After two years experience of the review program
a decision was made to reconsider past policies regarding ;
IBT data. A policy statement reflecting decisions made as a
~ result of this analysis was sent to registrants in July 1980.- -.--- ----
The decisions were: 1) that the moratorium on registration
actions was lifted unless a valid IBT study was essential to
the approval of a specific action, 2) that registrants would -
be required to fill data gaps resulting from invalid IBT
studies, 3) minor data gaps would be considered through
normal registration channels, 4) if the entire data base was
invalid, EPA would consider cancellation action, and 5) if
previously unreported adverse effects were discovered, the
study would have to be replaced, and in addition the Agency
would consider initiating either an intensive risk/benefit.
review, or formal hearings on a chemical's registration
status.
' The IBT Review Program consisted of validation review,
evaluation review, and data gap review. Validation review -;
was designed to determine whether the information in the
final report was supported by the raw data. Evaluation of
whether a study met Agency guidelines for studies used to.
support registration, was performed on studies determined
to be valid or at least reliable enough to supplement other
valid data. Data gap review was a search through a chemical's
entire data base to determine which invalid studies needed
to be replaced.
Because our experience with data gap. review proved it
to be extremely time consuming, options for completing the
IBT program more expeditiously were considered. As a result,
‘ several policy changes were adopted and conveyed to registrants
in a letter in April 1982 which stated: 1) that acute IBT .
studies would no longer be reviewed through the IBT program.
Instead, they would be reviewed through normal registration
channels; 2) that studies which were considered invalid
because the registrant initially chose not to audit them,
would not be reviewed by the Agency and our presumption would
be that they had to be replaced; 3) that EPA would no longer
perform a data gap review of a chemical's data base to
determine if other studies existed to replace the IBT studies,
instead we would assume that replacement was necessary unless ;
the registrant could convince us otherwise; and 4) that EPA
would not review an IBT study if the registrant identified a
replacement and agreed to have the IBT study considered
invalid. , .
The review stage of the IBT program is essentially
complete. The remainder of the program consists of obtaining
replacement studies and tracking commitments to replace
studies. -
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