Industry Calls on California to Change Proposition 65 Regs to Reduce Lawsuits
California should cut down on frivolous Proposition 65 lawsuits by clarifying and strengthening exemptions to labeling requirements, said the California Chamber of Commerce and almost 140 companies and trade associations in a Nov. 14 letter to the state’s Office of Environmental Health Hazard Assessment (OEHHA) (here). The law, which requires warning labels on products that contain certain listed chemicals that are known to cause cancer or birth defects, has created a situation where “a substantial portion of warnings provided to consumers and to the public are provided solely to avoid litigation,” said the letter. “Businesses would prefer not to be confronted with the Hobson’s choice of either warning or being sued. Unfortunately, that is the current reality in today’s Proposition 65 climate,” said the industry coalition.
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The letter comes in response to a request for comments by OEHHA “as part of its ongoing efforts to update and improve its implementing regulations (here). California Governor Jerry Brown first called for reforms in May 2013 in order to “restore the intent” of the thirty-year old law “that has been abused by some unscrupulous lawyers driven by profit rather than public health” (here). Under Proposition 65, private parties can bring lawsuits against businesses if the company exposes consumers to listed chemicals without providing a warning.
Highlights of the letter are as follows:
Exception for chemicals in foods produced by cooking. According to the coalition, even OEHHA agrees that chemicals produced by cooking food, as opposed to being intentionally added, should not be subject to the same threshold for warning label requirements. However, California has yet to create any “alternative risk levels” for foods that recognize this fact, said the coalition. The letter calls on California to create an exception to warning requirements when a Proposition 65 listed chemical arises in a food as a natural result of cooking and is not otherwise added. Otherwise, California should at least create a lower threshold for chemicals in food produced by cooking, and allow companies to satisfy the warning requirement by putting a symbol on labeling with the address of a website that includes the full warning.
Naturally occurring chemicals in food. Another food-related aspect of the Proposition 65 regulations that needs tweaking is the exception from warning requirements for chemicals that occur naturally in food, said the letter. The current exception “has had little practical effect on reducing warnings or lawsuits” when a chemical has been absorbed into a food because it was historically present in the environment where the food was grown or raised, said the letter. “The issue with this part of the regulation is that, in short, it is not practical to apply,” the coalition said.
According to the coalition, businesses that want to prove a chemical is naturally occurring not only have to prove they didn’t add the chemical, but also that the chemical did not result from any known human activity, that the chemical was not avoidable by good agricultural practices, and that there is no feasible way to lower the level. “This burden is virtually insurmountable and undermines the intent of the agency in adopting the regulation while subjecting those who produce and sell food to Californians to expensive litigation,” said the coalition. The regulatory exemption needs to be modified “significantly,” and OEHHA should work with industry and the California Department of Food and Agriculture to decide what adjustments are necessary, it said.
Strengthened agency exemptions for chemicals. OEHHA “safe use determinations” (SUDs) and “interpretive guidelines” (IGs) are two ways businesses can obtain some certainty that they can omit a warning label and not face Proposition 65 lawsuits. Unfortunately, each process has its faults, said the letter. But OEHHA has only issued two SUDs, because the cost and time required is uncertain and substantial, and the burden of proof is such that businesses face a tough road, it said. On the other hand, IGs provide a more straightforward process, but neither immunizes a company from lawsuits because they do not have legal effect, said the coalition.
To fix the SUD and IG system, OEHHA should lower the standard of proof that businesses have to meet to obtain them, said the letter. The agency should also set strict timelines and reduce costs for SUDs, and characterize both SUDs and IGs so that a court can rely on them to resolve a lawsuit before it goes to trial.
Developing safe harbor levels. Developing and updating safe harbor levels for protection from lawsuits “presents an opportunity for OEHHA to act on the Governor’s stated desire to ‘end frivolous ‘shakedown’ lawsuits,’” said the letter. Additionally, chemicals found in food should not be listed under Proposition 65 unless a safe harbor has been developed or affected industries request that no safe harbor be created, it said.
Exposure assessments. Even if a company expends the time and money to conduct an exposure assessment to find whether a warning is required, it is not protected from lawsuits because the assessment is usually challenged in court, said the coalition. In order to incentivize companies studying their products and making their own determinations, a company should be found to have no knowledge of an exposure so long as its exposure assessment is conducted by a qualified scientist and the assessment concludes that no Proposition 65 warning is required, it said.
Listing process. The rate at which new chemicals are being listed under Proposition 65 “ has increased in recent years,” said the coalition, and these new listings create uncertainty for business. In order to help companies comply, OEHHA should adopt procedures to ensure it precisely identifies the chemical at issue, as well as the method of exposure that is causing concern and the reason for the listing.