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Federal Register / Vol. 86, No. 13 / Friday, January 22, 2021 / Proposed Rules
On page 21 of their petition, the petitioners assert: key data gaps include measurement of physicalchemical properties, methods of analysis, assessment of partitioning, bioaccumulation, and degradation, pharmacokinetics, and toxicity, especially for the endpoints commonly observed for the better studied PFAS, such as liver toxicity, and effects on the immune system, lipid metabolism, kidney, thyroid, development, reproduction, and cancer. In addition, despite their widespread detection in environmental media, ecotoxicity data are generally lacking.
3. Need for Testing The petitioners assert that the mechanisms of PFAS toxic effects are not defined, and that in vitro assays or other predictive, computational approaches are not validated or available. The petitioners also request animal toxicity studies on three mixtures of PFAS that are allegedly representative of exposure for residents in the Cape Fear Watershed.
Finally, the petitioners request ecotoxicity studies, and studies of physical chemical properties and environmental fate and transport, which they say EPA has previously determined are necessary because of the widespread presence and mobility of PFAS in environmental media.

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4. Testing Framework and Specific Studies The petitioners propose a testing approach that they call for Chemours to perform. The list of 54 PFAS was divided into Tier 1 substances for which there is known human exposure based on detection in blood, food, or drinking water, and Tier 2 substances for which human exposure is probable based on detection in environmental media Ref.
1, pg.12. The testing approach includes human health effects studies in experimental animals, animal studies on PFAS mixtures, studies of communities exposed to PFAS-contaminated drinking water, human half-life studies, physicalchemical properties and fate and transport studies, and ecotoxicity testing.
III. Background Considerations: Review of EPA Actions, Activities, and Regulations Relating to PFAS
To understand EPAs reasons for denying the petitioners requests, it is important to first review the details of EPAs ongoing actions involving PFAS.
EPA is committed to supporting states, tribes, and local communities in addressing challenges with PFAS. As a part of this effort, EPA is already taking
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action to identify solutions to address PFAS in the environment. Examples of such ongoing actions are detailed in this unit.
A. PFAS Action Plan: Program Update In May 2018, EPA convened a twoday National Leadership Summit on PFAS that brought together more than 200 federal, state, and local leaders to discuss steps to address PFAS. The Summit set the following goals:
Evaluate the need for a maximum contaminant level for PFOA and PFOS
in drinking water, evaluate designating PFOA and PFOS as hazardous substances, issue groundwater cleanup guidances for PFOA and PFOS, and develop toxicity values for GenX and perfluorobutane sulfonic acid PFBS.
Following the Summit, EPA interacted with more than 1,000 people during PFAS-focused community engagement events in Exeter, New Hampshire;
Horsham, Pennsylvania; Colorado Springs, Colorado; Fayetteville, North Carolina; and Leavenworth, Kansas, as well as through a roundtable in Kalamazoo, Michigan, and an event with tribal representatives in Spokane, Washington. As a result of these meetings and building on the goals identified at the Summit and the approximately 120,000 public comments received by the agency, EPA
developed the PFAS Action Plan, which was issued in February 2019 Ref. 3.
The PFAS Action Plan is the first multi-media, multi-program, national research, management, and risk communication plan to address an emerging contaminant like PFAS. The PFAS Action Plan outlines the tools EPA is developing to, among other things, address PFAS in drinking water, identify and clean up PFAS
contamination, expand monitoring of PFAS, increase PFAS scientific research, and exercise effective enforcement tools. The Action Plan outlines EPAs commitment to take a wide variety of actions to address this emerging contaminant in both shortterm and long-term timeframes.
Together, these efforts are helping EPA
and its partners identify and better understand PFAS contaminants generally, clean up current PFAS
contamination, prevent future contamination, and effectively communicate risk with the public. In February 2020, EPA issued the PFAS
Action Plan: Program Update available at https www.epa.gov/pfas/pfasaction-plan-program-update-february2020 to provide an update on all of the actions taken and work completed in the year since the PFAS Action Plan was issued. As it continues to
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implement the PFAS Action Plan, EPA
is committed to coordinating closely with multiple entities, including other federal agencies, states, tribes, local governments, water utilities, industry, and the public.
B. Interim Strategy for PFAS in Federally Issued National Pollutant Discharge Elimination System NPDES
Permits EPAs Office of Water OW is currently leading multiple actions in the PFAS Action Plan that will help the Agency better understand and effectively manage risk from exposure to PFAS. These OW-led actions include developing analytical methods for detecting PFAS in drinking water and other environmental media, evaluating PFAS treatment techniques, conducting data collection and analysis to evaluate the need for regulations to control PFAS
discharges from certain categories of point sources, understanding PFAS
exposure from various environmental media, and evaluating statutory and regulatory mechanisms to manage adverse human health and environmental impacts from PFAS
exposure.
While OWs work is advancing, a need for an interim strategy to address point source discharges of PFAS in EPA-issued NPDES permits was identified. On February 6, 2020, a workgroup was established to develop an interim NPDES permitting strategy to address PFAS in EPA-issued CWA
section 402 permits. The workgroup was charged with exploring options for how to address these pollutants while the CWA framework for addressing PFAS
discharges pursuant to the NPDES
program is under development. The workgroups goal was to develop a strategy that would serve to guide the Agencys CWA NPDES permitting approach on an interim basis across the EPA Regions as informed by input from state partners. Each of the ten EPA
Regions appointed a representative to the workgroup.
To develop potential recommendations for an interim PFAS
NPDES strategy, the workgroup conducted a thorough review of the NPDES permitting process, with a specific focus on PFAS. This included examining CWA section 402 authorities and permit writing practices to understand where unregulated contaminants, such as PFAS, may fit into the permit development process;
analyzing existing state-issued NPDES
permits with PFAS monitoring requirements identified through EPAs NPDES Integrated Compliance Information System ICIS to
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