On July 5, 2019, the California Office of Environmental Health Hazard Assessment (OEHHA) published a notice modifying a proposed Proposition 65 regulation on how to calculate the intake of a reproductive toxicant in foods, and separately, by the average user of a consumer product. The deadline for comments on the modified proposal, originally set for July 22, 2019, has been extended to August 5, 2019.
OEHHA’s original proposed regulation was published for public comment on October 5, 2018. At that time, OEHHA explained that the proposal would specify procedures for determining the “level in question” for a reproductive toxicant in a food product and thereby guide businesses on an aspect of Proposition 65 which the regulations did not address. Specifically, under the proposal, businesses would be prohibited from “averaging the concentration of the chemical in food products from different manufacturers or producers, or that were manufactured in different manufacturing facilities from the product at issue.”
In another part of the October 2018 proposal, businesses would be prohibited from using geometric averaging of exposures to a listed reproductive toxicant in a consumer product. This would mean that, even if a disciplined statistical approach would demand the use of geometric averaging, businesses would be limited to using arithmetic averaging in determining whether exposures exceed the Maximum Acceptable Dosage Level (MADL) for the reproductive toxicant.
Such requirements could make a significant difference in the determination of whether Proposition 65 warnings are required or not. Members of the regulated business community and Proposition 65 defense attorneys viewed OEHHA’s October 2018 proposal as a clear attempt to prevent the averaging of exposures to reproductive toxicants, and to upend the California Court of Appeal’s opinion in Environmental Law Foundation v. Beech-Nut Nutrition Corporation, 235 Cal.App.4th 307 (2015). In that case, involving alleged exposures to lead in baby foods, the Court upheld the trial court’s ruling that defendants had appropriately averaged the test results of multiple food samples, and also appropriately averaged the level of exposure to lead using the geometric mean (rather than the arithmetic mean) of the calculated exposures to lead. Based on those findings, the trial court concluded that defendants met their burden of showing that no warnings were required for those foods.
A large coalition of business organizations opposed OEHHA’s October 2018 proposal, arguing (among other things) that:
- The prohibition on averaging “solves no actual problem that OEHHA can identify” but “will distort the determination of the reasonably anticipated rate of exposure” to a listed reproductive toxicant; and
- The arithmetic mean proposal is not based on statistics and, instead, “the best measure of the average must be determined on a case-by-case basis.”
In its July 2019 modification, OEHHA deleted the prohibition on geometric averaging of exposures from consumer products, thereby allowing businesses to use the best statistical approach in determining the level of exposure to a listed reproductive toxicant. However, the modified proposal does not appear to fully address other concerns. The modified proposal still would prohibit averaging the concentration of a reproductive toxicant in foods from different manufacturers, or averaging such concentration in foods produced or packaged in different facilities. This means, for example, that a business would not be able to average the concentration of a reproductive toxicant in a food produced by contract manufacturers – even though that food product is presented to consumers using the same brand and product name. And the prohibition on averaging concentrations of listed chemicals in foods across facilities would significantly increase costs without clearly advancing the public interest. No doubt the same coalition that opposed OEHHA’s original proposal will have something to say about this modified one.
Grimaldi Law Offices has been advising clients for over 20 years on chemical and product regulation. For knowledgeable advice and in-depth analysis on your chemical regulatory compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at firstname.lastname@example.org.
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