Risk Analysis in the Veterinary Services

1. Risk Analysis in the Veterinary Services Preben Willeberg Chief Veterinary Officer

2. Disease and trade Historically trade has led to disease spread: 1920 Rinderpest from India to Belgium 1946 FMD from Brazil to Mexico 1978 ASF Iberian peninsula? to Haiti 1997 CSF in the Netherlands 1997 FMD in Taiwan 2000 FMD in Asia 2001 FMD from the UK to mainland Europe International trade in live animals and animal products has occasionally lead to the spread of disease between countries resulting in severe consequences for the agricultural economy of a country. Several examples of trans-boundary spread of diseases have been documented. The spread of rinderpest to Belgium from cattle originating in India destined for Brazil and transiting in the port of Antwerp in 1920 reintroduced the cattle plague to Europe (OIE, 1999a). Foot-and-mouth disease was introduced to Mexico from Brazil in the fifties and led to the destruction of one million head of cattle, sheep and goats and to a severe socio-economic crisis (Machado, 1968). In 1978, an African swine fever epidemic broke out in the island of Hispaniola and could only be controlled by the destruction of the entire swine population on the island. In Haiti in particular, this had a dramatic effect in the already precarious livelihood of the rural population (Zepeda, 1988). More recently, in 1997 classical swine fever was introduced to the Netherlands and forced the destruction of roughly 11 million pigs (Dijkhuizen, 1999), that same year FMD caused the destruction of Taiwan’s swine industry (OIE, 1999b) and is currently affecting several Asian countries[1] (OIE 2000a).     International trade in live animals and animal products has occasionally lead to the spread of disease between countries resulting in severe consequences for the agricultural economy of a country. Several examples of trans-boundary spread of diseases have been documented. The spread of rinderpest to Belgium from cattle originating in India destined for Brazil and transiting in the port of Antwerp in 1920 reintroduced the cattle plague to Europe (OIE, 1999a). Foot-and-mouth disease was introduced to Mexico from Brazil in the fifties and led to the destruction of one million head of cattle, sheep and goats and to a severe socio-economic crisis (Machado, 1968). In 1978, an African swine fever epidemic broke out in the island of Hispaniola and could only be controlled by the destruction of the entire swine population on the island. In Haiti in particular, this had a dramatic effect in the already precarious livelihood of the rural population (Zepeda, 1988). More recently, in 1997 classical swine fever was introduced to the Netherlands and forced the destruction of roughly 11 million pigs (Dijkhuizen, 1999), that same year FMD caused the destruction of Taiwan’s swine industry (OIE, 1999b) and is currently affecting several Asian countries[1] (OIE 2000a).

3. The need for international regulation The 1920 Rinderpest outbreak in Belgium highlighted the need to have an international body to regulate trade in animals and animal products In 1924 the Office International des Epizooties (OIE) was created 28 countries The introduction of rinderpest to Belgium in 1920, highlighted the need to have an international body to help coordinate disease control efforts and in particular to regulate international trade in animals and animal products. In 1924, the Office International des Epizooties (OIE) was established by an international agreement signed by 28 countries. The introduction of rinderpest to Belgium in 1920, highlighted the need to have an international body to help coordinate disease control efforts and in particular to regulate international trade in animals and animal products. In 1924, the Office International des Epizooties (OIE) was established by an international agreement signed by 28 countries.

4. OIE role Disease information system Improve disease surveillance and control International trade regulations Its main purpose has been to inform Governments of the occurrence and course of animal diseases throughout the world and of ways to control these diseases, to coordinate, at the international level, studies devoted to the surveillance and control of animal diseases and to harmonize regulations for trade in animals and animal products among member countries (OIE, 2000b). Its main purpose has been to inform Governments of the occurrence and course of animal diseases throughout the world and of ways to control these diseases, to coordinate, at the international level, studies devoted to the surveillance and control of animal diseases and to harmonize regulations for trade in animals and animal products among member countries (OIE, 2000b).

5. WTO and OIE 1994 Final Act of GATT’s Uruguay Round World Trade Organization, January 1995 Agreement on the application of sanitary and phytosanitary measures (SPS) OIE is responsible for drafting international standards for animal health In April 1994, the Final Act of the Uruguay Round of Multilateral Trade Negotiations of the General Agreement on Tariffs and Trade (GATT) was signed; this led to the creation of the World Trade Organization (WTO) in January 1995. Among the agreements that were included in the treaty that established the WTO is the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) which sets out the basic rules for food safety and animal and plant health standards (WTO, 1995). The SPS Agreement specifically empowers the OIE as the organization responsible to draft international standards for animal health. In April 1994, the Final Act of the Uruguay Round of Multilateral Trade Negotiations of the General Agreement on Tariffs and Trade (GATT) was signed; this led to the creation of the World Trade Organization (WTO) in January 1995. Among the agreements that were included in the treaty that established the WTO is the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) which sets out the basic rules for food safety and animal and plant health standards (WTO, 1995). The SPS Agreement specifically empowers the OIE as the organization responsible to draft international standards for animal health.

6. OIE membership The renewed importance conferred by the SPS Agreement on the OIE has spurred the interest of countries across the globe; in 1989, 114 countries were members and by December 1999 membership had reached 155 countries (OIE 2000b). The renewed importance conferred by the SPS Agreement on the OIE has spurred the interest of countries across the globe; in 1989, 114 countries were members and by December 1999 membership had reached 155 countries (OIE 2000b).

7. SPS Agreement Allow increased trade of agricultural products Avoid the use of SPS measures as disguised barriers to trade Recognizes the right to protect human, animal and plant health The main goal of the SPS agreement is to allow for increased trade of agricultural products while recognizing the right of countries to protect human, animal and plant health. The main goal of the SPS agreement is to allow for increased trade of agricultural products while recognizing the right of countries to protect human, animal and plant health.

8. Risk, Trust and Trade Zero risk approach to trade If in doubt, keep it out... Effective in avoiding disease introductions BUT OFTEN... Excessively stringent measures Barriers to trade Lack of scientific basis Over the years, one of the most important means to prevent the introduction of disease through trade has been a policy of risk avoidance i.e. a “zero risk” approach to trade. The driving philosophy behind this approach is captured in a phrase widely used in past decades by animal health officials: “if in doubt, keep it out”. While it is recognized that the “zero risk” approach has been effective in preventing disease introductions, it is also widely accepted that it often led to unnecessarily stringent measures that frequently had no scientific basis and were in fact used as barriers to trade. Over the years, one of the most important means to prevent the introduction of disease through trade has been a policy of risk avoidance i.e. a “zero risk” approach to trade. The driving philosophy behind this approach is captured in a phrase widely used in past decades by animal health officials: “if in doubt, keep it out”. While it is recognized that the “zero risk” approach has been effective in preventing disease introductions, it is also widely accepted that it often led to unnecessarily stringent measures that frequently had no scientific basis and were in fact used as barriers to trade.

9. Zero risk and trade Zero risk does not exist Trade implies risk Lack of trade also implies risk Unregulated trade There is now common agreement that zero risk is not attainable. The validity of the zero risk approach to trade issues can be questioned with the following points: ·         In all areas of safety, risk can be reduced to an insignificant level, but scientifically it is impossible to reduce it to zero. Scientific evidence cannot prove the absence of risk, rather it gives some certainty of the potential for the absence of risk; ·         Nature does not respect political international boundaries. Thus, a disease can pass a political boundary without notice; ·         The use of unnecessarily restrictive technical barriers to trade can lead to smuggling as a means of getting around such barriers. This can seriously threaten agricultural security - the opposite effect to that intended. It can also lead to a country finding itself isolated from overseas market opportunities; ·         International travel and trade is a fact of our current global community and risk will always be present, no matter how small. In short, trade implies risk; however, the lack of trade also implies risk as it stimulates informal, unregulated trade. There is now common agreement that zero risk is not attainable. The validity of the zero risk approach to trade issues can be questioned with the following points: ·         In all areas of safety, risk can be reduced to an insignificant level, but scientifically it is impossible to reduce it to zero. Scientific evidence cannot prove the absence of risk, rather it gives some certainty of the potential for the absence of risk; ·         Nature does not respect political international boundaries. Thus, a disease can pass a political boundary without notice; ·         The use of unnecessarily restrictive technical barriers to trade can lead to smuggling as a means of getting around such barriers. This can seriously threaten agricultural security - the opposite effect to that intended. It can also lead to a country finding itself isolated from overseas market opportunities; ·         International travel and trade is a fact of our current global community and risk will always be present, no matter how small. In short, trade implies risk; however, the lack of trade also implies risk as it stimulates informal, unregulated trade.

10. The SPS Agreement contribution Regionalization Risk Analysis Harmonization Equivalence Transparency Some of the key notions contained in the SPS agreement are risk analysis, regionalization, harmonization, equivalence and transparency. Both risk analysis and regionalization are dependent on data generated by a comprehensive surveillance system with a sound epidemiological design. Thus, epidemiology is a key element in providing the scientific basis to satisfy international trade requirements. Harmonization, equivalence and transparency are the basis for mutual trust between veterinary services - an essential element to ensure safe trade. Some of the key notions contained in the SPS agreement are risk analysis, regionalization, harmonization, equivalence and transparency. Both risk analysis and regionalization are dependent on data generated by a comprehensive surveillance system with a sound epidemiological design. Thus, epidemiology is a key element in providing the scientific basis to satisfy international trade requirements. Harmonization, equivalence and transparency are the basis for mutual trust between veterinary services - an essential element to ensure safe trade.

11. International animal health standards OIE International Animal Health Code List A and B diseases Guidelines for: Risk Analysis Regionalization Surveillance Evaluation of veterinary services International animal health standards SPS measures should be scientifically based and follow international standards laid out in OIE’s International Animal Health Code (OIE, 1999c). The OIE Code covers the most important diseases and provides guidelines on issues like surveillance, risk analysis and regionalization. If a country chooses to adopt a higher standard of protection it must provide a scientific justification and base its decision on a risk analysis International animal health standards SPS measures should be scientifically based and follow international standards laid out in OIE’s International Animal Health Code (OIE, 1999c). The OIE Code covers the most important diseases and provides guidelines on issues like surveillance, risk analysis and regionalization. If a country chooses to adopt a higher standard of protection it must provide a scientific justification and base its decision on a risk analysis

12. Historical freedom OIE diseades surveilance group Guidelines for disease freedomHistorical freedom OIE diseades surveilance group Guidelines for disease freedom

13. Risk Analysis process With epidemiology Hazard identification Risk assessment Risk management Risk communication Without epidemiology Enthusiasm Skepticism Mistrust Depression Epidemiology and risk analysis As mentioned above, the relationship between epidemiology and international trade revolves around risk analysis and regionalization. Animal health risk analysis is a process composed of hazard identification, risk assessment, risk management and risk communication. Its objective is to identify the potential hazards associated with a commodity, assess the likelihood of introduction, establishment and spread within the importing country and estimate the potential consequences related to its introduction (OIE, 1999c). Although risk analysis as a methodological and documented approach is relatively new for veterinary services, the concept has been applied informally for many years. Epidemiology and risk analysis As mentioned above, the relationship between epidemiology and international trade revolves around risk analysis and regionalization. Animal health risk analysis is a process composed of hazard identification, risk assessment, risk management and risk communication. Its objective is to identify the potential hazards associated with a commodity, assess the likelihood of introduction, establishment and spread within the importing country and estimate the potential consequences related to its introduction (OIE, 1999c). Although risk analysis as a methodological and documented approach is relatively new for veterinary services, the concept has been applied informally for many years.

14. Epidemiology and risk analysis Animal health risk analysis relies on epidemiology The risk of risk analysis is to become merely a probabilistic exercise Veterinary epidemiology ensures biological coherence in the risk analysis process Animal health risk analysis relies on epidemiological input; without such input the process could become a probabilistic exercise that is not biologically coherent. Animal health risk analysis relies on epidemiological input; without such input the process could become a probabilistic exercise that is not biologically coherent.

15. In the following slides I will focus on the epidemiologic inputs in the risk analysis process. This slide summarizes the different steps in the process.In the following slides I will focus on the epidemiologic inputs in the risk analysis process. This slide summarizes the different steps in the process.

16. Challenges and opportunities The SPS agreement highlights the importance of veterinary epidemiology (ists) in international trade Solutions call for a multidisciplinary approach Shift from herd-level epidemiology to a broader scale: zone-country-region The SPS Agreement has opened a vast array of opportunities for veterinary epidemiologists. Nevertheless, the solutions required to facilitate safe trade call for an integrated multidisciplinary approach including other disciplines such as economics, statistics, geography and geographic information systems, ecology, sociology and politics. Epidemiologists have always dealt with the concept of health and disease in populations, however the promotion of international trade presents an additional challenge: it requires a shift from herd level epidemiology to a much larger scale that encompasses zones, countries and regions. The SPS Agreement has opened a vast array of opportunities for veterinary epidemiologists. Nevertheless, the solutions required to facilitate safe trade call for an integrated multidisciplinary approach including other disciplines such as economics, statistics, geography and geographic information systems, ecology, sociology and politics. Epidemiologists have always dealt with the concept of health and disease in populations, however the promotion of international trade presents an additional challenge: it requires a shift from herd level epidemiology to a much larger scale that encompasses zones, countries and regions.

17. Challenges and opportunities Methods to demonstrate disease freedom Statistically valid Practical and economically viable Quantitative link between risk assessment and the evaluation of veterinary services Training in epidemiology and risk analysis Universities Role of OIE Collaborating Centers There is a need to develop new methods to determine the disease status of countries and zones as prevalence approaches zero to be applied when an area (zone, country or region) is to be declared free from disease. These methods need to be statistically valid and at the same time economically viable and practical enough to be applicable under different field conditions, particularly in developing countries where different production systems may co-exist. An additional challenge is the quantitative integration of the results of the evaluation of veterinary services into the risk analysis process. Although there is widespread recognition that the quality of the veterinary services is linked to the level of risk, at present there is a lack of methods to assess this relationship in a quantitative way. Today, perhaps more than ever before, training in veterinary epidemiology is essential for veterinary services staff at every level. Formal postgraduate training programs currently offered need to be expanded to include risk analysis and economics in the broad context of international trade. The OIE through several of its Collaborating Centers is able to offer training in these fields, however the role of Collaborating Centers is to complement formal epidemiological training not be a surrogate for it. There is a need to develop new methods to determine the disease status of countries and zones as prevalence approaches zero to be applied when an area (zone, country or region) is to be declared free from disease. These methods need to be statistically valid and at the same time economically viable and practical enough to be applicable under different field conditions, particularly in developing countries where different production systems may co-exist. An additional challenge is the quantitative integration of the results of the evaluation of veterinary services into the risk analysis process. Although there is widespread recognition that the quality of the veterinary services is linked to the level of risk, at present there is a lack of methods to assess this relationship in a quantitative way. Today, perhaps more than ever before, training in veterinary epidemiology is essential for veterinary services staff at every level. Formal postgraduate training programs currently offered need to be expanded to include risk analysis and economics in the broad context of international trade. The OIE through several of its Collaborating Centers is able to offer training in these fields, however the role of Collaborating Centers is to complement formal epidemiological training not be a surrogate for it.

18. Conclusions The SPS agreement requires significant epidemiologic input to provide the scientific basis in the application of sanitary and phytosanitary measures Risk analysis and regionalization are the core concepts

19. Conclusions The SPS Agreement has had a major impact in the organizational structure of veterinary services Multidisciplinary groups Risk analysis and regionalization units Training Many countries face difficulties in implementation of the SPS Agreement The SPS Agreement has had a strong impact on the organizational structures of veterinary services internationally. Veterinary epidemiology has always been closely linked with the international trade of animals and animal products, nonetheless the Agreement on the Application of Sanitary and Phytosanitary Measures of the World Trade Organization has ratified its role, placing it at the center of animal health trade related decisions. Today, veterinary services worldwide acknowledge this fact and are strengthening their disease surveillance systems and are integrating specialized multidisciplinary groups to deal with risk analysis and regionalization. Unfortunately, several countries, particularly in the developing world, are facing considerable difficulties in the implementation of the SPS Agreement (WTO, 1999) The SPS Agreement has had a strong impact on the organizational structures of veterinary services internationally. Veterinary epidemiology has always been closely linked with the international trade of animals and animal products, nonetheless the Agreement on the Application of Sanitary and Phytosanitary Measures of the World Trade Organization has ratified its role, placing it at the center of animal health trade related decisions. Today, veterinary services worldwide acknowledge this fact and are strengthening their disease surveillance systems and are integrating specialized multidisciplinary groups to deal with risk analysis and regionalization. Unfortunately, several countries, particularly in the developing world, are facing considerable difficulties in the implementation of the SPS Agreement (WTO, 1999)

20. Conclusions In the past SPS measures have been applied in a defensive, reactive mode Opportunity to shift to a proactive approach that promotes scientific logic, epidemiology, agricultural production and international trade Disease surveillance systems play a central role in providing the scientifically based information needed to conduct risk assessments and regionalization appraisals. In the past, SPS measures have often been applied in a defensive, reactive mode, today there is the opportunity to shift to a proactive approach that truly promotes agricultural production and enhances international trade. The common thread supporting this effort is the scientific basis in the application of SPS measures, transparency and trust.Disease surveillance systems play a central role in providing the scientifically based information needed to conduct risk assessments and regionalization appraisals. In the past, SPS measures have often been applied in a defensive, reactive mode, today there is the opportunity to shift to a proactive approach that truly promotes agricultural production and enhances international trade. The common thread supporting this effort is the scientific basis in the application of SPS measures, transparency and trust.

23. Conclusions Good science, transparency and trust are the essential elements in the application of SPS measures