|
Letter to USDA Secretary Veneman
Sept 11, 2003
To the Honorable Secretary Veneman,
At Tuesday afternoon's press briefing, you gave incorrect information about the U.S. safety assessment of genetically engineered foods, which I would like to correct now. You indicated that the U.S. government has a thorough safety assessment process. Although the issue of human safety falls under the domain of the Food and Drug Administration (FDA), they actually have no mandatory safety assessment program in place. Instead, they leave the determination of safety entirely in the hands of the manufacturers of genetically modified (GM) foods. According to the FDA's Deputy Commissioner Lester Crawford, the agency does not even need to be notified that a company is introducing a GM food into the diets of millions of Americans.
Dangers of Genetically Engineered Foods
The following presents some of the dangers of genetically engineered foods, including evidence of sickness and death of Americans. The footnotes refer to page references in my book Seeds of Deception: Exposing Industry and Government Lies about the Safety of the Genetically Engineered Foods You're Eating. (I sent you a copy on Tuesday, via the Deputy Press Attaché of the American Embassy.) In it, you will find meticulously documented evidence that leaves no doubt that GM food should never have been approved.
There are only ten published animal feeding studies on the health effects of GM foods-only two of these are independent.
- One study showed evidence of damage to the immune system and vital organs, and a potentially pre-cancerous condition.12-13 When the scientist tried to alert the public about these alarming discoveries, he lost his job and was silenced with threats of a lawsuit.18-20
- In an unpublished study, laboratory rats fed a GM crop developed stomach lesions and seven of the forty died within two weeks. The crop was approved.37, 137-140
Many industry studies appear to be rigged to find no problems. In the case of a genetically engineered bovine growth hormone (rbGH), for example, researchers injected cows with only one forty-seventh the normal dosage before reporting hormone residues in milk.91-92 They heated the milk 120 times longer than standard, to report that pasteurization destroys the hormone.93-94 They added cows to their study that were pregnant before treatment, to claim that rbGH didn't impede fertility.89 Cows that fell sick were dropped from studies altogether.80-81
With soybeans, serious nutritional differences between GM and natural soy were omitted from a published paper.35-36 Feeding studies masked any problems by using mature animals instead of developing ones and by diluting their GM soy 10 to 1 with non-GM protein.34 And one company countered evidence that their beans had lower phytoestrogen levels by apparently instructing a testing lab to use an older, less reliable detection method.204
There are no adequate tests to verify that GM food will not create dangerous allergic reactions. While the FAO/WHO developed testing standards to minimize the possibility of allowing allergenic GM varieties on the market, GM corn currently sold in the U.S. has not been subjected to those tests and would most certainly fail them. One of these tests, for example, uses a test tube simulation to evaluate how long a potential GM allergen can last inside the digestive system before being broken down. Compared to the recommended FAO/WHO standards, however, one biotech company used a far stronger acid concentration and more than 1,250 times the recommended amount of a digestive enzyme to make the claim that their protein degrades too quickly to cause a reaction.179
The only human feeding trial ever conducted confirmed that genetically engineered genes from soy transferred to the bacteria inside the digestive tract. (The biotech industry had previously said that such a transfer was impossible.) The World Health Organization, the British and American Medical Associations, and several other groups have expressed concern that if the "antibiotic resistant marker genes" used in GM foods got transferred to bacteria, it could create super-diseases that are immune to antibiotics.59-60 More worrisome is that the "promoter" used inside GM foods could get transferred to bacteria or internal organs. Promoters act like a light switches, permanently turning on genes that might otherwise be switched off. Scientists believe that this might create unpredictable health effects, including the potentially pre-cancerous cell growth found in the animal feeding study mentioned above. 37
U.S. government spokespersons have claimed that millions have been eating GM foods without ill effect. This is misleading.
- About 100 people died and 5-10,000 to fell seriously ill when they consumed the food supplement L-Tryptophan. Only those who consumed the variety that was genetically modified became ill. That brand had minute, but deadly contaminants that would easily pass through current regulations today. If the disease it created had not been rare and acute, with crippling and deadly symptoms, the GM supplement might never have been traced as the cause. Once discovered, however, industry and government covered up facts and diverted the blame. Even the FDA testimony before Congress withheld vital information.107-125
- Milk from rbGH-treated cows contains an increased amount of the hormone IGF-1, which is one of the highest risk factors associated with breast and prostate cancer, among others.94-97
- Soy allergies skyrocketed by 50% in the UK, coinciding with the introduction of GM soy imports from the U.S.160-161
According to a March 2001 report, the Center for Disease Control says that food is responsible for twice the number of illnesses in the U.S. compared to estimates just seven years earlier. This increase roughly corresponds to the period when Americans have been eating GM food. Could that be contributing to the 5,000 deaths, 325,000 hospitalizations, and 76 million illnesses related to food each year? Might it play in role in our national epidemic of obesity or the rise in diabetes or lymphatic cancers? We have no way of knowing if there is a connection because no one has looked for one.
One of the most dangerous aspects of genetic engineering is the closed thinking and consistent effort to silence those with contrary evidence or concerns. Just before stepping down from office, your predecessor, former Secretary of Agriculture Dan Glickman, admitted the following:
"What I saw generically on the pro-biotech side was the attitude that the technology was good, and that it was almost immoral to say that it wasn't good, because it was going to solve the problems of the human race and feed the hungry and clothe the naked. . . . And there was a lot of money that had been invested in this, and if you're against it, you're Luddites, you're stupid. That, frankly, was the side our government was on. . . . You felt like you were almost an alien, disloyal, by trying to present an open-minded view"152-153
Contrast this with the warning by the editors of Nature Biotechnology: "The risks in biotechnology are undeniable, and they stem from the unknowable in science and commerce. It is prudent to recognize and address those risks, not compound them by overly optimistic or foolhardy behavior." 137 A January 2001 report from an expert panel of the Royal Society of Canada said it was "scientifically unjustifiable"136 to presume that GM foods are safe. Likewise, a 2002 report by the UK's Royal Society said that genetic modification "could lead to unpredicted harmful changes in the nutritional state of foods," and recommended that potential health effects of GM foods be rigorously researched before being fed to pregnant or breast-feeding women, elderly people, those suffering from chronic disease, and babies.263
The United States policy is not based on science. It is crafted for the benefit of industry and puts the population at risk. According to Henry Miller, who was in charge of biotechnology issues at the FDA from 1979 to 1994, "the U.S. government agencies have done exactly what big agribusiness has asked them to do and told them to do."
When the agency was examining the genetically modified bovine growth hormone, rbGH, several scientists claimed that the agency was sacrificing public safety in order to rush the drug to market. FDA chemist Joseph Settepani spoke out about "a systematic human food-safety breakdown at the Center for Veterinary Medicine (CVM)." He was reprimanded for insubordination, threatened with dismissal, and stripped of his duties as a supervisor. In testimony before a congressional subcommittee, Settepani said, "I was sent to a trailer at an experimental farm . . . completely isolated from agency policy-making on human food safety." He charged, "Dissent [at CVM] is not tolerated if it could seriously threaten industry profits."
FDA division director Alexander Apostolou, said, "Sound scientific procedures for evaluating human food safety of veterinary drugs have been disregarded. I have faced continuous pressure from my CVM superiors to reach scientific conclusions favorable to the drug industry. . . . In my time at CVM I have witnessed drug manufacturer sponsors improperly influence the agency's scientific analysis, decision-making, and fundamental mission."
FDA veterinarian Richard Burroughs said, "the Center decided to cover up inappropriate studies and decisions." Officials "suppressed and manipulated data to cover up their own ignorance and incompetence." Burroughs was fired. Other FDA employees had to resort to writing an anonymous letter to a Congressman, to complain that their superiors were engaging n fraud and conflict of interest.
It is interesting that when rbGH was being evaluated in Canada, six Health Canada scientists also complained of being pressured to approve the drug, even though they believed it to be unsafe for humans. They also said that data had been stolen from a locked file cabinet, and that a biotech representative had offered them a bribe of $1-2 million to approve the drug without further tests.
When the FDA was drafting its policy of GM foods in 1992, documents made public from a lawsuit reveal that division directors and senior scientists urged the agency to require mandatory safety evaluations. The Director of the Toxicology Group, wrote, "The possibility of unexpected, accidental changes in genetically engineered plants justifies a limited traditional toxicological study." And the Division of Food Chemistry and Technology outlined four potential dangers:
- "Increased levels of known naturally occurring toxins",
- "Appearance of new, not previously identified" toxins,
- Increased tendency to gather "toxic substances from the environment" such as "pesticides or heavy metals", and
- "Undesirable alterations in the levels of nutrients."
They warned, "unless genetically engineered plants are evaluated specifically for these changes," these four "may escape breeders' attention." The division recommended testing every GM food "before it enters the marketplace."
In spite of repeated internal memos outlining the potential for increased health risks posed by this new technology, subsequent drafts of the FDA's policy statement, overseen by Michael Taylor, then FDA Deputy Commissioner in charge of policy and formerly attorney for biotech giant Monsanto, deleted more and more of the scientist's input. It ultimately avoided implementing any of the safety assessment you referred to on Tuesday. The FDA justified this by saying, "The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way."
FDA microbiologist Louis Pribyl challenged the policy statement: "What has happened to the scientific elements of this document? Without a sound scientific base to rest on, this becomes a broad, general, 'What do I have to do to avoid trouble'-type document. . . . It will look like and probably be just a political document. . . . It reads very pro-industry, especially in the area of unintended effects." He said, "This is the industry's pet idea, namely that there are no unintended effects that will raise the FDA's level of concern. But time and time again, there is no data to back up their contention."
Pribyl also made two accurate predictions:
1. "Industry will do what it HAS to do to satisfy the FDA 'requirements' and not do the tests that they would normally do because they are not on the FDA's list;" and
2. "There will be . . . less concern about safety, because of a false sense of 'knowing what one is doing' and 'it's been done hundreds of times before without a problem, why check it now.'"
That's the situation today. Very few tests have been done, and the U.S. is ridiculing and legally challenging those nations who are appropriately concerned about safety.
A March 1992 memo from FDA Commissioner David Kessler shed some light on why the FDA ignored scientific concerns. Kessler wrote, "The approach and provisions of the policy statement are consistent with the general biotechnology policy established by the Office of the President. . . . It also responds to White House interest in assuring the safe, speedy development of the U.S. biotechnology industry."
The United Nations Biosafety Protocol goes into full force today. It allows nations to conduct a risk assessment based on the precautionary principle, and to impose a ban on GM crops. The revelations amassed in my book Seeds of Deception support such a ban. I have confirmed the link between the facts in my book and the Protocol with Dr. Tewolde, who negotiated the Protocol on behalf of most developing nations.
I invite you to read the book and to correct the statement made to the press on Tuesday. Further, I encourage you to take whatever steps are necessary to put in place that through safety evaluation of which you spoke. The health of the population is in the balance.
Respectfully,
Jeffrey M. Smith
|
