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Animal Residue Data Sheet - Fenvalerate and Esfenvalerate

Esfenvalerate is registered in Australia for use on various crops including cereals, pulses, legumes and pastures. Fenvalerate is also approved for use as a direct animal treatment on cows. Details of the registered use patterns can be found on the approved labels of registered products containing esfenvalerate / fenvalerate as the active constituent. This Animal Residue Data Sheet provides information on the possible residues in feed commodities obtained from crops treated with esfenvalerate, to provide assistance in the formulation of animal diets that should not result in the violation of animal commodity MRLs.

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Current MRLs

Residues of esfenvalerate are covered by the MRLs for fenvalerate. The Australian MRLs for fenvalerate in food and animal feed commodities, as listed in Table 1 and Table 4 of the MRL Standard[as at 31 March 2004] are shown below. The residue definition of fenvalerate is fenvalerate, sum of isomers.

Code Food Current MRLs, mg/kg
Food Commodities
VB 0040 Brassica (cole or cabbage) vegetables, Head cabbages, Flowerhead brassicas 1
VL 0054 Brassica leafy vegetables 1
VS 0624 Celery 2
GC 0080 Cereal grains 2
FB 0269 Grapes *0.05
VP 0060 Legume vegetables 0.5
SO 0088 Oilseed 0.5
FP 0009 Pome fruits 1
VD 0070 Pulses 0.5
FS 0012 Stone fruits 1
FB 0275 Strawberry 1
VO 0447 Sweet corn (corn-on-the-cob) 0.05
VO 0448 Tomato 0.2
CM 0654 Wheat bran, unprocessed 5
Animal commodities
MM 0105 Edible offal (mammalian) 0.05
MM 0095 Meat (mammalian) [in the fat] 1
ML 0106 Milks 0.2
PM 0110 Poultry meat [in the fat] 0.05
PO 0111 Poultry, Edible offal of *0.02
PE 0112 Eggs 0.02
Animal feed commodities
  Primary feed commodities (except alfalfa forage (green) and alfalfa fodder) 10
AL 1021 Alfalfa forage (green) 2
AL 1020 Alfalfa fodder 2

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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 esfenvalerate are summarised below.

Species MFL,ppm in diet Equivalent DDIL, mg/kg bw Equivalent intake of esfenvalerate, mg/animal/day
Cattlea 10 0.4 200
Sheepb 10 0.42 25
Pigc 10 0.42 25
Poultryd 3 0.23 0.48
a Based on a 500 kg animal consuming 20 kg DM/day
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 a 2 kg animal consuming 150 g DM/day

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Detailed Information

All Feed Commodities

Feed commodities that may contain residues of esfenvalerate 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 NRA when setting animal commodity MRLs are theoretical values, and they should not be taken as recommendations of appropriate rations for livestock.

Commoditya Assumed Maximum proportion of diet (%)b Feed intake (kg/animal/day)c MRL(mg/kg)d Maximum intake of esfenvalerate from commodity (mg/animal/day)e Theoretical maximum proportion of diet (%)f
Cattle (Based on a 500 kg animal consuming 20 kg DM/day)
Cereal grains 100 20 2 40 100
Pulses and legumes 100 20 0.5 10 100
Forage, fodder and straw of cereals, pulses and legumes, pastures 100 20 10 200 100
Alfalfa (dry) 100 20 2 40 100
Oilseeds 30 6 0.5 3 100
Processed grain fractions 40 8 5 40 100
Sheep (Based on a 60 kg animal consuming 2.5 kg DM/day)
Cereal grains 100 2.5 2 5 100
Pulses and legumes 100 2.5 0.5 1.25 100
Forage, fodder and straw of cereals, pulses and legumes, pastures 100 2.5 10 25 100
Alfalfa (dry) 100 2.5 2 5 100
Oilseeds 30 0.75 0.5 0.375 100
Pigs (Based on a 60 kg animal consuming 2.5 kg DM/day)
Cereal grains 100 2.5 2 5 100
Pulses and legumes 100 2.5 0.5 1.25 100
Oilseeds 30 0.75 0.5 0.375 100
Processed grain fractions 40 1 5 5 100
Poultry (Based on a 2 kg animal consuming 150 g DM/day)
Cereal grains 100 0.15 2 0.3 100
Pulses and legumes 100 0.15 0.5 0.075 100
Oilseeds 30 0.045 0.5 0.0225 100
Processed grain fractions 40 0.06 5 0.3 60

aThe feed commodities that may contain residues of esfenvalerate, and may form more than 20% of an animals diet.
bThe maximum % of the diet that the commodity is assumed to comprise for the purposes of setting MRLs, based on Stockfeed Information Document 1
cThe equivalent amount of feed for an animal of designated weight and feed intake that is assumed for the purposes of setting MRLs
dThe MRL for each feed commodity (correction for dry weight basis where required)
eThe maximum intake of esfenvalerate when the commodity is fed at the maximum assumed level (Column 1) in the absence of other sources of esfenvalerate.
fThe 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 esfenvalerate 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. 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].

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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 esfenvalerate, mg/animal/dayc
Fodder and forage Cereals, pulses and legumes, oilseeds, pastures 100 20 10 100 200
Total   100 20     200
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: 200 mg/animal/day
Equivalent to: 0.4 mg/kg bw
Equivalent to: 10 ppm in the diet
MFL (Based on the available animal feeding data (Attachment 2)): 10 ppm in the diet
Equivalent DDIL: 0.4 mg/kg bw

Sheep

Feed group Feed commodity % in the diet Feed intake, kg/animal/daya MRL, mg/kg % DMb Intake of esfenvalerate, mg/animal/dayc
Fodder and forage Cereals, pulses and legumes, oilseeds, pastures 100 2.5 10 100 25
Total   100 2.5     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
Maximum anticipated dietary exposure: 25 mg/animal/day
Equivalent to: 0.42 mg/kg bw
Equivalent to: 10 ppm in the diet
MFL (Based on the available animal feeding data (Attachment 2)): 10 ppm in the diet
Equivalent DDIL: 0.42 mg/kg bw

Pigs

Feed group Feed commodity % in the diet Feed intake, kg/animal/daya MRL, mg/kg % DMb Intake of esfenvalerate, mg/animal/dayc
Processed grain fractions Wheat bran 40 1 5 - 5
Cereal grains Cereal grains 60 1.5 2 - 3
Total   100 2.5

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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: 8 mg/animal/day
Equivalent to: 0.13 mg/kg bw
Equivalent to: 3.2 ppm in the diet
MFL (Based on the available animal feeding data (Attachment 2)): 10 ppm in the diet
Equivalent DDIL: 0.42 mg/kg bw

Poultry

Feed group Feed commodity % in the diet Feed intake, kg/animal/daya MRL, mg/kg % DMb Intake of esfenvalerate, mg/animal/dayc
Processed grain fractions Wheat bran 40 0.06 5 - 0.3
Cereal grains Cereal grains 60 0.09 2 - 0.18
Total   100 0.15

0.48
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: 0.48 mg/animal/day
Equivalent to: 0.24 mg/kg bw
Equivalent to: 3.2 ppm in the diet
MFL (Based on the available animal feeding data (Attachment 2)): 3 ppm in the diet
Equivalent DDIL: 0.23 mg/kg bw

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Attachment 2: Residue Data

Selected residue data for animal feed commodities

Results from a large number of residues trials on cereal crops were available and are summarised below.

At a PHI of 0 days, residues in wheat, barley and oat forage/whole plants ranged from 0.05-0.75 mg/kg (n=64 trials) following application at 12.5 g ai/ha (half the Australian rate). The median residue was 0.34 mg/kg. At a PHI of 7 days, residues in forage were 0.16-1.0 mg/kg (n=21) with a median residue of 0.29 mg/kg (12.5 g ai/ha).

It is assumed that the results are expressed on a fresh weight basis. Scaling for the approved Australian application rate of 25 g ai/ha and correction for an assumed dry mater content of 20% gives an estimated highest residue of 10 mg/kg and a median residue of 3.5 mg/kg (dry weight). The data support an MRL of 10 mg/kg for cereal forage (dry).

Residues in cereal grain in the trials were generally low (<0.1 mg/kg) at WHPs ranging from approximately 5 weeks to 3 months in most trials. However, the trials did not address the harvest WHP of 7 days for cereal grains therefore there is insufficient data available to establish whether the current cereal grain MRL of 2 mg/kg is appropriate.

Fenvalerate has been reviewed several times by the JMPR. Results from relevant trials reported by the 2002, 1986, 1981 and 1979 JMPR meetings were scaled for the maximum Australian application rate where necessary. Relevant trial results are discussed below.

Residues were 0.8-3.6 mg/kg in soya bean forage/plants (5 trials); <0.02-1.1 mg/kg in rape/canola forage (8 trials); and up to 0.92 mg/kg in kale (5 trials). Residues in alfalfa (fresh weight) were 0.15, 0.17 and 0.19 mg/kg and in alfalfa (dry) were 0.55, 0.58 and 0.7 mg/kg. Correction of the fresh weight results for an assumed dry matter content of 20% gives residues of 0.75, 0.80 and 0.95 mg/kg in dry alfalfa.

No residues data for were available for the following crops for which registered uses appear on current product labels: pastures, sorghum, maize, sweet corn, safflower, sunflower, linseed, pigeon peas, lentils, field peas, chick peas, lupins, navy beans, mung beans or green beans, garden peas, broad beans.

The available data support an MRL of 10 mg/kg for cereal forage and 2 mg/kg for alfalfa forage and fodder. In the absence of residues data for other potential animal feed commodities such as pastures, legumes and pulses an MRL for Primary Feed Commodities, at 10 mg/kg based on the cereal forage data, is appropriate.

Selected animal transfer data

The available metabolism and animal transfer studies for fenvalerate/esfenvalerate are summarised below. Several of these studies have been published in the literature.1

Cattle

Five cows weighing between 410-640 kg received a daily ration containing 14C-fenvalerate at a level equivalent to 79 ppm in the feed for 21 consecutive days. Two of the five animals were placed on untreated feed for an additional 10-20 days. Milk was collected twice daily throughout the trial and tissues collected at sacrifice at the end of the dosing period and after the depuration period.

Residues of fenvalerate (mg/kg) and TRR (mg/kg)

Matrix Day of trial 1 Maximum TRR (mg equiv/kg) Fenvalerate residues (mg/kg)
Fat 21 31 (+10) 43 (+22) 3.36 2.72 2.39 3.4 3.2 2.2
Kidney 21 31 (+10) 43 (+22) 0.35 0.32 0.10 0.06 0.05 0.02
Liver 21 31 (+10) 43 (+22) 1.93 0.68 0.48 0 0 0
Milk 1-3 5-21 22 (+1) 23 (+2) 24 (+3) 25 (+4) <0.06-0.63 0.42-0.76 0.28-0.34 0.11-0.13 <0.06-0.06 <0.06 0.04-0.58 0.32-0.75 0.23-0.33 0.10-0.12 0.05-0.08 0.03-0.05
Muscle 21 31 (+10) 43 (+22) 0.30 0.18 0.12 0.27 0.18 0.18
1Numbers in parentheses indicate days depuration.

In other experiments cows were exposed to 14C-fenvalerate at feed levels of 0.11 and 0.15 ppm in the feed for 21 days, and at 10.9 ppm in the feed for 28 days. Milk was collected twice daily and tissues were collected at sacrifice at the end of the dosing period.

14C-Residues (mg equiv/kg) in tissues and milk

Matrix Day of trial Residues (mg/equiv/kg) at Feed level (ppm)  
    0.11-0.15 ppm (21 days dosing) 10.9 ppm (28 days dosing)
Fat 21 28 0.014 0.79
Kidney 21 28 0.01 0.18
Liver 21 28 0.01 0.34
Milk 1-3 5-28 <0.001 0.001-0.002 0.02-0.07 0.06-0.09
Muscle 21 28 <0.01 0.06

A product containing fenvalerate is approved for use as a direct treatment on cattle. Residues in livestock resulting from both dietary exposure and direct animal treatment must therefore be considered. The registered use pattern for dermal treatment is for application of a 0.1% solution, with re-treatment allowed 3 weeks later. A nil slaughter withholding period applies.

Four trials involving dermal application to cows were reported in the 1979 JMPR. In an Australian trial cows were sprayed twice (7 day interval) with either 0.1 or 0.2% fenvalerate solution. Residues in liver, kidney and muscle were <0.01 mg/kg in all samples collected up to 14 days after the last treatment. Highest residues occurred in fat at 0.1 mg/kg following two applications of a 0.1% solution.

At the estimated maximum exposure level of 10 ppm in the diet, residues of esfenvalerate in tissues and milk are estimated at 0.47 mg/kg in muscle (fat), 0.01 mg/kg in kidney, 0 mg/kg in liver and 0.1 mg/kg in milk. Appropriate MRLs are 1 mg/kg for muscle (in fat), 0.05 mg/kg in offal and 0.2 mg/kg in milk. These MRLs should be adequate to cover residues occurring in tissues from both dietary exposure and direct animal treatment.

Poultry

Laying hens were exposed to 14C-fenvalerate residues in the feed at a dose level of 160 ppm for 5 consecutive days. Residues of total 14C were determined, and the radioactive residues were characterised at the end of the 5 day dosing period. Parent fenvalerate comprised approximately 62% in egg yolk, 80% in fat and 0% in liver. The level of fenvalerate residues in egg white and muscle was not reported because of the low radioactivity present in these samples.

Matrix Day of trial1 Maximum 14C-residues (mg equiv/kg) Fenvalerate residues (mg/kg)
Egg white 5 <0.2 -
Egg yolk 5 1.3 0.8
Fat 5 0.5 0.4
Liver 5 2.4 ND
Muscle 5 <0.2 -

Laying hens weighing 1.5 kg received a daily ration containing 14C-fenvalerate at levels equivalent to 9.2 ppm for 49 days plus up to 57 days on clean feed, and at 29 and 86 ppm for 23 days. For the 9.2 ppm group, animals were sacrificed on days 7, 14, 28, 42 and 50 of the exposure period, plus days 8, 15, 29 and 57 of the depuration period. Hens in the 29 and 86 ppm groups were sacrificed on day 23 of the dosing period. Eggs were collected throughout the trial period. The level of parent fenvalerate residues present was estimated using results from the above metabolism experiment.

Matrix Dose rate in ppm (no. of days dosed) Day of trial1 Maximum 14C-residues (mg equiv/kg) Fenvalerate residues (mg/kg)
Fat 9.2 (49) 29 (23) 86 (23) 7-49 56 (+8) 64 (+15) 78 (+29) 106 (+57) 23 23 0.08 0.05 0.04 0.03 0.03 0.17 0.28 0.06 0.04 0.03 0.02 0.02 0.14 0.22
Liver 9.2 (49) 29 (23) 86 (23) 7-49 56 (+8) 64 (+15) 78 (+29) 106 (+57) 23 23 0.55 0.13 0.11 0.07 0.04 0.64 2.6 0 0 0 0 0 0 0
Egg yolk 9.2 (49) 29 (23) 86 (23) 7-49 50 (+1) 53 (+4) 57 (+8) 7-23 7-23 0.11 0.10 0.07 <0.02 0.32 1.2 0.07 0.06 0.04 NA 0.20 0.74
Muscle, Skin 9.2 (49) 29 (23) 86 (23) 7-49 23 23 <0.02 <0.06 <0.2 NA NA NA
1Numbers in parentheses indicate days depuration. Residues in eggs are average from animals in the treatment group.

At the estimated maximum exposure level of 3.2 ppm in the diet, residues of esfenvalerate in tissues and eggs are estimated at approximately 0.02 mg/kg in muscle (fat), 0 mg/kg in liver and <0.01 mg/kg in eggs. Appropriate MRLs are 0.05 mg/kg for muscle (in fat), *0.02 mg/kg in offal and 0.02 mg/kg in eggs.

Residue depletion

Highest residues in tissues occur in fat for both cattle and poultry. Tissues, eggs and milk were analysed from depuration animals in some studies. Residues in fat declined slowly after removal of animals from contaminated feed. There are insufficient data available to allow a reliable estimate of half life of residue decline in fat or other tissues.

1See: Boyer, A. C, Lee, P. W and Potter, J. C., J. Agric. Food Chem., Vol 40, No. 5, 1992, pp. 914-918.