AUTORITATEA NATIONALA SANITARA VETERINARA

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ROMANIA AUTORITATEA NATIONALA SANITARA VETERINARA ACTION SI PLAN PENTRU FOLLOWING SIGURANTA THE ALIMENTELOR DG (SANCO) FVO MISSION 7820/2 CABINET PRESEDINTE SECRETAR DE STAT Bucuresti, Str. Negustori, nr. 1B, sect. 2, cod postal 023951; tel: 3157875, fax: 3124967; e-mail: office@ansv.ro Nr.6495/14.01.09 CA response received 14/01/2009 RECOMMENDATION 1.To ensure the efficient and effective coordination and cooperation between the HVPHD and the IBIPCGD regarding the organization of the official controls at the central level as required by paragraph 5 of the Article 4 of Regulation (EC) No 882/2004. The IBIPCGD should ensure effective communication between central and county level as is required by paragraph 3 of the same Article. ACTION OF NSVFSA As mentioned in the Regulation for organization and functioning of NSVFSA there is a collaboration system between HVPHD an IBIPCGD regarding the flow of information concerning the implementation of the legislation elaborated by HVPHD and the inspections results performed by IBIPCGD. In accordance with the Rules of Organization and Functioning of NSVFSA, Hygiene and Veterinary Public Health Directorate, has responsibilities for monitoring, surveillance ad evaluation, and Inspection Directorate carry out inspections/ official controls in the veterinary and food safety field. For better communication between the central level and the county level, the Inspection Directorate scheduled quarterly training with the heads of county inspection and

2. To ensure the training organized by the HVPHD is effective in reaching all the staff and the knowledge is successfully transmitted in the cascade training system to the OVEs and OVCs as is required by paragraph (b) of the Article 6 of Regulation (EC) No 882/2004 and to ensure that the technical knowledge of OVEs at food establishments is sufficient for proper auditing of own-check programmes, HACCP programmes and identification and labelling requirements. 3. To ensure appropriate training of CICS inspectors regarding their duties, tasks and responsibilities as is required by paragraph (a) of Article 6 of Regulation (EC) No 882/2004. control services. The aim of this training is to discuss about the issues of exchange and information, and also how to carry out their duties and responsibilities. The National Veterinary Training Programme for 2009 includes direct training by the representatives of Ovs from food industry establishments regarding the establishment s audit, implementation of HACCP programme, ante and postmortem inspection. These training are scheduled to start during the second trimester of 2009. Following the training, the evaluation of achieved knowledges will be tested. To fulfil the requirements of art. 6 (a) Regulation (CE) No 882/2004, the staff who carry out official controls must have adequate training. For this purpose the Inspection Directorate has prepared a Training Program for 2009, for the heads of county inspection and control services. The officials veterinarians from establishments are not subordinated to county inspection and control services, but they are subordinated to the Sanitary Veterinary and Food Safety Circumscriptions and the County Hygiene and Veterinary Public Health Services. Regarding of the veterinarians duties, responsibilities and activities from the inspection and control services, these are stipulated in the Regulation of Organisation and Functioning

4. To initiate further measures in order to be able to detect establishments that are not compliant with the general hygiene requirements in Annex II of Regulation (EC) No 852/2004 and the specific requirements in Annex III of Regulation (EC) No 854/2004 and if detected, take the necessary corrective action as foreseen in Article 54 of Regulation (EC) No 882/2004; to ensure that the approvals of the establishments are kept under review as laid down in the Article 31 of Regulation (EC) No 882/2004 5. To ensure that the official controls are carried out regularly, on a risk basis and with an appropriate frequency as laid down in the article 3 of Regulation (EC) 882/2004 and has been updated in the National Framework for Inspection Program for 2009. To understand the unity of these duties, responsibilities and activities, it was considered necessary this subject would be one of these training, in accordance with the Training Program for 2009, this objective has been scheduled in the first training session (the first quarter for 2009). Veterinarians responsibilities which carry out veterinary inspections including the checks of the official veterinarians activity from Sanitary Veterinary and Food Safety Circumscriptions and officials veterinarians at establishments level). On 14/11/2008 NSVFSA Order No 93/23.10.2008 for the approval of veterinary norm concerning veterinary procedure for the approval of establishments producing, processing, storing, transporting and/or distributing animal origin products was published in the Official Journal of Romania. Starting with 24.11.2008 the provisions of Order 93/20008 are in force and NSVFSA Order 276/2006 is repealed. This order states actions to be carried out when following official controls, establishments not fulfilling the requirements of Reg.852/2004 and 853/2004 are identified. According to the Service Note no. 65694/17.11.2008 was established a working group composed of 4 representatives of HVPHD an 6 chiefs of CHVPHS in order to elaborate procedures for official control based on risk analyses of

establishments in the light of art. 3 Reg. 882/2004 The first meeting of the working group was held between 20-21.11.2008 and the following was decided : -the decisional level in charge with evaluation and classification of establishments according to risk analyses; -the number of risk categories for establishments; - main evaluation criteria and the number of points given for each one; - way of calculation of final score; - frequency of inspections and audits from the central, district and local level according the classification based on risk analyses of establishments; The procedure will be finished by the end of first trimester, and discussed with professional associations in April 2009. Training of official veterinarians will be performed by NSVFSA. The deadline for application of the procedure is 01.06.2009. Inspection Directorate has established the following frequency for inspections, in compliance with requirements for art. 3 of the Regulation No. (EC) 882/2004, regarding of the frequency of official controls which must be carried out regularly and according to risk, considering the existing categories of units at this moment in Romania : - Approved establishments for community trade one

6. To establish the audit system as is required by paragraph 6 of Article 4 of Regulation (EC) No 882/2004 as a matter of urgency to detect all the deficiencies in the performance of the official controls and in the reporting system with special regard and attention paid to the following the SNs of the OVEs and OVCs; to ensure that CICS inspectors receive a clear description of their responsibilities, duties and tasks (paragraph (a) of the Article 6 of Regulation (EC) No 882/2004) and to ensure that the central level of the IBIPCGD has an overview of the preparation and execution of the annual working programmes of the inspectors (paragraph 3 of the Article 4 of Regulation (EC) No 882/2004). inspection a year; - Establishments in transition period two inspections a year; - Registered establishments- one inspection a year; Regarding the verification of veterinarians activities, it was agreed that both veterinarians (OVC and OVE) to be checked at least once per year, with the possibility of increase of frequency, when it is found deficient during the previous checks. All these regulations are stipulated in the National Framework Inspection and Control Program, prepared for 2009. The need for a unified, nationwide program of inspections has led to the elaboration of a model for programming activities for the staff of county inspection and control services. This includes scheduling of operators subject to the veterinary controls, but the official schedule for the verification activities of OVC and OVE. The need reporting types and number of noncompliance identified during inspections, in according with art.44 of EC regulation no.882/2004 it was concluded as required a new model for reporting of activities of county inspection and control services, which includes the results of official controls, incompliance, and the measures which are implemented.

7. To enforce the national strategy for improving the quality of raw milk is required by paragraph 1 of Article 5 of Commission Decision 2007/27/EC and take action in order to complete the amendments of national legislation for improving of the quality of raw milk and to establish a system for the control of producers as laid down in Article 6 of Regulation (EC) No 854/2004 and the elimination of non-compliant producers from deliveries of raw milk for processing. The National Framework for the Inspection and Control Program, approved by the president, was sent to the all county inspection and control services, with the note of service no. 37035/08.01.2009, noting that the layout filled with programming activities, to be sent to the Inspection Directorate for review and approval. NSVFSA has initiated and issued a draft order to approve the quality of raw milk, which contains measures to be applied at the farm level, collection centers, dairy establishments and laboratories for control quality of raw milk, as well as the responsibilities of institutions involved in the dairy sector. This draft order was submitted for analysis and proposals to Ministry of Agriculture, Forests and Rural Development, which will be adopted by common order of NSVFSA and Ministry of Agriculture, Forests and Rural Development. National program for improving the quality of raw milk, includes obligations for all stakeholders in the quality of raw milk for processing, as follows: - at laboratory level for raw milk control criteria, expanding the analytical capacity of laboratories, trainings, ring tests, validation of alternative methods for analysis for raw milk in relation too the reference method, and the accreditation of laboratories. - at milk production holdings, evaluation by CHVPHS, in

8. To establish procedures for food business operators and CHVPHS to follow when the conditional approvals are in question and to ensure that the establishment meets all the order to identify deficiencies which lead to obtain non complaint raw milk, and inform Ministry of Agriculture, Forests and Rural Development of the needs of these holdings in order to allocate funds, informing and organize trainings at local, county and national levels with the producers of milk - finalize of the upgrading programs for milk production holdings in order to comply the Community hygiene requirements. - stringent requirements for milk collection centers, regarding the conditions for receiving, storage and delivery of raw milk - establish national criteria for raw milk processed in establishments authorized for intra-community trade, which processes non compliant raw milk in cheeses with an ageing or ripening period of at least 60days, and dairy products obtained in connection with the manufacture of such cheeses - improving communication between the institutions involved and the veterinarians at the local, county and central levels, dairy establishments, collection centers and farmers, and drawing clear tasks for each of the stakeholders involved in the milk sector. NSVFSA Order no 276/2006 was repealed by NSVFSA Order 93/2008 for the approval of veterinary norm concerning veterinary procedure for the approval of

infrastructure and equipment requirements and that the prolongation is granted only if clear progress has been made as is required by paragraph 2 of the Article 31 of Regulation (EC) No 882/2004. 9. To take action in order to ensure that the requirements of Regulation (EC) No 2073/2005 are being complied within all establishments. establishments producing, processing, storing, transporting and/or distributing animal origin products. It clearly establishes procedures for conditional approval only for establishments fulfilling the structural and equipment requirements and the conditional approval may be prolonged only if progresses are noted. These procedures are according to art.31 of Reg. (CE) 882/2004 Starting with 24.11.2008 the provisions of the order applies. Order no.93/23.10.2008 for the approval of veterinary norm concerning veterinary procedure for approval of the establishments producing, processing, storing, transporting and/or distributing animal origin products contains provisions regarding the implementation control of Reg. (CE) 2073/2005. In the frame of audit of food industry establishments it is also verified the implementation by the food business operator of the provisions of Reg. ( CE) 2073/2005 regarding microbiological criterion. Romanian Meat Association has elaborated a guideline for implementation of Reg. (CE) 2073/2005 in meat establishments, which has been sent for analyze and approval to HVPHD. By the end of the first trimester 2009 it will be finalized.