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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 iprodione

. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which was posted in the iprodione registration review docket (EPA

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- 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 spo rts 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 continue s 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 practic es 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

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 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 iprodione. Lastly, ther e 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 endang ered species. The other registrants including Celsius Property, Redeagle International, United Phospho rus Inc., (UPI) and Arysta Life science are not members and, therefore, must offer to pay FESTF to rely on FESTF

submitted 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

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

of the data requirements which were discussed in the iprodione Preliminary Work Plan. The Health

Effec ts Division Response to Comments discusses this comment in more detail.

Bayer and FMC’s comments both included use clarification s and various comments associated with multiple data requirements. Bayer also specifically discussed registra tions 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 de letion. Public comments and EPA response memos (in their entirety) are located in the iprodione registration review docket, EPA

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- OPP

2012

- 0392. The data needs listed in the PWP were not changed as a result of comments received.

The public comments d o 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 F ertility

E ffects S tudy ( G uideline 870.3800) as 24 months. This study normally requires up to 48 month s 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 En vironmental 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 D ata Needs for the I pro d i one Registration Review

Guideline

Number 2 Study Title 2 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 A vailability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

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- 00284 Table 1: Planned D ata Needs for the I pro d i one Registration Review

Guideline

Number 2 Study Title 2 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 T oxicity E stuarine and M arine O rganisms

(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 P lant T oxicity, S eedling E mergence,

(10 species) TEP 12

850.4150 Terrestrial P lant T oxicity, V egetative V igor, (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 . The se studies are listed in this document as background; they will NOT be included in the anticipated R egistration R eview 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

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- OPPT

- 2009

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- 00285

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 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 res idues 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 assessment s
, as well as any changes to the standard operating p rocedures or default exposure assumptions

.

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

Problem Formulation and HED Scoping Document . T he 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

Eco logical 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 appropriate6

Occupational Handlers (m ixer s, loader s, 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 E valuates 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 D ocket 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 201 8

– Jan.

- Mar.7

Table 3: Registration Review for Iprodione

– Projected Registration Review Timeline
Open 30

- day Public Comment Period for Draft Risk Assessments 201 9

– Jul.

- Sept. Registration Review Decision Open 60

- day Public Comment Period for Proposed Registration Review

D ecision 20 20

– Jan.

- Mar.

Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 20 20 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 D ata C all

- I n Notice , expected to be issued in

2014.