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.
