Thanks for sending this George! I had seen a small portion of this material, the statements by Dr. Hansen, from other sources recently. I had not seen the rest of this text. It's interesting that these citizens of a so-called third world country, India, are better informed about genetic engineering issues than most people in the US are. I am forwarding this to several lists. I added the clarification in brackets of the British English term "dustbin." For all receiving this: GM and GMO mean "genetically modified" and "genetically modified organism," and both those terms describe organisms that have been altered by genetic engineering (GE), which is a laboratory technique used to splice genes in ways that cannot be accomplished by conventional breeding methods. Hybridization is a conventional breeding method. Genetic engineering is not the same as hybridization, contrary to major media and industry misinformation on the subject. For example, a conventional plant breeder is not able to put a gene from a bacterium into the genetic structure of a corn plant. But genetic engineers do just that when they engineer Bt corn. Conventional plant breeding uses the natural reproductive processes of the plant. Genetic engineering bypasses the natural reproductive process and instead uses laboratory means such as gene guns and viral vectors to move foreign genetic material into plant cells. The introduced genetic material does not even have to come from the same species or a related species. Thus genes from fish can be added to the genetic structure of a tomato plant. Compared to conventional breeding, genetic engineering is a radically different method of changing the genetic traits of living things. In recent years, the major media and the corporations and government officials promoting genetic engineering have used the term "biotechnology" as a euphemism to mean the same thing as genetic engineering. Genetic engineering is a new technology, first developed in a laboratory in 1973, and first applied to commercially-grown farm crops in 1996. In the 10,000-year history of agriculture, there has never before been anything like genetic engineering. In the 3.8 billion-year history of life on earth, there has never before been anything like genetic engineering. Genetic engineering has the potential to unravel the web of life that is our inheritance. Tom In a message dated 03-01-16 13:01:05 EST, you write: << Subj: US GM regulations "full of holes" Date: 03-01-16 13:01:05 EST From: [log in to unmask] (moonbean) Reply-to: [log in to unmask] (moonbean) To: [log in to unmask] (moonbean) > > > ====================== > The AgBioIndia Bulletin > http://www.agbioindia.org > > Presenting the Real Picture > ====================== > > 16 January 2003 > > Sub: US GM regulations "full of holes" > > At a time when the United States is forcing European, African and the Asia > countries into accepting genetically modified foods saying that it has been > adequately tested for safety, a damming report submitted by Dr Michael > Hansen of the Consumers International, has exposed the scientific > 'cover-up'. In fact, at every meeting the US government/biotech companies > organise in the developing world, the premise is that the GM food has > undergone strict tests and therefore there is no need to 'reinvent the wheel'. > > The safety question assumes importance for India, which is being forced to > accept GM food aid despite the highest regulatory authority -- the Genetic > Engineering Approval Committee -- rejecting it in the absence of any > assurance that it does not contain Starlink. Unfortunately, the USAID (some > call it the US Artificial Insemination Department) is projecting the entire > episode as if it is a humanitarian gesture on the part of the US, and the > Indian government is coming in the way of feeding its poor. The reality is > that the country has at present over 51 million tonnes stacked in the open, > and some estimates point to at least of 40 per cent of the stored grains > already rendered unfit for human consumption. By importing unwanted food > (and showing it as if it is 'aid'), surplus food lying within the country > is rendered waste. But then, for the US, the biggest problem is to get rid > of its GM food stocks at any cost. > > The industry's desperation at lifting all quality and safety controls is > apparent. The biotech industry pleaded at a conference organised at Chennai > last week for a single-window approval for GM foods, so that 'un-necessary > checks' are removed. But what in reality it wants is to turn India into a > dustbin [garbage can] for unhealthy GM foods. > > The two reports below expose the failure of the US agencies to maintain > strict safety checks. This should should serve as an eye-opener for the > regulatory authorities in developing countries. > > Contents: > > 1.US Government's lack of safety standards for GM crops revealed by > consumer representative in Brussels > > 2.Media briefing > ------------------------- > > US Government's lack of safety standards for GM crops revealed by consumer > representative in Brussels > > 1.Press Release from Consumers International > > Brussels, January 10, 2003 - Documentation showing that the US government > allows the biotechnology industry to police itself on safety testing of GM > crops were presented recently at a meeting hosted by the German Marshall > Fund in Brussels on GM crops, by Consumers International representative, > Dr. Michael Hansen. > > Dr. Hansen provided letters written by the US Food and Drug Administration > (FDA) to Monsanto accepting at face value Monsanto's own conclusions > regarding the safety of their GM corn variety (see attached media briefing > for excerpts of the letters) > > Dr. Hansen also states that, contrary to the impression given by US > ambassadors in Europe and elsewhere, the US government does not have > rigorous standards for safety assessments on GM crops, does not thoroughly > review company data, and has never formally approved any of the GM corn > varieties grown in the US. > > These allegations come at a critical time as the US government is making > every effort to persuade both European and African governments that GM > crops are thoroughly reviewed and that anyone raising questions about > safety is ignorant and acting immorally. > > "Consumers worldwide and especially in the US are outraged that the US > government is threatening the EU with WTO challenges for refusing to accept > GM corn until comprehensive labelling and traceability systems are in > place, when they themselves do not formally review and approve the safety > of the GM corn varieties grown in the US" said Dr. Hansen. > > Dr. Hansen further criticised the FDA for failing to follow through on > regulatory improvements proposed in 2001. "Back in 1992, the FDA claimed > that GM technology is similar to traditional breeding and would therefore > be regulated in the same way (see attached media briefing for excerpts from > FDA's policy document). Then, in 2001, the FDA admitted that there is a > difference between traditional breeding and GM technology and proposed that > there should be mandatory notification of GM food marketing and a mandatory > FDA data review. However, they have still not issued any such regulation" > > Consumers Union (CU) in the US and Consumers International (CI) worldwide > are calling on the US government to stop pressurising the EU and Africa to > accept its GM corn and instead get its own house in order by conducting > mandatory safety reviews of data provided by the biotechnology industry and > prohibiting the marketing of GM crops unless they have been approved by the > FDA. CU and CI point out that Africa's food needs could be met with non-GMO > foods. They note that 70 % of the corn grown in the US is not genetically > modified. > > [Michael Hansen, Ph.D. is a Senior Research Associate focussing on > biotechnology for the Consumers Policy Institute, a division of Consumers > Union, the largest consumer organization in the United States. For further > information, please contact Maya Vaughan on email: [log in to unmask]] > > ------------------------------------- > > 2. MEDIA BRIEFING > > The Food and Drug Administration (FDA) does not require safety testing for > genetically engineered (GE) plants and has not formally approved any of the > GE corn (maize) varieties being grown in the United States: The FDA's > original policy on GE/GM plants was introduced at a press conference at an > industry gathering on May 28, 1992 by then Vice-President Dan Quayle as a > de-regulatory initiative. The policy was based on the notion "that the new > techniques [e.g. genetic engineering] are extensions at the molecular level > of traditional methods and will be used to achieve the same goals as > pursued with traditional plant breeding" (57 FR 22991, May 29, 1992), and > therefore should be regulated in the same way. In other words, no > requirement for human safety testing. But FDA will conduct "voluntary > safety consultations" with companies. > > The fact that FDA does not approve GE/GM crops can be seen in the letter > FDA sends to the company after completion of a "safety consultation:" > > For example, the letter sent to Monsanto on September 25, 1996 about its > MON810 Bt maize states, "Based on the safety and nutritional assessment you > have conducted, it is our understanding that Monsanto has concluded that > corn grain and forage derived from the new variety are not materially > different in composition, safety, or other relevant parameters from corn > grain and forage currently on the market, and that they do not raise issues > that would require premarket review or approval by FDA" bold added > (www.cfsan.fda.gov/~acrobat2/bnfL034.pdf). Note that FDA does not state its > own opinion about the safety of this crop; it only states what the company > believes. The letters for all 52 "safety consultations" done since the > Flavr Savr tomato contain basically the same language. > > FDA has recently admitted that it should require mandatory notification of > GE/GM food marketing, but has not issued such a regulation: In 2001, the > FDA made a proposal requiring companies to notify the government at least > 120 days before commercializing a transgenic plant variety. As part of > that proposed rule, the FDA asked for data on each separate transformation > event: > "[B]ecause some rDNA-induced unintended changes are specific to a > transformational event (e.g. those resulting from insertional mutagenesis), > FDA believes that it needs to be provided with information about foods from > all separate transformational events, even when the agency has been > provided with information about foods from rDNA-modified > plants with the same intended trait and has had no questions about such > foods. In contrast, the agency does not believe that it needs to receive > information about foods from plants derived through narrow crosses [e.g. > traditional breeding]" italics added (FR 66(12), pg. 4711). In other > words, FDA finally admits that differences exist between GE and traditional > breeding, that companies should inform and provide basic data before > putting a GE/GM food on the market. Unfortunately, although the FDA > received over > 85,000 comments from the public overwhelmingly supporting mandatory > notification, and although industry also supported it as well, the Bush > Administration has not implemented this change and says it cannot predict > when it will have time to consider it. > > For GE/GM plants that produce a newly introduced pesticide, the > Environmental Protection Agency (EPA) reviews and approves the safety of > the pesticide, but not other plant characteristics. The safety of other > changes in the food are not reviewed and approved, as they come under the > jurisdiction of the FDA. > > A major food safety concern for GE plants is allergenicity, which is not > adequately addressed in the U.S: Last year, the report of a Joint FAO/WHO > Expert Consultation on Allergenicity of Foods Derived from Biotechnology, > held at FAO headquarters in Rome, laid out a detailed protocol (a decision > tree) for evaluating the allergenicity of GM foods (FAO, 2001). None of > the GE/GM crops, including GM maize, on the market in the U.S. have been > assessed, either by the EPA or the FDA, using such a protocol. > > Various types of scientific evidence suggest that Bt maize may contain a > transgenic allergen: Bt maize contains various modified endotoxins from the > soil bacterium Bacillus thuringiensis (Bt). These d-endotoxins are called > Cry proteins, in particular Cry1Ab or Cry1Ac. A study of farmworkers who > worked in onion fields where foliar Bt sprays were used found that 2 of > them contained antibodies to the d-endotoxins, Cry1Ab and/or Cry1Ac, > consistent with an allergy (Bernstein et al., 1999). One of the first steps in > assessing the allergic potential of a protein (most allergens are proteins) > is to determine if it has similarity in amino acid sequence to a known > allergen. A paper published in 1998 by the head of FDA's own biotechnology > studies branch, Dr. Steven Gendel, found significant amino acid sequence > similarity between Cry1Ab and Cry1Ac (found in Bt maize and Bt cotton) and > vitellogenin, the main precursor to egg yolk protein and a known allergen, > as well as between Cry3A (Bt potatoes) and b-lactoglobulin, a major milk > allergen (Gendel, 1998). > > Global agreement has been reached on what constitutes proper safety > assessment of foods derived from GE/GM plants, yet such suggested studies > have not been carried out on GM Bt maize (or any other GE/GM crop approved > in the US): > > Earlier this year, the Codex Alimentarius Ad Hoc Task Force on Foods > Derived from Biotechnology reached agreement on a "Draft guideline for the > conduct of food safety assessment of foods derived from recombinant-DNA > plants" (ALINORM 03/34, Appendix V, pp. 61-73). This document is at Step 8 > of the Codex procedure, which means that all 35 countries, including the > U.S., at the meeting in Yokahama, Japan agreed on this document and > recommended that it be adopted by the full Codex Alimentarius > Commission. This is important because in the case of trade disputes, the > World Trade Organization considers that, in terms of food safety, the > standards or guidelines of > Codex Alimentarius are deemed the global science-based standard and, thus, > immune to trade challenges, i.e. they are not considered to be a > "non-tariff trade barrier." At present, the U.S. has not subjected GE/GM > maize to the complete safety assessment laid out in this document. > > Related reports: > > A. Excessive levels of harmful compounds could show up in GM foods because > the government has failed to put sufficient safeguards in place to catch > them, according to a report from The Center for Science in the Public > Interest (CSPI - previously cautiously pro-GM), which contends that the > American Food and Drug Administration (FDA) missed "obvious errors" in > reviewing some GM crops. The group said the FDA's procedures are so full of > holes that safety cannot be ensured. CSPI argues that the voluntary system > of regulation must be scrapped. http://ngin.tripod.com/070103c.htm > > B. CSPI also said the FDA cannot guarantee the safety of GM foods because > it is unable to obtain all the scientific data it needs from companies like > Monsanto, Syngenta and Dow which have all declined to provide requested > scientific data to the FDA > http://www.abc.net.au/news/scitech/2003/01/item20030108090120_1.htm > > > ____________________________________________ > > The AgBioIndia bulletins are an effort by the Forum for Biotechnology & > Food Security to bridge the yawning gap in our understanding of the > politics of food. We believe these bulletins will create wider awareness > and understanding of the compexities of the crisis facing Indian > agriculture and food security. We will keep you posted on the intricacies > and games being enacted in the name of eradicating hunger. > > It is a non-commercial educational service for non-profit organisations and > individuals. 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