CPSC Publishes Request for Information Regarding PFAS in Consumer Products

On September 20, 2023, the Consumer Product Safety Commission (CPSC) published a request for information (RFI) in the Federal Register for information on PFAS in consumer products. The RFI requests information from all stakeholders, including “consumers, manufacturers and importers, government agencies, non-governmental organizations, and researchers.”

The requested information falls into three categories:

  1. Use or potential use of PFAS in consumer products, including information about the definition of PFAS, identification of specific PFAS potentially used or present in consumer products, and information about which PFAS or consumer products CPSC should prioritize in future assessments, among other information;
  2. Potential human exposures to PFAS associated with consumer products use, including information about the potential for exposure and risk from the presence of PFAS in consumer products, among other information; and
  3. Potential adverse human health effects informed by toxicological data, including reports that could inform whether individual PFAS or categories of PFAS have the potential for adverse human health effects, and information on additional data sources that CPSC should consider.

The Federal Register notice also announced the availability of a contract report that CPSC commissioned to characterize the use of PFAS in consumer products, identify PFAS regulations and restrictions, and summarize recent hazard, exposure, and risk assessments on PFAS. The contract report ultimately identified 863 PFAS with reported use or detection in consumer products. The RFI instructs reporting entities to consider information already available to CPSC in the contract report when reporting information.

CPSC does not explicitly state what it plans to do with the collected data in the RFI but states that the contract report “identif[ies] possible next steps.” The next steps identified by the contract report include research (such as developing a consensus on the definition of PFAS), new regulations, and consumer awareness.

The RFI comes after Minnesota, Maine, and other states passed regulations limiting the use of PFAS in consumer products. CPSC will accept the requested information through November 20, 2023.

CPSC Settles with NRDC Regarding the Restriction of Phthalates in Children’s Toys

The U.S. Consumer Product Safety Commission (CPSC) and the Natural Resources Defense Council (NRDC) have reached an agreement in principle for the federal agency to issue a rule banning five chemicals, known as phthalates, that may cause reproductive harm from their exposure in children’s products. Those five phthalates are: diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DnPP), di-n-hexyl phthalate (DnHP), dicyclohexyl phthalate (DCHP); and diisononyl phthalate (DINP). While the CPSC reached a tentative agreement with the NRDC on the timetable for issuing a rule, the contents of the final rule will be made by a vote of the CPSC Commission.

Phthalates are a class of chemicals used to soften plastics and are commonly found in children’s toys. Three phthalates, di-(2-ethylhexly) phthalate (DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP), were banned from use in toys and other children’s products in concentrations above 0.1 percent in 2009 under the Consumer Product Safety Improvement Act, and three more were banned on an interim basis based on the same concentration limit the same day. The 2009 interim banned substances include diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di-n-octyl phthalate (DnOP).

The CPSC published a proposed rule in December 2014 and was supposed to issue a final order within 180 days to continue an interim ban on the five phthalates, DIBP, DnPP, DnHP, DCHP, and DINP, within children’s toys, however, the 180-day period stretched to 950 days as of last week.

The NRDC, along with the Environmental Justice Health Alliance for Chemical Policy Reform and the Breast Cancer Fund, filed a complaint in December of 2016 seeking injunctive and declaratory relief to force the CPSC to regulate the five phthalates in children’s products.

A consent decree is expected to be finalized within the month.

The case is Natural Resources Defense Council et al. v. U.S. Consumer Product Safety Commission, case number 1:16-cv-09401, filed in the U.S. District Court for the Southern District of New York.

CPSC petitioned over labeling requirements for paint strippers containing DCM.

The Consumer Product Safety Commission (CPSC) is accepting public comments on a petition requesting that the Commission revise its Statement of Interpretation and Enforcement Policy regarding labeling household products containing methylene chloride (Policy Statement). As discussed in a Federal Register notice published today, the petition from the Halogenated Solvents Industry Alliance (HSIA) asks that the CPSC expand the Policy Statement’s labeling requirements to address acute hazards from inhaling vapors from methylene chloride. Methylene chloride is a widely used chemical solvent also known as dichloromethane (DCM).

The HSIA petition [PDF] notes that the Occupational Safety and Health Administration (OSHA) and National Institute for Occupational Health (NIOSH) have issued a Hazard Alert about methylene chloride in stripping agents used in bathtub refinishing, identifying at least 14 related worker deaths. The Hazard Alert also recommends ways to reduce or eliminate risk in refinishing bathtubs.

In its Policy Statement, which was issued in 1987 under the Federal Hazardous Substances Act (FHSA), the CPSC advised on labeling household products containing methylene chloride, with a focus on paint strippers. This guidance includes statements of principles and examples of how to warn consumers about the chemical’s potential cancer hazards, but does not address acute hazards.

In its petition, HSIA states that, to prevent future fatalities like those addressed in the OSHA/NIOSH Hazard Alert, “all that is needed is to extend the cautionary labeling so that it also warns of the threat of asphyxiation if DCM-based products are used in an enclosed space.” Consulting with CPSC, the industry group developed warning language and sample labels that have been circulated in the industry. However, HSIA seeks a revision to the Policy Statement because it would receive greater attention and avoid confusion among product manufacturers.

The petition further notes that revising the Policy Statement “is also important to ensure against inconsistent labeling requirements at the state or local level directed at the same risk.” Paint strippers containing DCM are on the draft list of initial Priority Products under California’s Safer Consumer Products program.

CPSC will accept comments on the petition through October 31, 2016.

CPSC: No mandatory recall for Lumber Liquidators.

Last week, the U.S. Consumer Product Safety Committee (CPSC) declined to issue a mandatory recall but announced that Lumber Liquidators has agreed to not sell its inventory of laminate wood flooring imported from China. The announcement marked the end of the CPSC’s investigation of Lumber Liquidators, which was prompted by a March 2015 segment on 60 Minutes alleging that the company sold Chinese-made flooring with unsafe formaldehyde levels.

Lumber Liquidators has agreed to continue operating its “recall to test” program, offering free test kits to the over 600,000 consumers who purchased the flooring before the company stopped selling it in May 2015. If the test kit reveals elevated formaldehyde levels, Lumber Liquidator has agreed to cover the costs of helping homeowners conduct additional tests and any necessary remediation. So far, the testing program has analyzed indoor air quality in 17,000 homes and found elevated formaldehyde levels in about 1,300 of them; however, CPSC reports that “none of the floors tested above the remediation guideline.”

Based on its examination of the product and test data, CPSC concluded that the flooring does not contain unsafe levels of formaldehyde. According to a report from the Centers for Disease Control and Prevention’s National Center for Environmental Health/Agency for Toxic Substances and Disease Registry,

eye, nose, and throat irritation could occur with the higher formaldehyde emitting flooring samples in certain home environments. Irritation can happen in anyone, but is more likely among children, older adults, and people with respiratory issues, such as asthma or other breathing problems. Very high levels of formaldehyde in homes may also be associated with a small increase in cancer risk.

CPSC will continue to monitor test results and consider new information as it becomes available. Lumber Liquidators has also agreed that future flooring products will be subject to “enhanced supplier controls designed to achieve compliance with California formaldehyde requirements and any future federal requirements for laminate flooring.” In March, the company paid $2.5 million to settle the California Air Resources Board’s claims that the flooring exceeded state formaldehyde limits and reported in May that it will pay $26 million to settle related shareholder suits.

CPSC proposes new ban on phthalates in children's products.

Regular readers know that in terms of domestic, national regulation, we usually focus on developments coming out of the Environmental Protection Agency (EPA). In the U.S., the EPA is the principal federal agency that regulates chemicals in products, but it’s not the only one. Last month, the U.S. Consumer Product Safety Commission (CPSC) approved for publication a proposed rule prohibiting the use in children’s toys and child care articles of certain phthalates, a type of plasticizer used in teethers, plastic toys, home furnishings, and cosmetics.

The rule expands the existing “permanent ban” on phthalates at levels greater than 0.1% in accessible plasticized components of toys and child care products. Diisononyl phthalate (DINP) is shifted from the “interim ban” list and di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and butyl benzyl phthalate (BBP) remain on the “permanent ban” list. The rule also adds to the “permanent ban list” the following: diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP) in concentrations greater than 0.1%. Two other phthalates, diisodecyl phthalate (DIDP) and di-n-octyl phthalate (DnOP), were removed from the “interim ban” list.

The Commission proposed the rule under § 108 the Consumer Product Safety Improvement Act (CPSIA), which requires promulgation of regulations in response to the Chronic Hazard Advisory Panel’s report and recommendations on the health effects of phthalates in children’s toys and child care articles. Under the CPSIA, a “child care article” is “a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.”

The Commission is accepting public comment on the proposed rule through March 16, 2015.

CA, MD, and NY enact laws against flame retardant chemicals; federal legislation proposed.

California, Maryland, and New York are the latest states with new laws regulating flame retardant chemicals in products.

On September 30, California Governor Jerry Brown signed into law a bill requiring manufacturers to disclose on labels whether furniture contains flame retardant chemicals. The requirement goes into effect on January 1, 2015.

Maryland’s HB 229, which bans child care products containing flame retardant chemicals, went into effect on October 1. Products intended for children under the age of three, like crib mattresses, car seats, and toys containing more than 0.01% by mass of tris(1,3-dichloro-2-propyl)phosphate (TDCPP) or tris(2-chloroethyl)phosphate (TCEP), may no longer be imported, sold, or offered for sale in Maryland.

In September, New York Governor Andrew Cuomo signed a law that would also ban TDCPP-containing child care products.

Meanwhile on the federal level, Senator Charles Schumer (D-NY) introduced a bill in the Senate that would ban the sale, manufacture, distribution, and import of children’s products and upholstered furniture containing the ten “most noxious” flame retardant chemicals, including TDCPP and TCEP. The legislation also directs the Consumer Product Safety Commission (CPSC) to study the health effects of other flame retardants and then extend the ban to any chemicals identified via this review that may cause substantial personal injury or illness.

CPSC finalizes new definition for "strong sensitizer."

Last week, the U.S. Consumer Product Safety Commission (CPSC or the Commission) released a Final Rule changing the supplemental definition for “strong sensitizer” under the Federal Hazardous Substances Act (FHSA), which requires appropriate cautionary labeling on certain hazardous household products. The revised definition becomes effective March 17, 2014.

The FHSA defines “strong sensitizer” as “a substance which will cause [a hypersensitivity] on normal living tissue through an allergic or photodynamic process.” The CPSC promulgated a supplemental definition in a 1986 rule. In 2005, the Commission initiated an extensive process to update the definition, first convening a panel of scientific experts to make recommendations to CPSC staff, and then developing a draft technical report that underwent federal agency and external scientific peer review. A Notice of Proposed Rulemaking and accompanying guidance document (Strong Sensitizer Guidance) were published together on March 12, 2013.

The new supplemental definition of “strong sensitizer” aims to bring the definition in better alignment with current science on sensitization. According to the CPSC, the revised definition:

  • eliminates redundancy;
  • removes certain subjective factors;
  • incorporates new and anticipated technology;
  • ranks the criteria for classification in order of importance;
  • defines criteria for “severity of reaction”; and
  • provides for a “weight-of-evidence” approach to determining whether a substance qualifies as a strong sensitizer.

In promulgating the new definition, the CPSC addressed several comments, summarized as follows:

Implementing GHS would be too far-reaching. Two commenters urged the Commission to implement the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The Commission clarified that GHS is not a standard-setting regulatory scheme but a set of criteria for classifying and communicating hazards. Moreover, CPSC stated that implementing GHS “would be broad-reaching, with potential impact beyond the FHSA,” and is far beyond the scope of the rulemaking.

No far-reaching effects. The CPSC rejected one commenter’s assertion that the revised definition would have “far-reaching effects,” since substances would still be subject to case-by-case hazard assessments which incorporate an approach based on science and risk.

No differentiation needed for different allergy types. The CPSC acknowledged a commenter’s recommendation to address Type I and Type IV allergies separately, but argued that this would make the definition “significantly and unnecessarily more complex.” Instead, the Commission posited that the criteria in the definition is sufficiently flexible to assess all types of allergic reactions without specifically differentiating them, and that the Strong Sensitizer Guidance released last year would provide further assistance in evaluating substances.

QSAR data accepted but not prioritized. The Commission emphasized that data from Quantitative Structure-Activity Relationship (QSAR) models was specified in the rule as a factor to be considered in a weight-of-evidence analysis of whether a substance has significant potential for causing hypersensitivity. However, QSAR data would not be given precedence over “high-quality human and animal data.”

Consumer incident reports may be considered. One comment urged including the CPSC’s and manufacturers’ records of incidents of hypersensitivity as factors to be considered in determining a substance’s ability to cause hypersensitivity. In response, the Commission emphasized that the revised definition includes “case histories” as a factor, which encompasses consumer-submitted incident reports received by the manufacturer or CPSC. The CPSC will also consider revising the Strong Sensitizer Guidance to elaborate on “the types and sources of incident reports” to use in determining whether a substance is a “strong sensitizer.”

The CPSC also defended and maintained the proposed order of ranked data criteria; changed the potential “clinically important reaction” of “substantial physical discomfort or distress” to “substantial physiological effects, such as discomfort and distress,” for purposes of clarity; and made other minor drafting changes.

Analysis: The “strong sensitizer” definition in the Final Rule does not significantly deviate from the revision proposed last year, so there is not much unexpected here. Moreover, a substance will, as before, have to undergo an individualized evaluation by the CPSC as to whether it can cause hypersensitivity and be determined to be a “strong sensitizer.” The CPSC’s possible revision of the Strong Sensitizer Guidance to address consumer incident reports will be an issue to keep an eye on.