By Lisa M. Campbell, Timothy D. Backstrom, Lisa R. Burchi, and James V. Aidala
On August 7, 2019, EPA took long awaited action concerning the inclusion of Prop 65 warning statements for glyphosate on EPA registered pesticide labels, which will likely impact the broader ongoing debate over EPA approval of Prop 65 warnings on pesticide labels. EPA’s August 7, 2019, letter to glyphosate registrants states that EPA “will no longer approve labeling that includes the Proposition 65 warning statement for glyphosate-containing products.” EPA stated further that “[t]he warning statement must also be removed from all product labels where the only basis for the warning is glyphosate and from any materials considered labeling under FIFRA for those products.” Moreover, EPA unequivocally states that “pesticide products bearing the Proposition 65 warning statement due to the presence of glyphosate are misbranded” under FIFRA Section 2(q)(1)(A). Registrants with glyphosate products currently bearing Prop 65 warning language, where the exclusive basis for such warning is based on the presence of glyphosate, must submit draft amended labeling that removes this language by November 5, 2019.
By way of background, California’s Office of Environmental Health Hazard Assessment (OEHHA) listed glyphosate as a chemical known to the state of California to cause cancer on July 7, 2017. OEHHA’s listing of glyphosate as a substance under Prop 65 is based on the International Agency on the Research for Cancer (IARC) classifying it as “probably carcinogenic to humans.” EPA scientists subsequently completed an independent review of the available scientific data on the potential carcinogenicity of glyphosate and do not agree with the IARC classification. Additional information regarding glyphosate is available at B&C’s blog.
Also of note is a February 26, 2018, preliminary injunction issued by the U.S. District Court for the Eastern District Court of California, in response to a motion filed by a coalition including Monsanto, CropLife America, and several growers associations alleging that the IARC classification decision for glyphosate is contrary to the international scientific consensus, that the required Prop 65 warning would be misleading to the ordinary consumer, that compelling the manufacturers of glyphosate to provide such a warning would violate the First Amendment because the warning is not factual and uncontroversial, and that the applicable criteria for injunctive relief were met. The February 26, injunction precluded OEHHA from enforcing its Prop 65 warning requirements against glyphosate registrants that otherwise would have taken effect on July 7, 2018. The Court did not rule that glyphosate should be removed from the Prop 65 list as a chemical known to the State of California to cause cancer, but did state that products containing glyphosate would not be required to comply with the warning requirements. In issuing the preliminary injunction, the Court stated that the required warnings are “false and misleading” and that plaintiffs “have shown that they are likely to succeed on the merits of their First Amendment claim, are likely to suffer irreparable harm absent an injunction, and that the balance of equities and public interest favor an injunction, the court will grant plaintiffs’ request to enjoin [Prop 65]’s warning requirement for glyphosate.” More information on that case is available at B&C’s blog. That injunction has not been appealed and remains in place.
Although the glyphosate warning that EPA has refused to allow is based on OEHHA’s recent listing under Prop 65, Prop 65 warnings on pesticide labels generally have been a significant issue since 2016 when OEHHA issued revised regulations regarding the content and transmission of Prop 65 warnings. As a result of these revisions, many registrants sought to add Prop 65 warning requirements to pesticide labels to meet Prop 65 requirements, but many registrants have not been able to obtain EPA approval for such warnings, resulting in much controversy and discussion. More information regarding the changes to Prop 65 warning requirements also are available at B&C’s blog.
In its press release announcing its guidance to glyphosate registrants, EPA Administrator Andrew Wheeler states: “It is irresponsible to require labels on products that are inaccurate when EPA knows the product does not pose a cancer risk. We will not allow California’s flawed program to dictate federal policy.” EPA states that its “independent evaluation of available scientific data included a more extensive and relevant dataset than IARC considered during its evaluation of glyphosate, from which the agency concluded that glyphosate is ‘not likely to be carcinogenic to humans.’” Wheeler is further quoted as stating: “It is critical that federal regulatory agencies like EPA relay to consumers accurate, scientific based information about risks that pesticides may pose to them. EPA’s notification to glyphosate registrants is an important step to ensuring the information shared with the public on a federal pesticide label is correct and not misleading.”
OEHHA immediately released its own press release on August 13, 2019, in which it “objects to US EPA’s characterization of any warning concerning glyphosate’s carcinogenicity as a false claim.’” After reiterating OEHHA’s listing glyphosate based on the IARC determination, OEHHA states that EPA’s position “conflicts with the determination made by IARC” and that “it is disrespectful of the scientific process for US EPA to categorically dismiss any warnings based on IARC’s determinations as false.”
The Court’s February 26, 2018, preliminary injunction was considered a significant development both for glyphosate specifically and perhaps for Prop 65 warning requirements generally, especially considering the recent influx to EPA of label amendments seeking EPA approval of revised Prop 65 warning language to address OEHHA’s revised regulatory changes. EPA’s guidance is equally significant, as EPA has now rejected the inclusion of a Prop 65 warning that EPA believes is misleading on a federal pesticide product label.
FIFRA Section 24(b) expressly prohibits any State from requiring any label language for a registered pesticide product beyond the labeling approved by EPA, and EPA has now declined to approve pesticide labeling that includes the Prop 65 warning for glyphosate. In some instances, EPA has been willing as a courtesy to approve labeling changes requested by a State, but the glyphosate determination demonstrates that EPA will not accept any label revisions that conflict materially with its own determinations. Although glyphosate is a fairly complex and controversial case, it will be important for registrants to monitor the evolution of EPA’s standard for when it will or will not approve a Prop 65 warning on a federal label, since this issue has been the subject of considerable controversy over the past several years.
By Lisa M. Campbell and Lisa R. Burchi
On April 23, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced it is proposing to amend Article 6 of Title 27 of the California Code of Regulations (C.C.R.), Section 25603, specifically the safe harbor warning content for on product warnings for exposures to listed chemicals in pesticides. OEHHA states that this regulation is “intended to provide compliance assistance for businesses that cause pesticide exposures in order to reduce the potential for litigation concerning the sufficiency of warnings, while still allowing them to comply with other federal and state requirements for warnings provided on a label.” It is a part of the new Article 6 Clear and Reasonable Warnings regulations, which OEHHA adopted in August 2016 and which become effective on August 30, 2018. These new regulations include safe harbor warning methods and content for consumer product exposures (Sections 25602 and 25603) and occupational exposures (Section 25606) to listed chemicals. The Initial Statement of Reasons (ISOR) is available here and the proposed regulatory text is available here. The ISOR summarizes the proposed rulemaking:
- This proposed rulemaking would add a new subsection (d) to Section 25603, addressing safe harbor warning content for on product labels for consumer product and occupational exposures to listed chemicals from the use of pesticides where those labels are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and related California laws and regulations.
- This new subsection would further the “right-to-know” purposes of the statute and clarify the content of safe harbor warnings for exposures that can occur from the use of pesticide products, where those warnings are provided on a label that is regulated under FIFRA and certain California laws.
The issue that OEHHA intends this proposal to address stems from the fact that OEHHA’s revised warning requirements require the signal word “WARNING” but the U.S. Environmental Protection Agency (EPA) “historically has not approved labels containing the terms ‘caution,’ ‘warning,’ or ‘danger,’ unless the word is the same as the [EPA]-required signal word for that label.” Thus, OEHHA is proposing the following regulatory exception from the “WARNING” requirement:
- Notwithstanding subsection (a)(2) or (b)(2) [setting forth the content of consumer product exposure warnings], where a warning for a consumer product exposure or occupational exposure from use of a pesticide is provided on a product label, and the pesticide label is regulated by the United States Environmental Protection Agency under the Federal Insecticide, Fungicide, and Rodenticide Act, Title 40 Code of Federal Regulations, Part 156; and by the California Department of Pesticide Regulation under Food and Agricultural Code section 14005, and Cal. Code of Regs., title 3, section 6242; the word “ATTENTION” or “NOTICE” in capital letters and bold type may be substituted for the word “WARNING.”
OEHHA states this is intended to be a “narrow exception” and that it is only intended to apply where EPA and California Department of Pesticide Regulation (CDPR) signal words and the Proposition 65 (Prop 65) signal word conflict. This proposal is intended to address the concerns of pesticide registrants encountering problems when they attempted to amend their EPA-approved labels to include the Prop 65 “WARNING” signal word. It remains unclear, however, whether the OEHHA proposal will fully address EPA’s concerns, and what effect it will have on EPA’s ability to approve labels that contain the language at issue. Registrants should review the proposal carefully and monitor closely EPA’s actions concerning it and this issue more generally.
Comments are due by June 11, 2018, and can be submitted to OEHHA via its website. OEHHA states that any requests for a public hearing on this proposed regulatory amendment should be submitted by May 25, 2018.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On February 26, 2018, the U.S. District Court for the Eastern District Court of California issued a memorandum and order on the plaintiff’s motion for preliminary injunction (Order) to “enjoin the listing of glyphosate under Proposition 65 (Prop 65) and the application of its attendant warning requirement pending a final judgment in this case and set a schedule for expedited final resolution of the case.” The Order (1) grants plaintiffs’ request for a preliminary injunction enjoining the warning requirement of California Health & Safety Code § 25249.6 as to glyphosate; and (2) denies the request for a preliminary injunction enjoining defendants from listing glyphosate as a chemical known to the State of California to cause cancer under California Health & Safety Code § 25249.8. Specifically, the Order states: “pending final resolution of this action, defendants … are hereby ENJOINED from enforcing as against plaintiffs … California Health & Safety Code § 25249.6’s requirement that any person in the course of doing business provide a clear and reasonable warning before exposing any individual to glyphosate.” Although this is only a preliminary injunction while the case continues further resolution, it is extremely significant that, for now, glyphosate will continue to be listed on California’s Prop 65 list as a “chemical known to the State of California to cause cancer,” but products containing glyphosate will not be required to comply with the warning requirement.
Plaintiffs’ memorandum supporting its motion for preliminary injunction states that Prop 65’s requirement for products containing glyphosate to include a warning that glyphosate is “known to the State of California to cause cancer” is unconstitutional under the First Amendment, and, if allowed to go into effect, will cause Plaintiffs’ “reputational, competitive, and economic harms for which they cannot be compensated.” Plaintiffs state that the “legal merit of their First Amendment claim is indisputable and obvious on the face of the attached documents without any need for discovery, and thus the claim is appropriate for expedited judicial resolution.” California’s Office of Environmental Health Hazard Assessment (OEHHA), the agency responsible for implementing Prop 65, listed glyphosate as a chemical known to the state of California to cause cancer on July 7, 2017, and the attendant warning requirement would have taken effect on July 7, 2018.
In support of denying the request for a preliminary injunction enjoining defendants from listing glyphosate under Prop 65, the court states that plaintiffs “have not shown a likelihood of success on the merits of their claim that the listing of glyphosate violates the First Amendment, because the listing is government speech, not private speech … [and it] is only the upcoming July 2018 deadline for providing the [Prop 65] warning that compels private speech.” The court noted further that Plaintiffs “have not shown a likelihood of irreparable harm should the court fail to enjoin the listing of glyphosate, because any harm that plaintiffs might suffer is caused by the warning requirements of [Prop 65], rather than the listing itself.” Accordingly, the court denied a preliminary injunction based on plaintiffs’ claim that the glyphosate listing violates the First Amendment.
On the other hand, in support of granting the request for a preliminary injunction enjoining the application of the attendant warning requirement, the court stated:
- On the evidence before the court, the required warning for glyphosate does not appear to be factually accurate and uncontroversial because it conveys the message that glyphosate’s carcinogenicity is an undisputed fact, when almost all other regulators have concluded that there is insufficient evidence that glyphosate causes cancer.
The court also stated that the required warnings are “false and misleading” and that plaintiffs “have shown that they are likely to succeed on the merits of their First Amendment claim, are likely to suffer irreparable harm absent an injunction, and that the balance of equities and public interest favor an injunction, the court will grant plaintiffs’ request to enjoin [Prop 65]’s warning requirement for glyphosate.”
This case, while not the end of the story, is a very significant development both for glyphosate specifically and perhaps for Prop 65 warning requirements generally. Industry should follow this case closely given the implications for glyphosate and potentially other Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)-regulated pesticides and chemicals generally. Some in industry have long been concerned that Prop 65 warning requirements contradict conclusions supported by the data and reached by other agencies such as the U.S. Environmental Protection Agency (EPA). This decision is a huge preliminary win for those with these concerns and, depending on the ultimate outcome of the case, could provide a precedent for additional challenges related to other substances. The potential reach of the case beyond glyphosate, however, will likely be dictated heavily by the facts of each case.
By Lisa R. Burchi and Lisa M. Campbell
On January 2, 2018, State Attorneys General from eleven states (Idaho, Indiana, Iowa, Kansas, Louisiana, Michigan, Missouri, North Dakota, Oklahoma, South Dakota, and Wisconsin) (collectively the States) filed a friend of the court brief in Nat’l Ass’n of Wheat Growers v. Zeise, E.D. Cal. (No. 2:17-cv-02401) (Brief), a case challenging California Office of Environmental Health Hazard Assessment’s (OEHHA) decision to list glyphosate as a carcinogen under Proposition 65 (Prop 65).
OEHHA listed glyphosate under Prop 65 on March 28, 2017, but the effective date of the listing was delayed until July 7, 2017, following a decision from the Fifth District Court of Appeals that denied Monsanto’s request for a stay of such listing. OEHHA stated that its listing was required under its Labor Code listing mechanism, which OEHHA states requires it to list under Prop 65 certain substances identified by the International Agency for Research on Cancer (IARC) as known to cause cancer. Information about Monsanto’s earlier challenge is available in our blog item California Court Tentatively Dismisses Monstano’s Lawsuit Against OEHHA to Block Addition of Glyphosate to Proposition 65 List.
On November 15, 2017, a nationwide coalition of agricultural producers and business entities (including Monsanto) filed a Complaint against OEHHA on the grounds that its listing of glyphosate as a carcinogen and the Prop 65 warning requirement triggered by that listing: (1) violate the First Amendment of the U.S. Constitution by compelling Plaintiffs and other entities to make false, misleading, and highly controversial statements about their products; and (2) violate the Due Process Clause of the Fourteenth Amendment of the U.S. Constitution because OEHHA’s actions are not rationally related to any legitimate state interest; and (3) violate the Supremacy Clause of the U.S. Constitution by conflicting with, and being preempted by, the Federal Food, Drug, and Cosmetic Act (FFDCA). Plaintiffs filed an amended Complaint on December 5, 2017.
On December 6, 2017, Plaintiffs also filed a motion for preliminary injunction (Motion), arguing that they are likely to succeed on the merits of their claim that the Prop 65 listing violates the First Amendment. The Motion argues that the warning will fail under any level of constitutional scrutiny, whether it is considered under “laws regulating commercial speech that generally receive at least intermediate scrutiny, i.e., they are prohibited if they do not directly and materially advance the government’s interest, or are more extensive than necessary,” or laws that require disclosure of information in connection with commercial transactions, which “are permissible only if the compelled disclosure is of information that is purely factual, uncontroversially accurate, reasonably related to a substantial government purpose, and not unduly burdensome or chilling. See Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651 (1985).” Motion at 23-36; Complaint at 26-28.
In agreeing with Plaintiffs that OEHHA’s Prop 65 listing of glyphosate forces businesses to issue “false and misleading” statements about their products and asking the court to grant the Plaintiffs’ motion for a temporary restraining order and preliminary injunction, the Attorneys General state in their Brief:
- The First Amendment injuries identified by Plaintiffs are heightened because they adversely impact the sovereign interests of other States in at least two ways. First, by requiring false or misleading statements about glyphosate products, California’s speech mandate imposes confusing and potentially inconsistent obligations on nonresident businesses that are bound by other States’ consumer-protection laws not to make false and misleading statements about their own products. Second, the speech mandate impairs consumer-protection efforts of the States that require sensible health-and-safety disclosures by contributing to the well-known phenomenon of disclosure fatigue.
Brief at 4-5 (emphasis in original).
The States also argue that while there may be a presumption to California’s favor that its enforcement of its duly enacted laws reflects the public interest, the Court also “should weigh heavily the fact that California’s mandate interferes with federalism and the sovereign interests of other States when assessing the public interest factor.” Brief at 10.
This case raises significant constitutional and preemption arguments in a factual context that many in industry believe compelling. It will be closely monitored.
OEHHA answered Plaintiff’s First Amended Complaint on January 9, 2018. It is expected to file its opposition to Plaintiff’s Motion for a Preliminary Injunction by January 22, 2018, and file its response to the two amicus curiae briefs filed on behalf of Plaintiffs by January 26, 2018. Following deadlines for Plaintiffs to file any reply in support of their motion for a preliminary injunction and any responses to amicus curiae briefs in support of Defendants, a hearing on Plaintiff’s motion will be held on February 20, 2018.
By Lynn L. Bergeson, Lisa R. Burchi, and Margaret R. Graham
A tentative ruling issued January 26, 2017, in Monsanto Company v. Office of Environmental Health Hazard Assessment, et al., Case No. 16 CE CG 00183, by the Superior Court of California, County of Fresno, granted the Office of Environmental Health Hazard Assessment’s (OEHHA or Defendant) motion for judgment on the pleadings as to Monsanto Company’s (Monsanto) petition and complaint, and sustained the demurrers to Monsanto’s petition and complaint (Sierra Club) and California Citrus’ complaint in intervention, for failure to state facts sufficient to constitute a cause of action. The tentative ruling was issued prior to the hearing date of January 27, 2017. If this ruling is made final, Monsanto’s case will be dismissed, but Monsanto has stated it will challenge the tentative ruling.
Monsanto’s complaint alleged various violations committed by OEHHA under the U.S. and California Constitutions in listing glyphosate on the Proposition 65 (Prop 65) list of chemicals that are known to the state to cause cancer. Monsanto argues, for example, that OEHHA engaged in an unconstitutional delegation of its rulemaking authority to the World Health Organization’s (WHO) International Agency for Research on Cancer (IARC) when it used the IARC’s classification of glyphosate as “probably carcinogenic to humans” as the basis for the Prop 65 listing. Specifically, Monsanto argued that the Labor Code listing mechanism upon which the glyphosate listing is based is unconstitutional because OEHHA “cedes the basis of its regulatory authority to an unelected and non-transparent foreign body that is not under the oversight or control of any federal or state government entity.” The five constitutional violations that Monsanto claimed are: (1) a violation of the due process clauses of the California and U.S. Constitutions; (2) a violation of free speech under the California and the U.S. Constitutions; (3) a violation of the Guarantee Clause of the U.S. Constitution; (4) a violation of the California Constitution regarding the naming/identifying of IARC (Article II, Section 12); and (5) a violation of the California Constitution through empowering IARC to make laws applicable to California (Article IV, Section 1).
The tentative ruling details the court’s arguments concerning Monsanto’s failure to state facts/insufficiently allege its claims for each of the claims. Concerning the first allegation on the unconstitutional delegation of authority, the court stated “there is no support for Monsanto’s conclusion that the OEHHA has unconstitutionally delegated its rulemaking authority to the IARC,” since, in part, “the voters and the legislature have established the basic legislative scheme and made the fundamental policy decision with regard to listing possible carcinogens under Proposition 65, and then allowed the IARC to make the highly technical fact-finding decisions with regard to which specific chemicals would be added to the list.” The court also found no support for any of Monsanto’s other claims. As of February 1, 2017, the ruling was not yet made final.