Docket Number EPA-HQ-OPP-2014-0199 

www.regulations.gov 

Boscalid Preliminary Work Plan 

Registration Review: Initial Docket 

Case Number 7039 

November 2014 

Approved by: :p Richard P. Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division 

Date: 
Boscalid Preliminary Work Plan - Table of Contents 

OVERVIEW ..... .... .... .... .... ........ ......... ............................. .... ........... ......................... .... .................... 4 

ANTICIPATED DATA NEEDS ........................................................................ .................. .......... 5 

STATUTORY AND REGULATORY AUTHORITY ................................................................... 6 

CHEMICAL FACTS ....... ......................... ............. ................................. ....... ....... .... ...................... 7 

USE AND USAGE INFORMATION ...... ... .' ........ .... ... ..... ......................... .............. ....................... 7 

RECENT ACTIONS ....... ............ .... ................. ............ .... ............................. ....... ............... ............ 9 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW ............... ........... ..... 9 

TIMELINE ............................................................................................................................ .... .... 11 

NEXT STEPS .............. ................. ... .................. ............................................................... ....... .... . 11 

Appendix -Additional Areas Considered in the Boscalid Registration Review ......................... 12 

References: 

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

based on the following documents: 

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

Endangered Species, and Human Health Drinking Water Exposure Assessments for 

Boscalid. Catherine Aubee, Katrina White. October 29, 2014. 

2. Boscalid. Human Health Assessment Scoping Document in Support of Registration Review. 

Barry O'Keefe, Cassi Walls, Steve Funk, Myron Ottley. September 11,2014. 

3. Boscalid: Tier 1 Review of Human Incidents. Shana Recore, Elizabeth Evans. June 25, 

2014. 

4. BEAD Chemical Profile (BCP) for Registration Review: Boscalid (1 28008). Leonard 

Yourman, Jihad Alsadek, Michelle Ranville. June 02,2014. 

5. Boscalid (128008) Screening Level Usage Analysis (SLUA). February 14,2014. 

2 
6. Environmental Fate and Effects Division (EFED) Label Data Report: Boscalid (1 28008). 

June 18,2014. 

7. HED Master Label Report: Boscalid (128008). June 18,2014. 

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

found in the docket EPA-HQ-OPP-2014-0199 at http://www.regulations.gov. 

3 
OVERVIEW 

The docket for boscalid is now open, initiating the fust public comment period for this 

registration review (docket number EPA-HQ-OPP-2014-0199). Boscalid, 3-

pyridinecarboxamide, 2-chloro-N-( 4'-chloro[l, 1'-biphenyl]-2-yl), is a carboxamide fungicide 

registered for the control of several economically important diseases, including gray mold on 

several crops, white mold on potato and beans, and lettuce drop. It is registered on numerous 

agricultural and orchard crops, and as a seed treatment. It is also registered for use on golf 

course turf, gardens, residential fruit and nut trees, ornamentals, including shrubs and bushes, 

and on tomato plants meant to be transplanted into home gardens. 

Boscalid may be formulated as a single active ingredient pesticide or co-formulated with the 

fungicides pyraclostrobin and chlorothalonil and with the insecticide lambda-cyhalothrin. 

Applications can be made with ground, aerial, airblast, chemigation, hand held, or seed treatment 

equipment. 

This Preliminary Work.Plan (PWP) document explains what EPA's Office of Pesticide Programs 

knows about boscalid, 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 boscalid. 

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 boscalid and what types of new data or other 

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

boscalid. 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 decisionmaking 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 boscalid. 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 boscalid. 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 boscalid. For additional discussion of the 

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

Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure 

Assessments for Boscalid and Boscalid. Human Health Assessment Scoping Document in 

Support of Registration Review. 

Table 1: Anticipated Data Needs for the Boscalid Registration Review 

Estimated 

Guideline Study Title1 Timeframe 

Number1 Test Material (Months from 

receipt of DC I) 

Anticipated Data Needs for Boscalid 

835.4100 Aerobic soil metabolism TGAI 24 

835.4400 Anaerobic aquatic metabolism TGAI 24 

Acute toxicity freshwater invertebrates -

850.1010 daphnids (with boscalid alone and representative TGAI, TEP 12-24 

end-use products) 

850.1035 Acute toxicity estuarine and marine organisms TGAJ 12 (mysid) 

850.1350 Aquatic invertebrate life cycle (saltwater) TGAI 12 

850.1400 Fish early-life (estuarine/marine) TGAI 12 

850.1500 Fish life cycle (freshwater) TGAI 24 

850.4150 Vegetative vigor (cabbage only) TEP 12 

Environmental Chemistry Methods and 

850.6100 Independent Laboratory validation for water, TGAI 12 

sediment, and soil for analysis of boscalid 

Non- Chronic sediment toxicity with Chironomus 

GDLN dilutus, Hyalella azteca, and Leptocheirus TGAI 24 

plumulosus 

870.3465 90-Day inhalation TGAI 24 

TGAI - techmcal grade active mgredtent; 1 EP - typtcal end-use product 

'On .June 27,2012, EPA announced certain revisions in harmonized guideline series 850 - Ecological Effects Tests - including renumbering 

and/or removal of the Tier designations for some guideline studies. See ''Final Test Guidelines; OCSPP 850 Series; Notice of Availability" 77 

FR 38282, June 27, 20 12. http://www.regulations.gov/#!documentDetaii:D=EPA-HO-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 boscalid. 

2 http://www.epa.gov/oppsrrd I /registration _review/ 

6 
CHEMICAL FACTS 

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

Table 2: Chemical Facts for Boscalid 

PC code 128008 

Case Number 7039 

CAS Number 188425-85-6 

Year first registered 2003 

Pesticide Type Fungicide 

Chemical class Carboxamide (or anilide) 

Reregistration Eligibility Because it was registered after November 1984, boscalid was not 

Decision subject to reregistration. 

Tolerance Reassessment Because it was registered after November 1984, boscalid was not 

Eligibility Decision subject to tolerance reassessment. 

(TRED) 

Cumulative group Not applicable. Boscalid has not been identified as a member of a 

cumulative group that shares a common mechanism of toxicity. 

40 CFR Citation Tolerances for boscalid are established in 40 CFR § 180.589. 

Dual-use Boscalid 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 boscalid. 

Pesticide Re-evaluation Maria Rivera Piansay 

Division, Chemical Piansay.maria@epa.gov 

Review Manager (703)308-8063 

Registration Division, Shaja Joyner 

ProductManager Joyner.shaja@epa.gov 

(703)308-3194 

USE AND USAGE INFORMATION 

Table 3 summarizes the use and usage information for boscalid. Please see the BEAD Chemical 

Profile for Registration Review: Boscalid, 128008 in the registration review docket for more 

details 

Table 3: Boscalid Use and Usage Information 

Summary of Use Boscalid is a succinate dehydrogenase inhibitor (SDHI) 

fungicide of the same chemical group as fluopyram and 

penthiopyrad and works by disrupting the mitochondrial activity 

of fungi to inhibit respiration. 

Use Sites Agricultural Use Sites: 

Boscalid i s registered for numerous agricultural use sites 

including: berries, bulb vegetables, carrots, artichoke, grapes, 

citrus, nut trees, pome fruits, stone fruits, tropical fruits, ginger, 

hops, cress, turmeric, cucurbits, eggplant, tomatoes, persimmon, 

Brassica leafy vegetables, root crops, beans, alfalfa, canola, 

7 
Table 3: Boscalid Use and Usage Information 

celery, cotton, peanuts, sunflower, spinach, strawberries, turnip 

greens, and soybeans. 

Non-agricultural Use Sites: 

Boscalid registered non-agricultural use sites include: 

ornamentals, golf courses, and fruit and nut trees. 

Summary of Usage Agricultural Usage: 

Based on private market usage data from 2004-2012, usage 

averaged approximately 410,000 pounds a.i. applied annually 

on approximately 1.9 million <"\Cres treated. 

Non-agricultural Usage: 

There were 26,000 lbs. of boscalid used by professionals on turf 

and ornamentals in 2011. Older data show minimal reported usage 

data of 3,000 lbs. a.i. (2004) and 4,000 lbs. a.i. (2006) on golf 

courses. 

Formulation Type(s) Water dispersible granules, emulsifiable concentrate, 

t1owable concentrate, soluble concentrate, ready-to-use 

solution, and soluble concentrate/solid. 

Application Method(s) Application is via multiple, foliar and broadcast sprays. 

Technical Registrant(s) BASF Corporation 

Number of Registrations Twelve Section 31 and 3 (24c) registrations 

Restricted Use No 

1 Section 3 product labels can. be obtained from the Pesticide Product Label System (PPLS) website (http://oaspub.epa.gov/pestlbl/ppls.home) 

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. 

• 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. 

• The labels for products with EPA Reg. Nos. 7969-197 and 7969-199, and SD090006 provide 

a maximum single application rate and a maximum number of applications per crop cycle or 

season; however, a maximum application rate per acre per year is not provided. Particularly 

for some vegetable crops, it is uncertain whether the chemical may be applied during 

multiple crop cycles in the same year. A maximum annual application rate per acre or a 

maximum number of seasons per year is needed to permit estimation of the maximum 

amount that may be applied to a given field during one year. The Agency will work with the 

registrant to address this issue. 

• Some labels do not include a minimum retreatment interval. The Agency will work with the 

registrant to address this issue. 

• Some use instructions are provided on a product basis rather than an a.i. basis. If a different 

product containing boscalid is used on the same site within the year or crop cycle, the user 

may have difficulty complying with limits to the total amount of boscalid he can use in one 

8 
year or season in a given area. The Agency will work with the registrant to address this 

ISSUe. 

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

• Median and 901

h 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. 

• Pounds of active ingredient applied, percent crop treated, and application rates on crops that 

are not captured in the BEAD Chemical Profile (e.g., lentil, triticale, and grasses) 

• Reports of resistance to this fungicide appear to be increasing. Additional information on the 

occurrence of resistance to boscalid or other SDHI fungicides would be useful in establishing 

benefits and developing resistance management language. 

• Foreign technical registrants not listed above who supply technical boscalid to the US 

market. 

RECENT ACTIONS 

The most recent risk assessment for boscalid was conducted in 20 13 for numerous new uses 

(0405063, B. O'Keefe, 08/22/2013). The review of the proposed new uses ofboscalid on herb 

subgroup 19A and dill seed is pending (Notice of Filing can be found on the docket at docket id: 

EPA-HQ-OPP-2013-0798). EFED also conducted recent environmental fate and ecological risk 

assessments for the proposed new uses ofboscalid (see USEPA, 2010, 0363523,2013, 

0405817+, 2014c). 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW 

The most recent dietary (food and drinking water) exposure assessment for boscalid was 

completed on 06/24/2013 using the Dietary Exposure Evaluation Model. Residential and 

occupational handler and post-application risk assessments were conducted around the same 

time. New assessments are not anticipated during registration review. The most recent 

ecological and environmental fate risk assessment was completed in 2003 (USEPA, 2003, 

0278387). Findings and conclusions from these risk assessments are summarized in 

Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, 

Endangered Species, and Human Health Drinking Water Exposure Assessments for Boscalid and 

Boscalid. Human Health Assessment Seeping Document in Support of Registration Review, 

which can be found in the docket for 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 boscalid. 

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 any new assessments, as well as 

any changes to the standard operating procedures or default exposure assumptions. 

Table 4 below 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 Boscalid Registration Review 

Type of Risk Assessment Conduct? Notes 

Ecological and Environmental Fate 

Comprehensive ecological y The Agency will conduct a comprehensive ecological 

(species to be assessed risk assessments for the parent boscalid, including an 

include terrestrial and aquatic endangered species assessment. 

organisms), including 

endangered species 

Incidents Will check for For a discussion of reported ecological incidents for 

updates boscalid, see page 21 of the Problem Formulation. 

Human Health 

Dietary 

Food N A new dietary (food) risk assessment is not 

anticipated to be needed during registration review. 

Drinking water N A new drinking water risk assessment is not 

anticipated to be needed during registration review 

unless there are significant increases to the drinking 

water exposure estimates. 

Occupational 

Handlers (mixers, loaders, N A new occupational handler risk assessment is not 

applicators) anticipated to be needed during registration review. 

However, if new subchronic inhalation data yield a 

different endpoint or a more sensitive POD, then an 

assessment may be needed. 

Post-application N A new occupational post-application exposure is not 

anticipated to be needed during registration review. 

Residential 

Handlers N New residential handler exposure is not anticipated to 

be needed during registration review unless new 

subchronic inhalation data yield a different endpoint 

and a more sensitive POD. 

Post-application y During registration review, the Agency will determine 

the need for drift and volatilization assessments for 

bystanders. 

Other 

Aggregate N A new aggregate assessment is not anticipated to be 

needed unless there are changes in endpoints, PODs, 

or other components of aggregate risk. 

Cumulative N EPA has not made a common mechanism of toxicity 

finding for boscalid and any other substances; and 

boscalid does not appear to produce a toxic metabolite 

produced by other substances. 

10 
Table 4: Anticipated Risk Assessments for the Boscalid Registration Review 

Type of Risk Assessment Conduct? Notes 

Tolerances y EPA will evaluate the possibility of harmonizing 

tolerances with Canadian and Codex MRLs. 

Incidents Will check for For a discussion of reported human incidents for 

updates boscalid, see pages 11-12 of the Seeping Document 

and the Boscalid: Tier 1 Review of Human Incidents. . . Guidance for Commenters: Add1t10nal ecological information requested for th1s 

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). 

TIME LINE 

EPA has created the following estimated timeline for the completion of the boscalid registration 

review in Table 5 below. 

Table 5: Projected Boscalid Registration Review Timeline 

Activities Estimated Date 

Opening the Docket 

Open Docket and 60-day Public Comment Period 20 14- December 

Close Public Comment 2015- February 

Case Development 

Final Work Plan 2015- May 

Issue DCI 2015- July - September 

Data Submission 2017- July - September 

60-day Public Comment Period for Draft Risk 2019- January- March 

Assessments 1 

Registration Review Decision 

60-day Public Comment Period for Proposed 2019- October - December 

Registration Review Decision 

Registration Review Decision and Begin Post-Decision 2020 

Follow-up 

Total (years) 6 

'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. 

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 boscalid. 

11 
Appendix- Additional Areas Considered in the Boscalid 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 ofMRLs 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: 

Boscalid is not identified as a cause of impairment for any water bodies listed as impaired under 

section 303(d) of the Clean Water Act.3 In addition, no Total Maximum Daily Loads (TMDL) 

have been developed for boscalid. More information on impaired water bodies and TMDLs can 

be found at the Agency's website.4 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 OP P 's Registration Review Risk Assessment and Management Process5 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 boscalid 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: 

3 http://iaspub.epa.gov/tmdl waters I 0/attains nation cy.causc detail 303d?p cause group id=885 4 http://www.epa.gov/owow/tmdl/ 

s http://www.epa.gov/oppsrrd 1/registration review/water quality sop.htm 

12 
A risk assessment that supports a complete endangered species determination has not been 

conducted for boscalid. The ecological risk assessment planned during registration review will 

allow the Agency to determine whether use of boscalid 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 boscalid, 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 ), boscalid is 

subject to the endocrine screening part of the Endocrine Disrupter 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, 20136 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 disrupters. 

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

chemicals. 

13 
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.7 

HUMAN STUDIES: 

Occupational and Residential 

Past boscalid 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), the Agricultural 

Reentry Task Force (ARTF) Database, and the Outdoor Residential Exposure Task Force 

(ORETF) Database. EPA has reviewed all the studies supporting these multi-pesticide generic 

exposure databases, and has found no clear and convincing evidence that the conduct of any of 

them was either fundamentally unethical or significantly deficient relative to the ethical 

standards prevailing at the time the research was conducted. 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. 

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

14