Controversy Abounds in Proposed Reproductive Toxicity Amendments

California’s Office of Environmental Health Hazard Assessment (OEHHA) recently proposed amendments to clarify Proposition 65 reproductive toxicity sampling requirements for food products has already stirred up considerable controversy about how the amendments would impact various food products if adopted by the agency.

Proposition 65 prohibits businesses from releasing chemicals “known to the State of California to cause cancer or reproductive toxicity,” and from exposing people to chemicals on the Prop 65 List without providing “clear and reasonable” compliant warnings.

OEHHA’s proposed amendments to Title 27, Cal. Code of Regulations, Section 25821, subsections (a) and (c)(2), would change how Prop 65 reproductive toxicity sampling for food products must be tested and calculated.

The controversy concerns the proposed method of calculating exposures to listed reproductive toxicants found in food products.

The proposed amendment to Section 25821, subsection (a) would clarify that where a business presents evidence for the “level in question” of a chemical on the Prop 65 List as causing reproductive toxicity in a food product based on the average of multiple samples of the food product, the level in question may not be calculated by averaging the concentration of the chemical in the food product from different manufacturers or producers of the food product, or that were manufactured in different facilities from the product at issue.

OEHHA’s proposed amendment to Section 25821, subsection (c)(2) is intended to clarify how a business should calculate exposures to listed reproductive toxicants and specifies the use of the arithmetic mean as the methodology to be used when calculating the rate of intake or exposure for users of the consumer product.

Previously, until the proposal was introduced by the agency, there had been flexibility for businesses to use the arithmetic or geometric mean; however, this proposal removes that flexibility in favor of a more stringent and rigid approach limiting food companies to calculate risk by the arithmetic mean.

Food companies benefitted greatly from the use of the Geometric mean in the past.  Most recently they used this method to prevail in the

Environmental Law Foundation v. Beech-Nut Nutrition Corp., et al. case, in 2013.

The defendants’ experts argued successfully that their food products would not cause an exposure to lead above the Safe Harbor level set for lead.

If the recently proposed amendments had been in force at the time it is likely that the outcome in the Beech-Nut trial would have been very different.

Expect the proposed regulation to be hotly disputed.

 

 

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