The proposed changes are part of rule making process set into motion in 2013 by California Gov. Jerry Brown to alter Prop 65 in a way that would lessen the number of lawsuits that have arisen from the act. Proposition 65, known informally as Prop 65 and formally as the Safe Drinking Water and Toxic Enforcement Act, is the citizen initiative dating from 1987 that mandated what toxic and/or hazardous chemicals whose presence must be called out via warnings to consumers. The law is the reason why one sees warnings in California in places such as hotel rooms and rental car agencies.
Fertile ground for lawsuits
Over the years dietary supplement companies doing business in the state have noted that the law has trigger levels for various substances of concern, such as lead, that in many cases are much lower than federal standards, creating confusion and burdens for industry without significantly improving public health. As the law has a ‘right of public enforcement’ aspect to it, it has provided a fertile field for plaintiffs law firms in which to do their business.
California’s Office of Environmental Health Hazard Assessment (OEHHA) had proposed changes to language in the act which governs how to make the decision about when the warnings required in the law would be needed. According to Rend Al-Mondhiry, associate general counsel for CRN, regulators have continued to miss the mark with the proposed changes.
“It’s very easy for private enforcers to challenge a company’s decision not to warn,” Al-Mondhiry told NutraIngredients-USA. “They can say, you used this test, when you should have used this other test. We think making these kind of determinations in the courts is not a good use of judicial resources. We don’t think this latest proposal meets Gov. Brown’s intent.”
CRN submitted comments to OEHHA on the proposed changes in January of this year and submitted a first round of comments on the initial proposal in 2014. CRN joined the California Chamber of Commerce Coalition, a group of more than 200 companies, in those efforts. When OEHHA posted the proposed modified final rule in late March, it unfortunately became clear that many of the comments submitted by the two organizations had fallen on deaf ears, sparking this most recent communication.
CRN said it “expressed concerns (in its January comments) about the risk of increased litigation due to a lack of sufficient clarity and guidance for businesses. It also raised questions about the potential public health benefit that would result from the revised warnings and the scientific basis for these changes.
“While the Modified Proposal attempts to address some of these issues, OEHHA continues to ignore the legitimate and significant concerns raised by CRN and the Coalition. From a practical, legal, and scientific standpoint, the Modified Proposal (like its previous iterations) is fundamentally flawed,” the organization continued.
Changes to ambiguous wording
CRN detailed a number of changes it would like to see made to the proposal for the final rule. Among these are a request to strike ambiguous phrases such as “any foreseeable use” that was added to the section that defines what constitutes a “consumer product exposure.” CRN said this phrase is overly broad, and seems to beg to be more precisely defined via just the sort of lawsuits the proposed rule change is supposed to obviate. A consumer exposure to a dietary supplement should be construed as use within the instructions provided on the label, CRN asserts.
The new rule also turns the warning decision-making situation on its head, CRN said. The new language could require a company to justify its decision to provide a warning; in the past this requirement has obtained only in the case of company deciding no warning is necessary. Fuzzy wording within the proposed final rule could give attorneys an opportunity to challenge a company’s decision to provide a warning as well as taking them to task if they decide not to warn, CRN said.
“If OEHHA is intending to reduce ‘over warning’ we once again suggest it focus on improving the scientific basis for Proposition 65 overall, rather than adding an additional burden on defendants,” CRN said.
CRN’s comments also include among other things suggested changes to provisions that govern where and now warnings may appear on labels or on package inserts and in what kind of language these warnings may be framed to better account for the naturally variable nature of some dietary supplement ingredients.
As for the chance that OEHHA will listen to these tweaks to the modified proposed final rule, Al-Mondhiry was less than hopeful.
“I wish I could be more positive and say that OEHHA will reconsider its current approach. we have asked that there be another round of comment but that is unlikely. We think they intend to go forward with a final rule making,” she said.