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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Proposed Rules
ADDRESSES section for submitting comments either by mail or hand delivery. Clearly mark the part or all of the information that you claim to be CBI. For confidential information in a disk or CDROM that you mail to EPA, mark the outside of the disk or CDROM
as CBI and then identify electronically within the disk or CDROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your comments, see the commenting tips at http www.epa.gov/dockets/
comments.html.

II. Background
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A. What is TSCA Section 8a?
TSCA section 8a1 authorizes EPA
to promulgate rules which require entities, that are not considered small manufacturers or processors, who manufacture, process, or propose to manufacture or process a chemical substance, to maintain such records and submit such reports as the EPA
Administrator may reasonably require.
Similarly, under those rules, entities who manufacture, process, or propose to manufacture or process a mixture or a chemical substance in small quantities subject to limitations must maintain records and submit reports to the extent necessary for the effective enforcement of TSCA.
Under TSCA section 8a2, EPA may require recordkeeping and reporting of the following information:
The covered common or trade name, chemical identity and molecular structure of each chemical substance or mixture;
Categories or proposed categories of use for each substance or mixture;
Total amount of each substance or mixture manufactured or processed, the amounts manufactured or processed for each category of use, and reasonable estimates of the respective proposed amounts;
Descriptions of byproducts resulting from the manufacture, processing, use, or disposal of each substance or mixture;
All existing information concerning the environmental and health effects of each substance or mixture;
The number of individuals exposed, and reasonable estimates on the number
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of individuals who will be exposed, to each substance or mixture in their places of work and the duration of their exposure, and;
The manner or method of disposal of each substance or mixture, and any change in such manner or method.
Under TSCA section 8a7, EPA
must promulgate a rule to require each person who has manufactured PFAS in any year since 2011 to report the data described in TSCA section 8a2A
through G to EPA.
B. What are PFAS?
PFAS are synthetic organic compounds that do not occur naturally in the environment. PFAS contain an alkyl carbon on which the hydrogen atoms have been partially or completely replaced by fluorine atoms. The strong carbon-fluorine bonds of PFAS make some of them resistant to degradation and thus highly persistent in the environment Refs. 1 and 2. Some of these chemicals have been used for decades in a wide variety of consumer and industrial products Ref. 1. Some PFAS have been detected in wildlife, including higher trophic organisms, indicating that at least some PFAS have the ability to bioaccumulate Ref. 2.
Some PFAS can accumulate in humans and remain in the human body for long periods of time e.g., months to years Refs. 1, 2, and 3. As noted in EPAs PFAS Action Plan Ref. 1, because of the widespread use of PFAS in commerce and their tendency to persist in the environment, most people in the United States have been exposed to PFAS. As a result, several PFAS have been detected in human blood serum Refs. 1, 2, 3, and 4.
Under TSCA section 8b, EPA
maintains the TSCA Chemical Substance Inventory Inventory, which contains all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA Ref. 5. EPA has identified 1,346 PFAS on the Inventory as of April 2021, 669 of which are on the active Inventory i.e., in U.S.
commerce. The list of active chemicals includes those known to be in commerce after June 2006.
C. What would be the reporting standard?
EPA is proposing that manufacturers will report information to the extent that the information is known to or reasonably ascertainable by the manufacturer see TSCA section 8b2.
Known to or reasonably ascertainable by would be defined to include all information in a persons possession or
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control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know. This reporting standard would require reporting entities to evaluate their current level of knowledge of their manufactured products including imports, as well as evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control. This standard carries with it an exercise of due diligence, and the information-gathering activities that may be necessary for manufacturers to achieve this reporting standard may vary from case-to-case.
This standard would require that submitters conduct a reasonable inquiry within the full scope of their organization not just the information known to managerial or supervisory employees. This standard may also entail inquiries outside the organization to fill gaps in the submitters knowledge. Such activities may, though not necessarily, include phone calls or email inquiries to upstream suppliers or downstream users or employees or other agents of the manufacturer, including persons involved in the research and development, import or production, or marketing of the PFAS. Examples of types of information that are considered to be in a manufacturers possession or control, or that a reasonable person similarly situated might be expected to possess, control, or know include: Files maintained by the manufacturer such as marketing studies, sales reports, or customer surveys; information contained in standard references showing use information or concentrations of chemical substances in mixtures, such as a Safety Data Sheet or a supplier notification; and information from the Chemical Abstracts Service CAS or from Dun &
Bradstreet DUNS. This information may also include knowledge gained through discussions, conferences, and technical publications. This definition is identical to the definition of the same term at 40 CFR 704.3. In addition, this is the same reporting standard employed in the TSCA section 8a Chemical Data Reporting CDR rule see 40 CFR 711.15. EPA has also provided CDR reporting guidance materials on this reporting standard, including hypothetical examples of applying the known to or reasonably ascertainable by reporting standard in the context of collecting processing and use data for CDR Ref. 6, pages 4547. Therefore, EPA anticipates many reporters under this proposed rule will be familiar with this reporting standard, and resources
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