### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , DC 20460

Ms. Nancy Delaney, Regulatory Manager Authorized Agent for Nichino America, Inc. c/o Bayer CropScience LP P.O. Box 12014, 2 T.W. Alexander Drive Research Triangle Park, NC 27709-2014

SUBJECT: Flubendiamide BELTTM SC Insecticide, EPA Reg. No. 264-1025 SYNAPSETM WG Insecticide, EPA Reg. No. 264-1026 FLUBENDIAMIDE Technical, EPA Reg. No. 71711-26 VETICA® Insecticide, EPA Reg. No. 71711-32 TOURISMO® Insecticide, EPA Reg. No. 71711-33

Dear Ms. Delaney: OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION
Friday, January 29, 2016

Bayer CropScience LP, on its behalf and as an agent for Nichino America, Inc., hereafterjointly identified as BCS/NAI, was granted a time-limited/conditional registration under section 3(c)(7) ofthe federal Insecticide, Fungicide and Rodenticide Act (FIFRA) for flubendiamide on August 1, 2008, with
an original registration expiration date ofJuly 31, 2013. The expiration date was included in the registration in large part because of EPA's initial concerns regarding flubendiamide's mobility,
stability/persistence, accumulation in soils, water columns and sediments, and the extremely toxic nature ofthe primary degradate NNI-001-des-iodo (des-iodo) to invertebrates of aquatic systems. As a condition of registration as established in the preliminary acceptance letter (PAL) for flubendiamide, dated July 31, 2008 (copy attached), ifthe Agency were to make a determination that further registration ofthe flubendiamide technical and end-use products would result in unreasonable adverse effects to the environment, within (1) week of notification ofthis finding, BCS/NAI will submit a request for the voluntary cancellation ofthe flubendiamide technical and all end-use products.

BCS/NAI's original release for shipment ofthe flubendiamide products constituted acceptance ofthe conditions of registration as outlined in the PAL. As stated in the notices of registration for each flubendiamide product, ifthe conditions of registration are not complied with, the registration for all flubendiamide products would be subject to cancellation in accordance with section 6(e) of FIFRA. In addition, as part ofthese conditions of registration, BCS/NAI agreed to generate and submit a vegetative buffer strip and water monitoring studies. These two studies were submitted to the Agency and have been reviewed.

A series of meetings between EPA scientists and BCS/NAI scientists have occurred since March 2015, where the Agency and BCS/NAI have continued to engage in dialogue about the referenced conditional data, various label mitigation proposals, and all the Agency's conclusions regarding the same. EPA has not altered its original conclusion that flubendiamide and its des-iodo degradate are mobile, stable/persistent, accumulate in soils, water columns and sediments and are toxic to aquatic invertebrates. In fact, EPA's most recent analysis suggests that the continued use of flubendiamide is expected to have significant negative impact on invertebrates of aquatic systems, which could lead to negative impacts on other taxa as well. For a complete Agency regulatory conclusion, please refer tothe following attached document: "EPA Recommendation to CancelAll Currently Registered Fl

ubendiami de Products."

The benefits offlubendiamide are that it plays a role in integrated pest management and insecticide resistance management based upon the following characteristics: (1) specificity to Lepidopteran larvae; (2) non-systemic but translaminar properties; and (3) no to low impacts on beneficial arthropods. Overall, EPA concludes that there are efficacious alternatives for flubendiamide. For a complete Agency benefits conclusion, please refer to the following attached document: "Review of Bayer CropScience Benefits DocumentSupporting the ContinuedRegistration ofFlubendiamide (Belt SC) andBCS White Paper."

The Agency has made a determination that the continued use ofthe currently registered flubendiamide products will result in unreasonable adverse effects on the environment. These conclusions are contained within the attached documents: "Flubendiam1de: Ecological RiskAssessmentAddendum SummarizingAllSubmissions andDiscussions to Date' and "EPA Recommendation to CancelAll Currently Registered Flubendiamide Products."

BCS/NAI understood and agreed by signing the PAL that if, after review ofthe referenced conditional data, EPA makes a determination of unreasonable adverse effects on the environment, that BCS/NAI would within one (1) week of notification ofthis finding submit a request for voluntary cancellation of all the flubendiamide registrations. We are hereby notifying you that we have made such a finding and under the terms ofthe time

-limited/conditional registration, you are obligated to submit an appropriate request for voluntary cancellation to EPA by or before Friday, February 5, 2016. This request for voluntary cancellation must include a statement that BCS/NAI recognizes and agrees that the cancellation request is irrevocable. Failure to submit a timely voluntary cancellation request will result in the Agency initiating cancellation of all currently registered flubendiamide products under section 6(e) of FIFRA.

Ifyou have any questions about anything contained in this letter, please contact either Mr. Carmen J. Rodia, Jr. by phone at (703) 306-0327 or via e-mail at Rodia.Carmenc@epa.govor Mr. Richard J. Gebken by phone at (703) 305-6701 or via e-mail at Gebken

.R1chard@ epa.gov

. 

### Ifthere are any legal concerns, you may contact the Office of General Counsel's Ariadne Goerke by phone at (202) 564-5471 or via email at Goerke.Anadne@epa.gov

.

Attachments: Copy ofPreliminaryAcceptance LetterforFlubendiamide, datedJuly31, 2008 CopyofDecision Memorandum "EPA Recommendation to CancelAll Currently Registered Flubendiamide Products ,"datedJanuary29
, 2016 CopyofBEAD ''Review ofBayerCropScience Benefits DocumentSupporting the Continued Registration of Flubendiamide (BeltSC) andBCS White Paper, " datedJuly24
, 2015 Copy ofEFED Memorandum "Flubendiamide: EcologicalRiskAssessmentAddendum SummarizingAll Submissions andDis cussions to Date, " datedJanuary28, 2016 Copy ofEFED ''Addendum to ClarifyInvertebrate Terminology in January28,2016 EcologicalRisk AssessmentAddendum Summarizing allSubmissions andDiscussions to Date"datedJanuary29, 2016

cc: Ms. Lydia Cox, Nichino America, Inc.