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PPDC Registration Review Implementation Workgroup - Summary of First Meeting Held March 8, 2007
- Highlights
- Meeting Attendees
- Introduction/Purpose of Meeting
- Background on Registration Review Dockets
- Clomazone and Hexythiazox Dockets
- Workgroup Discussion of Docketing Process and Development of Recommendations to PPDC
- Next Steps
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.
Highlights
Docket Improvements Needed:
- Guidance on how to navigate and use the Federal Document Management System (FDMS) dockets
- Organize dockets better, e.g., chronologically except for lead documents
- Provide easier access to labels, i.e., list registration numbers within docket
- Identify documents better, i.e., source, date, and document description
- Attempt to include all available background documents
- Provide more detail on incidents: what is captured and what is not
Summary Document Suggestions:
- Consider separating fact sheet and questions for comment as stand-alone documents; but other view was to have a single comprehensive summary document
- Have more summary and highlighting of Agency conclusions up front
- Highlight more the data requested and not requested with rationale
- Less jargon, write in clear and understandable language
- Better flow between sections of summary document
- Provide more usage information, detail on geographic limitations, and the dates and sources of this usage information
- List 24(c) registrations and detail on their use patterns
- More consistency in format between the eco and human health sections
- Include product/trade names in which each active ingredient is used
- Don’t go overboard with detail; awareness of Agency’s limited resources
- Information about and/or Internet sites for analytical methods needed to aid states
- Include the Pesticide Registration Improvement Act (PRIA) schedule for pending new use decisions and state whether these new uses are being evaluated within the registration review process
Registration Review Page:
- Provide links to pertinent information on each active ingredient (since can’t link from inside the docket system)
General:
- For those pesticides lacking water quality benchmarks, develop benchmarks as part of the registration review process
- Diagnostic biomarkers of pesticide exposure are needed
- Clarify when and how stakeholders could provide information for endangered species assessments in registration review, e.g., pesticide usage, crop location and species location, and life history information.
Positive Feedback:
- Water Quality Data Submission Standard Operating Procedure (SOP) is very helpful! Do other process SOPs as resources permit
- Clomazone and hexythiazox PowerPoint presentations are very clear and could be used as a model for summarizing important points in future dockets
- Pleased to get an early picture of EPA’s thinking and plans for dockets and this helps to focus comments.
- Overall EPA gave a lot of thought about how to organize dockets and create summary documents
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
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.
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 https://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.
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:
- In the Summary Document and in the docket index, reference where information came from and how old it is.
- Rationales for requiring additional data or not, as explained in the PowerPoint presentations or otherwise highlighted, should be included in the docket.
- FDMS docket system is not intuitively clear. Dockets need to be better organized and users need better guidance. Include the date when a document was signed, not just the date when it was posted, in the metadata record in the docket.
- Ask readers for more information on where key crops are grown.
- States have data on water quality, including non-detects. Is EPA interested in receiving this “good news”? [Agency Response – Yes, as described in the water quality data submission SOP.]
- EPA should provide a mechanism for reporting pesticide over-exposures and related symptoms, and be sure that reporting systems are accurate. Develop bio-markers of chemical over-exposure. These would be useful to physicians in diagnosing the specific chemical exposure(s) that resulted in an adverse effect or illness. [Counter-comment – This type of requirement would go beyond the scope of the current part 158 data requirements.]
- EPA just posted aquatic life benchmarks for many pesticides on its website. This is very useful information. For pesticides still lacking benchmarks, registration review could trigger their development.
Comments on Fact Sheet:
- Include trade or product names in which each pesticide active ingredient is used.
- Pull the fact sheet out of the Summary Document and incorporate a few key points from the PowerPoint slides that summarize the content. Provide as a quick reference. Counter-comment: There is value in having a stand alone document that can also be posted on the OPP website as a quick and permanent reference without having to go to the individual dockets.
- Better flow is needed between the fact sheet and the rest of the summary document. References might help. Also, more continuity between the human health and ecological sections is needed.
- Use less jargon and fewer acronyms.
- Do what we can to put more basic, summary information up front, but don’t take too much time and resources reworking the document for multiple audiences. It’s more important to make progress in tackling the large volume of decisions.
- Workgroup members would like the fact sheet to link to other documents in the docket or on EPA’s website, however FDMS does not allow links into or out of the electronic dockets.
Comments on EFED Preliminary Problem Formulation Section:
- Include more indication of what is going to happen during the risk assessment process (generically), especially for endangered species. Identify early in the process where ESA input is needed and can help take ESA assessment needs off the table.
- EFED registration review assessments should consider the potential impacts of aquatic life exposures to pesticides in sediment.
Comments on HED Human Health Risk Assessment Status Update:
[No Comments.]
Would Other Information be Useful?
- More comprehensive incident reporting data are needed. OPP made changes in the late 1990s to the 6(a)(2) rule that established a threshold for reporting of wildlife incidents, based on the number of animals (varies by species) per incident.
- Questions for readers now included in the Summary Document should be pulled out and presented as a separate item in the docket, so they stand out more clearly. [Counter-comment: Don’t do this; the questions may get lost if people don’t see them as part of the Summary Document.]
Other Comments?
- Consider how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and related Department of Health and Human Services (DHHS) privacy rules in 2000 and 2002 affect incident data reporting under FIFRA section 6(a)(2)(G).
- More is better re: use and usage data. For endangered species considerations, crop and pesticide data at the sub-county level may be needed. The registration review process is the appropriate mechanism to gather this geographically-based information.
- In a future meeting, include an example of a conventional pesticide with residential uses. Also include examples of “easy off” cases.
- Given uncertainty about how endangered species evaluations and other aspects of registration review implementation will evolve, it may help to have EPA convene a work group like this one when the next stage of the registration review process, after opening the docket, is underway.
- What are EPA’s criteria for including public literature in dockets? [Agency response: EPA won’t be dumping a lot of published studies into the docket. We are asking the public to provide any data they want us to consider. The Agency will just discuss whether we have considered public literature.]
- Research could be initiated to address some broad issues that apply across chemicals. EPA should meet with universities to discuss our current and future research needs.
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.