The California Office of Environmental Health Hazard Assessment (OEHHA) has proposed an amendment to an existing regulation governing the assessment of the daily intake of listed chemicals known to cause reproductive toxicity in food products. The proposal would amend Title 27, Cal. Code of Regulations, Section 25821 subsections (a) and (c)(2), Level of Exposure to Chemicals Causing Reproductive Toxicity. The effect of the proposal, if approved, would be the implementation of more exacting standards for food companies subject to Proposition 65. Food manufacturers face the possibility of new testing procedures and increased difficulty in complying with safe harbor regulations if the proposal is enacted.
The proposal would amend the method for calculating the chemical level in food products. Specifically, subsection (a) would be amended so that when a business offers evidence of the “level in question” of a chemical known to cause reproductive toxicity in a food based on the average of multiple samples of that food product, the chemical level cannot be assessed by the two means currently allowed – that is, either computing an average concentration level in food products made by different manufacturers or calculating an average of the concentration of the chemical in the food product produced in different facilities. Instead, the average concentration of a chemical known to cause reproductive toxicity must be based on products manufactured in the same facility.
The second amendment (subsection (c)(2)) would alter the rule for determining when exposure to a reproductive toxicant necessitates a warning. According to the proposal, the anticipated rate of exposure from products to a listed chemical should be calculated as the arithmetic mean, rather than the geometric mean, of the rate of exposure when assessing whether the product requires a warning. OEHHA’s proposed approach, disfavored among most scientists, means that the true “average” consumption of a food may be misrepresented.
OEHHA’s proposal, if adopted, will undermine an appellate court’s decision establishing the process for determining exposures to listed chemicals in foods, Environmental Law Foundation v. Beechnut Nutrition Corp, 235 Cal.App.4th 1317 (2015). In that case, Beech-Nut and other defendants were sued for allegedly exposing their consumers to lead without a warning. The issue was whether the lead exposure exceeded the Maximum Allowable Dose Level of 0.5 micrograms per day. The plaintiffs maintained that any exposure triggered a warning and that averaging exposure levels violated the statute. The defendants advocated for averaging the exposures based on the frequency of consumption, since the alleged reproductive harm resulting from exposure took place over a period of time. The California Court of Appeal ruled that exposure to reproductive toxicants can be calculated based on an average over time under Proposition 65 depending on the chemical being studied and – using the geometric mean rather than the arithmetic mean – the frequency of consumption of the food.
Public comments in writing will be accepted from October 5 until November 19, 2018 at 5:00 p.m.
Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis on your Prop 65 compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].