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4 SZ 3 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
, ef WASHINGTON, D.C. 20460
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: PEesTicipes ANO TOXIC SUBSTANCES
ADDITIONAL BACKGROUND ON THE IBT REVIEW PROGRAM
In 1976, during a routine lab. inspection of one of IBT's
facilities, FDA discoverd deficiencies in the manner in which
studies were being conducted and discrepancies between those
studies and their raw data. In 1977, EPA placed a moratorium
on registration actions involving data developed at [BT as a
result of this information. In the same year, EPA notified
registrants that they were required to audit the raw data
and validate both those IBT studies which were pivotal to the
data base of pesticides already registered and all those
which were supporting new registration actions.
In 1978 a joint EPA/FDA audit of IBT's two other
facilities uncovered problems similar to those discovered
during the initial audit. In March of that year EPA required
registrants to submit to EPA the raw data for the IBT studies
so that a review of registrant audits could be conducted.
EPA referred this case to the Department of Justice for
; investigation in April 1978. At approximately the same time,
the U.S. and Canada were negotiating an agreement to share
- the task of spot checking registrants' audits of IBT studies.
Through these checks, however, it became apparent that
registrants’ audits routinely overlooked some areas of concefn.
As a result, Canada and the U.S. agreed to review each audit
' and study.
Mutual agreement was reached as to which studies would
be reviewed by each country. It was also decided that each
country would accept the other's determination as to validity.
However, due to differences in data requirements, each country
would independently evaluate whether studies met their
regulatory requirements, and determine the need for replacement
studies. ,
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