2

; These tables also indicate the pesticides for which
new data have been required as a result of EPA regulatory

, actions. These include risk/benefit reviews undertaken

: - because. of specific evidence of.a hazard (known as . a
Rebuttable Presumption Against Registration, listed as
"RPAR" in-tables) or EPA's regular program for reregister-
ing all previously registered pesticides (in tables, 7
“Registration Standard" and “Data Call-In"). The reregis-
tration program is not specifically connected to the IBT ,
case, but serves the purpose of bringing the data on older
chemicals, including some tested by IBT, up to current , >
scientific standards. Under the authority of section
3(c)(2)(8) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) the Agency can require additional ;
data to maintain a registration, and may suspend a product's
registration if the registrant does not agree to provide
the data or if it is not provided pursuant to an agreement
with the Agency. .
Attached is also a list (Exhibit 8) of major health
effects studies on pesticides conducted by IBT identifying
which have been found valid or invalid, and which have
been or are in the process of being replaced. This list
covers 801 studies on 140 pesticides. An earlier draft
list of IBT tests prepared by EPA in May 1983 identified
1205 tests on 212 pesticides. The current list has
eliminated duplicative entries, preliminary range finding
and similar tests which were not true health effects
studies, and short-term, acute toxicity tests which
generally do not create a significant data gap and which
will be replaced if needed, through the existing reregis-
tration program described above. Thus, the current list | ,
of 801 studies covers health effects considered significant.
to regulatory decisions, such as induction of benign or
malignant tumors (oncogenicity), birth defects (teratogeni-
city), genetic mutations, other adverse reproductive effects,
and neurotoxicity. Of the 801 IBT studies in the pivotal
categories, 594 (74%) have been found invalid. To date,
of the invalid studies, 212 (36%) studies have been replaced
or are in progress, 38 (7%) are under discussion for possible
replacement, and 45 (7%) are of a type no longer required
for registration.
One way to assess the impact of I8T is to consider

the effect of invalid studies on the data base supporting
pesticides used in high volume. Although hundreds of
pesticides are registered, only 25 insecticides account for
85% of the actual pounds of insecticides used, 32 herbicides
account for 82%, and only 8 fungicides account for 71%
of the volume of those products used. Of these 65 most
heavily used pesticides, only 18 have IBT data in One or