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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Rules and Regulations 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 5g to make public, and submit for publication in the Federal Register, a statement of EPAs 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 EPAs 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 721.1725b1 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 EPAs determination under 40 CFR
721.85a3 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 5b1A 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 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 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 5a2 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
721.1725b1 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.
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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