{"id":25759,"date":"2019-10-11T00:00:00","date_gmt":"2019-10-11T04:00:00","guid":{"rendered":"http:\/\/beyondpesticides.org\/dailynewsblog\/?p=25759"},"modified":"2019-10-11T16:53:30","modified_gmt":"2019-10-11T20:53:30","slug":"in-response-to-a-lawsuit-epa-proposes-review-process-for-evaluating-the-effects-of-multiple-pesticide-ingredients-on-nontarget-organisms","status":"publish","type":"post","link":"https:\/\/beyondpesticides.org\/dailynewsblog\/2019\/10\/in-response-to-a-lawsuit-epa-proposes-review-process-for-evaluating-the-effects-of-multiple-pesticide-ingredients-on-nontarget-organisms\/","title":{"rendered":"In Response to a Lawsuit, EPA Proposes Review Process for Evaluating the Effects of Multiple Pesticide Ingredients on Nontarget Organisms"},"content":{"rendered":"

\"\"(Beyond Pesticides<\/em>, October 11, 2019)\u00a0The Office of Pesticide Programs (OPP) of the U.S. Environmental Protection Agency (EPA) is seeking public comment<\/a> on a document that describes an \u201cinterim process\u201d<\/a> 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<\/a> brought by a group of non-governmental organizations; that suit cited EPA\u2019s failure to evaluate<\/a> appropriately the impacts of a new herbicide, Enlist Duo<\/a>, on non-target species, including some endangered species. EPA\u2019s inattention to synergistic impacts<\/a> on non-target species has long been a deficiency of EPA\u2019s pesticide review and regulation and a focus for Beyond Pesticides\u2019 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.<\/p>\n

Manufactured by Dow AgroSciences, Enlist Duo combines glyphosate<\/a> and 2,4-D<\/a>. Increasingly, manufacturers create and market such \u201ctwofer\u201d products as responses to the burgeoning issue of plant resistance<\/a> to individual pesticides. As insects, fungi, weeds, or other \u201cpests\u201d 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 \u201cdouble down\u201d with combined-ingredient products that may be effective until the next wave of resistance develops.<\/p>\n

EPA acknowledged, during that 2015 litigation, which challenged EPA registration<\/a> of Enlist Duo, that some patent applications for registered pesticide products claim that they provide so-called \u201csynergistic\u201d control of target species. The patent assertions about greater than additive (GTA) effects have<\/a> \u201craised questions and concerns about the EPA\u2019s 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.\u201d Also in 2015, EPA asked the U.S. Court of Appeals<\/a> for the Ninth Circuit to \u201cvacate 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.\u201d The court denied<\/a> EPA\u2019s request.<\/p>\n

Of EPA\u2019s call for public comment, the National Law Review<\/em> notes<\/a> that, \u201cEPA 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.\u00a0In 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.\u201d<\/p>\n

Some background: an application for registration of a pesticide product must meet standards in order to be approved. EPA describes those:<\/a> \u201cApplicants 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.\u201d FIFRA defines<\/a> \u201cunreasonable adverse effects\u201d as \u201cany unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.\u201d<\/p>\n

For new chemicals in EPA\u2019s pesticide registration process \u2014 about which EPA has specific concerns about the potential for GTA effects \u2014 the OPP protocol proposes to \u201crequest\u201d<\/a> 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) \u201canalyze the data to determine if observations of greater than additive effects in mixtures are statistically significant in the context of test variability.\u201d 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\u2019 compliance with the \u201crequests.\u201d The Federal Register notice of the protocol<\/a> document does at least indicate that EPA is \u201cuncertain concerning the utility for risk assessment of the information used by manufacturers to support synergistic effects claims in pesticide patents.\u201d<\/p>\n

\u201cSynergy\u201d in the pesticide context has two aspects: one is what these patent applications claim, which is some \u201cgreater than the sum of its parts\u201d or \u201cgreater than additive\u201d impact on, e.g., weed suppression, by these herbicides with multiple active ingredients. The other aspect is the largely unexamined \u2014 by regulators \u2014 universe of threats that exposure to multiple pesticide ingredients poses to the environment and to nontarget plant and animal species.<\/p>\n

The OPP document<\/a>, 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<\/em>, sets out the process that OPP\u2019s 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\u2019s narrow focus ignores all the other potential synergistic impacts<\/a> \u2014 effects that may arise when organisms, whether floral or faunal, are exposed to multiple active pesticide ingredients. Such \u201cmixing\u201d may happen during industry formulation of a product, in an applicator\u2019s garage or barn, or at the organismic point of exposure via air, water, soil, and\/or food.<\/p>\n

OPP\u2019s protocol is typical of EPA\u2019s failure to consider risks related to all those other vectors for exposure to multiple pesticides. In a 2016 letter to EPA<\/a>, Beyond Pesticides noted, for example, that although EPA had concluded that \u201cthe combination of 2,4-D choline and glyphosate in Enlist Duo does not show any increased toxicity to plants,\u201d 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<\/a>, \u201cIt 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.\u201d Beyond Pesticides has advocated<\/a>, in the face of EPA\u2019s inattention synergistic impacts, that the EPA Office of the Inspector General<\/a> \u2014 tasked with conducting \u201caudits and investigations\u00a0of EPA to promote economy and efficiency, and to prevent and detect fraud, waste and abuse\u201d \u2014 investigate this critical failure.<\/p>\n

Beyond Pesticides advocates robustly for a regulatory approach\u00a0to 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\u00a0safer, effective alternatives, such as\u00a0organic agriculture<\/a>, which prohibits the vast majority of toxic chemicals.<\/p>\n

Beyond Pesticides encourages public comment on the OPP risk assessment protocol. Such commentary could include the following points:<\/p>\n