Part A: Sanitary and international standards considerations. Dr Gideon Brückner. January Page 1 of 43

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1 ASSESSING OPPORTUNITIES FOR AFRICAN COUNTRIES TO STRENGHTHEN TRADE IN ANIMAL PRODUCTS IN COMPLIANCE WITH INTERNATIONAL STANDARDS THROUGH COMMODITY BASED TRADE, ZONING, IMPROVED TRACEABILITY AND CERTIFICATION Part A: Sanitary and international standards considerations Dr Gideon Brückner January 2013 Page 1 of 43

2 ASSESSING OPPORTUNITIES FOR AFRICAN COUNTRIES TO STRENGHTHEN TRADE IN ANIMAL PRODUCTS IN COMPLIANCE WITH INTERNATIONAL STANDARDS THROUGH COMMODITY BASED TRADE, ZONING, IMPROVED TRACEABILITY AND CERTIFICATION Part A: Sanitary and international standards considerations Executive summary Page 2 of 43 Index 1. Introduction 4 2. Objective of the study 5 3. The current position globally and in sub-saharan Africa 6 for entry into international grade for animals and animal products 3.1 Disease free countries, zones, compartments and safe commodities Risk management principles to facilitate trade in safe commodities Policy versus risk management options The rights and obligations of countries for entering international trade The standards, guidelines and recommendations of the OIE The evaluation of Veterinary Services Guidelines for equivalence Risk mitigation for trade sensitive diseases Developing countries and the application of the SPS Agreement Harmonisation (Article 3 of the SPS Agreement) Equivalence (Article 4 of the SPS Agreement) Recognition of regional conditions, disease-free 19 areas or areas with low disease prevalence (Article 6 of the SPS Agreement)

3 5. Considering the options for entering international trade in compliance with international standards opportunities for sub-saharan countries Country freedom from disease OIE recognised zonal freedom from FMD The establishment of non-oie recognised export zones or disease free zones The establishment of disease-free compartments Commodity based trade (CBT) A model export system for deboned beef derived from countries or zones which are not certifiably free from one or more important animal diseases 29 Summary of stages in proposed model for export from Country X to Country B Schematic presentation of a possible model for Country X in SSA to enter trade in safe commodities (CBT) with Country B 6. The cost of compliance for entering internal trade Certification for export Animal identification Conclusion and summary of recommendations References 35 Page 3 of 43

4 ASSESSING OPPORTUNITIES FOR AFRICAN COUNTRIES TO STRENGHTHEN TRADE IN ANIMAL PRODUCTS IN COMPLIANCE WITH INTERNATIONAL STANDARDS THROUGH COMMODITY BASED TRADE, ZONING, IMPROVED TRACEABILITY AND CERTIFICATION Executive summary Dr Gideon Brückner 1 Countries in sub Saharan Africa (SSA) who do not yet have the advantage of OIE recognized free zones or status for animal diseases are currently experiencing a comparative disadvantage for entering international trade in animals and animal products. With boneless beef making up approximately 84% of total trade in beef and an increase in value in parallel with total beef and edible offal trade of 11% per annum, a vast potential market is in the waiting for countries in SSA to contribute to the worldwide demand that should and must be exploited (13). Without being able to comply with the strict sanitary guarantees required by trade partners especially in the developed world, these potential markets remain closed for the majority of SSA countries. Most countries in SSA where trade sensitive animal diseases are endemic do not have the ability, infrastructure and political support to establish and maintain disease free zones. There are also other constraints unique to Africa such as the wildlife-livestock interface, the permanent presence of the FMDV in the African buffalo cultural entities and transhumance that further place constraints on these countries to comply with international standards for market access. This study mandated by the Inter-African Bureau for Animal Resources of the African Union (AU- IBAR), researched and evaluated the options available to countries in SSA within the context of trade facilitating measures provided by international animal health standards of the World Organisation for Animal Health (OIE) and allowed within the rights and obligations for international trade provided for in the Sanitary and Phytosanitary Agreement (SPS Agreement) of the World Trade Organisation (WTO). In assessing the options available for countries in SSA wishing to enter international trade (either globally or on a regional basis) the critical issues to consider by potential exporting countries are: What trade facilitating options in terms of OIE standards and the SPS Agreement are available to mitigate the risks hindering safe trade in animals and animal products? What trade facilitating or risk mitigating measure would be the best suitable, the most cost-effective and most sustainable for the circumstances (disease and economic indicators) present in my country? 1 30 Schoongezicht, 1 Scholtz Street, Somerset West 7130, South Africa. gkbruckner@gmail.com Page 4 of 43

5 What would the cost implications be for the application as well as the maintenance of additional risk mitigation/sanitary measures to satisfy the need of trade partners? Considering the disease situation in my country, would the particular risk mitigation measures applied in my country be acceptable to my potential trade partners? If the risk mitigation measures/sanitary measures applied in my country are not identical to what is prescribed by trade partners would they be acceptable as equivalent measures as provided for in both the OIE Code and SPS Agreement? The risk mitigation and trade facilitating measures provided for in the OIE Code and also recommended within the SPS Agreement that were evaluated in this study, comprises basically the following options: Country freedom from disease with or without vaccination Zonal freedom from disease with or without vaccination The establishment of disease-free compartments The marketing of safe commodities from infected countries or areas where either country or zonal freedom is not achievable Taking into consideration that most countries in SSA are not in the position to successfully mitigate the risks to achieve and maintain either country or zonal freedom from disease, the various options available for the establishment of compartments or the marketing of safe commodities for trade either as a single trade facilitating measure or in combination are discussed in more detail. Taking into consideration possible constraints and pre-requisites needed for a successful outcome, the most desirable options are discussed with the proposal of a model that could be considered for possible application as a risk mitigation measure to enter international trade. The standards of the OIE provide the opportunity to countries to not only improve their veterinary service delivery to add more substance to their sanitary guarantees but also provide opportunities to combine various trade facilitating mechanisms in the Code and SPS Agreement that could be used as sanitary guarantees for trade. Over and above the option of establishing zonal freedom from disease which unfortunately would only be possible for a limited number of countries, the application of compartmentalization and commodity based trade either in isolation or in combination, now offers more viable opportunities to move towards market access. The latter is not only a viable alternative option but in most instances, the only viable option. The road ahead once the production of safe commodities for trade is achieved, would pose further challenges in terms of market access and competing with other countries in the international environment other than SSA, who would also exploit this opportunity and have the comparative advantage of already established markets and financial support of private-public partnerships. Private public partnerships and ready access to international markets, are far less common in SSA than in other beef trading countries of the world and presents a real constraint that must be overcome even if countries in SSA succeed in establishing acceptance of the sanitary guarantees of commodities from Africa as safe for trade. Page 5 of 43

6 In considering the various options available to SSA countries, it could be reasoned that the mere application of compartmentalisation as defined in the Code, could still be too restrictive and costly for most countries in SSA. Most countries would also need a multi-disease risk mitigation process i.e. not aimed at risk mitigation for foot and mouth disease virus (FMDV) alone but also including other diseases such as CBPP (Contagious bovine pleuropneumonia) or Rift Valley fever (RVF). The OIE standards for obtaining official recognition for disease free zones are disease specific i.e. the current system do not make provision for a zone to be officially recognised by the OIE as being free from more than one disease for example simultaneous recognition by the OIE for both FMD and CBPP freedom of the same zone. With the introduction of the concept of compartmentalisation in the Code, this shortcoming was somewhat addressed by defining a compartment as an animal subpopulation contained in one or more establishments under a common biosecurity management system with a distinct health status with respect to a specific disease or specific diseases for which required surveillance, control and biosecurity measures have been applied for the purpose of international trade. Compartments provide the opportunity of combining it with other options such as commodity based trade. In assessing all possible options it appears that a system that would provide for acceptable preabattoir risk mitigation (compartments or quarantine or bio-secure holding facilities) and an abattoir and processing plant that would be able to ensure pathogen risk mitigation to such a level that would meet the appropriate level of protection of the trade partner, would be the method of choice and the most preferred option for those SSA countries that are not in the position to successfully achieve and maintain zonal status for disease freedom. The proposed model describes this option in more detail especially as it relates to the trade facilitating risk measures described in the OIE Terrestrial Animal Health Code for the marketing of deboned beef from FMD infected countries while also providing for a multi-disease risk mitigation approach, pre- and post-slaughter, to offer a more complete package to possibly meet the appropriate level of protection for safe trade that might be required by potential importing countries. However, private public partnerships and ready access to international markets, are far less common in SSA than in other beef trading countries of the world and presents a real constraint that must be overcome even if countries in SSA succeed in establishing acceptance of the sanitary guarantees of commodities from Africa as safe for trade. Page 6 of 43

7 1. Introduction Despite the increasing demand for animal products within and outside Africa, African countries still face difficulties in participating in the international trade in animal products, including on the markets within Africa. Africa s share in international trade of livestock and animal products is less than 0.5 %, and the African trade balance in animal commodities records a deficit of about 3 billion US dollars annually. The reasons leading to that situation are multiple. Some are related to the production stage and the low productivity of the African livestock sector, others are linked to the value chain organization, or to the policy environment. One of the most important constraints remains the inability of African countries to comply with international standards that set the rules for international trade, including among African countries. This is mainly linked to the following: - The sanitary status of African countries for major trade sensitive diseases ( e.g. FMD, PPR, RVF, CBPP) is unfavorable - Presence of wildlife that affects sanitary status of many countries and prevents the effective control of some diseases. - Difficulties in establishing disease free zones/compartments within infected countries. - Difficulties in establishing reliable and recognized certification and traceability systems - Difficulties of exploiting opportunities from the Terrestrial Animal Health Code that provides conditions to trade from infected countries or from countries that are free of specified diseases but carry out vaccinations. - Difficulties in institutionalizing the principle of equivalence. Currently, only 4 countries on the continent are able to comply with the standards required for export of meat to Europe. A few other countries (in the Horn of Africa mainly) export outside the continent, mainly to the Middle East and the Indian Ocean, but even for them, the regular occurrence of outbreaks of trade sensitive diseases (FMD, RVF) and the increasing sanitary requirements from importing countries make these outlets very irregular and unpredictable. Traditional regional pathways like the Sahel to Coast pathway, which involve important quantities of animals, and operate so far in a very informal manner and without compliance to international standards, might also face difficulties in the future due to demands for compliance with international standards as a result of the increasing concern of importing countries over risks to public health and sanitary status. Finally, despite the high demand from Northern African countries, and their trade deficit in animal products, sub-saharan African countries are still unable, to supply these markets due to their inability to comply with the SPS requirements from these importing countries. The deficits in Northern Africa are largely satisfied by imports from Europe and South American countries. Policy makers in African countries and Regional Economic Communities are increasingly convinced about the need to boost trade of animal products to alleviate poverty, and are committed to provide support to trade. However, they lack evidence based policy and investment options which could guide them to choose the most adequate and efficient solutions. Page 7 of 43

8 2. Objectives of the study The Inter-African Bureau for Animal Resources of the African Union (AU-IBAR) has mandated a study by two consultants: To document the difficulties faced by African economic operators in exporting (within and outside the continent) livestock and animal products, in relation to compliance with sanitary standards To identify existing opportunities such as: - The establishment/improvement of certification and traceability schemes that are internationally recognized and compliant with international partners - The possibilities of the establishment of compartments and disease free zones - Utilizing opportunities offered by the OIE Terrestrial Animal Health Code for export of animals and animal products from countries with different sanitary status based on the type of commodity, the process or the characteristics of commodities - The application of principle of equivalence as provided for in the Terrestrial Code and the Agreement on Sanitary and Phytosanitary matters of the World Trade Organisation (SPS Agreement of the WTO) - To assess stakeholders requirements to explore these opportunities To assess potential benefits and costs of respective solutions To identify and document best practices and success stories of exports if they exist To identify possible improvements to be proposed to the OIE TAHC to facilitate trade for African countries without jeopardizing sanitary safety To propose modalities for piloting policy options at national/regional levels To guide policy makers on evidence based policy and investment options to improve trade in animal products This study addresses the issues from both a sanitary point of view as well as taking into consideration the economic aspects and implications related to compliance with standards while seeking entry into international trade. The sanitary issues in accordance with international standards were evaluated by Dr Gideon Brückner (Part A) and the economic aspects by Dr Thomas Barasa (Part B). The methodology used incorporated visits to a few selected countries; data obtained from a questionnaire completed by 5 countries representing the different geographical regions within sub-saharan Africa and an intensive study of available literature on the subject. 3. The current position globally and in sub-saharan Africa for entry into international grade for animals and animal products Page 8 of 43

9 In spite of intensive global, regional and national efforts to control or eradicate the most important trade-sensitive diseases, more than 100 developing and transitional Member countries of the OIE are still not free from foot and mouth disease (FMD) (18). In sub-saharan Africa only Swaziland and Lesotho have achieved country freedom from FMD while Namibia and Botswana have OIE recognised zones free from FMD. South Africa, who also was recognised by the OIE for zonal freedom from FMD, lost its status in 2011 after an outbreak of the disease. The vast majority of countries in especially Africa, South East Asia, some countries in the north of South America and Northern Europe are still infected with FMD, presenting a major challenge to establishing worldwide, liberalised and safe trade in animals and animal products which would contribute to both global food security and global market access. Since 1994, when the OIE initiated a system for recognising the favourable disease status of countries, the categories for freedom recognition have progressed from the official recognition of disease-free countries, to the recognition of disease-free zones within infected countries and, more recently, to making provision for the establishment of disease-free compartments. The dual purpose of safe but liberalised trade has been further expanded to identify and list those animal products that can be traded as safe commodities even in the presence of disease. Two of the four most important tradesensitive diseases recognised by the OIE are FMD and bovine spongiform encephalopathy (BSE). In the case of FMD for the 178 Member countries of the OIE, 65 Member Countries are recognised as being free from FMD without vaccination; 1 is recognised as being free with vaccination; 10 are recognised as having disease-free zones, without vaccination and 6 countries are r ecognised as having disease-free zones with vaccination. Although BSE has never been reported from Africa, there is no country that has an official OIE risk status classification for BSE. Globally there are 13 c o u n t r i e s recognised as having negligible risk status and 34 are recognised as having a controlled risk status (23). It is evident that obtaining official recognition of either a disease-free country or diseasefree zones is a slow process that depends on the ability of countries to achieve and maintain that status. It is also costly, since it requires a sustainable and effective Veterinary Service and the political will and commitment to maintain the achieved status. It is acknowledged that many developing and in-transition countries experience their own unique problems in moving towards the ideal of a disease-free country or disease-free zones, and that the international community should consider appropriate ways of assisting them to gain access to international markets as they become active participants on the pathway to obtain disease freedom (1). 3.1 Disease free countries, zones, compartments and safe commodities The WTO Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement ) specifically encourages trading parties to recognise the existence and application of disease-free zones (27). The OIE, as mandated by the WTO-SPS Agreement to set standards for establishing and recognising animal disease-free countries Page 9 of 43

10 or zones, has further strengthened this concept as a mechanism to facilitate trade (1, 21, 27). It could be argued that Article 6 of the SPS Agreement, in which this principle is outlined, was intended to enhance the application of sanitary measures only to the extent necessary to protect human and animal health. However, it is unfortunately still applied as a prerequisite for trade in the policies of many countries (1, 8, 12, 14). The application of such policies inevitably excludes the majority of countries i n S u b - S a h a r a n A f r i c a from lucrative international markets because they do not have such disease-free zones. This is despite the fact that several chapters of the OIE s Terrestrial Animal Health Code (the Code) make provision for the safe trade of animals and commodities from infected countries or zones, subject to the application of risk mitigation measures which render them safe (21). The concept of safe commodity trade is not new and has already been incorporated into the Code in which, for example, milk and milk products, semen, hides and skins, gelatine and collagen from hides and skins and deboned skeletal muscle meat from cattle can be traded without restriction from a country infected with BSE (21). The same principle is also applicable for deboned bovine meat that has undergone maturation and has a ph value of less than 6, to render it safe from FMD virus. Further research is under way to expand this concept to facilitate trade for areas with other OIE-listed diseases and commodities (8). For the purposes of this study, a distinction is made between those commodities already traded from zones officially recognised as being free from a disease such as FMD, and trade in commodities from countries that are not free of that disease, and from which such commodities are not officially listed as safe. The focus of this study is on the latter. A further distinction, proposed by Rich and Perry (9), who calls for a distinction between commodities and products, is also used in this study. While a commodity is defined in the Code as: live animals, products of animal origin, animal genetic material, biological products and pathological material, the emphasis for the purpose of this study is on a primary commodity to which no further value has been added. Furthermore, this commodity must either have been identified in the Code as an item recommended for safe trade without the need for risk mitigation (such as milk from countries at risk of BSE), or a commodity that has been subjected to risk mitigation measures described in the Code, such as deboned, chilled or frozen beef from FMD infected countries. Products, on the other hand, are commodities to which value has been added in accordance with consumer preferences or as prescribed in private standards applicable to a specific item (9). It is p r o p o s e d that the current definition of commodity in the Code should be revised to enable a clear distinction between commodities and products and also to potentially exclude live animals, genetic material and biological products, which are not, in the common understanding of the word, really perceived as commodities. Page 10 of 43

11 Trade in commodities, whether they come from disease- free zones or are listed in the Code as safe, is already common practice (14, 21). The question could however, be asked: why do countries (especially developed countries) continue to insist on guarantees of disease freedom before the import of a specific commodity will be considered? One reason could be that the principle of using the Code and the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (the Manual) to assist decision-making for the importation of animals or animal products is often not applied. The Code should be read, used and applied in its entire context to assist in decision-making. For example, when FMD-related sanitary measures are considered for the importation of beef from an infected country, it is also necessary to note and apply a number of other standards from the h o r i z o n t a l c h a p t e r s in t h e C o d e examples include chapters on the evaluation of Veterinary Services and import risk analysis as well as the vertical, disease- specific chapters. For example, an import risk analysis for a particular commodity might indicate some uncertainties about one or more of the risk mitigation measures recommended in the Code when importing that commodity. Nevertheless, it could be concluded that any risk is less than the appropriate level of protection of the importing country because the uncertainty is minimised, or the risk mitigated, by positive findings on the exporting country s horizontal standards, such as its level of disease surveillance or the quality of its Veterinary Services. The reverse could also be true. For example, when considering the importation of deboned skeletal muscle meat of cattle (beef), it would be against the spirit and intention of the Code to expect a developing country (for instance, some countries in Africa) to demonstrate a B S E surveillance programme when the Code already lists that commodity as safe for trade, irrespective of the B S E risk status of a country (21). It is also not always appreciated that the standards in the Code are themselves the outcome of a risk analysis process, and that the application of unnecessarily trade-restrictive disease control measures which are additional to, or stricter than, those in the Code must be scientifically justified (12, 14, 27). 3.2 Risk management principles to facilitate trade in safe commodities Risk management is defined in the Code as: the process of identifying, selecting and implementing measures that can be applied to reduce the level of risk. It involves a process of deciding upon, and carrying out, activities to achieve the appropriate level of protection while, at the same time, ensuring that negative effects on trade are minimised. The objective is to manage risk appropriately to ensure that a balance is achieved between a country s desire to minimise the likelihood or frequency of disease incursions and their consequences, and its desire to import commodities and fulfil its obligations under international trade agreements (3). The approach in the Code of recommending specific risk mitigation measures when importing commodities implies various risk management options depending on: Page 11 of 43

12 the type of commodity the disease, and the disease situation in the country of origin. These risk management options range from very basic to more intensive and focus primarily on risk mitigation measures applied in the country of origin. However, this does not exclude the importing country from applying risk management options after entry to achieve its appropriate level of protection. The Code also recommends that risk management decisions should not only be carefully evaluated but s hould also be monitored and reviewed to ensure that they continue to support the appropriate level of protection of the importing country (21). When importing fresh meat from cattle and buffalo (Bubalus bubalis note not Syncerus caffer African buffalo) (excluding feet, head and viscera) from a country infected with FMD, the Code recommends risk management procedures in the country of origin that include: an official control programme for FMD with compulsory systematic vaccination of cattle meat that comes from animals which have remained in the exporting country for at least 3 months prior to slaughter animals which have remained, during this period, in a part of the country where cattle are regularly vaccinated against FMD and where official controls are in operation animals that have been vaccinated at least twice, with the last vaccination not more than 12 months and not less than 1 month prior to slaughter animals that have been kept for the past 30 days in an establishment within a 10-km radius of which FMD has not occurred, during that period animals that have been transported, in a vehicle which was cleansed and disinfected before they were loaded, directly from the establishment of origin to the approved abattoir, without coming into contact with other animals which do not fulfil the required conditions for export animals that have been slaughtered in an approved abattoir that is officially designated for export and in which no FMD has been detected during the period between when the last disinfection was carried out before slaughter and when the shipment for export was dispatched animals that have been subjected to ante-mortem and post-mortem inspections for FMD with favourable results within 24 hours before and after slaughter meat that comes from deboned carcasses from which the major lymph nodes have been removed Page 12 of 43

13 meat that, prior to deboning, has been submitted to maturation at a temperature above +2 C for a minimum period of 24 hours after slaughter, and in which the ph value was below 6.0 when tested in the middle of both Longissimus dorsi. The FMD chapter of the Code does not list risk management considerations which are described in other chapters of the Code or Manual (19). These include, among others: the competence of the Veterinary Services of the exporting country the quality of disease surveillance vaccine quality and efficiency disease reporting. These risk management recommendations should be taken into consideration before the FMD risk posed by the importation of deboned beef can be regarded as negligible and as meeting the appropriate level of protection of the importing country. The risk management options described above have been reviewed and used in a scenario tree by Metcalf et al. (6) and, more recently, by Paton et al. (8) to assess the risk of FMD virus introduction following a failure of one or more of these procedures. In both the studies and evaluations by Metcalf (6) and Paton (8) it is acknowledged that the risk of FMDV could be mitigated in deboned, deglanded beef that were subjected to maturation and ph control (ph<6). However, the conclusions of Paton et al. (8) are significant, in that they acknowledge that there are a variety of issues around which uncertainty still exists and which warrant further research especially as it relates to other species such as sheep and pigs. Additional risk management options are suggested to address some of these uncertainties. Examples include pre-slaughter quarantine and either a single vaccination three weeks before slaughter or, alternatively, two vaccinations during this period and serological sampling to confirm the presence of antibodies (8, 13, 19). 3.3 Policy versus risk management options While the benefits of freer commodity-based trade may be subject to debate, there is little doubt that by allowing trade in safe commodities from countries or zones that are not yet free from disease will open up markets previously denied to many developing countries (8, 9, 12, 13, 14). However, despite the science-based and internationally adopted standards in the Code, many countries are still reluctant to import such safe commodities from countries or zones not certified free from certain diseases. In some instances, importing countries are even reluctant to import these commodities from countries or zones that have been certified free from disease. This issue has several times been raised as a trade concern at meetings of the SPS Committee of the WTO (26). Official recognition of a country s or zone s FMD, BSE or contagious bovine pleuropneumonia (CBPP) status is extended by the OIE in accordance with the standards in the Code (21), as is the listing of Page 13 of 43

14 commodities which are safe for trade, irrespective of the disease status of the exporting country. Disease-free zones and safe commodities, as defined by the Code, therefore represent international standards for trade purposes, as agreed in the SPS Agreement, and should be recognised in trade negotiations. Even where countries accept the scientific rationale underlying the standards of the Code for importing commodities from infected countries or zones, the alleged remaining uncertainties around possible exposure of susceptible animals (or humans, in the case of BSE) to the pathogenic agent in the importing country may be a reason for these countries to remain risk-averse in trade negotiations and not to deviate from their existing zero-risk policies. For a number of countries, therefore, safe import implies the importation of animals and animal products only from those countries where the total absence of the pathogen for a particular disease can be demonstrated. In the case of deboned beef from an FMD-infected country, one possible entry route for any virus that has escaped all the recommended risk mitigation options is the uncontrolled feeding of food waste (swill) to pigs. Domestic restrictions on swill feeding therefore constitute a risk management option that could be taken into account in an import risk analysis conducted by an importing country. However, the amount of virus required to infect pigs is uncertain and this aspect should be judged together with other risk mitigation factors, such as the dilution factor of one piece of infected meat within the total mixture of swill (3). It has also been documented that, since 1969, when only deboned beef was permitted to be imported from Argentina to the United Kingdom (UK), there has been no FMD outbreak attributable to these imports (8). This arguably reflects the application of good risk management practices in both Argentina and the UK. It also emphasises that risk management in trade is a two- way process that should be applied in both the exporting and importing countries. Where an exporting country infected with FMD complies with all the risk management standards of the Code, as in the case of deboned meat, for example, an importing country should not discriminate against that country but rather should ensure that appropriate risk management practices are put in place domestically. For example, the importing country could place a prohibition on feeding uncooked or untreated swill to pigs. One of the many arguments given for adhering to a zero- risk or acceptable risk policy (that is, importing commodities only from countries or zones certified as disease free) is that some importing countries fear that countries that are not free from disease but which do promote commodity-based trade might regard this as an alternative or short cut to practising good veterinary governance. Importing countries, therefore, are reluctant to trust certification where there are doubts about the competence of the certifying veterinary authority. Page 14 of 43

15 Although the scientific rationale and risk management options recommended in the Code are apparently accepted as sufficient to mitigate the risk of pathogen introduction, some countries require additional, accompanying pre-slaughter guarantees from exporting countries, such as: disease surveillance transparency of disease reporting diagnostic capability vaccine efficiency. It would, therefore, be irresponsible for exporting countries to adopt an approach based solely on the systematic inactivation of pathogens in commodities, while at the same time relaxing surveillance for animal diseases and policies for their control. The positive impact of animal health policies on poverty reduction and public health is, in itself, ample justification for financing and maintaining surveillance networks and rapid response mechanisms to deal with animal health risks (1). To establish trust with trading partners, a non-negotiable prerequisite for countries would be to provide evidence that their delivery of Veterinary Services complies with OIE standards. Such compliance includes taking responsibility for the integrity of the veterinary certificates they issue (21, 22). While the ideal is still for most risk mitigation to be applied in the country of origin of an intended export, the importing country should also ensure that appropriate risk management measures are applied domestically in their own country, to ensure that the estimated risk falls within its appropriate level of protection. 4. The rights and obligations of countries for entering international trade The golden rule applicable to all countries importing and exporting animals and animal products, is to what extend the exporting country can meet the appropriate level of protection required by the importing country to protect its animal and human health status. This principle requires an obligation from the exporting country to have sanitary measures and other assurances related to the intended export in place to such an extent that the importing country would be willing to accept such imports. The importing country on the other hand, if such a country is a member of the WTO and OIE, should ensure that the sanitary measures required from the exporting country, are not higher and out of context with the minimum international standards of the OIE. The SPS Agreement also confirms this obligation of importing countries i.e. that the sanitary measures required form an export country to satisfy the appropriate level of protection of the importing country, must only be at such a level as to protect human, animal and where applicable, plant health. Thus both the exporting and importing country have rights but also obligations in accordance with the SPS agreement and OIE Code. The rights of the exporting Page 15 of 43

16 country entail the application of sanitary measures, to insist that such measures if applied in accordance with the OIE Code, should be acceptable and also if equivalent measures i.e. sanitary measures that might differ from what is required by the importing country but still achieving the same outcome are applied, should be accepted by the importing country. The exporting country also has the right to object if the sanitary measures required by the importing country are not in compliance with the OIE Code or if not scientifically justified. The importing country also has rights in a trade transaction i.e. to set its required level of protection; to insist on the application of sanitary and risk mitigation measures by the exporting country and also have the right to refuse imports if the exporting country is not able to meet the demands set in accordance with the Code and within the rules of the game of the SPS Agreement. However, both importing and importing countries have specific obligations in a trade transaction. The exporting country is obliged to apply sanitary measures and obliged to be transparent in the information given to the importing country. The importing country on the other hand, has an obligation to not insist on sanitary standards or risk mitigation measures that are not in compliance with the Code or are scientifically unjustified. The rights and obligations are well described in both the OIE Code and SPS agreement and need not be repeated in full for the purpose of this study. However, it is important to acknowledge the complimentary actions and similarity in support actions provided for in both the OIE Code and the SPS Agreement. 4.1 The standards, guidelines and recommendations of the OIE The General Assembly of the OIE, consisting of official delegates from 178 Member Countries, annually evaluate and approve the standards, guidelines and recommendations that are presented to them by the Code Commission and the Aquatic Animals Commission. The submissions from these two Specialist Commissions represent contributions from the: Scientific Commission for Animal Diseases Biological Standards Commission Ad hoc Working Groups and permanent Working Groups (Wildlife Diseases, Animal Welfare and Food Safety) advising the Specialist Commissions Comments and recommendations from Member Countries and industry organisations with which the OIE has an official agreement. Without g i v i n g a detailed description of the requirements in the Code, it is important to note that it only provides standards, guidelines and recommendations to Member Countries for the formulation of disease control measures. Article 3.2. of the SPS Agreement states that disease control measures which conform to international standards ( such as the standards in the Code) Page 16 of 43

17 shall be deemed to be sufficient for the protection of human or animal health and therefore need not be subjected to a risk assessment. This important concept is often not fully appreciated by developing countries. Thus, developing countries tend not to challenge an importing country which insists on a risk assessment of a disease control measure in the exporting country, despite the fact that that disease control measure already complies with the international standard. Standards, guidelines and recommendations are described in the Code for the following. a) General provisions for: Animal disease diagnosis, surveillance and notification Risk analysis Quality of veterinary services General recommendations for disease prevention and control Trade measures, import and export procedures and veterinary certification Veterinary public health standards Animal welfare standards b) Recommendations applicable to specific diseases with the primary emphasis on disease control measures necessary to mitigate the risks associated with a particular disease. These measures enable the exporting country to supply the disease control guarantees required by the importing country for accepting animals or animal products. The measures include: requirements for freedom from disease and for certain diseases the specific surveillance standards for that disease such as FMD, BSE and Avian Influenza requirements for establishing disease-free zones and compartments specific disease control measures to ensure animal products are safe for trade. The recommendations in the Code are supplemented by specific guidelines for diagnostic tests in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, which is recognised as a standard international text by the SPS Agreement. The Code is often wrongly interpreted by some developing countries as being prescriptive and discriminating against those countries which cannot comply. This has caused a perception of the Code being uncompromising and insensitive to the needs of developing countries. There are, however, crucial provisions in the Code designed to assist developing countries in working towards compliance. Emphasis is placed on the pathway towards successfully entering the export market. Some of these provisions are: the evaluation of Veterinary Services guidelines for equivalence risk mitigation for trade-sensitive diseases. Page 17 of 43

18 4.1.1 The evaluation of Veterinary Services Over the past years, the General Assembly of the OIE has given specific attention to issues related to the quality of veterinary service delivery and the improvement thereof to increase the acceptance of the guarantees that can be provided by a country in trade negotiations. Some of the issues that have been addressed in detail and revised through the years are: risk analysis evaluation of Veterinary Services guidelines for the evaluation of Veterinary Services zoning and regionalisation animal disease surveillance. Complimentary to these actions, the OIE has also developed and implemented a system to evaluate the performance of veterinary services on a voluntary basis (the PVS Tool) (22), a Gap Analysis of countries that has undergone a PVS assessment as well as the assistance to countries to help and improve their legislation and communication skills. These are crucial issues for any country, but especially for developing countries that are working towards compliance. These additional evidence that a country could submit to substantiate its sanitary standing, are variables that should be taken into consideration when conducting import risk analyses. However, they are also equally important in endorsing the underlying concepts of harmonisation, transparency and equivalence which are expressed by the SPS Agreement. The Code is very explicit on how Member Countries should comply with the fundamental principles of Veterinary service delivery and states clearly that The Veterinary Services shall conform to these fundamental principles, regardless of the political, economic or social situation of a country (21). Although this statement might be perceived as uncompromising, it is also important to note that the guidelines for the evaluation of Veterinary Services allow for a gradual approach. That is, developing countries are encouraged to work towards compliance by addressing the most important issues for Veterinary Service delivery first (2). This also establishes a platform for negotiation with the importing countries. There are few, if any, developing countries which would be able to comply with all the criteria at once. However, not all of these criteria will be of immediate vital importance for compliance. An importing country should therefore negotiate with the exporting country on which issues are crucial for export certification and which can be dealt with later. This should especially be the case f o r exports from low-income to middle-income countries, or even middle- income countries to other middle-income countries. This approach could also be considered for regional trade, or for a free trade area. There would be advantages in harmonising standards in a specific region for example in west or southern Africa. The standards may be lower than those recommended by WTO rules but at least these countries would have started the process of compliance (28). It is also important that the Guidelines for the Page 18 of 43

19 evaluation of Veterinary Services should be used as a reference document for identifying specific areas of technical assistance which would aid a potential exporting country in its progress towards eventual compliance Guidelines for equivalence The OIE standards for the judgement of equivalent sanitary measures as described in Chapter 5.3 of the Code supports Article 4 of the SPS Agreement, as well as the Doha Ministerial Declaration, in which the SPS Committee was specifically requested to further the implementation of Article 4 as a matter of urgency (25). The OIE standards on judgement of equivalence promote a more flexible approach for interpreting and applying the Guidelines for the evaluation of Veterinary Services. The Code recognises equivalence by recommending alternative disease control measures for many diseases. This is of special importance for developing countries as it confirms to Member Countries that the concept of equivalence means disease control measures which need not be the same but at least achieve the same level of disease protection. In other words, the exporting country does not need to duplicate the disease control measures which might be applied in the importing country. In practice it means taking two or three different roads to reach the destination but with the same outcome some roads might be quicker, others might take longer but eventually the same destination is reached. It needs only to attain the same; appropriate level of protection which exists in the importing country and it is possible for this to be achieved by alternative measures (27). This is an important application for developing countries as they may be able to find more cost-effective, but equally as efficient, disease control and prevention measures in the process of working towards compliance Risk mitigation for trade sensitive diseases Risk management and the application of risk mitigation procedures are key features of the SPS Agreement and are also described in the Code for specific diseases by recommending alternative disease control measures to render animals and animal products safe for export. Such alternative measures could be used to facilitate the export of animals or animal products from countries which, for instance, have not yet achieved the ideal of disease-free status or zones which are free from disease, or from countries for which the achievement and maintenance of disease free zones is not attainable or is too costly, but which are able to mitigate risk through, for example, the application of compartmentalisation, safe commodity trade or the application of agro-processing or other pathogen reduction procedures. The disease control measures described for example for FMD in Chapter 8.5 of the Code are an excellent example of this approach. Trading in a variety of products is allowed between countries of different FMD status, provided the risk mitigation procedures described in the Code are applied. These procedures can be given as disease control guarantees to the importing country. The enabling environment created by this approach allows, for instance, the exporting of deboned meat from an infected country to a disease-free country or zone, provided specific risk mitigation procedures have been applied and can be certified by the exporting country. Page 19 of 43

20 While the Code and the SPS Agreement strongly encourage Member Countries to harmonise their disease control measures with international standards, the Code also recognises countries which are moving towards compliance, by making provision for alternative disease control measures such as the application of compartments or safe commodity trade and thus facilitating trade. It is important that both developed and developing countries take full advantage of this when they: apply the criteria for equivalence consider harmonising disease control measures between countries within a region en route to compliance with international standards before consider demanding a risk assessment, to determine the level of protection offered by the disease control measures applied in the exporting country. 4.2 Developing countries and the application of the SPS Agreement The SPS Agreement has been the subject of several excellent and well-documented studies intended to: evaluate the impact of SPS measures on developing countries explore why developing countries are apparently not able to make full use of the provisions of the SPS Agreement determine the concerns and constraints of developing countries in relation to the SPS Agreement propose potential solutions to the problems which have been identified (2). However, in several of these studies, the focus has been on seeking reasons for what went wrong and offering generic or general solutions which are already provided for in the Agreement, in terms of special and differential treatment. What is really necessary is to narrow the focus onto specific problems experienced in developing countries that must be resolved step by step, while gradually working towards compliance with international standards. No developing country can be forced into achieving sustainable compliance overnight. In spite of the Doha Declaration (25) providing flexibility to developing countries, by extending the timeframe for compliance with SPS measures to six months after the publication of a sanitary measure, time is not the real issue. Far more important is a clear indication of what is needed in the delay period to strengthen the capacity of the developing country to satisfy the SPS requirements of its trade partners. It is much more useful to the developing country to know which key performance areas need to be addressed. The outcomes of an OIE PVS evaluation and also a Gap Analysis would greatly assist countries in identifying which key performance areas need to be improved. Specifying time periods, rather than deficient performance issues, places developing countries under pressure and could force them into quick or ad hoc solutions that are essentially temporary in nature. Solutions need to be sustainable to ensure credibility in the export market and real progress towards compliance. It is often accepted by default that countries participating in trade or formulating sanitary control measures are familiar with the most essential concepts of the Agreement but experience have Page 20 of 43