Biotech companies are dependent on federal approval to introduce new or genetically modified organisms. But regulation by individual agencies is only the last step in a long process involving these organisms. Two recent developments highlight both the issues remaining before such regulations can be laid down, and how hard it will be to find common ground.
The first is a draft by the executive branch of a set of principles to govern the definition of such organisms. This so-called scope of oversight document appeared July 31 in the Federal Register (vol. 55, No. 147, p. 31118-21) after two years of debate on the subject among the relevant agencies and top administration officials.
The second is a bill, introduced July 10 by Rep. Robert Roe (D-N.J.), to create a uniform federal system to handle the regulation of such organisms and their release into the environment. The legislation, called the "Omnibus Biotechnology ...
