Legal and Advisory Frameworks


Legal and Advisory Frameworks
Public Interest
Educational Resources


Although both the United States and Europe developed their regulatory systems following the moratorium self-imposed by scientists in the 1970's, the regulatory systems moved apart significantly. In the United States it was decided not to impose new regulatory burdens on the biotechnology laboratory or industry. Guidelines for the safe use of modified organisms were introduced, in particular the NIH Guidelines, which imposed a set of safety precautions on those experiments funded by the NIH for the safe use of modified organisms. Most industries, although not funded by NIH, followed these guidelines, at least in spirit.

The US devised a framework for industrial applications.

In Europe, however, a newly devised statutory regulatory system is in force, which requires an assessment of the risks associated with the use of modified organisms in containment. The statutory system in Europe also depends on EU Directives which define the conditions in which biological agents (whether genetically modified or not) may be used in the workplace, or approved for commerce.