CPDA/EPA Pesticide Registration Workshop

October 29 - 30, 2008

U.S. Environmental Protection Agency

One Potomac Yard, 2777 Crystal Drive

Arlington, Virginia

DAY 1

8:00 AM  Registration

8:30 AM  Introduction:  Purpose of Workshop and Overview of Agenda

• Sue Ferenc, CPDA President
• Scott Pace, CPDA Regulatory Committee Chairman
• Marty Monell, EPA

8:45 AM  Fundamentals of Registration: Quick Overview of the Basics

• Linda Arrington, EPA

9:15 AM  PRIA - A New Way of Doing Business

• Marty Monell, EPA
• Elizabeth Leovey, EPA
  • New and Revised Product Categories
  • Electronic Payments (www.pay.gov)
  • Completeness Check of Application
  • Importance of Using an Approved Inert

9:45 AM  Labeling Accountability

• Don Stubbs, EPA
• Jim Roelofs, EPA
  • Update on OPP Initiatives to Address Label Quality Issues
  • Label Review Manual
  • Training Initiative
  • Division Quality Assurance Plans
  • Response to Problem Labels

10:15 AM  Break

10:30 AM  Electronic Submissions for Registering Pesticides

• Steve Robbins, EPA
• Thomas Harris, EPA
  • Advantages of Going Paperless
  • e-Submissions Using the XML Format
  • Specifications for Creating a PDF Version of Study Reports
  • Specifications for Text.PDF Electronic Labels

11:00 AM  Inert Approval Process

• PV Shah, EPA
  • How EPA Defines or Describes an "Inert"
  • "Approved" Inerts and their Relationship to "Approved" Formulations
  • A Detailed Description of the Inerts Approval Process
  • Resources

11:30 AM  Product Chemistry Submissions: Common Mistakes

• Debbie McCall, EPA

11:50 AM  Lunch (on your own)

12:50 PM  Registrant Panel:  An Applicant's Perspective on the Most Common Problems Encountered in Product Submission

• Scott Baker, Loveland Products (formulator perspective)
• Jon Gehring, Sipcam Agro USA (generic perspective)
• Julie Spagnoli, FMC (basic producer perspective)
• Frederick Betz, AgraQuest, Inc. (perspective on BPPD products)
• Donna Bishel, BioSafe Systems, LLC (perspective on AD products)

1:50 PM  EPA Panel:  Meet Your Product Manager

2:30 PM  Break

2:45 PM  Breakout Sessions (Attendees will be able to attend two out of the three that will run concurrently)

• Inerts - PV Shah, EPA & Scott Baker, Loveland Products, Inc.
• e-CSF and e-Submission - Dominque Rey-Carruth, EPA
• Labeling - Don Stubbs, EPA/OPP Labeling Committee & Scott Pace, Helena Chemical Company

4:15 PM  Breakout Sessions (Attendees will be able to attend two out of the three that will run concurrently)

• Inerts - PV Shah, EPA & Scott Baker, Loveland Products, Inc.
• e-CSF and e-Submission - Dominque Rey-Carruth, EPA
• Labeling - Don Stubbs, EPA/OPP Labeling Committee & Scott Pace, Helena Chemical Company

5:45 PM  Adjourn (Attendees are asked to leave their index cards and questions at the registration desk before leaving so that these can be addressed on Day 2)

DAY 2

8:45 AM  Recap and Overview of Day Two

• Scott Pace, Helena Chemical Company

9:00 AM  Data Reliance/Compensation Issues in Pesticides Registration

• James P. Rathvon, DLA Piper
• Robert Perlis, Office of General Counsel, EPA
  • Overview of FIFRA data reliance scheme
  • EPA"s implementation of data reliance scheme
  • Recent developments in data compensation arbitration
  • Data protection for inert ingredients/endocrine disruptors

10:45 AM  Break

11:00 AM  Overview of EPA Product Reregistration

• Peter Caulkins, Special Review & Reregistration Division, EPA

11:30 AM  New EPA Initiatives - What's Coming Up Next?

• Marty Monell, EPA
• Lois Rossi, EPA
  • OPP Priorities (Marty Monell)
  • International Harmonization and Joint Reviews (Lois Rossi)

11:45 AM  Lunch (on your own)

1:00 PM  EPA Panel:  "Ask the Experts" -- An Open Discussion Including Q&A With the Audience

• EPA Personnel from RD, AD, and BPPD and OPP Product Managers

3:00 PM  Adjourn

Click here for a participant list from the workshop