11
Oct
In Response to a Lawsuit, EPA Proposes Review Process for Evaluating the Effects of Multiple Pesticide Ingredients on Nontarget Organisms
(Beyond Pesticides, October 11, 2019) The Office of Pesticide Programs (OPP) of the U.S. Environmental Protection Agency (EPA) is seeking public comment on a document that describes an “interim process” being used to assess potential synergistic effects of admixtures of pesticide active ingredients on non-target organisms. This interim risk assessment process was catalyzed in part by a 2015 lawsuit brought by a group of non-governmental organizations; that suit cited EPA’s failure to evaluate appropriately the impacts of a new herbicide, Enlist Duo, on non-target species, including some endangered species. EPA’s inattention to synergistic impacts on non-target species has long been a deficiency of EPA’s pesticide review and regulation and a focus for Beyond Pesticides’ work to factor in uncertainties, or unknowns, in registering pesticides under a precautionary approach. Although EPA recognizes that pesticide exposures occur in combinations, it evaluates a very limited number of such interactions.
Manufactured by Dow AgroSciences, Enlist Duo combines glyphosate and 2,4-D. Increasingly, manufacturers create and market such “twofer” products as responses to the burgeoning issue of plant resistance to individual pesticides. As insects, fungi, weeds, or other “pests” inevitably develop resistance to pesticide, herbicide, fungicide, or insecticide compounds, the efficacy of the chemical treatment obviously plummets. Manufacturer response is often either to find a new chemical, or to “double down” with combined-ingredient products that may be effective until the next wave of resistance develops.
EPA acknowledged, during that 2015 litigation, which challenged EPA registration of Enlist Duo, that some patent applications for registered pesticide products claim that they provide so-called “synergistic” control of target species. The patent assertions about greater than additive (GTA) effects have “raised questions and concerns about the EPA’s current process for evaluating ecological risks of pesticide mixtures because some target pests are also members of taxonomic groups of nontarget organisms that EPA assesses.” Also in 2015, EPA asked the U.S. Court of Appeals for the Ninth Circuit to “vacate its [2014] registration decision and remand the application for Enlist Duo for further study of these effects and any measures that might be needed to mitigate the risk to non-target organisms.” The court denied EPA’s request.
Of EPA’s call for public comment, the National Law Review notes that, “EPA typically registers pesticide products that are not intended to protect public health without any independent evaluation of efficacy data. Nevertheless, in general EPA may choose to evaluate pesticidal efficacy data; such circumstances in the past often involved cases where EPA was required to consider whether pesticide benefits are sufficient to outweigh identified risks. In the Enlist [Duo] case, EPA determined that it should do so where potential synergy in pesticidal efficacy is pertinent to evaluating ecological effects on non-target species. What EPA must decide now is how often efficacy data that has been deemed adequate by the Patent and Trademark Office to support a patent for a new pesticide mixture will have any material significance in the context of ecological risk assessment. . . . EPA has decided it is prudent to afford all stakeholders an opportunity to comment on whether EPA has been asking the right questions.”
Some background: an application for registration of a pesticide product must meet standards in order to be approved. EPA describes those: “Applicants are responsible for citing or generating all data necessary to meet data requirements specified by FIFRA [the Federal Insecticide, Fungicide, and Rodenticide Act, the federal law that created the basic system of pesticide regulation]. The standard for determining whether an application should be granted includes a finding that: (1) a product’s composition warrants the proposed claims for it; (2) the product’s labeling and other material required to be submitted complies with FIFRA; (3) the product will perform its intended function without causing unreasonable adverse effects on the environment; and (4) when used in accordance with widespread and commonly recognized practice, the product will not cause unreasonable adverse effects on the environment.” FIFRA defines “unreasonable adverse effects” as “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.”
For new chemicals in EPA’s pesticide registration process — about which EPA has specific concerns about the potential for GTA effects — the OPP protocol proposes to “request” that registrants: (1) review data from existent patent applications that assert GTA effects from active ingredient interactions; (2) compare data from those applications to EPA ecological risk assessment relevancy criteria; (3) report effects testing data from relevant patents; and (4) “analyze the data to determine if observations of greater than additive effects in mixtures are statistically significant in the context of test variability.” EPA would then review all submitted information to decide whether it should be utilized in ecological risk assessment. Importantly, OPP would rely here on: (1) registrant-submitted data rather than independently secured data, and (2) registrants’ compliance with the “requests.” The Federal Register notice of the protocol document does at least indicate that EPA is “uncertain concerning the utility for risk assessment of the information used by manufacturers to support synergistic effects claims in pesticide patents.”
“Synergy” in the pesticide context has two aspects: one is what these patent applications claim, which is some “greater than the sum of its parts” or “greater than additive” impact on, e.g., weed suppression, by these herbicides with multiple active ingredients. The other aspect is the largely unexamined — by regulators — universe of threats that exposure to multiple pesticide ingredients poses to the environment and to nontarget plant and animal species.
The OPP document, titled Process for Receiving and Evaluating Data Supporting Assertions of Greater Than Additive (GTA) Effects in Mixtures of Pesticide Active Ingredients and Associated Guidance for Registrants, sets out the process that OPP’s Environmental Fate and Ecological Effects Division is using in its attempts to evaluate synergistic risks. However, that process reviews only those admixtures whose makers assert that their efficacy on the target weed or pest is synergistic. OPP’s narrow focus ignores all the other potential synergistic impacts — effects that may arise when organisms, whether floral or faunal, are exposed to multiple active pesticide ingredients. Such “mixing” may happen during industry formulation of a product, in an applicator’s garage or barn, or at the organismic point of exposure via air, water, soil, and/or food.
OPP’s protocol is typical of EPA’s failure to consider risks related to all those other vectors for exposure to multiple pesticides. In a 2016 letter to EPA, Beyond Pesticides noted, for example, that although EPA had concluded that “the combination of 2,4-D choline and glyphosate in Enlist Duo does not show any increased toxicity to plants,” it was unclear that EPA had evaluated synergistic risks to other, non-plant organisms (including humans), who would be exposed to this chemical mixture. Beyond Pesticides wrote, “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.” Beyond Pesticides has advocated, in the face of EPA’s inattention synergistic impacts, that the EPA Office of the Inspector General — tasked with conducting “audits and investigations of EPA to promote economy and efficiency, and to prevent and detect fraud, waste and abuse” — investigate this critical failure.
Beyond Pesticides advocates robustly for a regulatory approach to pesticides that prohibits high-risk chemical practices, and rejects uses and exposures deemed acceptable under risk assessment calculations filled with uncertainty. Rather, the federal regulatory framework should focus on safer, effective alternatives, such as organic agriculture, which prohibits the vast majority of toxic chemicals.
Beyond Pesticides encourages public comment on the OPP risk assessment protocol. Such commentary could include the following points:
- Impacts of pesticides mixtures, which occur in in air, soil, water, and agricultural products, should be considered in all EPA registration decisions.
- Any decision that a pesticide does not cause unreasonable adverse effects (considering all the risks and benefits) requires EPA to determine whether a pesticide is effective. Thus, efficacy data should be required for all pesticides.
- Synergistic effects of pesticides may involve interactions with pharmaceuticals or naturally occurring biochemicals and processes in humans and other organisms.
- Synergistic effects may be mediated in the environment; for example, an herbicide may destroy habitat for an animal that is also being poisoned by an insecticide.
- EPA should investigate potential synergistic impacts of all pesticides.
Public comments on the proposed EPA policy can be contributed here until October 24 at 11:59pm EST. Please consider incorporating the bullet points above in your comments to EPA.
All unattributed positions and opinions in this piece are those of Beyond Pesticides.
