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Registration & Reregistration

Draft Agenda

University of California, Davis

June 10-14, 2001

[updated 7/02/01]

Day One
Sunday, June 10, 2001

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

Jake Mackenzie, western director, Environmental Field Branch, Field and External Affairs Division, O.P.P., U.S. EPA;
Jennifer Krezman, project logistical coordinator, University Extension, U.C. Davis; and
Suzanne Forsyth, program manager, University Extension, U.C. Davis.

9:00

Introductory Exercise

10:00

Break

10:15

Federal Organization and State/Federal Relationship

	enforceability
	mutual accountability

Jim Roelofs, state liaison specialist, Government and International Services Branch, U.S. EPA; Lora Lee Schroeder, life scientist, Pesticides, U.S. EPA, Region 4

11:15

Review of the 2000 Registration Course Work Group Product

Jake Mackenzie

11:45

Overview of the Pesticide Registration Process

	mission & structure
	what is a pesticide?
	applicable statues
	primary functions
	decision-makers
	priority system
	Threshold of Regulations (TOR)
	North American Free Trade Agreement (NAFTA)

Donald Stubbs, chief, Herbicide Branch, Registration Division, Office of Pesticide Programs, 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

James Stone, 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 11, 2001

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

Donald Stubbs

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 Donald Stubbs

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

Special Registration Topics

Minor Uses

James Stone & Donald Stubbs

	Section 24 c
	restricted use products
	EUPs
	6(a)(2)

James Stone

	Inerts
	Distributors

Donald Stubbs

2:15

Load bus and depart for AgraQuest, Davis

Field Trip: Microbial Biopesticides

2:30		Development of a Microbial Biopesticide: Site Tour of AgraQuest, Inc.
		Jennifer Ryder Fox; director, Regulatory Affairs; Lori Lehman, senior staff researcher; Denise Manker, research manager, AgraQuest, Inc.

4:30		Load bus and depart for Hallmark Inn

Day Three
Tuesday, June 12, 2001

Antimicrobials and Pesticides

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, 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)

James Stone and Dennis Edwards

12:00 n.

Lunch at the University Club

12:45 p.m.

Overview of the Registration Process for Biopesticides

	plant pesticides
	label discussion

Brian Steinwand, chief of communications, Biopesticides and Pollution Prevention Division, U.S. EPA

2:15

Break

Special Review & Reregistration

2:30

Special Review & Reregistration

changes made, progress

Robert McNally, chief, Special Review and Reregistration Division, Office of Pesticide Programs, U.S. EPA

3:30

Risk Management Under Reregistration

public participation process

introduction to risk management under reregistration

Robert McNally

4:30

Adjourn & bus pick-up

Day Four
Wednesday, June 13, 2001

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.: Luis Suguiyama, senior advisor, Registration Division, U.S. EPA; Sacramento, CA: Rick Colbert, division director, Office of Enforcement and Compliance Assurance, Office of Compliance, Agriculture and Ecosystems Division, U.S. EPA Facilitated by Jake Mackenzie

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

10:30		Video Teleconference (continued)
		The Anti-Microbial Division
		Washington, D.C.: Frank Sanders, Antimicrobial Division, Office of Pesticide Programs, U.S. EPA Sacramento, CA: Rick Colbert Facilitated by Jake Mackenzie

11:15		Video Teleconference (continued)
		The Biopesticides and Pollution Prevention Division
		Washington, D.C.: TBA, Janet Anderson or Sheryl Reilly, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs, U.S. EPA Sacramento, CA: Rick Colbert Facilitated by Jake Mackenzie

12:00 n.		Adjourn video teleconference; load bus and depart for field trip (lunch on the bus)

Aquatic Weeds in the San Francisco Bay/Delta

1:00 p.m.		Arrive at marina in North Stockton; board boats (2) for tour on aquatic weeds
		Pat Thalken, supervisor, Aquatic Weed Control Program, California Department of Boating and Waterways; Chris Pirosko, technician, U.S. Department of Agriculture Agricultural Research Service, Exotic and Invasive Weed Research Unit; Rob Duvall, graduate student researcher, UC Davis, Exotic and Invasive Weed Research Unit

5:00		Return to marina in North Stockton; load bus and depart for restaurant for dinner ("Al The Wop’s") in Locke

5:20		Arrive in Locke

6:45		Load bus and return to Davis

7:30		Arrive in Davis

Day Five
Thursday, June 14, 2001

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 Jake Mackenzie

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

U.S. EPA faculty