2 INTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of spiromesifen . This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the spiromesifen registration review docket (EPA

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- 0263 ). Spiromesifen is a tetronic acid insecticide/miticide and is reported to act through the inhibition of lipid biosynthesis. Spiromesifen works on all developmental stages of mites. However, mite juvenile stages are more susceptible than adults. Products c ontaining this insecticide/miticide are registered for use to control a broad spectrum of mites and whiteflies. Spiromesifen is registered for use on the following agricultural crops: low growing berries, tuberous and corm vegetables, leafy greens

, fruitin g vegetables, brassica vegetables

, celery, com, cotton, and

cucurbits. The non

- agricultural use for spiromesifen is on ornamentals.

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 occur over time. The regis tration 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 review begins when the ini tial docket is opened for each case. Informatio n on this program is provided on the Agency’s website

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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 P WP 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 spiromesifen

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There are no additional updates on spiromesifen since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the spiromesifen Preliminary Work Plan , which opened on March 30, 2015 and closed on May 29, 2015 , the Agency received three sets of public

comments. Comments were submit ted by the FIFRA Endangered Species Taskforce (FESTF), the Center for Biological Diversity (CBD) and Bayer CropScience (BCS). The comments do not address the timeline described in the PWP, but they 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 information were received on those issues.

This section does not c apture every comment made about the PWP nor all of the Agency’s

responses. Summarized below are public comments that are of a broader regulatory nature. No

1 http://www.epa.gov/oppsrrd1/registration_review/3 comments resulted in changes to the anticipated registration review data needs, risk assessments or

timeline. Public comments and EPA responses in their entirety are located in the docket, EPA

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- 0263 . Summarized public comments and Agency respo nses related to the anticipated ecological risk assessment or data needs are in the Response to the Initial 60

- Day Public Comment

on: Registration Review: Draft Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species,

and Human Heal th Drinking Water Exposure Assessments for Spiromesifen

, while those relevant to the anticipated human health risk assessment or data needs are in the Spiromesifen ; Response to comments from Bayer Crop Science regarding HED’s most recent Human Health Regis tration Review Scoping Document

. Comment relevant to the use and chemical profile can be found in the Response to Public Comments from Bayer (registrant) on the BEAD Chemical Profiles for Spirodiclofen and Spiromesifen.

Comments submitted by FESTF in EPA

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Comment: FESTF noted that BCS is member of the task force and is entitled to make use of the FESTF database on species proximity to use sites.

Response: The Agency is aware of the data developed by FESTF and will use those data to evaluate risks to listed species, as appropriate.

Comments submitted by CBD in EPA

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Comment : CBD’s comments focus on the EPA’s independent duty under th e Endangered Species Act (ESA) to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration review of spiromesifen.

Response : EPA plans to address the concerns raised by CBD as part of the implementation plan for assessing the risks of pesticides to listed species, which will be based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to spiromesifen’s effects on listed species in connection with the development of its registration review

decision.

At this time, EPA has not fully developed its risk assessment process for listed species. In November 2013, the EPA, along with the Services and the U.S. Department of Agric ulture, released a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. The Interim Approaches were developed jointly by the Agencies in response to the NAS recommendations and reflect a common approach to risk assessment shared by the Agencies as a way of addressing scientific differences between the EPA and the Services.

The NAS report, available at http://www.nap.edu/catalog.php?record_id=18344 , outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA. The joint Interim Approache s were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Committee (PPDC) and State

- FIFRA Issues Research and Evaluation Group (S FIREG) meetings, allowing additional opportunities for stakeholders to comment on the Interim Approaches. As part of a phased, iterative process for developing the Interim Approaches, the Agencies will also consider public comments on the Interim Approach es in connection with the development of upcoming Registration Review decisions. The details of the4 joint Interim Approaches are contained in the white paper “Interim Approaches for National

- Level Pesticide Endangered Species Act Assessments Based on th e Recommendations of the National Academy of Sciences April 2013 Report,” dated November 1, 2013, available

at http://www.epa.gov/espp/2013/nas.html

.

Comments submitted by BCS in EPA

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Comment: Bayer CropScience provided comments intended to address requests, errors, and inconsistencies found in the following EPA documents: 1) Preliminary Work Plan 2) Label Review, BEAD Chemical Profile, Screening

Level usage Analysis 3) Problem Formulation for the Ecological Risk Assessment and the Drinking Water

- Exposure Assessment 4) Human Health Assessment Scoping Document and Tier I Review of Human Incidents

Response: The comments presented by BCS provide clarifications and consistency to the documents listed above. The response to comments documents from the Environmental Fate and Effects Division (EFED), the Health Effects Division (HED) and the Biological and Econom ical Analysis Division (BEAD) acknowledge general agreement with the comments of BCS on us ag e , formulation

type

, and use parameters . They also address BCS’s comments on the calculation of the formation/decline constants for modeling toxic residues of pest icides in the environment.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for spiromesifen based on the Registration Review: Draft Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Spiromesifen and Spiromesifen . Human Health Assessment Scoping 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 S piromesifen Registration Review

Guideline

Number 2 Study Title Test Material Estimated

Timeframe (Months from receipt of DCI)

850.1400 Fish early

- life stage toxicity (saltwater)

- Sheepshead minnow ( Cyprinodon variegatus ) TGAI 12

850.4500 Algal Toxicity

- freshwater diatom (Navicula pelliculosa) and marine diatom (Skeletonema

costatum ) TGAI 12

850.4550 Cyanobacteria ( Anabaena flos

- aquae ) toxicity TGAI 12

850.6100 Environmental chemistry methods and associated independent laboratory validations in

soil and water TGAI 12

2 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 A vailability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

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- 00285 Table 1: Planned D ata Needs for the S piromesifen Registration Review

Guideline

Number 2 Study Title Test Material Estimated

Timeframe (Months from receipt of DCI)

Non

- GLN Whole Sediment: 42

- day chronic toxicity test to freshwater invertebrate ( Hyalella azteca ) 3 TGAI 24

Non

- GLN Whole Sediment: 28

- day chronic toxicity test to estuarine/marine invertebrate ( Leptocheirus plumulosus ) 3 TGAI 24

850.3040 Field Testing for pollinators 4 TEP 24

Non

Guideline (OECD 237) Honey bee larvae acute oral toxicity 5

TGAI 12

Non

Guideline Honey Bee Adult Chronic Oral Toxicity TGAI 12

Non

Guideline Honey Bee Larvae Chronic Oral Toxicity TGAI 12

Non

Guideline Semi

- Field testing for Pollinators (Tunnel or Colony Feeding Studies) 6 TEP 24

Non

Guideline Residues in pollen and nectar/field residue analysis TEP 24

TGAI = technical grade active ingredient; TEP = typical end

- use product ;

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 spiromesifen

. For human health, EPA

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

.

Table 2 below summarizes the planned registration review risk assessments based on the EFED

Problem Formulation and HED Scoping Document . T he planned assessments have not changed

from what was included in the PWP

.

3 The anticipated Data Call

- In Notice will provide that a tiered testing approach may be considered for chronic sediment toxicity testing. Under this approach, testing would first be conducted using the sub

- chronic (10

- day) sediment toxicity test guidelines (OSCPP 850.1735 and 850.1740). Pending comparis on of estimated environmental concentrations in sediment and pore water with results from the 10

- day study, the Agency would determine the need for one or more chronic sediment toxicity studies.

4 Data requirement is dependent on a re

- review of the submi tted field studies with spiromesifen

. 5 Depending on the design of the “Honey Bee Larvae Chronic Oral Toxicity,” study, a 72

- hour LD 50 value may be derived. If this endpoint is able to be derived, then it would obviate the anticipated need for the Honey Bee Larvae Acute Oral Toxicity study (OECD TG 237) (Tier 1)

. 6 The registrant has the option to conduct either a tunnel or colony feedi ng semi

- field (Tier II) study and should consult with the Agency on protocol design prior to study initiation.6 Table 2: Planned Risk Assessments for the S piromesifen 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 Yes

Incidents Will check for updates For a discussion of reported ecological incidents for spiromesifen, see page 16 of the Problem Formulation.

Human Health Dietary

Food Yes A revised dietary exposure analysis may be required to reflect the most recent dietary exposure models. Drinking water Yes A revised dietary exposure analysis may be required to reflect potential revised EDWCs

- specifically, concentrations derived through use of PRZM

- GW. Occupational Handlers (mixers, loaders, applicators) Yes U pdated occupational handler and post

- application

assessment s may be conducted to reflect all currently registered uses and maximum application rates, using current policies. Post

- application Yes

Residential

Handlers Yes

Post

- application No Post

- application dermal exposure is anticipated, but will not quantitatively assessed because no hazard was

identified for the dermal route. Bystander exposure to drift

and volatilization Yes The need for spray drift and volatilization risk assessments for spiromesifen will be examined during registration review

. Other Aggregate Yes Evaluates the combined risk from dietary and residential exposures. A new aggregate assessment may be required during registration review if a revised dietary exposure analysis is required.

Cumulative No EPA has not made a common mechanism of toxicity finding for spiromesifen and any other substances; spiromesifen does not appear to produce a toxic metabolite produced by other substances.

Tolerances Yes Harmonization of tolerances/MRLs will be considered during Registration Review.

Incidents Will check for updates For a discussion of reported human incidents for spiromesifen, see page 10 of the Scoping Document

and Spiromesifen: Tier I Review of Human Incidents.7 TIMELINE

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

. The projected timeline has been adjusted only to reflect a change in the timeframe for submitting data on “Residues in pollen and nectar/field residue analysi s” from 36 months after receipt of the DCI to 24 months after receipt of the DCI.

Table 3: Registration Review for S piromesifen

– Projected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60

- day Public Comment Period 2015 March

- Completed

Close Public Comment 2015 May

- Completed Case Development

Final Work Plan 2015 August

- Completed

Issue DCI 2015

- October

- December

Data Submission 2017

- October

- December

60

- day Public Comment Period for Draft Risk Assessments 7 2019

- April

- June Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision 2020

- January

- March Registration Review Decision and Begin Post

- Decision Follow

- up 202 0 Total (years) 5

NEXT STEPS

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

human health studies for spiromesifen through a D ata C all

- I n Notice , expected to be issued in

October

- December of 2015.

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.