Over the last 100 years, agricultural research has been ballooning with developments and discoveries especially in plant breeding experiencing an all-time high. In tandem with traditional practices such as crosspollination, breeders have been allowed to use new and emerging technologies such as genetic modification of the plants among others. The resultant crops are tested for viability, production capacity, quality and safety for consumption over a period of time in varying climates and soil types (McHughen and Smyth, 2008). In the 1970s, the assumption that changes in plant genetics were benign and generally safe was challenged. This was a result of the advent of rDNA techniques (Cohen et al., 1973). The balance of potential versus risk was immediately clear to the scientific community and the necessity for regulation was determined.
The agencies that are tasked with the regulation of genetically modified crops in the US are the EPA, FDA and the USDA. The FDA is tasked with establishing the safety of the product as food and animal feed. The EPA has the mandate of determining the environmental impact of the biotech product as well as the toxicity profile to other organisms in the ecosystem. The USDA through it various departments regulates potential agricultural pests and noxious weeds. The major USDA departments that carry out this mandate are Animal and Plant Health Inspection Service (APHIS) and Food Safety Inspection Service (FSIS) (PIFB, 2001).
The FDA for instance, regulates the production of the fortified rice dubbed ‘golden rice’. The golden rice is modified to incorporate genes responsible for the production of beta carotene. This special rice was engineered to address Vitamin A deficiencies. Through the FDA regulatory agency however, research work into this product is monitored and the release of the golden rice into the market has hitherto, not taken place until safety standards are met.
Cohen, S. N., Chang, A. C., Boyer, H. W., & Helling, R. B. (1973). Construction of biologically functional bacterial plasmids in vitro. Proceedings of the National Academy of Sciences, 70(11), 3240-3244.
McHughen, A., & Smyth, S. (2008). US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars. Plant biotechnology journal, 6(1), 2-12.
Nap, J. P., Escaler, M., Metz, P. L., & Conner, A. J. (2003). The release of genetically modified crops into the environment. Part I. Overview of current status and regulations. The Plant Journal, 33(1), 1-18.
Pew Initiative on Food and Biotechnology (PIFB). (2001). Guide to U.S. guidelines on Genetically Modified Food and Agricultural Biotechnology goods. Retrieved from http://www.pewtrusts.org/~/media/legacy/uploadedfiles/wwwpewtrustsorg/reports/food_ and_biotechnology/hhsbiotech0901pdf.pdf.
US bureau of Science and Technology Policy (OSTP) (1986). Harmonized structure for regulation of biotechnology: Declaration of policy and notice for public remark. Federal Register 51:23 302–23 393.