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A Registrant’s Perspective on NOP & NOSB: Polyoxin D Zinc Salt Case Study

A Registrant’s Perspective on NOP & NOSB: Polyoxin D Zinc Salt Case Study. BPIA Symposium Biological Products and Organics March 13, 2019; Portland, Oregon Presented by Cynthia Ann Smith of Conn & Smith, Inc. Polyoxin D Zinc Salt. NOP petition [7 CFR §205.601(i)]

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A Registrant’s Perspective on NOP & NOSB: Polyoxin D Zinc Salt Case Study

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  1. A Registrant’s Perspective on NOP & NOSB:Polyoxin D Zinc Salt Case Study BPIA Symposium Biological Products and Organics March 13, 2019; Portland, Oregon Presented by Cynthia Ann Smith of Conn & Smith, Inc.

  2. Polyoxin D Zinc Salt • NOP petition [7 CFR §205.601(i)] • For allowed synthetic substance in organic crop production • For plant disease control • Polyoxin D is a non-GMO fermentation product • Chemical reaction used to produce the zinc salt • Zinc source purchased; no control of production • Mined vs recycled

  3. Only 10 Currently Listed Permitted Synthetic Substancesfor Plant Disease Control[7 CFR §205.601(i)] (Year Published):

  4. Submission to Final Rule: > 7 Years • 2012/03/04: FIRST TRY petition submitted • 2013/04/11: NOSB public hearing/vote (denied) • 2013-2016: New data development • 2016/05/31: SECOND TRY petition submitted • 2018/04/27: NOSB public hearing/vote (recommended) • 2019/02/15: Proposed rule published • 2019/04/16: 60-day public comment period ends • Future: Final rule FR publication

  5. Polyoxin D Zinc Salt Case Study:Timeline

  6. Polyoxin D Zinc Salt Case Study:Lessons Learned TECHNICAL REPORT • Written by an NOP contractor • Insufficient technical expertise for crop use pesticides • Product chem, residue chem, tox, ecotox, efate, efficacy • Re-writes the applicant’s petition based upon Internet searches • Many errors, e.g., Polyoxin D vs all polyoxins; US EPA vs NZ EPA; in vivo vs in vitro; stability vs solubility; heavy metals • Abstract info used without reading the reference • Errors get perpetuated through the review process • Effectively supersedes the registrant’s petition

  7. Polyoxin D Zinc Salt Case Study:Lessons Learned • Significant GROWER SUPPORT is ESSENTIAL for: • Favorable NOSB recommendation to NOP • Favorable and timely NOP decision • All 5-year sunset decisions • Needed for all NOSB public hearings • Likely min. 2 years conventional sales needed before submission • Know your users

  8. Polyoxin D Zinc Salt Case Study:Lessons Learned • NOSB suspicious of data developed by registrant, including: • GLP lab data accepted by EPA • University efficacy trial data • NOSB eager to accept the Technical Report, errors and all • NOSB members not members of the relevant subcommittee can be unprepared for the public hearing and vote • NOSB member attitudes and group dynamics matter • Precautionary principle vs help organic agriculture

  9. Polyoxin D Zinc Salt Case Study:Lessons Learned NOP IS WILDLY DIFFERENT THAN EPA • No fees, no deadlines • Vague, open-ended acceptability criteria only • No study-specific data requirements • No data reporting guidelines • No SEPs, no peer review • NOSB requested/required data beyond EPA registrationdata: • No bounds • No technical guidance

  10. For More Information, Contact: Cynthia Ann Smith, Partner Conn & Smith, Inc. 703-339-1117 cindy@connsmith.com

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