A Case for United States Overhaul of Its Current Biotechnology Regulation Scheme Through the Implementation of Biotechnology-Specific Legislation to Clarify Existing Uncertainties Seen in the Collective Framework

Authors

• Jordan Emmert, Benjamin N. Cardozo School of Law

Abstract

The U.S. biotechnology regulatory framework, established by the 1986 Coordinated Framework and its 1992 Update, is outdated and insufficient to address modern biotechnology products, particularly genetically modified organisms (GMOs). While efforts such as the Obama Administration’s 2015 Memorandum and the 2016 Update aimed to modernize the system, they failed to resolve jurisdictional ambiguities and regulatory gaps, leading to inconsistent agency enforcement and public distrust. The note argues that updating the statutory framework is essential to align U.S. regulations with international norms, ensure public safety, and maintain global competitiveness.

Disciplines

Comparative and Foreign Law | Food and Drug Law | International Law | Law | Science and Technology Law

Recommended Citation

Jordan Emmert, A Case for United States Overhaul of Its Current Biotechnology Regulation Scheme Through the Implementation of Biotechnology-Specific Legislation to Clarify Existing Uncertainties Seen in the Collective Framework, 2 Cardozo Int’l & Compar. L. Rev. 529 (2019).
Available at: https://larc.cardozo.yu.edu/ciclr/vol2/iss2/7