2 INTRODUCTION

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

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acid chemical cla ss that acts by interfering with development in eggs, and nymphal and adult female growth stages (adult males are not affected). Products containing spirodiclofen are registered to

control m ites and San Jose scale on c itrus, grapes, hops, pome fruit, stone fruit, tree nuts, tropical fruits (avocado, black sapote, canistel, mango, mamey sapote, papaya, sapodilla, star apple), and Christmas tree plantations There are no residential uses for spirodiclofen.

The Agency is i mplementing 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 f or registration. Changes in science, public policy, and pesticide use practices occur 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 pest icides continue to meet the statutory standard. The public phase of registration review begins when the initial 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 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 spirodiclofen

. Lastly, there is a discussion of next steps.

UP DATES SINCE THE PWP WAS ISSUED

There are no additional updates on spirodiclo fen since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the spirodiclofen PWP , which opened on March 20,

2015 and closed on May 29, 2015 the Agency received three sets of public comments. Comments were submitted by the FIFRA Endangered Species Taskforce (FESTF), the Center for Biological Diversity (CBD) and Bayer CropScience (BCS) . The comments do not address the timeline

describ ed 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 capture 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 comments resulted in changes to the anticipated registration review data needs, risk assessments or

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

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- 0262 . Summarized public comments and Agency res ponses related to the anticipated ecological risk assessment or data needs are in the Review of Public Response to Spirodiclofen Problem Formulation in the Registration Review Preliminary Work Plan

, while those relevant to the anticipated

human health risk assessment or data needs are in the Spirodiclofen: Response to Comments on the Human Health Scoping Document for Registration Review . Comments relevant to the pesticide’s 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

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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 speci es 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 the 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 spirodiclofen.

Respons e : 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 wil l address concerns specific to spirodiclofen’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, t he EPA, along with the Services and the U.S. Department of Agriculture, 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 t o 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 o bligations under the ESA and FIFRA. The joint Interim Approaches 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 (SFIREG) 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 Agen cies will also consider public comments on the Interim Approaches in connection with the development of upcoming Registration Review decisions. The details of the joint Interim Approaches are contained in the white paper “Interim Approaches for National

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

at http://www.epa.gov/espp/2 013/nas.html4 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) Usage Overview

– Label Review, BEAD Chemical Profile, Screening Level usage Analysis and Tier I Review of Human Incidents 3) Environmental Safety

- Problem Formulation for the Ecological Risk Assessment and Drinking Water Assessment 4) Human Safety

- Human

Health Assessmen t Scoping Document

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 Economical Analysis Division (BEAD) acknowledge general agreement with the comments of BCS on use sites and production practices and address BCS ’ s comments on the calculation of the formation/decline constants for modeling toxic resi dues of pesticides in the environment.

PLANNED DATA NEEDS

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

– Problem Formulation for the Ecological Risk Assessment and Drinking Water Exposure Assessment to be Conducted for Spirodiclofen and the Spirodiclofen . Human Health Assessment Scoping Document in Support of Registration Review

.

Tabl e 1: Planned D ata Needs for the S pirodiclofen Registration Review

Guideline

Number 2 Study Title Test

Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated Data Needs for the Parent Spirodiclofen

835.4200 Anaerobic Soil Metabolism TGAI 24

835.4400 Anaerobic Aquatic Metabolism 3 TGAI 24

850.1350 Aquatic Invertebrate Life Cycle (Saltwater) TGAI 12

850.1735 Whole Sediment: Acute Toxicity Freshwater

Invertebrates with Chironomus dilutus 4

, 5 TGAI 12

850.1735 Whole Sediment: Acute Toxicity Freshwater

Invertebrates with Hyalella aztec a 6, 7 TGAI 12

850.1740 Whole Sediment: Acute Toxicity Marine

Invertebrates with Leptocheirus plumulosus 7

, 6 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 “F inal 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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3 Testing on o ne additional w ater/sediment system is needed

4 Also known as “Whole Sediment: Subchronic Freshwater Invertebrates,” as per EFED Guidance Document Entitled “Toxicity Testing and Ecological Risk Assessment Guidance for Benthic Invertebrates. ” April 2014

5 A 10

- day study is anticipated to be requested

. 6 Also known as “Whole Sediment: Subchronic Marine Invertebrates,” as per EFED Guidance Document Entitled “Toxicity Testing and Ecological Risk Assessment Guidance for Benthic Invertebrates.” Ap ril 2014.5 Tabl e 1: Planned D ata Needs for the S pirodiclofen Registration Review

Guideline

Number 2 Study Title Test

Material Estimated

Timeframe

(Months from receipt of DCI)

850.2100 Avian Oral Toxicity (Passerine Species) 7 TGAI 12

850.3040 Field Testing for Pollinators TEP 24

850.6100 Environmental Chemistry Methods and Associated Independent Laboratory

Validations for Water TGAI 12

Non

- Guideline

(OECD 237) Honey bee larvae acute oral toxicity 8 TGAI 12

Non

- Guideline Honey Bee Adult Chronic Oral Toxicity TGAI 12

Non

- Guideline Honey Bee Larvae Chronic Oral Toxicity TGAI 12

Non

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

Non

- Guideline Semi

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

Spirodiclofen Degradates

850.6100 Environmental Chemistry Methods and Associated Independent Laboratory

Validations for Water Degradates 9 12

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 spirodiclofen

. 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 procedures or default exposure assumptions.

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

Problem Formulation and HED Scoping Document ; the planned assessments have not changed

from what was included in the PWP

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7 A protocol does not need to be submitted for Agency approval prior to study initiation provided that the study adheres to the parameters outlined in the guidance available at: http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/terrestrial_biology_tech_team/passerine_ ocspp850_2100_avian_oral_tox.pdf

8 Depending on the design of the “Honey Bee Larvae C hronic Oral T oxicity,” 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 (OECD TG 237) Honey Bee Larvae Acute Oral Toxic ity (Tier 1) study

9 Degradates of concern spirodiclofen

- enol (BAJ 2740

- enol), spirodiclofen

- dihydroxy (BAJ 2740

- dihydroxy), and spirodiclofen

- ketohydroxy (BAJ 2740

- ketohydroxy).6 Table 2: Planned Risk Assessments for the S pirodiclofen 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 es Spirodiclofen will be considered the stressor of concern for the risk assessment. Spirodiclofen and degradates

will be included in the drinking water exposure

assessment.
Incidents Will check for updates For a discussion of the sole reported ecological incident for spirodiclofen, see page 31 of the Problem

Formulation.

Human Health Dietary

Food Y es May be required to reflect the most recent dietary

exposure models and revised estimated drinking water concentrations (EDWCs). Drinking water Y es May be revised to reflect the most recent dietary

exposure models (specifically, use of PRZM

- GW). Occupati onal Handlers (mixers, loaders, applicators) Y es Updated inhalation assessments may be conducted to reflect maximum application rates, using current occupational exposure policies and updated inhalation toxicological points of departure.

Post

- application Y es A post

- application inhalation assessment may be conducted to reflect maximum application rates, the highest exposure post

- application activities, current exposure policies, and updated inhalation toxicological points of departure.

Residential

Handle rs N o There are no residential uses of spirodiclofen.

Post

- application Y es The need for spray drift and volatilization risk

assessments will be examined.

Other Aggregate Yes Evaluates the combined risk from dietary and residential exposures and may be required to reflect potentially

revised EDWCs.

Cumulative No Spirodiclofen has not been identified as a member of a cumulative group that shares a common mechanism of toxicity, and spirodiclofen does not appear to produce a toxic metabolite produced by o ther substances.

Tolerances Yes Decisions concerning harmonization of the U.S. tolerance values with either the Canadian and/or Codex MRLs will be made as part of Registration Review.

Incidents Will check for updates For a discussion of the small number of reported human incidents for spirodiclofen, see page 10 of the Scoping

Document and the Spirodiclofen: Tier I Review of Human

Incidents.7 TIMELINE

EPA has created the following estimated timeline for the completion of the spirodiclofen 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 analysis ” from 36 months after receipt of the DCI to 24 months after receipt o f the DCI.

Table 3: Registration Review for S pirodiclofen

– 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 10 2019

- April

- June Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

Decision 20 20

- 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 requ ire several environmental fate and ecological effects,

studies for spirodiclofen through a D ata C all

- I n Notice , expected to be issued in October

December 2015

.

10 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.