2 OVERVIEW

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of f amox a done . This work plan addresses publ ic comments received concerning the Preliminary Work Plan (PWP) , which was posted in the famox a done registration review docket (EPA

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- 0094 ). Famoxadone is a fungicide registered for use to control and/or manage a variety of fungal and bacterial diseases on caneberries ( subgroup 13

- 07A ); cilantro leaves; cucurbit vegetables; grapes (East of the Rocky Mountains); hops; bulb onion ( subgroup 3

- 07A ); green onion ( subgroup 3

- 07B ); potato; pepper; tomato; and leafy vegetables except Brassica ( group 4 ). Famoxadone is no t currently registered for residential use.

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. 1

Th is FWP begins with any updat es 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 th e 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 f amoxadone . Last, there is a discussion of next step s.

UPDATES SINCE THE PWP WAS ISSUED

EPA has revised the data requirements for the registration review of famoxadone as a result of comments submitted by DuPont Crop Protection, the famoxadone registrant. Two environmental

fate studies are no longer requi red: aerobic aquatic metabolism (OSCPP Guideline 835.4300) and storage stability in soil and water (OSCPP Guideline 860.1380) . Table 1 lists the updated data requirements for this registration review.

In addition, a study was submitted to fulfill the outstanding data requirement for a whole sediment acute toxicity study . This study is currently undergoing review to determine if it is scientifically sound and meets the requirements for OSCPP Guideline 850.1735

.

SUMMARY OF COMMENTS AND AGENCY RESPO NSES

During the 60

- day public comment period on the Famox a done Preliminary Work Plan, which opened on March 30, 2015 and closed on May 29, 2015

, the Agency received three public comments. Comments were submitted by the Center for Biological Diversity (CB D), DuPont Crop Protection (the famox a done registrant), and the FIFRA Endangered Species Task Force

1 http://www.epa.gov/oppsrrd1/registration_review/3 (FESTF). The comments do not address the timeline described in the PWP, but they do address the data requirements, and the planned human health and ecologic al risk assessments. In the PWP, EPA also solicited comments on the specific topics of environmental justice, water quality concerns, and trade irritants, but no comments or information were received on those issues.

This section does not capture every comment made about the PWP nor all of the Agency’s responses. Summarized below are public comments that resulted in changes to the anticipated registration review data needs, risk assessments, or timeline, or are of a broader regulatory

nature. Public co mments in their entirety are located in the docket, EPA

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, with the July 22, 2015

, Response to Public Comments on the Famoxadone Registration Review

Problem Formulation 2 and the August 3, 2015 memo, Famoxadone: Response to Comments on

the Sc oping Document 3 in Support of Registration Review

.

Comments submitted by CBD in EPA

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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 famoxadone 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 famoxadone on endangered and threatened species, and their designated critical habitat, for the famoxadone registration review.

Response : EPA has reviewed the comments from CBD on the registration review docket opening for famoxadone 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 4 . EPA will

add ress concerns specific to famoxadone in connection with the development of its final registration review decision for this pesticide.

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 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. 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 E PA and the Services. The NAS report outlines recommendations on specific scientific and technical issues related to the development

2 For human health effects

3 For environmental fate and effects

4 http:// www.nap.edu/catalog.php?record_id=183444 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 a series of stake holder meeting s 5 and workshops, allowing additional opportunities for stakeholders to comment on the Interim Approaches

. Additional workshops are planned to enhance stakeholder involvement

. As part of a phased, iterative process for developing the Interi m Approaches

, the agencies will also

consider public comments on the Interim Approaches in connection with the development of upcoming r egistration r eview decisions.

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 th is F WP for

famoxadone 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 ecological problem formulation for fam oxadone 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 famoxadone. This screening

- level assessment will

allow EPA to determine the potential effects of famoxadone 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 full y vetted. While the agencies continue to develop a common method for ESA analysis, the planned screening

level risk assessment for the registration review of famoxadone will describe the level of ESA analysis completed for this particular registration revi ew 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 famoxadone as part of completing this registration

review.

Comments Submitted by DuPont Crop Protection in EPA

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Comment: Du Pont Crop Protection believes that the sediment

- water test systems used in an existing aerobic aquatic metabolism study (MRID 44946405) meet the requirements for OSCPP Guideline 835.4300, aerobic aquatic metabolism.

Response: The Agency has re

- examined the cited study and agrees that an additional test system is not necessary. The organic carbon contents and texture differences of the sediments selected

for th e study cited by DuPont meet the guideline requirements for 835.4300. Th erefore, an aerobic aquatic metabolism study is no longer required for the famoxadone registration review.

Com ment: DuPont does not believe that a storage stability study for soil and water (Guideline 860.1380) is needed for the registration review of famoxadone. A n existing frozen storage stability study for soil (MRID 44302453) shows that residues are stable f or up to 18 months

5 Pesticide Program Dialogue Committee (PPDC) and State

- FIFRA Issues Research and Evaluation Group (SFIREG) meetings.5 when stored frozen. Therefore, another soil storage stability study is not necessary for famoxadone. In addition, DuPont’s standard practice for water samples is to immediately analyze the samples. Therefore, a water storage stability is not necessary.

Response: EPA appreciates the reference for the existing soil storage stability study , which
appears to s atisf y the guideline requirement for soil. In addition, the immediate analysis of

aqueous samples eliminates the need for storage s tability in water. The storage stability study for soil appears to meet the guideline requirements for 860.1380 , and therefore , additional environmental storage stability data are no t required for the famoxadone registration review.

Comment: DuPont expressed concern about the anticipated requirements for the non

- guideline study, Pollinator Semi

- field Toxicity Testing, and for Guideline 850.3040, Field Testing for Pollinators. The company believes that these studies should be conditionally required, p ending the results of lower tier studies.

Response: These Tier II and Tier III pollinator studies will be required, in accordance with EPA’s June 23, 2014 Guidance for Assessing Pesticide Risks to Bees

. The testing will be tiered.

Comment: DuPont beli eves that they have submitted a Dislodgeable Foliar Residue Dissipation Study to EPA and that this study fulfills the data requirement for OSCPP Guideline 875.2100. The study, which was conducted on tomatoes, is assigned MRID 44946432.

Response: Although a tomato foliar residue dissipation study (MRID 44946432) has been submitted for famoxadone, these data are in review, and the guideline requirement is not fulfilled until the review is complete and the studies are found to be acceptable.

Commen ts submitted by the FESTF in EPA

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Comment: DuPont Crop Protection, the famoxadone technical registrant, is a FESTF members and is therefore entitled to rely on the FESTF data

.

Response: The Agency thanks FESTF for its comment and will consider the FESTF data during the famoxadone registration review.

PLANNED DATA NEEDS

Table 1 summarizes the data needs for the fam o xadone registration review

. These will be

included in a data call

- in (DCI) to be issued for famoxadone. The p lanned data needs have changed from what was included in the PWP as a result of information provided in the public

comments. For additional discussion of the anticipated data needs, see the Response to Public Comments on the Famoxadone Registration Review Problem Formulation ; the Registration Review Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Assessment for Famoxadone ; and the Famoxadone Human Health Assessment Scoping Document in Support of Registration Review.6 Table 1: Planned Data Needs for the Famoxadone Registration Review

Guideline

Number Study Title Test 6

Material Estimated

Timeframe

(Months from receipt of DCI)

D ata Needs for the Parent Famoxadone

835. 4200 Anaerobic Soil Metabolism (3 additional soils) T GAI 24

8 35

. 4400 Anaerobic Aquatic Metabolism (2 additional

sediment

- water systems) TGAI 2 4

850. 6 100 Environmental Chemistry Methods and Independent Laboratory Validation in Soil TGAI 12

850.3040 Field Testing for Pollinators , Tier III T EP 24

850.2100 Avian Acute Oral Toxicity

– Passerine Species TGAI 12

860.1340 Livestock Enforcement Method and Independent Laboratory Validation TGAI 12

Non

- guideline Pollinator Tier I Acute Oral Toxicity, Adult TGAI 12

Non

- guideline Pollinator Tier I Acute Oral Toxicity, Larvae TGAI 12

Non

- guideline Pollinator Tier I Chronic Oral Toxicity, Adult TGAI 24

Non

- guideline Pollinator Tier I Chronic Oral Toxicity, Larvae TGAI 24

Non

- guideline Pollinator Tier II Semi

- field toxicity Testing (tunnel/enclosure and feeding studies) TEP 24

Non

- guideline Residues in Pollen and Nectar , Tier III (Semi

Field or Field Conditions) TEP 24

Non

Guideline Whole sediment : C hronic Invertebrates Freshwater and Marine ( using Chironomus

dilutus

, Hyal ella azteca

, and Leptocheirus plumulosus ) TGAI 24

870. 3465 90

- day Inhalation Toxicity

– Rat TGAI 12

875. 2100 Dislodgeable Foliar Residue 7 TEP 24

Data Needs for the Famoxadone Degradate s IN

- KZ007, IN

- MN467,

I N

- MN968

, IN

- MN468

- 0, IN

- KF015, and IN

- H3310

850.1010 Acute toxicity

, freshwater invertebrates
( Daphnia magna ) 7 DEGR 12

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 famox a done

. For human health,

EPA will conduct revised dietary and occupational risk assessment s during registration review

. If toxicological endpoints or points of departure are revised based on the data that are anticipated

to be required for registration review

, they will be considered in the new assessment s . The

6 TGAI = technical grade active ingredient; TEP = typical end

- use product ; DEGR = degradate

. 7 Although these data have been submitted and are in review, the guideline requirement is not fulfilled until the review is complete and the studies are found to be acceptable.7 Agency will also consider any changes to the standard operating p rocedures or default ex posure assumptions

. T able 2 summarizes the planned r egistration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document

.

Table 2 : Planned Risk Assessments for the Famoxadone Registration Review

Type of Risk

Assessment Conduct ? Notes

Ecological and Environmental Fate Comprehensive ecological (species to

be assessed include terrestrial and aquatic organisms ), including endangered species Yes

Incidents Will check for updates One ecological incident has been reported for famoxadone.

See page 18 of the Problem Formulation for details

. Human Health Dietary

Food Yes Drinking water Yes The anticipated assessment will consider famoxadone and degradates using the total toxic residue approach. Occupational Handlers (mixers, loaders, applicators) Yes Anticipated to be conducted for intermediate term

exposure.
Post

- application Yes

Residential

Handlers No Famoxadone is not registered for residential use.

Post

- application Yes EPA anticipates evaluating the need for spray drift and

volatilization assessments.

Other Aggregate Yes The anticipated assessment will evaluate only the dietary risk from food and drinking water.

Cumulative No Famoxadone has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

Tolerances Yes The tolerance expression for famoxadone will be evaluated during registration review to ensure that it appropriately covers the metabolites and degradates of famoxadone and that it specifies the residues to be measured for each commodity.

Incidents Will check for updates For a discussion of reported human incidents for famoxadone, see the October 28, 2014 document, Famoxadone: Tier I Review of Human Incidents.8 TIMELINE

EPA has created the following estimated timeline for the completion of the famoxadone registration review in Table 5 below

. The projected timeline has not changed significantly since

the PWP.

Table 5: Projected Famoxadone Registration Review Timeline

Activities Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period 2015

– March

Close Public Comment 2015

– May Case Development

Final Work Plan 2015

– September

Issue DCI 2015

– Oct.

- Dec.

Data Submission 2017

– Oct.

- Dec.

6 0

- day Public Comment Period for Draft Risk

Assessments 8 2019

– April

- June

Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision 2020

– Jan.

- March

Registration Review Decision and Begin Post

Decision Follow

- up 2021

Total (years) 6

NEXT STEPS

The Agency plans to require studies for famoxadone through a Data Call

- In Notice, expected to

be issued in late 2015.

8 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.