Jack E. Housenger, Director

Office of Pesticide Programs (7504C) US Environmental Protection Agency

One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202

Date: 2016 February 5 Bayer CropScience LP

2 T.W. Alexander Drive

P. O. Box 12014

RTP, NC 27709

Subject: Response to Request to Submit Voluntary Cancellation Requests for Flubendiamide

Technical Registration and Associated End Use Produ cts: Flubendiamide Technical, EPA Reg. No. 71711-26 Belt SC Insecticide, EPA Reg. No. 264-1025 Synapse WG Insecticide, EPA Reg. No. 264-1026 Vetica Insecticide, EPA Reg. No. 71711-32 Tourismo Insecticide, EPA Reg. No. 71711-33

Dear Mr. Housenger:

Bayer CropScience LP (Bayer), on its behalf and as regulatory agent for Nichino America, Inc. (Nichino ), provides the following response to the January 29, 2016 letter from Director Housenger requesting Baye r and Nichino to submit requests to voluntarily cance l all registrations issued under the Federal Insect icide, Fungicide, and Rodenticide Act (FIFRA) for products containing flubendiamide, as identified above.

As noted in Bayer’s December 21, 2015 letter to EPA , Bayer stopped using the Synapse WG Insecticide (EPA Reg. No. 264-1026) registration in 2012 and su bmitted a voluntary cancellation request for that registration by letter dated December 12, 2014. Ba yer stands by its cancellation request for Synapse WG Insecticide, which has been pending for more than a year, and does not plan to resubmit a cancellation request for that registration. For the reasons sta ted below, Bayer and Nichino decline to issue volun tary cancellation requests for the remaining flubendiami de registrations.

First, EPA’s demand that Bayer and Nichino issue im mediate, forced “voluntary” cancellation requests for the flubendiamide registrations in response to EPA’s just-issued, January 29, 2016 Recommendation to Cancel All Currently Registered Flubendiamide Pr oducts is unlawful. In making this demand, EPA relies on an unlawful condition of registration tha t EPA devised in an effort to bypass required statu tory cancellation proceedings, deny Bayer and Nichino du e process rights in their registrations granted by Congress, and shield EPA’s future scientific and re gulatory determinations from required interagency a nd scientific peer review. In granting the first flub endiamide registrations on August 1, 2008, EPA determined, as required under FIFRA Section 3(c)(7) (C), that conditional registration of flubendiamide would not cause “any unreasonable adverse effect on the environment” and served the public interest given flubendiamide’s many benefits and its excelle nt human health and environmental safety profile. In the eight years since, EPA has expanded flubendiami de registrations to approximately 200 crops, each time applying the FIFRA registration standard. Yet EPA refused in 2008 to issue the flubendiamide2

registrations without an unlawful condition purport ing to require Bayer and Nichino to “voluntarily” cancel their registrations if at some future point EPA changed its mind and concluded that the registrations posed unreasonable adverse effects. EPA cannot grant itself the right to bypass require d cancellation proceedings and deny registrants the d ue process rights they possess by statute.

Second, if EPA has now determined that further regi stration of flubendiamide will cause unreasonable adverse effects and wishes to cancel the registrati ons, EPA must initiate the normal cancellation proc ess under FIFRA Section 6(b). The full Section 6(b) ca ncellation process requires EPA, among other things

, to submit its findings for interagency and scientif ic peer review before initiating cancellation proce edings, and to provide registrants and other interested sta keholders the right to contest the substance of EPA ’s findings in an administrative hearing. Congress im posed these requirements to ensure that the benefit s of the product to the agricultural community and the p otential agricultural and commercial harms cancellation could cause are fully considered, and that the scientific grounds for the proposed cancel lation are subject to and can withstand independent scient ific peer review before a cancellation order issues

. EPA, apparently concerned that its determinations w ould not withstand this required scrutiny, seeks to bypass the Section 6(b) cancellation process by dem anding that Bayer and Nichino “voluntarily” cancel the registrations, and by threatening to seek cance llation under the streamlined Section 6(e) process if Bayer and Nichino do not comply with the unlawful c ancellation demand. Bayer and Nichino decline to request that their registrations be cancelled and w ill challenge any effort by EPA to cancel the registrations without the required Section 6(b) pro cess.

Third, and most significantly, Bayer and Nichino do not agree that continued registration of flubendiamide poses unreasonable adverse effects on the environment. EPA’s concerns are focused solely on the possibility that flubendiamide and a metabolite might accumulate in ponds and water systems to levels that may be toxic to aquatic inve rtebrates that dwell in sediment. In July 2013, EP A confirmed that Bayer had submitted all data require d in support of the original conditions of registra tion as of July 2012, and granted the first of several e xtensions of the registrations to allow for EPA’s f urther

review and discussion of the submitted data. In ad dition, during 2015, Bayer and EPA engaged in scientific exchanges, which included Bayer submitti ng pertinent new data and information, including an aqueous photolysis study showing the first identifi ed degradation pathway for the des-iodo metabolite of

flubendiamide, flubendiamide benefits information r equested by EPA, and detailed responses and scientific critiques of EPA’s assumptions on the ac cumulation of flubendiamide and the des-iodo metabolite. In meetings and discussions from July through November 2015, EPA identified a list of additional data that could be useful to address any remaining uncertainty regarding potential accumula tion and indicated that it planned to extend the registr ation for three years while Bayer generated the add itional

data.

However, in early December, EPA abruptly shifted co urse and expressed its intent to discount the real world monitoring data, conducted as EPA directed an d required, and to rely on overly conservative and unrealistic theoretical modeling to argue that flub endiamide is accumulating in the environment at or beyond levels of concern. This approach culminated in EPA’s issuance of the January 29, 2016 Recommendation that all flubendiamide registrations should be cancelled.

To support its finding, EPA suddenly shifted back t o a toxicity endpoint that is 70 times lower than t he endpoint that had been the basis of EPA’s and Bayer ’s 2015 scientific and regulatory analyses and discussions. According to EPA’s guidance, the appr opriate study to evaluate potential toxicity to sediment dwelling organisms is a spiked sediment st udy. Bayer conducted and submitted the appropriate spiked sediment study. Yet EPA is now ignoring tha t study in favor of a less appropriate study with a different endpoint. Notably, after seven years of flubendiamide use and monitoring, not one of the wa ter monitoring samples that EPA required and that was c ollected has met or exceeded even this lower endpoint.3

EPA also relies on theoretical modeling that is bas ed on highly unrealistic assumptions – including a farm pond model that assumes 30 years of substantial agr icultural runoff carrying flubendiamide residues in to the pond without any outflows. In fact, the real w orld monitoring data that Bayer collected as requir ed and as directed by EPA, as well as substantial real world data gathered by the United States Geologica l Survey (USGS), also at the request of EPA, show tha t when flubendiamide and its metabolite are found, it is in minute quantities well below levels of concer n.

Moreover, although the unreasonable adverse effects registration standard requires consideration of benefits as well as risks, EPA downplays or ignores the significant benefits flubendiamide provides compared to alternatives, including its excellent s afety profile and its targeted control. EPA has repeatedly concluded that use of flubendiamide rais es no human health or safety concerns, and EPA has identified no environmental concerns with respect t o fish, birds, mammals, crustaceans, mollusks, beneficial insects, and plants. Flubendiamide prov ides highly effective and selective control of lepidopteran insects (caterpillar pests and worms), is compatible with Integrated Pest Management (IPM ) techniques that focus on natural predation and mini mization of impact to beneficial insects, and provi des an alternative mode of action that is important to resistance management efforts. The scientific and regulatory record strongly supports the continued r egistration of flubendiamide. Removal of this important tool will have negative impacts on grower s, the nation’s food supply, and the environment.

For all these reasons, Bayer and Nichino decline EP A’s request to voluntarily cancel all flubendiamide registrations. We remain available to address the science in a transparent and methodical way, consis tent with the FIFRA registration standard and process. If this is done as Congress envisioned, the product s should remain registered.

Sincerely,

Dana Sargent Vice President of North American Regulatory Affairs Bayer CropScience LP

cc: Susan Lewis, Division Director, Registration D ivision (RD) Lydia Cox, Director, Regulatory Affairs, Nichino Am erica