Novaluron Preliminary Work Plan – Table of Contents

OVERVIEW ................................................................................................................................... 4

ANTICIPATED DATA NEEDS .................................................................................................... 5

STATUTORY AND REGULATORY AUTHORITY................................................................... 7

CHEMICAL FACTS ...................................................................................................................... 7

USE AND USAGE INFORMATION............................................................................................ 8

RECENT ACTIONS....................................................................................................................... 9

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW................................ 9

TIMELINE.................................................................................................................................... 13

NEXT STEPS ............................................................................................................................... 13

Appendix – Additional Areas Considered in the Novaluron Registration Review .................. 14

References:

This Preliminary Work Plan summarizes the Environmental Protection Agency's current position 

based on the following documents:

1. Registration Review: Preliminary Problem Formulation for Environmental Fate, 

Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for 

Novaluron. Ryan Mroz and He Zhong. February 26, 2015.

2. Novaluron: Human Health Assessment Scoping Document in Support of Registration 

Review. Julie L. Van Alstine, Lata Venkateshwara, and Anwar Y. Dunbar. March 16, 2015.

3. Novaluron: Tier I Review of Human Incidents. Elizabeth Evans and Shanna Recore. March 

3, 2015.

4. BEAD Chemical Profile (BCP) for Registration Review: Novaluron (124002). Colwell 

Cook, Rafael A. Prieto, and Elizabeth Hill. March 11, 2015.

5. Novaluron (124002) Screening Level Usage Analysis (SLUA). June 18, 2014.

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6. Novaluron EFED Label Data Report. September 30, 2014.

7. Novaluron HED Master Label Report. September 30, 2014.

These and other supporting documents for the novaluron registration review case may be found 

in the docket EPA-HQ-OPP-2015-0171 at http://www.regulations.gov.

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OVERVIEW

The docket for novaluron (PC Code 124002) is now open, initiating the first public comment 

period for this registration review (docket number 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 crop uses. This Preliminary Work Plan 

(PWP) document explains what EPA's Office of Pesticide Programs knows about novaluron, 

highlighting anticipated data and assessment needs, identifying the types of information that 

would be especially useful to the Agency in conducting the review, and providing an anticipated 

timeline for completing the registration review for novaluron.

The registration review process was designed to include a public participation component to 

solicit input from interested stakeholders. The Agency intends, by sharing this information in the 

docket, to inform the public of what it knows about novaluron and what types of new data or 

other information would be helpful for the Agency to receive as it moves toward a decision on 

novaluron. The Agency encourages all interested stakeholders to review the PWP and Appendix 

and to provide comments and additional information that will help the Agency’s decisionmaking process for this chemical. In addition to general areas on which persons may wish to 

comment, there are some areas identified in the PWP and Appendix about which the Agency 

specifically seeks comments and information. Interested stakeholders could include: 

environmental non-profit or interest groups; pesticide manufacturers; agricultural labor or 

commodity groups; commercial, institutional, residential, and other users of pesticides; or the 

public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for novaluron. Next, it 

discusses the statutory and regulatory authority for Registration Review. Then the document 

provides chemical facts, use and usage information, recent actions, the anticipated risk 

assessments, and a projected registration review timeline for novaluron. Finally, the Appendix to 

this document includes identification and discussion of some areas that are considered generally 

in Registration Review along with some additional chemical case-specific information.

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ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for novaluron. For additional discussion of the 

anticipated data needs, see 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.

Table 1: Anticipated Data Needs for the Novaluron Registration Review

Guideline 

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Anticipated Data Needs for the Parent Novaluron

850.6100

Environmental Chemistry Methods and 

Associated Independent Laboratory Validation 

(Soil & Water)2

TGAI 12

850.1400 Fish early-life stage toxicity (Saltwater only) TGAI 12

850.1740 Whole sediment – chronic freshwater

invertebrates3 TGAI 24

850.3040 Semi-Field Toxicity Test with Honeybee TGAI and 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 growth4 TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor TEP 12

860.1380 Storage Stability TEP 8

875.1400 Inhalation indoor exposure TEP 24

NonguidelineWhole sediment – chronic freshwater

invertebrates5 TGAI 24

1 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 2 It is preferred if the novaluron ECM/ILV (850.6100, soil and water) is to include both degradates (chlorophenyl 

urea and chloroaniline) in a same analytical method protocol. 3 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.

4 A study has been submitted and is currently under review. Results indicate a non-definitive NOAEC for dicots 

(bean). Without a definitive NOAEC risks for listed plants cannot be precluded.

5 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.

5

 
Table 1: Anticipated Data Needs for the Novaluron Registration Review

Guideline 

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Nonguideline

Honeybee larval chronic toxicity (including

Acute endpoints) TGAI 12

Nonguideline Residues in pollen and nectar6 TGAI 24

Anticipated Data Needs for the Chlorophenyl urea (275-352I) Degradate

850.6100 ECM/ILV (soil and water) TGAI 12

850.1035 Mysid acute toxicity (invertebrate acute toxicity)7 TGAI 12

850.1300 Freshwater invertebrate life cycle TGAI 12

850.1350 Saltwater invertebrates life cycle TGAI 12

850.1400 Fish early-life stage (freshwater) TGAI 12

850.4400 Aquatic plant Toxicity Test using Lemna spp. TGAI 12

850.4500 Algal toxicity – non-vascular plant toxicity 

(freshwater or saltwater diatom) TGAI 12

Anticipated Data Needs for the Chloroaniline (275-309I) Degradate

850.6100

Environmental Chemistry Methods and 

Associated Independent Laboratory Validation 

(Soil & Water)

TGAI 12

850.1075 Freshwater fish acute toxicity TGAI 12

850.1300 Freshwater invertebrate life cycle TGAI 12

850.4500 Algal toxicity – Non-vascular plant toxicity 

(green algae) TGAI 12

TGAI = technical grade active ingredient; TEP = typical end-use product

6 These studies 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. 7 A study is requested to establish the toxicity of chlorphenyl urea to invertebrates, a group sensitive to the parent.

6

 
STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States (U.S.) generally must be registered by the 

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. 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 of no unreasonable adverse effects to human health or the 

environment. Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided on EPA’s website.

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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. The regulations governing registration review begin at 40 CFR 155.40. The 

Agency will consider benefits information and data as required by FIFRA. The public phase of 

registration review begins when the initial docket is opened for each case. The docket is the 

Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses 

and data or information it believes are needed to make a registration review decision. After 

reviewing and responding to comments and data received in the docket during this initial 

comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for 

the registration review of novaluron.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for novaluron.

Table 2: Chemical Facts for Novaluron

PC code 124002

Case Number 7615

CAS Number 116714-46-6

Year first registered 2001

Pesticide Type Insecticide

Chemical class Benzoylphenyl urea

Reregistration Eligibility 

Decision (RED)

Because it was registered after November 1984, novaluron was 

not subject to reregistration.

Tolerance Reassessment 

Eligibility Decision 

(TRED)

Not applicable – none conducted.

Cumulative group Not applicable. Novaluron has not been identified as a member of 

a cumulative group that shares a common mechanism of toxicity.

8 http://www.epa.gov/oppsrrd1/registration_review/

7

 
Table 2: Chemical Facts for Novaluron

40 CFR Citation Tolerances for novaluron are established in §180.598.

Dual-use Novaluron is registered for conventional pesticidal uses only and 

has no registered antimicrobial or biopesticidal uses.

Non-pesticidal uses There are no identified non-pesticidal uses of novaluron.

Pesticide Re-evaluation 

Division, Chemical 

Review Manager

Margaret Hathaway, hathaway.margaret@epa.gov, 703-305-5076

Registration Division, 

Product Manager

Richard Gebken, gebken.richard@epa.gov, 703-305-6701

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for novaluron. Please see the BEAD 

Chemical Profile (BCP) for Registration Review: Novaluron (124002) in the registration review 

docket for more details.

Table 3: Novaluron Use and Usage Information

Summary of Use Novaluron is a non-systemic insecticide insect growth regulator 

(IGR) in the benzoylphenyl urea family of chemicals effective on 

many different insect pests, including immatures of mosquitoes, 

flies, lepidopterans, beetles, and heteropterans.

Novaluron inhibits chitin biosynthesis and cuticle formation in

molting/developing insects, resulting in adverse effects on insect 

growth and development, but has no effect on adult insects which

have completed all successive molts. Novaluron acts primarily by 

ingestion, but also has some contact activity.

Use Sites Novaluron has a variety of both agricultural crops and nonagricultural crop uses. Agricultural crop uses include: novaluron 

is registered for use on alfalfa, apple, beans, brassica (head and 

stem) vegetables, carrots, Swiss chard, corn, cotton, cranberry, 

cucurbit vegetables, fruiting vegetables, leafy greens, peanuts, 

pome fruits, potatoes, small fruits, sorghum, soybeans, stone 

fruits, sugarcane, sweet potatoes, tomatoes, and turnip greens.

Non-agricultural uses: Novaluron is registered for use on 

agricultural drainage systems, agricultural uncultivated areas, 

aquatic areas, automobiles/taxis/limousines/recreational 

vehicles/tires, barns, cattle feedlots, 

commercial/institutional/industrial premises/equipment (indoor

and outdoor), commercial storages/warehouses premises, 

commercial transportation vehicles, dogs/canines (adults/puppies),

drainage systems, eating establishments food handling areas 

(nonfood contact), food processing plant premises (nonfood 

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Table 3: Novaluron Use and Usage Information

contact), household/domestic dwellings indoor and outdoor 

premises, intermittently flooded areas, nonagricultural 

uncultivated areas/soils, ornamental ponds/aquaria, ornamentals, 

poultry litter, sewage systems, swamps/marshes/wetlands/stagnant 

water, swimming pool water systems, wide area/general outdoor 

treatment (public health use), wood protection treatment to 

buildings/products (indoor and outdoor).

Summary of Usage EPA has limited usage data for novaluron due to its nonagricultural and diffuse types of use patterns. According to 

average annual use data reported in the 2012 Novlauron SLUA, 

from 2004 to 2012 the crops with the highest pounds a.i. applied 

were apples (10,000 pounds a.i. applied) and cotton (20,000 

pounds a.i. applied). In terms of average percent crop treated 

(PCT), the top crops are pears and strawberries.

Formulation Type(s) 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.

Application Method(s) Applications are made manually (bait, spot/crack crevice, spot-on, 

cattle and poultry operations), aerially (broadcast), by ground 

(broadcast, band, direct spray, chemigation, and spot treatment), 

and directly to water (granule for mosquito control). Some 

pellets/tablets are applied directly to standing water that is 

disconnected from natural water ways (bird baths, swimming pool 

covers, boat covers, etc.) for mosquito control.

Technical Registrant ADAMA Makhteshim Ltd.

No. of Registrations 17 Section 3 products (1 technical and 16 end-use products)9 and 

11 and Section 24c registrations

Restricted Use One end-use product (66222-205), which is co-formulated with 

bifenthrin, is registered as a restricted use product. No other 

registered novaluron products are restricted use. 

RECENT ACTIONS

In 2014, EPA conducted both a drinking water assessment (Drinking Water Assessment in 

Support of IR-4 New and Revised Uses of Novaluron (RIM ON® 0.83 EC) on Avocado; Beans, 

Berries (LowGrowing), Bushberries, Carrot; Cotton, Cucurbit Vegetables, Fruiting Vegetables, 

Head and Stem Brassica, Leafy Brassica Greens, Ornamentals (Container Grown Ornamentals 

in Greenhouses, Shadehouses, Outdoor Nurseries), Peanuts, Pears, Pome Fruits, Potatoes / 

Sweet Potatoes, Sorghum, Soybeans, Stonefruits, Sweet Corn, Sugarcane, Swiss Chard, and 

Turnip Greens). D418740. September 2, 2014) and an ecological risk assessment (Novaluron: 

Ecological Risk Assessment to Support the IR-4 New and Revised Uses of Novaluron (RIMON® 

0.83 EC) on Avocado, Bean, Carrot, Cherry subgroup 12-12A, and Greenhouse 

9 Section 3 product labels can be obtained from the Pesticide Product Label System (PPLS) website 

(http://oaspub.epa.gov/pestlabl/ppls.home).

9

 
Cucumbers.D419642. November 24, 2014) for a variety of new and revised agricultural crop 

uses. The proposed application rates for the new uses were equal to or lower than the previously 

assessed crop uses.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for novaluron (D409210) was 

completed on February 5, 2014 in support of proposed Section 3 uses to control fleas, 

cockroaches, crickets, litter beetles, ants, and flying insect pests on furniture, animal quarters, 

carpets, kennels, livestock and poultry houses, food and non-food warehouses, in food-handling 

establishments, around perimeters, and lawns. There is also a pending 2015 human health risk 

assessment for novaluron in response a petition for the establishment of permanent tolerances for 

residues of novaluron on various crops. The most recent ecological and environmental fate risk 

assessment was completed on August 14, 2013 for the following uses: outdoor flea control, 

outdoor cockroach perimeter treatment, outdoor control of litter beetles in chicken houses, 

outdoor control of ants, outdoor control of flying insect pests, indoor control of litter beetles in 

chicken houses, cattle and horse operations (flies), and poultry operations (beetles). Findings and 

conclusions from these risk assessments are summarized in the 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.

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.

Table 4 below summarizes the anticipated registration review risk assessments based on the 

EFED Problem Formulation and HED Scoping Document.

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Table 4: Anticipated 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.

11
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.

Guidance for Commenters: Additional ecological information requested for this 

registration review, and of particular interest to EPA, is described below.

• Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) not already reported to the Agency.

• Water quality monitoring data (see Appendix for further details).

• Co-formulations of novaluron with additional insecticides could pose additional 

risks/stress, either additive or synergistic, to both larval and adult honeybees. Information 

is welcome on the effects of co-formulated pesticide products.

• 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. Data is welcome on these novaluron 

degradates.

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TIMELINE

EPA has created the following estimated timeline for the completion of the novaluron

registration review in Table 5 below.

Table 5: Projected Novaluron Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period 2015 – March

Close Public Comment 2015 – May

Case Development

Final Work Plan 2015 – August

Issue DCI 2015 Oct. – Dec.

Data Submission 2017 Oct. – Dec.

60-day Public Comment Period for Draft Risk 

Assessments10

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

NEXT STEPS

After the 60-day public comment period closes, the Agency will review and respond to any 

comments received in a timely manner and then issue a Final Work Plan for the registration 

review of novaluron.

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 60 calendar day public comment period generally for draft risk assessments.

13

 
Appendix – Additional Areas Considered in the Novaluron Registration 

Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency 

where your comments, data submissions, or reference to sources of additional information could 

be of particular use.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency 

will work to harmonize tolerances and international maximum residue limits (MRLs) and may 

modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to 

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. 

tolerances and MRLs in key export markets, providing as much specificity as possible regarding 

the nature of the concern.

Water Quality:

Novaluron is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.

11 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for novaluron.

12 More information on impaired water bodies and 

TMDLs can be found at the Agency’s website.

13 The Agency invites submission of water 

quality data for this pesticide. To the extent possible, data should conform to the quality 

standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and 

Management Process14 in order to ensure they can be used quantitatively or qualitatively in 

pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to novaluron compared to the general population. Please 

comment if you are aware of any sub-populations that may have atypical, unusually high 

exposure compared to the general population.

11 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885 12http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant

_group_name=PESTICIDES 13 http://www.epa.gov/owow/tmdl/ 14 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm

14

 
ENDANGERED SPECIES:

Consistent with EPA’s responsibility under the Endangered Species Act (ESA), the Agency will 

evaluate risks to federally listed threatened and endangered (listed) species from registered uses 

of pesticides in accordance with the Joint Interim Approaches developed to implement the 

recommendations of the April 2013 National Academy of Sciences (NAS) report, Assessing 

Risks to Endangered and Threatened Species from Pesticides. The NAS report 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. EPA will address concerns specific to novaluron in 

connection with the development of its final registration review decision for novaluron. 

In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries (the 

Services), and USDA released a white paper containing a summary of their joint Interim 

Approaches for assessing risks to listed species from pesticides. These 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. Details of the joint Interim Approaches are 

contained in the November 1, 2013 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.

Given that the agencies are continuing to develop and work toward implementation of the 

Interim Approaches to assess the potential risks of pesticides to listed species and their 

designated critical habitat, this ecological problem formulation supporting the Preliminary Work 

Plan for novaluron does not describe the specific ESA analysis, including effects determinations 

for specific listed species or designated critical habitat, to be conducted during registration 

review. While the agencies continue to develop a common method for ESA analysis, the 

planned risk assessment for the registration review of novaluron will describe the level of ESA 

analysis completed for this particular registration review case. This assessment will allow EPA to 

focus its future evaluations on the types of species where the potential for effects exists, once the 

scientific methods being developed by the agencies have been fully vetted. Once the agencies 

have fully developed and implemented the scientific methods necessary to complete risk 

assessments for listed species and their designated critical habitats, these methods will be applied 

to subsequent analyses of novaluron as part of completing this registration review.

ENDOCRINE DISRUPTOR SCREENING PROGRAM:

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

15
taxonomic groups. Novaluron was not included in the first group of 67 chemicals nor the second 

group of 109 chemicals that will or have been issued an order to conduct Tier 1 Endocrine 

Disruptor Screening Program (EDSP) testing. However, as required by FFDCA section 408(p), 

novaluron is subject to the endocrine screening part of the Endocrine Disruptor Screening 

Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list 

of chemicals identified for EDSP screening was published on June 14, 201315 and includes some 

pesticides scheduled for registration review and chemicals found in water. Neither of these lists 

should be construed as a list of known or likely endocrine disruptors. For further information on 

the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test 

guidelines and the Tier 1 screening battery, please visit our website.16

HUMAN STUDIES:

Occupational and Residential

Past novaluron risk assessments rely in part on data from studies in which adult human subjects 

were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. 

Many such studies, involving exposure to many different pesticides, comprise generic pesticide 

exposure databases such as the Pesticide Handlers Exposure Database (PHED), Agricultural 

Handlers Exposure Task Force (AHETF) database, the Agricultural Reentry Task Force (ARTF) 

database, and the Outdoor Residential Exposure Task Force (ORETF) database. EPA has 

reviewed all the studies supporting these multi-pesticide generic exposure databases, and has 

found no clear and convincing evidence that the conduct of any of them was either 

fundamentally unethical or significantly deficient relative to the ethical standards prevailing at 

the time the research was conducted. All applicable requirements of EPA’s Rule for the 

Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no 

regulatory barrier to continued reliance on these studies.

15 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals. 16 http://www.epa.gov/endo/

16