Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

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.


 

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.

Tags: PFAS, Water, GAO

 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
 
On October 11, 2022, the U.S. Chemical Safety Board (CSB) released its final investigative report into “a massive fire and explosions” at the Philadelphia Energy Solutions Refinery in Philadelphia, Pennsylvania, that occurred in June 2019. According to CSB, the incident occurred when a corroded pipe elbow ruptured, releasing process fluid into the refinery’s hydrofluoric acid (HF) alkylation unit. CSB states that over 5,000 pounds of “highly toxic” HF were released, “a 38,000-pound vessel fragment launched off-site and landed on the other side of the Schuylkill River, and an estimated property damage loss of $750 million resulted.”
 
In its final report, CSB notes that the U.S. Environmental Protection Agency (EPA) has not yet prioritized HF or performed a risk evaluation of HF under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. According to CSB, HF “is one of the eight most hazardous chemicals regulated by the EPA Risk Management Program (RMP).” CSB states that it concludes that EPA should initiate prioritization to evaluate whether HF is a high-priority substance for risk evaluation under TSCA. If HF is determined to be a high-priority substance, EPA should conduct a risk evaluation of HF and implement any identified corrective actions, as required by TSCA. CSB “recommends to EPA to take such action.”

Commentary

While we agree that HF is a highly hazardous substance that warrants prioritization for review under Section 6 of TSCA, it is not clear how a TSCA risk evaluation will address the risks related to accidents, such as the one that was the subject of this CSB investigation. Congress clearly stated that “reasonably foreseen” conditions of use exclude misuse of a chemical substance. CSB concluded that the facility had failed to meet its obligations under the Occupational Safety and Health Administration (OSHA) and other EPA regulations, and the accident was the result of the failure of a section of pipe that was decades old. We would argue that such a failure was a misuse of HF. As a result, we would expect a TSCA risk evaluation to conclude that as long as appropriate engineering controls are used to prevent worker exposure and prevent releases to the neighboring communities under the intended and reasonably foreseen conditions of use, there is not an unreasonable risk. EPA’s review might lead to the imposition of a lower workplace exposure limit (than the OSHA permissible exposure limit (PEL)) and might lead to a lower Hazardous Air Pollutant standard under the Clean Air Act. Neither of these protective measures would have prevented the accident. Others may argue that an accidental release is reasonably foreseen (after all, it did happen), but, in our view, this accident was the result of misuse, so it is outside the definition of reasonably foreseen conditions of use.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 6, 2022, the U.S. Environmental Protection Agency proposed to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 87 Fed. Reg. 54415. According to EPA, “[s]uch a designation would ultimately facilitate cleanup of contaminated sites and reduce human exposure to these ‘forever’ chemicals.” Comments are due November 7, 2022. EPA states that under the Paperwork Reduction Act, “comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before October 6, 2022.”
 
Upon designation, any person in charge of a vessel or an offshore or onshore facility, as soon as they have knowledge of any release of such substances at or above the reportable quantity (RQ) must immediately report such releases to the federal, state, tribal, and local authorities. The RQ for these designations is one pound or more in a 24-hour period. EPA states that once it has collected more data on the size of releases and the resulting risks to human health and the environment, it may consider issuing a regulation adjusting the RQs for these substances.
 
The five broad categories of entities potentially affected by this action include:

  • PFOA and/or PFOS manufacturers (including importers and importers of articles);
  • PFOA and/or PFOS processors;
  • Manufacturers of products containing PFOA and/or PFOS;
  • Downstream product manufacturers and users of PFOA and/or PFOS products; and
  • Waste management and wastewater treatment facilities.

More information is available in our August 29, 2022, memorandum.

Tags: PFAS, PFOA, PFOS, CERCLA

 

By Lynn L. Bergeson and Carla N. Hutton
 
ASTM has announced that a new subcommittee will develop standards on per- and polyfluoroalkyl substances (PFAS) that are present in consumer products. ASTM describes PFAS as “a group of chemicals that are used to make fluoropolymer coatings and products that resist heat, oil, stains, grease and water.” The new subcommittee (F15.81) will operate under the jurisdiction of ASTM’s consumer products committee (F15). According to ASTM, the new subcommittee “will develop standards that provide guidance on how to prepare and analyze a wide variety of consumer product samples for PFAS.” ASTM “welcomes participation in the development of its standards. Chemical engineers, analytical chemists, and advocacy group technical personnel are particularly encouraged to join the subcommittee.” More information is available online regarding ASTM membership.

Tags: ASTM, PFAS,

 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 14, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2022, that it is planning to consolidate several Information Collection Requests (ICR) covering reporting and recordkeeping activities under Section 8 of the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 12954. EPA has since submitted the ICR to the Office of Management and Budget (OMB) for review and approval. EPA published a notice on August 30, 2022, allowing for an additional 30 days for public comment. 87 Fed. Reg. 52967. Comments are due September 29, 2022.
 
The consolidated ICR is entitled “Reporting and Recordkeeping Under Section 8 of the Toxic Substances Control Act (TSCA)” and is identified under EPA ICR No. 2703.01 and OMB Control No. 2070-[NEW]. According to EPA, it is consolidating the existing ICRs to streamline the presentation of the paperwork burden estimates, thereby reducing the administrative burden for both the public and EPA and allowing a better assessment of the burden and costs for reporting and recordkeeping activities under TSCA Section 8. EPA’s Supporting Statement summarizes the currently approved ICRs that would be consolidated in the new ICR:

  • TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR): Under TSCA Section 8(a), persons who manufacture or import chemical substances listed at 40 C.F.R. Section 712.30 are subject to the Section 8(a) PAIR requirements. These manufacturers and importers must submit information about production, use, and/or exposure-related data. Certain specific chemical testing and reporting requirements under 40 C.F.R. Part 766 Subpart B that are very similar to the PAIR requirements are also covered within this information collection activity.
     
  • Chemical-Specific Rules, TSCA Section 8(a): Under TSCA Section 8(a), persons who manufacture, import, or process certain chemical substances or mixtures, or propose to manufacture, import, or process certain chemical substances or mixtures, are subject to chemical-specific rules promulgated under TSCA Section 8(a). A chemical-specific Section 8(a) rule requires more detailed and more types of information than is required by a PAIR rule. Any chemical covered by TSCA for which the Office of Pollution Prevention and Toxics (OPPT), other EPA offices, or another federal agency has a reasonable need for information, and that cannot be satisfied via readily available sources or by use of other rulemakings, is a proper potential subject for a chemical-specific TSCA Section 8(a) rulemaking.
     
  • Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment: Under TSCA Section 8(c), persons who manufacture, import, process, or distribute in commerce any chemical substance or mixture must keep records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture. TSCA Section 8(c) requires that allegations of adverse reactions to the health of employees be kept for 30 years, and all other allegations be kept for five years. The rule also prescribes the conditions under which a firm must submit or make the records available to a duly designated representative of the Administrator.
     
  • Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies: Under TSCA Section 8(d), certain persons, who manufacture, import, process, or distribute in commerce (or propose to manufacture, import, process, or distribute in commerce) chemical substances and mixtures, are required to submit to EPA lists and copies of health and safety studies in their possession that relate health and/or environmental effects of the chemical substances and mixtures.

 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 12, 2022, the Office of Management and Budget (OMB) completed its review of a proposed rule that would designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Such designations would require facilities to report on PFOA and PFOS releases that meet or exceed the reportable quantity. Publication of the proposed rule in the Federal Register will begin a public comment period.
 
As reported in our October 19, 2021, memorandum, as part of a multi-agency effort to address pollution from per- and polyfluoroalkyl substances (PFAS), the U.S. Environmental Protection Agency (EPA) released its PFAS Strategic Roadmap on October 18, 2021. The key actions outlined in the roadmap include proposing to designate PFOA and PFAS as CERCLA hazardous substances.

Tags: PFOA, PFOS

 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 28, 2022, the National Toxicology Program (NTP) announced that the following revised Technical Reports on the Toxicity Studies are available on the NTP website:

  • Perfluoroalkyl Sulfonates (Perfluorobutane Sulfonic Acid, Perfluorohexane Sulfonate Potassium Salt, and Perfluorooctane Sulfonic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised TOX-96); and
     
  • Perfluoroalkyl Carboxylates (Perfluorohexanoic Acid, Perfluorooctanoic Acid, Perfluorononanoic Acid, and Perfluorodecanoic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised TOX-97).

According to NTP, transcription errors were identified in these reports, and an audit was conducted. NTP revised and republished the reports with an appendix that identifies the corrections. NTP notes that the final tables are available in the Chemical Effects in Biological Systems (CEBS) database.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) published a report on July 28, 2022, entitled Persistent Chemicals: Technologies for PFAS Assessment, Detection, and Treatment. GAO was asked to conduct a technology assessment on per- and polyfluoroalkyl substances (PFAS) assessment, detection, and treatment. The report examines the technologies for more efficient assessments of the adverse health effects of PFAS and alternative substances; the benefits and challenges of current and emerging technologies for PFAS detection and treatment; and policy options that could help enhance benefits and mitigate challenges associated with these technologies. GAO assessed relevant technologies; surveyed PFAS subject matter experts; interviewed stakeholder groups, including government, non-governmental organizations (NGO), industry, and academia; and reviewed key reports. GAO identified three challenges associated with PFAS assessment, detection, and treatment technologies:

  • PFAS chemical structures are diverse and difficult to analyze for health risks, and machine learning requires extensive training data that may not be available;
     
  • Researchers lack analytical standards for many PFAS, limiting the development of effective detection methods; and
     
  • The effectiveness and availability of disposal and destruction options for PFAS are uncertain because of a lack of data, monitoring, and guidance.

GAO developed the following three policy options that could help mitigate these challenges:

  • Promote research: Policymakers could support development of technologies and methods to more efficiently research PFAS health risks. This policy option could help address the challenge of limited information on the large number and diversity of PFAS, as well as a lack of standardized data sets for machine learning;
     
  • Expand method development: Policymakers could collaborate to improve access to standard reference samples of PFAS and increase the pace of method and reference sample development for PFAS detection. This policy option could help address the challenges of a lack of validated methods in media other than water, lack of analytical standards, and cost, which all affect researchers’ ability to develop new detection technologies; and
     
  • Support full-scale treatment: Policymakers could encourage the development and evaluation of full-scale technologies and methods to dispose of or destroy PFAS. This policy option could help address the challenges of cost and efficiency of disposal and destruction technologies and a lack of guidance from regulators.

GAO notes that these policy options involve possible actions by policymakers, which may include Congress, federal agencies, state and local governments, academia, and industry.


 

 By Lynn L. Bergeson and Carla N. Hutton
 
On July 13, 2022, the White House Office of Science and Technology Policy (OSTP) requested input from all interested parties to identify data gaps in research and development (R&D) regarding several aspects of per- and polyfluoroalkyl substances (PFAS). 87 Fed. Reg. 41749. This information will be used to inform a strategic plan for federal coordination of PFAS R&D and, in compliance with Section 332 of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (NDAA), the interagency strategy team on PFAS will also develop an implementation plan for federal agencies.
 
For purposes of the RFI, the term PFAS has the definition provided in NDAA Section 332(g)(1): “(A) man-made chemicals of which all of the carbon atoms are fully fluorinated carbon atoms; and (B) man-made chemicals containing a mix of fully fluorinated carbon atoms, partially fluorinated carbon atoms, and nonfluorinated carbon atoms.” The RFI states that examples of products that use PFAS include food contact materials (e.g., packaging, cookware), stain- and water-repellant fabrics and carpets, and firefighting foams. PFAS may be present in water, soil, air, food, and other materials. According to the RFI, “[r]esearch has shown that PFAS are highly stable chemicals that accumulate in people, animals, and the environment over time, and in several cases, have been shown to cause adverse health effects.”
 
The RFI states that respondents may provide information for one or as many research goals below as they choose:

  • The removal of PFAS from the environment, in part or in total;
  • The safe destruction or degradation of PFAS;
  • The development and deployment of safer and more environmentally friendly alternative substances that are functionally similar to those made with PFAS;
  • The understanding of sources of environmental PFAS contamination and pathways to exposure for the public; and/or
  • The understanding of the toxicity of PFAS to humans and animals.

OSTP states that it is interested in responses to the following questions:

  • Should the federal government consider identifying priority PFAS when developing a strategic plan for PFAS R&D? If so, what criteria should be used to identify priority PFAS for R&D (e.g., tonnage used per year; releases to the environment per year; toxicology or other human or environmental health concerns; or national security or critical infrastructure uses)?
  • Are there criteria that could be applied across the five research goals identified above, or should specific criteria be developed for each individual research goal?
  • Based on the definition of PFAS in the RFI, what are the scientific, technological, and human challenges that must be addressed to understand and to reduce significantly the environmental and human impacts of PFAS and to identify cost-effective:
    • Alternatives to PFAS that are designed to be safer and more environmentally friendly;
    • Methods for removal of PFAS from the environment; and
    • Methods to destroy or degrade PFAS safely?
  • Are there specific chemistries and/or intended uses that PFAS provide for which there are no known alternatives at this time?
  • What are alternatives to the definition of PFAS provided in this RFI? What are the implications of these alternative definitions on possible remediation strategies?
  • What should be the R&D priorities for accelerating progress, improving efficiency, and reducing the cost of: analytical methods, detection limits, and non-targeted detection?
  • What studies would yield the most useful information and address the current gaps in understanding PFAS health effects in humans (e.g., in vitro, animal toxicological, and epidemiological studies)? Which health effects should be prioritized? What additional impacts beyond health should be prioritized? Social scientific approaches are welcome in addressing this question and any others, as appropriate.
  • One challenge across all research goals is PFAS mixtures and formulations. Currently, more information is needed to understand the identity, composition, occurrence, source, or effects on human health and the environment for mixtures of PFAS found in environmental media. Additionally, more information is needed to understand the best way to remediate or destroy media contaminated with multiple PFAS. What should be the R&D priorities for accelerating progress in these areas?
  • What goals, priorities, and performance metrics would be valuable in measuring the success of national, federally-funded PFAS R&D initiatives relating to:
    • The removal of PFAS from the environment;
    • Safely destroying or degrading PFAS;
    • Developing safer and more environmentally friendly alternatives to PFAS; and
    • Mitigating negative human effects of PFAS, whether related to health or additional domains?

Responses are due August 29, 2022.

Tags: OSTP, RFI, Data, PFAS

 
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