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The application of epidemiology in national veterinary services must take place at the interface between science and politics. Animal health policy development and implementation require attention to macro-epidemiology, the study of economic, social and policy inputs that affect the distribution and impact of animal or human disease at the national level. The world has changed fast over the last three decades including the delivery of veterinary services, their remit and the challenges addressed by public and animal health policies. Rethinking the role of public services and how to make public programs more efficient has been at the heart of the political discussion. The WTO through its SPS Agreement has changed the way in which national veterinary services operate and how trade decisions are made. Most low and middle income countries are still struggling to keep up with the new international scene. Some of these countries, such as Brazil, have very important livestock industries and are key to the global food systems. Over the last two decades, Brazil became a leading player in exports of livestock products, including poultry, and this created a strong pressure on the national veterinary services to respond to trade demands, leading to focus animal health policies on the export-driven sector. During the same period, Brazil has gone a long way in the direction of integrating epidemiology with veterinary services. Epidemiology groups grew at main universities and have been working with government to provide support to animal health policy. The scope and quality of the applied epidemiological work improved and focused on complex data analysis and development of technologies and tools to solve specific disease problems. Many public veterinary officers were trained in modern epidemiological methods. However, there are important institutional bottlenecks that limit the impact of epidemiology in evidence-based decision making. More complex challenges require high levels of expertise in veterinary epidemiology, as well as institutional models that provide an appropriate environment for building and sustaining capacity in national veterinary services. Integrating epidemiology with animal health policy is a great opportunity if epidemiologists can understand the real issues, including the socio-economic dimensions of disease management, and focus on innovation and production of knowledge. It may be a trap if epidemiologists are restricted to answering specific decision-making questions and policy makers perceive their role exclusively as data analysts or providers of technological solutions. Fostering solutions for complex issues is key to successful integration with policy making.

Continuous life-cycle management of veterinary drugs by the Food and Drug Administration Center for Veterinary Medicine (CVM) ensures that safe and effective approved animal drugs are available for use in the United States. This article summarizes basic requirements for the approval of new animal drugs, with a specific focus on the approval of analgesic drugs for use in cattle. CVM encourages drug companies to use innovative approaches to demonstrate the effectiveness of analgesic drugs for cattle. There is an obvious need for continued research into the development of new animal drugs for the control of pain in cattle.

This article focuses on the emerging field of equine regenerative medicine with an emphasis on the use of mesenchymal stem cells (MSCs) for orthopedic diseases. We detail laboratory procedures and protocols for tissue handling and MSC isolation, characterization, expansion, and cryopreservation from bone marrow, fat, and placental tissues. We provide an overview of current clinical uses for equine MSCs and how MSCs function to heal tissues. Current laboratory practices in equine regenerative medicine mirror those in the human field. However, the translational use of autologous and allogeneic MSCs for patient therapy far exceeds what is currently permitted in human medicine. © 2011 Elsevier Inc.

This article reviews laws and regulations related to drug use in sheep and goats, with special reference to the United States. The discussion includes drug licensing procedures, legalities of extralabel drug use, withdrawal time estimation, and residues in sheep and goat tissues; it refers also to regulations related to organic production, dairy production, and compounding. Canadian and European regulations are mentioned. Veterinarians working with sheep and goats must be familiar with regulations governing use of drugs, to prevent legal action, fulfill their fiduciary responsibility to producers, and help protect and provide for a wholesome and safe food supply.

Safety is an important part of veterinary drug assessment while user safety is a critical part of the overall safety assessment. In the European Union (EU), user safety is addressed through preclinical studies and by relationships with exposure but a key part of the process is the user safety assessment. EU user safety guidelines are available and these make certain recommendations but in places they lack detail and clarity. This paper seeks to examine the relevant factors that lie behind user risk assessments for veterinary medicinal products in general while focusing on EU requirements, the determination of risk management and risk communication strategies and how this relates to user safety assessment and pharmacovigilance responsibilities.

Diets fed to feedlot cattle typically contain nutritional ingredients along with other substances intended for various purposes, including growth promotion and disease prevention and control. Questions often arise as to the nature of those feed additives, whether and how they are regulated, and what is legal or illegal. In this article, the author discusses regulations pertinent to the use of drugs in feedlot diets. The article includes a discussion of what a drug is, how drugs are approved in the United States, what uses of drugs in feedlot diets are legal or illegal, and what is on the horizon for future drug regulations.

This paper discusses the efficacy of cat and dog vaccines, with respect to duration of immunity and regulatory issues. The European Union (EU) regulatory requirements are described: briefly, efficacy claims, which include duration of immunity, have to be specific for the product and supported by controlled laboratory and field trials. As a result, the duration of immunity shown has typically been a minimum, because of the cost and welfare implications of keeping animals for long periods of time in isolation. In contrast, in the US, duration of immunity has not traditionally been required for each individual product, only for rabies vaccines and some other vaccines for which no other products are available. The consequence of this is that in the US, various scientific authorities have produced guidelines appropriate for individual diseases. Undoubtedly this will continue, although the regulatory authorities also appear to be moving towards a position where lack of information may be indicated on the product label, and studies are required to support extended duration of immunity claims. The advantages and disadvantages of laboratory challenge studies versus field trials are discussed, and the use of alternatives such as surrogate markers of protection. The approaches used for small animal vaccines are compared to those used, for example, in human medicine. The main issue for small animals is that unlike in some other species, the aim generally is to maximise protection in the individual, rather than induce protection at the population level. The drawbacks of the present EU system are summarised, and the ways in which the situation is currently being approached and improved are presented.

In 1999, legislation in Denmark made anthelmintic drugs available only by prescription, and prohibited their use for routine, prophylactic treatment. A questionnaire survey was conducted in 2004 to determine current strategies for surveillance and control of equine strongyles used in Danish equine veterinary practices. Eighty-seven of 170 (51.2%) registered equine veterinary practices responded. Ninety seven percent of the respondents used faecal egg counts for diagnosis and surveillance, and 41% used larval cultures. Logistic regression revealed that the use of larval cultures was positively correlated with numbers of employees (P = 0.013) and the proportion of equine caseload in the practice (P < 0.000). Performing faecal egg counts and treating horses was most frequent during spring, summer and early autumn. Veterinary practices made treatment decisions based on cut-off values ranging from 20 to 500 eggs per gram (EPG) faeces. Ages of horses, clinical suspicions of parasitic disease, or requests by the owners were the most important factors in the strategies for faecal sampling. Less commonly, sampling strategies included all horses on the premises and random sampling. Ninety five percent of the respondents reported treating certain groups of horses without prior faecal analysis, including horses with clinical signs of parasitic disease (77%), foals (84%), horses less than 3 years of age (52%), and pregnant mares (51%). The respondents regarded the cyathostomin group as the most prevalent cause of parasitic disease and ill-thrift, followed by large strongyles and Parascaris equorum. Sixty seven percent rotated regularly between drugs, while 11% performed routine screening for anthelmintic resistance. Results of this survey suggest that limiting equine anthelmintics to prescription-only availability has increased the level of strongyle surveillance. Veterinary practitioners play a central role in equine parasite management with indications of a lowered intensity of treatment. However, screening for anthelmintic resistance remains uncommon.

Marker vaccines and diagnostic tests can prove to be invaluable in disease eradication and control programs, as was found in the pseudorabies (Aujeszky's Disease) virus eradication program in the U.S. During that campaign, numerous gene-deleted vaccines and companion diagnostic test kits were used to differentiate infected animals from vaccinated animals, in a strategy that ultimately led to eradication of the disease in commercial swine herds. The United States Department of Agriculture played a key role in delivery of that success by developing biologics policy, evaluating each product, and ensuring that the conditions of licensure were met. What was most critical in the overall eradication effort, however, was the detailed and dedicated interaction among key players: the biologics regulators, manufacturers, Federal, State, and local regulatory partners, veterinary researchers, industry associations, and animal owners. A good disease control program has to include all of these. The regulatory requirements for licensure of marker vaccines and diagnostic test kits are not different from that for other products. There are several mechanisms for vaccine approval, some more rapid than others, but only a few that could apply to these products. Generally, the platforms that might support marker vaccines and companion diagnostic kits are those based on genetic engineering or protein manipulation. If the product is derived from the application of biotechnology, then additional regulatory considerations are applicable. Most important of these are the considerations found in the National Environmental Policy Act (NEPA), wherein deliberate release of any organism containing recombinant DNA into the environment is subject to review and approval by appropriate federal agencies. Environmental release and NEPA compliance are discussed.

Exotic animal practice is like any other veterinary practice in that it deals with the prevention, diagnosis, and treatment of animal diseases. The species dealt with are different from those found in a traditional companion, food animal, or equine practice, and so are many of the handling techniques and pharmaceuticals. With the variation in species comes additional regulations, ranging in scope from animal transport and acquisition, to legalities and regulations of possessing or treating particular species, to the medical treatment options. Many of these laws are extensions of those designed for domestic animals, with additional legal implications and ethical responsibilities for the practitioner. These implications and responsibilities fit into two primary sections: (1) legal limitations of exotic animal possession, treatment, and practice originating from federal, state, and local laws and (2) legal issues originating from an ethical or liability perspective. Although many of these limitations and issues have counterparts in domestic animal practice, there are additional factors that need to be considered, such as legislation controlling or limiting possession of and approved therapies for less common species. This article provides an overview of available legislation that is pertinent to exotic animal practice and a summary of current accepted guidelines for which there is no official statute. It is not to be construed as an all-inclusive summary of exotic animal laws and legislation, nor is it to be deemed legal advice or replacement for legal counsel.

21 Code of Federal Regulations Part 556 (Tolerances for Residues of New Animal Drugs in Foods) is one of the Center for Veterinary Medicine's most significant set of regulations. However, in many respects, it is outdated. Subpart A (General Provisions) defines tolerance designations that are obsolete, while Subpart B (Specific Tolerances for Residues of New Animal Drugs) is inconsistent in terminology and often confusing. The purpose of this paper is to define the older terms and update the reader as to current concepts that apply to tolerance-setting for new animal drugs. A list of useful definitions appears at the end of the article.

Under the Animal Medicinal Drug Use Clarification Act of 1994, veterinarians are legally allowed to use drugs in food-producing animals in an extralabel manner. This could potentially lead to violative residues in food of animal origin. It is therefore essential that an appropriately extended withdrawal interval be established. Ideally, these extended withdrawal intervals should be calculated on the basis of the tissue half-life of the drug in the target animal. However, these data are not readily available for all drugs of extralabel use in food-producing animals. For this reason, the use of a half-life multiplier has been proposed as a simple alternative method to estimate the effective tissue half-life of a drug. Extended withdrawal intervals, estimated using various half-life multipliers, were compared with the withdrawal intervals calculated using actual tissue half-lives. For the group of drugs investigated, a half-life multiplier of 5 resulted in estimates of extended withdrawal intervals that were potentially inadequate to prevent violative tissue residues for drugs that had relatively long tissue half-lives, high tolerances, or both. This is possibly because fewer half-lives are required for these drugs to reach the target tissue concentrations following administration at label doses. Use of a smaller half-life multiplier (in this case 3) is therefore suggested to ensure that extended withdrawal intervals are adequate to prevent violative tissue residues.

When avoparcin was prohibited for use as feed additive in poultry in Norway on 31 May 1995, an increased incidence of Clostridium perfringens-associated necrotic enteritis (NE) and an increase in the use of antibacterial (AB) drug therapy in meat-type poultry was expected. The consumption of AB drugs for use against NE in poultry in the period 1990-2001 was investigated by use of sales statistics at the drug-wholesaler level. Defined daily dose (DDD) per kg live weight poultry was the unit of measurement for drug use (to correct for differences in the dosages). Sales figures of the AB drugs were converted to number of DDDpoultry sold for the numbers of broilers at risk (broilers were 97% of the slaughter poultry). Estimated annual percentages of the broilers treated against NE increased abruptly after the avoparcin ban--but in 1996, this figure declined to the same level as before the ban and has remained at that low level since then. In November 1995, narasin was approved temporarily as an ionophore feed additive (IFA) in broilers. The usage patterns of IFAs in broilers were measured as the weight of feed to which an IFA was added per broiler chicken produced. In 1996-2001, the IFAs used in broilers were predominantly narasin. We note that the temporary increase in NE after the avoparcin ban coincide with the period before narasin became available. The increase in the consumption of AB drugs for the treatment of NE in poultry following the avoparcin ban has been negligible.

Veterinarians have an opportunity to help educate their clients regarding the safety and efficacy of novel ingredients used by their clients. This is no small task because of the lack of acceptable information. Clients should be counseled regarding the lack of scientific evidence and be encouraged to discriminate fact from fiction, including many testimonials. Safety should be of primary concern, and clients should be encouraged not to neglect traditional therapies in lieu of novel ingredients unless clinical evidence of efficacy exists. Quality assurance is equally important and cannot be underestimated. Clients are likely to resort to less expensive products. Clients should be directed to the advice offered by the Arthritis Foundation as follows: "When a supplement has been studied with good results, find out which brand was used and buy that." Although skepticism is encouraged regarding any unknown product with medicinal indications, open mindedness should also guide the veterinarian as these products are considered. Indeed, veterinarians should take actions to ensure that the use of these compounds is accomplished within the confines of the veterinary-client-patient relationship, thus ensuring the role of the veterinarian in the health and well-being of animals, regardless of the modality of therapy. The veterinary profession should support the development of standards that might guide manufacturers of novel ingredients to meet criteria that protect the consumer. Likewise, we should encourage manufacturers and agencies to fund veterinary clinical trials to provide evidence for the use of these potentially exciting compounds. Above all else, the veterinarian needs to become a credible resource of information about the possible role of these products. The lack of a regulatory mechanism that establishes the safety and efficacy of these products is not justification for ignoring the potential therapeutic benefit of some of these products. Veterinarians should follow the advice of the Arthritis Foundation, which notes: "Since glucosamine is self-prescribed ... health care professionals are not regarded [to have] objective advice. This situation must change. It is time for the profession to accommodate the possibility that many nutritional products may have valuable therapeutic effects" [61].

This article reviews clinical pharmacology in food animal production in Canada and Mexico. The authors discuss topics such as drug availability, the drug-approval process, availability (prescription or over-the-counter) of drugs to producers, withdrawal times, and extralabel drug use. Drugs that are prohibited and proactive measures for drug use in Canadian food animals also are reviewed.

The author's interpretation of some of the regulations involved in drug selection and usage by bovine veterinarians has been presented here. If necessary, the practitioner should address further questions to the appropriate regulatory agencies. The role of the veterinarian in protecting the US food supply has never been more critical, and familiarity with the applicable regulations regarding drugs used in food animals is an important component of the food animal veterinarian's knowledge base.

This paper is in response to a previous article in a Special Issue of Toxicology Letters. That article criticised the current regulatory framework in the European Union for the environmental risk assessment of veterinary medicinal products (VMPs) and feed additives (FAs), in particular the ongoing process of international harmonisation of guidance. This response addresses the concerns raised in relation to veterinary medicinal products and demonstrates that the VICH process has been brought within the scope of current EU regulatory processes for veterinary medicines and therefore is not separate to them. Consultation with stakeholders takes place throughout the VICH process, with an additional period of open public consultation before guidance is adopted and implemented.

The author describes activities conducted by the International Organisation for Animal Health (OIE: Office International des Epizooties) to control foot and mouth disease (FMD) world-wide. These activities fall within the framework of the principal missions of the OIE. The first of these missions is the collection and dissemination of epidemiological information and of scientific knowledge on animal diseases, the socio-economic or disease implications of which can be particularly serious. The implementation of the measures required to control the disease and to protect countries threatened by FMD depends on the quality and rapidity of the transmission of this information. The co-ordination of studies, research and control programmes against FMD is equally important for the OIE. This work is based, in particular, on work conducted by the OlE foot and mouth disease and other epizootics Commission. OIE Member Countries not only have access to the most recent data on the diagnosis, surveillance and control of FMD but also have recourse to the official recognition procedure for disease-free status provided by this Commission. Finally, through the standardisation of health recommendations, diagnostic tests, manufacture protocols and the control of biological products, made available by the OIE International Animal Health Code Commission in regard to the former and by the OIE Standards Commission in regard to the latter, the OIE provides the reference for international trade in animals and animal products, and is recognised in this role by the World Trade Organization.

The ratite practitioner must balance the need to treat patients with the obligation to minimize the risk of drug residues. If a practitioner treats birds intended for market, the possibility of residues should be considered before administering therapeutic agents. Improved management practices can and will preclude the need in many instances for drug therapy. Practitioners should be aware of the conditions that must be met in order to justify extralabel use. When treating ratites intended for food, practitioners should comply with the documentation requirements listed in these regulations and be aware of the list of prohibited drugs. The Food Animal Residue Avoidance Databank (FARAD), at 1-888-US-FARAD (1-888-873-2723) or by electronic mail at farad@ucdavis.edu or farad@ncsu.edu, is a valuable source of information regarding residue avoidance. Emergence of ratites as food species should stimulate research to provide answers to questions concerning pharmacokinetics and tissue depletion in order to improve the quality of veterinary services for flock owners, to obtain approval for drugs for these species, and to provide information by which to establish appropriate withdrawal periods.

Negligence and malpractice are two of the most dreaded words to a veterinarian. This article defines the law of negligence and malpractice. Case results are used to explain some of the problems that have arisen in practice. Ideas and methods that the practitioner can use to avoid lawsuits for malpractice and negligence are included.

This article discusses the ways in which a veterinarian may be legally involved when there are charges under a humane animal law or a cruelty-to-animals law. Included is a discussion of the elements to be considered when there is prosecution of the veterinarian, action by a veterinary licensing and disciplinary board, action against a client, the veterinarian's duty to warn or disclose, and involvement of the veterinarian as an expert witness.

The Federal Food, Drug, and Cosmetic Act does not purport to interfere with the practice of veterinary medicine; however, it does regulate the drugs that veterinarians use in their practice. According to federal law, it is illegal for a veterinarian to use animal drugs in a manner other than that stated on the approved label, to use human-labeled drugs products to treat animals, or to compound drugs for their patients. Because the Act fails to meet the needs of the veterinary profession, the Food And Drug Administration (FDA) has adopted a policy of discretionary enforcement to "allow" veterinarians to use approved animal drugs in an extralabel fashion or to use human drugs to treat animals in certain situations. FDA will not enforce the law against practitioners treating companion, exotic, or sporting animals. Instead, enforcement effort will be directed to treating food-producing animals under conditions most likely to result in illegal drug residues. This is current effort to amend the Act in a way that will make it legal for the FDA to permit extralabel drug use rather than doing so only as a matter of enforcement discretion. Even so, practicing veterinarians will still be limited in how they can use drugs in everyday practice.

It is impossible to understand one's legal obligations without appreciating the ethical values these obligations are intended to promote. This article presents an overview of the sources of ethical values in veterinary practice. The author explains how legal requirements embody basic moral standards that veterinarians themselves regard as central to their professional role. It is argued that the most effective way of predicting many legal obligations and of motivating oneself to fulfill them is to accept and live by fundamental moral values. The article concludes that the underlying ethical motivation of the law underscores the importance of making attention to ethics an essential part of one's practice of veterinary medicine.

The biological basis of domestication was emphasized by Zeuner (1963) and he regarded this as a development of a natural association between man and animals. The domestication of the wolf probably provided man's first domestic animal, the dog. The next to be domesticated was the goat, in about 9000 B.C., followed closely by the sheep which emerged as the economically better animal making an immense contribution to the development of civilization in many countries. The patterns of trade in sheep and goats and the constraints on import/export can best be examined against the background of their distribution and importance in national economies.

International trade in dogs and cats is far from insignificant (Fig. 1). Within the dog and cat world British stock is highly regarded and in consequence the export trade in these species is appreciable. Concommitant importation of stock has to occur if adequate gene pools are to be maintained, especially in the numerically smaller breeds. In recent years fashion has also played a part in the import trade and it has become customary for specimens of breeds previously unknown in Britain to make their appearance, often “for exhibition only”, at the larger shows. Frequently these animals have only recently been released from quarantine.

Hollands reviews the activities of the Committee for the Reform of Animal Experimentation (CRAE) in securing passage of Britain's 1986 Animals (Scientific Procedures) Act. Founded in 1978 to seek reform of the law governing animal experimentation, CRAE allied itself with the British Veterinary Association and the Fund for the Replacement of Animals in Medical Experiments (FRAME) to influence government policy. Accepting that the abolishment of all animal research was an unrealistic goal, CRAE set four objectives for new legislation: the restriction of pain, a substantial decrease in the number of experimental animals used, the development and use of alternative research methods, and public accountability. Hollands asserts that these goals have been achieved in the 1986 Act, with its strong provisions for animal research oversight by the Home Secretary. He also notes increased interest by scientific groups in monitoring animal experimentation.