Genetic Engineering Error
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. RACHEL'S ENVIRONMENT & HEALTH WEEKLY #549 .
. ---June 5, 1997--- .
. HEADLINES: .
. GENETIC ENGINEERING ERROR .
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GENETIC ENGINEERING ERROR
According to the St. Louis POST-DISPATCH, Monsanto, the St. Louis
chemical and biotechnology giant, last month announced it had
recalled "small quantities" of a genetically engineered canola
seed containing an unapproved gene that had gotten into the
product by mistake. Canola is a crop grown for livestock feed,
and for oil consumed by humans. The canola-recall story, only 84
words long, was buried in the POST-DISPATCH April 18, under a
confusing headline, deep in a news-wrapup column on the business
Putting the wrong gene into a commercial product by mistake is
precisely the kind of error that opponents of genetic engineering
have been predicting for a decade. Proponents of genetic
engineering have said it could never happen because of rigorous
quality-assurance by the industry itself and tight regulation by
The recall was reportedly initiated by Monsanto Canada Ltd., and
by Limagrain Canada Seeds, Inc., of Saskatoon, Saskatchewan,
which was selling the seed under license from Monsanto. The
recalled canola seed was "Roundup ready" --meaning it had been
genetically engineered to withstand dousing with Monsanto's
herbicide, glyphosate, which is marketed under the trade name
Roundup. Since February, 1996, Monsanto has been marketing
various genetically-engineered crops that are "Roundup-ready" in
an effort to boost sales of Roundup, the herbicide responsible
for a large proportion of Monsanto's annual profits. (See REHW
#521.) The idea is to douse Roundup-ready crops with Roundup to
kill weeds, leaving the genetically-engineered crop intact.
According to the Associated Press, Monsanto refused to disclose
how much genetically misengineered canola seed is being recalled,
but said the amount was "small."
Canadian government officials say the quantity being recalled is
not small. Brewster and Cathleen Kneen, publishers of the RAM'S
HORN, a Canadian newsletter devoted to analysis of the food
system, said that, in mid-April, Monsanto reported to the
Evaluation Branch of the Biotechnology Strategies and
Coordination Office of the Canadian government that it was
recalling 60,000 bag units of two types of canola seeds (types
LG3315 and LG3295) because one or both types contained the wrong
gene. Thus the amount recalled is sufficient to seed 600,000
to 750,000 acres of land. According to RAM'S HORN, some of the
seed had already been planted when Monsanto discovered the
The MANITOBA CO-OPERATOR, a Canadian agricultural newspaper,
quoted Ray Mowling, a Monsanto spokesperson, saying, "In some
recent quality assurance testing by us, we've identified that
there's a possible variety contamination." Brewster Kneen of
RAM'S HORN points out that it takes a long time to produce enough
Roundup Ready seed for 600,000 acres, so this error went
undetected for a substantial period.
Under Canadian law, there are three levels of approval for
genetically engineered crops: environmental (meaning the crop can
be planted), livestock (the resulting crop can be fed to
livestock), and human (the resulting crop can be fed to humans).
Two Roundup-resistant canola genes, RT-73 and RT-200, had been
approved for planting, but only RT-73 was approved for livestock
and humans. It was the unapproved RT-200 that somehow ended up
in the seed that had to be recalled. "The preliminary testing
showed it to be the wrong configuration, as opposed to the one
approved," Monsanto's Mowling said.
Canola oil is used in low-fat foods, pharmaceuticals, nutritional
supplements, confectionery products, margarine and shortening,
personal care products, lubricants, soaps, and detergents.
The presence of the unapproved canola gene in a commercial
product reveals, at a minimum, that Monsanto's quality-assurance
programs failed in this instance, and that the biotechnology
regulatory system in Canada is ineffective. The regulatory
system in the U.S. is more lax than Canada's.
Limagrain's Gary Bauman said his company will try to discover how
the mistake occurred. However, he said it will be difficult to
trace exactly where in the process it happened because the seeds
available for testing now are progeny (offspring) of the original
seeds. "We may never know how it happened," he said.
Bauman later seemed to lay the blame squarely on Monsanto. He
said only Monsanto has the expertise to detect genetic
differences between seeds. "The apparent contamination,
discovered by Monsanto, is something only they are able to
detect. We are not even allowed to try to investigate how to
look at and discover this gene within our own varieties," Bauman
Recent history reveals that serious problems may occur when a
genetically engineered product appears on the market without
adequate testing. In 1989, a Japanese firm marketed an amino
acid, L-tryptophan, which was produced from a
genetically-engineered bacteria.[6,7,8] Unexpected trace
contaminants --not all of which were ever identified chemically
--appeared in the final product and an estimated 5 to 10 thousand
people in the U.S. fell ill with a new and exceedingly painful
disease called eosinophilia-myalgia syndrome (EMS). At least 37
people died and thousands more were disabled. Something in the
biotech-produced L-Tryptophan attacked people's immune systems.
Their joints and muscles ached excruciatingly. Their limbs
swelled. In many respects, their disease resembled scleroderma.
Studies of the new EMS disease revealed that people with the
disease most likely got it from L-tryptophan produced by the
fifth genetically-engineered version of a bacteria (called
BACILLUS AMYLOLIQUEFACIENS V).[10,11] Unfortunately, the company
producing the L-tryptophan made other changes in its production
process when it introduced the new bacteria, so researchers have
never been able to discern whether the disease was caused by the
changes in production methods or by the genetically-altered
bacteria (or both).
In any case, it is crystal clear that genetically-engineered
products need extensive testing before their effects can be
understood. The simple view, that genes control only one
characteristic of a bacterium, plant or animal has been shown to
be false. Genes contain a potential that can be expressed in
various ways, depending upon the environment in which the gene
grows. Thus a gene may develop in one way in one environment and
another way in another environment. Testing in one environment
may not reveal what the gene will do when it finds itself in
another environment. This has been demonstrated elegantly by
Craig Holdrege in his book, GENETICS AND THE MANIPULATION OF
LIFE: THE FORGOTTEN FACTOR OF CONTEXT.
Furthermore, Danish researchers have shown that
genetically-manipulated genes (transgenes, they are called) in
crops can make their way into nearby weeds under field
conditions. Thus genetic errors, of the kind made in
Monsanto's canola seeds, may propagate into the environment and
permanently alter the natural world in ways that no one is
prepared to understand.
Still, Monsanto management has bet the company on biotech and has
announced plans to press ahead aggressively. Roundup is
Monsanto's best-selling and most profitable product, bringing
Monsanto about $1.5 billion per year. "Roundup is the engine
that's driving Monsanto," said Paul Raman, a chemical industry
analyst for the investment banking firm S.G. Warburg & Co.
"In five to 10 years Roundup could be a $4 billion product,"
Raman said. That extra money would come chiefly from expanding
sales of crops that are genetically engineered to resist the weed
Monsanto announced eight months ago that it is selling off its
chemical divisions in order to focus its business entirely on
"What you are seeing is the beginning of the agri-industrial
complex," Sano Shimoda, president of BioScience Security, Inc.,
an investment banking company focusing on the biosciences, told
BIOTECHNOLOGY NEWSWATCH, an industry newsletter.
"From the big picture standpoint Monsanto has the ability to be
the dominant biotech-based ag-food company in the world," Shimoda
To get a stream of genetically-engineered products to market,
Monsanto will need to convince the U.S. Food and Drug
Administration (FDA) that these products are safe for human
consumption. In the past, Monsanto has been able to do this
partly because former Monsanto officials have become FDA
officials, who have then been assigned to approve Monsanto
products--in some cases, the products they worked on while at
There can be no doubt that a high-level revolving door exists
between Monsanto and the administration in Washington. The
WASHINGTON POST reported April 21, 1997, that Marcia Hale,
President Clinton's assistant for intergovernmental relations,
would be taking a "sweet" job with Monsanto. She will coordinate
public affairs and corporate strategy in the United Kingdom and
Ireland for about six months. She will then come back to work
out of Monsanto's Washington office to handle international and
The St. Louis POST-DISPATCH reported May 17, 1997, that
Monsanto's vice-president, Virginia Weldon, is a "top candidate"
for the job of chief of the U.S. Food and Drug Administration
(National Writers Union, UAW Local 1981/AFL-CIO)
 "Argosy Names Perry New Chief Executive," ST. LOUIS
POST-DISPATCH April 18, 1997, pg. C1.
 Robert Steyer, "Monsanto Makes a Bestseller Better," ST.
LOUIS POST-DISPATCH January 21, 1996, pg. D1.
 Brewster Kneen, "Monsanto's Claims Overturned," RAM'S HORN
No. 147 (April 1997), pg. 1. RAM'S HORN is available each month
(11 months each year) for $20 per year from: Box 3028, Mission,
B.C. V2V 4J3 Canada. Checks should be made out to THE RAM'S
HORN. [This is one of the most interesting newsletters I have
seen in a long time.--P.M.] Mr. Kneen also quoted Sheri Haas with
the Evaluation Branch of the Biotechnology Strategies and
Coordination Office of Agriculture Canada, a federal agency: Room
3369, 59 Camelot Drive, Nepean, Ontario K1A OY9; telephone (613)
225-2342 ext. 4175; internet: email@example.com.
 Laura Rance, "Registration Suspended; Genetic mixup prompts
recall of Roundup Ready canola," MANITOBA CO-OPERATOR April 24,
1997. The MANITOBA CO-OPERATOR is published weekly by Manitoba
Pool Elevators, 220 Portage Avenue, P.O. Box 9800, Sta. Main,
Winnipeg, Manitoba R3C 3K7, Canada. Telephone: (204) 934-0401.
Our thanks to Cathleen Kneen of RAM'S HORN for a copy of Laura
 Brewster Kneen, "Misguided Canola--Update," RAM'S HORN No.
148 (May 1997) quoting Mary MacArthur, a reporter for the WESTERN
PRODUCER, which is published weekly by Western Producer
Publications, P.O. Box 2500, Saskatoon, Saskatchewan S7K 2C4,
Canada. Telephone: (306) 665-3500.
 P.F. D'Arcy and others, "L-tryptophan: eosinophilia-myalgia
syndrome," ADVERSE DRUG REACTIONS TOXICOLOGY REVIEW Vol. 14, no.
1 (1995), pgs. 37-43.
 Robert H. Hill, Jr., and others, "Contaminants in
L-Tryptophan Associated With Eosinophilia Myalgia Syndrome,"
ARCHIVES OF ENVIRONMENTAL CONTAMINATION AND TOXICOLOGY Vol. 25
(1993), pgs. 134-142.
 Larry Thompson, "Treating L-Tryptophan Patients; Side
Effects of the Over-the-Counter Drug, Now Banned, Are Long
Lasting," THE WASHINGTON POST, August 7, 1990, p. Z7 in the
 S.R. Ahmad and D. Clauw, "USA: EMS and L-tryptophan," LANCET
Vol. 338 (December 14, 1991), pg. 1512.
 E.A. Belongia and others, "An investigation of the cause of
the eosinophilia-myalgia syndrome associated with tryptophan
use," NEW ENGLAND JOURNAL OF MEDICINE Vol. 323 (1990), pgs.
 Arthur N. Mayeno and Gerald J. Gleich, "Eosinophilia-myalgia
syndrome and tryptophan production: a cautionary tale," TRENDS IN
BIOTECHNOLOGY Vol. 12 (September, 1994), pgs. 346-352.
 Craig Holdrege, GENETICS AND THE MANIPULATION OF LIFE: THE
FORGOTTEN FACTOR OF CONTEXT (Hudson, N.Y.: Lindisfarne Press
[RR4, Box 94 A-1, Hudson, NY 12534], 1996).
 Thomas R. Mikkelson and others, "The risk of crop transgene
spread," NATURE Vol. 380 (March 7, 1996), pg. 31.
 Mike Pezzella, "Monsanto to sell chem biz in bid to dominate
ag bio," BIOTECHNOLOGY NEWSWATCH October 21, 1996, pg. 1.
 Bill Lambrecht, "House Members Urge BST Inquiry; Conflict
Alleged in Three FDA Officials' Past Work for Monsanto," St.
Louis POST DISPATCH April 19, 1994, pg. 2A. And see: "3 FDA
Staffers Cleared in Milk Drug Probe," St. Louis POST DISPATCH
October 29, 1994, pg. 9A.
 Al Kamen, "THE FEDERAL PAGE--IN THE LOOP --Clinton Assistant
Going Private," THE WASHINGTON POST, April 21, 1997, pg. A15.
 Jerry Berger, "Dr. Weldon is Reported Top Pick to Head FDA,"
St. Louis POST DISPATCH May 20, 1997, pg. D1.
Descriptor terms: genetic engineering; biotechnology; canada;
canola; agriculture; farming; monsanto; limagrain canada seeds;
roundup; glyphosate; ram's horn; brewster kneen; cathleen kneen;
agriculture canada; tryptophan; l-tryptophan;
eosinophilia-myalgia syndrome; ems; emerging diseases; marcia
hale; virginia weldon; roundup ready;
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