Animal Residue Data Sheet - Bifenthrin

Bifenthrin 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 bifenthrin as the active constituent. This Animal Residue Data Sheet provides information on the possible residues in feed commodities obtained from crops treated with bifenthrin. 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 bifenthrin in food and animal feed commodities, as listed in Table 1 and Table 4 of the MRL Standard (as at August 2002) are shown below. The residue definition of bifenthrin is the parent compound per se.

Code	Food	MRL, mg/kg
Food Commodities
FP 0226	Apple	*0.05
FI 0326	Avocado	T0.1
FI 0327	Banana	0.1
GC 0080	Cereal grains	T2
VL 0465	Chervil	T0.5
FC 0001	Citrus fruits	*0.05
SO 0691	Cotton seed	0.1
VO 0440	Egg plant	T0.5
VD 0561	Field Pea (dry)	T*0.01
VC 0045	Fruiting vegetables, cucurbits	T*0.1
HS 0783	Galangal, rhizomes	T10
FB 0269	Grapes	*0.01
HH 0092	Herbs	T10
	Kaffir lime leaves	T10
	Lemon balm	T10
	Lemon grass	T10
DT 1111	Lemon verbena	T10
VD 0545	Lupin (dry)	T*0.02
	Mizuna	T10
VO 0442	Okra	T0.5
FP 0230	Pear	0.5
VO 0051	Peppers	T0.5
VD 0070	Pulses [except field pea (dry), Lupin (dry)]	*0.02
SO 0495	Rape seed	*0.02
	Rucola (rocket)	T10
FS 0012	Stone fruit	T1.0
GS 0659	Sugarcane	*0.01
HS 0794	Tumeric, root	T10
VO 0448	Tomato	0.5
Animal commodities
MM 0095	Meat (mammalian) [in the fat]	2
MO 0105	Edible offal (Mammalian)	0.5
ML 0106	Milks	0.5
PE 0112	Eggs	*0.05
PO 0111	Poultry, Edible offal of	*0.05
PM 0110	Poultry meat [in the fat]	*0.05
Animal feed commodities
AL 1020	Alfalfa fodder [Lucerne]	0.1
AL 1021	Alfalfa forage (green)	0.1
	Canola fodder (dry)	*0.01
	Canola forage (green)	1
AL 1031	Clover hay or fodder	*0.05
	Clover forage (green)	*0.05
	Faba bean forage (green)	1
	Faba bean fodder (dry)	*0.02
	Field pea forage (green)	1
	Field pea fodder (dry)	*0.01
AL 0545	Lupin forage	1
	Lupin fodder (dry)	*0.02
	Forage (green) of cereal grains	0.2
	Navy beans fodder	1
	Navy beans forage (green)	5
AM 0659	Sugarcane fodder	*0.02
AS 0081	Straw and fodder (dry) of cereal grains	*0.01
	Pear pomace, dry	5

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 bifenthrin are summarised below.

Species	MFL, ppm in diet	Equivalent DDIL, mg/kg bw	Equivalent intake of bifenthrin, mg/animal/day
Cattle^a	5.7	0.22	93
Sheep^b	5.7	0.24	14.3
Pig^b	5.7	0.24	14.3
Poultry^c	0.5	0.0375	0.075
^a Based actual dose levels in dairy cattle study (413 kg bw, 16.4 kg DM/day) ^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 assumed bodyweight of 2 kg and feed consumption of 0.15 kg DM/day

Detailed information

All feed commodities

Feed commodities that may contain residues of bifenthrin are listed in the table below. The theoretical maximum proportion of the diet that the commodity can compose, 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 (mg/kg)^d	Maximum intake of bifenthrin from commodity (mg/animal/day)^e	Theoretical maximum proportion of diet (%)^f
Cattle (Based on a 500 kg animal consuming 20 kg DM/day)
Alfalfa fodder [Lucerne]	100	20	0.1	2	100
Alfalfa forage (green)	100	20	0.1	2	100
Canola fodder (dry)	100	20	*0.01	0.2	100
Canola forage (green)	100	20	1	20	100
Cereal grains	100	20	0.5 (Expected residue, Footnote g)	10	100
Clover hay or fodder	100	20	*0.05	1	100
Clover forage (green)	100	20	*0.05	1	100
Faba bean forage (green)	100	20	1	20	100
Faba bean fodder (dry)	100	20	*0.02	0.4	100
Field pea forage (green)	100	20	1	20	100
Field pea fodder (dry)	100	20	*0.01	0.2	100
Forage (green) of cereal grains	100	20	0.2	4	100
Lupin forage	100	20	1	20	100
Lupin fodder (dry)	100	20	*0.02	0.4	100
Navy beans fodder	100	20	1	20	100
Navy beans forage (green)	100	20	5	100	100
Pear pomace, dry	20	4	0.95 (STMR-P)	3.8	100
Sugarcane fodder	100	20	*0.02	0.4	100
Straw and fodder (dry) of cereal grains	100	20	*0.01	0.2	100
Sheep (Based on a 60 kg animal consuming 2.5 kg DM/day)
Alfalfa fodder [Lucerne]	100	2.5	0.1	0.25	100
Alfalfa forage (green)	100	2.5	0.1	0.25	100
Canola fodder (dry)	100	2.5	*0.01	0.025	100
Canola forage (green)	100	2.5	1	2.5	100
Cereal grains	100	2.5	0.5 (Expected residue, Footnote g)	1.25	100
Clover hay or fodder	100	2.5	*0.05	0.125	100
Clover forage (green)	100	2.5	*0.05	0.125	100
Faba bean forage (green)	100	2.5	1	2.5	100
Faba bean fodder (dry)	100	2.5	*0.02	0.05	100
Field pea forage (green)	100	2.5	1	2.5	100
Field pea fodder (dry)	100	2.5	*0.01	0.025	100
Forage (green) of cereal grains	100	2.5	0.2	0.5	100
Lupin forage	100	2.5	1	2.5	100
Lupin fodder (dry)	100	2.5	*0.02	0.05	100
Navy beans fodder	100	2.5	1	2.5	100
Navy beans forage (green)	100	2.5	5	12.5	100
Pear pomace, dry	20	0.5	0.95 (STMR-P)	0.475	100
Sugarcane fodder	100	2.5	*0.02	0.05	100
Straw and fodder (dry) of cereal grains	100	2.5	*0.01	0.025	100
Pigs (Based on a 60 kg animal consuming 2.5 kg DM/day)
Cereal grains	100	2.5	0.5 (Expected residue, Footnote g)	1.25	100
Cotton seed	30	0.75	0.1	0.075	100
Pear pomace, dry	20	0.5	0.95 (STMR-P)	0.475	100
Poultry (Based on a 2 kg animal consuming 150 g DM/day)
Cereal grains	100	0.15	0.5 (Expected residue, Footnote g)	0.075	100
Cotton seed	30	0.045	0.1	0.0045	100
Pear pomace, dry	20	0.03	0.95 (STMR-P)	0.0285	100
^a The feed commodities that may contain residues of bifenthrin, 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 STMR-P where noted) for each feed commodity (correction for dry weight basis where required) ^e The maximum intake of bifenthrin when the commodity is fed at the maximum assumed level (Column 1) in the absence of other sources of bifenthrin. ^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 STMR-P (or dry weight equivalent) and other dietary sources of bifenthrin are absent. ^g Highest residue expected to occur in grain under temporary trial use. Registered uses should result in residues of bifenthrin in cereal grains of <0.02 mg/kg.

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.

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 food 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) _ body weight (kg) ¸ 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 bifenthrin, mg/animal/day^c
Fodder and forage[100% maximum]	Navy bean forage	100	20	5	-	100
Total		100	20			100
^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

Maximum anticipated dietary exposure:	100 mg/animal/day
equivalent to:	0.2 mg/kg bw
equivalent to:	5 ppm in the diet

MFL:	5.7 ppm in the diet
equivalent DDIL:	0.22 mg/kg bw

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 bifenthrin, mg/animal/day^c
Fodder and forage[100% maximum]	Navy bean forage	100	2.5	5	-	12.5
Total		100	2.5	-	-	12.5
^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:	12.5 mg/animal/day
equivalent to:	0.21 mg/kg bw
equivalent to:	5 ppm in the diet

MFL:	5.7 ppm in the diet
equivalent DDIL:	0.24 mg/kg bw

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 animal consuming 2.5 kg DM per day.

Pigs

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	Expected residue, mg/kg	% DM^b	Intake of bifenthrin, mg/animal/day^c
Grain[100% maximum]	Cereal grains	100	2.5	0.5	-	1.25
Total		100	2.5	-	-	1.25
^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

Registered uses of bifenthrin should result in residues <0.02 mg/kg in cereal grains. The current MRL for cereal grains is T2 mg/kg to cover residues that may arise under a trial permit. The maximum expected residue in grain in the trial situation is 0.5 mg/kg. This figure has been used as the best estimate of pig dietary exposure from cereal grains.

Maximum anticipated dietary exposure:	1.25 mg/animal/day
equivalent to:	0.021 mg/kg bw
equivalent to:	0.5 ppm in the diet

MFL:	5.7 ppm in the diet
equivalent DDIL:	0.24 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 animal consuming 2.5 kg DM per day.

Poultry

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	Expected residue, mg/kg	% DM^b	Intake of bifenthrin, mg/animal/day^c
Grain[100% maximum]	Cereal grains	100	0.15	0.5	-	0.075
Total		100	0.15	-	-	0.075
^aBased on assumed feed consumption of 0.150 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:	0.075 mg/animal/day
equivalent to:	0.0375 mg/kg bw
equivalent to:	0.5 ppm in the diet

MFL:	0.5 ppm in the diet
equivalent DDIL:	0.0375 mg/kg bw

The MFL and DDIL were estimated from a poultry transfer study.

Attachment 2: Residue data

The residue definition of bifenthrin in Australia is the parent compound per se.

Selected residue decline data for animal feed commodities

The table below shows Australian residue data for lucerne forage and hay.

Data from trials conducted in NSW and SA were evaluated. The rates employed in lucerne trials were 1´ and 2´ the maximum label rate for native budworm control in lucerne seed crops.

Sample, Trial Site,	Application			Days after treatment	Residues of bifenthrin (mg/kg
Year	Rate (g ai/ha)	Timing	No.		dry matter)
Lucerne forage	60	Early flowering	1	0	38
NSW 1995				7	37
				14	6.8
				21	5.8
				28	4
	120	Early flowering	1	0	44
				7	9.4
				14	6.0
				21	3.0
				28	1.1
Lucerne forage	60	Early flowering	1	-1	<0.01
SA 1995				7	6.3
				14	4.3
				28	0.48
	120	Early flowering	1	-1	<0.01
				7	11.5
				14	8.3
				28	3.1

Selected animal transfer data

Lactating cows

Feeding studies in dairy cows were conducted at levels of 5, 15 and 50 ppm in the diet for 28 days (average actual dose levels were 5.7, 16.8 and 55.2 ppm in the diet, equivalent to 0.22, 0.64 and 1.75 mg/kg bw). [Source: FMC Studies PC-0023 & P-1030]

Day	Residues of bifenthrin (mg/kg) in whole milk
Day	5.7 ppm	16.8 ppm	55.2 ppm
0	< 0.005	< 0.007	0.02
1	0.05	-	0.25
3	0.08	0.11	0.58
5	0.10	-	0.53
8	-	0.21	0.72
12	0.06	-	0.79
16	-	0.14	0.59
20	0.09	-	0.63
24	-	0.18	0.67
28	0.08	-	0.65

Limit of detection = 0.005 mg/kg; limit of quantitation = 0.02 mg/kg

Sample	Bifenthrin (mg/kg) in tissues
Sample	5.7 ppm	16.8 ppm	55.2 ppm
Adductor muscle	0.03, 0.04	0.08, 0.09	0.10, 0.23
Pectoral muscle	0.05, 0.06	0.16 ,0.24	0.33, 0.88
Cardial muscle	0.04, 0.06	0.12, 0.17	0.27, 0.41
Liver	< 0.01, 0.02	0.02, 0.03	0.07, 0.09
Kidney	0.1, 0.04	0.18, 0.19	0.44, 0.49
Subcutaneous fat	0.25, 0.75	0.68, 0.92	2.00, 2.70
Peritoneal fat	0.77, 1.70	1.50, 2.20	3.30, 5.70

Limit of detection = 0.01 mg/kg; limit of quantitation = 0.1 mg/kg.

In a separate study lactating cows were dosed at nominal levels equivalent to 5 and 50 ppm in the diet for 28 days (average actual dose levels were 5.7 and 54.5 ppm in the diet, equivalent to 0.19 and 2.0 mg/kg bw). There were three cows per dose group. Bifenthrin residues were determined in milk fat only. [Source: FMC Study No. P-1703]

Day	Bifenthrin (mg/kg) in milk fat
Day	5.7 ppm	54.5 ppm
0	< 0.05	< 0.05
3	0.72, 0.78, 0.97	7.8, 8.8, 9.6
8	0.64, 0.67, 1.60	7.8, 8.9, 10.2
16	0.54, 0.62, 1.20	8.0, 8.2, 10.1
24	0.35, 0.70, 1.10	7.4, 8.6, 9.4
28	0.48, 0.50, 0.61	8.0, 9.4, 10.4

Limit of detection =. 0.05 mg/kg; limit of quantitation = 0.2 mg/kg.

Correcting for the slightly different dose levels used in the whole milk and milk fat studies indicates that the highest observed residues are 10-15 times higher when determined in milk fat compared to whole milk.

Laying Hens

Laying hens were dosed with acid-¹⁴C-bifenthrin for 10 days at a dose level equivalent to 31 ppm in the diet. The composition of the total radioactive residue was determined in various tissues. Residues of bifenthrin were as follows: egg yolk (day 10 eggs) 1.44 mg/kg; abdominal fat 1.0 mg/kg; adductor muscle 0.066 mg/kg; liver 0.05 mg/kg.

Laying hens were dosed with bifenthrin for 28 days at dose levels equivalent to 2.5, 25 and 250 ppb in the diet. At the highest dose level residues of bifenthrin were not detected in fat (<0.01 mg/kg), liver (<0.01 mg/kg) gizzard (<0.01 mg/kg) and muscle (<0.005 mg/kg). Residues in eggs were only observed at the highest feed level and were up to 0.004 mg/kg.