PART I - ASIA REGIONAL TECHNICAL GUIDELINES

Asia Regional Technical Guidelines on Health Management for the Responsible Movement of Live Aquatic Animals

1 SCOPE AND PURPOSE

Development of these Technical Guidelines has taken the different socio-economic and environmental circumstances of each country and area in the Asia Region into consideration, along with the diversity of current infrastructures (expertise and institutional capability), range of aquatic species being moved, diversity of pathogens, and the different reasons for live aquatic animal movement.

The intent of the Technical Guidelines is to assist countries to undertake movement of live aquatic animals in a way that minimises the disease risks associated with pathogen transfer and disease spread, both within and across boundaries. This will enhance protection of the aquatic environment and biodiversity, as well as the interests of aquaculture and capture fisheries. It also provides a mechanism to facilitate trade in aquatic species and to avoid unjustifiable trade barriers based on aquatic animal health issues. It is further hoped that the Technical Guidelines will assist governments to implement relevant provisions of the Code of Conduct for Responsible Fisheries (FAO 1995) and other international treaties and agreements applicable to the Asian Region (see Manual of Procedures). The Technical Guidelines have been developed pursuant to a set of Guiding Principles (see Section 5) agreed upon by national delegates and representatives from participating national, regional, and international agencies and organizations.

Although these guidelines are prepared for use by the countries that participated in their drafting, they are consistent with international legislation and agreements, and thus may be applicable to non-participating countries in Asia and other parts of the world.

2 BACKGROUND

The spread of pathogens with trans-boundary movements of live aquatic animals has been clearly associated with disease outbreaks and significant losses of aquaculture production and revenue. However, Asian aquatic food production has already been seriously affected by disease. With trans-boundary movement of live aquatic animals increasing for aquaculture and other purposes, practical measures which minimise the risk of introduction and spread of pathogens are urgently needed to sustain the growth of this sector (ADB/NACA 1991, Humphrey et al. 1996, DFID/FAO/NACA/GOB 2000).

The use of exotic species for fisheries and aquaculture diversification has been practised since the middle of the 19th century, however, recent advances in transportation efficiency, live animal trade and intensification of aquaculture have precipitated a significant increase in the number of species being moved on a global scale. On top of fisheries and aquaculture diversification, many species are introduced for sport-fisheries, the ornamental fish trade, research, biological control, and as bait and forage. Although many such introductions have been successful, others have resulted in highly publicised failure, generating controversy over protection of native biodiversity, spread of pathogens and disease, and the cost-benefits and risks for related socio-economic development.

Movement of live aquatic animals always poses some risk of pathogen transfer. Use of local stocks of native species for aquaculture development and fisheries enhancement significantly reduces this risk. In addition, native species are adapted for growth under local environmental conditions and usually have established markets. Many such species, however, have unknown culture potential and have not been domesticated to a level which will support sustained aquaculture development. In addition, some have limited market or trade potential, or have low commercial value. In such cases, pressure for importation of exotic species (or domesticated strains) is inevitable, and effective health safeguards are required.

Policies, legislation and guidelines relating to health management of live aquatic animals have to be flexible enough to support frequent revision and modification. This is necessary due to on-going developments in aquaculture and culture-based fisheries, increasing knowledge on diseases of aquatic animals, and improved or new diagnostic techniques. Changing political, industrial and socio-economic environments also contribute to the dynamic nature of aquatic animal health management.

The Fish Disease Commission of the Office International des Épizooties (OIE) has developed recommendations and protocols for preventing the international spread of aquatic animal diseases as part of its International Aquatic Animal Health Code (OIE 2000a). These concentrate on health surveillance of animals used in domestic and international trade. Recommendations for reducing the risks (ecological, genetic and disease) associated with the introduction and transfer of a broader range of aquatic species have also been developed by the International Council for the Exploration of the Sea (ICES) (ICES 1995) - an organisation of North Atlantic countries with fishery interests.

These codes and protocols have limited applicability in fishery and culture conditions in the Asian Region; thus fish and shellfish continue to be introduced within this area with little or no consideration of potential disease consequences. Substantial losses and adverse socio-economic impacts have already resulted, and these must be weighed against the cost of implementing and maintaining national and regional health management programs.

Knowledge of the health status of aquatic animal populations or stocks is an essential prerequisite for risk assessment of pathogen transfer. Thus, health certification and associated quarantine measures are integral parts of the overall health management process. This process should be practical, cost-effective and easy to implement e.g., using available laboratory and administration facilities.

Since some degree of risk is inevitable with trade in live aquatic animals, health management procedures, policies and practices must operate within the concept of minimising the risk of disease and pathogen incursion while, at the same time, avoiding imposition of unjustifiable or unnecessary impediments to trade, aquaculture development and aquatic food production.

Additional background material is presented in the Manual of Procedures. Included is information on world and regional aquaculture production; the trans-boundary movement of aquatic species and the introduction and transfer of associated pathogens; the economic significance of introduced pathogens; and details on pertinent international and regional conventions and codes, codes of practice, guidelines, recommendations and current sub-regional initiatives.

3 DEFINITIONS

This section provides definitions for the most important terms used in the Technical Guidelines and the BCIS (where possible, definitions provided by the International Aquatic Animal Health Code (OIE 2000a) have been adopted).

4 GUIDING PRINCIPLES

These Technical Guidelines have been developed based on a set of Guiding Principles which were reached by consensus among the participating countries during the Second Project Workshop held in Bangkok, Thailand, in February 1999. They are:

1. Movement of living aquatic animals within and across national boundaries is a necessity for economic, social and development purposes.

2. Such movements may lead to the introduction of new and emerging pathogens and to disease establishment and, therefore, may pose risks to the importing country's animal, plant and human health status.

3. The role of health management is to reduce the risks arising from the entry, establishment or spread of pathogens to a manageable level with the view to protecting animal, plant and human life. Health management should also protect living aquatic resources, the natural aquatic environment and aquatic biodiversity, as well as support the movement of aquatic animals and protect trade.

4. The health management process is defined, in the broad sense, as aquatic animal health management encompassing pre-border (exporter), border and post-border (importer) activities, as well as relevant national and regional capacity-building requirements (infrastructure and specialised expertise) for addressing health management activities, and development and implementation of effective national and regional policies and regulatory frameworks required to reduce the risk of disease spread through movement (intra- and international) of live aquatic animals.

5. Health management measures should be practical, cost-effective and easy to implement by utilising readily available facilities. Individual countries may need to adopt, modify or vary these Technical Guidelines to suit their own particular situations and resources.

6. The varying capacity of developing countries to implement programmes on health management should be acknowledged by relevant international organizations and financial institutions. These organizations should give full recognition to the special circumstances and requirements of many developing countries.

7. Health management measures shall be based on an assessment of the risk to animal, plant and human life or health. In assessing the risk, prevalence of specific pathogens in both the region of origin and the region of destination shall be a crucial issue. The likelihood of new or emerging pathogens becoming established in the region of destination is a major consideration.

8. All movements of aquatic animals should be conducted within the provisions given in existing relevant international agreements and instruments. Health management measures should not be applied in a manner which would constitute a disguised restriction on trade. Health management measures should be applied only to the extent necessary to protect animal, plant or human life or health, and must be based on scientific principles and not be maintained without sufficient scientific evidence.

9. In determining the appropriate level (stringency) of health management measures to be applied, relevant economic and ecological factors have to be taken into account. These are, inter alia: potential damage due to loss of production or value, and the cost of control or eradication. A conservative approach should be adopted in cases where insufficient knowledge exists in relation to disease risks posed by a particular import; a higher stringency of health management procedures should be adopted where inadequate knowledge exists.

10. The first movement (introduction) of a new species into a new area will require special health management considerations in light of the need to evaluate scientific evidence regarding the risk of introducing pathogens to new areas.

11. Different regions should attempt to harmonise health management procedures to facilitate safe movement of aquatic animals within and between regions.

12. Considering the free movement of aquatic species in trans-boundary waterways, division of regions into manageable sub-regional units based on factors such as geography, hydrography, ecosystems, epizootiological surveillance and effectiveness of control is necessary for the effective implementation of health management procedures. The basis for the establishment of such units should be uniform, clear and unambiguous.

13. Honest, conscientious and transparent reporting is essential for health management to be effective.

14. Technical co-operation among regional experts is essential to promote exchange of information and expertise.

15. Collaboration among the governments, public institutions, and the private sector, including all stakeholders, is important to achieve the full purpose of implementing effective health management. Opportunities for sharing the benefits of health management among all stakeholders should be explored.

5 PATHOGENS TO BE CONSIDERED

This section provides guidance in the preparation of a list of aquatic animal pathogens that should be considered when developing health management policies.

In establishing specific quarantine and health certification requirements, it is necessary to identify pathogens of importance and justify exclusion of others. These requirements are restricted to conditions justified as necessary to avoid or reduce the disease risks associated with the movement of live aquatic animals to acceptable limits. Requirements should not be a disguised restriction of trade.

This section, and the corresponding section of the Manual of Procedures, do not provide a definitive list, but rather guidance on how countries can develop a list that is appropriate to their special situations. In general, such a list should include diseases exotic to that country, in addition to those diseases/disease agents listed in the NACA/FAO and OIE Quarterly Aquatic Animal Disease Reports (Asia-Pacific) (see NACA/FAO 1999). The principles for drawing up these lists are outlined below, and are based on the International Aquatic Animal Health Code (OIE 2000a). More detailed treatment of the suggested procedures used to select pathogens to be included in regional or national pathogen lists is given in the Manual of Procedures, along with information on the use of pathogen inventories and databases to support these efforts.

5.1 Reasons for inclusion of a pathogen on a list

i. Presence or absence of a disease or a pathogen in the importing country -

The disease or pathogen is:

• exotic to the entire country;

• occurs in parts of the country, but there are zones that are officially recognised as free and that need to be protected; or

• occurs in parts of the country, and the country is running control programmes to minimise spread of the disease and/or to eradicate it.

ii. Pathogenicity - The disease or pathogen has a significant adverse effect on host health.

iii. Infectious aetiology of the disease - The disease is caused by an infectious agent which is transmissible horizontally and/or vertically, as well as directly or indirectly (via carriers or intermediate hosts existing in the receiving waters).

iv. Adverse socio-economic, public health or ecological impacts - The disease or pathogen is known or likely to cause significant adverse socio-economic, public health^[9] or ecological impacts.

5.2 Reasons for exclusion of a pathogen from a list

A disease or pathogen should not be included if:

• it occurs widely within the region with no infectious mortality or

• socio-economic impact, or

• it is controlled through improved husbandry handling

• (nonchemotherapeutic intervention).

5.3 Existing international pathogen lists

As indicated above, not every disease or infectious agent exotic to a country requires quarantine and health certification. Those which do are described in the following lists. More detailed information is given in the Manual of Procedures.

5.3.1 OIE lists of diseases of aquatic animals

In the International Aquatic Animal Health Code (OIE 2000a), the section on notification and epidemiological information states that "Countries shall make available to other countries, through the OIE, whatever information is necessary to minimise the spread of important aquatic animal diseases and their aetiological agents and to assist in achieving better world-wide control of these diseases."

The OIE has two lists of diseases of aquatic animals: "diseases notifiable to the OIE," and "other significant diseases." Definitions and the current lists are given in the Manual of Procedures.

These diseases, especially the notifiable ones, are of significance in international trade. The OIE lists are updated regularly, but do not yet include all diseases of concern in the Asia-Pacific Region. Thus, disease agents considered by regional health experts to pose significant risk if transferred from infected to uninfected populations (both within and from outside the Asia-Pacific Region) have been added to the original OIE lists when compiling the NACA/FAO and OIE regional lists (see below).

5.3.2 NACA/FAO and OIE lists of diseases of aquatic animals

The NACA/FAO and OIE lists of diseases reportable for the Asia-Pacific Region were developed to reflect the Asian situation. These lists, which are identical, include all “notifiable” and “other significant diseases” listed by the OIE, as well as a number of other serious diseases that occur in areas of the Asia-Pacific Region. A more detailed picture of the occurrence of these diseases is anticipated as more pathogen data are collected from participating countries submitting region-specific NACA/FAO and OIE Quarterly Aquatic Animal Disease Reports. The NACA/FAO list is given in the Manual of Procedures (see also NACA/FAO 1999).

As with the OIE disease lists, which are periodically reviewed by the OIE Fish Disease Commission (OIE/FDC), the NACA/FAO disease list will be reviewed and updated by members of the Asia Advisory Group on Aquatic Animal Health (AG) under NACA (supersedes the Regional Working Group (RWG) and Technical Support Services (TSS)). The AG, as did the RWG/TSS, will have collaborative links with the OIE/FDC to ensure full exchange of information on each other’s activities and decisions.

The lists are flexible to permit addition of new or emerging diseases of regional significance, as well as the removal of diseases which, because of changes in distribution or pathogenicity, are no longer considered to pose a high risk to the countries of the region. Changes to the NACA/FAO regional disease list will be signalled to OIE/FDC for consideration during review of the OIE disease lists and vice versa.

5.4 Process of compiling a list of diseases

In compiling national lists of diseases, the following points should be considered:

5.4.1 Technicalities of the process

Countries should design a "decision matrix" (see Manual of Procedures) using the criteria listed above.

In principle, the list should be an integral part of any import risk analysis (see Section 11 of the Technical Guidelines and the Manual of Procedures).

Certification of freedom from disease based solely on clinical freedom and aquatic animal population history is of limited value. This is also true for those diseases for which no specific diagnostic tests exist, or for which the sensitivity/specificity of the test is limited.

5.4.2 Policy of the process

Compilation of the list should be a consultative process, including state policy makers, aquatic animal disease experts and relevant representatives from the aquatic production sector (including farmers, service providers etc.) of the importing and exporting countries or within-country zones/provinces/regions. The process needs to be transparent to enable understanding and acceptance by potential exporting countries.

6 DISEASE DIAGNOSIS

The purpose of this section is to briefly discuss specific issues of diagnosis of regionally important diseases related to the movement of live aquatic animals.

Many factors play a role in a disease outbreak, and most disease agents are rarely so pathogenic that exposure of a host population is, by itself, sufficient to cause an epizootic. Thus, in the process of disease diagnosis, it is essential that a complete information package is submitted, along with actual samples of diseased specimens or their tissues, for diagnosis.

Diagnosis requires various levels of data, starting with farm- or site-level observations and progressing in technical complexity to electron microscopy, immunological and nucleic acid assays and other biomolecular methods. This means all levels of expertise, including that of the farmer and extension officer working at the pond side, make essential contributions to rapid and accurate disease diagnosis. For this purpose, the Technical Guidelines emphasise capacity building (facilities and expertise) for basic diagnosis and surveillance at the farm level. This is essential for early detection of, and implementation of response protocols to disease outbreaks in order to minimise their social and economic impacts.

6.1 Important diagnostic issues

Regional and national policy makers and planners need to consider disease diagnosis at different levels. The three levels (Levels I, II and III) agreed-upon by the countries participating in the development of the Technical Guidelines (see Manual of Procedures) for broad-scale application to disease detection and diagnosis are outlined in the following table. For the diagnosis of a given disease or pathogen, countries can move from one level to the next as they build capacity and experience.

At both the regional and national levels, there is an urgent need for improved capacity to diagnose aquatic animal diseases. This includes training of appropriately skilled personnel and establishment and/or upgrading of regional and national diagnostic laboratories. In order to take full advantage of this training/up-scaling process, it is essential that the region move towards a standardisation of diagnostic techniques. Procedures for the validation of the methods used by different laboratories should also be developed. Preparation of the Asia Diagnostic Guide to Aquatic Animal Diseases (ADG) is a step in this direction. This will require good communication, regionally and intra- and internationally, if a rapid and effective response is going to be achieved as diseases emerge. International collaboration is, therefore, essential for optimising communication and avoiding laboratory competitiveness that can hinder effective disease control.

7 HEALTH CERTIFICATION AND QUARANTINE MEASURES

The purpose of this section is to provide guidance on how to develop and implement effective programmes for health certification and quarantine measures for aquatic animals.

The purpose of applying quarantine measures and health certification is to facilitate trans-boundary trade in living aquatic animals, while minimising the risk of spreading infectious diseases. An effective system of quarantine measures and health certification also increases protection of surrounding resources e.g., harvest fisheries, non-exploited species and other components of the environment.

Aquatic animals differ from terrestrial animals and birds in their biology, anatomy, physiology and environmental requirements. This has to be clearly recognised when considering disease diagnosis, control, quarantine and certification for aquatic animals (see Manual of Procedures). Effective implementation and maintenance of health control measures also require a degree of flexibility, to adapt to changing circumstances, scientific knowledge (pathology, immunology, epidemiology etc.) and trade dynamics. However, the policy and related health management practices, by their very nature, must be based on established scientific knowledge and supported by legislation sufficiently adequate to encourage compliance.

Quarantine measures and health certification must also take into account both the existing and anticipated needs of the aquatic food production sector, many of which have developed in the absence of effective health management procedures. Such programmes must be responsive and effective, both internationally and nationally, in order to prevent the spread of disease agents into countries or zones where they have not previously occurred. The same principles apply to local quarantine and health certification programmes designed to protect individual aquatic resource stakeholders from disease losses.

At the international and national levels, quarantine and health certification programmes form an integral part of much broader strategies aimed to protect the natural environment and native faunas from the deleterious impacts of exotic species or diseases (e.g., ecological and genetic competition). Governments developing national health management strategies should also take these other factors into account (see Manual of Procedures). Each import request must be considered on an individual basis, with quarantine conditions imposed commensurate with risks. These risk factors will vary according to the source and destination of the aquatic animal transfer (see Manual of Procedures). The ultimate risk to be avoided is exposure to circumstances which favour the introduction and establishment of an exotic pathogen in a new environment/population (see Guiding Principles, Section 4).

Although some serious pathogens are host specific, many show little host specificity and may occur in both marine and freshwater species. Furthermore, since transmission of pathogens can occur across major taxonomic groups of aquatic animals, arbitrary distinctions between marine and freshwater species, or between wild, cultured or ornamental species, with respect to quarantine measures is scientifically unsound.

Because of the diversity of species, the purposes for which they are imported, and other variable factors described below, it is not possible to construct a single quarantine and health certification protocol applicable to all imports of live aquatic animals. Although routine movements may eventually result in development of appropriate general health certification procedures, all “first-time” cases must have their risk factors and mitigative measures considered case-by-case (see Manual of Procedures).

7.1 Some considerations related to health certification and quarantine measures

Current requirements for, and levels of, aquatic animal health certification and quarantine vary greatly from country to country within the region. Some countries have highly protective policies, supported by legislation, to ensure importations of aquatic animals are free from specific pathogens. Other countries have inadequately enforced, or no, legislation. In some countries, health certification and quarantine are supported by specific regulations and acts; however, other countries have only recently begun to consider the need to develop such legislation. This disparity in health certification requirements and quarantine also means that the vulnerability of aquatic resources differs between countries. In order to enhance trade and reduce risk of disease spread there is, therefore, a clear need to harmonise health certification and quarantine measures across the region. This section outlines some basic considerations related to this objective.

The foundation for success in this endeavour is open communication among Competent Authorities (CA) from the region, as well as maintenance of effective health certification programmes.

The Manual of Procedures provides details for participating countries to use in the development and implementation of meaningful health certification for aquatic animals, as does the OIE International Aquatic Animal Health Code (OIE 2000a).

Individual countries, obviously, retain the right to develop health certification protocols to meet their own the requirements; however, the list of regionally important diseases reportable to NACA/FAO and OIE should be considered as a basic component for all aquatic animal health certification programmes.

In some cases, health certificates currently used in the region are based solely on visual inspection for gross clinical signs, or on diagnostic procedures of limited or questionable scientific validity. Such certification lacks scientific input and, thus, has little value for protection against introduction or spread of specific disease.

Countries with such certification practices must revise them, in order to: i) ensure adequate diagnostic capability for the listed diseases; ii) avoid unjustifiable restrictions on movement, and iii) optimise protection from high-risk imports or exports.

Certification procedures adopted by countries indicating freedom from specific pathogens should comply with those outlined in the Asia Diagnostic Guide to Aquatic Animal Diseases and the OIE Diagnostic Manual for Aquatic Animal Diseases (OIE 2000b). In addition, successful international trade hinges upon mutual trust. Countries must, therefore, strive to maintain the highest possible ethical standards in the overall process of health certification, as well as to develop and maintain diagnostic capability. Schemes for evaluation of health risks associated with imports of live aquatic animals, and the consequent level of quarantine required to mitigate these risks, are described in the Manual of Procedures. Some importations may be assessed as having risks that are negligible. In such cases, measures such as the holding (see Section 3, Definitions) of animals in quarantine may not be required.

Conversely, importations considered to comprise a "high risk" will require more stringent procedures, such as those outlined in the ICES Code of Practice on the Introductions and Transfers of Marine Organisms (ICES 1995).

8 DISEASE ZONING

The purpose of this section is to provide guidance on how to develop zoning plans for delineating aquatic animal disease status in the countries of Asia. As Asia has little experience and capacity in zoning for aquatic animal diseases, the information given is based mainly on experience outside the region.

The advantage to developing countries of zoning is that it allows for part of a nation’s territory to be identified as free of a particular disease, rather than having to demonstrate that the entire country is free. This is particularly helpful for diseases where eradication is not a feasible option in the foreseeable future, as it permits protection of zones free of the disease by restricting introduction of aquatic animals to those originating from other free zones.

Because most aquatic animal transfers within the Asian Region are from open- or flow-through aquatic environments, it is generally more difficult to establish health status on a farm-by-farm or facility-by-facility basis (as is the case for most terrestrial health management programmes). In addition, natural migrations of some species which are moved between areas further broaden the geographic range over which specific disease agents may be distributed. In order to address this, the concept of “zoning” is commonly applied to aquatic environments and species with the goal of: i) facilitating trade between zones of equal health status, and ii) protecting zones determined to be free of specific disease agents from introductions from zones which are positive for these disease agents.

Traditionally, political boundaries have been used to delineate the aquatic animal disease status within a country. Often this has been extended to the country as a whole, even where the diseases of concern have a limited within-country distribution. This has been a common scenario due to administrative ease, rather than a reflection of true health profiles of aquatic animals being moved from one area or country to another.

Ecological, geographical, hydrographical or climatological barriers, rather than political boundaries, form a stronger basis for defining actual disease agent distribution. Since non-political boundaries, by definition, do not necessarily coincide with political boundaries (e.g., multinational river catchment areas, bays or ocean coastlines), this requires multinational or multi-jurisdictional collaboration in order for health management of aquatic animal movements to be effective.

Further detailed information on zoning and the principles governing the movement of aquatic animals between zones is presented in the Manual of Procedures.

8.1 Important considerations related to zoning

Zoning can be a highly effective tool to restrict the spread of important pathogens and aid in their eradication. Thus, the general principles of zoning should be considered by participating countries and sub-regions when preparing strategies for disease containment and eradication. This may require trans-boundary collaboration.

Implementation of zoning requires a high level of diagnostic, surveillance, monitoring and reporting capability, as well as adequate regulatory control mechanisms. Thus, some participating countries may not be able to establish zones in the immediate future. Zoning based on Level I diagnostic capability, however, is a valuable first step, while diagnostic capability, national legislation and related infrastructure are developed.

Pilot projects and exchange of information between countries will be necessary to further evaluate the feasibility of zoning within the region.

The nature and maintenance of zones will vary, depending on the particular disease(s) for which they are established. Thus, the size, location and delineation of the zone will depend on the characteristics of the disease, its modes of spread and prevalence in the country(ies) within the zone.

Some diseases will require zonation comprising an entire river catchment from source to sea, or two or more river catchments that are linked to each other. Other cases may permit zonation within part of a river system e.g., river stretches below a physical or ecological barrier could harbour hosts of infected or unknown health status, while upstream of the barrier hosts could be disease-free. The reverse situation is less likely.

Zoning for health status in coastal areas is often difficult due to the complexity of identifying distinct demarcations in contiguous stretches of water.

Where there are zones of equal health status, there is little, if any justification, on disease-risk grounds, for preventing trade in aquatic animals between them. This applies equally to trade between zones which have been demonstrated to be free of particular disease(s), and trade between zones which are positive for the same disease(s).

9 DISEASE SURVEILLANCE AND REPORTING

The purpose of this section is to provide guidance on developing national and regional disease surveillance and reporting systems.

To produce meaningful reports on the disease status of a farm, zone, country or region, some systematic process of gathering information about the occurrence of important diseases and pathogens must be in place. This process is known as surveillance. Surveillance will thus support import risk analysis, justify import health certification requirements, and enable export health certification, by providing evidence to substantiate claims of absence of a particular disease.

A national surveillance programme is a structured plan for the detection of specified diseases or disease agents in susceptible aquatic populations^[10] throughout a country. It involves input from personnel trained in disease recognition in the field, who report their observations, in a systematic fashion, to designated district or national health management personnel.

The programme is supported by reporting and diagnostics procedures to ensure accurate and rapid identification of pathogens. This surveillance applies to detection of the emergence of a “new” disease situation, as well as to monitoring the status (prevalence, geographic distribution etc.) of established disease agents. Surveillance data can usefully be entered into a database to allow easy access and analysis.

In addition to collection of data essential to support import risk analyses and zoning programmes, countries with national reporting systems for surveillance of aquatic animal health status have a greater capability to detect and identify disease outbreaks, and to quickly implement contingency plans for disease containment and eradication. An example of a developmental process to address surveillance and reporting issues conducted in the Asia-Pacific Region is that undertaken by Australia, as outlined in “AQUAPLAN” (AFFA 1999).

The regional reporting system that has been developed by NACA, FAO and OIE, the Quarterly Aquatic Animal Disease Reports (Asia and Pacific Region), is founded upon the national reporting systems being established by participating countries.

9.1 Major considerations

While countries may differ in their ability to diagnose diseases of aquatic animals or collect data through national networks, this should not be seen as a hindrance to developing and maintaining national surveillance and reporting systems. Every country can prepare National Summaries on a quarterly basis, to the best of their ability, while disease diagnosis infrastructure is being developed.

Several strategies for disease surveillance are recognised (see Manual of Procedures). Countries which have basic disease diagnostic capability are encouraged to continue developing capability for disease diagnosis, surveillance and reporting.

Investigations of suspected disease are significantly enhanced by access to appropriately trained and motivated personnel, standardised field and laboratory methodology, appropriate training/reference manuals and training workshops or programmes.

The design and structure of a surveillance programme depends on its purpose; however, all surveillance programmes have some common features. These include a clear purpose; a defined list of problems, diseases and pathogens of interest; the capability and resources necessary to conduct the surveillance to the required level of diagnostic certainty; and a well-defined system to collect, record and collate the data, as well as report the findings and conclusions.

It is in the interests of all participating countries to aim for regional consistency in surveillance and reporting. Thus, all countries are encouraged to work collectively to develop standardised data codes, recording formats and standards for laboratory diagnostic practices. This will facilitate development of a standard, low-cost, computerised database accessible to all countries requiring surveillance assistance. There are many benefits to such an approach.

FAO's Aquatic Animal Pathogen and Quarantine Information System (AAPQIS), where the Asian component (AAPQIS-Asia) is maintained by NACA, is an example of a computerised system which provides scientific information to help develop effective national surveillance programmes.

Regardless of the method of information management, countries should maintain clear records, which permit tracing of the source documentation/material upon which summary reports are based.

For more detailed information on surveillance and reporting, refer to the Manual of Procedures.

10 CONTINGENCY PLANNING

The purpose of this section is to provide guidance on contingency planning, the development of a detailed action plan outlining how to deal with any serious aquatic animal disease outbreak, whether at the national, sub-national or farm level, before any such disease outbreak occurs.

The advantage of contingency planning is that it provides a rapid and planned response for containment of a disease outbreak which can greatly reduce the impact, scale and costs of the outbreak.

Contingency planning applies to detection of an exotic pathogen, regardless of associated pathology, if it is considered significant and/or present on the regional list of diseases. There is a close link between the surveillance system, disease zoning and contingency planning.

Effective contingency planning ensures that all requirements are defined and available to ensure control of a potential disease emergency, and that these resources can be activated and deployed promptly. It is also important to establish a clear structure for effective decision-making with clearly defined responsibilities and authority.

The consequences of not planning the response to a significant disease emergency are clearly demonstrated by the difficulties faced by the governments within the region when attempting to deal with sudden major disease outbreaks, such as epizootic ulcerative syndrome (EUS) and white spot syndrome (WSS), that have swept the region.

Advance planning and rapid action can significantly reduce the social and economic impacts of aquatic animal disease, as well as control or reduce spread. Under rare, but opportune, circumstances, contingency planning may even be effective in eradicating the disease agent.

More details on the procedures required to support participating countries in contingency planning are given in the Manual of Procedures.

10.1 Some major considerations for contingency planning

Although contingency planning, by necessity, is often complex (see Manual of Procedures) the advantages clearly merit the effort required. Even if an “ideal” level of contingency planning is not initially obtainable in some participating countries, an incomplete plan will still be a valuable resource should governments suddenly be confronted by a disease emergency. It can be used to initiate rapid action and will form a strong framework which can be refined as aquatic animal health infrastructure is developed. Contingency planning should be recognised (as with all other aspects of aquatic animal heath management) as an on-going activity. Individual countries should develop plans which meet their particular situations and resources.

11 IMPORT RISK ANALYSIS

The purpose of this section is to outline the role of import risk analysis (IRA) in minimising trans-boundary movements of significant infectious agents associated with trade in live aquatic animals.

The movement of live aquatic animals involves a degree of disease risk to the importing country. Import risk analysis (IRA) is the process by which hazards associated with the movement of a particular commodity are identified and mitigative options are assessed. The results of these analyses are communicated to the authorities responsible for approving or rejecting the import.

An effective IRA recommends measures which will reduce the identified risk(s)to a level acceptable to the importing authorities. Two of the most important conditions for import are the availability of aquatic animal health certification and the presence of established health management protocols at the source of export.

It is important to note that the methods used in evaluating risk may differ between countries, and approaches taken by an importing country may vary for different commodities. Whatever methods are used, they should be science-based, transparent, and standardised (as far as possible), and the process must include detailed documentation.

The methodologies discussed, and guidelines provided in this section, are consistent with those of the OIE International Aquatic Animal Health Code (OIE 2000a) defined as: “...to provide importing countries with an objective and defensible method of assessing the disease risks associated with importation of aquatic animals, aquatic animal products, aquatic animal genetic material, foodstuffs, biological products and pathological material.”

11.1 Main strategies of import risk analysis

The main components of import risk analysis are: hazard identification, risk assessment, risk management and risk communication (see Manual of Procedures).

The first stage of an import risk analysis involves identification of any hazards, including all pests and disease agents associated with the commodity, which can be reasonably deemed (i.e., scientifically justified) to be of potential threat to any aquatic animals or component of the importing waters.

This is followed by a risk assessment, where the effect of each hazard under unrestricted importation conditions is evaluated. The risk assessment includes evaluation of the probability of an exotic disease agent becoming established in the importing environment and the consequences of that establishment. Depending on the epidemiological data available for each infectious agent identified, the risk may be estimated qualitatively, semi-quantitatively or quantitatively. Details of this process are given in the Manual of Procedures.

11.2 Ethics and import risk analysis

Ethics and transparency are essential for effective import risk analysis. The Competent Authority (CA) for the importing country that is undertaking the IRA relies on information provided by the CA for the exporting country. The CA for the exporting country relies on the ethical use of its information for scientifically sound import risk analysis. Abuse of trust on the part of either side, either in terms of non-declared infectious agents or through the rejection of imports on unfounded health risks, renders the whole process useless.

Thus, the importing country has an obligation to ensure that the IRA is: i) based on science, ii) adequately documented and iii) consistent with its international obligations. It must also ensure that claims about its own aquatic animal health status are accurate and based on systems of monitoring and surveillance that are as rigorous as those demanded of exporting countries.

Equally, the CA of an exporting country should ensure that information provided on its health status is accurate and based on internationally accepted standards for monitoring and surveillance. It also has an obligation to report any significant changes in health status to all trading partners in line with international conventions.

Finally, the CA of the exporting country should be prepared, and willing, to supply the importing CA with information on the structure of its veterinary (or equivalent) services and the authority they exercise.

11.3 International trading obligations

Member nations of the World Trade Organization (WTO) have certain rights and obligations under WTO agreements, including the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement).

At present, the SPS Agreement recognises the standards, guidelines and recommendations developed by the OIE as the international standard for animal health and zoonoses. Under the SPS Agreement, members are encouraged to ensure their health control measures are consistent with international standards. Members may require higher or supplemental levels of protection where these are based on a scientific risk analysis (see Manual of Procedures).

11.4 General guidelines on IRA

IRA provides a standardised, documented and defensible process for decision making. These Technical Guidelines on import risk analysis are consistent with OIE standards and the SPS Agreement.

The importing country uses the results of scientifically based IRA to determine whether or not the disease risks and related control measures (where applicable) are acceptable or not. All IRAs must, therefore, include a level of sanitary and phytosanitary protection which is appropriate to the disease risks identified. Since all IRAs must be transparent, objective and based on solid science, each analysis should be clearly documented and supported by references to scientific literature and other reliable expertise and resources. Transparency must be achieved through open communication and use of bilateral agreements to secure additional information to resolve outstanding issues arising from the IRA.

At the request of the importing country, the exporting country should be prepared to supply information on its aquatic animal health status and national aquatic animal health system(s). This may be necessary for the importing country to determine whether the exporting country is free of, or has zones free of, diseases notifiable to the OIE and/or NACA. The information required could include:

• the regulations in force to maintain its free status;

• information on the appearance or occurrence of transmissible diseases;

• details of the country’s ability to control or prevent diseases notifiable to the OIE and/or NACA from introduction and/or spread and, where appropriate, other diseases;

• information on the structure of the Competent Authority and the authority that it exercises; and

• technical information, particularly on diagnostic tests and vaccines applied in all or part of the national territory.

An importing country should consider all alternative mitigative measures proposed by the exporting country that would provide a level of protection equivalent to that acceptable by the importing country. Where there is a lack of information on the presence or prevalence of disease in the source population, and available diagnostic tests are of limited use, the IRA may adopt a science-based precautionary principle until sufficient data are gathered.

In the event of an importing country's decision to refuse importation or impose significant constraints on importation, however, it should be prepared to justify the decision by providing details of the analysis to the exporting country.

12 NATIONAL STRATEGIES AND POLICY FRAMEWORKS

This section provides guidance on the policy issues which have to be considered in the framing of legislation in support of these Technical Guidelines and the institutional issues to be considered by countries for development of their National Strategies.

The implementation of these Technical Guidelines in an effective manner requires an appropriate national administrative and legal framework, as well as sufficient expertise, manpower and infrastructure.

Additional information on institutional and policy analysis is provided in the Manual of Procedures.

12.1 Legislative and policy frameworks

Responsibility

The responsible authorities for aquatic animal health management vary from country to country, but most mandates lie within the ministries or departments responsible for agriculture, livestock and/or fisheries. The variety of governmental organizations responsible for aquatic animal health management and quarantine policy reflects the differing systems of government and the levels of aquaculture development across the region. Some countries have no government body with responsibility for live aquatic animal quarantine or health certification policy.

In order to effectively prevent the spread of controllable diseases, responsibility for aquatic animal health control needs to be clearly assigned, or confirmed in cases where jurisdiction is unclear. To this end, designation of a Competent Authority is essential. This CA should be capable of collating input from fisheries, environmental and animal health science expertise, as well as from quarantine and veterinary services.

Legislation and regulation

Participating countries should work to harmonise national legislation and regulations related to aquatic animal health management.

Regulations vary from country to country, however, all present legislation for trans-boundary movement of live aquatic animals is more comprehensive than that for movement within a country. In addition, most import legislation is more precise and stringent than export legislation. This reflects the fact that, in terms of health, export regulations are governed predominantly by importing country requirements.

Countries that have environmental or conservation policy or regulations which impact upon the movement of live aquatic animals, must take these policies and regulations into consideration when framing separate aquatic animal health protection legislation. Such legislation must also clearly address jurisdictional responsibility and ensure that it is consistent with international standards and obligations (e.g., the OIE‘s International Aquatic Animal Health Code and the World Trade Organization’s Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement)).

12.2 Institutional requirements

Trained personnel and infrastructure are required to implement and conduct strategies to control trans-boundary diseases.

Assessment of available institutional capacity and expertise to develop national policy and legislation is required. This must take into account the disease problems to be dealt with, and the institutional responsibilities and requirements. The different sections of the Technical Guidelines can be used as the basis for identifying institutional requirements, including the requirements for those organizations responsible for policy development, application and enforcement of the regulations.

Communication between departments responsible for preparing national policy, legislation and related regulations, and departments mandated to implement and enforce such policy and regulations is essential to ensure technical feasibility. In addition, the roles, interests and opinions of other organizations in this area, such as governmental and semi-governmental research organizations, universities, international research institutes and private-sector companies with diagnostic capability, should also be carefully considered when framing legislation.

12.3 Resource requirements

Resources required for aquatic animal disease control take many forms. These may be grouped as institutional, laboratory and human resources. Some guidance for consideration by participating countries is presented below. More specific and complete information relating to human and physical infrastructure is provided in the Manual of Procedures.

Extension services and integrated networks of support services, whether managed at a national or state level, are very effective for aquatic animal health management and should, therefore, be included. These help offset situations where diagnostic capability is not sufficient to meet the immediate needs of proposed health management activities. Enhancement of laboratory facilities and expertise has also been identified as an area of importance.

Training and infrastructure development should be clearly matched against specified requirements (e.g., potential pathogen risks, economic importance). Many of the least costly activities are ultimately the most important and are likely to generate the greatest benefits e.g., enhanced record keeping at the field level. Analysis of cost-benefits from investments in infrastructure and training should be considered early in the development of national strategies.

The capacity to carry out problem-solving research must also be available. This must be focussed on direct application to the health concerns of aquatic food-production industries. Research results must be delivered in a timely manner and in a form that serves both the research and user communities.

The range of expertise required will vary between countries and for different disease situations. Efficient staff development requires national institutions to define their requirements and areas of need, identify staff and provide them with the training and resources necessary to develop the facilities and services required. Provision of incentives to keep trained staff for prolonged periods (years) is also necessary to ensure the development of experience. Such experience is invaluable for maintaining a consistent health management programme and refining “apprenticeship” or “in-house” training. Most skills and facilities required already exist in this region. An inventory and database of personnel and institutions should be developed to assist in identifying them.

Lack of finance can hinder development of infrastructure, diagnostic facilities and relevant expertise. As beneficiaries of improvement in the aquatic animal health status in the region, the private sector should be considered as a potential source of funds for the development of disease control strategies. This requires a more innovative look into the application of the “user pays” principle in aquatic animal health management. Collaboration between terrestrial and aquatic animal health systems will provide increased efficiency and a larger workforce of trained staff at times of peak demand, as well as facilitate meeting international obligations.

Finally, capacity building is essential to support the implementation of these Technical Guidelines. Implementation at the national level requires supporting educational and training institutions to ensure long-term capacity building. Individual countries can assess training and educational needs to identify requirements and methods by which they can be met.

13 REGIONAL CAPACITY BUILDING

This section provides guidance on regional-level capacity building in support of the implementation of the Technical Guidelines.

As is clearly demonstrated in the development of these Technical Guidelines, aquatic organisms do not respect political boundaries, and the nature of regional and international trade means that effective aquatic animal health management requires international co-operation.

General principles are outlined in these guidelines, while more specific and complete procedures relating to regional-level human and physical infrastructure development are provided in the Manual of Procedures.

Participating countries should continue to work together to collectively improve the ability of all countries to diagnose and report diseases of concern. This includes identification of regional laboratories which maintain reference material and can verify diagnosis of diseases important to the region. Such laboratories need to be identified and their capacities reinforced. The regional disease list can be used as the basis for identification of the laboratories and skills required.

An emergency response mechanism also needs to be developed through regional-level contingency planning. Additional mechanisms for sharing experience e.g., publications and meetings, must also be encouraged at a regional level, and sources of support and funding for these must be identified.

Regional training and education programmes to assist with building national capacity, ensuring uniform and acceptable standards of diagnosis and reporting, should be further enhanced. Training is particularly needed in countries where technical skills are scarce (e.g., in epidemiology, histopathology, immunology and molecular biology, virology, extension methodology, mycology, research methodology and design, and risk analysis and management). Regional-level monitoring systems and databases should be enhanced and supported, with strong links to the Aquatic Animal Pathogen and Quarantine Information System (AAPQIS). This includes maintenance of the NACA/FAO and OIE Aquatic Animal Disease Reporting Systems.

A regional expert working group, the Advisory Group on Aquatic Animal Health (AG) is required to provide continued high-level support for development and implementation of the Technical Guidelines. Its active involvement in aquatic animal disease issues within the region must be sustained, in order to respond to new challenges and provide consistent leadership for regional developments in this field.

14 IMPLEMENTATION OF THE TECHNICAL GUIDELINES

In recognition of the potential benefits from application of these regional Technical Guidelines in terms of food production, income generation, poverty alleviation and protection of rural livelihoods based on aquatic food resources, the following implementation strategies are recommended:

• Countries adopting the Technical Guidelines should agree to implement them in line with their national circumstances and capacity.

• To assist the region in implementation of the Technical Guidelines, the Advisory Group on Aquatic Animal Health (AG), under the NACA Governing Council, should be supported to provide expert advice on aquatic animal health matters, including regular review of the diseases of importance (the NACA/FAO Regional Disease Reporting List).

• NACA has accepted to integrate the AG within its regular regional programme, and FAO and OIE are requested to support this activity. Linkage should also be established with other global organizations to provide a more coherent and stronger voice representing the region in international aquatic animal health affairs.

• Regional laboratories and specialised centres with responsibilities for providing diagnostic services, training for capacity building and maintaining reference material within Asia must be identified and designated.

• Monitoring of implementation of the Technical Guidelines is essential. The primary responsibility for this lies with the national governments. However, the AG is requested to provide guidance.

• A regular report on aquatic animal health should be provided by each government, as part of the regular reporting on the implementation of the FAO Code of Conduct for Responsible Fisheries, to the NACA Governing Council, FAO Committee on Fisheries (COFI), and other relevant subsidiary bodies and expert groups, as appropriate.

• Donors and regional/international organizations are requested to assist countries in building capacity to assist implementation of the Technical Guidelines.

• FAO, NACA and OIE are requested to provide support from their programmes, with special consideration of lesser-developed countries within the region, to assist in building their capacity to implement the Technical Guidelines.

15 REFERENCES

ADB/NACA. 1991. Fish Health Management in Asia-Pacific. Report on a Regional Study and Workshop on Fish Disease and Fish Health Management. ADB Aquaculture Department Report Series No. 1. Network of Aquaculture Centres in Asia-Pacific. Bangkok, 627 p.

AFFA. 1999. AQUAPLAN. Australia’s National Strategic Plan for Aquatic Animal Health 1998-2003. Commonwealth of Australia, 34 p.

(http://www.affa.gov.au/nat-offices/aquatic/aquaplan.pdf)

DFID/FAO/NACA/GOB. 2000. Primary Aquatic Animal Health Care in Rural, Small-scale Aquaculture Development. Report of an Asia Regional Scoping Workshop, 27-30 September 1999. Dhaka, Bangladesh. Department for International Development, Food and Agriculture Organization of the United Nations and the Network of Aquaculture Centres in Asia-Pacific. 36 p.

FAO. 1995. Code of Conduct for Responsible Fisheries. Food and Agriculture Organization of the United Nations, Rome. 41 p. (http://www.fao.org/fi/)

Humphrey, J., J.R. Arthur, R.P. Subasinghe and M.J. Phillips. 1997. Aquatic Animal Quarantine and Health Certification in Asia. Proceedings of the Regional Workshop on Health and Quarantine Guidelines for the Responsible Movement (Introduction and Transfer) on Aquatic Organisms. Bangkok, Thailand, 28 January 1996. FAO Fisheries Technical Paper No. 373, 153 p.

ICES. 1995. ICES Code of Practice on the Introductions and Transfers of Marine Organisms 1994. International Council for the Exploration of the Sea, Copenhagen, 12 p.

NACA/FAO. 1999. Quarterly Aquatic Animal Disease Report (Asia and Pacific Region), 98/2, October-December 1998. FAO Project TCP/RAS/6714, Bangkok, 42 p.

OIE. 2000a. International Aquatic Animal Health Code. 3rd edn. Office International des Épizooties, Paris.

(http://www.oie.int/norms/FCode/A_summry.htm)

OIE. 2000b. Diagnostic Manual for Aquatic Animal Diseases. 3rd edn., Office International des Épizooties, Paris.