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. Environmental Protection Agency (EPA) announced on November 9, 2022, that it awarded $7,770,044 in research grant funding to 11 institutions to develop and evaluate innovative methods and approaches to inform its understanding of the human health risks that may result from exposure to chemical mixtures in the environment. EPA states that toxicology studies have traditionally focused on the effects of single chemicals on human health. Chemicals in the environment are often present as mixtures in the air, water, soil, food, and products in commerce, however, and these chemical mixtures include per- and polyfluoroalkyl substances (PFAS), phthalates, polycyclic aromatic hydrocarbons (PAH), disinfection byproducts (DBP), and other well-characterized mixtures. According to EPA, there is a need to assess the toxicity of chemical mixtures to understand how their combined effects on human health and the environment differ from what is known about individual chemicals. Due to their lower cost and higher throughput, new approach methods (NAM) and use of alternative animal models have emerged as potential approaches to advance the risk assessment of mixtures.
 
To help address this research need, the institutions receiving these grants will conduct research focused on the development, improvement, evaluation, and integration of predictive toxicology methods to evaluate environmental chemical mixtures. The grantees and their project titles include:

  • Georgia Institute of Technology, Atlanta, Georgia -- High-Throughput Lung Damage and Inflammation Assessment of Polyaromatic Hydrocarbon Mixtures;
     
  • Medical University of South Carolina, Charleston, South Carolina -- Developing an Integrated Framework for Evaluating Toxicity of Real-life Chemical Mixtures;
     
  • Purdue University, West Lafayette, Indiana -- Protein Binding Affinity as the Driver for Studying PFAS Mixture Toxicity;
     
  • The Research Foundation of CUNY, New York, New York -- Innovative Approach to Assess the Effect of Metal Mixtures from Infant Meconium Associated with Adverse Infant Outcomes by Identifying Methylation Loci in Mothers and Infants;
     
  • Texas A&M University, College Station, Texas -- A Tiered Hybrid Experimental-Computational Strategy for Rapid Risk Assessment of Complex Environmental Mixtures Using Novel Analytical and Toxicological Methods;
     
  • University at Buffalo, Buffalo, New York -- Assessment of Neurotoxicity of Mixtures of PFAS and Other Neuroactive Organic Pollutants through Integrated in Silico, in Vitro Cellular, and in Vivo Models;
     
  • University of Georgia Research Foundation, Inc., Athens, Georgia -- Development of a Quantitative Adverse Outcome Pathway Network to Assess Neurodevelopmental Toxicity of PFAS Mixture in C. Elegans;
     
  • University of Houston, Houston, Texas -- Oral Toxicity Assessment of PAH Mixtures Using an in Vitro 3D Cell Culture Bioreactor Mimicking the in Vivo Intestinal Tract Environment;
     
  • University of Massachusetts Boston, Boston, Massachusetts -- Whole Animal New Approach Methodologies for Predicting Developmental Effects of Air Pollutant Mixtures;
     
  • University of North Carolina at Chapel Hill, Chapel Hill, North Carolina -- Wildfire Smoke Mixtures Toxicity Testing; and
     
  • Wayne State University, Detroit, Michigan -- Assessment of Underlying Molecular Mechanisms Promoting Adipogenic Outcomes in Complex Mixtures.

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on October 28, 2022, that it awarded $748,180 in research grant funding to three institutions for research to improve understanding of how people are exposed to per- and poly-fluoroalkyl substances (PFAS) in several communities throughout the country. EPA states that there is evidence that continued exposure above specific levels to certain PFAS may lead to adverse health effects. According to EPA, more data are needed to measure the nature and levels of PFAS in homes and food to understand pathways for human exposure and risk mitigation.
 
The following institutions are receiving awards:

  • Silent Spring Institute, Newton, Massachusetts, to measure PFAS in air and dust in homes and to evaluate associations between potential residential sources and PFAS occurrence at home. According to EPA, this research will enhance understanding of the contribution of residential pathways to PFAS exposures and improve the interpretation of PFAS biomonitoring data;
     
  • Duke University, Durham, North Carolina, to determine how different sources of PFAS exposure, including PFAS in drinking water and in homes, contribute to levels measured in blood. EPA states that this study will address key questions on the most relevant PFAS exposure pathways for the general U.S. population; and
     
  • Emory University, Atlanta, Georgia, to develop a standardized, validated, scientific protocol to measure levels of a targeted set of PFAS in the home. According to EPA, data collected from home samples will be compared to data collected from PFAS in blood to help identify residential sources of PFAS measured in people’s blood.

 

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 and Carla N. Hutton
 
On October 13, 2022, Earthjustice, on behalf of a coalition of environmental organizations and community advocates, petitioned the U.S. Environmental Protection Agency (EPA) to revoke the approval of approximately 600 per- and polyfluoroalkyl substances (PFAS) that were granted through low volume exemptions (LVE) or low release and low exposure exemptions (LoREX) to the premanufacture notice (PMN) requirements of the Toxic Substances Control Act (TSCA). In its October 13, 2022, press release, Earthjustice states that these exemptions “allow EPA to approve chemicals through lax safety reviews only if it ‘will not present an unreasonable risk’ to humans or the environment.” According to Earthjustice, PFAS do not meet that standard, and EPA must revoke previously granted LVEs and LoREXs for PFAS. The petition follows an April 27, 2021, petition filed by Earthjustice on behalf of many of the same petitioners, and it incorporates the 2021 petition by reference.
 
The petition requests the following actions:

  • For all outstanding LVEs and LoREXs granted for PFAS, EPA must make a preliminary determination that these LVEs and LoREXs do not meet the terms of TSCA Section 5(h)(4) or 40 C.F.R. Section 723.50(d);
  • For all outstanding LVEs and LoREXs granted for PFAS, EPA must notify their manufacturers that it believes their substance does not meet the requirements for a PMN exemption and then proceed to make a final determination based on the current science that no PFAS meets the TSCA Section 5(h)(4) standard for a PMN exemption, taking into account potentially exposed or susceptible subpopulations, in accordance with the protocols set forth in 40 C.F.R. Section 723.50(h);
  • In the alternative, EPA must individually re-assess all PFAS for which there is an outstanding LVE and/or LoREX to determine whether the substance meets the standard set forth in 40 C.F.R. Section 723.50(d) and in TSCA Section 5(h)(4); and
  • Petitioners incorporate by reference all of the requests set forth in the 2021 petition and reiterate the same requests here:
  • EPA must initiate a rulemaking to prohibit: (a) future use of the byproducts exemption for new PFAS; and (b) continued manufacture of any PFAS byproduct under the auspices of the byproducts exemption unless and until such PFAS has undergone a full PMN review and been approved by EPA, with a two-year window for manufacturers to receive such approval; and
  • EPA should immediately stop permitting the use of the LVE, LoREX, and polymer exemption for any new PFAS.

 

By Lynn L. Bergeson and Carla N. Hutton

Maine enacted “An Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution” in July 2021. Under the bill, manufacturers of products with intentionally added per- and polyfluoroalkyl substances (PFAS) must report the presence of the intentionally added PFAS in those products to the Maine Department of Environmental Protection (MDEP) beginning January 1, 2023. The law also prohibits the sale of carpets or rugs, as well as the sale of fabric treatments, that contain intentionally added PFAS beginning on January 1, 2023. Beginning January 1, 2030, any product containing intentionally added PFAS may not be sold in Maine unless the use of PFAS in the product is specifically designated as a currently unavoidable use by MDEP.

According to the MDEP website, MDEP is in the process of developing a rule to clarify the January 1, 2023, reporting requirements. MDEP states that during the rule development process, there will be an opportunity for stakeholder input on the implementation of the program. Stakeholders can subscribe to receive notification of MDEP rulemaking and opportunity to comment notices on its website.

Pending clarification of the reporting requirements, reporting entities may need to request an extension of time to notify MDEP of any products for sale in the state of Maine that contain intentionally added PFAS. At this time, terms in the statutory language are not defined to allow companies to report information with sufficient clarity to comply confidently with the law. Manufacturers will need to obtain information from many industry sectors and upstream suppliers to determine if PFAS was intentionally added to the product or is a component of the product. Suppliers in many industry sectors are numerous, and because of current and ongoing supply chain issues, manufacturers are challenged now more than ever. The frequently asked questions (FAQ) on MDEP’s website list information that will be required, “at a minimum,” but the website states that “[t]hese requirements will be further clarified as part of the rulemaking.”

Tags: Maine, MDEP, PFAS

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2022, that it selected 39 recipients that will receive nearly $12 million in pollution prevention (P2) grants made possible by President Joseph Biden’s Bipartisan Infrastructure Law’s $100 million program investment. According to EPA, the grants will allow states and Tribes to provide businesses with technical assistance to help them develop and adopt P2 practices to prevent or reduce pollution before it is even created, while also reducing business and liability costs. Proposed projects include reducing per- and polyfluoroalkyl substances (PFAS) contamination in food packaging and food waste recycling streams, increasing awareness of green cleaning chemicals in businesses and schools, and helping underserved communities implement P2 best practices to reduce waste and emissions from industrial plants.
 
EPA notes that the P2 program advances President Biden’s Justice40 Initiative, which aims to deliver at least 40 percent of the benefits of certain government programs to underserved communities. State and Tribal programs awarded grants will not be required to provide matching funds, as is required by traditional P2 grants.
 
According to EPA, selected and awarded grantees will document and share P2 best practices they identify and develop through these grants so that others can replicate the practices and outcomes. Each selected grantee will address at least one of the National Emphasis Areas (NEA) established to focus resources to achieve measurable results and to create opportunities to share information among P2 grantees and businesses affiliated with similar NEAs. Each selected grantee will also develop at least one case study during the grant period on P2 practices that are new or not widely known or adopted, or where detailed information on P2 practices could benefit other businesses or P2 technical assistance providers. The NEAs include food and beverage manufacturing and processing; chemical manufacturing, processing, and formulation; automotive manufacturing and maintenance; aerospace product and parts manufacturing and maintenance; metal manufacturing and fabrication; and supporting P2 in Indian country and for Alaska Native Villages.

Tags: P2, PFAS, pollution

 

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

The U.S. Environmental Protection Agency (EPA) will hold a webinar on August 17, 2022, on the “EPA PFAS Strategic Roadmap: Research Tools and Resources.” EPA states that “[a] growing body of scientific evidence suggests that exposure at certain levels to specific [per- and polyfluoroalkyl substances (PFAS)] can adversely impact human health and other living things.” The webinar will provide a brief overview of EPA’s PFAS Strategic Roadmap and ongoing efforts by EPA’s Office of Research and Development (ORD) to address key PFAS research needs for environmental decision-making. During the webinar, ORD scientists will highlight two recently released data sources: EPA’s PFAS Thermal Treatment Database (PFASTT), which contains information on the treatability of PFAS via various thermal processes, and Systematic Evidence Map for PFAS, which summarizes available toxicity evidence for approximately 150 different PFAS. Recent updates to other PFAS resources will also be shared. Registration is now open.

Tags: ORD, PFAS, PFASTT

 
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