U. S. ENVIRONMENTAL PROTECTION AGENCY

Washington, D.C. 20460

 OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

Date: July 16, 2009 

PC Code: 124002

DP Barcode: D363989 and D364309 

MEMORANDUM

Subject: Novaluron and Novaluron Degradates (Chlorophenyl urea and Chloroaniline) 

Drinking Water Assessment in Support of New Use Registration Action for 

Sorghum, Fruiting Vegetables (Group 8, D364309), Cucurbit Vegetables (Group 

9), Low-growing Berry Subgroup (13-07G), Snap and Dry Bean, and Swiss 

Chard.

To: George Kramer, RAB 1

Dana Vogel, Branch Chief, RAB1

Health Effects Division (7509P)

John Hebert, PM 07

Insecticide-Rodenticide Branch, Product Manager 7

Registration Division (7505P)

Barbra Madden, RM 05

Risk Integration, Minor Use and Emergency Response Branch

Registration Division (7505P)

From: Iwona L. Maher, Chemist, ERBI

Faruque, Khan, Ph.D., Senior Scientist, ERBI

Nancy Andrews, Ph.D., Branch Chief, ERBI

Environmental Fate and Effects Division (7507P)

The registrant is proposing to add six new uses: sorghum, fruiting vegetables (Group 8, 

D364309), cucurbit vegetables (group 9), low growing berry subgroup (13-07G), snap and dry

bean, and swiss chard (D364313) to the RimOn 0.83EC product label. Based on a review and 
2

analysis of the application information provided on the product label for this end-use product, 

novaluron application rates proposed for these six crop groups are lower than the highest 

application rates for currently registered and previously proposed, under review, uses for 

novaluron, on pome fruits and stone fruits, respectively. Since the application rates are 

significantly lower for the proposed uses than those for pome fruits and stone fruits, the 

estimated drinking water concentrations provided in the previous drinking water assessment 

dated March 10, 2009 (USEPA, D357061) and February 11, 2004 (USEPA, D285477) are 

applicable for the proposed uses.

Table 1 lists novaluron maximum application rates for the proposed and registered crop 

uses based on the RimOn 0.83EC product label dated March 13, 2009, and previously proposed,

under review, stone fruits uses based on the label dated January 29, 2009. The maximum 

application rates for the propose uses are 0.078 lbs a.i./A for a single application, and 0.234 lbs 

a.i./A for an annual application rate. These rates are four times lower than the previously 

proposed and registered uses (pome and stone fruits) for novaluron. The label language is not 

explicit whether aerial and ground application are allowed for each of the uses, however, based 

on the use directions provided, it was assumed that both ground and aerial applications are 

permitted.

Table 1. Novaluron application rates for the proposed, under review, and registered1 uses.

Crop

(Subgroup)

Maximum Application Rate

(Lb ai/A)

Maximum Number 

of Applications Per 

Year

Minimum 

Interval Between 

Applications

Application

Method

Single Annual

Pome Fruit10.324 0.972 3 10 G, A

Stone Fruit (12) 20.324 0.972 3 7

3 G, A

Sorghum 0.078 0.234 3 7 G, A

Fruiting

Vegetables 0.078 0.234 3 7 G, A

Cucurbit 

Vegetables 0.078 0.234 3 14 G, A

Low-growing 

Berry Subgroup 

(13-07G)

4

0.078 0.234 3 7 G, A

Strawberry 0.078 0.234 3 14 G, A

Snap and Dry 

Beans 0.078 0.234 3 7 G, A

Swiss Chard 0.078 0.234 3 7 G, A

1 

– It shows only the highest maximum registered application rate for novaluron; i.e. pome fruits (except pears) per March 19, 2009, label.

2

– EFED Sec 3 Chapter for stone fruits was completed in April 14, 2009 and the use is under review (petition 8E7426). 

3

– According to the proposed label the consequent applications to stone fruit should be made in seven to 14-day intervals, the lowest interval was 

selected.

4

– Include Bearberry, Bilberry, Lowbush Berry, Cloudberry, Cranberry, Lingonberry, Muntries , and Partridgeberry 

G – Ground applied, A – Aerially applied

Since the application rates are much lower for the proposed uses (annually 0.234 lb 

a.i./acre) than the application rates for apples and peaches (annually 0.972 lb a.i./acre), the 

estimated drinking water concentrations for apples and peaches at the maximum application rate 

(USEPA, 2009, D357061, and USEPA, 2004, D285477) are applicable to the proposed uses. 

Based on previously conducted modeling on stone and pome fruits, the acute estimated drinking 

water concentration (EDWC) of novaluron in surface water is 4.72 μg/l (peach via aerial 

application) exceeding the solubility of novaluron (3 μg/L), which is expected to be an upper 

bound environmental concentration. The chronic non-cancer EDWC is not expected to exceed 
3

0.76 μg/L, and the cancer/chronic drinking water concentration is not expected to exceed 0.62 

μg/L for use on apple via aerial application. An estimated peak drinking water concentration of 

chlorophenyl urea from surface water sources is 4.74 μg/L, and an estimated annual average 

concentration is 0.89 μg/L based on novaluron’s maximum application rate of 0.32 lb ai/acre 

applied 3 times a season every 7 days (0.96 lbs ai/year, stone fruit). The estimated peak drinking 

water concentration of chloroaniline is 11.4 μg/L and exceeding the estimated solubility of 

chloroaniline (10.6 μg/L), which is expected to be the upper bound environmental concentration. 

The estimated annual average chloroaniline concentration is 2.6 μg/L obtained from novaluron 

application rate of 0.32 lb ai/acre applied 3 times a season every 10 days (0.96 lbs ai/year, pome 

fruit). 

For the annual application rate of 0.96 lb a.i./acre (i.e., three applications of 0.32 lb 

a.i./acre; use on apples and peaches), SCI-GROW novaluron predicted ground water 

concentration is 5.6 x 10-3μg/L in drinking water from shallow ground water sources. The 

predicted ground water concentration is 4.5 x 10-3 μg/L for chlorophenyl urea and 9.0 x 10-3 

μg/L for chloroaniline from novaluron’s maximum up to date application rate (0.96 lb a.i./acre; 

pome and stone fruits). These concentrations may be considered as both the peak and annual 

average upper bound exposures. Table 2 provides the previously EDWCs for novaluron uses on 

pome and stone fruits that are recommended to be used for the human health exposure 

assessment for currently proposed uses. 

Table 2. Estimated drinking water concentrations (EDWCs) resulting from applications 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

4.59* 0.76 0.62

GA Peach

(0.972 lbs ai/A/year)

aerial application

4.72* 0.51 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

11.4** ≤ 2.60 ≤ 2.60
4

Table 2. Estimated drinking water concentrations (EDWCs) resulting from applications 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)

Groundwater 

(SCIGROW)

Apples/Peaches

(0.972 lbs ai/A/year)

aerial application

0.009 < 0.009 < 0.009

*These values exceed the measured water solubility of novaluron; i.e. 3 μg/L (3 ppb). 

**This value exceeds the estimated water solubility of chloroaniline; i.e. 10.6 μg/L (10.6 ppb). 

For further details regarding novaluron drinking water modeling for pome and stone 

fruits uses, refer to the previous drinking water assessments dated March 10, 2009 (USEPA,

D357061) and February 11, 2004 (USEPA, D285477).