1 The CA should finalise guidelines for official controls on the aquaculture sector in order to be able to check that the requirements in Articles 4 and 5 of the Directive are implemented in a harmonised way throughout the country. The Chief Veterinary Officer prepared draft version of the SPIWET check-list activity in the aquaculture sector This draft version was prepared pursuant to the national provisions in force, and in particular to: the Act of 11 March 2004 on protection of animal health and combating infectious animal diseases (i.e Journal of Laws of 2008, No 213, item 1342, as amended); the Act of 29 January 2004 on Veterinary Inspection (i.e. Journal of Laws of 2010, No. 112, item 744); Ordinance of the Minister of Agriculture and Rural Development of 14 October 2008 on detailed veterinary requirements for carrying out activity in the aquaculture sector (Journal of Laws of 2008, No 190, item 1167). The above legal acts transpose the provisions of the Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof and on the prevention and control of certain diseases in aquatic animals (OJ EU L 328, of 24.11.2006, p. 14, as amended). The SPIWET check-list aims at documenting the control results on meeting the veterinary requirements by the aquaculture business operators. The SPIWET check-list for the aquaculture animal holders is an uniform protocol allowing for proper identification of the Page: 1
controlled farm or mollusc farming area and verification of meeting by these farms or areas of the requirements concerning the following: general information on farm or mollusc farming area, veterinary conditions for animal keeping, animal welfare, keeping documentation containing information on, among others, movement of aquaculture animals, mortality and completed animal treatment. Upon approval by the Chief Veterinary Officer, the SPIWET check-list shall be provided to the field units for implementation and delivered to the European Commission. 2 The CA should coordinate activities and standardise procedures to ensure a harmonised supervision system of official controls in APBs in all Voivods, as required in Articles 4 and 8 of Regulation (EC) No. 882/2004. The Chief Veterinary Officer prepared draft version of the Chief Veterinary Officer Instruction on carrying-out the official controls of aquaculture business operators. The draft version will be a tool to harmonize the procedures to be followed by the official veterinarians during the controls of meeting by the aquaculture business operators of the veterinary requirements specified for conducting the individual activities in this sector. The arrangements for the content of the Instruction are at their final stage. The scheduled date for this Instruction to enter into force is on February 2011. Upon approval by the Chief Veterinary Officer, the Instruction will be provided to the field units for implementation. The Instruction describes the manner to perform the official controls. It defines what elements should be taken into Page: 2
particular consideration, when evaluating the level in which the veterinary requirements are met. The Instruction specifies also the frequency of the official control performance, which is defined depending on the epizootic situation of a given zone or compartment and the risk level in the farm or mollusc farming area. It contains guidelines referring to the frequency of the official controls performance, including the elements to be considered when determining the risk level risk analyses (probability of infection and disease spreading), which directly determines the frequency of controls. The Instruction describes also the manner of determining the risk level in the farm or mollusc farming area and lists the exemplary factors to be considered when determining the risk level. Also the guidelines for the district veterinary officers specifying the manner to determine zones and compartments are provided in the Instruction. The document lists also the control activities to be performed by the district veterinary officer in the farm or mollusc farming area depending on the type of surveillance (passive, active or targeted) as well as the factors to be considered when performing the control. Check-list SPIWET activity in the aquaculture sector, referred to in the answer to recommendation No. 1 from the mission, constitutes the integral part of this Instruction. This lists aims at documenting the control results in the scope of Page: 3
3 The CA should review their registration procedures in order to register, as required by Article 6 of the Directive, all premises that fall within the definition of an APB in Article 3. 1(c) without exceptions. meeting the veterinary requirements by the aquaculture business operators. Upon entrance of this instruction into force, the Chief Veterinary Officer intends to carry out trainings of the field units in the scope of performing the official controls of the aquaculture business operators. In addition, the Chief Veterinary Officer issued the Chief V requirements of Article 4(6) of the Regulation (EC) no. 882/2004. Performing of audits aims at verification, whether the offici the national control plans. Performing of internal audits aims at ensuring of the appropriate quality of the official controls in the scope specified by the Regulation (EC) No. 882/2004. They act as the factor ensuring proper quality of the Veterinary Inspection activities and therefore the requirements of standards referring to quality assurances system, such as PN-EN ISO 9001:2009 standard Quality management systems requirements apply for their organization. The Chief Veterinary Officer issued the letter to the Regional Veterinary Officers No. GIWz.401/R-03/1/2011 of 19 January 2011, in which it emphasizes the necessity of more detail execution of the registration procedures to ensure registration of all business entities defined as the aquaculture production businesses, pursuant to Article 2(20a) of the Act of 11 March 2004 on protection of animal health and combating Page: 4
4 The CA should review their registry of authorised farms, to include only APBs that fully implement the requirements in Articles 8, 9 and 10 of the Directive. infectious animal diseases, implementing the provisions of the Council Directive No. 2006/88/EC. It should be noted that pursuant to Article 5 of the Act of 11 March 2004 on protection of animal health and combating infectious animal diseases, the district veterinary officer may commence the procedure of registration of the farm or mollusc farming area only on the basis of the application and on request of the potential aquaculture business operator. The letter of the Chief Veterinary Officer, referred to in Clause 3 of the answers to the recommendations from the mission, formulates the instruction for the Regional Veterinary Officers on the manner to update the register of aquaculture business operators in a part concerning the entities subject to registration and authorisation. The Regional Veterinary Officers were instructed that only the aquaculture production businesses and the processing establishments slaughtering aquaculture animals for disease control purposes, meeting all the requirements specified for this type of activity in the Act of 11 March 2004 on protection of animal health and combating infectious animal diseases and in the Ordinance of the Minister of Agriculture and Rural Development of 14 October 2008 on detailed veterinary requirements for carrying out activity in the aquaculture sector transposing the requirements of Article 8, 9 and 10 of the Council Directive 2006/88/EC should be authorised. Page: 5
5 The CA should endeavour to prepare a CP for exotic diseases as required in chapter V article 47 of the Directive. The said letter clearly emphasizes that the register of the authorised farms and mollusc farming areas should include only the aquaculture production businesses and the processing establishments slaughtering aquaculture animals for disease control purposes, meeting all the veterinary requirements specified for conducting a given activity and authorised pursuant to Article 6 of the abovementioned Act (Article 4 of the Council Directive 2006/88/EC). The Chief Veterinary Officer requested from the Regional Veterinary Officers to verify and update the register of the supervised aquaculture business operators subject only to mandatory registration and registration and authorisation. The Regional Veterinary Officers were obliged to take the immediate actions in this scope. The Chief Veterinary Officer understands the need to prepare the contingency plans for exotic diseases of aquaculture animals, pursuant to the requirements of Article 47, Chapter VI of the Council Directive 2006/88/EC (and the Ordinance of the Minister of Agriculture and Rural Development of 21 November 2008 on the list of infectious animal diseases for which contingency plans are drawn up (Journal of Laws of 2008, No 218, item 1397), transposing the provisions of the Council Directive 2006/88/EC). The Chief Veterinary Officers intends to update the eight already prepared contingency plans for combating the infectious Page: 6
animal diseases. I additionally inform that due to the epizootic situation concerning the foot and mouth disease in Turkey and the African swine fever in Russia, the updating works shall be commenced from the contingency plans for the abovementioned diseases. In addition, non-exotic diseases of aquaculture animals, constituting a real threat on the territory of the Republic of Poland are the current priority, however the Chief Veterinary Officer recognizes the necessity of preparing the contingency plans for the exotic diseases of aquaculture animals and considers their preparation. At the same time, we enclose the schedule of works of the National Crisis Team at the Chief Veterinary Officer for the years 2011, 2012 and 2013 in the scope of updating and preparing the contingency plans for the infectious animal diseases. Preparation of the contingency plans for the exotic diseases of aquaculture animals is scheduled for the year 2012 and 2013, however the General Veterinary Inspectorate took all efforts to commence their preparation as soon as possible. 6 The CA should designate a laboratory to carry out diagnostic analyses on crustacean diseases; furthermore they should satisfy themselves that a laboratory is designated to carry out analyses for the exotic diseases listed in Annex IV part II to the Directive. With regard to amendment of the Act of 29 January 2004 on Veterinary Inspection, which took place in 2010 and included, among others, the changes referring to designation of the official laboratories, the General Veterinary Inspectorate commenced works on designation of the laboratories to perform the official Page: 7
tests of the infectious animal diseases. This process should be completed to the end of the current year at the latest. In addition, upon consulting the National Reference Laboratory in Pulawy, the following was agreed: in the case of any suspicion of the exotic and non-exotic diseases of crustacea and exotic diseases of molluscs, the National Reference Laboratory shall provide the relevant samples to the competent community reference laboratory, pursuant to the Ordinance of the Ministry of Agriculture and Rural Development of 23 December 2010 on National Reference Laboratories (Journal of Laws of 2011, No. 8, item 38)., in the case of exotic diseases of fish, i.e. epizootic haematopoietic necrosis (EHN) and epizootic ulcerative syndrome (EUS), the National Reference Laboratory shall finalize experimental works related to this issue to prepare the necessary research procedures and other documents and commence the accreditation of these research methods as soon as possible, in the case of non-exotic diseases of molluscs, at the end of 2010 the National Reference Laboratory prepared and accredited the research procedure No. ZCHR/PB-18 in the scope of bonamiosis (Bonamia ostreae) and marteiliosis diagnostics using the cytological method. 7 The NRL should achieve the accreditation process for the methods The National Reference Laboratory in Puławy has been Page: 8
used in the diagnosis of the diseases listed in Annex III and required in Article 56 of the Directive. accredited (Certificate No. AB 1090) for the methods used for diagnosing: viral hemorrhagic septicemia (VHS) since 16 September 2009, infectious haematopoietic necrosis (IHN) since 16 September 2009, koi herpes virus disease (KHV) since 7 December 2010, bonamiosis (Bonamia ostreae) and marteiliosis since 7 December 2010, The research procedures for the remaining diseases shall be prepared by the National Reference Laboratory and subject to accreditation process as soon as possible. 8 The NRL should review its methodology of analysis for VHS and IHN to take into consideration the requirements of Decision 2001/183/EC. Upon consultations carried out with the European Union Reference Laboratory (EURL) in Aarhus, Denmark, the following was agreed: serum with antibodies neutralizing the IPN virus in test for VHS and IHN presence shall be offered by no commercial company, the a/m serum should be manufactured / obtained by own means, the employee of the Department of Fish Diseases of the National Veterinary Research Institute in Puławy was sent to the EURL in Aarhus on 24 January 2011 to be trained in the Page: 9
scope of manufacturing / obtaining of the a/m serum and other details of performing laboratory tests for fish diseases diagnosing, to the moment of manufacturing / obtaining of the a/m serum by the NRL, serum obtained from the EURL will be used declaration of the EURL representative, as soon as possible from obtaining of the a/m anti-ipn serum, the necessary changes to the routine diagnostics of VHS and IHN will be introduced, considering the requirements of the Decision No. 2001/183/EC. Page: 10