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 Environmental Protection Agency's current position 

based on the following documents: 

1. Preliminary Problem Formulation for 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 Registration 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 iprodione 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, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2012-0392). Iprodione is a systemic 

fungicide registered for preventative maintenance use on turfgrass 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 being used on residential turf and lawns; 

however, it is registered for use on commercial turf, including sod farms, commercial lawns, golf 

courses, and sports fields. Additionally, iprodione 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 (such as forest trees, ornamental 

plants, turf, industrial maintenance 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, identifying 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 public participation component to 

solicit input from interested stakeholders. The Agency intends, by sharing this information in the 

docket, to inform the public of what it knows about iprodione and what types of new data or 

other information would be helpful for the Agency to receive as it moves toward a decision on 

iprodione. The Agency encourages all interested stakeholders to review the PWP and Appendix 

and to provide comments and additional information 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 stakeholders could include: 

environmental non-profit or interest groups; pesticide manufacturers; agricultural labor or 

commodity groups; commercial, institutional, and other 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 regulatory authority for Registration Review. Then the document 

provides iprodione’s chemical facts, use and usage information, recent actions, the anticipated 

risk assessments, and a projected registration review timeline. Finally, the Appendix to this 

document includes identification and discussion of some areas that are considered generally in 

Registration Review along with some additional chemical case-specific information. 

Iprodione is a dicarboximide fungicide registered for use on a variety of agricultural field, fruit, 

and vegetable crops, institutional turf, including sod farms, commercial lawns, golf courses, 

sports fields, etc. Iprodione is prohibited from being used on residential turf/lawn. It shares a 

common major metabolite, known as 3,5-dichloroaniline (3,5-DCA) with 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 needs for iprodione. For additional discussion 

of the anticipated data needs, see the Preliminary Problem Formulation for Ecological Risk 

and Environmental Fate, Endangered Species, and Drinking Water Assessments for 
4

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 Invertebrate, 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 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 
5

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 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

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 States (U.S.) generally must be registered by the 

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. 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 of no unreasonable 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 program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided on EPA’s website1

. 

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. The regulations governing registration 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 docket during this initial 

comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for 

the registration review of iprodione. 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 iprodione 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.james@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 preventative control of leaf spots and 

brown patch activity on turfgrass. 

Use Sites Registered for use on various crops including bushberries, 

caneberries, almonds, stone fruits, pome fruits, poppy, marigold, 

brassica cole crops, leafy and stem vegetables, carrots, onions, 

potatoes, bulb vegetables, beans, forage legumes, rice, ginseng, 

palm, cotton, peanuts, beans, apricots, cherries, garlic, grapes, rice, 

currant and rapeseed. 

Non-agricultural use sites included forest trees, herbaceous plants 

(flowering and foliage types), ornamental plants, ornamental lawns 

and turf, ornamental woody shrubs and vines, ornamental trees, and 

commercial, industrial and institutional maintenance. 

Summary of Usage From 2006 thru 2010 approx. 440,000 pounds (lbs) of iprodione 

was used to treat 700,000 acres per year which resulted in an 

overall application rate of 0.6 lbs active ingredient (a.i.) per acre. 

The crops with the most iprodione use in terms of pounds of active 

ingredient and total area treated (between 2006 and 2010) were 

almonds, lettuce, onions, and carrots. 

Formulation Type(s) Liquid, dry flowable, water soluble bags, wettable powder/dust and 

granular. 
7

Application Method(s) Aircraft (fixed-wing and helicopter), airblast 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 Section 3 and 20 Section 24c products2

Restricted Use No 

Guidance for Commenters: Additional areas of use and usage related information

requested for this registration review, and of particular interest to EPA, are described below. 

 Certain iprodione product labels are unclear with respect to a maximum single 

application rates, maximum annual application rates, application intervals, 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 iprodione product labels. 

 Confirmation of the following label information: sites of application; formulations; 

application methods and equipment; maximum application rates; frequency of 

application, application intervals, and maximum number of applications per season; and 

geographic limitations on use. 

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

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

state, and county 

 Application timing (date of first application and application intervals) – 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 technical 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 withdrawn. The most recent risk assessments were conducted in 

2012 and included new dietary, occupational and residential assessments for currently labeled 

uses of iprodione. These most recent risk assessments 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 registrants to address the risk concerns from 

existing uses. 

 

2

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

(http://oaspub.epa.gov/pestlabl/ppls.home). 
8

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for iprodione was completed in 

November 1998 in preparation for the Reregistration Eligibility Decision. In addition, updated 

dietary risk and occupational/residential exposure assessments were 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 risk 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 anticipates the need to 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. 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 anticipated to be required for 

registration review, they will be considered in the new assessments, as well as any changes to the 

residential exposure standard operating procedures or default exposure assumptions. 

Table 4 summarizes the anticipated registration 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 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. 

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 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 degradates 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 already reported to the Agency. 

 Water quality monitoring data (see Appendix for further details). 
10

TIMELINE

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

review. 

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 – 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 for 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 issue 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 submissions, or reference to sources of additional information could 

be of particular use.

Trade Irritants: 

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, 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, providing as much specificity as possible regarding 

the nature of the concern 

Water Quality: 

Iprodione is not identified as a cause of impairment for any water bodies listed as impaired under 

section 303(d) of the Clean Water Act3

. In addition, no Total Maximum Daily Loads (TMDL) 

have been developed for iprodione4. More information on impaired water bodies and TMDLs 

can be found at the Agency’s website5. The Agency invites submission of water quality data 

for this pesticide. To the extent possible, data should conform to the quality standards in 

Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and 

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

Process6

 in order to ensure they can be used quantitatively or qualitatively in pesticide risk 

assessments. 

Environmental Justice: 

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, 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 their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to iprodione 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.htm
12

A risk assessment that supports a complete endangered species determination has not been 

conducted for iprodione. The ecological risk assessment planned during 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 species) or their designated critical habitats. 

When an assessment concludes that a pesticide’s use “may affect” a listed species or its 

designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service 

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

ENDOCRINE DISRUPTOR SCREENING PROGRAM: 

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision for iprodione, EPA reviewed 

these data and selected the most sensitive endpoints for relevant risk assessment scenarios from 

the existing hazard database. However, as required by FFDCA section 408(p), iprodione is 

subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether 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 other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the 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 estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects 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 screen 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 testing. 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 procedures, the list of 67 

chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website7

. 

 

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 determine their dermal and inhalation exposure. 

Many such studies, involving exposure to many different pesticides, comprise generic pesticide 

exposure databases such as the Pesticide Handlers Exposure Database (PHED), the Agricultural 

Reentry Task Force (ARTF) Database, and the 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 convincing evidence that the conduct of any of 

them was either fundamentally unethical or significantly deficient relative to the ethical 

standards prevailing at the time the research was conducted. All applicable requirements of 

EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been 

satisfied, and there is no regulatory barrier to continued reliance on these studies.