An Introduction to Legal, Regulatory and Intellectual Property Rights Issues in Biotechnology

The Regulatory Framework

Author(s): Alessandro Stasi and Tan Weng Chiang David

Pp: 24-39 (16)

DOI: 10.2174/9789815080629123010003

* (Excluding Mailing and Handling)

Abstract

This chapter draws upon the role and responsibilities of federal agencies in regulating biotechnology products. It distinguishes the role of the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) through statutory definitions. Special emphasis is placed on defining the role of the Animal and Plant Health Inspection Service (APHIS), the Agricultural Research Service (ARS), the Agricultural Marketing Service (AMS), the Food Safety Inspection Service (FSIS), and the Foreign Agricultural Service (FAS). 

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