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 summarize s the Environmental Protection Agency's current position based on the following documents:

1. Environmental Fate and Effects Division (EF ED) 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. Env ironmental 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, broad

spectrum 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 espe cially 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 h ealth risk a ssessment 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 Pr eliminary

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 inten ds, b y 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 encoura ges 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 o r 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 i pconazole

. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the document provides chemical facts, use and usage information, recent actions, the anticipated ecological risk

assessment , a summary of the draft human hea lth 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 r egistration r eview along with

some additional ch emical 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

Number 1 Study Title 1 Test

Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata Needs for the Parent Ipconazole

835.1230 Adsorption/desorption 2 TGAI 12

835.4100 Aerobic soil metabolism TGAI 24

835.4300 Aerobic aquatic metabolism TGAI 24

835.4400 Anaerobic a quatic metabolism TGAI 24

850.1035 Saltwater invertebrate a cute toxicity (mysid ) 4 TGAI 12

850.1075 Saltwater fish a cute toxicity 5 TGAI 12

850.1075 Freshwater fish acute toxicity ( f athead m innow ) 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 f ish early

- life stage toxicity ( r ainbow

t rout ) 3 TGAI 12

850.1400 Saltwater f ish early

- life stage toxicity 5 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; OC SPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 0028

2 Th e Agency does no t anticipate requir ing 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 determi ne 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

app roach 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

Number 1 Study Title 1 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

Non

Guideline

( OECD 213 ) Honey bee adult acute oral toxicity TGAI 12

Non

Guideline ( OECD 237 ) Honey bee larvae acute oral toxicity TGAI 12

Non

Guideline Honey bee adult chronic oral toxicity TGAI 12

Non

Guideline Honey bee larval chronic oral toxicity TGAI 12

Non

Guideline Semi

- field testing for pollinators TEP or

TGAI 24

Non

Guideline 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 practic es 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. Informatio n 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

. 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 op ened 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 F inal W ork P lan (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 7 041

CAS Number 125225

- 28

- 7

Year first registered 200 4 Pesticide Type Fungicide

Chemical class Triazole

- derivative fungicide

R eregistration Eligibility Decision (R E D) 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 registere d use on cotton, cereal grains (Crop Group 15, except rice), peanuts, and legume vegetables. Registered u se on other crops (e.g., root and tuber vegetables, leafy greens, corn) is considered to be non

food , thus tolerances are not needed

. Dual

- use Ipcon azole 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

- 02 89

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 except ion 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.

R egistered non

- agricultural use site s as a seed treatment only

include orna m en tal 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 t he major ity of usage during thi s same time period. Formulation Type(s) Formulated as a n 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 products 7

Restricted Use No

Guidance for Commente rs: Additi onal areas of use and usage related information requested for this registration r eview , 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.

• C onfirmation of the following label information : sites of application ; formulations ; application methods and equipment ; maximum application rates ; and geographic

limitations on use

.

• U se distribution ( e.g. , acreage and geographical distribution of relevant use sites )

.

• M edian and 90 th percentile reported use rates (lbs ai/ A ) from usage data

– national, state, and county

.

• Usage/use information for non

- agricultural uses

.

• S tate or local use restrictions

.

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

market

.

RECENT ACTIONS

There are no recent actions f or 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, t he Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessme nt, 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 p rocedures or default exposure assumptions

.

T able 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 Produ ct Label System (PPLS) website

( http://oaspub.epa.gov/pestlabl/ppls.hom e ).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

Eco logical 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 level s 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 f urther investigation.

Guidance for Commente rs: Additional ecological i nformation r equested for this registration r eview , 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.

• Ec ological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

.

• Water quality m onitoring 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 Dat e Opening the Docket Open Docket and 60

- day Public Comment Period 8 2015

– December

Close Public Comment 2016

– February Case Development

Final Work Plan 2016

– May

Issue D ata Call

- In 2016 July

– Sept.

Data Submission 2018 July

– Sept.

6 0

- day Public Comment Period for Draft Risk

Assessments 9

, 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 da ys 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

. 10 The Agency expects to seek comment on the draft ecological a nd environmental fate risk assessments at this time.11 Table 5: Projected Ipconazole Registration Review Timeline

Activities Estimated Dat e Registration Review Decision and Begin Post

- Decision

Follow

- up 202 1

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 ipconazole

.12 

### Appendix

– Additional Areas Considered in the Ipconazole 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 informa tion 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 (MRL s ) and may modify tolerance levels to do so, when possible

. G rowers 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, n o Total Maximum Daily Load s (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 Stan dard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 14 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 la ws, 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, unu sually 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

12 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollut ant

_group_name=PESTICIDES

13 http://www.epa.gov/owow/tmdl/

14 http://www.epa.gov/oppsrrd1/registration_review/water_quality_so p.htm13 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 wil l 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

ou tcomes 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 end points 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 ecologic al 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 sele cted 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 (ED SP).

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 th e 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 av ailable 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 EDS P screening was published on June 14, 2013 15 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 website 16

.

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 a s the Pesticide Ha ndlers 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. A ll applicable requ irements 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

.

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