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By Lynn L. Bergeson and Carla N. Hutton
 
On March 1, 2021, the U.S. Government Accountability Office (GAO) publicly released a report entitled Man-Made Chemicals and Potential Health Risks:  EPA Has Completed Some Regulatory-Related Actions for PFAS.  GAO was asked to examine the status of regulatory-related actions in EPA’s 2019 Per- and Polyfluoroalkyl Substances (PFAS) Action Plan.  GAO found that EPA completed three of six selected regulatory-related actions for addressing PFAS outlined in the PFAS Action Plan.  For two of the three completed actions, the steps EPA took were also in response to the National Defense Authorization Act for fiscal year 2020 (FY20 NDAA):

  • After proposing a supplemental significant new use rule (SNUR) in February 2020, EPA met a June 2020 deadline set in the FY20 NDAA when the EPA Administrator signed the final rule.  Among other things, under the final rule, articles containing certain PFAS as a surface coating, and carpet containing certain PFAS, can no longer be imported into the United States without EPA review; and
     
  • EPA incorporated 172 PFAS into the Toxics Release Inventory in June 2020.  The FY20 NDAA directed EPA to take this action, extending EPA’s original planned action to explore data for listing PFAS chemicals to the inventory.

Finally, in March 2020, EPA completed a third regulatory-related action, not required under the FY20 NDAA, when it proposed a preliminary drinking water regulatory determination for two PFAS, “an initial step toward regulating these chemicals in drinking water.”
According to GAO, three of the six selected regulatory-related actions are ongoing, and EPA’s progress on these actions varies:

  • As of August 2020, EPA was developing a proposed rulemaking for a nationwide drinking water monitoring rule that includes PFAS, which EPA officials stated that EPA intends to issue in final by December 2021;
     
  • EPA is currently examining available information about PFAS discharges to surface water to identify industrial sources that may warrant further study for potential regulation through EPA’s National Effluent Limitations Guidelines.  EPA expects to publish a final Effluent Guidelines Program Plan 14 in early 2021 that will include an update on the current status of EPA’s multi-industry study; and
     
  • EPA plans to continue the regulatory process for designating two PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), which would allow EPA to require responsible parties to conduct or pay for cleanup.  On January 14, 2021, EPA issued an advance notice of proposed rulemaking for the hazardous substances designation to obtain public comment and data to inform EPA’s ongoing evaluation of the two PFAS.
Tags: GAO, PFAS, Water, CERCLA

 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 31, 2020, the plaintiffs and EPA filed a joint case management statement in the U.S. District Court for the Northern District of California case seeking a rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit the addition of fluoridation chemicals to drinking water supplies.  Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC.  As reported in our June 12 and June 22, 2020, blog items, the court held a bench trial that concluded on June 17, 2020.  After hearing closing arguments, Judge Chen asked plaintiffs and EPA to consider how to reach an agreement.  According to the joint case management statement, the parties have met and conferred to discuss the potential of EPA considering a new or amended petition so that EPA, inter alia, “could consider the new science that has been published subsequent to the initial petition.”  Plaintiffs offered to submit a new petition to EPA that contains all of the evidence presented at trial, including the expert declarations, expert testimony, and exhibits.  EPA contends that plaintiffs’ proposal to “package” the evidence presented at trial as a new petition under Section 21 of the Toxic Substances Control Act (TSCA) “would be insufficient to reach a finding of unreasonable risk.”  EPA maintains that “meaningful review of a new petition based on the specific evidence-base available for evaluating potential neurotoxic effects from exposure to fluoride from community water fluoridation programs” should include:  (1) a systematic review; (2) raw data for the key studies upon which plaintiffs rely; and (3) the data underlying plaintiffs’ risk calculations, including their benchmark dose (BMD) analysis.  Plaintiffs are willing to provide the data underlying Dr. Grandjean’s risk calculations, but “cannot agree to the other two requirements.”  The joint statement states that first, plaintiffs maintain that they have already presented sufficient evidence to demonstrate an unreasonable risk under TSCA and are unwilling to do a new systematic review above and beyond what their experts have already done.  Second, plaintiffs maintain that they do not have the ability to provide the “raw data” for the key studies upon which they rely because the data are not theirs, and that EPA is thus asking for something that plaintiffs cannot provide.  Finally, plaintiffs do not believe that the raw data are necessary for EPA to evaluate the published peer-reviewed studies, and, indeed, requiring these data is “contrary to the health protective goals of TSCA.”
 
On August 3, 2020, plaintiffs filed a further statement on EPA’s position regarding a new petition.  Plaintiffs state that they “feel compelled to bring to the Court’s attention the broader policy shift that EPA’s raw data demand represents, and the overwhelming criticism this policy has received from virtually all sectors of the public health and scientific communities.”  According to the plaintiffs, EPA articulated this policy shift in its March 18, 2020, supplemental notice of proposed rulemaking (SNPRM) regarding “Strengthening Transparency in Regulatory Science” in which “EPA proposed limiting, or excluding altogether, its reliance on any peer reviewed study -- no matter how relevant or well regarded -- if the underlying raw data [are] not made publicly available.”  Plaintiffs cite a “detailed analysis signed by dozens of Harvard scientists,” which states that “EPA’s new policy ‘is based on a profoundly misguided view of how the scientific process works’ and ‘unnecessarily impedes EPA’s ability to base its internal analyses and regulatory decisions on the best available science.’  Further, the rule ‘adopts a partial and biased approach to transparency that systematically favors industry science over academic science.’”
 
EPA filed a response on August 4, 2020, describing plaintiffs’ further statement as “procedurally inappropriate and substantively untrue.”  According to EPA, by releasing the raw data and a detailed explanation of their statistical methods, the authors of the studies “could satisfy incongruities and ensure the scientific record is clear.”  EPA states that it “takes the position that a meaningful substantive review, as contemplated by the Court, of the evolving scientific evidence published since Plaintiffs submitted their 2016 petition should include raw data for the key studies upon which Plaintiffs rely and, according to Dr. Grandjean’s trial testimony, is forthcoming.”  EPA reiterates that its position “is based on the specific evidence-base available for evaluating potential neurotoxic effects from exposure to fluoride from community water fluoridation programs as necessary to support a potential TSCA section 6(a) rulemaking” and not, as alleged by plaintiffs, “a broader policy shift.”
 
The court held a status conference on August 6, 2020, via Zoom.  The judge suggested that plaintiffs file a new petition and that he is holding the case open to allow them to do so.  The next status hearing will be held November 5, 2020.