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30210 Federal Register/Vol. 86, No. 107/Monday, June 7, 2021/Rules and Regulations
[FR Doc. 2021–11840 Filed 6–4–21; 8:45 am] not intended to be exhaustive, but rather II. Background
BILLING CODE 6560–50–P provides a guide to help readers A. What action is the Agency taking?
determine whether this document EPA is issuing amendments to the
ENVIRONMENTAL PROTECTION applies to them. Potentially affected SNURs for certain chemical substances
AGENCY entities may include: in 40 CFR part 721 subpart E.
• Manufacturers or processors of one Previously, in the Federal Register of
40 CFR Part 721 or more subject chemical substances November 18, 2020 (85 FR 73439) (FRL–
[EPA–HQ–OPPT–2020–0302; FRL–10022– (NAICS codes 325 and 324110), e.g., 10013–54), EPA proposed amendments
76] chemical manufacturing and petroleum to the SNURs for these chemical
refineries. substances and established the record
RIN 2070–AB27 This action may also affect certain for these SNUR amendments in the
entities through pre-existing import docket under docket ID number EPA–
Modification of Significant New Uses certification and export notification HQ–OPPT–2020–0302. That docket
of Certain Chemical Substances (20– rules under TSCA, which would includes information considered by the
2.M) include the SNUR requirements. Agency in developing the proposed and
AGENCY: Environmental Protection Chemical importers are subject to the final rules, including public comments.
Agency (EPA). TSCA section 13 (15 U.S.C. 2612) B. What is the Agency’s authority for
ACTION: Final rule. import provisions. The EPA policy in taking this action?
SUMMARY: EPA is amending significant support of import certification appears TSCA section 5(a)(2) (15 U.S.C.
new use rules (SNURs) issued under the at 40 CFR part 707, subpart B. In 2604(a)(2)) authorizes EPA to determine
Toxic Substances Control Act (TSCA) addition, pursuant to 40 CFR 721.20, that a use of a chemical substance is a
for certain chemical substances any persons who export or intend to ‘‘significant new use.’’ EPA must make
identified herein, which were the export a chemical substance that is the this determination by rule (i.e., a SNUR)
subject of premanufacture notices subject of this rule are subject to the after considering all relevant factors,
(PMNs) and significant new use notices export notification provisions of TSCA including those listed in TSCA section
(SNUNs). This action would amend the section 12(b) (15 U.S.C. 2611(b)), and 5(a)(2). EPA may also amend a SNUR
SNURs to allow certain new uses must comply with the export promulgated under TSCA section
reported in the SNUNs without notification requirements in 40 CFR part 5(a)(2). Procedures and criteria for
additional notification requirements and 707, subpart D. modifying or revoking SNUR
modify the significant new use requirements appear at 40 CFR 721.185.
notification requirements based on the B. How can I access the docket? Once EPA determines that a use of a
actions and determinations for the The docket includes information chemical substance is a significant new
SNUN submissions. EPA is issuing considered by the Agency in developing use, TSCA section 5(a)(1)(B) requires
these amendments based on review of the proposed and final rules. The docket persons to submit a SNUN to EPA at
new and existing data for the chemical for this action, identified by docket least 90 days before they manufacture,
substances. identification (ID) number EPA–HQ– import, or process the chemical
DATES: This rule is effective on August OPPT–2020–0302, is available at substance for that use. Persons who
6, 2021. For purposes of judicial review, https://www.regulations.gov or at the must report are described in 40 CFR
this rule shall be promulgated at 1 p.m. 721.5.
Office of Pollution Prevention and C. Do the SNUR general provisions
(e.s.t.) on June 21, 2021. Toxics Docket (OPPT Docket), apply?
FORFURTHERINFORMATIONCONTACT: Environmental Protection Agency
For technical information contact: Docket Center (EPA/DC), West William General provisions for SNURs appear
William Wysong, New Chemicals Jefferson Clinton Bldg., Rm. 3334, 1301 in 40 CFR part 721, subpart A. These
Division (7405M), Office of Pollution Constitution Ave. NW, Washington, DC. provisions describe persons subject to
Prevention and Toxics, Environmental The Public Reading Room is open from the final rule, recordkeeping
Protection Agency, 1200 Pennsylvania 8:30 a.m. to 4:30 p.m., Monday through requirements, exemptions to reporting
Ave. NW, Washington, DC 20460–0001; Friday, excluding legal holidays. The requirements, and applicability of the
telephone number: (202) 564–4163; telephone number for the Public rule to uses occurring before the
email address: wysong.william@epa.gov. Reading Room is (202) 566–1744, and effective date of the final rule.
For general information contact: The the telephone number for the OPPT Provisions relating to user fees appear at
TSCA-Hotline, ABVI-Goodwill, 422 Docket is (202) 566–0280. Please review 40 CFR part 700. According to 40 CFR
South Clinton Ave., Rochester, NY the visitor instructions and additional 721.1(c), persons subject to these SNURs
14620; telephone number: (202) 554– information about the docket available must comply with the same notice
1404; email address: TSCA-Hotline@ at https://www.epa.gov/dockets. requirements and EPA regulatory
epa.gov. procedures as submitters of PMNs under
SUPPLEMENTARYINFORMATION: Due to the public health emergency, TSCA section 5(a)(1)(A). In particular,
the EPA Docket Center (EPA/DC) and these requirements include the
I. General Information Reading Room is closed to visitors with information submission requirements of
A. Does this action apply to me? limited exceptions. The staff continues TSCA sections 5(b) and 5(d)(1), the
to provide remote customer service via exemptions authorized by TSCA
You may be potentially affected by email, phone, and webform. For the sections 5(h)(1), (h)(2), (h)(3), and (h)(5),
this action if you manufacture, process, latest status information on EPA/DC and the regulations at 40 CFR part 720.
or use the chemical substances services and docket access, visit https:// Once EPA receives a SNUN, EPA must
contained in this rule. The following list www.epa.gov/dockets. either determine that the significant
of North American Industrial new use is not likely to present an
Classification System (NAICS) codes is unreasonable risk of injury or take such
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Federal Register/Vol. 86, No. 107/Monday, June 7, 2021/Rules and Regulations 30211
regulatory action as is associated with fide intent to manufacture or process the those uses could result in changes in the
an alternative determination before the chemical substance and must identify type or form of exposure to the chemical
manufacture or processing for the the specific use for which it intends to substance, increased exposures to the
significant new use can commence. If manufacture or process the chemical chemical substance, and/or changes in
EPA determines that the significant new substance. If EPA concludes that the the reasonably anticipated manner and
use is not likely to present an person has shown a bona fide intent to methods of manufacturing, processing,
unreasonable risk, EPA is required manufacture or process the chemical distribution in commerce, and disposal
under TSCA section 5(g) to make public, substance, EPA will tell the person of the chemical substance.
and submit for publication in the whether the use identified in the bona VI. Applicability of Rules to Uses
Federal Register, a statement of EPA’s fide submission would be a significant Occurring Before Effective Date of the
findings. new use under the rule. Since most of Final Rule
III. Significant New Use Determination the chemical identities of the chemical
substances subject to these SNURs are To establish a significant new use,
A. Determination Factors also CBI, manufacturers and processors EPA must determine that the use is not
TSCA section 5(a)(2) states that EPA’s can combine the bona fide submission ongoing. EPA solicited comments on the
determination that a use of a chemical under the procedure in 40 CFR proposed rule, providing an opportunity
substance is a significant new use must 721.1725(b)(1) with that under 40 CFR for members of the public to indicate
be made after consideration of all 721.11 into a single step. whether any of the uses which are not
relevant factors, including: If EPA determines that the use significant new uses under the current
• The projected volume of identified in the bona fide submission rules, but which would be regulated as
manufacturing and processing of a would not be a significant new use, i.e., ‘‘significant new uses’’ if the proposed
chemical substance. the use does not meet the criteria rule is finalized, are ongoing. EPA
• The extent to which a use changes specified in the rule for a significant received no comments that these uses
the type or form of exposure of human new use, that person can manufacture or were ongoing. Therefore, EPA concludes
beings or the environment to a chemical process the chemical substance so long that the uses are not ongoing.
substance. as the significant new use trigger is not EPA designated November 18, 2020
• The extent to which a use increases met. In the case of a production volume (the date of publication of the proposed
the magnitude and duration of exposure trigger, this means that the production rule) as the cutoff date for determining
of human beings or the environment to volume limit is not exceeded by the whether the new use is ongoing. The
a chemical substance. amount identified in the bona fide objective of EPA’s approach has been to
• The reasonably anticipated manner submission to EPA. Because of ensure that a person could not defeat a
and methods of manufacturing, confidentiality concerns, EPA does not SNUR by initiating a significant new use
processing, distribution in commerce, typically disclose the actual production before the effective date of the final rule.
volume that constitutes the use trigger. In the unlikely event that a person
and disposal of a chemical substance. Thus, if the person later intends to began commercial manufacture or
In determining whether and how to exceed that volume, a new bona fide processing of the chemical substances
modify the significant new uses for the submission would be necessary to for a significant new use identified as of
chemical substances that are the subject determine whether that higher volume the cutoff date, that person will have to
of these SNURs, EPA considered would be a significant new use. cease any such activity upon the
relevant information about the toxicity IV. Public Comments effective date of the final rule. To
of the chemical substance, likely human resume their activities, that person
exposures and environmental releases EPA received three public comments would have to first comply with all
associated with possible uses, and the in response to the proposed SNURs. applicable SNUR notification
four TSCA section 5(a)(2) factors listed None of the comments pertained to the requirements and wait until EPA has
in this unit. proposed SNURs or the basis for these conducted a review of the notice, made
B. Procedures for Significant New Uses SNURs. As a result, EPA is finalizing an appropriate determination on the
Claimed as Confidential Business the rules as proposed and is not notice, and has taken such actions as are
Information (CBI) responding to the comments. required with that determination.
By this rule, EPA is establishing V. Rationale of the Final Rule VII. Development and Submission of
certain significant new uses which have These amendments are based on Information
been claimed as CBI subject to Agency EPA’s determination under 40 CFR EPA recognizes that TSCA section 5
confidentiality regulations at 40 CFR 721.85(a)(3) that significant new use generally does not require development
part 2 and 40 CFR part 720, subpart E. notices for some of the activities of any particular new information (e.g.,
Absent a final determination or other designated as significant new uses of the generating test data) before submission
disposition of the confidentiality claim relevant chemical substances were of a SNUN. There is an exception: If a
under 40 CFR part 2 procedures, EPA is submitted to EPA and after reviewing person is required to submit information
required to keep this information the notices, EPA concluded that there is for a chemical substance pursuant to a
confidential. EPA promulgated a no need to require additional notice rule, order or consent agreement under
procedure to deal with the situation from persons who propose to engage in TSCA section 4, then TSCA section
where a specific significant new use is identical or similar activities. In those 5(b)(1)(A) requires such information to
CBI, at 40 CFR 721.1725(b)(1) and has instances where EPA expanded the be submitted to EPA at the time of
referenced it to apply to other SNURs. scope of the significant new use, the submission of the SNUN.
Under these procedures a Agency identified concerns, as In the absence of a rule, order, or
manufacturer or processor may request discussed in Unit IV. of the proposed consent agreement under TSCA section
EPA to determine whether a proposed rule, associated with certain potential 4 covering the chemical substance,
use would be a significant new use new uses. In addition to considering the persons are required only to submit
under the rule. The manufacturer or factors discussed in Unit IV. of the information in their possession or
processor must show that it has a bona proposed rule, EPA determined that control and to describe any other
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30212 Federal Register/Vol. 86, No. 107/Monday, June 7, 2021/Rules and Regulations
information known to or reasonably EPA regulatory procedures as persons to average between 30 and 170 hours
ascertainable by them (see 40 CFR submitting a PMN under 40 CFR part per response. This burden estimate
720.50). However, upon review of PMNs 720, including submission of test data includes the time needed to review
and SNUNs, the Agency has the on health and environmental effects as instructions, search existing data
authority to require appropriate testing. described in 40 CFR 720.50. SNUNs sources, gather and maintain the data
Unit IV. of the proposed rule lists must be submitted on EPA Form No. needed, and complete, review, and
potentially useful information for all 7710–25, generated using e-PMN submit the required SNUN.
SNURs addressed in this final rule. software, and submitted to the Agency The listing of the OMB control
Descriptions are provided for in accordance with the procedures set numbers of the collection instruments
informational purposes. The forth in 40 CFR 721.25 and 720.40. E– and their subsequent codification in the
information identified in Unit IV. of the PMN software is available electronically table in 40 CFR 9.1 satisfies the display
proposed rule will be potentially useful at https://www.epa.gov/reviewing-new- requirements of the PRA and OMB’s
to EPA’s evaluation of a chemical chemicals-under-toxic-substances- implementing regulations at 5 CFR part
substance in the event that someone control-act-tsca. 1320. Since this ICR was previously
submits a SNUN for a significant new IX. Economic Analysis subject to public notice and comment
use pursuant to the SNURs addressed in prior to OMB approval, and given the
this final rule. Companies who are EPA has evaluated the potential costs technical nature of the table in 40 CFR
considering submitting a SNUN are of establishing SNUN requirements for part 9, EPA finds that further notice and
encouraged, but are not required, to potential manufacturers and processors comment to amend it is unnecessary. As
develop the potentially useful of the chemical substances subject to a result, EPA finds that there is ‘‘good
information on the substance. this rule. EPA’s complete economic cause’’ under section 553(b)(3)(B) of the
EPA strongly encourages persons, analysis is available in the docket for Administrative Procedure Act (5 U.S.C.
before performing any testing, to consult this rulemaking. 553(b)(3)(B)) to amend this table in 40
with the Agency. Furthermore, pursuant X. Statutory and Executive Order CFR 9.1 without further notice and
to TSCA section 4(h), which pertains to Reviews comment.
reduction of testing on vertebrate C. Regulatory Flexibility Act (RFA)
animals, EPA encourages consultation Additional information about these
with the Agency on the use of statutes and Executive orders can be Pursuant to the RFA section 605(b), 5
alternative test methods and strategies found at https://www.epa.gov/laws- U.S.C. 601 et seq., I hereby certify that
(also called New Approach regulations-and-executive-orders. promulgation of this SNUR would not
Methodologies, or NAMs), if available, A. Executive Order 12866: Regulatory have a significant adverse economic
to generate the recommended test data. Planning and Review and Executive impact on a substantial number of small
EPA encourages dialogue with Agency Order 13563: Improving Regulations entities. The requirement to submit a
representatives to help determine how and Regulatory Review SNUN applies to any person (including
best the submitter can meet both the small or large entities) who intends to
data needs and the objective of TSCA This action modifies SNURs for engage in any activity described in the
section 4(h). For more information on several new chemical substances that final rule as a ‘‘significant new use’’.
alternative test methods and strategies were the subject of PMNs and SNUNs. Because these uses are ‘‘new,’’ based on
to reduce vertebrate animal testing, visit The Office of Management and Budget all information currently available to
https://www.epa.gov/assessing-and- (OMB) has exempted these types of EPA, it appears that no small or large
managing-chemicals-under-tsca/ actions from review under Executive entities presently engage in such
alternative-test-methods-and-strategies- Orders 12866 (58 FR 51735, October 4, activities. A SNUR requires that any
reduce. 1993) and 13563 (76 FR 3821, January person who intends to engage in such
The potentially useful information 21, 2011). activity in the future must first notify
identified in Unit IV. of the proposed B. Paperwork Reduction Act (PRA) EPA by submitting a SNUN. Although
rule may not be the only means of some small entities may decide to
addressing the potential risks of the According to the PRA, (44 U.S.C. 3501 pursue a significant new use in the
chemical substance. However, et seq.), an agency may not conduct or future, EPA cannot presently determine
submitting a SNUN without any test sponsor, and a person is not required to how many, if any, there may be.
data or other information may increase respond to a collection of information However, EPA’s experience to date is
the likelihood that EPA will take action that requires OMB approval under PRA, that, in response to the promulgation of
under TSCA sections 5(e) or 5(f). EPA unless it has been approved by OMB SNURs covering over 1,000 chemicals,
recommends that potential SNUN and displays a currently valid OMB the Agency receives only a small
submitters contact EPA early enough so control number. The OMB control number of notices per year. For
that they will be able to conduct the numbers for EPA’s regulations in title 40 example, the number of SNUNs
appropriate tests. of the CFR, after appearing in the received was seven in Federal fiscal
SNUN submitters should be aware Federal Register, are listed in 40 CFR year (FY) 2013, 13 in FY2014, six in
that EPA will be better able to evaluate part 9, and included on the related FY2015, 12 in FY2016, 13 in FY2017,
SNUNs that provide detailed collection instrument or form, if and 11 in FY2018. Only a fraction of
information on the following: applicable. these were from small businesses. In
• Human exposure and The information collection activities addition, the Agency currently offers
environmental release that may result associated with these SNURs have relief to qualifying small businesses by
from the significant new use of the already been approved by OMB reducing the SNUN submission fee from
chemical substances; and pursuant to the PRA under OMB control $16,000 to $2,800. This lower fee
VIII. SNUN Submissions number 2070–0012 (EPA ICR No. 574). reduces the total reporting and
This action does not impose any burden recordkeeping of cost of submitting a
According to 40 CFR 721.1(c), persons requiring additional OMB approval. If SNUN to about $10,116 for qualifying
submitting a SNUN must comply with an entity were to submit a SNUN to the small firms. Therefore, the potential
the same notification requirements and Agency, the annual burden is estimated economic impacts of complying with
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Federal Register/Vol. 86, No. 107/Monday, June 7, 2021/Rules and Regulations 30213
this SNUR are not expected to be H. Executive Order 13211: Actions under this section for the significant
significant or adversely impact a Concerning Regulations That new uses described in paragraph (a)(2)
substantial number of small entities. In Significantly Affect Energy Supply, of this section.
a SNUR that published in the Federal Distribution, or Use (2) * * *
Register of June 2, 1997 (62 FR 29684) This action is not subject to Executive (ii) Industrial, commercial, and
(FRL–5597–1), the Agency presented its Order 13211 (66 FR 28355, May 22, consumer activities. Requirements as
general determination that final SNURs 2001), because this action is not specified in §721.80(f). It is a significant
are not expected to have a significant expected to affect energy supply, new use to import, process, or use this
economic impact on a substantial distribution, or use and because this chemical substance as a powder unless
number of small entities, which was action is not a significant regulatory less than 1% of particles by weight are
provided to the Chief Counsel for action under Executive Order 12866. less than 200 microns.
Advocacy of the Small Business * * * * *
Administration. I. National Technology Transfer and ■ 3. Amend §721.9675 by revising
D. Unfunded Mandates Reform Act Advancement Act (NTTAA) paragraphs (a)(1), (a)(2)(i), (a)(2)(ii) and
(UMRA) Since this action does not involve any (b)(1) to read as follows:
Based on EPA’s experience with technical standards, NTTAA section §721.9675 Titanate [Ti6O13 (2-)],
proposing and finalizing SNURs, State, 12(d) (15 U.S.C. 272 note), does not dipotassium.
local, and Tribal governments have not apply to this action. (a) Chemical substance and
been impacted by these rulemakings, J. Executive Order 12898: Federal significant new uses subject to reporting.
and EPA does not have any reasons to Actions To Address Environmental (1) The chemical substance identified as
believe that any State, local, or Tribal Justice in Minority Populations and titanate [Ti6O13 (2-)], dipotassium
government will be impacted by this Low-Income Populations (PMN P–90–226; SNUNs P–96–1408, S–
action. As such, EPA has determined This action does not entail special 08–6, S–09–4, S–13–49, S–16–5, and S–
that this action does not impose any considerations of environmental justice 17–6; CAS No. 12056–51–8) is subject to
enforceable duty, contain any unfunded related issues as delineated by reporting under this section for the
mandate, or otherwise have any effect Executive Order 12898 (59 FR 7629, significant new uses described in
on small governments subject to the February 16, 1994). paragraph (a)(2) of this section.
requirements of UMRA sections 202, (2) * * *
203, 204, or 205 (2 U.S.C. 1501 et seq.). K. Congressional Review Act (CRA) (i) Protection in the workplace. For
This action is subject to the CRA (5 manufacturing, processing, and use of
E. Executive Order 13132: Federalism U.S.C. 801 et seq.), and EPA will submit SN–17–6: Requirements as specified in
This action will not have federalism a rule report containing this rule and §721.63(a)(4), (5), (6), and (c). When
implications because it is not expected other required information to each determining which persons are
to have a substantial direct effect on House of the Congress and to the reasonably likely to be exposed as
States, on the relationship between the Comptroller General of the United required for §721.63(a)(4), engineering
national government and the States, or States. This action is not a ‘‘major rule’’ control measures (e.g., enclosure or
on the distribution of power and as defined by 5 U.S.C. 804(2). confinement of the operation, general
responsibilities among the various and local ventilation) or administrative
levels of government, as specified in List of Subjects in 40 CFR Part 721 control measures (e.g., workplace
Executive Order 13132 (64 FR 43255, Environmental protection, Chemicals, policies and procedures) shall be
August 10, 1999). Hazardous substances, Reporting and considered and implemented to prevent
F. Executive Order 13175: Consultation recordkeeping requirements. exposure, where feasible. For purposes
and Coordination With Indian Tribe Dated: May 25, 2021. of §721.63(a)(5), respirators must
Governments provide a National Institute for
Tala Henry, Occupational Safety and Health
This action will not have Tribal Deputy Director, Office of Pollution assigned protection factor of at least 10.
implications because it is not expected Prevention and Toxics. For purposes of §721.63(a)(6), the
to have substantial direct effects on Therefore, for the reasons stated in the airborne form(s) of the substance
Indian Tribes, significantly or uniquely preamble, 40 CFR chapter I is amended include particulate (including solid or
affect the communities of Indian Tribal as follows: liquid droplets).
governments, and does not involve or (A) As an alternative to the respirator
impose any requirements that affect PART 721—SIGNIFICANT NEW USES requirements in paragraph (a)(2)(i) of
Indian Tribes. Accordingly, the OF CHEMICAL SUBSTANCES this section, a manufacturer or processor
requirements of Executive Order 13175 ■ 1. The authority citation for part 721 may choose to follow the new chemical
(65 FR 67249, November 9, 2000), do continues to read as follows: exposure limit (NCEL) provision listed
not apply to this action. in the TSCA section 5(e) consent order
G. Executive Order 13045: Protection of Authority: 15 U.S.C. 2604, 2607, and for this substance. The NCEL is 0.8 mg/
2625(c). 3
Children From Environmental Health m as an 8-hour time weighted average.
Risks and Safety Risks ■ 2. Amend §721.983 by revising Persons who wish to pursue NCELs as
paragraphs (a)(1) and (a)(2)(ii) to read as an alternative to §721.63 respirator
This action is not subject to Executive follows: requirements may request to do so
Order 13045 (62 FR 19885, April 23, under §721.30. Persons whose §721.30
1997), because this is not an §721.983 Sulfonyl azide intermediate requests to use the NCELs approach are
economically significant regulatory (generic). approved by EPA will be required to
action as defined by Executive Order (a) * * * (1) The chemical substance follow NCELs provisions comparable to
12866, and this action does not address identified generically as sulfonyl azide those contained in the corresponding
environmental health or safety risks intermediate (PMN P–99–1202 and TSCA section 5(e) consent order.
disproportionately affecting children. SNUN S–15–6) is subject to reporting (B) [Reserved]
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