EPA RELEASES R-105 (202) 382-4355 The U.S. Environmental Protection Agency today notified pesticide registrants that products supported by invalid health effects studies conducted by the Industrial Bio-Test (IBT) laboratories face suspension action within 90 days unless replaced by other tests or a commitment to further testing. At the same time, the agency released a report showing that major portions of the data base invalidated by IBT have been or are being replaced. Many of the IBT tests no longer need replacing because the chemicals involved are cancelled, suspended, out of production, or are not used in the United States. Beginning in 1976, auditing by the Federal Food and Drug Administration and the EPA discovered the shortcomings in the IBT laboratory tests used by companies to support the registration of pesticides and drugs in the U.S. and Canada. In 1978, EPA referred the case to the Justice Department for investigation. To ensure that data providing the foundation of regulatory decisions in the future are adequately prepared and scrutinized and to maintain high laboratory standards, EPA and FDA established a joint laboratory audit program in 1977. The audit program includes visits to the laboratories throughout the U.S. to inspect their procedures, facilities and staff qualifications. About 60 audits per year of labs and/or individual pesticide studies are conducted to see if the reports are supported by "raw" data. Of the original 1,205 IBT studies identified by EPA, 801 are considered significant to regulatory decisions, such as the induction of tumors, birth defects, genetic mutations, neurotoxicity and other chronic reproductive effects. (more) About 400 studies were eliminated from review because of duplicative entries or were found not to be true health effects studies. Also not reviewed were short-term, acute toxicity tests which generally do not create a significant data gap and which will be replaced by the current agency program of bringing the data on old chemicals (including some tested by IBT) up to current scientific standards. Among the 801 health studies reviewed, 594 have been found invalid by EPA and Canada (EPA and the Health Protection Board of Health and Welfare, Canada, entered into an agreement to jointly reexamine the IBT studies for validity). A total of 212 of invalid IBT studies have been replaced or are in the process of being replaced and 38 studies are under discussion for replacement; 45 studies are no longer required for registration, 140 studies concern pesticides that have been cancelled, discontinued, are not registered for use in the U.S., or are no longer in production. And for 159 studies, the agency has received no previous response or a negative response for a request for replacement studies. . The report also shows that a large majority (93 percent) of the pesticides tested by IBT have other data available to support the safety of the pesticide products. Of the pesticides listed with a data base entirely of IBT studies, only five are registered for use in the U.S. and only two of them have an entirely invalid data base. Six of the 17 studies on these five chemicals will be replaced by the agency's ongoing program to keep the data base current on all chemicals. In addition, of the 65 most heavily used pesticides, only 18 have IBT data in one or more significant categories. Of the 18, all but one also have non-IBT data available in some or all of the same categories. Sixteen of the high volume chemicals are the subject of a current regulatory action by EPA to obtain replacement data. There have been suggestions that all chemicals tested in whole or in part by IBT be removed from the market pending retesting. That option is not available under the current law which requires valid evidence of risk as opposed to a lack of information before removing a product from use. 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. 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 Rebuttable Presumption Against Registration, listed as "RPAR" in tables) or EPA's regular program for reregistering all previously registered pesticides (in tables, "Registration Standard" and "Data Call-In"). The reregistration 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)(B) 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 B) 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 reregistration 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 (teratogenicity), 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 IBT 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 |