Craven Laboratories was an American research company based in

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History

Craven Laboratories was the first chemical testing lab charged in the

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following establishment of the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

's Good Laboratory Practices regulations.

Scientific fraud

Investigation

The

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announced on March 1, 1991, that it was investigating Craven Laboratories for "allegedly falsifying test data used by chemical firms to win EPA approval of pesticides." The investigation was coordinated by the

EPA The Environmental Protection Agency (EPA) is an independent executive agency of the United States federal government tasked with environmental protection matters. President Richard Nixon proposed the establishment of EPA on July 9, 1970; it be ...

Office of Prevention, Pesticides, and Toxic Substances, DOJ Environmental Crimes Division, and the

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Indictments

In 1991, a

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indicted the laboratory's owner, Don Allen Craven, with felony counts of conspiracy, mail fraud, making false statements, concealment of material facts, and obstructing EPA proceedings. The head of the Quality Assurance Unit was also charged, as were several lab technicians.

Scope

At least 48 chemicals were approved on the basis of Craven's fraudulent research, 28 of which remained on the market in

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as of 1993. In total, the FDA reported that Craven performed safety analysis for 262 companies.

Aftermath

Following conclusion of the EPA's investigation, the Department of Justice announced on February 25, 1994, that the president of Craven Laboratories and fourteen of its former employees were adjudged guilty for the falsification of research data. Monsanto has stated the Craven Labs investigation was started by the EPA after a pesticide industry task force discovered irregularities, that the studies had been repeated, and that Roundup's EPA certification does not now use any studies from Craven Labs.

Legal cases

Following Craven Laboratory's investigation, 11 multinational corporations filed suit against Craven for losses secondary to its misconduct.

References

Contract research organizations Scientific misconduct incidents {{US-company-stub