Tuesday, September 10, 2013

FDA monitors genetically modified animals

Office of the U.S. Food and Drug Administration has submitted to the stakeholder document that defines the rules for the supervision of genetically modified animals. According to the Office, the introduction of new rules for threatened mass commercialization of genetic engineering technologies. Published the 25-page document is subject to FDA jurisdiction explain, no animals with a modified genome, whether pets (eg, hypo-allergenic cats), cattle with additional nutritional properties, or animals that are used to produce drugs. In the future, FDA expects the manufacturer information about the properties, methods of cultivation and as you get to identify these animals and their possible impact on human health and the environment. While these requirements are not mandatory, the biomedical industry is trying representatives U.S. likely to follow them. Legal framework for the document as a law in 1983 served as a medical monitoring, treatment integrated into the genome of an additional DNA fragment. Since modern genetic engineering can not determine exactly what kind of a chromosome to obtain new genes, each row of the modified animals will be regulated separately. By the FDA, the need for new rules drawn by the increasing commercialization of bio-engineering technology. In this context, the focus is on the regulatory body will have, for example, animal, intended for mass breeding for commercial purposes. Rules for scientists using genetic engineering for research, do not change significantly. The final version of the rules of supervision will be prepared at the end of the 60-day trial period in which industry representatives can offer FDA changes.

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