Daff Releases Results of 2008 National Residue Plan s1

NATIONAL RESIDUE CONTROL PLAN REPORT 2014

Background on the National Residue Control Plan

1. Under EU legislation (Council Directive 96/23/EC1), 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 National Residue Control Programme (NRCP) for 2014 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 NRCP is provided for in the European Communities (Control of Animal Remedies and their Residues) Regulations 2009.

3. The scope of testing under the NRCP 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 environmental contaminants. Implementation of the NRCP 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. 85%) are taken in accordance with criteria designed to target animals or products that are more likely to contain illegal residues (‘targeted sampling’). 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

1 Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EC and 91/664/EEC 2

a positive result, food is withdrawn from the market if 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 and the Marine and Local Authorities, primary processors in the red and white meat sectors and the milk sector are required to carry out residue testing under legislation put in place in 1998. Processors are required to submit annual residue monitoring plans to the Department for approval. Under this regime, processors are required to apply a progressively increasing scale of testing to suppliers of residue positive animals or milk.

Outcome of 2014 official testing

8. In 2014, a total of 19095 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 42, or 0.22%. The comparable level for 2013 was 0.23% (46/19869) and for 2012 was 0.21% (44/20,580).

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 that indicate a potential use of banned substances i.e. hormones or other growth promoters prohibited under the EU Hormone Ban (Directive 92/22/EC2) or otherwise banned on public health grounds (Table 2 to Commission Regulation 37/2010). For example, in 2014, the substance, Thiouracil, which may indicate the potential use of growth promoters covered by the EU Hormone Ban, was detected in 13 animals in the bovine and farm game sectors. In addition, 2 animals in the bovine 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 given the very low levels found, which it is recognised are most likely attributable to natural/environmental or dietary factors, there is no 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 23 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 2014 was 0.1% (i.e. 13 non-compliant results out of 8062 samples). In the case of 10 of the animals involved, each carcase (bovine/equine) had been detained on suspicion by the Department’s veterinary inspectors in slaughter plants and were excluded from the food chain on foot of the analytical results. In the other cases (one porcine, one bovine, one honey), a risk assessment concluded that there was no need to recall food from the market. In the bovine, ovine, equine and milk sectors, 10 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 10 cases did not indicate an unacceptable risk to consumer health and therefore it was not necessary to recall the product.

2 Council Directive 96/22/EC concerning the prohibition on the use in stock-farming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC 3 4

12. As a follow-up to the 2 cases of elevated lead in honey identified in 2012 further intensive sampling of honey produced by these beekeepers took place in 2014. All samples analysed retuned acceptable results and the investigations into both cases have concluded.

13. Traces of an antibiotic (Chlortetracycline) were found in one sample of honey analysed in late 2014. However a risk assessment concluded that the level of antibiotic present in the honey did not represent a food safety risk and there was no need to recall the food from the market. Notwithstanding this a full follow-up investigation was conducted in early 2015 and the beekeeper involved will be subject to further sampling when his 2015 honey crop has been harvested.

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 2014, in excess of 706 tests and a total of 1,882 determinants were carried out on 136 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 2014. Overall, the outcome for aquaculture remains one of consistently low occurrence of residues in farmed finfish, with 0% non-compliant target residue results for the period 2006-2014.

15. In the wild game sector, 3 samples tested positive for lead. Presence of the residue is most likely due to environmental contamination or as a result of lead bullets used to kill the animals. Risk assessments conducted in the 3 cases did not indicate an unacceptable risk to consumer health and therefore it was not necessary to recall the product.

16. Separate from the NRCP and in order to monitor conformity with Community legislation, products of animal origin entering the EU through Ireland are subject to sampling and analysis for residues. Tests are carried out under monitoring plans or on suspicion of an irregularity. In 2014, 96 samples were taken from consignments imported directly into Ireland from countries outside the EU/EEA. 3 non compliant samples were identified. One of the consignments was withdrawn from the market and re-despatched to the third country of origin. A risk assessment for the other two consignments concluded there was no risk to human health from consumption. However batches that tested positive were not permitted to be placed on the market. In each case consignments from the same sources have been targeted for sampling.

4 APPENDIX 1

RESULTS OF DEPARTMENT OF AGRICULTURE, FOOD & THE MARINE RESIDUE MONITORING PROGRAMME FOR_2014

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 219 - 41 - 21 - 67 - - - 4 - - - - - 1 - - - - -

A2 239 12 36 - 18 - 19 - - - 4 - - - - - 2 1 - - - -

A3 1608 - 201 - 108 - 40 - 51 - 23 - 51 - - - 1 - - - - -

A4 263 - 60 - 44 - 56 - - - 3 - - - - - 2 - - - - -

A5 1132 - 101 - 79 - 65 - - - 31 - - - - - 5 - - - - -

A6 742 2 206 - 126 - 205 - 81 - 19 - 54 - 86 - 6 - - - 25 -

Total No. 4203 14 645 - 396 - 452 - 132 - 84 - 105 - 86 - 17 1 - - 25 - Analyses 6 Group B - Veterinary Drugs and Contaminants

B 1 – Antibacterial Substances

B1 4673 9 1502 2 847 - 301 - 319 0 145 1 91 - 126 - 26 - - - 32 1

B 2 - Other Veterinary Drugs

B2a 515 1 87 - 286 7 77 - 301 1 35 1 91 - - - 12 - - - - -

B2b 83 - 12 - 56 - 221 - - - 4 - - - 47 - 10 - - - - -

B2c 85 - 25 - 48 - - - - 13 - 91 - - - 8 - - - 20 - 46 B2d 28 - 29 - 16 - - - - - 25 ------

B2e 131 - 60 - 41 - 28 - - 162 1 - - - - 4 - - - - - 81 B2f 69 - 138 - 34 - - - - 20 1 103 ------80 Total No. 911 1 351 - 481 7 372 - 462 1 259 2 285 - 47 - 34 - - - 20 - Analyses

6 7 B 3 - Other Substances and Environmental Contaminants

B3a 130 - 65 - 94 - 34 - 60 - 28 - 29 - 25 - 12 - - - 10 -

B3b 120 - 55 - 86 - 24 - 60 - 8 - - - 10 - 12 - - - 10 -

B3c 118 - 43 - 62 - 57 - 58 - 9 - 10 - - - 28 - 111 3 18 -

B3d 40 - 15 - 18 - 25 - 103 - 4 - 6 ------

B3e ------69 ------

Total No. 408 - 178 - 260 - 140 - 281 - 49 - 114 - 35 - 52 - 111 3 38 - Analyses

OVERALL RESULT - TOTAL GROUP A + GROUP B

Overall - - - Total 10195 24 2676 2 1984 7 1265 - 1194 1 537 3 595 294 129 1 111 3 115 1 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 136 None N/A Bovine 10195 24 9 Antibiotics (4Oxytetracycline, 1Marbofloxacin, 1Benzylpenicillin(Pen G), 1 Sulfadiazine, 1 Amoxicillin, 1 Sulfamethazine), 1 Anthelmintic (Closantel), 12 Thyrostats (Thiouracil), 2 Nitrofurans (Nitrofurazone as SEM). Eggs 294 None N/A Equine 537 3 1 Antibiotic (Amoxicillin), 1 NSAID’s (Oxyphenylbutazone & Phenylbutazone), 1 Anthelmintic (Closantel) Farmed Game 129 1 1 Thyrostat (Thiouracil) (Deer) Honey 115 1 1 Antibiotic (Chlortetracycline) Milk 1194 1 1 Anthelmintic (Levamisole) Ovine/Caprine 1984 7 7 Anthelmintics (4 Closantel, 2 Rafoxanide, 1 Nitroxynil). Porcine 2676 2 2 Antibiotics (1Sulfadiazine & Trimethoprim, 1 Sulfadiazine). Poultry 1265 0 N/A Wild Game 111 3 3 Chemical Elements (Lead) (Deer/Birds) Total: 19095 42

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

Appendix 3

NON-COMPLIANT RESULTS IN 2014 Group A substances Non-compliant results Follow-up actions 14 non-compliant results Bovines  Thyrostats-Thiouracil 12 target samples confirmed non-compliant for Thiouracil  Urine at the following levels:  12 Non-Compliant results (1) 8.8µg/kg (2) 12.2 µg/kg (3) 30.7µg/kg (4) 21.2µg/kg (5) 14.5µg/kg (6) 32.3µg/kg (7) 10.8µg/kg (8) 14.7µg/kg (9) 31.6µg/kg (10) 8.0µg/kg (11) 9.6µg/kg (12) 13.6 µg/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 as 2 target samples confirmed non-compliant for SEM Nitrofurazone as SEM at the following levels:  Plasma (1) 0.69µg/kg (2) 0.23µg/kg  2 Non-Compliant result A follow up investigation was initiated at the farms of origin and no evidence of illegal use was identified. In line with scientific evidence, the Competent Authority has concluded that the residues may have resulted from accidental exposure to environmental or dietary factors.

1 Non-compliant results Farmed Game  Thyrostats-Thiouracil 1 target sample confirmed non-compliant for Thiouracil at  Urine 11.7µg/kg  1 Non-Compliant result A follow up investigation was initiated at farm level 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

10 non-compliant results Bovines  Antimicrobials  Muscle 9 suspect samples confirmed non-compliant for antibiotics  9 non-compliant results at the following levels: (1) Penicillin G >100µg/kg (2) Marbofloxacin 315.5µg/kg (3) Sulfadiazine >200µg/kg (4) Amoxicillin 71.6µg/kg (5) Oxytetracycline 190.5µg/kg (6) Oxytetracycline >400µg/kg (7) Oxytetracycline 383.1µg/kg (8) Oxytetracycline 371.7µg/kg (9) Sulfamethazine >200µg/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.

 Anthelmintics  Liver 1 target sample confirmed non-compliant for closantel at  1 non-compliant result the following level: 2930µg/kg A full on farm investigation including examination of medicines on farm and animal remedies records were carried out.

2 Non-compliant results Porcine  Antimicrobials  Muscle 1 target sample confirmed non-compliant for Sulfadiazine  2 non-compliant results >200µg/kg & Trimethoprim >100µg/kg

1 target sample confirmed non-compliant for Sulfadiazine at 198µg/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.

3 non-compliant result Equine  NSAID’s 1 target sample confirmed non-compliant for  Kidney Phenylbutazone 9.1µg/kg & Oxyphenbutazone >20µg/kg  1 non-compliant result Follow up investigation was carried out including examination of animal remedies records and appropriate advice given to the owner keeper

1 target sample confirmed non-compliant for Closantel at  Anthelmintics 9.2µg/kg  Liver Follow up investigation was carried out including  1 non-compliant result examination of animal remedies record and appropriate advice given to the owner keeper

1 suspect sample confirmed non-compliant for Amoxicillin at >100µg/kg  Antimicrobials  Muscle Follow up investigation was carried out including  1 non-compliant result examination of animal remedies record and appropriate advice given to the owner keeper

7 Non –compliant results Ovine  Anthelmintics 4 target samples confirmed non-compliant for closantel at  Liver the following levels:  7 non-compliant results (1) 2646µg/kg (2) 2433µg/kg (3) >3000µg/kg (4) >3000µg/kg

1 target sample confirmed non-compliant for nitroxynil at 26.1µg/kg

2 target samples confirmed non-compliant for rafoxanide at (1) 1098µg/kg (2) 249µg/kg

Full on farm investigations including examination of medicines on farm and animal remedies records were carried out in each case. As appropriate, advice is given to the farmer and follow-up visits take place.

3 non-compliant result Wild Game  Chemical Elements 1 target sample confirmed non-compliant for lead at  Wild Game varying levels (3 aliquots tested):  3 non-compliant result 124.458µg/kg, 29.682µg/kg, 269.025µg/kg

2 target samples confirmed non-compliant for lead at the following levels: (1) 192.46µg/kg (2) 275.93µg/kg

Inquiries of possible reasons for the presence of the substance were not conclusive. Possible contamination by bullet.

1 non-compliant result Milk

 Anthelmintics 1 target sample confirmed non-compliant for Levamisole  Milk at 1.38µg/kg  1 non-compliant result

A full on farm investigation including examination of animal remedies record carried out

1 non-compliant results Honey

 Antibiotics 1 target sample confirmed non-compliant for  Honey Chlortetracycline 47µg/kg.  1 non-compliant result The owner of the apiaries from which the honey sample originated was visited and records of purchase and use of medicines examined. No evidence that CTC was administered to treat bees on any sites.