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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

CHEMICAL SAFETY AND

 POLLUTION PREVENTION

MEMORANDUM

Date: XX-APR-2010

SUBJECT: Novaluron: Human-Health Risk Assessment for Proposed Section 3 Uses on

Sweet Corn and in Food- or Feed-Handling Establishments. 

PC Code: 124002 DP Barcodes: D378387, D377471

Decision Nos.: 432483, 430432 Registration Nos.: 66222-35, 66222-ERT

Petition Nos.: 0E7723, 0F7708 Regulatory Action: Section 3 Registration

Risk Assessment Type: Single Chemical Aggregate Case No.: 7615

TXR No.: NA CAS No.: 116714-46-6

MRID No.: NA 40 CFR: §180.598

FROM: Lata Venkateshwara, Environmental Scientist

Julie L. Van Alstine, MPH, Environmental Health Scientist

Anwar Dunbar, Ph.D., Pharmacologist

Risk Assessment Branch 1 (RAB1)

Health Effects Division (HED; 7509P)

THROUGH: Dana M. Vogel, Branch Chief 

George F. Kramer, Ph.D., Branch Senior Chemist 

RAB1/HED (7509P)

TO: Barbara Madden/Laura Nollen (RM 05)

Registration Division (RD; 7505P)

And

John Hebert (RM 07)/ Jennifer Gaines

RD (7505P)

The HED of the Office of Pesticide Programs (OPP) is charged with estimating the risk to human 

health from exposure to pesticides. The RD of OPP has requested that HED evaluate hazard and 

exposure data and conduct dietary, occupational, residential, and aggregate exposure 

assessments, as needed, to estimate the risk to human health that will result from all registered 

and proposed uses of novaluron (N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy] 

phenyl]amino]carbonyl]-2,6-difluorobenzamide). A summary of the findings and an assessment 
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of human risk resulting from the registered and proposed uses for novaluron are provided in this 

document. The risk assessment and occupational/residential exposure assessment were provided 

by Lata Venkateshwara (RAB1), the residue chemistry data review and dietary risk assessment 

were provided by Julie Van Alstine (RAB1), the hazard characterization by Anwar Dunbar

(RAB1), and the drinking water assessment by Iwona Maher of the Environmental Fate and 

Effects Division (EFED).

The most recent human-health risk assessment was conducted in conjunction with a request for 

the use of novaluron on grain sorghum (Memo, J. Van Alstine, et al., 23-FEB-2010; D364307). 

A detailed hazard characterization for novaluron is presented in a previous HED risk assessment 

(Memo, M. Clock-Rust, et al., 25-MAR-2004; D295824). This document contains only those 

aspects of the risk assessment which are affected by the proposed Section 3 requests for use of 

novaluron on sweet corn and in food- or feed-handling establishments. 
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Table of Contents

1.0 EXECUTIVE SUMMARY ...............................................................................................4

2.0 INGREDIENT PROFILE...............................................................................................12

2.1 Summary of Proposed Uses......................................................................................... 12

2.2 Structure and Nomenclature ...................................................................................... 14

2.3 Physical and Chemical Properties.............................................................................. 14

3.0 HAZARD CHARACTERIZATION/FQPA CONSIDERATIONS.............................15

3.1 FQPA Considerations.................................................................................................. 16

3.2 Endocrine Disruption................................................................................................... 18

4.0 DIETARY EXPOSURE/RISK CHARACTERIZATION ...........................................19

4.1 Food Residue Profile .................................................................................................... 19

4.2 Drinking Water Residue Profile ................................................................................. 25

4.3 Dietary Exposure and Risk ......................................................................................... 26

4.4 Anticipated Residue and %CT Information ............................................................. 27

5.0 RESIDENTIAL (NON-OCCUPATIONAL) EXPOSURE/RISK 

CHARACTERIZATION ................................................................................................28

5.1 Residential Handler Exposure and Risk.................................................................... 28

5.2 Residential Post application Exposure and Risk....................................................... 31

5.3 Combined Residential Risk Estimates........................................................................ 37

5.4 Bystander Post-application Inhalation Exposure ..................................................... 37

5.5 Spray Drift.................................................................................................................... 38

6.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION ........38

6.1 Short-Term Aggregate Risk........................................................................................ 39

6.2 Intermediate-Term Aggregate Risk ........................................................................... 40

6.3 Chronic Aggregate Risk .............................................................................................. 40

7.0 CUMULATIVE RISK.....................................................................................................41

8.0 OCCUPATIONAL EXPOSURE/RISK PATHWAY...................................................41

8.1.1 Occupational Pesticide Handler Exposure and Risk for Sweet Corn.................. 41

8.1.2 Occupational Pesticide Handler Exposure and Risk for Crack and Crevice ..... 44

8.2 Occupational Post-Application Worker Exposure and Risk ................................... 47

9.0 DATA NEEDS AND LABEL RECOMMENDATIONS..............................................50

9.1 Toxicology ..................................................................................................................... 50

9.2 Residue Chemistry ....................................................................................................... 50

9.3 Occupational and Residential Exposure .................................................................... 52

Appendix A: TOXICOLOGY ASSESSMENT........................................................................53

A.1. Acute Toxicity Profile .................................................................................................. 53

A.2 Toxicity Profiles............................................................................................................ 53
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1.0 EXECUTIVE SUMMARY

Under Section 3 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as 

amended, the Interregional Research Project No. 4 (IR-4) has submitted a petition (PP#0E7723)

to register the end-use product Rimon

®

0.83 Emulsifiable Concentrate (EC) Insecticide (EPA 

Reg. No. 66222-35) for use on sweet corn. To support the submission for permanent tolerances 

for residues of novaluron in/on sweet corn stover, forage, and kernel plus cob with husks 

removed (K+CWHR), IR-4 has also proposed tolerance increases for residues of novaluron in/on 

milk and milk fat. Concurrently, Makhteshim-Agan of North America (MANA) has submitted a 

petition (PP#0F7708) to register the end-use product Rimon®Supra 10EC Insecticide (EPA Est. 

No. 66222-ERT) for indoor and outdoor control of roaches and crickets in food- and feedhandling establishments. Both products are EC formulations which contain 9.3% novaluron (N-

[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy] phenyl]amino]carbonyl]-2,6-

difluorobenzamide) by weight [equivalent to 0.83 pound (lb) ai/gallon (gal)]. 

Novaluron, a benzoylphenyl urea compound, is a pesticide chemical belonging to the class of 

insecticides called insect-growth regulators (IGRs). Tolerances for residues of novaluron are 

established under 40 CFR §180.598 in/on a wide variety of crops at levels ranging from 0.05 to 

40 ppm. Tolerances for residues of novaluron are also established in/on the following livestock 

commodities: eggs, milk, milk fat, the meat, fat, kidney, liver, and meat byproducts (except 

kidney and liver) of cattle, goat, horse, and sheep, and the meat, fat, kidney, liver, and meat 

byproducts of poultry and hog. A time-limited tolerance, with an expiration date of 31-DEC2011, is established in association with a Section 18 Emergency Exemption for strawberries at 

0.50 ppm. 

All existing uses for novaluron are agricultural or commercial in nature. The proposed food- and 

feed-handling establishment use of novaluron includes uses in residential and commercial 

buildings and structures, and their immediate surroundings, and on modes of transportation. This 

is the first proposed residential use of novaluron. 

Hazard Characterization

Novaluron has low acute toxicity via the oral (Toxicity Category IV), dermal (Toxicity Category

III), and inhalation routes (Toxicity Category IV). No ocular (Toxicity Category IV) or dermal 

irritation (Toxicity Category IV) was noted. Novaluron is not a dermal sensitizer. In subchronic 

and chronic toxicity studies, novaluron primarily produced hematotoxic effects (toxicity to 

blood) such as methemoglobinemia, decreased hemoglobin, decreased hematocrit, and decreased 

red blood corpuscles (RBCs or erythrocytes) that were associated with compensatory

erythropoiesis. No maternal and/or developmental toxicity was observed in animals tested up to 

the limit dose in either the rat or rabbit developmental toxicity studies. In the two-generation 

reproductive toxicity study, increased spleen weights were observed in parents and offspring at 

the same dose, and reproductive toxicity was observed in males only at a higher dose. 

Neurotoxic effects, including clinical signs, changes in functional-observation battery (FOB) 

parameters, and neuropathology were observed following a single dose at the limit dose only

(2000 mg/kg/day) in the acute neurotoxicity study in rats. However, no signs of neurotoxicity or 

neuropathology were observed following repeated dosing in the subchronic neurotoxicity study
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in rats at similar doses, no evidence of neuropathology was observed in subchronic and chronic 

toxicity studies in rats, mice, or dogs, and novaluron is not considered acutely toxic (LD50>5000 

mg/kg). Therefore, RAB1 toxicologists reaffirmed the HED Hazard Identification Assessment 

Review Committee (HIARC) conclusion that there is not a concern for neurotoxicity resulting 

from exposure to novaluron. There was no evidence of either carcinogenic or genotoxic 

potential with novaluron. 

Dose Response and Endpoint Selection

The RAB1 toxicologists reevaluated the novaluron database, including the previous conclusion 

that the Food Quality Protection Act (FQPA) Safety Factor (SF) for increased susceptibility of 

infants and children can be reduced to 1X. RAB1 toxicologists have determined that reliable 

data show the safety of infants and children would be adequately protected if the FQPA SF were 

reduced to 1X. The decision was based on a lack of increased susceptibility in developmental 

toxicity studies at levels up to the limit dose in the rat or rabbit or in the two-generation 

reproduction study in rats. The risk assessment team concluded that the FQPA SF for increased 

susceptibility of infants and children can be reduced to 1X based on toxicological considerations 

(above), the conservative residue assumptions used in the dietary risk assessments, the 

completeness of the residue chemistry database, and conservative drinking water assessment. 

RAB1 toxicologists also reaffirmed the endpoints previously selected by the HIARC (16-DEC2003; TXR# 0052361). There is no concern for neurotoxicity resulting from exposure to 

novaluron and the overall weight of evidence suggests that novaluron does not directly target the 

immune system. An immunotoxicity study is required as part of the revised 40 CFR Part 158 

toxicology data requirements for novaluron; however, HED does not believe that conducting a 

functional immunotoxicity study will result in a lower NOAEL than the regulatory dose being 

used for risk assessment, and an additional UF for database uncertainty (UFDB) is not needed to 

account for the lack of the required immunotoxicity study.

An oral acute reference dose (aRfD) for the general population, including infants and children, 

was not established since an endpoint of concern attributable to a single dose was not identified. 

The chronic reference dose (cRfD) of 0.011 mg/kg/day was determined on the basis of the 

chronic toxicity/carcinogenicity study in the rat. An uncertainty factor (UF) of 100 (10-fold for 

interspecies extrapolation and 10-fold for intraspecies variability) was applied to the noobserved-adverse-effect-level (NOAEL) of 1.1 mg/kg/day to derive the cRfD. The lowestobserved-adverse-effect-level (LOAEL) of 30.6 mg/kg/day was based on evidence of RBC 

damage and turnover resulting in a regenerative anemia. The FQPA SF of 1X is applicable for 

chronic dietary risk assessment. Therefore, the chronic population-adjusted dose (cPAD) is 

0.011 mg/kg/day.

Based on the toxicological database, a short-term dermal endpoint was not selected; therefore, 

only intermediate-term dermal exposure was assessed. Short- and intermediate-term inhalation 

toxicological endpoints have been selected and are the same; therefore, the estimates of risk for 

short-term duration inhalation exposures are protective of those for intermediate-term inhalation 

duration exposures. A 10% dermal-absorption factor was based on an acceptable dermalabsorption study in rats in which the maximum total absorbed dose (expressed as percent of 

administered dose) ranged from approximately 0.5% to 10% of the applied dose. The level of 
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concern (LOC) for occupational and residential dermal and inhalation exposures are for margins 

of exposure (MOEs) <100. 

In accordance with the EPA Draft Guidelines for Carcinogen Risk Assessment (JUL-1999), 

novaluron is classified as “not likely to be carcinogenic to humans” based on the lack of 

evidence for carcinogenicity in mice and rats.

Endpoints applicable to risk assessments performed for novaluron in this document are 

summarized below.

Exposure Scenario Dose Endpoint Study/Effect

Chronic dietary NOAEL = 1.1 mg/kg/day cRfD and cPAD = 0.011 

mg/kg/day

Combined chronic toxicity/carcinogenicity 

feeding study-rat-erythrocyte damage and 

turnover resulting in a regenerative 

anemia at the LOAEL of 30.6 mg/kg/day. 

Intermediate-term dermal

(10% absorption rate) NOAEL = 4.38 

mg/kg/day

LOC for MOEs <100 

(occupational/residential)

90-day feeding study-rat-clinical 

chemistry and histopathology at the 

LOAEL of 8.64 mg/kg/day. Short-term inhalation

Intermediate-term inhalation

Dietary Exposure Estimate

An acute dietary assessment was not conducted for novaluron because an endpoint of concern 

attributable to a single dose was not identified. A cancer dietary assessment was not conducted 

because novaluron was classified as “not likely to be carcinogenic to humans.” 

A partially refined chronic dietary (food and drinking water) exposure and risk assessment was 

conducted for the proposed new uses on sweet corn and in food- and feed-handling 

establishments, all established uses, and drinking water. EFED provided the estimated drinking 

water concentrations (EDWCs) which were incorporated into the analysis. A percent crop 

treated for new use (PCTn) memorandum for sweet corn was provided by the Biological and 

Economic Analysis Division (BEAD). Additionally, data from a previously provided Screening 

Level Usage Analysis (SLUA) memorandum for existing uses and a PCTn memorandum for 

grain sorghum were used. The chronic analysis incorporated average percent crop treated (%CT) 

data for apples, cabbage, cotton, pears, and potatoes, and average PCTn data for sweet corn and 

grain sorghum. 100% CT was assumed for the remaining food commodities. Anticipated 

residues (ARs) for meat, milk, hog, and poultry commodities were calculated using average field 

trial residues, average PCTn for sweet corn and grain sorghum, average %CT for apple and 

cotton, and assumed 100% CT for sugarcane and cowpea seed. The chronic analysis also 

incorporated average field trial residues, average greenhouse trial residues for tomatoes,

empirical processing factors for apple juice (translated to pear and stone fruit juice), cottonseed 

oil, dried plums, and tomato paste and purée, and Dietary Exposure Evaluation Model (DEEMTM, 

ver. 7.81) default processing factors for the remaining processed commodities. In accordance 

with HED Standard Operating Procedure (SOP) 2000.1, average field trial residues were 

translated from representative commodities in the crop group to other commodities in that crop 

group as needed. 
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For this action, the chronic dietary (food and drinking water) exposure to novaluron is below 

HED’s LOC for the general U.S. population and all population subgroups. The chronic dietary

exposure results in a risk estimate that is 21% of the cPAD for the general U.S. population and 

72% of the cPAD for children 1-2 years old, the most highly exposed population subgroup. 

Residential Exposure/Risk

Novaluron is proposed for indoor and outdoor uses for the control of roaches and crickets (crack 

and crevice and spot treatments). Applications in residential areas, such as homes and apartment 

buildings, are allowed per label instructions. As stated earlier, this is the first proposed 

residential use of novaluron. Residential handler dermal and inhalation exposures were assessed 

for application via low-pressure handwands and trigger-pump sprayers. All residential handler 

risks do not exceed HED’s level of concern (i.e., MOEs ≥100). 

Residential post-application inhalation exposures were assessed for adults and children following 

indoor low-pressure handwand and trigger pump sprayer applications and no risks of concern 

were identified. 

Residential post-application dermal exposures were also assessed. Since there is no short-term 

dermal endpoint, these exposures are representative of intermediate-term exposures and are 

considered conservative since it has been assumed that adults and children are exposed to day-0 

residues for the length of the exposure duration (i.e., no dissipation or removal of residues has 

been assumed). At the maximum application rate (3.1 oz/gal and 0.1 gal per 1000 ft2), all dermal 

MOEs for adults and children are greater than the target MOE of 100 and do not exceed HED’s 

level of concern.

Residential post-application incidental oral exposures were assessed for children (3 to <6 years 

old). At the maximum application rate (3.1 oz/gal and 0.1 gal per 1000 ft2), short- and 

intermediate-term incidental oral MOEs are greater than the target MOE of 100 and do not 

exceed HED’s level of concern. 

A combined residential assessment was included for the indoor crack and crevice/spot use. The 

combined scenarios consisted of adult dermal and inhalation post-application exposures as well 

as children (3 to <6 years old) dermal, inhalation and oral (hand-to-mouth) post-application 

exposures. All of the combined MOEs for adults and children (3 to <6 year olds) are greater 

than the target MOE of 100 and do not exceed HED’s level of concern

Aggregate Exposure Scenarios and Risk Conclusions

For the proposed uses, human-health aggregate risk assessments have been conducted for shortterm aggregate exposure (food + drinking water + residential), intermediate-term aggregate 

exposure (food+ drinking water + residential), and chronic aggregate exposure (food + drinking 

water) exposure scenarios. An acute aggregate assessment was not conducted for novaluron 

because an endpoint of concern attributable to a single dose was not identified. A cancer 

aggregate risk assessment was not performed because novaluron was classified as “not likely to 

be carcinogenic to humans.” All potential exposure pathways were assessed in the aggregate 
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risk assessment as a conservative, health-protective measure. All aggregate risk estimates do not 

exceed HED’s level of concern for the scenarios listed above. 

Occupational Exposure Estimates

Occupational handler and post-application exposure from the proposed uses of novaluron are 

anticipated. Based on label information, exposure is expected to occur for short- and 

intermediate-term exposure durations. No chemical-specific handler exposure data were 

submitted in support of this Section 3 registration. It is the policy of HED to use data from the 

Pesticide Handlers Exposure Database (PHED) Version 1.1 as presented in the PHED Surrogate 

Exposure Guide (AUG-1998) to assess handler exposures for regulatory actions when chemicalspecific monitoring data are not available [HED Science Advisory Council for Exposure 

(ExpoSAC) Draft SOP #7, dated 28-JAN-1999]. 

HED has determined that risks do not exceed HED’s level of concern (i.e., MOEs ≥100), 

provided workers wear chemical-resistant gloves as recommended on the label. No shortterm point of departure (POD) was selected for the dermal route of exposure; therefore, the risks 

presented for handlers are representative of intermediate-term exposures and would be 

considered protective of short-term exposures.

The MOEs for occupational post-application exposure are all greater than the target MOE of 100 

on day 0 (12 hours after application) for all crops and activities and do not exceed HED’s level 

of concern. Post-application dermal risks were calculated based on an intermediate-term POD

and are considered highly conservative for the included activities.

Since the post-application assessment is not a concern on Day 0 (12 hours following 

application), the restricted-entry interval (REI) is based on the acute toxicity of novaluron 

technical material. The proposed label for Rimon®has a 12-hour REI. The technical material 

has a Toxicity Category III for acute dermal and a Toxicity Category IV for acute oral and 

inhalation and primary eye and skin irritation. It is not a dermal sensitizer. Per the Worker 

Protection Standard (WPS), a 12-hour REI is required for chemicals classified under Toxicity

Categories III and IV and is adequate for the proposed use patterns. 

Environmental Justice Considerations

Potential areas of environmental justice concerns, to the extent possible, were considered in this 

human-health risk assessment, in accordance with U.S. Executive Order 12898, “Federal Actions 

to Address Environmental Justice in Minority Populations and Low-Income Populations,”

(http://www.hss.energy.gov/nuclearsafety/env/guidance/justice/eo12898.pdf).

As a part of every pesticide risk assessment, OPP considers a large variety of consumer 

subgroups according to well-established procedures. In line with OPP policy, HED estimates 

risks to population subgroups from pesticide exposures that are based on patterns of that 

subgroup’s food and water consumption, and activities in and around the home that involve 

pesticide use in a residential setting. Extensive data on food consumption patterns are compiled 

by the U.S. Department of Agriculture (USDA) under the Continuing Surveys of Food Intakes 
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by Individuals (CSFII) and are used in pesticide risk assessments for all registered food uses of a 

pesticide. These data are analyzed and categorized by subgroups based on age, season of the 

year, ethnic group, and region of the country. Additionally, OPP is able to assess dietary

exposure to smaller, specialized subgroups and exposure assessments are performed when 

conditions or circumstances warrant. Whenever appropriate, non-dietary exposures based on 

home use of pesticide products and associated risks for adult applicators and for toddlers, youths, 

and adults entering or playing on treated areas post-application are evaluated. Further 

considerations are currently in development as OPP has committed resources and expertise to the 

development of specialized software and models that consider exposure to bystanders and farm 

workers as well as lifestyle and traditional dietary patterns among specific subgroups.

Review of Human Research

This risk assessment relies 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 PHED and the Outdoor Residential Exposure Task Force (ORETF) 

database. EPA has reviewed all the studies in these multi-pesticide generic exposure databases, 

and on the basis of available evidence has found them to have been neither fundamentally

unethical nor significantly deficient relative to standards of ethical research conduct prevailing 

when they were conducted. There is no regulatory barrier to continued reliance on these studies, 

and all applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research 

(40 CFR Part 26) have been satisfied.

Recommendation for Tolerances and Registration

Pending submission of revised Sections B and F and new analytical standards, there are no 

residue chemistry, toxicology, or occupational and residential exposure issues that would 

preclude granting a conditional registration for the use of novaluron on sweet corn and in foodand feed-handling establishments where food or feed products are held, processed, or prepared.

Registration should be made conditional upon submission of an immunotoxicity study as 

specified in the new 40 CFR Part 158 data requirements and a 90-day inhalation toxicity study.

The proposed uses and the submitted data support the permanent tolerances for residues of the 

insecticide novaluron, including its metabolites and degradates, in or on the commodities listed 

below. Compliance with the tolerance levels specified below is to be determined by measuring 

only novaluron (N-[[[3-chloro-4-[1,1,2-trifluoro-2-

(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide) in or on the 

following raw agricultural commodities (RACs):

Corn, Sweet, Stover ...................................................................................50 ppm

Corn, Sweet, Forage...................................................................................16 ppm

Corn, Sweet, Kernel Plus Cob With Husks Removed............................ 0.05 ppm

Food/feed commodities (other than those covered by a higher 

tolerance as a result of use on growing crops) in food/feed 

handling establishments.........................................................................0.01 ppm
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Data Needs and Label Recommendations

The residue chemistry, toxicology, and occupational and residential databases will support 

unconditional registration upon submission of data/information which adequately addresses the 

following issues: 

Toxicology

 A 90-day inhalation toxicity study is requested for further characterization of inhalation 

risk. Due to the potential for repeated inhalation exposure anticipated from the proposed 

residential use pattern, there is concern for toxicity by the inhalation route. An inhalation 

study would provide a dose and endpoint via the route of exposure of concern (i.e. route 

specific study) and thus would avoid using an oral study and route-to-route extrapolation. 

 An immunotoxicity study is required as specified in the new 40 CFR Part 158 data 

requirements.

Residue Chemistry

860.1200 Directions for Use

A revised Section B for PP#0E7723 should be submitted which:

 prohibits the use of novaluron on turnips harvested for the root and prohibits the feeding 

of turnip tops to livestock as previously requested (Memo, J. Van Alstine, 09-SEP-2009; 

D357060). This affects the current petition because it could result in increased livestock 

dietary burdens.

A revised Section B for PP#0F7708 should be submitted which:

 specifies an application rate of 0.1 gallons per 1000 ft2for indoor spot, crack and crevice, 

space spray, and general surface applications; 

 states that all food processing surfaces (including equipment) and utensils should be 

covered during treatment or thoroughly washed prior to use; 

 states the livestock feed items should be removed or covered prior to application; and

 removes all references to fogger and fog applications in the label, and specifies that 

applications should be made with mechanical cold mist/ultra-low volume (ULV)

equipment. 

860.1550 Proposed Tolerances

A revised Section F for PP#0E7723 should be submitted which:

 cites the appropriate CAS name for novaluron:

“Tolerances are established for residues of the insecticide novaluron, including its 

metabolites and degradates, in or on the commodities in the table below. Compliance 

with the tolerance levels specified below is to be determined by measuring only

novaluron (N-[[[3-chloro-4-[1,1,2-trifluoro-2-
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(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide) in or on 

the following raw agricultural commodities:”; and

 reflects the recommended tolerances and commodity definitions presented in Table 4.1.1. 

Additionally, a revised Section F for PP#0F7708 should be submitted which:

 reflects the commodity definition presented in Table 4.1.1. 

860.1650 Submittal of Analytical Reference Standards

The available analytical reference standards for novaluron have expired. MANA is required to 

submit an updated Certificate of Analysis (COA) or a new analytical standard to the EPA 

National Pesticide Standards Repository at the following address: 

USEPA

National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

701 Mapes Road

Fort George G. Meade, MD 20755-5350

Please note that the extended zip code is required for delivery.

Note to RD: Based on the Chemistry Science Advisory Council (ChemSAC) guidance that meat 

byproduct tolerances should be set at the highest residue level seen in any livestock commodity

(minutes from 12-JAN-2011), several meat byproduct tolerances in 40 CFR § 180.598(a) should 

be updated so that they are based on the highest expected residue. Additionally, two commodity 

descriptions should be updated. The tolerances and commodity descriptions should be updated 

as follows:

Current Commodity 

Description

Updated Commodity 

Description

Current Tolerance 

(ppm)

Updated Tolerance 

(ppm)1

Cattle, meat byproducts, 

except kidney and liver - 0.60 11

Goat, meat byproducts 

except kidney and liver - 0.60 11

Horse, meat byproducts, 

except kidney and liver - 0.60 11

Sheep, meat byproducts, 

except kidney and liver - 0.60 11

Hog, meat byproducts

Hog, meat byproducts, 

except kidney and 

liver2

0.10 1.5

Poultry, meat byproducts

Poultry, meat byproducts, 

except kidney and 

liver3

0.80 7.0

1 Based on the based on the highest expected secondary tissue residue [peritoneal fat in cattle (translated to goat, 

horse, and sheep); peritoneal fat in hog; abdominal fat in poultry]. 

2 Separate tolerances have been established for hog, kidney (0.10 ppm) and hog, liver (0.10 ppm). 

3

Separate tolerances have been established for poultry, kidney (0.80 ppm) and poultry, liver (0.80 ppm). 
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Occupational and Residential Exposure

A revised label (Section B) for PP#0E7723 should be submitted which:

 specifies that the retreatment of sweet corn with novaluron is prohibited (i.e., only 1 

application is allowed at a rate of 0.078 lb ai/A) in California and other arid areas which 

receive less than 20 inches of precipitation per year.

A revised label (Section B) should also be submitted for PP#0F7708 which:

 specifies an application rate of 0.1 gallons per 1000 ft2for indoor spot, crack and 

crevice, space spray, and general surface applications; and

 requires the addition of chemical-resistant gloves. 

2.0 INGREDIENT PROFILE

2.1 Summary of Proposed Uses

IR-4 and MANA have submitted draft labels for Rimon

®

0.83EC Insecticide (EPA Reg. No. 

66222-35) and Rimon®Supra 10EC Insecticide (EPA Reg. No. 66222-ERT) to include the 

proposed new uses (see Table 2.1) on sweet corn and in food- and feed-handling establishments, 

including residential sites. The current label for Rimon®Supra 10EC did not include an 

application rate for spot, crack and crevice, surface spray, and general surface applications; 

HED’s application rate calculations are included in the chemistry and ORE memos. 

Under petition PP#0F7708, novaluron is proposed for indoor and outdoor uses for the control of 

roaches and crickets (spot and crack and crevice treatments). The proposed label also 

recommends fogger applications; however, based on correspondence with the Registrant, this 

application is not made with an actual fogger, but rather with mechanical cold mist/ ULV 

equipment that deliver a very light mist that targets the treatment spots (such as, but not limited 

to, wooden pallet structures, under sink/counter voids, under equipment, enclosed machinery

housings, etc.). This application method is not considered to be a space or aerosol spray

treatment, where a fogger or vaporizer is used. 

The label directions recommend applying a dilute solution of 2.3 to 3.1 ounces of product per 

gallon of water (0.01 to 0.02 lb ai/gal). For outdoor perimeter treatments, the label recommends 

applications at a spray rate of 1 gal/1000 ft2. An indoor spray rate per area was not provided on 

the proposed label. Based on the submitted food handling residue study (MRID 48034903), an 

application rate of 0.1 gal/1000 ft2 was calculated for the proposed indoor use. HED assumed 

this spray rate for this assessment. 

It is anticipated that occupational and residential handlers will potentially be exposed through the 

crack and crevice use of novaluron. In addition, residents (adults and children) may potentially 

be exposed after treatments in residential areas. 
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Table 2.1. Summary of Proposed Use Pattern for Novaluron on Sweet Corn and in Food- or FeedHandling Establishments.

Applic. 

Equip.

Formulati

on

[EPA Reg. 

No.]

Applic. 

Rate

(lb ai/A)

Max. No. 

Applic. 

per 

Season

Max. 

Seasonal 

Applic. Rate

(lb ai/A)

PHI

(days) Use Directions and Limitations

Sweet Corn (PP#0E7723)

Aerial/ 

Groundboom

0.83 lb/gal 

EC

[66222-35]

0.058-

0.078 5-6 0.39 1

Apply in sufficient volume to 

ensure full coverage of foliage 

and developing ears. Use higher 

rates and higher spray volumes 

when larvae are large or foliage 

canopy is tall or dense. The use 

of surfactants/adjuvants 

(including non-ionic surfactants) 

is prohibited. Repeat 

applications as needed to protect 

new growth, but not less than 7 

days apart. 

Residential and Commercial Buildings and Structures and Their Immediate Surroundings and on Modes 

of Transporta (PP#0F7708)

Lowpressure 

handwand, 

trigger 

sprayer, 

ULV 

sprayer c 

0.83 lb/gal 

EC

[66222-

ERT]

0.1 

gal/1000 

ft2b

Not 

indicated

3.1 ounces 

per gallon of 

water = 0.02 

lb ai/gal

Spray rate per 

area:

0.1 gal/1000 

ft2=

0.002 lb 

ai/1000 ft2

NA

Prepare diluted spray solution by 

adding 2.3 to 3.1 ounces per 

gallon of water. 

Prior to application, remove or 

cover all food items in the area 

to be treated. In the home, all 

food-processing surfaces and 

utensils should be covered 

during treatment or thoroughly 

washed before use.

Do not replace food containers 

or foodstuffs until spray has 

dried.

A retreatment interval (RTI) is 

not specified. The label states 

the product is effective for 180 

days (26 weeks or 6 months). 

a The permitted areas of use include non-food/non feed areas of stores; warehouses, transportation equipment, manufacturing 

sites, industrial buildings, houses, apartment buildings, office buildings, laboratories, schools, daycare centers, nursing homes, 

hospitals, hotels and on vessels, railcars, aircraft, buses, trucks, and trailers.

b The current label for Rimon®

Supra 10EC did not include an application rate for spot, crack and crevice, surface spray, and 

general surface applications; please refer to for the chemistry and ORE memos for HED’s application rate calculations.

c Correspondence from MANA indicated that they do not intend to have a fogger use, but rather that applications should be made 

as a mechanical cold mist/ULV mist which targets the treatment spots. There are no unit exposures for this scenario but the 

available low-pressure handwand and trigger sprayer unit exposure data are protective of mechanical cold mist/ULV mist

applications.

Conclusions: The proposed labels are adequate to allow evaluation of the residue data relative to 

the proposed new uses on sweet corn and in food- and feed-handling establishments; however, a 

revised Section B for PP#0E7723 should be submitted which:
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 specifies that the retreatment of sweet corn with novaluron is prohibited (i.e., only 1 

application is allowed at a rate of 0.078 lb ai/A per growing season) in California and 

other arid areas, which receive less than 20 inches of precipitation per year; and

 prohibits the use of novaluron on turnips harvested for the root and prohibits the feeding 

of turnip tops to livestock as previously requested (Memo, J. Van Alstine, 09-SEP-2009; 

D357060). This affects the current petition because it could result in increased livestock 

dietary burdens.

Additionally, a revised Section B is requested for PP#0F7708 which: 

 requires the addition of chemical-resistant gloves; 

 specifies an application rate of 0.1 gallons per 1000 ft2for indoor spot, crack and crevice, 

space spray, and general surface applications; 

 states that all food processing surfaces (including equipment) and utensils should be 

covered during treatment or thoroughly washed prior to use; 

 states the livestock feed items should be removed or covered prior to application; and

 removes all fogger and fog references on the label, and specifies that applications should 

be made with mechanical cold mist/ULV equipment. 

2.2 Structure and Nomenclature 

Table 2.2. Novaluron Nomenclature.

Chemical structure

Common name Novaluron

IUPAC name 1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]-3-[2,6-

difluorobenzoyl]urea

CAS name N-[[[3-chloro-4-[1,1,2-trifluoro-2-

(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide

CAS registry number 116714-46-6

End-use products (EPs) Rimon

®

0.83EC Insecticide (0.83 lb/gal EC; EPA Reg. No. 66222-35); Rimon®

Supra 10EC Insecticide (0.83 lb/gal EC; EPA Est. No. 66222-ERT)

2.3 Physical and Chemical Properties

Table 2.3. Physicochemical Properties of Technical Grade Novaluron.

Parameter Value Reference

Melting range 176.5 - 178.0C DP# 315780, 3-NOV-2005, 

pH 6.5 S. Levy

O

N

H

N

H

O

F

F

Cl

O

O

CF3

F

F

F
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Table 2.3. Physicochemical Properties of Technical Grade Novaluron.

Parameter Value Reference

Density 1.56 g/cm3

at 22C

Water solubility 3 μg/L at 20C

Solvent solubility (at 25C) 0.00839 g/L in n-heptane

1.88 g/L in xylene

14.5 g/L in methanol

198 g/L in acetone

113 g/L in ethyl acetate

0.98 g/L in n-octanol

Vapor pressure (mm Hg) 1.2 x 10-7

Dissociation constant, pKa Not determined due to low water solubility.

Octanol/water partition coefficient, 

Log(KOW)

4.3 at 25C

UV/visible absorption spectrum Molar absorption coefficients of at 3 

maximum absorbances:

15,400 L/mol  cm at 253 nm (neutral)

9,780 L/mol  cm at 253 nm (acidic)

20,500 L/mol  cm at 263 nm (basic)

3.0 HAZARD CHARACTERIZATION/FQPA CONSIDERATIONS

A detailed hazard characterization for novaluron is presented in a previous HED risk assessment 

(Memo, M. Clock-Rust, et al., 25-MAR-2004; D295824). Novaluron has low acute toxicity via 

the oral (Toxicity Category IV), dermal (Toxicity Category III), and inhalation routes (Toxicity

Category IV). No ocular (Toxicity Category IV) or dermal irritation (Toxicity Category IV) was 

noted. Novaluron is not a dermal sensitizer. In subchronic and chronic toxicity studies, 

novaluron primarily produced red blood cells effects , such as methemoglobinemia, decreased 

hemoglobin, decreased hematocrit, and decreased RBCs (or erythrocytes) that were associated 

with compensatory erythropoiesis. Unlike white blood cells (leukocytes) which are cells of the 

immune system, red blood cells function to deliver oxygen to body tissues and are not involved in 

eliciting an immune response. Increased spleen weights and/or hemosiderosis in the spleen were 

considered to be due to enhanced removal of damaged erythrocytes and not to an immunotoxic 

effect.

There was no maternal or developmental toxicity seen in the rat and rabbit developmental 

toxicity studies up to the limit doses. In the two-generation reproductive toxicity study in rats, 

both parental and offspring toxicity (increased spleen weights) were observed at the same dose. 

Reproductive toxicity (decreases in epididymal sperm counts and increased age at preputial 

separation in the F1 generation) was observed at a higher dose than the hematotoxicity. Clinical 

signs of neurotoxicity and neuropathology were seen in the rat acute neurotoxicity study at the 

limit dose. However, no signs of neurotoxicity or neuropathology were observed in the 

subchronic neurotoxicity study in rats at similar doses or in any other subchronic or chronic 

toxicity study in rats, mice or dogs. In addition, there were no clinical signs of toxicity observed 

in the acute oral toxicity study with novaluron (LD50 >5,000 milligrams/kilogram (mg/kg)). 

Therefore, there is no concern for neurotoxicity resulting from exposure to novaluron. No 

toxicity was observed at the limit dose in the dermal study and there were no developmental 
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toxicity concerns at the limit-dose; therefore, quantification of short-term dermal risk is not 

necessary. Aditionally, in a rat dermal penetration study the maximum total absorbed dose 

(expressed as per cent of administered dose and determined as the sum of radioactivity in 

excreta, cage wash, untreated skin, fat, blood, and residual carcass) ranged from about 0.5% to 

10% of that administered, indicating low dermal absorption. There was no evidence of 

carcinogenic potential in either the rat or mouse carcinogenicity studies and no evidence of 

mutagenic activity in the submitted mutagenicity studies, including a bacterial (Salmonella, E. 

coli) reverse mutation assay, an in vitro mammalian chromosomal aberration assay, an in vivo

mouse bone-marrow micronucleus assay and a bacterial DNA damage/repair assay. Based on 

the results of these studies, EPA has classified novaluron as “not likely to be carcinogenic to 

humans.” 

3.1 FQPA Considerations

The RAB1 risk assessment team concluded that the FQPA SF can be reduced to 1X based on the 

following:

 There is no evidence of increased susceptibility in the rat or rabbit developmental toxicity

studies up to the limit dose or in the two-generation reproduction study in rats.

 There are no concerns or residual uncertainties for pre- and/or postnatal toxicity.

 Acute and subchronic neurotoxicity screening batteries were performed with novaluron in 

rats. Novaluron is not considered neurotoxic, since effects observed in the acute 

neurotoxicity study were observed at the limit dose only and were not reproduced at 

similar, repeated doses in the subchronic neurotoxicity study. In addition, no evidence of 

neuropathology was observed in subchronic and chronic toxicity studies in rats, mice, or 

dogs, and novaluron is not considered acutely toxic (LD50>5000 mg/kg).

 A developmental-neurotoxicity (DNT) study is not required.

 Histopathological examination of the organs of the immune system (i.e., thymus, spleen, 

lymph nodes) showed an increase in spleen weight and increased incidence and severity 

of hemosiderosis in the spleen in the chronic studies in rats and mice and in the 

reproduction study in rats. These findings were associated with the primary

hematotoxicity of novaluron, which caused secondary accumulation of damaged

erythrocytes in the spleen following removal from the blood. Therefore, these are not 

considered immunotoxic effects. The overall weight of evidence suggests that novaluron 

does not directly target the immune system. An immunotoxicity study is required as part 

of the revised 40 CFR Part 158 toxicology data requirements for novaluron; however, 

HED does not believe that conducting a functional immunotoxicity study will result in a 

lower NOAEL than the regulatory dose being used for risk assessment, and an additional 

UF for database uncertainty (UFDB) is not needed to account for the lack of the required 

immunotoxicity study.

 The protective residue assumptions were used in the dietary exposure risk assessment

such as assuming average residues based on field trial data [maximum application rate; 

minimum pre-harvest interval (PHI); and samples were frozen immediately after harvest]. 

Additionally, the current chronic analysis could be further refined through the use of 

monitoring data and preparation/cooking factors. 
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 The completeness of the residue chemistry database and conservative drinking water 

assessment.

 The residential exposure assessment was conducted using high-end estimates of use and 

potential exposure providing a conservative, health protective estimate of risk.

The doses and toxicological endpoints selected for human health risk assessment are summarized 

in Table 3.1.

Table 3.1. Summary of Toxicological Dose and Endpoints for Novaluron.

Exposure

Scenario

Dose Used in Risk 

Assessment, UF

FQPA SF and LOC 

for Risk Assessment Study and Toxicological Effects

Acute Dietary

(all populations)

Not applicable None An endpoint of concern attributable to 

a single dose was not identified. An 

acute RfD was not established.

Chronic Dietary

(all populations)

NOAEL = 1.1 

mg/kg/day

UF = 100

FQPA SF = 1X

cRfD = cPAD = 0.011 

mg/kg/day

Combined chronic 

toxicity/carcinogenicity feeding in rat.

LOAEL = 30.6 mg/kg/day based on 

erythrocyte damage and turnover 

resulting in a regenerative anemia.

Short-Term

Incidental Oral 

(1-30 days)

NOAEL = 4.38

mg/kg/day

Residential LOC for 

MOE <100

90-day feeding study in rat.

LOAEL = 8.64 mg/kg/day based on 

clinical chemistry (decreased 

hemoglobin, hematocrit, and RBC 

counts) and histopathology (increased 

hematopoiesis and hemosiderosis in 

spleen and liver).

Intermediate-Term

Incidental Oral 

(1-6 months)

NOAEL = 4.38

mg/kg/day

Residential LOC for 

MOE <100

90-day feeding study in rat.

LOAEL = 8.64 mg/kg/day based on 

clinical chemistry (decreased 

hemoglobin, hematocrit, and RBC 

counts) and histopathology (increased 

hematopoiesis and hemosiderosis in 

spleen and liver).

Short-Term

Dermal (1-30 

days)

Not applicable None No toxicity was observed at the limit 

dose in the dermal study and there 

were no developmental toxicity 

concerns at the limit-dose; therefore, 

quantification of short-term dermal risk 

is not necessary.

Intermediate-Term

Dermal 

(1-6 months)

Oral NOAEL = 4.38

mg/kg/day

(dermal-absorption 

rate = 10%)

Residential/ 

Occupational LOC for 

MOE <100

90-day feeding study in rat.

LOAEL = 8.64 mg/kg/day based on 

clinical chemistry (decreased 

hemoglobin, hematocrit, and RBC 

counts) and histopathology (increased 

hematopoiesis and hemosiderosis in 

spleen and liver).

Long-Term

Dermal 

(>6 months)

Oral NOAEL = 1.1 

mg/kg/day

(dermal-absorption 

rate = 10%)

Residential/ 

Occupational LOC for 

MOE <100

Combined chronic 

toxicity/carcinogenicity feeding in rat.

LOAEL = 30.6 mg/kg/day based on 

erythrocyte damage and turnover 
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Table 3.1. Summary of Toxicological Dose and Endpoints for Novaluron.

Exposure

Scenario

Dose Used in Risk 

Assessment, UF

FQPA SF and LOC 

for Risk Assessment Study and Toxicological Effects

resulting in a regenerative anemia.

Short-Term

Inhalation 

(1-30 days)

Oral NOAEL = 4.38

mg/kg/day

(inhalationabsorption rate = 

100%)

Residential/ 

Occupational LOC for 

MOE <100

90-day feeding study in rat.

LOAEL = 8.64 mg/kg/day based on 

clinical chemistry (decreased 

hemoglobin, hematocrit, and RBC 

counts) and histopathology (increased 

hematopoiesis and hemosiderosis in 

spleen and liver).

Intermediate-Term

Inhalation 

(1-6 months)

Oral NOAEL = 4.38

mg/kg/day

(inhalationabsorption rate = 

100%)

Residential/ 

Occupational LOC for 

MOE <100

90-day feeding study in rat.

LOAEL = 8.64 mg/kg/day based on 

clinical chemistry (decreased 

hemoglobin, hematocrit, and RBC 

counts) and histopathology (increased 

hematopoiesis and hemosiderosis in 

spleen and liver).

Long-Term

Inhalation 

(>6 months)

Oral NOAEL = 1.1 

mg/kg/day

(inhalationabsorption rate = 

100%)

Residential/ 

Occupational LOC for 

MOE <100 

Combined chronic 

toxicity/carcinogenicity feeding in rat.

LOAEL = 30.6 mg/kg/day based on 

erythrocyte damage and turnover 

resulting in a regenerative anemia.

Cancer Not likely to be carcinogenic to humans.

UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL = 

lowest-observed-adverse-effect-level, PAD = population-adjusted dose (a = acute, c = chronic), RfD = reference 

dose, MOE = margin of exposure, LOC = level of concern.

A 90-day inhalation toxicity study in the rat is requested for further characterization of inhalation 

risk. Due to the potential for repeated inhalation exposure anticipated from the proposed 

residential use pattern, there is concern for toxicity by the inhalation route. An inhalation study

would provide a dose and endpoint via the route of exposure of concern (i.e. route specific study) 

and thus would avoid using an oral study and route-to-route extrapolation.

3.2 Endocrine Disruption

As required under Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(p), EPA has 

developed the Endocrine Disruptor Screening Program (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 
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effects caused by the substance, and establish a dose-response relationship between the dose and 

the E, A, or T effect.

Between October 2009 and February 2010, EPA is issuing test orders/data call-ins for the first 

group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. 

This list of chemicals was selected based on the potential for human exposure through pathways 

such as food and water, residential activity, and certain post-application agricultural scenarios. 

This list should not be construed as a list of known or likely endocrine disruptors.

Novaluron is not among the group of 58 pesticide active ingredients on the initial list to be 

screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide 

chemicals. Accordingly, EPA anticipates issuing future EDSP test orders/data call-ins for all 

pesticide active ingredients. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

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

4.0 DIETARY EXPOSURE/RISK CHARACTERIZATION

The residue chemistry data submitted in support of the proposed uses are summarized in the 

pending HED memorandum by J. L. Van Alstine (D378631). The chronic dietary exposure 

assessment is summarized in the pending HED memorandum by J. L. Van Alstine (D383133).

4.1 Food Residue Profile

Nature of the Residue - Plants: HED previously concluded that the nature of the residue in 

plants is adequately understood based on acceptable metabolism studies conducted on apples, 

cabbage, cotton, and potatoes using [difluorophenyl-U14C]novaluron and [chlorophenyl-U14C]novaluron as the test substances (Memo, G. Kramer, 22-MAR-2004; D285474). These 

studies indicate that novaluron is not extensively metabolized in these crops. The parent 

compound, novaluron, was either the only residue component identified or was the predominant 

residue component in all analyzed plant matrices. The reviewed studies also indicate that 

novaluron, when foliarly applied during the vegetative growth stage, is not readily translocated 

to mature apple fruit, potato tubers, or cottonseed (Memo, G. Kramer, 22-MAR-2004; D285474). 

Based on these studies, the Metabolism Assessment and Review Committee (MARC) 

determined that the residue of concern in crops for purposes of tolerance enforcement and risk 

assessment is novaluron only (Memo, G. Kramer et al., 03-FEB-2004; D297646). 

Nature of the Residue - Livestock: HED also previously concluded that the nature of the residue 

in livestock is adequately understood based on the submitted goat and hen metabolism studies 

(Memo, G. Kramer, 22-MAR-2004; D285474). The HED MARC determined that the residue of 

concern in livestock for purposes of tolerance enforcement and risk assessment is novaluron only

(Memo, G. Kramer et al., 03-FEB-2004; D297646).
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Residue Analytical Enforcement Method - Plant: MANA previously submitted a gas 

chromatography/electron-capture detection (GC/ECD) residue analytical method for the analysis 

of novaluron residues in/on pome fruit, cabbage, and potato commodities; HED concluded that 

the method was adequate for gathering data on novaluron. A second method, high-performance 

liquid chromatography/ultraviolet (HPLC/UV), was submitted for the analysis of novaluron 

residues only in/on cotton commodities. Both methods were adequately validated by the 

petitioner and by an independent laboratory. Acceptable radiovalidation data for the GC/ECD 

method have been submitted and reviewed in a previous HED memorandum (Memo, S. Levy, 

23-AUG-2006; D325183) and both methods were forwarded to the EPA Analytical Chemistry

Branch (ACB)/Biological and Economics Analysis Division (BEAD) for petition method 

validation (PMV; Memo, G. Kramer, 05-DEC-2003; D296264).

ACB concluded that based upon review of the submitted method validation data, without 

laboratory validation, that the GC/ECD and HPLC/UV methods appear suitable for food 

tolerance enforcement in plants (apples, cabbage, and potatoes) and cotton. ACB recommended 

that the analytical methods do not need to be laboratory validated by EPA (Memo, S. Levy, 15-

SEPT-2004; D306998). Both methods have been forwarded to the Food and Drug 

Administration (FDA) for inclusion in the Pesticide Analytical Manual, Volume II (PAM II) as a 

Letter Method (S. Levy, 15-SEPT-2004; D307595). An interference study was requested and a 

specific single-analyte confirmatory method was submitted and considered acceptable (Memo, J. 

Langsdale, 21-OCT-2008; D355574).

For sweet corn, the enforcement method, with minor modifications, was used for data collection 

and the method was adequately validated in conjunction with the sweet corn field trials. The 

appropriate enforcement method for food- and feed-handling establishments is Method 243C106 (MRID 48034901), which was used for data collection for the food-handling establishment 

field trial and was adequately validated. 

Multiresidue Methods: Novaluron was tested through the FDA MRM Test guidelines in PAM I, 

Appendix II (JAN-1994). The results indicate that novaluron is not adequately recovered by any 

of the MRMs. This study was forwarded to FDA for further evaluation and updating of PAM 

Vol. I, Appendix I (Memo, S. Levy, 19-OCT-2005; D322359).

Magnitude of the Residue - Livestock: The potential for secondary transfer of novaluron

residues of concern in meat, milk, and eggs exists because there are livestock feedstuffs 

associated with the proposed/registered novaluron uses. Livestock dietary burdens of novaluron

were calculated, which incorporate the proposed/registered uses of novaluron. The calculations 

reflected the most recent guidance from HED (OPPTS 860.1000 Supplement, Table 1

Feedstuffs, 30-JUN-2008) concerning revisions of feedstuff percentages and constructing 

reasonably balanced dietary burdens (RBDBs). 

The currently established livestock tolerances are based on the following RBDBs for novaluron: 

16.9 ppm for beef cattle and 11.9 ppm for dairy cattle (Memo G. Kramer, 22-MAR-2004; 

D285474), and 2.4 ppm for poultry and 2.5 ppm for swine (Memo, J. Van Alstine, 23-FEB-2010; 

D374420). Based on the proposed/registered uses, the revised RBDBs for novaluron are 9.6 

ppm for beef cattle, 18.3 ppm for dairy cattle, 2.4 for poultry, and 2.5 for swine. No changes are 
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necessary for the tolerances for secondary residues in/on cattle, goat, horse, sheep, poultry, and 

swine commodities. Although IR-4 requested increasing tolerances for residues of novaluron in 

milk from 1.0 to 1.5 ppm and milk, fat from 20 to 35 ppm, increased tolerances are not required 

for these commodities at this time. IR-4 is requested to submit a revised Section F which 

removes the proposed changes to milk and milk fat tolerances. Additionally, based on 

ChemSAC guidance that meat byproduct tolerances should be set at the highest residue level 

seen in any livestock commodity (minutes from 12-JAN-2011), several meat byproduct 

tolerances in 40 CFR § 180.598(a) should be updated so that they are based on the highest 

expected residue. Additionally, two commodity descriptions should be updated. The tolerances 

and commodity descriptions should be updated as outlined in Table 4.1.2.

Magnitude of the Residue – Sweet Corn: The number and locations of field trials are in 

accordance with OPPTS Guideline 860.1500 for sweet corn. The field trial data reflect the 

proposed use rate and PHI for sweet corn. The field trial data for sweet corn stover and forage

were entered into the Agency’s tolerance spreadsheet as specified by the Guidance for Setting 

Pesticide Tolerances Based on Field Trial Data Standard Operating Procedure (SOP) to 

determine appropriate tolerance levels; see Appendix II. All residues in/on K+CWHR were less 

than the lowest level of method validation (LLMV; 0.05 ppm); therefore, the recommended 

tolerance for sweet corn K+CWHR is 0.05 ppm. The available data support tolerances of 50

ppm, 16 ppm, and 0.05 ppm for residues of novaluron in/on sweet corn sweet corn stover, 

forage, and K+CWHR, respectively.

Magnitude of the Residue – Food-Handling Establishments: The food-handling study is 

adequate and reflects the use of novaluron as a space spray treatment to a simulated commercial 

food establishment at a rate of 38.75 mg ai/m2(3X application rate), with a product application 

rate of 0.1 gal/1000 ft2[refer to the chemistry summary memo (J. Van Alstine; D378631) for 

calculations]. An exaggerated rate was used to generate worst-case residues. The residues for 

all covered food matrices samples treated at a 3X application rate were below the limit of 

quantitation (LOQ; <0.010 ppm) except for one sample of bread (0.0142 ppm) collected 4 hours 

post-application. HED does not expect residues to be higher than 0.01 ppm in covered food and 

feed items following treatment at a 1X application rate because 29 out of 30 measured residues 

were below the LOQ, even when treated at a 3X rate, and the food-handling establishment label 

states that food items should be removed or covered prior to treatment and that packaged food 

items should be stored in such a way that direct contact with foodstuff is not anticipated. The 

available data support the proposed tolerance of 0.01 ppm for residues in/on food/feed 

commodities (other than those covered by a higher tolerance as a result of use on growing crops) 

in food- and feed-handling establishments.

Processed Food and Feed: HED does not require residue data for any processed commodities 

associated with sweet corn. Therefore, data requirements for processed food and feed are not 

relevant to sweet corn commodities. Additionally, since the food and feed handling 

establishment label states that food items should be removed or covered prior to treatment and 

that packaged food items should be stored in such a way that direct contact with foodstuff is not 

anticipated, data requirements for processed food and feed are not relevant to this use pattern. 
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Submittal of Analytical Reference Standards: The available analytical reference standards for 

novaluron expired on 22-NOV-2010 (personal communication with Theresa Cole, 22-NOV2010). MANA is required to submit an updated COA or a new analytical standard to the EPA 

National Pesticide Standards Repository at the following address: 

USEPA

National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

701 Mapes Road

Fort George G. Meade, MD 20755-5350

Please note that the extended zip code is required for delivery.

Confined/Field Accumulation in Rotational Crops: The sweet corn commodities associated 

with the current petitions may be rotated. Based on the results of the submitted confined 

rotational crop study, the appropriate plantback interval (PBI) for all non-labeled crops is 30 

days. The current and proposed labels include a restriction that only registered crops may be 

rotated to a treated field within 30 days of the final application, which is appropriate for this 

petition. Future uses that have significantly higher application rates will require confined 

rotational crop studies at higher rates using chlorophenyl-labeled novaluron. The HED MARC 

has determined that for tolerance assessment and risk assessment, parent only is the residue of 

concern in rotational crops (Memo, G. Kramer et al., 03-FEB-2004; D297646).

 

Tolerance Summary: Permanent tolerances for novaluron have been established for a variety of 

commodities under 40 CFR §180.598. The HED MARC determined that the residue of concern 

in plants (primary and rotational crops) and livestock for purposes of tolerance enforcement and 

risk assessment is novaluron only (Memo, G. Kramer et al., 03-FEB-2004; D297646). Revised 

Section Fs are requested for PP#0E7723 and PP#0F7708 which reflect the HED-recommended 

tolerances and commodity definitions presented in Table 4.1.1. Additional, the revised Section F 

for PP#0E7723 should be submitted which cites the appropriate CAS name for novaluron:

“Tolerances are established for residues of the insecticide novaluron, including its 

metabolites and degradates, in or on the commodities in the table below. Compliance 

with the tolerance levels specified below is to be determined by measuring only 

novaluron (N-[[[3-chloro-4-[1,1,2-trifluoro-2-

(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide) in or on 

the following raw agricultural commodities:”

No Codex, Canadian, or Mexican maximum residue limits (MRLs) have been established for 

novaluron in/on sweet corn stover, forage, and K+CWHR. Canada is currently in the process of 

reviewing the use of novaluron on sweet corn stover, forage, and K+CWHR. The EPA and the 

Pest Management Regulatory Agency (PMRA) tolerance recommendations have been 

harmonized at 0.05 ppm for sweet corn K+CWHR. The PMRA is also proposing an increase in 

its MRL for milk to 1.0 ppm from 0.5 ppm, and as a result, the EPA and PMRA milk 

tolerances/MRLs are now harmonized. The PMRA does not recommend MRLs for livestock 

feed commodities; therefore it is not possible to harmonize tolerances/MRLs for sweet corn 

stover and sweet corn forage. The PMRA has not received a petition for the use of novaluron in 
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food and feed handling establishments; therefore, it is not possible to harmonize for the residues 

resulting from this proposed use. 

The Agency’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data was utilized 

for determining appropriate tolerance levels.

Table 4.1.1. Tolerance Summary for Novaluron.

Commodity Proposed 

Tolerance (ppm)

HED-Recommended 

Tolerance (ppm)

Comments; 

Correct Commodity Definition

Corn, Sweet, Stover 50 50 Corn, sweet, stover

Corn, Sweet, Forage 20 16 Corn, sweet, forage

Corn, Sweet, Kernel Plus 

Cob With Husks Removed 0.05 0.05 Corn, sweet, kernel plus cob with husks removed

Milk 1.5 1.0

An increase in the tolerance for 

residues of novaluron in milk is not 

needed at this time.

Milk, fat 35 20

An increase in the tolerance for 

residues of novaluron in milk fat is 

not needed at this time.

All food/feed items other 

than those covered by a 

higher tolerance as a result 

of use on growing crops

0.01 0.01

Food/feed commodities (other than 

those covered by a higher tolerance 

as a result of use on growing crops) 

in food/feed handling 

establishments

Note to RD: Based on ChemSAC guidance that meat byproduct tolerances should be set at the 

highest residue level seen in any livestock commodity (minutes from 12-JAN-2011), several 

meat byproduct tolerances in 40 CFR § 180.598(a) should be updated so that they are based on 

the highest expected residue. Additionally, two commodity descriptions should be updated. The 

tolerances and commodity descriptions should be updated as outlined in Table 4.1.2.

Table 4.1.2. HED-Proposed Updates to 40 CFR § 180.598 (a) Based on 12-JAN-2011 ChemSAC Guidance. 

Current Commodity 

Definition

Updated Commodity 

Description

Current Tolerance 

(ppm)

Updated Tolerance 

(ppm)1

Cattle, meat byproducts, 

except kidney and liver - 0.60 11

Goat, meat byproducts 

except kidney and liver - 0.60 11

Horse, meat byproducts, 

except kidney and liver - 0.60 11

Sheep, meat byproducts, 

except kidney and liver - 0.60 11

Hog, meat byproducts

Hog, meat byproducts, 

except kidney and 

liver2

0.10 1.5

Poultry, meat byproducts

Poultry, meat byproducts, 

except kidney and 

liver3

0.80 7.0

1 Based on the based on the highest expected secondary tissue residue [peritoneal fat in cattle (translated to goat, 

horse, and sheep); peritoneal fat in hog; abdominal fat in poultry]. 
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2 Separate tolerances have been established for hog, kidney (0.10 ppm) and hog, liver (0.10 ppm). 

3

Separate tolerances have been established for poultry, kidney (0.80 ppm) and poultry, liver (0.80 ppm). 
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4.2 Drinking Water Residue Profile

The drinking water residues used in the dietary risk assessment were provided by EFED (R. 

Miller, 29-SEP-2010; D378389). Since the application rates for the proposed new uses are 

significantly lower than the use rates for pome fruits and stone fruits, the EDWCs provided in the 

previous drinking water assessments dated 10-MAR-2009 (D357061) and 11-FEB-2004 

(D285477) are applicable for the proposed uses. EDWCs were not generated for the food- and 

feed-handling establishment uses because the use pattern is not expected to result in 

contamination of drinking water. The HED MARC concluded that parent and the chlorophenyl 

urea and chloroaniline degradates are residues of potential concern to be included in the drinking 

water assessment. Monitoring data are not available for novaluron or its chlorophenyl urea and 

chloroaniline degradates in surface water or ground water. Concentrations in surface water and 

ground water were estimated using standard EFED drinking water models.

Tier II Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) 

modeling was performed to estimate drinking water concentrations for surface water for the 

parent novaluron. The scenarios were selected to provide high-end drinking water 

concentrations for each crop and represent the geographic locations where the specific crops are 

grown in large quantities. The most-conservative estimates were obtained for aerial applications 

to apples grown in PA at the maximum annual application rate of 0.972 lb ai/acre, applied three 

times at approximately 0.32 lb ai/acre, with an interval between applications of ten days. For 

surface water, the 1-in-10-year annual mean EDWC for the parent novaluron is 0.76 ppb. 

A Tier I drinking water analysis was performed for the chlorophenyl urea and chloroaniline 

degradates using the FQPA Index Reservoir Screening Tool (FIRST) model to obtain surface 

water estimates. For surface water, the annual average EDWC for chlorophenyl urea is 0.89 ppb 

and the annual average EDWC for chloroaniline is 2.6 ppb. The chlorophenyl urea estimate is 

based upon the maximum application rate in peaches [approximately 0.32 lb ai/A applied 3 times 

per season every 7 days (0.972lb ai/year)] and the chloroaniline estimate is based upon the

maximum application rate in apples [approximately 0.32 lb ai/A applied 3 times per season every

10 days (0.972 lb ai/year)].

For ground water, the Screening Concentration in Ground Water (SCI-GROW) model was used 

to predict a ground water concentration for novaluron at the annual application rate of 0.972 lb 

ai/acre (i.e., three applications of approximately 0.32 lb ai/acre). The estimate for the parent 

novaluron is 0.0056 ppb in drinking water from shallow ground water sources. For the 

chlorophenyl urea degradate, the predicted ground water concentration is 0.0045 ppb, and for the 

chloroaniline degradate, the concentration is 0.0090 ppb. These concentrations were estimated 

with the same assumptions used for surface water modeling, and may be considered as both the 

peak and annual average upper-bound exposures.

These EDWC values are meant to represent upper-bound estimates of the concentrations that 

might be found in surface water and ground water based upon existing and proposed uses. Of 

the three EDWC values, chronic estimates for the terminal chloroaniline metabolite are the 

highest (100% conversion from parent to aniline was assumed). This is consistent with the 
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expected degradation pattern for novaluron. Therefore, the EDWC value for the chloroaniline 

degradate (2.6 ppb) was used to assess chronic aggregate risk.

Table 4.2. EDWCs Resulting from the Application of Novaluron.

Drinking Water 

Source (Model)

Use(Modeled Rate)

Application Type

1-in-10-Year Acute

(ppb)

1-in-10-Year

Chronic (ppb)

30-Year Average

(ppb)

Novaluron

Surface Water 

(PRZM/EXAMS)

PA Apples

(0.972 lbs ai/A/year)

aerial application

4.591

0.76 0.62

GA Peach

(0.972 lbs ai/A/year)

aerial application

4.7210.51 0.43

Groundwater

(SCIGROW)

Apples/Peaches

(0.972 lbs ai/A/year)

aerial application

0.0056 0.0056 ≤0.0056

Chlorophenyl Urea

Surface water

(FIRST)

Apples

(0.972 lbs ai/A/year)

Aerial Application

4.55 0.86 ≤0.86

Peaches

(0.972 lbs ai/A/year)

Aerial Application

4.74 0.89 ≤0.89

Groundwater

(SCIGROW)

Apples/Peaches

(0.972 lbs ai/A/year)

Aerial Application

0.0045 0.0045 ≤0.0045

Chloroaniline

Surface water

(FIRST)

Apples/Peaches

(0.972 lbs ai/A/year)

Aerial Application

11.422.60 ≤2.60

Groundwater

(SCIGROW)

Apples/Peaches

(0.972 lbs ai/A/year)

Aerial Application

0.009 0.009 ≤0.009

1 These values exceed the measured water solubility of novaluron; i.e., 3 μg/L.

2

This value exceeds the estimated water solubility of chloroaniline; i.e., 10.6 μg/L.

4.3 Dietary Exposure and Risk

An acute dietary assessment was not conducted for novaluron because an endpoint of concern 

attributable to a single dose was not identified. A cancer dietary assessment was not conducted 

because novaluron was classified as “not likely to be carcinogenic to humans.” A partially 

refined chronic dietary exposure and risk assessment was conducted to support Section 3 

requests for use of novaluron on sweet corn and in food- and feed-handling establishments using 

the DEEM-FCID, Version 2.03, which uses food consumption data from USDA’s CSFII from 

1994-1996 and 1998. 

The partially refined chronic dietary exposure and risk assessment was conducted for the 

proposed new uses on sweet corn and in food- and feed-handling establishments, all established 

uses, and drinking water to support Section 3 requests for use of novaluron on sweet corn and in 

food- and feed-handling establishments. A PCTn memorandum for sweet corn was provided by 
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BEAD. Additionally, data from a previously provided SLUA memorandum for existing uses 

and a PCTn memorandum for grain sorghum were used. The chronic analysis incorporated 

average %CT data for apples, cabbage, cotton, pears, and potatoes, and PCTn data for grain 

sorghum and sweet corn. 100% CT was assumed for the remaining food commodities. 

ARs for meat, milk, hog, and poultry commodities were calculated using average field trial 

residues, PCTn data for grain sorghum and sweet corn, average %CT data for apple and cotton, 

and assumed 100% CT for sugarcane and cowpea seed. The chronic analysis also incorporated 

average field trial residues, average greenhouse trial residues for tomatoes, empirical processing 

factors for apple juice (translated to pear and stone fruit juice), cottonseed oil, dried plums, and 

tomato paste and purée, and DEEM (ver. 7.81) default processing factors for the remaining 

processed commodities. In accordance with HED SOP 2000.1, average field trial residues were 

translated from representative commodities in the crop group to other commodities in that crop 

group as needed.

The chronic dietary (food and drinking water) exposure to novaluron is below HED’s LOC for 

the general U.S. population and all population subgroups. The chronic dietary exposure results 

in a risk estimate that is 21% of the cPAD for the general U.S. population and 72% of the cPAD 

for children 1-2 years old, the most highly exposed population subgroup. 

Table 4.3. Summary of Chronic Dietary Exposure (Food and Drinking Water) and Risk for Novaluron1,2.

Population Subgroup

Acute Dietary Chronic Dietary Cancer

Dietary 

Exposure 

(mg/kg/day)

% aPAD

Dietary 

Exposure

(mg/kg/day)

% cPAD

Dietary 

Exposure

(mg/kg/day)

Risk

General U.S. Population

N/A N/A

0.002298 21

N/A N/A

All Infants (<1 year old) 0.002922 27

Children 1-2 years old 0.007955 72

Children 3-5 years old 0.005989 54

Children 6-12 years old 0.003676 33

Youth 13-19 years old 0.002098 19

Adults 20-49 years old 0.001632 15

Adults 50+ years old 0.001576 14

Females 13-49 years old 0.001570 14

1 The chronic RfD (cRfd= cPAD = 0.011 mg/kg/day).

2 The highest dietary exposure is bolded. 

4.4 Anticipated Residue and %CT Information

A SLUA memorandum entitled, “Usage Report Package in Support of Registration for the 

Insecticide Novaluron (124002), BEAN DP# 371221” (A. Grube, 17-NOV-2009) and PCTn 

memorandums entitled, “Percent Crop Treated for New Use (PCTn): Novaluron (124002) Use 

on Sorghum, DP# 371615” (C. Doucoure, et al., 29-DEC-2009) and “Percent Crop Treated for 

Novaluron on Proposed New Uses for Sweet Corn (PC# 124002, DP# 384687)” (J. Alsadek et 

al., 18-FEB-2011) were provided by BEAD. The SLUA memo included %CT data for apples, 

cabbage, cotton, pears, and potatoes. The market leader approach was used by BEAD to 

determine the PCTn for sorghum and sweet corn. New SLUA and grain sorghum PCTn 
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memorandums were not required because the memos were completed within approximately one 

year of this analysis. 

The chronic dietary analysis incorporated average %CT data for apples (15%), cabbage (10%), 

cotton (2.5%), pears (10%), and potatoes (2.5%), and average PCTn data for grain sorghum (5%) 

and sweet corn (59%). 100% CT was assumed for the remaining food commodities. Livestock 

dietary burdens of novaluron were calculated based on the proposed/registered uses, average 

field trial residues, average PCTn data for grain sorghum (5%) and sweet corn (59%), average 

%CT data for apple (15%) and cotton (2.5%), and an assumption of 100% CT for sugarcane and 

cowpea seed. These livestock dietary burdens were used, along with average transfer 

coefficients, to calculate anticipated secondary residues for meat, milk, hog, and poultry

commodities which were incorporated into the chronic dietary assessment. 

5.0 RESIDENTIAL (NON-OCCUPATIONAL) EXPOSURE/RISK 

CHARACTERIZATION

Novaluron is proposed for indoor (crack and crevice and spot treatments) and outdoor 

(perimeter) uses for the control of roaches and crickets. Novaluron is proposed for use in 

residential and commercial buildings and structures and their immediate surroundings and on 

modes of transportation. The permitted areas of use include non-food/non feed areas of stores, 

warehouses, transportation equipment, manufacturing sites, industrial buildings, houses, 

apartment buildings, office buildings, laboratories, schools, daycare centers, nursing homes, 

hospitals, hotels and on vessels, railcars, aircraft, buses, trucks and trailers. There is a potential 

for exposure in residential settings during the application process for homeowners who use

products containing novaluron. There is also a potential for exposure from entering novalurontreated areas that could lead to exposures to adults and children. Risk assessments have been 

completed for both residential handler and post-application scenarios. Only the indoor use has 

been assessed as this is believed to cover the outdoor perimeter treatment. The outdoor 

perimeter treatment is to areas that adults and children would not spend much time, such as 

around window frames and doors. Dermal, inhalation and incidental oral exposure is expected to 

be higher from the indoor crack and crevice and spot treatments. 

A residential exposure assessment for novaluron was prepared in a pending HED memorandum 

(L. Venkateshwara; D378634). See Table 2.1 for a summary of the proposed use patterns. 

5.1 Residential Handler Exposure and Risk

Based upon the proposed use pattern, HED expects the following residential pesticide handler

scenarios:

 Mixing/loading/applying emulsifiable concentrate formulations with low-pressure 

handwand (PHED), and

 Applying ready to use formulations via trigger-pump sprayer (ORETF).

Assessing exposures and risks resulting from residential uses is very similar to assessing 

occupational exposures and risks, except that a tiered approach for personal protection using 
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increasing levels of personal protective equipment PPE is not used in residential handler risk 

assessments. Homeowner handler assessments are based on the assumption that individuals are 

wearing shorts, short-sleeved shirts, socks, and shoes.

No chemical-specific data were available with which to assess potential exposure to residential 

pesticide handlers. The estimates of exposure to pesticide handlers are based upon surrogate 

study data available in the PHED (v. 1.1, 1998) and ORETF. MANA is a member of ORETF.

For the purposes of assessing a crack and crevice exposure scenario, HED used the 

mixing/loading/applying wettable powders with a low-pressure handwand scenario as a surrogate 

to assess handler exposure to the emulsifiable concentrate formulation. Usually, HED would use 

surrogate data for liquid formulations as surrogate for EC formulation. However, the unit 

exposure values provided for the wettable powder formulation are based on actual exposures 

measured during crack and crevice applications; whereas, the unit exposure values for the liquid 

formulation are based on applications to chicken houses and greenhouses. Therefore, although 

the proposed product is formulated as an emulsifiable concentrate, HED believes that the use of 

unit exposure values resulting from crack and crevice applications provides a more accurate 

representation of handler exposure.

Daily dermal or inhalation handler exposures are estimated for each applicable handler task with 

the application rate, the area treated in a day, and the applicable dermal or inhalation unit 

exposure using the following formula:

Daily Exposure (mg ai/day) = Unit Exposure (mg ai/lb ai handled) x Application Rate (lb ai/area) x Daily Area 

Treated (area/day)

Where: 

Daily Exposure = Amount (mg ai/day) deposited on the surface of the skin that is 

available for dermal absorption or amount inhaled that is available for 

inhalation absorption;

Unit Exposure = Unit exposure value (mg ai/lb ai) derived from August 1998 PHED or 

ORETF data;

Application Rate = Normalized application rate based on a logical unit treatment, such as 

acres; and

Daily Area Treated = Normalized application area based on a logical unit treatment such as 

acres (A/day). 

The daily dermal or inhalation dose is calculated by normalizing the daily exposure by body

weight and adjusting, if necessary, with an appropriate dermal or inhalation absorption factor 

using the following formula:

Average Daily Dose (mg/kg/day) = Daily Exposure (mg ai/day) x (Absorption Factor (%/100)) / Body Weight (kg)

Where:

Average Daily Dose = Absorbed dose received from exposure to a pesticide in a 

given scenario (mg ai/kg body weight/day);
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Daily Exposure = Amount (mg ai/day) deposited on the surface of the skin that 

is available for dermal absorption or amount inhaled that is 

available for inhalation absorption;

Absorption Factor = A measure of the amount of chemical that crosses a biological 

boundary such as the skin or lungs (% of the total available 

absorbed); and

Body Weight = Body weight determined to represent the population of interest 

in a risk assessment (kg).

Non-cancer dermal and inhalation risks for each applicable handler scenario are calculated using 

an MOE, which is a ratio of the NOAEL to the daily dose. All MOE values were calculated 

using the formula below:

MOE = NOAEL or LOAEL (mg/kg/day) / Average Daily Dose (mg/kg/day).

Dermal and inhalation risks were combined in this assessment, since the toxicological effects for 

these exposure routes were similar. 

Dermal and inhalation risks were combined using the following formula:

Total MOE = NOAEL / (Dermal + Inhalation Dose).

Table 5.1 provides estimates of short-term exposure and risk for residential handlers. Since there 

is no short-term dermal endpoint, these exposures are representative of intermediate-term dermal 

exposures and are considered conservative since intermediate-term exposures are not likely

because of the intermittent nature of applications by homeowners. Although a PoD from an oral 

study was used to assess residential handler inhalation risks for novaluron, HED does not believe 

this assessment is under-protective of adult handlers. The inhalation MOEs calculated for 

residential handlers were all > 1 million, thus providing an ample margin of safety to account for 

any uncertainties in route-to-route extrapolation. The MOE calculated exceeds the LOC of 100 

and, therefore, is not of concern.

Table 5.1. Residential Handler Exposure and Risk for Novaluron.

Application 

Rate (lb 

ai/gallon)a

Amount 

Handled 

(gallons)b

Unit Exposure

(mg/lb ai)c Dose (mg/kg/day)e,f MOEg,h

Baseline 

Dermald

Baseline 

Inhalationd

Baseline 

Dermal

Baseline 

Inhalation

Combined 

Baseline 

Dermal + 

Baseline 

Inhalation

Baseline 

Dermal

Baseline 

Inhalation

Baseline 

Dermal + 

Baseline 

Inhalation

Mixing/Loading/Applying Wettable Powders with Low-pressure Handwand (PHED)

0.02 0.5 100 0.03 0.0014 0.0000043 0.0014 3,100 1,000,000 3,100

Applying Ready to Use Formulations Via Trigger Pump Sprayer (ORETF)

0.02 0.125 54 0.019 0.00019 6.8E-07 0.0002 23,000 6,500,000 23,000

a. Application rate based on proposed use on label for novaluron product RIMON® EC Insecticide (Reg. No. 66222-ERT). Maximum 

rate = 3.1 oz/gal (0.02 lb ai/gal).

b. ExpoSAC Policy #12. Assumed 16-oz bottle for trigger pump sprayer (16 oz * 128 oz/gal = 0.125 gallon).
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c. Unit Exposures for low-pressure handwand scenario based on PHED Version 1.1. For purposes of assessing a crack and crevice 

exposure scenario, HED used the mixing/loading/applying wettable powders with a low-pressure handwand scenario as a surrogate to 

assess handler exposure to the liquid formulation. See text above table for full explanation. Unit exposures for trigger-pump sprayer 

scenario based on ORETF (OMA006; MRID 444598-01). 

d. Baseline Dermal: Short-sleeve shirt, shorts, and no gloves. Baseline Inhalation: no respirator.

e. Dermal Dose (mg/kg/day) = daily unit exposure (mg/lb ai) * application rate (lb ai/gallon) * amount handled (gallons) * dermal 

absorption factor (10%) / body weight (70 kg).

f. Inhalation Dose (mg/kg/day) = daily unit exposure (mg/lb ai) * application rate (lb ai/gallon) * amount handled (gallons) * inhalation 

absorption (100%) / body weight (70 kg). 

g. MOE = NOAEL (short- and intermediate-term = 4.38 mg/kg/day) / daily dose (mg/kg/day). LOC = 100.

h. Baseline Dermal + Baseline Inhalation MOE = NOAEL (mg/kg/day) / (Baseline Dermal dose + Baseline Inhalation dose).

5.2 Residential Post-application Exposure and Risk

HED believes that short and intermediate residential post-application exposures are likely from 

the proposed use. Intermediate-term exposures have been estimated using Day-0 residue values 

along with an intermediate-term POD (applicable for exposures up to 6 months), which is 

considered a conservative assumption for longer-term exposures since residue values would be

expected to dissipate over time. For the proposed indoor use, HED anticipates that dermal 

(adults and children), inhalation (adults and children), and incidental oral (children only) 

exposures are possible. 

Post-application Inhalation

Post-application inhalation exposure can result from the proposed indoor use. The saturation 

concentration in air for novaluron was calculated and used as a screening level air concentration 

for the inhalation post-application exposure assessment. The following equation was used to 

estimate the saturation concentration for novaluron:

Csat = (VP * CF1 * MW * CF2 * CF3) / (R * T)

Where:

Csat = Saturation concentration (mg/m3),

VP = Vapor pressure (mmHg),

MW = Molecular weight (g/mol),

R = Gas constant = 0.0821 L-atm/mol-K,

T = Temperature of the air (296 K),

CF1 = Conversion factor (atm/760 mm Hg),

CF2 = Conversion factor (103 mg/g), and

CF3 = Conversion factor (103 L/m3).

The vapor pressure of novaluron is 1.2 x 10-7 mm Hg at 20oC and the molecular weight is 492.7 

g/mol. The saturation concentration was then used to calculate post-application inhalation 

exposure using the following assumptions:

 inhalation rate = 0.55 m3/hr for adults and 0.36 m3/hr for toddlers based on 

ExpoSAC Policy #12, and

 exposure time = 16 hours based on mean time spent in a residence from the U.S 

EPA Exposure Factors Handbook (1997).

Post-application inhalation dose is calculated as follows:
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Dose (mg/kg/day) = Csat * IR * ET / BW 

Where:

Csat = Saturation concentration (mg/m3),

IR = Inhalation rate (m3/hr),

ET = Exposure time (hr/day), and

BW = Body weight (kg).

All post-application inhalation scenarios resulted in MOEs greater than 100 and do not exceed 

HED’s level of concern. Table 5.2.1 summarizes the post-application inhalation exposure and 

risk from the indoor uses of novaluron. Although a PoD from an oral study was used to assess 

residential post-application inhalation risks for novaluron, HED does not believe this assessment 

is under-protective. The post-application inhalation MOEs calculated were all > 3,000, thus 

providing an ample margin of safety to account for any uncertainties in route-to-route 

extrapolation. Further, calculating postapplication inhalation exposure and risk using the 

saturation concentration should be considered a very conservative approach. The saturation 

concentration represents what would occur if a large amount of chemical were spilled in a nonventilated room and allowed to evaporate until equilibrium is reached.

Table 5.2.1. Post-application Inhalation Exposure for Children and Adults.

Population Csat

(mg/m3)

a IR (m3

/hr) ET (hr) Inhalation Dose 

(mg/kg/day)b

Inhalation MOEc

Short- and 

Intermediate-term

Adult

0.0032

0.55 16 0.0004 11,000

Children 

(3 to <6 years old) 0.36 16 0.0012 3,600

a. Csat = [Vapor pressure (1.2 X 10-7 mmHg) * Conversion factor (atm/760 mm Hg) * Molecular Weight (492.7 g/mol) * Conversion 

factor (103 mg/g) * Conversion factor (103 L/m

3

)] / [R (Gas constant = 0.0821 L-atm/mol-K)* Temperature (296 K)].

b. Inhalation Dose (mg/kg/day) = Csat * Inhalation Rate (m3/hr) * Exposure Time (hr) / Body Weight (kg).

c. Inhalation MOE = NOAEL (Short- and intermediate-term = 4.38 mg/kg/day) / Dose (mg/kg/day).

Post-application Dermal

Post-application dermal exposure can result from pesticide residue transfer to the skin of 

individuals who contact previously treated indoor surfaces (e.g., carpets, floors, furniture, and 

other surfaces) during standard activities. Such exposure is assumed to occur for adults and 

children. An assessment has been conducted for dermal exposures from the proposed indoor use 

(crack and crevice/spot). Since there is no short-term dermal endpoint, these exposures are 

representative of intermediate-term exposures.

Crack and Crevice/Spot Use

The following data, assumptions, and equations were used to assess dermal post-application 

exposure from the proposed indoor crack and crevice/spot use:

 Deposited residue: 

o Maximum application rate: 3.1 ounces per gallon (0.02 lb ai/gal), 
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o Based on information from a Registrant submitted food handling residue study

(MRID 48034903), assumed a spray rate of 0.1 gallon per 1000 sq feet,

o Dermal post-application exposure assessed using the following deposited residue 

value:

 0.02 lb ai/gal and 0.1 gal/1000 ft2= 0.002 lb ai/1000 ft2= 1.18 ug/cm2,

 Fraction of ai available for transfer: 0.05 for carpet and 0.1 for hard surfaces,

 Transfer coefficient: 16,700 cm2/hr for adults and 6,000 cm2/hr for children,

 Exposure time: 8 hours/day for carpet and 4 hours/day for hard surfaces, and

 Individuals contact previously treated carpets or hard surfaces on the same day a 

pesticide is applied. 

Dermal exposure for adults and children contacting treated indoor surface residue was calculated 

with the following equation:

ISR = DepR * F 

Where:

ISR = Indoor surface transferable residue (μg/cm2),

DepR = Deposited residue (ug/cm2), and

F = Fraction of ai available for transfer from carpet or hard surface (unitless).

D = (ISR * CF1 * TC * ET * DAF) / BW

Where:

D = Dermal dose (mg/day),

ISR = Indoor surface transferable residue (μg/cm2),

CF1 = Conversion factor (0.001 mg/μg),

TC = Transfer coefficient (cm2/hr), 

ET = Exposure time (hr/day), 

DAF = Dermal absorption factor, and

BW = Body weight (kg).

Dermal MOEs were calculated as follows:

Dermal MOE = NOAEL (mg/kg/day) / Dermal Dose (mg/kg/day).

Table 5.2.2 summarizes the dermal post-application exposure and risk from the crack and 

crevice/spot use at the maximum application rate allowed on the proposed label. At the 

maximum application rate (3.1 oz/gal and 0.1 gallon/1000 ft2), all dermal MOEs for adults and 

children are greater than the target MOE of 100 and do not exceed HED’s level of concern. 

Table 5.2.2. Post-application Dermal Exposure for Children (3 to <6 year olds) and Adults for Novaluron Crack 

and Crevice/Spot Use.

Surface 

Type Population

Application 

rate per 1000 

square feeta

Surface 

Residueb

(ug/cm2)

Fraction 

transferred

Transfer 

Coefficient 

(cm

2

/hr)

Exposure 

time 

(hr/day)

Dermal 

Dosec

(mg/kg/day)

Dermal 

MOEd

I-T

3.1 oz/gal = 0.02 lb ai/gal and 0.1 gal/1000 ft2= 0.002 lb ai/1000 ft2

Carpet Adult 0.002

a

1.18 0.05 16,700 8 0.011 390
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Table 5.2.2. Post-application Dermal Exposure for Children (3 to <6 year olds) and Adults for Novaluron Crack 

and Crevice/Spot Use.

Surface 

Type Population

Application 

rate per 1000 

square feeta

Surface 

Residueb

(ug/cm2)

Fraction 

transferred

Transfer 

Coefficient 

(cm

2

/hr)

Exposure 

time 

(hr/day)

Dermal 

Dosec

(mg/kg/day)

Dermal 

MOEd

I-T

Children 

(3 to<6 year olds) 6,000 0.019 230

Hard 

Surfaces

Adult

0.10

16,700

4

0.011 390

Children 

(3 to<6 year olds) 6,000 0.019 230

a. Maximum application rate is 3.1 oz/gal. The maximum spray rate per area assumed to be 0.1 gallon per 1000 sq ft based on a 

Registrant submitted food handling study (MRID 48034903).

b. Surface residue = conversion of the application rate from lb ai per sq ft to ug/cm2using two conversion factors (4.5 x 108ug/lb and 

1.08 x 10-3ft2/cm2).

c. Dose (mg/kg/day) = Surface residue (ug/cm2) * Fraction transferred * Transfer coefficient (cm2/hr) * Exposure time (hr/day) * 

Conversion factor (0.001 mg/ug) * Dermal Absorption Factor (10%) / Body Weight (70 kg for adults and 15 kg for children).

d. MOE = NOAEL (mg/kg/day) / Dose (mg/kg/day), where intermediate-term (I-T) dermal NOAEL = 4.38 mg/kg/day. 

Post-application Incidental Oral

Post-application incidental oral exposure resulting from hand-to-mouth activity can occur as a 

result of the indoor crack and crevice/spot use. The hand-to-mouth exposure scenario was 

assessed using the HED Draft SOP’s for Residential Exposure Assessments (2000), and the 

Revisions to the SOP’s for Residential Exposure Assessment (ExpoSAC Policy #12). This 

scenario assumes pesticide residues are transferred to the skin of children during post-application 

contact with treated indoor areas and are subsequently ingested as a result of hand-to-mouth 

transfer. The following assumptions, factors, equations and calculations were used to estimate 

hand-to-mouth transfer exposure:

 Deposited residue: 

o Maximum application rate: 3.1 ounces per gallon (0.02 lb ai/gal), 

o Based on information from a registrant-submitted food handling residue study

(MRID 48034903), assumed a spray rate of 0.1 gallon per 1000 sq feet,

o Dermal post-application exposure assessed using the following deposited residue 

value: 

 0.02 lb ai/gal and 0.1 gal/1000 ft2= 0.002 lb ai/1000 ft2= 1.18 ug/cm2,

 Fraction of ai available for transfer: 0.05 for carpet and 0.1 for hard surfaces,

 The median surface area of both hands for children: 20 cm2,

 The mean rate of hand-to-mouth activity: 20 times/hour for short-term exposure 

scenarios and 9.5 events per hour for intermediate-term exposure scenarios,

 Duration of exposure for children: 4 hours per day,

 The saliva extraction factor: 50%, and

 Toddlers are assumed to weigh 15 kg.

Incidental hand-to-mouth exposure for children contacting treated surfaces was calculated with 

the following equation:

ISR = DepR x F 

Where:
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ISR = Indoor surface transferable residue (μg/cm2),

DepR = Deposited residue (ug/cm2), and

F = Fraction of ai available for transfer from carpet or hard surface (unitless).

D = (ISR x SA x FQ x ET x SE x CF1) / BW

Where:

D = Dermal dose (mg/kg/day),

ISR = Indoor surface transferable residue (ug/cm2),

SA = Surface area of the hands (cm2/event),

FQ = Frequency of hand-to-mouth activity (events/hr), 

ET = Exposure time (hr/day),

CF1 = Conversion factor (0.001 mg/ug),

SE = Saliva extraction factor, and

BW = Body weight (15 kg).

Incidental oral MOEs were calculated as follows:

Incidental oral MOE = NOAEL (mg/kg/day) / Incidental Oral Dose (mg/kg/day).

Table 5.2.3 summarizes the MOEs for hand-to-mouth transfer of pesticide residues from the 

indoor crack and crevice/spot use at the maximum application rate allowed on the proposed 

label. At the maximum application rate (3.1 oz/gal and 0.1 gallon/1000 ft2), short- and 

intermediate-term incidental oral MOEs are greater than the target MOE of 100 and do not 

exceed HED’s level of concern. 
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Table 5.2.3. Post-application Incidental Oral (Hand-to-Mouth) Exposure for Children (3 to <6 year olds) for Novaluron Crack and Crevice/Spot Use.

Type of 

Surface

Application 

Rate (lb ai/1000 

sq ft)a

Fraction ai 

dislodgeable

Surface 

area of the 

hand (cm2)

Exposure Frequency 

(events/hr) Saliva 

Extraction 

Factor

Exposure 

Time 

(hrs/day)

Surface 

Residue 

(ug/cm2)

Average Daily Oral Dose 

(mg/kg/day)b Incidental Oral MOEc

ShorttermIntermediatetermShorttermIntermediatetermShorttermIntermediateterm

3.1 oz/gal = 0.02 lb ai/gal and 0.1 gallon/1000 ft2= 0.002 lb ai/1000 ft2

Carpet 0.002 0.05 20 20 9.5 50% 8 1.18 0.006 0.003 690 1,500

Hard 

surfaces 0.002 0.10 20 20 9.5 50% 4 1.18 0.006 0.003 690 1,500

a. Maximum application rate is 3.1 oz/gal. The maximum spray rate per area assumed to be 0.1 gallon per 1000 sq ft based on a Registrant submitted food handling study (MRID 48034903).

b. Dose (mg/kg/day) = Surface residue (ug/cm2) * Fraction transferred * Surface area of hands (cm2/event) * Exposure frequency (events/hr) * Exposure time (hr/day) x Saliva extraction 

factor x Conversion factor (0.001 mg/ug) / Body Weight (15 kg for children).

c. MOE = NOAEL (mg/kg/day) / Dose (mg/kg/day), where short- and intermediate-term (S-T and I-T) incidental oral NOAEL = 4.38 mg/kg/day. 
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5.3 Combined Residential Risk Estimates

HED combines risk values resulting from separate residential exposure scenarios when it is 

likely they can occur simultaneously based on the use-pattern and the behavior associated with 

the exposed population. Furthermore, since similar endpoints were selected for dermal, 

inhalation and oral exposures, risks from the three exposure routes may be combined. Therefore, 

all non-dietary sources of post-application exposure were combined to obtain an estimate of 

potential combined exposure which could be used for the aggregate assessment.

A combined residential assessment has been included here based on the indoor crack and 

crevice/spot use. These scenarios consisted of adult dermal and inhalation handler and postapplication exposures, as well as children (3 to <6 years old) dermal, inhalation and oral (handto-mouth) post-application exposures. All of the combined MOEs for adult and children (3 to <6 

year olds) are greater than the target MOE of 100 and do not exceed HED’s level of concern. 

Table 5.3.1 provides a summary of the combined residential post-application indoor crack and 

crevice exposures and risks for adult and children and handler indoor crack and crevice 

exposures and risks for adults. 

Table 5.3.1. Combined Residential Exposure and Risk Estimates from the Indoor Crack and Crevice/Spot 

Use.

Short-term Intermediate-term

Population Combined 

Dose1

Combined 

MOE2 Population Combined Dose1

Combined 

MOE2

Residential Handler Exposure3

Adults 

(inhalation 

only)

0.0000043 1,000,000 Adults 

(dermal + inhalation) 0.0014 3,100

Residential Post-Application Exposure

Adults 

(inhalation 

only)

0.0004 11,000 Adults 

(dermal + inhalation) 0.0114 380

Children 

(inhalation + 

HTM)

0.0072 580

Children 

(dermal + inhalation + incidental 

oral)

0.023 190

1 Combined Dose = see Table 5.1 for handler exposures and Tables 5.2.1 through 5.2.3 for post-application exposures.

2 Combined MOE = NOAEL (mg/kg/day) / Combined Dose (mg/kg/day); where S-T and I-T NOAEL = 4.38 mg/kg/day.

3 The values for the wettable powder exposure scenario were used because the wettable powder baseline doses were larger than the ready 

to use formulation baseline doses for both baseline inhalation and baseline combined (dermal + inhalation). 

5.4 Bystander Post-application Inhalation Exposure

Based on the Agency's current practices, a quantitative residential bystander post-application 

inhalation exposure assessment was not performed for novaluron at this time. However, 

volatilization of pesticides may be a potential source of post-application inhalation exposure to 

individuals nearby to pesticide applications. The Agency sought expert advice and input on 

issues related to volatilization of pesticides from its FIFRA Scientific Advisory Panel (SAP) in 
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December 2009. The Agency received the SAP’s final report on March 2, 2010 

(http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html). The Agency is in the 

process of evaluating the SAP report and may, as appropriate, develop policies and procedures, 

to identify the need for and, subsequently, the way to incorporate post-application inhalation 

exposure into the Agency's risk assessments. If new policies or procedures are put into place, the 

Agency may revisit the need for a quantitative post-application inhalation exposure assessment 

for novaluron.

5.5 Spray Drift 

Spray drift is always a potential source of exposure to residents nearby to spraying operations. 

This is particularly the case with aerial application but, to a lesser extent, could also be a 

potential source of exposure from the ground application method additionally employed for 

novaluron. The Agency has been working with the Spray Drift Task Force, EPA Regional 

Offices and State Lead Agencies for pesticide regulation and other parties to develop the best 

spray drift management practices. The Agency is now requiring interim mitigation measures for 

aerial applications that must be placed on product labels/labeling. The Agency has completed its 

evaluation of the new database submitted by the Spray Drift Task Force, a membership of U.S. 

pesticide registrants, and is developing a policy on how to appropriately apply the data and the 

AgDRIFT®computer model to its risk assessments for pesticides applied by air, orchard airblast,

and ground hydraulic methods. After the policy is in place, the Agency may impose further 

refinements in spray drift management practices to reduce off-target drift and risks associated 

with aerial as well as other application types where appropriate.

6.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION

In accordance with the FQPA, HED must consider and aggregate pesticide exposures and risks 

from three major sources: food, drinking water, and residential exposures. In an aggregate 

assessment, exposures from relevant sources are added together and compared to quantitative 

estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can be aggregated. When 

aggregating exposures and risks from various sources, HED considers both the route and

duration of exposure. In the case of novaluron, aggregate risk assessments were performed for 

short-term aggregate exposure (food + drinking water + residential), intermediate-term aggregate 

exposure (food + drinking water + residential), and chronic aggregate exposure (food + drinking 

water). Residential long-term exposure was not assessed because there are no chronic residential 

exposure scenarios for the registered and proposed uses, and was therefore not incorporated into 

the chronic aggregate exposure assessment. An acute aggregate assessment was not conducted 

for novaluron because an endpoint of concern attributable to a single dose was not identified. 

Additionally, a cancer aggregate assessment was not conducted because novaluron was classified 

as “not likely to be carcinogenic to humans.” All potential exposure pathways were assessed in 

the aggregate risk assessment. 
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6.1 Short-Term Aggregate Risk

The short-term aggregate risk assessment estimates risks likely to result from 1- to 30-day

exposures to novaluron residues from food, drinking water, and residential pesticide uses. Shortterm estimates of residential exposure are combined with background food and drinking water 

exposures.

Short-term aggregate risk assessments are necessary for both adults and children as there is 

potential for both short-term dermal and inhalation handler exposure and short-term postapplication exposure from the residential uses of novaluron. For the short-term aggregate risk 

assessment, potential residential post-application exposures were combined with food and 

drinking water exposures. A short-term dermal endpoint has not been selected for novaluron; 

therefore the short-term adult and child aggregate risk estimates do not include dermal 

exposures. Specifically, for young children, the short-term aggregate assessment combines 

dietary exposure with potential inhalation and incidental oral exposure (from hand-to-mouth 

contact with treated surfaces) resulting from the crack and crevice uses. The short-term 

aggregate assessment for adults combines dietary exposures with exposure from potential postapplication inhalation exposures resulting from indoor crack and crevice uses. See Table 5.3.1 

for more information on combined exposures. 

This is the first proposed residential use of novaluron; therefore, the short-term crack and crevice 

post-application exposure estimates were aggregated with the chronic dietary (food) to provide a 

worst-case estimate of short-term aggregate risk for the U.S. population and children 1-2 years 

old (the child population subgroup with the highest estimated chronic dietary food exposure). As 

the short-term aggregate MOEs are greater than 100, risks do not exceed HED’s level of

concern.

Table 6.1. Short-Term Aggregate Risk Calculations for Novaluron Using Post-Application Exposure 

Estimates.

Population

Subgroups

Short-Term Scenario1

NOAEL

(mg/kg/day) LOC2 Max Exposure3(mg/kg/day)

Average Dietary 

Exposure

(mg/kg/day)

Residential 

Exposure4

(mg/kg/day)

Aggregate MOE

(dietary and 

residential)5

U.S. 

Population 4.38 100 0.04 0.002298 0.0004 1600

Children 1-2 

years old 4.38 100 0.04 0.007955 0.0072 290

1 A short-term dermal endpoint has not been selected for novaluron; therefore dermal exposure was not included in the 

short-term aggregate assessment. Additionally post-application inhalation exposure estimates were used for adults as 

opposed to handler inhalation exposure estimates because the post-application inhalation dose was higher than the handler 

inhalation dose and resulted in a more conservative estimate of aggregate risk. 

2 The LOC (target MOE) includes 10X for interspecies extrapolation and 10X for intraspecies variation.

3 Maximum Exposure (mg/kg/day) = NOAEL/Target MOE.

4 Residential Exposure = [Oral exposure + Inhalation Exposure]. 

5 Aggregate MOE = [NOAEL ÷ (Avg. Dietary Exposure + Residential Exposure)].
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6.2 Intermediate-Term Aggregate Risk 

The intermediate-term aggregate risk assessment estimates risks likely to result from 1 to 6 

month exposures to novaluron residues from food, drinking water, and residential pesticide uses. 

Intermediate-term estimates of residential exposure are combined with background food and 

drinking water exposures.

Intermediate-term aggregate risk assessments are necessary for both adults and children as there 

is potential for both intermediate-term dermal and inhalation handler exposure and intermediateterm post-application exposure from the residential uses of novaluron. For the intermediate-term 

aggregate risk assessment, potential residential post-application exposures were combined with 

food and drinking water exposures. Specifically, for young children, the intermediate-term 

aggregate assessment combines dietary exposure with potential dermal, inhalation, and incidental 

oral exposure (from hand-to-mouth contact with treated surfaces) resulting from the crack and 

crevice uses. The intermediate-term aggregate assessment for adults combines dietary exposures 

with exposure from potential post-application dermal and inhalation exposures resulting from 

indoor crack and crevice uses. See Table 5.3.1 for more information on combined exposures.

This is the first proposed residential use of novaluron; therefore, the intermediate-term crack and 

crevice exposure estimates were aggregated with the chronic dietary (food) exposures to provide 

a worst-case estimate of intermediate-term aggregate risk for the U.S. population and children 1-

2 years old (the child population subgroup with the highest estimated chronic dietary food 

exposure). As the intermediate-term aggregate MOEs are greater than 100, risks do not exceed 

HED’s level of concern.

Table 6.2. Intermediate-Term Aggregate Risk Calculations for Novaluron Using Post-Application 

Exposure Estimates.

Population

Subgroups

Intermediate-Term Scenario1

NOAEL

(mg/kg/day) LOC2 Max Exposure3(mg/kg/day)

Average Dietary 

Exposure

(mg/kg/day)

Residential 

Exposure4

(mg/kg/day)

Aggregate MOE

(dietary and 

residential)5

U.S. 

Population 4.38 100 0.04 0.002298 0.0114 320

Children 1-2 

years old 4.38 100 0.04 0.007955 0.023 140

1 Combined post-application exposure estimates were used as opposed to combined handler exposure estimates because the 

combined post-application dose was higher than the combined handler dose and resulted in a more conservative estimate of 

aggregate risk. 

2The LOC (target MOE) includes 10X for interspecies extrapolation and 10X for intraspecies variation.

3 Maximum Exposure (mg/kg/day) = NOAEL/Target MOE.

4 Residential Exposure = [Oral exposure + Dermal exposure + Inhalation Exposure]. 

5 Aggregate MOE = [NOAEL ÷ (Avg. Dietary Exposure + Residential Exposure)].

6.3 Chronic Aggregate Risk 

The chronic aggregate risk assessment takes into account average exposure estimates from 

dietary consumption of novaluron (food and drinking water) and residential uses. Residential 
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long-term exposure was not assessed because there are no chronic residential exposure scenarios 

for the registered and proposed uses of novaluron, and was therefore not incorporated into the 

chronic aggregate exposure assessment. As a result, the chronic aggregate risk assessment 

considered exposure from food and drinking water only. The chronic dietary exposure estimates 

are below HED’s LOC (<100% cPAD) for the general U.S. population (21% of the cPAD) and 

all population subgroups (see Table 4.3). The most highly exposed population subgroup is 

children 1-2 years old, at 72% of the cPAD. Therefore, the chronic aggregate risk associated 

with the proposed uses of novaluron does not exceed HED’s LOC for the general U.S. 

population or any population subgroups.

7.0 CUMULATIVE RISK

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a 

common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as 

to novaluron and any other substances and novaluron does not appear to produce a toxic 

metabolite produced by other substances. For the purposes of this tolerance action, therefore, 

EPA has not assumed that novaluron has a common mechanism of toxicity with other 

substances. For information regarding EPA’s efforts to determine which chemicals have a 

common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the 

policy statements released by EPA’s Office of Pesticide Programs concerning common 

mechanism determinations and procedures for cumulating effects from substances found to have 

a common mechanism on EPA’s website at http://www.epa.gov/pesticides/cumulative/.

8.0 OCCUPATIONAL EXPOSURE/RISK PATHWAY

An occupational exposure assessment for the proposed use of novaluron on sweet corn was 

prepared in a pending HED memorandum (L. Venkateshwara; D378630). An occupational and 

residential exposure assessment for a proposed crack and crevice use was also prepared in a 

pending HED memorandum (L. Venkateshwara; D378634). See Table 2.1 for a summary of the 

proposed use patterns. 

8.1. Occupational Pesticide Handler Exposure and Risk

8.1.1 Sweet Corn Use

Occupational handler and post-application exposures from the proposed use of novaluron on 

sweet corn are anticipated. Based on label information, exposure is expected to occur for shortand intermediate-term exposure durations (e.g., maximum of 6 applications, 7 days apart).

Occupational handler’s exposure and risk were estimated for the following scenarios: 

Mixer/Loader:

1. Mixing/loading liquids for aerial application;
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2. Mixing/loading liquids for groundboom application;

Applicator:

3. Applying sprays via aerial applications;

4. Applying sprays via groundboom applications; and

Flagger:

5. Flagging to support aerial applications.

No chemical-specific data were available with which to assess potential exposure to pesticide 

handlers. The estimates of exposure to pesticide handlers are based upon surrogate study data 

available in the PHED (August, 1998). For occupational pesticide handlers, HED presents 

estimates of dermal exposure for “baseline” (i.e., workers wearing a single layer of work 

clothing consisting of a long-sleeved shirt, long pants, shoes plus socks, and no protective 

gloves), as well as for “baseline” and the use of protective gloves or other PPE, as might be 

necessary. The novaluron product labels direct applicators and other handlers to wear a longsleeved shirt, long pants, protective eyewear, chemical-resistant gloves, and shoes plus socks. 

Handler exposure is expected to be short- and intermediate-term based on information provided 

on the proposed label for sweet corn (e.g., maximum of 6 applications, 7 days apart). There is no 

short-term dermal POD; therefore, only intermediate-term dermal exposure has been assessed 

and is anticipated to be protective of short-term dermal exposure. Short- and intermediate-term 

inhalation exposures have been assessed. The short- and intermediate-term inhalation 

toxicological points of departure are the same; therefore, the estimates of risk for short-term 

duration inhalation exposures are protective of those for intermediate-term inhalation duration 

exposures. The average adult body weight of 70 kg was used for estimating inhalation and 

dermal dose. Long-term exposures are not expected; therefore, a long-term assessment was not 

conducted. Exposures, doses and MOEs were calculated using the equations presented in the 

residential section (Section 5.1).

Table 8.1.1 presents the estimated risks for workers based on the intermediate-term dermal and 

short- and intermediate-term inhalation exposures at baseline and with PPE. HED has 

determined that risks do not exceed HED’s level of concern (i.e., MOEs ≥100), provided 

workers wear chemical-resistant gloves as recommended on the label. No short-term POD

was selected for dermal exposure; therefore, the risks presented for handlers are representative of 

intermediate-term exposures and would be considered protective of short-term exposures. It 

should be noted that only engineering control data are available to assess dermal and inhalation 

risks to handlers operating aircraft (enclosed cockpit). The risks do not exceed HED’s level of 

concern for pilots using enclosed cockpits.
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Table 8.1.1. Occupational Handler Dermal and Inhalation Exposures and Risks from the Use on Sweet Corn.

Dermal and

Inhalation Unit 

Exposures

(mg/lb ai)

Application 

rate

(lb ai/A)1

Area 

Treated 

Daily (A)2

Short- and 

Intermediate-term

Doses (mg/kg/day)3

Total Dose4

Short- and 

Intermediateterm MOETotal MOEs 5

(1) Mixer/Loader – Groundboom Application

Dermal

Baseline: 2.9 

Single layer 

w/gloves: 0.023

Inhalation

Baseline: 0.0012 

0.078 80

Dermal

Baseline6: 0.026

Single layer 

w/gloves8: 0.00021

Baseline 

Dermal + 

Inhalation

0.026

Single layer 

w/gloves + 

Inhalation

0.00032

Dermal

Baseline6: 

170

Single layer 

w/gloves8: 

21,000

Baseline 

Dermal + 

Inhalation

170

Single layer 

w/gloves + 

Baseline 

Inhalation

14,000

Inhalation

Baseline7: 0.00011

Inhalation 

Baseline7: 

41,000

(2) Mixer/Loader – Aerial Application

Dermal

Baseline: 2.9

Single layer 

w/gloves: 0.023

Inhalation

Baseline: 0.0012 

0.078 350

Dermal

Baseline: 0.11

Single layer 

w/gloves:

0.00090

Baseline 

Dermal + 

Inhalation

0.11

Single layer 

w/gloves + 

Inhalation

0.0014

Dermal

Baseline: 39

Single layer 

w/gloves:

13,000

Baseline 

Dermal + 

Inhalation

39

Single layer 

w/gloves + 

Baseline 

Inhalation

3,200

Inhalation

Baseline: 0.00047

Inhalation

Baseline: 9,400

(3) Applicator – Groundboom Application

Dermal

Baseline: 0.014

Inhalation

Baseline: 0.00074

0.078 80

Dermal

Baseline: 0.00012 Baseline 

Dermal + 

Inhalation

0.0002

Dermal

Baseline: 

35,000

Baseline 

Dermal + 

Inhalation

23,000 Inhalation

Baseline: 0.000066

Inhalation

Baseline: 

66,000

(4) Applicator – Aerial Application

Dermal

Engineering 

Control: 0.0050

Inhalation

Engineering 

Control: 0.000068 

0.078 350

Dermal

Engineering control:

0.0002 Combined 

Engineering 

Control

0.00023

Dermal

Engineering 

control:

22,000

Combined 

Engineering 

Control

20,000 Inhalation

Engineering control: 

0.000027

Inhalation

Engineering 

control: 

170,000
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Table 8.1.1. Occupational Handler Dermal and Inhalation Exposures and Risks from the Use on Sweet Corn.

Dermal and

Inhalation Unit 

Exposures

(mg/lb ai)

Application 

rate

(lb ai/A)1

Area 

Treated 

Daily (A)2

Short- and 

Intermediate-term

Doses (mg/kg/day)3

Total Dose4

Short- and 

Intermediateterm MOETotal MOEs 5

(5) Flagger – Aerial Application

Dermal

Baseline: 0.011

Inhalation

Baseline: 0.00035 

0.078 350

Dermal

Baseline: 0.00043 Baseline 

Dermal + 

Inhalation

0.0006 

Dermal

Baseline: 

10,000

Baseline 

Dermal + 

Inhalation

7,700 Inhalation

Baseline: 0.00014 

Inhalation

Baseline: 

32,000

1 Application rate is the maximum recommended rate provided on the novaluron product label.

2 Area treated per day values are HED estimates based on ExpoSAC Policy #9 “Standard Values for Daily Acres Treated in 

Agriculture,” industry sources, and HED estimates.

3 Dose (mg/kg/day) = Unit exposure (mg/lb ai) x App Rate (lb ai/acre) x Area Treated (acres/day) x % Absorption (10% dermal 

and 100% inhalation assumed) / Body weight. The body weight is 70 kg for the inhalation and dermal dose. 

4 Total Dose = Dermal + Inhalation Dose.

5

Short-/Intermediate-term MOE = Intermediate-term dermal or Short/Intermediate-term inhalation NOAEL (4.38 mg/kg/day) / 

Dermal or Inhalation dose (mg/kg/day)

6 Total MOE = NOAEL (4.38 mg/kg/day)/Total Dose.

7 Baseline Dermal: long-sleeved shirt, long pants, no gloves.

8 Baseline Inhalation: no respirator.

9

Single layer with gloves: single layer baseline attire plus chemical-resistant gloves.

8.1.2 Crack and Crevice/Spot Use

There is also a potential for occupational handler exposure from the proposed use for indoor and 

outdoor control of roaches and crickets. Occupational handler’s exposure and risk were

estimated for the following scenarios: 

 Mixing/loading/applying emulsifiable concentrate formulations with low-pressure 

handwand (PHED), and

 Applying ready to use formulations via trigger-pump sprayer (ORETF).

Chemical-specific data were not submitted to the Agency in support of this Section 3 application. 

It is HED policy to use data from PHED Version 1.1 and/or the ORETF to assess handler 

exposures when chemical-specific data are not submitted. 

As with the residential assessment for purposes of assessing a crack and crevice exposure 

scenario for commercial applicators, HED used the mixing/loading/applying wettable powders

with a low-pressure handwand scenario as a surrogate to assess handler exposure to the 

emulsifiable concentrate formulation. Usually, HED would use surrogate data for liquid 

formulation as surrogate for EC formulation. However, The unit exposure values provided for 

the wettable powder formulation are based on actual exposures measured during crack and 

crevice applications; whereas, the unit exposure values for the liquid formulation are based on 

applications to chicken houses and greenhouses. Therefore, although the RIMON®SUPRA 
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10EC Insecticide is formulated as an EC, HED believes that the use of unit exposure values 

resulting from crack and crevice applications provides a more accurate representation of handler 

exposure. 

There is no short-term dermal POD; therefore, only intermediate-term dermal exposure has been 

assessed and should be considered protective of short-term dermal exposure. Short- and 

intermediate-term inhalation exposures have been assessed. In addition, the short- and 

intermediate-term inhalation toxicological points of departure are the same; therefore, the 

estimates of risk for short-term duration inhalation exposures are protective of those for 

intermediate-term inhalation duration exposures. The average adult body weight of 70 kg was 

used for estimating inhalation and dermal dose. A 10% dermal-absorption factor was used to 

estimate dermal exposure for all durations. Long-term exposures are not expected; therefore, a 

long-term assessment was not conducted. Exposures, doses and MOEs were calculated using the 

equations presented in the residential section (Section 5.1).

Table 8.1.2 presents a summary of the short- and intermediate-term occupational handler 

exposures and risks. The results of the occupational handler exposure and risk assessment 

indicate that MOEs do not exceed HEDs LOC (i.e., MOEs ≥100) with either baseline attire (i.e., 

single layer of clothing, no respirator) or with the addition of gloves. There is no unit exposure 

data for the mixing/loading/applying wettable powders scenario with baseline attire and no 

gloves; therefore, this scenario was only assessed assuming handlers were wearing gloves. The 

proposed label for novaluron does not currently recommend any personal protective equipment 

for handlers. HED recommends RD require the addition of chemical-resistant gloves to the 

label.
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Table 8.1.2. Short- and Intermediate-Term Occupational Handler Exposure and Risk for Novaluron.

Application 

Ratea

Amount 

applied 

Dailyb 

Unit Exposures (mg/lb ai)c Dose (mg/kg/day)f,g Short- and Intermediate-term MOEsh,i

Baseline 

Dermald

Baseline 

Inhalationd

PPE-G 

Dermale

Baseline 

Dermal

Baseline 

Inhalation

PPE-G 

Dermal

Baseline 

Dermal

Baseline 

Inhalation 

PPE-G 

Dermal

Total MOE

Baseline Dermal + 

Baseline 

Inhalation

PPE-G Dermal + 

Baseline 

Inhalation

Mixing/Loading/Applying Wettable Powders with Low-Pressure Handwand (PHED)

0.02 lb 

ai/gal 40 gallons No Data 1.1 8.6 N/A 0.013 0.0098 N/A 350 450 N/A 200

Applying Ready-to-Use Formulations via Trigger-Pump Sprayer (ORETF)

0.02 lb 

ai/gal 2 gallons 42 0.019 1.8 0.0024 0.000011 0.0001 1,800 400,000 43,000 1,800 39,000

a. Application rate based on proposed use on label for novaluron product RIMON® EC Insecticide (Reg. No. 66222-ERT). Maximum rate = 3.1 oz/gal (0.02 lb ai/gal).

b. ExpoSAC Policy # 9.1.

c. Unit Exposures for low-pressure handwand scenario based on PHED Version 1.1. For purposes of assessing a crack and crevice exposure scenario for commercial applicators, 

HED used the mixing/loading/applying wettable powders with a low-pressure handwand scenario as a surrogate to assess handler exposure to the liquid formulation. See text 

above table for full explanation. Unit exposures for trigger-pump sprayer scenario based on ORETF (OMA006; MRID 444598-01). 

d. Baseline Dermal: Long-sleeve shirt, long pants, and no gloves (none is specified on the label); Baseline Inhalation: no respirator. Unit exposure data for the 

mixing/loading/applying wettable powders with low pressure handwand scenario at baseline with no gloves is not available; therefore, this scenario was only assessed with the use 

of gloves.

e. PPE-G Dermal: Baseline plus chemical-resistant gloves.

f. Dermal Dose (mg/kg/day) = daily unit exposure (mg/lb ai) * application rate (lb ai/gallon) * amount handled (gallons) * dermal absorption factor (10%) / body weight (70 kg).

g. Inhalation Dose (mg/kg/day) = daily unit exposure (mg/lb ai) * application rate (lb ai/gallon) * amount handled (gallons) * inhalation absorption (100%) / body weight (70 kg). 

h. MOE = NOAEL (short- and intermediate-term = 4.38 mg/kg/day) / daily dose (mg/kg/day). LOC = 100.

i. Total MOEs = NOAEL (mg/kg/day) / (Dermal dose + Inhalation dose).
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8.2 Occupational Post-Application Worker Exposure and Risk

8.2.1 Occupational Post-Application Worker Exposure and Risk for Sweet Corn

The proposed use is for a post emergent application; therefore, a dermal post-application 

exposure assessment was conducted. The registrant submitted two studies:

Willard, T. (2002) Foliar Dislodgeable Residue Dissipation of Novaluron in Cotton: Final Study Report: 

Lab Project Number: AA010705: R-13884:989W. Unpublished study prepared by American Agricultural 

Services, Inc. 214 p. {OPPTS 875.2100}

Willard, T. (2002) Foliar Dislodgeable Residue Dissipation of Novaluron in Apple: Lab Project Number: 

AA01076: R-13883: AA010706.CA. Unpublished study prepared by American Agricultural Services, Inc. 

204 p. {OPPTS 875.2100}

HED decided not to use the apple study due to some study limitations and differences in the use 

pattern (different application rate and application equipment used) and differences in plant/leaf 

morphology (apple versus corn). 

HED did use chemical-specific data provided in the cotton study. This study was designed to 

determine the dissipation of dislodgeable foliar residues (DFR) of novaluron applied to cotton 

foliage at two test sites located in Porterville, California and Washington, Louisiana. Three 

applications of Rimon®10EC, an EC formulation containing novaluron (0.83 lb ai/gal) were 

made to cotton foliage at a target rate of 0.091 lb ai/A/application. The re-treatment interval was 

7 days. Applications were made as a foliar broadcast spray at a spray volume of approximately

21 to 28 gallons of spray solution per acre (GPA) using groundboom equipment. There were no 

surfactants/adjuvants included in the spray mixtures. 

At the California site, the highest average DFR value occurred immediately after the third 

application (0.673 μg/cm2). The residues declined to an average of 0.361 μg/cm2 by Day 21 after 

the third application, and then increased to an average of 0.483 μg/cm2by Day 35 after the third 

application. At the Louisiana site, the highest average DFR value occurred immediately after the 

third application (0.142 μg/cm2). The residues then declined to below the LOQ by Day 28 after 

the third application. The registrant generated dissipation curves using a linear first order kinetic 

model of the natural log transformed data. The analysis was conducted using the individual DFR 

values collected immediately after the third application through the last day of sampling. The 

registrant’s calculated half-lives for novaluron in cotton foliage were 59 days for the California 

site and 8 days for the Louisiana site. This difference in dissipation is due to the difference in 

climate, with Louisiana being a more humid climate (more rainfall), and California being a more 

arid climate (less rainfall). In California and other arid areas which receive less than 20 inches of 

precipitation per year, the residues are not expected to dissipate, and therefore only 1 application 

of novaluron should be required. The registrant should submit a revised label which specifies 

that the retreatment of sweet corn with novaluron is prohibited (i.e., only 1 application is allowed 

at a rate of 0.078 lb ai/A) in California and other arid areas which receive less than 20 inches of 

precipitation per year. See Memo, L. Venkateshwara, 29-MAR-2011; D387931 for the analysis 

of the data from the CA site, and see memo, L. Venkateshwara, 29-MAR-2011; D387932 for the 

analysis of the data from the LA site.
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Post-application exposures have been assessed using the submitted dislodgeable foliar residue 

data as well as dermal transfer coefficients from HED’s ExpoSAC Policy Number 3.1 

“Agricultural Transfer Coefficients” (August, 2000). Table 8.2.1 summarizes the scenarios 

assessed. In addition, the following assumptions were used in the calculations: 

 Application Rate = 0.078 lb ai/A 

 Exposure Duration = 8 hours per day

 Body Weight = 70 kg for adult male

 Dermal Absorption = 10%

 Dislodgeable foliar residue (DFR) = chemical-specific data from MRID # 

456384-16.

Table 8.2.1. Anticipated Post-application Activities and Dermal Transfer Coefficients.

Proposed Crop Policy Crop Group Category Transfer Coefficients (cm2/hr) Activities

Sweet Corn Field/row crop tall

100 Hand weeding

1000 Irrigation and scouting

17000 Detasseling and hand harvest

Equations/Calculations:

Daily dermal exposures were calculated on each post-application day after application using the 

following equation:

Daily Dermal Doset = [DFRt (μg/cm2) x 0.001 mg/μg x TC (cm2/hr) x DA x ET (hrs)] / BW 

(kg)

Where:

DFRt = dislodgeable foliage residue on day "t" (ug/cm2);

TC = transfer coefficient (cm2/hr);

DA = dermal absorption factor (100%);

ET = exposure time (8 hr/day); and

BW = body weight (70 kg).

Once daily exposures are calculated, the calculation of daily absorbed dose and the resulting 

MOEs use the same algorithms that are described above for the handler exposures. These 

calculations are completed for each day or appropriate block of time after application.

Table 8.2.2 presents a summary of occupational post-application risks associated with use of

novaluron at the Louisiana site and Table 8.2.3 presents the summary of the occupational postapplication risks associated with use of novaluron at the California site. 
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Table 8.2.2. Post-application Risks for Novaluron Using Data from the Louisiana Site.

Crop Application Rate

(lb ai/A)

Transfer Coefficient

(cm2/hr)

DFR1

(ug/cm2)

Days After 

Treatment

Daily Dose2

(mg/kg/day)

MOE3

Sweet 

Corn 0.078

100

0.118 12 hours (0 

days)

0.000137 32,000

1,000 0.00137 3,200

17000 0.023 190

The information in the table is based on proprietary and non-proprietary data.

1 DFR calculated from MRID #456384-16 Louisiana site.

2 Daily Dose = [DFR (ug/cm2

) x TC (cm2/hr) x 0.001 mg/μg x Dermal Absorption (10%) x 8 hrs/day] ÷ Body Weight (70 kg).

3 NOAEL/Daily Dose (Intermediate-term NOAEL = 4.38 mg/kg/day).

Table 8.2.3. Post-application Risks for Novaluron Using Data from the California Site.

Crop Application Rate

(lb ai/A)

Transfer Coefficient

(cm2/hr)

DFR1

(ug/cm2)

Days After 

Treatment

Daily Dose2

(mg/kg/day)

MOE3

Sweet 

Corn 0.078

100

0.58 12 hours (0 

days)

0.00066 6,600

1,000 0.0066 660

17000 0.113 39

The information in the table is based on proprietary and non-proprietary data.

1 DFR calculated from MRID #456384-16 California site.

2 Daily Dose = [DFR (ug/cm2

) x TC (cm2/hr) x 0.001 mg/μg x Dermal Absorption (10%) x 8 hrs/day] ÷ Body Weight (70 kg).

3 NOAEL/Daily Dose (Intermediate-term NOAEL = 4.38 mg/kg/day).

Based on the differences in DFR data from the Louisiana site (a more humid climate) and the 

California site (a dry climate), HED is recommending two different retreatment intervals, one for 

humid climates and one for arid climates. For humid climates a retreatment interval of 7 days is 

acceptable; however, for arid climates where DFR data show that there is no dissipation, only 1 

application should be allowed at a rate of 0.078 lb ai/A. Table 8.2.4 shows the calculations for 

the MOE at the California site after one application. The MOE at the highest TC is 175, which is 

greater than 100. 

Table 8.2.4. Post-application Risks for Novaluron at California Site after 1 Application.

Crop

Application 

Rate

(lb ai/A)

Transfer Coefficient

(cm2/hr)

DFR 

(ug/cm2)

Days After 

Treatment

Daily Dose1

(mg/kg/day)

MOE2

Sweet 

Corn 0.078

100

0.13

12 hours (0 

days)

0.00015 29,000

1,000 0.0015 2,900

17000 0.025 175

The information in the table is based on proprietary and non-proprietary data.

1

 Daily Dose = [DFR (ug/cm2) x TC (cm2/hr) x 0.001 mg/μg x Dermal Absorption (10%) x 8 hrs/day] ÷ Body Weight (70 kg)

2

 NOAEL/Daily Dose (Intermediate-term NOAEL = 4.38 mg/kg/day)

Inhalation

Based on the Agency's current practices, a quantitative occupational post-application inhalation 

exposure assessment was not performed for novaluron at this time. However, there are multiple 

potential sources of post-application inhalation exposure to individuals performing postapplication activities in previously treated fields. These potential sources include volatilization 

of pesticides and resuspension of dusts and/or particulates that contain pesticides. The Agency

sought expert advice and input on issues related to volatilization of pesticides from its FIFRA
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SAP in December 2009. The Agency received the SAP’s final report on March 2, 2010 

(http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html). The Agency is in the 

process of evaluating the SAP report as well as available post-application inhalation exposure 

data generated by the Agricultural Reentry Task Force and may, as appropriate, develop policies 

and procedures, to identify the need for and, subsequently, the way to incorporate occupational 

post-application inhalation exposure into the Agency's risk assessments. If new policies or 

procedures are put into place, the Agency may revisit the need for a quantitative occupational 

post-application inhalation exposure assessment for novaluron.

Restricted Reentry Interval 

Novaluron is classified as acute Toxicity Category III for acute dermal toxicity. It is classified as 

Toxicity Category IV for primary eye irritation and primary skin irritation. Therefore, the 

interim WPS REI of 12 hours is adequate to protect agricultural workers from post-application 

exposures to novaluron.

8.2.2 Crack and Crevice/Spot Use

Based on the proposed use sites associated with the indoor crack and crevice/spot use, HED 

believes the presence of commercial workers in treated areas is minimal after application. 

Therefore, an occupational quantitative post-application assessment for this product was not 

conducted. 

9.0 DATA NEEDS AND LABEL RECOMMENDATIONS

9.1 Toxicology

 A 90-day inhalation toxicity study is requested for further characterization of inhalation 

risk. Due to the potential for repeated inhalation exposure anticipated from the proposed 

residential use pattern, there is concern for toxicity by the inhalation route. An inhalation 

study would provide a dose and endpoint via the route of exposure of concern (i.e. route 

specific study) and thus would avoid using an oral study and route-to-route extrapolation. 

An immunotoxicity study is required as specified in the new 40 CFR Part 158 data 

requirements.

 An immunotoxicity study is required as specified in the new 40 CFR Part 158 data 

requirements.

9.2 Residue Chemistry

 860.1200 Directions for Use

o A revised Section B for PP#0E7723 should be submitted which:

 prohibits the use of novaluron on turnips harvested for the root and 

prohibits the feeding of turnip tops to livestock as previously requested 

(Memo, J. Van Alstine, 09-SEP-2009; D357060). This affects the current 

petition because it could result in increased livestock dietary burdens.

o A revised Section B for PP#0F7708 should be submitted which:
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 specifies an application rate of 0.1 gallons per 1000 ft2for indoor spot, 

crack and crevice, space spray, and general surface applications; 

 states that all food processing surfaces (including equipment) and utensils 

should be covered during treatment or thoroughly washed prior to use; 

 states the livestock feed items should be removed or covered prior to 

application; and

 removes all references to fogger and fog applications in the label and 

specifies that applications should be made with mechanical cold mist/ULV 

equipment. 

 860.1550 Proposed Tolerances

o A revised Section F for PP#0E7723 should be submitted which:

 cites the appropriate CAS name for novaluron:

“Tolerances are established for residues of the insecticide novaluron, 

including its metabolites and degradates, in or on the commodities in the table 

below. Compliance with the tolerance levels specified below is to be 

determined by measuring only novaluron (N-[[[3-chloro-4-[1,1,2-trifluoro-2-

(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide) in 

or on the following raw agricultural commodities:”; and

 reflects the recommended tolerances and commodity definitions presented 

in Table 14. 

o Additionally, a revised Section F for PP#0F7708 should be submitted which:

 reflects the commodity definition presented in Table 14. 

 860.1650 Submittal of Analytical Reference Standards

o The available analytical reference standards for novaluron have expired. MANA 

is required to submit an updated COA or a new analytical standard to the EPA 

National Pesticide Standards Repository at the following address: 

USEPA

National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

701 Mapes Road

Fort George G. Meade, MD 20755-5350

Please note that the extended zip code is required for delivery.

Note to RD: Based on ChemSAC guidance that meat byproduct tolerances should be set at the 

highest residue level seen in any livestock commodity (minutes from 12-JAN-2011), several 

meat byproduct tolerances in 40 CFR § 180.598 (a) should be updated so that they are based on 

the highest expected residue. Additionally, two commodity descriptions should be updated. The 

tolerances and commodity descriptions should be updated as follows:
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Current Commodity 

Description

Updated Commodity 

Description

Current Tolerance 

(ppm)

Updated Tolerance 

(ppm)1

Cattle, meat byproducts, 

except kidney and liver - 0.60 11

Goat, meat byproducts 

except kidney and liver - 0.60 11

Horse, meat byproducts, 

except kidney and liver - 0.60 11

Sheep, meat byproducts, 

except kidney and liver - 0.60 11

Hog, meat byproducts

Hog, meat byproducts, 

except kidney and 

liver2

0.10 1.5

Poultry, meat byproducts

Poultry, meat byproducts, 

except kidney and 

liver3

0.80 7.0

1 Based on the based on the highest expected secondary tissue residue [peritoneal fat in cattle (translated to goat, 

horse, and sheep); peritoneal fat in hog; abdominal fat in poultry]. 

2 Separate tolerances have been established for hog, kidney (0.10 ppm) and hog, liver (0.10 ppm). 

3

Separate tolerances have been established for poultry, kidney (0.80 ppm) and poultry, liver (0.80 ppm). 

9.3 Occupational and Residential Exposure

 A revised label (Section B) for PP#0E7723 should be submitted:

o which specifies that the retreatment of sweet corn with novaluron is prohibited (i.e., 

only 1 application is allowed at a rate of 0.078 lb ai/A) in California and other arid 

areas which receive less than 20 inches of precipitation per year. 

 A revised label (Section B) should also be submitted for PP#0F7708 which:

o specifies an application rate of 0.1 gallons per 1000 ft2for indoor spot, crack 

and crevice, space spray, and general surface applications; and

o requires the addition of chemical-resistant gloves. 

Attachments:

Appendix A: TOXICOLOGY ASSESSMENT

A.1 Acute Toxicity Profile.

A.2 Toxicity Profiles.

cc: L. Venkateshwara, J. Van Alstine, 

RDI: RAB1 Branch (03/09/11); G. Kramer (3/7/11); D. Vogel (03/09/11)

L.Venkateshwara:S10956:Potomac Yard 1:703-308-2722:7509P:RAB1
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Appendix A: TOXICOLOGY ASSESSMENT

A.1. Acute Toxicity Profile

Table A.1. Acute Toxicity of Novaluron.

Guideline No. Study Type MRID #(s) Results Toxicity Category

870.1100

(81-1) Acute Oral (rat) 44961001 LD50 > 5000 mg/kg IV

870.1200

(81-2) Acute Dermal (rat) 45003201 LD50 > 2000 mg/kg III

870.1300

(81-3) Acute Inhalation (rat) 45003202 LC50 > 5.15 mg/L IV

870.2400

(81-4) Primary Eye Irritation (rabbit) 45003203 Not an eye irritant IV

870.2500

(81-5 ) Primary Skin Irritation (rabbit) 45003204 Not a dermal irritant IV

87.2600

(81-6) Dermal Sensitization (guinea pig) 45084001 Not a dermal sensitizer N/A

A.2 Toxicity Profiles

Table A.2. Toxicity Profile of Novaluron.

Guideline No/ 

Study type MRID No.(year)/Doses/Classification Results

870.3100

90-Day oral 

toxicity rodents

45651504/45651503 (1993/1990);

Acceptable/guideline

Study I: 0, 50, 100, 200, or 400 ppm 

(equivalent to 0, 3.52, 6.93, 13.03, and

27.77 mg/kg bw/day, respectively in 

males and 0, 4.38, 8.64, 17.54, and 

34.39 mg/kg bw/day, respectively in 

females)

Study II: 0, 10, 320, or 10,000

ppm (equivalent to 0, 0.7, 22.2, and 713 

mg/kg bw/day, respectively in males and 

0, 0.8, 24.3, and 754 mg/kg bw/day, 

respectively in females)

NOAEL = 320 ppm (22.2 mg/kg/day) in males 

and 50 ppm (4.38 mg/kg/day) in females.

LOAEL = 400 ppm (27.77 mg/kg/day) in males 

based on increased occurrence of extramedullary 

hematopoiesis and hemosiderosis in spleen; and

100 ppm (8.64 mg/kg/day) in females based on 

reduction in hemoglobin, hematocrit, and RBC 

count; increased occurrence of extramedullary 

hematopoiesis in the spleen and hemosiderosis in 

the spleen and liver.

870.3200

28-day Dermal 

Toxicity - rat

45288501 (1998);

0, 75, 400, 1000 mg/kg/day 

Acceptable/Guideline

Systemic NOAEL = 1000 mg/kg/day; LOAEL = 

not established.

Dermal NOAEL = 1000 mg/kg/day; LOAEL = 

not established.

870.3700

Prenatal 

Developmental 

in rodents-Rat

45082602 (1997); 

0, 250, 500, 1000 mg/kg/day

Acceptable/Guideline

Maternal NOAEL = 1000 mg/kg/day; LOAEL =

not established.

Developmental NOAEL = 1000 mg/kg/day; 

LOAEL = not established.
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Table A.2. Toxicity Profile of Novaluron.

Guideline No/ 

Study type MRID No.(year)/Doses/Classification Results

870.3700

Prenatal 

Developmental 

in nonrodentsRabbit

45638316, 45638318, 45638317

(1997,1998);

0, 100, 300, 1000 mg/kg/day 

Acceptable/Guideline

Maternal NOAEL = 1000 mg/kg/day; LOAEL = 

not established.

Developmental NOAEL = 1000 mg/kg/day; 

LOAEL = not established.

870.3800 

Reproduction 

and fertility- rat

45651505 (Main Study, 1999), 

45638319 (Preliminary Study, 1998);

0, 1000, 4000, or 12,000 ppm ;

M: 0, 74.2, 297.5, or 894.9 mg/kg/day 

F: 0, 84.0, 336.7, or 1009.8 mg/kg/day

Acceptable/Guideline

Parental NOAEL = Not established; LOAEL 

(M/F) = 74.2/84.0 mg/kg/day based on increased 

absolute and relative spleen weights.

Offspring NOAEL = Not established; LOAEL 

(M/F) = 74.2/84.0 mg/kg/day based on increased 

absolute and relative spleen weights.

Reproductive NOAEL (M/F) = 74.2/1009.8 

mg/kg/day; LOAEL (M) = 297.5 mg/kg/day 

based on decreased epididymal sperm counts and 

increased age of preputial separation in the F1

generation; Reproductive LOAEL for females was 

not established.

870.4100

Chronic 

toxicity - dog

45638320 (1999);

0, 10, 100, 1000 mg/kg/day 

Acceptable/Guideline

NOAEL = 10 mg/kg/day.

LOAEL = 100 mg/kg/day based on hematologic 

changes associated with histopathological changes 

in liver and spleen.

870.4300 

Chronic/

Carcinogenicity

-rat

45651506 (1995);

0, 25, 700, or 20,000 ppm test material;

M: 0, 1.1, 30.6, and 884.2 mg/kg/day 

F: 0, 1.4, 39.5, and 1113.5 mg/kg/day

Acceptable/Guideline

NOAEL (M/F) = 1.1/1.4 mg/kg/day.

LOAEL (M/F) = 30.6/39.5 mg/kg/day based on 

erythrocyte damage and turnover resulting in a 

regenerative mild anemia.

870.4300

Chronic/

Carcinogenicity

-mouse

45651507/45877901 (2000/2003);

0, 30, 450, or 7000 ppm test material;

M: 0, 3.6, 53.4, or 800.0 mg/kg/day 

F: 0, 4.3, 63.3, or 913.4 mg/kg/day

Acceptable/Guideline

NOAEL (M/F) = 3.6/4.3 mg/kg/day.

LOAEL (M/F) = 53.4/63.3 mg/kg/day based on 

increased erythrocyte turnover due to hemoglobin 

oxidation and resulting in a mild anemia.

870.5100

Salmonella 

typhimurium

and 

Escherichia 

coli Reverse 

Mutation Assay

44961013 (1997);

0, 312.5, 625, 1250, 2500, or 5000 

μg/plate in the presence and absence of 

metabolic activation (±S9)

Acceptable/Guideline

Novaluron, tested up to the limit of solubility 

(2500 μg/plate) and the limit dose (5000 μg/plate), 

was not cytotoxic with or without S9 activation in 

four S. typhimurium strains and one strain of E. 

coli, and did not induce a genotoxic response in 

any strain.

870.5100

Salmonella 

typhimuriumbacterial 

reverse gene 

mutation assay

45030003 (1986);

0, 10, 33, 100, 333, 1000, or 3333 

μg/plate in the presence and absence of 

mammalian metabolic activation (±S9)

Novaluron, tested up to the limit of solubility 

(3333 μg/plate), was not cytotoxic with or without 

S9 activation in five S. typhimurium strains, and 

did not induce a genotoxic response in any strain.
Novaluron DRAFT Human-Health Risk Assessment DP#: 364307

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Page 55 of 56

Table A.2. Toxicity Profile of Novaluron.

Guideline No/ 

Study type MRID No.(year)/Doses/Classification Results

Acceptable/Guideline

870.5300

Gene Mutation

45638321(1989);

0, 50, 100, 125, 150, 175, or 200 μg/mL 

with and without metabolic activation 

(S9-mix) in two independent assays.

Acceptable/Guideline

There was no evidence of biologically significant 

induction of mutant colonies over background.

870.5375

In vitro

mammalian 

chromosome 

aberration test

44961015 (1992);

40, 200, and 1000 μg/mL, with and 

without metabolic activation (±S9)

Acceptable/Guideline

Novaluron produced no evidence of clastogenic

activity in primary human lymphocytes, in the 

presence or absence of S9 activation.

870.5395

Mammalian 

erythrocyte 

micronucleus 

test in mice

45638322(1989);

0, 1250, 2500, or 5000 mg/kg body 

weight

Acceptable/Guideline

There was no statistically significant increase in 

the frequency of micronucleated polychromatic 

erythrocytes in mouse bone marrow at any dose or 

harvest time.

870.5500

Mutagenicity–

Rec assay with 

Bacillus subtilis

44961014 (1998);

50, 150, 500, 1,500, or 5,000 μg/plate, 

with and without mammalian metabolic 

activation (±S9)

Acceptable/Guideline

Novaluron was equivocal for bacterial DNA 

damage in the absence of S9 activation, and 

negative for bacterial DNA damage in the 

presence of S9 activation.

870.5550

Unscheduled 

DNA Synthesis 

in HeLa S3 

Human 

Epitheliod cells

45030002 (1988);

0.125, 0.25, 0.5, 1, 2, 4, 8, 16, 32, 64, 

128, or 256 μg/mL (±S9)

Acceptable/Guideline

Novaluron was considered not to show any

evidence of causing DNA damage to HeLa S3 

epithelioid cells in this unscheduled DNA 

synthesis test for mutagenic potential.

870.6200

Acute 

Neurotoxicity 

screening 

battery- rat

45082601 (1999);

0, 200, 650, 2000 mg novaluron/kg

Acceptable/Guideline

NOAEL = 650 mg/kg/day; LOAEL = 2000 

mg/kg/day based on clinical signs (piloerection, 

irregular breathing), FOB parameters (increased 

head swaying, abnormal gait) and neuropathology 

(sciatic and tibial nerve degeneration).

870.6200

Subchronic 

Neurotoxicity 

screening 

battery- rat

46086204 (2002);

0, 17.5/20.5, 174/207, 1752/2000

mg/kg/day

(M/F)

Acceptable/Guideline

NOAEL (M/F) = 1752/2000 mg/kg/day; LOAEL

= not established.

870.7485

Metabolism-rat

45638401 (2000), 45638323 (1998);

single dose of 2 mg/kg or 1000 mg/kg, 

or 14 multiple 2 mg/kg/day doses of 

unlabeled novaluron (Lot no. 970211/4, 

99.3% chemical purity) followed by a 

single dose of radiolabeled novaluron.

Novaluron exhibited marginal absorption (16-

18%), relatively rapid and complete excretion 

within 48 hours primarily via the feces and to a 

lesser extent via urine in rat. Biliary contribution 

for fecal excretion appears to be insignificant. 

Absorption appeared to be approaching saturation

at high doses. Peak plasma concentration 
Novaluron DRAFT Human-Health Risk Assessment DP#: 364307

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Page 56 of 56

Table A.2. Toxicity Profile of Novaluron.

Guideline No/ 

Study type MRID No.(year)/Doses/Classification Results

Acceptable/Guideline

occurred at 2-5 hours. Urinary metabolite profiles 

revealed 15 components and 8 components 

following administration of [chlorophenyl14C]novaluron or [difluorophenyl14C]novaluron, 

respectively. The most prevalent urinary 

metabolite was 2,6-difluorobenzoic acid 

represented the majority of the urinary 

radioactivity. Other components individually 

represented no more than 5.9% of the dose and 

most represented considerably less than 1%. 

Parent compound was the most prevalent 

contributor in the feces. The fecal metabolite 

profile revealed two metabolites; 3-chloro-4-

(1,1,2-trifluoro-2-trifluoromethoxyethoxy)aniline, 

and 1-[3-chloro-4-(1,1,2-trifluoro-2-

trifluoromethoxyethoxy)phenyl]urea. 

Quantitatively, these were minor components 

accounting for <2% of the dose. In the repeateddose group, some tissues such as fat contained 

measurable radioactivity at 168 hours post dose 

but did not appear to suggest significant potential 

for bioaccumulation or sequestration at the doses 

tested.

870.7600

Rat Dermal 

Penetration

45638415 (2000);

1.0, 0.067, 0.0048, or 0.0003 mg/cm2

Acceptable/Guideline 

Recovery of administered radioactivity was an 

acceptable 90.19-105.26%. The maximum total 

absorbed dose (expressed as per cent of 

administered dose and determined as the sum of 

radioactivity in excreta, cage wash, untreated skin, 

fat, blood, and residual carcass) ranged from 

about 0.5% to 10% of that administered.