2

Diclosulam Preliminary Work Plan – Table of Contents

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

ANTICIPATED DATA NEEDS .................................................................................................... 4

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

CHEMICAL FACTS ...................................................................................................................... 5

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

RECENT 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 summarizes 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, Meheret. 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, 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 

diclosulam.

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 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 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 diclosulam. 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 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 Diclosulam Registration Review

Guideline 

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Anticipated Data Needs for the Parent Diclosulam

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

NonGuideline**Field trial of residues in pollen and 

nectar 

TGAI 24

NonGuideline** 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 Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028
5

STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States (U.S.) generally must be registered by the 

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. The registration review program is intended to make sure that, as the ability 

to assess risk evolves and as policies and practices change, all registered pesticides continue to 

meet the statutory standard of no unreasonable adverse effects to human health or the 

environment. Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided on EPA’s website.

2

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The regulations governing registration review begin at 40 CFR 155.40. The 

Agency will consider benefits information and data as required by FIFRA. The public phase of 

registration review begins when the initial docket is opened for each case. The docket is the 

Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses 

and data or information it believes are needed to make a registration review decision. After 

reviewing and responding to comments and data received in the docket during this initial 

comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for 

the registration review of diclosulam.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts 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

Reregistration Eligibility 

Decision (RED)

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_review/
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 produced 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 are 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 (129122) in the registration review 

docket for more details.

Table 3: Diclosulam 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 trees, 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 soybean in Alabama, Arkansas, 

Delaware, Florida, Georgia, Kentucky, Louisiana, Maryland, 

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: Diclosulam 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 formulated 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 products3, 5 section 24c products

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.

• 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 uses 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 Product Label System (PPLS) website 

(http://oaspub.epa.gov/pestlabl/ppls.home).
8

assessment was completed 2000 for the same purpose. Findings and conclusions 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 Health 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 Scoping 

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.

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

Problem Formulation for Environmental Fate, Ecological Risk and Endangered Species for 

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 Ecological 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 and 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%, therefore, 

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. No 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 exposure 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 The 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 postapplication inhalation exposure data generated by the Agricultural Reentry Task 

Force. 

An inhalation exposure assessment was performed for occupational/commercial 

handlers, and MOEs are not of concern. Since handler exposure resulting from 

application of pesticides outdoors is likely to result in higher exposure than postapplication 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 

Post-application No not performed.

Bystander/Spray 

drift 

Completed A quantitative spray drift assessment was conducted for diclosulam. Incidental 

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 

concern 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. Since 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 produced 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 Diclosulam 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) 6
12

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 diclosulam.
13

Appendix – Additional Areas Considered in the diclosulam 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:

Diclosulam 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 on 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 Operating Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and 

Management Process7 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 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.htm
14

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” 

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 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 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, 20138 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 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.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 determine their dermal and inhalation exposure. 

Many such studies, involving exposure to many different pesticides, comprise generic pesticide 

exposure databases such as the Pesticide Handlers Exposure Database (PHED) and the 

Agricultural Reentry Task Force (ARTF) Database. EPA has reviewed all the studies supporting 

these multi-pesticide generic exposure databases, and has found no clear and convincing 

evidence that the conduct of any of them was either fundamentally unethical or significantly 

deficient relative to the ethical standards prevailing at the time the research was conducted. All 

applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 

CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on 

these studies.

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