The state Office of Environmental Health Hazard Assessment (OEHHA) should reject two Proposition 65 proposals that place additional and unjustified burdens solely on businesses, a California Chamber of Commerce-led coalition of more than 200 entities wrote in a recent comment letter.
The coalition explains that businesses already face a significant disparity in the burden of proof in Proposition 65 cases. A plaintiff does not need to prove the level of exposure to a Proposition 65-listed chemical or show that anyone has been harmed. The regulations proposed by OEHHA exacerbate that problem.
OEHHA’s proposals threaten the law’s longstanding average exposure-based approach to warnings—without justification and with significant cost and risk to California businesses.
For more than 25 years, the regulations have required compliance with Proposition 65 to be measured based on “the reasonably anticipated rate of intake or exposure for average users of the consumer product” at issue.
Proposition 65’s unique approach to regulation, based on exposure thresholds for warnings and not concentration thresholds, recognizes that different consumers may use the same product in a way that results in different exposure levels.
Far from being a mere “clarification” to existing regulations, OEHHA’s proposals present entirely new regulatory requirements that will directly affect businesses’ Proposition 65 compliance efforts, as well as place additional obstacles to a defendant meeting its burden of proof in litigation.
OEHHA is proposing two changes to requirements for when businesses must warn people of potential exposure to Proposition 65-listed chemicals:
• Businesses are prohibited from averaging concentration levels for a company’s food product across different facilities or different manufacturers or producers.
• When calculating an average user’s exposure to a Proposition 65 chemical, the regulation mandates the arithmetic mean be used.
The prohibition on using average concentration levels solves no actual problem that OEHHA can identify, yet it will have an impact on manufacturers and have ripple effects upstream, forcing agricultural growers to incur increased production costs, testing costs, and litigation risk.
The coalition points out that to evaluate exposure levels under Proposition 65, concentration data—just like consumption data—must reflect what is typical. It is not scientifically appropriate for OEHHA to exclude this important variable (across manufacturing facilities) from a case-specific consideration of the data. The proposal will distort the determination of the reasonably anticipated rate of exposure and render it unreliable.
Increased Risk of Lawsuits
The arithmetic mean proposal also is a “solution” in search of a problem, the coalition asserts. There is no need for OEHHA to put its thumb on the scale and favor one measure of average over all others in all instances.
This proposal is inconsistent with sound principles of statistics and data evaluation. The appropriate measure of average depends on the facts and data in specific cases and is not amenable to a one-size-fits-all proposal that will lead to increased litigation risk to companies and to overwarning.
Use Case-by-Case Approach
The questions of how to determine the most appropriate measure of the average exposure and how to average concentration data should continue to be left to a case-by-case determination, the coalition told OEHHA. In any dispute about the data, courts are fully capable of evaluating the relevant evidence.
The coalition also expressed concern about a confusing statement in OEHHA’s justification for its proposed regulations. According to that Initial Statement of Reasons, in the context of food, the average consumption amount “would be the amount of a food eaten on the day in question.”
The coalition urged OEHHA to clarify that the issue of averaging exposures over a period longer than a single day is not addressed in the OEHHA proposals or the regulatory materials accompanying them.
OEHHA should not adopt these proposals, the coalition stated. What OEHHA characterizes as a lack of clarity on these issues is not a problem that needs a solution. Instead, it represents the appropriate flexibility needed for a reliable determination of average exposure levels.
If OEHHA intends to proceed with its proposals, the coalition said, it must first conduct a cost analysis and provide evidence of the need for the proposals that justifies the exorbitant costs to businesses.
Comments on the proposed regulations were due December 3. OEHHA must now review and respond to comments. It published the proposed regulations on October 5, and has one year from that date to respond.