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 summarize s 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 Healt h Assessment Sco ping 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 Incident s

. Elizabeth Evans and Shanna Recore

. F ebruary 21, 2013

.

5. Fenhexamid (0 90209 ) 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 f enhexamid 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, fru iting vegetab les, 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 anti cipated 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, b y 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 s pecifically 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 pe sticides; 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 R egistration R eview. 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 R egistration R eview 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 Sco ping Document in Support of Registration Revi ew

.

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 T EP 24

850.6100 E nvironmental chemistry methods and associated independent laboratory validation for soil T GAI 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 t oxicity, seedling emergence (10 species) TEP 12

850.4150 Terrestrial plant t oxicity, v egetative 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 p lant

, cyanobacterium TEP 12

870.7800 Immunotoxicity 1 TGAI 12

1 Re cently, 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 is5 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 s ediment: chronic invertebrates marine, Leptocheirus plumulosus TGAI 24

Non

- GDLN Special Study Honeybee s, acute oral toxicity TGAI 12

Non

- GDLN Special Study Honeybee, l arval t oxicity 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) Degradate s

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 Dissipation 3 TEP Submitted

- Supplemental

850.1730 Fish BCF TGAI Waiver request submitted, but

not granted 4

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 fro m 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 a vailable from structurally

- related compounds.

2 The studies listed in this section were previously required as a condition of r egistration.

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 Ecolog ical 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 Agenc y (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 pra ctices 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. Informatio n on this program is provided on EPA’s webs ite 5

.

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

. T he Agency will consider benefits information an d 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 i nformation 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 F inal W ork P lan (FWP) and anticipated schedu le 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

R eregistration Eligibility Decision (R E D) 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 Part 180.553

Dual

- use Conventional pesticidal uses

- agricultural and ornamental crops, no

residential uses

Non

- pesticida l 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 inf ormation 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 H ydroxyanilide fungicide registered for use on the following agricultural use sites: almonds, asparagus, bushberries, caneberries,

cherr y
, cilantro, cucumber, flavoring/ spice crops, fruiting vegetables, ginseng, grapes, kiwi fruit, leafy greens (except spinach) , pear , pistachio

, pomegranate, raspberr y , stone fruits,

strawberr y , 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 200 9 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 usi ng ground equipment (such as boom type, air blast, hand gun

, or mist blower sprayer)

Technical Registrant (s) Ba yer CropScience; Arysta LifeS cience North America No. of Registrations 5 Section 3 products 6

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

( http://oaspub.epa.gov/pestlabl/ppls.home ).8 Restricted Use No

Guidance for Commente rs: Additi onal areas of use and usage related information requested for this registration r eview , and of particular interest to EPA, are described below.

• Certain fenhexamid labels are unclear with respect to application parameters like the maximum single ap plication 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.

• C onfirmation 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

.

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

.

• M edian and 90 th percentile reported use rates (lbs ai/ A ) from usage data

– national, state, and county

.

• Typical a pplication timing (date of first application and application intervals)

– national, state, and county

.

• Usage/use information for non

- agricultural uses

.

• Typica l application interval (days)

.

• S tate or local use restrictions

.

• F oreign 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

. T he 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 Ecolog ical Risk and Environmental Fate, Endangered Species, and Drinking Water Assessments for Fenhexamid (PC Code 090209) and Fenhexamid Human Health Assessment Sco ping Document in Support of Registration Review

.

During registration review, t he Agency anticipa tes 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 assessment s during registration review

. A residential exposure assessment will not be required because there are no residential uses of fenhexamid. If toxicological endpoints or9 points of departure are revised based on the data that are anticipated to be required for regis tration review

, they will be considered in the new assessment s
, as well as any changes to the standard operating p rocedures or default exposure assumptions

.

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

EFED Pr oblem Formulation and HED Scoping Document

.

Table 4: Anticipated Risk Assessments for Fenhexamid Registration Review

Type of Risk Assessment Conduct ? Notes

Eco logical 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 deg radates 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.

Incident s 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,

includi ng those from drinking water; new toxicological points of departure are identified, including revisions to the FQPA S afety 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 post

application exposure assessments may be required under Registration Review EPA will incorporate new exposure monitoring data, as necessary, during Registration Review. Additionally, revised10 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, r esidential 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 E valuates 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 fenhexam id 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 Commente rs: Additional ecological i nformation r equested for this registration r eview , and of particular interest to EPA, is described below.

• Ec ological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

.

• Water quality m onitoring 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 Dat e 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

6 0

- day Public Comment Period for Draft Risk

Assessments 7 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 6 0

- 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, t he Agency plans to provide a 60 calendar day public comment period generally for draft risk assessment s

.12 

### Appendix

– Additional Areas Considered in the Fenhexamid Registration

Review

PUBLIC COMMENTS AND FEEDBACK :

Guidance for C ommenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or reference to sou rces of additional information c ould 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 (MRL s ) 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 natur e 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 Act 8

. In addition, n o Total Maximum Daily Load s (TMDL) have been developed for fenhex amid 9 . More information on impaired water bodies and

TMDLs can be found at the Agency’s website 10

. 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 Process 11 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 popula tion 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, unus ually 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.ep a.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.htm13 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 ap propriate.

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, neurotoxicit y, 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 maturatio n, 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 p art 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),

fenhexam id 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 wildl ife 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 batte ry 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 cause d 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 ca ll

- 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 par t of registration review, EPA will issue future EDSP orders/data call

ins, requiring the submission of EDSP screening assays for fenhexamid

. For further information14 on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future l ists, the test guidelines and the Tier 1 screening battery, please visit our website 12

.

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 gen eric pesticide exposure databases such as the Pesticide Ha ndlers 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. A ll applicable requirements of EPA’s Rule f or the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied , and t here is no regulatory barrier to continued reliance on

these studies

.

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