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April 7, 2005 Minutes - PPDC Registration Review Workgroup Meeting

April 7, 2005
1:00 pm - 4:00 pm
Room 311, Crystal Mall 2
1801 South Bell Street
Arlington, Virginia

MINUTES – Completed April 26, 2005

Background information is available on EPA’s PPDC Registration Review Workgroup web page, http://www.epa.gov/oppfead1/cb/ppdc/regisreview/index.html, and in Edocket #OPP-2004-0014.

PPDC Workgroup Members:
Sue Crescenzi, Steptoe & Johnson
Nancy Golden, Fish and Wildlife Service
Ted Head, NuFarm Americas, Inc. (by phone)
Ray McAllister, CropLife America (by phone)
Troy Seidel, People for the Ethical Treatment of Animals (PETA) (by phone)

Other Public Participants:
John Worgan, PMRA, Health Canada
Phil Zahodiakin, PESTICIDE.NET Insider

EPA Workgroup Members and Participants:
Shanaz Bacchus
Suzanne Cerrelli
Jim Downing
Richard Dumas
Jay Ellenberger
Kennan Garvey
Stephanie Irene
Amaris Johnson
Tony Kish
Marianne Lewis
Susan Lewis
Judy Loranger
Michael Nieves
Stephanie Plummer
Vivian Prunier
Kylie Rothwell
Jennifer Slotnick
Debbie Smegal
Dana Spatz
Carol Stangel
Jim Tompkins
Kendra Tyler
TJ Wyatt

I. Review of Minutes from December 8, 2004, Workgroup Meeting

Minutes from the December 8, 2004, Workgroup meeting, including an additional comment received in February 2005, were accepted without comment.

II. Discussion Topics

 

A. Documentation of the Registration Review Decision – What will the Registration Review decision document look like?

Richard Dumas led the discussion to seek the PPDC Workgroup's input regarding documenting Registration Review decisions. He asked for input in two broad areas – first, what to convey and second, how to convey that information.

Question 1: What does the decision document need to convey?

In advance of the meeting, EPA suggested a list of potential elements to provide a basis for discussion (see below). Although this list does not represent an EPA position, one element is important to the Agency. The Registration Review record will need to clearly convey what EPA considered for every type of assessment. That is, it will not be sufficient to simply say that all the old assessments are still valid. Instead, EPA will need to let the public know that, for example, the Agency considered acute dietary risk and its previous assessment is still adequate.

Possible Decision Document Elements (provided in advance of the meeting):

  1. Decision on adequacy of data
  2. Changes in use patterns or understanding of benefits
  3. Decision on adequacy of previous assessments based on current assessment methodology, use patterns, science policies, and changes in regulatory framework (i.e.; approaches dealing with ESA)
  4. Description of new assessments (with or without a detailed description of the reasoning for performing the assessment)
  5. Describe any risks of concern
  6. Describe how the risks are mitigated
  7. Safety finding/decision
  8. Others

Question 2: How should the information be conveyed?

This question has two sub-issues – the level of detail and how to present the information. The group was provided a range of levels of detail, described below.

Possible Levels of Detail for Assessments

  1. Summary of assessments
  2. Full description of RA (parallel to a RED)
  3. Full assessment
  4. Summary of old risk assessments and detailed description of any new assessments (to focus on what's changed/new)

B. Product Level Review/Labeling –

To what extent should registration review include consideration of individual pesticide products and labels?

Susan Lewis led this discussion.

C. Scheduling

Kennan Garvey gave an update on EPA's development of a proposed, draft, tentative schedule for Registration Review.

D. Status of Proposed Rule

Vivian Prunier discussed the current status of the proposed rule for Registration Review. Interagency review is underway and should end in mid-May. After the Administrator signs it, EPA anticipates publishing the proposed rule in July 2005 and offering a 60-day public comment period. The Agency’s goal is to have a final rule before summer 2006.

III. Preparation for Full PPDC Meeting on May 11-12, 2005

The PPDC Registration Review Workgroup is scheduled to give a presentation at the next full PPDC meeting, on Thursday, May 12, 2005, from 9:00 - 10:00 a.m. Potential topics include:

Sue Crescenzi will discuss these topics with other Workgroup members.

The Workgroup plans to hold a conference call on Monday, April 25, 3:30 - 4:30 pm, to finalize their PPDC presentation.

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