The problems have various origins. For example, the reviews are sometimes secretive, and pesticide companies and other stakeholders are severely limited in their ability to contribute valuable data and otherwise participate in critical discussions. Meetings where problems and solutions are discussed do not occur or do occur at times when the data needed for better decision making are not available. The EPA and the wildlife Services (the U.S. Fish and Wildlife Service and the National Marine Fisheries Service) have different ways of conducting risk assessments and have trouble agreeing in an expeditious manner on final documents.
Following persistent requests from stakeholders to fix the process, EPA’s Office of Pesticide Programs recently invited public comment on a proposal to better integrate the Agency’s registration reviews of pesticides with the work of the Services. The EPA developed the proposal in cooperation with the Services and the U.S. Department of Agriculture (USDA).
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A Little Background …
Under the ESA, any federal agency that determines that an action it proposes may affect a listed species must enter into consultation with the Services to ensure that the action does not result in likely jeopardy to the species. The EPA often determines that FIFRA pesticide product registration and reregistration reviews may affect the ESA-listed species. Accordingly, the Agency initiates consultation with the Services. Both formal and informal consultations are held.
In the course of their own reviews, the Services prepare draft biological opinions (BiOp) that contain analyses and conclusions on whether use of the pesticide is likely to jeopardize the continued existence of a federally listed species or destroy or adversely modify critical habitat. If the Services determine that jeopardy and/or adverse modification is likely, the BiOp would include proposed reasonable and prudent alternatives (RPAs) to the pesticide registration that will avoid the likelihood of jeopardy and/or destruction or adverse modification of critical habitat. The EPA then has the option to include the RPAs in pesticide registration decisions.
The proposal to improve reviews was developed jointly by the EPA, the Services, and the USDA with input from the federal Pesticide Program Dialogue Committee. Enhancements that the agencies believe will streamline the consultation process include: holding focus meetings at the start of registration reviews; convening informal consultations early in the review process; convening formal consultations later in the review process to promote openness, stakeholder participation, and more refined ecological risk assessments; conducting more frequent discussions with stakeholders on the economic and technical feasibility of RPAs; and ensuring that public comments received by the EPA on RPAs are considered by the Services in the development of the final BiOp. Details follow.
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Early Involvement of Stakeholders
As part of the registration review process, the EPA annually publishes a 4-year work plan schedule showing when individual pesticides will enter the registration review program. The Agency wants to provide this information to stakeholders to give them years of advance notice about when reevaluations will begin.
The EPA is also exploring the initiation of focus meetings as early as this year. These meetings would provide interested stakeholders with opportunities to:
- Identify the explicit uses the registrant intends to support for registration review, particularly if these uses have changed from historical uses. This would enable the EPA to begin an early process of defining the scope of the federal action that may need to be considered under the ESA.
- Address label clarity issues at an early stage of the review process. By working with growers and registrants, any confusion regarding label directions could be addressed at an earlier stage to expedite a risk assessment that accurately reflects the intended use of the pesticide.
- Based on previous assessments, provide for early adoption of risk reduction before the registration review begins. Previous assessments may have indicated the potential ecological risks. Based on further field experience with the pesticide, there may also be the potential to identify the key efficacious rates critical for crop protection and/or existing conservation practices being employed, which could be incorporated into labels as part of early risk reduction. It would be EPA’s goal to have any early risk reduction incorporated onto product labels before the pesticide reaches the preliminary risk assessment stage, says the Agency.
See tomorrow’s Advisor for more on EPA’s proposal.