2

Pyraflufen-ethyl Preliminary Work Plan – Table of Contents 

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

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

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

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

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 Pyraflufen-ethyl Registration Review ......... 12 

References:

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

based on the following documents: 

1. EFED Registration Review Problem Formulation for Pyraflufen-ethyl. Housenger, 

Ruhman. June 3, 2014. 

2. Pyraflufen-Ethyl. Human Health Assessment Scoping Document in Support of Registration 

Review. Rury, Ottley, Dodd. April 16, 2014. 

3. Revised: Pyraflufen-ethyl: Tier I Review of Human Incidents. Recore, Evans. February 18, 

2014. 

4. BEAD Chemical Profile (BCP) for Registration Review: Pyraflufen-ethyl (030090). 

Ratnayke, Alsadek, Lee. May 5, 20014.

5. Pyraflufen-ethyl (030090) Screening Level Usage Analysis (SLUA). April 15, 2013.
3

6. Environmental Fate and Effects Division Table 1 Report, Pyraflufen-ethyl (030090). March 

18, 2014.

7. Health Effects Division Master Label Report, Pyraflufen-ethyl (030090). March 18, 2014.

8. Pyraflufen-ethyl: Focus Meeting with Nichino America Notes. May 5, 2014.

These and other supporting documents for the pyraflufen-ethyl registration review case may be 

found in the docket EPA-HQ-OPP-2014-0415 at http://www.regulations.gov. 
4

OVERVIEW 

The docket for pyraflufen-ethyl is now open, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2014-0415). Pyraflufen-ethyl is a contact 

type herbicide registered for use as a defoliant in cotton, and as a desiccant in potatoes to 

facilitate the harvesting of these crops. Pyraflufen-ethyl is also registered for use as a pre-plant 

burn-down, on plant before crop emergence, and as a post-emergence treatment depending on 

the crop and stage of crop growth. This Preliminary Work Plan (PWP) document explains what 

EPA's Office of Pesticide Programs knows about pyraflufen-ethyl, 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 pyraflufen-ethyl. 

 

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 pyraflufen-ethyl and what types of new data 

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

pyraflufen-ethyl. 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 pyraflufen-ethyl. 

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 pyraflufen-ethyl. 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. 

 
5

ANTICIPATED DATA NEEDS 

Table 1 below summarizes anticipated data needs for pyraflufen-ethyl. For additional discussion 

of the anticipated data needs, see the EFED Registration Review Problem Formulation for 

Pyraflufen-ethyl and Pyraflufen-Ethyl. Human Health Assessment Scoping Document in Support 

of Registration Review. 

Table 1: Anticipated Data Needs for the Pyraflufen-ethyl Registration Review 

Guideline 

Number1 Study Title1 

Test Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

Anticipated Data Needs for the Parent Pyraflufen-ethyl

850.6100 

Environmental chemistry methods and associated 

independent laboratory validations for soil, 

sediment, and water 

TGAI 12 

860.1650 Submittal of Analytical Reference Standards TGAI Currently 

needed2

860.1300 Nature of the Residue – Orange3 TGAI 6 

Anticipated Data Needs for the Degradates E1, E2, E3, and E-15

850.6100 

Environmental chemistry methods and associated 

independent laboratory validations for soil, 

sediment, and water 

Degradate E1, 

E2, and E3 12 

860.1650 Submittal of Analytical Reference Standards E-15 

Metabolite 

Currently 

needed2

TGAI = technical grade active ingredient; TEP = typical end-use product; 

 

 

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

 Previous reference standards have expired and new ones are currently needed. 

3

 Information needs to be submitted on sample storage conditions and durations for samples analyzed in the orange 

plant metabolism study (MRID 47872706). 
6

STATUTORY AND REGULATORY AUTHORITY 

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

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

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

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

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

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

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

environment. Changes in science, public policy, and pesticide use 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.4

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 pyraflufen-ethyl. 

CHEMICAL FACTS 

Table 2 provides a summary of the chemical facts for pyraflufen-ethyl. 

Table 2: Chemical Facts for Pyraflufen-ethyl

PC code 030090 

Case Number 7259 

CAS Number 129630-19-9 

Year first registered 2002 

Pesticide Type Contact herbicide 

Chemical class Pyraflufen-ethyl is a phenyl pyrazole.5

Reregistration Eligibility 

Decision (RED) 

Because it was registered after November 1984, pyraflufen-ethyl 

was not subject to reregistration. 

Tolerance Reassessment 

Eligibility Decision 

(TRED) 

No TRED was done for pyraflufen-ethyl, tolerances were last 

reassessed through a 2008 registration action. 

 

4

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

5

 Pyraflufen-ethyl is also a light-dependent peroxidizing herbicides (LDPH) because it contains a light-dependent 

moiety. LDPH herbicides are known to have a photo-toxic mode of action in plants and possibly in fish. LDPHs 

may be more toxic when exposed to natural sunlight. 
7

Table 2: Chemical Facts for Pyraflufen-ethyl

Cumulative group Not applicable. Pyraflufen-ethyl has not been identified as a 

member of a cumulative group that shares a common mechanism 

of toxicity. 

40 CFR Citation Tolerances for pyraflufen-ethyl are established in §180.585. 

Dual-use Pyraflufen-ethyl 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 pyraflufen-ethyl. 

Pesticide Re-evaluation 

Division, Chemical 

Review Manager 

Steven Snyderman, snyderman.steven@epa.gov, 703-347-0249 

Registration Division, 

Product Manager 

Kathryn Montague, montague.kathryn@epa.gov, 703-305-1243 

USE AND USAGE INFORMATION 

Table 3 summarizes the use and usage information for pyraflufen-ethyl. Please see the BEAD 

Chemical Profile (BCP) for Registration Review: Pyraflufen-ethyl (030090) in the registration 

review docket for more details. 

Table 3: Pyraflufen-ethyl Use and Usage Information

Summary of Use Pyraflufen-ethyl is a contact type herbicide registered for use as a 

defoliant in cotton and desiccant in potatoes to facilitate the 

harvesting of these crops as well as a pre-plant burn-down, on 

plant prior to crop emergence, and as a post-emergence treatment 

depending on the crop and stage of the crop growth. 

Use Sites The registered agricultural use sites of pyraflufen-ethyl include: 

bulb vegetables, tree nuts, grapes, pome fruits, stone fruits, dates, 

figs, feijoa, mangos, loquat, persimmons, pomegranates, kiwi, 

chicory, ginger, turmeric, cucurbits, fruiting vegetables, leafy 

vegetables, cole crops, root crops, beans, peas, lentils, corn, 

barley, oats, rye, wheat, sugarcane, ginseng, flax, safflower, 

sunflower, canola, sugar beets, celery, cotton, mustard, olives, 

sorghum, peanuts, soybeans, pastureland, conservation reserve 

program, and Christmas trees. 

Registered non-agricultural use sites of pyraflufen-ethyl include: 

ornamentals, grasses, ditch banks, uncultivated areas, vacant lots, 

airfields, rights-of-way, roadsides, railroads, lumber yards, 

industrial sites, storage areas, fencerows, hedgerows, fences and 

commercial areas.

Summary of Usage Based on private market usage data from 2003-2012, usage 

averaged approximately 2,000 pounds active ingredient (a.i.) 

applied annually on approximately 654,000 acres treated. The 

average application rate over this time period was 0.003 pounds 
8

Table 3: Pyraflufen-ethyl Use and Usage Information

a.i./acre. Total area treated (in acres) of pyraflufen-ethyl has 

tripled since 2009 with major uses on cotton, grapes (for raisins 

and wine) and spring wheat. 

Formulation Type(s) Emulsifiable and soluble concentrates. 

Application Method(s) Products can be applied by ground and aerial application 

equipment. 

Technical Registrant(s) Nichino America, Inc 

No. of Registrations 16 Section 3 products6 and one Special Local Need in Arizona 

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. 

 Certain pyraflufen-ethyl labels are unclear with respect to application parameters such as 

the number of applications and retreatment intervals. Without further information, EPA 

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

conduct a quantitative risk assessment. However, the Agency will work with registrants 

to clarify information on pyraflufen-ethyl product labels. 

 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. 

 Usage/use information for non-agricultural uses. 

 Typical application interval (days). 

 State or local use restrictions. 

 Foreign technical registrants not listed above who supply technical pyraflufen-ethyl to the 

US market. 

 Information about the following use sites are needed to help improve future assessments 

by the Agency related to these specific uses and the importance of pyraflufen-ethyl use 

therein: 

o flax, Christmas trees, ornamentals, rights-of-way, roadsides, railroads, lumber 

yards, industrial sites, storage areas, fencerows, hedgerows, fences and 

commercial areas. 

 

6

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

(http://oaspub.epa.gov/pestlabl/ppls.home). 
9

RECENT ACTIONS 

On May 5, 2014, the Agency’s pyraflufen-ethyl team, along with representatives from USDA, 

met with Nichino America, the sole technical registrant for pyraflufen ethyl to discuss usage of 

pyraflufen-ethyl nationwide and to clarify several label uncertainties. Notes from this meeting 

can be found in the pyraflufen-ethyl registration review docket, Pyraflufen-ethyl: Focus Meeting 

with Nichino America Notes. 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW 

The most recent human health risk assessment for pyraflufen-ethyl was completed on October 1, 

2012 for a new use request on hops and peanuts. The most recent ecological and environmental 

fate risk assessment was completed for the same purpose. It should be noted that both risk 

assessments relied upon information from the last comprehensive risk assessment conducted in 

2002 in support of pyraflufen-ethyl’s initial registration. Findings and conclusions from these 

risk assessments are summarized in the EFED Registration Review Problem Formulation for 

Pyraflufen-ethyl and Pyraflufen-Ethyl. 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 

pyraflufen-ethyl. For human health, EPA anticipates the need to conduct revised dietary, 

residential, aggregate, 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 below summarizes the anticipated registration review risk assessments based on the 

EFED Problem Formulation and HED Scoping Document. 
10

Table 4: Anticipated Risk Assessments for the Pyraflufen-ethyl 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 

Y Chronic estimated drinking water concentrations 

(EDWCs) will be determined by modeling the total 

toxic residues of parent and the E-1, E-2, and E-3 

degradates, noting that exposure will be mainly 

associated with E-3 as it is the most persistent 

degradate. 

Incidents Will check for 

updates 

For a discussion of reported ecological incidents for 

pyraflufen-ethyl, see page 25 of the Problem 

Formulation. 

Human Health 

Dietary 

Food Y A new dietary exposure and risk assessment may be 

needed during Registration Review to incorporate 

updated EDWCs into the chronic and cancer dietary 

exposure assessments. 

Drinking water Y 

Occupational 

Handlers (mixers, loaders, 

applicators) 

Y Occupational uses are expected to result in both shortand intermediate-term exposures. An updated 

occupational assessment may be needed to account 

for changes in occupational assessment policies (e.g. 

unit exposures and transfer coefficients) and to 

evaluate the maximum registered single application 

rate for each use site. 

Post-application Y 

Residential 

Handlers Y The agency will be considering volatilization 

exposure, as well as the potential for exposure from 

spray drift as part of the residential assessment. 

Post-application Y 

Other 

Aggregate Y Evaluates the combined risk from dietary and 

residential exposures. 

Cumulative N/A Pyraflufen-ethyl is not a member of a cumulative 

group. 

Tolerances Y The Agency anticipates updating tolerances to include 

parent and metabolites E-1 and E-9 for livestock 

commodities. 

Incidents Will check for 

updates 

Due to low frequency and severity of incident cases 

reported for pyraflufen-ethyl, there does not appear to 

be a concern at this time that would warrant further 

investigation. For further discussion of reported 

human incidents for pyraflufen-ethyl, see page 10 of 

the Scoping Document and the Revised: Pyraflufenethyl: Tier I Review of Human Incidents. 
11

Guidance for Commenters: Additional ecological information requested for this 

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

 Further toxicity data on the degradation products of pyraflufen-ethyl would be useful in 

reducing the uncertainties associated with ECOSAR analysis if available. 

 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). 

TIMELINE 

EPA has created the following estimated timeline for the completion of the pyraflufen-ethyl 

registration review in Table 5 below. 

Table 5: Projected Pyraflufen-ethyl Registration Review Timeline

Activities Estimated Date

Opening the Docket 

Open Docket and 60-day Public Comment Period 2014 – June 

Close Public Comment 2014 – August 

Case Development 

Final Work Plan 2014 – November 

Issue DCI 2015 Jan. - March

Data Submission 2016 Jan. - March

60-day Public Comment Period for Draft Risk 

Assessments[1]

2017 July – Sept. 

Registration Review Decision 

60-day Public Comment Period for Proposed 

Registration Review Decision 

2018 April - June

Registration Review Decision and Begin Post-Decision 

Follow-up 

2019

Total (years) 5 

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 pyraflufen-ethyl. 

 

[1] 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. 
12

Appendix – Additional Areas Considered in the Pyraflufen-ethyl 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: 

Pyraflufen-ethyl is not identified as a cause of impairment for any water bodies listed as 

impaired under section 303(d) of the Clean Water Act.7

 In addition, no Total Maximum Daily 

Loads (TMDL) have been developed for pyraflufen-ethyl.8 More information on impaired water 

bodies and TMDLs can be found at the Agency’s website.9 The Agency invites submission of 

water quality data for this pesticide. To the extent possible, submissions should include the 

key data elements noted in the OPP Guidance for Submission of State and Tribal Water Quality 

Monitoring Data10 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 pyraflufen-ethyl 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.

 

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

8

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

group_name=PESTICIDES 9 http://www.epa.gov/owow/tmdl/

10 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
13

ENDANGERED SPECIES: 

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

conducted for pyraflufen-ethyl. The ecological risk assessment planned during registration 

review will allow the Agency to determine whether use of pyraflufen-ethyl 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 pyraflufen-ethyl, 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), 

pyraflufen-ethyl 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, 201311 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. 

 

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

chemicals. 
14

For further information on the status of the EDSP, the policies and procedures, the lists of 

chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website.12

HUMAN STUDIES: 

Occupational and Residential 

Past pyraflufen-ethyl 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. 

 

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