2

OVERVIEW

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

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

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

review docket (EPA-HQ-OPP-2015-0094). 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 not 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 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.1

This 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 famoxadone. Last, there is a discussion of next steps.

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 required: 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 RESPONSES

During the 60-day public comment period on the Famoxadone 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 (CBD), DuPont 

Crop Protection (the famoxadone 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 ecological 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 comments in their entirety are located in the docket, EPA-HQ-OPP-2015-0094, 

with the July 22, 2015, Response to Public Comments on the Famoxadone Registration Review 

Problem Formulation2 and the August 3, 2015 memo, Famoxadone: Response to Comments on 

the Scoping Document3 in Support of Registration Review. 

Comments submitted by CBD in EPA-HQ-OPP-2015-0094-008.

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) report4

. EPA will 

address 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 EPA 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=18344
4

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 stakeholder 

meetings5 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 Interim Approaches, the agencies will also 

consider public comments on the Interim Approaches in connection with the development of 

upcoming registration review 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 this FWP for 

famoxadone 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 famoxadone 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 fully vetted. While 

the agencies continue to develop a common method for ESA analysis, the planned screeninglevel risk assessment for the registration review of famoxadone 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 famoxadone as part of completing this registration 

review. 

Comments Submitted by DuPont Crop Protection in EPA-HQ-OPP-2015-0094-0009

Comment: DuPont 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 the study cited by DuPont meet the guideline requirements for 835.4300. Therefore, an 

aerobic aquatic metabolism study is no longer required for the famoxadone registration review. 

Comment: DuPont does not believe that a storage stability study for soil and water (Guideline 

860.1380) is needed for the registration review of famoxadone. An existing frozen storage 

stability study for soil (MRID 44302453) shows that residues are stable for 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 satisfy the guideline requirement for soil. In addition, the immediate analysis of 

aqueous samples eliminates the need for storage stability 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 not 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, pending 

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 believes 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. 

Comments submitted by the FESTF in EPA-HQ-OPP-2015-0094-0010.

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 famoxadone registration review. These will be 

included in a data call-in (DCI) to be issued for famoxadone. The planned 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 Test6

Material

Estimated 

Timeframe

(Months 

from receipt 

of DCI)

Data Needs for the Parent Famoxadone

835.4200 Anaerobic Soil Metabolism (3 additional soils) TGAI 24

835.4400 Anaerobic Aquatic Metabolism (2 additional 

sediment-water systems) TGAI 24

850.6100 Environmental Chemistry Methods and 

Independent Laboratory Validation in Soil TGAI 12

850.3040 Field Testing for Pollinators, Tier III TEP 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 (SemiField or Field Conditions) TEP 24

NonGuideline

Whole sediment: Chronic Invertebrates 

Freshwater and Marine (using Chironomus 

dilutus, Hyalella azteca, and Leptocheirus 

plumulosus)

TGAI 24

870.3465 90-day Inhalation Toxicity – Rat TGAI 12

875.2100 Dislodgeable Foliar Residue7 TEP 24

Data Needs for the Famoxadone Degradates IN-KZ007, IN-MN467, 

IN-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, the Agency will conduct a comprehensive ecological risk assessment, 

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

EPA will conduct revised dietary and occupational risk assessments 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 assessments. 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 procedures or default exposure 

assumptions. Table 2 summarizes the planned registration 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 Date

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.

60-day Public Comment Period for Draft Risk 

Assessments8

2019 – April-June 

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2020 – Jan.-March

Registration Review Decision and Begin PostDecision Follow-up2021

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.