Reforming the 'Uncoordinated' Framework for Regulation of Biotechnology

57 Pages Posted: 16 Nov 2012

Date Written: November 14, 2012


This Article will focus on how the United States can reform the current regulatory system for agricultural biotechnology given the significant political, economic, and social challenges the regulations governing this industry pose. The proposed reform will emphasize four key objectives to be achieved through legislative mandates. First, the Coordinated Framework was built upon dated scientific principles that have since proven to be flawed, and the doctrine of “substantial equivalence,” the premise and driving force behind the U.S. regulatory system, is no longer credible and should be abandoned. Second, systematic risk assessment and safety testing must be incorporated into the pre-release or pre-market review process. Third, post-market monitoring must be instituted as part of the overall risk management program. Lastly, a system of coordination should be developed for the three agencies involved in biotech monitoring.

Aside from legislative changes, policy objectives should strive to encourage independent research and investments. Transparency should be improved because continual success for the industry will depend on society’s willingness to purchase and consume food produced through biotechnology. In order for this to take place, consumers must trust that regulators are being forthright with them while exercising proper oversight.

Keywords: Agriculture, Biotechnology, Biotech, Framework, Regulation

Suggested Citation

Lee-Muramoto, Maria, Reforming the 'Uncoordinated' Framework for Regulation of Biotechnology (November 14, 2012). Drake Journal of Agricultural Law, Vol. 17, No. 2, 2012. Available at SSRN:

Maria Lee-Muramoto (Contact Author)

affiliation not provided to SSRN ( email )

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