California May Amend Prop 65 Regulations to Require Testing from a Single Lot after Court Allows Averaging
California's Office of Environmental Health Hazard Assessment (OEHHA) announced that it is considering amending Proposition 65's regulations to specify that chemical concentrations may not be averaged across different lots of food to determine the level of exposure to a reproductive toxicant. Proposition 65, also known as The Safe Drinking Water and Toxic Enforcement Act of 1986, requires the governor of California to publish, at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity.
In a pre-regulatory draft, OEHHA proposed added the following paragraph to Title 27, Section 25821 (Level of Exposure to Chemicals Causing Reproductive Toxicity) of the Act:
The chemical concentration in a food product is based on a single lot of the final product in the form it will be purchased by the consumer. For purposes of this section, a ‘lot' is that quantity of a food product offered for consumer purchase having uniform characteristics and quality that is generated by one producer during a single production run, on a single processing line. Chemical concentrations may not be averaged across lots. Concentrations of the listed chemical in the lot should be determined using a representative sample or other scientifically valid methodology for ensuring the concentration calculated accurately reflects the average concentration of the listed chemical in the lot.
OEHHA scheduled a pre-regulatory workshop to discuss the potential amendment for October 19, 2015. In an announcement on the workshop, OEHHA said that Section 25821, subsection (a) has been interpreted to allow for averaging of samples from various lots of products and that was "contrary to the intent of the regulations." On March 17, 2015, the Court of Appeal of the State of California affirmed a lower court's ruling that food companies may average exposures over time to determine if levels of reproductive toxicants in their products are sufficiently low to exempt them from the need to provide a warning under Proposition 65. The ruling stems from a complaint the Environmental Law Foundation (ELF) filed in 2011 against Beech-Nut Nutrition Corporation and other companies seeking enforcement of the provisions of Proposition 65 with respect to lead content in certain food products. (For more information on the ELF lawsuit, see the PackagingLaw.com article, Averaging to Determine Exposure under California's Prop 65 Allowed, Says Court.)