US Environmental Protection Agency Office of Pesticide Programs Petition for Cyazofamid April 2014 ------- September 6, 2013 iSK BIOSCIENCES Nicole Williams. Registration Division Document Processing Desk (REGFFF i (Sent \ia ; c-1 i \ * 01 lice of Pesticide Programs U.S. HPA, Room S-4400 One P.)!oni;ic Yard (South Building) 277? South Crystal Drive Arlington, VA 22202-4501 Phone number: 703-308-5551 SUBJECT: ATTENTION: MINOR USE - EXCEt JSIVH USE REQUEST - PR1A MOOU/" CYAZOFAM1D TECHNICAL (EPA REGISTRATION NUMBER 71512-2) RANMAN 400SC (EPA REGISTRATION NUMBER 71512-3) Dear Ms. Williams, ISK. Biosciences Corporation (ISKBC. EPA Company Number 71512) is submitting this petition for the extension of the exclusive use period for Cya/ofamid under F1FRA section 3(c}( 1 >< F)(ii). and requests that EPA grant a 3 year extension for the Cyazofamid data. Please find enclosed with this letter three (3) copies of the petition along with one CD and a copy of the payment receipt as noted below; Petition; Application for Extension of the Exclusive IJ so Period for Cyazofamid. One Compact Disc of the complete petition document (fully linked. PDF tl.e). One copy of the PRIA Code MOO? Fee Payment Email Receipt for $5000. FI ERA section 3(c)( 1 )(F){ii) provides for up to a 3 year extension of the exclusive use period for an active ingredient if it meets the qualifying criteria for 9 minor use crop registrations, obtained within the specified 7 year period following the initial registration. Ranman 400SC end use product (EPA Reg. No. 71512-3} containing Cyazofamid was first registered on November 12. 2004, and Technical Cyazofamid (EPA Reg. No. 71512-2) on November 9. 2004. The initial registration included Cucurbit Vegetables (Crop Group 9): and potatoes and field tomatoes. Potatoes and tomatoes are not part of the submission supporting the requested exclusive use period extension. On August 1, 2008, EPA amended the RANMAN 400SC registration to add Carrot, On July 29, 2009, EPA amended the RANMAN 400SC registration to add Grapes, fast of the Rocky Mountains; and Fruiting Vegetables (Crop Group 8) and Okra. Further, on August 13. 2010, EPA amended the RANMAN 400SC registration to add Brassica (Cole) I.eafv Vegetables (Crop Group 5) and Turnip Greens: Spinach; and flops. Note that these uses were registered within seven years of the initial Cyazofamid registration. Minor uses included in the 2004, 2008, 2009 and 2010 registration actions are thus eligible for consideration in a request to extend the exclus ve use period. On September 14, 2012. EPA further amended the RANMAN 400SC registration to add basil: succulent-podded and succulent-shelled beans; and expanded label from spinach to leafy greens (Crop Subgroup 4A) including lettuce: and expanded from potatoes to tuberous and corm I S K Biosciences Corporation 7470 Auburn Road, Suite A, Concord, Ohio 44077, U.S.A tel: 440/357-4640 • fax: 440/357-4661 ------- Ms. W illiams September 6. 2013 Page 2 vegetables (Crop Subgroup !C) and expanded fruiting vegetables crop Group 8 to Group 3-id. I fowevcr, the crops added in September 14, 2012 amendment are not within the scope of tins requested extension of the exclusive use period as the amendment was not within 7 years of the initial Cyazofamid registration. With this petition, 1SKBC provides justification and evidence for 4X minor use e.r<«ps in the above crop groups, approved during the 7 year period following the initial registration, and meeting at least one of the FIFRA criteria. 1 he available data on these crops and crop groups were reviewed and analyzed and the eligibility of many more than 9 minor use erops was detennineo. The evidence and justification are detailed in the enclosed petition, and ISKBC believes that Cyazofamid fully meets the statutory criteria to qualify for a 3 year exclusive use extension. The current exclusive use period for Cyazofamid expires in November 2014. If EPA grams the requested extension, the new exclusive use period will expire November 12, 2017. We appreciate EPA's efforts to implement this provision of FIFRA, and hope that the information provided in this petition is helpful to EPA's evaluation of the extension request. We look forward to working with the agency. Please let us know if we can provide an}' further information and if you ha\e any questions. I can be contacted by photic at (440)-357-4653, h\ lax at <440)-357-4661, or by e-maii at pe p 1 o wsk i m: w i sk be .com. Michael A. Peplowski Manager. Product Registrations Enclosures Cc: Lois Rossi, Director. Registration Division Michelle Knorr.. KPA- Office of Genera! Counsel William Chism. Specialty Crops Advisor Sincerely, 1SK BIOSCIENCES CORPORATION ------- |