1. OIE Aquatic Animal Health Standards
OIE Global Conference on Aquatic Animal Health
Panama City, Panama
28-30 June 2011
OIE Aquatic Animal Health Standards
Barry Hill
President
OIE Aquatic Animal Health Standards Commission 1

2. Aquaculture has been experiencing a boom since the mid-1970s, sustaining an average annual growth rate of around 9% until a recent slight fall back.
Today it continues to expand in almost all regions of the world and is the fastest growing food animal production sector globally.
There is substantial and growing international trade in live aquatic animals and their products.

3. A detailed analysis of aquaculture production and wild capture fisheries is published every 2 years by FAO.

5. 24th Conference of the OIE Regional Commission for Europe, Astana, Kazakhstan, 20-24 September 2010
World fish trade: export value - in 1000 US$ (FAO) -
developing
developed

7. However, infectious diseases are causing major aquaculture production losses in many countries, even having a significant negative impact on some national economies

8. In some countries, the rapid increase in aquaculture output has been based on species diversification which has led to an increase in the demand for introduction and transfers of live non-indigenous aquatic animals, some of which have introduced new diseases with them.

9. Economic losses of many $100 millions.
For example, outbreaks of infectious salmon anaemia (ISA) in Chile since 2007 have had a devastating impact on the salmon farming industry, causing a massive reduction in production and in export volumes.
Economic losses of many $100 millions.
High numbers of farms closed and large numbers of job losses.
Will take years to recover.
A national disaster.
Imported (from ??) 9

10. The main aim of OIE is to ensure the sanitary safety of international trade in live animals and their products.
This includes providing standards and guidelines on the health measures to be used by the Aquatic Animal Health Services of importing and exporting countries to prevent the transfer of agents pathogenic for aquatic animals, while avoiding unjustified trade barriers.

11. Aquatic animals

12. The OIE standards applicable to international trade in aquatic animals and their products are laid out in the OIE Aquatic Animal Health Code and in the OIE Manual of Diagnostic Tests for Aquatic Animals.

13. The OIE standards and guidance in the Aquatic Code and Aquatic Manual aim to reduce disease risks

14. Developing the OIE standards for aquatic animals is the role of the Aquatic Animal Health Standards Commission

15. Aquatic Animal Health Standards Commission (elected May 2009 for 3 years)
President:
Dr Barry Hill (UK)
Vice-President:
Dr Ricardo Enriquez Sais (Chile)
General Secretary:
Dr Franck Berthe (EFSA)
Members:
Dr Olga Haenen (Netherlands)
Dr Huang Jie (China)
Dr Victor Manuel Vidal (Mexico)

16. The Commission is regularly assisted by:
Don Lightner
USA
Rohana Subasinghe
FAO, Rome
Eli Katunguka-Rwakishaya
Uganda

17. With advances in scientific knowledge, the Aquatic Health Standards Commission prepares draft texts for new chapters, or revises existing chapters of the Aquatic Code and the Aquatic Manual with the input of internationally renowned independent experts, OIE ad hoc groups, and expertise at the many OIE Reference Laboratories for aquatic animal diseases.
These drafts are further refined with input from national experts of OIE Members before being finalised and presented to the National Delegates at the OIE General Session in May each year for adoption.

18. OIE Aquatic Animal Health Code
(‘Aquatic Code’)

19. Also available on-line at the OIE website

21. Some of the information available in the Aquatic Code
Zoning & compartmentalisation
Guidelines for risk analysis
Quality of Aquatic Animal health Services
Criteria for disease freedom
Conditions for trade
Model export certificates
Surveillance for disease
Disease reporting obligations
Transport of farmed fish
OIE listed diseases
Procedures for aquatic animal waste disposal
Responsible and prudent use of antimicrobial agents
Stunning and killing of farmed fish for human consumption 21

22. Contents of the Aquatic Code
General Provisions (Horizontal issues)
User’s guide
Glossary
Section 1 : Animal disease diagnosis, surveillance and notification
Section 2 : Risk analysis
Section 3 : Quality of Aquatic Animal Health Services
Section 4 : General recommendations : disease prevention and control
Zoning/compartmentalisation
Recommendations on disinfection
Contingency planning
Fallowing in aquaculture
Handling, disposal and treatment of aquatic animal waste

23. Contents of the Aquatic Code
General Provisions (contd)
Section 5 : Trade measures, import/export procedures and health certification
General obligations
Certification procedures
Criteria to assess safety of aquatic animal commodities
Border posts and quarantine stations
Model veterinary certificates…
Section 6 : Veterinary Public Health
Control of aquatic animal health hazards in aquatic animal feed
Antimicrobials: prudent use/monitoring/ controlling resistance (under development)
Section 7 : Welfare of Farmed Fish
Transport
Stunning and killing for human consumption
Killing for disease control purposes (under development)

24. Contents of the Aquatic Code
Disease specific chapters
(OIE listed diseases - of importance to international trade)
Section 8 : Diseases of Amphibians
Section 9 : Diseases of Crustaceans
Section 10 : Diseases of Fish
Section 11 : Diseases of Molluscs

25. Aquatic Code Chapter 1.2. Criteria for Listing Aquatic Animal Diseases

26. Aquatic Code Chapter 1.2 Article 1.2.1.
Criteria for listing an aquatic animal disease
Article
Criteria for listing an emerging aquatic animal disease

27. Criteria for listing an aquatic animal disease
A disease proposed for listing should meet all the relevant parameters set for each of the criteria;
Parameters that support a listing include:
Consequences
Spread and
Diagnosis
Such proposals should be accompanied by a case definition for the disease.

30. For the purposes of the Aquatic Code
An emerging disease means a newly recognised infection resulting from the evolution or change of an existing pathogenic agent, a known infection spreading to a new geographical area or population, or a previously unrecognised pathogenic agent or disease diagnosed for the first time and which has a significant impact on aquatic animal populations or public health.

31. Chapter 1.3. OIE list of aquatic animal diseases
The list is reviewed annually by the AAHSC and recommendations for deletions and additions are proposed to OIE Members for adoption
Notification and reporting requirements apply to all listed diseases and any new emerging diseases.

32. 26 aquatic animals diseases listed by OIE (2011)
2 diseases of amphibians
8 diseases of crustaceans
9 diseases of fish
7 disease of molluscs

33. OIE list of aquatic animal diseases
A key purpose of listing a disease in the Aquatic Code is to ensure transparency of the aquatic animal health status world-wide, by obliging Member Countries to report its occurrence to OIE.
The OIE collates and disseminates the information received in reports on the status of those listed diseases in Member Countries (WAHIS and WAHID).

34. Obligation to notify and report disease detection to OIE

35. “Disease” notification
In this context, it is important to understand that the circumstances for regular as well as immediate notification of aquatic animal diseases do not require the presence of clinical disease or mortality.
The Aquatic Code clarifies in Article :
“This means that the presence of an infectious agent, even in the absence of clinical disease, should be reported.”

36. OIE guidance on import requirements

37. Section 5. Trade measures, importation/exportation procedures and health certification
General obligations related to certification
Certification procedures
Criteria to assess the safety of aquatic animal commodities
Control of aquatic animal health risks associated with transport of aquatic animals
Aquatic animal health measures applicable before and at departure
Aquatic animal health measures applicable during transit from the place of departure in the exporting country to the place of arrival in the importing country

38. Section 5. Trade measures, importation/exportation procedures and health certification
Frontier posts in the importing country
Aquatic animal health measures applicable on arrival
Measures concerning international transport of aquatic animal pathogens and pathological material
Model health certificates for international trade in live aquatic animals and products of aquatic animal origin

39. Chapter 5.3 Criteria to assess the safety of aquatic animal commodities and products
2 sets of criteria:
Criteria to assess the safety of aquatic animal commodities irrespective of country disease status
Criteria to assess the safety of aquatic animal products destined for human consumption irrespective of country disease status
The Aquatic Animals Commission have endorsed the two sets of criteria developed by the ad hoc Group on Safety of Products Derived from Aquatic Animals for assessing the safety, from an aquatic animal health perspective, of aquatic animal commodities in international trade. These criteria, which provide a basis for assessing the safety of aquatic animal commodities irrespective of the country’s aquatic animal disease status, had been presented for Member comment with the Commission’s October 2008 report.
The first set of criteria, which deal with the safety of aquatic animal commodities, are based either on the absence of the aquatic animal disease agent in the traded commodity or on the inactivation of the agent by processing the product. The second set of criteria, which deal with the safety of aquatic animal products destined for human consumption, are based on the expected volume of waste and absence of the pathogen in the waste tissue, as discarded (waste) tissues are an important pathway for exposure of susceptible aquatic animals to pathogens, if such are present in the imported aquatic animal product.
The Aquatic Animals Commission reviewed the two sets of criteria in light of Member comments, and made some amendments. The Commission noted that an introductory text had been proposed by the ad hoc Group as a means to provide clarification to Members. As this text is of an explanatory nature and does not in any way modify the proposed criteria, the Aquatic Animals Commission proposes this text, along with the two sets of criteria, for adoption. 39 39

40. Sections 8-11 Specific disease chapters
Each specific disease chapter includes recommendations to prevent the disease in question being introduced into the importing country
definition of the pathogen / disease
list of susceptible species
what are ‘safe’ commodities (irrespective of disease status)
how to determine the free status of a country, zone or compartment
recommendations for importations of aquatic animal commodities from a country, zone or compartment declared free
recommendations for importations of aquatic animal commodities from a country, zone or compartment not declared free.

41. Manual of Diagnostic Tests for Aquatic Animals (‘Aquatic Manual’)

42. ‘Aquatic Manual’
Sixth edition of the Manual of Diagnostic Tests for Aquatic Animals (2009) 42

43. 6th edition, 2009 Published in September 2009
Major updates for all diseases
Chapters only for listed diseases
Amended format for future editions
Next printed edition will be in 2012
In the meantime, amendments can
be made to the web version
Now a brief update on progress with preparation of the sixth edition of the Aquatic Manual, which is due for publication in the third quarter of The OIE Central Bureau circulated the draft chapters for comment to Members and reviewers in December The Consultant Editor addressed those of a specific technical/scientific nature or sent them to the chapter authors. Those comments of a general nature, or that were on policy or procedure were dealt with by the Commission.
One Member had commented that not enough time had been given to properly review all the chapters sent. I would like to explain that production of the Aquatic Manual had met with some problems when the original Consultant Editor had to be replaced at short notice. These were exceptional circumstances that led to a reduction in the review time (to 11 weeks) and it is most unlikely that the problem will be repeated for future editions of the Aquatic Manual. Another Member requested that the sample sizes recommended in the OIE protocols be re-evaluated. The Commission has clarified that the issue of sampling and sample sizes will be addressed in detail in the OIE Guide for Aquatic Animal Health Surveillance and also in the disease-specific surveillance chapters that are to be prepared for inclusion in the Aquatic Code.
Some Members had requested that the chapters on de-listed diseases be retained in the 2009 edition of the Aquatic Manual, while other Members requested that these chapters be removed. Some Members proposed to maintain access to Aquatic Manual chapters on de-listed diseases for reference purposes, via a page on the OIE website. The Commission has proposed that the 2009 edition of the Aquatic Manual should contain only chapters on OIE listed diseases. In response to an offer from Members to update information on the de-listed diseases, the Commission decided that it would review updated information and, if the update was satisfactory, the information could be made available to Members on the Aquatic Animals Commission web pages.
One Member asked if diagnostic test protocols other than those described in the Aquatic Manual could be used, in particular commercial kits. The Commission has pointed out that all test methods used must be validated as ‘fit for purpose’ and shown to be equivalent to the method described in the Aquatic Manual. I would remind Delegates of the OIE Register of Diagnostic Tests. Should a Member wish to add a test to the OIE Register, the proposal must be accompanied with all the required validation data in accordance with the OIE validation template: such a proposal for a test kit for white spot disease (WSD) in crustaceans was adopted last year at the 76th General Session.
Finally, for your information, in future the Aquatic Manual will be reformatted to simplify the numbering system and to eliminate some duplication of information.

44. 2011 edition of the Aquatic Manual is available
on-line at the OIE website

46. Purpose of Aquatic Manual
Provide internationally agreed standardised approach to the diagnosis of OIE-listed diseases (Aquatic Code)
Facilitate international trade in aquatic animals and their products by:
- ensuring harmonisation of diagnostic testing
- avoiding differences in interpretation of results
- ensuring quality of diagnostic tests
Improve aquatic animal health worldwide;

47. Purpose of Aquatic Manual
Describes diagnostic laboratory methods which are suitable for the detection of disease as part of a national aquatic animal health surveillance/control programme, or as part of a programme to underpin claims of freedom from a specific disease;
To assist with the development of surveillance methodologies for OIE-listed diseases;

48. Purpose of Aquatic Manual
Surveillance programmes aim to determine, from the results provided by standardised laboratory methods performed with samples collected according to defined rules, the health status for a country, zone or compartment for a specified disease.

49. Contents of the Aquatic Manual
Part 1 General Provisions
Section 1.1 Introductory Chapters
Quality management in veterinary testing laboratories
Principles and methods of validation of diagnostic assays for infectious diseases
Methods for disinfection of aquaculture establishments

50. Contents of the Aquatic Manual
Part 2 Recommendations Applicable to Specific Diseases
Diseases of Amphibians (adopted May 2011)
Diseases of Crustaceans
Diseases of Fish
Diseases of Molluscs

51. General information
Each Section starts with general information on diseases of amphibians (in preparation), crustaceans, fish, molluscs
A. Sampling
B. Material and biological products required for the isolation and identification of pathogens

52. CHAPTER X.X.X. DISEASE X 1. Scope 2. Disease information
“For the purpose of this chapter, DISEASE NAME is considered to be
INFECTION WITH [PATHOGEN NAME].”
2. Disease information
2.1. Agent factors
2.2. Host factors
2.3. Disease pattern
2.4. Control and prevention

53. 3.1. Selection of individual specimens
3. Sampling
3.1. Selection of individual specimens
3.2. Preservation of samples for submission
3.3. Pooling of samples
3.4. Best organs or tissues
3.5. Samples/tissues that are not suitable (i.e. not possible to detect)

54. 5. Rating of tests against purpose of use
4. Diagnostic methods
4.1. Field diagnostic methods
4.2. Clinical methods
4.3. Agent detection and identification methods
5. Rating of tests against purpose of use
6. Test(s) recommended for targeted surveillance to declare freedom from Disease X.
Describes test methods, for use in targeted surveillance to declare freedom from disease as outlined in the Aquatic Code.

55. OIE guidelines on disease surveillance

56. Chapter 1.4. of the Aquatic Code
- provides standards for aquatic animal health surveillance
Guide for Aquatic Animal Health
Surveillance (2009)
- provides detailed guidance on
surveillance principles and practice.

57. Thank you for your attention