Characterizing chronic and acute health risks of residues of veterinary drugs in food: latest methodological developments by the joint FAO/WHO expert committee on food additives

Figures & data

Table 1. Food consumption data for estimating chronic exposure to veterinary drug residues for the general population (including children) and children (as of 2016) compared with values used for EDI.

	Adults^a (g/person/day)	General population^b (g/person/day)			Children^c (g/person/day)
	EDI	Cluster diets	GECDE		GECDE
Food type as raw commodity	Model diet^d	Highest mean^e	Mean^f	High-level chronic^g	Mean^f	High-level chronic^g
Mammalian muscle
All mammalian muscle	300	114	100	415	62	478
Beef and other bovines		47	63	291	37	159
Pork and other porcines		114	58	415	31	162
Sheep and other ovines		21	13	315	13	158
Goat and other caprines		5	1	315	1	67
Horse and other equines		3	1	557	2	478
Rabbit		2	4	309	2	149
Mammalian trimmed fat, skin and added fat excluding butter
Mammalian fat	50	14	4.4	125	1.7	29
Mammalian offal
All mammalian offal		8	4	269	3	193
Mammalian liver	100	–	2	237	3	103
Mammalian kidney	50	–	0.5	166	0.5	150
Fish and seafood
All fish and seafood	300	27	75	655	34	189
Fish		27	26	655	24	226
Crustaceans		4	6	250	3	140
Molluscs		2	7	263	3	189
Poultry
Poultry muscle	300	118	59	352	35	207
Poultry fat and skin	50	1	0.4	23	0.05	3
Poultry offal (all)		5	2	188	0.4	87
Liver	100
Kidney	50
Eggs
Eggs (all)	100	42	39	169	25	143
Milk
Milk^h	1500	425	1072	2917	809	1736
Honey
Honey	50	3	5	140	2	84

^a JECFA model diet was proposed for an adult person weighing 60 kg and did not including children except those over 15 years old which weigh approximately 60 kg.

^b Includes children different from those described in the “children” column.

^c Aged from 36 months up to and including 9 years of age.

^d Veterinary drugs JECFA model diet consumed daily by an adult person weighing 60 kg.

^e The highest reported mean chronic consumption is derived from total population across population groups and surveys lasting at least 2 d among countries for which data were made available to FAO/WHO.

^f per capita estimates are derived from FAO Food Balance Sheet.

^g The high-level chronic consumption is assessed as the highest 97.5th percentile in consumers only for surveys lasting at least 2 d among countries for which data were made available to FAO/WHO.

^h Includes whole liquid milk, secondary milk products (e.g. skimmed milk, evaporated milk, milk powders), derived milk products (e.g. cream, butter) and manufactured milk products (yoghurt, cheese, ice cream).

Table 2. Food consumption data for estimating acute exposure to veterinary drug residues for the general population (including children) and children (as of 2016).

	GEADE
	97.5th percentile^c
Food type as raw commodity	General population^a (g/person/day)	Children^b (g/person per day)
Mammalian muscle
All mammalian muscle	1000	337
Beef and other bovines	514	337
Pork and other porcines	704	312
Sheep and other ovines	1000	311
Goat and other caprines	479	200
Horse and other equines	400	210
Rabbit	780	444
Mammalian trimmed fat, skin, and added fat excluding butter
Mammalian trimmed fat	258	73
Mammalian offal
All mammalian offal	1000	300
Mammalian liver	439	165
Mammalian kidney	360	300
Mammalian lung	300	150
Fish and seafood
All fish and seafood	2000	481
Fish	2000	345
Crustaceans	500	248
Molluscs	832	481
Poultry
Poultry muscle	1120	467
Poultry fat and skin	50	20
Poultry offal	389	130
Liver
Kidney
Eggs
Eggs (all)	450	196
Milk
Milk^d	3235	1551
Honey
Honey	194	90

^a General population includes children different from those described in the “children” column.

^b Children from 2 up to and including 9 years of age.

^c The high-level acute consumption is assessed as the single highest 97.5th percentile consumption over 1 d among countries for which data were made available to FAO/WHO.

^d Includes whole liquid milk, secondary milk products (e.g. skimmed milk, evaporated milk, milk powders), derived milk products (e.g. cream, butter) and manufactured milk products (yoghurt, cheese, ice cream).

Table 3. Hypothetical example of the impact of veterinary drug residue and food consumption estimates on dietary exposure calculations.

			EDI^a (adults)	GECDE^b (general population)		GEADE^c (general population)
Animal-derived tissue	Median drug residue at time × (μg/kg)	95/95 UTL drug residue at time × (μg/kg)	Mean level (μg/person/day)	Mean level (μg/person/day)	High level chronic (μg/person/day)	High level acute (μg/person/day)
Mammalian muscle (sheep and other ovines)	50	200	15 (50 μg/kg × 300 g/1000)	1.1 (50 μg/kg × 21 g/1000)	15.8 (50 μg/kg × 315 g/1000)	200 (200 μg/kg × 1000 g/1000)
Mammalian liver	200	700	20 (200 μg/kg × 100 g/1000)	0.4 (200 μg/kg × 2 g/1000)	47.4 (200 μg/kg × 237 g/1000)	307 (700 μg/kg × 439 g/1000)
Mammalian kidney	100	400	5 (100 μg/kg × 50 g/1000)	0.1 (100 μg/kg × 0.5 g/1000)	16.6 (100 μg/kg × 166 g/1000)	144 (400 μg/kg × 360 g/1000)
Mammalian trimmed fat	20	80	1 (20 μg/kg × 50 g/1000)	0.3 (20 μg/kg × 14 g/1000)	2.5 (20 μg/kg × 125 g/1000)	21 (80 μg/kg × 258 g/1000)
Milk	2	6	3 (2 μg/kg × 1500 g/1000)	2.1 (2 μg/kg × 1072 g/1000)	5.8 (2 μg/kg × 2917 g/1000)	19 (6 μg/kg × 3235 g/1000)
Eggs (all)	150	500	15 (150 μg/kg × 100 g/1000)	6.3 (150 μg/kg × 42 g/1000)	25.4 (150 μg/kg × 169 g/1000)	225 (500 μg/kg × 450 g/1000)
Honey	20	60	1 (20 μg/kg × 50 g/1000)	0.1 (20 μg/kg × 5 g/1000)	2.8 (20 μg/kg × 140 g/1000	12 (60 μg/kg × 194 g/1000)
Sum			Total mean exposures	Highest exposure high level (liver, 47.4) + total mean exposures (excl. liver, 9.9)		Highest exposure only
Total estimated exposure (μg/person/day)			60	57		307

^a EDI exposure = sum of (median tissue conc. × tissue consumption) for all tissues for an adult person weighing 60 kg.

^b GECDE = Highest 97.5th percentile exposure in consumers only from one animal-derived tissue (e.g. liver) + mean exposure in total population of all remaining animal-derived tissue. Numbers in italics are used in the calculation of total estimated exposure.

^c GEADE = (95/95 UTL residue concentration × the highest 97.5th percentile acute food consumption).

Table 4. Daily food consumption for a 60 kg adult used a by various regulatory agencies as inputs into exposure estimates.

	Consumption value (g/person/d)
Animal-derived tissue	European Medicines Agency (EU)^a	FDA Center for Veterinary Medicine (USA)^b	Australia^c	Veterinary Drugs Directorate (Canada)^d
Muscle^e	300	300	Data tables that report mean consumption for Australian NNS	500
Liver^e	100	100		250
Kidney^e	50	50		167
Fat^e	50	50		125
Milk	1500	1500		1670
Eggs	100	100		500
Honey	20	20		167

^a Consumers are assumed to eat EACH animal-derived tissue listed daily, so the ADI is allocated between all tissue types.

^b The Center for Veterinary Medicine (CVM) assumes that, when an individual consumes a full portion of edible muscle, liver, kidney, or fat tissue from one species, that individual would not consume a full portion of the same edible tissue from another species on the same day. CVM regulates milk, eggs and honey as independent food commodities; this means that CVM assumes these edible tissues are consumed in addition to the consumption of muscle, fat, kidney, or liver. Note that unlike the EMA approach, the ADI allocated for animal-derived tissue is not split between muscle, fat, kidney, and liver (i.e. a consumer is assumed to eat only one of these animal-derived tissues each day).

^c FSANZ (2009), p 52f.

^d Beef-specific tissue consumption factors (values differ for other commodities). As per the USA approach, Canada assumes a consumer will eat an entire portion of only one solid tissue type each day (the entire ADI is allocated to each solid tissue type) (VDD Health Canada 2007).

^e Mammalian tissues. Consumption amounts may differ for poultry or fish.

Table 5. Impact of variance in veterinary drug residue availability, and extremely low availability, on hypothetical correction factors for use in exposure assessments.

Compound	Mean availability of incurred residues	Availability range of incurred residues	Correction factor for mean availability	Correction factors for range of availability
A1	0.75	0.70–0.80	1.33	1.25–1.43
A2	0.75	0.60–0.90	1.33	1.11–1.67
B	0.15	0.10–0.20	6.67	5.0–10

FSANZ (Food Standards Australia New Zealand). 2009 Principles and Practices of Dietary Exposure Assessment for Food Regulatory Purposes [accessed 2017 Mar 14]. https://www.foodstandards.gov.au/publications/Documents/Principlespractices%20exposure%20assessment%202009.pdf.

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VDD Health Canada. 2007. Guidance for industry preparation of veterinary new drug submissions [accessed 2017 Mar 14]. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/vet/vdd_nds_guide-eng.pdf.

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