approximately 24 days. It is
categorically excluded from further
review under paragraph L[60a] of
Appendix A, Table 1 of DHS Instruction
Manual 023–01–001–01, Rev. 1. A
Record of Environmental Consideration
supporting this determination is
available in the docket. For instructions
on locating the docket, see the
ADDRESSES section of this preamble.
G. Protest Activities
The Coast Guard respects the First
Amendment rights of protesters.
Protesters are asked to call or email the
person listed in the FOR FURTHER
INFORMATION CONTACT section to
coordinate protest activities so that your
message can be received without
jeopardizing the safety or security of
people, places or vessels.
List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation
(water), Reporting and recordkeeping
requirements, Security measures,
Waterways.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
1. The authority citation for part 165
continues to read as follows:
■
Authority: 46 U.S.C. 70034, 70051; 33 CFR
1.05–1, 6.04–1, 6.04–6, and 160.5;
Department of Homeland Security Delegation
No. 0170.1.
2. Add § 165.T05–0285 to read as
follows:
■
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§ 165.T05–0285 Security Zone; Christina
River, Newport, DE.
(a) Location. The following area is a
security zone: All waters of the
Christina River, from shoreline to
shoreline bounded on the east by a line
drawn from 39°42.55′ North Latitude
(N), 075°35.88′ West Longitude (W),
thence southerly to 39°42.50′ N,
075°35.87′ W thence along the Christina
River in a westerly direction and
bounded by the South James Street
Bridge at 39°42.63′ N, 075°36.53′ W.
These coordinates are based on North
American Datum 83 (NAD83).
(b) Definitions. As used in this
section—
Designated representative means any
Coast Guard commissioned, warrant, or
petty officer who has been designated
by the Captain of the Port Delaware Bay
(COTP) to act on his or her behalf. The
designated representative may be on an
official patrol vessel or may be on shore
and will communicate with vessels via
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VHF–FM radio or loudhailer. In
addition, members of the Coast Guard
Auxiliary may be present to inform
vessel operators of the regulations in
this section.
Official patrol vessel means any Coast
Guard, Coast Guard Auxiliary, State, or
local law enforcement vessel assigned or
approved by the COTP.
USSS protectee means any person for
whom the United States Secret Service
(USSS) requests implementation of a
security zone in order to supplement
protection of said person(s).
(c) Regulations. (1) In accordance with
the general regulations contained in
§ 165.33, entry into or movement within
this zone is prohibited unless
authorized by the COTP, Sector
Delaware Bay, or designated
representative.
(2) Only vessels or people specifically
authorized by the Captain of the Port,
Delaware Bay, or designated
representative, may enter or remain in
the regulated area. To request
permission to enter or remain in the
regulated area contact the COTP or the
COTP’s representative on VHF–FM
channel 13 or 16. Vessel operators and
persons within the security zone must
comply with all lawful orders or
directions given to them by the COTP or
the COTP’s designated representative.
No person may swim upon or below the
surface of the water of this security zone
unless authorized by the COTP or his
designated representative.
(3) Upon being hailed by an official
patrol vessel or the designated
representative, by siren, radio, flashing
light, or other means, the operator of the
vessel shall proceed as directed. Failure
to comply with lawful direction may
result in expulsion from the regulated
area, citation for failure to comply, or
both.
(d) Enforcement. (1) This security
zone is effective without actual notice
from April 30, 2021 through May 17,
2021. For the purposes of enforcement,
actual notice will be used from 2 p.m.
on April 23, 2021 until April 30, 2021.
(2) This security zone will be enforced
with actual notice by the U.S. Coast
Guard representatives on scene, as well
as other methods listed in § 165.7. The
Coast Guard will enforce the security
zone created by this section only when
it is necessary for the protection of
persons under the protection of the
USSS traveling across the route 141
bridge in Newport, Delaware. The U.S.
Coast Guard may be additionally
assisted in the patrol and enforcement
of the zone by Federal, State, and local
agencies.
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Dated: April 23, 2021.
Leon McClain, Jr.,
Captain, U.S. Coast Guard, Acting Captain
of the Port, Delaware Bay.
[FR Doc. 2021–08853 Filed 4–29–21; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9, 721, and 725
[EPA–HQ–OPPT–2020–0094; FRL–10016–
30]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances (20–3.B)
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is issuing significant new
use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for
chemical substances which were the
subject of premanufacture notices
(PMNs) and a microorganism that was
the subject of a Microbial Commercial
Activity Notice (MCAN). This action
requires 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 rule. This
action further requires 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: This rule is effective on June 29,
2021. For purposes of judicial review,
this rule shall be promulgated at 1 p.m.
(e.s.t.) on May 14, 2021.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
William Wysong, New Chemicals
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
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:
SUMMARY:
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I. General Information
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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 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. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, pursuant to 40 CFR 721.20 or
725.920 for the MCAN substance, any
persons who export or intend to export
a chemical substance that is the subject
of this rule 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. How can I access the docket?
The docket includes information
considered by the Agency in developing
the proposed and final rules. The docket
for this action, identified by docket
identification (ID) number EPA–HQ–
OPPT–2020–0094, is available at
https://www.regulations.gov and at the
Office of Pollution Prevention and
Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC.
The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPPT
Docket is (202) 566–0280.
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
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email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
II. Background
EPA is finalizing SNURs under TSCA
section 5(a)(2) for chemical substances
which were the subject of MCAN J–19–
1 and PMNs P–18–391 and P–20–13.
These SNURs 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.
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, and (for
microorganisms) 40 CFR part 725,
subpart L. 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
significant new use is not likely to
present an unreasonable risk of injury or
take such regulatory action as is
associated with an alternative
determination before manufacture or
processing for the significant new use
can commence. If EPA determines that
the significant new use is not likely to
present an unreasonable risk, EPA is
required under TSCA section 5(g) to
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make public, and submit for publication
in the Federal Register, a statement of
EPA’s findings.
III. Significant New Use Determination
A. Determination Factors
A. What action is the Agency taking?
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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 designating
those reasonably foreseen conditions of
use as well as certain other
circumstances of use as significant new
uses.
B. Procedures for Significant New Uses
Claimed as Confidential Business
Information (CBI)
By this rule, EPA is establishing
certain significant new uses which have
been claimed as CBI subject to Agency
confidentiality regulations at 40 CFR
part 2 and 40 CFR part 720, subpart E.
Absent a final determination or other
disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is
required to keep this information
confidential. EPA promulgated a
procedure to deal with the situation
where a specific significant new use is
CBI, at 40 CFR 721.1725(b)(1) and has
referenced it to apply to other SNURs.
Under these procedures a
manufacturer or processor may request
EPA to determine whether a specific use
would be a significant new use under
the rule. The manufacturer or processor
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must show that it has a bona fide intent
to manufacture or process the chemical
substance and must identify the specific
use for which it intends to manufacture
or process the chemical substance. If
EPA concludes that the person has
shown a bona fide intent to manufacture
or process the chemical substance, EPA
will tell the person whether the use
identified in the bona fide submission
would be a significant new use under
the rule. Since most of the chemical
identities of the chemical substances
subject to these SNURs are also CBI,
manufacturers and processors can
combine the bona fide submission
under the procedure in 40 CFR
721.1725(b)(1) with that under 40 CFR
721.11 into a single step.
If EPA determines that the use
identified in the bona fide submission
would not be a significant new use, i.e.,
the use does not meet the criteria
specified in the rule for a significant
new use, that person can manufacture or
process the chemical substance so long
as the significant new use trigger is not
met. In the case of a production volume
trigger, this means that the aggregate
annual production volume does not
exceed that identified in the bona fide
submission to EPA. Because of
confidentiality concerns, EPA does not
typically disclose the actual production
volume that constitutes the use trigger.
Thus, if the person later intends to
exceed that volume, a new bona fide
submission would be necessary to
determine whether that higher volume
would be a significant new use.
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IV. Public Comments
EPA received public comments on the
proposed rule (85 FR 15406, March 18,
2020) from four identifying entities. The
Agency’s responses are presented in the
Response to Public Comments
document that is available in the docket
for this rule. EPA has made changes to
the final rule as described in these
comments.
V. Substances Subject to This Rule
EPA is establishing significant new
use and recordkeeping requirements for
chemical substances in 40 CFR part 721,
subpart E, and in 40 CFR part 725 for
one chemical substance that is a
microorganism (MCAN J–19–1). In Unit
IV. of the proposed SNUR, EPA
provided the following information for
each chemical substance:
• PMN or MCAN number.
• Chemical name (generic name, if
the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS)
Registry number (if assigned for nonconfidential chemical identities).
• Basis for the SNUR.
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• Potentially useful information.
• CFR citation assigned in the
regulatory text section of this final rule.
The regulatory text section of these
rules specifies the activities designated
as significant new uses. Certain new
uses, including production volume
limits and other uses designated in the
rules, may be claimed as CBI.
VI. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs and
MCAN submitted for the chemical
substances that are the subject of these
SNURs and as further discussed in Unit
IV. of the proposed rule, 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 designating
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 issuing 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
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
or MCAN substances, while deferring
analysis on the significant new uses
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proposed in these rules unless and until
the Agency receives a SNUN.
Issuance of a 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.
VII. Applicability of the 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 rule were undergoing
premanufacture review at the time of
signature of the 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
SNURs EPA concluded at the time of
signature of the proposed rule that the
designated significant new uses were
not ongoing.
EPA designated March 4, 2020 (the
date of web posting of the 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 began commercial
manufacture or processing of the
chemical substances for a significant
new use identified on or after that date
will 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.
VIII. 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, then TSCA section
5(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
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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. of the proposed rule lists
potentially useful information for all
SNURs listed here. Descriptions are
provided for informational purposes.
The potentially useful information
identified in Unit IV. of the proposed
rule 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
election. 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. of the proposed
rule 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.
IX. 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
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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 (or 40 CFR 725.25 and
725.27 for an MCAN). E–PMN software
is available electronically at https://
www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca.
X. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers and processors
of the chemical substances subject to
this rule. EPA’s complete economic
analysis is available in the docket for
this rulemaking.
XI. 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 establishes 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 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. 0574).
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
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22873
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 RFA section 605(b), 5
U.S.C. 601 et seq., I hereby certify that
promulgation of this 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 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
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significant regulatory action under
Executive Order 12866.
economic impact on a substantial
number of small entities, which was
provided to the Chief Counsel for
Advocacy of the Small Business
Administration.
I. National Technology Transfer and
Advancement Act (NTTAA)
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. 1501 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).
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. Accordingly, the
requirements of Executive Order 13175
(65 FR 67249, November 9, 2000), do
not apply to this action.
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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 a
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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).
242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
6901–6992k, 7401–7671q, 7542, 9601–9657,
11023, 11048.
2. In § 9.1, amend the table by adding
entries for §§ 721.11460 and 721.11461
in numerical order under the
undesignated center heading
‘‘Significant New Uses of Chemical
Substances’’ to read as follows:
■
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
*
*
*
40 CFR citation
*
K. Congressional Review Act (CRA)
*
OMB control No.
*
*
*
Significant New Uses of Chemical
Substances
This action is subject to the CRA (5
U.S.C. 801 et seq.), and EPA will submit
a rule report containing this rule and
other required information to each
House of the Congress and to the
Comptroller General of the United
States. This action is not a ‘‘major rule’’
as defined by 5 U.S.C. 804(2).
*
*
*
721.11460 .........................
721.11461 .........................
List of Subjects
*
40 CFR Part 9
PART 721—SIGNIFICANT NEW USES
OF CHEMICAL SUBSTANCES
Environmental protection, Reporting
and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
40 CFR Part 725
Environmental protection, Chemicals,
Hazardous substances, Microorganisms,
Reporting and recordkeeping
requirements.
Dated: January 14, 2021.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Editorial Note: This document was
received for publication by the Office of the
Federal Register on April 23, 2021.
Therefore, for the reasons set forth in
the preamble, EPA amends 40 CFR parts
9, 721, and 725 as follows:
PART 9—OMB APPROVALS UNDER
THE PAPERWORK REDUCTION ACT
1. The authority citation for part 9
continues to read as follows:
■
Authority: 7 U.S.C. 135 et seq., 136–136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
21 U.S.C. 331j, 346a, 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
1321, 1326, 1330, 1342, 1344, 1345(d) and
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971–1975 Comp. p. 973; 42 U.S.C. 241,
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*
*
*
*
*
*
*
*
2070–0012
2070–0012
*
*
*
3. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
4. Add §§ 721.11460 and 721.11461 to
read as follows:
■
§ 721.11460 1-Propanaminium, N(carboxymethyl)-N,N-dimethyl-3-[(3,5,5trimethyl-1-oxohexyl)amino]-, inner salt.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-Propanaminium, N-(carboxymethyl)N,N-dimethyl-3-[(3,5,5-trimethyl-1oxohexyl)amino]-, inner salt. (PMN P–
18–391; CASRN 2169783–63–3) 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 substance for any use that results in
inhalation exposures.
(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
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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.
§ 721.11461 2-Propenoic acid, 2-methyl-,
(2-oxo-1,3-dioxolan-4-yl)methyl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 2-methyl-, (2-oxo-1,3dioxolan-4-yl)methyl ester (PMN P–20–
13; CASRN 13818–44–5) 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 (o). It is a
significant new use to manufacture or
import greater than the confidential
annual production volume identified in
the PMN.
(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.
PART 725—REPORTING
REQUIREMENTS AND REVIEW
PROCESSES FOR MICROORGANISMS
5. The authority citation for part 725
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, 2613, and
2625.
■
6. Add § 725.1080 to read as follows:
jbell on DSKJLSW7X2PROD with RULES
§ 725.1080
Trichoderma reesei (generic).
(a) Microorganism and significant new
uses subject to reporting. (1) The
genetically modified microorganism
identified as Trichoderma reesei strain
3CH–3 (MCAN J–19–1) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2)(i) The significant new use is any
manufacturing, processing, or use of the
microorganism other than in a
fermentation system that meets all of the
following conditions:
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(A) Enzyme production occurs by
submerged fermentation (i.e., for
enzyme production, growth of the
microorganism occurs beneath the
surface of the liquid growth medium);
and
(B) Any further fermentation, such as
saccharification (i.e., addition of
Trichoderma reesei fermentation broth
to solid plant material or insoluble
substrate after the standard industrial
fermentation is completed), is initiated
only after the inactivation of the
microorganism as delineated in
§ 725.422(d).
(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) though (c) and (i) of this
chapter, are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 of this chapter
apply to this section.
[FR Doc. 2021–08880 Filed 4–29–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 62
[EPA–R06–OAR–2021–0059; FRL–10022–
53–Region 6]
Approval and Promulgation of State
Air Quality Plans for Designated
Facilities and Pollutants; Louisiana;
Control of Emissions From Existing
Other Solid Waste Incineration Units
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
Pursuant to the Federal Clean
Air Act (CAA or the Act), the
Environmental Protection Agency (EPA)
is notifying the public that we have
received a CAA section 111(d)/129
negative declaration from Louisiana for
existing incinerators subject to the Other
Solid Waste Incineration units (OSWI)
emission guidelines (EG). This negative
declaration from Louisiana certifies that
incinerators subject to the OSWI EG and
the requirements of sections 111(d) and
129 of the CAA do not exist within the
jurisdiction of Louisiana. The EPA is
accepting the negative declaration and
amending the agency regulations in
accordance with the requirements of the
CAA.
SUMMARY:
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DATES:
22875
This rule is effective on June 1,
2021.
The EPA has established a
docket for this action under Docket ID
No. EPA–R06–OAR–2021–0059. All
documents in the docket are listed on
the https://www.regulations.gov
website. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically through
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Karolina Ruan Lei, EPA Region 6 Office,
Air and Radiation Division—State
Planning and Implementation Branch,
1201 Elm Street, Suite 500, Dallas, TX
75270, (214) 665–7346, ruanlei.karolina@epa.gov. Out of an
abundance of caution for members of
the public and our staff, the EPA Region
6 office will be closed to the public to
reduce the risk of transmitting COVID–
19. Please call or email the contact
listed above if you need alternative
access to material indexed but not
provided in the docket.
SUPPLEMENTARY INFORMATION:
Throughout this document ‘‘we,’’ ‘‘us,’’
and ‘‘our’’ means the EPA.
ADDRESSES:
I. Background
The background for this action is
discussed in detail in our February 24,
2021, proposal (86 FR 11212). In that
document we proposed to accept the
OSWI negative declaration from the
Louisiana Department of Environmental
Quality (LDEQ) and to amend the Code
of Federal Regulations (CFR) in
accordance with the requirements of the
CAA. No comments were received on
the February 24, 2021, proposal.
II. Final Action
In this final action, the EPA is
amending 40 CFR part 62, subpart T, to
reflect receipt of the negative
declaration letter from LDEQ, received
on November 24, 2020, certifying that
there are no existing incinerators subject
to 40 CFR part 60, subpart FFFF, in its
jurisdiction in accordance with 40 CFR
60.23(b), 40 CFR 62.06, 40 CFR 60.2982,
and sections 111(d) and 129 of the CAA.
III. Statutory and Executive Order
Reviews
Under the CAA, the Administrator is
required to approve a CAA section
111(d)/129 submission that complies
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]]>Agencies
[Federal Register Volume 86, Number 82 (Friday, April 30, 2021)]
[Rules and Regulations]
[Pages 22870-22875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08880]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9, 721, and 725
[EPA-HQ-OPPT-2020-0094; FRL-10016-30]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (20-3.B)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is issuing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances which were
the subject of premanufacture notices (PMNs) and a microorganism that
was the subject of a Microbial Commercial Activity Notice (MCAN). This
action requires 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 rule. This action further
requires 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: This rule is effective on June 29, 2021. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
May 14, 2021.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; 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:
[[Page 22871]]
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 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. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, pursuant to 40 CFR 721.20 or 725.920 for the MCAN substance,
any persons who export or intend to export a chemical substance that is
the subject of this rule 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. How can I access the docket?
The docket includes information considered by the Agency in
developing the proposed and final rules. The docket for this action,
identified by docket identification (ID) number EPA-HQ-OPPT-2020-0094,
is available at https://www.regulations.gov and at the Office of
Pollution Prevention and Toxics Docket (OPPT Docket), Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280.
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.
II. Background
A. What action is the Agency taking?
EPA is finalizing SNURs under TSCA section 5(a)(2) for chemical
substances which were the subject of MCAN J-19-1 and PMNs P-18-391 and
P-20-13. These SNURs 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.
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,
and (for microorganisms) 40 CFR part 725, subpart L. 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 significant new use is not
likely to present an unreasonable risk of injury or take such
regulatory action as is associated with an alternative determination
before manufacture or processing for the significant new use can
commence. If EPA determines that the significant new use is not likely
to present an unreasonable risk, EPA is required under TSCA section
5(g) to make public, and submit for publication in the Federal
Register, a statement of EPA's findings.
III. Significant New Use Determination
A. Determination Factors
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
designating those reasonably foreseen conditions of use as well as
certain other circumstances of use as significant new uses.
B. Procedures for Significant New Uses Claimed as Confidential Business
Information (CBI)
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1) and has referenced it to apply to other SNURs.
Under these procedures a manufacturer or processor may request EPA
to determine whether a specific use would be a significant new use
under the rule. The manufacturer or processor
[[Page 22872]]
must show that it has a bona fide intent to manufacture or process the
chemical substance and must identify the specific use for which it
intends to manufacture or process the chemical substance. If EPA
concludes that the person has shown a bona fide intent to manufacture
or process the chemical substance, EPA will tell the person whether the
use identified in the bona fide submission would be a significant new
use under the rule. Since most of the chemical identities of the
chemical substances subject to these SNURs are also CBI, manufacturers
and processors can combine the bona fide submission under the procedure
in 40 CFR 721.1725(b)(1) with that under 40 CFR 721.11 into a single
step.
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.
IV. Public Comments
EPA received public comments on the proposed rule (85 FR 15406,
March 18, 2020) from four identifying entities. The Agency's responses
are presented in the Response to Public Comments document that is
available in the docket for this rule. EPA has made changes to the
final rule as described in these comments.
V. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for chemical substances in 40 CFR part 721, subpart E, and
in 40 CFR part 725 for one chemical substance that is a microorganism
(MCAN J-19-1). In Unit IV. of the proposed SNUR, EPA provided the
following information for each chemical substance:
PMN or MCAN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Basis for the SNUR.
Potentially useful information.
CFR citation assigned in the regulatory text section of
this final rule.
The regulatory text section of these rules specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits and other uses designated in the rules, may be
claimed as CBI.
VI. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs and MCAN submitted for the chemical
substances that are the subject of these SNURs and as further discussed
in Unit IV. of the proposed rule, 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
designating 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 issuing 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 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 or MCAN substances, while deferring analysis on the
significant new uses proposed in these rules unless and until the
Agency receives a SNUN.
Issuance of a 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.
VII. Applicability of the 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 rule were
undergoing premanufacture review at the time of signature of the
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 SNURs EPA concluded at the
time of signature of the proposed rule that the designated significant
new uses were not ongoing.
EPA designated March 4, 2020 (the date of web posting of the
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 began commercial manufacture or processing of the
chemical substances for a significant new use identified on or after
that date will 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.
VIII. 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, then TSCA section 5(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
[[Page 22873]]
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. of the proposed rule
lists potentially useful information for all SNURs listed here.
Descriptions are provided for informational purposes. The potentially
useful information identified in Unit IV. of the proposed rule 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 election. 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. of the
proposed rule 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.
IX. 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 (or 40 CFR 725.25 and 725.27 for
an MCAN). E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
X. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket for this rulemaking.
XI. 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 establishes 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 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. 0574). 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 RFA section 605(b), 5 U.S.C. 601 et seq., I hereby
certify that promulgation of this 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 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
[[Page 22874]]
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. 1501 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).
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. 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 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).
K. Congressional Review Act (CRA)
This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA
will submit a rule report containing this rule and other required
information to each House of the Congress and to the Comptroller
General of the United States. This action is not a ``major rule'' as
defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
40 CFR Part 725
Environmental protection, Chemicals, Hazardous substances,
Microorganisms, Reporting and recordkeeping requirements.
Dated: January 14, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Editorial Note: This document was received for publication by
the Office of the Federal Register on April 23, 2021.
Therefore, for the reasons set forth in the preamble, EPA amends 40
CFR parts 9, 721, and 725 as follows:
PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. 9.1, amend the table by adding entries for Sec. Sec.
721.11460 and 721.11461 in numerical order under the undesignated
center heading ``Significant New Uses of Chemical Substances'' to read
as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.11460............................................. 2070-0012
721.11461............................................. 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. Sec. 721.11460 and 721.11461 to read as follows:
Sec. 721.11460 1-Propanaminium, N-(carboxymethyl)-N,N-dimethyl-3-
[(3,5,5-trimethyl-1-oxohexyl)amino]-, inner salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-Propanaminium, N-
(carboxymethyl)-N,N-dimethyl-3-[(3,5,5-trimethyl-1-oxohexyl)amino]-,
inner salt. (PMN P-18-391; CASRN 2169783-63-3) 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 substance for
any use that results in inhalation exposures.
(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
[[Page 22875]]
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. 721.11461 2-Propenoic acid, 2-methyl-, (2-oxo-1,3-dioxolan-4-
yl)methyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, (2-oxo-1,3-dioxolan-4-yl)methyl ester (PMN P-20-13; CASRN
13818-44-5) 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 (o). It is a significant new use to
manufacture or import greater than the confidential annual production
volume identified in the PMN.
(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.
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR
MICROORGANISMS
0
5. The authority citation for part 725 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
0
6. Add Sec. 725.1080 to read as follows:
Sec. 725.1080 Trichoderma reesei (generic).
(a) Microorganism and significant new uses subject to reporting.
(1) The genetically modified microorganism identified as Trichoderma
reesei strain 3CH-3 (MCAN J-19-1) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2)(i) The significant new use is any manufacturing, processing, or
use of the microorganism other than in a fermentation system that meets
all of the following conditions:
(A) Enzyme production occurs by submerged fermentation (i.e., for
enzyme production, growth of the microorganism occurs beneath the
surface of the liquid growth medium); and
(B) Any further fermentation, such as saccharification (i.e.,
addition of Trichoderma reesei fermentation broth to solid plant
material or insoluble substrate after the standard industrial
fermentation is completed), is initiated only after the inactivation of
the microorganism as delineated in Sec. 725.422(d).
(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) though (c) and (i) of this chapter, are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 of this chapter apply to this section.
[FR Doc. 2021-08880 Filed 4-29-21; 8:45 am]
BILLING CODE 6560-50-P
