2

Acequinocyl Preliminary Work Plan – Table of Contents

OVERVIEW ................................................................................................................................... 4

ANTICIPATED DATA NEEDS .................................................................................................... 5

STATUTORY AND REGULATORY AUTHORITY................................................................... 7

CHEMICAL FACTS ...................................................................................................................... 7

USE AND USAGE INFORMATION............................................................................................ 8

RECENT ACTIONS....................................................................................................................... 9

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW................................ 9

TIMELINE.................................................................................................................................... 13

NEXT STEPS ............................................................................................................................... 13

Appendix – Additional Areas Considered in the Acequinocyl Registration Review............... 14

References:

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

based on the following documents:

1. Registration Review: Problem Formulation for the Environmental Fate, Ecological Risk, 

Endangered Species, and Drinking Water Assessments for Acequinocyl. Freeborn Jewett, 

Michael Lowit, and Sujatha Sankula. 18 May, 2015.

2. Acequinocyl. Human Health Assessment Scoping Document in Support of Registration 

Review. Sarah J. Levy, Anwar Y. Dunbar, George F. Kramer, and James S. Miller. 27 May 

2015.

3. Acequinocyl; Human-Health Risk Assessment for Proposed Section 3 Uses on Succulent 

Soybean Vegetable; Succulent Shelled Beans; Cowpea Forage; Caneberry Subgroup 13-

07A; Melon Subgroup 9A; Cucumber, Cherry; Low-Growing Berry Subgroup 13-07G; and 

Small Fruit Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F. (D389519). Sarah J. 

Levy, Anwar Y. Dunbar, and Kelly M. Lowe. 30 November 2011.
3

4. BEAD Chemical Profile for Registration Review: Acequinocyl (006329). Nikhil 

Mallampalli, Cynthia Doucoure, and Michelle Ranville. 1 June 2015.

5. Acequinocyl (006329) Screening Level Usage Analysis (SLUA). 10 November 2014.

6. Acequinocyl: Tier I Review of Human Incidents. Shanna Recore and Elizabeth Evans. 10 

February 2015.

7. Ecological Risk Assessment for the Proposed IR-4 Uses of Acequinocyl (PC 006329) on 

Succulent Soybean Vegetable (i.e., edamame), Low Growing Berry Subgroup 13-07G, 

Small Fruit Vine Climbing (except fuzzy kiwifruit) Subgroup 13-07F, Bean (succulent 

shelled), Cowpea Forage, Caneberry Subgroup 13-07A, Melon Subgroup 9A, Cucumber, 

and Cherry (DP 390259). Robin Sternberg, Robert Miller, Nancy Andrews, and Sujatha 

Sankula. 25 October 2011. 

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

in the docket EPA-HQ-OPP-2015-0203 at http://www.regulations.gov.
4

OVERVIEW

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

registration review (docket number EPA-HQ-OPP-2015-0203). Acequinocyl is a quinoline-type 

miticide currently registered for use in the U.S. on various food and ornamental plant crops for 

the control of mites. Acequinocyl is registered for use in greenhouses, shadehouses, and 

nurseries as well as in and around residences, businesses, public property, schools, 

interiorscapes, and other non-production areas by commercial applicators and homeowners. This 

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

knows about acequinocyl, 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 acequinocyl.

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 acequinocyl and what types of new data or 

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

acequinocyl. 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 acequinocyl. 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 acequinocyl. 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.
5

ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for acequinocyl. For additional discussion of 

the anticipated data needs, see the Registration Review: Problem Formulation for the 

Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Assessments for 

Acequinocyl and Acequinocyl. Human Health Assessment Scoping Document in Support of 

Registration Review.

Table 1: Anticipated Data Needs for the Acequinocyl Registration Review

Guideline 

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Anticipated Data Needs for the Parent Acequinocyl

850.1025 Acute toxicity estuarine and marine organisms -

oyster TGAI 12

850.1400 Fish early-life stage toxicity (freshwater) TGAI 12

850.1400 Fish early-life stage toxicity (saltwater) TGAI 12

850.2100 Avian acute oral toxicity2 TGAI 12

850.3040 Field testing for pollinators4 TEP 12

850.4400 Aquatic vascular plant toxicity TEP 12

850.4500 Guideline Estuarine/marine diatom toxicity test 

using Skeletonomea costatum TEP 12

850.4500 Freshwater diatom toxicity test using Navicula 

pelliculosa TEP 12

850.4550 Cyanobacterial Toxicity (Blue green algae 

toxicity test using Anabaena flos-aquae) TEP 12

NonGuideline

Whole sediment chronic invertebrates3 -

freshwater midge Chironomus dilutus, freshwater 

amphipod Hyalella azteca, and estuarine/marine 

amphipod Leptocheirus plumulosus 

TGAI 12

NonGuideline Pollinator Chronic Oral Toxicity, adult TGAI 12

NonGuideline Pollinator Acute Toxicity, larvae TGAI 12

 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 To be conducted with a passerine species.

3 EFED acknowledges that acequinocyl stability issues have been reported in estuarine/marine invertebrate tests that 

resulted in a waiver for the chronic estuarine/marine invertebrate study (USEPA, 2010). If chemical stability is an 

issue during the chronic testing with a marine/estuarine amphipod species, consulting with EFED scientists about 

other testing options may be possible. A protocol must be provided for Agency review prior to initiation of the 

study.
6

Table 1: Anticipated Data Needs for the Acequinocyl Registration Review

Guideline 

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

NonGuideline Pollinator Chronic Toxicity, larvae TGAI 12

NonGuidelineResidues in Pollen and Nectar/Field Residue 

Analysis4 TEP 24

NonGuidelinePollinator Tier 2 Semi-Field Toxicity Testing 

(tunnel/enclosure or colony feeding)4 TEP 24

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

 4 The need for theses anticipated data requirements is contingent on results of the tier 1 bee studies (including acute 

oral toxicity to adult honey bees, acute oral toxicity to larval honey bees, chronic oral toxicity to adult honey bees, 

and chronic oral toxicity to larval honey bees).
7

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.

5

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 acequinocyl.

CHEMICAL FACTS

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

Table 2: Chemical Facts for Acequinocyl

PC code 006329

Case Number 7621

CAS Number 57960-19-7

Year first registered 2003

Pesticide Type Miticide 

Chemical class Quinoline

Reregistration Eligibility 

Decision (RED)

Not applicable – acequinocyl was registered after November 

1984; therefore, it was not subject to reregistration.

Tolerance Reassessment 

Eligibility Decision 

(TRED)

Not applicable.

 5 http://www.epa.gov/oppsrrd1/registration_review/
8

Table 2: Chemical Facts for Acequinocyl

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

of a cumulative group that shares a common mechanism of 

toxicity.

40 CFR Citation Tolerances for acequinocyl are established in § 180.599.

Dual-use Acequinocyl 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 acequinocyl.

Pesticide Re-evaluation 

Division, Chemical 

Review Manager

Margaret Hathaway, hathaway.margaret@epa.gov, 703-305-5076

Registration Division, 

Product Manager

Venus Eagle, eagle.venus@epa.gov, 703-308-8045

USE AND USAGE INFORMATION

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

Chemical Profile for Registration Review: Acequinocyl (006329) in the registration review 

docket for more details.

Table 3: Acequinocyl Use and Usage Information

Summary of Use Miticide used on a wide variety of agricultural and ornamental 

plants. It is applied as a foliar spray and has no systemic activity 

but provides contact control of all life stages of mites, acting by 

disrupting cellular respiration in the target pests.

Use Sites Agricultural Use Sites: Pome fruit, citrus, caneberry (crop 

subgroup 13-07A), cherry, cucumber (field and commercial 

greenhouse grown), small fruit vine climbing subgroup except 

fuzzy kiwifruit (subgroup 13-07F), low growing berries 

(subgroup 13-07G), melon (subgroup 9A), succulent shelled 

bean, succulent soybean vegetable, tree nuts (including almonds 

and pistachios), fruiting vegetables except cucurbits (field grown 

and commercial greenhouse grown), edible podded beans, hops, 

and okra.

Non-Food Crop Use Sites: Commercial greenhouse and shade 

house on ornamental, floral, foliage, and ornamental nursery 

crops; on ornamentals in outdoor landscapes around the perimeter 

of residences, businesses, schools, and public property, and on 

ornamentals in non-residential interior settings.

Summary of Usage The acequinocyl screening level usage profile (SLUA), which 

summaries data represent annual data from 2004-2012, lists the 

primary uses in terms of average weight of applied product of 

acequinocyl as almonds, apples, oranges, and strawberries. The 

SLUA also that of reported crops on which acequinocyl is used, 
9

Table 3: Acequinocyl Use and Usage Information

strawberry is the crop with the highest percent crop treated from 

2004-2012 (average = 5%; maximum = 10%).

Formulation Type(s) Soluble concentrate.

Application Method(s) Acequinocyl is applied to crop or plant foliage via a ground-based 

sprayer. No aerial applications are permitted.

Technical Registrant(s) Arysta LifeScience North America, LLC

No. of Registrations 2 Section 3 products6

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 acequinocyl labels are unclear with respect to application parameters. 

Clarification is requested on product use patterns for cases where the annual application 

rate is currently written on the label in terms of per season use rather than per year use.

Without further information, EPA expects to use conservative assumptions to 

approximate these parameters in order to conduct a quantitative risk assessment.

• Details on the pest management importance of acequinocyl in ornamental production.

• If more than one application is typically made, the typical re-application interval (per 

crop).

• Recent resistance reports for acequinocyl in populations of important target pests.

RECENT ACTIONS

There are no recent actions for acequinocyl.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for acequinocyl was completed on 

November 30, 2011 for a request for tolerances in/on a variety of agricultural crops (D389519). 

The most recent ecological and environmental fate risk assessment was completed in 2011 

(D390259) for various new use requests.7 Findings and conclusions from these risk assessments 

are summarized in the Registration Review: Problem Formulation for the Environmental Fate, 

Ecological Risk, Endangered Species, and Drinking Water Assessments for Acequinocyl and 

Acequinocyl. 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

acequinocyl. For human health, EPA anticipates the need to conduct revised dietary, residential,

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 

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

(http://oaspub.epa.gov/pestlabl/ppls.home). 7 For additional information, please see the 2011 human health and ecological risk assessments located in the 

acequinocyl docket, EPA-HQ-OPP-2015-0203.
10

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.
11

Table 4: Anticipated Risk Assessments for the Acequinocyl 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 The ecological dataset for acequincyl is currently 

incomplete.

Incidents Will check for 

updates

No ecological incidents were recorded resulting from 

the use of acequinocyl.

Human Health

Dietary

Food Yes A revised dietary-exposure analysis may be required 

to reflect the most recent dietary-exposure models and 

potential revised EDWCs (specifically, use of PRZMGW).

Drinking water Yes The 2011 chronic dietary assessment did not utilize 

the latest dietary exposure model or consumption 

database. The impact of using the most up-to-date 

models and guidance at the time of the risk 

assessment will need to be considered during 

Registration Review.

Occupational

Handlers (mixers, loaders, 

applicators)

Yes Updated occupational handler assessments will be 

required using current Agency policies to reflect all 

currently registered uses and maximum application 

rates.

Post-application Yes Post-application exposure is anticipated since 

acequinocyl is applied post-emergence as a foliar 

spray. Updated occupational assessments may be 

conducted to reflect all currently registered uses, 

using current Agency policies.

Residential

Handlers Yes An updated residential exposure assessment will be 

needed for acequinocyl during Registration Review to 

incorporate the 2012 Residential Standard Operating 

Procedures (SOPs).

Post-application Yes An updated residential exposure assessment will be 

needed for acequinocyl during Registration Review to 

incorporate the 2012 Residential SOPs.

Other

Aggregate Yes A revised aggregate exposure assessment may be 

needed to reflect a revised dietary-exposure analysis 

and/or an updated residential exposure assessment.
12

Cumulative No Not applicable. Acequinocyl has not been identified 

as a member of a cumulative group that shares a 

common mechanism of toxicity.

Tolerances Yes EPA will consider harmonizing tolerances as 

appropriate.

Incidents Will check for 

updates

There were no incident cases reported for 

acequinocyl. The Agency will continue to monitor 

the incident information and if a concern is triggered, 

additional analysis will be included in the risk 

assessment.

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).
13

TIMELINE

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

registration review in Table 5 below.

Table 5: Projected Acequinocyl Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period 2015 – June

Close Public Comment 2015 – August

Case Development

Final Work Plan 2015 – November

Issue DCI 2016 Jan. – March

Data Submission 2018 Jan. – March

60-day Public Comment Period for Draft Risk 

Assessments8

2020 July – Sept

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2020 Oct. - Dec

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 acequinocyl.

 8 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.
14

Appendix – Additional Areas Considered in the Acequinocyl 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:

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

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

9

 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for acequinocyl.

10 More information on impaired water bodies 

and TMDLs can be found at the Agency’s website.

11 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 Process12 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 acequinocyl 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.

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

10http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant

_group_name=PESTICIDES 11 http://www.epa.gov/owow/tmdl/ 12 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
15

ENDANGERED SPECIES:

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

conducted for acequinocyl. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether use of acequinocyl 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 acequinocyl, 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), 

acequinocyl 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, 201313 and includes some 

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

chemicals.
16

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. 

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.14

HUMAN STUDIES:

Occupational and Residential

Past acequinocyl 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.

 14 http://www.epa.gov/endo/