Risk Management Under the Toxic Substances Control Act: Certain Per- and Polyfluoroalkyl Substances

Certain Per- and Polyfluoroalkyl Substances (PFAS) Risk Management Under the Toxic Substances Control Act (TSCA); Request for Comment

Dates

Comments must be received on or before November 29, 2024.

Supplementary Information

I. Executive Summary

A. Does this action apply to me?

This action is directed to the public in general and may be of particular interest to those involved in the manufacture, processing, distribution, use, and disposal of PFAS, including PFOA, PFNA, and PFDA, formed during the fluorination of plastic containers, related industry trade organizations, non-governmental organizations with an interest in human and environmental health, state and local governments, Tribal Nations, and/or those interested in the assessment or management of risks involving chemical substances and mixtures regulated under TSCA. As such, the Agency has not attempted to describe all the specific entities that this action might apply to. If you need help determining applicability, consult the technical contact listed under FOR FURTHER INFORMATION CONTACT .

B. What is the Agency's authority for taking this action?

Under TSCA section 6(a), if EPA determines that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents an unreasonable risk of injury to health or the environment, EPA conducts a rulemaking to apply one or more of the TSCA section 6(a) requirements to the extent necessary so that the chemical substance or mixture no longer presents such risk. In proposing and promulgating rules under TSCA section 6(a), EPA considers, among other things, the provisions of TSCA sections 6(c)(2), 6(d), 6(g), and 9. In addition, to the extent that EPA makes a decision based on science, TSCA section 26(h) requires EPA, in carrying out TSCA sections 4, 5, and 6, to use "scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science," while also taking into account other considerations, including the relevance of information and any uncertainties. TSCA section 26(i) requires that decisions under TSCA sections 4, 5, and 6 be "based on the weight of the scientific evidence." TSCA section 26(k) requires that EPA consider information that is reasonably available in carrying out TSCA sections 4, 5, and 6.

C. What action is the Agency taking?

On April 11, 2024, the Center for Environmental Health, Public Employees for Environmental Responsibility, Alaska Community Action on Toxics, Clean Cape Fear, Clean Water Action, Delaware Riverkeeper and Merrimack Citizens for Clean Water submitted a petition under TSCA section 21 requesting that EPA establish regulations under TSCA section 6 prohibiting the manufacturing, processing, use, distribution in commerce and disposal of PFOA, PFNA and PFDA formed during the fluorination of plastic containers. On July 10, 2024, EPA granted this petition. TSCA section 21(b)(3) requires EPA to "promptly commence an appropriate proceeding" following the grant of a petition.

EPA has identified information necessary to inform the Agency's path forward with respect to regulation of these PFAS formed during the fluorination of plastic containers under TSCA section 6 and is issuing this notice to collect such information. EPA is seeking public comment and information regarding the number, location, and uses of fluorinated containers in the United States, including any uses critical to the national economy, national security, or critical infrastructure (which may include uses in medical devices); alternatives to the fluorination process that generates PFAS including PFOA, PFNA, and PFDA; and measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers. As discussed above, in carrying out section 6 of TSCA, EPA considers the provisions of TSCA sections 6(c)(2), 6(d), and 6(g). The information requested in this notice will inform EPA's considerations of these provisions. For example, information about alternative fluorination processes is necessary for EPA to consider the availability of technically and economically feasible alternatives that benefit health or the environment, as required under TSCA section 6(c)(2)(C). Similarly, consistent with TSCA section 6(d), EPA is seeking input about the availability of alternatives and the number, location, and uses of fluorinated containers to inform its consideration of compliance dates regulation as appropriate under TSCA. Further, information about the uses of fluorinated containers, alternatives to the fluorination process, and measures to address risk from PFAS formed during the fluorination of plastic containers will inform EPA's consideration of exemptions from regulation and conditions on such exemptions, as outlined in TSCA section 6(g).

D. What should I consider as I prepare my comments?

1. Submitting CBI.

Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR parts 2 and 703, as applicable.

2. Tips for preparing your comments.

When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Request for Comment

EPA seeks information on the manufacture of PFAS including PFOA, PFNA, and PFDA during the fluorination of HDPE and other plastic containers. Input on the following is of particular interest to EPA:

• Number, location, and uses of fluorinated containers in the United States, including any uses critical to the national economy, national security, or critical infrastructure (which may include uses in medical devices);
• Alternatives to the fluorination process that generates PFAS including PFOA, PFNA, and PFDA; and
• Measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers.

To the extent possible, the Agency asks commenters to please cite and provide any public data related to or that supports comments provided, and to the extent permissible, describe and provide any supporting data that is not publicly available.

Authority: 15 U.S.C. 2605.