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By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On March 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the publication of its Revised Method for National Level Listed Species Biological Evaluations of Conventional Pesticides (Revised Method), a method for conducting Biological Evaluations under the Endangered Species Act (ESA). 

The Revised Method will be used by EPA to evaluate potential risks from pesticides to federally listed endangered and threatened species and to make effects determinations during initial registration and as part of periodic registration review.  The Revised Method allows EPA to include historical usage data that reflects where and how certain pesticides have been applied to make predictions about the future.

The Revised Method includes a three-step process to identify and evaluate the potential risk to endangered species by the assessed pesticide:

Topic Step 1 Step 2 Step 3
Assessment Biological Evaluation Biological Evaluation Biological Opinion
Scale Individual and Field Individual and Field/Landscape/Watershed1 Population and Landscape/Watershed
Determination No Effect/May Affect Not Likely to Adversely Affect/Likely to Adversely Affect No Jeopardy/Jeopardy2

1 Although Step 2 is conducted at an individual level, consideration is given to the likelihood that an exposure and effect will occur. This step considers the proportion exposed across the landscape/watershed and the distribution of exposure among individuals.

2 This is the determination for listed species. The determination for designated critical habitats is “No Adverse Modification/Adverse Modification.”

EPA Administrator Andrew Wheeler stated: “EPA’s improved methodology will better protect and promote the recovery of endangered species while ensuring pesticide registration review decisions are conducted in a timely, transparent manner and are based on the best available science.”

EPA has also released for public comment draft Biological Evaluations for carbaryl and methomyl, which were conducted using the final Revised Method.  If EPA determines a pesticide may affect a listed species or its critical habitat, it must consult with the Fish and Wildlife Service and the National Marine Fisheries Service (the Services).  The Services will then issue a Biological Opinion to determine if the population of a species would be adversely impacted and, if so, propose ways to reduce risks.

Comments on the draft Biological Evaluations are due on or before May 18, 2020.  The public can submit comments at www.regulations.gov in Docket Number EPA-HQ-OPP-2020-0090

Commentary

Critics of the new method for doing Biological Evaluations have alleged that the purpose of the changes in this method, and of other recent revisions in ESA procedures, is to reduce the number of formal consultations that must be conducted with the Services.  Such allegations must be evaluated in the context of the severe bottlenecks in the current consultation process created by the limited resources and personnel that are available at the Services to conduct any required consultations and to prepare formal Biological Opinions.  The EPA method for doing Biological Evaluations has always been intended to use worst case assumptions to quickly remove from consideration those pesticides that are unlikely to pose any potential risk to endangered and threatened species, so that the limited resources available for the more extensive assessment triggered by consultation are used efficiently to address the most significant potential hazards.  Worst case assumptions, however, exaggerate the “reasonable worst case” and other more realistic scenarios.  Given the reality of limited review resources, focus on more uncertain risks draws resources away from attention on more certain risks to species.  Eventually the assessment system is expected to include other techniques (example: use of probabilistic models) to refine the analyses to concentrate further regulatory options on the most effective ways to protect species.

The draft BE for carbaryl and methomyl are available here and here.  More information on ESA issues is available on our blog.


 

By James V. Aidala and Margaret R. Graham

On December 11, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) made publicly available several documents associated with the Biological Evaluations (BE) for the first three “pilot” chemicals that are being evaluated:  chlorpyrifos, diazinon, and malathion.  For each chemical, the following supporting documents are now available:  problem formulation; fate and effects characterizations; and related appendices.  The provisional models are available here

EPA states on its website that these documents contain the analysis plan and underlying data that will be used to make effects determinations as part of the pesticide consultation process.  The entire draft biological evaluations for the three chemicals, including the effects determinations, will be released for public comment in the spring of 2016

These BEs are a product of the collaboration among the National Marine Fisheries Service (NMFS), the U.S. Fish & Wildlife Service (FWS) (together, the Services), EPA, and the U.S. Department of Agriculture (USDA) in response to the National Academy of Sciences’ April 2013 report, Assessing Risks to Endangered and Threatened Species from Pesticides, which examined topics pertaining to tools and approaches for assessing the effects of proposed Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions on endangered and threatened species and their critical habitats, and provided recommendations.

USDA provided expertise on crop production and pesticide uses and assistance with the use of the National Agricultural Statistics Service Cropland Data Layer to help define the footprint of agricultural use patterns.  The FWS and the NMFS will use the analyses and data from the biological evaluations and integrate it into their final Biological Opinions for the three chemicals due in December 2017.

Commentary

This is the opening blow for developing the next round of the EPA-Services’ Endangered Species Act (ESA) assessment process.  This bolus of information, in the range of 30,000 pages, is the EPA part of the assessment process -- now to be examined by the Services to become the complete ESA assessment of the pesticide products and their possible impact.

It is less clear what these extensive efforts will achieve; in essence, it is likely to indicate little more than “everything affects everything.”  On the other hand, it will provide information useful to indicate where the greatest risks to certain species in specific habitats may lie.  Separately, the mere volume of the information and the amount of effort needed to produce it presents a daunting prospect for the ability of the government agencies (EPA and the Services) to further refine the process into anything resembling a timely and efficient process (not to mention the implications for any public review of the information or associated regulatory conclusions).