2

Fenhexamid Preliminary Work Plan – Table of Contents

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

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

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

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

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

RECENT ACTIONS..................................................................................................................... 8

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

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

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

Appendix – Additional Areas Considered in the Fenhexamid Registration Review........ 12

References:

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

based on the following documents:

1. Registration Review – Preliminary Problem Formulation for Ecological Risk and 

Environmental Fate, Endangered Species, and Drinking Water Assessments for 

Fenhexamid (PC Code 090209). Scott Glaberman and Katrina White. May 15, 2013.

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

Review. Monica Hawkins, P. Yvonne Barnes, Nancy McCarroll, and Bridgett Bobowiec.

May 9, 2013.

3. BEAD Chemical Profile for Registration Review: Fenhexamid (090209). Carl Chen, Jihad 

Alsadek, and Andrew Lee. May 22, 2013.
3

4. Fenhexamid: Review of Human Incidents. Elizabeth Evans and Shanna Recore. February 

21, 2013.

5. Fenhexamid (090209) Screening Level Usage Analysis (SLUA). June 19, 2012.

6. PRD Label Data Report: Food/Feed & Non-Food/Non-Feed Uses Considered in 

Registration Review Work Planning (090209 Fenhexamid). April 17, 2013.

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

in the docket EPA-HQ-OPP-2013-0187 at http://www.regulations.gov.

OVERVIEW

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

registration review (docket number EPA-HQ-OPP-2013-0187). The fungicide fenhexamid is a 

water dispersible granule that is applied on a variety of agricultural and ornamental crops in the 

field, greenhouses, and in post-harvest production. Specific agricultural use sites are almonds, 

asparagus, bushberries, caneberries, cilantro, cherries, cucumbers, flavoring/spice crops, fruiting 

vegetables, ginseng, grapes, kiwi fruit, leafy greens (except spinach), pears, pistachios, 

pomegranates, raspberries, stone fruits, strawberries, and tomatoes. This Preliminary Work Plan 

(PWP) document explains what EPA's Office of Pesticide Programs knows about fenhexamid, 

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 fenhexamid.

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 fenhexamid and what types of new data or 

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

fenhexamid. 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 fenhexamid. 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 fenhexamid. 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 fenhexamid. For additional discussion of 

the anticipated data needs, see the Registration Review – Preliminary Problem Formulation for 

Ecological Risk and Environmental Fate, Endangered Species, and Drinking Water Assessments 

for Fenhexamid (PC Code 090209) and Fenhexamid Human Health Assessment Scoping 

Document in Support of Registration Review.

Table 1: Anticipated Data Needs for Fenhexamid’s Registration Review

Guideline 

Number Study Title Test 

Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

835.4100 Aerobic soil metabolism TGAI 24

835.4300 Aerobic aquatic metabolism TGAI 24

835.4400 Anaerobic aquatic metabolism TGAI 24

835.6100 Terrestrial field dissipation TEP 24

850.6100

Environmental chemistry methods and associated 

independent laboratory validation for soil TGAI 24 Environmental chemistry methods and associated 

independent laboratory validation for water

850.1730 Fish bioconcentration factor (BCF) TGAI 12

850.1025 Acute toxicity estuarine and marine organisms, 

oysters TGAI 12

850.1035 Acute toxicity estuarine and marine organisms, 

crustacean TEP 12

850.1350 Aquatic invertebrate life cycle (saltwater), 

reproduction test TGAI 12

850.1735 Whole sediment: acute freshwater invertebrates, 

Chironomus dilutus and Hyalella azteca TGAI 12

850.1740 Whole sediment: acute marine invertebrates, 

Leptocheirus plumulosus TGAI 12

850.2100 Avian oral toxicity, passerine species TGAI 12

850.4100 Terrestrial plant toxicity, seedling emergence (10 

species) TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor (10 

species) TEP 12

850.4500 Aquatic plant growth (algal toxicity) freshwater 

diatom TEP 12

850.4500 Aquatic plant growth (algal toxicity) marine diatom TEP 12

850.4550 Aquatic plant, cyanobacterium TEP 12

870.7800 Immunotoxicity1 TGAI 12

 1 Recently, OPP published the findings of its retrospective analysis of immunotoxicity studies submitted to the 

Agency, concluding that none of the studies included in the analysis resulted in a Point of Departure (POD) that is 
5

Table 1: Anticipated Data Needs for Fenhexamid’s Registration Review

Guideline 

Number Study Title Test 

Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Non-GDLN 

Special Study

Whole sediment: chronic invertebrates freshwater, 

Chironomus dilutus and Hyalella azteca TGAI 24

Non-GDLN 

Special Study

Whole sediment: chronic invertebrates marine, 

Leptocheirus plumulosus TGAI 24

Non-GDLN 

Special Study Honeybees, acute oral toxicity TGAI 12

Non-GDLN 

Special Study Honeybee, larval toxicity test TGAI 12

Anticipated Data Needs for the C-C Biphenyl Dimer, M4, and WAK 7004 (7-Chloro-2-(1-

methylcyclohexyl)-1,3-benzoxazol-6-ol) Degradates

835.6100 Terrestrial field dissipation, major degradates TEP 24

850.6100

Environmental chemistry methods and associated 

independent laboratory validation for soil, major 

degradates TGAI 24 Environmental chemistry methods and associated 

independent laboratory validation for water, major 

degradates

Outstanding Data Requirements from Conditional Registration(s)2

835.6100 Terrestrial Field Dissipation3 TEP Submitted -

Supplemental

850.1730 Fish BCF TGAI

Waiver request 

submitted, but 

not granted4

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

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 

 

lower than the PODs selected from other available guideline toxicology studies 

(http://www.epa.gov/pesticides/regulating/immunotoxicity-retro-analysis.pdf). EPA will consider requests for 

waivers for this study, particularly in light of the retrospective analysis. A weight-of-evidence rationale will be 

considered relative to the chemical’s toxicological profile, primary target organ system(s) and mode of toxic action, 

and any immuno-related data available from structurally-related compounds. 2 The studies listed in this section were previously required as a condition of registration. 3 Study has been classified as supplemental because it lacked supporting environmental chemistry methods and 

storage stability data were not available. If these deficiencies are corrected, the study could be upgraded to satisfy 

the data requirement for a terrestrial field dissipation study. Please see the Registration Review – Preliminary 

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

Assessments for Fenhexamid (PC Code 090209) for additional information. 4 Sutton, C. Fenhexamid: Response to Waiver Requests for Additional Aerobic Soil Metabolism Data and Additional

Fish Bioacccumulation Data. U.S. EPA May 27, 2003.
6

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 website5

.

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 fenhexamid.

CHEMICAL FACTS

Table 2 provides a summary of the current regulatory status of fenhexamid.

Table 2: Chemical Facts for Fenhexamid

PC code 090209

Case Number 7039

CAS Number 126833-17-8

Year first registered 1999

Pesticide Type Fungicide

Chemical class Anilide

Reregistration Eligibility 

Decision (RED)

Because fenhexamid was registered after November 1984, it was 

not subject to reregistration.

Tolerance Reassessment 

Eligibility Decision 

(TRED)

Not applicable

Cumulative group Not applicable

40 CFR Citation Tolerances for fenhexamid are established in 40 CFR Part180.553

Dual-use Conventional pesticidal uses - agricultural and ornamental crops, no 

residential uses

Non-pesticidal uses No non-pesticidal uses of fenhexamid

 5 http://www.epa.gov/oppsrrd1/registration_review/
7

Pesticide Re-evaluation 

Division, Chemical 

Review Manager

Joel Wolf, wolf.joel@epa.gov, 703-347-0228

Registration Division Erin Malone, malone.erin@epa.gov, 703-347-0253

Cynthia Giles-Parker, giles-parker.cynthia@epa.gov, 703-305-7740

USE AND USAGE INFORMATION

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

Chemical Profile for Registration Review: Fenhexamid (090209) in the registration review 

docket for more details.

Table 3: Fenhexamid Use and Usage Information

Summary of Use Hydroxyanilide fungicide registered for use on the following 

agricultural use sites: almonds, asparagus, bushberries, caneberries, 

cherry, cilantro, cucumber, flavoring/spice crops, fruiting 

vegetables, ginseng, grapes, kiwi fruit, leafy greens (except 

spinach), pear, pistachio, pomegranate, raspberry, stone fruits, 

strawberry, and tomato. Non-agricultural uses include ornamental 

plants.

Use Sites Agricultural Use Sites

Fenhexamid is registered for use on small fruits and berry crops, 

strawberries, grapes, fruiting vegetables, leafy greens, pistachios, 

and stone fruits. 

Non-Agricultural Use Sites 

Fenhexamid is registered for use on ornamental herbaceous plants, 

ornamental woody shrubs and vines, ornamental plants and/or 

greenhouse.

Summary of Usage From 2007-2011, the annual total agricultural usage for fenhexamid 

averaged approximately 90,000 pounds. On average, the states with 

the most agricultural usage in terms of pounds a.i. applied are 

California (86%), Florida (5%), and Washington (4%). The most 

recent information EPA has on fenhexamid usage in 

nurseries/greenhouses is from 2009 where available data indicate 

usage of approximately 6,000 lbs a.i.

Formulation Type(s) Water dispersible granules

Application Method(s) Product can be applied using ground equipment (such as boom 

type, air blast, hand gun, or mist blower sprayer)

Technical Registrant(s) Bayer CropScience; Arysta LifeScience North America

No. of Registrations 5 Section 3 products6

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

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

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 fenhexamid labels are unclear with respect to application parameters like the

maximum single application rates, maximum number of crop cycles per year, retreatment 

intervals, or any limitation on aerial applications. In the lack of further information, EPA 

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

conduct a quantitative risk assessment for fenhexamid. The Agency will work with

registrants to clarify fenhexamid 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 fenhexamid to the US 

market.

RECENT ACTIONS

A tolerance for asparagus was established in April 2008 (73 FR 19154).

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

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

December 2007 in preparation for a new use request for a proposed Section 3 registration for use 

on asparagus. The most recent ecological and environmental fate risk assessment was completed 

in June 2007 for the same purpose. Findings and conclusions from these risk assessments are 

summarized in the Registration Review – Preliminary Problem Formulation for Ecological Risk 

and Environmental Fate, Endangered Species, and Drinking Water Assessments for Fenhexamid 

(PC Code 090209) and Fenhexamid 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

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

occupational risk assessments during registration review. A residential exposure assessment will 

not be required because there are no residential uses of fenhexamid. If toxicological endpoints or 
9

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.

Table 4: Anticipated Risk Assessments for Fenhexamid 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 A total toxic residue approach for degradates is the 

default option for the risk assessment if suitable 

toxicity information on degradates is not available. 

However, if suitable degradate toxicity data and 

environmental fate data are submitted or located 

through the ECOTOX database, there is the potential 

to derive exposure and risk values for these 

degradates independently.

Incidents Will check for 

updates

For a discussion of reported ecological incidents for 

fenhexamid, see page 21 of the Problem Formulation.

A formal review is not planned, but the agency will 

continue to monitor incident data throughout 

registration review.

Human Health

Dietary

Food Y If no new relevant data regarding the environmental 

fate, toxicity, or uses of parent fenhexamid are

submitted, the Estimated Drinking Water 

Concentrations from the most current drinking water 

assessment may be used in the registration review risk 

assessment. A new dietary assessment may be needed 

if one or more of the following occur: new data are 

identified which impact dietary exposure estimates, 

including those from drinking water; new 

toxicological points of departure are identified, 

including revisions to the FQPA Safety Factor; or 

Office of Pesticide Program dietary exposure policies 

and procedures are revised.

Drinking water Y

Occupational

Handlers (mixers, loaders, 

applicators)

Y Updated occupational handler exposure and postapplication exposure assessments may be required 

under Registration Review EPA will incorporate new 

exposure monitoring data, as necessary, during 

Registration Review. Additionally, revised 
10

Post-application Y occupational handler and post-application 

assessments may also be needed if toxicological 

endpoints change or other new data are received by 

EPA that impact exposure estimates. The need for 

spray drift and volatilization assessments will also be 

evaluated. 

Residential

Handlers N There are no residential uses for fenhexamid; 

therefore, a residential exposure assessment will not 

be required. However, residential bystander inhalation 

exposures resulting from off-site transport (e.g., spray 

drift or volatilization) may occur as a result of 

applications of fenhexamid. EPA is currently

evaluating these types of exposures and will examine 

the need for spray drift and volatilization assessments 

for fenhexamid during registration review.

Post-application N

Other

Aggregate Y Evaluates the combined risk from dietary and 

residential exposures. There are currently no 

registered residential uses, nor are any residential uses 

proposed for fenhexamid. Therefore, at this time, 

dietary (food + water) exposure is the only component 

of an aggregate exposure analysis

Cumulative N At this time, EPA has insufficient evidence to suggest

fenhexamid shares a common mechanism of toxicity 

with other chemical substances.

Tolerances N Tolerances for fenhexamid are established under 40 

CFR §180.553, only the parent is of regulatory 

concern. At this time, there are no pending requests to 

establish a new fenhexamid tolerance.

Incidents Will check for 

updates

For a discussion of reported human incidents for 

fenhexamid, see page 9 of the Scoping Document. A 

formal review is not planned, but the agency will 

continue to monitor incident data throughout 

registration review.

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).
11

TIMELINE

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

registration review in Table 5 below.

Table 5: Projected Fenhexamid Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period 2013 – June

Close Public Comment 2013 – August

Case Development

Final Work Plan 2013 - November

Issue DCI 2014 – July - September

Data Submission 2016 – July – September

60-day Public Comment Period for Draft Risk 

Assessments7

2018 – January – March 

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2018 – October - December

Registration Review Decision and Begin Post-Decision 

Follow-up

2019

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 fenhexamid.

 7 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 Fenhexamid 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:

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

under section 303(d) of the Clean Water Act8

. In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for fenhexamid9

. More information on impaired water bodies and 

TMDLs can be found at the Agency’s website10. 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 Process11 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 fenhexamid 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.

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

9

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

group_name=PESTICIDES

10 http://www.epa.gov/owow/tmdl/ 11 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 fenhexamid. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether use of fenhexamid 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 fenhexamid, 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), 

fenhexamid 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. Fenhexamid is 

not among the group of 58 pesticide active ingredients on the initial list to be screened under the 

EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data callins, requiring the submission of EDSP screening assays for fenhexamid. For further information 
14

on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the 

test guidelines and the Tier 1 screening battery, please visit our website12.

HUMAN STUDIES:

Occupational

Past fenhexamid 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.

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