Fit for Purpose Assessment: A New Direction for IACUCs.

The organization and function of the institutional animal care and use committee (IACUC) is the key component of government regulation and oversight of necessary scientific research using live animals and of AAALAC - International accreditation of animal care and use programs in the United States. The regulations, roles, and responsibilities of IACUCs have evolved since their inception 35 years ago from a limited focus on animal welfare and specific animal procedures to embracing scientific quality, data reproducibility and translation, and animal welfare as inextricably interdependent and critical components of generation of new scientific knowledge and medical treatments. A current challenge for IACUCs is in evaluating whether benefits to be derived (eg, new knowledge or treatments) justify any unavoidable pain, stress, or injury associated with proposed research protocols, because the former are long-term and at best speculative outcomes, whereas the latter are immediate and tangible for the study animals. Scientific consensus is that research most likely to generate significant new knowledge and medical treatments is that conducted to high scientific, technical, and quality standards and reported with full transparency to facilitate reproducibility. As an alternative to current benefits evaluations included in risk benefit and harm benefit constructs, the authors propose that IACUCs assess the proposed research for scientific quality and alignment of study elements with the study purpose (e.g., Fit for Purpose [FfP]), including justifications for study design components, selection of primary endpoints and technologies, rationale for data and statistical analyses, and research communication plans. Fit for Purpose endpoints are objective, immediate, and impactful as are the potential risks for study animals, and at the same time they are the best predictors for achievement of longer-term benefits. We propose that IACUCs and any revision of The ILAR Guide consider FfP concepts in place of traditional benefits assessment to accelerate the generation of new knowledge and treatments benefiting medical and veterinary patients and the environment through better science and animal welfare rather than to continue to rely on speculative future outcomes.

Can our food production system meet demand in a changing global society?

The worldwide demand for animal protein will grow as the world's population grows and the economies of developing countries evolve and mature. The veterinary profession must be a leader in advocating for responsible changes in production practices that will improve the welfare of food animals, ensure a safe and secure food supply, and minimize negative impacts on the environment.

Animal health: foundation of a safe, secure, and abundant food supply.

During the past century, reductions in animal diseases have resulted in a safer, more uniform, and more economical food supply. In the United States, the passage of the 1906 Federal Meat Inspection Act mandated better sanitary conditions for slaughter and processing, as well as inspection of live animals and their processed products. Following World War II, Congress passed the Poultry Products Inspection Act. Both acts are regulated by the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA). The USDA's Animal and Plant Health Inspection Service (APHIS) is responsible for regulations governing the health of live animals prior to slaughter. This article is a brief overview of the ways in which the current predominance of zoonotics among emerging diseases underscores the importance of veterinary health professionals and the need for continued coordination between animal-health and public-health officials. Examples of intersections between animal- and public-health concerns include bovine spongiform encephalopathy (BSE) and Johne's disease, as well as extending beyond food safety to diseases such as avian influenza (AI). In the United States, we have in place an extensive public and private infrastructure to address animal-health issues, including the necessary expertise and resources to address animal-health emergencies. However, many challenges remain, including a critical shortage of food-animal veterinarians. These challenges can be met by recruiting and training a cadre of additional food-supply veterinarians, pursuing new technologies, collaborating with public-health officials to create solutions, and sending a clear and consistent message to the public about important animal-health issues.

Best practices for animal care committees and animal use oversight.

Regulatory authorities around the world with oversight responsibility for the welfare of research animals have placed heavily reliance on local oversight committees. These animal care committees (ACCs) are part of an institutional animal welfare team that includes the institutional administration, principal investigators, attending veterinarian and animal care staff, as well as regulatory organizations and authorities. As a key component of this team, most ACCs function as an agent of the institution to ensure regulatory animal welfare compliance. Although regulatory testing involving animals presents some unique circumstances, the focus of all animal care committees is to minimize animal pain and distress. Federal requirements are often couched within a regulatory framework that is performance based and therefore very flexible. Thus, it is important for ACCs to establish very simple and specific institutional requirements and procedures and to work at promoting a broad understanding of them within their respective institutions. Experience suggests that ambiguity at the local level results in many unintended side effects and confusion. There are many "best practices" that can help the ACC promote institutional compliance and good animal welfare. These practices, although not universally appropriate for all institutions or activities, include ACC coordinator or administrator, designated protocol reviewer, alternate or duel ACC members, generic protocols and standard operating procedures, centralized controls and animal care facilities, conducting pilot studies, and ensuring the most humane endpoints.