EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

DG(SANTE) 2019-6616

FINAL REPORT OF AN AUDIT

CARRIED OUT IN

BELARUS

FROM 11 NOVEMBER 2019 TO 15 NOVEMBER 2019

IN ORDER TO

EVALUATE THE ANIMAL HEALTH CONTROLS ON LIVE AQUACULTURE ANIMALS INTENDED FOR EXPORT TO THE EUROPEAN UNION

Ref. Ares(2020)1187982 - 25/02/2020

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Executive summary

This report describes the outcome of an audit in the Republic of Belarus, carried out from 11 to 15 November 2019, as part of the published Directorate-General for Health and Food Safety's audit programme. The objectives of the audit were to evaluate whether i) the competent authority can provide guarantees for aquaculture animals intended to be exported to the EU which are equivalent to the relevant animal health requirements of EU legislation and ii) the certification system in place allows the competent authority to certify the animal health requirements needed for export of these commodities to the EU.

The Republic of Belarus has applied to be listed to be able to export live aquaculture animals intended for farming, relaying areas, put and take fisheries, and ornamental facilities into the European Union.

The competent authority has adequate structure and legal powers to implement a system of animal health controls on aquaculture production businesses. However, the system does not provide sufficient animal health guarantees for aquaculture animals intended for export to the EU.

The central authorities do not have an overview over aquaculture production businesses and they do not check the reliability of the local registers. This limits their disease surveillance abilities and would hamper their response to possible disease outbreaks. This, together with the fact that the official veterinarians who are checking aquaculture have no training on viral fish diseases and therefore mainly check conditions related to intensive production (e.g. parasitic infections or environmental contamination), does not ensure the early detection of viral fish diseases. The absence of any national contingency plans for viral fish diseases would slow down the response to control any future outbreak.

The country has self-declared disease freedom for the five viral fish diseases most relevant for this audit, but it does not comply with two of the rules within the International Organisation for animal health's aquatic code in order to be eligible to self-declare disease freedom (related to import rules and disease status of shared water bodies with neighbouring countries). Viral diseases are not routinely considered in the investigation of mass mortality events - there has not been any testing based on suspicion for any of the relevant viral diseases since 1996, despite several cases of mass mortality events and outbreaks in neighbouring countries.

There are no import requirements for fish vector species equivalent to those in EU legislation, which increases the possibility of importing disease into the Republic of Belarus.

In principle, the veterinary authorities rely on laboratories in Lithuania and the Russian Federation to diagnose viral fish diseases. However, they have no written agreements in place for this purpose, nor have they ever tested the arrangements for testing suspicion of disease in practice.

The veterinary authorities have not provided any training or instructions to official veterinarians who would be responsible for issuing the model health certificate from Regulation 1251/2005.

The system in place does not allow the authorities to give the necessary assurances regarding compliance or equivalence with the relevant aquatic animal health conditions when certifying live

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aquaculture fish for export to the EU.

The report contains recommendations to the competent authority of the Republic of Belarus to address the shortcomings identified.

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Table of Contents

1 Introduction ....................................................................................................................................1

2 Objectives and scope......................................................................................................................1

3 Legal Basis .....................................................................................................................................2

4 Background ....................................................................................................................................2

4.1 General background.................................................................................................................2

4.2 Production and trade information............................................................................................2

5 Findings and Conclusions ..............................................................................................................3

5.1 Competent authorities..............................................................................................................3

5.1.1 Legislation and documented procedures .........................................................................3

5.1.2 Designation of competent authorities: organisation, resources and cooperation...........4

5.1.3 Staff – independence and training....................................................................................5

5.1.4 Verification of animal health related official controls.....................................................5

5.2 Registration and authorisation of aquaculture production businesses.....................................6

5.2.1 Registration/authorisation of aquaculture production businesses ..................................6

5.2.2 Animal health related official controls of aquaculture production businesses................7

5.3 Animal health situation............................................................................................................9

5.3.1 Import controls and quarantines......................................................................................9

5.3.2 Surveillance....................................................................................................................10

5.3.3 Control measures / outbreak management ....................................................................12

5.4 Laboratories ...........................................................................................................................13

5.4.1 Laboratory network........................................................................................................13

5.5 Export ....................................................................................................................................14

5.5.1 Authorisation of exporters to the EU .............................................................................14

5.5.2 Certification ...................................................................................................................14

6 Overall conclusions ......................................................................................................................16

7 Closing meeting ...........................................................................................................................16

8 Recommendations ........................................................................................................................17

IV

Abbreviations and definitions used in this report

Abbreviation Explanation

APB aquaculture production business

DG Directorate-General

DVFS Department of Veterinary and Food Supervision

EC European Community

EAEU Eurasian Economic Union

EU European Union

IHN Infectious haematopoietic necrosis

KHV Koi herpes virus

NRL National Reference Laboratory

OIE World Organisation for Animal Health

SOP Standard Operating Procedure

SVC Spring viremia of carp

TRACES Trade Control and Expert System

VHS Viral haemorrhagic septicaemia

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1 INTRODUCTION

This audit took place in the Republic of Belarus from 11 to 15 November 2019. The audit team comprised three auditors from Directorate-General (DG) Health and Food Safety and a National Expert from a Member State of the EU. The audit was undertaken as part of the planned audit programme of DG Health and Food Safety.

The opening meeting was held in Minsk on 11 November at the Ministry of Agriculture and Food with the competent authorities for the activities covered under the scope of this audit including the Department of Veterinary and Food Supervision, State Institution for “Veterinary Supervision”, Belarusian State Veterinary Centre (central laboratory). At this meeting, the audit team confirmed the objectives of, and the itinerary for the audit, and requested additional information on specific elements of the control system in place. Representatives from the CAs accompanied the audit team during the entire audit.

2 OBJECTIVES AND SCOPE

The objectives of the audit were to evaluate whether:

the competent authority can provide guarantees for aquaculture animals intended to be exported to the European Union (EU) which are equivalent to the relevant animal health requirements of EU legislation;

the certification system in place allows the competent authority to certify the animal health requirements needed for export of these commodities to the EU.

The scope of the audit covered the production chain for live aquaculture fish and products thereof to be exported to the EU, in particular the legal framework, staff competence, registration and authorisation of aquaculture production businesses, the aquaculture animal health situation, the laboratory capability and capacity, and the systems in place for import and export of fish and products thereof. The table below lists the sites visited and meetings held in order to achieve the objectives:

MEETINGS / VISITS No. COMMENTS

Central 2 Opening and closing meetings with the Department of Veterinary and Food Supervision

Competent authorities Regional

/local 2Committee on Agriculture and Food of Brest Regional Executive Committee. Local veterinary offices in Brest region

Aquaculture Production Businesses

2 Two aquaculture production businesses

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3 LEGAL BASIS

The audit was carried out under the general provisions of EU legislation and, in particular:

Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, and

Article 58 of Council 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.

4 BACKGROUND

4.1 GENERAL BACKGROUND

The Republic of Belarus is not included in the list of third countries, territories, zones or compartments laid down in Annex III to Commission Regulation (EC) No 1251/2008 (hereafter, Regulation 1251/2008) from which Member States of the EU are authorised to import “live aquaculture animals intended for farming, relaying areas, put and take fisheries, and ornamental facilities” in accordance with the conditions laid down in Articles 10 and 11 of the said Regulation.

The Republic of Belarus has applied to be listed in Annex III for export to the EU for the following fish species: Cyprinidae family (Carp species), Acipenseridae family (Sturgeon species) and Esox lucius (Pike).

The Republic of Belarus is listed in Annex II to Commission Decision 2006/766/EC and has been exporting fishery products for human consumption to the EU in recent years. The most recent audit for this area was carried out in May 2019 (ref. DG (SANTE)/2019-6688). The associated report contains a number of recommendations related to systemic issues which are relevant for the current audit such as export certification. The report from that audit can be viewed at: http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=4176.

The Republic of Belarus is a member of the World Organisation for Animal Health (OIE) but not of the World Trade Organisation.

4.2 PRODUCTION AND TRADE INFORMATION

According to data provided by the competent authority, the country produced 16,128 tonnes of fish during 2018, including 13,860 tonnes of “pond fish” (84.5% carp), 1,235 tonnes of “lake-river fish” and 806 tonnes of “valuable fish species”, i.e. salmon, trout, sturgeon and catfish. By the end of 2020, within the framework of the State Programme measures, it is planned to increase the volume of production up to 18.2 thousand tons of fish.

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5 FINDINGS AND CONCLUSIONS

5.1 COMPETENT AUTHORITIES

Legal requirements

Article 23(3) (a), (b) and (c) of Directive 2006/88/EC, Article 46 of Regulation (EC) No 882/2004

Findings

5.1.1 Legislation and documented procedures

1. The main pieces of national legislation (as amended) relevant for animal health related official controls/inspections on live fish include:

Order No. 161-З (2010) “On Veterinary Activities” - sets out the structure of the state veterinary service and general rules for state regulation in the veterinary field;

Resolution No. 91 (2007) - Veterinary and sanitary rules for organizations engaged in fish farming;

Order No. 758 (2013) - "Additional measures for elimination and prevention of spread of the African swine fever and other dangerous diseases of animals"; (restriction and quarantine rules for wide range of listed diseases including those of fish).

Joint Order 81/123/859 (2011) - "Order of Interaction of the Ministry of Agriculture and Food, the Ministry of Health and the State Committee for Standardisation" of 2011 – defines the competencies of each competent authority and arrangements for annual joint inspections of companies approved to export to the EU.

Resolution No 319 (2017) - "On some issues of veterinary activities" (Regulations on the procedure and conditions for issuing veterinary export certificates to the EU).

Order No. 510 (2009) "On improving control (supervision) activity in the Republic of Belarus".

Order No. 277 (1999) – "Rules for veterinary handling of animals during selection and sale to agricultural and other organizations engaged in the production of agricultural products, and when exchanging animals for breeding and production purposes". (Section 12 includes specific animal health requirements for live fish before they are placed on the market).

2. In addition to the national legislation, there are a number of rules set at the level of the Eurasian Economic Union (EAEU)1. According to the competent authority, the harmonised EAEU rules supersede the national rules.

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The applicable EAEU legislation includes:

Decision No. 317 (2010) of the Customs Union Commission - "Common Veterinary (Veterinary and Sanitary) Requirements for Goods Subject to Veterinary Control /Supervision"; (Chapter 17 includes specific detailed veterinary requirements when importing live fish/germinal products intended for productive rearing, breeding into the customs territory of the EAEU and/or moving between its Member States).

Decision No. 94 of 2014 of the Council of the Eurasian Economic Commission - "On a single procedure for carrying out joint inspections of facilities and sampling of goods (products) subject to veterinary control (supervision)". This Decision includes provisions for the inspections of establishments with a view of including them into the register of establishments of the Customs Union and regular inspections of those establishments already listed.

3. In general, the official control system related to aquaculture relies heavily on the legal texts that often include inspection checklists. Very few additional "standard operating procedures” or guidance documents are provided to official control staff.

5.1.2 Designation of competent authorities: organisation, resources and cooperation

4. The Department of Veterinary and Food Supervision (DVFS) within Ministry of Agriculture and Food, is responsible for the planning, implementation and supervision of the animal health related controls on aquaculture production businesses. The DVFS has 6 regional divisions (corresponding to the "Oblasts") and 118 districts (corresponding to the "rayons"). The organisational structure of the DVFS is as follows:

The State Institution “Belarusian Authority of the State Veterinary Supervision at the State Border and Transport” carries out state veterinary control over

1 the Republic of Belarus, Russia, Kazakhstan, Armenia and Kyrgyzstan.

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compliance with veterinary and sanitary requirements for the export, import and transit of goods including live animals.

The State Institution “Belarusian State Veterinary Centre” carries out laboratory and diagnostic studies to monitor animal health and identify the causes of their diseases (see section 5.4 below).

The State Institution “Veterinary Supervision” implements state control and supervision in the field of veterinary medicine, to ensure animal product safety in veterinary and sanitary terms.

5.1.3 Staff – independence and training

5. The Law of the Republic of Belarus No. 305-З “On Combating Corruption” (2015) provides rules on conflict of interest. In the event of a conflict of interest, the State Veterinary Inspectors are obliged to notify their direct supervisor in writing of the conflict of interest or the possibility of it as soon as he/she becomes aware of such conflict.

6. There is a range of fish health-related training courses available for the specialists of the state veterinary service and specialists of aquaculture production business (APBs), e.g. 25 places on an "advanced training in fish diseases" which is held once every 2 years at the Educational Institution “Vitebsk State Academy of Veterinary Medicine”. Expert advice is available to state veterinarians working in APBs from the State Veterinary Centre and regional laboratories.

7. The “animal health specialists” employed by each of the APBs visited during the audit had a high level of knowledge of fish diseases including the relevant viral diseases included on the health certificate in Regulation 1251/2008. Each of these two APBs were regularly visited by two state veterinarians who carried out periodic official inspections and/or certified consignments of fishery products to the EU or live fish/fishery products to other EAEU member countries. All four of these official veterinarians had received no additional training on viral fish diseases. (One of them had a qualification in fish parasitology).

5.1.4 Verification of animal health related official controls

8. There is no legal basis or formalised system in place for verifying the quality of official controls via supervision (witnessing an official carrying out inspections by another official) or internal/external audits. The audit team was informed at several locations visited that this does take place but is not reported upon in writing.

9. There is a system for reporting control activities from District to Regional offices including a monthly summary report.

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Conclusions on competent authorities

10. The competent authority has the necessary structure and legal powers in place to implement a system of animal health controls on APBs that allows it to trade live fish between other member countries or import into the EAEU.

11. Although a range of fish health-related training opportunities are available for official staff, none of the four official veterinarians met during the audit who regularly carry out official controls at APBs and issue export certificates had received any training on viral diseases of fish.

5.2 REGISTRATION AND AUTHORISATION OF AQUACULTURE PRODUCTION BUSINESSES

Legal requirements

Articles 4-9 and Article 23(3) (c), (d) and (g) of Directive 2006/88/EC; Points II.1. (2, 3 and 4) of Part A, and Points II.1 (2 and 3) of Part B of Annex IV to Regulation (EC) No 1251/2008, Point I.1.(a) of Part 1, and Point I.1. of Part 2 of Annex I to Decision (EU) 2015/1554

Findings

5.2.1 Registration/authorisation of aquaculture production businesses

12. Before the audit, the central competent authority provided the audit team with a list of 43 "registered" APBs. The list of 43 was created by combining all APBs from two existing lists of registered companies, i.e.:

1) companies that export food or live fish to other member states of the EAEU, and

2) companies approved to export fishery products (including live fish) to the EU.

The location of these 43 APBs is as follows:

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13. This list of "registered” APBs does not include information such as the disease health status or the species of fish kept at each location which would be required in the event of an outbreak of a viral disease.

14. APBs are divided into two groups under Resolution 91, i.e.:

1) "Fish breeding organisations" where fish are bred and reared, and

2) "natural reservoirs" where fish are reared and then may involve commercial or recreational fishing.

15. Only "fish breeding organisations" are included in the list of 43 APBs. According to the central competent authority there were about 700 APBs using "natural reservoirs" but a specific list/information system is not maintained at central level and there are no checks carried out to ensure that local registers are accurate.

16. Eight of the APBs on the national list of 43 were located in the Brest region. When the audit team discussed this with the regional authorities, it was clarified that two of the eight APBs should no longer be on the list as one had ceased trading for two years and the other for three.

17. According to the competent authority, there are no registered enterprises producing ornamental fish.

5.2.2 Animal health related official controls of aquaculture production businesses

18. According to the competent authority, every location that carries out aquaculture activity is under official control (supervision). Official veterinarians at district level are responsible for periodically inspecting each APB with a specific vet linked to a specific APB.

19. "Fish breeding organisations" are subject to the following official controls/inspections by official veterinarians:

Monthly:

- For APBs registered to trade within EAEU - a template checklist from Order No. 29 is used on a monthly basis that includes inspections of live fish.

Twice per year:

- Using a template checklist from Order No. 91. Non-compliances and deadlines for corrective actions are issued to the APB.

- Inspections related to implementation of the "Annual Plan for anti-epizootic and preventive activities against contagious diseases". This largely focuses on treatments for endemic diseases (e.g., aeromonas infections, parasites) and environmental contamination of ponds (treatment with quicklime).

Annually:

- For APBs registered to export to the EU - using a template checklist from

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Order No. 81/123/859 – joint inspection by three competent authorities (i.e., Ministry of Agriculture and Food, Ministry of Health and the State Committee for Standardisation) on compliance with EU requirements. (A revised checklist had recently been introduced and used at both APBs visited during the audit. The checklist contained many incorrect references to pieces of EU legislation and the competent authority agreed to revise it.)

20. The audit team noted that although inspections detected issues which lead to a written corrective action plan with deadlines being agreed between the official veterinarian and the APB, in several cases, there was no formal/written confirmation that the issue had been addressed.

21. The “animal health specialist” employed by the APB also carries out periodic inspections of live fish and can consult with state veterinarians if required, e.g. control catch every 10 days during the growing season.

22. The "veterinary-sanitary passport" as required by Article 29 of Resolution No. 91, is a document in which the veterinary-sanitary relevant records are kept such species kept by the APB, details of arriving consignments and any treatments provided). The list of species being kept at the second "fish breeding organisation" visited during the audit, had not been updated to reflect the fact that it was keeping sturgeon.

23. The 700 + "natural reservoirs" are subject to an annual "ichtyopathological survey […] for prevention of a mass epizooty «under Article 57 of Decree No. 580 which relates to "measures for increasing efficiency of fishing activities". (Art 42 of Resolution 91 also requires annual inspections of "fishing reservoirs").

24. The audit team examined several annual inspection reports from "natural reservoirs" and commented that they did not include:

any confirmation that the "veterinary-sanitary passport" (as required by Article 29 of Resolution No. 91) was being maintained, and

the water temperature during the inspection (which is very important for observing clinical signs of certain diseases, e.g., should be below 14 degrees centigrade for VHS and IHN and above 15 degrees for KHV in accordance with Commission Implementing decision (EU) 2015/1554).

Conclusions on registration and authorisation of aquaculture production businesses

25. The veterinary authorities at central level do not maintain an overview over APBs at national level. They rely on the district authorities to maintain registers on the location of local fish farms. No information systems have been established for this purpose and no checks are carried out to ensure that local registers are in place. This limits their disease surveillance abilities and would hamper their response to possible disease outbreaks.

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26. The system of official controls at APBs may not ensure the early detection of viral fish diseases due to the fact that they are carried out by official veterinarians with no training on viral fish diseases and are mainly focused on conditions related to intensive production such as parasitic and bacterial infections or environmental contamination.

5.3 ANIMAL HEALTH SITUATION

Legal requirements

Articles 12, 23(3) (d), (g) and (h), and 49 of Directive 2006/88/EC; Points II.3, II.4 and II.7 Part A, and Points II.3 and II.5 of Part B of Annex IV to Regulation (EC) No 1251/2008; Part 1 and Part 2 of Annex I to Decision (EU) 2015/1554; Annex I to Decision 2008/946/EC

Findings

5.3.1 Import controls and quarantines

27. The rules for the importation of live fish into the country are set out in chapter No. 17 of Decision No. 317 of the EAEU and the requirements include that the consignment:

was obtained in natural bodies of water or originates from aquaculture farms recognised as free during the last 24 months from listed diseases. (The list of diseases includes Koi herpes virus (KVH), Epizootic haematopoietic necrosis (EHN), Viral haemorrhagic septicaemia (VHS), Infectious haematopoietic necrosis (IHN) and Spring viraemia of carp (SVC)).

underwent a visual inspection within 72 hours prior to shipment.

had been quarantined for at least 30 days at a temperature above 12 °C in a quarantine enterprise (site) prior to shipment and during that time underwent a visual inspection of a representative sample of live fish and clinical studies for the presence of specific listed diseases are carried out.

the health status of the consignment was maintained during transport.

must undergo post-import quarantine at approved quarantine ponds at the destination (when the live fish were obtained in natural bodies of water).

28. The country has no import requirements for vector species equivalent to those in Article 10 and the related model health certificate in Part A of Annex IV Regulation (EC) No 1251/2008 and Article 17 of Council Directive 2006/88/EC.

29. The following data was provided by competent authority for trade in live fish between the Republic of Belarus and non-EU countries:

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2016 2017 2018(tonnes)

Import Export Import Export Import Export

Breeding

Rearing/cultivation 1 (Sturgeon)

Ornamental Ornamental fish - 21 Aquarium fish - 2,430

30. The Republic of Belarus imported 17,400kg of live sturgeon from Lithuania during 2018 and the first six months of 2019.

5.3.2 Surveillance

31. The country has self-declared freedom based on "historical grounds" from all five of the below diseases which are relevant for the three species (Carp species, Sturgeon species and Pike) that the Republic of Belarus has requested to be listed for in Annex III of Regulation (EU) No 1251/2008. The "Model animal health certificate for the import into the European Union of aquaculture animals for farming, relaying, put and take fisheries and open ornamental facilities" in Part A of Annex IV of the same Regulation includes certification for these diseases (either as susceptible or as vector species).

Disease name/agent Occurrence Official disease free status

Last notified suspicion or testing based on suspicion

Epizootic haematopoietic necrosis

Never reported

Yes Never

Viral haemorrhagic septicaemia

Never reported

Yes Never

Infectious haematopoietic necrosis

Never reported

Yes Never

Koi herpes virus Never reported

Yes Never

Spring viraemia of carp 1996 Yes 1996

32. The Aquatic Animal Health Code of the OIE sets out the rules for self-declaration of disease freedom based on "historical grounds" in chapter 1.4.6 and relevant disease specific chapters, e.g. chapter 10.7.4 for KHV. Chapter 10.7.4 includes several conditions for declaring historical freedom as well as not confirming the specific disease during the previous ten years. One of the conditions is the continuous implementation during those ten years of "basic biosecurity conditions". This is defined in the glossary of the OIE's Code and includes "to prevent the introduction of the pathogenic agent .... in accordance with the relevant disease specific chapter".

33. Chapter 10.7.3.2 sets out the trade rules in the case of KHV and includes import rules that are directly linked to "the health status of the exporting country, zone or compartment". OIE member countries that self-declare disease freedom may only

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import susceptible live fish from other disease free "countries, zones or compartments" (as defined in the OIE Aquatic Animal Health Code). The common EAEU rules for trade in live fish only require disease freedom for the "farm" of origin for 24 months pre-movement and not from a “country, zone or compartment”. This is less strict than the OIE requirement. The same principle for disease free for the "countries, zones or compartments" of origin applies for the other four diseases.

34. The introductory paragraph to chapter 10.7.4 states that " If a country shares a zone with one or more other countries, it can only make a self-declaration of freedom from infection with KHV if all the areas covered by the shared water bodies are declared countries or zones free from infection with KHV (see Article 10.7.5.) " Lithuania and Poland have both confirmed outbreaks of KHV since 2018 and the country shares a border and water bodies with both countries. The areas covered by the shared water bodies have not been declared countries or zones free from infection with KHV.

35. The authorities have not established buffer zones at the borders with these neighbouring countries equivalent to those referred to in Article 49.2 and 49.3 of Council Directive 2006/88/EC.

36. Early detection relies solely on passive surveillance (with the exception of some testing for all fives diseases in connection with pre-export quarantine testing of live trout destined for Russia). There is no active or targeted surveillance for any of the five viral diseases relevant for proposed species to be exported to the EU included in the model health certificate in Part A of Annex IV Regulation (EC) No 1251/2008.

37. Several pieces of national legislation provide the legal basis for notification of the suspicion of disease in fish, i.e.:

Article 13 of Order No. 161-3 "on Veterinary Activities" which requires "legal entities and individuals …to inform immediately the State Veterinary Service of the Republic of Belarus at the location of animals at suspicion on any animal diseases;

Paragraph 31 of Resolution No. 91 states that: “In the event of a fish disease, the leaders of the hatchery organizations are obliged to inform the veterinarian about this…”;

Paragraph 4 of Decree 758 states that: “If you suspect an infectious animal disease included in the list of infectious animal diseases for which quarantine is established, …legal entities and individuals, are obliged to immediately inform … the authorities)”.

38. There have been no information campaigns for the industry (workers in APBs) or groups involved with fishing activities, e.g. anglers or environmental authorities. The competent authority did not issue guidance or fact sheets to official veterinarians responsible for official controls at APBs.

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39. Six incidents of increased mortality have been notified to the State Veterinary Service since 2014. Four were related to deaths in "natural reservoirs" and two were in "fish breeding organisations". According to the competent authority, in every case, the water was tested for quality and bacteriological, parasitological, chemical and toxicological tests were performed on the fish. Deaths were attributed to a range of causes including overcrowding, ammonia via wastewater, pesticide being washed into the water and high water temperatures. No tests had been performed to exclude or diagnose viral fish diseases.

40. One on the six reported incidents occurred in 2014 at one of the APBs visited during the audit. Staff of the APB initially noticed a change in behaviour of fish and high mortality levels in a single species (over 83,000 carp died within 24 hours). The fish were kept in nets in a warm water channel that was fed by warm water from a nearby electricity generating plant. On the day in question, the water in the warm channel was recorded at 38 degrees centigrade. The competent authority was confident that the high temperature was causing the mass mortalities. Some samples were taken and tested for bacteriology and parasitology but no samples were tested to rule out the possibility at an early stage that an outbreak of Koi herpes virus might have been triggered by the stress caused by the increased water temperature.

41. Occasionally, APBs do submit samples to the laboratory network in connection with unexplained deaths of fish. These had been tested for parasitological/bacterial disease but not for viral fish diseases, which weakens the early detection system (Points 1.2(b) and 1.3 in Part I of Annex V to Council Directive 2006/88/EC).

42. According to the competent authority, the environmental authorities (State Inspectorate for Wildlife and Flora, units of the Ministry of Natural Resources and Environmental Protection) oversee the state of wild fish stocks. The competent authority stated that in the event of mass deaths in wild fish stocks that the environmental authorities would notify the State Veterinary Service. The audit team did not meet any representatives from the environmental authorities during the audit.

5.3.3 Control measures / outbreak management

43. The last outbreak of one of the five viral fish diseases most relevant for this audit in the Republic of Belarus was in 1996 but due to the length of time since that outbreak, the competent authority no longer have any records related to the control measures implemented at that time.

44. The Republic of Belarus has no national contingency plan for any viral fish disease. (Chapter 4.5.5 of the OIE’s Aquatic Animal Health Code state that: “The introduction of such diseases into countries … may result in significant losses. In order to diminish such losses, the Competent Authority responsible for aquatic animal health may need to act quickly and should develop a contingency plan(s) before such events occur”.

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Conclusions on the animal health situation

45. Although the Republic of Belarus has self-declared disease freedom for the five viral fish diseases most relevant for this audit, it does not comply with two of the rules within the OIE's aquatic animal health code in order to be eligible to self-declare disease freedom (i.e., import rules and disease status or shared water bodies).

46. Groups involved with fishing activities and official veterinarians are unaware of the risk from viral diseases in fish. These diseases are not routinely considered in the investigation of mass mortality events. In fact, no testing based on suspicion for any of the relevant viral diseases has been performed for decades, despite several cases of mass mortality events and outbreaks in neighbouring countries. This weakens the early detection system as described in points 1.2(b) and 1.3(a)(b) in Part I of Annex V to Council Directive 2006/88/EC.

47. The absence of national contingency plans for viral fish diseases could slow down the response to control any future outbreak.

48. There are no import requirements for fish vector species equivalent to those in EU legislation that increases the possibility of importing disease into the Republic of Belarus.

5.4 LABORATORIES

Legal requirements

Article 46(1)(d) of Regulation (EC) No 882/2004; Article 23(3) (d) and (h) of Directive 2006/88/EC; Points II.3, II.4 and II.7 of Part A and points II.3 and II.5 pf Part B of Annex IV to Regulation (EU) No 1251/2008

Findings

5.4.1 Laboratory network

49. The country's central laboratory for diagnosing animal diseases, including fish, is the Belarusian State Veterinary Centre in Minsk. There are regional veterinary laboratories in each of the six regions of the country. There are also nine inter-district veterinary laboratories and 107 diagnostic departments in district veterinary stations. All conduct diagnostic sampling and testing of fish in their area mainly focused on parasitology and bacteriology.

50. Testing for the five viral diseases cannot currently be performed in the Republic of Belarus. According to the competent authority, if necessary, the methods for diagnosing KVH, EHN, VHS, IHN and SVC as recommended by the OIE Guidelines can be developed and validated within a few months at the BSVC.

51. If testing (in case of suspicion) would be required before then, samples would be sent to accredited state laboratories in the Russian Federation or Lithuania.

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52. At the time of the audit, there was no written agreement in place between the competent authority of the Republic of Belarus and either laboratory in the Russian Federation or Lithuania to formalise future testing and details such as submission/transportation of samples, numbers of samples that would be accepted in case of increased sample numbers related to confirmation of disease, maximum turnaround time for result, etc.

53. According to the competent authority, a draft written contingency plan for taking and submitting samples for the five relevant viral diseases listed on the EU health certificate is nearly finalised and should be issued before the end of 2019.

Conclusion on laboratories

54. In principle, the veterinary authorities rely on laboratories in Lithuania and the Russian Federation to diagnose viral fish diseases. However, they have no written agreements in place for this purpose nor have they ever tested the arrangements in practice.

5.5 EXPORT

Legal requirements

Article 23(3) (d), (g) and (h) of Directive 2006/88/EC; Part A and Part B of Annex IV to Regulation (EU) No 1251/2008; Article 3 of Directive 96/93/EEC

Findings

5.5.1 Authorisation of exporters to the EU

55. The competent authority informed the audit team that it intends to issue a new law that will specify the requirements for APBs to be approved to export live fish to the EU using the model health certificate in Part A of Annex IV Regulation (EC) No 1251/2008.

This would include annual inspections similar to the annual joint inspections currently carried out on companies approved to export fishery products to the EU under Order No. 81/123/859.

56. A revised checklist related to the above new law had recently been introduced and used at the two APBs visited during the audit. The checklist was very comprehensive but contained numerous incorrect references to EU legislation which the competent authority agreed to revise.

5.5.2 Certification

57. The Republic of Belarus has self-declared disease freedom for the five viral fish diseases for relevant species within the scope of this audit listed in the model health certificate in Part A of Annex IV Regulation (EC) No 1251/2008, i.e. KVH, EHN, VHS, IHN and SVC. However, based on findings 33-36, it is not entitled to do so under the rules of the OIE's Aquatic Animal Health Code.

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58. Based on findings 35 and 36, (related to the current import rules for live fish into the Eurasian Customs Union being linked to "farm" freedom rather than "country, zone or compartment" freedom), the competent authority cannot certify the following attestation for relevant susceptible species in the model health certificate in Part A of Annex IV Regulation (EC) No 1251/2008: “all introductions of species susceptible to the relevant diseases come from an area declared free from the diseases".

59. This same attestation exists in the model health certificate in Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005 which must be certified when relevant susceptible species of live fish are being exported as fishery products for human consumption to the EU. The competent authority had incorrectly issued about 180 such certificates for Carp and Pike since 2014. (The competent authority stated that they understood that the wording related to the establishment of origin. However, “all introductions” relates to the area being certified disease free which was the entire country.)

60. No instructions or training has been provided for official veterinarians at APBs who would issue the model health certificate in Part A of Annex IV Regulation (EC) No 1251/2008.

61. The competent authority informed the audit team that veterinary certificates for products being exported to the EU were being issued at the establishment of origin rather than the exit BIP which had been the previous practice up until just before the audit. This change was as a result of the report from the audit carried out in May 2019 (ref. DG (SANTE)/2019-6688). (The audit team did not verify this as there was no certification in place within the scope of the current audit

Conclusion on export

62. The Republic of Belarus is not entitled to certify disease freedom under the rules in the OIE's aquatic animal health code for relevant viral diseases of fish included in the export certificate to the EU. A similar situation applies to the attestation that “all introductions of species susceptible to the relevant diseases come from an area declared free from the diseases".

63. Due to the absence of training and instructions, the official veterinarians who would be responsible for issuing the export certificate do not have the sufficient knowledge to ascertain the statements they need to sign.

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6 OVERALL CONCLUSIONS

The competent authority has adequate structure and legal powers to implement a system of animal health controls on aquaculture production businesses. However, the system does not provide sufficient animal health guarantees for aquaculture animals intended for export to the EU.

The central authorities do not have an overview over aquaculture production businesses and they do not check the reliability of the local registers. This limits their disease surveillance abilities and would hamper their response to possible disease outbreaks. This, together with the fact that the official veterinarians who are checking aquaculture have no training on viral fish diseases and therefore mainly check conditions related to intensive production (e.g. parasitic infections or environmental contamination), does not ensure the early detection of viral fish diseases. The absence of any national contingency plans for viral fish diseases would slow down the response to control any future outbreak.

The country has self-declared disease freedom for the five viral fish diseases most relevant for this audit, but it does not comply with two of the rules within the International Organisation for animal health's aquatic code in order to be eligible to self-declare disease freedom (related to import rules and disease status of shared water bodies with neighbouring countries). Viral diseases are not routinely considered in the investigation of mass mortality events - there has not been testing based on suspicion for any of the relevant viral diseases since 1996, despite several cases of mass mortality events and outbreaks in neighbouring countries.

There are no import requirements for fish vector species equivalent to those in EU legislation, which increases the possibility of importing disease into the Republic of Belarus.

In principle, the veterinary authorities rely on laboratories in Lithuania and the Russian Federation to diagnose viral fish diseases. However, they have no written agreements in place for this purpose nor have they ever tested the arrangements for testing suspicion of disease in practice.

The veterinary authorities have not provided any training or instructions to official veterinarians who would be responsible for issuing the model health certificate from Regulation 1251/2005.

The system in place does not allow the authorities to give the necessary assurances regarding compliance or equivalence with the relevant aquatic animal health conditions when certifying live aquaculture fish for export to the EU.

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7 CLOSING MEETING

On 15 November, the audit team held a closing meeting with representatives of the Department of Veterinary and Food Supervision and presented the main findings and preliminary conclusions of the audit.

8 RECOMMENDATIONS

The Competent Authorities are invited to provide, within one month of receipt of the report, an action plan containing details of the actions taken and planned, including deadlines for their completion, aimed at addressing the recommendations set out below:

No. Recommendation

1. Ensure that all relevant rules within the OIE’s Aquatic animal Health Code in order to self-declare disease freedom.

Chapter 1.4.6 of the OIE’s Aquatic animal Health Code and specific chapters for relevant diseases.

Recommendation based on conclusion: 45.

Associated findings: 31-34.

2. Ensure that the official veterinarians responsible for export certification to the EU have satisfactory knowledge of the legal requirements and are informed of the rules to be followed for drawing up and issuing certificates.

Article 23(3)(b) of Directive 2006/88/EC; Article 3(1)(2) and (3) and Article 6 of Council Directive 96/93/EC.

Recommendation based on conclusion: 63.

Associated finding: 60.

3. Ensure that a national contingency plan is created for relevant viral fish disease.

Chapter 4.5.5 of the OIE’s Aquatic Animal Health Code.

Recommendation based on conclusion: 47.

Associated finding: 44.

4. Ensure that level of awareness of relevant viral diseases of fish is increased amongst official veterinarians, officials responsible for monitoring the health of wild fish stocks and anglers to help ensure early notification and detection of disease.

Article 1.2(b) and 1.3(a)(b) in Part I of Annex V of Council Directive 2006/88/EC.

Recommendation based on conclusion: 46.

Associated findings: 7 and 38.

5. Ensure that import requirements for vector species are put in place which are equivalent to those in EU legislation.

Article 10 and the related model health certificate in Part A of Annex IV Regulation

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No. Recommendation(EC) No 1251/2008 and Article 17 of Council Directive 2006/88/EC.

Recommendation based on conclusion: 48.

Associated finding: 28.

6. Ensure that designated laboratories responsible for diagnosis of fish diseases that are relevant in the context of exports of live fish to the EU:

a) can offer guarantees equivalent to requirements laid down in Articles 56 and 57 of, and Annex VI to Directive 2006/88/EC (as required by Art. 23(3)(b) and (g) of that Directive), and

b) follow quality management principles and are able to generate technically valid results in accordance with international standards laid down in the OIE Aquatic Manual (Chapter 1.1.2 and the relevant chapters of Section 2.3 of the OIE Manual of Diagnostic tests for Aquatic Animals).

Recommendation based on conclusion: 54.

Associated finding: 52.

The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2019-6616

ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal TitleReg. 882/2004 - Article 46 (TC)

OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Reg. 1251/2008 OJ L 337, 16.12.2008, p. 41-75

Commission Regulation (EC) No 1251/2008 of 12 December 2008 implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species

Dir. 96/93/EC OJ L 13, 16.1.1997, p. 28-30

Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products

Dir. 2006/88/EC OJ L 328, 24.11.2006, p. 14-56

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

Dec. 2008/946/EC OJ L 337, 16.12.2008, p. 94-101

2008/946/EC: Commission Decision of 12 December 2008 implementing Council Directive 2006/88/EC as regards requirements for quarantine of aquaculture animals

Reg. 2074/2005 OJ L 338, 22.12.2005, p. 27-59

Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004

Dec. 2015/1554/EU OJ L 247, 23.9.2015, p. 1–62

Commission Implementing Decision (EU) 2015/1554 of 11 September 2015 laying down rules for the application of Directive 2006/88/EC as regards requirements for surveillance and diagnostic methods