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Federal Register / Vol. 86, No. 53 / Monday, March 22, 2021 / Rules and Regulations I. General Information
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A. Does this action apply to me?
You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System NAICS codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject chemical substances NAICS codes 325 and 324110, e.g., chemical manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 15
U.S.C. 2612 import provisions. This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA, which would include the SNUR
requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this rule are subject to the export notification provisions of TSCA
section 12b 15 U.S.C. 2611b, and must comply with the export notification requirements in 40 CFR part 707, subpart D.
B. How can I access the docket?
The docket includes information considered by the Agency in developing the proposed and final rules. The docket for this action, identified by docket identification ID number EPAHQ
OPPT20200138, is available at https www.regulations.gov and at the Office of Pollution Prevention and Toxics Docket OPPT Docket, Environmental Protection Agency Docket Center EPA/DC, West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is 202 5661744, and the telephone number for the OPPT
Docket is 202 5660280. Please review the visitor instructions and additional information about the docket available at https www.epa.gov/dockets.
Due to the public health emergency, the EPA Docket Center EPA/DC and Reading Room is closed to visitors with
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limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC
services and docket access, visit https
www.epa.gov/dockets.
II. Background A. What action is the Agency taking?
EPA is finalizing SNURs under TSCA
section 5a2 for chemical substances which were the subject of PMNs P18
59, P1860, and P18381. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.
Previously, in the Federal Register of April 17, 2020 85 FR 21366 FRL
1000750, EPA proposed SNURs for these chemical substances. More information on the specific chemical substances subject to this final rule can be found in the Federal Register document proposing the SNURs. The docket includes information considered by the Agency in developing the proposed and final rules, including public comments and EPAs responses to the public comments received on the proposed rules, as described in Unit IV.
B. What is the Agencys authority for taking this action?
TSCA section 5a2 15 U.S.C.
2604a2 authorizes EPA to determine that a use of a chemical substance is a significant new use. EPA must make this determination by rule after considering all relevant factors, including the four TSCA section 5a2
factors listed in Unit III.
C. Do the SNUR general provisions apply?
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1c, persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5a1A. In particular, these requirements include the information submission requirements of TSCA sections 5b and 5d1, the exemptions authorized by TSCA
sections 5h1, 5h2, 5h3, and 5h5 and the regulations at 40 CFR
part 720. Once EPA receives a SNUN,
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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 A. Determination Factors 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.
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
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