OEHHA proposes new glyphosate warning while First Amendment appeal to 9th Circuit remains pending

Background

In July 2017, glyphosate was added to the list of chemicals known to the state of California to cause cancer for purposes of Proposition 65.  Shortly after the July 2017 listing of glyphosate and before the OEHHA warning requirements were set to take effect, a collection of state agriculture organizations and agriculture industry members filed for a preliminary injunction against the glyphosate warning requirement claiming that because the listing was based on a disputed classification the chemical cannot be “known” to cause cancer and to require such a false or misleading statement would violate the First Amendment.¹ As we reported earlier, a permanent injunction was issued in 2020 prohibiting the state from imposing the warning requirement.² The District Court found that, as applied to glyphosate, the standard safe harbor warning as well as alternative language suggested during the litigation were false and misleading under standard First Amendment analysis.  The court noted that every regulator of which the court is aware, with the sole exception of International Agency for Research on Cancer (IARC), has found that glyphosate does not cause cancer or that there is insufficient evidence to show it does.  Even if it may be literally true that California technically “knows” that glyphosate causes cancer as the State has defined that term in the statute and regulations, the required warning would nonetheless be misleading to the ordinary consumer. The state appealed the injunction to the 9th Circuit Court of Appeals where it remains on-going.³  In the appeal, the state argues that the First Amendment does not bar the State from requiring companies to inform Californians before exposing them to a chemical which an authoritative body, such as IARC, has classified as both an animal carcinogen and a probable human carcinogen.  On July 30^th, following the current proposed rulemaking discussed below, the state filed a motion to hold the case in abeyance for 180 days while OEHHA conducts the rulemaking progress.⁴

Proposed Rule

In response to the permanent injunction, OEHHA proposed a new safe harbor warning regulation with different warning language for glyphosate.⁵ According to OEHHA’s Initial Statement of Reasons (ISOR), each of the statements in the proposed warning is factual and was developed taking into account the District Court decision.  The proposed warnings, OEHHA claims, are intended to present “a balanced description of the conflict between IARC’s conclusion and those of other regulatory agencies, including US EPA” and provide the “clear message that an individual’s personal risk of cancer from use of these products is a function of level and duration of exposure to the chemical.”

Specifically, the proposed warning would read:

• The symbol required in Section 25603(a)(1).

• The words “CALIFORNIA PROPOSITION 65 WARNING” in all capital letters and bold print, or, for EPA-regulated pesticide labels, the word “ATTENTION” or “NOTICE.”

• The words, “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.”

In the ISOR, OEHHA noted the new warning includes information on why the chemical is considered a carcinogen (in part because it is classified as “probably carcinogenic to humans” by IARC), and a statement that the level and duration of exposures affect a person’s cancer risk.  The statements regarding carcinogenicity also reflect the range of opinion, as described  above.  US EPA and some governmental bodies found glyphosate is unlikely to be a human carcinogen, while other bodies noted the evidence of effects in epidemiology studies and certain findings from animal studies, but concluded this evidence is insufficient for assigning a cancer category.  OEHHA believes the newly tailored warning for glyphosate avoids the First Amendment concerns that have been challenged in the lawsuit. 

Comments on the proposed regulation are due by September 7, 2021. 

Next steps

Hogan Lovells will continue to closely monitor Proposition 65 developments related to food and beverages. Please do not hesitate to contact us if you have any questions regarding this or other matters.