Last
updated: June 2002
Fipronil is registered in Australia for use on various crops. Details
of the registered use patterns can be found on the approved labels of
registered products containing fipronil as the active constituent. This
Animal Residue Data Sheet provides information on the possible residues
in feed commodities obtained from crops treated with fipronil. It also
provides information on the anticipated maximum dietary exposure of
animals fed treated commodities, which should not result in the violation
of animal MRLs.
Current
MRLs
The
Australian MRLs for fipronil in food and animal feed commodities, as
listed in Table 1 and Table 4 of the MRL Standard (as at 4 June
2002), are shown below. The residue definition of fipronil is:
Sum
of fipronil, the sulphenyl metabolite (5-amino-1-[2,6-dichloro-4-(trifluoromethyl)
phenyl]-4-[(trifluoromethyl) sulphenyl]-1H-pyrazole-3-carbonitrile),
the sulphonyl metabolite (5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(trifluoromethyl)sulphonyl]-1H-pyrazole-3-carbonitrile),
and the trifluoromethyl metabolite (5-amino-4-trifluoromethyl-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazole-3-carbonitrile).
Code
|
Food
|
MRL,
mg/kg
|
Food
Commodities
|
|
VS
0621
|
Asparagus
|
T0.5
|
FI
0030
|
Assorted
tropical and sub-tropical fruit, inedible peel [except banana]
|
T*0.01
|
FI
0327
|
Banana
|
*0.01
|
|
Bergamot
|
T0.1
|
FB
0018
|
Berries
and other small fruit [except wine-grapes and strawberries]
|
T*0.01
|
VB
0040
|
Brassica
(cole or cabbage) vegetables, Head cabbages, Flowerhead brassicas
|
T0.05
|
|
Chervil
|
T0.1
|
FC
0001
|
Citrus
fruits
|
T*0.01
|
|
Coriander
(leaves, stems, roots)
|
T0.1
|
HS
0779
|
Coriander
seed
|
T0.1
|
SO
0691
|
Cotton
seed
|
*0.01
|
OC
0691
|
Cotton
seed oil, crude
|
*0.01
|
HS
0730
|
Dill
seed
|
T0.1
|
HS
0731
|
Fennel
seed
|
T0.1
|
HH
0092
|
Herbs
|
T0.1
|
|
Kaffir
lime leaves
|
T0.1
|
|
Lemon
grass
|
T0.1
|
DT
1111
|
Lemon
verbena (fresh weight)
|
T0.1
|
|
Mizuna
|
T0.1
|
VO
0450
|
Mushrooms
|
0.02
|
SO
0697
|
Peanut
|
T*0.01
|
OC
0697
|
Peanut
oil, crude
|
T*0.01
|
TN
0672
|
Pecan
|
T*0.01
|
VO
0051
|
Peppers
|
T0.1
|
FP
0009
|
Pome
fruit
|
T*0.01
|
VR
0589
|
Potato
|
*0.01
|
SO
0495
|
Rape
seed
|
*0.01
|
GC
0649
|
Rice
|
*0.005
|
VL
0496
|
Rucola
(rocket)
|
T0.1
|
GC
0651
|
Sorghum
|
0.01
|
FS
0012
|
Stone
fruits
|
T*0.01
|
GS
0659
|
Sugar
cane
|
*0.01
|
SO
0702
|
Sunflower
seed
|
*0.01
|
VR
0508
|
Sweet
Potato
|
T*0.01
|
FB
1236
|
Wine-grapes
|
T*0.01
|
Animal
commodities
|
|
MO
0105
|
Edible
offal (mammalian)
|
0.02
|
PE
0112
|
Eggs
|
0.02
|
MM
0095
|
Meat
[mammalian] [in the fat]
|
0.1
|
ML
0106
|
Milks
|
0.01
|
PO
0111
|
Poultry,
Edible offal of
|
*0.01
|
PM
0110
|
Poultry
meat [in the fat]
|
0.02
|
Animal
feed commodities
|
|
|
Pastures
(mixed grasses/leguminous)[fresh weight]
|
0.02
|
AL
0697
|
Peanut
forage and fodder
|
0.01
|
|
Rape
(canola) forage (green)
|
*0.01
|
|
Rape
(canola) straw and fodder
|
*0.01
|
AS
0649
|
Rice
straw and fodder, dry
|
0.005
|
AF
0651
|
Sorghum
forage (green)[fresh weight]
|
0.02
|
|
Sorghum
straw and fodder
|
*0.01
|
AM
0659
|
Sugar
cane fodder
|
0.01
|
|
Sunflower
forage (green) [fresh weight]
|
0.01
|
Summary
of maximum feeding levels and livestock dietary intakes
The
Maximum Feeding Level (MFL, the feeding level at which the MRLs are
based), the equivalent Daily Dietary Intake For Livestock (DDIL) and
the equivalent daily intake of fipronil are summarised below.
Species
|
MFL,
ppm in diet
|
Equivalent
DDIL, mg/kg bw
|
Equivalent
intake of fipronil,
mg/animal/day
|
Cattlea
|
0.04
|
0.0012
|
0.85
|
Sheepb
|
0.04
|
0.0017
|
0.1
|
Pigb
|
0.04
|
0.0017
|
0.1
|
Poultryc
|
0.01
|
0.00065
|
0.000975
|
a
Based on actual dose levels and feed consumption in cattle study
b MFL is based on cattle data as no sheep or pig data
available, DDIL is calculated from MFL assuming a 60 kg animal
consuming 2.5 kg DM/day
c Based on actual dose levels and feed consumption
in poultry study
|
Detailed
information
All
feed commodities
Feed
commodities that may contain residues of fipronil are listed in the
table below. Note that many of the approved uses of fipronil result
in residue levels in animal feeds that are below the limit of analytical
determination. The following table includes only feed commodities where
there is a reasonable expectation of measurable residues occurring.
The theoretical maximum proportion of the diet that the commodity can
comprise, when residues are present at the MRL, without the significant
risk of animal commodity MRLs being violated is also given. It should
be noted that the feeding levels assumed by the NRA when setting animal
commodity MRLs are theoretical values, and they should not be taken
as recommendations of appropriate rations for livestock.
Commodity
a
|
Assumed
Maximum proportion of diet (%)b
|
Feed
intake (kg/animal/day)c
|
MRL
/ HR
(mg/kg) d
|
Maximum
intake of chemical X from commodity (mg/animal/day)e
|
Theoretical
maximum proportion of diet (%)f
|
Cattle
(Based on a 500 kg animal consuming 20 kg DM/day)
|
Sorghum
|
100
|
20
|
0.01
|
0.2
|
100
|
Pastures
(mixed grasses/leguminous)[fresh weight]
|
100
|
20
|
0.028
(HR, dry wt)
|
0.56
|
100
|
Peanut
forage and fodder
|
100
|
20
|
0.01
|
0.2
|
100
|
Rice
straw and fodder, dry
|
100
|
20
|
0.005
|
0.1
|
100
|
Sorghum
forage (green)[fresh weight]
|
100
|
20
|
0.035
(HR, dry wt)
|
0.7
|
100
|
Sugar
cane fodder
|
100
|
20
|
0.01
|
0.2
|
100
|
Sunflower
forage (green)
|
100
|
20
|
0.01
|
0.2
|
100
|
Sheep
(Based on a 60 kg animal consuming 2.5 kg DM/day)
|
Sorghum
|
100
|
2.5
|
0.01
|
0.025
|
100
|
Pastures
(mixed grasses/leguminous)[fresh weight]
|
100
|
2.5
|
0.028
(HR, dry wt)
|
0.07
|
100
|
Peanut
forage and fodder
|
100
|
2.5
|
0.01
|
0.025
|
100
|
Rice
straw and fodder, dry
|
100
|
2.5
|
0.005
|
0.0125
|
100
|
Sorghum
forage (green)[fresh weight]
|
100
|
2.5
|
0.035
(HR, dry wt)
|
0.0875
|
100
|
Sugar
cane fodder
|
100
|
2.5
|
0.01
|
0.025
|
100
|
Sunflower
forage (green)
|
100
|
2.5
|
0.01
|
0.025
|
100
|
Pigs
(Based on a 60 kg animal consuming 2.5 kg DM/day)
|
Sorghum
|
100
|
2.5
|
0.01
|
0.025
|
100
|
Poultry
(Based on a 2 kg animal consuming 150 g DM/day)
|
Sorghum
|
100
|
0.15
|
0.01
|
0.0015
|
100
|
a
The feed commodities that may contain residues of fipronil, and
may form more than 20% of an animals diet.
b The maximum % of the diet that the commodity is assumed
to comprise for the purposes of setting MRLs, based on Stockfeed
Information Document 1
c The equivalent amount of feed for an animal of designated
weight and feed intake that is assumed for the purposes of setting
MRLs
d The MRL (or other residue level as denoted) for each
feed commodity. Corrected for dry weight basis where required
e The maximum intake of fipronil when the commodity
is fed at the maximum assumed level (Column 1) in the absence
of other sources of fipronil.
f The maximum % of the diet at which the commodity
could theoretically be fed without significant risk of exceeding
animal commodity MRLs. It is assumed that the residue in the feed
commodity is present at the MRL (or other residue level as noted,
corrected for dry weight equivalent) and other dietary sources
of fipronil are absent.
|
Abbreviations
and definitions
DM:
Dry matter. The feed consumption for livestock and the residue levels
in feed commodities are expressed on a dry matter basis.
DDIL:
Daily Dietary Intake for Livestock. The level of dietary exposure for
a specified chemical in a specified species that should not result in
exceedance of the relevant animal commodity MRLs. Expressed in mg chemical/kg
bodyweight.
HR:
Highest residue. The highest residue value observed in supervised residue
trials complying with good agricultural practice.
MFL:
Maximum Feeding Level. The level of dietary exposure for a specified
chemical in a specified species that should not result in exceedance
of the relevant animal commodity MRLs. Expressed in terms of ppm in
the feed.
MRL:
The concentration of a chemical residue, in units of mg/kg, that is
legally permitted in or on a food or animal feed commodity.
ppm
in the feed: Parts per million in the feed. An alternate way of
expressing the level of dietary exposure for a chemical. The level of
chemical intake is calculated as though it were present uniformly in
the total feed intake. The ppm in the feed is calculated using the following
formula: DDIL (mg chemical/kg bw) X body weight (kg) divided by daily
feed intake (kg).
STMR-P:
Supervised Trial Median Residue of the processed commodity. The highest
residue that livestock are likely to be exposed to in practice when
fed processed commodities over a prolonged period. This is derived from
the STMR of the whole commodity multiplied by the processing factor.
Attachment
1: Anticipated maximum dietary exposure
The
following calculations outline the theoretical diet used to calculate
the maximum anticipated dietary exposure, maximum feeding level (MFL)
and the daily dietary intake for livestock (DDIL) for cattle, sheep,
pigs and poultry.
Cattle
Feed
group
|
Feed
commodity
|
%
in the diet
|
Feed
intake, kg/animal/daya
|
MRL,
mg/kg
|
%
DMb
|
Intake
of chemical X, mg/animal/dayc
|
Fodder
& forage
[100% maximum]
|
Sorghum
forage (green)
[fresh weight]
|
100
|
20
|
0.035
(HR)d
|
-
|
0.7
|
Total
|
|
100
|
20
|
-
|
-
|
0.7
|
aBased
on assumed feed consumption of 20 kg dry matter/day
bEstimate of percentage dry matter. Applied to MRLs
expressed on a fresh weight basis
cBased on assumed bodyweight of 500 kg
dHighest residue (HR) on a dry weight basis reported
in a residue trial conducted according to good agricultural practice
|
Maximum
anticipated dietary exposure:
|
0.7
mg/animal/day
|
equivalent
to:
|
0.0014
mg/kg bw
|
equivalent
to:
|
0.035
ppm in the diet
|
|
|
MFL:
|
0.04
ppm in the diet
|
equivalent
DDIL:
|
0.0012
mg/kg bw
|
The
MRL for sorghum forage is expressed on a fresh weight basis. The anticipated
dietary exposure has been estimated using the actual dry weight residue
level observed in an Australian residue trial.
MFL
and DDIL are based on actual dose level, animal bodyweight and feed
consumption in the dairy cattle transfer study.
Sheep
Feed
group
|
Feed
commodity
|
%
in the diet
|
Feed
intake, kg/animal/daya
|
MRL,
mg/kg
|
%
DMb
|
Intake
of chemical X, mg/animal/dayc
|
Fodder
& forage
[100% maximum]
|
Sorghum
forage (green)
[fresh weight]
|
100
|
2.5
|
0.035
(HR)d
|
-
|
0.0875
|
Total
|
|
100
|
20
|
-
|
-
|
0.0875
|
aBased
on assumed feed consumption of 2.5 kg dry matter/day
bEstimate of percentage dry matter. Applied to MRLs
expressed on a fresh weight basis
cBased on assumed bodyweight of 60 kg
dHighest residue (HR) on a dry weight basis reported
in a residue trial conducted according to good agricultural practice
|
Maximum
anticipated dietary exposure:
|
0.0875
mg/animal/day
|
equivalent
to:
|
0.0015
mg/kg bw
|
equivalent
to:
|
0.035
ppm in the diet
|
|
|
MFL:
|
0.04
ppm in the diet
|
equivalent
DDIL:
|
0.0017
mg/kg bw
|
The
MRL for sorghum forage is expressed on a fresh weight basis. The anticipated
dietary exposure has been estimated using the actual dry weight residue
level observed in an Australian residue trial.
No
sheep transfer data are available. The MFL is based on actual dose level,
animal bodyweight and feed consumption in the dairy cattle transfer
study. The DDIL is calculated from the MFL assuming a 60 kg sheep consuming
2.5 kg DM per day.
Pigs
Feed
group
|
Feed
commodity
|
%
in the diet
|
Feed
intake, kg/animal/daya
|
MRL,
mg/kg
|
%
DMb
|
Intake
of chemical X, mg/animal/dayc
|
Cereal
grain
[100% maximum]
|
Sorghum
|
100
|
2.5
|
0.01
|
-
|
0.025
|
Total
|
|
100
|
20
|
-
|
-
|
0.025
|
aBased
on assumed feed consumption of 2.5 kg dry matter/day
bEstimate of percentage dry matter. Applied to MRLs
expressed on a fresh weight basis
cBased on assumed bodyweight of 60 kg
|
Maximum
anticipated dietary exposure:
|
0.025
mg/animal/day
|
equivalent
to:
|
0.0004
mg/kg bw
|
equivalent
to:
|
0.01
ppm in the diet
|
|
|
MFL:
|
0.04
ppm in the diet
|
equivalent
DDIL:
|
0.0017
mg/kg bw
|
No
pig transfer data are available. The MFL is based on actual dose level,
animal bodyweight and feed consumption in the dairy cattle transfer
study. The DDIL is calculated from the MFL assuming a 60 kg pig consuming
2.5 kg DM per day.
Poultry
Feed
group
|
Feed
commodity
|
%
in the diet
|
Feed
intake, kg/animal/daya
|
MRL,
mg/kg
|
%
DMb
|
Intake
of chemical X, mg/animal/dayc
|
Cereal
grain
[100% maximum]
|
Sorghum
|
100
|
0.15
|
0.01
|
-
|
0.0015
|
Total
|
|
100
|
20
|
-
|
-
|
0.0015
|
aBased
on assumed feed consumption of 0.15 kg dry matter/day
bEstimate of percentage dry matter. Applied to MRLs
expressed on a fresh weight basis
cBased on assumed bodyweight of 2 kg
|
Maximum
anticipated dietary exposure:
|
0.0015
mg/animal/day
|
equivalent
to:
|
0.00075
mg/kg bw
|
equivalent
to:
|
0.01
ppm in the diet
|
|
|
MFL:
|
0.01
ppm in the diet
|
equivalent
DDIL:
|
0.00065
mg/kg bw
|
The
MFL and DDILs are based on actual dose level, animal bodyweight and
feed consumption in the poultry transfer study.
Attachment
2: Residue data
Attachment
2 has been removed from this version of the ARDS as it contains commercial-in-confidence
data that has not been approved for general release.
Persons
wishing to view the data for legitimate residue management purposes
should contact the NRA. Release of the data to any nominated person
will be at the discretion of the data owner.