NPIRS CONFERENCE AGENDA Bally s Hotel Skyview Las Vegas Blvd. South, Las Vegas, Nevada

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1 Moderator: Ana Cristina Rodriguez, DuPont Crop Protection 9:00a > 9:15a WELCOME AND INTRODUCTIONS Ana Cristina Rodriguez, State Registration & Regulatory Affairs Manager DuPont Crop Protection 9:15a > 9:45a THE EPA SMARTLABEL PILOT The EPA SmartLabel Pilot is an initiative to develop an electronic system for pesticide labels that will ultimately provide many benefits to everyone involved. As part of the SmartLabel Pilot, nine pesticide registrants have been submitting pesticide labels to EPA through a fully electronic system, instead of paper or PDF files. This presentation will provide an overview of the SmartLabel Pilot initiative and the activities that have taken place since its inception. Marietta Echeverria, Branch Chief Invertebrate and Vertebrate Branch I 9:45a > 10:15a THE SMARTLABEL DATA MODEL SmartLabel will make the label review process more efficient by creating a standard template for the submission of pesticide label content to EPA, allowing for faster reviews and easier comparisons to previous label versions. Additionally, SmartLabel will allow the agency to set up a searchable database of standardized label use data for all products, which can be used in support of risk assessments and registration decisions. This presentation will outline the label sections and data elements in the data model. Dominic Schuler, Acting Ombudsman (via webinar) Antimicrobial Division 10:15a > 10:30a BREAK 1

2 Ana Cristina Rodriguez, DuPont Crop Protection 10:30a > 11:15a USING STRUCTURED PRODUCT LABELING XFORM A simple web-builder for creating a SmartLabel file will be demonstrated using the Structured Product Labeling (SPL) Editor Xforms. Currently used by the U.S. Food and Drug Administration, SPL Xforms is a web application compatible with both Macs and PCs that will allow manufacturers to input pesticide label text by category such as Precautionary Statements or Directions for Use. Gina Burnett, Regulatory Action Leader Biochemical Pesticides Branch Biopesticides and Pollution Prevention Division, OPP, U.S. EPA 11:15a > 11:45a THE SMARTLABEL USE INDEX The data model will be presented for collecting the SmartLabel detailed use index information that EPA will utilize for risk assessment purposes. This information includes application instructions specific to the use site, such as application rate, number of applications, reapplication interval, application timing, target pest, and site-specific restrictions. Clair Paisley-Jones, Biologist (via webinar) Science and Information Analysis Branch Biological and Economic Analysis Division, OPP, U.S. EPA 11:45a > 1:00p Lunch On your own Moderator: Charlie Clark, Florida Dept. of Ag & Consumer Services 1:00p > 1:30p PESTICIDE RESIDUE TOLERANCE INDEXING EPA is responsible for regulating the pesticides that are used by growers to protect crops and for setting limits on the amount of pesticides that may remain in or on foods marketed in the USA. These limits on pesticides left on foods are called "tolerances" in the U.S and are often referred to as maximum residue limits, or MRLs. EPA establishes tolerances for each pesticide based on the potential risks to human health posed by that pesticide. The SmartLabel data model for pesticide residue tolerance indexing information will be presented and the Xform web-builder to collect the MRL information will be demonstrated. Julie Chao, Product Manager (via webinar) Risk Management Branch Antimicrobials Division, OPP, U.S. EPA 2

3 Moderator: Charlie Clark, Florida Dept. of Ag & Consumer Services 1:30p > 2:00p SMARTLABEL TERMINOLOGY Managing terms and their meanings; explaining acronyms and abbreviations; and clearly defining the terms that are used within EPA, for partners and collaborators, and for the public, are a key to performing EPA s science, regulatory, and information mission. The main tool within EPA s Terminology Services is Synaptica, a commercial software product for creating, storing, maintaining, and distributing vocabularies. This software supports workflow, including input from multiple editors, and term statuses that support a process for review and governance. This presentation will include a discussion of the EPA vocabulary lists, terms and definitions. Brittany Pruitt, Chemical Review Manager (via webinar) Risk Management and Implementation Branch III Pesticide Re-evaluation Division, OPP, U.S. EPA 2:00p > 2:45p DEFINING SMARTLABEL BENEFITS As a fully electronic system, SmartLabel will provide benefits to EPA, state regulatory agencies, chemical companies, university extension offices, and many other stakeholders. One clear benefit is that the SmartLabel system will make pesticide label information quickly available to the public in an easily searchable format. This presentation will outline potential benefits defined by EPA and ALSTAR workgroup leaders representing states and industry. Marietta Echeverria, Branch Chief Invertebrate and Vertebrate Branch I Lauren Myers, Senior Regulatory Affairs Specialist Jessica Goldberg, Senior Regulatory Affairs Specialist United Industries Corporation Charlie Clark, Administrator Florida Department of Agriculture & Consumer Services 2:45p > 3:00p BREAK 3

4 Moderator: Charlie Clark, Florida Dept. of Ag & Consumer Services 3:00p > 3:45p CURRENT ISSUES OF IMPORTANCE AG CROP PROTECTION Jeff Case, Senior Director, Government Affairs CropLife America 3:45p > 4:15p AWARDS AND RECOGNITION OF RECEPTION SPONSORS 5:00p > 7:00p RECEPTION Skyview 4 4

5 Thursday, October 1, 2015 Moderator: Denise Alder, California Dept. of Pesticide Regulation 9:00a > 9:15a ANNOUNCEMENTS 9:15a > 10:00a HAVING A CONVERSATION WITH EASE Ever wonder what you could say that would make a difference in how modern agriculture is perceived? Listen and learn from USFRA's research and adopt tips and tactics for how to spread the positive message of today's agriculture within your community using language that resonates with consumers. Randy Krotz, Chief Executive Officer U.S. Farmers & Ranchers Alliance 10:00a > 10:15a BREAK 10:15a > 11:00a MANAGEMENT OF DATA FOR DATA COMPENSATION PURPOSES Robert Butz, Ph.D., Staff Scientist Sullivan and Worchester LLP 11:00a > 11:45a WEB DISTRIBUTED SECTION 24(C), FEDERAL SUPPLEMENTAL AND SECTION 18 LABELING William Jordan, Senior Policy Adviser (via webinar) Michelle Arling, (via webinar) Steve Foss, Registration Specialist Pesticide Management Division Washington State Department of Agriculture Dirk Fredrichsdorf, Head of Knowledge and Information Mgt. Bayer CropScience 11:45a > 1:00p Lunch On your own 5

6 Thursday, October 1, 2015 Moderator: Debbie Stubbs, Syngenta 1:00p > 1:30p SUCCESSES AND CHALLENGES OF ELECTRONIC DOCUMENT COMPARISON Denise Alder, Senior Environmental Scientist Pesticide Programs Division California Department of Pesticide Regulation 1:30p > 2:15p VERIFYING DISTRIBUTOR DATA Ed White, Assistant Pesticide Administrator Office of the Indiana State Chemist Martin Deubler, State Registration Manager Nufarm Americas, Inc. 2:15p > 2:30p BREAK 2:30p > 3:30p A UNIVERSAL APPLICATION FOR NEW STATE REGISTRATIONS Lauren Myers, Senior Regulatory Affairs Specialist United Industries Corporation Charlie Clark, Administrator Florida Department of Agriculture & Consumer Services Oleta Melnicoe, Vice President Chair (invited) Technology Sciences Group, Inc. 3:30p > 4:00p USING ALSTAR TO MANAGE STATE SPECIFIC REGISTRATIONS 25(B) S, ADJUVANTS, DEVICES, STATE EUP S AND CO-PACKS The functionality for companies to upload labels for products registered in states that do not have an EPA Registration Number has been added to ALSTAR. This presentation will cover the details of how this works and how it will benefit the ALSTAR participants. 6