By Lynn L. Bergeson and Carla N. Hutton
 
On November 10, 2022, California filed suit in California Superior Court against the manufacturers of per- and polyfluoroalkyl substances (PFAS) “for endangering public health, causing irreparable harm to the state’s natural resources, and engaging in a widespread campaign to deceive the public.” According to California Attorney General Rob Bonta’s November 10, 2022, press release, California “alleges that these manufacturers, including 3M and DuPont, knew or should have known that PFAS are toxic and harmful to human health and the environment, yet continued to produce them for mass use and concealed their harms from the public.” California claims that as a result, “these toxic ‘forever chemicals’ are pervasive across California’s bays, lakes, streams, and rivers; in its fish, wildlife, and soil; and in the bloodstream of 98% of Californians.” The complaint claims that the manufacturers “created and/or contributed to a public nuisance, harmed and destroyed natural resources, marketed defective products, failed to provide adequate warnings concerning the use of their products, and engaged in unlawful business practices.”
 
The press release states that the lawsuit concerns seven common PFAS that have been detected in drinking water supplies, surface waters, and groundwater in California: perfluorooctanoic acid (PFOA); perfluorooctanesulfonic acid (PFOS); perfluorobutanesulfonic acid (PFBS); perfluorohexanesulfonic acid (PFHxS); perfluorohexanoic acid (PFHxA); perfluoroheptanoic acid (PFHpA); and perfluorononanoic acid (PFNA). California requests statewide treatment and destruction of PFAS, including, but not limited to, the treatment of drinking water by regulated water systems; water drawn from private wells and unregulated systems used for drinking water and irrigation; and water from other wastewater treatment plants and systems. California also seeks payment of funds necessary to mitigate the impacts to human health and the environment through environmental testing, medical monitoring, public noticing, replacement water (for period between testing and installation of treatment), and safe disposal and destruction.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) released a report on October 19, 2022, entitled “Persistent Chemicals: EPA Should Use New Data to Analyze the Demographics of Communities with PFAS in Their Drinking Water.” The Congressional requesters asked GAO to examine per- and polyfluoroalkyl substances (PFAS) contamination in drinking water and related state actions. GAO’s report examines what recent data from selected states show about the occurrence of PFAS in drinking water; the demographic characteristics of communities in selected states with and without PFAS in their drinking water; and factors that influenced states’ decisions to test and develop standards or guidance for PFAS in drinking water. GAO states that recent drinking water data from six selected states show that at least 18 percent of the states’ 5,300 total water systems had at least two PFAS -- perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) --above the U.S. Environmental Protection Agency’s (EPA) 2022 interim revised health advisory levels. GAO found that 978 water systems had the two PFAS at or above EPA’s minimum reporting level of 4 parts per trillion (ppt), the lowest level reliably quantified by most laboratories, and above EPA’s health advisory levels. The demographic characteristics of communities with PFAS in their drinking water varied in the states GAO examined. GAO states that according to EPA officials, EPA does not currently have information to determine the extent to which disadvantaged communities are exposed to PFAS in drinking water nationally; EPA plans to collect comprehensive nationwide data, however.
 
GAO states that according to state officials, public health and PFAS contamination concerns influenced some states’ decisions to test and develop enforceable standards or nonenforceable guidance for PFAS in drinking water. As of July 2022, six states set standards and were influenced to do so by public health concerns. When the states set standards, the levels they set were more stringent than EPA’s 2016 lifetime health advisory levels. Fourteen additional states developed guidance or began developing standards because of PFAS contamination.
 
GAO recommends that EPA conduct a nationwide analysis using comprehensive data to determine the demographic characteristics of communities with PFAS in their drinking water. EPA agreed with the recommendation.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 7, 2022, that registration is now open for the March 15-17. 2022, meeting of the Science Advisory Committee on Chemicals (SACC) to peer review EPA’s “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0” (screening level methodology). As reported in our January 24, 2022, memorandum, EPA will use the screening level methodology to evaluate potential chemical exposures and associated potential risks to fenceline communities in its Toxic Substances Control Act (TSCA) risk evaluations. EPA has extended the comment period to March 22, 2022, to give stakeholders additional time to provide input. EPA “encourages” written comments for consideration by SACC during its peer review be submitted by the original deadline of February 22, 2022. EPA states that it will provide comments submitted after this date to the SACC members, but notes that members “may not have adequate time to consider those comments prior to the meeting’s discussions.” While SACC is unable to consider comments submitted after the March 15-17, 2022, meeting, EPA will consider all comments submitted by March 22, 2022.
 
To provide oral comments during the virtual peer review meeting, registration must be received by 12:00 p.m. (EST) on February 25, 2022. Stakeholders may register as a listen-only attendee at any time until the end of the meeting on March 17, 2022.

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By Lynn L. Bergeson and Carla N. Hutton

On January 21, 2022, the U.S. Environmental Protection Agency (EPA) announced that it will hold a virtual peer review meeting of the Science Advisory Committee on Chemicals (SACC) to consider and review the “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0.” 87 Fed. Reg. 3294. The meeting will be held March 15-17, 2022, and will be open to the public. Along with presenting the methodology, EPA will also present results of applying the screening methodology (case studies) to 1-bromopropane (1-BP) (air pathway), N-methylpyrrolidone (NMP) (water pathway), and methylene chloride (MC) (air and water pathway). In addition, EPA announced the availability of and solicited public comments on the draft approach, which will be presented as a screening level methodology for assessing potential air and water chemical exposures to fenceline communities. Comments are due February 22, 2022.

EPA's background documents, related supporting materials, and draft charge questions to the SACC are available in Docket ID EPA-HQ-OPPT-2021-0415 and on the SACC website. EPA will provide additional background documents (e.g., SACC members and consultants participating in this meeting and the meeting agenda) as the materials become available. Registration is required to receive the webcast meeting link and audio teleconference information. EPA states that it intends to announce registration instructions on the SACC website by early February 2022.

More information and a detailed commentary will be available in a forthcoming memorandum that will be posted on our website.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced the availability of its fiscal year (FY) 2022 oversight plan on December 14, 2021. According to OIG, the plan reflects the priority work that the OIG believes is necessary to keep EPA, the U.S. Chemical Safety and Hazard Investigation Board (CSB), and Congress fully informed about issues relating to the administration of EPA programs and operations. The planned oversight projects concerning Ensuring the Safe Use of Chemicals include:

• Audit of EPA’s Management of New Chemical Risk Assessments Conducted under the Toxic Substances Control Act (TSCA): Determine the extent to which EPA is using and complying with applicable records-management and quality-assurance requirements and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks;
   
• Evaluation of EPA Regions’ Oversight Responsibilities for State and Tribal Drinking Water Certification Programs: Determine whether select EPA regions are fulfilling oversight responsibilities for drinking water certification programs in states and tribal nations;
   
• Evaluation of EPA’s Use of Pesticide Incident-Reporting Data: Determine whether EPA uses pesticide incident-reporting data to prevent unreasonable adverse effects on human health and the environment;
   
• Evaluation of Implementation of EPA’s Federal Certification for Applicators and Dealers of Restricted-Use Pesticides within Indian Country: Determine how EPA monitors and enforces the requirements for restricted-use pesticide applicators (private and commercial) and restricted-use pesticide dealers in Indian Country;
   
• Evaluation of EPA’s Progress toward Providing States with Clear Benchmarks to Address Per- and Polyfluoroalkyl Substances (PFAS) in Drinking Water: Determine why EPA has not established a mandatory limit for PFAS in drinking water; what challenges may prevent EPA from setting such a limit; and what EPA’s plan -- if one exists -- is for implementing such a limit; and
   
• Evaluation of EPA’s Progress to Identify Key Regulatory Stakeholders for TSCA Existing Chemical Risk Management: Determine whether EPA identified and partnered with key regulatory stakeholders and developed a process to coordinate the regulation of occupational exposures from existing chemicals under TSCA.

Ongoing projects concerning Ensuring the Safe Use of Chemicals include:

• Evaluation of EPA’s Cancer Assessment Review for Pesticide 1,3-Dichloropropene: Evaluate the extent to which EPA followed policies and procedures in developing the cancer assessment for the 1,3-dichloropropene pesticide registration review decision to prevent unreasonable adverse effects on human health; and
   
• Evaluation of EPA’s Overdue Residual Risk and Technology Reviews: Evaluate whether EPA has conducted residual risk and technology reviews in a timely manner, as required for EPA to revise standards, as needed, to protect the public from air toxics emitted by stationary sources.

Planned and ongoing projects concerning Safeguarding Scientific Integrity Principles include:

• Congressional Request: Evaluation of EPA’s Changes to Final Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Significant New Use Rule (SNUR): Determine the extent to which EPA followed applicable policies, procedures, and guidance for the changes made to the Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances SNUR between the EPA Administrator’s signing of the final SNUR on June 22, 2020, and the publication of the final SNUR in the Federal Register on July 27, 2020; and
   
• Evaluation of EPA’s January 2021 Perfluorobutane Sulfonic Acid (PFBS) Toxicity Assessment: Determine whether EPA’s Office of Research and Development (ORD) and Office of Chemical Safety and Pollution Prevention (OCSPP) followed applicable policies and procedures in the development and publication of the January 19, 2021, PFBS toxicity assessment.

OIG states that it is important to note that its planning efforts “are not static and that the projects included herein may be modified throughout the year as challenges and risks for the EPA and the CSB evolve and emerge.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On May 21, 2021, the U.S. Environmental Protection Agency (EPA) published its response to a portion of the petition it received February 8, 2021, from People for Protecting Peace River, Center for Biological Diversity, and 16 other organizations. 86 Fed. Reg. 27546. While the petition requested three actions related to the Toxic Substances Control Act (TSCA), EPA states that it has determined that only one of those actions is an appropriate request: a request to issue a test rule under TSCA requiring testing of phosphogypsum and process wastewater from phosphoric acid production. According to the notice, EPA is treating the other portions of the petition involving TSCA as a petition under the Administrative Procedure Act (APA); those other portions request EPA to initiate the prioritization process for designating phosphogypsum and process wastewater as high-priority substances for risk evaluation and to make a determination by rule under TSCA that the use of phosphogypsum in road construction is a significant new use. Therefore, the notice does not provide EPA’s response to these two TSCA-requested actions. Also, it does not address the petitioners’ requests under the Resource Conservation and Recovery Act (RCRA). EPA states that “[a]fter careful consideration,” it has denied the TSCA Section 21 portion of the petition for the following reasons:

• Request for prioritization under TSCA Section 6 and related testing under TSCA Section 4(a)(2)(B): Because TSCA Section 21 does not provide an avenue for petitioners to request the initiation of the prioritization process for phosphogypsum and process wastewater, EPA is treating this portion of the request as a petition for action under the APA. Petitioners assert that “should EPA initiate prioritization but find that the development of new information is necessary to finalize a prioritization decision for phosphogypsum and process wastewater, EPA should exercise its authority under section 4(a)(2)(B) to obtain that information and establish priority.” EPA states that because it is not addressing the request for prioritization and has not otherwise initiated prioritization on phosphogypsum or process wastewater, it is not in a position to exercise its authority under TSCA Section 4(a)(2)(B) in the manner and for the reason described by petitioners.
• Request for significant new use rule (SNUR) under TSCA Section 5: TSCA Section 21 does not provide for the submission of a petition seeking the initiation of a rule under TSCA Section 5. EPA states that SNURs are issued under the authority of TSCA Section 5(a)(2). Since TSCA Section 21 does not provide an avenue for petitioners to request the initiation of a proceeding to make a determination by rule under TSCA Section 5(a), EPA is treating this portion of the request as a petition for action under the APA.
• Request for issuance of a test rule under TSCA Section 4(a)(1)(A): According to the notice, TSCA Section 21 does provide for the submission of a petition seeking issuance of a test rule under TSCA Section 4(a)(1)(A). EPA states that it finds that the petitioners have not met their burden as defined in TSCA Sections 4(a)(1)(A) and 21(b)(1) because the petitioners have not provided the facts necessary to determine for phosphogypsum and process wastewater that existing information and experience are insufficient and testing with respect to such effects is necessary to develop such information.

More information about the petition is available in our March 12, 2021, memorandum, “EPA Receives Petition Seeking RCRA and TSCA Regulatory Action for Phosphogypsum and Process Wastewater.”

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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.

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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.

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