2 

### D iclosulam Preliminary Work Plan

– Table of Contents

OVERVIEW

................................ ................................ ................................ ................................ ... 3

ANTICIPATED DATA NEEDS

................................ ................................ ................................ .... 4

STATUT ORY AND REGULATORY AUTHORITY

................................ ................................ ... 5

CHEMICAL FACTS

................................ ................................ ................................ ...................... 5

USE AND USAGE INFORMATION

................................ ................................ ............................ 6

RECE NT ACTIONS

................................ ................................ ................................ ....................... 7

RISK ASSESSMENTS FOR REGISTRATION REVIEW

................................ ........................... 7

TIMELINE

................................ ................................ ................................ ................................ .... 11

NEXT STEPS

................................ ................................ ................................ ............................... 12 Appendix

– Additional Areas Considered in the diclosulam Registration Review

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

References:

This Preliminary Work Plan summarize s the Environmental Protection Agency's current position based on the following documents:

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

and Endangered Species for Diclosulam

. Clock

- Rust, Mary; Carleton, Jim

. June 9, 2015

.

2. Diclosulam. Human Health Assessment Scoping Document and Preliminary Human

Health Risk Assessment in Support of Registration Review. Rury, Kristin; Ottley, Myron; Negussie, Mehe ret

. May 28, 2015

.

3. Diclosulam: Tier I Review of Human Incidents . Shanna, Recore. March 25, 2015

4. BEAD Chemical Profile (BCP) for Registration Review: Diclosulam (129122)

. Yourman, Leonard; Prieto Rafael A.; Berwald, Derek

. December 12, 2014

.

5. Diclosulam (129122) Screening Level Usage Analysis (SLUA)

. July 25, 2014.

6. EFED Table 1 Report. August 11, 2014.

7. HED Master Label Report

. August 11, 2014.

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

in the docket EPA

- HQ

- OPP

- 2015

- 0285 at http://www.regulations.gov

.3 OVERVIEW

The docket for diclosulam is now open, initiating the first public comment period for this registration review (docket number EPA

- HQ

- OPP

- 2015

- 0285). Diclosulam is a broad spectrum herbicide and is a member of the triazolopyrimidine sulfonamide class of pesticides. It is formulated as a water dispersible granular (WDG) in water soluble packets (WSP), and is currently registered for use on cottonwood trees, peanuts, and soybeans; and used in impregnated dry bulk fertilizers. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about diclosulam, highligh ting 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

diclosulam.

The regi stration 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 diclosulam and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on diclosulam. The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional informat ion 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 in formation. 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 diclosulam. Next, it discusses the statutory and regulatory authority for Registration Review. Then the document provides chemical facts, use and usage information, recent actio ns, the anticipated risk assessments, and a projected registration review timeline for diclosulam. Finally, the Appendix

to this document includes identification and discussion of some areas that are considered generally in Registration Review along with some additional chemical case

- specific information.4 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for diclosulam . For additional discussion of the anticipated data needs, see the Registration Review: Problem Formulation for Environmental Fate, Ecological Risk and Endangered Species for Diclosulam.

Table 1: Anticipated Data Needs for the D iclosulam Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata Needs for the Parent D iclosulam

835.4100 Aerobic Soil Metabolism TGAI 12

850.2300 Avian reproduction toxicity test,

mallard duck TGAI 24

850.1350 Invertebrate Lifecycle Toxicity test

with a marine/estuarine invertebrate species TGAI 12

850.1400 Fish Early Life Stage Toxicity Test with a marine/estuarine fish species TGAI 12

850.1400 Fish Early Life Stage Toxicity Test with a freshwater fish species TGAI 12

Non

- guideline* Acute oral toxicity to adult honey bees TGAI 12

Non

- guideline* Acute oral toxicity to larval honey bees TGAI 12

Non

- guideline* Chronic oral toxicity to larval honey

bees TGAI 12

Non

- guideline * Chronic oral toxicity to adult honey

bees TGAI 12

Non

Guideline** Field trial of residues in pollen and

nectar TGAI 24

Non

Guideline** Semi

- field testing for pollinators TGAI 24

850.3040 ** Field testing for pollinators TGAI 24

TGAI = technical grade active ingredient; TEP = typical end

- use product ; *Tier 1 (Laboratory

- based studies) **Tier 2 and 3 (Semi

- field and full field colony

- level studies) The need for a higher tier test for pollinators will be determined based upon lower

- tiered tests and/or other lines of data and the need for a refined pollinator risk

assessment.

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

- 00285 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 scienti fic 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 t he 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

. 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

. 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 opene d 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 diclosulam

.

CHEMICAL FACTS

Table 2 provides a summary of the chemical fac ts for diclosulam

.

Table 2: Chemical Facts for diclosulam

PC code 129122

Case Number 288998

CAS Number 145701

- 21

- 9

Year first registered 2000 Pesticide Type Herbicide

Chemical class Triazolopyrimidine Sulfonamide

R eregistration Eligibility Decision (R E D) Diclosulam was registered after November 1984; therefore, it was not subject to reregistration.

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

2 http://www.epa.gov/oppsrrd1/registration_rev iew/6 Table 2: Chemical Facts for diclosulam

Cumulative group Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding with

diclosulam

. Diclosulam does not appear to produce a toxic metabolite produce d by other substances.

40 CFR Citation Tolerances for diclosulam are established in §180.543.

Dual

- use Diclosulam is registered for conventional pesticidal uses only and has no registered antimicrobial or biopesticidal uses.

Non

- pesticidal uses There ar e no identified non

- pesticidal uses of diclosulam

. Pesticide Re

- evaluation Division, Chemical Review Manager Matthew Manupella, manupella.matthew@epa.gov, (703) 347

- 0411

Registration Division

, Product Manager Shaja Joyner, joyner.shaja@epa.gov , (703) 308

- 3194

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for diclosulam

. Please see the BEAD Chemical Profile (BCP) for Registration Review: Diclosulam (12 9122) in the registration review

docket for more details

.

Table 3: D iclosulam Use and Usage Information

Summary of Use Diclosulam is a broad spectrum herbicide and is a member of the triazolopyrimidine sulfonamide class of pesticides. It is formulated as a water dispersible granular (WDG) in water soluble packets (WSP), and is currently registered for use on

cottonwood tr ees, peanuts, and soybeans; and used in impregnated dry bulk fertilizers.

Use Sites Diclosulam is used for production of peanuts and is registered in Alabama, Arkansas, Florida, Georgia, Illinois, Louisiana, Missouri, Mississippi, North Carolina, South Carolina,
Tennessee, and Virginia. There are 24(c) Special Local Needs (SLN) registrations indicating a special local need for diclosulam to control tropical spiderwort in peanut in Georgia, Florida and Mississippi.

Diclosulam is labeled for use on soybe an in Alabama, Arkansas, Delaware, Florida, Georgia, Kentucky, Louisiana, Maryl and, Mississippi, Missouri, New Mexico, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, and Virginia. EPA has no information or usage data suggesting that diclosulam is actually used on soybean fields.7 Table 3: D iclosulam Use and Usage Information

There are two diclosulam SLN labels for cottonwood plantings in

Missouri and Tennessee. Summary of Usage For the 2000

- 2012 timeframe, the annual usage of diclosulam averaged 4,000 pounds a.i. treating an annual average of 200,000 acres of peanuts, with an overall average application rate of 0.02 pounds a.i. per acre. Formulation Type(s) Diclosulam is formul ated as a water dispersible granular (WDG) in water soluble packets (WSP)

. Application Method(s) Diclosulam is labeled for soil applications for most peanut production. It may be applied preplant incorporated into soil, preplant surface application, or preemergence through the soil "cracking" phase of the peanut emergence (i.e., germinating plant breaking through the soil).

For soybean, a single preplant soil incorporated application, soil surface application, or a preemergent incorporation is indicated

on at least one label. Technical Registrant (s) Dow Agrosciences, LLC. No. of Registrations 2 Section 3 products 3 , 5 section 24c products

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.

• EPA has little information as to additional possible niche uses, use patterns, or specific problem weeds where diclosulam might fill a need that is currently lacking for growers.

• EPA information indicates no use of diclosulam in soybean fields in the U.S. Information on diclosulam use on soybean fields in general and particularly in Texas, Oklahoma, and New Mexico may be valuable.

• EPA has no information on diclosulam SLN u ses for cottonwood plantings. Information on particular weed issues may be helpful if a benefits assessment is required.

RECENT ACTIONS

There are no recent actions for diclosulam.

RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for diclosulam was completed in

2000 at the time it was registered . The most recent ecological and environmental fate risk

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

( http://oaspub.epa.gov/pestlabl/ppls.home ).8 assessment was completed 2000 for the sam e purpose . Findings and conclus ions from these risk

assessments are summarized in the Registration Review: Problem Formulation for Environmental Fate, Ecological Risk and Endangered Species for Diclosulam and Diclosulam: Human Health Assessment Scoping Document and Preliminary Human Hea lth Risk Assessment in Support of Registration Review

.

During registration review, the Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of

diclosulam. For human health, EPA has evaluated the status of the human health risk

assessments for diclosulam and has determined that sufficient data are available in order to complete the risk assessment at this time. The Diclosulam: Human Health Assessment Scopin g Document and Preliminary Human Health Risk Assessment in Support of Registration Review

, summarized in Table 4 below, evaluates the hazard and exposure data and conduct occupational and residential exposure assessments, as needed, to estimate the risk to human health that will result from the currently registered uses of pesticides.

T able 4 below summarizes the anticipated registration review risk assessment based on the Problem Formulation for Environmental Fate, Ecological Risk and Endangered Species f or Diclosulam and the completed registration review human health risk assessment based on the Diclosulam: Human Health Assessment Scoping Document and Preliminary Human Health Risk Assessment in Support of Registration Review.9 Table 4: Risk Assessments for the Diclosulam Registration Review

Type of Risk

Assessment Conduct? Notes

Anticipated Eco logical and Environmental Fate Risk Assessment Comprehensive ecological (species to be

assessed include

terrestrial and aquatic organisms), including endangered species Yes Additional data is required in order to conduct the ecological risk assessment.

Incidents Will check

for updates For a discussion of reported ecological incidents for diclosulam, see page 18 of

the Problem Formulation.

Human Health Risk Assessment Dietary

Food Completed An acute dietary exposure assessment was not performed because an acute dietary a dose and endpoint of concern attributable to a single dose was not observed

. Acute dietary risk is not expected. In support of Registration Review, an updated chronic dietary (food and drinking water) exposure and risk assessment was

conducted. The chronic dietary (food an d drinking water) exposure estimates are

below the level of concern (<100% cPAD) for the general U.S. population and all population subgroups (<1% of the cPAD), except all infants at 1.2% , t herefore, the chronic aggregate diclosulam risk estimates are not of concern. Drinking water Completed

Occupational

Handlers (mixers, loaders, applicators) Completed In support of Registration Review, an updated occupational exposure assessment for diclosulam was conducted for mixers/loaders of WSP formulations, mixer/loaders for impregnation of dry bulk fertilizers, and for applicators of spray and dry bulk fertilizer containing diclosulam. The assessment was based on the maximum registered application rates. Occupational handlers are anticipated to

have short

- and intermediate

- term dermal and inhalation exposures. N o short

- or intermediate

- term dermal toxicological endpoints were identified so a quantitative dermal risk assessment was not conducted; dermal risk is not of concern. The occupational handler expos ure and risk estimates indicate that the short

- and

intermediate

- term inhalation margins of exposure ( MOEs ) are not of concern (i.e., an MOE > the LOC of 100) at baseline personal protective equipment (PPE; i.e., no respirator).10 Post

- application Completed T he Agency did not conduct a quantitative post

- application inhalation risk

assessment for performing post

- application activities in previously treated fields

. It will determine in future assessments if data (i.e., flux studies, route

- specific

inhalation toxicological studies) or further analysis is required for specific

chemicals. In addition, the Agency is continuing to evaluate the available post

application inhalation exposure data generated by the Agricultural Reentry Task

Force.

An inhalation expo sure assessment was performed for occupational/commercial

handlers , and MOEs are not of concern

. Since h andler exposure resulting from application of pesticides outdoors is likely to result in higher exposure than post

application exposure. Therefore, it is expected that these handler inhalation exposure estimates would be protective of most occupational post

- application inhalation exposure scenarios.

Residential

Handlers No There are no proposed or registered products containing diclosulam that would result in residential exposure. Therefore, a residential exposure assessment was not performed. Post

- application No Bystander /Spray

drift Completed A quantitative spray drift assessment was conducted for diclosulam. I ncidental

oral risk estimates were evaluated. The incidental oral margins of exposure (MOEs) for children 1 to <2 years old were >270,000 at the field's edge, and are

not of concern.

Other Aggregate Completed An acute aggregate risk assessment was not performed because an endpoint of

con cern attributable to a single oral dose was not selected for any population subgroup (including infants and children). Short

- and intermediate

- term aggregate risk assessments were not performed because there are no registered

residential non

- food uses. S ince there are no residential uses, the chronic dietary (food and water) exposure estimates represent chronic aggregate exposure. Therefore, the chronic aggregate risk estimates are not of concern to EPA

. Cumulative No Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to diclosulam and any other substances and diclosulam does not appear to produce a toxic metabolite produc ed by other

substances.11 Tolerances Yes According to EPA’s Interim Guidance on Tolerance Expressions, the tolerance expressions for diclosulam should be revised as follows:

Under 40 CFR §180.543(a): “Tolerances are established for residues of diclosulam, including is metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified in the table is to be determined by measuring only diclosulam [ N

- (2,6

- dichlorophenyl)

- 5

- ethoxy

- 7

- fluoro[1,2,4] triazolo[1 ,5

- c]pyrimidine

- 2

- sulfonamide] in or on the following

commodities:

Table 2.2.3.1. Tolerance Summary for Diclosulam (40 CFR §180.543).

Commodity Established Tolerance (ppm) Comments

40 CFR §180. 543 : diclosulam [ N

- (2,6

- dichlorophenyl)

- 5

- ethoxy

- 7

- fluoro[1,2,4] triazolo[1,5

-

c ]pyrimidine

- 2

- sulfonamide

Peanut 0.02
Soybean, seed 0.02
Incidents Will check

for updates For a discussion of reported human incidents for diclosulam see page 11 of the Scoping Document and the Diclosulam: Tier I Review of Human Incidents

.

TIMELINE

EPA has created the following estimated timeline for the completion of the diclosulam registration review in Table 5 below

.

Table 5: Projected D iclosulam Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60

- day Public Comment Period June 2015

Close Public Comment August 2015 Case Development

Final Work Plan November 2015

Issue DCI January

- March 2016

Data Submission January

- March 2018

60

- day Public Comment Period for Draft Ecological

Risk Assessment July

- September 2019

Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision October

– December 2020

Registration Review Decision and Begin Post

- Decision

Follow

- up 2021

Total (years) 612 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 diclosulam

.13 

### Appendix

– Additional Areas Considered in the diclosulam 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 tra de 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

. Growers an d 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:

D iclosulam is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 4 In addition, no Total Maximum Daily Loads (TMDL) have been developed for diclosulam

. 5 More information o n impaired water bodies and TMDLs can be found at the Agency’s website

. 6 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 Operati ng Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 7 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 law s, 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 diclosulam 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.

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

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

group_name=PESTICIDES

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

7 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm14 ENDANGERED SPECIES :

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

conducted for diclosulam

. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of diclosulam has “no effect” or “may affect”

fede rally 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, neurotoxici ty, 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 maturati on, 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 the 2000 registration decision for diclosulam

, 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), diclosulam 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 wildlif e 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, 2013 8 and includes some

8 See http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.15 pesticides scheduled for registrat ion 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, t he test guidelines and the Tier 1 screening battery, please visit our

website. 9

HUMAN STUDIES :

Occupational

Past diclosulam risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to det ermine 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 rel ative 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 contin ued reliance on

these studies.

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