2

Ipconazole Preliminary Work Plan – Table of Contents

OVERVIEW ................................................................................................................................... 3

ANTICIPATED DATA NEEDS .................................................................................................... 4

STATUTORY AND REGULATORY AUTHORITY................................................................... 6

CHEMICAL FACTS ...................................................................................................................... 6

USE AND USAGE INFORMATION............................................................................................ 7

RECENT ACTIONS....................................................................................................................... 8

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW................................ 8

TIMELINE.................................................................................................................................... 10

NEXT STEPS ............................................................................................................................... 11

Appendix – Additional Areas Considered in the Ipconazole Registration Review.................. 12

References:

This Preliminary Work Plan summarizes the Environmental Protection Agency's current position 

based on the following documents:

1. Environmental Fate and Effects Division (EFED) Registration Review Problem 

Formulation for Ipconazole. Ruhman, Mohammed, Yingling, Hannah; 10 December 2015.

2. Ipconazole - Health Effects Draft Risk Assessment in Support of Registration Review.

Doherty, Michael; 10 June 2015.

3. Ipconazole: Tier I Review of Human Incidents. Recore, Shanna, Evans, Elizabeth. 16 June 

2015.

4. BEAD Chemical Profile (BCP) for Registration Review: Ipconazole Case. Chandgoyal, 

Tara, Alsadek, Jihad, Smearman, Stephen. 14 May 2015.

5. Ipconazole Case Screening Level Usage Analysis (SLUA). 12 November 2014.

6. Environmental Fate and Effects Division Spreadsheet: Ipconazole. 3 November 2014.

7. Health Effects Division Master Label Spreadsheet: Ipconazole. 3 November 2014. 

These and other supporting documents for the ipconazole registration review case may be found 

in the docket EPA-HQ-OPP-2015-0590 at http://www.regulations.gov.
3

OVERVIEW

The docket for ipconazole is now open, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2015-0590). Ipconazole is a systemic, broadspectrum fungicide seed dressing used to protect plants from soil borne and seed borne disease. 

Ipconazole is registered for agricultural use as a seed treatment only on various crops and as a 

nonagricultural seed treatment for turf grass and ornamental flowers. Ipconazole is formulated as a 

water dispersible granular. While ipconazole is registered for use on turf, it is as a seed-treatment 

use and is not expected to result in residential exposures.

This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs 

knows about ipconazole, 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 the registration review for ipconazole. This 

PWP also includes a summary of the draft human health risk assessment for registration review.

As there are no anticipated human health data needs and only minor updates were required to 

meet current assessment standards, EPA developed a combined scoping document and draft 

human health risk assessment. Both that draft human health risk assessment and this Preliminary 

Work Plan are now in the docket and a 60-day public comment period for them has commenced.

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 ipconazole and what types of new data or 

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

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

Appendix, and associated draft human health risk assessment and to provide comments and 

additional information that will help the Agency’s decision-making 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, residential, 

and other users of pesticides; or the public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for ipconazole. Next, it 

discusses the statutory and regulatory authority for Registration Review. Then the document 

provides chemical facts, use and usage information, recent actions, the anticipated ecological risk 

assessment, a summary of the draft human health risk assessment, and a projected registration 

review timeline for ipconazole. 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.
4

ANTICIPATED DATA NEEDS

Table 1 summarizes anticipated data needs for ipconazole. For additional discussion of the 

anticipated data needs, see the EFED Registration Review Problem Formulation for Ipconazole

and Ipconazole - Health Effects Draft Risk Assessment in Support of Registration Review.

Table 1: Anticipated Data Needs for the Ipconazole Registration Review

Guideline 

Number1 Study Title1 Test 

Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Anticipated Data Needs for the Parent Ipconazole

835.1230 Adsorption/desorption2 TGAI 12

835.4100 Aerobic soil metabolism TGAI 24

835.4300 Aerobic aquatic metabolism TGAI 24

835.4400 Anaerobic aquatic metabolism TGAI 24

850.1035 Saltwater invertebrate acute toxicity (mysid) 4 TGAI 12

850.1075 Saltwater fish acute toxicity 5 TGAI 12

850.1075 Freshwater fish acute toxicity (fathead minnow) 3 TGAI 12

850.1300 Freshwater invertebrate life cycle (Daphnia magna)4 TGAI 12

850.1350 Saltwater invertebrate life cycle (mysid)4 TGAI 12

850.1400 Freshwater fish early-life stage toxicity (rainbow 

trout)

3 TGAI 12

850.1400 Saltwater fish early-life stage toxicity5 TGAI 12

850.1730 Fish Bio-concentration TGAI 12

850.1735 Whole sediment acute toxicity invertebrates, 

freshwater TGAI 12

850.2100 Avian acute oral toxicity (passerine) TGAI 12

850.3020 Honeybee acute contact toxicity TGAI 12

850.3040 Field testing for pollinators TEP 24

 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 2 The Agency does not anticipate requiring this study if the registrant confirms that previous studies were conducted 

with an isomer mixture similar to that stated for the active ingredient of ipconazole. 3 The Agency anticipates requiring both studies in the registration review data call-in (DCI). Registrants may elect 

to do one of these studies to satisfy the data requirements. The Agency anticipates applying the acute-to-chronic 

ratio approach to determine additional endpoints. 4 The Agency anticipates requiring all three studies in the registration review DCI. Registrants may elect to do two 

of these studies to satisfy the data requirements. The Agency anticipates applying the acute-to-chronic ratio 

approach to determine additional endpoints. 5 The Agency anticipates requiring both studies in the registration review data call-in (DCI). Registrants may elect 

to do one of these studies to satisfy the data requirements. The Agency anticipates applying the acute-to-chronic 

ratio approach to determine additional endpoints.
5

Table 1: Anticipated Data Needs for the Ipconazole Registration Review

Guideline 

Number1 Study Title1 Test 

Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

850.4100 Terrestrial plant toxicity, seedling emergence TEP 12

850.4400 Aquatic plant toxicity test using Lemna spp. TGAI 12

850.4500 Aquatic plant growth, Algal toxicity TGAI 12

850.4550 Cyanobacteria toxicity TGAI 12

850.6100

Environmental chemistry methods and associated 

independent laboratory validations for soil/sediment

and water

TGAI 12

NonGuideline 

(OECD 213)

Honey bee adult acute oral toxicity TGAI 12

NonGuideline

(OECD 237)

Honey bee larvae acute oral toxicity TGAI 12

NonGuideline Honey bee adult chronic oral toxicity TGAI 12

NonGuideline Honey bee larval chronic oral toxicity TGAI 12

NonGuideline Semi-field testing for pollinators TEP or 

TGAI 24

NonGuideline Field trial of residues in pollen and nectar TEP 24

TGAI = technical grade active ingredient; TEP = typical end-use product;
6

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 website.

6

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 ipconazole.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for ipconazole.

Table 2: Chemical Facts for Ipconazole

PC code 125618

Case Number 7041

CAS Number 125225-28-7

Year first registered 2004

Pesticide Type Fungicide

Chemical class Triazole-derivative fungicide

Reregistration Eligibility 

Decision (RED)

Because it was registered after November 1984, ipconazole was 

not subject to reregistration.

Tolerance Reassessment 

Eligibility Decision 

(TRED)

Not applicable due to ipconazole’s recent registration.

Cumulative group Not applicable. Ipconazole has not been identified as a member of 

a cumulative group that shares a common mechanism of toxicity.

 6 http://www.epa.gov/oppsrrd1/registration_review/
7

Table 2: Chemical Facts for Ipconazole

40 CFR Citation Tolerances for ipconazole are established in 40 CFR

§180.646 at the limit of quantitation to support the registered use 

on cotton, cereal grains (Crop Group 15, except rice), peanuts, 

and legume vegetables. Registered use on other crops (e.g., root 

and tuber vegetables, leafy greens, corn) is considered to be nonfood, thus tolerances are not needed. 

Dual-use Ipconazole is registered for conventional pesticidal uses only and 

has no registered antimicrobial or biopesticidal uses.

Non-pesticidal uses There are no identified non-pesticidal uses of ipconazole.

Pesticide Re-evaluation 

Division, Chemical 

Review Manager

Brittany Pruitt, pruitt.brittany@epa.gov, 703-347-0289

Registration Division, 

Product Manager

Tony Kish, kish.tony@epa.gov, 703-308-9443

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for ipconazole. Please see the BEAD 

Chemical Profile (BCP) for Registration Review: Ipconazole in the registration review docket for 

more details. Note: Ipconazole usage information as a seed treatment is not available for corn 

and all other registered use sites, with the exception of cotton, soybeans and wheat. Therefore 

ipconazole usage estimates are most likely underestimated. 

Table 3: Ipconazole Use and Usage Information

Summary of Use Ipconazole is a systemic, broad-spectrum fungicide seed dressing 

used to protect plants from soil borne and seed borne disease. It is 

classified as a Group 3 fungicide by the Fungicide Resistance Action 

Committee.

Use Sites Registered agricultural use sites as a seed treatment only include

barley, beans, buckwheat, canola, cole crops, conifers, corn, 

cotton, cucurbits, leafy vegetables, legume vegetables, millet, 

mustard, oats, peanuts, peas, root and tuber vegetables, rye, 

sorghum, soybeans, sunflower, triticale and wheat.

Registered non-agricultural use sites as a seed treatment only

include ornamental flowers and turf.

Summary of Usage Over the 2010 to 2013 timeframe, approximately 600 pounds 

active ingredient was used annually. In terms of average annual 

pounds applied, use on cotton, soybeans, and wheat comprised the 

majority of usage during this same time period.

Formulation Type(s) Formulated as an emulsifiable concentrate, a flowable 

concentrate, a ready-to-use liquid, and a soluble concentrate.

Application Method(s) Applied as a seed treatment. 

Technical Registrant(s) Macdermid Agricultural Solutions, Inc.
8

Table 3: Ipconazole Use and Usage Information

No. of Registrations 20 Section 3 products7

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.

• Seed treatment usage information for ipconazole, including pounds ai used and total area 

treated as a seed treatment, for each registered crop.

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

application methods and equipment; maximum application rates; 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/A) from usage data – national, state, 

and county.

• Usage/use information for non-agricultural uses.

• State or local use restrictions.

• Foreign technical registrants not listed above who supply technical ipconazole to the US 

market.

RECENT ACTIONS

There are no recent actions for ipconazole. 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent ecological and environmental fate risk assessment was completed in 2007 when 

ipconazole was registered as a new chemical with EPA. The most recent human health risk 

assessment for ipconazole was completed in 2013, prior to which the most recent assessment was 

completed in 2011. Findings and conclusions from these risk assessments are summarized in the 

EFED Registration Review Problem Formulation for Ipconazole and Ipconazole - Health Effects 

Draft Risk Assessment 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

ipconazole. 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 assessment,

as well as any changes to the standard operating procedures or default exposure assumptions.

Table 4 below summarizes the recently completed draft human health risk assessment and the 

anticipated ecological and environmental fate risk assessment for registration review.

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

(http://oaspub.epa.gov/pestlabl/ppls.home).
9

Table 4: Anticipated Ecological and Environmental Fate Risk Assessments and Summary of Draft 

Human Health Risk Assessment for the Ipconazole Registration Review

Type of Risk Assessment Conduct/ed? Notes

Ecological and Environmental Fate

Comprehensive ecological 

(species to be assessed 

include terrestrial and aquatic 

organisms), including 

endangered species

Y EPA plans to assess parent ipconazole alone as the 

stressor of concern.

Incidents Will check 

for updates

There are no reported ecological incidents for 

ipconazole. See p. 22 of the EFED Problem 

Formulations for a listing of the databases searched.

Human Health

Dietary

Food Y EPA confirms its previous conclusion that dietary risk 

estimates for ipconazole are below both the acute and 

chronic levels of concern for all population groups.

Drinking water Y

Occupational

Handlers (mixers, loaders, 

applicators)

Y EPA confirms its previous conclusions that 

occupational risk estimates are not of concern. The 

Restricted Entry Interval on the ipconazole labels is 

supported by the acute toxicity categories. 

Post-application

Residential

Handlers N Although ipconazole is registered for use on turf, it is as 

a seed-treatment use and is not expected to result in 

residential exposures. Therefore, EPA did not assess 

residential exposure and risk for ipconazole. 

Post-application

Other

Aggregate Y As use of ipconazole is not expected to result in 

residential exposure, the aggregate risk assessment is 

equivalent to the dietary assessment and not of concern.

Cumulative N EPA has not made a common mechanism of toxicity 

finding as to ipconazole and any other substances and 

ipconazole does not appear to produce a toxic 

metabolite produced by other substances. Therefore, 

EPA has assumed that ipconazole does not have a 

common mechanism of toxicity with other substances.
10

Tolerances N The tolerance expression for ipconazole appropriately 

covers the metabolites and degradates of ipconazole and 

specifies the residues to be measured for each 

commodity. US tolerances are harmonized with 

Canadian maximum residue limits (MRL) for all 

commodities for which Canada has established a 

specific MRL. There are no Codex MRLs at this time.

Incidents Will check 

for updates

Based on the low frequency and low severity of 

reported incident cases, there does not appear to be a 

concern at this time that would warrant further 

investigation.

Guidance for Commenters: Additional ecological information requested for this 

registration review, and of particular interest to EPA, is described below.

• Additional information on the isomer mixture of the ipconazole active ingredient and 

confirmation that previous fate studies were conducted with the same mixture of isomers. 

• 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).

TIMELINE

EPA has created the following estimated timeline for the completion of the ipconazole

registration review in Table 5 below.

Table 5: Projected Ipconazole Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period8 2015 – December

Close Public Comment 2016 – February

Case Development

Final Work Plan 2016 – May

Issue Data Call-In 2016 July – Sept.

Data Submission 2018 July – Sept.

60-day Public Comment Period for Draft Risk 

Assessments9, 10

2020 Jan. - March

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2020 Oct. – Dec.

 8 The Agency is seeking comment on the PWP and the draft human health risk assessment during this comment 

period.

9 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. 10 The Agency expects to seek comment on the draft ecological and environmental fate risk assessments at this time.
11

Table 5: Projected Ipconazole Registration Review Timeline

Activities Estimated Date

Registration Review Decision and Begin Post-Decision 

Follow-up

2021

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 ipconazole.
12

Appendix – Additional Areas Considered in the Ipconazole 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:

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

under section 303(d) of the Clean Water Act.

11 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for ipconazole.

12 More information on impaired water bodies and 

TMDLs can be found at the Agency’s website.

13 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 Process14 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 ipconazole 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.

 11 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885 12http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant

_group_name=PESTICIDES 13 http://www.epa.gov/owow/tmdl/ 14 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
13

ENDANGERED SPECIES:

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

conducted for ipconazole. The ecological risk assessment planned during registration review will 

allow the Agency to determine whether use of ipconazole 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 ipconazole, 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), ipconazole 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. A second list of chemicals 

identified for EDSP screening was published on June 14, 201315 and includes some pesticides 

scheduled for registration review and chemicals found in water. Neither of these lists should be 

construed as a list of known or likely endocrine disruptors.

 15 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals.
14

For further information on the status of the EDSP, the policies and procedures, the lists of 

chemicals, future lists, the test guidelines and Tier 1 screening battery, please visit our website16.

HUMAN STUDIES:

Occupational

Past ipconazole 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 

Handler Exposure Task Force (AHETF) database, and the Agricultural Reentry Task Force 

(ARTF) 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.

 16 Available: http://www.epa.gov/endo/