June 17, 2022
In its latest action on its PFAS roadmap, the US Environmental Protection Agency issued new and updated drinking water health recommendations for four PFAS chemicals. These health councils are an intermediate step in the larger process of regulating PFAS at the federal level and come to a time of unprecedented state and federal regulatory and legislative action to address PFAS in the environment.
On 15 June, the Environmental Protection Agency (EPA) released significantly reduced lifetime health drinking water levels (HALs) for four per- and polyfluoroalkyl substances (PFAS) in accordance with its Safe Drinking Water Act (SDWA). These include revised intermediate levels for perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), together with new, final limits for perfluorobutane sulfonic acid (PFBS) and hexafluoropropylene oxide.
Lifetime health counseling levels identify the concentration of chemicals in a person’s lifelong drinking water at or below which no adverse health effects are expected. Although HALs are not applicable and non-regulatory standards, they can be used to develop drinking water regulations and restrictions, to influence state and local regulations, and to shape public debate about the safety of certain chemicals.
Newly announced PFAS HAL
- Provisionally updated health advice for PFOA = 0.004 ppt
- Provisionally updated health advice for PFOS = 0.02 ppt
- Final health advice for chemicals GenX = 10 ppt
- Final health advice for PFBS = 2,000 pp
The EPA issued these new values for PFOA and PFOS as “interim” advice, confirming that it is based on new toxicity data and drafts of analyzes currently being reviewed by the Agency’s Scientific Advisory Board and is likely to become additional new data available. The health councils are expected to remain in force until the entry into force of the forthcoming national regulation on EPA PFAS primary drinking water, unless otherwise updated by the EPA.
The EPA has set intermediate advisory levels of 0.004 parts per trillion (ppt) for PFOA – or four parts per quadrillion (ppq) – and 0.02 ppt – or 20 ppq – for PFOS. To put this in perspective, a fraction of a quadrillion is equivalent to one drop of water in a cube of water approximately 368 meters on the side and approximately as tall as the Empire State Building, or one second of time for approximately 31.7 million years. The new EPA intermediate PFOA and PFOS HAL replace the Obama-era target values of 70 ppt for PFOA and PFOS individually or in combination, set by the EPA in 2016.
The new EPA final health advice for PFBS and GenX chemicals – which are generally considered to be substitutes for PFOS and PFOA, respectively, in the manufacture of chemicals and products – sets lifelong exposure levels at 2000 ppt for PFBS and 10 ppt for GenX. These final HALs are based on the EPA’s final 2021 animal toxicity studies for PFBS and GenX chemicals. Unlike the recommendations for PFOA and PFOS, the EPA announced that the recommendations for PFBS and GenX are final.
POTENTIAL IMPACT OF NEW HEALTH CONSULTATIONS
EPA’s newly announced HALs will influence the development of future federal and state regulation, identify and clean up contaminated sites, herald potential trends in litigation and signal the PFAS industries of EPA’s possible approach to future regulation and guidance. The updated recommendations for PFOA and PFOS are an order of magnitude lower than those identified by EPA in 2016, and its HALs for GenX and PFBS reflect the EPA’s intention to aggressively address potential PFAS exposure.
These updated health councils are also an intermediate step in a larger process of regulating PFOA and PFOS at the federal level and come amid unprecedented state regulatory and legislative action, as dozens of states are actively considering laws and policies to address PFAS pollution. According to the EPA PFAS Roadmap, the EPA is expected to propose a rule in the autumn of 2022 (with a final rule expected in the autumn of 2023) to establish a National Primary Drinking Water Regulation (NPDWR) for PFOA and PFOS, which will set applicable limits and require monitoring of public water supply. Although the criteria that the EPA must take into account when setting applicable standards under the SDWA differ from those for issuing the HAL (for example, the EPA must take into account economic factors when proposing an NPDWR), the EPA’s updated interim guidelines for PFOA and PFOS signals that we can expect the EPA to act aggressively in setting applicable limits.
In addition, the newly announced HALs can stimulate pressure for stricter cleaning requirements across the country, while acting as a springboard for stricter enforcement at the state level. As HALs (intermediate and final) are not applicable standards, they will not be considered applicable or relevant and appropriate requirements (ARARs) under CERCLA, but may be referred to as “TBC” (to be considered), similar to a document with guidelines.
Accordingly, these tips could inform the levels of remediation not only for future clean-ups, but also for clean-ups in progress. At the federal level, PFAS historic councils have been adopted as interim recommendations for groundwater treatment by the Land and Emergency Management Service, and a level of 70 ppt has been used as a guide by the U.S. military for its cleanup. Many states have accepted the EPA’s inapplicable lifelong health levels of 70 ppt for PFOA and PFOS (eg Colorado, Ohio) or have not taken formal action and simply relied on the EPA’s HAL as de facto standards. Countries that have issued criteria for dealing with GenX chemicals have concentration levels well above those of the new EPA HAL (eg North Carolina’s temporary health target of 140 ppt for GenX). Other states (eg New Jersey and Vermont) have gone a step further and set standards that would be ARARs that are lower than the previous HALs but higher than the new HALs. Responsible parties and regulators will have to deal with the impact of the new EPA HALs.
These new levels of health advice also raise questions about the long-term usefulness of regional levels of screening (RSL) and regional levels of removal management (RML), recently revised by the EPA’s Land Management and Emergency Service for five PFAS, including PFOA, PFOS and GenX. Regulated entities can expect RSL and RML to be adjusted in the next semi-annual update.
Finally, it remains to be seen how these recently reduced tips will work in practice, given current constraints on testing (such as laboratory detection limits and methods) and treatment options. For example, according to currently approved analytical methods, the detection limits for PFOA and PFOS are 4 ppt-1000x and 200x above the EPA intermediate HALs for PFOA and PFOS, respectively. In its statements following the announcement of the new HALs, the EPA acknowledged the limitations of the currently approved testing and detection methods, but in turn stressed to regulated countries that notifications are not levels of detection.
It will be essential for stakeholders to continue to monitor both state and federal actions and guidelines and to evaluate operations, as states and stakeholders and regulated parties continue to assess the impact of new councils.
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If you have any questions or would like more information on the issues discussed in this LawFlash, please contact one of the following Morgan Lewis attorneys:
Stephanie R. Feingold
Julie Silva Palmer
Duke K. McCall, III
Drew Clear Jordan
Glenn R. Stewart
James R. Dragna
Rick R. Rothman
Yardena R. Zwang-Weissman
Denise G. Fellers
Come Foley Gannon
 The 2016 EPA Health Councils for PFOA and PFOS have not been without criticism at both the state and federal levels since their announcement, including the findings of the Toxic Substances Agency and the Disease Registry, which suggest that the EPA’s recommendations for 70 ppt may be too high.
 “Based on current methods, the health advice levels for PFOA and PFOS are below both detection (quantification or non-quantification) and quantification (the ability to reliably determine how much of a substance is present). This means that PFOA or PFOS may be present in drinking water at levels that exceed health recommendations, even if tests do not show levels of these chemicals. EPA, Questions and Answers: Health Drinking Water Tips for PFOA, PFOS, GenX Chemicals and PFBS.