3 more important categories. Of those 18, all but one also have non-IBT data available in some or all of the same cagetories. The exception, prometon, a herbicide not used on food crops, has one partially valid IBT study and many non-IBT acute and subacute studies. Sixteen of these high volume chemicals are the subject of one of the regulatory procedures described above requiring additional data. Thus, the data bases for the high volume chemicals to which people are most likely to be exposed are for the most part unaffected by the IBT situation, and where there is an impact,, EPA has taken active regulatory steps to obtain replacement data. The principal remaining task of the IBT program is to clarify the status of the invalid studies for which registrants have indicated they do not intend to provide replacements, or have not communicated an intention one way or the other to EPA. Although around 300 studies are in this category, a significant number (140) of negative and non-responses involve discontinued or cancelled products, or pesticides of such low volume use that registrants may choose not to invest in further testing needed to maintain registrations. The replacement status column of Exhibit B indicates that there are 159 invalid studies (26% of invalid IBT tests) for which there is negative or no response. However, as previously noted, most of these chemicals have non-IBT data available. Exhibit A shows that only five chemicals still registered and actually used have entirely IBT data bases. The 17 studies involved with those 5 chemicals constitute 3% of invalid IBT studies. A registration standard will result in replacement of 6 of these studies. This leaves only 11 studies or 2% of the invalid IBT tests which constitute the sole support of registered pesticides, and for which no regulatory action to generate replacement data has yet been initiated. Several of these 11 are valid or have at least supplementary value. This report is being furnished to the registrants of the affected chemicals for which negative or no responses have been received concerning replacement of invalid IBT studies. We are also sending the registrants 3(c)(2)(B) notifications which require a registrant to make a specific commitment within 90 days or the registration may be suspended. In some cases, EPA and a registrant may agree that a specific study does not need to be replaced. The IBT case caused serious concern and uncertainty about the potential hazards of the hundreds of pesticides involved, both for EPA and the public. Although it was advocated by some that all 212 pesticides tested in whole or in part by IBT be removed from the market pending retesting, that option is not available under current law. 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. EPA ASSESSMENT OF EFFECT OF IBT DATA ON 65 LARGEST USE PESTICIDES* PESTICIDES WITH NO IBT DATA PESTICIDES WITH IBT PESTICIDES TWO PESTICIDES WITH *25 INSECTICIDES ACCOUNTING FOR 85% OF POUNDAGE USED, 32 HERBICIDES ACCOUNTING FOR 82% OF POUNDAGE USED, AND 8 FUNGICIDES ACCOUNTING FOR 71% OF POUNDAGE USED, IN 1980. 6 116 24 20% NEGATIVE RESPONSE BUT PRODUCTS ARE CANCELLED, 4% NO RESPONSE BUT PRODUCTS ARE CANCELLED, DISCONTINUED -86 14% NEGATIVE RESPONSE AND INVALID 73 12% NO RESPONSE AND INVALID 100% IBT STUDIES PROVIDING SOLE SUPPORT FOR REGISTRATION 17 3% IBT STUDIES PROVIDE SOLE SUPPORT FOR REGISTRATION 7 |