Animal welfare and toxicology/safety studies: Making sense of the regulatory environment

The importance of the use of laboratory animals in safety and toxicologic studies of new compounds for medical treatments is clearly illustrated in the history of biomedical research and development. To understand the animal welfare regulatory environment, one should first be familiar with the applicable regulations and guidelines. Animal product safety testing requirements cover the use of laboratory animals for determining the effects of human exposure to a new chemical entity or product or a new indication for an old chemical. Such studies are used by federal agencies to ascertain risk assessment and determine whether the benefit of a particular compound outweighs the potential risk, Likewise, there are regulatory requirements and guidelines for the proper care and use of animals in biomedical research and development. Animal welfare requirements are either involuntary regulations (i. e., required by law or set forth as a condition of funding) or voluntary requirements (i. e., adhered to as a part of an institution's overall commitment to research and development and to academic excellence), These requirements cover the animal's environment, housing, and management; medical care; physical facilities; and institutional policies and responsibilities for the institutional official, attending veterinarian, Institutional Animal Care and Use Committee, and investigators, Secondly, one should be familiar with the primary parties within the regulated biomedical research community including industry, academia, and government, Particularly in industry, regulated parties who conduct nonclinical safety assessment studies are diverse, Lastly, biomedical professionals should have a good understanding of the pertinent current issues and trends, The animal welfare regulatory environment is dynamic, constantly being influenced by a number of factors such as changing regulatory requirements, emerging technologies (i. e., gene transfer), changing views involving fundamental concepts (e. g., alternatives in animal use, establishment of endpoints, and effective leadership), and economic concerns (e. g., animal facility expansion and animal facility management).