California’s Proposition 65: Key Topics from the “Prop 65” Conference 2024

This blog was originally posted on 7th October, 2024. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY VICTORIA SMART, SENIOR REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

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Proposition 65 Annual Conference, September 2024

The Proposition 65 Annual conference, was held in San Francisco on September 23, 2024, with more than 100 attorneys, scientists, manufacturers, and journalists attending, including representatives of the implementing agency OEHHA (Office of Environmental Health Hazard Assessment). The program included six panels on significant issues stemming from the California law.

This year’s Conference focused primarily on chemical testing and defense of products, specifically on PFAS and exposures, and amendments proposed to modify Proposition 65 Warnings. This blog summarizes key takeaways from the conference. 

Key Takeaways

Proposition 65, officially the “Safe Drinking Water and Toxic Enforcement Act”, was a ballot initiative that became a California state law in November 1986 with the intent to address Cailfornians’ growing concerns about exposure to toxic chemicals. The law and its regulations require warnings of potential harm to be placed on products containing chemicals that Prop 65 administrators have identified and “listed” as hazardous to human health. 

Panel sessions addressed the following topics:

Key recommendations for manufacturers, from the plenary sessions included:

• Know your laboratory, your toxicologist, and your consultant well
• Have a testing plan and priorities; and communicate with your lab
• Robust dialogue with your suppliers
• Have indemnification provisions

PFAS: Approaches to Testing and Defending Products

The initial panel discussed the testing of PFAS, known as fluorine-based chemicals with widely varied definitions from the US and the EU. The EU has listed PFAS, with over 15,000 variants; the US over 12,000.

On testing of PFAS, the panel held that the best of accredited laboratories, a “gold standard” like ISO 17025, are essential for accurate and effective process, results and reports.

According to the panel, there is not yet a validated test measure for PFAS. Screening tests are run for total fluorine, in a low cost single run test for the presence of a PFAS chemical or compound. Testing parameters could include the standard of 100 ppm, and there is also a Limit of Detection (“LOD”), among other elements of a complex test.

PFAS chemicals were said to be “super strong” and they bond, forming so strong a bond that the chemical will persist and then metabolize. This is one of the most significant and most difficult aspects of PFAS and the basis for its tag of “the forever chemical”.

For PFAS, and chemicals in general, aspects of effective testing for Prop 65 include the determination of exposure: involving the examination of products for surface contact, for exposure to skin (dermal exposure), for ingestion, for inhalation, and for frequency and duration of contact; and for use and users.

Defense of the product would involve one or more of these: the use of reformulation, which involves a reduction below the enforcement threshold or is a replacement using another chemical, or removal of the chemical.

New Product Testing: Proactive or Reactive Analytical Testing

The Round Table discussed “when and how to test a product”, based on product content and exposure: what is natural in the product, what information is available, what is reasonably anticipated by use or user, and testing appropriately for the product. PFAS testing is underway at this time, using analytical methods.

Reasons for testing early were to support product stewardship and regulatory compliance; support non-detection defense; respond to retailer requests; or refute supplier requests. The panel discussed a testing approach of selected samples: setting an applicable safe harbor level, is there a detection limit, and is the analytical method successfully applied.

Analytic forms of testing were described as Suppressive (Actual/Low value); Additive (High Measure/actual value) and Neutralizing (Actual / False negative).

Testing processes may result in the Matrix Effect – “Something that is affecting what you are looking for”. The matrix in chemical analysis refers to the components of a sample other than the subject chemical, which would be PFAS in this instance.

The OEHHA-Proposed Amendments to Short and Long-Form Warnings: Minimal Benefit for Significant Cost to Manufacturers

This year’s panel delved into the current proposal to amend warning labels, revising  the labeling and altering the internet warnings and package labeling.

The proposed amendment of the labeling for short term warnings would include chemical names and modify terms to: “Warning”, or “CA Warning”, or “California Warning”, and would use statements of “Risk of Cancer harm”, or “…Carcinogen and reproductive harm” or “Cancer from exposure of [chemical name]”. The proposed regulation similarly revises long term warnings, including the chemical names.

The regulation would extend the application of the amended warnings to three years from the date of adoption of the regulation, a delay that is intended to maintain safe harbor protection. 

A panelist noted that the OEHHA’s stated reasons for the amendments are to seek information by listing chemical names; to stem overuse of warnings no matter the size of product and packing, and to reduce the unnecessary warnings that mislead consumers. The panel considered whether the proposed changes would assert any reduction of the practice of over warning, and suggested the outcome may be yet more warnings, including those of the internet and in packaging, or could result in the removal of the chemical from the product.

Panelists commented on whether chemical names will have the intended effect; and if a product contains multiple listed chemicals, only one will be marked. The use of warnings on the internet (also applicable to packaging) was seen as inevitable, and necessary where the product is sold online, with the panel concurring that such warnings create regulatory ambiguity.  

Among the panel, some sought a known outcome from the proposed amendment, or generally expected the amendment to result in more litigation; and many questioned if the rule creates a benefit to the public.

The Proposition 65 Clearinghouse conferences bring together some of the best minds in law, in science, and in industry, all to discuss a single law and its supporting regulation that affect products across the US. This year, the conference’s focus on testing for food products and PFAS in products generally may have initiated processes that could apply across borders.

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