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December 8, 2004 Minutes - PPDC Registration Review Workgroup Meeting
December 8, 2004
1:00 p.m. - 4:00 p.m.
Background information is available on EPA's PPDC Registration Review Workgroup web page, https://www.epa.gov/oppfead1/cb/ppdc/, and in Docket # OPP-2004-0014.
PPDC Workgroup Members:
Patti Bright
Sue Crescenzi
Ray McAllister
Therese Murtagh
Peg Perrault (by phone)
George Wichterman (by phone?)
Other Public Participants:
Patrick McCain, Syngenta
Karen Warkentien, Compliance Services International
Phil Zahodiakin, Pesticide Insider
EPA Work Group Members and Participants:
Jay Ellenberger
Susan Lewis
Phil Ross (by phone)
Amaris Johnson
Ray Kent
Stephanie Plummer
Jennifer Slotnick
Deborah Smegal
Dana Spatz
Carol Stangel
Kendra Tyler
Review of Minutes from September 28, 2004, Workgroup Meeting
Minutes from the all-day workgroup meeting on September 28, 2004, were presented. Workgroup members were asked to review these minutes and contact Carol Stangel by cob Friday, December 17, 2004, with any comments or corrections. No changes were requested so the minutes were accepted as presented.
Discussion of Key Issues from October 21, 2004, Full PPDC Meeting
The following notes summarize remarks, suggestions and recommendations offered primarily by the non-EPA Registration Review Workgroup members who participated in the workgroup meeting on December 8, 2004, and an additional comment received in February 2005. EPA's Office of Pesticide Programs (OPP) will consider these recommendations in developing procedures for the registration review program.
A. Data Call-In's (DCIs)
- If EPA has new, generic/Part 158, risk-driven data needs, and the Agency decides that a particular type of study is needed for one type of pesticide, then the Agency should require the study for all pesticides at that time. Don't wait for registration review to call in the data.
- It's OK to put pesticides with similar data needs and issues into separate "buckets"; but if a risk concern develops, EPA should deal with a pesticide out of its order.
- EPA should prioritize among compounds so that the Agency is not overcome with DCIs at any particular time. Science and risk should drive this process.
- EPA should not require studies across the board if they are no longer needed. The Agency should look at the data coming in and determine whether our assumptions and priorities still stand. Lift the data requirements as appropriate.
- This approach could present "level playing field" issues, but the Agency could address this problem by using a cluster approach (for example, deal with all herbicides together, then all fungicides, etc.), or some other priority system.
- For antimicrobials, the Agency should think about what data we know will be required, and issue the DCI two years in advance of starting the registration review.
- All stakeholders want to have access to information about DCIs. EPA must make sure that all interested parties have an opportunity to be involved, and be sure to get input from all perspectives.
- The steps are clear; we just need to decide which point to call the starting line, and decide what is an adequate amount of time to complete each step.
- Additional comment received on February 18, 2005: In filling data gaps and introducing new data requirements during registration review, EPA must clearly address the methods by which the data requirements are to be filled and the validation status of the test methods. Proper test method validation is important not only for new toxicological endpoints, such as endocrine disruption, but also for more conventional studies. Any new or revised test methods must be validated before their use is required, recommended or encouraged.
What types of information would be helpful to stakeholders early in the process?
- Summary-type information on risk assessments, data gaps, incidents, as well as a bibliography, etc., would be helpful.
- REDs and EDockets currently available on EPA’s website should remain there for reference. It’s important to be able to look back over time at decisions made previously and understand why.
- Current use and usage information is an important starting point. USDA's Pesticide Data Program (PDP) would prefer to do more advance planning. The sooner they can get registration review schedules, the better.
- Where pesticides are being used is important to groups such as the American Bird Conservancy. If pesticide risks are identified, they would like to overlay use locations with the locations of any endangered species. Any regional, state, or local use information that EPA may have would be helpful.
- The timing of pesticide use is also an important factor. USDA’s new crop profiles were updated recently for worker risks to show time lines of use. See www.pmcenters.org.
- EPA has found that industry marketing specialists usually have current information on where pesticides are used, and independent sources such as Doane's are also available.
- Even if EPA is not the source, the Agency could link to other sources of use-related information on its website.
- EPA anticipates that detailed use information won't be required for all pesticides during registration review. However, when use information is needed, it’s usually needed quickly.
How/when should EPA inform the public of activity, such as issuing a DCI, that might occur after publishing the schedule but before the Agency places registration review information in the case docket? This time interval could be a year or more.
- EPA does not usually notify the public about issuance of a DCI by publishing a Federal Register notice or by other means.
- It’s important for EPA to reflect DCIs in our status reporting for each pesticide, using the fewest resources possible.
- A new pesticide status website would be useful, showing the schedule for each pesticide and tracking its status against the schedule.
- Q – When should EPA open a Docket for a pesticide in registration review?
- A – Why ever close an earlier Docket? Include all sorts of registration- and reregistration-related information for a pesticide in its registration review Docket.
- Consider creating a public repository for information related to each pesticide in registration review. Problems could arise, however, with extraneous or frivolous information being included. EPA should develop a mechanism to store key information electronically that is easy to find and ties together the reregistration status web page and EDocket. Establish criteria to determine what information belongs in the Docket for a pesticide's registration review.
Need for flexibility – how to tailor opportunities for public participation to the circumstances? E.g., public participation for "E-Z off ramp" cases.
- For low risk pesticides, it's fine for EPA to handle pesticides as we do now, as long as the Agency provides a comment period on the decision.
- EPA should continue to offer degrees of process depending on each pesticide’s uses, risks, etc. Continue to avoid process for its own sake.
- EPA should not spend too much time sorting out which process to use; just get the job done.
How to handle risks of concern as they emerge outside of registration review.
- When a new risk emerges, if 5% more effort will be required to complete the registration review at that time, then EPA should complete it; otherwise, wait until the scheduled review time.
- Looking at new information re: an emerging risk is not a waste or loss of time, since the information takes us closer to a decision.
- EPA should finish that piece of the review, at least, even if the Agency must return to the pesticide later to complete the registration review.
- EPA should communicate what it decides in such situations so that stakeholders and the public know the pesticide’s current status.
- Timeline – still must complete.
- Other areas to discuss:
- What should the decision document look like?
- To what extent should end-use products be reviewed?
- IT needs.
- The group discussed the schedule for the registration review rule, and the schedule for issuing the revised Part 158 data requirements.