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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations
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B. Procedures for Significant New Uses Claimed as Confidential Business Information CBI
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 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 aggregate annual production volume does not exceed that 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.
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
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Comments document that is available in the docket for this rule. EPA made changes to two of the proposed rules based on these comments, 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 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 The chemical substances that are the subjects of these SNURs received not likely to present an unreasonable risk determinations under TSCA section 5a3C based on EPAs review of the intended, known, and reasonably foreseen conditions of use. However, EPA has identified other circumstances that, should they occur in the future, even if not reasonably foreseen, may present risk concerns. Specifically, EPA
has determined that deviations from the protective measures identified in the PMN submissions could result in changes in the type or form of exposure to the chemical substances, increased exposures to the chemical substances, and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances. These SNURs identify as a significant new use manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the protective measures identified in the submissions.
As a result, those significant new uses cannot occur without first 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:

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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.
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 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 the 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, the identities of many of the 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
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