2 

### Iprodione Preliminary Work Plan – Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 5

Chemical Facts 6

Use and Usage Information 6

Recent Actions 7

Anticipated Risk Assessments for Registration Review 8

Timeline 9

Next Steps 9

Appendix – Additional Areas Considered in Iprodione’s Registration Review 10

References:

This Preliminary Work Plan summarizes the En vironmental Protection Agency's current position based on the following documents:

1. Preliminary Problem Formulation fo r Ecological Risk and Environmental Fate, Endangered Species, and Drinking Water Assessments for Iprodione

. Chuck Peck and Scott Glaberman, 12/6/12

2. Iprodione. Human Health Assessment Scoping Document in Support of Registration Review . Donna Davis.

11/06/12.

3. BEAD Chemical Profile for Regist ration Review: Iprodione (109801). Carl Chen, Jihad Alsadek and Derek

Berwald. 05/30/12.

4. Iprodione: Review of Human Incidents . Shanna Recore. 07/31/12.

5. Iprodione: Occupational Exposure and Risk Assessment for the Proposed New Uses on Cucurbits, Fruiting Vegetables (includes Updated Non-Occupational Cancer Assessment. Matthew Lloyd. 03/07/12.

6. Iprodione. Acute Probabilistic, Chronic and Cancer Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for Parent and 3,5-DCA to Support New Section 3 Registration Actions and Cucurbits (Crop Group 9) and Fruiting Vegetables (Crop Group 8-10 and to Support a Tolerance for Imported Canola.
Donna Davis. 03/15/12

These and other supporting documents for the ipr odione registration review case may be found in the docket EPA-HQ-OPP-2012-0392 at http://www.regulations.gov

.3 OVERVIEW

The docket for iprodione is now open, initiati ng the first public comment period for this registration review (docket number EPA-HQ- OPP-2012-0392). Iprodione is a systemic fungicide registered for preven tative maintenance use on turfgra ss and general use against fungal

diseases such as Monilinia laxa (on almonds), Sclerotinia spp. (on lettuce), and Alternaria spp. (on carrots and onions). Iprodione is prohibited from be ing used on residential turf and lawns; however, it is registered for use on commercial turf, including s od farms, commercial lawns, golf courses, and sports fields. Additionally, ipro dione is used on agricultural crops (such as bushberries, caneberries, almonds, stone fruits, pome fruits, vegetables and etc.,) and in addition to the turf sites described above, other non-agricultural use sites (suc h as forest trees, ornamental plants, turf, industrial maintena nce and etc.). This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about iprodione, highlighting anticipated data and assessment needs, identify ing the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing iprodione’s review.

The registration review process was designed to include a publi c participation component to solicit input from interested stake holders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows ab out iprodione and what types of new data or other information would be helpful for the Agen cy to receive as it moves toward a decision on iprodione. The Agency encourages all interest ed stakeholders to review the PWP and Appendix and to provide comments and additional inform ation that will help the Agency’s decisionmaking process for this chemical. In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP and Appendix about which the Agency specifically seeks comments and information. Interested stakeholde rs could include: environmental non-profit or interest groups; pe sticide manufacturers; agricultural labor or commodity groups; commercial, institutional, and othe r users of pesticides; or the public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for iprodione. Next, it discusses the statutory and regul atory authority for Registration Review. Then the document provides iprodione’s chemical facts, use and us age information, recent actions, the anticipated risk assessments, and a projecte d registration review timeline. Finally, the Appendix to this

document includes identification a nd discussion of some areas that are considered generally in Registration Review along with some addi tional chemical case-specific information.

Iprodione is a dicarboximide fungi cide registered for use on a vari ety of agricultural field, fruit, and vegetable crops, institutiona l turf, including sod farms, co mmercial lawns, golf courses, sports fields, etc. Iprodione is prohibited from being used on re sidential turf/lawn. It shares a common major metabolite, known as 3,5-dichloro aniline (3,5-DCA) w ith vinclozolin and procymidone. The Reregistration Eligibility Decision (RED) for Iprodione was finalized on September 30, 1998.

ANTICIPATED DATA NEEDS

1. Table 1 below summarizes anticipated data n eeds for iprodione. For additional discussion of the anticipated data needs, see the Preliminary Problem Formul ation for Ecological Risk and Environmental Fate, Endangered Species , and Drinking Water Assessments for4 Iprodione , 12/6/12 and Iprodione. Human Health Assessment Scoping Document in Support of Registration Review , 11/06/12.

.

Table 1: Anticipated Data Needs for Iprodione’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4100 Aerobic Soil Metabolism (Parent only) TGAI 24
835.4300 Aerobic Aquatic Metabolism (Parent & 3,5 DCA) TGAI 24 835.4400 Anaerobic Aquatic Metabolism (Parent & 3,5 DCA) TGAI 24

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

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 Warm and Cold Water Species and Estuarine Marine Species TGAI 12

850.1300 Aquatic Invertebrate Life Cycle (freshwater) parent and 3,5-DCA TGAI 12

850.1350 Estuarine/Marine Inverteb rate, Reproduction Test TGAI 12 850.1400 Fish Early Life Stage (saltwater) TGAI 12
850.1500 Fish Life Cycle Test (freshwater) TGAI 12 850.2100 Avian Acute Oral Toxicity - Passerine Species TGAI 12 OECD 213 Honey Bee Acute Oral Toxicity TGAI 12

Special Study Honey Bee Larval Toxicity Test TGAI 12

850.4100 Terrestrial Plant Toxicity, Seedling Emergence,

1 (10 species) TEP 12

850.4150 Terrestrial Plant Toxicity, Vegetative Vigor, 1 (10 species) TEP 12

850.4550 Aquatic Plant, cyanobacterium TGAI 12

850.4500 Aquatic Plant, freshwater diatom and freshwater green algae species TGAI 12

870.3800 Reproduction and Fertility Effects TGAI 24 870.3465 Inhalation Toxicity Study TGAI 12
The studies listed below were previously required through a generic data call-in (GDCI-109801-17793), issued on November 25, 1998, and are still outstandi ng. 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 245 Table 1: Anticipated Data Needs for Iprodione’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

860.1400 Residue Decline in Rice Water TEP 24
TGAI = technical grade active ingredie nt; 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/#!documen tDetail;D=EPA-HQ-OPPT-2009-0154-0028

STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the United Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonabl e adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided on EPA’s website 1

.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The regulations governing regi stration review begin at 40 CFR 155.40. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses

and data or information it believes are needed to make a registration review decision. After reviewing and responding to comments and data received in the docke t during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of iprodion e. Table 2 provides a summary of the current regulatory status of iprodione.

Table 2: IPRODIONE CHEMICAL FACTS

PC code 109801

Case Number 2335

CAS Number 36734-19-7 Year first registered 5/12/1972

1 http://www.epa.gov/oppsrrd1/registration_review/6 Pesticide Type Fungicide

Chemical class Dicarboximide Reregistration Eligibility Decision (RED) September 1998

Tolerance Reassessment Eligibility Decision (TRED) Not Applicable

Cumulative group Not Applicable 40 CFR Citation Tolerances for iprodi one are established in 40 CFR 180.399. Dual-use Conventional Pesticide Uses only Non-pesticidal uses No Non-pesticidal Uses Pesticide Re-evaluation Division, Chemical Review Manager James Parker, parker.jam es@epa.gov, (703) 306-0469

Registration Division, Product Manager Marcel Howard, howard. marcel@epa.gov, (703) 305-6784

USE AND USAGE INFORMATION Table 3 summarizes the use and usage information for iprodione. Please see the BEAD Chemical Profile for Registration Review: Iprodione (109801) in the registration review docket for more

details.

Table 3: USE AND USAGE INFORMATION

Summary of Use Contact and/or locally systemic fungicide with protective and curative capabilities, registered to treat various fungal diseases. It is also registered for use as a pr eventative control of leaf spots and brown patch activity on turfgrass.

Use Sites Registered for use on va rious crops including bushberries, caneberries, almonds, stone fru its, pome fruits, poppy, marigold, brassica cole crops, leafy and st em vegetables, carrots, onions, potatoes, bulb vegetables, beans, forage legumes, rice, ginseng, palm, cotton, peanuts, beans, aprico ts, cherries, garlic, grapes, rice, currant and rapeseed.

Non-agricultural use sites included forest trees, herbaceous plants (flowering and foliage types), orna mental plants, ornamental lawns and turf, ornamental woody shrubs a nd vines, ornamental trees, and commercial, industrial and in stitutional maintenance. Summary of Usage From 2006 thru 2010 approx. 440,000 pounds (lbs) of iprodione was used to treat 700,000 acres pe r year which resulted in an overall application rate of 0.6 lbs act ive ingredient (a.i.) per acre.

The crops with the most iprodion e use in terms of pounds of active ingredient and total area trea ted (between 2006 and 2010) were almonds, lettuce, onions, and carrots. Formulation Type(s) Liquid, dry flowable, wa ter soluble bags, wettable powder/dust and granular.7 Application Method(s) Aircraft (fixed-wing and helicopter), ai rblast sprayer, chemigation, groundboom, high- and low-pressure handwand, backpack sprayer and tractor-drawn spreader. Technical Registrant(s) Bayer Environmental Science, FMC Corp. Agricultural Products Group, Nufarm Limited, Arysta Lifescience North America LLC., United Phosphorus, Inc., and Celsius Property B.V. (NL) No. of Registrations Approx. 44 S ection 3 and 20 Section 24c products 2

Restricted Use No

Guidance for Commenters: Additional areas of use and usage related information requested for this registration review, and of part icular interest to EPA, are described below.

 Certain iprodione product la bels are unclear with re spect to a maximum single application rates, maximum annual application rates, application in tervals, and whether or not aerial applications are permitted. EPA expects to approximate these parameters in order to conduct a quantitative assessment for iprodione. The Agency will work with registrants to clarify ip rodione product labels.

 Confirmation of the following label information: sites of application; formulations; application methods and equipment; maxi mum application rates; frequency of application, application intervals, and maxi mum number of applica tions per season; and geographic limitations on use.

 Use distribution ( e.g. , acreage and geographical distri bution of relevant use sites)

 Median and 90 th percentile reported use rates (lbs ai/Acre) from usage data – national, state, and county

 Application timing (date of firs t application and application in tervals) – national, state, and county

 Usage/use information for non-agricultural uses

 Typical application interval (days)

 State or local use restrictions

 Foreign technical registrants not listed above who supply tech nical iprodione to the US

market

RECENT ACTIONS

In 2006 and 2009 EPA received new and expanded use requests from Bayer CropScience and DevGen US, which were later with drawn. The most recent risk assessments were conducted in 2012 and included new dietary, occ upational and residential assessments for currently labeled uses of iprodione. These most recent risk assessm ents which identified risks of concern for some existing uses of iprodione are available in this docket.

All new and expanded use amendment requests were withdrawn in 2012. During registration review, EPA will be working with the iprodione re gistrants to address the risk concerns from existing uses.

2 Section 3 product labels can be obtained from th e Pesticide Product Label System (PPLS) website

(http://oaspub.epa.gov/pestlabl/ppls.home).8 ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent comprehensive human health ri sk assessment for iprodione was completed in November 1998 in preparation for the Reregistra tion Eligibility Decisi on. In addition, updated dietary risk and occupational/re sidential exposure assessments we re completed in March 2012 to support a new use request (on cucurbits and fruiting vegetables). The most recent ecological and environmental fate risk assessment was completed in February 2012 for the same purpose. Findings and conclusions from these ri sk assessments are summarized in the Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species, and Drinking Water Assessments for Iprodione and the Iprodione Human Health Assessment Scoping Document in Support of Registration Review.

During registration review, the Agency antici pates the need to conduct a comprehensive ecological risk assessment, including an enda ngered species assessment, for all uses of iprodione. For human health, EPA believes th at the dietary and dri nking water assessments conducted for the 2009 risk assessment are very re fined. EPA does not anticipate the need to conduct revised dietary, residentia l, and occupational risk assessm ents during registration review unless EPA receives toxicological data which ch ange the assessment endpoints or exposure data which change the amount of estimated residues in drinking water.. If toxi cological endpoints or points of departure are revised based on the da ta that are anticipate d to be required for registration review, they will be considered in th e new assessments, as well as any changes to the residential exposure standard operating pro cedures or default exposure assumptions.

Table 4 summarizes the anticipated registrati on review risk assessments based on the EFED Problem Formulation and HED Scoping Document.

Table 4: Anticipated Risk Assessments for Iprodione’s 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.9 Drinking water Yes The 2012 dietary wa ter 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. Occupational Handlers (mixers, loaders, applicators) Yes

Post-application Yes

Residential

Handlers Not Applicable Post-application Yes The 2012 assessmen t outlines post-application golfer exposure which may be updated if additional toxicological data are submitted.

Additionally, an evaluati on of incidental oral exposure for children may be appropriate during registration review base d on the registered use
pattern.

Other Aggregate Yes An updated assessment may be required to incorporate any new endpoints, revisions to the drinking water exposures and the updated residential

assessment.
Cumulative No Tolerances Yes Tolerance expression may need to be revised to include all appropriate degr adates and the livestock

tolerance will be determined after the enforcement

method is evaluated.

Incidents No For a discussion of iprodione’s reported human incidents, see page 9 of the Scoping Document.

Guidance for Commenters: Additional ecological information requested for this registration review, and of particular interest to EPA, is described below.

 Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not alr eady reported to the Agency.

 Water quality monitoring data (s ee Appendix for further details).10 TIMELINE

EPA has created the following estimated timeline for the completion of ip rodione’s registration

review.

Registration Review for Iprodione – Pr ojected 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 – May

Issue DCI 2014 – Jan. - Mar.

Data Submission 2016 – Jan. - Mar. 30-day Public Comment Period for Draft Risk Assessments 2017 – Jul. - Sept. Registration Review Decision 60-day Public Comment Period fo r Proposed Registration Review

Decision 2018 – Jan. - Mar.

Registration Review Decision and Begin Post-Decision Follow-up 2018 Total (years) 6

NEXT STEPS

After the 60-day public comment period closes , the Agency will review and respond to any comments received in a timely manner and then i ssue a Final Work Plan for the registration review of iprodione.11 

### Appendix – Additional Areas Considered in Iprodione’s Registration Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency where your comments, data submi ssions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. The Agency will work to harmonize tolerances and international maximum residue limits (MRLs) and may modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, provi ding as much specificity as possible regarding

the nature of the concern

Water Quality:

Iprodione is not identified as a cau se of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 3 . In addition, no Total Maximum Daily Loads (TMDL) have been developed for iprodione 4 . More information on impaired water bodies and TMDLs can be found at the Agency’s website 5

. The Agency invites submissi on of water quality data for this pesticide. To the extent possible, data shoul d conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: In clusion of Impaired Water Body and

Other Water Quality Data in OPP’s Registratio n Review Risk Assessment and Management

Process 6 in order to ensure they can be used quant itatively or qualitativel y in pesticide risk

assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to iprodi one compared to the general population. Please comment if you are aware of any sub-populations that may have atypical, unusually high exposure compared to the general population.

ENDANGERED SPECIES:

3 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

4 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl _pollutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES

5 http://www.epa.gov/owow/tmdl/

6 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm12 A risk assessment that supports a complete endangered species determination has not been conducted for iprodione. The ecolo gical risk assessment planned dur ing registration review will allow the Agency to determine whether iprodione’ s use has “no effect” or “may affect” federally listed threatened or endangered species (listed sp ecies) or their designate d critical habitats. When an assessment concludes that a pesticid e’s use “may affect” a listed species or its designated critical habitat, the Agency will c onsult with the U.S. Fish and Wildlife Service

and/or National Marine Fisheries Service (the Se rvices), as appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological h azard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its most re cent registration de cision for iprodione, EPA reviewed these data and selected the most sensitive endpoint s for relevant risk assessment scenarios from the existing hazard database. However, as re quired by FFDCA section 408(p), iprodione is subject to the endocrine screen ing part of the Endocrine Disr uptor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must scre en all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Iprodione was included

on that list and has been issued an order to conduct the Tier 1 te sting. Once all required Tier 1

and Tier 2 data have been received and reviewed , the endpoints and safety factors used for risk assessment purposes will be examined and a new risk assessment performed if necessary. For further information on the status of the EDSP, the policies and procedur es, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening batt ery, please visit our

website 7

.

7 http://www.epa.gov/endo/13 HUMAN STUDIES:

Occupational and Residential

Past iprodione risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to de termine their dermal and inhalation exposure. Many such studies, involving exposur e to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Handl ers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Database, and th e Outdoor Residential Exposure Task Force (ORETF) Database. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databases, and has found no clear and c onvincing evidence that the conduct of any of them was either fundamentally unethical or si gnificantly deficient relative to the ethical standards prevailing at the time the research wa s conducted. All applicab le requirements of EPA’s Rule for the Protection of Human Subject s of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barri er to continued reliance on these studies.