The U.S. Consumer Product Safety Commission (CPSC) published a request for information (RFI) on per- and polyfluoroalkyl substances (PFAS) used in commerce or potentially used in consumer products, potential exposures associated with the use of PFAS in consumer products, and potential human health effects associated with exposures to PFAS from their use in consumer products. 88 Fed. Reg. 64890. CPSC also announced the availability of a contractor report with a focus on PFAS that are potentially used or present in consumer products. CPSC notes that the RFI “does not constitute or propose regulatory action, but rather is intended to inform the Commission and the public.” Comments are due November 20, 2023.

Background

CPSC states that there is no single, universally accepted definition of PFAS or authoritative list of PFAS, “although some researchers and organizations have published preferred definitions or have generated such lists.” According to CPSC, the U.S. Environmental Protection Agency (EPA) and other data sources indicate that there are thousands of PFAS that could be registered on U.S. or global chemical inventories and are potentially in commerce, hundreds of PFAS with reported use information from the U.S. or international sources, and several dozen PFAS that are more commonly measured in consumer products, the environment, or in people. CPSC notes that PFAS are used in: non-stick cookware; water-repellent and stain resistant clothing, carpets, and other fabrics; some cosmetics; some firefighting foams; and common home products such as cleaning supplies, waxes, coatings, adhesives, paints, and sealants. The RFI concerns “consumer products,” which includes products used in or around the home or school that are subject to CPSC jurisdiction under the Consumer Product Safety Act (CPSA), Federal Hazardous Substances Act, and other statutes administered by CPSC. CPSC notes that cosmetics, drugs, and pesticides are generally not within its jurisdiction under the CPSA.

According to CPSC, local jurisdictions, states, and other federal agencies, including EPA, the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture, are currently studying PFAS occurrences, human exposures, and health effects that are largely associated with environmental exposures (e.g., contaminated drinking water, food chain). As reported in our March 16, 2023, blog item, in March 2023, the White House Office of Science and Technology Policy (OSTP) released a PFAS Report informed by an RFI and developed in collaboration with many federal agencies. CPSC states that the OSTP report provides a “comprehensive and recent summary of known data and research gaps in four areas: removal, destruction, or degradation of PFAS, safer alternatives, source and pathways of exposure, and toxicity.” CPSC’s RFI is focused solely on “potential use or presence of PFAS in consumer products, potential human exposures associated with consumer product use, and potential adverse human health effects associated with consumer product use.”

CPSC contracted with RTI International to complete an overview of PFAS with a focus on PFAS that are potentially used or present in consumer products. According to CPSC, the main objectives were to characterize PFAS broadly and identify the uses and applications of PFAS in consumer products, identify significant individual PFAS with known or potential consumer product applications, and identify trends associated with production and use of PFAS in consumer products; identify international, federal, state, and local regulations or restrictions for individual or grouped PFAS; and summarize recent hazard (toxicity), exposure, or risk assessments that have been completed by authoritative bodies. CPSC states that the final RTI report, CPSC staff’s statement on the report, and the accompanying appendices and database files provide this information, describe some data gaps, limitations, and uncertainties, and identify possible next steps. The completed contractor report and associated materials are available at https://www.regulations.gov under docket number CPSC-2023-0033 and on CPSC’s website under the heading “Per- and Polyfluoroalkyl Substances (PFAS).”

Information Requested

CPSC requests information from all stakeholders such as consumers, manufacturers and importers, government agencies, non-governmental organizations (NGO), and researchers. CPSC seeks information focused on consumer products and with consideration for the information already available to CPSC in the contract report and associated supporting files. CPSC notes that the contractor report is not a risk assessment and did not identify all potential data sources that could be used for risk assessment.

CPSC states that it is “particularly requesting information on PFAS and potential use or presence of PFAS in consumer products, potential human exposures to PFAS associated with consumer product use including information about potentially highly exposed population groups, and potential adverse human health effects informed by toxicological data sources.” CPSC seeks comment on all “significant aspects of this issue,” including but not limited to the following questions.

• Please provide information about the definition of PFAS, including which chemical substances should be considered a perfluoroalkyl or polyfluoroalkyl substance, which chemical substances should be excluded from consideration as a PFAS, and which PFAS are considered in commerce.
• Please identify specific PFAS potentially used or present in consumer products that are not already included in the contract report and related supporting files. For each PFAS chemical identified, specify relevant consumer product(s) and/or use categories.
• Please provide information about which specific PFAS CPSC should prioritize in assessments of potential uses or presence of PFAS in consumer products.
• Please provide information about which specific consumer products CPSC should prioritize in assessments of potential uses or presence of PFAS.
• Please provide information about consumer products or materials used in consumer products that may be sources of PFAS.
  • For intentional uses of PFAS, please provide information on chemical identity and physical form (solid, liquid, gas, semi-solid); functional purpose of the PFAS; and measurements or estimates of levels/concentration of PFAS used in consumer products.
  • Where PFAS may be present in consumer products other than for intentional, functional uses (such as manufacturing or environmental contaminants), please provide information on sources of contaminants; chemical identity and physical form; degradation of substances or materials in consumer products to PFAS; and measurements or estimates of levels/concentration of PFAS in consumer products other than from intentional uses.

Potential Human Exposures to PFAS Associated with Consumer Products Use, Including Information about Potentially Highly Exposed Population Groups

• Please provide information related to the emission of PFAS from consumer products into the indoor environment. For example, studies or data that estimate emission rates or mass transfer parameters of PFAS chemicals from consumer products or materials.
• Please provide information related to the migration of PFAS from consumer products into saliva, gastrointestinal fluid, or skin. For example, studies or data that estimate migration rates into biological fluids or surfaces based on sustained contact time.
• Please provide information about the potential for exposure and risk from the presence of PFAS in consumer products (including contact exposures from direct use of consumer products and mediated exposures such as through emission of PFAS from products to surfaces, indoor dust, or indoor air). Please provide:
  • Data related to specific exposure pathways from consumer product sources and associated data or estimates of occurrence of PFAS in environmental media;
  • Data on measurements or estimates of PFAS intake, uptake, clearance, half-life, or occurrence in people (biomonitoring); and
  • Data on the relative source contribution of consumer product(s) or ingestion of indoor dust, or inhalation of indoor air compared with other relevant sources such as ingestion of drinking water or ingestion of food associated with estimates of aggregate exposures.
• Please provide information about population groups that may use certain consumer products for a greater than average magnitude, frequency, or duration based on habits, practices, and characteristics specific to that population group.

Potential Adverse Human Health Effects Informed by Toxicological Data

• Please provide reports and underlying data for data sources that could inform whether individual PFAS or subclasses or categories of PFAS have potential for adverse human health effects. This includes human or animal studies that report the relationship between known exposures and observed effects. This also includes new approach methodology studies such as in vitro assays or in silico predictions that report the relationship between known exposures and observed biological activities related to health effects.
• Please provide information on additional sources of data and other information that CPSC should consider that are not already included or mentioned in the contract report and associated data files.

Commentary

Given the federal government’s hyperfocus on PFAS, the RFI is entirely predictable. The granularity of the requests, however, particularly the toxicity and exposure data, raises questions about how willing entities will be in sharing these data. As noted, the comment period is open until November 30, 2023. We will see how willing entities are to submit information that will be used in any number of ways by the government and those stalking the docket.

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