Pesticide Program Dialogue Committee PRIA Process Improvement Workgroup January 25, 2005 Meeting Minutes
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
Ron Derbyshire, Johnson Diversey, Representing CSPA
Dennis Edwards, AD, EPA
Michael Goodis, SRRD, EPA
Ted Head, Nufarm, Representing CPDA
Steve Jarboe, BEAD, EPA
David Jones, Nice-Pak, Representing ISSA
Rick Keigwin, EPA
Phil Klein, Representing CSPA
Jim Kunstman, PBI Gordon, Representing CPDA
Elizabeth Leovey, EFED, EPA
Mike Mendelsohn, BPPD, EPA
Marty Monell, EPA
Erik Olson, NRDC
Sheryl Reilly, BPPD, EPA
Steve Robbins, IRSD, EPA
Amy Roberts, TSG, Representing BPIA
Lois Rossi, RD, EPA
Julie Schlekau, MGK, Representing RISE
Julie Spagnoli, Bayer Healthcare, PPDC Member
Warren Stickle, Representing ISSA
Greg Watson, Syngenta, Representing CLA
Others in Attendance
Jim Downing, BPPD, EPA
Brenda Finn, Bergeson & Campbell
Steve Kellner, CSPA
Anne Middleton, CPDA
Gary Orr, Rivendell USA
- Process Improvements Implemented in the Antimicrobials Division
- Process Improvements Implemented in the Biopesticides & Pollution Prevention Division
- Industry proposal on broadening stakeholder input in the registration process
- Product category labeling issues
- Improvements to the Label Review Manual
- Next Phase of Electronic Submissions
- Next Steps
Overview of Process Improvements in the Antimicrobials Division
Dennis Edwards, Chief of Regulatory Management Branch I, Antimicrobials Division, presented an overview of the Antimicrobials Divisions efforts to improve the registration process. The Antimicrobials Division has been working with decision timeframes since the amendments to the Food Quality Protection Act in 1996. Dennis indicated that initially adjustments to this type of review format did require some cultural changes.
Under PRIA, Antimicrobials Division management meets twice each week to discuss PRIA implementation issues. Teams go over each application received by the division, identifying any unresolved issues and determining the type of review required. These meetings are attended by the branch chiefs and science staff, as needed. The division begins its regulatory review ahead of the completion of the science review.
The division is also holding scoping meetings on new uses and new active ingredients. These are held at the beginning of the review process. They look at the type of data presented and look at what data might be publicly available. To date, 12 chemicals have been evaluated through this process and it has been determined that no further review was needed.
Proposal from ISSA/ACC/CSPA
Member companies would like to have regular meetings with the Antimicrobials Division to continue discussions on process improvements. Their initial focus would be on front end processing issues and how to prepare better quality applications. They also expressed an interested in holding regional workshops for small pesticide companies, particularly those companies with only 1 or 2 registrations.
Overview of Process Improvements in the Biopesticides & Pollution Prevention Division
Mike Mendelsohn from the Biopesticides & Pollution Prevention Division described a new service created by the division called BPPD Consistency. Through this service, registrants submit issues to email@example.com regarding perceived biopesticide registration inconsistencies that affect processing of submissions. The Division’s biopesticide Regulatory Action Leaders (RALs) meet on a regular basis to discuss issues raised through this service and provide an answer usually within two to three weeks. BPPD posts the resolution of issues at: http://www.epa.gov/pesticides/biopesticides/.
Other Process Improvements
Marty Monell described the Agency’s process for renegotiating decision time review periods. All negotiations currently must be approved by the Deputy Director, Office of Pesticide Programs. Senior managers meet on a bi-weekly basis to discuss the need to renegotiate decision times for specific actions. The purpose of this approach is to achieve program-wide consistency on renegotiations.
Stakeholder Involvement in the Registration Process
Greg Watson, Syngenta, presented a proposal developed by industry representatives regarding opportunities to involve stakeholders in the registration process (see attached). In general, industry believes that there are many opportunities for public comment throughout the registration process, including the notice of filing of a tolerance petition, the notice of receipt of a new active ingredient, and the final rule establishing a new tolerance. Industry supports the concept of creation of a public docket containing DERs of the individual studies, risk assessments, and FQPA committee meeting minutes in a public docket after a registration decision has been made. Public interest group representatives recommended that the Agency expand the use of dockets, believing that all parties should have access to information supporting registration decisions. They also expressed that meeting minutes should be docketed, as occurs in the Special Review Process.
Next Steps: Lois Rossi, Director of the Registration Division, indicated that the Agency would develop a standard operating procedure for stakeholder involvement.
Improvements to the Label Review Manual
Industry representatives recommended that the Agency do more to keep the Label Review Manual up-to-date. They expressed that the Agency should set goals of periodically updating the manual. They indicated that inconsistencies between the Label Review Manual and the existing regulations should be rectified. There was general agreement that a repository for determinations on label claims should be created. Other suggestions including translating the Label Review Manual into a checklist to held both registrants and reviewers; hotlinking Pesticide Registration Notices and requirements from Reregistration Eligibility Decision documents.
Next Steps: Marty Monell agreed to bring this issue to the next PRIA meeting with Agency senior managers.
Product Category Labeling Issues
Industry members presented an initial set of label categories that they believe need more work in the area of consistency. The list for BPPD and RD are very similar, and includes:
Public health pests: termiticides, mosquito control, rodenticides, indoor insecticides
Turf use: including golf course, around buildings & non-park grounds, parks, playing fields
Sod farm use
Next Steps: EPA needs to identify what needs to be done and develop a plan to move forward
Marty Monell presented some initial cost estimates for enabling the Agency to receive applications electronically. Initial start-up costs are approximately $1 million in the first year, about $800 thousand in the second year, and $400 thousand in each successive year. Initially the Agency would need to address confidential business information requirements, security, firewall issues, and hardware development. The question was asked whether PRIA resources should be used to fund this endeavor.
- For the next meeting, EPA will prepare a presentation on what is envisioned, costs, etc.
- Stakeholders would also like an update on the use of the OPPIN system.
The Agency is working to set up another workgroup meeting in conjunction with an upcoming SFIREG or AAPCO meeting to begin discussions with state regulators on some federal-state-registrant interaction issues that were discussed at the October 2004 meeting.
The next meeting of the full PPDC is likely to be scheduled for April 2005. The workgroup will need to make a presentation on its progress to date.
Attachment: Industry Proposal
STAKEHOLDER INVOLVEMENT IN THE REGISTRATION PROCESS
January 14, 2005
Under the Re-registration process, “EPA is strongly committed to involving stakeholders and the public in its re-registration and tolerance reassessment decisions. Now, the Agency would like to make the Registration process more transparent as well. CropLife America (CLA) agrees that there needs to be transparency in all of the Agency’s processes and provides this input on stakeholder involvement in the registration process. Because all chemicals do not present the same complexity of issues or risk, there should be flexibility in the public participation process while making timely pesticide registration decisions.
PUBLIC PARTICIPATION PROCESS
The Agency currently has processes in place for stakeholder involvement. These processes include the Federal Register (FR) publications such as the “Notice of Filing”, “Receipt of a New Active Ingredient”, and “Establishment of Tolerance.”
In EPA's schedule for new active ingredient applications, there is a step for a registrant meeting where the registrant briefs Agency personnel on the registration package and potential risk issues, including ESA issues; provides input on problem formulation; and addresses issues arising from the completeness cand the risk manager’s letter. CLA agrees that this is a valuable step. A similar registrant meeting for new uses would also be helpful but could be more similar to a “SMART” meeting as utilized under the re-registration process. The registrant could utilize that opportunity to update the EPA about pesticide uses and usage information so that the correct pesticide use information is used in the risk assessment.
There may be other reasons in the review process for ”Registrant Meetings,” such as discussing technical aspects of the submitted studies and endpoints to be used in the risk assessment.
EPA already has adequate processes in place that allow for public involvement. Federal Register publications such as the “Notice of Filing”, “Receipt of a New Active Ingredient”, and “Establishment of Tolerance” provide notice to the public and opportunities for comment and participation.
CLA agrees with EPA’s proposal to post in a public docket the decision(s) to register a product, including appropriate documents such as risk assessments and data evaluation records that do not contain confidential business information (as determined under FIFRA §10). This proposal is similar to the public consultation process promulgated in the new Pest Control Products Act recently enacted by Canada.