by Jeffrey Smith
“Welcome to the year 2021. Genetically engineered wonder seeds lead to exploding crop yields.…But there’s a problem. When the wheat seed was modified, a long-dormant gene was activated causing severe allergic reactions in nearly 3 billion people. Years pass before the connection is made. By then, the world’s wheat supplies must be destroyed, and a global food shortage sets in.”
This was the scene described by the narrator of a Modern Marvels episode entitled Doomsday Tech, shown on the History Channel throughout the U.S. on December 28, 2004. Are similar disasters possible? Unfortunately yes, and new guidelines proposed by the Food and Drug Administration (FDA) increase the likelihood that GM crops will make people sick in new, hard-to-track ways.
Genetically modified (GM) crops may produce dangerous allergens or toxins that are difficult to detect. Since the FDA does not require safety testing and refuses to monitor the effects of GM foods on public health, the seeds for such a catastrophe might have already been sown.
While the seven approved, commercialized varieties of GM food crops (soy, corn, cotton, canola, Hawaiian papaya, zucchini and crook neck squash) may pose a greater threat to our health, increasing risk comes from more than 100 other GM species, not approved for human consumption, that have been planted in experimental field trials since 1987. About 40,000 test sites covering approximately half a million acres are virtually unregulated. Several are reported to have contaminated non-GM crops, but the overall extent of contamination is unknown and potentially widespread.
This makes the food and the biotech industries nervous, and rightly so. When a corn engineered to produce a pig vaccine contaminated half a million bushels of soybeans, the corn’s producer required a government bail out to pay nearly $3 million in fine and cleanup costs—a fraction of the cost if the drug had made it to grocery shelves. When StarLink™ corn, a potentially allergenic GM variety, did end up in the food supply, product recalls, lost exports, clean-up efforts, and lawsuits totaled about $1 billion.
On August 2, 2002, a White House directive issued by its Office of Science and Technology Policy (OSTP) told the FDA, USDA, and EPA to create ways that contamination from “field tests could be found acceptable.”  On November 19, 2004, the FDA proposed a “Guidance for Industry,” which acting FDA commissioner Lester Crawford described as “a high priority for the Administration and the industry, to enhance public confidence [and] avoid product recalls.” What the new guidance does not do, however, is protect public health. In fact, it does the opposite. If approved, it would increase the chances that the world food supply will suffer dangerous untraceable contamination.
The gist of the new draft guidance is this: A GM crop developer voluntarily provides the FDA with answers to two pages of questions. These may include the results of two superficial tests on their crop that take as little as 20 hours to complete. If crop contamination is later discovered, companies can claim that they have complied with FDA requirements and the agency can declare that their prior “evaluation” shows that the contamination will not cause harm. Armed with what appears to be a legal defense, companies would become less likely to spend the money needed to prevent contamination.
FDA Ignores Science
Biotech scientists insert genes into DNA to produce new proteins. According to the draft guidance, a new protein “might be an allergen or toxin.” That’s true. But the guidance also states that the “FDA believes that any potential risk from” contamination by GM field trials “would be limited to” this potentially allergenic or toxic protein.  That’s not true.
There is evidence of numerous other ways in which GM plants may create a health catastrophe. In the History Channel scenario, for example, “When the wheat seed was modified, a long-dormant gene was activated.” Later in the TV program, I am quoted describing one way this might occur: the promoter, which is inserted with the foreign gene to switch it on, might accidentally switch on other genes—permanently. This danger is not acknowledged in the guidance. Nor are other dangers described by FDA scientists in internal memos, made public by a lawsuit. The FDA’s Division of Food Chemistry and Technology, for example, predicted in 1991 that genetic engineering might create “increased levels of known naturally occurring toxins” or the “appearance of new, not previously identified” toxins.  Subsequent studies have verified this. GM yeast, for example, contained a 200-fold increase in a naturally occurring toxin. A GM tobacco plant produced a toxin not found in natural tobacco, and not directly created by the inserted gene. The FDA division also warned of “undesirable alterations in the levels of nutrients,” and of an increased tendency to gather “toxic substances from the environment” such as “pesticides or heavy metals.”6 These concerns were also later verified. But the warnings by FDA scientists’ were ignored, even denied, in the official FDA policy. That policy was overseen by Michael Taylor, former outside attorney for Monsanto, turned FDA policy chief, later turned Monsanto vice-president.
In a 2001document, the agency finally acknowledged that genetic engineering carried risks that were different from traditional breeding. They described insertion mutations—a well known effect of gene insertion that damages DNA. Each GM variety may be uniquely damaged, which can lead to unpredicted problems. Thus, the document states that, “FDA believes that it needs to be provided with information about foods from all separate” GM varieties, even if the gene that was inserted was the same one used in another, already approved variety. This logical position is reversed, however, in the new draft guidance, which says that if the FDA looks at a novel protein created in one GM variety “and no safety concerns are identified,”12 they do not have to look at other GM crops that insert the same gene.
So what do they propose to look at? Not much that would protect public health. For example, they will tell biotech companies, “You should consider whether the new protein is an allergen, or a toxin.” From the formerly secret FDA memos, FDA scientist Carl Johnson wrote in 1991, “Are we asking the crop developer to prove that food from his crop is non-allergenic? This seems like an impossible task.” While there are no tests to verify that a novel protein is not a human allergen, the World Health Organization and the United Nations FAO recommend criteria to minimize the likelihood that it is. The GM corn, soybeans, and papaya already on the market, however, fail those criteria. That hasn’t stopped them from being approved.
The FDA recommends test tube studies to simulate digestion, but they are a poor indicator of what really happens inside human beings or animals. Moreover, biotech companies typically manipulate the test parameters to force their own conclusions, so that the tests often give a false sense of security.
But even these poorly designed studies, like all FDA regulation of GM foods, are entirely voluntary. The draft guidance states: “The use of the word should in agency guidances means that something is suggested or recommended, but not required.” Thus, if a company’s response to the FDA’s questionnaire “raises questions about the food safety of” the new protein, the best that the FDA can come up with is to say to the company: “You may wish to discuss the identified issues with us prior to engaging in any activity that might result in material from your plant inadvertently entering the food supply.”12
Threat Grows Over Time
Even if harm from experimental crops were a small probability, repeated enough times, it becomes a certainty. From 1987 through 2002, the USDA issued 8,571 permits and more are expected. The government identifies about 500 different foreign genes used, but the actual number is higher since most are kept secret—classified by companies as confidential business information. We don’t know what might end up in our food supply and we don’t even know how to test for its presence. In some cases, even tiny amounts of contamination carry significant risks. According to the EPA’s expert Scientific Advisory Panel, no minimum amount of StarLink was considered safe. Some GM crops produce pharmaceutical products which are known to be active at billionths of a gram. While the current draft guidance addresses food crops, the FDA is considering an analogous guidance for pharmaceuticals.4
In an April 2004 joint press release, the Biotechnology Industry Organization and the U.S. grain industry instructed the U.S. government that it “must vigorously promote global adoption of compatible regulatory systems.”  They want the world to also accept contaminated food. Five months later, acting FDA commissioner Crawford heralded the draft guidance as “an international model.”4
In the History Channel scenario, Years pass before the connection is made. This may be optimistic. Without monitoring, a food-related health problem could go untracked for decades. And even if evidence were compiled, like tobacco and pesticides, the biotech industry may fight to keep their products on the market.
Soy allergies skyrocketed in the UK by 50% after GM soy was introduced. According to Russian scientists, allergies there tripled in the three years corresponding to the widespread introduction of GM foods. And food related illnesses in the U.S. doubled between 1994 and 2001, when many GM crops entered the food supply. A History Channel scenario might already be in the making.
from January 2005 Spilling the Beans newsletter
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 Jeffrey M. Smith, “Genetically Engineered Foods may Pose National Health Risk,” Spilling the Beans, August 1, 2004, http://responsibletechnology.org/irtnew/docs/8.pdf
 Richard Caplan, “Raising Risk: Field Testing of Genetically Engineered Crops in the United States,” U.S.PIRG Education Fund, June 2003 http://www.uspirg.org/reports/RaisingRisk2003.pdf
 OSTP (2002). “Proposed federal actions to update field test requirements for biotechnology derived plants and to establish early food safety assessments for new proteins produced by such plants,” Notice, Office of Science and Technology Policy, Federal Register,Vol.67, No.149, p. 50578-50580.
 Lester M. Crawford, Acting Commissioner of the FDA. Speech before The U.S. Vatican Mission’s Conference “Feeding A Hungry World: The Moral Imperative Of Biotechnology,” September 2004 www.agbioworld.org
 FDA Proposes Draft Guidance for Industry for New Plant Varieties Intended for Food Use, FDA Talk Paper, November 19, 2004, http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01327.html
 Division of Food Chemistry and Technology and Division of Contaminants Chemistry, “Points to Consider for Safety Evaluation of Genetically Modified Foods: Supplemental Information,” November 1, 1991, www.biointegrity.org
 Doug Gurian-Sherman, “A Look at the Unintended Effects of Genetically Engineering Food Plants Re. The National Academy of Sciences Report on Unintended Effects,” The Center for Food Safety, Briefing Paper.
 Premarket Notice Concerning Bioengineered Foods, Food and Drug Administration, 21 CFR Parts 192 and 592, [Docket No. 00N-1396] Federal Register, Volume 66, Number 12. page 4711, January 18, 2001
“Because some rDNA-induced unintended changes are specific to a transformational event (e.g., those resulting from insertional mutagenesis), FDA believes that it needs to be provided with information about foods from all separate transformational events, even when the agency has been provided with information about foods from rDNA-modified plants with the same intended new trait and has had no questions about such foods. Similarly, the agency believes that it needs to be provided with information about foods from rDNA-modified plants whose intended change is the introduction of a pesticidal protein subject to oversight by the Environmental Protection Agency (EPA) rather than by FDA, because the transformational event that is used to introduce the pesticidal trait may also cause unintended changes to the food that would raise adulteration or misbranding questions subject to FDA jurisdiction.”
 Carl B. Johnson, Memo on the “draft statement of policy 12/12/91,” January 8, 1992 www.biointegrity.org
 Guidance for Industry Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use, U.S. Department of Health and Human Services, November 2004, http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0369-gdl0001.pdf
 “Assessment of Additional Scientific Information Concerning StarLink Corn,” FIFRA Scientific Advisory Panel to the EPA, SAP Report No. 2001-09, from meeting on July 17/18, 2001.
 Bill Freese, “Manufacturing Drugs and Chemicals in Crops: Biopharming Poses New Threats to Consumers, Farmers, Food Companies and the environment,” July 2002, Friends of the Earth, www.foe.org/biopharm.
 “US Grain Industry, BIO Urge US Government to Expedite ‘Trace-Amounts ‘ Policy for Biotech Products,” press release, Biotechnology Industry Organization & National Grain & Feed Association, and other trade groups, April 7,2004, http://www.bio.org/media/press-release/us-grain-industry-bio-urge-us-government-expedite-trace-amounts-policy-biotech-p.