Craven Laboratories was an American research company based in
Austin, Texas
Austin ( ) is the List of capitals in the United States, capital city of the U.S. state of Texas. It is the county seat and most populous city of Travis County, Texas, Travis County, with portions extending into Hays County, Texas, Hays and W ...
.
History
Craven Laboratories was the first chemical testing lab charged in the
United States
The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic of 50 U.S. state, states and a federal capital district, Washington, D.C. The 48 ...
following the 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 respo ...
's
Good Laboratory Practices regulations.
Scientific fraud
Investigation
The
Environmental Protection Agency 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 Office of Prevention, Pesticides, and Toxic Substances,
DOJ Environmental Crimes Division, and the
United States Attorney
United States attorneys are officials of the U.S. Department of Justice who serve as the chief federal law enforcement officers in each of the 94 U.S. federal judicial districts. Each U.S. attorney serves as the United States' chief federal ...
.
Indictments
In 1991, a
federal grand jury 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
New Zealand
New Zealand () is an island country in the southwestern Pacific Ocean. It consists of two main landmasses—the North Island () and the South Island ()—and List of islands of New Zealand, over 600 smaller islands. It is the List of isla ...
as of 1993.
In total, the FDA reported that Craven performed safety analysis for 262 companies.
Aftermath
Following the 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
The Monsanto Company () was an American agrochemical and agricultural biotechnology corporation founded in 1901 and headquartered in Creve Coeur, Missouri. Monsanto's best-known product is Roundup, a glyphosate-based herbicide, developed ...
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.
See also
*
Good Laboratory Practice The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical (non-pharmaceutical) health and environmental safety–or simply toxi ...
*
Industrial Bio-Test Laboratories
*
Pesticide regulation in the United States
Pesticide regulation in the United States is primarily a responsibility of the Environmental Protection Agency (EPA). In America, it was not till the 1950s that pesticides were regulated in terms of their safety. The Pesticides Control Amendment ...
References
Contract research organizations
Scientific misconduct incidents
{{US-company-stub