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Registration & Reregistration

Draft Agenda

University of California, Davis

June 9-13, 2002

[updated 6/04/02]

Day One
Sunday, June 9, 2002

The Registration Process
Class Location – University Club (bus pick-up 8:10 a.m.)

8:15 a.m.

Registration/Refreshments

8:30

Welcome and Course Overview

Course Goal: for participants to come away with a fuller understanding of the registration /reregistration process in the context of the state/federal relationship

John Ward, PREP coordinator, Government and International Services Branch, Field and External Affairs Division, OPP, U.S. EPA;
Linda Vance, director, Biological Sciences, UC Davis Extension;
Jennifer Krezman, project logistical coordinator, UC Davis Extension; and
Suzanne Forsyth, PREP program manager, UC Davis Extension

9:00

Introductory Exercise

10:00

Break

10:15

Federal Organization and State/Federal Relationship

John Ward

11:15

Review of the 2001 Registration Course Work Group Product

John Ward

11:45

Overview of the Pesticide Registration Process

Donald Stubbs, chief, Herbicide Branch, Registration Division, OPP, Office of Prevention, Pesticides, and Toxic Substances, U.S. EPA

12:15 p.m.

Lunch at the University Club

1:00

Group Photo

1:15 p.m.

Overview of the Pesticide Registration Process (continued)

2:30

Break

2:45

Case Study: Life of a New Active Ingredient Through the Registration Process

	data requirements
	submission process

Linda Arrington, ombudsperson, Registration Division, Office of Pesticide Programs, Office of Prevention, Pesticides, and Toxic Substances, U.S. EPA

4:30

Adjourn & bus pick-up

Day Two
Monday, June 10, 2002

Registration Considerations

Class Location – University Club (bus pick-up 8:10 a.m.)

8:30 a.m.

Federal and State Perspectives on Section 18

	Section 18 purpose and history
	how EPA evaluates/processes Section 18s
	FQPA impacts on Section 18s
	agency view on factors likely to affect trends in Section 18s in the future.
	federal vs. state applications and how they are processed
	reminder on how States can improve applications/process

	trends in Section 18 applications- types of crops/pests, #/year, seasons, repeats vs. first time applications (discussion of factors affecting trends)
	how the State processes its Section 18s, cradle to grave (with an example?)
	Section 18 enforcement and follow up

Linda Arrington

9:00

Facilitated Discussion on Section 18 Topics

	common problems with Section 18 preparation, submission to EPA and review
	what could be done to improve the Section 18 process?
	emerging issues and questions
	liability waivers
	role of consultants
	role of registrants
	endangered species

Facilitated by Linda Arrington

10:00

Break

10:15

Risk Management Considerations Under the Registration Process

Donald Stubbs

12:30 p.m.

Lunch at the University Club

1:15

Demonstration of the Label Accountability Program

Donald Stubbs and Linda Arrington

2:15

Break

2:30

Load bus and depart for AgraQuest, Davis

Field Trip: Microbial Biopesticides

2:45		Development of a Microbial Biopesticide: Site Tour of AgraQuest, Inc.
		Jennifer Ryder Fox; director, Regulatory Affairs, AgraQuest, Inc.

4:30		Load bus and depart for Hallmark Inn

Day Three
Tuesday, June 11, 2002

Antimicrobials and Biopesticides

Class Location – University Club (bus pick-up 8:10 a.m.)

8:30 a.m.

Overview of the Registration Process for Antimicrobials

Dennis Edwards, chief, Regulatory Management Branch, Antimicrobial Division, OPP, U.S. EPA

10:00

Break

10:15

Product Labeling

	basis
	labeling requirements, including antimicrobials
	directions for use
	specific items of interest (warranty statements, efficacy/phototoxicity, liability disclaimer [indemnification], mandatory versus advisory)

Dennis Edwards

12:00 n.

Lunch at the University Club

12:45 p.m.

Overview of the Biopesticide Division

	registration process
	plant pesticides

Diana Horne, Biopesticides and Pollution Prevention Division, OPP, U.S. EPA

2:15

Break

Special Review & Reregistration

2:30

Special Review & Reregistration

changes made, progress

Venus Eagle-Kunst, Special Review and Reregistration Division, OPP, U.S. EPA

3:30

Risk Management Under Reregistration

public participation process

	introduction to risk management under reregistration
	federal/regional/state partnerships

Venus Eagle-Kunst

4:30

Adjourn & bus pick-up

Day Four
Wednesday, June 12, 2002

Special Review & Reregistration (continued)

Class Location – Sac State University Teleconference Studio (bus pick-up 8:10 a.m.)

9:00 a.m.		Live Video Teleconference: Sacramento, CA & Washington D.C.
		EPA Senior Managers’ Perspectives on Registration and Reregistration
		Washington, D.C.: Debbie Edwards, Registration Division, OPP, U.S. EPA; TBA, Special Review and Reregistration Division, OPP, U.S. EPA; Marcia Mulkey or Jim Jones, OPP, U.S. EPA and Frank Sanders, Antimicrobial Division, OPP, U.S. EPA Sacramento, CA: TBA Facilitated by John Ward

10:00		Break (on your own in the Student Union area)

10:30		Video Teleconference (continued)
		The Biopesticides and Pollution Prevention Division: Biotech 101 Presentation & Discussion
		Washington, D.C.: Janet Anderson, Biopesticides and Pollution Prevention Division, OPP, U.S. EPA Sacramento, CA: TBA Facilitated by John Ward

12:00 n.		Adjourn video teleconference; lunch at Sac State

Field Trip: Pheromone Technology in Walnuts

12:45 p.m.		Load bus and depart for field trip to Marysville

2:15		Arrive in Marysville
		Pheromone Technology in Walnuts
		Carolyn Pickel, IPM advisor, Sacramento Valley, Statewide IPM Program, University of California, Cooperative Extension

4:00		Load bus and return to Davis

5:30		Arrive at Hallmark Inn, Davis

Day Five
Thursday, June 13, 2002

More Registration / Reregistration Considerations

Class Location – University Club (bus pick-up 8:10 a.m.)

8:30 a.m.

Issues for States in Registration

(to be determined)

	discussion of distributor labels
	approved labels vs. retail packaging
	anti-microbials: common sense decisions
	state registration of EPA cancelled pesticides
	range registrations
	25(b) problems and labels
	co-packs
	label changes via notification vs. amendment
	state input on new EPA decisions prior to registration or publication
	necessity of EPA requiring analytical methods prior to registration

Facilitated by John Ward

10:00

Break

10:15

Issues for States in Registration (continued)

12:00 n.

Lunch at the University Club

12:45 p.m.

Office of Pesticide Programs Web Site Demonstration

Dennis Edwards, Donald Stubbs, Linda Arrington, et al

1:30

Overview of the Pesticide Regulator's Forum

Ed White, Office of the Indiana State Chemist

2:15

Break

2:30

Issues for States in Reregistration

Facilitated by John Ward

4:15

Wrap-up

4:30

Adjourn and bus pick-up

6:00

Bus pick-up at hotel for graduation

6:15

Graduation Dinner at the International House

7:45

Bus pick-up and return to Hallmark Inn