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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Rules and Regulations
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.
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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IV. Public Comments on Proposed Rule and EPA Responses EPA received public comments from four identifying entities on the proposed rule. The Agencys responses to three of these comments are described in a separate Response to Public Comments document that is available in the public docket for this rulemaking. EPA made changes to one of the proposed rules, as described in the response to comments.
EPA also received three anonymous comments. These three anonymous comments and the fourth identifying entity comment were general in nature and did not pertain to the proposed rule; therefore, no response is required.
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
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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.

TSCA section 5a3A or B and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.
To be able to complete its review and determination on each of the PMN
substances, while deferring analysis on the significant new uses proposed in these rules unless and until the Agency receives a SNUN.
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at https www.epa.gov/tscainventory.

VI. Rationale and Objectives of the Rule
VII. Applicability of the Rules to Uses Occurring Before the Effective Date of the Final Rule To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule were undergoing premanufacture review at the time of signature of the proposed rule and were not on the TSCA inventory. In cases where EPA has not received a notice of commencement NOC and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for the chemical substances subject to these SNURs EPA concluded at the time of signature of the proposed rule that the designated significant new uses were not ongoing.
EPA designated June 2, 2020 the date of the web posting of the proposed rule as the cutoff date for determining whether the new use is ongoing. The objective of EPAs approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.
Persons who began commercial manufacture or processing of the chemical substances for a significant new use identified on or after that date will have to cease any such activity upon the effective date of the final rule.
To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and EPA would have to take action under section 5 allowing manufacture or processing to proceed.

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 these conditions of use as well as certain other circumstances of use as significant new uses. As a result, those significant new uses cannot occur without going through a separate, subsequent EPA review and determination process associated with a SNUN.
B. Objectives EPA is issuing these SNURs because the Agency wants:
To have an opportunity to review and evaluate data submitted in a SNUN
before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
To be obligated to make a determination under TSCA section 5a3 regarding the use described in the SNUN, under the conditions of use.
The Agency will either determine under TSCA section 5a3C that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under
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VIII. Development and Submission of Information EPA recognizes that TSCA section 5
does not require development of any particular new information e.g., generating test data before submission
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