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Daily News Blog

11
Aug

Court Decision Highlights Systemic Failure of Federal Pesticide Law to Protect Health and the Environment, Despite a Silver Lining and a Must-Read, Powerful Dissenting Opinion

U.S. Circuit Judge Paul J. Watford, in a must-read dissent: “Because courts in our circuit must now accept that fundamentally flawed data as the ‘best’ scientific data available, the agency will have no incentive to implement the scientific methods necessary to obtain reliable data.”

(Beyond Pesticides, August 11, 2020) Petitioners who mounted a legal challenge to the Environmental Protection Agency’s (EPA’s) registration of Enlist Duo, a relatively new and highly toxic pesticide product, recently learned of a mixed decision from the U.S. Ninth Circuit Court of Appeals in the case. The good news is that Judge Ryan D. Nelson, writing the opinion for the court, found that EPA, in registering the herbicide Enlist Duo, had failed to protect monarch butterflies, which are under consideration as a threatened species under the Endangered Species Act (ESA). On the other and disturbing hand, the court concluded that EPA registration of the product was otherwise lawful — which means that this toxic compound will for now remain on the market. As one of the plaintiffs in the case, Beyond Pesticides is adamant that this product should not be registered for use by EPA.

George Kimbrell, Legal Director of Center for Food Safety and Lead Counsel for the plaintiffs, commented on the decision in the organization’s July 22 press release on the decision: “The panel majority’s unprecedented decision is contrary to controlling law and established science, and Center for Food Safety is analyzing all legal options, including seeking a full court rehearing.”

Enlist Duo is a highly toxic mixture of two herbicides, glyphosate and 2,4-D (2,4-Dichlorophenoxyacetic acid), as well as an unknown number of unlisted adjuvant ingredients. (The latter, 2,4-D, comprises roughly half of the notorious defoliant compound, Agent Orange.) Beyond Pesticides lists both glyphosate and 2,4-D as “toxic” in its Pesticide Gateway database, and identifies both as causing or associated with a variety of human health harms: cancer, and reproductive, neurological, hepatic, renal, natal and developmental anomalies. In addition, glyphosate is an endocrine disruptor (ED), and 2,4-D is a probable ED.

The herbicide also threatens harms to nontarget species. Monarch butterfly populations have suffered greatly from exposure to pesticides, including Enlist Duo. Monarch larvae, which reside and feed on milkweed plants, endure devastating impacts from pesticide drift from nearby treated agricultural fields. A 2015 lawsuit brought by Beyond Pesticides and other petitioners cited EPA’s consistent failure to consult with the U.S. Fish and Wildlife Service (FWS) on impacts to endangered species, as it is statutorily required to do. That suit focused on impacts of Enlist Duo on two endangered species: the whooping crane and the Indiana bat.

The combined herbicide was developed to be used on genetically engineered (GE), herbicide-tolerant crops, such as corn, soybeans, and cotton — the notion being that when applied, it would knock down broadleaf weeds, but not affect the GE crops. Enlist Duo was created in response to target weeds’ development of resistance to glyphosate herbicides, most notably, Monsanto’s (now Bayer’s) Roundup, which has been used intensively during the past two decades. Dow Chemical rushed to offer Enlist Duo as a quick fix to the problem, but independent scientists and USDA analysis predict that its use will inevitably foster more weed resistance.

Plaintiffs in the case included the National Family Farm Coalition, Family Farm Defenders, Beyond Pesticides, Center for Biological Diversity, Center for Food Safety, and Pesticide Action Network North America. The National Resources Defense Council joined the suit as a petitioner. The lawsuit alleged that EPA’s 2014, 2015, and 2017 registrations of Enlist Duo violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Endangered Species Act (ESA). Suits were brought against each of EPA’s registrations; the Ninth Circuit Court consolidated them into this single case that was adjudicated in late July 2020.

EPA’s 2014 registration of Enlist Duo was amended in 2015 and again in 2017, with resulting allowances for use on the three GE commodity crops deregulated in 34 states. (Enlist Duo was originally manufactured by Dow Chemical, which in 2017 merged with DuPont to form DowDuPont — which in turn spun off the chemical and seed businesses into Corteva AgriScience.) Until the hearing of this case, no court had ever reviewed whether the registration of Enlist Duo met basic safety standards required by FIFRA and ESA. Plaintiffs’ central arguments are: the compound is an existential threat to the monarch butterfly, and EPA has ignored, in its registration of the pesticide, compelling evidence that Enlist Duo represents serious threats to human health.

Beyond Pesticides has often challenged EPA’s failure to assess adequately the risks of this dual compound, through its reporting and its participation in litigation. In 2017, Beyond Pesticides reported that although a “new process for handling ESA consultations was outlined in 2013, EPA continues to bring pesticides to market without adequate data on a chemical’s adverse effects. EPA routinely disregards this requirement, and has been sued numerous times for failing to ensure adequate protections for endangered species.” It wrote in 2019 about EPA’s ongoing failure to assess potential synergistic effects of the compound, saying: “It does not appear that assessments, based on exposure to both glyphosate and 2,4-D choline, have been conducted to properly assess whether synergistic effects can occur in non-plant organisms.”

Despite the Ninth Circuit Court’s decision not to vacate EPA registration of Enlist Duo, there may be potential silver linings in this decision. The court agreed — in opposition to the defendant’s multiple challenges on timing of the petition and on standing — that plaintiffs’ filing was timely and that they had standing to bring the suit. (Having “standing” in legal cases means that a petitioning individual or entity can demonstrate that it has a legal right or interest in bringing an action to challenge the constitutional validity of a law.) In addition, the court did, rather than assume EPA’s claims on their face, actually explore the details of plaintiffs’ arguments related to tank mixing of Enlist Duo with glufosinate, and volatility of the compound and impacts on nontarget organisms.

In addition, the dissenting opinion on the case is encouraging in its recognition of EPA’s failings. In crafting that strong dissenting opinion, Judge Paul J. Watford wrote: “EPA also violated the Endangered Species Act by failing to use the best scientific data available to assess whether Enlist Duo will adversely affect threatened or endangered species. For that reason, I would vacate the 2014 and 2017 registrations under review. . . . The method [EPA] used to assess Enlist Duo’s effects on listed species is scientifically unsound. . . . To evaluate the risks that Enlist Duo poses to listed species, EPA applied the ‘risk quotient’ method. . . . But as the National Academy of Sciences explained in a 2013 report — issued in response to EPA’s own request for advice on the subject — the risk quotient method does not ‘estimate risk’ at all. . . . [The] National Research Council of the National Academies [said] ‘It provides no information about the probability of an adverse effect’ because single-point estimates do not account for the full range of possible exposure scenarios . . . [and] risk quotients may not even reflect the worst-case scenario. . . . The Academy concluded that risk quotients ‘are not scientifically defensible for assessing the risks to listed species posed by pesticides or indeed for any application in which the desire is to base a decision on the probabilities of various possible outcomes.’ . . . [The Academy] reiterated that EPA’s current approach to risk assessments is ‘not appropriate.’ . . . EPA’s use of the risk quotient method violated the Endangered Species Act, and the 2014 and 2017 registrations of Enlist Duo should be vacated as a result.”

In his dissent, Judge Watford also offered some cautionary criticism of the majority’s ruling: “In reaching this outcome, the majority has created a new rule with serious implications. Following today’s decision, an agency may rely on data produced by a scientifically indefensible methodology so long as better data, produced by a methodology that is scientifically defensible, has not yet been generated. Because courts in our circuit must now accept that fundamentally flawed data as the ‘best’ scientific data available, the agency will have no incentive to implement the scientific methods necessary to obtain reliable data. That is not what Congress intended when it required EPA and other federal agencies to use the best scientific data available, and it is certainly not the outcome that our cases demand.”

The larger issue this case (and many others) demonstrate is that federal pesticide regulation — enabled primarily by FIFRA, ESA, the Food Quality Protection Act (FQPA), and the Federal Food, Drug, and Cosmetic Act (FFDCA) — and as it currently is enacted, is inadequate to the task of protecting human and ecosystem health. Multiple agencies bear some responsibility for regulation, though EPA is primary in this regard. EPA’s registration of pesticides is characterized by:

  • egregious impacts of industry influence
  • the agency’s withdrawal of focus on protection of health, biodiversity, and ecosystems, as well as a delegitimizing of independent science and scientists
  • failure to consider adequately health impacts of pesticide exposures during vulnerable human developmental windows, or harms to biodiversity, or synergistic dynamics of multiple compounds as they exist in the real world
  • a risk assessment process that addresses one pesticide product at a time, though multiple products may contain the same problematic active ingredient

Taken together, these gaps constitute a systemic failure of the current approach. Beyond Pesticides describes that failure as “the folly of the federal regulatory system’s attempts to ‘mitigate’ risks of pesticide exposure through small and piecemeal rules. Given the many thousands of chemical pesticides on the market, the complexity of trying to ensure ‘relative’ safety from them . . . and the heaps of cash that fund corporate interests . . . via lobbyists and trade associations, there is one conclusion. ‘Mitigation’ of pesticide risks is a nibble around the edges of a pervasive poison problem; this approach does not at all adequately protect the fragility of life.”

Beyond Pesticides wrote recently, “Piecemeal, locality-by-locality initiatives represent mere ‘drops’ of protection in an ocean of toxic chemical pesticides to which the U.S. public is exposed. A far more effective, protective solution is the much-needed transition from chemical-intensive agriculture and other kinds of land management to organic systems that do not use toxic pesticides.” Beyond Pesticides advocates for a statutory and regulatory approach to pesticides that prohibits high-risk chemical practices, and rejects uses and exposures deemed acceptable under risk assessment calculations filled with uncertainty.

A genuinely protective, precautionary approach requires systemic change to organic and regenerative approaches to land and pest management. These systems would, for example, proscribe use of petrochemical “controls” and inputs (e.g., pesticides and synthetic fertilizers), and arrest the current trajectory of more, and more-toxic, chemical use that threatens human health, ecosystems, biodiversity, and the climate. Beyond Pesticides Executive Director Jay Feldman says, “This transformation should be propelled by the reality that, with the viability of organic practices, we do not need pesticides to meet our agricultural needs or to sustain human health.”

The public can help catalyze this transition through education about organic agriculture, buying organic products (food and non-food items), growing your own organic produce, creating marketplace demand, advocating for organic regulations in the marketplace, and pressuring elected officials to enact legislation and executive action to advance progress toward a far less toxic world.

Sources: https://www.centerforfoodsafety.org/press-releases/6094/court-of-appeals-decision-on-epa-approval-of-dows-enlist-duo-pesticide and http://cdn.ca9.uscourts.gov/datastore/opinions/2020/07/22/17-70810.pdf

All unattributed positions and opinions in this piece are those of Beyond Pesticides.

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