The method for calculating consumer exposure to Proposition 65-listed chemicals that are reproductive toxins is undergoing a proposed change in response to a landmark 2015 court case (Environmental Law Foundation [ELF] vs. Beech-Nut Nutrition Corp).
In this case 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 below Safe Harbor Levels, exempting them from the need to provide a Proposition 65 warning.
ELF (the plaintiff) argued that a single exposure to lead above the 0.5 ug/day would cause a product to violate Proposition 65. The trial court disagreed. A question on appeal was whether the Proposition 65 regulations administered by OEHHA prohibit the averaging of exposures. The appeals court agreed with the defendants and affirmed the trial court’s conclusions with respect to averaging. Overall, this means that under certain circumstances it is appropriate to average exposures to reproductive toxicants for purposes of determining whether a warning is required.
Now, OEHHA proposes:
a) that the reasonably anticipated rate of intake or exposure to a reproductive toxin from a consumer product be calculated using the arithmetic mean only (instead of any appropriate method, such as geometric mean, the median level, some other percentile, or the arithmetic mean). Essentially, using the arithmetic mean would include all data and gives all data points equal weight (even for rare instances of very high intake values). Using the geometric mean, as was used successfully in the Beechnut case, minimizes the effect of the outlier data so that the data is not skewed by data points that are not representative of the reasonable average intake of consumers. There are more details explanations in OEHHA’s statement of reason. Overall, it is concerning that calculating exposures would be dictated, instead of using sound statistical principles.
b) when determining the “level in question” of a listed chemical (reproductive toxin) in a food product, averaging of samples cannot be done with samples made at a different manufacturing facility, location, or producer. The reasoning is that if there are issues with the processing at one location, the average concentration may be artificially diluted and warnings would not be provided where they are needed. There are some indicating that averaging between lots is not permitted (at the same location); however, reading the proposed amendment does not seem to indicate such a prohibition.
There were many comments received regarding this proposal and industry anxiously awaits the final regulatory text and whether OEHHA adjusted its stance on any of the regulatory language.
RegTox will continue to monitor this situation and will post an update as soon as it is published by OEHHA. In the meantime, if you have questions about this or any aspect of Prop 65 compliance, reach out to one of our experts here.