Trifloxystrobin. March 28, 2002. Residue Data Sheet. Australia NRA for Agricultural & Veterinary Chemicals.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Trifloxystrobin. March 28, 2002. Residue Data Sheet. Australia National Regulatory Authority (NRA) for Agricultural & Veterinary Chemicals.

http://www.nra.gov.au/residues/ARDS-trifloxystrobin.shtml

Residue Data Sheet - Trifloxystrobin

last updated: 28 March 2002

Trifloxystrobin is registered in Australia for use on grapevines and pome fruit. Details of the registered use patterns can be found on the approved labels of registered products containing trifloxystrobin as the active constituent. This Animal Residue Data Sheet provides information on the possible residues in feed commodities obtained from crops treated with trifloxystrobin. 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 trifloxystrobin in food and animal feed commodities, as listed in Table 1 and Table 4 of the MRL Standard [as at February 2002] are shown below. The residue definition of trifloxystrobin is the sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluormethylphenyl)-ethylideneaminooxymethyl]phenyl]acetic acid), expressed as trifloxystrobin equivalents.

Code	Food	MRL, mg/kg
Food Commodities
FI 0327	Bananas	T0.1
DF 0269	Dried grapes	2
FB 0269	Grapes	0.5
FP 0009	Pome fruit	0.3
Animal commodities
MO 0105	Edible offal (mammalian)	*0.05
MM 0095	Meat (mammalian)	*0.05
ML 0106	Milks	*0.02
Animal feed commodities
AB 0269	Grape pomace (dry)	3
	Pome fruit pomace, dry	15

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 trifloxystrobin are summarised below.

Species	MFL, ppm in diet	Equivalent DDIL, mg/kg bw	Equivalent intake of trifloxystrobin, mg/animal/day
Cattle^a	6	0.24	120
Sheep^b	6	0.25	15
Pig^c	6	0.25	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

Detailed information

All feed commodities

Feed commodities that may contain residues of trifloxystrobin 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. In this instance, fruit by-products may be fed to cattle, sheep and pigs at 100% of the diet with minimal risk of animal 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	STMR-P (mg/kg)^d	Maximum intake of trifloxystrobin from commodity (mg/animal/day)^e	Theoretical maximum proportion of diet (%)^f
Cattle (Based on a 500 kg animal consuming 20 kg DM/day)
Apple pomace, dry	20	4	2.3	9.2	100
Grape pomace, dry	20	4	0.57	2.28	100
Sheep (Based on a 60 kg animal consuming 2.5 kg DM/day)
Apple pomace, dry	20	0.5	2.3	1.15	100
Grape pomace, dry	20	0.5	0.57	0.29	100
Pigs (Based on a 60 kg animal consuming 2.5 kg DM/day)
Apple pomace, dry	20	0.5	2.3	1.15	100
Grape pomace, dry	20	0.5	0.57	0.29	100
^a The feed commodities that may contain residues of trifloxystrobin, 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 STMR-P for each feed commodity (correction for dry weight basis where required) ^e The maximum intake of trifloxystrobin when the commodity is fed at the maximum assumed level (Column 1) in the absence of other sources of trifloxystrobin. ^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 trifloxystrobin 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 no trifloxystrobin and 10 kg of apple pomace containing 3 mg/kg of trifloxystrobin. The total intake of trifloxystrobin is 30 mg in 20 kg of feed. This is equivalent to 1.5 ppm in the feed [30÷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	STMR-P, mg/kg	% DM^b	Intake of trifloxystrobin, mg/animal/day^c
Fruit by-products [20% maximum]	Apple pomace, dry	20	4	2.3	-	9.2
Total						9.2
^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:	9.2 mg/animal/day
equivalent to:	0.0184 mg/kg bw
equivalent to:	0.46 ppm in the diet

MFL (dairy cattle data):	6 ppm in the diet
equivalent DDIL:	0.24 mg/kg bw

Sheep

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	STMR-P, mg/kg	% DM^b	Intake of trifloxystrobin, mg/animal/day^c
Fruit by-products [20% maximum]	Apple pomace, dry	20	0.5	2.3	-	1.15
Total						1.15
^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:	1.15 mg/animal/day
equivalent to:	0.019 mg/kg bw
equivalent to:	0.46 ppm in the diet

MFL (based on extrapolation from cattle data):	6 ppm in the diet
equivalent DDIL:	0.25 mg/kg bw

Pigs

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	STMR-P, mg/kg	% DM^b	Intake of trifloxystrobin, mg/animal/day^c
Fruit by-products [20% maximum]	Apple pomace, dry	20	0.5	2.3	-	1.15
Total						1.15
^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:	1.15 mg/animal/day
equivalent to:	0.019 mg/kg bw
equivalent to:	0.46 ppm in the diet

MFL (based on extrapolation from cattle data):	6 ppm in the diet
equivalent DDIL:	0.25 mg/kg bw

Attachment 2: Residue data

The residue definition of trifloxystrobin in Australia is the sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluormethylphenyl)-ethylideneaminooxymethyl]phenyl]acetic acid), expressed as trifloxystrobin equivalents.

Selected animal transfer data

Lactating cows — milk and tissues

Lactating cows were dosed orally for 28 consecutive days with trifloxystrobin at levels equivalent to 2, 6 and 20 ppm in the diet (0.08, 0.24 and 0.8 mg/kg bw/day based on a 500 kg animal consuming 20 kg DM/day).

Residues of trifloxystrobin in tissues and milk following 28 consecutive daily doses at 6 and 20 ppm.

Matrix	Feed level, ppm in diet	Maximum residue, mg/kg
		Trifloxystrobin	Acid metabolite

Muscle	20	<LOQ	<LOQ
Fat	20	0.06	<LOQ
	6	<LOQ	<LOQ
Liver	20	<LOQ	0.09
	6	<LOQ	<LOQ*
Kidney	20	<LOQ	0.02
	6	<LOQ	<LOQ
Milk (whole, days 1-28)	20	<LOQ	<LOQ

*The Limit of Quantitation(LOQ) for animal tissue is 0.02mg/kg for both trifloxystrobin and its acid metabolite. The LOQ for milk is 0.01 mg/kg for both trifloxystrobin and its acid metabolite. No residues above the LOQ were detected in milk during the 28 day study.

Residue Data Sheet - Trifloxystrobin

Last updated: 28 March 2002

Trifloxystrobin is registered in Australia for use on grapevines and pome fruit. Details of the registered use patterns can be found on the approved labels of registered products containing trifloxystrobin as the active constituent. This Animal Residue Data Sheet provides information on the possible residues in feed commodities obtained from crops treated with trifloxystrobin. 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 trifloxystrobin in food and animal feed commodities, as listed in Table 1 and Table 4 of the MRL Standard [as at February 2002] are shown below. The residue definition of trifloxystrobin is the sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluormethylphenyl)-ethylideneaminooxymethyl]phenyl]acetic acid), expressed as trifloxystrobin equivalents.

Code	Food	MRL, mg/kg
Food Commodities
FI 0327	Bananas	T0.1
DF 0269	Dried grapes	2
FB 0269	Grapes	0.5
FP 0009	Pome fruit	0.3
Animal commodities
MO 0105	Edible offal (mammalian)	*0.05
MM 0095	Meat (mammalian)	*0.05
ML 0106	Milks	*0.02
Animal feed commodities
AB 0269	Grape pomace (dry)	3
	Pome fruit pomace, dry	15

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 trifloxystrobin are summarised below.

Species	MFL, ppm in diet	Equivalent DDIL, mg/kg bw	Equivalent intake of trifloxystrobin, mg/animal/day
Cattle^a	6	0.24	120
Sheep^b	6	0.25	15
Pig^c	6	0.25	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

Detailed information

All feed commodities

Feed commodities that may contain residues of trifloxystrobin 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. In this instance, fruit by-products may be fed to cattle, sheep and pigs at 100% of the diet with minimal risk of animal 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	STMR-P (mg/kg)^d	Maximum intake of trifloxystrobin from commodity (mg/animal/day)^e	Theoretical maximum proportion of diet (%)^f
Cattle (Based on a 500 kg animal consuming 20 kg DM/day)
Apple pomace, dry	20	4	2.3	9.2	100
Grape pomace, dry	20	4	0.57	2.28	100
Sheep (Based on a 60 kg animal consuming 2.5 kg DM/day)
Apple pomace, dry	20	0.5	2.3	1.15	100
Grape pomace, dry	20	0.5	0.57	0.29	100
Pigs (Based on a 60 kg animal consuming 2.5 kg DM/day)
Apple pomace, dry	20	0.5	2.3	1.15	100
Grape pomace, dry	20	0.5	0.57	0.29	100
^a The feed commodities that may contain residues of trifloxystrobin, 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 STMR-P for each feed commodity (correction for dry weight basis where required) ^e The maximum intake of trifloxystrobin when the commodity is fed at the maximum assumed level (Column 1) in the absence of other sources of trifloxystrobin. ^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 trifloxystrobin 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 no trifloxystrobin and 10 kg of apple pomace containing 3 mg/kg of trifloxystrobin. The total intake of trifloxystrobin is 30 mg in 20 kg of feed. This is equivalent to 1.5 ppm in the feed [30÷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	STMR-P, mg/kg	% DM^b	Intake of trifloxystrobin, mg/animal/day^c
Fruit by-products [20% maximum]	Apple pomace, dry	20	4	2.3	-	9.2
Total						9.2
^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:	9.2 mg/animal/day
equivalent to:	0.0184 mg/kg bw
equivalent to:	0.46 ppm in the diet

MFL (dairy cattle data):	6 ppm in the diet
equivalent DDIL:	0.24 mg/kg bw

Sheep

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	STMR-P, mg/kg	% DM^b	Intake of trifloxystrobin, mg/animal/day^c
Fruit by-products [20% maximum]	Apple pomace, dry	20	0.5	2.3	-	1.15
Total						1.15
^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:	1.15 mg/animal/day
equivalent to:	0.019 mg/kg bw
equivalent to:	0.46 ppm in the diet

MFL (based on extrapolation from cattle data):	6 ppm in the diet
equivalent DDIL:	0.25 mg/kg bw

Pigs

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	STMR-P, mg/kg	% DM^b	Intake of trifloxystrobin, mg/animal/day^c
Fruit by-products [20% maximum]	Apple pomace, dry	20	0.5	2.3	-	1.15
Total						1.15
^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:	1.15 mg/animal/day
equivalent to:	0.019 mg/kg bw
equivalent to:	0.46 ppm in the diet

MFL (based on extrapolation from cattle data):	6 ppm in the diet
equivalent DDIL:	0.25 mg/kg bw

Attachment 2: Residue data

The residue definition of trifloxystrobin in Australia is the sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluormethylphenyl)-ethylideneaminooxymethyl]phenyl]acetic acid), expressed as trifloxystrobin equivalents.

Selected animal transfer data

Lactating cows — milk and tissues

Lactating cows were dosed orally for 28 consecutive days with trifloxystrobin at levels equivalent to 2, 6 and 20 ppm in the diet (0.08, 0.24 and 0.8 mg/kg bw/day based on a 500 kg animal consuming 20 kg DM/day).

Residues of trifloxystrobin in tissues and milk following 28 consecutive daily doses at 6 and 20 ppm.

Matrix	Feed level, ppm in diet	Maximum residue, mg/kg
		Trifloxystrobin	Acid metabolite

Muscle	20	<LOQ	<LOQ
Fat	20	0.06	<LOQ
	6	<LOQ	<LOQ
Liver	20	<LOQ	0.09
	6	<LOQ	<LOQ*
Kidney	20	<LOQ	0.02
	6	<LOQ	<LOQ
Milk (whole, days 1-28)	20	<LOQ	<LOQ

*The Limit of Quantitation(LOQ) for animal tissue is 0.02mg/kg for both trifloxystrobin and its acid metabolite. The LOQ for milk is 0.01 mg/kg for both trifloxystrobin and its acid metabolite. No residues above the LOQ were detected in milk during the 28 day study.