EPA PFAS Grouping Regulations Gather Additional Support
On December 28, 2021, the EPA issued a bulletin that directed PFAS manufacturers to provide several types of new data with respect to several types of PFAS, which will be utilized to assess further regulations needed to protect human health and the environment. The EPA’s actions stem from a petition from six North Carolina public health and environmental justice organizations. Notable in the EPA’s bulletin is not only that the EPA is requiring PFAS manufacturers to provide toxicity data (which in turn could provide foundational support for future EPA dose exposure statements, which would be the linchpin for future PFAS litigation), but also the EPA PFAS grouping theme underlying the EPA’s bulletin. Grouping PFAS into certain categories and regulating those classes of categories, as opposed to each individual PFAS, may have significant impacts on many different industry types in the future.
Today’s PFAS Bulletin By EPA
The EPA’s actions today were designed to “…advance the Biden-Harris Administration’s commitment to improve understanding of, and to protect people from, the potential risks of PFAS” and were the result of a petition that asked the EPA to require health and environmental impact testing on 54 chemical substances that the petition identifies as PFAS manufactured by The Chemours Company in Fayetteville, North Carolina. The petition was initially denied by the EPA under the prior administration. However, the EPA under Biden-Harris agreed to revisit the petition and ultimately granted the petitioners’ requests. The EPA indicated that “the petitioners’ request that EPA leverage its authorities to compel development of much needed new information on PFAS underscored the need for robust testing on PFAS, and played a key role in advancing the Agency’s plans for a National PFAS Testing Strategy, a pillar of the agency’s PFAS Strategic Roadmap that will lead to improved health protections for all communities.”
The EPA’s actions will require PFAS manufacturers to provide the agency with toxicity data and information on categories of PFAS. EPA expects to exercise its TSCA section 4 order authority to require recipients of test orders to conduct and fund the studies. The information gathered as a result of this testing will help EPA deepen its understanding of the impacts of PFAS, including potential hazards. “As the agency learns more about the impacts of PFAS, EPA will continue to take action to protect human health and the environment.”
The EPA will act on the petitioners’ request with respect to 54 PFAS in the following ways:
Near-Term Testing Covers 30 of 54 Petition Chemicals – Under the Testing Strategy, EPA’s first test orders for 24 categories of PFAS about which the least is known will provide human health hazard data that cover 30 of the 54 petition chemicals.
Subsequent Testing May Cover 9 of 54 Petition Chemicals – An additional nine PFAS identified in the petition belong to one other category included in the Testing Strategy. EPA is conducting more in-depth analyses of the sufficiency of the existing data, which will inform later phases of testing.
Remaining 15 of 54 Petition Chemicals – 15 chemicals identified in the petition do not fit the definition of PFAS used in developing the Testing Strategy. EPA has determined that there is robust data on some of them available to the Agency. EPA is conducting more in-depth analyses of the existing data, which will inform later phases of testing.
Mixtures Studies – EPA will address PFAS mixtures by using the toxicity of the individual substances to predict the toxicity of the mixture, an approach which is consistent with the current state-of-science on PFAS. EPA is proceeding with development and peer review of these methods as specifically applied to PFAS.
Human Studies – EPA is contributing to and reviewing numerous existing ongoing human studies, including studies on potentially exposed workers and communities in North Carolina, and is evaluating how to further advance and expand on these efforts. These include studies of health outcomes for people in communities impacted by industrial PFAS releases, as well studies that explore the connection between chronic health outcomes and PFAS exposures in North Carolina.
Analytical Standards – EPA does not believe it is appropriate to require the development or submission of analytical standards with the initial test orders that will be issued under the Testing Strategy and lacks the ability to order the submission of all analytical standards in the manner requested. Nonetheless, EPA has requested comment on whether to require the submission of existing analytical methods for PFAS under a separate rulemaking that the Agency expects to finalize next year.
EPA PFAS Grouping Approach
In October 2021, EPA announced a National PFAS Testing Strategy, which identifies priority substances for the first of several described phases of a testing approach based on grouping of chemicals by chemistry features and available toxicity data. These substances include many of the chemicals identified in the petition, but also additional PFAS which will inform a wider universe of categories of PFAS where key data is lacking. For example, the first phase of testing on 24 PFAS is expected to provide data that can be extrapolated to 2,950 PFAS that belong to the same categories as the 24 individual substances.
The EPA’s determination in October 2021 and today appears to add further evidence that the EPA does indeed intend to ultimately regulate PFAS as various classes or groups based on similarities in the chemical structures of the various PFAS. Prior to this fall, much debate took place in the United States (and continues abroad in the European Union) as to whether the over 9,000 PFAS should be regulated as an entire class or individually. The cons of both approaches (too far-reaching regulation for chemicals that do have different toxicity concerns among the class versus an endeavor that would likely take over a hundred years to accomplish) led to debate centering on an intermediary approach – to try to group PFAS into various classes and encourage the EPA to regulate the chemicals in that manner.
EPA PFAS Grouping Impact On Businesses
Should the EPA ultimately enact regulations with respect to PFAS based on categorization of the chemicals into various groups, the resulting regulations could lead to confusion for certain industries. For example, a company that utilizes several currently unregulated PFAS in a manufacturing process may find that those PFAS are someday categorized into different groups, with varying toxicity assessments and permissible emission levels. While it is safe to assume that a grace period to transition will be built into any future EPA action, these regulatory steps could nevertheless lead to businesses having to significantly adapt their processes at significant cost.
The key for businesses at this juncture is to ensure day-to-day monitoring of PFAS regulatory developments – not only enacted regulations, but proposed regulations and clues within agency statements that provide indications of what future regulations will look like. Hand-in-hand with knowledge is discussing potential future risks with experienced experts on PFAS issues to ensure the best compliance approach not only for today, but for the future.