4
The regulatory response authorized by FIFRA requires
valid evidence of risk, as opposed to a lack of information, ;
: before removing a product from the market, and allows for
_the replacement of inadequate data. As we reach the final
resolution of the IBT problem, it appears that this approach
was appropriate and adequate to deal with this event.
The IBT scandal shook the industry and government
regulators. Obviously, steps had to be taken, not just
to deal with the IBT situation itself, but to ensure that
data providing the foundation of regulatory decisions in
the future are adequately prepared and scrutinized. Thus,
another result of the IBT case was the establishment in
1977 of a joint EPA-FDA audit program to help ensure that
another IBT situation has not occurred and will not in
the future. The lab audit program includes visits to
laboratories to inspect their procedures, facilities and
staff qualifications, and about sixty audits per year of
labs and/or individual pesticide studies to see if the ;
reported results are supported by the "raw" laboratory
records and data. In the past six years, we have found
the large majority of laboratories to be in compliance ;
with current standards, and producing scientifically valid
Studies. An important effect of the IBT case has been to
make the testing community, the industries which use their
services, and government regulators keenly aware of the
need to maintain high standards of quality control over
health effects testing.