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The Impact of FFDCA on Animal Biotechnology Ronak Gandhi University of Maryland The U.S Federal and Drug administration (FDA) in 1938 created the Federal Food Drug, and Cosmetic Act (FFDCA), a government policy decision that has impacted the field of biotechnology. This policy ensures that food, drugs, and cosmetics are safe for the public. The use of animal biotechnology acts through this administration. The FFDCA policy gives regulation for industries to offer guidance and requirements to study genetically engineered animals in agriculture. This policy decision is also directed with the National Environmental Policy Act (NEPA). The resulting effects of biotechnology used in animals have brought positive and negative effects. Biotechnology industries that test animals are known as genetically engineered (GE) animals. This innovation uses recombinant DNA (rDNA) to bring new characteristics into an animal. Depending on the trait acquired given to the animal, it differs from an ordinary animal. The FFDCA uses a nine-step approach to regulate GE animals. The product is first defined by its name, genus, lineage and the name of the rDNA assembly. Then, FFDCA reviews the molecular characterization of the construct and animal by determining the purpose of the GE event, as well as site of insertion of the rDNA trait. Phenotypic characterization is then considered to check the physiological level such as the blood chemistry, hematology, and histological pathology. After, the reviewers exercise the durability plan to express the effect of the DNA construct across multiple generations. Finally, the environmental and the food/feed safety step prescribes a look at the genotype, phenotype, and biology of the GE animal, i... ... middle of paper ... allowed biotechnologist to expand on their research, which has depicted great benefits in terms of possibility of receiving more nutritional value from animals, reducing waste products, and help industries increase their profits. However, the use of rDNA on animals, under this policy, has brought ethical issues from the public. The enormous data indicating the rise in mortality rate and muscular abnormalities in animals has brought negative attention to the field of biotechnology. The regulation of GE animals is a controversial topic in the United States. We have the luxury of debating the negative and positive aspects of the use of GE. The use of GE animals could increase the food supply and decrease the amount of malnourished people. For countries suffering from poverty, the use of GE animals can help their political, economic, and social status.

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