GM Food Fight
Published October 30, 2009 @ 06:00AM PT
In the debate over genetically modified food, one thing is clear: we can't agree. And not only do we disagree but we disagree passionately and intransigently. Statistics are hurled back and forth, each one seemingly contradicting the last, until everyone has pie in their face and no one knows what's fact and what's fallacy.
Change.org member Dawn Gifford noted the intensity of the debate in a recent comment: "this issue is more divisive than almost any other international issue, barring war."
So what's a thinking person to do? Many people I talk to feel a sense of unease with GM foods, but don’t have a clearly defined opinion and don’t know which information to trust.
Unfortunately finding answers is not as simple as turning to the experts. A quick perusal of the New York Times opinion roundtable, released earlier this week, reveals that there are as many opinions as there are commentators (6), ranging from staunch support of GM foods to total rejection of them.
While the discussion doesn't provide us one clear answer, it is refreshing to hear a panoply of thoughtful opinions on the subject. So much of the discourse has become overheated and irrational. As Jonathan Foley, director of the new Institute on the Environment at the University of Minnesota, writes in his entry in the Times article: "Genuine discourse has broken down: You’re either with Michael Pollan or you’re with Monsanto."
As if to illustrate this point, Paul Collier, an Oxford University economist, uses his turn in the roundtable to espouse Monsanto's viewpoint: "The debate over genetically modified crops and food has been contaminated by political and aesthetic prejudices: hostility to U.S. corporations, fear of big science and romanticism about local, organic production."
Alternately, however, one could say that the discussion has been contaminated by agribusiness dollars, blind faith in science's ability to cure all ills and categorical dismissal of the power of simple, low-tech and nature-based solutions. Hello, Michael Pollan!
Could it be that the solution lies somewhere in the middle? Could we apply the best of biotech with surgical precision while still, as Vandana Shiva wisely puts it, focusing on “biodiversity intensification, not chemical intensification . . . work[ing] with nature’s nutrient cycles and hydrological cycle, not against them”?
What about a holistic vision that acknowledges the dire problem facing us, accounts openly for all the options on the table and uses the best elements of each in the most targeted way possible? Such a solution will take discussion, cooperation, openness and, most importantly, political will. Tall order, but not impossible.
Jonathan Foley's vision is closest of all the commentators' to this idea:
Rather than voting for just one solution, we need a third way to solve the crisis. Let’s take ideas from both sides, creating new, hybrid solutions that boost production, conserve resources and build a more sustainable and scalable agriculture. There are many promising avenues to pursue: precision agriculture, mixed with high-output composting and organic soil remedies; drip irrigation, plus buffer strips to reduce erosion and pollution; and new crop varieties that reduce water and fertilizer demand.
I would add to that list all manner of low-tech innovations, like the Kickstart Super MoneyMaker Pump, that target the “bottom of the pyramid” market and provide affordable solutions to basic agricultural problems.
The World Summit on Food Security is coming up; world leaders will meet in Rome on November 16 to discuss the best ways to invest in agriculture in developing countries and thereby reduce hunger. Let's hope, at the very least, for an open and honest discussion among the Monsantos and Michael Pollans of this world.
Photo of the Tomatina Festival courtesy of revolution cycle via flickr
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Comments (23)
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Good column Katherine.
Mi
May I suggest people start by reading "Tomorrows Table". It focuses on exactly the middle ground and how both organic and biotech solutions are needed. This is where the future lies IHMO.
If people want to understand the science of biotech crops I suggest "Pandora's Picnic Basket" by Alan McHughen. Both Nature and Science gave it two thumbs up!
Posted by Robert Wager on 10/30/2009 @ 07:09AM PT
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Part of the problem is, many people perceive that organic farming is going back to "old" methods of farming and rejecting technology. This is not so. There is all kinds of innovation going on in the organic farming sector, exciting new techniques which reject the use of chemicals, and, as Shiva says, work with nature instead of against it. Modern organic farming is not "old-fashioned" at all, although it does reject certain *types* of technology.
Posted by Michelle Bak on 11/01/2009 @ 09:31AM PT
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Here is a huge first step: GIVE CONSUMERS THE CHOICE. Require truth in labeling laws to include whether or not any ingredient in a product contains GMOs and whether a fresh fruit or vegetable has been grown with GM seeds. Give the consumer the right to know what they are purchasing. Just as the label on a jar of pasta sauce on my supermarket shelf has to tell me what's in it (tomatoes, onions, salt, preservatives, etc.), it should also tell me whether those are GM tomatoes. If food manufacturers refuse to do so, my only question is: what are they afraid of?
Posted by Jacqueline L'Heureaux on 11/01/2009 @ 10:47AM PT
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Jacqueline
Have a look at my website and the article titled "No Label Required" if you would like to understand the reasons we label food the way we do.
http://web.viu.ca/wager
Cheers
Posted by Robert Wager on 11/03/2009 @ 08:47AM PT
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Robert, thanks for your post. Interesting article. Alas, I am not convinced, and I do not agree that it is a false argument that labeling GM food will give consumers a choice. Are there inherent challenges? Yes, but also inherent solutions. As for the statement in your article that "since there is absolutely no evidence of any harm coming to anyone from consuming food biotechnology products..." I, as a consumer, prefer to rely on information such as this: "When a German court ordered Monsanto to make public a controversial 90-day rat study on June 20, 2005, the data upheld claims by PROMINENT SCIENTISTS who said that animals fed the genetically modified (GM) corn developed extensive health effects in the blood, kidneys and liver and that humans eating the corn might be at risk. The 1,139 page research paper on Monsanto's "Mon 863" variety also revealed that European regulators accepted the company's assurances that their corn is safe, in spite of the UNSCIENTIFIC and CONTRADICTORY rationale that was used to dismiss significant problems. In addition, the study was so full of flaws and omissions, critics said it wouldn't qualify for publication in most journals and yet it was the primary document used to evaluate the health impacts."
You can read the rest of this article at http://www.newswithviews.com/Smith/jeffrey7.htm.
I think I speak for a growing segment of the public when I say that we no longer trust others (politicians, government agencies, corporations, industry lobbyists, corporate-funded universities, etc.), to make our food choices for us. We're just not nearly as trusting as we used to be.
Cheers!
Posted by Jacqueline L'Heureaux on 11/03/2009 @ 01:45PM PT
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Sorry Jacqueline but you have been misled again by Mr Smith. It is not your fault as his brand of pseudo-science is polished. The fact is the researcher used unconventional statistics to try to prove a bad outcome. The European Food Safety Agency looked at his so-called research (actually just statistics redone) and concluded there was nothing new and his unconventional statistics do not represent anything to change their safe opinion of Mon863. I can send you their opinion if you like.
Posted by Robert Wager on 11/03/2009 @ 04:40PM PT
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Here is the link to the ESFA report.
http://www.efsa.europa.eu/cs/BlobServer/Statement/GMO_statement_MON863,0.pdf?ssbinary=true
Posted by Robert Wager on 11/03/2009 @ 05:06PM PT
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Robert, lovely to hear from you again!
Goodness - you needn't be sorry for something which has nothing to do with you (i.e. whether or not I was misled). (Or wait a second - was that a "sorry," as in condescending?) I confess that until about two years ago, I was completely oblivious to there even being an issue around GMOs. However, in late 2007 I heard a lecture at a nearby university and the presentation piqued my interest.
Since then, I've read about both sides of this issue IN DEPTH, and I don't think I've been misled by Mr. Smith or by individuals such as respected former US National Institutes of Health scientist Candace Pert, PhD., who I have heard speak and who has described Mr. Smith as "the leading world expert in the understanding and communication of the health issues surrounding genetically modified foods." Dr. Pert received her Ph.D. in pharmacology from Johns Hopkins University School of Medicine and has served as Chief of the Section on Brain Biochemistry of the Clinical Neuroscience Branch of the National Institute of Mental Health (NIMH), and held a Research Professorship in the Department of Physiology and Biophysics at Georgetown University School of Medicine in Washington, DC. Unless you are also suggesting that Dr. Pert engages in "pseudo science," it seems highly unlikely that she would publicly refer to Mr. Smith as the leading world expert on this matter.
Is the EFSA anything like the USA's FDA? As you can see from this http://online.wsj.com/article/SB123629954783946701.html March 2009 article in the Wall Street Journal, political lobbying is as often as not the driving force at the FDA in terms of what gets approved. So, if the EFSA is anything like our FDA, they hardly merit trust or one iota of faith that they have the best interests of the public at heart.
To the detriment of the public good, many of my fellow consumers in the US erroneously believe that the FDA approves GM foods through scrupulous in-depth, long-term studies (like those that drug companies must conduct before the FDA will approve a new drug).
In truth, the FDA has literally no safety testing requirements. Rather, our FDA relies on research, from companies like your former benefactor Monsanto, which is meticulously designed to avoid finding problems.
As in so many other government agencies in Washington, there is a revolving door between agency regulators and the companies they regulate. Classic example: the White House mandate to the FDA (under Daddy Bush) was to promote biotechnology, and the person in charge of developing the agency's policy at that time was a former Monsanto attorney, Michael Taylor, who later returned to Monsanto as their vice president, and who is now back at the FDA as the supposed Czar of Food Safety (good one; eh?).
The FDA has claimed it was not aware of any information showing that GM crops were different "in any meaningful or uniform way" from non-GMO crops and therefore didn't require testing. Yet 44,000 internal FDA documents made public by a lawsuit show that this was a COMPLETE LIE. The overwhelming consensus among the FDA's own scientists was that GM foods were quite different and could lead to unpredictable and hard-to-detect allergens, toxins, new diseases and nutritional problems. Those FDA scientists who had urged superiors to require long-term studies, and who are to be commended for doing so, were roundly ignored.
Yes, indeed; as you have written, there are a great many myths about GM crops and food. One of them is that they are safe. Perhaps they are safe; but we don't know that, and the cover up by the FDA suggests otherwise.
It's becoming ever more difficult to convince us consumers to drink the Kool-Aid!
Regards, Jacqueline
Posted by Jacqueline L'Heureaux on 11/03/2009 @ 09:33PM PT
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Wow. The tone here has changed a lot since the last time I was around. Nice.
I applaud you for working against what Michael Pollan called "monoculture thinking" that I see so often on this topic.
http://agro.biodiver.se/2009/10/empty-vessels-and-gmos/ for the reference.
Posted by Mary M on 11/02/2009 @ 03:17PM PT
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Please have a look at the EFSA report on feeding trials linked on my website. The 30+ pages of references say GM food is as safe or safer than food from conventionally bred plants. While there one can see the world experts from the UN-FAO to Health Canada to the AUNZ food authority all agree on the safety of GM crops and food. Simply trying to cast doubt about the EFSA or the FDA for that matter is no substitute for the real science.
cheers
Posted by Robert Wager on 11/04/2009 @ 08:53AM PT
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My problem with GMO's is not safety concerns. My problem is with making a seed intellectual property, making it illegal for farmers to save seed, and strong-arming them with lawsuits and fees. GMO's often spell financial disaster, or at the very least indentured servitude, for the farmers that use them, and for what? A slightly increased yield? Better resistance to one disease? This all just falls into the trap of thinking yield and uniformity are all that matter. This is why I don't even grow hybrids myself - for one thing you can't save seed from them, but really more importantly, they are lmost never developed for taste. It's FOOD! Shouldn't that be the first priority?
Posted by Kristen Ridley on 11/04/2009 @ 11:56AM PT
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I like how you tried to link me to Monsanto. Too bad it is not true I could use the cash. Truth is my entire salary comes from my University. No one pays me to speak on their behalf.
Now back to the so-called unknown effects of GM foods. Lets explore this. Can anyone give this forum a scientifically defendable hypothesis of a mechanism that imparts a unique risk from eating any food with GM ingredients? I can show several ways which GM crops reduce the risk of eating.
Just saying "but what if" does not mean there is a reasonable argument. The National Academy of Science in the US has repeatedly stated there is NO unique risk from consuming food containing GM ingredients?
This quote from the American Medical association sums it up rather well.
"Genetically modified foods "raise many issues--scientific, technological, environmental, social, ethical, economic, and political."132 Controversy over GM food exposes larger issues about public trust in science and the role of science in policymaking. In an increasingly complex world, trust functions as a substitute for knowledge. Interference with our systems of food production has always aroused public concern, occasionally with justification. Attempts to introduce GM foods have stimulated not a reasoned debate, but a potent negative campaign by people with other agendas. Opponents ignore common farming practices and well investigated facts about plants, or inaccurately present general problems as being unique to GM plants. "
Having fears is natural but that does not mean they are grounded in facts.
May I ask what your definition of a longterm is for safety of GM crops?
Posted by Robert Wager on 11/04/2009 @ 09:46AM PT
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Product safety studies, definition of "long-term": It takes about 10-15 years to develop one new medicine from the time it is discovered to when it is available for treating patients. For every 5,000-10,000 compounds that enter the research and development R&D pipeline, ultimately only one (1) receives approval. Following your reasoning, if we were to apply the same standards to drug companies untested drugs that you want to apply to GMOs, drug companies could rightly tell us at any time during that 10- to 15-year process that, "there is absolutely no evidence of any harm coming to anyone from" ingesting Drug XYZ. Likewise, they could say, "Just saying ‘what if' does not mean there is a reasonable argument as to why this drug isn't safe, and WE say it's safe, and we want to bring it to market NOW, not in 10 or 15 years."
Actually, I do trust science - science not tainted by hidden, politicized agendas. Unfortunately, it's difficult for non-scientists to get around inconvenient facts such as the FDA's claiming it was not aware of any information showing that GM crops were different "in any meaningful or uniform way" from non-GMO crops and THEREFORE DIDN'T REQUIRE TESTING, yet 44,000 internal FDA documents made public by a lawsuit showed that the overwhelming consensus among the FDA's own scientists was that GM foods were quite different and could lead to unpredictable and hard-to-detect allergens, toxins, new diseases and nutritional problems, and yet the bureaucrats of the FDA chose to ignore the science. But you're a scientist; can you explain it? Were all of those FDA scientists just pretending to be scientists? Can you explain why the FDA's own scientists would urge the FDA to embark on long-term studies of GMOs if there wasn't some scientific basis (versus that common bugaboo, fear) to their consensus?
I'm not sure if the human animal is predisposed to blind trust or not (we have, after all, been described as a nation of sheep), but if so, that would explain a willingness to believe that what a government agency, one unequivocally exposed for its dishonesty with the public and for politically motivated cover-ups, tells us should be trusted DESPITE and contrary to the urgings of that agency's own scientists.
I believe this quote from the American Medical Association sums it up rather well.
"Substantial information about (GMOs) actual effects on the environment and on biological diversity is lacking. As a consequence there is no consensus as to the seriousness, or even the existence, of any potential environmental harm from GM technology." Does that mean there are no negative effects? No. It means GMOs need to be studied long-term, just like new medicines are, to determine their safety.
Posted by Jacqueline L'Heureaux on 11/04/2009 @ 02:19PM PT
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So we have twenty plus years of study and no harm found. Therefore by your numbers my statement of safety stands.
There is no such thing as risk free anything and there is nothing natural about agriculture. The question becomes how much risk for how much gain is tolerated.
I would love to see the reference for the 44,000 documents. Do you have it available?
Posted by Robert Wager on 11/04/2009 @ 02:51PM PT
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You should look back at her AMA quote:
"Substantial information about (GMOs) actual effects on the environment and on biological diversity is lacking."
Every independent source I've found discussing this matter says the same thing: we just don't know, because there's not enough reliable studies out there. Just because something's been around for a while doesn't mean people have been studying it. There very much seems to be a "shoot first and ask questions later" policy in place regarding GMO's, and so far the questions haven't really been answered.
Posted by Kristen Ridley on 11/05/2009 @ 12:33PM PT
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No, what we have is 20± years of study (laboratory development of GMs), much of it funded by the biotech industry (did you not receive research grants from Monsanto at one time?), NOT 20± years of clinical trials to scientifically determine safety. Show me evidence of clinical trials NOT conducted by biotech companies, and your statement of safety will have merit.
To quote David B. Fankhauser, PhD., one of the scientist-plaintiffs in the lawsuit discussed below, "For man to believe that he can predict the impact of all of these newly created life forms is folly. The ancient Greeks called this arrogance hubris. First potential risks associated with their release into the environment and their use in our foods should be thoroughly investigated." This has not yet happened. http://biology.clc.uc.edu/fankhauser/Society/Gen_Engnrg7Oct99.html
I come from a long line (traced from the 15th Century to present day 2009) of farmers and ranchers, and I am all for anything that improves the science - once it has been proven using recognized scientific criteria. This has not yet happened.
On May 19th, 2009, the American Academy of Environmental Medicine (AAEM) called on physicians to "educate their patients, the medical community, and the public to avoid GM (genetically modified) foods when possible and provide educational materials concerning GM foods and health risks."[1] They called for a moratorium on GM foods, LONG-TERM INDEPENDENT STUDIES, AND LABELING. AAEM's position paper stated, "SEVERAL ANIMAL STUDIES INDICATE SERIOUS HEALTH RISKS ASSOCIATED WITH GM FOOD," INCLUDING INFERTILITY, IMMUNE PROBLEMS, ACCELERATED AGING, INSULIN REGULATION, AND CHANGES IN MAJOR ORGANS AND THE GASTROINTESTINAL SYSTEM. They conclude, "There is more than a casual association between GM foods and adverse health effects. There is causation," as defined by RECOGNIZED SCIENTIFIC CRITERIA. "The strength of association and consistency between GM foods and disease is confirmed in several animal studies."
More and more doctors are already prescribing GM-free diets. Dr. Amy Dean, a Michigan internal medicine specialist, and board member of AAEM says, "I strongly recommend patients eat strictly non-genetically modified foods." Ohio allergist Dr. John Boyles says "I used to test for soy allergies all the time, but now that soy is genetically engineered, it is so dangerous that I tell people never to eat it."
World renowned biologist Pushpa M. Bhargava goes one step further. After reviewing more than 600 scientific journals, he concludes that genetically modified organisms (GMOs) are a major contributor to the sharply deteriorating health of Americans. Robert, are you a world-renouned biologist?
The 44,000± documents I referred to were made public as a result of the lawsuit. Some of them are available for downloading and printing here: http://www.biointegrity.org/list.html They may have been posted in their entirety somewhere on the internet, and if you are interested I will attempt to find out where. At a minimum, because they are part of the public record, anyone is entitled to request copies from the District Court in Washington, DC (usually costs a few cents per page plus postage). Nevertheless, perhaps this will save you a little time:
In May of 1998 the Alliance for Bio-Integrity led an unprecedented coalition of public interest groups, religious leaders, and EMINENT SCIENTISTS in filing a lawsuit to reform U.S. Food and Drug Administration policy on genetically engineered (GE) foods.
Following are the nine SCIENTISTS who were plaintiffs in the law suit against FDA policy on genetically engineered foods:
Dr. Richard Strohman, Emeritus Professor of Molecular and Cell Biology at the University of California, Berkeley. He has written extensively on biotechnology issues.
Dr. Philip J. Regal, Professor of Ecology, Behavior and Evolution at the University of Minnesota. Among the nation's most distinguished plant biologists. Has written extensively on the genetic engineering of plants and the ecological and human health risks associated with it.
Dr. John Fagan, Professor of Molecular Biology at Maharishi University of Management. Recipient of Research Career Development Award from the National Cancer Institute. Has written extensively on the hazards of genetic engineering. Gained world-wide attention in 1994 when he returned a $613,000 grant to the NIH as an ethical stand against genetic engineering.
Dr. Liebe Cavalieri, Molecular Biologist, Professor, Division of Natural Sciences, State University of New York at Purchase. Has written extensively on biotechnology issues.
Dr. David Ehrenfeld, Professor of Biology, Rutgers University. Has written on the dangers of genetically engineered foods.
Dr. David Fankhauser, Professor of Biology and Chemistry, University of Cincinnati.
Hanif Khalak, Computational Biologist, The Institute for Genomic Research, Rockville, MD. Though he does research that facilitates applications of biotechnology for curing human disease, he thinks that the current applications of biotech in food production are based in scientifically flawed assumptions.
Dr. Gary Kaplan, MD, PhD, Director of Clinical Neurophysiology, North Shore University Hospital; Assoc. Professor of Clinical Neurology, NYU School of Medicine.
Dr. Rama Dwivedi, Associate Director, Targeted Mutagenics, Department of Pediatrics, Northwestern University Medical School. Although he performs biotechnology for medical purposes, he believes that the program to genetically reconfigure food organisms, as currently conducted, is unsound.
The suit was filed in U.S. District Court in Washington, D.C., and its outcome demonstrated the irresponsibility of FDA policy and the falsity of some of the major claims made in support of GE foods. Proponents of these foods repeatedly claim that: (a) the FDA rigorously regulates them; (b) FDA policy is science-based; and (c) there is overwhelming scientific consensus that GE foods are safe. But on September 29, 2000 Judge Coleen Kollar-Kotelly issued a ruling that starkly refutes each claim. She determined that:
The FDA is not regulating GE foods at all. The FDA's politically appointed bureaucrats did not follow the advice and warnings of the agency's scientific staff about GE foods but disregarded them. There is currently significant disagreement among scientific experts about the safety of GE foods.
Further, the Judge avoided the issue of whether adequate safety testing has been done and failed to make a determination that GE foods have been demonstrated to be safe -- even though such a determination is legally required in order for these foods to be on the market.
Despite the above findings, the Judge upheld the FDA's policy on narrow, technical grounds. The Plaintiffs' burden was to demonstrate that the FDA administrators had abused their discretion by acting arbitrarily and capriciously in adopting the presumption that GE foods are generally recognized as safe (GRAS). This was the key issue: whether the administrators had acted arbitrarily in presuming that GE foods are GRAS, not whether these foods actually are. Ultimately, the Judge held that there was some rational basis for the FDA's presumption and that its policy could therefore be upheld. The following paragraphs more fully explain her decision and the evidence she had to disregard in order to reach it. *(see note)
A. Establishing That the FDA Does Not Regulate GE Foods
Plaintiffs alleged that FDA violated the National Environmental Protection Act (NEPA) by not performing an Environmental Assessment or preparing an Environmental Impact Statement. In response, the FDA argued its policy is not subject to these requirements because it does not regulate GE foods in any manner and is therefore not a significant federal action. The Judge agreed with the FDA. She declared that its policy on GE foods is essentially ONE OF "INACTION" AND DOES "NOT IMPOSE ANY ... OBLIGATIONS" ON THE BIOTECH INDUSTRY [emphasis mine].
B. Disregarding Evidence of Disagreement Within the Scientific Community
The FDA claims that GE foods are recognized as safe by an overwhelming consensus among scientists, and this is the sole legal basis on which it has allowed them on the market. The lawsuit refuted this claim by demonstrating there is a substantial conflict among experts. Nine well-credentialed scientific experts took the unprecedented step of joining the suit as plaintiffs to emphasize their concerns about the hazards of GE foods, and several submitted declarations detailing the scientific grounds for regarding these foods as unreasonably risky.
The Judge acknowledged the Plaintiffs had introduced many statements from experts explaining that genetic engineering is "inherently risky", and it stated: "Plaintiffs have produced numerous documents showing significant disagreements among scientific experts." However, she said that because she was specifically reviewing an FDA policy decision of May 1992, she was restricted to consider only the information the FDA had before it at that time. She then ruled that based on that information, the FDA administrators had reasonable grounds to presume there was an overwhelming consensus about safety as of May 1992.
The Judge made this ruling even though the Plaintiffs called her attention to a document in the FDA files indicating that by 1991 the agency clearly knew there was not a scientific consensus about the safety of GE foods. This piece of evidence is a letter of October 23, 1991 from FDA's biotechnology coordinator to a Canadian health official. It commented on a document containing proposed guidelines for assessing the safety of GE foods. In it, the biotech coordinator stated: "As I know you are aware, there are a number of specific issues addressed in the document for which a scientific consensus does not exist currently, especially the need for specific toxicology tests." He added: "I think the question of the potential for some substances to cause allergenic reactions is particularly difficult to predict." (See #8 in the set of photocopies of FDA documents at www.biointegrity.org ) Surprisingly, the Judge's opinion failed to mention this letter. The Judge also failed to properly address the fact that by May 1992 the FDA knew that most of its own experts regarded GE foods as more risky than conventional ones -- which in itself shows they are not generally recognized as safe. This point is more fully discussed in the following paragraph.
C. Permitting FDA Administrators To Ignore the Warnings of Their Own Experts -- and Then To Misrepresent the Facts
Before the FDA issued its policy statement, it had been repeatedly informed by its own experts that GE foods are inherently risky and cannot be presumed safe. This was revealed when, as an aspect of the lawsuit, the FDA was required to divulge its internal files. These records clearly show (1) that the predominant opinion of the agency's own scientific experts was that GE foods pose unique health risks and (2) that they repeatedly cautioned their superiors about these risks. The uniformity of opinion within the FDA's scientific staff is attested by the official responsible for monitoring their input, who reported: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." (FDA Document #1 at www.biointegrity.org ) Further, during the lawsuit the FDA never cited even one document from any of its scientists supporting its claim that GE foods do not pose additional risks and therefore do not need to be tested.
The Judge acknowledged the FDA's files contained statements from its scientists "warning" about unintended harmful side effects and "criticizing" the lack of scientific basis for the FDA's policy. However, she held that the agency's politically appointed administrators were legally entitled to establish policy arbitrarily despite the contrary opinion of their scientific staff. In doing so, she disregarded the fact that the FDA administrators were not merely setting policy but were PERPETRATING A MAJOR MISREPRESENTATION OF REALITY: they were alleging there is an overwhelming consensus that GE foods are safe when the overwhelming consensus of their own experts was that such foods entail unique risks.
Moreover, the Judge failed to mention another blatant misrepresentation the Plaintiffs had brought to her attention. The FDA administrators had not only disregarded the information from their scientists but had even denied they knew of any such thing. In their formal policy statement they claimed: "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." The law clearly does not grant federal administrators the discretion to intentionally misstate basic facts, and it is surprising that the Judge allowed the FDA bureaucrats to do so.
D. Overlooking the Fact That No Adequate Evidence of Safety Exists
The law explicitly requires that even if there is overwhelming expert consensus about the safety of a new food (such as GE foods), each product must still be demonstrated safe through "technical evidence." The FDA's own experts clearly informed their superiors about the kinds of tests that are necessary to yield such evidence (e.g. long-term toxicological feeding studies using the whole GE food). But such tests are rarely used for GE foods, and no GE food on the market has been confirmed safe through them, as the scientist-plaintiffs thoroughly explained in statements filed with the Court. Moreover, the Plaintiffs directed the Judge's attention to a memo by an FDA official to the Biotechnology Coordinator admitting that the necessary evidence was lacking: " . . . [A]re we asking the scientific experts to generate the basis for this policy statement in the ABSENCE OF ANY DATA?" (FDA Document #1 at www.biointegrity.org )
Although the Judge stated that technical evidence of safety is required, she then sidestepped this crucial issue and completely failed to address it. Consequently, she did not make any finding that GE foods have been demonstrated to be safe. Had she forthrightly addressed the issue, she would have been obliged to acknowledge that the requisite evidence is lacking -- and that GE foods are on the market illegally.
E. Outcome: Continuation of FDA's 1992 Policy Despite Exposure of How Unsound and Unconscionable It Is
The Judge ruled that the FDA administrators did not act arbitrarily in presuming that GE foods are generally recognized as safe -- even though it is clear from the FDA's own files that (a) such general recognition has never existed within the scientific community and (b) the technical evidence of safety upon which such recognition is legally required to rest does not exist either.
THE JUDGE DID NOT RULE THAT GE FOODS ACTUALLY HAVE BEEN SHOWN TO BE SAFE. NOR DID SHE DETERMINE THAT THERE EVER WAS A GENERAL RECOGNITION OF SAFETY AMONG THE FDA SCIENTISTS OR WITHIN THE SCIENTIFIC COMMUNITY. MOREOVER, SHE DID NOT EVEN SAY THAT THE FDA COULD JUSTIFIABLY CONTINUE TO PRESUME THAT GE FOODS ARE SAFE. Her decision was strictly limited to the particular exercise of discretion made by the FDA in May of 1992 only. She ruled that at that specific point in time, the FDA was entitled to have presumed there was a general recognition of safety among scientific experts; but Judge also indicated the Plaintiffs had presented evidence showing that there was not then (and as of November 2009) general recognition of safety. Further, she emphasized that the FDA's presumption is supposed to be rebuttable by evidence it receives to the contrary. Nonetheless, the FDA continues to pretend that there is an overwhelming consensus among experts that GE foods have been demonstrated to be safe.
Because of the major flaws in the Judge's opinion, the Plaintiffs filed an appeal in November 2000. Then in January 2001, the FDA proposed new regulations on GE foods. Although these regulations still did not require any safety testing or labeling of GE foods, had they been implemented, they would have replaced the less formal policy decision of May 1992 against which this lawsuit was brought. This appeared to render it a waste of time for the Plaintiffs to further pursue their suit, because if the proposed regulations had been enacted, their suit would have become moot, and they would have needed to proceed against the new regulations by filing a new lawsuit. Therefore, the Alliance for Bio-Integrity and the other plaintiffs in the lawsuit dropped their appeal, intending to bring a new lawsuit when the regulations took effect.
However, after the Plaintiffs dropped their appeal, and after a two year delay in enacting the proposed regulations, the FDA announced it was withdrawing them. So the FDA continues to rely on its policy statement of 1992, and the Plaintiffs cannot revive their appeal of the Court's decision. Further, because the 1992 policy has already been upheld in a federal court, it is unlikely that anyone else would be able to sustain a new lawsuit against it. This means that GE foods will continue to be unknowingly consumed by most Americans on a daily basis even though they are on the market in stark violation of the food safety laws.
On balance, this lawsuit accomplished a lot by exposing the FDA's fraud and revealing the unsoundness of its policy and the irresponsibility of its behavior. Even though the Plaintiffs failed to overturn the FDA's policy, the Court's ruling refutes the standard claims of the biotech industry about the rigor of FDA oversight and the proven safety of its own products. It gives the FDA nothing to be proud of nor does it give the biotech industry anything to brag about. But it does give all consumers something to be very concerned about.
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*In referring to the outcome of this lawsuit, proponents of GE foods usually state merely that the Court dismissed it, thereby implying that their action had no legal merit and was rejected without the need for substantial legal proceedings. In fact, extensive proceedings occurred during which both sides submitted a series of three written arguments, after which the Court issued its ruling in a long written opinion. By mutual agreement, there was not a trial, because there was no need for one. That's because trials are only used to resolve disputed issues of fact, and in this case the material facts were limited to the contents of the documents in the FDA's files -- and were therefore undisputed. The Court's judgment was not issued until more than two years after the lawsuit was filed, and only after issuing this judgment did the Court then dismiss the lawsuit, which is the standard result in such situations.
Posted by Jacqueline L'Heureaux on 11/05/2009 @ 02:36PM PT
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I will sum up your post. In 1991 the science of GM crops and food was not as robust as some felt it should have been for commercialization. You do realize the first GM crop was commercialized in 1996?
And 18 years later and a great deal of research?
Dismissing research because you don't like who does it is not a valid scientific criticism.
Quoting the AAEM does not help your position, they also avocate homeopathy.
No I once had outreach grants from Council for Biotechnology Information which payed for students to help collect data and to pay for my attendance at scientific conferences to learn more about the real science. None of the money went in my pocket.
So the 44,000 pages of FDA documents are available from an organization highly critical of GM crops, is that correct. Hmmm
Posted by Robert Wager on 11/05/2009 @ 06:25PM PT
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"Dismissing research because you don't like who does it is not a valid scientific criticism.
Quoting the AAEM does not help your position, they also avocate homeopathy."
These two things directly contradict one another. Either the source matters or it doesn't...
Posted by Kristen Ridley on 11/05/2009 @ 07:26PM PT
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I do not think so unless one considers homeopathy science. I most certainly do not.
Posted by Robert Wager on 11/06/2009 @ 03:08PM PT
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Ah, but just because they may advocate something foolish in other areas doesn't *necissarily* mean that their research is flawed; that's just an ad hominim attack. Liars can speak the truth and all that... However, you are correct in that reasonable people can assume that it is more LIKELY that research is flawed if other research by the same party is flawed, or reaches obviously flawed conclusions (which is of course in the eye of the beholder). Similarly, it is LIKELY that the research on GM safety by biased parties is flawed, which is why we have a problem with *reliable* information on GM safety. There is really no way to know for sure whether or not a study is valid, however, without actually looking at their full research papers and seeing precisely their methods, which I suspect others who care/know more about this issue than I do have done, but without investing the monumental amount of time and research that that entails, people unfortunately usually must rely on the source alone to judge the viability of a study.
Posted by Kristen Ridley on 11/07/2009 @ 03:38PM PT
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I believe that quote came from 2000 report on GM food safety by the AMA. Since that time there has been literally thousands of studies. With the result of little if any environmental impact from GM crop cultivation. Remember there is no such thing as impact free agriculture. All agriculture has impact. The trick is to maximize yields with minimal impact and that is where GM crops have proven to be better than conventional agriculture (in some case better than organic agriculture) . There is no free luch.
Posted by Robert Wager on 11/05/2009 @ 02:21PM PT
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"So the 44,000 pages of FDA documents are available from an organization highly critical of GM crops, is that correct. Hmmm."
Dear me, Roberto, do I detect sarcasm in your response? Hmmm, indeed. No need to feel so threatened.
Actually, those 44,000 internal FDA documents are available BECAUSE of a lawsuit filed by an organization highly critical of GM crops. Your "hmmm" implies that they were fabricated by that organization rather than copies of the FDA's own internal communications. You can also get them from the court where the lawsuit was filed. Do you also consider the U.S. District Court in Washington to be suspect? If so, don't feel bad. You've just been misled. You'll be fine if you don't allow yourself to lose sight of the fact that all of those documents came from the FDA.
"Dismissing research because you don't like who does it is not a valid scientific criticism."
That would be true, if it were the reason for my criticism. It is not. What renders research less than credible is when it is conducted by entities who have an enormous conflict of interest and stand to reap enormous profits if the results of those studies are positive or, if not positive, then at least not negative.
If you believe that companies like Monsanto are motivated by altruism, then you believe in fairytales.
Like it or not, consumers have the right to expect objective, independent, science-based clinical studies conducted WITHOUT MOTIVE OR AGENDA. If my reservations about GM crops were simply a result of hysteria-induced fear, that would be one thing, but they are not. They are based on the opinions of far too many scientific experts (not "pseudo-scientists") worldwide who disagree with your position that safety has long since been proved, and who instead, to this very November day in 2009, insist that what has been and continues to be lacking are long-term, independent clinical trials. Independent. Do you understand the difference?
Robert, you appear to have a great deal of ego invested in this issue. I don't. I am simply a consumer among millions of other consumers some of whom, like me, are keenly interested in something that affects not only our own health and that of those we care about, but the health of the entire world. We are critical thinkers who are educating ourselves by reading all there is on the subject, both negative and positive. We get to do that because, hey, we're consumers. You can either accept that thinking people who have serious reservations about GM foods/crops are growing in number for a reason or continue to let it irritate the crap out of you.
When I pick up something in the grocery store, I want to know if it contains GMOs, and I shouldn't have to move to Europe or Russia in order to have that information provided on the label. In Russia the GM-foodstuffs labeling system was first introduced in 1999. Labeling was not mandatory but recommended. Beginning in September 2002, compulsory labeling of food containing over 5% of GMO was imposed. Since June 2004, consistent with the European truth-in-labeling system, a threshold of 0.9% is the labeling level enshrined in current Russian law on biotech food and feed. Apparently they have found a way to surmount all of the reasons you claim labeling is not feasible.
Posted by Jacqueline L'Heureaux on 11/05/2009 @ 11:56PM PT
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http://scienceblogs.com/tomorrowstable/2009/11/biotechnology_for_sustainabili.php#more
Posted by Robert Wager on 11/09/2009 @ 09:12AM PT
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