OEHHA Proposes Glyphosate Proposition 65 Regulations

On July 23, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) proposed regulations that would establish tailored safe harbor warning language to be used with products that exceed the No Significant Risk Level (NSRL) for glyphosate. We describe below the content of the rulemaking and the potential impact on industry.

The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) requires California to maintain a list of chemicals known to cause cancer, birth defects, or other reproductive harm. Products that contain a listed chemical must give “clear and reasonable warning” to consumers that the product contains a chemical known to the State of California to cause cancer, birth defects, or other reproductive harm, and OEHHA has established “safe harbor” warning language that qualifies as “clear and reasonable warning.”[1] Responsible parties are exempted from warning consumers if the substance poses “no significant risk” for a carcinogen or “no observable effect” for a reproductive toxicant. To that end, OEHHA publishes NSRLs, below which companies need not provide warnings for listed chemicals.[2] Proposition 65 provides for monetary penalties for violators and authorizes enforcement by state and local government and by private citizens.[3] Failure to provide Proposition 65 warnings where required thus may result in substantial liability.

Glyphosate is an herbicide used extensively in consumer products to control plants and grasses. In 2017, glyphosate was listed as a chemical known to the State of California to cause cancer. OEHHA listed glyphosate as a carcinogen on the basis of a report published by the International Agency for Research on Cancer (IARC), a subdivision of the World Health Organization (WHO).[4] This IARC report concluded that glyphosate is “probably carcinogenic to humans.” However, other health authorities have reached different conclusions. For example, the US Environmental Protection Agency (EPA) concluded that glyphosate is “not likely to be carcinogenic to humans.” Nevertheless, OEHHA maintained its position that glyphosate should be a listed carcinogen and set an NSRL for glyphosate at 1100 micrograms per day.

OEHHA’s listing of glyphosate triggered Proposition 65's requirement that any product that could potentially expose consumers to glyphosate must contain a clear and reasonable warning of the cancer risk posed by the chemical. The listing prompted industry pushback. In particular, the National Association of Wheat Growers moved to enjoin OEHHA from requiring that responsible parties warn consumers about glyphosate residues in their products, arguing that such required warnings linking glyphosate to cancer risk would violate the First Amendment.[5] The district court enjoined enforcement of the warning requirement, finding that the standard safe harbor warning was false and misleading (i.e., it is misleading to say that it is known to the state of California that glyphosate causes cancer given that non-IARC regulators have found that glyphosate does not cause cancer or that there is insufficient evidence to show that it does).

Now, instead of requiring the standard safe harbor warning, OEHHA has proposed regulations that would establish a tailored safe harbor warning for products that exceed the NSRL for glyphosate. OEHHA has proposed the following warning language:

CALIFORNIA PROPOSITION 65 WARNING: Using this product can expose you to glyphosate. The International Agency for Research on Cancer classified glyphosate as probably carcinogenic to humans. Other authorities, including US EPA, have determined that glyphosate is unlikely to cause cancer, or that the evidence is inconclusive. A wide variety of factors affect your personal cancer risk, including the level and duration of exposure to the chemical. For more information, including ways to reduce your exposure, go to www.P65Warnings.ca.gov/glyphosate.[6]

OEHHA intends for this language to account for the National Association of Wheat Growers court’s concerns and reflect the range of regulatory opinions regarding the carcinogenicity of glyphosate. Additionally, OEHHA acknowledges that no enforcement action can be taken against businesses that do not comply with the glyphosate warning requirement so long as the National Association of Wheat Growers injunction is still in effect.[7]

In the short term, finalization of OEHHA’s proposed regulations would not result in enforcement against products that do not include glyphosate warnings due to the National Association of Wheat Growers injunction. However, looking ahead, the injunction could potentially be lifted if a court determines that the tailored safe harbor warning is no longer false and misleading for purposes of First Amendment analysis. Moreover, consumers may point to the lack of a glyphosate warning in actions brought under other consumer protection statutes.

More broadly, this proposed regulation may signal OEHHA’s willingness to craft additional tailored warning statements in the future when regulators disagree about whether a chemical is carcinogenic or causes reproductive harm. OEHHA acknowledged that glyphosate “is an unusual case because several regulatory agencies did not reach a similar conclusion as IARC.” Moving forward, if IARC and other regulators disagree about the risk profile of a certain chemical, OEHHA may decide to add the chemical to the Proposition 65 list with a corresponding tailored safe harbor warning rather than leaving the chemical off the list altogether.

Comments on OEHHA’s proposed regulations are due September 7, 2021. Covington will continue to monitor California’s treatment of products containing glyphosate.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drug, and Device practice.

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