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-HQ-OPP-2015-0179)

Summary 

This document summarizes the U.S. Environmental Protection Agency's (the Agency, EPA)

responses to public comments received through the public notification of the receipt of the

application for new uses for flutriafol on hops.

On April 15th, 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 responses are summarized in this 

document.

Summary of Comments on Applications to Register Pesticide Products Containing 

Flutriafol 

Comments from: Center for Food Safety Document ID: EPA-HQ-OPP-2015-0179-0006

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 this systemic fungicides on honey bees and other 

pollinators. Because of its systemic nature, flutriafol poses 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 chemicals’ impacts on pollinator 

health.

 The additional proposed outdoor uses of this systemic fungicide would create another 

stressor to honey bees and other pollinators, and further threaten the health of these 

precarious species. 
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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 conditional registration under Section 3(c)(7) of FIFRA.

EPAs Response:

 The agency’s position is that flutriafol 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.

 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 incomplete 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 indicates 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 pollinator 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,

the Agency’s position is that it is appropriate to conditionally register the new hops use

under Section 3(c)(7)(B).

II. EPA MUST CONSIDER THE ECONOMIC IMPACTS AND ADVERSE 

EFFECTS ON U.S. AGRICULTURE STEMMING FROM THE PROPOSED 

USE OF FLUTRIAFOL

 Effects 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 applications for new uses present unreasonable adverse effects to bee species, 

pollinators, and other beneficial organisms.
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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)1classifies 

flutriafol as a Group 3, DMI fungicide. Flutriafol is typically used as one of the 

fungicides in rotation to manage powdery mildew in certain crops, including grape (e.g., 

UC Pest Management Guidelines, 2014)2and would likely be used as one component of 

a program to manage powdery mildew of hops. In addition to chemical 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., 2008)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., Grove 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 action 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-source/publications/frac-code-list/frac-code-list-2015-

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., Grove, 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%203-12.pdf 
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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 alternatives 

currently registered that can be used to manage the disease. Therefore, use of flutriafol on 

hops could offer benefits to the U.S agriculture and economy by sustaining the 

commodities it has been effective in treating and adding to the current fungi pest 

management practices available for hops use. This in turn 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 potential 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 data5and potential effects on tested soil macroand microorganisms, flutriafol generally appears to pose low toxicity to soil microorganisms at the currently registered application rates.

IV. EPA MUST CONSULT ON THE POTENTIAL IMPACTS OF THE 

PROPOSED PESTICIDE PRODUCTS AS REQUIRED UNDER THE ESA

 

5 http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/1868.pdf
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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 review 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 the 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 Hops 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 white 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 

Approaches 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 approaches 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 generally 
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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 restrictions 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 nontarget 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 decisions.

EPAs Response:

 EPA provides 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 assessments 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 applications: new active ingredients, first 

food uses; first outdoor uses; first residential uses and other actions of significant interest. 

 In reference to Flutriafol, pursuant 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 only a subset of those 

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 first 
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residential uses. In some cases the Office of Pesticide Programs may determine that a 

registration actions is of significant interest, and the action would be included in the 

public participation 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 apples and soybeans. Risk 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-HQ-OPP-2009-0184-0008