Process for Assessing Pesticide Risks to Endangered Species

Quick Resources

Overview of the Ecological Risk Assessment Process (92 pp., 628 kb, about PDF)
Services' evaluation of EPA's Risk Assessment Process (26 pp., 520 kb, about PDF)

The Endangered Species Act
EPA Responsibilities
Effects Determinations
Consultation with the Services
Implementing Measures to Protect Listed Species

The Endangered Species Act

The Endangered Species Act (ESA) is intended to protect and promote the recovery of animals and plants that are in danger of becoming extinct. All federal agencies are required under the ESA to ensure that their regulatory actions are not likely to jeopardize the continued existence of threatened or endangered species (listed species) or destroy or adversely modify their critical habitat, including EPA’s registration of pesticides in the United States. The ESA also prohibits both federal and non-federal entities from injuring or killing individual listed animals without authorization. The ESA is administered by the U.S. Fish and Wildlife Service and NOAA Fisheries Service (together referred to as the Services).

EPA Responsibilities

When registering a pesticide or reassessing the potential ecological risks from use of a currently registered pesticide, EPA evaluates extensive toxicity and ecological effects data to determine how a pesticide will move through and break down in the environment. Risks to birds, fish, invertebrates, mammals and plants are routinely assessed and used in EPA’s determinations of whether a pesticide may be licensed for use in the United States.

EPA’s core pesticide risk assessment and regulatory processes ensure that protections are in place for all populations of non-target species. Because endangered species may need specific protection, EPA has developed risk assessment procedures (described in the Overview of the Ecological Risk Assessment Process) to determine whether individuals of a listed species have the potential to be harmed by a pesticide, and if so, what specific protections may be appropriate. EPA’s conclusion regarding the potential risks a pesticide may pose to a listed species and any designated critical habitat for the species, after conducting a thorough ecological risk assessment, results in an "effects determination."

Effects Determinations

The result of an assessment to determine potential effects of a pesticide’s registration to a listed species will result in one of two determinations:

the pesticide’s registered use will have "no effect" on the species; or
the pesticide’s registered use "may affect" the species.

If EPA determines the pesticide "may affect" the species it refines its assessment to determine whether the pesticide’s use:

"may affect, but is not likely to adversely affect" the species; or
"may affect and is likely to adversely affect" the species.

A determination that the pesticide "may affect, but is not likely to adversely affect," is made where the effects on the listed species are expected to be discountable, or insignificant, or completely beneficial; terms which the Services have discussed in guidance as including effects extremely unlikely to occur, which cannot be evaluated, would never reach a scale where take would occur or are wholly beneficial.

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Consultation with the Service

Informal Consultation - If EPA determines that a pesticide will have "no effect" on a listed species, no further action is required relative to the pesticide’s registration, label or use instructions. If EPA determines that a pesticide’s use "may affect, but is not likely to adversely affect" a listed species, the Agency will engage the Services in a process called informal consultation. The result of this process is typically a letter of concurrence or non-concurrence from the Services, with EPA’s determination.

Formal Consultation - If the Services non-concur with EPA’s determination that a pesticide’s registered use is "not likely to adversely affect" a species or if EPA determines that the pesticide "may affect and is likely to adversely affect" a listed species, it will engage the Services in a process called formal consultation.

During formal consultation (under 50 CFR Part 402, Subpart B), 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 then generally provide EPA with a Biological Opinion, a document providing the Services' assessment and recommendations for steps that EPA should take, if any, to reduce or eliminate potential risk to the species.

The Services’ Biological Opinion provides the Services’ view of whether the pesticide’s registered use is likely to jeopardize the continued existence of the species and, if so, describes alternatives to avoid jeopardy. The Services also authorize any "take" (unintended injury or killing of individual listed animals) that would otherwise be prohibited, as long as measures to minimize take are implemented.

Implementing Measures to Protect Listed Species

If as a result of EPA’s risk assessment or formal consultation with the Services, EPA determines that a pesticide’s registration, label, or use instructions should be altered to ensure use of a pesticide will not take or jeopardize the continued existence of a listed species, EPA may require changes to the use conditions specified on the label of the product. When such changes are necessary only in specific geographic areas rather than nationwide to ensure protection of the listed species, EPA implements these changes through geographically-specific Endangered Species Protection Bulletins.