Consideration of Data
Registrants of pesticide products develop toxicity and exposure data that they submit to the EPA during completion of the work plan. As this information is being submitted to the Agency, the EPA would, if needed, solicit updated use and usage information from a variety of reliable sources, including the USDA and grower organizations, to help frame the ecological risk assessment. The data would include application methods, application rates, frequency of application, and application timing. The EPA would incorporate these data into the risk assessment and biological evaluation.
These data can also serve to help further refine the label, the uses that will be supported for registration review, and adoption of any additional needed risk reduction, with the possibility of reducing or eliminating the number of “may affect” determinations under the ESA. For example, the EPA notes that utilizing more data on local or regional use patterns could help reduce concerns for listed species and could potentially preclude or minimize the need for consultation with the Services.
According to the EPA, the Services, the USDA, and the EPA are currently engaged in a pilot to determine how best to incorporate these data into the evaluation process.
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Informal Consultation
The EPA is also proposing to change the points in the process where any necessary consultations would be initiated with the Services. Rather than initiate formal consultation during the preliminary risk assessment state, the EPA envisions that it may instead initiate informal consultation at an earlier stage in the process to obtain reliable data on species habitat, range, and behavior. The EPA says it would like to use knowledge gained from informal consultations to discuss potential risk reduction measures with the pesticide registrant.
The Agency believes that focus meetings held with growers before informal consultations can go a long way toward identification of technologically and economically feasible risk reduction measures that can be incorporated into labels.
Formal Consultation
When the EPA determines that formal consultation with the Services is necessary, continued engagement with interested stakeholders and the registration applicant is vital. For example, the applicant should have the opportunity during formal consultation to both submit information and review the draft BiOp. The proposal’s multiple recommendations to streamline formal consultations include the following:
- Upon receiving a request for consultation from the EPA, the Service would convene a meeting with the EPA and the applicant to identify additional information–beyond that provided by the EPA in its package initiating consultation–that can be provided to develop the draft BiOp. If the Services believe that changes to the pesticide label may be necessary, they would work with the EPA, the applicant, and product users to discuss those changes.
- Once the draft BiOp has been developed, the Service would notify the EPA and the applicant. Before formally transmitting the draft BiOP to the EPA, the Services would provide the Agency and the applicant with an opportunity to identify any perceived errors in the description of the proposed action and the effects analysis (e.g., use rates, registered uses, scope of the proposed action). The EPA would make the corrected draft BiOp available for public comment and provide the Services with all comments received. This would provide another opportunity for the public to provide input on the RPAs and provide/suggest/propose alternative risk reduction measures that accomplish the same protection goals that are easier/less costly for the grower/user community to implement.
- During this public comment period, the EPA and the Services would specifically reach out to growers to discuss technologically and economically feasible approaches that could be implemented to minimize the impact on growers and allow them to meet their pest control needs while achieving the necessary protection goals to avoid jeopardy to listed species.
- Upon receipt of the organized public comments from the EPA, the Services would prepare a document that details how such comments were considered and, if appropriate, how the final document was modified to address the comments. The document would be included in the administrative record of the consultation.
- The EPA would generally seek any necessary extensions to the consultation process if the statutory time frames fail to provide adequate time for consideration of information obtained through this process. However, if the extension exceeds more than 60 days (i.e., 150 days from formal initiation), the EPA and the Services must seek consent of the applicants.
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Recognize Expertise
The EPA emphasizes that throughout this process, it is critical that the established expertise of each agency is well-recognized–the Services are the expert agencies regarding the species; the EPA is the expert agency on pesticide regulation and the enforceability of labels. The USDA could lend its expertise on farming/pest management practices and the technological or economic feasibility of adopting risk reduction strategies. Therefore, in developing draft RPAs, the Services should include only those risk reduction measures that the EPA has the authority to impose and should then defer to the EPA to implement those measures utilizing its existing statutory authorities.
“In summary,” states the EPA, “the Services, EPA, and USDA intend that these proposed changes will result in greater openness and transparency in the process of developing Biological Opinions for pesticides under the ESA. Consistent with the statutory mandate to use the best available information, the goal of these changes is to improve the respective agencies’ understanding, through greater engagement of affected stakeholders, of how pesticides are used, the ways in which they may affect listed species, and how any risks can be effectively mitigated, while preserving the beneficial uses of the pesticides to the extent possible.”
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