pre S747
2 r  \ % ..
3 SZ 3 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
%, oe WASHINGTON, D.C. 20460
7, ;
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
The IBT Review Program
This report summarizes the findings of the joint
” program conducted by the Environmental Protection Agency
(EPA) and the Health Protection Branch of Health and
Welfare Canada to reexamine the validity of health effects
studies on pesticides tested by Industrial Bio-Test
Laboratories, Inc. (IBT). This program is one result of :
discoveries made during a series of audits beginning in
1976 by the Food and Drug Administration (FDA) and EPA
which revealed serious deficiencies in IBT tests conducted
to support the registration of numerous pesticides and
some drugs in both the United States and Canada. This
report assesses the impact of the IBT situation on the
registration status of the chemicals involved and describes
the steps the Agency has taken to resolve this problem and
to prevent its recurrence.
Exhibit A shows how many IBT and non-IBT tests are
available to EPA in each testing category for the pesticide
chemicals having some IBT conducted studies in their :
data base. As these tables show, a large majority (93%) of
the pesticides tested by IBT, also have non-IBT data
available. Only 12 of the pesticides listed have a data .
base entirely of ,IBT studies. However, seven of these are
either not registered for use in this country or are
cancelled or discontinued products. Some of the IBT ;
studies on the remaining five chemicals are at least
partially valid or "supplemental", meaning the data can be
used to support the findings of other studies.