§ 25821. Level of Exposure to Chemicals Causing Reproductive Toxicity
(a) For purposes of the Act, “level in question” means the chemical concentration of a listed chemical for the exposure in question. The exposure in question includes the exposure for which the person in the course of doing business is responsible, and does not include exposure to a listed chemical from any other source or product. For purposes of this section, where a business presents evidence fo r the “level in qu e stio n ” of a listed chemical in a food product based on the average of multiple samples of that food, the level in question may not be calculated by 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.
This proposed rule bars a producer from calculating an average exposure level from multiple samples based on food from different manufacturers or producers or from different manufacturing facilities. OEHHA stated that they believe that it is inconsistent with the purposes of [Prop. 65] to average concentrations of chemicals in products manufactured over extended periods, and “based on concentrations measured in samples of foods from different manufacturers or producers, or from different manufacturing facilities, because these are not necessarily representative of the levels of the chemical in products an individual would typically be exposed to when consuming a particular product in California.” Initial Statement of Reasons https://oehha.ca.gov/media/downloads/crnr/isor25821100518.pdf at p.9.
OEHHA also made proposed changes to the way the rate of intake or exposure is calculated:
§ 25821.(c)(2) For exposures to consumer products, the level of exposure shall be calculated using the reasonably anticipated rate of intake or exposure for average users of the consumer product, and not on a per capita basis for the general population. This rate of intake or exposure is calculated as the arithmetic mean of the rate of intake or exposure for users of the product. The rate of intake or exposure shall be based on data for use of a general category or categories of consumer products, such as the United States Department of Agriculture Home Economic Research Report, Foods Commonly Eaten by Individuals: Amount Per Day and Per Eating Occasion, where such data are available.
In this section 27 CCR § 25821(c)(2), OEHHA attempts to define the method of calculating the reasonably anticipated rate of intake by using the arithmetic mean of differing exposure rates. According to OEHHA the arithmetic mean best captures that variability because it, unlike a geometric mean or median methodology it “accounts for consumption levels at both the low and the high end of the range, weighing the intake of each consumer equally.” Initial Statement of Reasons at p.8.
These amendments would arguably abrogate the state appellate court decision in Environmental Law Foundation v. Beech-Nut Nutrition. et al., (2015) 235 Cal.App.4th 307, (“Beech-Nut”) in which the Court allowed exposure calculations based on the average lead levels across different manufacturers and facilities. It also permitted the use of the geometric mean to calculate rates of rather than the arithmetic as these proposed rules require.
OEHHA in the Initial Statement or Reasons makes it clear that they believe that the Court in Beech-Nut was wrong:
Neither [of the Court] finding[s] is consistent with the intent of OEHHA’s regulations or Proposition 65, which is focused on an individual exposure from a specific product. Therefore, OEHHA believes that the regulations should be clarified so that businesses and courts can apply the correct analysis in the future. It should be noted that it is also inconsistent with the purposes of the Act to average concentrations of chemicals in products manufactured over extended periods. OEHHA considered including a time element in this regulation. Initial Statement of Reasons at p.11
The consequence of these new rules would be to make it more difficult for food producers to support a decision to forego labeling certain food products, as the proposed rule makes the Prop 65 threshold more difficult to calculate because of the inherent variability of constituents in foods with respect to the levels in the foods and the variability of the rate of exposure to consumers.
The Public comment cutoff was extended until November 26, 2018 and with a public hearing that will be held on November 19, 2018.Public comments cutoff was extended until November 26, 2018 and with a public hearing that will be held on November 19, 2018.