ARDS-Spinosad 11 June 2003

Spinosad is registered in Australia for use on cotton, brassica vegetables, grapes, pome fruit, tomatoes, capsicum, peppers, lettuce, spinach and sweet corn. Spinosad is present in registered veterinary formulations for use on sheep. Details of the registered use patterns can be found on the approved labels of registered products containing spinosad as the active constituent. This Animal Residue Data Sheet provides information on the possible residues in feed commodities obtained from crops treated with spinosad. 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 spinosad in food and animal feed commodities, as listed in Table 1 and Table 4 of the MRL Standard [as at 12 March 2003] are shown below. The residue definition of spinosad is the "Sum of spinosyn A and spinosyn D".

Code	Food	Current MRL, mg/kg
Food Commodities
FI 0030	Assorted tropical and sub-tropical fruits —inedible peel	T0.5
VP 0061	Beans, except broad bean and soybeans	T0.2
	Bergamot	T5
FB 0018	Berries and other small fruit [excluding grapes]	T0.5
VB 0040	Brassica (cole or cabbage) vegetables, head cabbages, flowerhead brassicas	0.5
VS 0624	Celery	T*0.25
FC 0001	Citrus fruits	T0.1
VL 0465	Chervil	T5
	Coriander (leaves, stems, roots)	T5
HS 0779	Coriander seed	T5
SO 0691	Cotton seed	*0.01
HS 0730	Dill seed	T5
VO 0440	Egg plant	T0.1
HS 0731	Fennel seed	T5
VR 0581	Galangal, greater	T*0.01
FB 0269	Grape	0.5
HH 0092	Herbs	T5
	Kaffir lime leaves	T5
VL 0053	Leafy vegetables	5
	Lemon grass	T5
DT 1111	Lemon verbena (dry leaves)	T5
VC 0046	Melons, except watermelon	T0.2
	Mizuna	T5
VP 0063	Peas	T0.2
VO 0051	Peppers	0.2
FP 0009	Pome fruit	0.2
VR 0589	Potato	T*0.01
VD 0070	Pulses	T*0.01
VL 0496	Rucola (rocket)	T5
	Salad burnett	T5
GC 0651	Sorghum	T*0.01
FS 0012	Stone fruit	T0.2
VO 0447	Sweet corn (corn-on-the-cob)	0.02
VO 0448	Tomato	0.2
TN 0085	Tree nuts	T*0.01
HS 0794	Tumeric, root	T*0.01
Animal commodities
MO 0105	Edible offal (mammalian)	0.05
PE 0112	Eggs	T0.05
MM 0095	Meat (mammalian) [in the fat]	0.2
ML 0106	Milks	0.02
PO 0111	Poultry, Edible offal of	T0.05
	Poultry fat/skin	T0.2
PM 0110	Poultry meat	*0.01
Animal feed commodities
AB 0226	Apple pomace, dry	1
	Grape pomace	1 (dry wt basis)
	Cottonseed by-products	*0.01
AL 0157	Legume animal feeds	T0.05
AF 0651	Sorghum forage (green)	T0.05
AS 0651	Sorghum straw and fodder, dry	T0.05

Summary of maximum feeding levels and livestock dietary intakes (Note that all calculations have been performed using the proposed new MRLs and MFLs, where applicable.)

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 spinosad are summarised below.

Species	MFL, ppm in diet	Equivalent DDIL, mg/kg bw	Equivalent intake of spinosad, mg/animal/day
Cattle^a	0.56	0.012	5.45
Sheep^b	0.56	0.023	1.4
Pig^c	0.56	0.023	1.4
Poultry^d	1.0	0.075	0.15
^a Based on animal transfer study ^b Based on a 60 kg animal consuming 2.5 kg DM/day ^c Based on a 60 kg animal consuming 2.5 kg DM/day ^d Based on animal transfer study

Detailed information

All feed commodities

Feed commodities that may contain residues of spinosad 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. For instance, were apple pomace to be fed to cattle at 50% of the diet, the remainder of the diet would need to be free of residues of spinosad to minimise the risk of cattle commodity MRLs being violated. 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^d or STMR-P^e (mg/kg)	Maximum intake of spinosad from commodity (mg/animal/day)^f	Theoretical maximum proportion of diet (%)^g
Cattle (Based on a 500 kg animal consuming 20 kg DM/day)
Cotton seed	30	6	0.01^d	0.06	100
Cotton seed meal and hulls	30	6	0.01^d	0.06	100
Apple pomace, dry	20	4	0.57^e	2.28	48
Grape pomace, dry	20	4	0.47^e	1.88	58
Sheep (Based on a 60 kg animal consuming 2.5 kg DM/day)
Cotton seed	30	0.75	0.01^d	0.0075	100
Cotton seed meal and hulls	20	0.5	0.01^d	0.005	100
Apple pomace, dry	20	0.5	0.57^e	0.285	98
Grape pomace, dry	20	0.5	0.47^e	0.235	100
Pigs (Based on a 60 kg animal consuming 2.5 kg DM/day)
Cotton seed	30	0.75	0.01^d	0.0075	100
Cotton seed meal and hulls	30	0.75	0.01^d	0.0075	100
Apple pomace, dry	20	0.5	0.57^e	0.285	98
Grape pomace, dry	20	0.5	0.47^e	0.235	100
Poultry (Based on a 2 kg animal consuming 150 g DM/day)
Cotton seed	20	0.03	0.01^d	0.0003	100
Cotton seed meal and hulls	20	0.03	0.01^d	0.0003	100
Apple pomace, dry	5	0.0075	0.57^e	0.0043	100
Grape pomace, dry	5	0.0075	0.47^e	0.0035	100
^a The feed commodities that may contain residues of spinosad, 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 for each feed commodity (correction for dry weight basis where required) ^e.The STMR-P for each feed commodity (correction for dry weight basis where required) ^f The maximum intake of spinosad when the commodity is fed at the maximum assumed level (Column 1) in the absence of other sources of spinosad. ^g 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 dry weight equivalent) and other dietary sources of spinosad 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.

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. For example: a cow consumes 10 kg of grain containing 10 mg/kg of Chemical X and 10 kg of apple pomace containing 5 mg/kg of Chemical X. The total intake of Chemical X is 150 mg in 20 kg of feed. This is equivalent to 7.5 ppm in the feed [150÷20].

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/STMR-P, mg/kg	% DM^b	Intake of spinosad, mg/animal/day^c
Fruit by-products [20 % maximum]	Apple pomace, dry	20	4	0.57	--	2.28
Oilseeds [30 % maximum]	Cotton seed / by-products	30	6	0.01	--	0.06
Total		50	10			2.34
^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:	2.34 mg/animal/day
equivalent to:	0.005 mg/kg bw
equivalent to:	0.12 ppm in the diet

MFL (beef cattle data)	0.56 ppm in the diet
equivalent DDIL:	0.012 mg/kg bw

Sheep

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	MRL/STMR-P, mg/kg	% DM^b	Intake of spinosad, mg/animal/day^c
Fruit by-products [20 % maximum]	Apple pomace, dry	20	0.5	0.57	--	0.2850
Oilseeds [30 % maximum]	Cotton seed	30	0.75	0.01	--	0.0075
Total		50	1.25			0.2925
^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:	0.2925 mg/animal/day
equivalent to:	0.005 mg/kg bw
equivalent to:	0.12 ppm in the diet

MFL (Based on extrapolation of cattle data)	0.56 ppm in the diet
equivalent DDIL:	0.023 mg/kg bw

Pigs

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	MRL/STMR-P, mg/kg	% DM^b	Intake of spinosad, mg/animal/day^c
Fruit by-products [20 % maximum]	Apple pomace, dry	20	0.5	0.57	--	0.2850
Oilseeds [30 % maximum]	Cotton seed / by-products	30	0.75	0.01	--	0.0075
Total		50	1.25			0.2925
^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:	0.2925 mg/animal/day
equivalent to:	0.005 mg/kg bw
equivalent to:	0.12 ppm in the diet

MFL (Based on extrapolation of cattle data):	0.56 ppm in the diet
equivalent DDIL:	0.023 mg/kg bw

Poultry

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	MRL/STMR-P, mg/kg	% DM^b	Intake of spinosad, mg/animal/day^c
Fruit by-products [5 % maximum]	Apple pomace, dry	5	0.0075	0.57	--	0.0043
Oilseeds [30 % maximum]	Cotton seed / by-products	20	0.03	0.01	--	0.0003
Total		25	0.03575			0.0046
^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:	0.0046 mg/animal/day
equivalent to:	0.0023 mg/kg bw
equivalent to:	0.03 ppm in the diet

MFL (Based on animal transfer data):	1.0 ppm in the diet
equivalent DDIL:	0.075 mg/kg bw