August 17, 2020
Increasing activity & OEHHA proposed regulation on food products
The COVID-19 pandemic does not appear to be slowing down Proposition 65 activity. Notably, there was nearly a 40% increase in the number of Plaintiff Proposition 65 Notices of Violations during the June — July period in 2020 compared to the same period in 2019.
Nearly half of the recent Notices involve food products that claim Proposition 65 warnings are required due to the alleged presence of chemicals including acrylamide, inorganic arsenic, cadmium, lead, and furan. The remaining Notices include a variety of industrial and consumer products, with the vast majority of violations focusing on the presence of phthalates (e.g., diethylhexyl phthalate [DEHP] and diisononyl phthalate [DINP]), lead, cadmium, hexavalent chromium, bisphenol-A (BPA), carbon monoxide, and wood dust that allegedly resulted in exposure above Safer Harbor Levels.
Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses to provide warnings to Californians if chemicals in their products result in a reasonably anticipated exposure that exceeds Safe Harbor Levels.
Additionally, on August 4th the Office of Environmental Health Hazard Assessment (OEHHA) — the lead agency for the implementation of Proposition 65 — released a proposed regulation that describes what constitutes an "exposure" and requires warnings for those chemicals formed by cooking or heat processing. The proposed regulation provides maximum average and/or unit acrylamide concentration levels that OEHHA considers the lowest levels currently feasible in 13 specific food products, including cookies, crackers, almonds, bread products, potato products, waffles, and prune juice. Acrylamide concentrations at or below these proposed levels in the food product would not require a warning.
With the exception of bread products, the maximum acrylamide concentration levels proposed in the regulation are based on previous settlements and consent judgments under the assumption that if one food manufacturer can meet the level for a given food product involved in the settlement, the remainder of food manufacturers can as well. Public comments on this proposed action are due by October 6, 2020.
How Exponent Can Help
Exponent is unique in that it approaches Proposition 65 from both a scientific and strategic basis. Exponent's team of toxicologists, food scientists, materials engineers, and exposure assessors can evaluate product lines, identify high-risk products, and provide the scientific information companies need to make informed decisions and minimize the risk of litigation. Proposition 65 compliance is often complicated in that the limits for identified chemicals can vary for compound and product. Product limits are often established based on settlements resulting from prior litigation from individual or groups challenging the warning requirements. At Exponent, we work with clients and their legal counsel to address a variety of Proposition 65 issues, including:
- Reviewing product lines to help companies understand and focus efforts on their highest-risk chemicals and products to determine whether warning labels are needed
- Sampling of consumer and food products, including food market basket studies
- Developing Safe Harbor Levels for chemicals that don't already have them
- Applying toxicological expertise to evaluate the relevant exposure windows and data supporting current Safe Harbor Levels
- Gathering exposure data, conducting exposure simulations, and developing strategies for product assessment and comparison to Safe Harbor Levels and in support of Safe Use Determinations (SUDs)
- Providing toxicology and scientific expertise during the Proposition 65 listing mechanism process
- Evaluating chemical substitutions
- Providing litigation support and expert testimony on technical issues including product sampling, statistics, exposure assessment, and toxicology