We previously commented on the significance of the four days of hearings held by the Science Advisory Board (SAB) on issues related to the EPA’s proposals to regulate two legacy PFAS – PFOA and PFOS – in drinking water. On April 1, 2022, the SAB released its draft report summarizing its findings after the hearings and a thorough review of the scientific literature provided by the EPA. While the SAB PFAS findings support many of the EPA’s proposed conclusions, most notably a finding that PFOA constitutes a “likely carcinogen”, the report also echoed many of the comments from the SAB in the hearings, including lack of transparency, flawed data, inconsistent methodologies, and potentially unsound scientific foundations for some conclusions. Once the SAB’s report is finalized, the EPA will use the information in the report to further its goal of setting National Drinking Water Standards for PFAS by fall 2022.
SAB PFAS Findings
As the EPA seeks to meet its goal of setting Maximum Contaminant Levels (MCLs) for at least PFOA and PFOS by fall 2022, it submitted thousands of pages of scientific and medical literature to the SAB for review towards the end of 2021. The EPA sought Feedback from the SAB on a number of issues related to the reliance documents, including whether it was adequately describing the documents upon which it was relying for setting a MGL, whether the EPA’s cancer classifications for PFOA and PFOS were appropriate, whether the agency used appropriate toxicology models, and whether the EPA relied on adequate and valid epidemiological studies in determining reference doses (RfDs) for PFOA and PFOS.
Some of the key takeaways from the 15 hours of hearings and 124 pages of written findings from the SAB were:
The EPA may not be adequately explaining its rationale for the conclusions that it made related to PFOA and PFOS;
The documents contain errors and inconsistencies, which should be rectified by the EPA before promulgating any final MCL;
Lack of transparency regarding which studies were considered, which were not, and why studies were either included or excluded in all cases;
Some decisions to exclude certain studies appear to be inconsistent with the review process established by the Office of Research and Development for chemical hazard assessments;
Inconsistent review process of the literature that was included in the reliance document set;
Questions concerning the EPA’s decision to base the RfDs proposals on studies regarding lowered immune response to tetanus and diphtheria vaccines, which Board members indicated do not show an increase in disease;
With respect to PFOA, the EPA is proposing a classification of a “likely carcinogen” and the SAB is poised to agree with this classification; other
With respect to PFOS, the EPA is proposing a classification of a “suggestive carcinogen”, and the SAB appears to concur with that finding; however, it also recommended that the EPA undertake further evaluation of certain studies and revise its methodology for determining whether the find PFOS as a “suggestive” versus a “likely” carcinogen.
PFAS Drinking Water Standards: Impacts on Businesses
Many states have stepped in and created enforceable limits for PFAS in drinking water. The permissible levels range widely, generally within the 5 parts per trillion (ppt) to 70 ppt range. Many have argued that when the EPA sets aa PFAS National Primary Drinking Water Regulation, it will fall somewhere near the midpoint in this range. However, the data submitted regarding PFOA and PFOS, particularly the “likely carcinogen” categorization for PFOA, suggests that the EPA’s regulation for PFOA and PFOS may fall well below the 30-40ppt range that many felt was a reasonable estimate. Some believe that a classification as a “likely carcinogen” or simply a “carcinogen” will mean that the MGL will be set at 0ppt.
In states that currently have PFAS drinking water standards in place, businesses have seen an uptick in enforcement actions related to PFAS remediation costs. If the EPA were to set significantly lower PFAS drinking water standards than initially predicted, it will naturally mean that the EPA will have a broader pool of alleged polluters to choose from for pursuing PFAS remediation costs. Depending on the scope of the PFAS pollution issue, cleanup costs can range anywhere from a few hundred thousand dollars to millions of dollars.
Now more than ever, the EPA is clearly on a path to regulate PFAS contamination in the country’s water, land and air. The SAB PFAS findings are a clear indicator of this. The EPA has also publicly stated for the first time when they expect such regulations to be enacted. These regulations will require states to act, as well (and some states may still enact stronger regulations than the EPA). Both the federal and the state level regulations will impact businesses and industries of many kinds, even if their contribution to drinking water contamination issues may seem on the surface to be de minimus. In states that already have PFAS drinking water standards enacted, businesses and property owners have already seen local environmental agencies scrutinize possible sources of PFAS pollution much more closely than ever before, which has resulted in unexpected costs. Beyond drinking water, though, the EPA PFAS plan shows the EPA’s desire to take regulatory action well beyond just drinking water, and companies absolutely must begin preparing now for regulatory actions that will have significant financial impacts down the road.
©2022 CMBG3 Law, LLC. All rights reserved.National Law Review, Volume XII, Number 110