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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 iprodione. This work plan addresses public comments received 

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

review docket (EPA-HQ-OPP-2012-0392). Iprodione is a systemic fungicide registered for 

preventative maintenance use on non-agricultural (including turf uses) and agricultural use sites. 

Iprodione is prohibited from being used on residential turf and lawn; however, it is registered for 

use on commercial turf, including sod farms, commercial lawns, golf courses, and sports fields. 

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 iprodione. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There are no additional updates on iprodione since the PWP was issued.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

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

on 12/14/12 and closed on 02/12/13, the Agency received four sets of public comments. Comments 

were received from Bayer, FMC, Physicians Committee for Responsible Medicine (PCRM), and 

FIFRA Endangered Species Task Force (FESTF). 

The FESTF comment indicated that specific registrants (including Nufarm, Bayer Environmental 

Science, and FMC Corp. Agricultural Products (FMC) are current members of FESTF, and as such, 

are entitled to the FESTF data on federally-listed threatened and endangered species. The other 

registrants including Celsius Property, Redeagle International, United Phosphorus Inc., (UPI) and 

Arysta Lifescience are not members and, therefore, must offer to pay FESTF to rely on FESTFsubmitted data or develop substantial or similar data on their own. PCRM provided comments 

which highlighted the availability of public data which may be able to supplement or replace several 

 

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http://www.epa.gov/oppsrrd1/registration_review/
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of the data requirements which were discussed in the iprodione Preliminary Work Plan. The Health 

Effects Division Response to Comments discusses this comment in more detail. 

Bayer and FMC’s comments both included use clarifications and various comments associated with 

multiple data requirements. Bayer also specifically discussed registrations which they intend to 

support and requested clarification regarding the Cancer Assessment Review committee’s cancer 

classification. In addition to their other comments, FMC proposed alternative approaches for the 

pending risk assessments and requested a rice use deletion. Public comments and EPA response 

memos (in their entirety) are located in the iprodione registration review docket, EPA-HQ-OPP2012-0392. The data needs listed in the PWP were not changed as a result of comments received.

The public comments do not address the timeline described in the PWP. However, an error in 

the PWP listed the estimated timeframe for the submission of the Reproduction and Fertility 

Effects Study (Guideline 870.3800) as 24 months. This study normally requires up to 48 months 

for submission; therefore, the dates in the Projected Registration Review Timeline have been 

revised to reflect the correct timeframe. 

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.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for iprodione based on the Registration 

Review – Preliminary Problem Formulation for Ecological Risk and Environmental Fate, 

Endangered Species, and Drinking Water Assessments for Iprodione, Human Health Assessment 

Scoping Document in Support of Registration Review, and Response to Comments documents. 

The planned data needs have not changed from what was included in the PWP.

Table 1: Planned Data Needs for the Iprodione Registration Review

Guideline 

Number2 Study Title2

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

835.1230 Leaching and Adsorption/Desorption (degradates 

only) TGAI 12

835.2120 Hydrolysis (3,5 DCA only) TGAI 12

835.2240 Photodegradation in Water (3,5 DCA only) TGAI 12

835.2410 Photodegradation in Soil (3,5 DCA only) TGAI 12

835.4100 Aerobic Soil Metabolism (Parent only) TGAI 24

 

2 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850 – Ecological Effects Tests 

– including renumbering and other designations or changes for some guideline studies. See “Final Test 

Guidelines; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028
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Table 1: Planned Data Needs for the Iprodione Registration Review

Guideline 

Number2 Study Title2

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

835.4300 Aerobic Aquatic Metabolism (Parent & 3,5 DCA) TGAI 24

835.4400 Anaerobic Aquatic Metabolism (Parent & 3,5 

DCA) TGAI 24

850.1010 Acute Toxicity Freshwater Invertebrate TEP 12

850.1035 Acute Toxicity Estuarine and Marine Organisms 

(mysid) TGAI 12

850.1075 Fish Acute Toxicity (Freshwater species (Warm & 

Cold Water) and Estuarine/Marine species) TGAI 12

850.1300 Aquatic Invertebrate Life Cycle (freshwater)

parent and 3,5-DCA TGAI 12

850.1350 Estuarine/Marine Invertebrate, Reproduction Test TGAI 12

850.1400 Fish Early Life Stage (saltwater) TGAI 12

850.1500 Fish Life Cycle Test (freshwater) TGAI 24

850.2100 Avian Acute Oral Toxicity - Passerine Species TGAI 12

850.4100 Terrestrial Plant Toxicity, Seedling Emergence, 

(10 species) TEP 12

850.4150 Terrestrial Plant Toxicity, Vegetative Vigor, (10 

species) TEP 12

850.4550 Aquatic Plant, cyanobacterium TGAI 12

850.4500 Aquatic Plant, freshwater diatom TGAI 12

850.4500 Aquatic Plant, freshwater green algae species TGAI 12

OECD 213 Honey Bee Acute Oral Toxicity TGAI 12

Special 

Study Honey Bee Larval Toxicity Test TGAI 12

870.3800 Reproduction and Fertility Effects TGAI 48

870.3465 Inhalation Toxicity Study TGAI 24

The studies listed below were previously required through a generic data call-in (GDCI-109801-17793), 

issued in November 25, 1998, and are still outstanding. These studies are listed in this document as

background; they will NOT be included in the anticipated Registration Review DCI as they are already 

required through the earlier DCI.

860.1340 Residue Analytical Methods for Livestock Residue of 

Concern 24

860.1400 Residue Decline in Rice Water TEP 24

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

1 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850 – Ecological Effects Tests

– including renumbering and other designations or changes for some guideline studies. See “Final Test Guidelines;

OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012.

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028
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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 iprodione. For human health, EPA 

believes that the dietary and drinking water assessments conducted for the 2009 risk assessment 

are very refined, however may need to be revised. EPA does not anticipate the need to conduct 

revised dietary, residential, and occupational risk assessments during registration review unless 

EPA receives toxicological data which change the assessment endpoints or exposure data which 

change the amount of estimated residues in drinking water. If toxicological endpoints or points 

of departure are revised based on the data that are required for registration review, they will be 

considered in the new assessments, as well as any changes to the standard operating procedures

or default exposure assumptions.

Table 2 below summarizes the planned registration review risk assessments based on the EFED 

Problem Formulation and HED Scoping Document. The planned assessments have not changed 

from what was included in the PWP.

Table 2: Planned Risk Assessments for the Iprodione 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 Yes For a discussion of iprodione’s reported ecological

incidents, see pages 16 and 17 of the Problem

Formulation.

Human Health

Dietary

Food No The 2012 dietary food assessment was very refined

and therefore EPA does not believe a new food

assessment needs to be conducted unless the

toxicological endpoints are lowered by the 

submission of additional data.

Drinking water Yes The 2012 dietary water assessment was very 

refined.

However, EPA intends to call in certain

environmental fate data which may allow for

additional refinement of the drinking water

assessment. If additional fate data are submitted, a

new dietary drinking water assessment may be

appropriate
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Occupational

Handlers (mixers, loaders, 

applicators)

Yes

Post-application Yes

Residential

Handlers Not 

Applicable

Post-application Yes The 2012 assessment outlines post-application 

golfer exposure which may be updated if additional

toxicological data are submitted.

Additionally, an evaluation of incidental oral

exposure for children may be appropriate during

registration review based on the registered use

pattern.

Other

Aggregate Yes Evaluates the combined risk from dietary and 

residential exposures.

Cumulative No

Tolerances Yes Tolerance expression may need to be revised to

include all appropriate degradates and the livestock

tolerance will be determined after the enforcement

method is evaluated.

Incidents Will check for 

updates

For a discussion of iprodione’s reported human

incidents, see page 9 of the Scoping Document.

TIMELINE

EPA has created the following estimated timeline for the completion of the iprodione registration

review in Table 3 below. The projected timeline in the PWP has been revised here to include the 

correct estimated submission time for the Reproduction Study Guideline 870.3800.

Table 3: Registration Review for Iprodione – Projected Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period 2012 – December 

Close Public Comment 2013 – February 

Case Development

Final Work Plan 2013 – June

Issue DCI 2014 – Jan. - Mar.

Data Submission 2018 – Jan. - Mar.
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Table 3: Registration Review for Iprodione – Projected Registration Review Timeline

Open 30-day Public Comment Period for Draft Risk Assessments 2019 – Jul. - Sept.

Registration Review Decision

Open 60-day Public Comment Period for Proposed Registration Review 

Decision

2020 – Jan. - Mar.

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

Total (years) 8

NEXT STEPS

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

and human health studies for iprodione through a Data Call-In Notice, expected to be issued in 

2014.