Animal Residue Data Sheet - Fipronil

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
Cattle^a	0.04	0.0012	0.85
Sheep^b	0.04	0.0017	0.1
Pig^b	0.04	0.0017	0.1
Poultry^c	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 APVMA 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/day^a	MRL, mg/kg	% DM^b	Intake of chemical X, mg/animal/day^c
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/day^a	MRL, mg/kg	% DM^b	Intake of chemical X, mg/animal/day^c
Fodder & forage [100% maximum]	Sorghum forage (green) [fresh weight]	100	2.5	0.035 (HR)^d	-	0.0875
Total		100	2.5	-	-	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/day^a	MRL, mg/kg	% DM^b	Intake of chemical X, mg/animal/day^c
Cereal grain [100% maximum]	Sorghum	100	2.5	0.01	-	0.025
Total		100	2.5	-	-	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/day^a	MRL, mg/kg	% DM^b	Intake of chemical X, mg/animal/day^c
Cereal grain [100% maximum]	Sorghum	100	0.15	0.01	-	0.0015
Total		100	0.15	-	-	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.