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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations
Center EPA/DC and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC
services and docket access, visit https
www.epa.gov/dockets.
II. Background A. What action is the Agency taking?
EPA is finalizing SNURs under TSCA
section 5a2 for certain chemical substances which were the subject of PMNs. EPA will address the other proposed SNURs in future Federal Register notices.
Previously, EPA proposed SNURs for these chemical substances and established the record for these SNURs in the following Federal Registers and docket ID numbers:
October 3, 2018 83 FR 49903
FRL998381; Docket ID No. EPA
HQOPPT20180627;
July 31, 2019 84 FR 37199 FRL
999462; Docket ID No. EPAHQ
OPPT20180777;
August 6, 2019 84 FR 38158 FRL
999662; Docket ID No. EPAHQ
OPPT20190359;
October 11, 2019 84 FR 54816
FRL999864; Docket ID No. EPA
HQOPPT20190228;
November 4, 2019 84 FR 59335
FRL1000054; Docket ID No. EPA
HQOPPT20190494; and December 6, 2019 84 FR 66855
FRL1000148; Docket ID No. EPA
HQOPPT20190530.
The dockets include information considered by the Agency in developing the proposed and final rules, including public comments and EPAs responses to the public comments received.
B. What is the Agencys authority for taking this action?
TSCA section 5a2 15 U.S.C.
2604a2 authorizes EPA to determine that a use of a chemical substance is a significant new use. EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA
section 5a2 factors listed in Unit III.

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C. Applicability of General Provisions General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1c, persons subject to
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these SNURs must comply with the significant new use notice SNUN
requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5a1A. In particular, these requirements include the information submission requirements of TSCA sections 5b and 5d1, the exemptions authorized by TSCA
sections 5h1, h2, h3, and h5, and the regulations at 40 CFR part 720.
Once EPA receives a SNUN and before the manufacture or processing for the significant new use can commence, EPA
must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5g to make public, and submit for publication in the Federal Register, a statement of EPAs findings.
III. Significant New Use Determination A. Considerations for Significant New Use Determinations When the Agency issues an order under TSCA section 5e, section 5f4
requires that the Agency consider whether to promulgate a SNUR for any use not conforming to the restrictions of the TSCA Order or publish a statement describing the reasons for not initiating the rulemaking. TSCA section 5a2
states that EPAs determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a chemical substance.
The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with possible uses of these chemical substances, in the context of the four
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bulleted TSCA section 5a2 factors listed in this unit.
B. Procedures for Significant New Uses Claimed as 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 721.1725b1 and has referenced it to apply to other SNURs.
Under these procedures a manufacturer or processor may request EPA to determine whether a specific use would be a significant new use under the rule. The manufacturer or processor 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
721.1725b1 with that under 40 CFR
721.11 into a single step.
If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger.
Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.
IV. Public Comments on Proposed Rule and EPA Responses EPA received public comments from nine identifying entities on the
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