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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations 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.
III. Significant New Use Determination 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 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.

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IV. Public Comments EPA received a public comment from one identifying entity on the proposed rule. The comment was broadly supportive and requested no changes to the final rule; therefore, no response is required. EPA made no changes to the final rule as a result of this comment.

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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 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 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 section 5a3C that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially
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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.
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 December 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 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 TSCA section 5
allowing manufacture or processing to proceed.

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