EUROPEAN COMMISSION HEALTH AND CONSUMER PROTECTION DIRECTORATE-GENERAL

Directorate D - Food and Veterinary Office

DG(SANCO)/1021/1999- MR Final

FINAL REPORT OF A MISSION

CARRIED OUT IN FROM 17 TO 21 MAY 1999

FOR THE PURPOSE OF REPORTING ON THE GENERAL PUBLIC HEALTH SITUATION WITH PARTICULAR REFERENCE TO FRESH MEAT, MEAT PRODUCTS, AND WILD GAME ESTABLISHMENTS AND RESIDUE MONITORING

18/10/99 - 16604 TABLE OF CONTENTS

1. MISSION DETAILS ...... 3

1.1. Mission team ...... 3

1.2. Reason for mission ...... 3

2. PURPOSE OF THE MISSION...... 3

2.1. Sites visited ...... 4

3. BACKGROUND ...... 4

3.1. Introduction ...... 4

3.2. Summary of previous mission findings ...... 5

3.2.1. Animal Health situation...... 5

3.2.2. Public Health situation ...... 5

4. LEGAL BASIS FOR MISSION ...... 6

5. MAIN OBSERVATIONS...... 7

5.1. Competent authority...... 7

5.2. Slaughterhouses/Cutting/Meat processing plants...... 7

5.3. Wild game plants ...... 8

5.4. Laboratories - Veterinary institute ...... 8

5.5 Residue control plan ...... 9

5.6. FMD challenge test performed for ...... 9

5.7. Export of ...... 9

6. CONCLUSIONS ...... 9

7. RECOMMENDATIONS...... 10

7.1. To the Romanian authorities...... 10

7.2. To the European Commission...... 11

2 1. MISSION DETAILS

The mission took place from 16 to 21 May 1999.

1.1. Mission team

Organisation Number

Food and Veterinary Office 3 Member State 0*

Two representatives from the National Veterinary Health Agency (central competent authority) accompanied the inspection team throughout the mission.

1.2. Reason for mission

Category Reason for mission Tick as appropriate JPP Included in planned mission programme X JEF Follow-up mission to earlier emergency health - problem

2. PURPOSE OF THE MISSION

Category Purpose of the mission Tick as appropriate

ATC Audit of competent authority in first approval third country mission ATS subsequent X mission Audit in a specified food product X sector: AM1 Meat products routine/initial X mission AM Red meat follow-up X 2/3/4.. mission RRR Residue controls Red X meat/products

* A National Expert from a Member state was invited but in the very last moment the Competent Authority of the Member State declined to contribute.

3 2.1. Sites visited

Category Sites visited Number CCA Competent authority offices Central 1 CRA Regional CLA Local LCR Laboratory service Central/reference 1 LRR Regional LLL Local TIR Technical institutes and research stations BIP Border inspection posts FFF Farms FBC Breeding centres FNN Nurseries FGC Garden centres FCC Collection centres FSP Staging posts FQC Quarantine centres FMM Markets MAM Animal feed manufacturers MRM Rendering premises MSH Slaughterhouses 4 MCP Cutting premises MCS Temperature controlled stores MPP Meat product premises 4 MPR Meat preparation premises MMP Milk processing premises MEG Egg packing/storage premises MEP Egg products premises MWG Wild game premises 1 MXX Other sites (specify)……………………………………

3. BACKGROUND

3.1. Introduction

Romania is a traditional exporter of fresh meat and meat products to the (EU). However, due to the changes in the economy of the country after the fall of communism, food exports decreased dramatically. The specific reasons cited include the rapid privatisation of agriculture, followed by shortage in animals, increased import of animal products, drastically changed relationship between own costs and the price of imported food and the weak economic situation of many

4 enterprises. According to the statistics, in 1997 Romania exported to the EU: Fresh meat – 158, 2 tonnes, poultry meat: 800,4 tonnes, other meats: 118,9 tonnes. Most of the approved establishments have not exported meat/meat products to the EU for a few years and this situation remains true in 1999.

3.2. Summary of previous mission findings

Several Community veterinary missions took place to Romania in the past in the field of animal and public health: The most recent missions were the following:

1991 (AH, PH VI/2097/92),

1992 (PH, VI/3340/92, PH, VI/5558/92),

1993 (PH, VI/2077/94)

1995 (AH, VI/5997/95),

1997 (AH, PH, XXIV/1760/97),

1999 (AH, XXIV/1024/99).

3.2.1 Animal health situation

No OIE list “A” diseases have occurred in Romania in recent years. Vaccination against CSF in pigs is carried out.

Bovine brucellosis: systematic tests for brucellosis are carried out, no positive results in 1998.

Brucella melitensis: systematic tests are not carried out because the country considers itself free from B. Melitensis. All tests carried out in 1998 were negative.

Bovine tuberculosis: is present in 17 of 41 districts, 71 cases in 1998. TB eradication is considered a priority by the veterinary services.

Enzootic bovine leucosis: is present in 27 districts, 277 cases in 1998.

Rabies: is present in 13 districts, 53 confirmed positive cases in 1988.

For more details, see the report of mission in February 1999 (document XXIV/1024/99), from which the data mentioned above has been derived.

3.2.2. Public health situation

3.2.2.1. Fresh meat / meat products imports. List of approved plants.

Romanian slaughterhouses were approved 20 years ago by the EEC and were visited almost every year by the Community veterinary experts, mainly with satisfactory findings.

The meat processing plants, however, first became approved by the Community in October 1997 on the basis of the “prelisting” decision (Council Decision 95/408/EC). Up until this date, the meat processing plants were approved by separate Member

5 states (mainly Germany and the United Kingdom) and inspected by their veterinary experts. During the last inspection by the U.K. veterinary experts in October 1997, two meat processing plants on the British and EC list of approved establishments declined to be inspected implying that they did not comply with the EC requirements. The British competent authority (MAFF) made a recommendation to the Romanian authority that these plants should be removed from the EC list and requested that this proposal should be presented to the Standing Veterinary Committee. For various reasons, these plants remained on the EC list until May 1999. When the Commission made a request to visit them during the mission in May 1999, the Romanian authorities answered that they had been removed from the list by MAFF. As these plants were still on the Community list, however, the Commission recommended that the Romanian competent authority should make an application to delist any plants that no longer wished to export. The Romanian authorities subsequently applied to delist three meat-processing plants and a wild game plant in addition to the two plants referred to above.

4. LEGAL BASIS FOR MISSION

The mission was carried out under the general provisions of Community legislation and, in particular:

4.1. Commission Decision 98/140/EC laying down detailed rules concerning on- the-spot checks carried out in the veterinary field by Commission experts in third countries.

4.2. Council Directive 72/462/EEC, on health and veterinary inspection problems upon importation of bovine, ovine and caprine animals and swine, fresh meat or meat products from third countries (as last amended).

4.3. Council Directive 96/23/EC of 29 April 1996 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/EEC and 91/664/EEC.

4.4. Council Decision 77/96/EEC on the examination for trichinae (trichinella spiralis) upon importation from third countries of fresh meat derived from domestic swine.

4.5. Council Decision 79/542/EEC, drawing up a list of third countries from which the Member States authorise imports of bovine animals, swine, equidae, sheep and goats, fresh meat and meat products (as last amended).

4.6. Council Decision 95/408/EC on the conditions for drawing up, for an interim period, provisional lists of third country establishments from which Member States are authorised to import certain products of animal origin, fishery products or live bivalve molluscs.

6 5. MAIN OBSERVATIONS

5.1. Competent authority

In addition to the detailed description of the Romanian competent authority in the report from the previous missions in June/August 1997 (XXIV/1760/97) and in March 1999 (Document XXIV/1024/99) the following should be added:

5.1.1. On the day of arrival in Bucharest the mission team was informed of changes in the CVO post. The former CVO had been removed from his post and nominated deputy CVO, which is a new post in the structure of the Romanian veterinary service. This change was the second change in two months and the mission team was told that the recent changes in CVO were often followed by further changes at the level of district director. These changes have a substantial influence on the policy of the competent authority.

5.1.2. The Romanian veterinary service, the National Veterinary Health Agency, is currently reconstructing the Animal Health Service. This reconstruction, referred to in the previous report as “privatisation”, is more correctly called decentralisation. It means that the general practitioners, previously employed and paid directly by the competent authority, are now the responsibility of the Municipalities. Two legal acts facilitate this restructuring: the Public Services Law and the Budget Law. The Municipalities are still part of the State structure. The veterinarians mentioned have not been paid since 1 April by the National Veterinary Health Agency, as they are supposed to be paid by the municipalities.

5.1.3. The mission team was told that in many cases even veterinarians employed by the State have not received their salary for over a month. The mission was also informed about a recent one-week’s delay in the payment of salaries to the personnel of the Veterinary Institute in Bucharest.

5.1.4. The competent authority stated during the initial meeting that they did not fully understand the “prelisting” requirements as laid down in Council Decision 95/408.

5.1.5. The mission team was informed that no training was provided for the veterinarians and auxiliaries due to the lack of funds.

5.1.6. There is no written evidence of proper veterinary supervision in the meat factories (canning).

5.2. Slaughterhouses / Cutting / Meat processing plants

5.2.1. Four of the 11 EC approved slaughterhouses and four of the six EC approved meat-processing plants were visited. Three of them were integrated slaughterhouse/cutting/meat processing plants, one was a combined slaughterhouse/cutting plant and one an independent meat processing plant.

5.2.2. Major differences could be seen in the hygienic standard of establishments (structures, layout, installations, equipment, maintenance and cleanliness, 7 operational practices and hygiene). The best plant (almost fully complying with the EC requirements) and the plant with the most serious deficiencies (inadequate maintenance, absence of wash cabinets and ineffective sterilizers) were both situated in the same town and supervised by the same District Veterinary Service.

5.2.3. In one slaughterhouse visited, poor hygiene practices caused visible contamination of sheep carcasses. Inflation for skin loosening of sheep over 15 kg, washing of carcasses with a brush and hosing down of faecal contamination were noted. These operational malpractices did not elicit a response from the veterinary service.

5.2.4. In all slaughterhouses visited, deficiencies were observed in the stunning of animals. Stunning boxes and stunning equipment were not designed properly. In a number of cases the stunning equipment did not work properly or was not used correctly.

5.2.5. Examination for trichinae in all pig slaughterhouses visited was carried out using trichinoscopic method (pressure glass method). For reasons of cost the artificial digestion method was only used for confirmation of a positive finding. The veterinary supervision and record keeping was adequate. The personnel performing the tests were paid by the plant owners.

5.2.6. The autoclaves for sterilisation of cans were in poor condition in one meat processing plant. For example, there was water leakage from the autoclaves and broken water level indicators and manometers had not been repaired or replaced.

5.2.7. The double seam evaluation and incubation procedures were not uniform in all canneries visited.

5.3. Wild game plants

After arrival in Romania, the Mission team was informed by the CA, that it was not the season for game meat processing, and the plants were not therefore in operation. One wild game plant was visited, for information purposes only.

5.4. Laboratories

One central veterinary laboratory was visited. This laboratory is a national reference laboratory for residues, and is responsible for the national residue plan. The laboratory is fitted with equipment which is adequate for carrying out the residue examinations and it uses internationally approved methods (ISO methods for microbiology, ELISA for species identification, b-agonists and steroids, g-spectrometry for radioactivity, thin layer chromatography for aflatoxins, mycotoxins and sulphonamides). The staff seemed to be well motivated and professional. The building was about 40 years old and the working conditions were thus somewhat difficult. In some laboratories there were no fume cupboards to extract harmful gasses. A training programme for the staff had been designed. However, its range was limited because of the difficult financial situation of the Institute. Until now, the Institute has not benefited from EC aid programmes.

8 5.5. Residue control plan

According to the 1998 year plan, residue tests were carried out in sheep, bovine, poultry, pig meat and food additives. A number of samples were positive for chlorinated hydrocarbons: three sheep meat, 20 pig meat and 20 bovine meat samples.

5.6. FMD challenge tests performed in Romania for Belgium.

During the FVO mission to Belgium in March 1999 to evaluate the Belgian contingency plan for FMD (mission number XXIV/1019/99), it was found out that a private institute in Romania carried out tests for Belgium with live FMD virus. The mission team requested information about the circumstances in which these tests take place. The answer from the Deputy CVO was very vague. The mission requested detailed written information on this matter.

5.7. Export of Sibiu Salami

The mission team visited two meat processing plants producing Sibiu Salami. Several Romanian establishments are interested in exporting this product to the EU. Sibiu Salami is made from raw pig meat and fat, and undergoes one week’s cold smoking and 90 days maturation. Romania is not approved to export fresh pig meat and for the approval of meat products “D” (70°C, or, for ham, natural maturation and fermentation during nine months) or “B” (sterilisation, F°value of 3,0 or more) heat treatment is required. The Scientific Veterinary Committee (ScVC) examined the Romanian application in 1997 and found the technical information insufficient. For this reason, the ScVC made a statement based on the assessment of the epizootological situation in Romania and recommended regionalisation of the country in relation to Teschen disease and SVD. The mission team explained to the competent authority that Sibiu Salami was basically an animal health question. Three solutions were possible: providing the ScVC with more information about the process used, regionalisation of the country or production of Sibiu Salami using approved (imported) meat only.

6. CONCLUSIONS

6.1. The competent authority did not fully understand the “prelisting” requirements as laid down in Council Decision 95/408. The competent authority did not inform the Commission prior to the mission about the plants currently on the Community list, which did not fulfil the EC requirements and, as a consequence, they failed to suspend approval as required by Council Decision 95/408/CE, Art. 2§1 c and d.

6.2. Frequent changes have taken place in the structure and staffing of the central competent authority. In particular, structural changes within the Animal Health Service (decentralisation) have created practical problems for the personnel working at the level of the local veterinary service.

6.3. The competent authority does not at present provide a uniform level of veterinary supervision and implementation of the Community requirements in

9 all Romanian plants listed. This problem is exacerbated by the lack of training for veterinarians and auxiliaries.

6.4. Poor hygiene practices were observed in one slaughterhouse (see 5.2.3) which, were not rectified “on-the-spot” by the competent authority.

6.5. Faulty equipment and poor stunning techniques were identified in all slaughterhouses and these deficiencies compromise animal welfare.

6.6. There was little written evidence to demonstrate proper veterinary supervision of the control of the heat process in one of the canneries. Furthermore, the incubation criteria (temperature and time) for cans are not uniform in all establishments and do not, therefore, guarantee effective sterilisation.

6.7. Inadequate information was received “on-the-spot” from the competent authority about the tests carried out with live FMD virus in a Romanian institute (on behalf of Belgium).

A final meeting with the National Veterinary Health Agency took place, chaired first by the Head of the Public Health Division and later by the Deputy Chief Veterinary Officer. The findings/deficiencies were presented at this meeting, and were accepted by the competent authority representatives.

7. RECOMMENDATIONS

7.1. To the Romanian authorities:

7.1.1. Take urgent action to review the list of approved/pre-listed establishments (slaughterhouses, meat processing, dairy and wild game plants) in order to assure their compliance with the Community requirements. The revised lists should be submitted to the Commission within two months of receiving this report.

7.1.2. Take urgent action to rectify the plant deficiencies found during the mission. A report of the findings, indicating the actions that have or will be taken, should be submitted to the Commission within two months of receiving this report;

7.1.3. Take urgent action to ensure a uniform level of veterinary supervision and implementation of the Community requirements at all Romanian plants currently on the list. A report should be submitted to the Commission, detailing the action taken to improve a) the management of the National Veterinary Health Agency Service at the central level, and b) the co-ordination between the central and local levels;

7.1.4. Take urgent action to ensure that the Council Directive 93/119/EC provisions on the protection of animals at the time of slaughter and killing are followed;

7.1.5. Urgently inform the Commission about the tests carried out with live FMD virus in a Romanian institute (on behalf of Belgium).

10 7.1.6. Establish uniform incubation criteria (temperature and time) for all establishments. The following measurements for double seam check should be made (as a minimum): % overlap, free space, wrinkling rate and internal droop.

7.2. To the European Commission:

7.2.1. Urgently consider the removal of one slaughterhouse from the list (see 5.2.2. & 5.2.3.).

7.2.2. Consider the withdrawal of the "prelisting" arrangement used by the Romanian authorities as laid down in Council Decision 95/408 and revision of the fresh meat list if the information requested and satisfactory guarantees are not forthcoming.

7.2.3. Carry out a further veterinary mission to Romania when the Commission Services are in receipt of a) a revised list of the plants (slaughterhouses, meat processing, dairy and wild game plants) approved by the Romanian Competent Authority for export to the EU (see 7.1.1.) and b) adequate guarantees that the recommendations (7.1.2.-7.1.5.) are being implemented.

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