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INTRODUCTION

This is the Environmental 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-HQ-OPP-2015-0171). Novaluron is a non-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, flies, 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 variety 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 FIFRA 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. 

Information 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 responses to those 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. The FWP separately lists “Honeybee larval chronic oral toxicity” 

and “Honey bee larvae acute oral toxicity” as planned data requirements. This change 

clarifies that while both acute and chronic larval oral toxicity 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 (single 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 850.3040 corresponds with the Tier III 

 1 http://www.epa.gov/oppsrrd1/registration_review/
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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 PWP, which opened on March 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 comments concerning future 

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

and the FIFRA Endangered 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 

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

information were received on those issues. The public comments are summarized below. Public 

comments and EPA responses in their entirety are located in the docket, EPA-HQ-OPP-2015-

0171.

Comments submitted by FESTF in EPA-HQ-OPP-2015-0171-0009

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. 

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-HQ-OPP-2015-0171-0010

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 

address 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 

November 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 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.
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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 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.gov/espp/2013/nas.html.

Comments submitted by ADAMA Makhteshim Ltd. in EPA-HQ-OPP-2015-0171-0011

Comment: ADAMA Makhteshim Ltd., the novaluron technical registrant, supplied use 

information on current novaluron registrations. 

Response: The Agency thanks 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 changed from what was included in the PWP to clarify the Agency’s 

anticipated pollinator data needs for novaluron.
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Table 1: Planned Data Needs for the Novaluron Registration Review

Guideline 

Number2 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 

invertebrates4 TGAI 24

850.3040 Field Testing for Pollinators5 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 growth6 TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor7 TEP 12

860.1380 Storage Stability TEP 8

875.1400 Inhalation indoor exposure TEP 24

NonguidelineWhole sediment – chronic freshwater 

invertebrates8 TGAI 24

Nonguideline Honeybee larval chronic oral toxicity9 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 Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028 3 It is preferable that the novaluron ECM/ILV (850.6100, soil and water) include both degradates (chlorophenyl urea 

and chloroaniline) in the same 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 

cabbage 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 (single dose) and chronic (repeat dose) toxicity tests.
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Table 1: Planned Data Needs for the Novaluron Registration Review

Guideline 

Number2 Study Title Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Nonguideline Honeybee larval acute oral toxicity10 TGAI 12

NonguidelineResidues in pollen and nectar/field residue 

analysis 11 TEP 24

NonGuidelineSemi-field testing for pollinators (tunnel or 

colony feeding studies)12 TEP 24

Planned Data Needs for the Chlorophenyl 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 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. Typically semi-field studies are 

usually conducted under conditions 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.
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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 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 assessments, 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 and the planned assessments have not 

changed from what was included in the PWP.
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Table 2: Planned Risk Assessments for the Novaluron 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 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 nonvascular 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 possible 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 Evaluates 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.
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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 and 

if a concern is triggered, additional analysis will be 

included in the risk assessment. For a discussion of 

reported human incidents for novaluron, see 

Novaluron: Tier I Review of Human Incidents and 

page 8 of the Novaluron: Human Health Assessment 

Scoping Document in Support of Registration 

Review.

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 Docket

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 Assessments14 2019 April - June

Registration Review Decision

60-day Public Comment Period for Proposed Registration Review 

Decision

2020 Jan. - March

Registration Review Decision and Begin Post-Decision Follow-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.
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NEXT STEPS

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

and human health studies for novaluron through a Data Call-In Notice, expected to be issued in 

early 2016.