2 I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of fenhexamid . This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which was posted in the fenhexamid registration review docket (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 vege tables, ginseng, grapes, kiwi fruit, leafy greens (except spinach), pears, pistachios, pomegranates, raspberries, stone fruits, strawberries, and tomatoes.

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. Changes in science, public policy, and pesticide use practices occ ur over time. 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. The public phase of registration rev iew begins when the initial docket is opened for each case.

Informatio n on this program is provided on the Agency’s website

. 1

The FWP begins with any updates since the PWP was issued. Next is a summary of substantive

comments received during the public comment period for the PWP concerning anticipated data

needs

, expected risk assessments, or the estimated timeline identified in the PWP

, and a summary of the Agency’s response s to th o se comments

. This section is followed by registration

review planned data needs, risk assessments expected to be conducted , and the projected registration review timeline for fenhexamid

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There are no additional updates on fenhexamid since the P WP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the Fenhexamid Preliminary Work Plan , which opened on June 26, 2013 and closed on August 2 6 , 2013 , the Agency received three public

comments. Comments were submitted by Arysta LifeScience

, the Western Integrated Pest Management Center (WIPMC) , and the FIFRA Endangered Species Task Force

. The comment

from WIMPC provided the Agency with additional use, distribution, application

, and MRL information which stressed the importance of fenhexamid in Integrated Pest Management (IPM) practices throughout the western states of California, Oregon, Washington, and Utah. The comments do not address the timeline described in the PWP, but th ey do address the planned ecological and human health risk assessments and data requirements. In the PWP, EPA also solicited comments on the specific topics of environmental justice, water quality concerns , and trade irritants, but no comments or informati on were received on those issues.

1 http://www.epa.gov/oppsrrd1/registration_review/3 Public comments are located in the docket, EPA

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- OPP

- 2013

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. No comments resulted in changes to the anticipated registration review data needs, risk assessments, or timeline. The Agency thanks all commenters for thei r comments and will consider the information provided during registration review.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for fenhexamid based on 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 Review

. The planned data needs have not changed from what was included in the PWP

.

Table 1: Planned D ata Needs for the Fenhexamid Registration Review

Guideline

Number 2 Study Title 2 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

2 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850

– Ecological Effects Tests

– including renumbering a nd 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

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- 00284 Table 1: Planned D ata Needs for the Fenhexamid Registration Review

Guideline

Number 2 Study Title 2 Test Material Estimated

Timeframe

(Months from receipt of DCI)

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 Immunotoxicity 3 TGAI 12

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

Planned 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) 4

835.6100 Terrestrial Field Dissipation 5 TEP Submitted

- Supplemental

850.1730 Fish BCF TGAI Waiver request submitted, but not granted 6

TGAI = technical grade active ingredient; TEP = typical end

- use product ;

3 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 lower than the PODs selected from other available guideline toxicology studies ( http://www.epa.gov/pesticides/regulating/immunoto xicity

- 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 org an system(s) and mode of toxic action, and any immuno

- related data available from structurally

- related compounds.

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

5 Study has been classified as supplemental beca use 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.

6 Sutton, C. Fenhexamid: Response to Waiver Requests for Additional Aerobic Soil Metabolism Data and Additional

Fish Bioacccumulation Data . U.S. EPA May 27, 2003.5 RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, t he Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of fenhexamid

. For human health, EPA

will conduct revised dietary and occupational risk assessment s during registration review

. If toxicological endpoints or points of departure are revised based on the data that are required for registration 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 2 below summarizes the planned registration review risk assessments based on the EFED

Problem Formulation and HED Scoping Document and the planned assessments have not changed from what was included in the PWP

.

Table 2: Planned Risk Assessments for the 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.

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

fenhexamid , see page 21 of the Problem Formulation.

Human Health Dietary

Food Y If no new relevant data regarding the environmental fate, toxicity, or uses of the parent fenhexamid and/or its degradate 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 Progr am 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, revised occupational handler and post

- application Post

- application Y6 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 curre ntly 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 anal ysis

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 and the

Incident Report Title

.7 TIMELINE

EPA has created the following estimated timeline for the completion of the fenhexamid registration review in Table 3 below

. The projected timeline has been updated since the PWP to reflect impacts of recent Agency actions shorteni ng the timeframe between FWP and DCI issuance and adding a quarter in between posting of PRAs and proposed decisions.

Table 3: Registration Review for Fenhexamid

– Projected Registration Review Timeline

Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period June 2013

– Completed

Close Public Comment Aug. 2013

– Completed Case Development

Final Work Plan Nov

. 2013

– Completed

Issue DCI 2014: Jan.

– March

Data Submission 2016: Jan.

– March

6 0

- day Public Comment Period for Draft Risk Assessments 7 2017: July

- Sept

. Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

D ecision 2018: Jan.

– March

Registration Review Decision and Begin Post

- Decision Follow

- up 2019 Total ( years ) 6

NEXT STEPS

As noted previously, the Agency plans to require several environmental fate, ecological effects,

and human health studies for fenhexamid through a D ata C all

- I n Notice , expected to be issued in early 2014

.

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 6 0 calendar day public comment period generally for draft risk assessments.