2 I NTRODUCTION

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

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- systemic insecticide / insect growth regulator (IGR) that inhibits chitin biosynthesis and cuticle formation in molting/developing insects but has no effect on adult insects which have completed all

successive molts. It is effective on many different insect pests, including the immature stages of mosquitoes, fli es, lepidopterans, beetles, and heteropterans. It is formulated as an emulsifiable concentrate, suspension concentrate, flowable, water dispersible granule, bait cartridge, pellet, granule, and ready

- to

- use solution depending on the use. Novaluron has a v ariety of both agricultural crop and non

- agricultural uses

.

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 F IFRA standard for 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 pesticides 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

. 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

summ ary 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 novaluron

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

Since the PWP, Table 1 has been updated to clarify the Agency’s planned data needs for potential risks to pollinators

. Two changes were made:

• The PWP listed “Honeybee larval chronic toxicity (including Acute endpoints)” as an anticipated data need . T he FWP separately lists “Honeybee larval chronic oral toxicity” and “Honey bee larvae acute oral toxicity” as planned data requirements. Th is change

clarifies that while bo th acute and chronic larval oral toxici ty endpoints are needed by the Agency, the registrant may satisfy this data need in one of two ways. The registrant may

either submit a 21

- day larval toxicity study that provides both acute and chronic oral toxicity data , or may submit separate acute (sin gle dose) and chronic (repeat dose) toxicity tests.

• The PWP included “850.3040: Semi

- Field Toxicity Test with Honeybee” as an anticipated data requirement. However, “ Semi

- field testing with honeybees ” is a Tier II

non

- guideline study , and the GLN number 8 50.3040 corresponds with the Tier III

1 http://www.epa.gov/oppsrrd1/registration_review/3 pollinator study “Field Testing for Pollinators.” Depending on the results of Tier I pollinator studies anticipated as data needs for novaluron, one or both of these higher tier studies may needed to clarify potential risks to bees from novaluron. Both studies are now included in Table 1 on separate lines.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the Novaluron P W P , which opened on Ma rch 29,

2015 and closed on May 29, 2015

, the Agency received 3 public comments

. Use information was submitted by ADAMA, the novaluron technical registrant, and c omments concerning future

e ndangered species consultations were provided by the Center for Biological Diversity (CBD)

and the FIFRA End angered Species Task Force (FESTF) . The comments do not address the

timeline described in the PWP or the planned ecological and human health risk assessments and data requirements. In the PWP, EPA also solicited comments on the specific topics of

environ mental justice, water quality concerns , and trade irritants, but no comments or

information were received on those issues. The public comments are s ummarized below. Public comments and EPA responses in their entirety are located in the docket, EPA

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Comments submitted by FESTF in EPA

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Comment: FESTF noted that the registrant, ADAMA Makhteshim Ltd., is member of the task force and is entitled to make use of the FESTF database on species proximity to use sites.

Resp onse: 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 novaluron.

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

ad dress concerns specific to carboxin’s and oxycarboxin’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

Novembe r 2013, the 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 r esponse 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.4 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 wit h their obligations 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 Agencies 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.g ov/espp/2013/nas.html

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Comments submitted by ADAMA Makhteshim Ltd . in EPA

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Comment: ADAMA Makhteshim Ltd., the novaluron technical registrant, supplied use information on current novaluron registrations

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Response: The Agency than ks ADAMA for the data will use them, as appropriate, to characterize potential risks from the use of novaluron

.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for novaluron based on the documents Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Novaluron and Novaluron: Human Health Assessment Scoping Document in Support of Registration Review

. The planned data needs change d from what was included in the PWP to clarify the Agency’s anticipated pollinator data needs for novaluron

.5 Table 1: Planned D ata Needs for the Novaluron Registration Review

Guideline

Number 2 Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

Planned Data Needs for the Parent Novaluron

850.6100 Environmental Chemistry Methods and

Associated Independent Laboratory Validation (Soil & Water) 3 TGAI 12

850.1400 Fish early

- life stage toxicity (Saltwater only) TGAI 12

850.1740 Whole sediment

– chronic freshwater

invertebrates 4 TGAI 2 4

850.3040 Field T esting for Pollinators 5 TEP 24

850.4500 Algal toxicity

– Non

- vascular plant toxicity (freshwater diatom) TGAI 12

850.4550 Algal toxicity

– Non

- vascular plant toxicity (estuarine/marine diatom) TGAI 12

850.4100 Terrestrial plant toxicity, Seedling emergence and Seedling growth 6 TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor 7 TEP 12

860.1380 Storage Stability TEP 8

875.1400 Inhalation indoor exposure TEP 24

Non

guideline Whole sediment

– chronic freshwater

invertebrates 8 TGAI 24

Non

guideline Honeybee larval chronic oral toxicity 9 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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3 It is prefer able that the novaluron ECM/ILV (850.6100, soil and water) include both degradates (chlorophenyl urea

and chloroaniline) in the s ame analytical method protocol.

4 An estuarine/marine organism is required for sediment testing. A 28

- day TGAI1 test with additional Leptocheirus plumulosus should be performed to evaluate the potential differential sensitivity among sediment organisms. A protocol should be submitted in advance of conducting the study.

5 Tier III conditional. The need for a higher tier test for pollinators will be determined based upon lower

- tiered tests

and/or other lines of data and the need for a refined pollinator risk assessment . A protocol should be submitted in advance of conducting the study.

6 Since the PWP, a previously submitted study (MRID 48690104) was reviewed. Additional data are needed for

cab bage and corn.

7 Only bean data are needed.

8 A test with Hyalella azteca for potential differential sensitivity among sediment organisms is required. A protocol

should be submitted in advance of conducting the study.

9 Both an acute and chronic endpoint are needed. The 21

- day larval toxicity study currently under development by OECD provides both acute and chronic oral toxicity data on developing bee brood. Alternatively, the registrant can submit separate acute (singl e dose) and chronic (repeat dose) toxicity tests.6 Table 1: Planned D ata Needs for the Novaluron Registration Review

Guideline

Number 2 Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

Non

guideline Honey bee larval acute oral toxicity 10 TGAI 12

Non

guideline Residues in pollen and nectar/field residue analysis 11 TEP 24

Non

Guideline Semi

- field testing for pollinators (tunnel or colony feeding studies) 12 TEP 24

Plann ed Data Needs for the C hlorophenyl urea (275

- 352I) Degradate

850.6100 Environmental Chemistry Methods and Associated Independent Laboratory Validation (Soil & Water) degradate 12

850.1035 Mysid acute toxicity (invertebrate acute toxicity) 13 degradate 12

850.1300 Freshwater invertebrate life cycle degradate 12

850.1350 Saltwater invertebrates life cycle degradate 12

850.1400 Fish early

- life stage (freshwater) degradate 12

850.4400 Aquatic plant Toxicity Test using Lemna spp. degradate 12

850.4500 Algal toxicity

– non

- vascular plant toxicity (freshwater or saltwater diatom) degradate 12

Planned Data Needs for the Chloroaniline (275

- 309I) Degradate

850.6100 Environmental Chemistry Methods and Associated Independent Laboratory Validation (Soil & Water) degradate

12

850.1075 Freshwater fish acute toxicity degradate 12

850.1300 Freshwater invertebrate life cycle degradate 12

850.4500 Algal toxicity

– Non

- vascular plant toxicity (green algae) degradate 12

TGAI = technical grade active ingredient; TEP = typical end

- use product ;

10 See footnote 8.

11 Tier II conditional. May be necessary if risk concerns are identified for juvenile bees at the tier I level. A protocol

should be submitted in advance of conducting the study.

12 Tier II c onditional. The need for a higher tier test for pollinators will be determined based upon lower

- tiered tests

and/or other lines of data and the need for a refined pollinator risk assessment. Typically semi

- field studies are usually conducted under cond itions that represent the worst

- case exposure scenario of proposed uses to the entire colony. A protocol should be submitted in advance of conducting the study.

13 A study is requested to establish the toxicity of chlorphenyl urea to invertebrates, a group sensitive to the parent.7 RISK ASSESSMENTS FOR 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

novaluron. For human health, EPA anticipates the need to conduct spray drift risk and volatilization risk assessments during registrati on 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

.8 Table 2: Planned Risk Assessments for the Novaluron 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 Yes See the document Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species , and Drinking Water Exposure Assessments for Novaluron for

additional details. Previous ecological assessment

work for novaluron indicates that novaluron’s degradates, chlorophenyl urea and chloroaniline, are more toxic to both freshwater fish and aquatic non

vascular plants than the parent novaluron

. Incidents Will check for updates For a discussion of reported ecological incidents for novaluron, see page 21 of the Problem Formulation. An incident search performed on 12/4/14 found no ecological incidents were reported in any of the databases for novaluron or its degradates. Although incident reporting is required under FIFRA Section 6(a)(2), the absence of reports in EIIS does not indicate that the chemical has no effects on wildlife; rather, it is possib le that incidents have gone unreported

Human Health Dietary

Food No None needed at this time. Drinking water No None needed at this time. Occupational Handlers (mixers, loaders, applicators) No None needed at this time.

Post

- application No None needed at this time.

Residential

Handlers No None needed at this time.

Post

- application Yes Spray drift and volatilization assessment needed.

Other Aggregate No E valuates the combined risk from dietary and residential exposures.

Cumulative No None needed at this time.

Tolerances Yes Updates are need to harmonize tolerances with

international standards. See page 9 of the

Novaluron: Human Health Assessment Scoping Document in Support of Registration Review for

details.9 Incidents Will check for updates Based on the low frequency and low severity of human health incidents involving novaluron, there does not appear to be a concern at this time that would warrant further investigation. The Agency

will continue to monitor the incident information an d if a concern is triggered, additional analysis will be

included in the risk assessment. For a disc ussion of reported human incidents for novaluron, see Novaluron : Tier I Review of Human Incidents and page 8 of the Novaluron: Human Health Assessment Scopi ng Document in Support of Registration

Review

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TIMELINE

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

.

Table 3: Registration Review for Novaluron

– Projected Registration Review Timeline

Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period March 2015

– Completed

Close Public Comment May 2015

– Completed Case Development

Final Work Plan September 2015

– Completed

Issue DCI 2016 Jan

. – Mar

. Data Submission 2017 Oct.

– Dec.

60

- day Public Comment Period for Draft Risk Assessments 14 2019 April

- June Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

D ecision 2020 Jan.

- March

Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2021 Total ( years ) 6

14 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.10 NEXT STEPS

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

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

- I n Notice , expected to be issued in early 2016

.