Will Popular Proposition 65 Carcinogen-Listing Device Survive Constitutional Challenge?

grimaldi-bio-photo-warmGuest Commentary

By Ann Grimaldi, Principal, Grimaldi Law Offices

In a significant challenge to the so-called “Labor Code mechanism” of adding chemicals to the California Proposition 65 list, Monsanto Company filed a lawsuit against the California Office of Environmental Health Hazard Assessment (“OEHHA”) in response to the agency’s September 2015 proposal to list glyphosate—the active ingredient in Roundup® weed and grass herbicide products—as a carcinogen. Monsanto Company v. Office of Environmental Health Hazard Assessment, et al. (Fresno County Superior Court). Asserting violations of the U.S. and California Constitutions, Monsanto seeks an injunction against the agencies’ listing of glyphosate and a court declaration that the Labor Code listing mechanism violates the U.S. and California Constitutions as applied to the proposed listing.

The California Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as “Proposition 65,” prohibits businesses from exposing individuals to specified carcinogens and reproductive toxicants without a clear and reasonable warning. Cal. Health & Safety Code § 25249.6. OEHHA, the state agency charged with implementing Proposition 65, must update the Proposition 65 list of chemicals at least once per year. Id. at § 25249.8(a). OEHHA expands the list of chemicals via the mechanisms identified by the statute, including the Labor Code mechanism.

Under this mechanism, OEHHA lists a chemical if it is “identified by reference in [California] Labor Code Section 6382(b)(1)….” This Labor Code worker-safety statute, in turn, requires the California Director of Industrial Relations to establish a list of hazardous substances using specified criteria—including the criterion at issue in the Monsanto lawsuit: substances listed as human or animal carcinogens by the International Agency for Research on Cancer (“IARC”).

The Proposition 65 Labor Code statutory-listing mechanism has previously been the subject of lawsuits. In 2007, the Sierra Club sued OEHHA for, among other things, failure to list chemicals using this method. Taking an opposite view of the issue, the California Chamber of Commerce also challenged this listing method in a separate lawsuit that subsequently was consolidated with the Sierra Club action. Ultimately, the court concluded that “[T]he statute imposes a clear ministerial duty on [OEHHA] to list the carcinogens and reproductive toxicants identified by reference to the Labor Code sections without further review.” Sierra Club v. Schwarzenegger, Alameda County Superior Court Consolidated Case No. RG07356881 (Apr. 24, 2009). The Court of Appeal upheld this interpretation, pointing to the law’s remedial purpose. California Chamber of Commerce v. Brown.

As part of a consent judgment settling the Sierra Club litigation, OEHHA promulgated a regulation implementing this statutory mechanism in 2015. 27 Cal. Code Regs. § 25904. In doing so, OEHHA transplanted the Labor Code § 6382(b)(1)’s IARC carcinogen-identification criterion—though OEHHA arguably went beyond that Labor Code section’s approach. Monsanto’s lawsuit is the first legal challenge to the Labor Code listing mechanism as implemented by OEHHA through this regulation.

Interestingly, the California Director of Industrial Relations has not added glyphosate to the Labor Code list of hazardous substances. See 8 Cal.Code Regs. § 339. Thus, the proposed Proposition 65 listing is not based directly on the Director of Industrial Relations’ hazardous substance list. Rather, the sole trigger for OEHHA’s proposed listing is IARC’s designation, in complete isolation from any formal regulatory action, of glyphosate as a probable human carcinogen. OEHHA’s argues that its duty is ministerial and that it has no discretion to evaluate the underlying science of IARC’s designation.

And that is the basis of Monsanto’s objection to the proposed listing. According to Monsanto’s complaint, the following regulatory bodies have concluded, after extensive evaluation, that glyphosate does not pose a cancer hazard: the U.S. EPA, the German Federal Institute for Risk Assessment (acting as the Rapporteur Member State for the European Union), the European Food Safety Authority (performing a peer review of the BfR assessment), the European Commission, the Canadian Pest Management Regulatory Authority, and the Joint FAO/WHO Meeting on Pesticide Residues, which is an international scientific group administered jointly by the Food and Agriculture Organization of the United Nations, and the World Health Organization.

OEHHA itself, in the context of setting a Public Health Goal for glyphosate on drinking water, concluded in 2007 that “based on the weight of evidence, glyphosate is judged unlikely to pose a cancer hazard to humans.” Yet, according to Monsanto, OEHHA is proposing to list glyphosate as a carcinogen on the basis of a conclusion by an organization that “convenes ad hoc groups of scientists … selected by IARC staff in an opaque, non-public process, to review and summarize scientific research on the carcinogenicity of a particular substance or chemical.” Complaint at ¶ 50. “IARC explicitly disavows any policy-or law-making role, and does not intend its determinations to carry the force of law,” and the preamble to each IARC Monograph admonishes, “‘no recommendation is given with regard to regulation or legislation, which are the responsibility of individual governments or other international organizations.’” Complaint at ¶ 55.

Further, in an ironic twist of events, in 2007, OEHHA examined the studies that IARC evaluated, and reached a conclusion directly contrary to IARC’s. Complaint ¶ 59. In other words, the very same studies that OEHHA previously rejected as demonstrating glyphosate’s cancer potential now are forming the basis for OEHHA’s proposed carcinogen listing.

Thus, Monsanto alleges that the Labor Code listing mechanism, as applied to the proposed glyphosate listing, violates the U.S. and California Constitutions because, among other reasons, it:

  • Constitutes an unlawful delegation of legislative authority because it “leaves the resolution of fundamental policy issues—i.e., decisions about which chemicals should be placed on the Proposition 65 list—to IARC, an unelected, undemocratic, foreign body that is not under the oversight or control of any California governmental entity.” Complaint at ¶66;
  • Violates due process because it “does not include sufficient procedural safeguards and, as such, is overwhelmingly likely to lead to erroneous results.” Complaint at ¶ 84;
  • Is effectively an unlawful attempt to amend the California Constitution by conferring OEHHA’s power to list chemicals to IARC—a non-governmental organization. Complaint at ¶91; and
  • Intrudes on the company’s First Amendment free-speech rights by compelling it to provide cancer warnings for its products when no warnings are needed. Complaint at ¶102.

This “as applied” constitutional challenge surely will fare better than a facial challenge to OEHHA’s Labor Code listing regulation. In a facial challenge, the plaintiff must demonstrate that there are no circumstances in which the law or regulation would be constitutionally valid. That is a high bar. Here, Monsanto has strong facts demonstrating that, as applied to this specific proposed listing, OEHHA’s regulation is unconstitutional. Still, OEHHA undoubtedly will point to the rulings and settlement in the Sierra Club lawsuit, and the California Chamber of Commerce appellate ruling, to argue that it cannot reverse course. In that regard, it does indeed appear that OEHHA is between the proverbial rock and a hard place, and a court may be sympathetic to OEHHA’s position.

There is much at stake. Glyphosate is a widely-used herbicide with a high volume of sales in California and worldwide. California’s current Proposition 65 enforcement climate is an aggressive one; on average, private enforcers collectively serve almost three Notices of Intent to sue per day. And no wonder: with entitlement to attorneys’ fees and a portion of civil penalties (which themselves are typically based on California sales volume), there are strong financial incentives for private persons to pursue Proposition 65 claims under the law’s citizen suit provisions. Placing a cancer warning on glyphosate products certainly will immunize a company from a Proposition 65 enforcement action, but it also may well deter purchasers from buying them. Worse, a cancer warning would misstate the current scientific understanding of glyphosate’s cancer potential as evaluated by numerous regulatory agencies around the world. Monsanto and the regulated community, as well as consumers who benefit from farmers’ use of Roundup®, can only hope that good law and good science will prevail.

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