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INTRODUCTION

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for 

the registration review of fenamidone. This work plan addresses public comments received 

concerning the Preliminary Work Plan (PWP), which was posted in the fenamidone registration 

review docket (EPA-HQ-OPP-2014-0048). Fenamidone is an imidazoline fungicide registered 

for use to control downy mildew and Pythium species and to manage Alternaria species, rust, 

early and late blight, and several other pathogens. It is currently registered for use on leafy 

vegetables (both Brassica and non-Brassica); turnip greens; carrots; cotton; cucurbits; grapes; 

potatoes, various bulb/root/tuberous/corm vegetables; tomatoes, peppers and other fruiting 

vegetables; sunflower; tobacco; and commercial greenhouse ornamentals. Fenamidone is also 

registered for use as a seed treatment of sunflower and cotton. 

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. Changes in science, public policy, and pesticide use practices occur over time. The 

registration review program is intended to make sure that, as the ability to assess risk evolves and 

as policies and practices change, all registered pesticides continue to meet the statutory standard. 

The public phase of registration review begins when the initial docket is opened for each case. 

Information on this program is provided on the Agency’s website.

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The FWP begins with any updates since the PWP was issued. Next is a summary of substantive 

comments received during the public comment period for the PWP concerning anticipated data 

needs, expected risk assessments, or the estimated timeline identified in the PWP, and a 

summary of the Agency’s responses to those comments. This section is followed by registration 

review planned data needs, risk assessments expected to be conducted, and the projected

registration review timeline for fenamidone. Last, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

The Agency amended the fenamidone registration for the soluble concentrate product, EPA 

Registration Number 264-695, on June 2, 2014 to add use of fenamidone on ginseng, bulb 

onions, and succulent beans and peas, except cowpea. The Agency established tolerances for 

these commodities on March 12, 2014 (79 FR 13877).

On June 23, 2014, EPA, Health Canada’s Pest Management Regulatory Agency, and the 

California Department of Pesticide Regulation issued Guidance for Assessing Pesticide Risks to 

Bees. This guidance describes a tiered risk assessment process, and associated data 

requirements, for any pesticides with registered uses resulting in non-target exposure to bees. In 

accordance with this guidance, EPA has amended the ecological problem formulation for 

fenamidone to add three honey bee toxicity studies. For details, please see the September 8, 

2014 memo, Addendum to the EFED Registration Review Problem Formulation for Fenamidone 

Regarding Tier I Honey Bee Toxicity Testing. 

 

1 http://www.epa.gov/oppsrrd1/registration_review/
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SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the Fenamidone Preliminary Work Plan, which 

opened on March 28, 2014 and closed on May 27, 2014, the Agency received four public 

comments. Comments were submitted by the Western Integrated Pest Management Center, the 

Center for Biological Diversity (CBD), the FIFRA Endangered Species Task Force (FESTF), 

and the Arizona Pest Management Center. The comments do not address the timeline described 

in the PWP, the data requirements, or the planned human health risk assessment, but they do 

address the planned ecological risk assessments. In the PWP, EPA also solicited comments on 

the specific topics of environmental justice, water quality concerns, and trade irritants, but the 

Agency received no comments or information on those issues. The public comments, and EPA’s 

response, are summarized below. The comments do not change the planned risk assessments, 

data needs, or registration review timeline for fenamidone. Public comments in their entirety are 

located in the docket, EPA-HQ-OPP-2014-0048. 

Comments submitted by the Western Integrated Pest Management Center in EPA-HQOPP-2014-0048-0010.

1. Comment: The Western Integrated Pest Management Center submitted information on the 

use of fenamidone in integrated pest management (IPM) programs to control bacterial and 

fungal pests in Brassica, carrots, greenhouses, lettuce and spinach, and ornamentals. The 

commenter provided information on fenamidone use in Alaska, California, Idaho, Montana, 

Oregon, Utah, and Washington. 

 

Response: The Agency thanks the Western Integrated Pest Management Center for its 

comments. EPA will consider this information during the fenamidone registration review. 

Comments submitted by CBD in EPA-HQ-OPP-2014-0048-0011.

2. Comment: CBD’s comments focus on EPA’s duty to consult with the U.S. Fish and Wildlife 

Service and the National Marine Fisheries Service (the Services) on the registration review 

of fenamidone in accordance with the Endangered Species Act (ESA). The CBD comments 

mention various aspects of the risk assessment process, including use of the best available 

data to develop endangered species risk assessments, and evaluation of effects on 

endangered and threatened (listed) species and their designated critical habitat. CBD also 

expresses concern regarding the rigor of the Agency’s preliminary determinations regarding 

the effects of fenamidone on endangered and threatened species, and their designated critical 

habitat, for the fenamidone registration review.

 

Response: EPA has reviewed the comments from CBD on the registration review docket 

opening for fenamidone and plans to address many of the concerns raised by CBD as part of 

the implementation plan for assessing the risks of pesticides to listed species based on the 

recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will 

address concerns specific to fenamidone in connection with the development of its final 

registration review decision for this pesticide.
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In November 2013, the EPA, along with the Services and the USDA, released a summary of 

their joint Interim Approaches for assessing risks to endangered and threatened (listed) 

species from pesticides. The Interim Approaches were developed jointly by the agencies in 

response to the 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. The NAS report outlines recommendations on specific scientific and technical 

issues related to the development of pesticide risk assessments that EPA and the Services 

must conduct in connection with their obligations under the ESA and FIFRA. 

The joint Interim Approaches were released prior to a stakeholder workshop held on 

November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the 

December 2013 Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues 

Research and Evaluation Group (SFIREG) meetings. The agencies also held a stakeholder 

workshop in April 2014, allowing additional opportunities for stakeholders to comment on 

the Interim Approaches. Additional workshops are planned to enhance stakeholder 

involvement; the next workshop is scheduled for October 2014. As part of a phased, iterative 

process for developing the Interim Approaches, the agencies will also consider public 

comments on the Interim Approaches in connection with the development of upcoming 

registration review decisions. The details of the joint Interim Approaches are contained in 

the 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, dated November 1, 2013.

Given that the agencies 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, the ecological problem formulation supporting this Final Work 

Plan for fenamidone does not describe the specific ESA analysis, including effects 

determinations for specific listed species or designated critical habitat, to be conducted 

during registration review. However, the ecological problem formulation for fenamidone 

described the screening-level risk assessment, which will assume that listed species and their 

designated critical habitats may be present in the vicinity of the application of fenamidone. 

This screening-level assessment will allow EPA to determine the potential effects of 

fenamidone on all taxa of non-target wildlife and plants and to focus its future evaluations on 

the types of species where the potential for effects exists once the scientific methods being 

developed by the agencies have been fully vetted. While the agencies continue to develop a 

common method for ESA analysis, the planned screening-level risk assessment for the 

registration review of fenamidone will describe the level of ESA analysis completed for this 

particular registration review case. Once the agencies have fully developed and implemented 

the scientific methods necessary to complete risk assessments for endangered and threatened 

(listed) species and their designated critical habitats, these methods will be applied to 

subsequent analyses for fenamidone as part of completing this registration review. 

Comments submitted by the FESTF in EPA-HQ-OPP-2014-0048-0012.

3. Comment: Bayer CropScience, the fenamidone technical registrant, is a FESTF members 

and is therefore entitled to rely on the FESTF data. 
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Response: The Agency thanks FESTF for its comment and will consider the FESTF data 

during the fenamidone registration review. 

Comments submitted by the Arizona Pest Management Center in EPA-HQ-OPP-2014-

0048-0013.

4. Comment: The Arizona Pest Management Center provided information on fenamidone use 

in Arizona, California, New Mexico, and Nevada. The most important use of fenamidone in 

this region is to control downy mildew on lettuce, spinach, and other vegetables.

Response: EPA thanks the Arizona Pest Management Center for its comment. This 

information will be considered during the fenamidone registration review. 

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for fenamidone based on the following 

documents: Registration Review – Preliminary Problem Formulation for the Ecological Risk 

Assessment & Drinking Water Exposure Assessment to be Conducted for Fenamidone, 

Addendum to the EFED Registration Review Problem Formulation for Fenamidone Regarding 

Tier I Honey Bee Toxicity Testing, and Fenamidone: Human Health Risk Assessment Scoping 

Document in Support of Registration Review. The planned data needs have changed from what 

was included in the PWP in accordance with the June 23, 2014 Guidance for Assessing Pesticide 

Risks to Bees.

Table 1: Planned Data Needs for the Fenamidone Registration Review

Guideline 

Number Study Title

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

850.6100 Environmental chemistry methods & associated 

independent laboratory validations for water TGAI 12

850.1075 Freshwater fish toxicity (fathead minnow) TGAI 12

850.4150 Vegetative vigor TEP 12

Nonguideline

Acute oral toxicity to larval honey bees†

 TGAI 12

Chronic oral toxicity to larval honey bees*† TGAI 24

Chronic oral toxicity to adult honey bees TGAI 24

TGAI = technical grade active ingredient; TEP = typical end-use product.

* OECD Test Guideline 237 may be used 

for this study. † A 21-day larval toxicity study may be sufficient to assess both acute and chronic toxicity to 

developing brood. 

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the Agency will conduct a comprehensive ecological risk assessment, 

including an endangered species assessment, for all uses of fenamidone. For human health, EPA 

does not plan to conduct revised dietary, residential, and occupational risk assessments during 
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registration review with the possible exception of a residential bystander assessment. However, 

if toxicological endpoints or points of departure are revised, or if there are changes to the

standard operating procedures or default exposure assumptions, then EPA plans to evaluate the 

need to conduct revised human health risk assessments. Table 2 summarizes the planned 

registration review risk assessments based on the EFED Problem Formulation and Addendum, 

and on the HED Scoping Document. The planned assessments have been updated since the PWP 

to include a pollinator risk assessment. 

Table 2: Planned Risk Assessments for the Fenamidone Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate

Comprehensive ecological 

assessment (species to be assessed 

include terrestrial and aquatic 

organisms), including endangered 

species 

Yes The risk assessment will be conducted on the parent 

compound. 

Incidents Will check for 

updates

For a discussion of reported ecological incidents for 

fenamidone, see pages 19 and 20 of the Problem 

Formulation.

Human Health

Dietary

Food No EPA does not anticipate conducting a dietary risk assessment 

unless the toxicology points of departure, uncertainty factors, 

or estimated drinking water concentrations change. 

Drinking water No

Occupational

Handlers (mixers, loaders, 

applicators)

No EPA does not anticipate conducting an occupational risk 

assessment unless the toxicology points of departure or 

uncertainty factors for dermal and/or inhalation exposure 

change. 

Post-application No

Residential

Handlers No Fenamidone is not registered for residential use. However, 

Post-application Yes EPA may need to conduct a residential bystander assessment.

Other

Aggregate No Evaluates the combined risk from dietary and residential 

exposures. 

Cumulative No Fenamidone is not a member of a cumulative group. 

Tolerances Yes EPA anticipates updating fenamidone tolerances, established 

in 40 CFR §180.579, to align with new crop groups and, 

where possible, to harmonize with international MRLs. 

Incidents Will check for 

updates

At present, EPA is aware of only one reported human 

incident for fenamidone. For details, see Fenamidone: Tier I 

Review of Human Incidents.

EPA has created the following estimated timeline for the completion of the fenamidone

registration review in Table 3 below. The projected timeline has not changed since the PWP. 
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Table 3: Registration Review for Fenamidone – Projected Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period March 2014 – Completed

Close Public Comment May 2014 – Completed

Case Development

Final Work Plan Sept. 2014 - Completed

Issue DCI 2014: Oct. – Dec.

Data Submission 2016: Oct. – Dec.

60-day Public Comment Period for Draft Risk Assessments2[1] 2018: April - June

Registration Review Decision

60-day Public Comment Period for Proposed Registration Review 

Decision 

2019: Jan. - March

Registration Review Decision and Begin Post-Decision Follow-up 2020

Total (years) 6

NEXT STEPS

As noted previously, the Agency plans to require environmental fate and ecological effects 

studies for fenamidone through a Data Call-In Notice, expected to be issued in late 2014. 

 

2 The regulations governing Registration Review generally require the Agency to provide a public comment period 

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.