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., hereafter jointly 

identified as BCS/NAI, was granted a time-limited/conditional registration under section 3(c)(7) of the 

federal Insecticide, Fungicide and Rodenticide Act (FIFRA) for flubendiamide on August 1, 2008, with 

an original registration expiration date of July 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 of the 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), if the Agency were to make a determination that further 

registration of the flubendiamide technical and end-use products would result in unreasonable adverse 

effects to the environment, within (1) week of notification of this finding, BCS/NAI will submit a request 

for the voluntary cancellation of the flubendiamide technical and all end-use products. 

BCS/NAI's original release for shipment of the flubendiamide products constituted acceptance of the 

conditions of registration as outlined in the PAL. As stated in the notices of registration for each 

flubendiamide product, if the 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 of these 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 to 
the following attached document: "EPA Recommendation to Cancel All Currently Registered 

Flubendiamide Products." 

The benefits of flubendiamide 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 Document Supporting the Continued Registration of Flubendiamide (Belt 

SC) and BCS White Paper." 

The Agency has made a determination that the continued use of the currently registered flubendiamide 

products will result in unreasonable adverse effects on the environment. These conclusions are 

contained within the attached documents: "Flubendiam1de: Ecological Risk Assessment Addendum 

Summarizing All Submissions and Discussions to Date' and "EPA Recommendation to Cancel All 

Currently Registered Flubendiamide Products." 

BCS/NAI understood and agreed by signing the PAL that if, after review of the referenced conditional 

data, EPA makes a determination of unreasonable adverse effects on the environment, that BCS/NAI 

would within one (1) week of notification of this 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 of the 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. 

If you 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.gov or Mr. Richard J. Gebken 

by phone at (703) 305-6701 or via e-mail at Gebken.R1chard@epa.gov. If there 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 of Preliminary Acceptance Letter for Flubendiamide, dated July 31, 2008 

Copy of Decision Memorandum "EPA Recommendation to Cancel All Currently Registered Flubendiamide 

Products," dated January 29, 2016 

Copy of BEAD ''Review of Bayer CropScience Benefits Document Supporting the Continued Registration of 

Flubendiamide (Belt SC) and BCS White Paper, " dated July 24, 2015 

Copy of EFED Memorandum "Flubendiamide: Ecological Risk Assessment Addendum Summarizing All 

Submissions and Discussions to Date, " dated January 28, 2016 

Copy of EFED ''Addendum to Clarify Invertebrate Terminology in January 28,2016 Ecological Risk 

Assessment Addendum Summarizing all Submissions and Discussions to Date" dated January 29, 2016 

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