Federal Register - June 28, 2021

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Fuente: Federal Register

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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Proposed Rules in CDR submissions Ref. 13. EPA is similarly proposing that a person submitting a reporting form under this action may claim portions of the form as confidential, consistent with TSCA
section 14. TSCA requires that the submitter make several statements relating to the treatment of the information as confidential and competitive harm of disclosure, and to certify that these statements and any substantiation provided are true and correct. Consistent with the format of other TSCA reporting forms, the statements and certification would be combined into a single certification statement. There is also a requirement that when a chemical identity is claimed as CBI, a non-CBI structurally descriptive generic name be provided.
To help reporters, EPAs reporting platform can auto-populate generic names on the Inventory using EPAs Substance Registry Services SRS.
TSCA section 14 further requires that substantiation be provided when a confidentiality claim is asserted.
However, TSCA section 14c2
exempts certain information from the substantiation requirements e.g., specific production volume. Under the proposed rule, specific production or import volumes of the manufacturer, as well as the percent production volume for each consumer or commercial use, need not be substantiated. All other information submitted under this proposed rule would not be exempt from substantiation requirements.
Any information which is claimed as confidential will be disclosed by EPA
only in accordance with the procedures and requirements of TSCA section 14
and 40 CFR part 2. TSCA limits confidentiality protections for health and safety studies, information from health and safety studies except to the extent such studies or information reveals information that discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the portion of the mixture comprised by any of the chemical substances in the mixture, and certain other information. Submitters asserting a confidentiality claim for such information in health and safety studies will be required to submit a sanitized copy of the study, removing only that information which is claimed as confidential and that discloses the process or portion of mixture information described in TSCA section 14b.

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G. What are the recordkeeping requirements?
EPA proposes that each person who is subject to the reporting requirements must retain records that document any information reported to EPA. Consistent with the CDR rule, EPA is proposing a five-year recordkeeping period, beginning on the last date of the submission period. The five-year retention requirement corresponds with the statute of limitations for violations and is necessary to preserve records to support future regulatory activities that would be informed by this information collection. Further, EPA believes the burden of retaining these records, which are likely electronic, is minimal.
IV. Request for Comments EPA is seeking public comment on all aspects of this proposed rule and the Economic Analysis prepared in support of this proposed rule Ref. 14. In addition to specific requests for comment included throughout this document, EPA is interested in comments pertaining to the specific issues discussed in this unit. EPA
encourages all interested persons to submit comments on the issues identified in this Notification and to identify any other relevant issues as well. This input will assist the Agency in developing a final rule that successfully addresses information needs while minimizing potential reporting burdens associated with the rule. EPA requests that commenters making specific recommendations include supporting documentation where appropriate.
1. Identifying the chemical substances that would be subject to reporting. EPA
has provided a structural definition of PFAS for the purposes of this proposed rules scope. To assist reporting entities with determining whether a chemical substance or mixture falls within this scope, EPA has also provided a list of PFAS identified by CASRN, TSCA
Accession Number, or LVE case number and structural diagrams to include any PFAS whose chemical identity is not specifically listed due to CBI protections. EPA is soliciting comment on this approach for defining or identifying PFAS. Additionally, EPA
is interested in comments identifying specific substances of interest and the rationale for the interest, that may be outside the scope of this proposed definition. EPA is also interested in public comments related to including imported articles containing PFAS
within the scope of this proposed rule.
2. Considerations for the Agencys economic analysis. EPA has evaluated
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the potential costs for PFAS
manufacturers for this proposed rule Ref. 14. EPA is specifically seeking additional information and data that EPA could consider in developing the final economic analysis. In particular, EPA is seeking data that could facilitate the Agencys further evaluation of the potentially affected industry and firms, including data related to potential impacts for those small businesses and importers that would be subject to reporting. The agency is specifically interested in available data on small entity importers of articles containing PFAS for its impact analysis for small entities. EPA is also especially interested in available data or other measures of the number of facilities or firms that might manufacture such materials, including importing PFAS in articles.
3. Submission period. EPA is proposing a six-month submission period for reporting entities, which will begin six months following the effective date of the final rule. Thus, PFAS
manufacturers will have one year following the effective date of the final rule to submit all required information to EPA. Since many of the reporters under this proposed rule have reported under CDR, EPA is basing the proposed submission period, in part, on the CDR
submission period. Given the fourmonth submission period for the CDR
reporting cycle every four years, the Agency believes six months is sufficient time for manufacturers to report the required information under this proposed rule, noting that the scope of this rule covers more years than a CDR
reporting cycle. Reporters will also have the additional six months between the effective date of the rule and the start of the submission period for rule familiarization and data gathering.
Additionally, the six months between the effective date of the final rule and the beginning of the submission period allows the Agency time to finalize the reporting software. Congress required EPA to promulgate the rule no later than January 1, 2023; therefore, EPA
anticipates the reporting period for this proposed rule will precede the reporting period for the 2024 CDR reporting cycle JuneSeptember 2024. EPA is specifically asking for comment on additional considerations related to the start date and duration of the submission period.
4. Duplicative reporting. EPA has identified the data elements in this proposed rule for which information may have been submitted to EPA
previously under CDR see Unit III.D., which the Agency is proposing to allow manufacturers to indicate through the
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Federal Register - June 28, 2021

TítuloFederal Register

PaísEstados Unidos de América

Fecha28/06/2021

Nro. de páginas282

Nro. de ediciones7801

Primera edición14/03/1936

Ultima edición24/06/2026

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