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The program, implemented by a final rule that became effective Oct. 10, establishes a "flexible, transparent, and open process" that includes publicparticipation, Debbie Edwards, director of the agency's Special Review & Reregistration Division,said (152 DEN A-6, 8/8/06 ).
Under the agency's "new decision paradigm" for each pesticide, EPA will ask what has changed since the chemical's last assessment, how significant the change is, whether new information is needed, and whether the agency's regulatory position is likely to change as a result, Edwards said.
The registration review process was discussed at a meeting of the Pesticide Program Dialogue Committee (PPDC), a panel that advises EPA with members from the pesticide industry, growers, environmental and worker organizations, and state agencies. Periodic registration reviews are mandated under Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act and the Food Quality Protection Act.
EPA's goal is to have nonfood registration eligibility decisions (REDs) completed in fiscal year 2008, with the goal of a "seamless transition" from reregistration--a one-time process involving older pesticides--to registration review.
During the first public comment period after opening the docket for a given pesticide, EPA will present what it knows and involve the public in developing a work plan, which will be posted on the Web. The second comment period will involve preliminary risk assessment generally, and the third comment period will address the agency's draft decision.
After receiving and reviewing comments, EPA will determine if new risk assessments are required and if more data are needed. It will then develop a final work plan for the case and proceed with review.
Docket Goals Explained
The agency plans to open 25 dockets in fiscal year 2007, including 15 conventional pesticides and 10 antimicrobials and biopesticides.
To promote transparency, Edwards said, the same docket number will be used throughout the review of a particular pesticide's registration. In addition, a website will provide status and docket information.
Edwards said EPA was "learning by doing," and that its goals for each docket included explaining the agency's current understanding and anticipated path forward; analyzing all relevant dietary, residential, occupational, and ecological factors; explaining the rationale for any data or assessment needs; and posing questions for public comment.
In preparing a given docket, Edwards said, EPA will start by assembling and reviewing background information, including data that are "as specific as possible" for each individual crop. "We want to see everything," she said. "I can't think of a particular kind of data that isn't relevant."
The agency will then prepare a summary describing what it knows and does not know, and the significance of any knowledge gaps, especially with regard to effects on endangered species and emerging concerns like endocrine disruption.
Each docket also will include the anticipated work plan, describe how EPA reached its preliminary conclusions, and pose questions on which the agency seeks comment.
Past Performance Praised
Committee members widely praised EPA for nearly meeting a congressional deadline that required the reassessment of thousands of limits on food-related pesticide residues over a 10-year period ending Aug. 3. According to Edwards, EPA completed more than 99 percent of all tolerance reassessments by the deadline.
"This program achieved a pretty monumental accomplishment" in meeting the registration goals, Jim Jones, director of EPA's Office of Pesticide Programs, said. "I'm not familiar with another federal agency that has had such a all encompassing requirement to conduct such a comprehensive review in such a short amount of time. We were able to do it, and do it on time."
The agency also registered 32 new active ingredients (11 conventional pesticides, 15 biopesticides, and six antimicrobials), as well as two new active ingredients in FY 2007.
In addition, EPA: (1) approved 186 new uses--associated with 723 crops--of 44 previously registered conventional active ingredients; (2) approved 278 of 419 "Section 18" requests with a 48-day average turnaround time; (3) completed 3,332 non-PRIA fast-track amendments; and (4) processed 13 inert ingredients.
More information on the PPDC advisory panel and its various working groups is available at http://www.epa.gov/pesticides/ppdc/.