Apicultural Review Letters

Letter # 982
2015 May 29

Genetically Modified Seeds Cause More Harm Than Good I-VII


Part VII

Beware of U.S. scientists from Harvard, Yale & Co as they got the wrong philosophy; a materialistic-mechanistic view of the world and some emty words and phrases are enough. It is a saying that the United States ruined the soil and produces food which is able to pass for weapons of mass destruction.


What happens if there is a wrong Philosophy of Sciences? Are breeding American Elite-Universities stupid konformists? Most U.S. scientists from Harvard, Yale & Co are thinking a philosophy of nature is without meaning, because in the United States nature is an object of exploitation (fracking, genetically engineered plants, animals and human beings) - and that is also possible without thinking, wthout real science and philosophy. A materialistic-mechanistic view of the world and some emty words and phrases are enough. It is a saying that the United States ruined the soil and produces food which is able to pass for weapons of mass destruction. [1][2][3]
__________
[1] Course No. 518 Philosophy of Nature I. More...
[2] Course No. 532 Philosophy of Sciences. More...
[3] Course No. 020 Goethe - Science, Art and Religion. More...
 

Part VI

Beware of U.S. Ambassadors and USAID, as they are salesmen of Monsanto & Co.

Beware of U.S. Ambassadors and USAID, as they are salesmen of Monsanto & Co. The President of the El Salvadoran Center for Appropriate Technologies (CESTA), Ricardo Navarro, has demanded that the U.S. Ambassador to El Salvador, Mari Carmen Aponte, stops pressurizing the Government of El Salvador to buy Monsanto’s GM seeds rather than non-GMO seeds from domestic suppliers. “I would like to tell the U.S. Ambassador to stop pressuring the Government (of El Salvador) to buy ‘improved’ GM seeds,” said Navarro, which is only of benefit to U.S. multinationals and is to the detriment of local seed production, Verdad Digital reported last week. [1][2]

At the end of 2013it was announced that without ‘specific’ economic and environmental policy reforms, the
U.S. government would not provide El Salvador with $277 million in aid money through the Millennium Challenge Corporation (MCC). [3]

It is now clear that by ‘specific reforms’ the MCC means reforms that allow GM crops and their associated pesticides to be forced on El Salvador’s Government and citizens. Is it a coincidence that the MCC delayed its initial agreed aid payments following the announcement by the El Salvador Government that they were
banning the use of Glyphosate (Roundup) and 52 other dangerous chemicals in September 2013?

Glyphosate (Roundup) herbicide sales are the main money earner for the Biotech industry worldwide and the chemical is also the base of the whole system that allows GM Crops to be grown.

The El Salvadoran Government’s ban on Glyphosate came amidst a mysterious kidney disease that is killing thousands of the region’s agricultural laborers. Central America’s health ministries signed a declaration in March 2013 citing the ailment as a top public health priority and committing to a series of steps to combat its reach, the Center of Public Intergrity revealed. [4]

Over the last two years, the Center for Public Integrity has examined how a rare type of chronic kidney disease (CKDu) is killing thousands of agricultural workers along Central America’s Pacific Coast, as well as in Sri Lanka and India. Scientists have yet to definitively uncover the cause of the malady, although emerging evidence points to toxic heavy metals contained in pesticides as a potential culprit. Sri Lankan scientist Dr Jayasumana recently released a study in the International Journal of Environmental Research and Public Health that proposes a link between Roundup (aka Glyphosate) and CKDu. [5]

“There is a harmful corporation on the planet called Monsanto …  it is truly disturbing that the U.S. is trying to promote them …” concluded Navarro, who hopes that the Members of the El Salvadoran Legislative
Assembly do not accept any manipulation by the U.S. Ambassadors and Government officials who are salesmen of Monsanto & Co need to be sacked as they are part of an emerging global crisis and the impending extinction of certain plant and animal species.

______________________
[1] Api Review Letters 2014, 13, Nr. 884 and http://deutsche-wirtschafts-nachrichten.de
[2] Api Review Letters 2014, 13, Nr. 884 and
Http://www.verdaddigital.com/index.php/nacionales/10809-cesta-exige-a-embajada-de-ee-uu-que-deje-de-presionar-al-pais-en-la-compra-semillas-mejoradas
[3] Api Review Letters 2014, 13, Nr. 884 and http://vivaecoviva.wordpress.com/2013/12/02/millennium-challenge-corporation-stalls-on-compact-signing
[4] Science Review Letters 2014, 13, Nr. 560 and
http://sustainablepulse.com/2013/09/19/el-salvador-government-bans-roundup-over-deadly-kidney-disease
[5] Science Review Letters 2014, 13, Nr. 560 and
http://sustainablepulse.com/2014/03/24/scientist-slams-biotech-industry-deadly-kidney-disease-epidemic-exclusive-interview/#.U5RjFfnV9cQ
 

Part V

Abstract: The whole catastrophe of genetically modified foods and GMOs can be seen by daylight now. Companies like Monsanto gave bribes and questionable payments to officials, attempting to get their genetically modified (GM) plants approved. On Monsanto`s bribery-system, dirty tricks, pack of lies and all the little blackguards and vice-blackguards. BASF-CEO Jürgen Hamprecht tells us about his partnership with Monsanto because he believes in the 'compentence' of Monsanto in these matters. The conflict of interest among scientists at the European Food Safety Authority (EFSA) GMO Panel and FDA - FDA created health crisis - how corporations engineered the non-regulation of dangerous genetically modified foods. The FDA's "non-regulation" Of GM Foods - Humans as guinea pigs - covering up health dangers - fake safety assessments

More and more the whole catastrophe of genetically modified foods and GMOs can be seen by daylight. Companies like Monsanto gave bribes and questionable payments to officials, attempting to get their genetically modified (GM) plants approved*. We remember how BASF-CEO Jürgen Hamprecht tells us about his partnership with Monsanto because he believes in the 'compentence' of Monsanto in these matters**.

„Government officials around the globe have been coerced, infiltrated, and paid off by the agricultural biotech giants. In Indonesia, Monsanto gave bribes and questionable payments to at least 140 officials, attempting to get their genetically modified (GM) cotton approved.[1] [4] In India, one official tampered with the report on Bt cotton to increase the yield figures to favor Monsanto.[2] [5] In Mexico, a senior government official allegedly threatened a University of California professor, implying "We know where your children go to school," trying to get him not to publish incriminating evidence that would delay GM approvals.[3] [6] While most industry manipulation and political collusion is more subtle, none was more significant than that found at the US Food and Drug Administration (FDA).

The FDA's "non-regulation" Of GM Foods

Genetically modified crops are the result of a technology developed in the 1970s that allow genes from one species to be forced into the DNA of unrelated species. The inserted genes produce proteins that confer traits in the new plant, such as herbicide tolerance or pesticide production. The process of creating the GM crop can produce all sorts of side effects, and the plants contain proteins that have never before been in the food supply. In the US, new types of food substances are normally classified as food additives, which must undergo extensive testing, including long-term animal feeding studies.[4] [7] If approved, the label of food products containing the additive must list it as an ingredient.

There is an exception, however, for substances that are deemed "generally recognized as safe" (GRAS). GRAS status allows a product to be commercialized 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 that some experts contend was illegal, in 1992 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 labels whatsoever. A company can even introduce a GM food to the market without telling the agency.

Such a lenient approach to GM crops was largely the result of Monsanto's legendary influence over the US government. 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." According to Dr. Henry Miller, who had a leading role in biotechnology issues at the FDA from 1979 to 1994, "In this area, the U.S. government agencies have done exactly what big agribusiness has asked them to do and told them to do."

Following Monsanto's lead, in 1992 the Council on Competitiveness chaired by Vice President Dan Quayle identified GM crops as an industry that could increase US exports. On May 26, Quayle announced "reforms" to "speed up and simplify the process of bringing" GM products to market without "being hampered by unnecessary regulation."[5] [8] 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.

COVERING UP HEALTH DANGERS

The policy he oversaw needed to create the impression that unintended effects from GM crops were not an issue. Otherwise their GRAS status would be undermined. 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 problems. They had urged superiors to require long-term safety studies.[6] [9] 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)."[7] [10]

FDA microbiologist Louis Pribyl 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."[8] [11]

The FDA scientists' concerns were not only ignored, their very existence was denied. Consider the private memo summarizing opinions at the FDA, which 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] [12] Contrast that with the official policy statement: "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."[10] [13] On the basis of this manufactured and false notion of no meaningful differences, the FDA does not require GM food safety testing.

To further justify their lack of oversight, they claimed that GM crops were "substantially equivalent" to their natural counterparts. But this concept does not hold up to scrutiny. The Royal Society of Canada described substantial equivalence as "scientifically unjustifiable and inconsistent with precautionary regulation of the technology." In sharp contrast to the FDA's position, the Royal Society of Canada said 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."[11] [14]

FAKE SAFETY ASSESSMENTS

Biotech companies do participate in a voluntary consultation process with the FDA, but it is derided by critics as a meaningless exercise. Companies can submit whatever information they choose, and the FDA does not conduct or commission any studies of their own. Former EPA scientist Doug Gurian-Sherman, who analyzed FDA review records obtained through the Freedom of Information Act, states flatly, "It is clear that FDA's current voluntary notification process (even if made mandatory) is not up to the task of ensuring the safety of future GE [genetically engineered] crops." He says, "The FDA consultation process does not allow the agency to require submission of data, misses obvious errors in company-submitted data summaries, provides insufficient testing guidance, and does not require sufficiently detailed data to enable the FDA to assure that GE crops are safe to eat."[12] [15] Similarly, a Friends of the Earth review of company and FDA documents concluded:

"If industry chooses to submit faulty, unpublishable studies, it does so without consequence. If it should respond to an agency request with deficient data, it does so without reprimand or follow-up.. . . If a company finds it disadvantageous to characterize its product, then its properties remain uncertain or unknown. If a corporation chooses to ignore scientifically sound testing standards . . . then faulty tests are conducted instead, and the results are considered legitimate. In the area of genetically engineered food regulation, the ‘competent' agencies rarely if ever (know how to) conduct independent research to verify or supplement industry findings."[13] [16]

At the end of the consultation, the FDA doesn't actually approve the crops. Rather, they issue a letter including a statement such as the following:

"Based on the safety and nutritional assessment you have conducted, it is our understanding that Monsanto has concluded that corn products derived from this new variety are not materially different in composition, safety, and other relevant parameters from corn currently on the market, and that the genetically modified corn does not raise issues that would require premarket review or approval by FDA. . . . As you are aware, it is Monsanto's responsibility to ensure that foods marketed by the firm are safe, wholesome and in compliance with all applicable legal and regulatory requirements."[14] [17]

The National Academy of Sciences and even the pro-GM Royal Society of London[15] [18] 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."[16] [19]

PROMOTING AND REGULATING DON'T MIX

The FDA and other regulatory agencies are officially charged with both regulating biotech products and promoting them—a clear conflict. Suzanne Wuerthele, a US EPA toxicologist, says, "This technology is being promoted, in the face of concerns by respectable scientists and in the face of data to the contrary, by the very agencies which are supposed to be protecting human health and the environment. The bottom line in my view is that we are confronted with the most powerful technology the world has ever known, and it is being rapidly deployed with almost no thought whatsoever to its consequences."

Canadian regulators are similarly conflicted. The Royal Society of Canada reported that, "In meetings with senior managers from the various Canadian regulatory departments . . . their responses uniformly stressed the importance of maintaining a favorable climate for the biotechnology industry to develop new products and submit them for approval on the Canadian market. . . . The conflict of interest involved in both promoting and regulating an industry or technology . . . is also a factor in the issue of maintaining the transparency, and therefore the scientific integrity, of the regulatory process. In effect, the public interest in a regulatory system that is ‘science based'—that meets scientific  standards of objectivity, a major aspect of which is full openness to scientific peer review—is significantly compromised when that openness is negotiated away by regulators in exchange for cordial and supportive relationships with the industries being regulated."[17] [20]

The conflict of interest among scientists at the European Food Safety Authority (EFSA) GMO Panel is quite explicit. According to Friends of the Earth, "One member has direct financial links with the biotech industry and others have indirect links, such as close involvement with major conferences organized by the biotech industry. Two members have even appeared in promotional videos produced by the biotech industry. . . . Several members of the Panel, including the chair Professor Kuiper, have been involved with the EU-funded ENTRANSFOOD project. The aim of this project was to agree [to] safety assessment, risk management and risk communication procedures that would ‘facilitate market introduction of GMOs in Europe, and therefore bring the European industry in a competitive position.' Professor Kuiper, who coordinated the ENTRANSFOOD project, sat on a working group that also included staff from Monsanto, Bayer CropScience and Syngenta." The report concludes that EFSA is "being used to create a false impression of scientific agreement when the real situation is one of intense and continuing debate and uncertainty."[18] [21] This parallels the deceptive façade at the FDA". (*) - This conflict of interest among scientists at the European Food Safety Authority (EFSA) GMO Panel is documented in Science Review Letters 2002-2007 and Apicultural Review Letters 2002-2007***

The pro-GM European Commission repeats the same ruse. According to leaked documents obtained by Friends of the Earth, while they privately appreciate "the uncertainties and gaps in knowledge that exist in relation to the safety of GM crops . . . the Commission normally keeps this uncertainty concealed from the public whilst presenting its decisions about the safety of GM crops and foods as being certain and scientifically based." Further, in private "they frequently criticize the European Food Safety Authority (EFSA) and its assessments of the safety of GM foods and crops, even though the Commission relies on these evaluations to make recommendations to member states. . . [and] to justify its decisions to approve new GM foods."[19] [22] For example, the Commission privately condemned the submission information for one crop as "mixed, scarce, delivered consecutively all over years, and not convincing." They said there is "No sufficient experimental evidence to assess the safety."[20] [23]

almost animal toxicity testing EVALUATIONS MISS MOST HEALTH PROBLEMS

Although the body of safety studies on GM foods is quite small, it has verified the concerns expressed by FDA scientists and others.

But there is not a single government safety assessment program in the world that is competent to even identify most of these potential health problems, let alone protect its citizens from the effects.[21][24]

A review of approved GM crops in Canada by professor E. Ann Clark, for example, reveals that 70% (28 of 40) "of the currently available GM crops . . . have not been subjected to any actual lab or animal toxicity testing, either as refined oils for direct human consumption or indirectly as feedstuffs for livestock. The same finding pertains to all three GM tomato Decisions, the only GM flax, and to five GM corn crops." In the remaining 30% (12) of the other crops tested, animals were _not_ fed the whole GM feed. They were given just the isolated GM protein that the plant was engineered to produce. But even this protein was not extracted from the actual GM plant. Rather, it was manufactured in genetically engineered bacteria. This method of testing would never identify problems associated with collateral damage to GM plant DNA, unpredicted changes in the GM protein, transfer of genes to bacteria or human cells, excessive herbicide residues, or accumulation of toxins in the food chain, among others. Clark asks, "Where are the trials showing lack of harm to fed livestock, or that meat and milk from livestock fed on GM feedstuffs are safe?"[22] [25]

Epidemiologist and GM safety expert Judy Carman shows that assessments by Food Safety Australia New Zealand (FSANZ) similarly overlook serious potential problems, including cancer, birth defects, or long-term effects of nutritional deficiencies. [23] [26]

"A review of twelve reports covering twenty-eight GM crops - four soy, three corn, ten potatoes, eight canola, one sugar beet and two cotton - revealed no feeding trials on people. In addition, one of the GM corn varieties had gone untested on animals. Some seventeen foods involved testing with only a single oral gavage (a type of forced-feeding), with observation for seven to fourteen days, and only of the substance that had been genetically engineered to appear [the GM protein], not the whole food. Such testing assumes that the only new substance that will appear in the food is the one genetically engineered to appear, that the GM plant-produced substance will act in the same manner as the tested substance that was obtained from another source [GM bacteria], and that the substance will create disease within a few days. All are untested hypotheses and make a mockery of GM proponents' claims that the risk assessment of GM foods is based on sound science. Furthermore, where the whole food was given to animals to eat, sample sizes were often very low - for example, five to six cows per group for Roundup Ready soy - and they were fed for only four weeks."[24] [27]

HIDDEN INFORMATION, LACK OF STANDARDS, AND BREAKING LAWS

Companies claim that their submissions to government regulators are "confidential business information" so they are kept secret. Some industry studies that have been forced into the public domain through Freedom of Information requests or lawsuits have been appalling in design and execution. This is due in part to the lack of meaningful and consistent standards required for assessments. Gurian-Sherman says of the FDA's voluntary consultation, "Some submissions are hundreds of pages long while others are only 10 or 20."[25] [28] A Friends of the Earth report on US regulation and corporate testing practices states, "Without standardization, companies can and do design test procedures to get the results they want." [26] [29] Regulators also reference international standards as it suits them. According to the Centre for Integrated Research in Biosafety, for example, FSANZ "relaxed adherence to international standards for safety testing when that better suited the Applicant's submitted work, and imposed international standards whenever that was a lower standard than we recommended."[27] [30]

Regulators also break laws. The declaration of GRAS status by the FDA deviated from the Food and Cosmetic Act and years of legal precedent. In Europe, the law requires that when EFSA and member states have different opinions, they "are obliged to co-operate with a view to either resolving the divergence or preparing a joint document clarifying the contentious scientific issues and identifying the relevant uncertainties in the data."[28] [31] According to FOE, in the case of _all_ GM crop reviews, none of these legal obligations were followed.[29] [32]

HUMANS AS GUINEA PIGS

Since GM foods are not properly tested before they enter the market, consumers are the guinea pigs. But this doesn't even qualify as an experiment. There are no controls and no monitoring. Without post-marketing surveillance, the chances of tracing health problems to GM food are low. The incidence of a disease would have to increase dramatically before it was noticed, meaning that millions may have to get sick before a change is investigated. Tracking the impact of GM foods is even more difficult in North America, where the foods are not labeled. Regulators at Health Canada announced in 2002 that they would monitor Canadians for health problems from eating GM foods. A spokesperson said, "I think it's just prudent and what the public expects, that we will keep a careful eye on the health of Canadians." But according to CBC TV news, Health Canada "abandoned that research less than a year later saying it was ‘too difficult to put an effective surveillance system in place.'" The news anchor added, "So at this point, there is little research into the health effects of genetically modified food. So will we ever know for sure if it's safe?"[30]

Not with the biotech companies in charge. Consider the following statement in a report submitted to county officials in California by pro-GM members of a task force. "[It is] generally agreed that long-term monitoring of the human health risks of GM food through epidemiological studies is not necessary because there is no scientific evidence suggesting any long-term harm from these foods."[31] Note the circular logic: Because no long-term epidemiological studies are in place, we have no evidence showing long-term harm. And since we don't have any evidence of long-term harm, we don't need studies to look for it.

What are these people thinking? Insight into the pro-GM mindset was provided by Dan Glickman, the US Secretary of Agriculture under President Clinton.

"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. Without thinking, we had basically taken this issue as a trade issue and they, whoever ‘they' were, wanted to keep our product out of their market. And they were foolish, or stupid, and didn't have an effective regulatory system. There was rhetoric like that even here in this department. You felt like you were almost an alien, disloyal, by trying to present an open-minded view on some of the issues being raised. So I pretty much spouted the rhetoric that everybody else around here spouted; it was written into my speeches."[32]

Fortunately, not everyone feels that questioning GM foods is disloyal. On the contrary, millions of people around the world are unwilling to participate in this uncontrolled experiment. They refuse to eat GM foods. Manufacturers in Europe and Japan have committed to avoid using GM ingredients. And the US natural foods industry, not waiting for the government to test or label GMOs, is now engaged in removing all remaining GM ingredients from their sector using a third party verification system. The Campaign for Healthier Eating in America will circulate non-GMO shopping guides in stores nationwide so that consumers have clear, healthy non-GMO choices. With no governmental regulation of biotech corporations, it is left to consumers to protect themselves" (Spilling the Beans, October 2007).*

-------------------------
Notes and further reading
*) Spilling the Beans, October 2007, Science Review Letters 2007, Vol. 6 #172
**) Apicultural Review Letters 2007, Vol. 6, #121
***)see also Science Review Letters 2002-2007: 2006,5,#612006,5,#20
and Apicultural Review Letters 2002-2007

[1] "Monsanto Bribery Charges in Indonesia by DoJ and USSEC," Third World Network, Malaysia, Jan 27, 2005, http://www.mindfully.org/GE/2005/Monsanto-Indonesia-Bribery27jan05.htm
[2] "Greenpeace exposes Government-Monsanto nexus to cheat Indian farmers: calls on GEAC to revoke BT cotton permission," Press release, March 3, 2005, http://www.greenpeace.org/india_en/news/details?item_id=771071
[3] Jeffrey M. Smith, Seeds of Deception, (Iowa: Yes! Books, 2003), 224.
[4] See Federal Food, Drug and Cosmetic Act (FFDCA)
[5] Dan Quayle, "Speech in the Indian Treaty Room of the Old Executive Office Building," May 26, 1992.
[6] See Smith, Seeds of Deception; and for copies of FDA memos, see The Alliance for Bio-Integrity, www.biointegrity.org
[7] Steven M. Druker, "How the US Food and Drug Administration approved genetically engineered foods despite the deaths one had caused and the warnings of its own scientists about their unique risks," Alliance for Bio-Integrity, http://www.biointegrity.org/ext-summary.html
[8] Louis J. Pribyl, "Biotechnology Draft Document, 2/27/92," March 6, 1992, www.biointegrity.org http://www.biointegrity.org/FDAdocs/04/view1.html
[9] Linda Kahl, Memo to James Maryanski about _Federal Register_ Document "Statement of Policy: Foods from Genetically Modified Plants," Alliance for Bio-Integrity(January 8, 1992) http://www.biointegrity.org
[10] "Statement of Policy: Foods Derived from New Plant Varieties," Federal Register 57, no. 104 (May 29, 1992): 22991.
[11] "Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada; An Expert Panel Report on the Future of Food Biotechnology prepared by The Royal Society of Canada at the request of Health Canada Canadian Food Inspection Agency and Environment Canada" The Royal Society of Canada, January 2001.
[12] Doug Gurian-Sherman, "Holes in the Biotech Safety Net, FDA Policy Does Not Assure the Safety of Genetically Engineered Foods," Center for Science in the Public Interest, http://www.cspinet.org/new/pdf/fda_report__final.pdf
[13] Bill Freese, "The StarLink Affair, Submission by Friends of the Earth to the FIFRA Scientific Advisory Panel considering Assessment of Additional Scientific Information Concerning StarLink Corn," July 17-19, 2001.
[14] FDA Letter, Letter from Alan M. Rulis, Office of Premarket Approval, Center for Food Safety and Applied Nutrition, FDA to Dr. Kent Croon, Regulatory Affairs Manager, Monsanto Company, Sept 25, 1996. See Letter for BNF No. 34 at http://www.cfsan.fda.gov/~lrd/biocon.html
[15] See for example, "Good Enough To Eat?" New Scientist (February 9, 2002), 7.
[16] "Health risks of genetically modified foods," editorial, _Lancet_, 29 May 1999.
[17] "Elements of Precaution," The Royal Society of Canada, January 2001.
[18] Friends of the Earth Europe, "Throwing Caution to the Wind: A review of the European Food Safety Authority and its work on genetically modified foods and crops," November 2004.
[19] Friends of the Earth Europe and Greenpeace, "Hidden Uncertainties What the European Commission doesn't want us to know about the risks of GMOs," April 2006.
[20] European Communities submission to World Trade Organization dispute panel, 28 January 2005.
[21] Jeffrey M. Smith, _Genetic Roulette_: _The Documented Health Risks of Genetically Engineered Foods_, Yes! Books, Fairfield, IA USA 2007
[22] E. Ann Clark, "Food Safety of GM Crops in Canada: toxicity and allergenicity," GE Alert, 2000.
[23] FLRAG of the PHAA of behalf of the PHAA, "Comments to ANZFA about Applications A372, A375, A378 and A379."
[24] Judy Carman, "Is GM Food Safe to Eat?" in R. Hindmarsh, G. Lawrence, eds., Recoding Nature Critical Perspectives on Genetic Engineering (Sydney: UNSW Press, 2004): 82-93.
[25] Doug Gurian-Sherman, "Holes in the Biotech Safety Net, FDA Policy Does Not Assure the Safety of Genetically Engineered Foods," Center for Science in the Public Interest, http://www.cspinet.org/new/pdf/fda_report__final.pdf
[26] William Freese, "Genetically Engineered Crop Health Impacts Evaluation: A Critique of U.S. Regulation of Genetically Engineered Crops and Corporate Testing Practices, with a Case Study of _Bt_ Corn," Friends of the Earth U.S., http://www.foe.org/camps/comm/safefood/gefood/index.html
[27] M. Cretenet, J. Goven, J. A. Heinemann, B. Moore, and C. Rodriguez-Beltran, "Submission on the DAR for Application A549 Food Derived from High-Lysine Corn LY038: to permit the use in food of high-lysine corn, 2006, www.inbi.canterbury.ac.nz
[28] EU Regulation 178/2002 (Article 30)
[29] See note 18.
[30] "Genetically modified foods, who knows how safe they are?" CBC News and Current Affairs, September 25, 2006.
[31] Mike Zelina, et al., The Health Effects of Genetically Engineered Crops on San Luis Obispo County," A Citizen Response to the SLO Health Commission GMO Task Force Report, 2006.
[32] Bill Lambrecht, Dinner at the New Gene Café, St. Martin's Press, September 2001, pg 139.
 
 

Part IV
 

Abstract: Genetically Engineered Crops May Produce Herbicide Inside Our Intestines - Disturbing gut bacteria - Endocrine disruption at extremely low doses - Inadequate animal feeding studies


The full catastrophe regarding Agrobiotechnology, genetically modified (GM) foods, genetically modified organisms (GMOs) started in the US. Now, about ten years after no true scientist and University in the US and elsewhere say there aren’t any dangerous risks. Only a few scientists, who are being sold by biotech-Industry still trying to do a kind of scientific research on „Biosafety-issues" outside reality (but even they found out many negative side-effects of GMOs - as now published secret documents show). Nearly all scientists reveal more and more the negative effects of genetically modified organisms (GMOs) on human health, nature, environment, landscape, animals, especially cows, pigs, sheep and honeybees. The last issues of Science Review Letters (#156-159)  documented the now increasing US- resistance against genetically modified foods. Also further issues of Science Review Letters will focus on well-done resistance against genetically modified foods, especially a review of scientific research regarding all the innumerous dangerous and life threatening side effects of modern Biotechnology.

Genetically Engineered Crops May Produce Herbicide Inside Our Intestines: Pioneer Hi-Bred’s website boasts that their genetically modified (GM) Liberty Link[1] corn survives doses of Liberty herbicide, which would normally kill corn. The reason, they say, is that the herbicide becomes "inactive in the corn plant."[2] They fail to reveal, however, that after you eat the GM corn, some inactive herbicide may become reactivated inside your gut and cause a toxic reaction. In addition, a gene that was inserted into the corn might transfer into the DNA of your gut bacteria, producing long-term effects. These are just a couple of the many potential side-effects of GM crops that critics say put the public at risk.Herbicide tolerance (HT) is one of two basic traits common to nearly all GM crops. About 71% of the crops are engineered to resist herbicide, including Liberty (glufosinate ammonium) and Roundup[3] (glyphosate).  About 18% produce their own pesticide. And 11% do both. The four major GM crops are soy, corn, cotton and canola, all of which have approved Liberty- and Roundup-tolerant varieties. Herbicide tolerant (HT) crops are a particularly big money-maker for biotech companies, because when farmers buy HT seeds, they are required to purchase the companies’ brand of herbicide as well. In addition, HT crops dramatically increase the use of herbicide,[4] which further contributes to the companies’ bottom line. There are no required safety tests for HT crops in the US—if the biotech companies declare them fit for human consumption, the FDA has no further questions. But many scientists and consumers remain concerned, and the Liberty Link varieties pose unique risks. Liberty herbicide (also marketed as Basta, Ignite, Rely, Finale and Challenge) can kill a wide variety of plants. It can also kill bacteria,[5] fungi[6] and insects,[7] and has toxic effects on humans and animals.[8] The herbicide is derived from a natural antibiotic, which is produced by two strains of a soil bacterium. In order that the bacteria are not killed by the antibiotic that they themselves create, the strains also produce specialized enzymes which transform the antibiotic to a non-toxic form called NAG (N-acetyl-L-glufosinate). The specialized enzymes are called the pat protein and the bar protein, which are produced by the pat gene and the bar gene, respectively. The two genes are inserted into the DNA of GM crops, where they produce the enzymes in every cell. When the plant is sprayed, Liberty’s solvents and surfactants transport glufosinate ammonium throughout the plant, where the enzymes convert it primarily into NAG. Thus, the GM plant detoxifies the herbicide and lives, while the surrounding weeds die. The problem is that the NAG, which is not naturally present in plants, remains there and accumulates with every subsequent spray. Thus, when we eat these GM crops, we consume NAG. Once the NAG is inside our digestive system, some of it may be re-transformed back into the toxic herbicide. In rats fed NAG, for example, 10% of it was converted back to glufosinate by the time it was excreted in the feces.[9] Another rat study found a 1% conversion.[10] And with goats, more than one-third of what was excreted had turned into glufosinate.[11] It is believed that gut bacteria, primarily found in the colon or rectum, are responsible for this re-toxification.[12] Although these parts of the gut do not absorb as many nutrients as other sections, rats fed NAG did show toxic effects. This indicates that the herbicide had been regenerated, was biologically active, and had been assimilated by the rats.[13] A goat study also confirmed that some of the herbicide regenerated from NAG ended up in the kidneys, liver, muscle, fat and milk.[14]   More information about the impact of this conversion is presumably found in "Toxicology and Metabolism Studies" on NAG, submitted to European regulators by AgrEvo (now Bayer CropScience). These unpublished studies were part of the application seeking approval of herbicide-tolerant canola. When the UK government’s Pesticide Safety Directorate attempted to provide some of this information to an independent researcher, they were blocked by the company’s threats of legal action.[15] The studies remained private. Toxicity of the herbicide Glufosinate ammonium is  structurally similar to a natural amino acid called glutamic acid, which can stimulate the central nervous system and, in excess levels, cause the death of nerve cells in the brain.[16] The common reactions to glufosinate poisoning in humans include unconsciousness, respiratory distress and convulsions. One study also linked the herbicide with a kidney disorder.[17] These reactions typically involve large amounts of the herbicide. It is unclear if the amount converted from GM crops would accumulate to promote such responses or if there are low dose chronic effects. Perhaps a more critical question may be whether infants or fetuses are impacted with smaller doses. A January 2006 report issued by the Environmental Protection Agency’s (EPA) Office of Inspector General said that  studies demonstrate that certain pesticides easily enter the brain of young children and fetuses, and can destroy cells. That same report, however, stated that the EPA lacks standard evaluation protocols for measuring the toxicity of pesticides on developing nervous systems.[18] Scientists at the agency also charged that "risk assessments cannot state with confidence the degree to which any exposure of a fetus, infant or child to a pesticide will or will not adversely affect their neurological development." [19] Furthermore, three trade unions representing 9,000 EPA workers claimed that the evaluation techniques used at the agency were highly politicized. According to a May 24, 2006 letter to the EPA’s administrator, the unions cited "political pressure exerted by Agency officials perceived to be too closely aligned with the pesticide industry and former EPA officials now representing the pesticide and agricultural community."[20] Although the EPA may be hampered in its evaluations, research has nonetheless accumulated which suggests that glufosinate carries significant risks for the next   generation. According to Yoichiro Kuroda, the principal investigator in the Japanese project entitled "Effects of Endocrine Disrupters on the Developing Brain," glufosinate is like a "mock neurotransmitter." Exposure of a baby or embryo can affect behavior, because the chemical disturbs gene functions that regulate brain development.[21] When mouse embryos were exposed to glufosinate, it resulted in growth retardation, increased death rates, incomplete development of the forebrain and cleft lips,[22] as well as cell death in part of the brain.[23] After pregnant rats were injected with glufosinate, the number of glutamate receptors in the brains of the offspring appeared to be reduced.[24] When infant rats were exposed to low doses of glufosinate, some of their brain receptors appeared to change as well.[25] Glufosinate herbicide might also influence behavior. According to Kuroda, "female rats born from mothers that were given high doses of glufosinate became aggressive and started to bite each other—in some cases until one died." He added, "That report sent a chill through me."[26]

Disturbing gut bacteria: If the herbicide is regenerated inside our gut, since it is an antibiotic, it will likely kill gut bacteria. Gut microorganisms are crucial for health. They not only provide essential metabolites like certain vitamins and short fatty acids, but also help the break down and absorption of food and protect against pathogens. Disrupting the balance of gut bacteria can cause a wide range of problems. According to molecular geneticist Ricarda Steinbrecher, "the data obtained strongly suggest that the balance of gut bacteria will be affected"[27] by the conversion of NAG to glufosinate. When eating Liberty Link corn, we not only consume NAG, but also the pat and bar genes with their pat and bar proteins. It is possible that when NAG is converted to herbicide in our gut, the pat protein, for example, might reconvert some of the herbicide back to NAG. This might lower concentrations of glufosinate inside of our gut. On the other hand, some microorganisms may be able to convert in both directions, from glufosinate to NAG and also back again. If the pat protein can do this, that is, if it can transform NAG to herbicide, than the presence of the pat protein inside our gut might regenerate more herbicide from the ingested NAG. Since there are no public studies on this, we do not know if consuming the pat gene or bar genes will make the situation better or worse. But one study on the pat gene raises all sorts of red flags. German scientist Hans-Heinrich Kaatz demonstrated that the pat gene can transfer into the DNA of gut bacteria. He found his evidence in young bees that had been fed pollen from glufosinate-tolerant canola plants. The pat gene transferred into the bacteria and yeast inside the bees’ intestines. Kaatz said, "This happened rarely, but it did happen."[28] Although no studies have looked at whether pat genes end up in human gut bacteria, the only human GM-feeding study ever conducted did show that genetic material can transfer to our gut bacteria. This study, published in 2004, confirmed that portions of the Roundup-tolerant gene in soybeans transferred to microorganisms within the human digestive tract.[29] Since the pat gene can transfer to gut bacteria in bees, and since genetic material from another GM crop can transfer to human gut bacteria, it is likely that the pat gene can also transfer from Liberty Link corn or soybeans to our intestinal flora. If so, a key question is whether the presence of the pat gene confers some sort of survival advantage to the bacteria. If so, "selection pressure" would favor its long term proliferation in the gut. Because the pat protein can protect bacteria from being killed by glufosinate, gut bacteria that take up the gene appears to have a significant survival advantage. Thus, the gene may spread from bacteria to bacteria, and might stick around inside us for the long-term. With more pat genes, more and more pat protein is created. The effects of long-term exposure to this protein have not been evaluated. Now suppose that the pat protein can also re-toxify NAG back into active herbicide, as discussed above. A dangerous feedback loop may be created: We eat Liberty Link corn or soy. Our gut bacteria, plus the pat protein, turns NAG into herbicide. With more herbicide, more bacteria are killed. This increases the survival advantage for bacteria that contain the pat gene. As a consequence, more bacteria end up with the gene. Then, more pat protein is produced, which converts more NAG into herbicide, which threatens more bacteria, which creates more selection pressure, and so on. Since studies have not been done to see if such a cycle is occurring, we can only speculate.

Endocrine disruption at extremely low doses: Another potential danger from the glufosinate-tolerant crops is the potential for endocrine disruption. Recent studies reveal that endocrine-disrupting chemicals (EDCs) can have significant hormonal effects at doses far below those previously thought to be significant. The disruptive effects are often found only at minute levels, which are measured in parts per trillion or in the low parts per billion. This is seen, for example, in the way estrogen works in women. When the brain encounters a mere 3 parts per trillion, it shuts down  production of key hormones. When estrogen concentration reaches 10 parts per trillion, however, there is a hormone surge, followed by ovulation.Unfortunately, the regulation and testing of agricultural chemicals, including herbicides, has lagged behind these findings of extremely low dose effects. The determination of legally acceptable levels of herbicide residues on food was based on a linear model, where the effect of toxic chemicals was thought to be consistent and proportional with its dosage. But as the paper Large Effects from Small Exposures shows, this model underestimates biological effects of EDCs by as much as 10,000 fold.[30] In anticipation of their (not-yet-commercialized) Liberty Link rice, Bayer CropScience successfully petitioned the EPA in 2003 to approve maximum threshold levels of glufosinate ammonium on rice. During the comment period preceding approval, a Sierra Club submittal stated the following. "We find EPA’s statements on the potential of glufosinate to function as an endocrine-disrupting substance in humans and animals as not founded on logical information or peer-reviewed studies. In fact EPA states that no special studies have been conducted to investigate the potential of glufosinate ammonium to induce estrogenic or other endocrine effects. . . . We feel it’s totally premature for EPA at this time to dismiss all concerns about glufosinate as an endocrine-disrupting substance. . . . Due to the millions of Americans and their children exposed to glufosinate and its metabolites, EPA needs to conclusively determine if this herbicide has endocrine-disrupting potential." The EPA’s response was that "glufosinate ammonium may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption"[31]  but this will only take place after these protocols are developed. In the mean time, the agency approved glufosinate ammonium residues on rice at 1 part per million. Since glufosinate ammonium might have endocrine disrupting properties, even small conversions of NAG to  herbicide may carry significant health risks for ourselves and our children.

Inadequate animal feeding studies: If we look to animal feeding studies to find out if Liberty Link corn creates health effects, we encounter what independent observers have expressed for years—frustration. Industry-sponsored safety studies, which are rarely published and often kept secret, are  often described as designed to avoid finding problems. In a 42-day feeding study on chickens, for example, 10 chickens (7%) fed Liberty Link corn died compared to 5 chickens eating natural corn.[32]  Even with the death rate doubled, "because the experimental design was so flawed," said bio-physicist Mae-Wan Ho, "statistical analysis failed to detect a significant difference between the two groups." [33]  Similarly, although the GM-fed group gained less weight, the study failed to recognize that as significant. According to testimony by two experts in chicken feeding studies,[34] the Liberty  Link corn study wouldn’t identify something as significant unless there had been "huge" changes. The  experts said, "It may be worth noting, in passing, that if one were seeking to show no effect, one of the best methods to do this is would be to use insufficient replication, a small n,"[35]  which is exactly the case in the chicken study.  Without adequate tests and with a rubber stamp approval process, GM crops like Liberty Link corn may already be creating significant hard-to-detect health problems. In  Europe, Japan, Korea, Russia, China, India, Brazil and elsewhere, shoppers have the benefit of laws that require foods with GM ingredients to be labeled. In the US, however, consumers wishing to avoid them are forced to eliminate all products containing soy and corn, as well as canola and cottonseed oils. Or they can buy products that are organic or say "non-GMO" on the package. Changing one’s diet is a hassle, but with the hidden surprises inside GM foods, it may be a prudent option for health-conscious people, especially young children and pregnant women." (NL Spilling the Beans, April-May 2006, Science Review Letters 2007, Vol. 6 #159)
_____________
[1] Liberty Link is a registered trademark of Bayer CropScience.
[2] http://www.pioneer.com/canada/crop_management/fsllink.htm.
[3] Roundup is a registered trademark of Monsanto.
[4] Charles Benbrook, "Genetically Engineered Crops and Pesticide Use in the United States: The First Nine Years," October 2004 http://www.biotech-info.net/Technical_Paper_6.pdf.
[5] Colanduoni JA and Villafranca JJ (1986). Inhibition of Escherichia coli glutamine-synthetase by phosphinothricin. Bioorganic Chemistry 14(2): 163-169, and Pline W A~ Lacy GH~ Stromberg V ~ Hatzios KK (200I). Antibacterial activity of the herbicide glufosinate on Pseudomonas syringae pathovar glycinea. Pesticide Biochemistry And Physiology 71(1): 48-55.
[6] Liu CA; Zhong H; Vargas J; Penner D; Sticklen M (1998). Prevention of fungal diseases in transgenic, bialaphos- and glufosinate-resistant creeping bentgrass (Agrostis palustrls). Weed Science 46(1): 139-146, and Tada T~ Kanzaki H~ Norita E~ Uchimiya H~ Nakamura I (1998). Decreased symptoms of rice blast disease on leaves of bar-expressing transgenic rice plants following treatment with bialaphos. MolecularPlant-Microbe Interactions 9(8): 762-764.
[7] Ahn Y -J, Kim Y -J and Yoo J-K (2001). Toxicity of the herbicide glufosinate-ammonium to predatory insects and mites of Tetranychus urticae (Acari: Tetranychidae) under laboratory conditions. Journal Of Economic Entomology 94(1): s157-161.
[8] Watanabe T and Sano T (1998). Neurological effects of glufosinate poisoning with a brief review. Human & Experimental Toxicology 17(1): 35-39.
[9] Bremmer IN and Leist K-H (1997). Disodium-N-acetyl-L-glufosinate; AE F099730 - Hazard  evaluation of Lglufosinate produced intestinally from N-acetyl-L-glufosinate. Hoechst Schering AgrEvo GmbH, Safety Evaluation Frankfurt. TOX97/014. A58659. Unpublished. (see FAO publication on  www.fao.org/ag/agp/agpp/pesticid/jmpr/Download/98/glufosi3.pdf).
[10]Kellner H-M, StumpfK and Braun R (1993). Hoe 099730-14C Pharmacokinetics in rats following single oral and intravenous administration of3 mg/kg body.    Hoechst RCL, Germany, 01-L42­0670-93. A49978. Unpublished.
[11] Huang, M.N. and Smith, S.M. 1995b. Metabolism of  [14C]-N-acetyl glufosinate in a lactating goat. AgrEvo USA Co.Pikeville, PTRL East Inc., USA. Project 502BK. Study U012A/A524. Report A54155. Unpublished. Http://www.fao.org/WAICENT/FAOINFO/AGRICULT/AGP/AGPP/Pesticid/JMPR/Download/98_eva/glufosi.pdf.
[12] In one study, for example, protein produced from a gene found in E. coli turned NAG into glufosinate. G.Kriete et al, Male sterility in transgenic tobacco plants induced by tapetum-specific deacetylation of the  externally applied non-toxic compound N-acetyl-L-phosphinothricin, Plant Journal, 1996, Vol.9, No.6, pp.809-818.
[13] Bremmer IN and Leist K-H (1998). Disodium-N-acetyl-L-glufosinate (AE F099730, substance  technical) - Toxicity and metabolism studies summary and     evaluation. Hoechst Schering AgrEvo, Frankfurt.TOX98/027. A67420. Unpublished. (see FAO publication on www.fao.org/ag/agp/agpp/pesticid/jmpr/Download/98/glufosi3.pdf).
[14] Huang, M.N. and Smith, S.M. 1995b. See note 11.
[15]Ricarda A. Steinbrecher, Risks associated with ingestion of Chardon LL maize, The reversal of N-acetyl-L- glufosinate to the active herbicide L-glufosinate in the gut of animals, Chardon LL Hearing, May 2002, London. (Note: This work is an excellent  summary of the risks associated with NAG conversion  within the gut.)
[16] Fujii, T., Transgenerational effects of maternal exposure to chemicals on the functional development of  the brain in the offspring. Cancer Causes and Control, 1997, Vol. 8, No. 3, pp. 524-528..
[17] H. Takahashi et al., "A Case of Transient Diabetes Isipidus Associated with Poisoning by a Herbicide Containing Glufosinate." Clinical Toxicology 38(2), 2000, pp.153-156.
[18] Ohn J. Fialka, EPA Scientists Pressured to Allow Continued Use of Dangerous Pesticides, Wall Street Journal Page A4, May 25, 2006,                        Http://online.wsj.com/article/SB114852646165862757.html.
[19] EPA SCIENTISTS PROTEST PENDING PESTICIDE APPROVALS;Unacceptable Risk to Children and Political Pressure on Scientists Decried, Press release, Public Employees for Environmental Responsibility. May 25, 2006,  http://www.peer.org/news/news_id.php?row_id=691.
[20] EPA SCIENTISTS PROTEST PENDING PESTICIDE APPROVALS; see note 19.
[21] Bayer's GE Crop Herbicide, Glufosinate, Causes Brain Damage, The Japan Times, 7 December 2004.
[22] Watanabe, T. and T. Iwase, Development and dymorphogenic effects of glufosinate ammonium on mouse  embryos in culture. Teratogenesis carcinogenesis and mutagenesis, 1996, Vol. 16, No. 6, pp. 287-299.
[23] Watanabe, T. , Apoptosis induced by glufosinate ammonium in the neuroepithelium of developing mouse embryos in culture. Neuroscientific Letters, 1997, Vol. 222, No. 1, pp.17-20, as cited in Glufosinate ammonium fact sheet, Pesticides News No.42, December 1998, p 20-21.
[24]Fujii, T., Transgenerational effects of maternal exposure to chemicals on the functional development of the brain in the offspring. Cancer Causes and Control,  1997, Vol. 8, No. 3, pp. 524-528.
[25] Fujii, T., T. Ohata, M. Horinaka, Alternations in the response to kainic acid in rats exposed to glufosinate-ammonium, a herbicide, during infantile period. Proc. Of the Japan Acad. Series B-Physical and Biological Sciences, 1996, Vol. 72, No. 1, pp. 7-10.
[26]Bayer's GE Crop Herbicide, Glufosinate, Causes Brain Damage, The Japan Times, 7 December 2004.
[27]Ricarda A. Steinbrecher, see note 15.
[28]Antony Barnett, New Research Shows Genetically Modified Genes Are Jumping Species Barrier, London Observer, May 28, 2000.
[29]Netherwood, et al, Assessing the survival of transgenic plant DNA in the human gastrointestinal tract, Nature Biotechnology, Vol 22 Number 2 Feb. 2004.
[30] Wade V. Welshons et al, Large Effects from Small Exposures. I. Mechanisms for Endocrine-Disrupting Chemicals with Estrogenic Activity, Table  2,Environmental Health Perspectives Volume 111, Number  8, June 2003.
[31]  Glufosinate Ammonium; Pesticide Tolerance, Environmental Protection Agency, Federal Register:September 29, 2003 (Volume 68, Number 188), 40 CFR Part 180, ACTION: Final rule, http://www.epa.gov/fedrgstr/EPA-PEST/2003/September/Day-29/p24565.htm.
[32] S. Leeson, The effect of Glufosinate Resistant Corn on Growth of Male Broiler Chickens, by Department of Animal and Poultry Sciences, University of Guelph.  Report No. A56379; July 12, 1996.
[33] Mae-Wan Ho, Exposed: More Shoddy Science in GM Maize Approval, ISIS Press Release 13/03/04, http://www.i-sis.org.uk/MSSIGMMA.php.
[34]Testimony of Steve Kestin and Toby Knowles, Department of Clinical Veterinary Science, University of Bristol on behalf of Friends of the Earth, before the  Chardon LL Hearings of the Advisory Committee on Releases to the Environment, November 2000.
[35] See note 34.
 
 

Part III
 

Abstract: The Documented Health Risks of Genetically Engineered Foods - Americans are Uninformed and Misinformed on GMOs - The fact that GMOs flourish in the US because of ignorance leaves the biotech industry extremely vulnerable - Three Practical Industry and Consumer Steps to Success


There is an interesting campaign in the US (Campaign for Healthier Eating) which also may apply to other countries who introduced GMOs in the food chain as well as a New Book "Genetic Roulette" which documents serious health dangers.

"The Documented Health Risks of Genetically Engineered Foods: With input from more than 30 scientists over two years, it presents 65 health risks of GM foods and why current safety assessments are not competent to protect us from most of them. The book documents lab animals with damage to virtually every system and organ studied; thousands of sick, sterile, or dead livestock; and people around the world who have traced toxic or allergic reactions to eating GM products, breathing GM pollen, or touching GM crops at harvest. It also exposes many incorrect assumptions that were used to support GM approvals. Organizations worldwide are presenting the book to policy makers as  evidence that GM foods are unsafe and need to be removed immediately.

The GM crops sold in the US include soy (including soy lecithin used in chocolate and thousands of other products as an emulsifier), corn (including high fructose corn syrup), cottonseed and canola (both used in vegetable oil), Hawaiian papaya, and a small amount of zucchini and crook-neck squash. There is also alfalfa for cattle (the sale of which was halted by a federal judge on March 13, 2007), GM additives such as aspartame, and milk from cows treated with GM bovine growth hormone. There is not yet any GM popcorn, white corn or blue corn. And the industry is threatening to introduce GM sugar from sugar beets next year". (NL Spilling the Beans, August 2007)

„You may have heard that genetically modified (GM) foods are safe, properly tested, and necessary to feed a hungry world. UNTRUE! Genetically modified organisms (GMOs), introduced into our food supply in the mid-1990s, are one of history’s most dangerous and radical changes in our diet. These largely unregulated ingredients are in 60-70% of the foods in the US, but are well worth efforts to avoid them. Fortunately, health-conscious retailers, distributors, manufacturers, and growers are now participating in The Campaign for Healthier Eating in America, which will eliminate GMOs from thousands of products. This will make it easier for you to feed your family a healthier "non-GMO" diet and may even end the genetic engineering of the entire US food supply. This industry-wide rejection of GMOs can be achieved by a "tipping point," in which a sufficient number of shoppers in the US avoiding GM ingredients force the major food companies to stop using them.

Informed European Shoppers Say No to GMOs: Europe reached the tipping point in April 1999 and within a single week, virtually all major manufacturers publicly committed to stop using GM ingredients in their European brands. This consumer-led revolt against GMOs in the EU was generated by a February 1999 media firestorm after a top GMO safety researcher, Dr. Arpad Pusztai, was "ungagged by Parliament" and able to tell this alarming story to the press. Dr. Pusztai was the world’s top researcher in his field and a senior researcher at the prestigious Rowett Institute in Scotland. He had been working on a UK government grant to design long-term testing protocols that were intended to become part of the official European GM food safety assessment process. But when Pusztai fed supposedly harmless GM to rats, they developed potentially pre-cancerous cell growth, smaller brains, livers, and testicles, partially atrophied livers, and a damaged immune system. Moreover, the results clearly indicated that the cause of the problem was due to the unpredictable side effects arising from the process of genetic engineering itself. In other words, it suggested that the GM foods already on the market, which were created from the same process, might also create such effects. When he expressed his concern he was fired from his job after 35 years and silenced with threats of a lawsuit, his 20 member research team was disbanded, the testing protocols were abandoned, and the pro-GM establishment embarked on an extensive disinformation campaign to discredit the study’s results and protect the reputation of GM foods. But when an invitation to testify before Parliament allowed Pusztai to finally tell his story, all hell broke loose. The outpouring of news coverage, wrote one columnist, "divided society into two warring blocs"[1] over the GM food issue. The tipping point was reached quickly thanks to the buying power of consumers that convinced manufacturers to keep GMOs out of the EU, in spite of official approvals by the pro-GM European Commission.

Americans are Uninformed and Misinformed on GMOs: In the US, the Pusztai story was barely mentioned. Project Censored described it as one of the 10 most underreported events of the year. Indeed, the US mainstream media has been consistently close-lipped about the enormous health risks of GM foods. They failed to cover the preliminary study from the Russian National Academy of Sciences, for example, that showed that more than half the offspring of mother rats fed GM soy died within three weeks (compared to 9% from mothers fed natural soy). They neglected to report that the only human GM feeding study ever published showed that the foreign genes inserted into GM food crops can transfer into the DNA of our gut bacteria. This means that long after we stop eating GM corn chips, our intestinal flora might continue to manufacture the "Bt" pesticide that the GM corn plants are engineered to produce. And Americans were not told about the estimated 10,000 sheep that died within 5-7 days of grazing on GM cotton plants—also designed to produce this Bt-toxin.Many consumers in the US mistakenly believe that the FDA approves GM foods through rigorous, in-depth, long-term studies. In reality, the agency has absolutely no safety testing requirements. (The tests that biotech companies voluntarily perform on their own crops are often meticulously designed to avoid finding problems.) The reason for the FDA’s industry-friendly policy on GMOs is that the White House (under the first George Bush) ordered the agency to promote biotechnology. Also, the person in charge of developing the policy was the former attorney of biotech giant Monsanto—and later their vice president. The policy he oversaw claimed that the agency was not aware of any information showing that GM crops were different "in any meaningful or uniform way," and therefore didn’t need testing. But 44,000 FDA internal documents made public from 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. They had urged superiors to require long-term studies, but were ignored. Evidence of this apparent fraud at the FDA was presented at a Washington, D.C. press conference in 1999. Although major media were in attendance, they didn’t run that story either. Americans know so little about this subject, that only about 1 in 4 are aware that they have ever eaten a GM food in their lives (even though the vast majority of processed foods contain derivatives from the four major GM crops: soy, corn, cottonseed and canola). Thus, the same companies that carefully avoid GM ingredients for concerned Europeans are happy to sell GMOs to unknowing consumers in the US.

The fact that GMOs flourish in the US because of ignorance leaves the biotech industry extremely vulnerable: If some campaign or event were to push this issue above the national radar screen, consumer reaction could force a Euro-style retreat from GMOs. How many of us would have to reject brands that contain GMOs to reach this tipping point? Even 5 percent of shoppers, or 15 million Americans, would likely be more than enough. When marketing executives at top companies see the drop in market share and the emergence of a trend, kicking out GMOs will be a natural reaction. After all, the brands don’t gain anything from using them. Their foods aren’t fresher, tastier, or healthier. The two major traits in GM crops are herbicide tolerance, which allows farmers to spray herbicide on the crops without killing them, and pesticide production, in which the crops produce an insect-killing toxin in every cell.So how do we inspire enough consumers to avoid GM brands? Do the math. Already, 29 percent of Americans are strongly opposed to GM foods and believe they are unsafe.[2] That represents about 87 million people. But even among the 28 million Americans who regularly buy organic (and therefore non-GMO) food,[3] many do not conscientiously avoid GM ingredients in their non-organic purchases; they usually don’t know how. By educating health-conscious shoppers about GM food dangers and providing clear choices in the store, brands without GM ingredients will have the clear advantage. As millions begin to make brand choices based on GMO content, it is just a matter of time before the food industry responds.

Three Practical Industry and Consumer Steps to Success:

The nonpartisan Campaign for Healthier Eating in America will move the market in three ways.

1. Industry-Wide GMO Cleanout : The Campaign is helping to orchestrate a full clean out of GMOs from the entire natural food industry. The mechanism is being organized by a group called The Non-GMO Project, which offers a uniform standard for defining non-GMO and a low-cost, online, third-party verification program to ensure that farming and production methods are designed to meet that standard. When the Campaign for Healthier Eating was announced at the March 2007 Natural Products Expo in Anaheim, California, the Non-GMO Project announced endorsements from Whole Foods Market, United Natural Foods (the industry’s largest distributor), Eden Foods, Lundberg Family Farms, and Straus Family Creamery. Many others throughout the natural product sector, including Organic Valley and Nature’s Path, have also jumped on board this impressive initiative in self-regulation and healthier food. Retailers, distributors, manufacturers, and growers are embracing this practical plan to rid their industry of GMOs.Organic products are included in this program. They are not allowed to use GMOs and have been an important oasis for non-GMO shoppers. But research shows that some batches of organic seed and crops contain tiny amounts of GM contamination. If unchecked, this can grow over time. By including the organic sector in the campaign, organic producers will use GMO testing methods and procedures that will help clean up seeds and crops and ensure that certified organic foods continue to be a trusted source of non-GMO products.

2. Educating Health-Conscious Shoppers: To reach health-conscious shoppers, the Campaign will provide GMO-education centers in natural food stores nationwide. The brochures, books, DVDs, and CDs, will make it absolutely unmistakable that "Healthy Eating Means No GMOs." The Campaign will also provide regular features on GMO health risks to magazines and websites. These compelling facts should inspire a turning point in your digestive life.

3. Providing Clear Non-GMO Product Choices in the Store: As more and more products participate in The Non-GMO Project’s verification program, the Campaign will offer a series of updated Non-GMO Shopping Guides, listing non-GMO products by brand and category. It is expected that all the brands in the natural products industry will be able to successfully achieve non-GMO status within about 18 months. At that time the Campaign will provide in-store, on-shelf labels for retailers to indicate any holdout products that have not participated in the GMO cleanout and are still using GM ingredients." (NL Spilling the Beans, August 2007, Science Review Letters 2007, Vol. 6 #158)

___________
[1]Ziauddin Sardar, "Loss of Innocence: Genetically Modified Food," New Statesman (UK), 129, no. 4425,  (February 26, 1999) 47
[2]Public Sentiment About Genetically Modified Food (2006 update). The Pew Initiative on Food and Biotechnology, December 2006, http://pewagbiotech.org/polls/
[3]"Hot New Consumer and Retail Trends," The Natural Marketing Institute, Presented at Expo West, March 24, 2006.
 
 

Part II
 

Abstract: Bt cotton triggers allergic reactions - Bt corn pollen may cause allergies - Studies show immune responses to GM crops -


More scientific research on Genetically Engineered Corn show that it triggers allergic reactions and may cause allergies. Studies show immune responses to GM crops.

„The biotech industry is fond of saying that they offer genetically modified (GM) crops that resist pests. This might conjure up the image of insects staying away from GM crop fields. But "resisting pests" is just a euphemism for contains its own built-in pesticide. When bugs take a bite of the GM plant, the toxin splits open their stomach and kills them. The idea that we consume that same toxic pesticide in every bite is hardly appetizing. But the biotech companies and the Environmental Protection Agency—which regulates plant produced pesticides—tell us not to worry. They contend that the pesticide called Bt (Bacillus thuringiensis) is produced naturally from a soil bacterium and has a history of safe use. Organic farmers, for example, have used solutions containing the natural bacteria for years as a method of insect control. Genetic engineers simply remove the gene that produces the Bt in bacteria and then insert it into the DNA of corn and cotton plants, so that the plant does the work, not the farmer. Moreover, they say that Bt-toxin is quickly destroyed in our stomach; and even if it survived, since humans and other mammals have no receptors for the toxin, it would not interact with us in any case. These arguments, however, are just that—unsupported assumptions. Research tells a different story. Bt spray is dangerous to humans When natural Bt was sprayed over areas around Vancouver and Washington State to fight gypsy moths, about 500 people reported reactions—mostly allergy or flu-like symptoms. Six people had to go to the emergency room for allergies or asthma.[1],[2] Workers who applied Bt sprays reported eye, nose, throat, and respiratory irritation,[3] and some showed an antibody immune response in linked to Bt.[4] Farmers exposed to liquid Bt formulations had reactions including infection, an ulcer on the cornea,[5] skin irritation, burning, swelling, and redness.[6] One woman who was accidentally sprayed with Bt also developed fever, altered consciousness, and seizures.[7] In fact, authorities have long acknowledged that "People with compromised immune systems or preexisting allergies may be particularly susceptible to the effects of Bt."[8] The Oregon Health Division advises that  "individuals with . . . physician-diagnosed causes of severe immune disorders may consider leaving the area during the actual spraying."[9] A spray manufacturer warns, "Repeated exposure via inhalation can result in sensitization and allergic response in hypersensitive individuals."[10] So much for the contention that Bt does not interact with humans. As for being thoroughly destroyed in the digestive system, mouse studies disproved this as well. Mice fed Bt-toxin showed significant immune responses—as potent as cholera toxin. In addition, the Bt caused their immune system to become sensitive to formerly harmless compounds This suggests that exposure might make a person allergic to a wide range of substances.[11],[12] The EPA’s own expert advisors said that the mouse and farm worker studies above "suggest that Bt proteins could act as antigenic and allergenic sources."[13]The toxin in GM plants is more dangerous than natural sprays. The Bt-toxin produced in GM crops is "vastly different  from the bacterial [Bt-toxins] used in organic and traditional farming and forestry."[14] First of all, GM plants produce about 3,000-5,000 times the amount of toxin as the sprays. And the spray form is broken down within a few days to two weeks by sunlight,[15] high temperatures, or substances on the leaves of plants; and it can be "washed from leaves into the soil by rainfall,"[16] or rinsed by consumers. A Bt producing GM plant, on the other hand, continuously produces the toxin in every cell where it does not dissipate by weather and cannot be washed off. The natural toxic produced in bacteria is inactive until it gets inside the alkaline digestive tract of an insect. Once inside, a "safety catch" is removed and the Bt becomes toxic. But scientists change the sequence the Bt gene before inserting it into GM plants. The Bt toxin it produces usually comes without the safety catch. The plant-produced Bt toxin is always active and more likely to trigger an immune response than the natural variety.[17] Bt-toxin fails safety studies but is used nonetheless. Tests cannot verify that a GM protein introduced into the food supply for the first time will not cause allergies in some people. The World Health Organization (WHO) and UN Food and Agriculture Organization (FAO) offer criteria designed to reduce the likelihood that allergenic GM crops are approved.[18] They suggest examining a protein for 1) similarity of its amino acid sequence to known allergens, 2) digestive stability and 3) heat stability. These properties aren’t predictive of allergenicity, but their presence, according to experts, should be sufficient to reject the GM crop or at least require more testing. The Bt-toxin produced in GM corn fails all three criteria. For example, the specific Bt-toxin found in Monsanto’s Yield Guard and Syngenta’s Bt 11 corn varieties is called Cry1AB. In 1998, an FDA researcher discovered that Cry1Ab shared a sequence of 9-12 amino acids with vitellogenin, an egg yolk allergen. The study concluded that "the similarity . . . might be sufficient to warrant additional evaluation."[19] No additional evaluation took place.[20] Cry1Ab is also very resistant to digestion and heat.[21] It is nearly as stable as the type of Bt-toxin produced by StarLink corn. StarLink was a GM variety not approved for human consumption because experts believed that its highly stable protein might trigger allergies.[22] Although it was grown for use in animal feed, it contaminated the US food supply in 2000. Thousands of consumers complained to food manufacturers about possible reactions and over 300 items were subject to recall. After the StarLink incident, expert advisors to the EPA had called for "surveillance and clinical assessment of exposed individuals" to "confirm the allergenicity of Bt products."[23] Again, no such  monitoring has taken place.

Bt cotton triggers allergic reactions: A 2005 report by medical investigators in India describes an ominous finding. Hundreds of agricultural workers are developing moderate or severe allergic reactions when exposed to Bt cotton. This includes those picking cotton, loading it, cleaning it, or even leaning against it. Some at a ginning factory must take antihistamines daily, in order to go to work. Reactions are only triggered with the Bt varieties.[24] Furthermore, the symptoms are virtually identical to those described by the 500 people in Vancouver and Washington who were sprayed with Bt. Only "exacerbations of asthma" were in one list and not the other (see table).
                              Upper respiratoryEyesSkinOverall
                              Bt SpraySneezing,
                              runny nose,
                              exacerbations of asthmaWatery,
                              redItching, burning, inflammation, red,
                              swellingFever,
                              some in hospital
                              Bt cottonSneezing,
                              runny noseWatery,
                              redItching, burning, eruptions,
                              red, swellingFever,
                              some in hospital

(We are unaware of similar reports in the US, where 83% of the cotton is Bt. But in the US, cotton is harvested by machine, not by hand.) The experience of the Indian workers begs the question, "How long does the Bt-toxin stay active in the cotton?"  Is there any risk using cotton diapers, tampons, or bandages? In the latter case, if the Bt-toxin interfered with healing it could be a disaster. With diabetics, for example, unhealed wounds may be cause for amputation. Cottonseed is also used for cottonseed oil—used in many processed foods in the US. The normal methods used to extract oil likely destroy the toxin, although cold pressed oil may still retain some of it. Other parts of the cotton plant, however, are routinely used as animal feed. The next part of this series—focused on toxicity—presents evidence of disease and deaths associated with animals consuming Bt cotton plants.

Bt corn pollen may cause allergies: Bt-toxin is produced in GM corn and can be eaten intact. It is also in pollen, which can be breathed in. In 2003, during the time when an adjacent Bt cornfield was pollinating, virtually an entire Filipino village of about 100 people were stricken by a disease. The symptoms included headaches, dizziness, extreme stomach pain, vomiting, chest pains, fever and allergies, as well as respiratory, intestinal, and skin reactions. The symptoms appeared first in those living closest to the field, and then progressed to others by proximity. Blood samples from 39 individuals showed antibodies in response to Bt-toxin; this supports, but does not prove a link to the symptoms. When the same corn was planted in four other villages the following year, however, the symptoms returned in all four areas—only during the time of pollination. The potential dangers of breathing GM pollen had been identified in a letter to the US FDA in 1998 by the UK Joint Food Safety and Standards Group. They had even warned that genes from inhaled pollen might transfer into the DNA of bacteria in the respiratory system.[25] Although no studies were done to verify this risk, years later UK scientists confirmed that after consuming GM soybeans, the foreign inserted genes can transfer into the DNA of gut bacteria. If this also happens with Bt genes, than years after we decide to stop eating GM corn chips, our own gut bacteria may continue to produce Bt-toxin within our intestines.

Studies show immune responses to GM crops: Studies confirm that several GM crops engineered to produce built-in pesticides provoke immune responses in animals. A Monsanto rat study on Bt corn (Mon 863), that was made public due to a lawsuit, showed a significant increase in three types of blood cells related to the immune system: basophils, lymphocytes, and total white cell counts.[26]  Australian scientists took an insecticide producing gene (not Bt) from a kidney bean and put it into a pea, in hopes of killing the pea weevil. The peas had passed the tests normally used to approve GM crops and were on the way to being commercialized. But the developers decided to employ a mouse study that had never before been used on other GM food crops. When they tested the pesticide in its natural state, i.e. the version produced within kidney beans, the protein was not harmful to mice. But that "same" protein, when produced by the kidney bean gene that was inserted into pea DNA, triggered inflammatory responses in the mice, suggesting that it would cause allergies in humans. Somehow, the protein had been changed from harmless to potentially deadly, just by being created in a different plant. Scientists believe that subtle, unpredicted changes in the pattern of sugar molecules that were attached to the protein were the cause of the problem. These types of subtle changes are not routinely analyzed in GM crops on the market. Experimental potatoes engineered with a third type of insecticide caused immune damage to rats.[27] Blood tests showed that their immune responses were more sluggish, and organs associated with immune function also appeared to be damaged. As with the peas, the insecticide in its natural state was harmless to the rats. The cause of the health problems was therefore due to some unpredicted change brought about by the genetic engineering process. And like the peas, if the potatoes had been subjected to only the type of tests that are  typically used by biotech companies to get their foods on the market, the potatoes would have been approved. Allergic reactions are a defensive, often harmful immune system response to an external irritant. The body interprets something as foreign, different and offensive, and reacts accordingly. All GM foods, by definition, have something foreign and different. According to GM food safety expert Arpad Pusztai, "A consistent feature of all the studies done, published or unpublished, . . . indicates major problems with changes in the immune status of animals fed on various GM crops/foods." [28] In addition to immune responses, several studies and reports from the field provide evidence that GM foods are toxic. In the next article in this series, we look at thousands of sick, sterile and dead animals, linked to consumption of GM crops". (NL Spilling the Beans, June 2007, Science Review Letters 2007, Vol. 6 #157)

__________
[1] Washington State Department of Health, "Report of health surveillance activities: Asian gypsy moth control program," (Olympia, WA: Washington State Dept. of Health, 1993).
[2] M. Green, et al., "Public health implications of the microbial pesticide Bacillus thuringiensis: An epidemiological study, Oregon, 1985-86," Amer. J. Public    Health 80, no. 7(1990): 848–852.
[3] M.A. Noble, P.D. Riben, and G. J. Cook,  "Microbiological and epidemiological surveillance program to monitor the health effects of Foray 48B BTK spray" (Vancouver, B.C.: Ministry of Forests, Province of British Columbi, Sep. 30, 1992).
[4] A. Edamura, MD, "Affidavit of the Federal Court of Canada, Trial Division. Dale Edwards and Citizens Against Aerial Spraying vs. Her Majesty the Queen, Represented by the Minister of Agriculture," (May 6, 1993); as reported in Carrie Swadener, "Bacillus thuringiensis (B.t.)," Journal of Pesticide Reform, 14,  no, 3 (Fall 1994).
[5] J. R. Samples, and H. Buettner, "Ocular infection caused by a biological insecticide," J. Infectious Dis. 148, no. 3 (1983): 614; as reported in Carrie Swadener,   "Bacillus thuringiensis (B.t.)", Journal of Pesticide Reform 14, no. 3 (Fall 1994)
[6] M. Green, et al., "Public health implications of the microbial pesticide Bacillus thuringiensis: An epidemiological study, Oregon, 1985-86," Amer. J. Public  Health, 80, no. 7 (1990): 848–852.
[7] A. Edamura, MD, "Affidavit of the Federal Court of Canada, Trial Division. Dale Edwards and Citizens Against Aerial Spraying vs. Her Majesty the Queen,    Represented by the Minister of Agriculture," (May 6, 1993); as reported in Carrie Swadener, "Bacillus thuringiensis (B.t.)," Journal of Pesticide Reform, 14, no, 3 (Fall 1994).
[8] Carrie Swadener, "Bacillus thuringiensis (B.t.),"  Journal of Pesticide Reform 14, no. 3 (Fall 1994).
[9] Health effects of B.t.: Report of surveillance in Oregon, 1985-87. Precautions to minimize your exposure (Salem, OR: Oregon Departmentof Human Resources, Health Division, April 18, 1991).
[10] Material Safety Data Sheet for Foray 48B Flowable Concentrate (Danbury, CT: Novo Nordisk, February, 1991).
[11] Vazquez et al, "Intragastric and intraperitoneal administration of Cry1Ac protoxin from Bacillus  thuringiensis induces systemic and mucosal antibody     responses in mice," Life Sciences, 64, no. 21 (1999): 1897–1912; Vazquez et al, "Characterization of the  mucosal and systemic immune response induced by Cry1Ac protein from Bacillus thuringiensis HD 73 in mice," Brazilian Journal of Medical and Biological Research 33  (2000): 147–155.
[12] Vazquez et al, "Bacillus thuringiensis Cry1Ac protoxin is a potent systemic and mucosal adjuvant," Scandanavian Journal of Immunology 49 (1999): 578–584. See also Vazquez-Padron et al., 147 (2000b).
[13] EPA Scientific Advisory Panel, "Bt Plant-Pesticides Risk and Benefits Assessments," March 12, 2001: 76.  Available
at:http://www.epa.gov/scipoly/sap/2000/october/octoberfinal.pdf
[14] Terje Traavik and Jack Heinemann, "Genetic Engineering and Omitted Health Research: Still No  Answers to Ageing Questions, 2006. Cited in their quote    was: G. Stotzky, "Release, persistence, and biological  activity in soil of insecticidal proteins from Bacillus thuringiensis," found in Deborah K. Letourneau and Beth  E. Burrows, Genetically Engineered Organisms. Assessing Environmental and Human Health Effects (cBoca Raton, FL:  CRC Press LLC, 2002), 187–222.
[15] C. M. Ignoffo, and C. Garcial,  "UV-photoinactivation of cells and spores of Bacillus thuringiensis and effects of peroxidase on inactivation," Environmental Entomology 7 (1978): 270–272.
[16] BT: An Alternative to Chemical Pesticides, Environmental Protection Division, Ministry of Environment, Government of British Columbia, Canada,            http://www.env.gov.bc.ca/epd/epdpa/ipmp/fact_sheets/BTfacts.htm
[17] See for example, A. Dutton, H. Klein, J. Romeis, and F. Bigler, "Uptake of Bt-toxin by herbivores feeding  on transgenic maize and consequences for the predator Chrysoperia carnea," Ecological Entomology 27 (2002): 441–7; and J. Romeis, A. Dutton, and F. Bigler,  "Bacillus thuringiensis toxin (Cry1Ab) has no direct effect on larvae of the green lacewing Chrysoperla carnea (Stephens) (Neuroptera: Chrysopidae)," Journal of Insect Physiology 50, no. 2–3 (2004): 175–183.
[18] FAO-WHO, "Evaluation of Allergenicity of Genetically Modified Foods. Report of a Joint FAO/WHO  Expert Consultation on Allergenicity of Foods Derived   from Biotechnology," Jan. 22–25, 2001; http://www.fao.org/es/ESN/food/pdf/allergygm.pdf
[19] Gendel, "The use of amino acid sequence alignments to assess potential allergenicity of proteins used in genetically modified foods," Advances in Food and  Nutrition Research 42 (1998), 45–62.
[20] US EPA, "Biopesticides Registration Action Document  (BRAD)—Bacillus thuringiensis Plant-Incorporated Protectants: Product Characterization & Human Health Assessment," EPA BRAD (2001b) (October 15, 2001): IIB4, http://www.epa.gov/pesticides/biopesticides/pips/bt_brad2/2-id_health.pdf
[21] ibd.
[22] "Assessment of Additional Scientific Information Concerning StarLink Corn," FIFRA Scientific Advisory Panel Report No. 2001-09, July 2001.
[23] EPA Scientific Advisory Panel, "Bt Plant-Pesticides Risk and Benefits Assessments," March 12, 2001: 76. Available at:http://www.epa.gov/scipoly/sap/2000/october/octoberfinal.pdf
[24] Ashish Gupta et. al., "Impact of Bt Cotton on  Farmers’ Health (in Barwani and Dhar District of Madhya Pradesh)," Investigation Report, Oct–Dec 2005.
[25] N. Tomlinson of UK MAFF's Joint Food Safety and Standards Group 4, December 1998 letter to the U.S. FDA, commenting on its draft document, "Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants," http://www.food.gov.uk/multimedia/pdfs/acnfp1998.pdf;  (see pages 64–68).
[26] John M. Burns, "13-Week Dietary Subchronic Comparison Study with MON 863 Corn in Rats Preceded by a 1-Week Baseline Food Consumption Determination with PMI Certified Rodent Diet #5002," December 17, 2002 http://www.monsanto.com/monsanto/content/sci_tech/prod_safety/fullratstudy.pdf, see also Stéphane Foucart, "Controversy Surrounds a GMO," Le Monde, 14 December 2004; and Jeffrey M. Smith, "Genetically Modified Corn Study Reveals Health Damage and Cover-up," Spilling the Beans, June 2005,
[27] A. Pusztai, et al, "Genetically Modified Foods: Potential Human Health Effects," in: Food Safety: Contaminants and Toxins (ed. JPF D’Mello) (Wallingford    Oxon, UK: CAB International), 347–372, also additional communication with Arpad Pusztai.
[28] October 24, 2005 correspondence between Arpad Pusztai and Brian John
 
 
 

Part I
 

Abstract: On Genetically Modified Foods -Toxins and Reproductive Failures - Higher death rates and organ damage - Reproductive failures and infant mortality - Farmers report livestock sterility and deaths


In the next issues of Science Review Letters we'll document the now increasing US- resistance against genetically modified foods. Science Review Letters will focus on well-done resistance against genetically modified foods, especially a review of scientific research regarding all the innumerous dangerous and life threatening side effects of modern Biotechnology.

On Genetically Modified Foods -Toxins and Reproductive Failures: „Rhetoric from Washington since the early 1990s proclaims that genetically modified (GM) foods are no different from their natural counterparts that have existed for centuries. But this is a political, not a scientific assertion. Numerous scientists at the FDA consistently described these newly introduced gene-spliced foods as cause for concern. In addition to their potential to produce hard-to-detect allergies and nutritional problems, the scientists said that "The possibility of unexpected, accidental changes in genetically engineered plants" might produce "unexpected high concentrations of plant toxicants."[1] GM crops, they said, might have "Increased levels of known naturally occurring toxins, .. . appearance of new, not previously identified" toxins, and an increased tendency to gather "toxic  substances from the environment" such as "pesticides or heavy metals." They recommended testing every GM food "before it enters the marketplace."[2] But the FDA was under orders from the first Bush White House to promote the biotechnology industry, and the political appointee in charge of agency policy was Monsanto’s former attorney—later their vice president. The FDA policy ignored the scientists’ warnings and allowed GM food crops onto the market without any required safety studies. From the few safety tests that have been conducted, the results are disturbing—lab animals fed GM diets show damage to virtually every system studied. Reports from farmers are even less encouraging—thousands of sick, sterile and dead animals are traced to GM feed.[3] GM diet shows toxic reactions in 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.[4] The director of FDA’s Office of Special Research Skills wrote that the  tomatoes did not demonstrate a "reasonable certainty of no harm,"[5] which is their normal standard of safety. The Additives Evaluation Branch agreed that "unresolved questions still remain."[6] The political appointees, however, did not require that the tomato be withdrawn.[*]  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]."[7] Pusztai believes that the digestive tract should be the first  target of GM food risk assessment, because the gut is the first (and largest) point of contact with the foods; it can reveal various reactions to toxins. He was upset, however, that the research on the FlavrSavr never looked passed the stomach to the intestines. Other studies that did look found problems. Mice were fed potatoes with an added bacterial gene, which produced an insecticide called Bt-toxin. Scientists analyzed the lower part of their small intestines (ileum) and found abnormal and damaged cells, as well as proliferative cell growth.[8] 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 photo).[9] Although the guts of rats fed GM peas were not examined for cell growth, the intestines were mysteriously heavier; possibly resulting from such growth.[10] Cell proliferation can be a precursor to cancer and is of special concern. GM diets cause liver damage.  The state of the liver—a main detoxifier for the body—is another indicator of toxins.  Rats fed the GNA lectin potatoes described above had smaller and partially atrophied livers.[11] Rats fed Monsanto’s Mon 863 corn, engineered to produce Bt-toxin, had liver lesions and other indications of toxicity.[12] Rabbits fed GM soy showed altered enzyme production in their livers as well as higher metabolic activity.[13]

The livers of rats fed Roundup Ready canola were 12%–16% heavier, possibly due to liver disease or inflammation.[14]  And microscopic analysis of the livers of mice fed Roundup Ready soybeans revealed altered gene expression and structural and functional changes.[15] Many of these changes reversed after the mice diet was switched to non-GM soy, indicating that GM soy was the culprit. The findings, according to molecular geneticist Michael Antoniou, PhD, "are not random and must reflect some ‘insult’ on the liver by the GM soy." Antoniou, who does human gene therapy research in King’s College London, said that although the long-term consequences of the GM soy diet are not known, it "could lead to liver damage and consequently general toxemia."[16]

Higher death rates and organ damage: Some studies showed higher death rates in GM-fed animals. In the FlavrSavr tomato study, for example, a note in the appendix indicated that 7 of 40 rats died within two weeks and were replaced.[17] In another study, chickens fed the herbicide tolerant "Liberty Link" corn died at twice the rate of those fed natural corn.[18] But in these two industry-funded studies, the deaths were dismissed without adequate explanation or follow-up.In addition, the cells in the pancreas of mice fed Roundup Ready soy had profound changes and produced significantly less digestive enzymes;[19] in rats fed a GM potato, the pancreas was enlarged.[20] In various analyses of kidneys, GM-fed animals showed lesions, toxicity, altered enzyme production or inflammation. Enzyme production in the hearts of mice was altered by GM soy.[21] And GM potatoes caused slower growth in the brain of rats.[22]

Reproductive failures and infant mortality: In both mice and rats fed Roundup Ready soybeans, their testicles showed dramatic changes. In rats, the organs were dark blue instead of pink (see photo).[23] In mice, young sperm cells were altered.[24] Embryos of GM soy-fed mice also showed temporary changes in their DNA function, compared to those whose parents were fed non-GM soy.[25] More dramatic results were discovered by a leading scientist at the Russian National Academy of sciences. Female rats were fed GM soy, starting two weeks before they were mated. Over a series of three experiments, 51.6 percent of the offspring from the GM-fed group died within the first three weeks, compared to 10 percent from the non-GM soy group, and 8.1 percent for non-soy controls. "High pup mortality was characteristic of every litter from mothers fed the GM soy flour."[26] The average size and weight of the GM-fed offspring was quite a bit smaller.[27] In a preliminary study, the GM-fed offspring were unable to conceive.[28] After the three feeding trials, the supplier of rat food used at the Russian laboratory began using GM soy in their formulation. Since all the rats housed at the facility were now eating GM soy, no non-GM fed controls were available for subsequent GM feeding trials; follow-up studies were canceled. After two months on the GM soy diet, however, the infant mortality rate of rats throughout the facility had skyrocketed to 55.3 percent (99 of 179).[29]

Farmers report livestock sterility and deaths: About two dozen farmers reported that thousands of their pigs had reproductive problems when fed certain varieties of Bt corn. Pigs were sterile, had false   pregnancies, or gave birth to bags of water. Some cows and bulls also became sterile. Bt corn was also implicated by farmers in the deaths of cows, horses, water buffaloes, and chickens. [30] When Indian shepherds let their sheep graze continuously on Bt cotton plants, within 5-7 days, one out of four sheep died. There was an estimated 10,000 sheep deaths in the region in 2006, with more reported in 2007. Post mortems on the sheep showed severe irritation and black patches in both intestines and liver (as well as enlarged bile ducts). Investigators said preliminary evidence "strongly suggests that the sheep mortality was due to a toxin. . . . most probably Bt-toxin."[31]

Dangerous denial: The warnings of the FDA scientists appear to have come true. But we were not supposed to know about their concerns. The agency’s internal memos were only made public due to a lawsuit. Instead, we were supposed to believe the official FDA policy, claiming that the agency is not aware of information showing that GM foods are meaningfully different. This statement, crafted by political appointees, directly contradicts the scientific consensus at the FDA.. Nearly every independent animal feeding safety study on GM foods shows adverse or unexplained effects. But we were not supposed to know about these problems either—the biotech industry works overtime to try to hide them. Industry studies described above, for example, are neither peer-reviewed nor published. It took lawsuits to make two of them available. And adverse findings by independent scientists are often suppressed, ignored, or denied. Moreover, researchers that discover problems from GM foods have been fired, stripped of responsibilities, deprived of tenure, and even threatened. The myth that GM crops are the same safe food we have always eaten continues to circulate. With the overwhelming evidence of problems since their introduction in 1996, however, it is likely that GM foods are contributing to the deterioration of health in the United States. Without human clinical trials or post-marketing surveillance, we can’t tell which worsening health statistic may be due to these foods. But we also can’t afford to wait until we find out. GM foods must be removed from our diet immediately. Fortunately, more and more people are making healthy non-GM choices for themselves and their family." (NL Spilling the Beans, July 2007, Science Review Letters 2007, Vol. 6 #156)

_________________
[*] Calgene had submitted data on two lines of GM tomatoes, both using the same inserted gene. They voluntarily elected to market only the variety that was not associated with the lesions. This was not required by the FDA, which did not block approvals on the lesion-associated variety. The FlavrSavr tomato has since been taken off the market. After the FlavrSavr, no other biotech company has submitted such detailed data to the FDA. And the superficial summaries they do present to the agency are dismissed by critics as woefully inadequate to judge safety.

[1] Edwin J. Mathews, Ph.D., in a memorandum to the Toxicology Section of the Biotechnology Working Group. Subject: Analysis of the Major Plant Toxicants. Dated October 28, 1991
[2] 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
[3] Jeffrey M. Smith, Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods, Yes! Books, Fairfield, IA USA 2007
[4] Department of Veterinary Medicine, FDA, correspondence June 16, 1993. As quoted in Fred A. Hines, Memo to Dr. Linda Kahl. "Flavr Savr Tomato: . . . Pathology Branch’s Evaluation of Rats with Stomach Lesions From Three Four-Week Oral (Gavage) Toxicity Studies . . . and an Expert Panel’s Report," Alliance for Bio-Integrity (June 16, 1993)  http://www.biointegrity.org/FDAdocs/17/view1.html
[5] Robert J. Scheuplein, Memo to the FDA Biotechnology Coordinator and others, "Response to Calgene Amended Petition," Alliance for Bio-Integrity (October 27, 1993) www.biointegrity.org
[6] Carl B. Johnson to Linda Kahl and others, "Flavr Savr™ Tomato: Significance of Pending DHEE Question,"  Alliance for Bio-Integrity (December 7, 1993)
[7] Arpad Pusztai, "Genetically Modified Foods: Are They a Risk to Human/Animal Health?" June 2001 Action Bioscience www.actionbioscience.org/biotech/pusztai.html
[8] Nagui H. Fares, Adel K. El-Sayed, "Fine Structural Changes in the Ileum of Mice Fed on Endotoxin Treated Potatoes and Transgenic Potatoes," Natural Toxins 6, no. 6 (1998): 219–233.
[9] Stanley W. B. Ewen and Arpad Pusztai, "Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine," Lancet, 1999 Oct 16; 354 (9187): 1353-4.
[10] Arpad Pusztai, "Facts Behind the GM Pea Controversy: Epigenetics, Transgenic Plants & Risk Assessment," Proceedings of the Conference, December 1st   2005 (Frankfurtam Main, Germany: Literaturhaus, 2005).
[11] Arpad Pusztai, "Can science give us the tools for recognizing possible health risks of GM food," Nutrition and Health, 2002, Vol 16 Pp 73-84.
[12] John M. Burns, "13-Week Dietary Subchronic Comparison Study with MON 863 Corn in Rats Preceded by a 1-Week Baseline Food Consumption Determination with PMI Certified Rodent Diet #5002," December 17, 2002  www.monsanto.com/monsanto/content/sci_tech/prod_safety/fullratstudy.pdf
[13] R. Tudisco, P. Lombardi, F. Bovera, D. d’Angelo, M. I. Cutrignelli, V. Mastellone, V. Terzi, L. Avallone, F. Infascelli, "Genetically Modified Soya Bean in Rabbit Feeding: Detection of DNA Fragments and Evaluation of Metabolic Effects by Enzymatic Analysis," Animal Science 82 (2006): 193–199.
[14] Comments to ANZFA about Applications A346, A362 and  A363 from the Food Legislation and Regulation Advisory Group (FLRAG) of the Public Health Association of  Australia (PHAA) on behalf of the PHAA, "Food produced from glyphosate-tolerant canola line GT73," www.iher.org.au/
[15] M. Malatesta, C. Caporaloni, S. Gavaudan, M. B.Rocchi, S. Serafini, C. Tiberi, G. Gazzanelli, "Ultrastructural Morphometrical and Immunocytochemical Analyses of Hepatocyte Nuclei from Mice Fed on Genetically Modified Soybean," Cell Struct Funct. 27  (2002): 173–180
[16] Jeffrey M. Smith, Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods, Yes! Books, Fairfield, IA USA 2007
[17] Arpad Pusztai, "Can Science Give Us the Tools for Recognizing Possible Health Risks for GM Food?" Nutrition and Health 16 (2002): 73–84.
[18] S. Leeson, "The Effect of Glufosinate Resistant Corn on Growth of Male Broiler Chickens," Department of Animal and Poultry Sciences, University of Guelph,  Report No. A56379, July 12, 1996.
[19] Malatesta, et al, "Ultrastructural Analysis of Pancreatic Acinar Cells from Mice Fed on Genetically modified Soybean," J Anat. 2002 November; 201(5):    409–415; see also M. Malatesta, M. Biggiogera, E. Manuali, M. B. L. Rocchi, B. Baldelli, G. Gazzanelli, "Fine Structural Analyses of Pancreatic Acinar Cell     Nuclei from Mice Fed on GM Soybean," Eur J Histochem 47  (2003): 385–388.
[20] Arpad Pusztai, "Can science give us the tools for recognizing possible health risks of GM food," Nutrition and Health, 2002, Vol 16 Pp 73-84
[21] R. Tudisco, P. Lombardi, F. Bovera, D. d’Angelo, M. I. Cutrignelli, V. Mastellone, V. Terzi, L. Avallone, F. Infascelli, "Genetically Modified Soya Bean in Rabbit Feeding: Detection of DNA Fragments and Evaluation of Metabolic Effects by Enzymatic Analysis," Animal Science  82 (2006): 193–199.
[22] Arpad Pusztai, "Can science give us the tools for recognizing possible health risks of GM food," Nutrition and Health, 2002, Vol 16 Pp 73-84
[23] Irina Ermakova, "Experimental Evidence of GMO Hazards," Presentation at Scientists for a GM Free Europe, EU Parliament, Brussels, June 12, 2007
[24] L. Vecchio et al, "Ultrastructural Analysis of Testes from Mice Fed on Genetically Modified Soybean," European Journal of Histochemistry 48, no. 4 (Oct–Dec   2004):449–454.
[25] Oliveri et al., "Temporary Depression of Transcription in Mouse Pre-implantion Embryos from Mice Fed on Genetically Modified Soybean," 48th Symposium of the Society for Histochemistry, Lake Maggiore (Italy), September 7–10, 2006.
[26] I.V.Ermakova, "Genetically Modified Organisms and Biological Risks," Proceedings of International Disaster Reduction Conference (IDRC) Davos, Switzerland August 27th – September 1st, 2006: 168–172.
[27] Irina Ermakova, "Genetically modified soy leads to the decrease of weight and high mortality of rat pups of  the first generation. Preliminary studies," Ecosinform 1 (2006): 4–9.
[28] Irina Ermakova, "Experimental Evidence of GMO Hazards," Presentation at Scientists for a GM Free Europe, EU Parliament, Brussels, June 12, 2007
[29] I.V.Ermakova "GMO: Life itself intervened into the experiments," Letter, EcosInform N2 (2006): 3–4.
[30] See note 16.
[31] "Mortality in Sheep Flocks after Grazing on Bt Cotton Fields—Warangal District, Andhra Pradesh" Report of the Preliminary Assessment, April 2006, http://www.gmwatch.org/archive2.asp
 
 

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