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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Rules and Regulations C. Do the SNUR general provisions apply?
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1c, persons subject to these SNURs must comply with the same 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, 5h2, 5h3, and 5h5 and the regulations at 40 CFR
part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5g to make public, and submit for publication in the Federal Register, a statement of EPAs findings.

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III. Significant New Use Determination A. Determination Factors 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 the
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substances, in the context of the four bulleted TSCA section 5a2 factors listed in this unit. During its review of these chemicals, EPA identified certain conditions of use that are not intended by the submitters, but reasonably foreseen to occur. EPA is designating those reasonably foreseen conditions of use as well as certain other circumstances of use as significant new uses.
B. Procedures for Significant New Uses Claimed as Confidential Business Information CBI
By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR
part 2 and 40 CFR part 720, subpart E.
Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725b1 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 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.

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Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.
IV. Public Comments EPA received public comments from seven identifying entities on the proposed rule. In addition, EPA
received two anonymous comments.
The Agencys responses are described in a separate Response to Public Comments document that is available in the public docket for this rulemaking.
The two anonymous comments and four of the comments from identifying entities were either general in nature and did not pertain to the proposed rule or were broadly supportive of the rule and requested no changes to the rule itself; therefore, no response is required.
EPA made no changes to the final rules as a result of these comments.
V. Substances Subject to This Rule EPA is establishing significant new use and recordkeeping requirements for chemical substances in 40 CFR part 721, subpart E. In Unit IV. of the proposed SNUR, EPA provided the following information for each chemical substance:
PMN number.
Chemical name generic name, if the specific name is claimed as CBI.
Chemical Abstracts Service CAS
Registry number if assigned for nonconfidential chemical identities.
Basis for the SNUR.
Potentially useful information.
CFR citation assigned in the proposed regulatory text, and the final citation assignment is in the regulatory text section of this final rule.
The regulatory text section of these rules specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the rules, may be claimed as CBI.
VI. Rationale and Objectives of the Rule A. Rationale During review of the PMNs submitted for the chemical substances that are the subject of these SNURs and as further discussed in Unit IV. of the proposed rule, EPA identified certain other reasonably foreseen conditions of use in addition to those conditions of use intended by the submitter. EPA has determined that the chemical under the intended conditions of use is not likely to present an unreasonable risk.
However, EPA has not assessed risks associated with the reasonably foreseen conditions of use. EPA is designating
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