Regulating Pharm Crops and their Products

Federal regulators play an important role in agricultural biotechnology, balancing their obligation to protect the environment and society from dangerous applications against facilitating the development of beneficial ones. They have taken criticism from opponents of biotechnology who claim that regulatory schemes give preference to private sector companies, and they have been criticized by proponents of agricultural biotechnology who feel that the regulatory framework creates unnecessary stumbling blocks to the advancement of novel technologies. Thus, federal regulators have the potential to shape the market success or failure of biopharming.

The Coordinated Framework for Regulation of Biotechnology was established in 1986 when the Reagan administration and the White House Office of Science and Technology Policy assigned to the USDA, EPA, and FDA the task of taking the then-present regulatory framework that pertained to products developed by traditional genetic manipulation techniques and adapting it to accommodate newly emerging genetic engineering technologies. The Coordinated Framework describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology research and products, with each of the three federal agencies given specific oversight responsibilities.

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