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 Substances for Plant Disease Control [7 CFR § (i)] (Year Published): 1.
Aqueous potassium silicate
(2010) 6.
Lime sulfur
(2000) 2.
Coppers, fixed - copper hydroxide, copper oxide, copper oxychloride 7.
Oils, horticultural 3.
Copper sulfate 8.
Peracetic acid
(2013) 4.
Hydrated lime 9.
Potassium bicarbonate 5.
Hydrogen peroxide
10.
Elemental sulfur

4. Submission to Final Rule: > 7 Years
2012/03/04: FIRST TRY petition submitted
2013/04/11: NOSB public hearing/vote (denied)
: 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
Submission to …
1st Try
2nd Try
Technical report
6 mo.
19 mo.
Crops Subcommittee proposal and vote
11 mo.
21 mo.
NOSB public hearing and vote
13 mo.
23 mo.
NOP proposed rule NA
32 mo.
NOP final rule
(after 60-day public comment period)
34+ mo.

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 registration data:
No bounds
No technical guidance

10. For More Information, Contact:
Cynthia Ann Smith, Partner
Conn & Smith, Inc.