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BADGER BEAT
Endangered species protection program is a critical component of pesticide registration decisions
By Paul Bethke, U.S. Department of Agriculture and University of Wisconsin-Madison Department of Horticulture
Recent changes in how the U.S. Environmental Protection Agency (EPA) evaluates ecological risks from pesticides could make labels more detailed, complex and longer in the registration process.
Public participation is also a key process component, so awareness of what’s changing is critical to maintaining our crop protection tools.
Between 26 and 40 percent of the world’s potential crop production is lost annually because of weeds, pests and diseases (https://www.oecdilibrary.org/agriculture-and-food/ oecd-fao-agricultural-outlook-2012_ agr_outlook-2012-en). Without crop protection, these losses could easily double. Crop protectants or pesticides provide protection of food, feed, fiber and fuel crops. Regulation of these pesticides to ensure minimal risk to human health and the environment is the work of the EPA.
The EPA’s ability to pursue its mission to protect human health and the environment depends upon the integrity and quality of the science on which it relies.
The environmental policies, decisions, guidance and regulations that impact the lives of all Americans must be grounded at a most fundamental level in sound, high-quality science.
CONSIDERING DATA
The EPA considers data from many sources, including pesticide companies, other governments, academia and published scientific literature. EPA scientists and analysts carefully review these data to determine whether to register (license) a pesticide product or use and if specific restrictions are necessary. EPA maintains a transparent, public process for assessing potential risks to human health when evaluating pesticide products. The process EPA uses for evaluating the potential for health and ecological effects of a pesticide is referred to as a risk assessment. The risk assessment is crucial to the overall decision-making process for pesticides, both new and existing. New pesticides must be evaluated before they can enter the market, and existing pesticides must be reevaluated periodically to ensure that they continue to meet the appropriate safety standard. EPA’s decision-making relies on a risk management process, which is conducted in registration for new pesticide chemicals or new uses of existing chemicals, or re-registration/ registration review in the case of a general review of an existing chemical.
There are two main components to the risk assessment: Ecological Risk Assessment and Human Health Risk Assessment.
The National Research Council of the National Academies provides information and guidance on evaluating ecological risks from pesticides in its publication “Assessing Risks to Endangered and Threatened Species from Pesticides.”
BIOLOGICAL EVALUATIONS
In late August, the U.S. EPA released draft biological evaluations (BEs) for three of the most commonly used neonicotinoid insecticides (https:// www.epa.gov/pesticides/epareleases-draft-biological-evaluationsthree-neonicotinoids-publiccomment). The neonicotinoids are used across a range of commodity crops, for home and ornamental uses and commercial indoor/outdoor applications. The release of draft BEs draws new attention to the process of how the EPA determines the ecological risk for any pesticide during the process of re-registration. When determining the ecological risks of all pesticides, the EPA needs to evaluate environmental fate and toxicity data, how pesticides break down and whether potential exposure to the pesticide will result in adverse effects to wildlife and habitats.
As part of EPA’s ecological pesticide risk assessment process, the agency has responsibility for determining
the risk of a pesticide to non-target organisms, with special emphasis on federally listed species and designated critical habitat (https:// www.epa.gov/sites/default/ files/2014-11/documents/ecoriskoverview.pdf). Determining the risk of a pesticide to federally listed species and critical habitat is outlined under the Endangered Species Act (ESA; https:// www.epa.gov/endangered-species). The ESA has the authority to rule on actions taken or permitted by the federal government (through registration or re-registration eligibility), and specifically to ensure that these actions “will not jeopardize the continued existence of a listed species or result in adverse modification of designated critical habitat.” Specifically, the ESA requires federal agencies to: • determine whether their actions might harm a listed species or its designated critical habitat • ensure the action taken or permitted will not jeopardize the continued existence of a listed species or result in adverse modification of its designated critical habitat (substantive obligations) The ESA also includes provisions that allow the public to not only provide comment on the process, but also to bring suit in court against a federal agency when they believe a listed species is not being adequately protected. Several citizen suits have been issued over the past two decades that have required EPA to refine and re-evaluate scientific assessments and make effects determinations for numerous pesticides. These endangered species assessments, which begin with the development of nationwide draft biological evaluations—BEs, have just been initiated for the neonicotinoid insecticides and are currently underway with five additional insecticides, including chlorpyrifos, malathion, diazinon, carbaryl and methomyl. Additionally, BEs were initiated for four herbicides, including atrazine, simazine, propazine and glyphosate. In part because of the many citizen suits filed in the past over the process of “effects determination,” the EPA and the Departments of Agriculture, Commerce and the Interior
continued on pg. 54
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continued from pg. 53 requested, in 2011, that the National Research Council (NRC) of the National Academy of Science (NAS) convene a committee of independent experts. The committee was tasked with examining topics pertaining to tools and approaches for assessing the BEs of proposed ESA actions on endangered and threatened species and their critical habitats. The National Academy released its report in 2013 (https://www.nap. edu/catalog/18344/assessing-risksto-endangered-and-threatenedspecies-from-pesticides), where they were asked to consider the following issues in support of BE’s. • Identifying the best available scientific data and information • Considering sub-lethal, indirect and cumulative effects • Assessing the effects of chemical mixtures and inert ingredients • Using models to assist in analyzing the effects of pesticide use • Incorporating uncertainties into the evaluations effectively • Using geospatial information and datasets in the course of these assessments
A rationale for the development and release of the new report by the NRC was summarized as, “The agencies have developed their own approaches to evaluating environmental risk, and their approaches differ because their legal mandates, responsibilities, institutional cultures and expertise differ.” “Over the years,” the NRC continued, “the agencies have tried to resolve their differences but have been unsuccessful in reaching a consensus regarding their assessment approaches.”
Between 26 and 40 percent of the world’s potential crop production is lost annually because of weeds, pests (such as the Colorado Potato Beetle shown) and diseases. The Environmental Protection Agency (EPA) maintains a transparent, public process for assessing potential risks to human health when evaluating pesticide products.
Since the release of the NAS report, the EPA, U.S. Fish and Wildlife Service & National Marine Fisheries Service (referred to as “the services”) have been working together to develop and improve methods for assessing risks to listed species. In March 2020, EPA released the “Revised Method for National Level Listed Species Biological Evaluations of Conventional Pesticides” (https:// www.epa.gov/endangered-species/ revised-method-national-levellisted-species-biological-evaluationsconventional). The revised method updates the earlier methods originally developed in 2015, and further allows the opportunity for public inquiry and comment.
In response to the implementation of the newly revised method, the EPA has been releasing results of final BEs on several active ingredients to include insecticides like carbaryl and methomyl (March 2021), as well as updated draft BEs for the herbicides glyphosate and simazine.
ADVERSE EFFECT?
Assessing potential effects of a pesticide’s registration to a listed species will result in one of two determinations: (1) the pesticide’s registered use will have “no adverse effect” on the species or designated critical habitat, or (2) the pesticide’s registered use is “likely to adversely affect—LAA” the species or designated critical habitat. These methods are designed to adequately and accurately evaluate the potential risks to federally listed threatened and endangered species and their designated critical habitat from registered uses of pesticides. The EPA will continue to work collaboratively with “the services” to further develop scientific criteria to determine the potential a pesticide may have to result in a LAA determination. During this next step of the evaluation process, EPA provides the services with its detailed assessment
of potential risks and its effects determination. The services review that information and consider it in light of the status and needs of the particular species potentially affected. The services provide EPA with a “Biological Opinion”—a document providing the assessment and recommendations for steps that EPA should take, if any, to reduce or eliminate potential risk to the species. This Biological Opinion provided by the services represents their qualified view of whether the pesticide’s registered use is likely to jeopardize the continued existence of the species and, if so, describes alternatives. to evaluate the ecological risk to endangered or threatened species and their habitat posed by pesticides is not new.
This authority was granted to the EPA in Section 7(a) (2) of the Endangered Species Act (1988) under the Endangered Species Protection Program. As noted previously, ongoing litigation has slowed the implementation and review of both Biological Evaluations and the development of Biological Opinions by the services. Through new guidance from the NRC’s report, the EPA has now developed a defensible and revised method for determining ecological risk.
NOT A NEW MANDATE
To be clear, the EPA's mandate Moreover, the EPA intends the approach to be flexible to achieve
21-10 Badger Common'Tater (7x5).v1.outlines.pdf 1 2021-09-08 11:50 AM the goals of protecting listed species while minimizing the impact on pesticide users. The ongoing program will incorporate public participation within existing processes of registration and registration review. Because several new biological evaluations and biological opinions are being developed, it is time to be aware of the process and the implications that could include extended length of revision timelines and the level of detail or complexity included on pesticide labels. For more information, visit https:// www.epa.gov/guidance or https://www.epa.gov/endangeredspecies/about-endangered-speciesprotection-program.
