UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION

Flutriafol: Response of Public Comments on EPA’s “Proposed Registration of the New Use Hops” (Docket ID: EPA

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Summary

This document summarizes the U.S. Environmental Protection Agency's (the A gency , EPA) responses to public comments received through the public notification of the receipt of the application for new uses for flutriafol on h ops

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On April 15 th , 2015, EPA published a notice of receipt in the Federal Register for Pesticide Product Registration ; Receipt of Application for new uses. The Notice for the proposed new use announced a public comment period of 30 days; two comments were received on the notice of receipt.

Both comments were submitted by the Center for Food Safety. The first comment provided information and cited abstracts

. The other comments were outlined in a document submitted by the Center for Food Safety. The agency’s review and r esponses are summarized in this document.

Summary of Comments on Applications to Register Pesticide Products Containing Flutriafol

Comment s from : Cente r for Food Safety Document ID: EPA

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I. EPA MUST CRITICALLY ASSESS THE IMPACTS OF THE PROPOSED NEW SYSTEMIC FUNGICIDES ON POLLINATOR HEALTH

 In evaluating the applications for use of flutriafol, EPA must critically assess the potential adverse effects from the uses of th is systemic fungicides on honey bees and other pollinators. Because of its systemic nature, flutriafol pose s similar dangers as the currently widely

- used neonicotinoid pesticides, for which EPA has recently moved up registration review in order to better assess this toxic chemica ls’ impacts on pollinator health.

 The additional proposed outdoor uses of th is systemic fungicide would create another stressor to honey bees and other pollinators, and further threaten the health of these precarious species.Page 2 of 7

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 Outstanding data gaps and studies on systemic fungicides and their impacts on honey bees and pollinators dictate that EPA cannot register the proposed pesticide products and their uses unconditionally under Section 3 (c)(5) of FIFRA, but can only consider them for con ditional registration under Section 3 (c)(7) of FIFRA.

EPAs Response :

 The agency’s position is that f lutriafol does not have the same mode of action as a neonicotinoid and EPA has classified it as practically non

- toxic to adult honey bees on a contact basis. No effects in honey bees were observed in oral toxicity testing. More generally, risk is a function of toxicity as well as exposure

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 Flutriafol is practically non

- toxic to adult honey bees on an acute contact basis, and no effects were observed in the oral toxicity study at the highest tested dose. However, a full risk assessment for pollinators has not been completed due to an incomple te tier I battery of pollinator studies and EPA is initiating an enhanced approach for evaluating risks to pollinators. This project is being undertaken largely through the Registration Review program and has generally prioritized insecticide chemicals for early review. EPA has not considered the chemical flutriafol in the context of this enhanced risk assessment program for pollinators and will evaluate it during the Registration Review ; which based on this evaluation the agency may address the lack of honey bee data at this time

. However, because the available hazard information indicat es that acute hazard is very low, and also that hops are a wind pollinated crops

, EPA does not believe that its registration will create significant opportunities for p ollinator exposure. All previous conditional data gaps have been met for the chemical Flutriafol, but due to the new use and because EPA expects to call in additional data on bees during Registration Review,

t he Agency ’s positi on is that it is appropriate to conditionally register the new hops use under Section 3(c)( 7)(B)

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II. EPA MUST CONSIDER THE ECONOMIC IMPACTS AND ADVERSE EFFECTS ON U.S. AGRICULTURE STEMMING FROM THE PROPOSED USE OF FLUTRIAFOL

 E ffects on U.S agriculture economy, and on honey bees and other terrestrial invertebrates, including native bees and other vital pollinator species whose existence is the backbone of the U.S. agricultural economy.

 Given the uncertainties and initial results that point to significant acute hazards, the
propose ap plications for new uses present unreasonable adverse effects to bee species, pollinators, and other beneficial organisms.Page 3 of 7

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EPAs Response:

 The Agency does not believe flutriafol would pose adverse economic effects on the U.S agricultural market or environment

. Since, flutriafol is a triazole derivative acting as a demethylation (sterol biosynthesis) inhibitor in fungi, the Fungicide Resistance Action Committee (FRAC, 2015) 1 classifies flutriafol as a Group 3, DMI fungicide. Flutriafol is typica lly used as one of the fungicides in rotation to manage powdery mildew in certain crops, including grape (e.g., UC Pest Management Guidelines, 2014) 2 and would likely be used as one component of a program to manage powdery mildew of hops. In addition to c hemical sprays, cultural practices are important for managing powdery mildew on hops. Appropriate spring pruning has reduced disease pressure, which can result in greater efficacy of fungicides, reduced use of fungicides, and cost

- savings (Gent et al., 20 08) 3 , which this management directly benefits the U.S agriculture and economy. While the registration of flutriafol would add an additional active ingredient to manage powdery mildew there are effective fungicide alternatives currently registered (e.g., Gr ove and Nelson, 2012) 4

. These include the DMI fungicides (Group 3) tebuconazole

, triflumizole

, myclobutanil , and
fenarimol

. Best management practices require alternating chemistry modes of action and several effective fungicides of different modes of act ion are registered and used in a fungicide rotation. Quinone outside inhibitors (QoI) trifloxystrobin and pyraclostrobin (Group 11), quinoxyfen (Group 13, an aza

- naphthalene affecting signal transduction), spiroxamine (Group 5) a sterol biosynthesis inhibitor of the amine group, and boscalid

, a carboxamide (Group 7). Other active ingredients that might be used at specific stages

1 FRAC. 2014. Fungicide Resistance Action Committee Code List: Fungicides Sorted by Mode of Action. http://www.frac.info/docs/default

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- finalC2AD7AA36764.pdf?sfvrsn=4

2 UC Pest Management Guidelines. 2014. Grape Powdery Mildew. University of California Extension. http://www.ipm.ucdavis.edu/PMG/r302100311.html

3 Gent, D. H., Nelson, M. E., George, A. E., G rove, G. G., Mahaffee, W. F., Ocamb, C. M., Barbour, J. D., Peetz, A., and Turechek, W. W. 2008. A decade of hop powdery mildew in the Pacific Northwest. Plant Management Network, Plant Health Progress. http://www.plantmanagementnetwork.org/pub/php/review/2008/hop/

4 Grove, G. G. and Nelson, M. E. 2012. Fungicides for hop powdery mildew management, 2012. Washington State University Extension. http://www.usahops.org/graphics/File/Newsletters/HPM%20resistance%20management%20article%203

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of a season

- long management program include potassium bicarbonate, petroleum oil, sulfur, and biological products with Reynoutria sachalinensis (Group P5), and Bacillus subtilis and B. pumilis (Group 44). In summary, the registration of flutriafol for use on hops would add an additional active ingredient, but there are several effective altern atives currently registered that can be used to manage the disease. The refore, use of f lutriafol on
h ops could offer benefits to the U.S agriculture and economy by sustaining the
commodities it has be en effective in treating a nd adding to the current fungi p est management practices available for hops use. This in t urn could be advantageous to the U.S economy and agriculture through sustaining crop life . The effects flutriafol may have on agriculture and the economy as it relates to honey bees and other pollinator species
will be addressed in the bullet below.

 The Agency is actively assessing potential impacts to honey bees generally as part of the Agency's registration review program for currently registered or existing pesticides. This allows the Agency to focus on chemicals with potentially higher risk and to address any
issues that arise from them , resulting in the greatest potentia l benefits for listed species and therefore the economy

. As flutriafol is already registered and does not pose significant risks to bees, EPA expects to wait until registration review to further assess flutriafol’s impacts on honey bees.

III. EPA MUST CONSIDER THE POTENTIAL ADVERSE EFFECTS ON ORGANISMS, SOIL HEALTH AND U.S. AGRICULTURE STEMMING FROM THE PROPOSED USE OF FLUTRIAFOL

 EPA must critically assess the potential adverse effects on beneficial soil organisms, soil health and their interrelated impacts on U.S. agriculture.

EPAs Response:

 Based on available European reviews of data 5 and potential effects on tested soil macro

and microorganisms, flutriafol generally appears to pose low toxicity to soil micro

organisms at the currently registered application rates.

IV. EPA MUST CONSULT ON THE POTENTIAL IMPACTS OF THE PROPOSED PES T I CI DE PRODUCTS AS REQUIRED UNDER THE ESA

5 http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/1868.pdfPage 5 of 7

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 EPA must comply with the agency’s duty under the ESA and consult the expert agencies on the potential effects of three active ingredients on listed species or their critical habitats.

EPAs Response:

 The Agency has been working collaboratively and actively with the United States Fish and Wildlife Service (USFWS) and the National Marine Fisheries Service (NMFS or “Services”) to design a framework for efficiently completing the consultation process for pesticide actions in accordance with the Endangered Species Act (ESA). The Agency is focusing most of its resources for assessing impacts to listed species on the Agency's registration revie w program for currently registered or existing pesticides. This allows the Agency to focus on chemicals with higher risk, i.e., the “worst first”, resulting in the greatest potential benefits for listed species. The EPA believes that, as a general matter, currently registered and existing pesticides may present a greater degree of risk to listed species than most new chemistries and new uses coming to market, and that it is therefore environmentally preferable in most circumstances for the EPA to assess th e impacts of existing pesticides sooner in the process than newer pesticides that are designed to compete with more risky alternatives. The Agency does not believe the environment or the public would be best served by delaying the approval of the new use H ops on the already registered Flutriafol. Additionally, the EPA has also negotiated with our partner agencies to phase

- in interim scientific approaches over time. In November 2013, EPA, USFWS, NMFS, and the US Department of Agriculture (USDA) released a w hite paper containing a summary of their joint interim approaches for assessing risks to listed species from pesticides. These interim approaches were developed jointly by the agencies in response to the National Academy of Sciences (NAS) recommendations, and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. Details of the joint interim approaches are contained in the November 1, 2013 white paper, Interim App roaches for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report . The EPA, USFWS and NMFS are continuing to develop and work toward implementation of the interim appr oaches to assess the potential risks of pesticides to listed species and their designated critical habitat, and will apply these approaches to initial consultations and, based upon the experience gained with these approaches as well as any new science that may develop, modify procedures as appropriate.

 With respect to the evaluation of flutriafol specifically and as explained in this document, current data indicate that the ecological risks presented by uses of flutriafol are generallyPage 6 of 7

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low. To the extent that the EPA receives new information indicating that flutriafol may pose a greater risk to listed species than indicated by the existing scientific database for this pesticide, the EPA will re

- evaluate the terms of registration and determine whether

use r estrictions to protect listed species are necessary.

 Based on the ecological assessment conducted for hops, EPA determined that there were

no effects finding to aquatic plants or animals. Additionally, no effects finding to non

target plants (exposed to spray drift) are expected.

V. EPA SHOULD ALLOW OPPORTUNITY FOR SUBSTANTIVE PUBLIC COMMENT ON THE AGENCY’S DECISION

- MAKING DOCUMENTS, INCLUDING RISK ASSESSMENTS AND ANY OTHER SUPPORTING DOCUMENTATION

 EPA should give the public and interested parties an opportunity to give substantive input into EPA’s decision

- making process by publishing and allowing for comments on the registrants’ application materials, EPA’s risk assessments, and EPA’s proposed registration decisions prior to issuing EPA’s final decis ions.

EPAs Response:

 EPA provide s several ways for public participation in the pesticide registration process. In response to President Obama’s directive on transparency and open government, EPA’s Pesticide Program explored opportunities for expanding the openness of the process, and accordingly in October of 2009 began implementing a public participation process for certain registration actions. By establishing this process, the Agency has increased opportunities for the public to comment on risk asses sments and proposed registration actions. Both EPA and the public will benefit from a public participation process because the public will help to inform the risk assessment and risk management processes associated with registration. Such input can aid in understanding potential risks and benefits, contribute to meaningful protective measures, and improve the public dialogue on pesticide registration decisions . The agency intends to use the outlined public participation process for the following types of a pplications : new active ingredients, first food uses; first outdoor uses; first residential uses and other actions of significant interest

.

 In reference to Flutriafol, p ursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA § 3(c)(4) ), the agency is required to publish a notice of receipt for all applications for pesticides containing “any new active ingredient or if [the application] would entail a changed use pattern. ” OPP has chosen to make o nly a subset of th o se actions that have published notices of receipt available for a second round of public comment at a stage when risks assessments can be provided

. Generally, those decisions include applications for new active ingredients, first food uses, first outdoor uses and fir stPage 7 of 7

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residential uses. In some cases the Office of Pesticide Programs may determine that a registration actions is of significant interes t
, and the action would be included in the public parti ci pation process. Under this guidance, when Flutriafol was initially registered as a new active ingredient there was a 30

- day public comment period for registration of

uses on a pples and s oybeans

. R isk assessments and proposed labels for the associated products were made available to the public

. 6 For the current new use, hops, we made the notice of receipt available for public comments as required.

6 http://www.regulations.gov/#!documentDetail;D=EPA

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