Regulatory and Biosafety Issues in Relation to Transgenic Animals in Food and Agriculture, Feeds Containing Genetically Modified Organisms (GMO) and Veterinary Biologics

Abstract

Development of an effective regulatory system for genetically engineeredanimals and their products has been the subject of increasing discussionamong researchers, industry and policy developers, as well as thepublic. Since transgenesis and cloning are relatively new scientifictechniques, transgenic animals are new organisms for which there islimited information. The issues associated with the regulation andbiosafety of transgenic animals pertain to environmental impact, humanfood safety, animal health and welfare, trade and ethics. To regulatethis new and powerful technology predicated on limited backgroundinformation is a challenge not only for the regulators, but also for thedevelopers of such animals, who strive to prove that the animals aresafe and merit bio-equivalency to their conventional counterparts. Inprinciple, an effective regulatory sieve should permit safe productswhile forming a formidable barrier for those assessed of posing anunacceptable risk.Adoption of transgenic technology for use in agriculture will dependupon various factors that range from perceived benefits for humans andanimals, to safe propagation, animal welfare considerations andintegrity of species, as well as effects on bio-diversity. A regulatoryframework designed to address the concerns connected with theenvironmental release of transgenic animals needs to also take intoaccount the ability of genetically modified animals to survive andcompete with conventional populations. Regulatory initiatives forbiotechnology-derived animals and their products should ensure highstandards for human and animal health; a sound scientific basis forevaluation; transparency and public involvement; and maintenance ofgenetic diversity.Feeds obtained by use of biotechnology have to be evaluated for animaland human safety by using parameters that define their molecularcharacterization, nutritional qualities and toxicological aspects, whileveterinary biologics derived from biotechnology must be shown to bepure, potent, safe and effective when used according to labelrecommendations.The Canadian regulatory system relies on the ``precautionaryprinciple{''} in its approach to regulate the ``product{''} instead ofthe ``process{''}. The regulatory framework captures transgenic animalsunder the Canadian Environmental Protection Act (CEPA). Food fromtransgenic animals is assessed for safety by Health Canada under itsNovel Foods Regulations of the Food and Drugs Act. Feed containing anygenetically modified organism is considered Novel Feed under the FeedsAct and Regulations. The regulation of veterinary biologics, in aneffort to prevent and diagnose infectious diseases of animals, relies oneffective science-based regulatory controls under the Health of AnimalsAct and Regulations. The Canadian system of regulation for feeds,veterinary biologics and transgenic animals could be useful todeveloping countries in the process of establishing an effectiveframework for new regulations.