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ADVICE SUMMARY
APPLICATION FOR VARIATION OF A REGISTERED CHEMICAL PRODUCT
Product name:
Applicant:
Product number:
Application number:
CONFIDOR 200 SC INSECTICIDE
BAYER CROPSCIENCE PTY LTD
50548
43536
Purpose of Application and Description of Use: Variation of the label approval to extend the use to include the control of currant-lettuce aphid in lettuce
when applied as a seedling drench, and the control of various pests in certain brassica crops when applied as a seedling drench or to
the soil as a furrow spray or plant hole drench.
Active Constituent(s):
IMIDACLOPRID
Regulatory Decision:
To grant the application subject to the following conditions:
Standard Conditions of Label Approval
1. Label must contain a Date of Manufacture and Batch Number
For full conditions, refer to http://www.apvma.gov.au/advice_summaries/adv_summaries.shtml.
43536
Page 1 of 7
KP25S_F40 Version: 2 Issued: 10/08/2007
ADVICE
Australian Government Department Of Health And Ageing, Office Of Chemical Safety
No toxicological data was submitted in support of this application. The Office of Chemical Safety (OCS) relied on the extensive toxicology database that
already exists for imidacloprid and the formulated product Confidor 200SC Insecticide.
Imidacloprid is in Schedule 5 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) for preparations containing 20% or less. The ADI
for imidacloprid is 0.06 mg/kg bw/day, based on a NOEL of 6 mg/kg bw/day in a two year rat study. No ARfD has been set for imidacloprid. OCS advised
that the existing health standards remain appropriate based on the present submission.
OCS considered that workers may become contaminated with Confidor 200SC Insecticide during mixing/loading, application, cleaning up spills and
maintaining equipment. The main routes of exposure to Confidor 200 SC Insecticide will be dermal and inhalation, though ocular exposure may also occur.
OCS advised that Confidor 200 SC Insecticide is of low acute oral toxicity, very low dermal and inhalation toxicity and a skin and eye irritant. The
formulated product taking into consideration all formulation components is likely to be a skin sensitiser.
OCS advised that based upon the proposed use pattern and toxicological database examined that existing Safety Directions where appropriate. However due
to the new use pattern including seedling drench applications and potential for new exposures to persons handling treated seedlings and trays OCS have
recommended appropraite re-entry and re-handling instructions which have been included on the product label.
In conclusion, OCS have advised that based on the toxicity profile and the use pattern of the product, the proposed extension of use of Confidor 200SC
Insecticide will not be an undue health hazard to humans according to the criteria stipulated in Section 14 of the Ag/Vet Code.
Australian Government Department Of Environment And Heritage
Two studies concerning environmental fate were submitted in support of the application that included chemical concentration in runoff water from seedling
trays. Additionally previously submitted data for imidacloprid and the formulated product were considered.
The first study was conducted at a commercial seedling production in Queensland to determine imidacloprid concentration in lettuce seedling and leachate
following application of imidacloprid and subsequent waterings. The results indicated at the rate of 290.4 mL of water applied per tray, no leachate was
collected. As the amounts of water applied were increased to 1096mL, 1442 mL, 1903ml, 2634mL, the amount of leachates also increased to 7mL, 35mL,
405mL and 675mL respectively. The concentrations of imidacloprid in the leachate remained relatively constant (10.4mg/L, 19.6mg/L, 9.0mg/L) and only
increasing substantially to 34.7mg/L for the highest level of watering.
43536
Page 2 of 7
KP25S_F40 Version: 2 Issued: 10/08/2007
The second study was conducted at a commercial seedling production in Victoria to determine imidacloprid leachate residues and impact of watering treatment
trays following a single overhead seedling drench application of Confidor 200SC Insecticide to lettuce seedlings and leachate following application of
imidacloprid and subsequent watering. In this trial Confidor 200SC Insecticide was applied at 11 grams active ingredient per 1000 lettuce seedlings (maximum
rate proposed). The trays containing 144 plants were watered with 1036 mL of water at different intervals: 3, 6, 9, 12 or 24 hours after treatment. The results
indicated that the lowest level of imidacloprid in leachate was 3.3 mg/L when watering was carried out at 6 hour intervals; the lowest total quantity of leachate
was 335mL, which was also collected at a 6 hour watering time interval. The results indicated that imidacloprid is mostly held by the seedling substrate.
From previously assessed data it has been determined that imidacloprid is water soluble, hydrolytically stable and can be considered moderately mobile. The
main routes of degradation are by photolysis (particularly in water) and by microbial degradation. Imidacloprid is not likely to bioaccumulate. The active
constituent is highly toxic to terrestrial and aquatic invertebrates. It is of low toxicity to birds and mammals, but highly toxic to bees and most terrestrial
invertebrates. Imidacloprid is non-toxic to fish, and daphnids are the least sensitive aquatic invertebrates.
Given the proposed application, as a seedling drench, furrow and plant hole application the risk to bees is acceptable. The risk to earthworms is also considered
to be acceptable. Warnings and restrictions on the proposed label should minimise off-target movements of imidacloprid at both nurseries and on farm
applications. These restrictions aim to enforce the use of appropriate methodologies in nurseries to ensure minimal spray-drift and runoff, including the
application of Confidor 200 SC Insecticide to seedling drench in enclosed spaces and the recapture of the excess chemical.
These restrictions ensure that the assessed risks to aquatic organisms as a result of runoff, leaching and spray drift are considered acceptable, when the product is
used according to the label instructions.
Data relied on to provide the advice
Data
No
Data
Source*
18210
S
D. Biffin
18211
S
R. Vitelli
43536
Author(s)
Title
Date
Determination of imidacloprid concentration in
lettuce seedlings and leachate following topical
application of imidacloprid and subsequent
watering.
Determination of imidacloprid leachate residues
and the impact of watering treated trays
following a single overhead seedling drench
application of Confidor 200 SC to nursery
iceberg lettuce seedlings cv. Marksman. Lara,
Victoria. 2006
Page 3 of 7
Data Type
Data Sub-type
Authorising
Party
28/08/0
6
Environment Fate
Mobility Leaching
Potential
Applicant
28/08/0
6
Environment Fate
Mobility Leaching
Potential
Applicant
Inherited
Application
No.
KP25S_F40 Version: 2 Issued: 10/08/2007
APVMA Agricultural Residues Team
To support the application four studies were submitted in which both proposed application methods were tested at rates up to 1.5 times the maximum proposed
rate.
Five separate trials were considered on head lettuce, which showed after the product had been used at the proposed rate, that the maximum imidacloprid residue
after 6 weeks was 3 mg/kg. On this basis an MRL for imidacloprid in head lettuce of 5 mg/kg with a 6 week WHP was recommended.
Six trials were considered on leafy lettuce varieties and the data generated was also considered sufficient to cover other leafy vegetables. The results, which
varied significantly between the different locations in Queensland and Victoria, showed residues as high as 14.57 mg/kg 4 weeks after the product had been
applied at the recommended rates using the seedling drench application technique. As a result a MRL of 20mg/kg is proposed for leafy vegetables.
Two trials were conducted in brassicas (cabbages, cauliflower and broccoli) in which imidacloprid was applied at 1 and 1.5 times the maximum proposed
application rate using either the seedling tray or plant hole drench techniques. The tests showed that, at the time of harvest for each brassica (9-12 weeks),
imidacloprid residue levels were in general at or below the LOQ (0.05mg/kg). Consequently, the current MRL for Brassica (cole or cabbage) vegetables, head
cabbages and flower head brassicas of 0.05 mg/kg remains appropriate.
Finally as neither brassicas nor lettuce are considered major trade commodities the overall trade risk from the MRL amendments proposed in this application is
considered small.
Data relied on to provide the advice
Data
No
Data
Source*
18206
S
R. Burn
18209
S
L. Radunz
18208
S
K. Allen
18207
S
R. Burn
43536
Author(s)
Title
Date
Determine residues of imidacloprid in lettuce
when applied by seedling drench or plant hole
drench to field grown lettuce
Determination of residues of imidacloprid in
brassicas (cabbage, cauliflower and broccoli)
following a drench application of Confidor 200
SC (12 or 18 g a.i./1000 seedlings) over seedling
trays, or from an in-field application (plant-hole
drench) of Confidor Guard Soil Insecticide (12
or 18 g a.i./1000 seedlings).
Determine residues of Confidor 200 SC in
lettuce when applied by seedling drench to field
grown lettuce
Determination of residues of Imidacloprid and
Page 4 of 7
Data Type
Data Sub-type
Authorising
Party
6 July
2007
Residues
Crop Residues Human
Consumption
Applicant
28 June
2006
Residues
Crop Residues Human
Consumption
Applicant
17
October
2007
4 June
Residues
Crop Residues Human
Consumption
Applicant
Residues
Crop Residues Human
Applicant
Inherited
Application
No.
KP25S_F40 Version: 2 Issued: 10/08/2007
Spirotetramat following applications of Confidor
200 SC and BYI-08330 to lettuce by seedling
drench or foliar spray.
2007
Consumption
State/External Efficacy Reviewer
In support of this submission 16 efficacy trials were submitted in total. Eight trials were on lettuce crops to assess the efficacy of Confidor 200 SC Insecticide
for Currant lettuce aphid (CLA) control. Seven trials were on brassica crops (broccoli, cauliflower and cabbage) to assess the efficacy of Confidor 200 SC
Insecticide for Silverleaf whitefly (SLW) (Bemisia tabaci), Green peach aphid (GPA) (Myzus persicae) and Onion thrips (OT) (Thrips tabaci). In the
Brassica trials not all three pests were present in each trial; five of the Brassica trials tested for SLW, five for OT and three for GPA.
A rate response of Confidor 200 SC Insecticide applied as a seedling drench was evaluated in three of the trials for CLA. Another trial evaluated the highest
rate (55mL/1000 seedlings), which provided a high degree of CLA control. CLA pressure varied from trial to trial, with one having no aphids present in the
control plots at harvest. Generally these trials indicate that the 35 and 55mL/1000 seedling rate of Confidor 200 SC Insecticide as a pre-planting treatment
provided good control of CLA.
Four of the seven Brassica trials were replicated. These four trials provided statistical evidence that SLW densities were reduced when Confidor 200 SC
Insecticide was applied as a seedling drench, plant hole drench or in furrow spray. Two of the replicated Brassica trials provided statistical evidence that
Confidor 200 SC Insecticide applied as a seedling drench provides effective control of GPA and OT.
There was no evidence that watering the seedling trays of lettuce crops before or after treatment had any impact on treatment efficacy.
The crop safety (phytotoxicity) data presented in the submission indicates that Confidor 200 SC Insecticide when used on lettuce and brassica crops as
proposed should be safe. No phytotoxicity symptoms were observed with any of the treatments in the brassica trials at the proposed label rates. Extensive use
of Confidor 200 SC Insecticide under minor and emergency use permits reported no phytotoxic effects.
The trial designs were generally sound, and appropriate statistical analyses were conducted in the majority of cases, although in some trials specific details of
the analysis were not provided.
The data presented in the efficacy trials is adequate to support the label rates of a seedling drench at 35-55mL/1000seedlings in lettuce for CLA and a
seedling drench of 40mL/1000seedlings in brassicas for SLW. The data also supports a plant hole drench and furrow spray at 60mL/1000seedlings for SLW
and a seedling drench of 20-40 mL/1000 seedlings for GPA and OT in brassicas.
43536
Page 5 of 7
KP25S_F40 Version: 2 Issued: 10/08/2007
Data relied on to provide the advice
Data
No
Data
Source*
18215
S
A. J. De Monte
18223
S
S. Holzknecht
18227
S
S. Skopilianos
18212
S
S. Flynn and P. Frost
18224
S
S. Holzknecht
18226
S
J. Duff
18225
S
J. Duff
18213
S
S. Flynn and P. Frost
18214
S
S. Flynn and P. Frost
18219
S
T. O'Grady
43536
Author(s)
Title
Date
Evaluation of Confidor 200 SC applied as an
overhead seedling tray drench for the control of
lettuce aphid (Nasonovia ribis-nigri) in leafy
lettuce variety Virtuose, iceberg lettuce variety
Silverado, leafy lettuce variety Lagon, cos lettuce
and radicchio lettuce. Keilor, Vic. 2005-06.
Evaluation of the efficacy of pre-plant
applications of Confidor Guard for the control of
silverleaf whitefly in brassicas. One field trial in
broccoli. Kalkie, Qld. 2006
Performance report for Confidor 200 SC
Insecticide used under permit 7416
Evaluation of Confidor 200 SC as a soil drench
and in-furrow application for control of lettuce
aphid (Nasanovia ribis-nigri) in head lettuce cv.
Toronto. Forth, North-West Tasmania, 2005.
Evaluation of the efficacy of pre-plant
applications of Confidor Guard for the control of
silverleaf whitefly in brassicas.
Bayer CropScience Trial June 2006. Confidor
Guard in broccoli. Gatton, Queensland.
Bayer CropScience Trial June 2006. Confidor
Guard in cauliflower. Gatton, Queensland.
Evaluation of Confidor 200 SC as a seedling
drench and in-furrow application for control of
lettuce aphid (Nasanovia ribis-nigri) in leafy
lettuce var. Deltona. Forthside, North-West
Tasmania, 2005.
Evaluation of BYI 08330 + Hasten as foliar
applications compared to Confidor 200 SC as a
seedling drench for control of lettuce aphid
(Nasonovia ribis-nigri) in head lettuce var.
Oxley. Forth, NW Tasmania, 2005
Confidor 200 SC insecticide lettuce seedling
drench phytotoxicity trials.
Page 6 of 7
Data Type
Data Sub-type
Authorising
Party
04/08/0
6
Efficacy and Safety
Efficacy
Applicant
13/06/0
6
Efficacy and Safety
Efficacy
Applicant
17.08.0
6
29 July
2005
Efficacy and Safety
Efficacy
Applicant
Efficacy and Safety
Efficacy
Applicant
03/07/0
6
Efficacy and Safety
Efficacy
Applicant
22/08/0
6
11/08/0
6
29 July
2005
Efficacy and Safety
Efficacy
Applicant
Efficacy and Safety
Efficacy
Applicant
Efficacy and Safety
Efficacy
Applicant
31 July
2005
Efficacy and Safety
Efficacy
Applicant
29/06/0
6
Efficacy and Safety
Phytotoxicity and
Crop Safety
Applicant
Inherited
Application
No.
KP25S_F40 Version: 2 Issued: 10/08/2007
18216
S
R. Vitelli
18217
S
R. Vitelli
18218
S
R. Vitelli
Evaluation of crop safety of two rates of
Confidor 200 SC compared to Confidor Guard
Soil Insecticide 350 SC applied as a pretransplant overhead seedling drench to head
lettuce cv. Brisbane Gatton, Queensland. 2004.
Evaluation of crop safety of three rates of
Confidor 200 SC compared to Confidor Guard
Soil Insecticide 350 SC applied overhead, as a
pre-plant seedling drench to head lettuce cv.
Raider. Toowoomba, Queensland. 2004.
Evaluation of crop safety of three rates of
Confidor 200 SC compared to Confidor Guard
Soil Insecticide 350 SC applied overhead, as a
pre-plant seedling drench to cos lettuce cv. Nero.
Toowoomba, Queensland. 2004.
4 July
2006
Efficacy and Safety
Phytotoxicity and
Crop Safety
Applicant
11/08/0
6
Efficacy and Safety
Phytotoxicity and
Crop Safety
Applicant
29 June
2006
Efficacy and Safety
Phytotoxicity and
Crop Safety
Applicant
* S = Data submitted with the application
I = Data inherited (that is, referenced) from another application
43536
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KP25S_F40 Version: 2 Issued: 10/08/2007