June 23, 2013
By: STATE OF THE SCIENCE (A 25 page, scientific breakdown of the GMO issue)
We all know stories of tobacco, asbestos, and DDT. Originally declared safe, they caused widespread death and disease. Although their impact was vast, most of the population was spared. The same cannot be said for sweeping changes in the food supply. Everyone eats; everyone is affected. The increase in several diseases in North America may be due to the profound changes in our diet. The most radical change occurred a little over a decade ago when genetically modified (GM) crops were introduced. Their influence on health has been largely ignored, but recent studies show serious problems. Genetically modified organisms (GMOs) have been linked to thousands of toxic or allergic-type reactions, thousands of sick, sterile, and dead livestock, and damage to virtually every organ and system studied in lab animals.(1) Nearly every independent animal feeding safety study shows adverse or unexplained effects.
GM foods were made possible by a technology developed in the 1970s whereby genes from one species are forced into the DNA of other species. Genes produce proteins, which in turn can generate characteristics or traits. The promised traits associated with GMOs have been sky high—vegetables growing in the desert, vitamin fortified grains, and highly productive crops feeding the starving millions. None of these are available. In fact, the only two traits that are found in nearly all commercialized GM plants are herbicide tolerance and/or pesticide production.
Herbicide tolerant soy, corn, cotton, and canola plants are engineered with bacterial genes that allow them to survive otherwise deadly doses of herbicides. This gives farmers more flexibility in weeding and gives the GM seed company lots more profit. When farmers buy GM seeds, they sign a contract to buy only that seed producer’s brand of herbicide. Herbicide tolerant crops comprise about 80% of all GM plants. The other 20% are corn and cotton varieties that produce a pesticide in every cell. This is accomplished due to a gene from a soil bacterium called Bacillus thuringiensis or Bt, which produces a natural insect-killing poison called Bttoxin. In addition to these two traits, there are also disease resistant GM Hawaiian papaya, zucchini and crook neck squash, which comprise well under 1% of GMO acreage.
THE FDA’S “NON-REGULATION” OF GM FOODS
Rhetoric from the United States government since the early 1990s proclaims that GM foods are no different from their natural counterparts that have existed for centuries. The Food and Drug Administration (FDA) has labeled them “Generally Recognized as Safe,” or GRAS. This status allows a product to be ommercialized without any additional testing. According to US law, to be considered GRAS the substance must be the subject of a substantial amount of peer-reviewed published studies (or equivalent) and there must be overwhelming consensus among the scientific community that the product is safe. GM foods had neither. Nonetheless, in a precedent-setting move in 1992 that some experts contend was illegal, the FDA declared that GM crops are GRAS as long as their producers say they are. Thus, the FDA does not require any safety evaluations or labeling of GMOs. A company can even introduce a GM food to the market without telling the agency.
Such a lenient approach was largely the result of the influence of large agricultural corporations According to Henry Miller, who had a leading role in biotechnology issues at the FDA from 1979 to 1994, “In this area, the US government agencies have done exactly what big agribusiness has asked them to do and told them to do.”(2) The Ag biotech company with the greatest influence was clearly Monsanto. According to the New York Times, “What Monsanto wished for from Washington, Monsanto and, by extension, the biotechnology industry got. . . . When the company abruptly decided that it needed to throw off the regulations and speed its foods to market, the White House quickly ushered through an unusually generous policy of self- policing.”(3)
This policy was heralded by Vice President Dan Quayle on May 26, 1992. He chaired the Council on Competitiveness, which had identified GM crops as an industry that could boost US exports. To take advantage, Quayle announced “reforms” to “speed up and simplify the process of bringing” GM products to market without “being hampered by unnecessary regulation.”(4) Three days later, the FDA policy on non-regulation was unveiled.
The person who oversaw its development was the FDA’s Deputy Commissioner for Policy, Michael Taylor, whose position had been created especially for him in 1991. Prior to that, Taylor was an outside attorney for both Monsanto and the Food Biotechnology Council. After working at the FDA, he became Monsanto’s vice president. The Obama administration has put Talyor back into the FDA as the US Food Safety Czar.
THE FDA COVERS UP HEALTH RISKS
Taylor’s GMO policy needed to create the impression that unintended effects from GM crops were not an issue. Otherwise their GRAS status would be undermined and they would need the extensive testing and labels that are normally required for food additives. But internal memos made public from a lawsuit showed that the overwhelming consensus among the agency scientists was that GM crops can have unpredictable, hard-to-detect side effects. Various departments and experts spelled these out in detail, listing allergies, toxins, nutritional effects, and new diseases as potential dangers. They urged superiors to require long-term safety studies.(5) In spite of the warnings, according to public interest attorney Steven Druker who studied the FDA’s internal files, “References to the unintended negative effects of bioengineering were progressively deleted from drafts of the policy statement (over the protests of agency scientists).”(6)
FDA microbiologist Louis Pribyl, PhD, wrote about the policy, “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.”(7)
The scientists’ concerns were not only ignored, their very existence was denied. The official FDA policy stated, “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.”(8) In sharp contrast, an internal FDA report stated, “The processes of genetic engineering and traditional breeding are different and according to the technical experts in the agency, they lead to different risks.”(9) The FDA’s deceptive notion of no difference was coined “substantial equivalence” and formed the basis of the US government position on GMOs.
Many scientists and organizations have criticized the US position. The National Academy of Sciences and even the pro-GM Royal Society of London (10) describe the US system as inadequate and flawed. The editor of the prestigious journal Lancet said, “It is astounding that the US Food and Drug Administration has not changed their stance on genetically modified food adopted in 1992. . . . The policy is that genetically modified crops will receive the same consideration for potential health risks as any other new crop plant. This stance is taken despite good reasons to believe that specific risks may exist. . . . Governments should never have allowed these products into the food chain without insisting on rigorous testing for effects on health.”(11) The Royal Society of Canada described substantial equivalence as “scientifically unjustifiable and inconsistent with precautionary regulation of the technology.”(2)
GMO’s ARE INHERENTLY UNSAFE
There are several reasons why GM plants present unique dangers. The first is that the process of genetic engineering itself creates unpredicted alterations, irrespective of which gene is transferred. The gene insertion process, for example, is accomplished by either shooting genes from a “gene gun” into a plate of cells, or using bacteria to infect the cell with foreign DNA. Both create mutations in and around the insertion site and elsewhere.13 The “transformed” cell is then cloned into a plant through a process called tissue culture, which results in additional hundreds or thousands of mutations throughout the plants’ genome. In the end, the GM plant’s DNA can be a staggering 2-4% different from its natural parent.14 Native genes can be mutated, deleted, or permanently turned on or off. In addition, the insertion process causes holistic and not-well-understood changes among large numbers of native genes. One study revealed that up to 5% of the natural genes altered their levels of protein expression as a result of a single insertion.
The Royal Society of Canada acknowledged that “the default prediction” for GM crops would include “a range of collateral changes in expression of other genes, changes in the pattern of proteins produced and/or changes in metabolic activities.”15 Although the FDA scientists evaluating GMOs in 1992 were unaware of the extent to which GM DNA is damaged or changed, they too described the potential consequences. They reported, “The possibility of unexpected, accidental changes in genetically engineered plants” might produce “unexpected high concentrations of plant toxicants.”16 GM crops, they said, might have “increased levels of known naturally occurring toxins,” and the “appearance of new, not previously identified” toxins.17 The same mechanism can also produce allergens, carcinogens, or substances that inhibit assimilation of nutrients.
Most of these problems would pass unnoticed through safety assessments on GM foods, which are largely designed on the false premise that genes are like Legos that cleanly snap into place. But even if we disregard unexpected changes in the DNA for the moment, a proper functioning inserted gene still carries significant risk. Its newly created GM protein, such as the Bt-toxin, may be dangerous for human health (see below). Moreover, even if that protein is safe in its natural organism, once it is transferred into a new species it may be processed differently. A harmless protein may be transformed into a dangerous or deadly version. This happened with at least one GM food crop under development, GM peas, which were destroyed before being commercialized.
FDA scientists were also quite concerned about the possibility of inserted genes spontaneously transferring into the DNA of bacteria inside our digestive tract. They were particularly alarmed at the possibility of antibiotic resistant marker (ARM) genes transferring. ARM genes are employed during gene insertion to help scientists identify which cells successfully integrated the foreign gene. These ARM genes, however, remain in the cell and are cloned into the DNA of all the GM plants produced from that cell. One FDA report wrote in all capital letters that ARM genes would be “A SERIOUS HEALTH HAZARD,” due to the possibility of that they might transfer to bacteria and create super diseases, untreatable with antibiotics.
Although the biotech industry confidently asserted that gene transfer from GM foods was not possible, the only human feeding study on GM foods later proved that it does take place. The genetic material in soybeans that make them herbicide tolerant transferred into the DNA of human gut bacteria and continued to function18. That means that long after we stop eating a GM crop, its foreign GM proteins may be produced inside our intestines. It is also possible that the foreign genes might end up inside our own DNA, within the cells of our own organs and tissues.
Another worry expressed by FDA scientists was that GM plants might gather “toxic substances from the environment” such as “pesticides or heavy metals,”19 or that toxic substances in GM animal feed might bioaccumulate into milk and meat products. While no studies have looked at thebioaccumulation issue, herbicide tolerant crops certainly have higher levels of herbicide residues. In fact, many countries had to increase their legally allowable levels—by up to 50 times—in order to accommodate the introduction of GM crops.
The overuse of the herbicides due to GM crops has resulted in the development of herbicide resistant weeds. USDA statistics show that herbicide use is rapidly accelerating. Its use was up by 527 million pounds in the first 16 years of GM crops (1996-2011). Glyphosate use per acre on Roundup Ready soybeans was up by 227% while use on non-GMO soy acreage decreased by 20% over the same time period. The rate of application is accelerating due in large part to the emergence of herbicide tolerant weeds, now found on millions of acres. According to a study by Charles Benbrook, the incremental increase per year was 1.5 million pounds in (3) (4) 1999, 18 million in 2003, 79 million in 2009, and about 90 million in 2011. And as Roundup becomes less effective, farmers are now using more toxic herbicides, such as 2-4D. The pesticide-producing Bt crops do reduce the amount of sprayed on insecticides, but the total amount produced by the crops is far greater than the amount of displaced spray. For example, Bt corn that kills the corn rootworm produces one to two pounds of Bt toxin per acre, but reduces sprayed insecticides by only about 0.19 pounds. SmartStax corn with eight genes produces 3.7 pounds of Bt toxin per acre, but displaces only 0.3 pounds of sprayed insecticides. (20) All of the above risks associated with GM foods are magnified for high-risk groups, such as pregnant women, children, the sick, and the elderly. The following section highlights some of the problems that have been identified.
GM DIET SHOWS TOXIC REACTIONS IN THE DIGESTIVE TRACT
The very first crop submitted to the FDA’s voluntary consultation process, the FlavrSavr tomato, showed evidence of toxins. Out of 20 female rats fed the GM tomato, (7) developed stomach lesions.(21) The director of FDA’s Office of Special Research Skills wrote that the tomatoes did not demonstrate a “reasonable certainty of no harm,”(22) which is their normal standard of safety. The Additives Evaluation Branch agreed that “unresolved questions still remain.”(23) The political appointees, however, did not require that the tomato be withdrawn.(1) According to Arpad Pusztai, PhD, one of the world’s leading experts in GM food safety assessments, the type of stomach lesions linked to the tomatoes “could lead to life-endangering hemorrhage, particularly in the elderly who use aspirin to prevent [blood clots].”(24) Dr. Pusztai believes that the digestive tract, which is the first and largest point of contact with foods, can reveal various reactions to toxins and should be the first target of GM food risk assessment. He was alarmed, however, to discover that studies on the FlavrSavr never looked passed the stomach to the intestines. Other studies that did look found problems. Mice fed potatoes engineered to produce the Bt-toxin developed abnormal and damaged cells, as well as proliferative cell growth in the lower part of their small intestines (ileum).(25) Rats fed potatoes engineered to produce a different type of insecticide (GNA lectin from the snowdrop plant) also showed proliferative cell growth in both the stomach and intestinal walls (see photos).(26) Although the guts of rats fed GM peas were not examined for cell growth, the intestines were mysteriously heavier; possibly as a result of such growth.(27) Cell proliferation can be a precursor to cancer and is of special concern.
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