After California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed amendments to Proposition 65’s regulations governing the calculation of safe harbor levels for reproductive toxicants in consumer products, food manufacturers and other stakeholders weighed in on the proposed changes. OEHHA’s proposed changes concerned the averaging of concentrations of reproductive toxicants in food products and determining the average use of a consumer product for purposes of calculating exposures to listed reproductive toxicants. The stated purpose of the proposed amendments is to clarify how a business should calculate exposures to listed reproductive toxicants, but if passed, the proposed changes could significantly impact food manufacturers who rely on the statute’s safe harbor levels as a basis for not providing Proposition 65 warnings with their products. Many stakeholders view the proposed changes as OEHHA’s reaction to Environmental Law Found. v. Beech-Nut Nutrition Corp., 235 Cal. App. 4th 307 (2015), in which the court allowed averaging to be used in calculating the baseline for determining whether a warning is required.
BACKGROUND
California’s Proposition 651 requires OEHHA to publish a list of chemicals known to the state to cause cancer or developmental or reproductive toxicity. The list is updated annually and has grown to include over 800 chemicals. The law requires businesses offering products or services in California that expose any person to a listed chemical above a threshold level to provide a “clear and reasonable” warning prior to such exposure. Given the breadth of the statute, Proposition 65 impacts any business that manufactures or sells a product that could reach California and any business that owns or operates a facility in California.
Businesses are exempt from Proposition 65’s warning requirement if the exposures they cause are so low as to create no significant risk of cancer or birth defects or other reproductive harm. OEHHA develops numerical guidance levels known as “safe harbor numbers” for determining whether a warning is necessary. A business has a safe harbor from Proposition 65’s warning requirements if exposure to a chemical occurs at or below these levels. These safe harbor levels consist of No Significant Risk Levels (NSRLs) for chemicals listed as causing cancer and Maximum Allowable Dose Levels (MADLs) for chemicals listed as causing birth defects or other reproductive harm. OEHHA has established over 300 safe harbor levels to date, but a majority of the chemicals on the Proposition 65 list do not have published safe harbor numbers.
For those chemicals for which OEHHA has not established a regulatory safe harbor level, the regulations set forth guidelines for the calculation of an NSRL or MADL. For a MADL, a warning is not required for chemicals listed as reproductive toxicants if the business can demonstrate that the exposure will produce no observable effect, even at exposures 1,000 times the “level in question” – defined under the current regulations as the concentration of a listed chemical for the exposure at issue.
CONCERNS EXPRESSED ABOUT PROPOSED CHANGES TO DETERMINATION OF SAFE HARBOR LEVELS FOR FOOD PRODUCTS
The newly proposed regulation would amend the current definition of “level in question” to clarify that where a business presents evidence regarding a reproductive toxicant in a food product, the level in question may not be calculated by averaging the concentration of the chemical in food products from different manufacturers or products. Further, the level in question in a food product may not be calculated by averaging the concentrations of the chemical in food products that were manufactured in different facilities than the product at issue. If these new regulations are passed, food companies attempting to establish that their products do not require a Proposition 65 warning, despite the presence of a listed reproductive toxicant, will need to meet a higher standard as they will be limited to evidence of the concentrations of the chemical in their products and only from the relevant identified facility. The practical effect would be that some units sold by a manufacturer could require warnings, while others might not.
OEHHA has stated that the proposed limitation will further the purposes of Proposition 65 by helping ensure that food warnings are more specifically based on actual exposures to Californians. Unlike other consumer products, the concentration of a given chemical in a food product can vary significantly based on when and where the food was grown, manufactured or packaged. As a result, the agency believes it is inconsistent with the purpose of the act to rely on a broad average to determine the level in question, because that average may not be representative of the products an actual California consumer would consume. As a result, the agency seeks to limit the use of averages by food manufacturers so that such averages more closely reflect the actual concentrations that will be found in products that are sold in California.
Manufacturers expressed concern that these proposed limitations could make it more difficult for food manufacturers to establish that their product does not require a Proposition 65 warning.2 Because the level in question will be more narrowly defined, food manufacturers will be precluded from relying on industry averages. It could also mean that if a food manufacturer produces a product that contains a listed reproductive toxicant at multiple facilities, it will need to separately determine a level in question for each of its production facilities if products from each facility are sold in California.3 Manufacturers also noted that if they are required to restrict their averaging to a single facility, then private enforcers should be required to do the same.4 In contrast, consumer advocate stakeholders argued for even more narrowly drawn restrictions on averaging.5
PROPOSED CHANGES TO CALCULATION OF AVERAGE EXPOSURES TO A REPRODUCTIVE TOXICANT
The proposed regulatory changes would also modify the subsection that governs the calculation of the reasonably anticipated rate of exposure to a chemical listed as causing reproductive toxicity to clarify that when determining whether exposure to a reproductive toxicant in a consumer product requires a warning, the reasonably anticipated rate of intake or exposure be calculated as the arithmetic mean of the rate of intake or exposure for product users. The stated purpose of this change is to clarify which mathematical method of determining an average should be used. If companies have previously used other methods (i.e., mode or median) to determine that potential exposures to reproductive toxicants are beneath the MADL, they will need to reevaluate those results.
Manufacturers explained in their comments that well-established scientific methodology directs that analysis tools should reflect the nature of the data. Such methodologies stipulate different averaging methods for uniform versus skewed data sets.6 Accordingly, commenters urged OEHHA to continue to allow manufacturers to follow such established scientific principles.
1 Formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986.
2 See, e.g., CalChamber Comments (Dec. 3, 2018); Food Coalition Comments (Dec. 3, 2018); Exponent Comments (Dec. 3, 2018).
3 Commenters also requested clarification concerning the definition of a “facility” to prevent inconsistent assertions and uncertainty in litigation. CalChamber Comments, at 6.
4 See Food Coalition Comments, at 9.
5 See As You Sow Comments (Dec. 3, 2018) (requesting prohibition of averaging across time periods, multiple production runs, and locations).
6 See Food Coalition Comments, at 3; CalChamber Comments, at 2.
