Daff Releases Results of 2008 National Residue Plan

NATIONAL RESIDUE PLAN REPORT 2012.

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 2012 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 categories 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; authorised veterinary medicines; approved animal feed additives and finally, 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 by sampling the most appropriate matrix for each substance.

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 2

a positive result, food is withdrawn from the market in the event that a risk assessment deems this to be necessary.

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, restriction of farms and application of the appropriate penalty to the farmer’s Single Payment arising from Cross-Compliance 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.

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 2012 official testing.

8. In 2012, a total of 20,580 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 44, or 0.21%. The comparable positive levels respectively for 2010 and 2011 were 0.26%, (62/23099) and 0.20% (40/20501).

9. An overview of the distribution of sampling 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.

10. The Department has a particular focus on 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). For example, in 2012, 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, 7 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, in any event, pose a risk to public health.

11. Residues of authorised veterinary medicines in excess of thresholds set for the major food- producing species under EU legislation (Maximum Residue Limits set under Commission Regulation 37/2010 ) were found in a total of 19 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 2012 was 0.1% (i.e. 13 non- compliant results out of 9,442 samples). In the case of the 13 animals involved, each carcase (bovine/ovine) 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 ovine and equine sectors, 6 samples contained residues of anthelmintics (medicines for the control and treatment of parasites) which indicated that specified post- treatment withdrawal periods had not been observed. Risk assessments conducted in the 6 cases did not indicate an unacceptable risk to consumer health and therefore it was not necessary to recall the product.

12. In the poultry sector, 1 egg sample was found to contain residues of Nicarbazin and Narasin, feed additives approved for use to maintain healthy poultry flocks. The Food Safety Authority of Ireland (FSAI) and the Department are satisfied on the basis of risk assessment that a specific risk to consumers of eggs resulting from this positive does not arise. The 3 4

European Food Safety Authority has also concluded that residues of Nicarbazin and other related substances at the level detected do not pose a risk to public health.

13. Two routine targeted samples taken in late 2012 from two small-scale honey producers’ premises tested positive for the environmental contaminant, lead. The honey involved had not been placed on the market and all affected honey was removed for destruction. Restrictions on the premises concerned remain in place while the Department’s investigations are on-going in the context of the seasonal production patterns in the sector.

14. 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 2012, in excess of 759 tests for 1,596 substances were carried out on 169 samples of farmed finfish for a range of residues. As in previous years, no non-compliant results were reported from the national monitoring programme for farmed finfish in 2012. Overall, the outcome for aquaculture demonstrates an absence 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 2006-2012.

15. In order to monitor conformity with Community legislation products of animal origin entering the EU from Third Countries through Ireland are subject to sampling and analysis for residues. Tests are carried out under monitoring plans or on suspicion of an irregularity. In 2012, 107 samples were taken from consignments imported directly into Ireland from Third Countries. 9 non compliant samples were identified, of which 7 were detained and rejected and 2 were withdrawn from the market.

4 APPENDIX 1

RESULTS OF DEPARTMENT OF AGRICULTURE, FOOD & THE MARINE RESIDUE MONITORING PROGRAMME FOR_2012

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 245 - 36 - 17 - 66 - - - 4 - - - - - 2 - - - - -

A2 243 11 32 - 14 1 25 - - - 4 - - - - - 2 - - - - -

A3 1723 - 203 - 100 - 42 - 53 - 21 - 64 - - - 1 - - - - -

A4 286 - 50 - 49 - 44 - - - 3 - - - - - 2 - - - - -

A5 1139 - 97 - 76 - 69 - - - 26 - - - - - 6 - - - - -

A6 745 6 208 - 126 1 185 - 78 - 17 - 79 - 87 - 5 - - - 25 -

Total No. 4381 17 626 - 382 2 431 - 130 - 75 - 143 - 87 - 18 - - - 25 - Analyses 6 Group B - Veterinary Drugs and Contaminants

B 1 – Antibacterial Substances

B1 5821 12 1817 - 870 1 264 - 314 - 64 - 112 - 126 - 24 - - - 30 -

B 2 - Other Veterinary Drugs

B2a 504 - 91 - 267 5 48 - 322 - 29 1 112 - - - 9 - - - - -

B2b 85 - 12 - 60 - 214 - - - 5 - 14 - 46 1 9 - - - - -

B2c 76 - 24 - 47 - 35 - - - 13 - 112 - - - 6 - - - 20 -

B2d 29 - 30 - 16 - - - - - 20 ------

B2e 142 - 66 - 46 - 25 - 80 - 70 - - - - - 3 - - - - -

B2f 69 - 147 - 29 - - - 78 - 17 - 126 ------

Total No. 905 -- 370 - 465 5 322 - 480 - 154 1 364 - 46 1 27 - - - 20 - Analyses

6 7 B 3 - Other Substances and Environmental Contaminants

B3a 132 - 69 - 91 - 34 - 68 - 28 - 35 - 9 - 9 - - - 10 -

B3b 122 - 59 - 81 - 24 - 68 - 8 - - - 9 - 9 - - - 10 -

B3c 143 - 40 - 64 - 63 - 67 - 9 - 12 - - - 30 - 72 - 20 5

B3d 37 - 13 - 18 - 24 - 103 - 3 - 7 ------

B3e ------86 ------

Total No. 434 - 181 - 254 - 145 - 306 - 48 - 140 - 18 - 48 - 72 - 40 5 Analyses

OVERALL RESULT - TOTAL GROUP A + GROUP B

Overall 11541 29 2994 - 1971 8 1162 - 1230 - 341 1 759 - 277 1 117 - 72 - 115 5 Total Analyses

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.

7 8 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 residue level could be set).

Group B – Veterinary drugs and contaminants

B1 – Antibacterial substances, including sulphonamides, quinolones

B2 - Other veterinary drugs

B2a Anthelmintics B2b Anticoccidials B2c Carbamates and pyrethroids B2d Sedatives B2e Non-steroidal anti-inflammatory drugs (NSAIDs) B2f Other pharmacologically active substances

B3 – Other substances and environmental contaminants

B3a Organochlorine compounds B3b Organophosphorus compounds B3c Chemical elements B3d Mycotoxins B3e Others

8 9 Appendix 2

Details of Non-compliant Results

Species/ Total No. Total No. of Non- Substance Animal Of compliant results* produce Samples* Farmed Fish 759 None N/A Bovine 11541 29 12 Antibiotics (2Oxytetracycline, 6Marbofloxacin, 1Danofloxacin&Oxytetracycline, 1 Amoxycillin,1 Penicillin G,1 Chlortetracycline), 11 Thyrostats (Thiouricil), 6 Nitrofurans (Nitrofurazone as SEM), Eggs 277 1 1 Anticoccidial (1 Nicarbazin & Narasin) Equine 341 1 1 Anthelmintic (Closantel) Farmed 117 None N/A Game (Deer) Honey 115 5 5 Chemical Elements (Lead) Milk 1230 None N/A Ovine 1971 8 1 Antibiotic (1 Oxytetracycline), 5Anthelmintics (3 Closantel, 1Nitroxynil, 1Rafoxanide & Fenbendazole Sulphone), 1 Thyrostats (Thiouracil) 1 Nitrofurans (1 Nitrofurazone as SEM). , Porcine 2994 None N/A Poultry 1162 None N/A Wild Game 72 None N/A (Deer) Grand totals 20580 44

*Numbers relate to samples taken on a routine targeted basis and also on suspicion, including follow-up investigations.

Appendix 3

Non-Compliant Results 2012

Group A substances

Non-compliant results Follow-up actions

17 Non-compliant Results Bovines

 Thyrostats-Thiouracil 11 target samples confirmed non-compliant for Thiouracil at the  Urine following levels:  11 non-compliant results (1) 8.7µg/kg (2) 9.4µg/kg (3) 11.0µg/kg (4) 27.6µg/kg (5) 19.5µg/kg (6) 20.1µg/kg (7) 11.3µg/kg (8) 12.2µg/kg (9) 9.8µg/kg (10) 9.3µg/kg (11) 12.0µg/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.

 Nitrofurans-Nitrofurazone 5 target samples confirmed non-compliant for Nitrofurazone as as SEM SEM at the following levels:  Plasma  5 non-compliant results (1) 0.139µg/kg (2) 0.154µg/kg (3) 0.140µg/kg (4) 0.285µg/kg (5) 0.26µg/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. A number of feed samples that were analysed for Nitrofurans/ SEM proved negative.

 Nitrofurans-Nitrofurazone 1 target sample confirmed non-compliant for Nitrofurazone as as SEM, Furaltadone as SEM, Furaltadone as AMOZ & Furazolidone as AOZ AMOZ & Furazolidone as AOZ (1) SEM - 0.298µg/kg, AMOZ 0.156µg/kg, AOZ  Plasma 0.231µg/kg  1 non-compliant result A follow up investigation was initiated at the farm of origin and no evidence of illegal use was identified.

2 Non-compliant Results Ovine

 Nitrofurans-Nitrofurazone 1 target sample confirmed non-compliant for Nitrofurazone as as SEM SEM at the following level 0.076µg/kg  Liver  1 non-compliant result

 Thyrostats-Thiouracil 1 target sample confirmed non-compliant for Thiouracil at the  Urine following level 12.7µg/kg  1 non-compliant result 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.

Group B Substances

Non-compliant Results Follow-up actions

12 Non-compliant Results Bovines

 Antimicrobials  Muscle 12 Suspect samples confirmed non-compliant for antibiotics as  12 non-compliant results follows:  1 >500µg/kg & 265.8µg/kg Oxytetracycline & Danofloxacin  1 Amoxycillin >100µg/kg  1 Oxytetracycline >1000µg/kg  1 Oxytetracycline >500µg/kg  1 Marbofloxacin 172.2µg/kg  5 Marbofloxacin >300µg/kg  1 Penicillin G >100µg/kg  1 Chlortetracycline 237µg/kg

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.

6 Non-compliant Results Ovine

 Antimicrobials 1 suspect sample confirmed non-compliant for  Muscle Oxytetracycline >500µg/kg  1 non-compliant result

 Anthelmintics 1 target sample confirmed non-compliant for Nitroxynil 164µg/kg  Liver  5 non-compliant results 1 target sample confirmed non-compliant for Rafoxanide & Fenbendazole at 2771µg/kg & 5079.2µg/kg

3 target samples confirmed non-compliant for Closantel (1) 2608.04µg/kg (2) 4290.58µg/kg (3) 2429.7µg/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.

5 Non-compliant Results Honey

 Chemical Elements 2 target samples confirmed non-compliant for Lead  Honey (1) 65.61µg/kg (2) >200µg/kg  5 non-compliant results 3 suspect samples confirmed non-compliant for Lead (1) >200µg/kg (2) >200µg/kg (3) 61.4µg/kg

Above samples relate to two honey producers. When initial results were received, further sampling and comprehensive follow-up investigations took place at apiary level. All honey found to be contaminated was seized for destruction.

Restrictions have been placed on the movement of the two beekeepers hives and the extraction of their honey. Due to the seasonal nature of honey production follow-up investigations are on-going in an effort to identify the source of the contamination.

1 Non-compliant Result Equine

 Anthelmintics 1 target sample confirmed non-compliant for Closantel  Liver 5.9µg/kg  1 non-compliant result A full on farm investigation including examination of animal remedies record carried out.

1 Non-compliant Result Egg

 Anticoccidials 1 target sample confirmed non-compliant for Narasin at  Egg 3.961µg/kg & Nicarbazin at 823.15µg/kg  1 non-compliant result Available evidence indicated that the most likely cause was cross contamination of poultry feed at the supplying feed mill, which has since ceased production for unrelated reasons.