Modification of Significant New Uses of Certain Chemical Substances (20-2.M), 30210-30215 [2021-11768]
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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Rules and Regulations
[FR Doc. 2021–11840 Filed 6–4–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2020–0302; FRL–10022–
76]
RIN 2070–AB27
Modification of Significant New Uses
of Certain Chemical Substances (20–
2.M)
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is amending significant
new use rules (SNURs) issued under the
Toxic Substances Control Act (TSCA)
for certain chemical substances
identified herein, which were the
subject of premanufacture notices
(PMNs) and significant new use notices
(SNUNs). This action would amend the
SNURs to allow certain new uses
reported in the SNUNs without
additional notification requirements and
modify the significant new use
notification requirements based on the
actions and determinations for the
SNUN submissions. EPA is issuing
these amendments based on review of
new and existing data for the chemical
substances.
DATES: This rule is effective on August
6, 2021. For purposes of judicial review,
this rule shall be promulgated at 1 p.m.
(e.s.t.) on June 21, 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.
SUMMARY:
SUPPLEMENTARY INFORMATION:
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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
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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, which would
include the SNUR requirements.
Chemical importers are subject to the
TSCA section 13 (15 U.S.C. 2612)
import provisions. 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 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–2020–0302, is available at
https://www.regulations.gov or 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. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
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.
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II. Background
A. What action is the Agency taking?
EPA is issuing amendments to the
SNURs for certain chemical substances
in 40 CFR part 721 subpart E.
Previously, in the Federal Register of
November 18, 2020 (85 FR 73439) (FRL–
10013–54), EPA proposed amendments
to the SNURs for these chemical
substances and established the record
for these SNUR amendments in the
docket under docket ID number EPA–
HQ–OPPT–2020–0302. That docket
includes information considered by the
Agency in developing the proposed and
final rules, including public comments.
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 (i.e., a SNUR)
after considering all relevant factors,
including those listed in TSCA section
5(a)(2). EPA may also amend a SNUR
promulgated under TSCA section
5(a)(2). Procedures and criteria for
modifying or revoking SNUR
requirements appear at 40 CFR 721.185.
Once EPA determines that a use of a
chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires
persons to submit a SNUN to EPA at
least 90 days before they manufacture,
import, or process the chemical
substance for that use. Persons who
must report are described in 40 CFR
721.5.
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 final rule, recordkeeping
requirements, exemptions to reporting
requirements, and applicability of the
rule to uses occurring before the
effective date of the final rule.
Provisions relating to user fees appear at
40 CFR part 700. According to 40 CFR
721.1(c), persons subject to these SNURs
must comply with the same notice
requirements and EPA regulatory
procedures as submitters of PMNs under
TSCA section 5(a)(1)(A). In particular,
these requirements include the
information submission requirements of
TSCA sections 5(b) and 5(d)(1), the
exemptions authorized by TSCA
sections 5(h)(1), (h)(2), (h)(3), and (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
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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 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.
those uses could result in changes in the
type or form of exposure to the chemical
substance, increased exposures to the
chemical substance, and/or changes in
the reasonably anticipated manner and
methods of manufacturing, processing,
distribution in commerce, and disposal
of the chemical substance.
B. Procedures for Significant New Uses
Claimed as Confidential Business
Information (CBI)
IV. Public Comments
EPA received three public comments
in response to the proposed SNURs.
None of the comments pertained to the
proposed SNURs or the basis for these
SNURs. As a result, EPA is finalizing
the rules as proposed and is not
responding to the comments.
VI. Applicability of Rules to Uses
Occurring Before Effective Date of the
Final Rule
To establish a significant new use,
EPA must determine that the use is not
ongoing. EPA solicited comments on the
proposed rule, providing an opportunity
for members of the public to indicate
whether any of the uses which are not
significant new uses under the current
rules, but which would be regulated as
‘‘significant new uses’’ if the proposed
rule is finalized, are ongoing. EPA
received no comments that these uses
were ongoing. Therefore, EPA concludes
that the uses are not ongoing.
EPA designated November 18, 2020
(the date of publication of the proposed
rule) as the cutoff date for determining
whether the new use is ongoing. The
objective of EPA’s approach has been to
ensure that a person could not defeat a
SNUR by initiating a significant new use
before the effective date of the final rule.
In the unlikely event that a person
began commercial manufacture or
processing of the chemical substances
for a significant new use identified as of
the cutoff date, that person will have to
cease any such activity upon the
effective date of the final rule. To
resume their activities, that person
would have to first comply with all
applicable SNUR notification
requirements and wait until EPA has
conducted a review of the notice, made
an appropriate determination on the
notice, and has taken such actions as are
required with that determination.
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 proposed
use would be a significant new use
under the rule. The manufacturer or
processor must show that it has a bona
V. Rationale of the Final Rule
These amendments are based on
EPA’s determination under 40 CFR
721.85(a)(3) that significant new use
notices for some of the activities
designated as significant new uses of the
relevant chemical substances were
submitted to EPA and after reviewing
the notices, EPA concluded that there is
no need to require additional notice
from persons who propose to engage in
identical or similar activities. In those
instances where EPA expanded the
scope of the significant new use, the
Agency identified concerns, as
discussed in Unit IV. of the proposed
rule, associated with certain potential
new uses. In addition to considering the
factors discussed in Unit IV. of the
proposed rule, EPA determined that
VII. Development and Submission of
Information
EPA recognizes that TSCA section 5
generally 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
4 covering the chemical substance,
persons are required only to submit
information in their possession or
control and to describe any other
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 whether and how to
modify the significant new uses for the
chemical substances that are the subject
of these SNURs, EPA considered
relevant information about the toxicity
of the chemical substance, likely human
exposures and environmental releases
associated with possible uses, and the
four TSCA section 5(a)(2) factors listed
in this unit.
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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 production
volume limit is not exceeded by the
amount 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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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 addressed in this final rule.
Descriptions are provided for
informational purposes. The
information identified in Unit IV. of the
proposed rule will be potentially useful
to EPA’s evaluation of a chemical
substance in the event that someone
submits a SNUN for a significant new
use pursuant to the SNURs addressed in
this final rule. Companies who are
considering submitting a SNUN are
encouraged, but are not required, to
develop the potentially useful
information on the substance.
EPA strongly encourages persons,
before performing any testing, to consult
with the Agency. Furthermore, pursuant
to TSCA section 4(h), which pertains to
reduction of testing on 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 dialogue with Agency
representatives to help determine how
best the submitter can meet both the
data needs and the objective of TSCA
section 4(h). For more information on
alternative test methods and strategies
to reduce vertebrate animal testing, visit
https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/
alternative-test-methods-and-strategiesreduce.
The potentially useful information
identified in Unit IV. of the proposed
rule may not be the only means of
addressing the potential risks of the
chemical substance. However,
submitting a SNUN without any test
data or other information 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 that provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances; and
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons
submitting a SNUN must comply with
the same notification requirements and
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EPA regulatory procedures as persons
submitting a PMN under 40 CFR part
720, 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 721.25 and 720.40. E–
PMN software is available electronically
at https://www.epa.gov/reviewing-newchemicals-under-toxic-substancescontrol-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 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 modifies SNURs for
several new chemical substances that
were the subject of PMNs and SNUNs.
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 activities
associated with these SNURs have
already been approved by OMB
pursuant to the 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
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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.
The listing of the OMB control
numbers of the collection instruments
and their subsequent codification in the
table in 40 CFR 9.1 satisfies the display
requirements of the PRA and OMB’s
implementing regulations at 5 CFR part
1320. Since this ICR was previously
subject to public notice and comment
prior to OMB approval, and given the
technical nature of the table in 40 CFR
part 9, EPA finds that further notice and
comment to amend it is unnecessary. As
a result, EPA finds that there is ‘‘good
cause’’ under section 553(b)(3)(B) of the
Administrative Procedure Act (5 U.S.C.
553(b)(3)(B)) to amend this table in 40
CFR 9.1 without further notice and
comment.
C. Regulatory Flexibility Act (RFA)
Pursuant to the 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
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this SNUR are not expected to be
significant or adversely impact a
substantial number of small entities. In
a SNUR that published in the Federal
Register of June 2, 1997 (62 FR 29684)
(FRL–5597–1), the Agency presented its
general determination that final SNURs
are not expected to have a significant
economic impact on a substantial
number of small entities, which was
provided to the Chief Counsel for
Advocacy of the Small Business
Administration.
D. Unfunded Mandates Reform Act
(UMRA)
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government will be impacted by this
action. As such, EPA has determined
that this action does not impose any
enforceable duty, contain any unfunded
mandate, or otherwise have any effect
on small governments subject to the
requirements of UMRA sections 202,
203, 204, or 205 (2 U.S.C. 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).
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F. Executive Order 13175: Consultation
and Coordination With Indian Tribe
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
Risks 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.
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H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 (66 FR 28355, May 22,
2001), because this action is not
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
I. National Technology Transfer and
Advancement Act (NTTAA)
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 in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: May 25, 2021.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Therefore, for the reasons stated in the
preamble, 40 CFR chapter I is amended
as follows:
PART 721—SIGNIFICANT NEW USES
OF CHEMICAL SUBSTANCES
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Amend § 721.983 by revising
paragraphs (a)(1) and (a)(2)(ii) to read as
follows:
■
§ 721.983 Sulfonyl azide intermediate
(generic).
(a) * * * (1) The chemical substance
identified generically as sulfonyl azide
intermediate (PMN P–99–1202 and
SNUN S–15–6) is subject to reporting
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30213
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) * * *
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f). It is a significant
new use to import, process, or use this
chemical substance as a powder unless
less than 1% of particles by weight are
less than 200 microns.
*
*
*
*
*
■ 3. Amend § 721.9675 by revising
paragraphs (a)(1), (a)(2)(i), (a)(2)(ii) and
(b)(1) to read as follows:
§ 721.9675 Titanate [Ti6O13 (2-)],
dipotassium.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
titanate [Ti6O13 (2-)], dipotassium
(PMN P–90–226; SNUNs P–96–1408, S–
08–6, S–09–4, S–13–49, S–16–5, and S–
17–6; CAS No. 12056–51–8) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) * * *
(i) Protection in the workplace. For
manufacturing, processing, and use of
SN–17–6: Requirements as specified in
§ 721.63(a)(4), (5), (6), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(4), engineering
control measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible. For purposes
of § 721.63(a)(5), respirators must
provide a National Institute for
Occupational Safety and Health
assigned protection factor of at least 10.
For purposes of § 721.63(a)(6), the
airborne form(s) of the substance
include particulate (including solid or
liquid droplets).
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.8 mg/
m3 as an 8-hour time weighted average.
Persons who wish to pursue NCELs as
an alternative to § 721.63 respirator
requirements may request to do so
under § 721.30. Persons whose § 721.30
requests to use the NCELs approach are
approved by EPA will be required to
follow NCELs provisions comparable to
those contained in the corresponding
TSCA section 5(e) consent order.
(B) [Reserved]
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(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (l). In
addition, a significant new use of the
substance is importation of the chemical
substance if:
(A) Manufactured by other than the
method described in premanufacture
notice P–90–226 and significant new
use notices P–96–1408, S–08–6, S–09–4,
S–13–49, S–16–5, and S–17–6.
(B) Manufactured producing
respirable, acicular fibers with an
average aspect ratio of greater than 5.
The average aspect ratio is defined as
the ratio of average length to average
diameter. For manufacture of S–17–6:
Manufacture with a particle size
distribution containing greater than
30% of particles less than 10 microns.
(b) * * *
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (d) and (i) are
applicable to manufacturers and
processors of this substance.
*
*
*
*
*
■ 4. Amend § 721.10288 by revising
paragraphs (a)(1) and (a)(2)(i) to read as
follows:
§ 721.10288 Cyclohexane, oxidized, byproducts from, distn. residues.
(a) * * * (1) The chemical substance
identified as cyclohexane, oxidized, byproducts from, distn. residues (PMN P–
11–316; CAS No. 1014979–92–0) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) * * *
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=470.
*
*
*
*
*
■ 5. Amend § 721.10432 by:
■ a. Revising paragraphs (a)(1), (a)(2)(i)
and (a)(2)(ii);
■ b. Adding paragraphs (a)(2)(iii) and
(iv); and
■ c. Revising paragraph (b)(1).
The revisions and additions read as
follows:
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§ 721.10432 1,2,4,5,7,8-Hexoxonane, 3,6,9triethyl-3,6,9-trimethyl-.
(a) * * * (1) The chemical substance
identified as 1,2,4,5,7,8-hexoxonane,
3,6,9-triethyl-3,6,9-trimethyl- (PMN P–
98–1028 and SNUNs S–14–9, S–17–12,
and S–17–15; CAS No. 24748–23–0) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) * * *
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3) through (5),
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(a)(6)(v), (b), and (c). When determining
which persons are reasonably likely to
be exposed as required for § 721.63(a)(1)
and (4), engineering control measures
(e.g., enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
assigned protection factor of at least 50.
For purposes of § 721.63(b), the
concentration is set at 1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1) through (3), (g)(4)(i),
and (g)(5). For purposes of § 721.72(e),
the concentration is set at 1.0%. For
purposes of § 721.72(g)(1), the required
human health hazard statements
include: Internal organ effects;
reproductive effects; allergic skin
reaction. For purposes of § 721.72(g)(2),
the required human health
precautionary statements include: Use
skin protection; where engineering
controls are not determined to be
adequate, use respiratory protection. For
purposes of § 721.72(g)(3), the required
environmental hazard statements
include: This substance may cause long
lasting harmful effects to aquatic life.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Industrial commercial, and
consumer activities. It is a significant
new use to process or use the substance
with an application method that
generates a mist, vapor, or aerosol.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=56.
(b) * * *
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i), and (k) are
applicable to manufacturers and
processors of this substance.
*
*
*
*
*
■ 6. Amend § 721.10907 by revising
paragraphs (a)(1) and (a)(2)(i) to read as
follows:
§ 721.10907
(generic).
Polyfluorohydrocarbon
(a) * * * (1) The chemical substance
identified generically as
polyfluorohydrocarbon (PMN P–15–326
and SNUN S–17–11) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) * * *
PO 00000
Frm 00064
Fmt 4700
Sfmt 4700
(i) Industrial commercial, and
consumer activities. Requirements as
specified in § 721.80(o). It is a
significant new use to use the substance
other than for the confidential uses
described in PMN P–15–326 and SNUN
S–17–11.
*
*
*
*
*
■ 7. Amend § 721.10922 by:
■ a. Revising paragraphs (a)(1), (a)(2)(i)
and (a)(2)(ii);
■ b. Adding paragraphs (a)(2)(iii) and
(iv);
■ c. Revising paragraph (b)(1); and
■ d. Removing paragraph (b)(3).
The revisions and additions read as
follows:
§ 721.10922 1,2,4,5,7,8-Hexoxonane, 3,6,9trimethyl-, 3,6,9-tris(alkyl) derivs. (generic).
(a) * * * (1) The chemical substance
identified generically as 1,2,4,5,7,8hexoxonane, 3,6,9-trimethyl-, 3,6,9tris(alkyl) derivs. (PMN P–15–607 and
SNUN S–17–13) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) * * *
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3) through (5),
(a)(6)(v), (b), and (c). When determining
which persons are reasonably likely to
be exposed as required for § 721.63(a)(1)
and (4), engineering control measures
(e.g., enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
assigned protection factor of at least 50.
For purposes of § 721.63(b), the
concentration is set at 1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1) through (3), (g)(4)(i),
and (g)(5). For purposes of § 721.72(e),
the concentration is set at 1.0%. For
purposes of § 721.72(g)(1), the required
human health hazard statements
include: Internal organ effects;
reproductive effects; allergic skin
reaction. For purposes of § 721.72(g)(2),
the required human health
precautionary statements include: Use
skin protection; where engineering
controls are not determined to be
adequate, use respiratory protection. For
purposes of § 721.72(g)(3), the required
environmental hazard statements
include: This substance may cause long
lasting harmful effects to aquatic life.
Alternative hazard and warning
statements that meet the criteria of the
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Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Industrial commercial, and
consumer activities. It is a significant
new use to process or use the substance
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with an application method that
generates a mist, vapor, or aerosol.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=56.
(b) * * *
(1) Recordkeeping. Recordkeeping
requirements as specified in
PO 00000
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Fmt 4700
Sfmt 9990
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§ 721.125(a) through (i) and (k) are
applicable to manufacturers and
processors of this substance.
*
*
*
*
*
[FR Doc. 2021–11768 Filed 6–4–21; 8:45 am]
BILLING CODE 6560–50–P
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]]>Agencies
[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Rules and Regulations]
[Pages 30210-30215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11768]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2020-0302; FRL-10022-76]
RIN 2070-AB27
Modification of Significant New Uses of Certain Chemical
Substances (20-2.M)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is amending significant new use rules (SNURs) issued under
the Toxic Substances Control Act (TSCA) for certain chemical substances
identified herein, which were the subject of premanufacture notices
(PMNs) and significant new use notices (SNUNs). This action would amend
the SNURs to allow certain new uses reported in the SNUNs without
additional notification requirements and modify the significant new use
notification requirements based on the actions and determinations for
the SNUN submissions. EPA is issuing these amendments based on review
of new and existing data for the chemical substances.
DATES: This rule is effective on August 6, 2021. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
June 21, 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:
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, which
would include the SNUR requirements. Chemical importers are subject to
the TSCA section 13 (15 U.S.C. 2612) import provisions. 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 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-2020-0302,
is available at https://www.regulations.gov or 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. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
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 issuing amendments to the SNURs for certain chemical
substances in 40 CFR part 721 subpart E.
Previously, in the Federal Register of November 18, 2020 (85 FR
73439) (FRL-10013-54), EPA proposed amendments to the SNURs for these
chemical substances and established the record for these SNUR
amendments in the docket under docket ID number EPA-HQ-OPPT-2020-0302.
That docket includes information considered by the Agency in developing
the proposed and final rules, including public comments.
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 (i.e., a SNUR) after
considering all relevant factors, including those listed in TSCA
section 5(a)(2). EPA may also amend a SNUR promulgated under TSCA
section 5(a)(2). Procedures and criteria for modifying or revoking SNUR
requirements appear at 40 CFR 721.185. Once EPA determines that a use
of a chemical substance is a significant new use, TSCA section
5(a)(1)(B) requires persons to submit a SNUN to EPA at least 90 days
before they manufacture, import, or process the chemical substance for
that use. Persons who must report are described in 40 CFR 721.5.
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 final rule,
recordkeeping requirements, exemptions to reporting requirements, and
applicability of the rule to uses occurring before the effective date
of the final rule. Provisions relating to user fees appear at 40 CFR
part 700. According to 40 CFR 721.1(c), persons subject to these SNURs
must comply with the same notice requirements and EPA regulatory
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In
particular, these requirements include the information submission
requirements of TSCA sections 5(b) and 5(d)(1), the exemptions
authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (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
[[Page 30211]]
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 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 whether and how to modify the significant new uses
for the chemical substances that are the subject of these SNURs, EPA
considered relevant information about the toxicity of the chemical
substance, likely human exposures and environmental releases associated
with possible uses, and the four TSCA section 5(a)(2) factors listed in
this unit.
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 proposed use would be a significant new use
under the rule. The manufacturer or processor 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 production volume limit is not
exceeded by the amount 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 three public comments in response to the proposed
SNURs. None of the comments pertained to the proposed SNURs or the
basis for these SNURs. As a result, EPA is finalizing the rules as
proposed and is not responding to the comments.
V. Rationale of the Final Rule
These amendments are based on EPA's determination under 40 CFR
721.85(a)(3) that significant new use notices for some of the
activities designated as significant new uses of the relevant chemical
substances were submitted to EPA and after reviewing the notices, EPA
concluded that there is no need to require additional notice from
persons who propose to engage in identical or similar activities. In
those instances where EPA expanded the scope of the significant new
use, the Agency identified concerns, as discussed in Unit IV. of the
proposed rule, associated with certain potential new uses. In addition
to considering the factors discussed in Unit IV. of the proposed rule,
EPA determined that those uses could result in changes in the type or
form of exposure to the chemical substance, increased exposures to the
chemical substance, and/or changes in the reasonably anticipated manner
and methods of manufacturing, processing, distribution in commerce, and
disposal of the chemical substance.
VI. Applicability of Rules to Uses Occurring Before Effective Date of
the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. EPA solicited comments on the proposed rule, providing
an opportunity for members of the public to indicate whether any of the
uses which are not significant new uses under the current rules, but
which would be regulated as ``significant new uses'' if the proposed
rule is finalized, are ongoing. EPA received no comments that these
uses were ongoing. Therefore, EPA concludes that the uses are not
ongoing.
EPA designated November 18, 2020 (the date of publication of the
proposed rule) as the cutoff date for determining whether the new use
is ongoing. The objective of EPA's approach has been to ensure that a
person could not defeat a SNUR by initiating a significant new use
before the effective date of the final rule.
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of the cutoff date, that person will have to cease any
such activity upon the effective date of the final rule. To resume
their activities, that person would have to first comply with all
applicable SNUR notification requirements and wait until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and has taken such actions as are required with that
determination.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 generally 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 4 covering the chemical substance, persons are required only to
submit information in their possession or control and to describe any
other
[[Page 30212]]
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 addressed in this
final rule. Descriptions are provided for informational purposes. The
information identified in Unit IV. of the proposed rule will be
potentially useful to EPA's evaluation of a chemical substance in the
event that someone submits a SNUN for a significant new use pursuant to
the SNURs addressed in this final rule. Companies who are considering
submitting a SNUN are encouraged, but are not required, to develop the
potentially useful information on the substance.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency. Furthermore, pursuant to TSCA section 4(h),
which pertains to reduction of testing on 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 dialogue with Agency representatives to help determine how
best the submitter can meet both the data needs and the objective of
TSCA section 4(h). For more information on alternative test methods and
strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
The potentially useful information identified in Unit IV. of the
proposed rule may not be the only means of addressing the potential
risks of the chemical substance. However, submitting a SNUN without any
test data or other information 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 that provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances; and
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 under 40 CFR part 720, 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 721.25 and 720.40. 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 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 modifies SNURs for several new chemical substances that
were the subject of PMNs and SNUNs. 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 activities associated with these SNURs
have already been approved by OMB pursuant to the 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.
The listing of the OMB control numbers of the collection
instruments and their subsequent codification in the table in 40 CFR
9.1 satisfies the display requirements of the PRA and OMB's
implementing regulations at 5 CFR part 1320. Since this ICR was
previously subject to public notice and comment prior to OMB approval,
and given the technical nature of the table in 40 CFR part 9, EPA finds
that further notice and comment to amend it is unnecessary. As a
result, EPA finds that there is ``good cause'' under section
553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C.
553(b)(3)(B)) to amend this table in 40 CFR 9.1 without further notice
and comment.
C. Regulatory Flexibility Act (RFA)
Pursuant to the 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
[[Page 30213]]
this SNUR are not expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 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
Tribe 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 Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not expected to affect energy
supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
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 in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: May 25, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended 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. Amend Sec. 721.983 by revising paragraphs (a)(1) and (a)(2)(ii) to
read as follows:
Sec. 721.983 Sulfonyl azide intermediate (generic).
(a) * * * (1) The chemical substance identified generically as
sulfonyl azide intermediate (PMN P-99-1202 and SNUN S-15-6) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) * * *
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to import,
process, or use this chemical substance as a powder unless less than 1%
of particles by weight are less than 200 microns.
* * * * *
0
3. Amend Sec. 721.9675 by revising paragraphs (a)(1), (a)(2)(i),
(a)(2)(ii) and (b)(1) to read as follows:
Sec. 721.9675 Titanate [Ti6O13 (2-)], dipotassium.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as titanate [Ti6O13
(2-)], dipotassium (PMN P-90-226; SNUNs P-96-1408, S-08-6, S-09-4, S-
13-49, S-16-5, and S-17-6; CAS No. 12056-51-8) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) * * *
(i) Protection in the workplace. For manufacturing, processing, and
use of SN-17-6: Requirements as specified in Sec. 721.63(a)(4), (5),
(6), and (c). When determining which persons are reasonably likely to
be exposed as required for Sec. 721.63(a)(4), engineering control
measures (e.g., enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health assigned protection factor of at least 10. For purposes of
Sec. 721.63(a)(6), the airborne form(s) of the substance include
particulate (including solid or liquid droplets).
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.8 mg/
m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(B) [Reserved]
[[Page 30214]]
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (l). In addition, a significant new
use of the substance is importation of the chemical substance if:
(A) Manufactured by other than the method described in
premanufacture notice P-90-226 and significant new use notices P-96-
1408, S-08-6, S-09-4, S-13-49, S-16-5, and S-17-6.
(B) Manufactured producing respirable, acicular fibers with an
average aspect ratio of greater than 5. The average aspect ratio is
defined as the ratio of average length to average diameter. For
manufacture of S-17-6: Manufacture with a particle size distribution
containing greater than 30% of particles less than 10 microns.
(b) * * *
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d) and (i) are applicable to manufacturers and
processors of this substance.
* * * * *
0
4. Amend Sec. 721.10288 by revising paragraphs (a)(1) and (a)(2)(i) to
read as follows:
Sec. 721.10288 Cyclohexane, oxidized, by-products from, distn.
residues.
(a) * * * (1) The chemical substance identified as cyclohexane,
oxidized, by-products from, distn. residues (PMN P-11-316; CAS No.
1014979-92-0) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) * * *
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=470.
* * * * *
0
5. Amend Sec. 721.10432 by:
0
a. Revising paragraphs (a)(1), (a)(2)(i) and (a)(2)(ii);
0
b. Adding paragraphs (a)(2)(iii) and (iv); and
0
c. Revising paragraph (b)(1).
The revisions and additions read as follows:
Sec. 721.10432 1,2,4,5,7,8-Hexoxonane, 3,6,9-triethyl-3,6,9-
trimethyl-.
(a) * * * (1) The chemical substance identified as 1,2,4,5,7,8-
hexoxonane, 3,6,9-triethyl-3,6,9-trimethyl- (PMN P-98-1028 and SNUNs S-
14-9, S-17-12, and S-17-15; CAS No. 24748-23-0) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) * * *
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5), (a)(6)(v), (b), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (4), engineering control measures
(e.g., enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health assigned protection factor of at least 50. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1) through (3), (g)(4)(i), and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), the required human health hazard
statements include: Internal organ effects; reproductive effects;
allergic skin reaction. For purposes of Sec. 721.72(g)(2), the
required human health precautionary statements include: Use skin
protection; where engineering controls are not determined to be
adequate, use respiratory protection. For purposes of Sec.
721.72(g)(3), the required environmental hazard statements include:
This substance may cause long lasting harmful effects to aquatic life.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial commercial, and consumer activities. It is a
significant new use to process or use the substance with an application
method that generates a mist, vapor, or aerosol.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=56.
(b) * * *
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
* * * * *
0
6. Amend Sec. 721.10907 by revising paragraphs (a)(1) and (a)(2)(i) to
read as follows:
Sec. 721.10907 Polyfluorohydrocarbon (generic).
(a) * * * (1) The chemical substance identified generically as
polyfluorohydrocarbon (PMN P-15-326 and SNUN S-17-11) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) * * *
(i) Industrial commercial, and consumer activities. Requirements as
specified in Sec. 721.80(o). It is a significant new use to use the
substance other than for the confidential uses described in PMN P-15-
326 and SNUN S-17-11.
* * * * *
0
7. Amend Sec. 721.10922 by:
0
a. Revising paragraphs (a)(1), (a)(2)(i) and (a)(2)(ii);
0
b. Adding paragraphs (a)(2)(iii) and (iv);
0
c. Revising paragraph (b)(1); and
0
d. Removing paragraph (b)(3).
The revisions and additions read as follows:
Sec. 721.10922 1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-
tris(alkyl) derivs. (generic).
(a) * * * (1) The chemical substance identified generically as
1,2,4,5,7,8-hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(alkyl) derivs.
(PMN P-15-607 and SNUN S-17-13) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) * * *
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5), (a)(6)(v), (b), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (4), engineering control measures
(e.g., enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health assigned protection factor of at least 50. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1) through (3), (g)(4)(i), and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), the required human health hazard
statements include: Internal organ effects; reproductive effects;
allergic skin reaction. For purposes of Sec. 721.72(g)(2), the
required human health precautionary statements include: Use skin
protection; where engineering controls are not determined to be
adequate, use respiratory protection. For purposes of Sec.
721.72(g)(3), the required environmental hazard statements include:
This substance may cause long lasting harmful effects to aquatic life.
Alternative hazard and warning statements that meet the criteria of the
[[Page 30215]]
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial commercial, and consumer activities. It is a
significant new use to process or use the substance with an application
method that generates a mist, vapor, or aerosol.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=56.
(b) * * *
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
* * * * *
[FR Doc. 2021-11768 Filed 6-4-21; 8:45 am]
BILLING CODE 6560-50-P
