EPA Petition on Chemours PFAS

On October 14, 2020, EPA received a petition to require health and environmental testing under Section 21 of the Toxic Substances Control Act (TSCA) on certain PFAS manufactured by Chemours in Fayetteville, North Carolina.  The petitioners consist of the Center for Environmental Health, the Cape Fear River Watch, Clean Cape Fear, Democracy Green, Toxic Free NC, and the NC Black Alliance.  The petition requests testing on 54 PFAS which Chemours produces.  The petition states that the 54 PFAS meet the criteria for testing in section 4(a) of TSCA.  It states that,

Based on the known hazards of these analogues, untested PFAS with potential for exposure would meet the criteria for testing in section 4(a)(1)(A) of TSCA because they “may present an unreasonable risk of injury” and have “insufficient information and experience” to determine their effects on health or the environment.

The PFAS produced by Chemours includes both commercial products and byproducts from their manufacturing process.  Some of the testing differs based on whether the compound is Tier 1 (detection in human sera, food or drinking water) or Tier 2 (significant potential for human exposure based on detection in environmental media and other evidence).  The petition also states that Gen X chemicals have been detected in drinking water and private wells in the vicinity of the Chemours plant.  A major point of concern for the petitioners involves the North Carolina consent order, which is the result of a lawsuit against Chemours from the North Carolina Department of Environmental Quality addressing PFAS contamination in the Cape Fear River basin from the Chemours’ facility.  The petition states current testing of Gen X chemicals by Chemours has been inadequate to fully evaluate the risks and additional carcinogenicity studies are needed.

The petition proposes testing with animal studies:

  • 28-day repeated dose rodent toxicology studies to determine impact on health,
  • Multigeneration or extended one-generation and 2-year rodent carcinogenicity studies for Tier 1 substances,
  • Testing on both mice and rats using oral routes of administration,
  • Inhalation testing used for volatile chemicals, and
  • Toxicokinetic studies to characterize relationship between serum concentrations and dermal to evaluate biological half-life and potential for bioaccumulation.

The petition also proposes the following human studies:

  • A human health study for the Cape Fear watershed to determine the relationship between exposure in the Cape Fear watershed and health outcomes.
  • Testing to determine human half-lives of the listed chemicals through longitudinal biomonitoring and exposure estimation in workers.

The European Commission’s Chemicals Strategy for Sustainability

On October 14, 2020 the European Commission communicated the Chemicals Strategy for Sustainability Towards a Toxic-Free Environment to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.  This ambitious Strategy is intended to “chart a new long-term vision for the EU’s chemical policy … [that] strives for a toxic-free environment, where chemicals are produced and used in a way that maximises their contribution to society including achieving the green and digital transition, while avoiding harm to the planet and to current and future generations.”  If fully implemented, the Strategy would amend REACH, the CLP (the Regulation on the Classification, Labelling and Packaging of hazardous substances), and other legislation addressing the safety of toys, cosmetics, biocides, plant protection products, food, carcinogens in the workplace as well as legislation on environmental protection.

The Strategy focuses on the following topics:

  • Safe and Sustainable-by-Design
  • Non-Toxic Material Cycles
  • Innovating Industrial Production
  • Protection Against Most Harmful Chemicals
  • Endocrine Disruptors
  • Chemical Pollution in [the] Natural Environment
  • PFAS
  • Coordinate and Simplify Actions across EU Chemical Legislation
  • Zero Tolerance for Non-Compliance
  • Information Requirements

The Strategy will implement a new hierarchy for chemical management with a three-level approach.  The use of safe and sustainable chemicals for both humans and the environment will be highlighted and is the first level.  Minimizing and controlling hazardous substances is the second level.  Eliminating and remediating substances of concern is the third and final level.  The Strategy will implement their new hierarchy through a series of methods mentioned below.

To facilitate Safe and Sustainable-by-Design, the Commission will:

  • Develop EU safe and sustainable-by-design criteria for chemicals;
  • Ensure the development, commercialization, deployment and uptake of safe and sustainable-by-design substances; and
  • Establish Key Performance Indicators to measure the industrial transition towards the production of safe and sustainable chemicals.

To address non-toxic material cycles, the Commission will:

  • Minimize the presence of substances of concern in products;
  • Ensure that authorizations and derogations from restrictions for recycled materials under REACH are exceptional and justified;
  • Support investments in sustainable innovations that can decontaminate waste streams, increase safe recycling and reduce the export of waste, in particular plastics and textiles; and
  • Develop methodologies for chemical risk assessment that take into account the whole life cycle of substances, materials and products.

To implement Innovating Industrial Production, the Commission will support:

  • Research and development in advanced materials; and
  • Research, development and deployment of low-carbon and low environmental impact chemical and material production processes.

To extend protection against most harmful chemicals, the Commission will:

  • Extend the generic approach to risk management to ensure that consumer products do not contain chemicals that cause cancers, gene mutations, affect the reproductive or the endocrine system, or are persistent and bioaccumulative;
  • Define criteria for essential uses to ensure that the most harmful chemicals are only allowed if their use is necessary for health, safety or is critical for the functioning of society and if there are no alternatives that are acceptable from the standpoint of environment and health; and
  • Extend to professional users under REACH the level of protection granted to consumers.

To address endocrine disruptors, the Commission will:

  • Propose to establish legally binding hazard identification of endocrine disruptors;
  • Ensure that endocrine disruptors are banned in consumer products;
  • Strengthen workers’ protection by introducing endocrine disruptors as a category of substances of very high concern under REACH; and
  • Ensure that sufficient and appropriate information is made available to authorities to allow the identification of endocrine disruptors.

To address chemical pollution in the natural environment, the Commission will:

  • Propose new hazard classes and criteria in the CLP Regulation to fully address environmental toxicity, persistency, mobility and bioaccumulation;
  • Introduce endocrine disruptors, persistent, mobile and toxic and very persistent and very mobile substances as categories of substances of very high concern; and
  • Ensure that the information made available to authorities on substances allows comprehensive environmental risk assessments.

To address PFAS, the Commission will:

  • Ban all PFAS in fire-fighting foams as well as in other uses;
  • Establish an EU-wide approach to identify and develop innovative methodologies for remediating PFAS contamination in the environment and in products; and
  • Provide research and innovation funding for safe innovations to substitute PFAS.

To coordinate and simplify actions across EU chemical legislation, the Commission will:

  • Use a ‘Public Activities Coordination Tool’ to provide an up-to-date overview of all planned and ongoing initiatives on chemicals by authorities across legislation;
  • Establish an expert working group to discuss initiatives on hazard/risk assessment on chemicals across chemical legislation; and
  • Reform the REACH authorization and restriction processes.

To effect zero tolerance for non-compliance, the Commission will:

  • Strengthen the principles of ‘no data, no market’ and the ‘polluter-pays’ under REACH;
  • Carry out audits in Member States to ensure compliance and enforcement of chemicals legislation;
  • Target known areas of high risk of non-compliance, in particular online sales, imported articles, classification and labelling and restrictions; and
  • Extend the scope of action of the European Anti-Fraud Office for coordination and investigation, to tackle the circulation of illicit chemical products in the EU.

To extend information requirements, the Commission will:

  • Extend the duty of registration under REACH to certain polymers of concern;
  • Assess how to best introduce information requirements under REACH on the overall environmental footprint of chemicals;
  • Amend REACH information requirements to enable an effective identification of substances with critical hazard properties; and
  • Amend REACH information requirements to enable identification of all carcinogenic substances manufactured or imported in the EU.

PFAS in California’s Water Supply

Testing of California’s public water supply wells reveals that 60 percent of them contain the “forever” chemicals, perfluoroalkyl and polyfluoroalkyl substances (PFASs). The concentrations of these substances were higher at airports than landfills and public supply wells.  One million parts per trillion were detected at airports, while landfills had 10,000 parts per trillion and public wells had 100 parts per trillion. EPA has established a health advisory level at 70 parts per trillion for the combined amounts of PFOA and PFOS.

The health advisories from EPA offer guidance for states and the federal government to meet standards that will avoid adverse health effects.  Studies of individuals exposed to PFASs show increases in hormonal issues, organ damage, and cancer. Nationally, the Safe Drinking Water Act (SDWA) regulates maximum contaminant levels (MCLs) allowed in drinking water for over 90 chemicals.  However, PFASs currently remain on EPA’s unregulated and non-enforceable list for SDWA MCLs.  EPA’s PFAS Action Plan shows that the Agency is still in the information gathering phase to determine the prevalence and full effects of the PFASs with regulation in the future.

Individual states have been putting their own regulation forward for PFASs.  For example, in September 2020 California Governor Gavin Newsom signed Senate Bill No. 1044, which governs the tracking and recall of firefighting foam containing PFASs.