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

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

DOI: 10.2174/9789815080629123010003

The Regulatory Framework

Pp: 24-39 (16)

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Abstract

SHS investigation development is considered from the geographical and historical viewpoint. 3 stages are described. Within Stage 1 the work was carried out in the Department of the Institute of Chemical Physics in Chernogolovka where the scientific discovery had been made. At Stage 2 the interest to SHS arose in different cities and towns of the former USSR. Within Stage 3 SHS entered the international scene. Now SHS processes and products are being studied in more than 50 countries.

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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