April 7, 2005 Minutes - PPDC Registration Review Workgroup Meeting
1:00 pm - 4:00 pm
Room 311, Crystal Mall 2
1801 South Bell Street
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:
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):
- Decision on adequacy of data
- Changes in use patterns or understanding of benefits
- 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)
- Description of new assessments (with or without a detailed description of the reasoning for performing the assessment)
- Describe any risks of concern
- Describe how the risks are mitigated
- Safety finding/decision
- There was a general consensus that the elements currently conveyed in the Reregistration Eligibility Decision (RED) document would be appropriate for Registration Review decision documents.
- The group discussed what use information should be conveyed. There was general agreement that a summary of current uses/use patterns, available at the front end of the process, would be useful.
- Asked if any current elements of the RED could be omitted, a Workgroup member responded that the risks addressed during Registration Review should be newly revealed risks; the Agency should document but not describe risks addressed previously.
- Asked what EPA should do in situations where changes in policy have occurred but they do not change the Agency’s decision, the Workgroup responded that the Agency should just describe the policy changes and explain that they do not change the risk assessment.
- The Workgroup noted that EPA should describe any new data that were received and evaluated in making the Registration Review decision. If more data are needed, the Agency should describe this briefly in the document, too. Make it clear why a decision was made in the absence of any data typically available in the assessment process.
- Another suggestion was that the Agency include a discussion of ongoing regulatory activities at the time of the decision. Clarify any new policies or activities in the works but not explicitly addressed in the Registration Review decision.
- Bullet Revised Based on Comment from Eric Olson on April 25, 2005: The group discussed what needs to be included regarding tolerances. If dietary risk has not changed, then tolerances will not need to be changed; however the Agency will make a finding under FIFRA whether the standard for registration as set forth in sections 3(c)(5) and 2(bb) has been satisfied. The group noted that most dietary risk assessment work should be completed by Registration Review and little new work should be needed.
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
- Summary of assessments
- Full description of RA (parallel to a RED)
- Full assessment
- Summary of old risk assessments and detailed description of any new assessments (to focus on what's changed/new)
- The workgroup quickly converged to recommending that the decision document be an overview document with links to risk assessments, risk mitigation discussions, and other more detailed information. There was general agreement that for areas where the risk picture has not changed, the description should be very short (1-3 sentences). A somewhat more robust discussion should be provided for areas of change.
- For mitigation, one suggestion was to provide a brief description of the risk management decision and, in cases where the decision is complex, provide a link to a more detailed risk management memo or document.
- All supported an electronic document with live links. One comment was that the summary should be a free standing document, so the references to support documents need to be clear, even in a paper copy (i.e., not just a hyperlink).
- The Workgroup discussed the value of providing different levels of detail about Registration Review decisions for different audiences. In addition to the overview document, a fact sheet summarizing the decision may be useful for the casual reader.
B. Product Level Review/Labeling –
To what extent should registration review include consideration of individual pesticide products and labels?
Susan Lewis led this discussion.
- The Workgroup would like to see a summary of the label uses/rates which would be used in a risk assessment at the time a Registration Review docket is open. Also, a link to all the labels would be helpful. This would allow stakeholders to comment on the label rates prior to a risk assessment being generated if needed.
- The Workgroup did not have any new ideas/proposals for a more efficient process to ensure that the risk mitigation or other label changes make it to the user community in a short time. If label changes are necessary, the registrants stated a need for the typical 18 months for existing stocks prior to marketing the new revised label, mainly because of the need to go to the states first with the label amendment. EPA’s label review should be quicker than it has been during product reregistration because new acute toxicity and product chemistry data usually will not be required as part of Registration Review, except in the Antimicrobial Division.
- The Fish and Wildlife Service participant indicated a need for rapid change of labels when endangered species mitigation is involved.
- The group encouraged the Agency to move toward electronic labeling in the future.
- There was a discussion of whether or not confidential statements of formula (CSFs) should be called in during Registration Review. The PPDC co-chair indicated that this was not previously considered.
Kennan Garvey gave an update on EPA's development of a proposed, draft, tentative schedule for Registration Review.
- The Workgroup agreed that they would like to see the Agency's proposed draft schedule for the first five years of the Registration Review program, as well as a full list of all Registration Review cases, ASAP.
- There was discussion about the need to advance certain cases in the schedule based on endangered species or other issues that must be addressed more immediately than through the chronological schedule. The Workgroup has long recommended that EPA follow an "oldest first" predictable schedule with only limited changes, and address significant issues as they come up, rather than saving them for Registration Review. The Agency must consider ways to make the best use of resources while conducting several important new programs simultaneously. It is possible, for example, that the endangered species determination could be handled separately from the Registration Review schedule.
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:
- summary of recommendations re: documentation of decisions
- recommendations re: labeling/end use products
- rule update, including communications/outreach, public meetings
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.