No assessment of the veterinary regulatory environment since the Rio Conference can ignore the dramatic influence of animal disease outbreaks within the last several years. The increase in intensive livestock farming in industrialized countries during this century might have suggested that infectious animal diseases would be confined to the developing world. However, during the last ten years, animal disease emergencies, both infectious and vector-borne, have been occurring with increasing frequency even in the developed world.
The recent outbreaks of bovine spongiform encephelopathy (BSE) and foot and mouth disease (FMD) first appeared in the 1990s in the United Kingdom and then spread to other parts of Europe. Although the extent of the effects of these two diseases is not yet known, together they have already taken an extraordinary toll in human and animal life and have caused severe financial impacts both nationally and internationally. They have also had the effect of raising worldwide awareness of animal diseases, those affecting animals alone and those affecting both animals and humans.
Animal disease control is one of four distinct subject areas addressed by what is commonly called veterinary legislation. The regulation of the veterinary profession is the second; the control of veterinary drugs is the third; and the control of animal feeds is the fourth. Each of these elements will be addressed in this chapter, although the bulk of the discussion will centre on the first, as legislation in this subject area has evidenced more noticeable trends since Rio.
In the last decade there have been a number of economic, biological and other trends which have affected the incidence and the control of animal diseases worldwide. By extension, they have also informed regulatory efforts during this period. Some of these are observable empirical trends; others fall under the heading of developments in the international framework of agreements and organizations related to animal health.
Within the past few decades, increases in the movement of animals have aided the spread of animal diseases. Trade liberalization is one explanation, as countries have been seeking to benefit from lowered barriers to regional and international trade in animals and animal products. Infrastructure improvements in response to expanding industrial needs have also contributed to the rapid spread of animal diseases. Road construction as well as modernized sea and air freight systems have greatly facilitated the transport of animals around the world. Modern animal transport systems unfortunately assist in the transmission of animal disease, since the animals being transported generally originate from different herds or flocks and they are often confined together for long periods in environments that foster disease spread.
Paradoxically, the greater potential for economic gain through easier access to international trade has been accompanied by greater risks of even more debilitating animal diseases with wider-ranging economic effects. The outbreaks of FMD in dairy herds in Saudi Arabia and in sheep in Kuwait in 2000 probably resulted from the importation of cattle or sheep from Eastern Africa. Another instance of the long-distance spread of FMD occurred in 1999 in North Africa. Regulation of transport means, transport procedures and imports and exports; introduction of livestock tracking systems; and implementation of other mechanisms to facilitate trade while safeguarding animals and humans can lower those risks to some degree, but the reality is that in the current circumstances some diseases have easier pathways to cause greater harm.
The economic effects of the increased movement of animals have been coupled with other economic factors affecting the appearance and results of animal diseases. In order to properly control animal diseases, government authorities must have the financial wherewithal to carry out agreed-upon measures, such as purchasing and distributing vaccines, setting up surveillance systems and providing other resources to implement disease control strategies. Most of the countries which have been most directly affected by animal disease outbreaks in recent years do not have the resources required to carry out all of these necessary activities, and thus some gaps necessarily occur. And as a more general matter, veterinary services may get less attention than other sexier issues and thus they may get a smaller piece of the economic pie when budgets are devised.
The structural adjustment programmes adopted in many developing countries mainly in the 1980s have also had significant effects in the last ten years. Structural adjustment required widespread privatization of government-owned enterprises and the devolution of government services to private actors, on the assumption that the private sector would act more efficiently and cost-effectively than the public sector. Downsizing official animal health services was also intended to take some of the burden off of developing country budgets.
Some of the weaknesses of this approach have only become apparent in recent years. In the field of animal disease control, privatization meant that the sale of veterinary medicines, the administration of vaccines and the provision of clinical services gained primary importance, whereas surveillance, early warning, laboratory diagnostic services and disease control programmes fell to a secondary role. Less attention was paid to public good issues like the control of animal diseases and the obligations to manage and report on disease outbreaks. Coupled with the weakened financial state of many veterinary departments, the result was an increase in animal disease outbreaks and the resurgence of many diseases heretofore thought eliminated. Some examples of this are the appearance of BSE (United Kingdom 1986), the Nipah virus (Malaysia 1999) and the bird flu influenza virus (Hong Kong 1997). Zoonotic diseases that had lain dormant have also been breaking out in recent years, such as leptospirosis (Thailand 1995 and 2000, Ecuador 1998, Peru 1998, USA 1998), monkeypox (DR Congo 1996 and 1997), Rift Valley Fever (Senegal 1986, Egypt 1993), visceral leishmaniasis (Brazil 1993, Kenya 2000) and arbovirus (USA 1999).
The privatization activities connected with structural adjustment were often accompanied by moves to decentralize government services, as part of the same effort to reduce the government's role in animal disease control. The decentralization of many government veterinary departments has meant that veterinary officers are often placed under the control of regional and local authorities, which also means a weakened chain of veterinary command which should otherwise facilitate notification of disease outbreaks and a coordinated response to disease emergencies.
Political upheaval can have dramatic effects on animal disease outbreaks and disease control programmes. Of the 40 poorest countries in the world, 24 are either in the midst of armed conflict or have recently emerged from it. Civil strife can cause refugee movements, with refugees often fleeing with livestock and introducing animal diseases into previously unaffected areas. The Gulf War, the genocide in Rwanda and the civil war in Burundi were all followed by sudden movements of people and livestock, which caused widespread outbreaks of animal disease: rinderpest in the case of Kurdish refugees fleeing into Turkey, and foot and mouth disease in the case of Rwanda, Tanzania, Uganda and the Democratic Republic of the Congo. In Somalia and Southern Sudan, conflicts have been hindering progress in the control of rinderpest, and in Zimbabwe the recent conflicts over land reform issues are preventing the implementation of normal animal health practices.
Climate variability and climate change have implications for the incidence, spread and control of animal diseases. Periods of drought due to changes in weather patterns can cause the extensive migration of herds in search of water and grazing, which can favour the spread of disease due to increased contact among livestock, and between livestock and wildlife. The introduction of contagious bovine pleuropneumonia in the early 1990s into Botswana and Tanzania was due to the movement of only a few infected animals from endemic areas.
Climate change characterized by global warming is expected to cause more frequent storms and flooding, which may already be observed in the floods in Mozambique in 2000 and 2001. Scientists measuring ice at the two poles have concluded that the Earth's temperature has been rising in recent years and will continue to do so. Rising sea levels can be expected to displace some human populations, perhaps resulting in migration into wilderness areas where infectious agents can be transmitted. Higher temperatures, increased humidity and more extensive surface water may result in increased insect populations and a higher incidence of vector-borne diseases. It appears increasingly likely that climate changes and altered weather patterns will affect the range, intensity and seasonality of many vector-borne and other animal diseases.
In addition to the empirical changes outlined above, the last decade has seen several new international agreements, programmes and organizations which directly or indirectly address veterinary issues.
The three relevant agreements under the World Trade Organization (WTO) are the most significant regulatory development in the international arena in terms of impact on the animal sector. The Uruguay Round of Multilateral Trade Negotiations which established the WTO included negotiations on reducing non-tariff barriers to international trade in agricultural products. The agreements relevant to the animal sector are the Agreement on Agriculture, the Agreement on the Application of Sanitary and Phyto-sanitary Measures (SPS Agreement) and the Agreement on Technical Barriers to Trade. These Agreements entered into force with the establishment of the WTO on 1 January 1995.
Animal health, as it relates to trade, is covered by the SPS Agreement which concerns the application of food safety and animal and plant health regulations. The Agreement encourages governments to harmonize their sanitary measures, by basing those national measures on international standards, guidelines and recommendations. Significantly, the SPS Agreement permits governments to set more stringent requirements than the international standards, i.e., to their own appropriate level of sanitary and phytosanitary protection. However, the Agreement also provides that all national sanitary measures must be based on an analysis of scientific evidence and the risks involved, and transparent. They must not unjustifiably discriminate between countries, and one measure should not be preferred over another if the end result is the same.
These principles have wide implications for governments seeking, for example, to regulate trade in live animals or animal products. Whereas earlier, countries could enact restrictive animal quarantine or import rules which were in fact disguised trade restrictions, under the WTO scheme all such sanitary measures, where they depart from international standards, must be scientifically justified.
The Office international des épizooties (OIE), or World Organization for Animal Health, is an intergovernmental organization created in 1924, based in Paris, with 158 member states. Member countries of the OIE commit to collecting information on animal diseases present in their territories, which the OIE analyses and disseminates in order to facilitate prevention and control by other potentially affected states. The OIE also more generally collects and distributes scientific information on animal diseases and the methods used to control them, and assists member countries in disease control activities. Finally, the OIE develops rules and standards which member countries can use as models in developing their own national measures to prevent the outbreak and spread of animal diseases. This last standard-setting role of the OIE is extremely significant in light of the SPS Agreement, which identifies the OIE as the source for international standards for animal health.
In the world economy, the unimpeded flow of international trade in animals and animal products requires rules that permit governments to prevent the spread of transmissible diseases to animals and to human beings without creating unjustified trade barriers. The sources for international norms which have been prepared by the OIE are the International Animal Health Code (2001), the Manual of Standards for Diagnostic Tests and Vaccines (2000), the International Aquatic Animal Health Code (2001) and the Diagnostic Manual for Aquatic Animal Diseases (2000). These promote the harmonization of regulations applicable to trade in animals and animal products. The two Health Codes provide standards for international trade, whereas the Diagnostic Manuals establish standardized diagnostic techniques and vaccine control methods for use in international trade.
International Animal Health Code: The 10th edition of this Code was published in 2001. The Code is divided into four parts, with the first containing general provisions for animal health, the second, recommendations applicable to specific diseases, the third, appendices and the last, model international veterinary certificates. Among the general provisions in the Code are guidelines and principles for conducting transparent, objective and defensible risk analyses for international trade. The components of risk analysis described in the Code are hazard identification, risk assessment, risk management and risk communication. Because of the variations in animal health situations in different countries, the Code offers options to importing countries, incorporating the view that only by considering the animal health situation in the exporting country can the importing country precisely articulate the requirements which are to be met for imports.
Manual of Standards for Diagnostic Tests and Vaccines: This Manual, from 2000, is the companion volume to the Code and provides a wealth of essential internationally agreed scientific and technical information to complement the International Animal Health Code's trade provisions. The aims of the Manual are to facilitate international trade in animals and animal products and to contribute to the improvement of animal health services worldwide. By describing internationally agreed laboratory methods for disease diagnosis, as well as requirements for the production and control of biological products (mainly vaccines), its objective is to harmonize these important elements of animal disease prevention, surveillance and control.
International Aquatic Animal Health Code: This Code was last revised in 2001, with the aim of facilitating trade in aquatic animals and aquatic animal products. It gives detailed definitions of the minimum health guarantees required of trading partners in order to avoid the risk of spreading aquatic animal diseases, and includes sections on import risk analysis and import/export procedures. The Code also sets out detailed rules for Diseases Notifiable to the OIE. Less detailed chapters cover additional diseases classified as Other Significant Diseases (of lesser economic importance, limited geographical distribution or too recent definition to justify inclusion in the primary list). The Code also contains sections on health control and hygiene, and includes model international health certificates for trade in live and dead aquatic animals.
Control of Veterinary Drugs: A seminar on quality control of veterinary drugs was held in Niamey, the Niger in 1997, organized by OIE and the Niger. Biologists, pharmacists and veterinarians responsible for the registration and control of veterinary drugs in Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Côte d'Ivoire, Madagascar, Mali, the Niger, Senegal and Togo gathered to discuss quality control, marketing authorization, good manufacturing practices and export licensing for vaccines and drugs.
At the end of the seminar, fifteen recommendations were adopted with the aim of alleviating any deficiencies still existing in francophone African countries in terms of veterinary drug control, registration and quality. Among the most important recommendations were:
the creation or strengthening of national laboratories for the control of veterinary drugs and the designation of regional reference laboratories, which would receive technical support from the OIE Collaborating Centre in Fougères;
the development, or strengthening, of national legislation on veterinary drugs with a team of state inspectors to ensure compliance;
the improvement of quality control of veterinary drugs, and especially of vaccines, with technical support of the Pan-African Veterinary Vaccine Centre;
the continuation of information and training activities already undertaken by the OIE in the field of veterinary drug control.
All these recommendations should help to strengthen regional cooperation in francophone Africa, with the aim of stemming the proliferation of unauthorized veterinary drugs.
The Codex Alimentarius Commission (Codex) is a subsidiary organ of FAO and the World Health Organization (WHO). The SPS Agreement designates Codex as the authority for all matters related to international food safety evaluation and harmonization. The main task of Codex is to develop scientific methodologies, concepts and standards to be used worldwide for food additives, microbiological contaminants and veterinary drug and pesticide residues. Among the most important subjects addressed by Codex in the years since Rio is whether the precautionary principle, which applies in many other international contexts, should also explicitly apply under Codex. This issue was most recently addressed in the Codex Committee on General Principles in 2001.
The Codex standards for Veterinary Drugs Residues in Food include: (a) Guidelines for the Establishment of a Regulatory Programme for Control of Veterinary Drug Residues in Foods (1993), in order to assure citizens of a safe and wholesome food supply; (b) a Recommended International Code of Practice for Control of the Use of Veterinary Drugs (1993), which sets out guidelines for the prescription, application, distribution and control of drugs used for treating animals, maintaining animal health or improving animal production; (c) a Glossary of Terms and Definitions (1993), developed with a view towards providing information and guidance to the Codex Committee on Residues of Veterinary Drugs in Food; and (d) a list of Codex Maximum Residue Limits for Veterinary Drugs (1999). Draft Guidelines for Residues at Injection Sites were considered at Codex's December 2001 session.
The Ad Hoc Intergovernmental Task Force on Animal Feeding is now discussing the text of a proposed draft Code of Practice on Good Animal Feeding which will apply to feed manufacturing and to the use of all feeds other than those consumed while animals are grazing free range. The main objective of this Code is to encourage adherence to good practice during the procurement, handling, storage, processing and distribution of feed for food-producing animals, and a further objective is to encourage good feeding practices on the farm.
In 1994, FAO established the Emergency Prevention System for Transboundary Animal and Plant Pests and Diseases (EMPRES). The migration of agricultural pests and diseases across borders has caused major losses and emergencies, at times leading to famine and triggering trade restrictions. EMPRES is designed to bolster existing crisis management to permit early and rapid action, raising efficiency and lowering costs. The initial focus was on two transboundary pest and disease components: animal diseases and the desert locust. For the locust component, see Chapter 4.
The programme's focus is on major transboundary livestock diseases, including rinderpest and other epidemic animal diseases (contagious bovine and caprine pleuropneumonias, FMD, peste de petit ruminants, Rift Valley Fever and lumpy skin disease). These diseases are among the most contagious and are a serious burden on the economies of the countries in which they occur.
The Programme Against African Trypanosomiasis (PAAT) was created in 1997 by an international alliance of FAO, WHO, the International Atomic Energy Agency and the Interafrican Bureau for Animal Resources of the Organization for African Unity, to promote integrated trypanosomiasis control through coordinated international action. PAAT treats the tsetse/trypanosomiasis problem as an integral part of development and poverty alleviation in tryps-affected areas, as part of its ultimate goal of improving food security and sustainable agricultural and rural development.
Several regional organizations are in the process of harmonizing their legislation in order to improve international trade and expand their export markets. Some of the legislation addresses animal health or animal-related issues.
The Andean Agricultural Health System, established in 1992 through Decision 328 of the Andean Community (which consists of Bolivia, Colombia, Ecuador, Peru and Venezuela), has made it possible to coordinate and carry out sanitary activities; assist in harmonizing trade-oriented plant and animal health legislation; monitor the onset of epidemics or diseases; carry out joint action programmes; and help settle trade-motivated disputes between member countries. The Decision establishes objectives, elements, structures and regulations that should be applied within the system. The Andean Community countries are currently working together on a project to update and improve the contents of Decision 328.
In 2000 the Community adopted Decision 483 establishing requirements and harmonized procedures for the registration, control, sale and use of veterinary products in member countries, in order to facilitate trade, ensure their proper use and improve their quality while minimizing risks to animal and human health and the environment.
The Caribbean Community (CARICOM) has drafted a model Act entitled the Animals (National & International Movement & Disease Prevention) Draft Act. This Act has as its objectives the control of the movement of animals and the prevention of the introduction and spread of animal diseases within the member countries of CARICOM (Antigua and Barbuda, Bahamas, Barbados, Belize, Dominica, Grenada, Guyana, Haiti, Jamaica, Montserrat, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname and Trinidad and Tobago). It addresses the importation of animals and animal-related products, establishes conditions for quarantine, gives powers to inspectors and sets out a list of prescribed diseases.
In March 1992 in Nouakchott, Mauritania, at a conference jointly sponsored by the Economic Community of Cattle and Meat (Communauté économique du bétail et de la viande, CEBV) and the Permanent Interstate Committee for Drought Control in the Sahel (Comité Permanent Inter-Etats de Lutte contre la Sécheressse dans le Sahel, CILSS), representatives of twelve nations in the Sahel and coastal West Africa adopted a modified version of an action plan to improve the efficiency of livestock trade in the central corridor of the Sahel, by lowering administrative and procedural barriers to regional commerce. The representatives also recommended that Burkina Faso, Côte d'Ivoire and Mali implement a pilot effort to promote regional economic integration. The Nouakchott Plan is an integrated approach to reform that is intended to harmonize the interests of governments, which would like to see their economies grow, and private sector actors, which are the direct beneficiaries of reform. These include livestock producers and traders, professional organizations, private transporters and the consumers of livestock products. National coordinating committees were established, made up of government officials from a variety of organizations and private actors representing stakeholder groups. While the committees were at first largely informal, in less than a year they obtained legal recognition.
In 2000, the member countries of the CEBV - Benin, Burkina Faso, Côte d'Ivoire, the Niger and Togo - announced their intention to extend the market to cover all West African countries. Such a market would be in line with the integration goal of the Economic Community of West African States.
Discussions have also been under way for the CEBV to be folded into the Union économique et monétaire ouest-africaine (UEMOA). The Council of Ministers and the Commission of UEMOA have approved the concept and at the end of 2000, the Council of Ministers invited the Commission to finalize efforts in this regard.
As part of its trade promotion programme adopted in 1992, the Economic Community of West African States (ECOWAS) carried out market surveys of veterinary medicines in 1995. Furthermore, in an attempt to better coordinate national policies, an annual meeting of heads of national veterinary services and directors of animal vaccine laboratories of the member states has been institutionalized, with the first meeting held in October 2000. The member countries of ECOWAS are Benin, Burkina Faso, Cape Verde, Côte d'Ivoire, the Gambia, Ghana, Guinea, Guinea-Bissau, Liberia, Mali, Mauritania, the Niger, Nigeria, Senegal, Sierra Leone and Togo.
The European Union (EU) has adopted numerous Directives, Regulations and Decisions during the last ten years related to animal health. There are Directives establishing conditions for intra-community trade of bovine, swine, ovine and caprine animals; conditions for imports from third countries of poultry and eggs, fresh poultry meat, semen, ova and embryos; and conditions governing the sale of aquaculture animals and products, among others. The legislation applies within the territories of the EU member countries (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden and the United Kingdom).
With regard to animal disease control, the EU has had to focus a great deal of attention on foot and mouth disease (FMD). The EU's FMD control policy in the early 1990s was designed to achieve high livestock health status prior to the advent of the Single Market on 1 January 1993. This required free trade in livestock within the member states. The EU decided to adopt a policy of non-vaccination based on two reports, one identifying FMD vaccine/research laboratories and the use of poorly inactivated vaccine as the likely source of more than a third of the primary outbreaks between 1977 and 1987, and the other showing that it would be cheaper to compensate for outbreaks than to continue mass prophylactic vaccination Union-wide. Another perceived advantage of the non-vaccination policy was the potential for international trade.
The initial outlook appeared to be that non-vaccination was appropriate, and that the financial benefits of FMD-free status far outweighed the costs incurred in stamping out new introductions of the disease (Italy in 1993; Greece in 1994 and 1996); in each of those instances the disease was eradicated without recourse to vaccination. However, it remains to be seen whether the costs of the latest outbreaks in the late 1990s and early 2000s may alter these calculations. In 2002 the EU was considering implementing a vaccination policy, likely not prophylactically, but for emergency situations.
With regard to Bovine Spongiform Encephelopathy (BSE), in 2000 the EU banned meat and bone meal in all animal feeds and also excluded all cattle over 30 months old from the food chain unless tested for BSE. These rules were intended to harmonize the measures applicable in Europe, as previously a number of EU member countries had imposed their own rules to contain the spread of BSE.
The EU has also been active in the last ten years in the regulation of veterinary drugs control. Directive 96/22/EC of 1996 prohibits the use of certain substances in stockfarming; Directive 96/23/EC, also of 1996, establishes measures to monitor certain substances and residues in live animals and animal products. Decision 97/747/EC of 1997 fixes the levels and frequencies of sampling to be carried out under Directive 96/23/EC; Decision 98/179/EC of 1998 sets out detailed rules for official sampling for the monitoring of certain substances and residues; and Decision 98/140/EC of 1998 lays down rules for checks by Commission veterinary personnel.
In 1992, the Southern African Development Community (SADC) became a formal treaty organization with the signature of the SADC Treaty and Declaration at Windhoek, Namibia. Its founding member states were Angola, Botswana, Democratic Republic of the Congo, Lesotho, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, Tanzania, Zambia and Zimbabwe. One of the Community's core mandates is food, agriculture and natural resources, which encompasses sanitary and animal husbandry policies. Its Food, Agriculture and Natural Resources Directorate must develop, promote and harmonize member states' husbandry policies.
The Southern Common Market (Mercado Común del Sur, MERCOSUR) has as members Argentina, Brazil, Paraguay and Uruguay. MERCOSUR was quite active in veterinary regulation in the last decade. For example, Resolution No. 6/96 establishes sanitary regulations for the transit of specific kinds of animals within MERCOSUR. In 1997 various regulations were issued dealing with animal health matters. Regulation No. 2 includes technical information concerning pharmaceutical products for veterinary use; Regulation No. 3 deals with registration of antimicrobial products; and Regulation No. 4 addresses the production and control of vaccines, antigens and solvents for poultry farming. Finally, Resolution No. 45/98 of 1998 establishes a glossary of terms and definitions for residues in veterinary medicines.
In addition to the developments in the international arena outlined above, the decade since Rio has seen a number of changes and trends in countries' national legal frameworks relating to animal issues. One of the main trends is that an increasing number of FAO member countries have requested assistance in revising their existing veterinary legislation or drafting new laws covering animal diseases and animal movements, as well as the control of veterinary drugs and drug residues. Many countries still have colonial-era legislation for the control of animal movement and animal disease, the regulation of the veterinary profession, the control of veterinary drugs and even the structure of veterinary services delivery. While the age of existing legislation does not per se argue for its amendment or replacement, there have been important international developments which have caused many countries to take a new look at their veterinary legislative frameworks.
As noted earlier, the WTO SPS Agreement identifies the OIE as the main source of internationally agreed standards in animal health, and many countries are seeking to harmonize their legislation with the Agreement and with the standards established by the OIE. Countries that have joined the WTO, or that intend to trade with or within the EU, are looking closely at their laws, regulations and standards in order to ensure that these meet agreed international standards and do not run afoul of international obligations. Each country must assess its legal framework in order to determine whether its legislation meets the country's particular needs in light of its economy, trade, policies, government structures and, perhaps most importantly, its international commitments. In particular, countries must ensure that their sanitary measures do not depart from international norms.
Although specific guidance to countries seeking to amend their veterinary legislation is difficult without a close examination of the country's general and specific legal framework, there are some broad principles regarding legislation on veterinary issues which can prove useful and have wider application. Elements of national veterinary laws are examined in more detail below, and at the same time any observed trends since Rio are noted.
The following list of elements has been used in recent years by FAO as a guide for updating existing animal health legislation or preparing new laws. An examination of the presence or absence of these elements can help determine whether there are gaps in the existing legal framework for animal health and how they might be filled. However, not all of the matters outlined here are essential in all countries, as the contents of a particular country's laws and regulations depend on the policy priorities and exigencies of that country at that particular time.
Scope and definitions: The scope provisions describe the ambit of the animal diseases law and provide the tools for its interpretation. A provision in the law stating its purpose, objectives or scope generally precedes all others. For example, article 1 of the German Act on Animal Diseases dating from 2001 states that the Act deals with the fight against animal diseases. Such a provision serves to explain why the law was enacted, what purpose it is intended to serve and what areas are covered by the law. The 1992 Veterinary Law of Kyrgyzstan was enacted for purposes of the protection of animal health and the prevention of diseases common to animals and people.
Countries often include a list of definitions of the main terms employed in the animal diseases law. There has been a clear trend in the last several years for countries to closely consult internationally agreed sources such as the OIE and Codex, along with other national legislation on related issues, in drafting definitions.
Enabling provisions, administration and powers of delegation: An animal diseases law must define the nature and the limits of the powers to be exercised under it and should designate those who will exercise authority under the law. The Sri Lanka Animal Diseases Act of 1992 provides for the appointment of a Director of Animal Production and Health and subordinate or substituting officers. Most animal diseases laws vest power in the Minister responsible for agriculture, who can then in turn delegate necessary powers to the Chief Veterinary Officer (CVO). For example, the Animal Health Act of Australia, of 1995, provides in article 10 that the Minister may delegate to the Secretary, Chief Veterinary Officer or Deputy Chief Veterinary Officer any of his or her functions under the Act, other than the power of delegation. As will be discussed below, there has been a trend in recent years of countries acknowledging the weaknesses of systems that rely solely on professionally trained veterinarians for animal health activities. Particularly in light of many governmental efforts to decentralize activities to the regions (where there may be fewer trained veterinarians), legislation needs amending to ensure that community veterinary health workers are permitted to carry out certain extension activities and treatments. This may include, for example, the power to prescribe and dispense certain veterinary drugs. Also, in the context of an emergency when there may not be sufficient staff strength for all the required tasks, the CVO must also be able to press other Ministry staff as well as private veterinarians into service. Under Kyrgyzstan's 1992 Veterinary Law, for example, veterinary activity is to be performed by the state veterinary service of the Ministry of Agriculture as well as by other ministries, institutions, organizations, enterprises and veterinarians in private practice.
Another trend is to combine animal health, plant health and food safety into one agency. This is discussed in Chapter 2.
Reporting requirements: Animal disease laws must impose a duty on both government officials (veterinary officers, extension agents, border guards) and private citizens (farmers, private veterinarians) to report the appearance of certain diseases, even before the existence of the disease can be diagnostically confirmed, as is the case for example in article 3 of the 1997 Animal Disease Act of Morocco.
Inspection: Most animal diseases laws contain a set of provisions establishing administrative structures to carry out the activities necessary to enforce the law. For example, the law will in some fashion set up an inspection service within the veterinary department, or at the least, veterinary officers should carry out an inspection function (including taking samples) in addition to their other tasks. The Sri Lankan Act of 1992, for instance, outlines the powers of the Director of Animal Production and Health and appointed officers to take measures to prevent or contain animal diseases.
The law does not usually delve into great detail on the functioning of the various structures it establishes, but instead describes mandates, defines roles and outlines some other basic rules. Subsidiary regulations may contain the operational details. For example, Regulations No. 184 of 2001 charge the Belize Agricultural Health Authority with veterinary inspection functions, outlining specific procedures for control of the manufacture, placing on the market and importation of veterinary products and animal feeds.
Power to impose and lift quarantine: An animal diseases law must provide the Minister with the power to declare certain areas under quarantine, with concomitant restrictions. These may concern, among other things, the movement of animals or animal products. For example, Part 3 of the Australian Act outlines the conditions for declaring a quarantine area. As noted above, under the SPS Agreement all of these quarantine restrictions must have a scientific foundation and be based on risk assessment. The law should also contain a procedure for review of areas under quarantine and the lifting of quarantine where the danger has abated.
Assistance from forces of public order: The Minister must be able to request the assistance and presence of the forces of public order in carrying out control measures such as those associated with the imposition of quarantine, inspection, slaughter, road blocks and the like.
List of quarantinable diseases: All animal diseases acts must have a list of diseases that may lead to a potential declaration of quarantine by the Minister. For example, article 38 of the Animal Diseases Act of Sri Lanka (1992) defines as disease any infectious or contagious disease among animals or birds listed in the first schedule. Containing the list of diseases in an annex or schedule is desirable because the list may change over time. The necessity to add diseases also means that the competent authority is given the mandate to declare other diseases to be diseases under the act (e.g., article 2 of Botswana's Diseases of Animals Act of 1979). Equally, a particular disease may have to be deleted from the list when the country determines that that particular disease is no longer a danger in its territory.
Power to declare emergency: The Minister or his/her delegate must have the power to declare an animal disease emergency. Ideally, such a declaration should trigger the release of funds to combat it, and there must be sufficient funds set aside and immediately available upon the declaration of an animal disease emergency anywhere in the country.
Import controls: Animal diseases laws regulate the import, and often also the export, of live animals and all kinds of animal products. For example, article 6 of the Diseases of Animals Act of Botswana provides that no person shall, without the consent of the Director of Veterinary Services, import or export any animal or any other product of animal origin.
In a country where there is an outbreak of a particular animal disease, the law should permit post-import quarantine of animals and animal products, or possibly the temporary ban on imports altogether. It should however be borne in mind that the principles of the WTO SPS Agreement would prohibit discrimination against imported animals and animal products. Moreover, as noted, all measures intended to protect animal health must be scientifically justified.
Slaughter: Certain animal diseases have no cure or are best stamped out through a slaughter programme. The animal diseases act must give the Minister or CVO the power to order the destruction of dead and dying animals, with all details contained in standing orders or in decrees or orders to be issued rapidly as needed. Article 6 of the Moroccan law states that on the proposition of the CVO, the Minister of Agriculture can order, first, the destruction of all animals infected or suspected of being affected; second, the destruction of all animals of a specific farm where there are some animals infected; and third, animals belonging to surrounding farms.
Compensation: Rapidly compensating farmers whose animals have died or whose animals are slaughtered may be absolutely essential to arresting the spread of certain diseases. The law should indicate whether and under what conditions compensation is permitted and how it shall be authorized and carried out. Regulations or standing orders can contain details such as how compensation will be calculated and whether compensation will be in kind or in cash. There are arguments in favour of each, and policymakers will have to weigh them before the emergency arises. The basic questions with regard to compensation should be regulated by the act itself. In the German Animal Diseases Act, for example, there is a specific chapter outlining in detail in which cases how much compensation will be paid.
Collection of data: Under the animal diseases act or its accompanying regulations, some person or department should be charged with collecting and analysing epidemiological data so that the disease status of the country - and its various regions - can be monitored. This information should be shared on a regional and international basis.
Animal and farm registration: It is advisable that the law establish a system of control to identify farms and track animals in the country, and there has been growing interest in such systems in recent years. Article 17(h) of the German Animal Diseases Act, for example, provides that the Minister may introduce an obligation to register animals or animal products. Such measures offer benefits even in the absence of animal disease outbreaks, as through extension activities farmers can be sensitized to proper zoosanitary procedures. Several countries in Eastern and Southern Africa, including Malawi and Rwanda, have launched efforts to regulate livestock identification and movement.
Offences and penalties: Offences against the animal diseases law must be defined, and their associated penalties listed. The level at which the penalties are set depends on the particular country and situation, and they should be linked to the nature of the offence. Many countries complain that the level of the penalties in their animal diseases laws is too low, because the laws are outdated and the currency has lost its value over time. A recent trend in some laws is to apply the concept of penalty units rather than fixed amounts, so that inflation will not erode the punitive and deterrent value of penalties as the legislation ages.
Another trend in the last ten years is the inclusion of forfeiture provisions in some laws: provisions like article 77 of the German Animal Diseases Act allow the government to seize vehicles and other property used in the commission of an offence.
Repeal and savings: Where a new animal diseases law makes significant changes to an existing system, laws or regulations already in force may have to be amended or repealed. In such cases the new law will have to list which provisions in which other laws are to be repealed or altered. However, in order not to dismantle the existing system entirely, many laws contain a provision stating that any regulations made under any provision repealed under the new law remain effective, just as if they had been issued under the new law itself.
Regulations: The general form of the basic animal diseases law depends on the legislative traditions of the particular country, but in most cases the best policy is to limit the contents of the basic law to the enabling provisions together with a few very general principles. The advantage of this approach, in all legal systems, is that because the law is basic and all details are confined to the regulations and standards, changes can be more easily and quickly made.
In most cases, the animal diseases law will contain a provision or provisions listing the many subject matters that the Minister may address through regulations in order to carry out the purposes of the law. The list of regulations may be extremely detailed or it may simply give broad outlines to the kinds of topics that the Minister may address. There may be a trend toward the latter, to avoid later accusations that the government acted ultra vires in elaborating regulations on particular issues. In any case, the Minister's powers are rarely limited, as in almost all cases the law will contain a general statement that the Minister may make all regulations he or she deems necessary to achieve the purposes of this law. A good example of this is the Animal Diseases Act of Sri Lanka which states in article 37 that the Minister may make regulations in respect of all matters that are required in the Act.
In preparing regulations and standards, countries that have amended their veterinary legislation or prepared new veterinary regulations in the past ten years have been taking full advantage of OIE and Codex standards and lessons learned in other countries. National standards developed in this fashion complement international ones while respecting local needs and conditions.
The veterinary profession has seen remarkable developments in the last ten years. Advances in DNA technology have improved vaccines, risk analysis has been borrowed from the field of nuclear energy and quality assurance has been introduced widely, including Good Clinical Practice, Good Laboratory Practice and Good Management Practice in Veterinary Medicine. Finally, there has been a dramatic increase in the use of Geographical Information Systems to map the presence of disease worldwide.
Many of the elements of national laws addressed above under animal diseases laws also apply to laws governing the veterinary profession, often called veterinary surgeons laws. Accordingly, the specific elements outlined above are not repeated here, nor in the following sections on the regulation of veterinary drugs and animal feeds. Only those new elements specific to these subject matters will be explored.
The scope and purpose of most veterinary surgeons laws is to regulate the practice of veterinary medicine and to protect consumers from unlawful acts by animal health care providers. Laws regulating the veterinary profession usually create a statutory body, such as a Veterinary Council, to carry out a variety of registration and certification functions. For example, the Council will have responsibility for examining and certifying new veterinary graduates and immigrant veterinarians; registering veterinarians and other animal health care providers; and generally policing the activities of registered veterinarians and other providers. Disciplinary measures have to be provided for, ranging from suspension of the licence to practise, to fines, compulsory retraining, expulsion from registration or imprisonment. The veterinary board or council should be independent of the national veterinary service.
Another important purpose of veterinary surgeons laws is to determine those remedies and vaccines that can be sold and dispensed by each class of animal health care practitioner. One notable change in recent years is the increasing involvement of non-veterinarians in the provision of veterinary services. This is partly as a result of the decentralization of ministries of agriculture and also a result of some of the economic factors outlined in Part II of this chapter. Often formal and informal groups of livestock owners employ animal health assistants or, more often, lower-level para-veterinary agents (such as community veterinary health workers), particularly in the rural areas. These non-veterinarians are called upon to provide primary services such as administering remedies against easily diagnosable diseases, prescription drugs and vaccines.
These empirical trends are at times in tension with existing veterinary surgeons laws, which establish strict rules for who may prescribe certain medications and carry out certain procedures. In many cases, these changes have meant that legislation governing the veterinary profession has had to be amended. Ghana and Rwanda have recently begun efforts to revise their veterinary legislation to take account of these developments.
As suggested, another observed trend is the privatization of veterinary services, with many activities previously carried out by government officers now being carried out by private veterinarians. In some cases major disease outbreaks in the last ten years have meant that governments have had to rely on private veterinarians to carry out vaccination campaigns or otherwise to assist in the control and eradication of disease. Legislative amendments to permit this delegation of duties to private actors in such cases are required.
Veterinary drugs, including growth promoters, are increasingly used in attempts to improve food animal production. Legislation for the control of veterinary drugs generally sets up a national authority to register all veterinary medicines for use in the country. The distribution, sale or administration of unregistered drugs is prohibited under the law. The law also identifies who may prescribe veterinary drugs, how they must be stored and disposed of, what information must be contained on the label and what records must be kept. To harmonize with the changes to veterinary surgeons laws as discussed in the previous section, existing veterinary drugs legislation may also need to be amended as countries may wish to relax the requirement that certain drugs be prescribed only by veterinarians. Portugal adopted in 1999 a Decree-Law regulating the production, trade, storage, transport and use of veterinary drugs. Cameroon's 2000 Act on Veterinary Pharmacy similarly provides a legal framework for the trade, distribution and import of veterinary drugs.
The law may also detail who may prepare veterinary medicines, using what techniques and under what conditions. Withdrawal periods before slaughter and/or permissible maximum residue levels (MRLs) for meat and milk may also be established in the regulations, although frequently such rules are found in regulations issued under a country's food safety laws rather than in its veterinary legislation.
Producer compliance with veterinary drug regulations should be monitored by national testing laboratories according to nationally or internationally accepted sampling protocols and assay methods. Many developing countries lack the capacity to operate quality assured testing programmes for detection of regulated residues in food animals and their products. Since 1990, within the EU a group of laboratories have been accorded responsibility for the effectiveness of analytical residue control programmes, including methods and materials. These laboratories assess programmes in EU member countries as well as countries trading with the EU.
Draft legislation currently under consideration in Mozambique is based on a comparative study of the regimes in seven neighbouring countries, with which Mozambique has substantial trade. The major innovation inspired by the comparative study is bringing control of veterinary and human medicines under the oversight of a single agency and subjecting them to the Medicines Law. Veterinary treatments that fall under the Pesticides Law (e.g., insecticides) will be regulated under that Law. New procedures under the Medicines Law are proposed for registration of veterinary drugs on the advice of a Veterinary Medicines Commission. Distribution of veterinary drugs through veterinarians is permitted although some will be obtainable only through pharmacies.
Animal feeds laws regulate the import, manufacture, registration, sale, advertising and use of animal feeds and the raw materials used in their manufacture. Generally the law appoints a Registrar of Animal Feeds who has responsibility for registering animal feeds and raw materials used in animal feeds, and listing them in the Register also established in the law. Other administrative provisions may establish an Animal Feeds Committee which is responsible for providing technical advice to the relevant Minister (usually the Minister responsible for agriculture) on all issues relating to animal feeds in the country, in particular the detailed standards that will apply under the law. The internal workings of the Committee are generally set out in subsidiary regulations or in the Committee's own by-laws. Most important, the Committee advises on the contents of the schedules to the law, such as which raw materials and animal feeds are permitted; which ingredients are prohibited; and other matters. The Committee will also advise on any regulations to be proposed under the law.
Generally the law will provide that any person intending to import or manufacture raw materials or animal feeds will have to apply for a licence, and it is an offence under the law to do these activities without such a licence. For example, Egypt adopted a Ministerial Resolution in 1999 regulating feed, feed production, circulation and control. This resolution states that the approval of the Technical Apparatus of the General Union of Poultry Producers is necessary to obtain the licences for production or import of feed.
Licences can be suspended or revoked for any of the reasons enumerated in the law, although the law should also establish procedures for allowing any licence holder to appeal any such decision.
Inspection should also be authorized to control locales where raw materials or animal feeds are imported, manufactured, sold, advertised or used. Inspections are intended to assess the manufacturing processes and the quality control procedures at that establishment. Naturally, any inspectors authorized or appointed under the law may take samples and request documents. Regulations under the law may set out procedures for the taking and marking of samples.
Some animal feeds laws provide that the Registrar may grant provisional registration for the import or manufacture of certain raw materials or animal feeds. This gives flexibility to the Registrar to exempt certain raw materials and animal feeds from the strict registration requirements, for example where a manufacturer has only produced a small amount and cannot pay the full fee. Similar flexibility is also granted in regard to imports: the law may provide that the Minister, acting on the advice of the Committee, may waive normal requirements and permit the import of any raw material or animal feed for research purposes. The Committee can also impose conditions on any importation permitted in this fashion.
Recording responsibilities under the law include those falling on the Registrar as referred to above; in addition, the law may provide that any person who imports or manufactures raw materials or animal feeds must keep records of the quantities dealt with.
Animal feeds laws also enumerate requirements for the sale or use of particular animal feeds and the use of certain additives, providing that they may only be used in relation to the particular species associated with that raw material. A schedule will contain prohibited substances which may not be used for any animal species.
Some animal feeds laws prohibit the advertisement of any unregistered raw material or animal feed, of any raw material or animal feed for a purpose for which it is not intended or in a false or misleading manner or that is contrary to any of the conditions under which it was registered.
Recent disease outbreaks even in the most developed countries have raised a great deal of public interest in the causes, prevention and economic effects of animal diseases. The World Food Summit in 1996 recognized the importance of epidemic diseases of livestock to both international trade and world food security. On that occasion, governments and civil society committed to strive for effective prevention and progressive control of such diseases.
Effective control requires efficient disease detection systems, competent diagnostic laboratories and close cooperation among official veterinary services, private veterinarians, farmers, industry, consumers and other organizations. Existing legislation and the concomitant institutional set-up may not foster cooperative effort or joint management and may hinder the effective delivery of veterinary services. Legislative frameworks may also fail to regulate important areas such as veterinary drugs and animal feeds. Comprehensive solutions are needed.
Inadequacies at national level due to outdated or weak legislative frameworks have been compounded by developments at the international level, which are not yet reflected in many countries' legislative systems. The adoption of the WTO SPS Agreement, which underlined the importance of harmonized international standards and of scientific justification, gave prominence to the Office international des épizooties and its important standard-making work. This has spurred many countries to take a closer look at their veterinary legislation to determine whether it meets present needs. Efforts are under way, at national and regional level, to review and revise the legislative frameworks in many countries. It is hoped that some of the analysis and recommendations in this chapter may aid in that endeavour.
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