Comparative Analysis of National Legal Frameworks Relevant for Aquatic Animal Health of the Countries of Western Balkans Dr. Mateja Djurovic LLM International Legal Consultant

SCOPE OF THE REPORT five countries of the Western Balkan: 1) Bosnia and Herzegovina, 2) Croatia, 3) the Former Yugoslav Republic of Macedonia (FYROM), 4) Montenegro, and 5) Serbia.

OBJECTIVES: The Report provides:  an overview of the relevant legal frameworks applicable to aquatic animal health in all five countries,  an identification of possible gaps, overlaps and inconsistencies  recommendations on priorities for development of national legal frameworks to comply with international standards and for improving harmonization at the regional level.

Applicable international standards and EU Legislation OIE Aquatic Animal Health Code Manual for Diagnosis of Aquatic Animal Diseases Directive 2006/88/EC on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals Proposal for a Regulation on Animal Health

Sources of the rules on aquatic animal health Laws (in particular those on Animal/Veterinary) Health Decisions Rulebooks Decrees Orders Recommendations

Competent authorities The OIE Aquatic Animal Health Code 2013 defines the competent authority as the Veterinary Authority or other Governmental Authority of a Member Country having the responsibility and competence for ensuring or supervising the implementation of aquatic animal health and welfare measures, international health certification and other standards and recommendations in the Aquatic Code in the whole territoryVeterinary Authority aquatic animalAquatic Code EU Regulation 854/2004: the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence

Competent authorities BiH: State Office of Animal Health of Bosnia and Herzegovina Croatia: Ministry of Agriculture FYROM: Food and Veterinary Agency Montenegro: Ministry of Agriculture and Rural Development and the Directorate of Animal Health Serbia: Ministry of Agriculture

Veterinary Inspectors Chapter 5 of the OIE Aquatic Animal Health Code 2013 Directive 2006/88/EC: as well as the performance of official controls and issuance of veterinary certificates Two types: ordinary veterinary inspectors border veterinary inspectors

Official and reference laboratories OIE Aquatic Animal Health Cod: veterinary laboratories are essential for diagnosing and differencing diseases Recital 25 of Directive 2006/88/EC: unified rules be adopted in relation to reference laboratories as a means to contribution to the high quality and uniformity of diagnostic results

Veterinary laboratories Three types of laboratories in the five countries of the Western Balkans:  reference laboratories,  official laboratories, and  authorized laboratories.

Authorization of fish farms Articles 4 and 6 of Directive 2006/88/EC: the obligation that that all EU fish farms and other aquaculture businesses have to be authorized by competent authorities and registered in a publicly available a register of aquaculture production businesses and authorised processing establishments

Main conditions for authorisation Under EU Law any aquaculture business must fulfill the requirements defined by Directive 2006/88/EC regarding: 1) traceability (the obligation to keep record of all relevant information for aquatic animal health)  good hygiene practice (a standard of hygiene), and  a risk based animal health surveillance scheme  to have such a system that would enable to operators to show to competent authorities that conditions have been duly fulfilled and that shall remain under the supervision of competent authority

Responsibility of economic operators Primary responsibility of economic operators includes  the obligation to identify and address potential failures to meet legal requirements in case of risk  the responsibility to ensure compliance with legislation.  entails the obligation to introduce self-control mechanisms and to recall unsafe products (in addition to notification obligations that may exist). Directive 2006/88/EC: an obligation to immediately notify to competent authority a suspicion or confirmation of occurrence of any of the diseases that shall be notified to the European Commission

Notifiable Diseases and notification Article of the Aquatic Animal Health Code: Members of the OIE make available to other countries, through the OIE, whatever information is necessary to minimize the spread of important animal diseases and thus assist in achieving better worldwide control of these diseases. Directive 2006/88/EC: Member States notify, within 24 hours, other Member States, the European Commission and EFTA Member States about occurrence of an enlisted exotic disease or also an enlisted non-exotic disease in cases when the Member State concerned, zone or compartment has been declared free of that disease. For those countries listed as third countries from which exports to the EU are allowed, in accordance with Directive 2006/88, these countries are also under the obligation to notify the EU of outbreaks

Contingency planning Chapter 4.4. of the OIE Aquatic Animal Health Code: diverse measures that countries need to follow while preparing contingency plans, in particular a detailed set of instructions Directive 2006/88/EC: establishes detailed rules on contingency planning

Zoning and Compartmentalization Zoning is the procedure by which a (part of a) water catchment area, coastal area or estuary is established as a defined area with a contiguous hydrological system with a distinct status with respect to a specific disease or diseases. Compartmentalization is the indication for an area within which one or more aquaculture establishments that fall under a common biosecurity management system that contains an aquatic animal population with a distinct health status with respect to a specific disease or diseases for which required surveillance and control measures are applied and basic bioseciurity conditions are met.

Surveillance The purpose of surveillance by competent authorities is three-fold:  to verify whether there is an absence of particular disease or diseases in a country, zone or compartment,  to identify the events that require notification, such as a suspicion of occurrence of a disease  to determine occurrence or distribution of endemic diseases. Article of the OIE Aquatic Animal Health Code

Control measures set of measures used for prevention of the spreading and combating of diseases in case of outbreaks. Control measures are based on the legal powers granted to the competent authority to act in cases of risk. Examples: investigation, taking of samples, the declaration of infected areas or farms, the declaration of protection zones, quarantine areas, and the adoption of measures associated with such areas, such as the restriction of movement of animals, disinfection of animals, aquaculture facilities and goods that have been in contact with contaminated material, the observation of animals in quarantine, the culling of animals and the destruction of animal waste

Export requirements and International animal health certificate the Aquatic Animal Health Code: each country should only authorize the export from its territory of aquatic animals and animal products that are properly identified and inspected Chapter 5.10 of the Aquatic Animal Health Code: a unified model of the international health certificate EU Law: any aquatic animal or aquatic animal products which enters the European Union is accompanied by an animal health certificate

Import requirements for aquaculture OIE Aquatic Animal Health Cod: countries should only accept those animals or products that were adequately examined and that are supported by an International Veterinary Certificate Directive 2006/88/EC: regulates and imposes the conditions and the factors in comparison to which it will be decided whether the import of aquatic animals and their products is allowed in the European Union.

Veterinary pharmaceuticals Authorization by the State for: - production - import - distribution - sale of veterinary pharmaceuticals

Feed safety OIE Aquatic Animal Health Code: standards for ensuring that diseases do not spread via aquatic animal feed, addressing both food safety and aquatic animal health hazards. Codex Alimentarius Commission (CAC) Code of Practice on Good Animal Feeding (CAC/RCP ) Laws on Food (or Feed) Safety Medicated feed

RECOMMENDATIONS: Bosnia and Herzegovina The overlap of competencies and the division of mandates between the different levels of government calls for a strong coordination mechanism, which the current law could introduce. This coordination role should relate to all competent authorities at State level and at the level of the entities and the district to ensure a coordinated approach in addressing aquatic animal diseases. The legislation does not provide for a coordination mechanism between the State border inspectors and the inspectors of the entities and it is recommended that the legislation at both the State level and at the entities and the District of Brcko should address this issue. The legislation does not entail provisions for the designation of official laboratories, which would carry out specific tests as part of official controls. The designation of official laboratories is important to ensure that services can be provided in the context of animal health, in addition to designating authorized laboratories. Regulatory response is advisable..

RECOMMENDATIONS: The legislation does not provide for provisions to establish a register of authorized fish farms, which would be recommendable to ensure that competent authorities have an up-to-date overview of aquaculture activities, which facilitates effective response to hazards. Regulatory response is advisable As legislative procedures may be long, the adoption of the list of notifiable diseases by way of a subsidiary legal instrument, as opposed to primary legislation, would be recommendable. Clarification on the procedure to be followed for the listing of certain diseases as notifiable, including criteria for listing and aspects of consultations, would be recommendable to be included in legislation. Further rules on the modalities of notification, including the means by which notification is to be done, the kind of supportive information and documentation to be provided as well as time-limits could be regulated in subsidiary legislation.

RECOMMENDATIONS: Given that the competence to declare zones or compartments free from disease remains at the regional level, and in light of the centralized role of the State level competent authority to communicate with the competent authorities of other countries and with the OIE, it is necessary that legislation provides for the possibility to establish a mechanism that ensure that there is a clear line of command between the State level authorities and the authorities in the regional subdivision to declare zones free or not free of disease. This system should in addition facilitate exchange of information on the disease status of zones and compartments, including the scientific information that provided the base for declaring zones/compartments free from disease. Regulatory response is advisable. The legislation does not provide clarity on the division of overlapping powers of the State level competent authority and those of the entities and district in relation to the adoption of control measures. A regulatory response is advisable.

RECOMMENDATIONS: Coordination at the State level between the authorities responsible for veterinary pharmaceuticals and those responsible for human pharmaceuticals of the authorization and registration system for production, sale, distribution and placing on the market of veterinary pharmaceuticals is recommendable and addressing this matter in State legislation to ensure coordination is advisable. In Bosnia and Herzegovina, the competent authorities of the two entities are in charge of registration of veterinary pharmaceuticals which is a necessary prerequisite for productions and placing veterinary pharmaceuticals at the market, whereas a State authority, the State Office of Animal Health is in charge of issuing permits for import. As consequence, a foreign veterinary pharmaceutical in order to be placed at the market, needs to pass a complex procedure of approval both by the State and regional authorities. Regulatory response is advisable to facilitate import procedures.

RECOMMENDATIONS: The legislation does not specify which rules apply to medicated feed, which needs to be addressed, preferably by subjecting medicated feed also to the legislation applying to pharmaceuticals. Regulatory response is advisable. The legislation seemingly does not subject use of anti- bacterial agents to a record keeping obligations, which would be recommendable, in case the legislation is silent on this matter.

RECOMMENDATIONS: Croatia Croatian legislation does not provide for the designation of authorized laboratories, which would be useful in case of outbreaks and limited capacities of official and reference laboratories. The competent authority could designate authorized laboratories for certain tests for a limited period of time. Further rules on the modalities of notification of diseases, including the means by which notification is to be done, the kind of supportive information and documentation to be provided as well as time-limits should be regulated in subsidiary legislation. Regulatory response is advisable. The conditions and procedure for declaration of certain zone as a disease free zone are defined by a separate rulebook to be adopted by the Minister in charge of agriculture. It is important that the Rulebook is adopted.

RECOMMENDATIONS: FYROM Legislation of FYROM does not provide for the designation of authorized laboratories, which would be useful in case of outbreaks and limited capacities of official and reference laboratories. The competent authority could designate authorized laboratories for certain tests for a limited period of time. In FYROM, conditions are imposed only in case of placement on the market of aquatic animals and their products and not in a case of production, which should be modified as there is an inherent risk in production, not only when a product is placed on the market. Regulatory response is advisable. Coordination between authorities responsible for registration and authorizing production, sale, distribution and placing on the market of human pharmaceuticals with those responsible for veterinary pharmaceuticals is important, especially in cases where use of human pharmaceuticals is possible in animals or vice versa. Regulatory response is advisable.

RECOMMENDATIONS: The use of parallel systems in addition to using the International Veterinary Certificate is not in line with the OIE standards. Adjustment of the legal framework is advisable. The law does not provide that the official authorized person for the purpose of issuing the international animal health certificate should be a veterinarian. The law also omits to provide the criteria for issuing the certificate, and does not make reference to the application of the criteria of the country of import. It would be recommendable to specify these elements in the legislation. The legislation does not provide for specific powers and responsibilities of border inspections, despite their different role. Providing specific, additional powers to border inspectors in the legislation is advisable.

RECOMMENDATIONS: Clarification on the procedure to be followed in case of notifiable diseases, including criteria for listing and aspects of consultations, would be recommendable. In order to comply with EU obligations in case of trade with the EU, the obligation to notify the relevant body in the EU of the outbreak of a notifiable disease could be included in the primary legislation. Further rules on the modalities of notification, including the means by which notification is to be done, the kind of supportive information and documentation to be provided as well as time-limits could be regulated in subsidiary legislation.

RECOMMENDATIONS: The legislation of FYROM does not specify the standards with which these surveillance plans must comply. Legislation, if not providing these details could refer to the OIE standards in relation to surveillance. FYROM legislation does not provide rules on inspections before and at departure, which needs to be addressed to ensure compliance with the OIE aquatic animal health Code. The legislation of FYROM seemingly does not subject use of anti-bacterial agents to a record keeping obligations, which would be recommendable, in case the legislation is silent on this matter.

RECOMMENDATIONS: Montenegro In Montenegro, the conditions imposed for operation of aquatic farms, such as those on traceability or good hygiene practice, are not in line with the requirements of Directive 2006/88/EC that apply to third country willing to export their aquatic animal product to the EU Member States. Legislation does not subject aquaculture activities to obtaining an authorization, which is a missed opportunity for ensuring that additional conditions, for example in relation to animal health, are fulfilled. It is advisable to introduce an obligation to subject aquaculture activities to authorization. The legislation does not provide for rules on registration of disease outbreak history, waste management plan, environmental impact assessment, which should all be addressed.

RECOMMENDATIONS: The occurrence of similar reporting obligations on the basis of legislation on animal welfare and on animal health in case of (suspicion of) certain diseases may require coordination at the legislative level between the legislation on animal welfare and the legislation on animal health, as similar but different duties exist in comparable cases of (suspicion of) occurrence of disease. It is advisable that a coordination mechanisms is introduced. Further rules on the modalities of notification of diseases, including the means by which notification is to be done, the kind of supportive information and documentation to be provided as well as time-limits could be regulated in subsidiary legislation.

RECOMMENDATIONS: The legislation of Montenegro does not provide the standards with which surveillance programmes must comply. Legislation, if not providing these details, should refer to the OIE standards in relation to surveillance. Early warning procedure is missing. Regulatory response is advisable. Different definition of animal holders in Law on Animal Health and the Law on Protection of Animal Welfare. Regulatory response is advisable. In Montenegro, no particular rules exist for declaration of certain zones as disease free. It would be recommendable to adopt such a set of rules in accordance with the OIE standards.

RECOMMENDATIONS: Rulebook on reference laboratory should be adopted as envisaged by the Law on Animal Health. Rulebook on medicated feed should be adopted by the Ministry in charge of agriculture. Regulatory response is advisable. The legislation seemingly does not subject use of anti- bacterial agents to a record keeping obligations, which would be recommendable, in case the legislation is silent on this matter.

RECOMMENDATIONS: Serbia The conditions for aquaculture facilities are not in line with the requirements of Directive 2006/88/EC that apply to third country willing to export their aquatic animal product to the EU Member States. Moreover, a general observation is that Serbian legislation is not aligned with the provisions of Directive 2006/88/EC. The alignment is advisable as an important prerequisite to increase commercial relations of Serbia with the European Union in the area of aquaculture products. The introduction of an authorization system in accordance with Directive 2006/88/EC for carrying out aquaculture activities is advisable as it provides an opportunity to ensure that the activities are carried out according to specific conditions, including e.g. in relation to animal health. In case of the list of notifiable diseases, clarification on the procedure to be followed, including criteria for listing and aspects of consultations, would be recommendable.

RECOMMENDATIONS: No Rulebook has been adopted that would regulate further the conditions and procedure for declaring of certain, compartments zones, regions or the entire country as disease free zones or to give them a particular status. A regulatory response is recommended. It would be recommendable to include, in the main legislation a clear obligation to notify the OIE as well as the relevant body in EU, in case of trade with the EU, of the outbreak of a notifiable disease. Further rules on the modalities of notification, including the means by which notification is to be done, the kind of supportive information and documentation to be provided as well as time-limits could be regulated in subsidiary legislation.

RECOMMENDATIONS: The legislation of Serbia should clearly indicate the rules and procedures relating to surveillance and refer to the OIE standards for surveillance, if not providing such criteria itself. The legislation seemingly does not subject use of anti- bacterial agents to a record keeping obligations, which would be recommendable, in case the legislation is silent on this matter.

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