2 

Famoxadone	Preliminary	Work	Plan	–	Table	of	Contents	

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

ANTICIPATED DATA NEEDS .................................................................................................... 3

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

CHEMICAL FACTS ...................................................................................................................... 6

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

RECENT ACTIONS ....................................................................................................................... 7

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW ................................ 8

TIMELINE .................................................................................................................................... 10

NEXT STEPS ............................................................................................................................... 10

Appendix – Additional Areas Considered in the Famoxadone Registration Review ............... 11

References:

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

based on the following documents: 

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

Endangered Species, and Drinking Water Assessment for Famoxadone. F. Jewett and CM 

Koper. March 3, 2015. 

 

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

Review. I. Negron-Encarnacion, S. Dapson, and K. King. March 4, 2015. 

3. Famoxadone: Tier I Review of Human Incidents. S. Recore and E. Evans. October 28, 

2014. 

4. BEAD Chemical Profile for Registration Review: Famoxadone. T. Chandgoyal. October 

12, 2014.

5. Famoxadone Screening Level Usage Analysis. June 17, 2014. 

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

found in docket EPA-HQ-OPP-2015-0094 at http://www.regulations.gov. 
3 

OVERVIEW 

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

registration review (docket number EPA-HQ-OPP-2015-0094). Famoxadone is a fungicide 

registered for use to control and/or manage a variety of fungal and bacterial diseases on 

caneberries (subgroup 13-07A); cilantro leaves; cucurbit vegetables; grapes (East of the Rocky 

Mountains); hops; bulb onion (subgroup 3-07A); green onion (subgroup 3-07B); potato; pepper; 

tomato; and leafy vegetables except Brassica (group 4). Famoxadone is not currently registered 

for residential use. This Preliminary Work Plan (PWP) document explains what EPA's Office of 

Pesticide Programs knows about famoxadone, 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 famoxadone. 

 

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 famoxadone and what types of new data or 

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

famoxadone. 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 famoxadone. 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 famoxadone. 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. 

ANTICIPATED DATA NEEDS 

Table 1 summarizes anticipated data needs for famoxadone. For additional discussion of the 

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

Fate, Ecological Risk, Endangered Species, and Drinking Water Assessment for Famoxadone

and the Famoxadone Human Health Assessment Scoping Document in Support of Registration 

Review. 
4 

Table 1: Anticipated Data Needs for the Famoxadone Registration Review 

Guideline 

Number1 Study Title Test2

Material 

Estimated 

Timeframe 

(Months 

from receipt 

of DCI) 

Anticipated Data Needs for the Parent Famoxadone

835.4200 Anaerobic Soil Metabolism (3 additional soils) TGAI 24 

835.4300 Aerobic Aquatic Metabolism (1 additional 

sediment-water system) TGAI 24 

835.4400 Anaerobic Aquatic Metabolism (2 additional 

sediment-water systems) TGAI 24 

850.6100 Environmental Chemistry Methods and 

Independent Laboratory Validation in Soil TGAI 12 

850.3040 Field Testing for Pollinators TEP 24 

850.2100 Avian Acute Oral Toxicity – Passerine Species TGAI 12 

860.13403 Livestock Enforcement Method and 

Independent Laboratory Validation TGAI 12 

860.1380 Storage Stability in Soil and Water TGAI 12 

Non-guideline Pollinator Acute Oral Toxicity, Adult TGAI 12 

Non-guideline Pollinator Acute Oral Toxicity, Larvae TGAI 12 

Non-guideline Pollinator Chronic Oral Toxicity, Adult TGAI 24 

Non-guideline Pollinator Chronic Oral Toxicity, Larvae TGAI 24 

Non-guideline Pollinator Tier II Semi-field toxicity Testing 

(tunnel/enclosure studies) TEP 24 

Non-guideline Pollinator Tier II Semi-field toxicity Testing 

(feeding studies) TEP 24 

Non-guideline Residues in Pollen and Nectar (Higher Tier 

Testing Under Semi-Field or Field Conditions) TEP 24 

 

NonGuideline4

Whole sediment: Chronic Invertebrates 

Freshwater and Marine (using Chironomus 

dilutus, Hyalella azteca and/or Leptocheirus 

plumulosus) 

TGAI 24 

870.3465 90-day Inhalation Toxicity – Rat TGAI 12 

875.2100 Dislodgeable Foliar Residue 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; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028 2 TGAI = technical grade active ingredient; TEP = typical end-use product. 3

 If the registrant proposes DuPont Method 1452 for livestock tolerance enforcement, an independent laboratory 

validation is not anticipated to be required. 

4

 ORD Study Methods 600/R-099-064 for Chironomus and Hyalella and 600/R-099-020 for Leptocheirus.
5 

Table 1: Anticipated Data Needs for the Famoxadone Registration Review 

Guideline 

Number1 Study Title Test2

Material 

Estimated 

Timeframe 

(Months 

from receipt 

of DCI) 

Anticipated Data Needs for the Famoxadone Degradates IN-KZ007, IN-MN467, 

IN-MN968, IN-MN468-0, IN-KF015, and IN-H3310

850.1010 Acute toxicity, freshwater invertebrates 

(Daphnia magna)5

 

DEGR 12 

Outstanding Data Requirement from Conditional Registration(s)6

850.1735 Whole Sediment: Acute Freshwater 

Invertebrates (Chironomus dilutus)

7 TGAI Due 

6/30/2015 

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.8

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 famoxadone. 

 

5

 Although data for famoxadone degradates IN-MN468-0, IN-KF015, and IN-H3310 have been submitted and are 

in review, this is considered a data gap until the review is complete and the studies are found to be acceptable. 6

 The study listed in this section was previously required as a condition of registration in July 2003 and is still 

outstanding. This study is not anticipated to be required in the anticipated Registration Review DCI because it is 

already required as a condition of registration. 7

 The required 28-day study must use OECD Method 218 (modified). 

8 http://www.epa.gov/oppsrrd1/registration_review/
6 

CHEMICAL FACTS 

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

Table 2: Chemical Facts for Famoxadone

PC code 113202 

Case Number 7038 

CAS Number 131807-57-3 

Year first registered 2003 

Pesticide Type Fungicide 

Chemical class Quinone Outside Inhibitor (QoI) 

Reregistration Eligibility Decision 

(RED) 

Not applicable. Because famoxadone was registered after 

November 1984, it was not subject to reregistration. 

Tolerance Reassessment Not applicable. Because famoxadone was registered after 

the passage of FQPA, it was not subject to tolerance 

reassessment. 

Cumulative group Not applicable. Famoxadone has not been identified as a 

member of a cumulative group that shares a common 

mechanism of toxicity. 

40 CFR Citation Tolerances for famoxadone are established in 40 CFR 

§180.587. 

Dual-use Famoxadone 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 famoxadone. 

Pesticide Re-evaluation Division, 

Chemical Review Manager 

Christina Scheltema, scheltema.christina@epa.gov, 

(703)308-2201 

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 famoxadone. Please see the October 12, 

2014 BEAD Chemical Profile for Registration Review: Famoxadone and June 17, 2014 

Famoxadone Screening Level Usage Analysis in the registration review docket for more details. 

Table 3: Famoxadone Use and Usage Information

Summary of Use Famoxadone is a fungicide registered for use to control and/or manage 

bacterial and fungal disease. Famoxadone is always co-formulated with 

cymoxanil for resistance management. Famoxadone must also be tank 

mixed with a contact fungicide that has a different mode of action. 

Use Sites Famoxadone is registered for use on caneberries (subgroup 13-07A); 

cilantro leaves; cucurbit vegetables; grapes (East of the Rocky Mountains); 

hops; bulb onion (subgroup 3-07A); green onion (subgroup 3-07B); potato; 

pepper; tomato; and leafy vegetables except Brassica (group 4). Not 

currently registered for residential use. 
7 

Table 3: Famoxadone Use and Usage Information

Summary of Usage Between 2008 and 2012, ~ 41,000 pounds of famoxadone were used to 

treat an average of 352,000 acres across the US. The average application 

rate was 0.12 pounds active ingredient per acre. The major uses in terms 

of percent crop treated are cucumbers (25%); cranberries (15%); and 

onions, peppers, potatoes, and pumpkin (10% for each). In terms of 

pounds applied, major uses are potatoes, cucumbers, tomatoes, and 

peppers. 

Formulation Type(s) Water-dispersible granules (dry flowable) 

Application 

Method(s) 

Ground, air, and chemigation 

Technical Registrant DuPont 

No. of Registrations Two 

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. 

 The famoxadone (Tanos®) product label (EPA Reg. No. 352-604) is unclear with 

respect to the number of cropping cycles per season and per year, retreatment 

intervals, or maximum annual application rates. Without further information, EPA 

expects to use conservative assumptions to approximate these parameters in order to 

conduct a quantitative risk assessment. However, the Agency anticipates working 

with the registrant to clarify this information on the famoxadone product label, and to 

amend the label as needed. 

 Confirmation of the following label information: sites of application; formulations; 

application methods and equipment; maximum application rates; frequency of 

application, application intervals, and maximum number of applications per season; 

and geographic limitations on use. 

 Use distribution (e.g., acreage and geographical distribution of relevant use sites). 

 Median and 90th percentile reported use rates (lbs ai/A) from usage data – 

national, state, and county. 

 Typical application timing (date of first application and application intervals) – 

national, state, and county. 

 Typical application interval (days). 

 State or local use restrictions. 

 Foreign technical registrants not listed above who supply technical famoxadone to the 

US market. 

RECENT ACTIONS 

There are no recent actions for famoxadone. New food uses for leafy greens (crop subgroup 4A), 

bulb vegetables (group 3), cilantro, caneberry (subgroup 13A), and leaf petioles (subgroup 4B)

9

 

9

 The famoxadone registrations were amended in 2011 to delete use on leaf petioles (subgroup 4B). 
8 

were registered in April 2009; associated tolerances were established in March 2009 (74 FR 

9358). 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW 

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

2008 to support a petition to register new food uses of famoxadone in or on leafy greens (crop 

subgroup 4A), bulb vegetables (group 3), cilantro, caneberry (subgroup 13A), and leaf petioles 

(subgroup 4B) and to establish associated tolerances. The most recent ecological and 

environmental fate risk assessment was completed in 2008 for the same purpose. Findings and 

conclusions from these risk assessments are summarized in the Famoxadone Registration Review 

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

Drinking Water Assessment for Famoxadone and the Famoxadone Human Health Assessment 

Scoping Document in Support of Registration Review. 

During registration review, the Agency anticipates the need to conduct a comprehensive 

ecological risk assessment, including an endangered species assessment, for all uses of 

famoxadone. For human health, EPA anticipates the need to conduct revised dietary and 

occupational risk assessments during registration review. If toxicological endpoints or points of 

departure are revised based on the data that are anticipated to be required for registration review, 

they will be considered in the new assessments, as well as any changes to the standard operating 

procedures or default exposure assumptions. 

Table 4 summarizes the anticipated registration review risk assessments based on the EFED 

Problem Formulation and HED Scoping Document. 
9 

Table 4: Anticipated Risk Assessments for the Famoxadone 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 anticipated risk assessment will include an updated 

drinking water assessment using the total toxic residues 

approach. 

Incidents Will check for 

updates 

One ecological incident has been reported for famoxadone. 

See page 18 of the Problem Formulation for details. 

Human Health 

Dietary 

Food Yes 

Drinking water Yes The anticipated assessment will consider famoxadone and 

degradates using the total toxic residue approach. 

Occupational 

Handlers (mixers, 

loaders, applicators) 

Yes Anticipated to be conducted for intermediate term 

exposure. 

Post-application Yes 

Residential 

Handlers No Famoxadone is not registered for residential use. 

Post-application Yes EPA anticipates evaluating the need for spray drift and 

volatilization assessments. 

Other 

Aggregate Yes The anticipated assessment will evaluate only the dietary 

risk from food and drinking water. 

Cumulative No Famoxadone has not been identified as a member of a 

cumulative group that shares a common mechanism of 

toxicity. 

Tolerances Yes The tolerance expression for famoxadone will be evaluated 

during registration review to ensure that it appropriately 

covers the metabolites and degradates of famoxadone and 

that it specifies the residues to be measured for each 

commodity. 

Incidents Will check for 

updates 

For a discussion of reported human incidents for 

famoxadone, see the October 28, 2014 document, 

Famoxadone: Tier I Review of Human Incidents. 

Guidance for Commenters: Additional ecological information requested for this registration 

review, and of particular interest to EPA, is described below. 

 Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) not already reported to the Agency. 

 Water quality monitoring data (see Appendix for further details). 
10 

Guidance for Commenters: Additional human health information requested for this 

registration review, and of particular interest to EPA, is described below. 

 Information to better characterize the eye cataracts, to resolve the uncertainties related to 

the microscopic findings in the eye observed in the chronic dog feeding study, to 

elucidate the mechanism of action of famoxadone in the eyes, and to evaluate whether 

this is a species-specific effect. See page 6 of the Scoping Document for further details. 

 

TIMELINE 

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

registration review in Table 5 below. 

Table 5: Projected Famoxadone Registration Review Timeline

Activities Estimated Date

Opening the Docket 

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

Close Public Comment 2015 – May 

Case Development 

Final Work Plan 2015 – August 

Issue DCI 2015 – Oct.-Dec. 

Data Submission 2017 – Oct.-Dec. 

60-day Public Comment Period for Draft Risk 

Assessments10

2019 – April-June 

Registration Review Decision 

60-day Public Comment Period for Proposed 

Registration Review Decision 

2020 – Jan.-March 

Registration Review Decision and Begin PostDecision Follow-up 2021 

Total (years) 6 

NEXT STEPS 

After the 60-day public comment period closes, the Agency will review and respond to any 

comments received in a timely manner and then issue a Final Work Plan for the registration 

review of famoxadone. 

 

 

10 The regulations governing Registration Review generally require the Agency to provide a public comment period 

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments. 
11 

Appendix – Additional Areas Considered in the Famoxadone 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: 

Famoxadone 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, no Total Maximum Daily Loads 

(TMDL) have been developed for famoxadone.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 Standard 

Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in 

OPP’s Registration Review Risk Assessment and Management Process14 in order to ensure they 

can be used quantitatively or qualitatively in pesticide risk assessments. 

Aquatic benchmarks have been established for famoxadone and are available at 

http://www.epa.gov/oppefed 1/ecorisk_ders/aquatic_life_benchmark.htm. Any data submitted or 

otherwise located as part of the registration review process may be used to update aquatic life 

benchmarks, if applicable. 

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, 

 

11 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885 12http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant

_group_name=PESTICIDES 13 http://www.epa.gov/owow/tmdl/ 14 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
12 

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 famoxadone 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.

ENDANGERED SPECIES: 

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

conducted for famoxadone. The ecological risk assessment anticipated to be conducted during 

registration review will allow the Agency to determine whether use of famoxadone has “no 

effect” or “may affect” federally listed threatened or endangered species (listed species) or their 

designated critical habitats. When an assessment concludes that a pesticide’s use “may affect” a 

listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and 

Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM: 

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision for famoxadone, 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), 

famoxadone 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 
13 

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, 201315 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. 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.16

HUMAN STUDIES: 

Past famoxadone 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. 

 

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

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