1. S MART L ABEL Pilot Program Update Nicole Zinn Office of Pesticide Programs April 14, 2015 1 U.S. Environmental Protection Agency

2. O UTLINE I. Background II. Pilot Program Overview and Preliminary Feedback III. Next Steps 2 U.S. Environmental Protection Agency

3. S MART L ABEL IS … Master pesticide label in a structured format Address label pain points Part of OPP Vision to have instantaneous access to quality information Inclusive of all EPA-registered products Building on previous work (e.g., FDA structured labeling) 3 U.S. Environmental Protection Agency

4. L ABEL P AIN P OINTS Manual/time-intensive label review Manual extraction of label information; manual entry into EPA databases Unclear label information; uncontrolled vocabularies Inconsistent EPA reviews/interpretations Limited ability to query across products Diminishing resources 4 U.S. Environmental Protection Agency

5. S TRUCTURED VS. U NSTRUCTURED Unstructured Information 5 U.S. Environmental Protection Agency Structured Information Street Address: City: State: Zip Code: 2777 S. Crystal Drive, Arlington, VA 22202 2777 S. Crystal Drive Arlington VA 22202

6. S TRUCTURED VS. U NSTRUCTURED ( CONT.) 6 U.S. Environmental Protection Agency Structured Master label information Available in EPA database 100% searchable “Meets EPA requirements for killing norovirus. ” “Kills norovirus. ” Unstructured Master label Available in PPLS May be text searchable Note: image above is a conceptual drawing for informational purposes only.

7. O VERVIEW Purpose: Gather feedback on proposed data model (data elements, labeling sections) and guidance documentation Duration: December 2014 to ~September 2015 Meetings in December, February, TBD Participants: 1. Bayer CropScience 2. Syngenta 3. Dow 4. SePRO 5. Reckitt Benckiser 6. EcoLab 7. Marrone Bio 8. Clorox 9. United Industries Corporation 7 U.S. Environmental Protection Agency

8. F EEDBACK 8 U.S. Environmental Protection Agency FeedbackEPA Response Data entry is labor- intensive and not user- friendly The pilot’s purpose is to evaluate the data model concept Certain data fields are not applicable to antimicrobials Data fields may or may not apply to individual products Certain data fields are new or different SmartLabel does not change 40 CFR 156.10 Overly complicated model Working to simplify Burden to regulated community and benefits are not apparent Expected benefits are presented on slide 9

9. S MART L ABEL B ENEFITS Pain points Manual/time-intensive label review Manual extraction of label information Unclear label information Inconsistent EPA reviews/interpretations Limited ability to query across products Unlevel playing field Diminishing resources 9 U.S. Environmental Protection Agency SmartLabel Solution Electronic comparison of labels and claims Automated label extraction and entry into EPA databases Improved label quality More consistent EPA reviews Advanced querying ability Level playing field Reduced review time

10. S MART L ABEL B ENEFITS BenefitRegistrantsEPAStatesPublic Electronic comparison of labels and claims Automated label extraction and entry into EPA databases Improved label quality More consistent EPA reviews Advanced querying ability Level playing field Reduced EPA review time 10 U.S. Environmental Protection Agency

11. E NGAGING S TATES AAPCO meeting in 2014 SFIREG Updates at SFIREG meetings SFIREG SmartLabel Sub-group Meeting regularly throughout pilot process PREP courses Presented SmartLabel at Compliance and Enforcement PREP course in 2014 SmartLabel session being planned for the Registration and Re-evaluation PREP course in July 11 U.S. Environmental Protection Agency

12. A PRIL 2015 AND BEYOND Continue pilot as EPA develops draft vocabularies, validation rules, database, governance plan Incorporate feedback received during pilot into data model and documentation Continue collaborating with states, industry and FDA Pilot webinar being planned for late April 12 U.S. Environmental Protection Agency

13. C ONTACTS AND R ESOURCES Pilot web page http://www2.epa.gov/pesticide-registration/pesticide- smartlabel-pilot http://www2.epa.gov/pesticide-registration/pesticide- smartlabel-pilot Project leads Patricia Parrot: parrot.patricia@epa.govparrot.patricia@epa.gov Marietta Echeverria: echeverria.marietta@epa.govecheverria.marietta@epa.gov Philip Villanueva: villanueva.philip@epa.govvillanueva.philip@epa.gov 13 U.S. Environmental Protection Agency