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Re: [SANET-MG] Biotest Lab- pesticide fraud of 1970s
HI Hector,
Enclosed below is the Monsanto explanation of the involvement of
glyphosate in the IBT fraud. I understand the president of IBT was
convicted and given a prison term, but he never served a day because his
heart was bad. sincerly, prof. joe cummins
Backgrounder
Testing fraud: IBT and Craven
February 2002
Monsanto Company
I
BT Laboratories
I
n 1976, during a routine inspection of a testing company named
Industrial Bio-Test Laboratories (IBT), the U.S. Food and Drug
Administration (FDA) uncovered discrepancies between raw data and
reports of pesticide toxicology studies IBT had conducted. As a result,
the U.S. Environmental Protection Agency (EPA) ordered an audit of all
IBT studies conducted in support of pesticide product
registration. Monsanto was one of several pesticide manufacturers who
had used IBT test results.The audit found some toxicology studies
conducted with the original Roundup® herbicide to be
invalid.As a result, Monsanto repeated all the studies in accordance
with applicable EPA testing guidelines.
Today, no IBT-generated data are used to support glyphosate registration
anywhere in the world.
Craven Laboratories In 1990, the pesticide industry was once again the
victim of testing fraud. This time, the studies were
not toxicology studies but analyses to determine the amount of pesticide
residues in treated crops. A pesticide industry task force discovered
irregularities in testing conducted at Craven Laboratories of
Dallas, Texas, and alerted the EPA. An investigation was initiated.
The U.S. Department of Justice announced February 25, 1994, that Don
Craven, company president, and 14 former employees of Craven
Laboratories received punishments ranging from fines to prison
terms following their convictions on charges of falsifying pesticide
residue tests conducted over a 10-year period.Hundreds of residue
studies for Monsanto agricultural products, required for product
registration by the EPA, have been completed by Monsanto or by one of 16
independent laboratories that are used
under contract. Of these, a small fraction were conducted at Craven
Laboratories.Monsanto, along with other pesticide manufacturers,
repeated the pesticide residue studies conducted at Craven Laboratories.
The repeat studies cost Monsanto approximately $6.5 million.
The damage caused to Monsanto's reputation by discussion of this issue
by the media, and then further use by activists to question the
integrity of Monsanto’s data, cannot be calculated. All affected
residue studies have been repeated and the data are sound, up-to-date
and have been accepted by the EPA.
After the testing problems, the EPA instituted procedures known as Good
Laboratory Practices, which
are designed to ensure reliable generation and verification of all data.
The penalties for falsifying data
are severe, including large fines and prison terms.
Hector Valenzuela wrote:
Aloha all,
Does anyone have insight, references, on the Biotest Lab (private lab)
pesticide fraud case of the 1970s? Fraudalent/biased safety research is
more of a concern today when corporations are allowed to conduct their
own testing w/ respect to the safety of pharmaceuticals/gmos.
FYI, an old article from the Washington Post below.
Thank-you for any leads.
Hector Valenzuela
Univ. Hawaii-Manoa
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Copyright 1977 The Washington Post
The Washington Post
September 8, 1977, Thursday, Final Edition
SECTION: First Section; A11
LENGTH: 749 words
HEADLINE: Wide Errors, Possible Fraud Found in Private Lab Testing
BYLINE: By Bill Richards, Washington Post Staff Writer
BODY:
Federal investigators have uncovered widespread flaws and in some cases
possible fraud in private testing laboratory results that form the data
base for much of the government's chemical, drug and pesticide safety
standards.
Information gathered by the Food and Drug Administration on test
procedures by three private laboratories has been turned over to Justice
Department officials in Chicago and New Jersey, according to federal
officials. The investigations began last year.
Officials involved in the investigations by both the FDA and the
Environmental Protection Agency said the faulty test results could cause
problems in determining whether some products already approved for the
marketplace are safe.
"Based on what we've found so far there is a serious question about the
data generated by any private testing laboratory," and FDA official said
yesterday. "We don't know what data is bad but at the same time we don't
know what is good either."
Last month EPA announced it had found "deficiencies" in tests performed
for pesticide firms by Industrial Biotest Laboratory of Northbrook, Ill.
The suburban Chicago laboratory ran 3,400 pesticide tests and has done
other types of testing for a wide variety of manufacturers dealing with
federal agencies such as FDA and the National Cancer Institute.
Federal officials who declined to be identified, said virtually every
major or "pivotal" study done by IBT has shown serious flaws. The
laboratory is one of the firms referred to the Chicago U.S. attorney's
office for further investigation based on the FDA's investigation.
EPA officials said they have found at lest four other testing
laboratories with suspect testing results. The four firms, officials
said, have conducted a total of 4,000 animal tests for pesticide firms
which in turn were used by EPA to set safety standards.
"We're looking at IBT as just the tip of the iceberg," said Edwin L.
Johnson, EPA's pesticides chief. "There is no indication that the rest
of the industry runs its business any differently that IBT does."
The other two firms identified as having been referred to Justice
officials for further action are G. D. Searle & Co., a leading
pharmaceutical manufacturer, and Biometric Testing Inc. of Englewood
Cliffs, N.J.
IBT and Searle have denied manipulating test data. Bimetric could not be
reached for comment.
The Searle firm was the subject of extensive hearings last year by the
Senate Health and Administrative Practice and procedure subcommittees.
At those hearings subcommittee Chairman Sen. Edward M. Kennedy (D-Mass.)
sharply questioned the entire animal research industry. The hearings
touched off the FDA's investigation into testing laboratories, FDA
officials said.
Federal officials estimate that there are about 700 private testing
laboratories scattered around the United States. Most do only a few
animal studies on contract to commercial manufacturers. But some, such
as IBT, offer a wide variety of testing services.
EPA officials said they are preparing a spot-check program of as many as
100 laboratories which do pesticide testing for commercial
manufacturers. The agency has already notified 33 pesticide makers to
review their own data supplied by IBT, and plans to call on as many as
100 more for similar in-house reviews.
The spot checks by the agency will be full-scale audits matching raw
data complied by testing laboratories with the final reports they submit
to manufacturers, EPA officials said.
Similar audits already run on some pesticide testing labs have turned up
test animals which were reported to have died one week and then been
alive the next officials said.
The officials said a large number of the pesticide products tested by
lags which have turned up suspect results are used on crops grown for
human consumption.
FDA officials appeared split over the seriousness of the laboratory data
findings. One official, who asked not to be named, said the pattern of
the test data deficiencies appeared "mind boggling."
Ernest Brisson, coordinator of the FDA's toxicological laboratory
inspection program, however, said the FDA's findings so far were not
overly disturbing. "We expected worse," Brison said.
In its first 40 laboratory examinations, Brisson said, FA investigators
had to notify five firms of "serous deficiencies."
He acknowledged that the early inspections were superficial and were
done by inexperienced inspectors. ""We're learning as we go along," he
said.
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