Technology Sciences Group Inc. 712 Fifth St., Suite A Davis, CA 95616 Direct: (530) 601-5064 Fax: (530) 757-1299 E-Mail: [email protected] Jacob S. Moore Regulatory Consultant September 1, 2016 USDA/AMS/NOP, Standards Division 1400 Independence Ave. SW Room 2648-So., Ag Stop 0268 Washington, DC 20250-0268 Attention: Lisa Brines, PhD National List Manager RE: National Organic Program Petition for Classification of Natamycin as an Allowed Nonsynthetic Substance Dear Dr. Brines: Technology Sciences Group Inc., on behalf of DSM Food Specialties B.V., submits the enclosed petition for classification of natamycin as an allowed nonsynthetic substance. Natamycin is a naturally-occurring compound produced by fermentation of Streptomyces natalensis. As natamycin is known to the National Organic Program and National Organic Standards Board, the petitioner requests that a focused Technical Report be issued to complement the work previously done and resolve the classification status of the petitioned substance. Please contact me with any questions or concerns. Jacob S. Moore TITLE Petition for Classification of Natamycin as an Allowed Nonsynthetic Substance in Organic Crop Production AUTHOR Technology Sciences Group Inc. DATE September 1, 2016 Page 1 of 212 Natamycin Allowed Nonsynthetic Petition – National Organic Program – September 1, 2016 Table of Contents Item A—Indicate which section or sections the petitioned substance will be included on and/or removed from the National List. .................................................................................................................................. 3 Item B ............................................................................................................................................................ 3 1. Substance Name: ............................................................................................................................... 3 2. Petitioner and Manufacturer Information: ....................................................................................... 3 3. Intended or Current Use .................................................................................................................... 3 4. Intended Activities and Application Rate .......................................................................................... 3 5. The source of the substance and a detailed description of its manufacturing or processing procedures from the basic components to the final product. .......................................................... 6 6. Ancillary Substances .......................................................................................................................... 7 7. Previous Reviews ............................................................................................................................... 7 8. Regulatory Authority ......................................................................................................................... 8 9. Chemical Abstract Service (CAS) Number and Product Labels .......................................................... 8 10. Physical and Chemical Properties ...................................................................................................... 9 11. Safety Information ............................................................................................................................. 9 12. Research Information ...................................................................................................................... 11 13. Petition Justification Statement ...................................................................................................... 13 References .................................................................................................................................................. 16 Attachment 1 – Organic Materials Review Institute Canada Certificate .................................................... 18 Attachment 2 – EPA Stamped Acceptable Labels for Natamycin as a Pesticide ........................................ 20 Attachment 3 – Natamycin Safety Data Sheet (SDS) .................................................................................. 45 Attachment 4 – Petitioner Response to Dalhoff & Levy, 2015 ................................................................... 56 APPENDIX – REFERENCES ............................................................................................................................ 63 Natamycin Allowed Nonsynthetic Petition – National Organic Program – September 1, 2016 Page 2 of 212 Item A—Indicate which section or sections the petitioned substance will be included on and/or removed from the National List. Petition for classification of natamycin as an allowed nonsynthetic substance. This petition is at the recommendation of the NOP, as the classification of natamycin is considered unclear. Item B 1. Substance Name: Natamycin 2. Petitioner and Manufacturer Information: DSM Food Specialties B.V. Alexander Fleminglaan 1 2613 AX Delft Netherlands +31 6 13 48 46 97 André Keuter [email protected] Global Regulatory Affairs Manager 3. Intended or Current Use Natamycin is a United States Environmental Protection Agency (US EPA)-registered biochemical pesticide for use as a fungistat in enclosed mushroom production facilities and for use as a post- harvest treatment on food commodities to control fungal diseases. 4. Intended Activities and Application Rate Natamycin is currently approved by the US EPA for use in enclosed mushroom production facilities on mushrooms growth media to prevent the germination of fungal spores and on pineapples, citrus, pome and stone fruit crop groups, cherries, avocado, kiwi, mango, and pomegranate, to control fungal diseases. A summary of the uses and application rates are presented in Table 1. Natamycin Allowed Nonsynthetic Petition – National Organic Program – September 1, 2016 Page 3 of 212 Commodity Diseases Method of Application Use Rate (ai = Natamycin) Mushrooms in Dry Bubble Surface drench 0.36 – 0.73 oz. ai / enclosed production (Verticillium fungicola) 1000 sq. ft. facilities Citrus Green or blue rot In-line dip/drench 6.6 – 13.3 oz. ai / 100 (Penicillium spp.) In-line aqueous or fruit gallons Sour rot coating spray (Geotricum citri-aurantii, Geotricum candidum) Gray mold (Botrytis cinerea) Mucor rot (Mucor spp.) Pome Fruit Blue mold Bin/truck drench 6.6 – 13.3 oz. ai / 100 (Penicillium expansum) In-line dip/drench gallons Gray mold Flooders (Botrytis cinerea) In-line aqueous or fruit Mucor rot (Mucor spp.) coating spray Sphaeropsis rot (Sphaeropsis pyriputrescens) Phacidiopycnis rot (Phacidiopycnis piri) Speck rot (Phacidiopycnis washingtonensis) Stone Fruit Brown rot (Monilinia spp.) In-line dip/drench 6.6 – 13.3 oz. ai / 100 Gray mold gallons (Botrytis cinerea) In-line aqueous or fruit 3.3 – 13.3 oz. ai / Sour rot (Geotricum spp.) coating spray 200,000 lbs of fruit Rhizopus rot (Rhizopus spp.) Cherries Brown rot (Monilinia spp.) In-line aqueous or 3.3 – 13.3 oz. / Gray mold (Botrytis cinerea) flooder application 50,000 lbs of fruit High volume application Avocado Anthracnose In-line dip/drench 6.6 – 13.3 oz. ai / 100 (Colletotrichum spp.) gallons Stem end rot In-line aqueous or fruit 6.6 – 13.3 oz. ai / (Dothiorella spp.) coating spray 200,000 lbs of fruit application Kiwi Botrytis fruit rot (Botrytis In-line dip/drench 6.6 – 13.3 oz. ai / 100 cinerea) gallons In-line aqueous or fruit 6.6 – 13.3 oz. ai / coating spray 200,000 lbs of fruit application Natamycin Allowed Nonsynthetic Petition – National Organic Program – September 1, 2016 Page 4 of 212 Commodity Diseases Method of Application Use Rate (ai = Natamycin) Mango Anthracnose In-line dip/drench 6.6 – 13.3 oz. ai / 100 (Colletotrichum spp.) gallons Stem end rot In-line aqueous or fruit 6.6 – 13.3 oz. ai / (Dothiorella spp.) coating spray 200,000 lbs of fruit application Pomegranate Botrytis fruit rot In-line dip/drench 6.6 – 13.3 oz. ai / 100 (Botrytis cinerea) gallons Blue mold (Penicillium expansum) Pineapple Fusarium oxysporum Dip/pour/cascade 0.18 – 1.44 oz. ai / Penicillium funiculosum gallon of water and Rhizophus stolonife aqueous dilution of Aspergillus niger wax Thielaviopsis paradoxa Table 1. Summary of EPA-approved uses of natamycin. Natamycin Allowed Nonsynthetic Petition – National Organic Program – September 1, 2016 Page 5 of 212 5. The source of the substance and a detailed description of its manufacturing or processing procedures from the basic components to the final product. Natamycin is a nonsynthetic pesticide active ingredient produced by fermentation of a naturally- occurring soil microorganism, Streptomyces natalensis. As discussed in Item B.13, natamycin meets the NOP criteria for classification as a nonsynthetic. The manufacturing process of commercially-produced natamycin follows these general steps. Step 1 – Fermentation Controlled fermentation of the Streptomyces spp. results in the production of natamycin in a crystal form. Natamycin exists naturally within the fermentation broth in crystal form due to its low water solubility. Step 2 - Autolysis The fermentation biomass is lysed under heat to release the natamycin crystals. Step 3- Harvest & Centrifuge Concentration The fermentation broth containing natamycin crystals is then centrifuged to remove the biomass; a solvent that is later removed is added to maintain microbiological stability. Step 4 – Recovery Acid-base extraction is then used to purify and remove the solid