NATIONAL RESIDUE CONTROL PLAN REPORT 2016 · PDF fileNATIONAL RESIDUE CONTROL PLAN REPORT 2016...

NATIONAL RESIDUE CONTROL PLAN REPORT 2016

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 2016 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 8 food producing

species and milk, eggs and honey 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 of

animals or animal products. In such cases, the animals/products concerned are withheld

from the food chain, pending the outcome of the analysis. In the event of a positive result

from routine targeted samples, where animals/products are not detained, food is withdrawn

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

or recalled from the market, if deemed necessary in the interests of public health following a

risk assessment.

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 (the Department) 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 2016 official testing

8. In 2016, a total of 19,250 samples were taken from all 8 food producing species, as well

as from milk, eggs and honey. The overall level of non-compliance across all substances

was 40, or 0.2%. The comparable level for 2015 was 0.18% (33/19,439) and for 2014

was 0.22% (42/19,095).

9. An overview of the distribution of sampling across species/products and residue groups is

provided in Appendix 1. An overview of all positives results is provided 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). In the course of the 2016 NRCP, a target sample

from a bovine animal on farm was found to contain Clenbuterol (a beta agonist covered by

the EU Hormone ban on growth promoters). Twenty-seven other animals on the farm

concerned were tested in the course of the investigation, during which the farm was

restricted. All twenty-seven samples proved positive for the presence of Clenbuterol.

Subsequently, these twenty-seven animals were destroyed by the Department in line with

Regulation 18 of SI 183 of 2009 (European Communities (Control of Animal Remedies

and their Residues) Regulations 2009). While the evidence suggests that the finding of the

illegal growth promoter, was an isolated incident, the Department initiated increased

surveillance, which included an increased level of focussed testing at farm level. This

involved supplementing the existing sampling programme by an additional number of

samples. No further Clenbuterol positives have been detected in the interim.

11. In 2016, the substance, Thiouracil, which may indicate the potential use of growth

promoters covered by the EU Hormone Ban, was detected in 8 animals in the bovine and

ovine sector. 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, it is recognised that they are most likely attributable to natural/environmental or

dietary factors, and as a consequence, there is no risk to public health.

12. 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 2016 was 0.2% (i.e. 9 non-

compliant results out of 8,118 samples). In the case of 3 of the animals involved, each

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

carcase (bovine, ovine and porcine) had been detained on suspicion by Department

veterinary inspectors in slaughter plants and were excluded from the food chain on foot of

the analytical results. In the other cases (one bovine, one porcine, one ovine, three equine),

a risk assessment concluded that there was no need to recall food from the market. In the

bovine, ovine, porcine, equine and milk sectors, 17 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 17 cases did not indicate an unacceptable risk to consumer health and

therefore it was not necessary to recall the product.

13. In the aquaculture sector, the Sea Fisheries Protection Authority (SFPA), in conjunction

with the Department with support from the Marine Institute (MI), are responsible for

residue controls on farmed finfish under the national residue-monitoring plan. In 2016, in

excess of 691 tests and a total of 1,933 determinants were carried out on 126 samples of

farmed finfish for a range of residues. All 2016 samples were compliant with the

exception of two harvest samples from one farm which were found to have oxy-

tetracycline (Group B1- antibacterial substance) present. An investigation took place at

the processing plant and at farm level. The investigation included examination of

medicines on farm, animal remedies on farm, animal remedies records on farm and feed

records on farm. Distribution records were examined at the processing plant. All records

at the farm and processing plant were in order and in compliance with legislation;

however the outcome of the on farm investigation was inconclusive. Both investigations

have now been closed. 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, with a slight increase to 0.11% in 2015 and 0.10% in 2016.

14. 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 2016, 99 samples were taken from consignments imported directly into

Ireland from countries outside the EU/EEA. No positive sample was identified.

APPENDIX 1

RESULTS OF DEPARTMENT OF AGRICULTURE, FOOD & THE MARINE

RESIDUE MONITORING PROGRAMME FOR_2016

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 235 - 43 - 18 - 74 -

- -

5 -

- -

- -

2 -

- -

- -

A2 235 6 36 - 18 2 17 -

-

-

4 -

- -

- -

1 -

- -

- -

A3 1657 - 246 - 95 - 48 -

47 -

23 -

43 -

- -

2 -

- -

- -

A4 286 - 71 - 44 - 80 -

- -

3 -

- -

- -

2 -

- -

- -

A5 1315 1 113 - 80 - 74 -

- -

15 -

-

-

- -

6 -

- -

- -

A6 743 1 222 - 125 - 236 -

81 -

18 -

43 -

86 -

6 -

- -

25 -

Total No.

Analyses

4471 8 731 - 380 2 529 -

128 -

68 -

86 -

86 -

19 -

- -

25 -

Group B - Veterinary Drugs and Contaminants

B 1 – Antibacterial Substances

Substance Bovine Pigs Sheep/Goats Poultry Milk Horses Aquaculture Eggs Farm Game Wild Game Honey


B1 4375 3 1840 1 839 2 387 - 344 0 123 3 102 2 153 - 27 - - - 30 0

B 2 - Other Veterinary Drugs



B2a 508 1 91 1 297 11 76 - 338 2 30 2 92 - - - 16 - - - - -

B2b 79 - 12 - 58 - 212 0 - - 4 - - - 48 -

10 - - - - -

B2c 83 - 24 - 45 -

45

1 - - 13 - 92 - 5 - 8 - - - 20 -

B2d 23 - 31 - 10 - - - - - 25 - - - - - - - - - - -

B2e 131 - 63 - 40 - 22 -

81

- 140 - - - - - 4 - - - - -

B2f 70 - 151 - 28 - - -

77

- 20 -

101 - - - - - - - - -

Total No.

Analyses

894 1 372 1 478 11 355 1 496 2 232 2 285 - 53 - 38 - - - 20 -

B 3 - Other Substances and Environmental Contaminants



B3a 131 - 80 - 96 - 33 - 83 1 28 - 29 - 26 - 12 - - - 10 -

B3b 119 - 60 - 86 - 25 - 83 - 8 - - - 11 - 12 - - - 10 -

B3c 121 - 41 - 62 - 59 - 71 - 10 - 10 - - - 29 - 95 0 20 0

B3d 34 - 17 - 14 - 25 - 105 - 5 - 6 - - - - - - - - -

B3e - - - - - - - - - - - - 59 - - - - - - - - -

Total No.

Analyses

405 - 198 - 258 - 142 - 342 1 51 - 104 - 37 - 53 - 95 0 40 0

OVERALL RESULT - TOTAL GROUP A + GROUP B



Overall

Total

Analyses

10145

12

3141

2

1955

15

1413

1

1310

3

474

5

577

2

329

-

137

0

95

0

115

0

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, 128 fish were tested in total.

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

Appendix 2: Details of Non-compliant Results

Species/

Animal

produce

Total No.

Of

Samples*

Total No. of

Non-compliant

samples*

Substance

Farmed Fish 136 2 2 Antibiotics (2 oxy-tetracycline)

Bovine 10145 12 3 Antibiotics (1 marbofloxacin, 1 sulfadiazine, 1 sulfadiazine & trimethroprim)

1 Anthelmintic (1 levamisole)

6 Thyrostats3 (6 thiouracil)

1 Nitrofuran (1 nitrofurazone as SEM)

1 Beta Agonists (1 clenbuterol)

Eggs 329 0 N/A

Equine 474 5 2 Anthelmintics (1 closantel, 1 oxyclozanide)

3 Antibiotics (marbofloxacin)

Farmed Game

(Deer)

137 0 N/A

Honey 115 0 N/A

Milk 1310 3 2 Anthelmintics (2 ivermectin)

1 Organochlorine compounds including PCB’s (1MCPA, mecoprop & 2, 4-D)

Ovine/Caprine 1955 15 11 Anthelmintics (8 closantel, 1 fenbendazole & rafoxanide, 1 levamisole, 1 rafoxanide).

2 Antibiotic (2 oxytetracycline)

2 Thyrostats (2 thiouracil)

Porcine 3141 2 1 Antibiotic (1 chlortetracycline).

1 Anthelmintic (1 closantel)

Poultry 1413 1 1 Pyrethroid (1 flumethrin)

Wild Game

(Deer/Birds)

95 0 N/A

Total: 19250 40

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

3 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, it is

recognised that they are most likely attributable to natural/environmental or dietary factors, and as a consequence, there is no risk to public health.

Appendix 3

FOLLOW-UP ACTIONS FOR NON-COMPLIANT RESULTS IN 2016

Group A substances

Non-compliant results Follow-up actions

8 non-compliant results Bovines

Thyrostats-Thiouracil

Urine

6 Non-Compliant results

6 target samples confirmed non-compliant for Thiouracil at

the following levels:

(1) 38.1µg/kg (2) 29.8µg/kg (3) 13.0µg/kg

(4) 11.9µg/kg (5) 8.6µg/kg 6) 14µg/kg

Investigations of Thiouracil residue positives carried out over a

ten year period at farm level did not reveal any evidence of

illegal use and it was concluded that they were from dietary

factors. Having consulted with the FSAI a decision was taken to

only carry out on farm investigations on levels exceeding

20µg/kg4. Follow up investigations were initiated at farm level

in 2 cases >20µg/kg 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

1 Non-Compliant result

1 target sample confirmed non-compliant for Clenbuterol at

the following level >0.5µg/kg

A follow up investigation was initiated at farm level and

restrictions were imposed in accordance with Article 16 & 17 of

Directive 96/23/EC.

Criminal prosecution was initiated and is still ongoing.

Nitrofurans-Nitrofurazone as SEM

Plasma

1 Non-Compliant result

1 target sample confirmed non-compliant for Nitrofurazone

as SEM at the following level 1.45µg/kg

(1)

(2)

(3) 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 may have resulted from accidental exposure to

environment or dietary factors.

2 Non-compliant results Ovine

Thyrostats-Thiouracil

Urine

2 Non-Compliant results

2 target samples confirmed non-compliant for Thyrostats at


2 x Thiouracil 7.8µg/kg

Investigations of Thiouracil residue positives carried out over a

ten year period at farm level did not reveal any evidence of

illegal use and it was concluded that they were from dietary

factors. Having consulted with the FSAI a decision was taken to

only carry out on farm investigations on levels exceeding

20µg/kg4

4The approach is contingent on the potential risk posed and would consequently be reviewed in light of any new emerging data, results and or any new

guidance from the EURL/European Commission

Group B substances Non-compliant results Follow-up actions

4 non-compliant results Bovines

Antimicrobials

Muscle

3 non-compliant results*

2 Target samples confirmed non-compliant for antibiotics at


(1) Marbofloxacin >300µg/kg

(2) Sulfadiazine 211.2µg/kg

Full on farm investigations were completed including

examination of medicines on farm and animal remedies records

were carried out and appropriate advice given to the owner

keepers.

1 Suspect sample confirmed non-compliant for antibiotics at

the following level:

(1) Sulfadiazine 362.7µg/kg &Trimethoprim 70.8µg/kg

Suspect carcase declared unfit for human consumption and

destroyed. Full on farm investigation including examination of

medicines on farm and animal remedies record was carried out.

Appropriate advice was given to the farmer regarding the use of

VMPs and a follow-up visit was scheduled.

Anthelmintics

Liver

1 non-compliant result

1 Suspect sample confirmed non-compliant for

anthelmintics at the following level:

(1) Levamisole 173µg/kg






13 Non-compliant results Ovine

Antimicrobials

Muscle

2 non-compliant results

1 Suspect sample confirmed non-compliant for antibiotics at


Oxytetracycline >400µg/kg






1 Target sample confirmed non-compliant for antibiotics at


Oxytetracycline 241.4µg/kg

Full farm investigation was completed including examination of

animal remedies records and appropriate advice given to the

owner keeper.

Anthelmintics

Liver


11 Target samples confirmed non-compliant for

anthelmintics at the following levels:

(1) Fenbendazole 663µg/kg & Rafoxanide 2056µg/kg

(2) Levamisole 120µg/kg (3) Closantel 2725µg/kg

(4) Closantel 2743µg/kg (5) Closantel 2652µg/kg

(6) Closantel 2633µg/kg (7) Closantel 2464µg/kg

(8) Rafoxanide 1252µg/kg

(9) Closantel >3000µg/kg x3

Full on farm investigations were carried out in each case,

including examination of animal remedies records. Appropriate

advice was given to the flock owners and follow-up visits were

scheduled.

5 non-compliant results Equine

Anthelmintics

Liver


Antimicrobials

Muscle


2 Target samples confirmed non-compliant for

Anthelmintics at the following levels:

(1) Closantel 12.2µg/kg (2) Oxyclozanide 5.5µg/kg

3 Target samples confirmed non-compliant for Antibiotics

at the following levels:

(1) 70µg/kg (2) 168µg/kg (3) 71µg/kg

Full investigations were carried out including examination of

animal remedies records. The owners of the equines were given

appropriate advice and further visits were scheduled.

1 non-compliant result Poultry

Pyrethroids

Fat


1 target sample confirmed non-compliant for Flumethrin at


(1) 67µg/kg

Full on farm investigation was carried out. Flock owner was

treating cattle with Bayticol and sprayed the product to kill flies

in his wheelie bins. Cross contamination of this product to the

live birds via poor biosecurity resulted in contamination of the

birds.

3 non-compliant results Milk

Anthelmintics

Milk


Organochlorine Compounds

including PCBs

Milk


2 target samples confirmed non-compliant for Ivermectin at


(1) 0.74µg/kg (2) 0.72µg/kg

Full on farm investigations including examination of animal

remedies/records were carried out and appropriate advice given

to the owner keepers.

1 target sample confirmed non-compliant for

MCPA 390µg mecoprop 350µg/kg & 2,4-D 290µg/kg

A follow up investigation was carried out. Further milk samples

from the associated farm were tested. All milk and products

sourced from the implicated lot were traced, sampled and

detained pending results. All results were compliant. A risk

analysis was performed in conjunction with FSAI and all

products were deemed to be safe for consumption.

2 non-compliant results Porcine

Anthelmintics

Porcine


Antimicrobials

Porcine


1 target sample confirmed non-compliant for

anthelmintics at the following level Closantel 14.6µg/kg

Full on farm investigation including examination of animal

remedies records carried out.

1 suspect sample confirmed non-compliant for antibiotics at

the following levels Chlortetracycline 126.8µg/kg





VMPs and a follow up visit was scheduled.

2 non-compliant results Fish

Antimicrobials

Muscle & Skin


2 target samples confirmed non-compliant for oxy-

tetracycline at the following levels:

(1) 143µg/kg (2)174µg/kg

An investigation took place at the processing plant and at farm

level. The investigation included examination of medicines on

farm, animal remedies on farm and feed records on farm.

Distribution records were examined at the processing plant. All

records at the farm and processing plant were in order and in

compliance with legislation; however the outcome of the on

farm investigation was inconclusive. Both investigations have

now been closed.

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