2

Uniconazole-P Preliminary Work Plan – Table of Contents 

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

ANTICIPATED DATA NEEDS .................................................................................................... 3

STATUTORY AND REGULATORY AUTHORITY ................................................................... 5

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

USE AND USAGE INFORMATION ............................................................................................ 6

RECENT ACTIONS ....................................................................................................................... 7

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

TIMELINE .................................................................................................................................... 11

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

Appendix – Additional Areas Considered in the Uniconazole-P Registration Review ................ 12

References:

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

based on the following documents: 

1. Problem Formulation for the Ecological Risk and Drinking Water Exposure 

Assessments to be Conducted for the Registration Review of Uniconazole and 

Uniconazole-P. James K. Wolf, Frank Farruggia, and Rosanna Louie-Juzwiak. 

December 15, 2015.

2. Uniconazole-P. Human Health Assessment Scoping Document in Support of Registration 

Review. Jaime D’Agostino, Zaida Figueroa, and William Drew. December 15, 2015. 

3. Uniconazole: Tier I (Scoping) Review of Human Incidents and Epidemiology. Shana 

Recore. September 1, 2015. 

4. BEAD Chemical Profile (BCP) for Registration Review: Uniconazole (128676). Leonard 

Yourman, Don Atwood, and Andrew Lee. December 22, 2015.

5. EFED Table 1 Report. Ingredient: Uniconazole (128976). April 8, 2015.

6. HED Master Label Report. Ingredient: Uniconazole (128976). April 8, 2015.

These and other supporting documents for the uniconazole-P registration review case may be 

found in the docket EPA-HQ-OPP-2015-0729 at http://www.regulations.gov. 
3

OVERVIEW 

The docket for uniconazole-P is now open, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2015-0729). Uniconazole is a plant growth 

regulator. The resolved S-isomer, identified as uniconazole-P, is the active pesticidal ingredient 

and is the active ingredient in registered end-use products. Uniconazole-P is registered for use in 

greenhouses on ornamental plants and fruiting vegetables (Crop Group 8) transplants, including 

eggplant, groundcherry, pepino, pepper, tomatillo, and tomato. The product is specified for use 

in commercial greenhouses, lathhouses, and shadehouses as a foliar spray, bulb dip, or grounddirected applications using handheld equipment. There are no uniconazole registrations. This 

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

knows about uniconazole-P, 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 uniconazole-P. 

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 uniconazole-P and what types of new data or 

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

uniconazole-P. 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 

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 uniconazole-P. 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 risk 

assessments, and a projected registration review timeline for uniconazole-P. 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. 

ANTICIPATED DATA NEEDS 

Table 1 below summarizes anticipated data needs for uniconazole-P. Proposed label language 

would limit shadehouse and lathhouse applications to soil drench; if approved, the vegetative 

vigor toxicity study (GL. 850. 4150) would not be needed. For additional discussion of the 

anticipated data needs, see the Problem Formulation for the Ecological Risk and Drinking Water 

Exposure Assessments to be Conducted for the Registration Review of Uniconazole and 

Uniconazole-P and Uniconazole-P. Human Health Assessment Scoping Document in Support of 

Registration Review. 
4

Table 1: Anticipated Data Needs for the Uniconazole-P Registration Review 

Guideline 

Number1 Study Title1 Test Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

850.4400 Aquatic plant growth: Tier II vascular plants TGAI 12 

850.4500 Aquatic Plant Growth: Tier II Algal Toxicity TGAI 12 

850.4550 Aquatic Plant Growth: Tier II Cyanobacteria 

Toxicity TGAI 12 

850.3020 Honey bee acute contact toxicity TGAI 12 

NonGuideline 

Study (Tier I) 

Honey bee adult acute oral toxicity TGAI 12 

NonGuideline 

Study (Tier I) 

Honey bee larvae acute oral toxicity TGAI 12 

NonGuideline 

Study (Tier I) 

Honeybee adult chronic oral toxicity TGAI 12 

NonGuideline 

Study (Tier I) 

Honey bee larvae chronic oral toxicity TGAI 12 

850.3030 Honey bee toxicity of residues on foliage TGAI 12 

NonGuideline 

Study (Tier II) 

Semi-field testing for pollinators (tunnel or 

colony feeding studies) TEP 24 

NonGuideline 

Study (Tier II) 

Field trial of residues in pollen and nectar TEP 24 

850.3040 

(Tier III) Field testing for pollinators TEP 24 

850.4100 Terrestrial plant toxicity: Tier II seedling 

emergence 

TEP 12 

850.4150 Terrestrial plant toxicity: Tier II vegetative 

vigor TEP 12 

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 
5

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.2

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 uniconazole-P. 

 

2

 http://www2.epa.gov/pesticide-reevaluation 
6

CHEMICAL FACTS 

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

Table 2: Chemical Facts for Uniconazole-P

PC code 138976 (The uniconazole PC Code is 128976.) 

Case Number 7007 

CAS Number 83657-17-4 (The uniconazole CAS Number is 83657-22-1.) 

Year first registered 1984 

Pesticide Type Plant Growth Regulator 

Chemical class Triazole 

Reregistration Eligibility 

Decision (RED) 

No RED was completed for uniconazole-P. 

Tolerance Reassessment 

Eligibility Decision 

(TRED) 

Not applicable. 

Cumulative group Not applicable. Uniconazole-P has not been identified as a 

member of a cumulative group that shares a common mechanism 

of toxicity. 

40 CFR Citation Tolerances for uniconazole-P are established in 180.643. 

Dual-use Uniconazole-P 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 uniconazole-P. 

Pesticide Re-evaluation 

Division, Chemical 

Review Manager 

Susan Bartow, bartow.susan@epa.gov, 703-603-0065 

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 uniconazole-P. Please see the BEAD 

Chemical Profile (BCP) for Registration Review: Uniconazole (128676) in the registration 

review docket for more details. 

Table 3: Uniconazole-P Use and Usage Information

Summary of Use Uniconazole is a plant growth regulator. The resolved S-isomer, 

identified as uniconazole-P, is the active pesticidal ingredient and 

is the active ingredient in registered end-use products. 

Uniconazole-P reduces plant height by reducing internode 

elongation through inhibition of gibberellin biosynthesis. 

Use Sites Uniconazole-P is registered for use in greenhouses on ornamental 

plants and fruiting vegetables (Crop Group 8) transplants, 

including eggplant, groundcherry, pepino, pepper, tomatillo, and 
7

Table 3: Uniconazole-P Use and Usage Information

tomato. The product is specified for use in commercial 

greenhouses, glasshouses, lathhouses, and shadehouses (where 

plants are grown in containers). Direct application to dirt floors or 

to plants/pots in direct contact with dirt floors of greenhouses, 

lathhouses or shade structures is prohibited. 

Summary of Usage EPA does not have current usage data for uniconazole-P. 

Formulation Type(s) Emulsifiable and soluble concentrates. 

Application Method(s) Products can be applied by foliar spray, drench, bulb or cutting 

dip, and as a pre-plant application to the soil surface. 

Technical Registrant(s) Valent U.S.A. Corporation; Fine Agrochemicals, Ltd 

No. of Registrations 4 section 3 products3 and 1 section 24c product. 

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. 

 Updated information on the use of uniconazole-P to indicate its role in nursery and 

transplant management. 

 The relative importance of uniconazole-P (in comparison with alternatives, such as 

paclobutrazol) to assess benefits or impacts to growers of uniconazole-P. 

 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/A) from usage data – national, state, 

and county. 

 Typical 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 uniconazole-P to the 

US market. 

RECENT ACTIONS 

There are no recent actions for uniconazole-P. 

 

3

 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 uniconazole-P was completed 

on March 31, 2008 in preparation for a new use request on Fruiting Vegetables Crop Group 8 

(Except Cucurbits). The most recent ecological and environmental fate risk assessment was 

completed on April 10, 2008 in support of the proposed addition of shadehouse and lathhouse 

uses to the Sumagic product label. Findings and conclusions from these risk assessments are 

summarized in the Problem Formulation for the Ecological Risk and Drinking Water Exposure 

Assessments to be Conducted for the Registration Review of Uniconazole and Uniconazole-P and 

Uniconazole-P. 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 outdoor uses of 

uniconazole-P. For human health, EPA anticipates the need to conduct revised dietary and 

occupational risk assessments during registration review. 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 standard operating 

procedures or default exposure assumptions. 

Table 4 below summarizes the anticipated registration review risk assessments based on the 

EFED Problem Formulation and HED Scoping Document. 
9

Table 4: Anticipated Risk Assessments for the Uniconazole-P 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 In support of registration review, an exposure and risk 

assessment for outdoor uses will be conducted for the 

parent uniconazole-P. An updated drinking water 

assessment (DWA) is anticipated to be needed 

Incidents Will check for 

updates 

For a discussion of reported ecological incidents for 

uniconazole-P, see page 9 of the Problem 

Formulation. 

Human Health 

Dietary 

Food Yes The Agency will conduct a new dietary risk 

assessment to incorporate a new acute endpoint and 

point of departure for the general U.S. population. 

The assessment will include revised estimated 

drinking water concentrations (EDWCs), if 

applicable, as well as updated consumption 

information and the latest version of the dietary 

model. 

Drinking water Yes The agency will conduct a new drinking water 

assessment for uniconazole-P, to account for new 

modeling techniques introduced since the previous 

risk assessment. The new drinking water assessment 

will include the current residues of concern 

(uniconazole-P, its R-enantiomer and the Z-isomer).

Occupational 

Handlers (mixers, loaders, 

applicators) 

Yes The Agency will reevaluate the occupational handler 

assessment for uniconazole-P to address updates to 

exposure policies, including updates to default 

exposure data used for handler scenarios and 

assumptions for body weights. 

Post-application Yes Updated post-application (dermal) exposure 

assessments may be required in Registration Review 

based upon revisions to the Agency’s scenariospecific surrogate exposure data and assumptions for 

body weights. Any changes related to toxicological 

POD will also be incorporated. The Agency may also 

revisit the need for a quantitative occupational postapplication (inhalation) exposure assessment. 

Residential 

Handlers No There are no residential uses currently registered for 

uniconazole-P; therefore, a quantitative residential 

exposure/risk assessment is not necessary. 
10

Post-application No Exposure from drift is not expected, but the Agency 

may consider whether a volatilization risk assessment 

will be needed for uniconazole-P during registration 

review. 

Other 

Aggregate Yes Evaluates the combined risk from dietary and 

residential exposures. 

Cumulative No There is currently no evidence to indicate that 

conazoles share common mechanisms of toxicity, and 

the Agency is not following a cumulative risk 

approach based on a common mechanism of toxicity 

for the conazoles. 

Tolerances Yes The tolerance expression for uniconazole in 40CFR 

§180.643[a] should be revised to state, “Tolerances 

are established for residues of the fungicide/plant 

growth regulator uniconazole-P, including its 

metabolites and degradates, in or on the commodities 

listed in the table below. Compliance with the 

tolerance levels specified below is to be determined 

by measuring only uniconazole-P [(E)-(S)-1-(4-

chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-

yl)pent-1-en-3-ol], its R-enantiomer and its Zisomer.” 

Incidents Will check for 

updates 

There were no reported human incidents for 

uniconazole-P, see page 10 of the Scoping Document 

and Uniconazole: Tier I (Scoping) Review of Human 

Incidents and Epidemiology. 

Guidance for Commenters: Additional ecological information requested for this 

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

 Clarification of the test material (e.g., uniconazole-P) in the environmental fate studies. 

 The soil texture (i.e., particle size distribution) and cation exchange capacity (CEC) 

information submitted by the registrant (MRID 40573602) in order to compare Japanese 

soils to United States soils is not sufficient. Other factors such as parent material is 

equally important, for which there was no information submitted, may influence the 

sorption observed in these two soils. The units of measurement and what was included in 

the exchangeable acidity would be informative (it is assumed to be meq Fe+3 + Al+3/100 

g). Specific information would include soil mineralogy (i.e., clay), soil parent material 

(i.e., volcanic), drainage class, and climate conditions (temperature and precipitation) 

would be informative to relate the Japanese soils used for the aerobic soil metabolism 

study and the soil sorption partition coefficients to U.S. soils. 

 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). 
11

TIMELINE 

EPA has created the following estimated timeline for the completion of the uniconazole-P 

registration review in Table 5 below. 

Table 5: Projected Uniconazole-P Registration Review Timeline

Activities Estimated Date

Opening the Docket 

Open Docket and 60-day Public Comment Period 2015 December 

Close Public Comment 2016 February 

Case Development 

Final Work Plan 2016 May 

Issue DCI 2016 July - September 

Data Submission 2018 July - September 

60-day Public Comment Period for Draft Risk 

Assessments4

2020 January - March 

Registration Review Decision 

60-day Public Comment Period for Proposed 

Registration Review Decision 

2020 October - December 

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 uniconazole-P. 

 

 

4

 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. 
12

Appendix – Additional Areas Considered in the Uniconazole-P 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: 

Uniconazole-P is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.5

 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for uniconazole-P.6 More information on impaired water bodies 

and TMDLs can be found at the Agency’s website.7 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 Process8 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 uniconazole-P 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.

 

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

6

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES 7 http://www.epa.gov/owow/tmdl/

8 http://www2.epa.gov/pesticide-reevaluation/opp-guidance-submission-state-and-tribal-water-quality-monitoringdata
13

ENDANGERED SPECIES: 

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

conducted for uniconazole-P. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether use of uniconazole-P 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 uniconazole-P, 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), 

uniconazole-P 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, 20139

 and includes some pesticides 

 

9

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

chemicals. 
14

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. 

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

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

website.10

HUMAN STUDIES: 

Occupational 

Past uniconazole-P 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) 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. 

 

10 http://www2.epa.gov/endocrine-disruption