Regulatory Developments

EPA and USDA Seek to Expand Public Engagement in Proposed Revisions to ESA Consultation Process within Registration Review

August 7, 2012

On August 3, 2012, the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), the National Marine Fisheries Service (NMFS), and the U.S. Fish and Wildlife Service (FWS) (together, the Services) announced the availability of proposed revisions to the Endangered Species Act (ESA) consultation process as it is conducted within the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Registration Review process. The written proposal is available online. EPA states it will publish shortly a notice in the Federal Register announcing the 60-day public comment period for the proposal, though this notice has not yet been published. As discussed below, the revisions would expand opportunities for public involvement in the registration review process.

Summary

In the written proposal, developed jointly by EPA, USDA, and the Services, the following changes to the Registration Review process are discussed:

  • Increased involvement and opportunity for input by stakeholders at the beginning of the Registration Review process through focus meetings. The focus meetings would allow interested stakeholders to: (1) identify the uses that the registrant intends to support for registration review; (2) address label clarity issues at an early state of the Registration Review process; and (3) discuss early adoption of risk reduction, based on previous assessments, before Registration Review begins. As a result, changes may be made to product labels before the pesticide reaches the preliminary risk assessment stage, thereby supporting a more targeted risk assessment.
     
  • Outreach by EPA to USDA and grower groups to solicit updated use and usage information, such as application methods, rates, frequencies, and timing, to improve the ecological risk assessment and effects determination. EPA states that with this information, it may be able to develop additional risk reduction and reduce the number of consultations required.
     
  • Informal consultations between EPA and the Services early in the Registration Review process, at the preliminary risk assessment stage, with more formal consultations delayed until later in the process, at the proposed decision stage. Through informal consultations, EPA hopes to incorporate more refined species habitat, range, and behavior information into EPA effects determinations before formal consultation. EPA thereby hopes to reduce the number of its "may affect" determinations and reduce the number of formal consultations required, thereby saving resources.
     
  • Following a "may affect" finding and the start of a formal consultation process, increased outreach to growers by EPA and the Services during the public comment period for the draft biological opinion, to solicit feedback regarding the technologically and economically feasible options for minimizing effects on growers and allowing them to meet their pest control needs while avoiding jeopardy to threatened and/or endangered species.
     
  • Improved coordination between and recognition of the respective expertise of EPA, regarding pesticide regulation and label enforcement; USDA, regarding farming/pest management practices and the technological or economic feasibility of risk reduction strategies; and the Services, regarding species-specific information.

Background

Under FIFRA Section 3(g), EPA is required every 15 years to review all registered pesticides and confirm based on the available science that they continue to pose no unreasonable risks to human health, workers, or the environment when used according to product labeling. To implement this mandate, EPA published in 2006 procedural regulations for the Registration Review process, codified in 40 C.F.R. Part 155, Subpart C. EPA periodically publishes schedules according to which it will open dockets for registration review of individual pesticides and cases (pesticides grouped because of similar chemical structure or for other reasons). EPA initiates a pesticide's registration review by establishing a docket for each registration review case and opening it for public comment.

ESA Section 7(a)(2) requires each federal agency to insure, in consultation with the Secretary of the Interior that "any action authorized, funded, or carried out, by such agency...is not likely to jeopardize the continued existence of any endangered or threatened species." If during registration of a new active ingredient or registration review of an existing active ingredient, EPA determines the pesticide may affect a listed threated or endangered species, EPA engages in a consultation process with the Services to assess the risk and implement risk mitigation measures.

As with any administrative process, enhanced public participation offers potential rewards and opportunities for mischief. Stakeholders in the process will want to review the proposal carefully and comment as appropriate to ensure their interests are reflected in the process. Whatever emerges as a final consultative process will be an important part of the registration review process. As noted, comments will be due 60-days from the date the notice is published in the Federal Register, which presumably will be shortly.


 
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