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PPDC Registration Review Implementation Workgroup - Summary of First Meeting Held March 8, 2007


The first meeting of the Pesticide Program Dialogue Committee’s Registration Review Implementation Work Group was held on March 8, 2007.  The work group is providing input to the PPDC on several initial registration review dockets from among those opened in FY 2007.  Highlights of the work group’s discussion are provided below.  Following that is the full meeting report.


Docket Improvements Needed:

Summary Document Suggestions:

Registration Review Page:


Positive Feedback:

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Meeting Attendees

Workgroup Attendees:
Dr. John Ayers, NE IPM Center, Pennsylvania State University
Cindy Baker, Exigent Company (by phone)
Daniel Botts, Florida Fruit and Vegetable Association
Joseph Conlon, American Mosquito Control Association (by phone)
Caroline Cox, Center for Environmental Health
Sue Crescenzi, Steptoe & Johnson
Shelley Davis, Farmworker Justice Fund (by phone)
Larry Elworth, Center for Agricultural Partnerships
Dr. Michael Fry, American Bird Conservancy
Dr. Nancy Golden, US Fish and Wildlife Service
Dennis Howard, Florida Dept of Agriculture and Consumer Services
Sam Jackling, New York Department of Environmental Conservation (by phone)
Dr. Allen Jennings, USDA Office of Pest Management Policy
Susan Kegley, Pesticide Action Network, North America
Dr. Matthew Keifer, University of Washington (by phone)
Steve Kellner, Consumer Specialty Products Association
Isi Siddiqui, CropLife America
Bernalyn McGaughey, FIFRA Endangered Species Task Force & Compliance Services International (and standing in for Syngenta at this meeting)

John Schell, BBL Industries (by phone)
Julie Spagnoli, FMC Corporation
Kristie Stoick, Physicians Committee for Responsible Medicine (by phone)
James Wallace, S.C. Johnson & Sons, Inc.

EPA Participants:
Debbie Edwards, then Director of the Special Review and Reregistration Division (SRRD), Office of Pesticide Programs (OPP)
Kennan Garvey, SRRD/OPP (Workgroup Chair)
Amaris Johnson, SRRD/OPP (Workgroup Coordinator)
Carol Stangel, SRRD/OPP (Rapporteur)
Casey Jarvis, SRRD/OPP
Ray Kent, Health Effects Division (HED), OPP
Dana Spatz, Environmental Fate and Effects Division (EFED), OPP
Molly Clayton, SRRD/OPP
Christine Ollinger, HED/OPP
Jean Holmes, EFED/OPP

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Introduction/Purpose of Meeting

Debbie Edwards opened the first meeting of the Registration Review Implementation Workgroup with an introduction and a discussion of the purpose of the workgroup.  In the registration review program, EPA is following a new paradigm for public participation.  During reregistration, the public’s first opportunity for involvement was after the Agency prepared and issued a risk assessment for a pesticide.  In registration review, however, public involvement starts as soon as the Agency opens a docket to begin the review process. 

Public involvement is especially important because of the high volume of decisions that EPA needs to make during registration review (more than one decision per week).  To maintain this pace, the Agency must be efficient, effective, and wise in its use of resources.  The endangered species issue adds further complexity to the registration review process.

In considering the presentations today on the registration review pesticides clomazone and hexythiazox, the participants are asked not to evaluate specific content, but instead to use these as examples of opening registration review dockets.  Is this way of setting up dockets going to be useful to the public?

Background on Registration Review Dockets

Kennan Garvey presented an overview of registration review including the new decision paradigm, a comparison of reregistration and registration review, and steps in the registration review process.  He discussed the first registration review dockets that opened on February 2, 2007, the structure of the dockets, and the content of the summary document prepared for each pesticide.  For each chemical, the docket lays out the Agency’s preliminary workplan for completing registration review, including any additional data needed and risk assessments planned.  The Agency’s goal is to make the dockets as transparent as possible in order to facilitate comments from the public.  In focusing on two of the recently opened dockets today, we look forward to getting the workgroup’s feedback on format and content.

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Clomazone and Hexythiazox Dockets

The clomazone and hexythiazox registration review teams gave presentations on the Agency’s current thinking about data and risk assessment needs for these pesticides, as reflected in the Summary Document prepared and the background information included in the docket for each pesticide.  Questions and comments from the workgroup members included the following.

Question – Does the Agency have adequate resources to do registration reviews?  How constrained is the Agency in conducting risk assessments for registration review pesticides? 
Agency Response – EPA expects resources for registration review to become available and to increase as reregistration winds down.  In the meantime, our scientists are not making decisions about the need for additional studies or risk assessments based on budget concerns.

Question – How and when will EPA release the final workplans?  What will these documents look like?
Agency Response – EPA will post the final workplans, typically within 90 days after the public comment period closes, on the chemical status pages on the registration review website, at http://www.epa.gov/oppsrrd1/registration_review/reg_review_status.htm.  The Agency may also announce them via EPA Pesticide Programs Updates.  The final workplans will look much like the Summary documents.  They will include the Agency’s plans regarding issuing any Data Call-In notices (DCI’s), risk assessments needed, etc.

Comment – EPA should list and provide more information about FIFRA section 24(c) special local need registrations in developing registration review dockets.  Often the amount of pesticide used is less important than the use locations.

Comment – EPA should include more detailed analyses of incident reports in registration review dockets.

Comment – EPA was asked to explain the new system for assessing drinking water exposure, since Drinking Water Levels of Comparison (DWLOCs) are no longer being used. 
Agency Response – Water is now directly included in the exposure models along with food.

Question – Is EPA planning to call in use and usage data if the US Department of Agriculture (USDA) or the growers cannot provide it?
Agency Response – This is not on the table, so far.  The Agency hopes to obtain use and usage information voluntarily.  

Question - Where are the product labels for pesticides with dockets open?  It’s difficult to find them.   
Agency Response – We will look into this and see if it’s possible to post the labels or a list of product registration numbers in the docket for each pesticide.

Comment – Several workgroup members commended EPA on its approach to registration review.  The first phase is very helpful to states and others; they appreciate knowing the Agency’s concerns going into registration review and knowing how new data may change things later. 

Comment -- The Agency’s water quality data submission SOP was helpful.

Comment -- The Agency’s registration review website is easy to navigate.

Comment – Several workgroup members were concerned that the Agency is predicting effects from other studies rather than calling in data to fill data gaps. 
Agency Response – As part of the new registration review approach, it is appropriate for the Agency to consider whether the uncertainties could significantly impact our decision-making, rather than automatically calling in data to fill data gaps.  This approach is part of conducting the new program efficiently but without compromising the Agency’s ability to predict and assess risks of concern.  Other workgroup members supported the Agency’s conclusion not to require more data.  Work group members were encouraged to submit formal comments to the public dockets regarding any concerns about anticipated data requirements.

Comment – Workgroup members liked information in the PowerPoint slides summarizing EPA’s risk assessment and data needs, and suggested that the Agency include this information in the summary materials for each pesticide.

Comment – Workgroup members believe that the Agency should consider new uses pending registration during a pesticide’s registration review.
Agency Response – EPA looks at pending new uses in a general way and considers whether they may increase risks.  However, the formal review and decision making for new uses occurs in the context of PRIA and its mandates regarding timing.  Any new uses approved at the time a registration review risk assessment begins will be folded into the registration review process.

Comment – EPA should include in dockets the PRIA deadlines on pending registration decisions for new uses.
Agency Response – EPA agrees and will include PRIA deadlines in future Summary documents.

Comment – EPA should get out in front of potential risks during registration review, rather than trying to catch up later.  (For example, pyrethroids entering water systems.)
Agency Response – We are just at the first stage of the review process and are not assessing risks yet; however, the Agency will carefully consider all public comments on its preliminary workplan for risk assessments needed.

Comment – The discussion of degradates is useful from a state perspective.  States need to monitor for both the parent and the degradates.  State labs need access to current analytical methods for degradates.  Internet sites would be helpful.
Agency Response – EPA’s labs have reference standards that the states can request and many methods are available on line.  However, the Agency will review and consider any comments regarding the need for additional analytical method development for specific degradates.

Comment – Endocrine disruptor screening should be included during registration review.
Agency Response – EPA’s Office of Science Coordination and Policy (OSCP) will be requiring the testing of 50 to 100 chemicals in an initial battery of endocrine disruption screening assays in the next year or two.  OPP expects that future screening and testing will be implemented through the registration review program.  In the meantime, OPP will continue to use existing data to evaluate endocrine effects. 

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Workgroup Discussion of Docketing Process and Development of Recommendations to PPDC

The Workgroup discussed the components of the Summary Document and considered whether other information would be useful to include in registration review dockets.

Comments on Preliminary Work Plan:  

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Comments on Fact Sheet:

Comments on EFED Preliminary Problem Formulation Section:

Comments on HED Human Health Risk Assessment Status Update:  

[No Comments.]

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Would Other Information be Useful?

Other Comments?

Next Steps

EPA is opening six more registration review dockets in March 2007.  In terms of workgroup process, the Agency will draft a report summarizing the meeting in a few weeks.  The final report will be considered by the full PPDC at their meeting in May.  Future workgroup meetings will focus on registration review dockets for antimicrobials and biopesticides, and will likely include one or more additional conventional pesticides.

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