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I NTRODUCTION

This is the Environm ental 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

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- 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, vario us 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 F IFRA 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.

Informatio n on this program is provided on the Agency’s website

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The FWP begins with any update s 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 response s to th o se 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 an d 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 Guidan ce 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 B ee Toxicity Testing

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1 http://www.epa.gov/oppsrrd1/registration_review/3

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 p ublic comments, and EPA’s response, are summarized below. The comments do not change the planned risk assessments, data needs, or registratio n review timeline for fenamidone. Public comments in their entirety are located in the docket, EPA

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Comments submitted by the Western Integrated Pest Management Center in EPA

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1. Comment: The Western Integrated Pes t 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 informati on on fenamidone use in Alaska, California, Idaho, Montana, Oregon, Utah, and Washington.

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

comment s. EPA will consider this information during the fenamidone registration review.

Comments submitted by CBD in EPA

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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 als o 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.

Respo nse : 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

add ress 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 E PA, 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 o utlines 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 ( SF IREG) 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

r egistration r eview decisio ns. The details of the joint Interim Approaches are contained in

the white paper

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nterim 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

d esignated critical habitat, the ecological problem formulation supporting this Final Work

Plan for fenamidone does not describe the specific ESA analysis

, includ ing effects determinations for specific listed species or designated critical habitat , to be conducted during registration review

. However, the ecologic al 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 f or 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 fenami done 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

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3. Comment: Bayer CropScien ce, the fenamidone technical registrant, is a FESTF members and is therefore entitled to rely on the FESTF data.5

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

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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.

PL ANNED DATA NEEDS

Table 1 below summarizes the planned data needs for f enamidone 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 S upport 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

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Table 1: Planned D ata 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

Non

guideline Acute oral toxicity to larval honey bees † TGAI 12

Chronic oral toxicity to larval honey bees * † TGAI 2 4
Chronic oral toxicity to adult honey bees TGAI 2 4
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, t he 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 occup ational risk assessments during6

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 p rocedures 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

. T he 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,

EPA may need to conduct a residential bystander assessment. Post

- application Yes

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

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EPA has created the following estimated timeline for the completion of the fenamidone registrat ion review in Table 3 below

. The projected timeline has not changed since the PWP.7

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 201 6 : Oct.

– Dec.

60

- day Public Comment Period for Draft Risk Assessments 2 [1] 201 8 : April

- June Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

Decision 201 9 : Jan.

- March

Registration Review Decision and Begin Post

- Decision Follow

- up 20 20 Total (years) 6

NEXT STEPS

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

studies for fenamidone through a D ata C all

- I n 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 CF R Part 155.53(c). For conventional pesticides, the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.