Genetic ID Neutral in Testing of Food
BILL WITHERSPOON / Letters to the Editor / Wall Street Journal 18oct00
In response to Holman Jenkins's Oct. 4 Business World column "Eek! Attack of the Perfectly Harmless Tacos!" (below) criticizing Dr. John Fagan and Genetic ID:
The "original charge against Kraft" did not, as he states, come from Dr. Fagan or from Genetic ID. As reported, Friends of the Earth submitted samples to Genetic ID and requested DNA testing for the presence of StarLink corn. Confidential assay reports were then sent to Friends; what followed was its responsibility. To release a client's confidential information to anyone other than that client is opposed to both our ethics and our operating procedures.
Genetic ID is not Dr. Fagan's "latest gambit . . . to turn public fear into gold." Genetic ID LLC. was founded in 1996 by three businessmen for genetic testing of food. Dr. Fagan provided technology, but received no salary and had no ownership in the company. In July 1998, Genetic ID was reorganized as Genetic ID Inc., a neutral, independent DNA testing lab; at that time Dr. Fagan became an owner and employee.
The food industry represents 99.99% of our testing client base. Governments, media and consumer groups that test with us sometimes make the results public for their own purposes. The resulting publicity that may occur is not part of our marketing campaign, as Mr. Jenkins implied.
Finally, Mr. Jenkins questions the accuracy of test results of a taco shell "where the genetic material is subjected to grinding and cooking." Our result indicating the presence of StarLink corn in taco shells has been confirmed by Kraft and the FDA.
Bill Witherspoon
President and CEO
Genetic ID Inc.
Fairfield, Iowa
Eek! Attack of the Perfectly Harmless Tacos!
HOLMAN W. JENKINS JR. / Wall Street Journal 4oct00
It took Kraft about two days to begin carting back millions of taco shells believed to have been slightly tainted by a genetically-modified corn variety not yet approved for human consumption. But before succumbing to hysterics, we should consider what's already in the taco supply.
In every 50 grams of cornmeal (the primary ingredient in tacos) the FDA will allow one "whole insect," 50 insect fragments, two rodent hairs, or one "rodent excreta fragment." Similar standards apply to other foods such as Macaroni, a package of which may contain 225 insect fragments and 4.5 rodent hairs per 225 grams.
And if you are in doubt about what manner of winged creature has been injecting debris into your breakfast puffs, the FDA is happy to refer you to a research article entitled "Distinguishing Common Food-contaminating Bat Hairs from Certain Feather Barbules."
You may be looking more suspiciously at your lunch right now, but it has reason to eye you warily too. Studies find that while hamburger contains dioxin in concentrations of 1.9 parts per trillion, that's below the nine parts per trillion found in the average human being.
Not that we're blaming Kraft for following in the tradition of Gerber, Heinz, Frito-Lay and other companies that lately have decided not to risk a fight with consumers over the acceptability of GMOs, or genetically modified organisms. These companies and their ilk spend $35 billion a year promoting food products to U.S. consumers, a sum that dwarfs the annual sales and market cap of the seed industry. Their executives aren't going to fall on their swords for the ag science boys.
No doubt we can find ways to measure ever more minute traces of contaminants. Yet even the FDA frankly acknowledges that its concern for rodent hairs and the like is "aesthetic." The major source of risk in the food supply is living microbes like salmonella and e.coli. Nearly one American in two claims to have been felled by food poisoning at least once and bacteria are almost always the culprit.
Sure, go ahead and impose an "aesthetic" limit on how much "unapproved" genetically engineered crop material may get into food. We're still talking about corn being contaminated by corn.
Not adequately flagged by the network news, the original charge against Kraft comes from John Fagan, the dean of Maharishi University, a devotee of "vedic" medicine and opponent of biotech. His latest gambit has been to turn public fear into gold by creating a company, Genetic ID, to test for GMOs. Kraft's embarrassment has become Mr. Fagan's marketing bonanza. Yet testing methods are iffy enough when applied to the raw commodity. We're entitled to wonder how exacting the results are when applied to a taco shell, where the genetic material has been subjected to grinding and cooking.
At worst, the offending "StarLink" variety seems to have been present in concentrations of around 1%. But only a single protein, Cry9C, stands between the corn and approval for human consumption. EPA says the protein resembles a known human allergen. Testing for the possibility makes perfect sense, but StarLink has been out there for three years, approved for animal feed and ethanol, and we just have to think that it's been eaten by enough people that if they were getting sick we'd know.
In any case, we're worrying about the leakage of infinitesimal amounts of one protein among the dozens of proteins in corn. If a single Kraft employee exacerbates his hernia schlepping the shells out of the stores, the recall will have posed a far worse health crisis for America than the shells ever did.
Why StarLink hasn't been approved for wider use is another question. StarLink's protein acts at a different site in the innards of the targeted pest, the European corn borer, compared to other, "approved," gene-altered corn varieties. Potentially it offers an alternative to planting large reserves of conventional corn to maintain a mating stock of susceptible bugs. Such insect "refuges" suddenly have become a hot topic inside the EPA. Just two months ago the agency issued stiff new rules requiring farmers to plant refuges of at least 20%.
As with Coca-Cola's surrender over a tainted-beverage scare in Europe last summer, Kraft will plead "sorry" and ask questions later. Cleverly beating a retreat to the front of the mob, the company has even begun calling for more regulation of biotech products.
There are real concerns with biotech, but these involve genetic "outcrossing" and problems of breeding hardier strains of pests. Trying to make it a food-adulteration issue is a non sequitur, though this has become the principal tactic of the technology's opponents.
That said, labeling is bound to come and labeling would be a good thing, converting an involuntary experiment into a voluntary one. When most consumers discover they haven't sprouted a second head or given birth to fish larvae, they will lose whatever fears they had about gene-splicing.
Then, as it properly should, the cost of maintaining a "GMO-free" food channel will fall on those who care about such things. Two au naturel California grocery chains, Whole Foods and Wild Oats, already boast "gene-free" private label lines. Not for nothing is 76% of the Kosher food in this country bought by non-Jews. People choose the authority they trust and buy accordingly. This is pluralism at work and no bad thing.
To date, genes have been transplanted primarily to allow farmers to produce food more cheaply. Coming next are plants and animals modified to give them nutritional and medicinal characteristics that consumers will be expected to pay more for. Notably because these do not enhance the evolutionary fitness of the creature, the chances are vastly reduced of outcrossing of the gene traits.
Once these products reach the public, the anti-biotechs can coalesce with the Christian Scientists, forswearing medical modernity for religious reasons. The GMO controversy will have run its course. We can move on to something else, like fear of an asteroid crashing into the earth.
Detection of StarLink Corn in Taco Shells
Genetic ID Release (from website 20oct00 undated)
There has been widespread media coverage resulting from the announcement by one of Genetic ID's testing clients that we had detected StarLink corn in a sample of taco shells. While our confidentiality policy prohibits us from discussing even the names of our clients, let alone test results, in this case our client has given us permission to publicly discuss the details of these tests.
In August, Friends of the Earth contracted with Genetic ID to perform a Varietal IDSM test on taco shells, specifically screening for the StarLink variety of corn. Seven boxes of taco shells purchased from food stores in the Washington, D.C., area, each containing 12 shells, were submitted for testing. Three production lots and expiration dates were represented by these samples. Four of the boxes were from a single lot, two from another, and one box from a third.
Our test identified the presence of StarLink corn at a concentration of about 1%. We repeated the test three times; each test was run in duplicate. All six duplicate tests confirmed the presence of StarLink at 1%.
Genetic ID's specific detection methods, used in these tests, have been accredited by the internationally recognized United Kingdom Accreditation Service (UKAS). UKAS based its accreditation on (1) inspection of Genetic ID's laboratory facilities; (2) in-depth evaluation of the analytical procedures; and (3) review of extensive validation data.
Neutrality of Genetic ID
Genetic ID is an impartial laboratory, dedicated to serving the needs of its clients. We do not participate or take a stance in the debate over genetically modified foods. More than 99.9% of all tests performed by Genetic ID are submitted by food growers, processors, and manufacturers. However, on rare occasion, we are asked to perform tests for governments, consumers groups, and the press.
We provide the same high-quality analytical services to all clients, focusing on scientific rigor, strict confidentiality, and the highest quality service. Impartiality is ensured by a number of measures. For instance, before a sample is sent to the lab for analysis, our order processing department replaces all information that could identify the client or brand with a coded label, thus ensuring that lab personnel will not be biased during analysis by client identity.
Industry Response to the Discovery of StarLink in Taco Shells
The announcement by Friends of the Earth that StarLink was discovered in human food has certainly had unwelcome repercussions for companies engaged in developing transgenic foods. The most obvious of these repercussions has been increased consumer concern about genetically modified foods and government scrutiny.
With many millions of dollars in development costs at stake, some of these same developers have attempted to divert public attention from the central concerns raised by this finding by casting doubt on Genetic ID's reliability and objectivity. In fact, no laboratory in the world offers more robust and objective GMO testing, a claim born out by both by the independent confirmation of our findings by Kraft and the United States Food and Drug Administration, as well as by our Global Laboratory AllianceSM of independent laboratory licensees, which utilize our proprietary testing methods.
Genetic ID is committed to providing the food and agricultural industries with the most advanced and reliable testing technology and professional services available anywhere. We are not funded by, nor do we support, any individuals, companies, or organizations on either side of the biotech debate. And while it is natural that individual employees of Genetic ID have differing views about genetically modified foods, our company is firmly committed to leaving the GMO debate to others. Instead, we will continue to focus our attention on providing companies at all levels of the supply chain with the expert support needed to operate safely in today’s increasingly complex, high-tech marketplace.
StarLink Analytical Method Summarized
Genetic ID milled the contents of all seven boxes of taco shells, grinding the product into a homogenous fine powder, and extracted DNA from two representative samples of this powder, using verified reagents.
PCR analysis was carried out with these DNA samples, and with a series of quantitative external reference standards. We used several primer sets for these analyses, including the following:
- Primers specific for a species-specific reference gene. We used a primer set that detects the DNA of all corn varieties, conventional as well as genetically modified. When we carried out PCR reactions with this set of primers, we learned that the taco shell DNA was clearly derived from corn, and that it was sufficiently intact to allow us to effectively analyze it by PCR.
- Primers specific for an internal control. For these control PCR reactions, we added a known quantity of a DNA molecule that is not normally found in foods to a test tube containing the taco DNA sample. This second DNA molecule functions as an internal control, and is recognized by the internal control primer set. By assessing the efficiency with which this internal control DNA is amplified during PCR in the presence of the taco shell DNA, we were able to learn whether or not inhibitors to the PCR process are present in the taco shell DNA preparation. What we found was that the taco shell DNA was free from inhibitors that might interfere with the PCR analysis.
- Primers specific for the StarLink corn variety. Two StarLink-specific primer sets were used. These primer sets have been empirically verified to interact only with StarLink DNA and not with any other variety of genetically modified corn currently commercialized in the US. Furthermore, it has been verified empirically that these primer sets do not interact with any other genetically modified product, such as genetically modified soy, canola, potatoes, etc. When PCR reactions were carried out with taco shell DNA using these primers, PCR products were produced that were of the size expected for StarLink corn. These two primer sets scanned for different DNA sequences, both of which were unique to StarLink corn. We carried out DNA sequencing on one of these PCR products, and found that the sequence was identical to that expected for StarLink corn. This confirms that this primer set accurately detected StarLink-specific DNA in the taco shell sample. Comparing the PCR products generated from the taco shell DNA to those generated with a set of quantitative external standards (a series of samples with known concentrations of StarLink corn DNA, e.g., 0.1%, 1%, etc.) indicated that the taco shell sample contained about 1% StarLink corn.
- Primers specific for another genetically modified DNA sequence that would be expected in StarLink corn. The cauliflower mosaic virus 35S promoter is a DNA sequence that is found in many genetically modified crops, including StarLink. We tested taco shell DNA samples with a primer set specific for the 35S promoter. These PCR reactions revealed that the 35S promoter was present in the taco shell DNA. Comparison of the PCR products from the taco shell DNA to the PCR products generated using a set of external reference standards (a series of samples with known concentrations of genetically modified corn DNA, e.g., 0.1%, 1%, etc.) revealed that the level of genetically modified material in the taco shells was in the range of 1%. This confirmed results obtained with the StarLink-specific primer sets (Point #3, above).
All of the controls, standards, and reactions, described above were run in duplicate, and the results obtained with all reactions were consistent, in duplicate, and lead to the conclusion that we reported to the client: StarLink corn is present in taco shell sample at about 1%.
A total of three independent tests were carried out, all in duplicate, thereby strongly confirming our results.
Based on these results, Genetic ID is confident in the analytical methods used, and in the results obtained with the taco shell DNA samples. We invite you to take a deeper look at our methods, by reviewing our Analytical Methods paper.
Our Founder | John Fagan
Dr.
John Fagan has spent more than twenty years employing cutting-edge
molecular genetic techniques for both cancer research and detection of
genetically modified crops and foods. He earned a bachelor of science
(cum laude with distinction in chemistry) from the University of
Washington and a doctorate in biochemistry and molecular biology from
Cornell University. He then spent seven years doing research in
molecular biology at the National Institutes of Health (NIH), first as a
postdoctoral fellow and then, from 1980 to 1984, leading his own
research group under NIH grants.
After leaving the NIH, Dr. Fagan received more than $2.5 million in research grants from the National Cancer Institute. These grants supported DNA research, whose long-term goal was to identify cancer susceptibility genes and to understand how carcinogens and environmental pollutants such as dioxin influence gene expression. He has authored more than thirty technical articles on these topics, which have been published in internationally recognized, peer-reviewed journals, including Molecular and Cellular Biology, Journal of Biological Chemistry, Journal of Molecular Biology, and Biochemistry.
From 1991 to 1995 Dr. Fagan was the recipient of the prestigious Research Career Development Award from the National Cancer Institute, an award that is given directly to promising scientists to enhance their professional development.
Dr. Fagan made use of his decades of research experience in molecular biology when in 1996 he developed highly sensitive and accurate methods for detecting and quantifying genetically engineered organisms in foods and ingredients. He founded Genetic ID, Inc., the first international company to offer analytical services for genetically engineered foods and agricultural products. Dr. Fagan is chairman and chief scientific officer of Genetic ID, which licenses these technologies to laboratories in countries around the world.
Since that time Dr. Fagan has taken an active role in working with governmental agencies, as well as governmental and commercial laboratories in the U.S., Europe, Japan, and elsewhere around the globe. His goal has been to develop, implement, and validate procedures for analyzing genetically engineered foods.
Dr. Fagan serves as a scientific consultant on health and environmental issues and as an editorial advisor and reviewer for scientific journals. He has also served on committees for the peer review of federal government-sponsored research grants.
During the last two years, Dr. Fagan’s work has taken him to Australia, Austria, Belgium, Brazil, Croatia, Denmark, England, France, Germany, Indonesia, Ireland, Italy, Japan, the Netherlands, Northern Ireland, Norway, Sweden, and Switzerland, as well as many cities in Canada and the United States. During these visits Dr. Fagan met with legislators, government representatives, leaders in the scientific community, and the public. He is a frequent speaker at international scientific and professional conferences and often speaks to students, civic groups, and organizations involved in food, the environment, agriculture, and health. He has also made presentations to national and international regulatory bodies, such as the U.S. Department of Agriculture, the U.S. Food and Drug Administration, committees of the Codex Alimentarius Commission, and the Convention on Biological Diversity.
Dr. Fagan has been interviewed by major media worldwide, including the Wall Street Journal, New York Times, Christian Science Monitor, Washington Post, Boston Globe, Los Angeles Times, Chicago Tribune, International Herald Tribune, Independent, Des Moines Register, Minneapolis Star Tribune, L’Express, Science, Elle, numerous trade and industry journals, ABC Nightline, CBS and NBC national news, and PBS Nightly Business Report
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