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Animal Residue Data Sheet - Emamectin

Emamectin is registered in Australia for use on cotton, brassica vegetables and grapes. Details of the registered use patterns can be found on the approved labels of registered products containing emamectin as the active constituent. This Animal Residue Data Sheet provides information on the possible residues in feed commodities obtained from crops treated with emamectin. 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.

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Current MRLs

The Australian MRLs for emamectin in food and animal feed commodities, as listed in Table 1 and Table 4 of the MRL Standard (as at September 2002) are shown below. The residue definition of emamectin is "emamectin B1a, plus its 8,9-Z isomer and emamectin B1b, plus its 8,9-Z isomer".

Code Food Current MRL, mg/kg
Food Commodities
Bergamot T0.05
VB 0040 Brassica (cole or cabbage) vegetables, Head cabbages, Flowerhead brassicas 0.02
VL 0465 Chervil T0.05
Coriander (leaves, stem, roots) T0.05
HS 0779 Coriander seed T0.05
SO 0691 Cotton seed 0.005
HS 0730 Dill seed T0.05
HS 0731 Fennel seed T0.05
FB 0269 Grapes *0.002
HH 0092 Herbs T0.05
Kaffir lime leaves T0.05
Lemon grass T0.05
DT 1111 Lemon verbena (fresh weight) T0.05
Mizuna T0.05
VL 0496 Rucola (rocket) T0.05
HH 4731 Salad burnett T0.05
Animal commodities
MO 0105 Edible offal, mammalian 0.01
MM 0095 Meat (mammalian) *0.002
ML 0106 Milks *0.0005
Animal feed commodities
none established

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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 emamectin are summarised below.

Species MFL,
ppm in diet		 Equivalent DDIL, mg/kg bw Equivalent intake of emamectin,
mg/animal/day
Cattlea 0.0264 0.0012 0.671
Sheepb 0.0264 0.0012 0.072
Pigc 0.0264 0.0012 0.072

a Based on animal transfer data
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

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Detailed Information

All Feed Commodities

Feed commodities that may contain residues of emamectin are listed in the table below. 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
(mg/kg) d		 Maximum intake of emamectin from commodity (mg/animal/day)e Theoretical maximum proportion of diet (%)f
Cattle (Based on a 500 kg animal consuming 20 kg DM/day)
Cotton seed 30 6 0.005 0.03 100
Cotton seed meal and hulls 30 6 0.005 0.03 100
Sheep (Based on a 60 kg animal consuming 2.5 kg DM/day)
Cotton seed 30 0.75 0.005 0.00375 100
Cotton seed meal and hulls 30 0.75 0.005 0.00375 100
Pigs (Based on a 60 kg animal consuming 2.5 kg DM/day)
Cotton seed 30 0.75 0.005 0.00375 100
Cotton seed meal and hulls 30 0.75 0.005 0.00375 100

a The feed commodities that may contain residues of emamectin, 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 maximum intake of emamectin when the commodity is fed at the maximum assumed level (Column 1) in the absence of other sources of emamectin.
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 dry weight equivalent) and other dietary sources of emamectin are absent.

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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.

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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 emamectin, mg/animal/dayc
Oilseeds Cotton seed 30 6 0.005 -- 0.03
Total   30 6     0.03

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: 0.03 mg/animal/day
Equivalent to: 0.00006 mg/kg bw
Equivalent to: 0.0015 ppm in the diet
MFL (Based on the available animal feeding data (Attachment 2)):

0.0264 ppm in the diet
Equivalent DDIL: 0.0012 mg/kg bw

Sheep

Feed group Feed commodity % in the diet Feed intake, kg/animal/daya MRL, mg/kg % DMb Intake of emamectin, mg/animal/dayc
Oilseeds Cotton seed 30 0.75 0.005 -- 0.00375
Total   30 0.75     0.00375

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: 0.00375 mg/animal/day
Equivalent to: 0.00006 mg/kg bw
Equivalent to: 0.0015 ppm in the diet
MFL (Based on the available animal feeding data (Attachment 2)): 0.0264 ppm in the diet
Equivalent DDIL: 0.0012 mg/kg bw

Pigs

Feed group Feed commodity % in the diet Feed intake, kg/animal/daya MRL, mg/kg % DMb Intake of emamectin, mg/animal/dayc
Oilseeds Cotton seed 30 0.75 0.005 -- 0.00375
Total   30 0.75     0.00375

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: 0.00375 mg/animal/day
Equivalent to: 0.00006 mg/kg bw
Equivalent to: 0.0015 ppm in the diet
MFL (Based on the available animal feeding data (Attachment 2)):

0.0264 ppm in the diet
Equivalent DDIL: 0.0012 mg/kg bw

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Attachment 2: Residue Data

The residue definition of emamectin in Australia is "emamectin B1a, plus its 8,9-Z isomer and emamectin B1b, plus its 8,9-Z isomer".

Selected Residue Data for Animal Feed Commodities

Emamectin Residues in Lucerne

Location, year, Ref Rate, g ai/ha Rate No. Volume, L/ha PHI, days % DM Emamectin, mg/kg DM

Narrabri, NSW
(2000)

Study No. P00/27

(Application made to lucerne at 30 cm growth stage, ~2 weeks since last cut)

1.19

(0.1x)		 1 90 0 22 0.131, 0.121
1 22 <0.02, <0.02
3 22 <0.02, <0.02
7 24 <0.02, <0.02
11.9 (1x) 1 90 0 22 1.07, 1.62
1 22 0.188, 0.362
3 22 0.138, 0.213
7 24 0.090, 0.144
23.8 (2x) 1 90 0 22 2.53, 2.50
1 22 0.650, 0.959
3 22 0.330, 0.351
7 24 0.213, 0.340

Selected Animal Transfer Data

Lactating Cows — Milk and Tissues

Lactating cows were dosed orally for 28 consecutive days with emamectin at levels of 26.4, 79.2 and 264 ppb in the diet (equivalent to 1.15, 3.5 and 11.55 g/kg bw, respectively).

Residues of emamectin in tissues following 28 consecutive daily doses

Matrix Feed level, g/kg feed Dose rate, g/kg bw Maximum residue, mg/kg
Muscle 26.4 1.2 <0.002
79.2 3.5 0.002
264 11.6 0.006
Fat 26.4 1.2 0.002
79.2 3.5 0.009
264 11.6 0.017
Liver 26.4 1.2 0.010
79.2 3.5 0.031
264 11.6 0.124
Kidney 26.4 1.2 0.004
79.2 3.5 0.013
264 11.6 0.046
Milk(whole,days 1-28) 26.4 1.2 <0.0005
79.2 3.5 0.0015
264 11.6 0.0066