Document ID: EPA-HQ-OPP-2009-0273-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-01-27T05:00Z

SEQ CHAPTER \h \r 1 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
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 Fruit1 	0.324	0.972	3	10	G, A

Stone Fruit (12) 2	0.324	0.972	3	73	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

 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 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 10-3 μg/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)

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 (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

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). 

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eeds 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).

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