On April 25, 2019, the U.S. Environmental Protection Agency (“EPA”) published its Interim Recommendations for Addressing Groundwater Contaminated with PFOA and PFOS (the “Interim Recommendations”) and received 373 comments before the public comment period closed on June 10, 2019. Below we provide both an overview of EPA’s Interim Recommendations and of the issues raised in the public comments, all with the goal of helping impacted industries anticipate potential changes to the proposed regulations.
So, how does this pertain to your company? If you are a company that has historically used per- or polyfluourinated chemicals (“PFAS”) in your operations, stored or sold products containing PFAS, conducted fire suppression activities using aqueous film forming foam, or are located near facilities that engaged in any of these activities, you may be impacted by these regulations. EPA’s interim recommendations are important because they apply to all facilities nationwide, but the comments – particularly those submitted by some of the more PFAS-focused states – are also a good indication of state-specific views on PFAS regulation.
Background and Applicability of Interim Recommendations
EPA developed the Interim Recommendations to provide screening levels and preliminary remediation goals (“PRGs”) for EPA regional offices, state regulators, and private entities to use as a “starting point” when they are making site-specific cleanup decisions. More specifically, the Interim Recommendations are intended “to inform final cleanup levels for PFOA and/or PFOS contamination of groundwater that is a current or potential source of drinking water.” (Emphasis added). Although not discussed in detail in the document, this statement suggests that EPA’s Interim Recommendations only apply to groundwater which is a “current or potential source” of drinking water.
Additionally, the Interim Recommendations are just that – a recommendation rather than an enforceable groundwater concentration limit, or remediation standard. The suggested screening levels and PRGs are expected to serve as a basis for federal cleanup programs, such as the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (“CERCLA”) and the Resource Conservation and Recovery Act (“RCRA”), involving the presence of these two chemicals in groundwater.
Recommended Screening Levels - 40 ppt for Both PFOA and PFOS
EPA used the more conservative of the two hazard quotients to develop the proposed 40 ppt screening level, and based it on non-cancer effects. With respect to the cancer effect, EPA noted that “[i]n the case of PFOS, the existing evidence does not support a strong correlation between the tumor incidence and dose to justify a quantitative assessment,” and in the case of PFOA, “a screening value derived from the developmental endpoint for the RfD will be protective for the cancer endpoint as well.” Essentially, EPA has stated that there is insufficient evidence to demonstrate a link between PFOS and cancer effects for human beings, and the cancer risk posed by PFOA is less acute than the non-cancer, or reproductive, risk.
The proposed 40 ppt screening level for each chemical is not a cleanup level. However, it does suggest that every site that is being investigated for a federal cleanup action will require further investigation, characterization, and possible remediation of PFOA and PFOS in groundwater if the concentration of either chemical exceeds the applicable screening level.
Recommended PRG - 70 ppt Combined Concentration
EPA has recommended a combined concentration of 70 ppt for PFOA and PFOS in groundwater “that is a current or potential source of drinking water” based on the existing Health Advisory for the combined concentration of the two chemicals in drinking water. The PRGs in the Interim Recommendations are intended as a suggested starting point rather than an inflexible regulatory requirement. However, EPA does note that in “situations where groundwater is being used for drinking water, EPA expects that responsible parties will address levels of PFOA and/or PFOS over 70 ppt.” Ultimately, while there may be some flexibility about the cleanup requirement and levels for groundwater that is a “potential source of drinking water,” under the Interim Recommendations document, if finalized, EPA is likely to require cleanup to the 70 ppt level for groundwater that is being actively used for drinking water.
Some States May Not Wait for the EPA
Several states have started the process of regulating the concentration of PFOA, PFOS, and other PFAS in a variety of media, including groundwater. [ADD LINKS TO THE TWO STATE SURVEY CLIENT ALERTS] The Interim Recommendations specifically state that “[w]here state or tribal laws or regulations qualify as [applicable or relevant and appropriate requirements] for PFOA or PFOS, those standards should be used to develop PRGs.” Essentially, where state or tribal regulations set cleanup levels that are as stringent, or more stringent than EPA’s recommended PRGs for PFOA and/or PFOS, federal EPA is likely to apply or follow the state cleanup level when establishing a PRG for any particular site.
Public Comment Period
As noted above, EPA received 373 public comments on the Interim Recommendations from a variety of sources including various agencies, anonymous individuals, and national associations. Some of the comments were supportive of EPA’s position, but many called for revisions. Specifically, numerous state agencies commented separately calling for the following revisions, among others:
- Promulgate regulations for PFOA and PFOS as “hazardous substances” under CERCLA.
- Subject all applicable parties to the Natural Resource Damage and Restoration (“NRDAR”) regulations pursuant to CERCLA.
- Establish Maximum Contaminant Levels (“MCLs”) for these compounds in drinking water.
- Address all sources of drinking water, including surface water restrictions. Specifically develop standards and validated testing methods for other forms of water: surface water, non-potable groundwater, and/or wastewater.
- Discussion of how EPA intends to implement or enforce this action.
- Consider adding limits for additional PFAS compounds (PFNA, PFHxS, PFHpA, PFDA, PFBS, GenX, etc.).
- Review comments quickly so EPA can change “Interim Standards” to “Final Standards.”
- Provide resources for sampling PFAS materials at Superfund sites that are located near sources of drinking water.
- Add PFAS to EPA’s risk assessment guidance.
- The standard proposed is too high as it is not protective of human health and not supported by science.
- The standard should apply to all potential sources of drinking water, not just groundwater that is currently used for that purpose.
For access to all of the public comments please visit the following site: https://www.regulations.gov/docket?D=EPA-HQ-OLEM-2019-0229
EPA is now in the process of reviewing, prioritizing, and evaluating the relative merits of these comments in order to finalize the Interim Recommendations. Based upon the volume of submissions, the agency is expected to submit a final version of the recommendations to the Office of Management and Budget later this year or early next year. Additional information regarding the specific details of this process will unfold as time continues.
Importantly, however, the comments provide a roadmap which states may be implementing regulations beyond what EPA has proposed, including the following: regulating additional PFAS compounds (e.g., PFNA, PFHxS, PFHpA, PFDA, PFBS, GenX); introducing enforceable drinking water and cleanup standards; and promulgating enforceable soil and groundwater cleanup standards. Alternatively, the comments also indicate some states are not prioritizing the regulation of these compounds, and appear to be relying on the federal government to take the lead on their regulation.
Federal and state regulation of PFOA, PFOS, and other PFAS chemicals in groundwater and other media is rapidly developing, so it is vital for impacted facilities and industries to continue to monitor those regulatory developments, especially the groundwater standards.
We are closely monitoring the state and federal regulation of PFAS in drinking water, groundwater, soil, and consumer products. If you have a question regarding the Interim Recommendations, or if you would like to discuss any concerns about PFAS regulations in a specific jurisdiction, contact Tom Lee at Bryan Cave Leighton Paisner.