On January 11, 2022, the Environmental Protection Agency (“EPA”) announced that effective immediately it had changed its policy regarding Endangered Species Act (“ESA”) consultations for newly registered pesticide active ingredients. According to EPA, the new policy is expected to allow the agency to consistently assess the impacts conventional pesticides have on species listed under the ESA which should help to reduce litigation and ultimately provide greater stability to the agricultural producers who rely on pesticide use.

Under Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), the term “active ingredient” is defined as “any substance (or group of structurally similar substances, if specified by [EPA]) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, defoliant, or nitrogen stabilizer[.]” 40 C.F.R. § 158.300. EPA has noted that its new policy will apply only those active ingredients being registered under FIFRA for the first time. Other pesticides which are already registered under FIFRA, or which contain active ingredients already registered by EPA may not be subject to the same policy. Registering those pesticides may still require ESA consultation, but the decision to do so may not necessarily be directed by EPA’s new policy.

What is ESA Consultation?

The main purpose of the ESA is to prevent imperiled wildlife species from becoming extinct, and to recover species at-risk of extinction to the point where the ESA’s protections are no longer needed. One of the ways that the ESA accomplishes this goal is by requiring all federal agencies to consider the impact their actions have on listed species and areas designated as critical habitat for listed species. If an agency finds that its action “may affect” a listed species, then the ESA requires the agency to engage in consultation with the U.S. Fish and Wildlife Service (“FWS”) or the National Marine Fisheries Service (“NMFS”) (collectively “the Services”) to determine how much of an affect the action will have and what, if any, mitigation measures can be adopted.

In order to begin ESA consultation, a federal agency must first determine if consultation is even necessary. The text of the ESA states that consultation is required for any action an agency has “authorized, funded, or carried out[.]” 16 U.S.C. § 1536(a)(2). Registering a new pesticide active ingredient is an agency action because it is authorized by EPA. Therefore, whenever EPA registers a new active ingredient, the ESA would require the agency to go through consultation.

There are two types of ESA consultation, formal and informal. Informal consultation can begin during the planning stage of a project. At that point, the federal agency taking the action (otherwise known as “the action agency”) can reach out to the Services to begin discussions about what listed species may be affected by the proposed action. It is during informal consultation when the action agency will determine whether its proposed action “may affect” any listed species or critical habitat. A may affect finding includes actions that are “not likely to adversely affect” as well as actions that “are likely to adversely affect” listed species or critical habitat. If the agency finds that the proposed action will have no effect, then informal consultation is the end of the road and no further action is needed. If an agency determines that it’s proposed action may affect listed species or habitat, but that it is not likely to adversely affect species or habitat, and the Services agree with that conclusion, then no further action is required. 50 C.F.R. § 402.13(c). However, if an agency concludes that it’s proposed action is likely to adversely affect listed species or critical habitat, then it is required to begin formal consultation. 50 C.F.R. § 402.14(a).

Formal consultation is a mandatory process for any proposed federal agency action that may adversely affect listed species or critical habitat. 50 C.F.R. § 402.14(a). The ultimate goal of the formal consultation process is to ensure that the proposed agency action will neither jeopardize the continued existence of a listed species, or destroy or adversely modify critical habitat. Under the ESA, jeopardy is defined as “an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of that species.” 50 C.F.R. § 402.02. Additionally, destruction or adverse modification of critical habitat is defined to mean “a direct or indirect alteration that appreciably diminishes the value of critical habitat as a whole for the conservation of a listed species.” 50 C.F.R. § 402.02. During formal consultation, the consulting Service to develop a document known as a biological opinion (“BiOp”) which states the opinion of the Service as to whether the federal action is likely to jeopardize listed species or result in the destruction or adverse modification of critical habitat. If the Service concludes that jeopardy or adverse modification will occur, the BiOp will also contain recommended mitigation measures intended to minimize the impacts of the action.

Formal consultation may take up to 90 days to complete. Once the action agency completes consultation with either a finding from the Services that the action will not result in jeopardy or adverse modification, or a completed BiOp, the agency can go forward with its proposed action.

EPA’s New Policy

Before a pesticide may be legally used in the United States, it must be registered under FIFRA. In order to register a pesticide under FIFRA, EPA must make a finding that the pesticide will not cause “unreasonable adverse effects on the environment.” 7 U.S.C. § 136a(c)(5)(C). FIFRA goes on to define “unreasonable adverse effects on the environment” as “any unreasonable risk to man or the environment, taking in account the economic, social, and environmental costs and benefits of the use of any pesticide[.]” 7 U.S.C. § 136(bb). In other words, EPA conducts a risk/benefit analysis to determine whether registering a pesticide under FIFRA will cause unreasonable adverse effects on the environment. This differs from the ESA’s “may affect” standard which requires federal agencies to consult with either FWS or NMFS any time they determine that an action may impact listed species in any way.

According to its January 11 announcement, prior to registering a new pesticide active ingredient for use under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), EPA will evaluate the potential effects of the ingredient on listed species and critical habitat and will initiate ESA consultation when appropriate. Before to enacting the new policy, EPA states that it “did not consistently assess” the possible effects of active ingredients on listed species prior to registering new ingredients. EPA claims that failing to do so resulted in insufficient protections for listed species, as well as “resource-intensive litigation” against EPA that caused uncertainty over registered pesticide ingredients. In essence, EPA’s new policy is intended to bring stability and consistency to the process of registering new pesticide active ingredients.

To achieve those goals, the new policy will direct EPA to complete ESA consultation prior to officially registering a new pesticide active ingredient for use. If formal consultation with the Services is necessary, EPA will initiate such consultation before granting the new registration. Additionally, if the Services conclude that use of the active ingredient may jeopardize the continued existence of a listed species or adversely modify designated critical habitat, then EPA will require the ingredient’s use label to contain mitigation measures before the ingredient is registered for use. Additionally, EPA may require the party registering the pesticide active ingredient to incorporate a link to Bulletins Live! Two (EPA’s online system showing use limitations for registered pesticides by geographic area) into the product’s labeling. Under FIFRA, a violation of a pesticide’s labeling instructions is a violation of federal law. Any mitigation measures included in the label of a newly registered pesticide active ingredient would be subject to FIFRA’s requirements.

Going Forward

In its announcement, EPA stated that the new policy would be immediately effective. Going forward, EPA will complete ESA consultation for any new pesticide active ingredient prior to registering under FIFRA. EPA has also stated that the new policy will apply to those active ingredients that were submitted to EPA before the new policy was announced, but which have yet to receive registration. Additionally, EPA noted that it is currently considering how it may apply the policy to antimicrobials and biopesticides in the future.

For more information from EPA on its new policy, click here.

To read the text of the ESA, click here.

To read the text of FIFRA, click here.

For more National Agricultural Law Center resources on the ESA, click here.

Fore more National Agricultural Law Center resources on pesticides, click here.