Industrial Bio-Test Laboratories

Early years IBT was founded in 1953 by Joseph C. Calandra, an Italian American professor of pathology and biochemistry at Northwestern University. Calandra, the first of his family to pursue higher education, contributed to the concept of toxicologically innocuous doses during his tenure at Northwestern. By 1960, IBT reported that its professional staff included twelve biologists, five chemists, a mathematician, four physicians and a veterinarian, and that it employed sixteen technicians. Calandra was president and director and John H. Kay was the associate director. At that time, it listed its research areas as "industrial toxicology, food, drugs, cosmetics, pharmacology, radioisotopes, medical, dental, and veterinary products". As of mid-decade, it had annual revenue estimated at nearly $2 million US. In 1970, Calandra began construction of a large $2 million laboratory and made two executive appointments: Moreno Keplinger as Manager of Toxicology and James Plank as Group Lead of Rat Toxicology. Donovan E. Gordon joined IBT as a pathologist in August 1971, and IBT finalized its safety analysis of PCBs in November 1971. During Gross' physical inspection of the laboratory, he gained access to the study's raw safety data and found frequent references to an unknown acronym, "TBD/TDA," which he said perplexed him until learning that it denoted a testing animal whose body had "too badly decomposed." 1977–1983: Investigation, indictment, notoriety Revelations of suspected scientific misconduct would go on to be presented in March 1977 at Senate Subcommittee on Health and Scientific Research hearings held by U.S. Senator Ted Kennedy (D-MA), in which the integrity of safety data produced by IBT, as well as G. D. Searle & Company and Biometric Testing, Inc., was publicly called into question by FDA officials. Plank parted ways with IBT in April, and Philip Smith, who would later testify against the laboratory, was "fired and given 20 minutes to clean out his office" in approximately June 1977. IBT was criminally implicated in 1977 for producing fraudulent studies on widely used household and industrial products, including Nemacur, Sencor, Naprosyn, and trichlorocarbanilide. The magnitude of IBT's scientific misconduct was considered to have been extensive: 618 of 867 (71%) of studies audited by the FDA were invalidated for having "numerous discrepancies between the study conduct and data." Consequently, IBT would later be described as being "at the center of one of the most far-reaching scandals in modern science, as thousands of its studies were revealed through EPA and FDA investigations to be fraudulent or grossly inadequate." Although the criminal case against IBT and its employees was proceeding, information about which chemicals were "suspect" because of IBT's misconduct was kept confidential by the Canadian and American government agencies responsible to regulating them. In early 1980 the Regina Leader-Post obtained a Canadian government agency list of 106 chemicals about which there were concerns. They were convicted after one of the longest criminal trials in US history, involving six months of testimony and nearly eleven days of jury deliberation. At the time it was regarded as "the most massive scientific scandal in the history of this country and perhaps the world." ==Federal trial==

Following the 1981 grand jury indictment of several key IBT officials, a federal trial began on April 4, 1983, to evaluate whether IBT had committed scientific fraud. According to a May 13 article in The Wall Street Journal, "investigators charged that three big chemical companies—[Monsanto, Olin Corporation, and FMC Corporation]—knowingly submitted flawed data to the EPA in support of a widely used swimming pool chlorinator that was suspected of causing kidney and bladder problems." All three companies denied allegations of wrongdoing and reaffirmed the safety of their products. On May 25, Cornelius Garrett testified that "[no] research animals survived the entire testing period" for either Sencor or Nemacure. Garrett also testified that Smith instructed him to falsify subject data, which he said was a "common practice". Smith testified that he was himself instructed by Wright to similarly falsify data on trichlorocarbanilide tests. Calandra requested a mistrial to have cardiac surgery and received approval on July 11. Keplinger, Plank and Wright resultingly argued that they should also receive a mistrial because his absence would undermine their case, but their request was denied on July 12. Testimony drew to a close on September 22. The case was decided by John Albert Nordberg on October 21, 1983. ==Aftermath==

The United States Environmental Protection Agency (EPA) announced on July 11, 1983, that 34 pesticides would be pulled from the market unless manufacturers provided additional safety data within 90 days, although an indefinite exception was made for those who committed to do so at a later time. Environmental organizations characterized the EPA's response as insufficient and negligent, expressing a desire for more decisive action. The Law Reform Commission of Canada noted in a 1987 report that Canadian agriculture's increasing dependence on pesticides had led to inaction against many of those approved on the basis of IBT's research data. Agriculture Canada banned use of Reglone until further safety testing could be conducted and evaluated by Health and Welfare Canada, though application of the chemical continued illegally on a significant majority of lentils produced. Chlorbromuron, cyprazine, dinitramine, and phosphamidon were also banned "because their manufacturers did not promise replacement studies," with Allidochlor and Captan being restricted. ==Clientele==

According to various reports, IBT's clientele included a wide variety of companies such as 3M, American Cyanamid, American Seed, Avitrol Corp, BFC, Black Leaf Chemical, Buckman, Casoron, Chemagro, Chevron, Ciba‑Geigy, Conrel, Diamond Shamrock, Dow Corning, DuPont, FMC, Glyco, Gulf, MGK, Mobay, Mobil, Monsanto, Montedison, Nissan, Noram, Olin, Penwalt, Procter & Gamble, PPG, Sandoz, Shell, Thompson-Hayward, Uniroyal, Upjohn, US Borax, Velsicol Chemical Company, Vertac Chemical Corporation, and Zoecon, as well as the United States Army, the Department of Defense, the Environmental Protection Agency, the Food and Drug Administration, the National Cancer Institute, and the World Health Organization. ==Associated substances==

Polychlorinated biphenyls Eric Francis and Marie-Monique Robin have cited IBT's research into the safety of polychlorinated biphenyl, which was not investigated, as also being potentially fraudulent. Philip Smith later testified on October 28, 1991, during a court case against Monsanto, that he had observed PCB data falsification during his employment as an assistant toxicologist at IBT. Other In April, 1980 the Regina Leader-Post obtained and published a Canadian government list of more than 97 chemicals tested by IBT for which studies were considered "suspect". In June, 1980 an additional nine chemicals were added. IBT performed safety tests on Dinoseb, which was later discovered to cause birth defects and then pulled from the U.S. market in 1986. IBT also originally evaluated the safety of atrazine, a herbicide now thought to be an endocrine disruptor, suspected carcinogen, and possible teratogen. ==See also==