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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations
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proposed rules. The Agencys responses are presented in the Response to Public Comments document that is available in each of the dockets for these rules. EPA
made changes to three 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 SNURs, EPA provided the following information for each chemical substance:
PMN number.
Chemical name generic name, if the specific name is claimed as confidential business information CBI.
Chemical Abstracts Service CAS
Registry number if assigned for nonconfidential chemical identities.
Effective date of and basis for the TSCA Order.
Potentially Useful Information. This is information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substances if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.
CFR citation assigned in the regulatory text section of these rules.
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.
These final rules include PMN
substances that are subject to orders issued under TSCA section 5e1A, as required by the determinations made under TSCA section 5a3B. Those TSCA Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The final SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA
Orders, consistent with TSCA section 5f4.
Where EPA determined that the PMN
substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA Order usually requires that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New
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Chemical Exposure Limit NCEL. The comprehensive NCELs provisions in TSCA Orders include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. No comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the 40 CFR 721.63
respirator requirements may request to do so under 40 CFR 721.30. EPA expects that persons whose 40 CFR 721.30
requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA
Order.
VI. Rationale and Objectives of the Rule A. Rationale During review of the PMNs submitted for the chemical substances that are subject to these SNURs and as further discussed in Unit IV. of the proposed rules, EPA concluded that regulation was warranted under TSCA section 5e, pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. Based on such findings, TSCA Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow TSCA Orders with a SNUR that identifies the absence of those protective measures as significant new uses to ensure that all manufacturers and processorsnot just the original submitterare held to the same standard.
B. Objectives EPA is issuing these SNURs because the Agency wants to Receive notice of any persons intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.
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; and 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 significant
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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.
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory 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 Significant New Use Designation To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. 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 chemical substances for which an NOC
has not been submitted, EPA concludes that the designated significant new uses are not ongoing.
When chemical substances identified in this rule are added to the TSCA
Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA Orders have been issued for all the chemical substances that are the subject of this rule, and the PMN
submitters are prohibited by the TSCA
Orders from undertaking activities which will be designated as significant new uses. The identities of 50 of the 57
chemical substances subject to this rule have been claimed as confidential per 40 CFR 720.85. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.
Furthermore, EPA designated the publication dates of the proposed rules see Unit II. as the cutoff dates for determining whether the new uses are 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.

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