NATIONAL RESIDUE PLAN REPORT 2011.
Background on the National Residue Plan.
1. Under EU legislation (Council Directive 96/23/EC), each member state is required to
implement a residue monitoring plan and to submit their programmes annually to the
European Commission for approval. Ireland’s Residue Monitoring Programme for 2011 was
approved by the European Commission. Third Countries wishing to export animal products
to the EU are similarly required to satisfy the European Commission that their legislation,
controls and residue surveillance measures provide equivalent guarantees for EU consumers.
2. The national legal basis for the Residue Plan is provided for in the European Communities
(Control of Animal Remedies and their Residues) Regulations 2009.
3. The scope of testing under the Plan is very comprehensive, covering all 11 animal/food
areas and 18 distinct residue groups (each residue group is, in turn, comprised of a number
of sub-groups). These residue-groups fall into four broad categories: banned substances,
such as growth-promoting hormones, approved veterinary medicines, approved animal feed
additives and environmental contaminants. Implementation of the Plan involves taking
samples from food producing species at farm and primary processing/packing levels; this
strategic approach reflects current scientific and analytical advice designed to maximise the
effectiveness of the testing regime.
4. Most samples (c. 80%) are taken in accordance with criteria designed to target animals or
products, which are more likely to contain illegal residues (‘targeted sampling’). However,
the results also reflect the outcome of sampling conducted in specific cases where the
presence of illegal residues was suspected (‘suspect sampling’) by Department or Local
Authority inspectors. This can arise, for example, on the basis of the ante or post-mortem
examinations of animals at slaughterhouses, or the previous history of the supplier; in such
cases the animals concerned are withheld from the food chain, pending the outcome of the
test. In the case of routine targeted samples, where animals are not detained, in the event of
a positive result, food is withdrawn from the market in the event that a risk assessment
deems this to be necessary.
2
5. All positive results lead to a follow-up investigation at the farm of origin. This inspection
involves not just an examination of the cause of the particular breach but also a general
review of the arrangements in place on the farm in relation to veterinary medicines,
including record-keeping. Follow-up measures are taken, including, where appropriate,
application of the appropriate penalty to the farmer’s Single Payment arising from CrossCompliance requirements. Positive results also usually result in an increased level of
residue monitoring for the supplier concerned.
6. Samples are analysed at officially approved laboratories holding accreditation to the
International Standard (ISO 17025) and incorporating current analytical technology. The
laboratory network continuously engages in research and development of analytical
methodologies in line with scientific developments under the guidance of the EU reference
laboratories. This ensures improvement in analytical capability with a view to meeting
current and future requirements towards enhancement of consumer protection. The fruits of
this work are evidenced by the fact that laboratories are now capable of detecting residues at
extremely low levels which, are far below the levels at which the residues concerned pose an
unacceptable risk to human health.
7. In addition to official testing carried out by the Department of Agriculture, Food & the
Marine and Local Authorities, primary processors in the red and white meat sectors and also
in the milk sector are required to carry out residue testing under legislation put in place in
1998. Processors are required to submit to the Department for approval annual residue
monitoring plans. Under this regime, processors are required to apply a progressively
increasing scale of testing to suppliers of residue positive animals or milk.
Outcome to the 2011 official testing.
8. In 2011, a total of 20,501 samples were taken from all 8 food producing species, as well as
from milk, eggs and honey. The overall level of positives across all substances was 40, or
0.20%. The comparable positive levels respectively for 2009 and 2010 were 0.33%
(85/25,234) and 0.26% (62/23099).
9. An overview of the distribution of samples and positive results across species/products and
residue groups is given in Appendix 1. An overview of all positives results is given in
Appendix 2, while more detailed information on these positives is given in Appendix 3.
2
3
10. In the course of 2011, as a result an on-farm investigation by Department inspectors, 2
bovine animals were found to contain Clenbuterol (a beta agonist covered by the EU
Hormone Ban on growth promoters). A small quantity of the illegal substance itself was
also found and seized. Other animals on the farm concerned tested in the course of the
investigation, during which the farm was restricted, were found to be negative. A
prosecution file in the case concerned has been forwarded to the Director of Public
Prosecutions. While the evidence suggests that this finding of the illegal growth promoter,
the first in Ireland since 1999, was isolated, the Department initiated increased surveillance,
including an increased level of focussed testing at slaughter plants. This involved
supplementing the existing sampling programme by an additional 324 samples. No further
Clenbuterol positive has been detected in the interim.
11. The Department also fully investigated any other laboratory findings which indicated a
potential use of banned substances i.e. hormones or other growth promoters prohibited under
the EU Hormone Ban (Directive 92/22/EC) or otherwise banned on public health grounds
(Table 2 to Commission Regulation 37/2010). The substance, Thiouracil, which may
indicate the potential use of growth promoters covered by the EU Hormone Ban, was
detected in 12 animals in the bovine and ovine sectors. In addition, 5 animals in the bovine
and ovine sector indicated a presence of ‘SEM’ (Semicarbazide), an indicator of the
potential use of the banned antibiotic substance nitrofurazone. The Department’s
investigations concluded that no illegal administration had taken place. Current national and
EU scientific evidence is that the low levels found, which, it is recognised, are most likely
attributable to natural/environmental factors, or dietary factors, do not pose a risk to public
health.
12. Residues of authorised veterinary medicines in excess of thresholds set under EU legislation
(Maximum Residue Limits set under Commission Regulation 37/2010 ) were found in a
total of 14 samples. In the case of antibiotic medicines, where testing continues at levels
well in excess of those required by EU obligations, the overall positive level across all
species in 2011 was 0.07% (i.e. 7 non-compliant results out of 9,341 samples). In the case of
5 of the animals involved, each carcase (bovine) had been detained on suspicion by the
Department’s veterinary inspectors in slaughter plants and was excluded from the food chain
on foot of the analytical results; in the two other cases (porcine), a risk assessment
concluded that there was no need to recall food from the market. Also in the bovine and
3
4
ovine sectors, 7 samples contained residues of anthelmintics (medicines authorised for the
control and treatment of parasites) which indicated that specified post-treatment withdrawal
periods had not been observed.
13. In the bovine milk sector, continuing a trend initially discovered in 2010 as a result of
advances in analytical techniques, very low levels of residues of authorised flukicides were
detected in 2 bovine milk samples. Action has already been taken by the Irish Medicines
Board (as licensing authority) to have the medicinal product labelelling amended by the
licence holders to address this issue. A risk assessment by the Food Safety Authority of
Ireland also concluded that the very low levels found did not of themselves indicate a
specific risk to human health.
14. In the poultry sector, 1 sample was found to contain a trace of Isoxsuprine, which is a beta
agonist, and as such covered by the EU Hormone Ban on growth promoters – however, its
use is authorised under EU legislation for very limited medicinal purposes in horses and
bovines. While the potential for its illegal use in poultry is, for practical purposes,
negligible, in view of the nature of the substance, a comprehensive follow-up investigation
was conducted embracing the farm of origin (including follow-up sampling, which proved
negative) and its feed sources. This investigation was able to establish that illegal treatment
had not taken place.
15. A routine targeted sample taken in late 2011 from the premises of a small-scale honey
producer tested positive for the environmental contaminant, lead. Having consulted with the
FSAI, as a precautionary measure, the Department recalled a small quantity of product
already present on the market. Restrictions on the premises concerned remain in place while
the Department’s investigations are on-going. An ongoing investigation at the premises of
another honey producer, arising from lead positives detected in 2010 was closed out in 2011
when it was established from follow-up sampling that appropriate remedial actions taken
were effective.
16. In the aquaculture sector, the Sea Fisheries Protection Authority (SFPA), with support from
the Marine Institute (MI), is responsible for residue controls on farmed finfish under the
national residue-monitoring plan. In 2011, in excess of 630 tests for 1,566 substances were
carried out on 140 samples of farmed finfish for a range of residues. As in previous years,
4
5
no non-compliant results were reported in the routine ‘target’ national monitoring
programme samples for farmed finfish in 2011. Overall, the outcome for aquaculture
remains one of consistently low occurrence of residues in farmed finfish in recent years,
with 0.23% non-compliant results from routine targeted in 2004, 0.09% in 2005 and 0% in
2006-2011.
17. In order to complement the approval and control arrangements of Third Country food plants
exporting to the EU, sampling and analysis for residues is also carried out on produce of
animal origin entering the EU from Third Countries through Ireland. Of the 93 samples
taken in 2011 from consignments imported directly into Ireland from Third Countries, 2
positive samples were identified. While, the concentration of residues detected was below
the level to cause a food safety risk, nevertheless, subsequent consignments from the same
sources have been targeted.
5
APPENDIX 1
RESULTS OF DEPARTMENT OF AGRICULTURE, FOOD & THE MARINE
RESIDUE MONITORING PROGRAMME FOR_2011
Group A Prohibited Substances
Substance
Bovine
Pigs
Sheep/Goats
Poultry
Milk
Horses
Aquaculture
Eggs
Farm Game
Wild Game
Honey
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
A1
243
-
36
-
19
-
57
-
-
-
4
-
-
-
-
-
2
-
-
-
-
-
A2
242
11
28
-
11
1
29
-
-
-
4
-
-
-
-
-
2
-
-
-
-
-
A3
1740
-
190
-
105
-
40
-
54
-
24
-
40
-
-
-
2
-
-
-
-
-
A4
289
-
47
-
49
-
62
-
-
-
3
-
-
-
-
-
2
-
-
-
-
-
A5
1459
2
93
-
79
-
68
1
-
-
28
-
-
-
-
-
6
-
-
-
-
-
A6
749
1
205
-
122
4
184
-
83
-
18
-
40
-
86
-
6
-
-
-
25
-
4722
14
599
-
385
5
440
1
137
-
81
-
80
-
86
-
20
-
-
-
25
-
Total No.
Analyses
7
Group B - Veterinary Drugs and Contaminants
B 1 – Antibacterial Substances
Substance
B1
Bovine
Pigs
Sheep/Goats
Poultry
Milk
Horses
Aquaculture
Eggs
Farm Game
Wild Game
Honey
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
5535
5
2111
2
841
-
222
-
312
-
45
-
92
-
127
-
27
-
-
-
30
-
B 2 - Other Veterinary Drugs
Substance
Bovine
Pigs
Sheep/Goats
Poultry
Milk
Horses
Aquaculture
Eggs
Farm Game
Wild Game
Honey
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
B2a
498
3
91
-
260
4
44
-
312
2
20
-
92
-
-
-
12
-
-
-
-
-
B2b
82
-
12
-
57
-
216
-
-
-
4
-
-
-
46
1
10
-
-
-
-
-
B2c
76
-
25
-
43
-
34
-
-
-
13
-
92
-
-
-
8
-
-
-
20
-
B2d
28
-
31
-
13
-
-
-
-
-
16
-
-
-
-
-
-
-
-
-
-
-
B2e
139
-
65
-
42
-
19
-
83
-
58
-
-
-
-
-
4
-
-
-
-
-
B2f
66
-
138
-
31
-
-
-
84
-
20
-
92
-
-
-
-
-
-
-
-
-
Total No.
Analyses
889
--
362
-
446
4
313
-
479
2
131
-
276
-
46
1
34
-
-
-
20
2
7
8
B 3 - Other Substances and Environmental Contaminants
Substance
Bovine
Pigs
Sheep/Goats
Poultry
Milk
Horses
Aquaculture
Eggs
Farm Game
Wild Game
Honey
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
B3a
131
-
86
-
92
-
35
-
59
-
18
-
18
-
12
-
13
-
-
-
10
-
B3b
121
-
60
-
82
-
25
-
59
-
8
-
-
-
12
-
13
-
-
-
10
-
B3c
144
-
40
-
63
-
58
-
63
-
10
-
9
-
-
-
29
-
108
-
16
3
B3d
-
-
-
-
-
-
-
-
102
-
-
-
7
-
-
-
-
-
-
-
-
-
B3e
-
-
-
-
-
-
-
-
-
-
-
-
75
-
-
-
-
-
-
-
-
-
Total No.
Analyses
396
-
186
-
237
-
118
-
283
-
36
-
109
-
24
-
55
-
108
-
36
3
OVERALL RESULT - TOTAL GROUP A + GROUP B
Substance
Overall
Total
Analyses
Bovine
Pigs
Sheep/Goats
Poultry
Milk
Horses
Aquaculture
Eggs
Farm Game
Wild Game
Honey
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
Num.
Pos.
11542
22
3258
2
1909
9
1093
1
1211
2
293
-
557
-
283
1
136
-
108
-
111
3
Notes
(a) See over for key to each substance sub-group
(b) Results are from routine targeted and on suspicion testing
(c) Results reflect testing at primary processing plants and, where appropriate, on farm.
(d) It is not mandatory to test for all substances in every species/product
(e) In the case of aquaculture, 144 fish were tested in total.
8
9
Group A – (Prohibited Substances) Substances having anabolic effect and unauthorised substances
A1 - Stilbenes, stilbene derivatives, and their salts and esters
A2 - Antithyroid agents
A3 - Steroids
A4 - Resorcylic acid lactones including zeranol
A5 - Beta-agonists
A6 - Compounds included in Annex IV to Council Regulation (EEC) No. 2377/90 of 26 June 1990 (i.e. for which no maximum
level could be set).
Group B – Veterinary drugs and contaminants
B1 –
Antibacterial substances, including sulphonomides, quinolones
B2 - Other veterinary drugs
B2a
B2b
B2c
B2d
B2e
B2f
Anthelmintics
Anticoccidials
Carbamates and pyrethroids
Sedatives
Non-steroidal anti-inflammatory drugs (NSAIDs)
Other pharmacologically active substances
B3 – Other substances and environmental contaminants
B3a
B3b
B3c
B3d
B3e
Organochlorine compounds
Organophosphorus compounds
Chemical elements
Mycotoxins
Others
9
residue
10
Appendix 2
Details of Non-compliant Results
Species/
Animal
produce
Farmed Fish
Bovine
Total No.
Of
Samples*
557
11542
Eggs
Equine
Farmed
Game (Deer)
Honey
Milk
Ovine
283
293
136
1
None
None
111
1211
1909
3
2
9
3258
1093
108
2
1
None
20501
40
Porcine
Poultry
Wild Game
(Deer)
Grand totals
Total No. of Noncompliant results*
Substance
None
22
N/A
5 Antibiotics (3 Oxytetracycline, 1 Marbofloxacin, 1 Sulfamethazine), 11 Thyrostats (Thiouricil),
1 Nitrofurans (Nitrofurazone as SEM), 3 Anthelmintics (1 Triclabendazole, 2 Ivermectin),
2 Beta Agonists (2 Clenbuterol).
1 Anticoccidial (1 Monensin)
N/A
N/A
3 Chemical Elements (Lead)
2 Anthelmintics (1 Ivermectin, 1 Nitroxinil).
4 Anthelmintics (3 Closantel, 1 Hydroxy-flubendazole & Amino-flubendazole), 1 Thyrostats (Thiouracil)
4 Nitrofurans (4 Nitrofurazone as SEM).
,
2 Antibiotics (1 Sulfadimidine, 1 Sulfadiazine)
1 Beta Agonists (1 Isoxsuprine).
N/A
*Numbers relate to samples taken on a routine targeted basis and also on suspicion, including follow-up investigations.
10
11
Appendix 3
Non-Compliant Results 2011
Group A substances
Non-compliant results
14 non-compliant results
Thyrostats-Thiouracil
Urine
11 Non-Compliant results
Follow-up actions
Bovines
11 target samples confirmed non-compliant for
Thiouracil at the following levels:
(1) 12.9µg/kg (2) 16.6µg/kg (3) 23.6µg/kg
(4) 22.5µg/kg (5) 9.0µg/kg (6) 15.2µg/kg
(7) 13.7µg/kg (8) 8.8µg/kg (9) 11.6µg/kg
(10) 10.3µg/kg (11) 10.7µg/kg
Follow up investigations were initiated at farm level
in all cases and no evidence of illegal use was
identified. In line with scientific evidence, the
Competent Authority has concluded that the residues
resulted from dietary factors.
Beta Agonists
Urine
2 Non-Compliant results
2 samples tested in the context of an on-farm investigation
confirmed non-compliant for Clenbuterol at the following
levels:
(1) 5.2µg/kg (2) 0.7µg/kg
The farm was placed under strict surveillance
including blocking of all transportation of any
animals to and from the farm. Criminal prosecution
for alleged illegal treatment was initiated and remains
ongoing.
Nitrofurans-Nitrofurazone as
SEM
Plasma
1 Non-Compliant result
1 target sample confirmed non-compliant for
Nitrofurazone as SEM at the following levels:
(1) 0.189µg/kg
A follow up investigation was initiated at the farm of
origin and no evidence of illegal use was identified.
In line with scientific evidence, the Competent
Authority has concluded that the residues resulted
from extraneous factors.
11
12
1 non-compliant Result
Beta Agonists
Liver
1 Non-Compliant result
Poultry
1 target sample confirmed non-compliant for
Isoxsuprine at 0.16µg/kg
A follow up investigation was initiated at the plant
and associated rearing units and did not reveal any
evidence of illegal administration.
5 Non-compliant results
Nitrofurans-Nitrofurazone as
SEM
Liver
4 Non Compliant Result
Thyrostats-Thiouracil
Urine
1 Non-compliant results
Ovine
4 target samples confirmed non-compliant for
Nitrofurazone as SEM at the following levels:
(1) 0.115µg/kg
(2) 0.139µg/kg (3) 0.159µg/kg
(4) 0.171µg/kg
1 target sample confirmed non-compliant for
Thiouracil at the following level:
(1) 38.2µg/kg
Follow up investigations were initiated at farm level
in all cases and no evidence of illegal use was
identified. In line with scientific evidence, the
Competent Authority has concluded that the residues
resulted from dietary factors.
12
13
Group B substances
Non-compliant results
8 non-compliant results
Antimicrobials
Muscle
5 non-compliant results*
Anthelmintics
Liver
3 Non-compliant results
Follow-up actions
Bovines
5 Suspect sample confirmed non-compliant for
antibiotics
(1) 131.5µg/kg oxytetracycline
(2) >300µg/kg marbofloxacin
(3) >200µg/kg sulfamethazine
(4) 360µg/kg oxytetracycline
(5) 150µg/kg oxytetracycline
3 target sample confirmed non-compliant for
anthelmintics
(1) 3591 µg/kg triclabendazole
(2) 816.5 µg/kg ivermectin
(3) 302 µg/kg ivermectin
All suspect carcases declared unfit for human
consumption and destroyed. Full on farm investigations
including examination of medicines on farm and animal
remedies record were carried out in each case. As
appropriate, advice is given to the farmer and follow-up
visits take place.
2 non-compliant results
Antibiotics
Muscle
2 non-compliant results*
Porcine
2 Target sample confirmed non-compliant for
Antibiotics as follows:
(1) Sulfadiazine >200µg/kg
(2) Sulfadimidine 1250µg/kg
Full on farm investigations including examination of
medicines on farm and animal remedies record were
carried out in each case. As appropriate, advice is given
to the farmer and follow-up visits take place.
4 Non –compliant results
Anthelmintics
Liver
4 non-compliant result
Ovine
3 target sample confirmed non-compliant for
Closantel
(1) 2860.3µg/kg (2) 5284µg/kg (3) 2566µg/kg
1 target sample confirmed non-compliant for
Hydroxy-flubendazole & Amino-flubendazole at
3.95µg/kg & 2.65µg/kg
Full on farm investigations including examination of
medicines on farm and animal remedies record were
carried out in each case. As appropriate, advice is given
to the farmer and follow-up visits take place.
13
14
3 non-compliant result
Chemical Elements
Honey
3 non-compliant result
Honey
2 target sample confirmed non-compliant for Lead
(1) 87.381µg/kg (2) 199.99µg/kg
1 suspect sample confirmed non-compliant for Lead
(1) 90.492µg/kg
Targeted sample (1) was taken as part of the follow-up
investigation into an apiary that had a non-compliance
associated with lead in honey in late 2010. Honey
produced on this apiary in 2011 was detained in the hives
and was not extracted for human consumption.
Targeted sample (2) relates to a separate case. The above
suspect sample was taken as part of the follow-up activity
arising from the earlier targetted non-complaint result.
This beekeeper’s honey was removed from the market and
restrictions placed on his hives and future honey. Due to
the seasonal nature of honey production the follow-up
investigation in this case is on-going.
1 non-compliant result
Anticoccidials
Eggs
1 non-compliant result
2 non-compliant results
Anthelmintics
Bovine Milk
2 non-compliant results
Eggs
1 target sample confirmed non-compliant for
Monensin 20.7µg/kg
A full on farm investigation including examination of
animal remedies record carried out
Milk
2 target samples taken from milk tanks at farm level
confirmed non-compliant as follows:
1 x Ivermectin at 1.2µg/kg
1 x Nitroxynil at 8.8µg/kg
Follow up farm investigations were carried out in all
cases. Risk assessment concluded that at very low levels
found, it was not necessary to withdraw milk from the
market.
14