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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Rules and Regulations
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 three identifying entities on the proposed rule. The Agencys responses are presented in the Response to Public Comments document that is available in the docket for this rule. EPA made changes to two of the proposed rules, as described in the response to 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.

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 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 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.

A. Rationale
VII. Applicability of the Rules to Uses Occurring Before the Effective Date of the Final Rule
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 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.

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 May 4, 2020 the date of web posting of the proposed rule as the cutoff date for determining whether the new use is ongoing. The objective of
VI. Rationale and Objectives of the Rule
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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.
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 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 information known to or reasonably ascertainable by them see 40 CFR
720.50. However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing.
Unit IV. of the proposed rule lists potentially useful information for all SNURs listed here. Descriptions are provided for informational purposes.
The potentially useful information identified in Unit IV. of the proposed rule will be useful to EPAs evaluation in the event that someone submits a SNUN for the significant new use.
Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPAs analysis of the SNUN.
EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol election. Furthermore, pursuant to TSCA section 4h, which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies also called New Approach Methodologies, or NAMs, if available, to generate the recommended test data.
EPA encourages dialog with Agency
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