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

R ECENT ACTIONS

................................ ................................ ................................ ....................... 9

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

................................ 9

TIMELINE

................................ ................................ ................................ ................................ .... 13

NEXT STEPS

................................ ................................ ................................ ............................... 13

Appendix

– Addi tional Areas Considered in the Acequinocyl Registration Review

............... 14

References:

This Preliminary Work Plan summarize s 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 Sankul a

. 18 M ay, 2015.

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

Review

. Sarah J. Levy, Anwar Y. Dunbar, George F. Kramer, and J ames 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

. ( D389 519 ). 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 Leve l 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 Sternber g, Robert Miller, Nancy Andrews, and Sujatha

Sankula. 2 5 October 20 11

.

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 mite s . Acequinocyl is registered for use in greenhouses, shadehouses, and

nurseries as well as in and around residences, bu sinesses, 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 a nticipated 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, b y 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 in formation 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 R egistration R eview. Then the document provides chemical facts, use and usage information, recen t 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 R egistration R eview alo ng 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 Formulati on 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

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata 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 toxicity 2 TGAI 12

850.3040 Field testing for pollinators 4 TEP 12

850.4400 Aq uatic 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

Non

Guideline Whole sediment chronic invertebrates 3

- freshwater midge Chironomus dilutus , freshwater amphipod Hyalella azteca , and estuarine/marine amphipod Leptocheirus plumulosus TGAI 12

Non

Guideline Pollinator Chronic Oral Toxicity, adult TGAI 12

Non

Guideline 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 A vailability” 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

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Non

Guideline Pollinator Chronic Toxicity, larvae TGAI 12

Non

Guideline Residues in Pollen and Nectar/Field Residue Analysis 4 TEP 2 4

Non

Guideline Pollinator Tier 2 Semi

- Field Toxicity Testing (tunnel/enclosure or colony feeding) 4 TEP 2 4

TGAI = technical grade active ingredient; TEP = typical end

- use product ;

4 The need for theses anticipated data requireme nts 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 cau se 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 p esticides 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 Age ncy periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Informatio n 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

. T he 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 i n the docket during this initial comment period, the Agency will develop a F inal W ork P lan (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

R eregistration Eligibility Decision (R E D) 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.ep a.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 th at 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, h athaway.margaret @ epa.gov, 7 03

- 3 05

- 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 exc ept 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 comm ercial 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 prim ary 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 N orth America, LLC No. of Registrations 2 Section 3 products 6

Restricted Use No

Guidance for Commente rs: 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 t he annual ap plication

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 assessmen t.

• 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 targ et 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)

. T he 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 Heal th Assessment Scoping Document in Support of Registration Review

.

During registration review, t he 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 assessment s during registration review

. If toxicological endpoints or points of departure are revised based on the data that are anticipated to be re quired for

6 Section 3 product labels can be obtained from the Pesticide Produ ct 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 assessment s
, as well as any changes to the standard operating p rocedures or default exposure assumptions

.

T able 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 acequinc yl 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 PRZM

GW). Drinking water Yes T he 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 Regis tration 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 P ost

- 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 (SOP s )

. Post

- application Yes An updated residential exposure assessment will be

needed f or 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 T here 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 Commente rs: Additional ecological i nformation r equested for this registration

r eview , 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 Dat e 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 201 6 Jan.

– March

Data Submission 2018 Jan.

– March

60

- day Public Comment Period for Draft Risk

Assessments 8 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 6 0

- 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, t he Agency plans to provide a 60 calendar day public comment period generally for draft risk assessment s

.14 

### Appendix

– Additional Areas Considered in the Acequinocyl Registration

Review

PUBLIC COMMENTS AND FEEDBACK :

Guidance for C ommenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or reference to sou rces of additional information c ould 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 r esidue limits (MRL s ) 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 market s, 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 Process 12 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 popula tion 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, unu sually 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

10 http://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.htm15 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 r eview

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 requi red 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, deve lopmental, 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, fert ility, 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 s imilar 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 o f 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

- i ns 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, 2013 13 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 registratio n 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 :

Occupationa l and Residentia l

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 Ha ndlers Exposure Database (PHED), the Agricultural Reen try 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. A ll applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research ( 40 CFR Part 26) have been

satisfied , and t here is no regulatory barrier to continued reliance on these studies

.

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