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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Proposed Rules
reporting tool has already been submitted rather than re-submit the information. EPA is requesting comment on whether any additional data elements may be duplicative of information collected by EPA under TSCA or other federal statutes. Please identify the information that you believe is duplicative and the statute under which it is submitted, as well as the precision of the information if appropriate for example, whether the data are submitted as a range or as an integer to the nearest significant digits.
5. Scope of environmental and health effects information collected. EPA is requesting comment on what existing environmental and health effects information should be within the scope of this rule. EPA is proposing to require such information be submitted in the form of OECD harmonized templates, to the extent they are available, and as full study reports and any supporting documents. The Agency is requesting comments on the scope of existing environmental and health information that may be requested from PFAS
manufacturers. The Agency is also interested in comments on the proposed format of these submissions.
6. Additional information or data elements. EPA has provided the list of proposed data elements for this rule in Unit III.C Ref. 10, which EPA is authorized to request under section 8a7. EPA is interested in public comment on the scope of these proposed data elements, including whether there are additional data elements EPA should collect under the authority of section 8a7. Specifically, EPA is interested in comments on whether the final rule should include a data field allowing reporters to provide generic names or descriptions in the event a manufacturer is aware they have produced or imported a PFAS but are not able to reasonably ascertain the specific PFAS identity. The Agency is also requesting comments on additional data elements such as composition information if a PFAS has a variable composition, analytical methods, and whether occupational exposure information should distinguish occupational non-users i.e., those nearby but not in direct contact with the chemical from workers i.e., those who are in direct contact with the chemical.
7. EPAs use and publication of certain non-CBI data. EPA is requesting public comment on how the Agency may consider using the data received under this reporting rule, beyond those activities previously mentioned in Unit II.E. Additionally, the Agency is interested in comment on the extent to which non-CBI data submitted under
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this rule should be provided to the general public.
8. Joint submissions. EPA is requesting public comment on whether the Agency should enable the use of joint submissions in specific circumstances, similar to CDR joint submissions. Joint submissions may be necessary under circumstances when:
1 A company imports a chemical or a mixture under a trade name and the substance identity, or individual components, are not known to the importer, or 2 a manufacturer cannot provide the entire chemical identity of a chemical substance it manufactures because the chemical substance is manufactured using a reactant having an identity that the reactant supplier claims as confidential. In these circumstances, the supplier has identified that it will not disclose to the manufacturer or importer or does not, itself, know the chemical identity.
9. Small manufacturers. EPA is requesting public comment on how the Agency may assist small manufacturers with compliance with this proposed rule. The Agency appreciates comments related to both regulatory and nonregulatory assistance, such as different reporting timelines and outreach.
V. References The following is a list of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
1. EPA 2019. EPAs Perand Polyfluoroalkyl Substances PFAS
Action Plan, EPA823R18004.
February 14, 2019. Available at https
www.epa.gov/sites/production/files/
2019-02/documents/pfas_action_plan_
021319_508compliant_1.pdf.
2. EPA 2017. Technical Fact Sheet Perfluorooctane Sulfonate PFOS and Perfluorooctanoic Acid PFOA, EPA
505F17001. November 2017.
Available at https www.epa.gov/sites/
production/files/2017-12/documents/
ffrrofactsheet_contaminants_pfos_pfoa_
11-20-17_508_0.pdf.
3. EPA 2009. Long-Chain Perfluorinated Chemicals PFCs Action Plan. December 30, 2009. Available at https
www.epa.gov/sites/production/files/
2016-01/documents/pfcs_action_
plan1230_09.pdf.
4. ATSDR 2018. Toxicology Profile for Perfluoroalkyls. June 2018. Available at
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https www.atsdr.cdc.gov/toxprofiles/
tp200.pdf.
5. EPA. TSCA Chemical Substance Inventory.
No date. Available at https
www.epa.gov/tsca-inventory. Accessed November 12, 2020.
6. EPA. Instructions for Reporting: 2020
TSCA Chemical Data Reporting.
November 2020. Available at https
www.epa.gov/sites/production/files/
2020-12/documents/instructions_for_
reporting_2020_tsca_cdr_2020-11-25.pdf.
7. EPA. Examples of PFAS and Structural Diagrams included in the Proposed Rule for Reporting and Recordkeeping Requirements for PFAS. October 2020.
8. EPA. Filing a Pre-manufacture Notice with EPA. No date. Available at https
www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/
filing-pre-manufacture-notice-epa.
Accessed November 12, 2020.
9. EPA 2020. CDX Chemical Safety and Pesticide Programs CSPP Registration User Guide; Version 3.02. March 6, 2020.
Available at https www.epa.gov/
chemical-data-reporting/cspp-cdxregistration-guide.
10. EPA. Data Elements included in the Proposed Rule for Reporting and Recordkeeping Requirements for PFAS.
October 2020.
11. OECD. OECD Harmonised Templates. No date. Available at https www.oecd.org/
ehs/templates/harmonisedtemplates.htm. Accessed November 12, 2020.
12. EPA 2013. Electronic Reporting under the Toxic Substances Control Act; Final Rule. 78 FR 72818, December 4, 2013
FRL93946.
13. EPA 2020. TSCA Chemical Data Reporting Revisions Under TSCA
Section 8a; Final Rule. 85 FR 20122, April 9, 2020 FRL1000556.
14. EPA 2020. Economic Analysis for the Proposed Rule for Reporting and Recordkeeping Requirements for PFAS.
November 2020.
15. EPA 2020. Information Collection Request Supporting Statement. Proposed Rule ICR: Reporting and Recordkeeping Requirements for PFAS. EPA ICR No.
2682.01. November 2020.

VII. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at http www2.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is a significant regulatory action that was submitted to the Office of Management and Budget OMB for review under Executive Orders 12866
58 FR 51735, October 4, 1993 and 13563 76 FR 3821, January 21, 2011.
EPA prepared an analysis of the estimated costs and benefits associated
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